Techagappe 25th Edition (October-December 2020) Ebook by Techagappe

Vol.6 Issue 1

OCTOBER - DECEMBER 2020

THE DIAGNOSTICS NEWS JOURNAL

Published at Agappe Diagnostics Limited on October 01, 2020 | 62 Pages | ` 20

AGAPPE IN THE FOREFRONT OF THE BATTLE AGAINST COVID-19 WITH INDIGENOUS SOLUTIONS

EDITION

Mr. Thomas John

Vaccines

COVID-19 VACCINE DEVELOPMENT CHALLENGES GALORE Prof. Dr. D. M. Vasudevan

IF EVERYTHING GOES WELL, VACCINE WILL BE READY BY EARLY 2021 Dr. Soumya Swaminathan

RACE AGAINST COVID-19 THE ROLE OF LABORATORY PHYSICIANS Dr. Barnali Das

PREGNANCY DURING COVID-19 AFFECTS MOTHER AND BABY? Dr. Lavanya Kiran

SUDHARYA DIAGNOSTICS STRONG ADVOCATE OF AGAPPE PRODUCTS

COVID - 19

Mr. Ameer Ali

CHALLENGES DISCUSSING THE CHALLENGES AHEAD TO ERADICATE CORONAVIRUS DISEASE 2019

HAVE YOU RECEIVED TECHAGAPPE (24 t h EDITION)

COVID-19 (Season 1)

SCAN THE QR CODE TO CONNECT WITH US 02

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OCTOBER- DECEMBER 2020

www.agappe.com

3 Part Differential Hematology Analyzer

3Throughput of 60 samples per hour 320 parameters + 3 histograms 310.4” touch screen display 3Real time reagent inventory 3Intuitive software 3Memory of 35,000 sample results with histogram

+91 9745794444

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OCTOBER - DECEMBER 2020

CONTENTS ○

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Volume 6 | Issue 1 | October-December 2020 ○

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The Great Covid Warriors

12-15 Covid-19: Vaccine DevelopmentChallenges Galore 16-19 Adding New Dimensions to Selfless Social Service - Story of a Chennai Youth 20-22 If everything goes well, Vaccine will be ready by early 2021- Chat with Dr. Soumya Swaminathan -WHO

08-11

36-39 AGAPPE IN THE FOREFRONT OF THE BATTLE

AGAINST COVID-19 WITH INDIGENOUS SOLUTIONS 44-46 Pregnancy During Covid-19: Affects Mother and Baby?

THE STORY OF A COVID-19 INFECTED JOURNALIST 24-27 Covid-19: Current Trends in In-Vitro Diagnostics 28-30 Role of Laboratory Tests in Covid-19 Prognosis 32-34 Race against Covid-19: Redefines the role of Laboratory Physicians 40-42 Sutharya Healthcare and DiagnosticsOne of Kerala’s Pioneers in Professional Diagnostics - Interview

52-54 Health Tips 55 Testimonials 56-57 Covid-19: Antigen Test Using Lateral Flow Immunoassay

48-51

THE AGONY AND ECSTASY OF A COVID-19 INFECTED NRI AND HIS EXPECTANT WIFE

Views and opinions expressed in this magazine are not necessarily those of Agappe Diagnostics Limited, its publisher, or editors. We do our best to verify the information published but do not take any responsibility for the absolute accuracy of the information. We do not take responsibility for returning unsolicited material sent without due postal stamps for return postage. No part of this magazine can be reproduced without the prior written permission of the publisher. Techagappe publishers reserve the right to use the information published herein in any manner whatsoever. Caution: After going through the techniques, procedures, theories, and materials that are presented in Techagappe, you must make your own decisions about specific treatment for patients and exercise personal/professional judgment for further clinical testing or education and your own clinical expertise before trying to implement new procedures. Contact info: The Manager-Corporate Communication, Agappe Diagnostics Limited, “Agappe Hills”, Pattimattom P.O., Ernakulam district , Kerala-683 562, India. www.agappe.com Contact: Ph: + 91 484 2867065, Mob: +91 9349011309. Published from Agappe Diagnostics Limited, “Agappe Hills”, Pattimattom P.O., Ernakulam district , Kerala-683 562, India. Contact: Ph: + 91 484 2867000, Fax: + 91 484 2867222; Printed at Five Star Offset Printers, Nettoor, Cochin-40, for Agappe Diagnostics Limited Printed and Published by Ms. Meena Thomas on behalf of Agappe Diagnostics Limited and Printed at Five Star Offset Printers, Nettoor, Cochin-40 and published from Agappe Diagnostics Limited, “Agappe Hills”, Pattimattom P.O, Ernakulam district, Kerala-683 562. Editor is Ms. Meena Thomas.

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From The Chief Editor’s Desk

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THE DIAGNOSTICS NEWS JOURNAL

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edition of TechAgappe. It is a landmark in the growth of this publication. During the last 6 years of its existence, I am happy to report that this magazine is being regularly published every 3 months. As the whole world is passing through the dreaded pandemic, it is appropriate that last edition as well as this edition project Covid-19 disease. We understand the need of inspiring stories and scientific articles in connection with this pandemic. That is why we are dedicating this edition for Covid-19 patients. In this issue, we have included three medical articles, three live stories, and two interviews with eminent personalities, two technical articles and a few health tips. th

In the medical articles section, we have included three articles. The first one is from my desk, giving an overview on the work on Covid 19 vaccines. The second article from Mumbai explains the important role played by the laboratory medicine during the Covid era. The third article from Bangalore explains the precautions to be taken by pregnant ladies during this pandemic.

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In the live story session, the first story is from Delhi, where a journalist got Covid-19 infection during his routine job assignments, and then undergone the brutal manifestations of the disease. The second story is from Chennai depicting the life of a Covid-19 warrior. The third story is from Kasaragod, illustrating the pathetic story of the victim of a fake news. In addition, we have included two interviews to share their contributions to the society. The first interview is with Dr. Soumya Swaminathan, who was Director-General of Indian Council of Medical Research (ICMR) and is now Deputy Director-General for Programmes and Chief Scientist of World Health Organization (WHO). The second interview is with one of our customers, the CEO of the Sutharya Healthcare and Diagnostics where he explains his happy association with Agappe. In the technical session, we have reproduced an article published in an international journal. This work was carried out by the R&D (Reagent) team of Agappe. This publication deals with the recent trends of IVD diagnostics in connection with Covid pandemic. The second technical article is about Antigen Testing of Covid-19. We have included a few health tips explaining the best diet guidelines to prevent and manage Covid-19. Due to lockdown restrictions, we could not print hard copies of the last two editions (23rd and 24th editions) of TechAgappe, and consequently we could not distribute the printed copies. However, we published these editions in time online and eagerly read by our passionate well-wishers. I am also pleasantly surprised to see that we have received very good feed backs and great appreciating letters for the previous issue.

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EXECUTIVE DIRECTORS Meena Thomas Sangeeta Joseph Mary Baby Meleth Prof. Dr.D M Vasudevan

I am proud to bring out this 25

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MANAGING DIRECTOR Thomas John

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CHAIRMAN Prof. M.Y. Yohannan

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BOARD OF DIRECTORS

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PHOTOGRAPHY Nelson Thomas

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DESIGN AND LAYOUT M T Gopalakrishnan www.dezigncentre.com

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PUBLISHING COORDINATOR Jayesh Kumar

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LEGAL ADVISORY BOARD Adv. Denu Joseph

EXPLORING THE PANDEMIC COVID-19 (SEASON-2)

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EDITORIAL ADVISORY BOARD Vikram Tandon Dr. C S Satheesh Kumar Abraham K C Varghese George Sanjaymon K R Sankar T S Bintu Lijo

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CONSULTING EDITOR Saj Mathews

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CHIEF EDITOR Prof. Dr. D M Vasudevan

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EDITOR Meena Thomas

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EDITORIAL BOARD

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Volume 6 | Issue 1| October-December 2020 ○

With warm personal regards

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Subscription-For subscription queries, write to techagappe@ agappe.in or call us at +91 484 2867065. Permissions-For permissions to copy or reuse material from Techagappe, write to techagappe @agappe.in Letters to the editor-Email: techagappe@agappe.in Postal address: The Manager-Corporate Communication, Agappe Diagnostics Limited, “Agappe Hills”, Pattimattom P.O., Ernakulam district, Kerala-683 562, India. Advertisement QueriesEmail: techagappe@agappe.in

I am glad to state that we are about to launch a new website where Techagappe will be well-exhibited for the convenience of our online readers.I personally thank all the readers for their continued support. Your constructive criticisms to improve the contents will be greatly appreciated.

Dr. D.M. Vasudevan

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OCTOBER - DECEMBER 2020

VOICE OF READERS

Exceptional in Lab Diagnostic Industry

Power of printing media is proven Hats off you dear Team Techagappe for such a wonderful magazine. In today’s life, so many medical advancements are happening. But the progress of medias by which news are getting circulated is not appreciable. Here comes the importance of Techagappe. We are very happy to realise that the power of printing media is proven when reding such a magazines where all type of people irrespective of their profession, gender and interest would be benefitted. You are requested to keep us in regular subscription list. Wish you all hearty blessings to continue this great mission. S. Sarkhel, Director, CINPS, Kolkata.

Helpful for Ayurvedic Students We are very much impressed with your magazine ‘Techagappe’. Our ayurved ic students are very much eager to read its content. Through magazine is based on Allopathic medicines, the latest updates are clearly communicated in each and every edition which will be useful to approach diseases from Ayurvedic view.. Life story sessions are quiet interesting. Great Job Done by Agappe team. Good Luck. Shreya Das, Lecturer, Maria Ayurveda Med ical Col lege, Kanyakumari.

TECHAGAPPE

Techagappe is exceptional in lab diagnostic industry. Being an administrator of a laboratory, we found it very useful to update our knowledge especially when it comes to technical articles which is coming under good laboratory practise. All the other stories are also good and worth to read. Most prominent feature of your magazine is discipline you keep in presenting all the content which is very appreciable. We would also like to inform you that our address has been recently changed, we are informing it for not to miss any valuable editions. K. K. Das, Amrita Laboratory, Coimbatore.

Physiological boost to the depressedsufferers We are highly thankful for having spread your most precious valuable information through Techagappe journal. Every issue is placing more valuable details useful not only to the doctors, but also to the patients. Beside clinical advice, your journal is inculcating lot of encouragement and providing morale support to those suffering from the ailments. The language being lucid and information being comprehensive, even a lay man can easily understand the information you are placing. The life story sessions are very impressive and provide physiological boost to the depressed sufferers. We would like to hear your opinion whether this type of

OCTOBER - DECEMBER 2020

treatment is at the reach of the common man. Ramana, Bless College of Nursing, Tirupati.

Business Deals which Noble Missions Hats off to Team Techagappe, Very proud to declare that I am a regular reader of Techagappe news journal. By your latest edition, I have come to know that Agappe is celebrating their silver jubilee. We are delighted to know your business deals which has a certain noble missions. Divine love is always precious and you ensure your words in quality and innovations. May god bless you all to serve the public. Regarding magazine, congrats to the entire team for your excellent presentations in all the way. Here asking you a support. I would like to know the methods/tests to confirm the presence of Mycobacterium leprae in wound discharges or tissue biopsy of non-healing ulcers or osteomyelitis bones or cutaneous nerves. This could enable me to proceed with treatment. Kindly

guide me in this juncture and expecting an article about this topic in future editions. Thanks to you in advance. Dr.M.Pasupat hi.,

M.Ch.,

Erode.

Salubrious Content in Lucid Language Very happy to receive your magazine. Since each edition is published with specific cover stories, it is easy to order book in our library and concerned departments can easily use its content for educating their students. Other articles like health tips and life stories are good and excellent parts of the magazine. It provides a charming effect to the analysing habits of readers. Nicely presented and lucid language is the essence of easy reading from an ordinary man’s view. The entire team deserves a sincere pat. Keep going with this great effort. Dr. Kamlesh Kumar Tanwani, J L N Hospital, Ajmer

Splendid Life Stories and Awesome Articles

I am receiving your magazine regularly and I am very happy to inform you that the life story session is great and the medical articles are awesome. Many persons get support and ample motivation from this journal. Hope you can continue with same spirit and quality. All the Best. Dr. S B Lal Mittal, Ex-National Vice President (IMA)

Cover Story

Poem on COVID-19

Corona, descended as balancing force of our Nature, as undisputable from time immemorial Slaying innumerable human beings on earth barbarous, chal lenging humankind merciless Itâ&#x20AC;&#x2122;s our own Health professionals, with the noblest hearts, ever this century witnessed Clad in total PPE covering al l over the trunk, face and head covered airtight secure The true angels of this world, Florence Nightingales, ladies with the lamp, toiling Pharmacist, technicians & assistants work in unison with Covid plans, boiling Health workers, the ignoble unlucky Samaritans of the Corona, suffering Crews of ambulances flying day-night without food & sleep, struggling Our clinicians ral lying ward2ward & ICUs in perpetuum, saving jil lions The tribulations, sacrifices, hardships, breathless, sleepless nights & days Endangering own lives, families & health, al l always work in total ad herence The ever great towering force behind whole Covid management and mitigation Let the whole world salute and grossly obliged to these dedicated health workforce For their unprecedented, unparal lel and the unexampled commitments for our welfare, Hats off to our Corona warriors across the world, working with no complaints & clamours, Whole humanity is deeply indebted to these gemstones of our cosmos, salute great saviours

Dr. Satheesh Kumar C.S, Senior Vice President, Supply Chain Management,

TECHAGAPPE

AGAPPE

OCTOBER - DECEMBER 2020

Agappe MD’s Desk

AGAPPE IN THE FOREFRONT OF THE BATTLE

AGAINST COVID-19 WITH INDIGENOUS SOLUTIONS Thomas John, Managing Director, AGAPPE

Life is not going to be the same again. We are still under the grip of Covid-19 pandemic and the situation calls for significant indigenous initiatives in the medical field and especially the diagnostics segment for building a self sustaining offensive against the pandemic. Against this backdrop we at Agappe are proud that we have joined the nation’s fight against Covid-19 with a host of innovative indigenous diagnostics solutions, which are the need of the hour for making ‘Atmanirbhar Bharatto’ a reality. Let us together proactively fight this pandemic for a better tomorrow even as we are moving through one of our darkest days.

he year 2020 has changed our way of functioning to a different level. We have adapted to the new normal post COVID scenario and the changes that we have adopted to incorporate into our functions are slowly getting familiarized. COVID-19 has spread throughout India and has affected us severely. We are at present is the second most infected country in the world. This has catapulted us to a situation where we have to be self-reliant and self sufficient for our basic needs. It’s a true necessity at this time of our history. The COVID19 is wreaking havoc to the concept of Global Village as the travel restrictions are imposed throughout and travel as such is considered as a risk.

Thomas John

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All these changes have pointed us to the necessity of being self-reliant and self sufficient in all our means. The resolve to pave way for an ‘Atmanirbhar Bharatto’ has made India stand tall among the nations especially as our country is an important part of the global economy. We aim to pursue strategies that are efficient, competitive and resilient. A policy that moulds us to be selfsustaining and self-generating rather than forcing us to be a protectionist or isolating away from the world is the need of the hour. Our paths to be Atmanirbhar or self-sustaining was envisioned since our inception and has been in our DNA ever since. This has helped Agappe to design, develop and launch our range of equipment and Reagents for the Indian market. The success of these products has made their presence felt in many other developing countries as well. Supported by our three quality pillars of Quality, Innovation and

Affordability, we have been able to address the Atmanirbhar need of Indian market for many our products. Path-breaking Initiatives by Agappe In the year 2011, Agappe launched the first semi-automated protein estimation system in Ind ia, a time when protein estimation was not so common. The importance of protein estimation came to limelight when COVID-19 pandemic affected globally and we are proud to support more than 10,000 laboratories in India and other developing countries with our i-series range of instrument and CRP, D-Dimer and Ferritin Mispa Count X Launched by Mr. Thomas John, Managing Director-Agappe Diagnostics Ltd. assays. Today we are proud in middle. Dr. D M Vasudevan, Technical Director-Reagent on extreme left and Ms. Meena to have a series of instruThomas, COO, left to Mr. Thomas John, Mr. Varghese Ouseph, Associate Vice President R&D ments in protein estimaEquipment on right from Mr. Thomas John and Dr. C S Satheesh Kumar, Sr. Vice President tion from Semi-automated Supply Chain Management, Agappe on extreme right. to ful ly automated platforms installed across the globe counting to more than 15,000 installations. engineering services company for developing the 3-part HeHematology Segment was identified as the most complex of matology Analyzer. This R&D partnership with Agappe- L&T the segments due to the engineering complexity in the Analyzer. Technology Services has lead to the design, development and Indiaâ&#x20AC;&#x2122;s dependence on import for the 3-part and 5-part analyzer commercialization of the first indigenously engineered 3-part was reflected in most socio-political scenarios with a dearth in hematology analyzer Mispa Count X. Mispa Count X is the first availability of these instruments whenever an issue arises in the among the array of instruments in hematology segment and international forum. Aiming to provide a solution for this non- we have planned a range of Hematology systems in the X Seavailability we have entered into an alliance for Hematology R&D ries to cater to the different customer segment in India and in 2015 with L&T Technology Services a leading global pure-play other developing countries.

Hematology Segment was identified as the most complex of the segments due to the engineering complexity in the Analyzer. Indiaâ&#x20AC;&#x2122;s dependence on import for the 3-part and 5-part analyzer was reflected in most socio-political scenarios with a dearth in availability of these instruments whenever an issue arises in the international forum.

Out of the 55,000 laboratories in India more than 40,000 laboratories are in the Tier-II & Tier-III segment covering the rural population with limited access. In India more than 67,000 dengue cases are reported in the year 2019. Since the platelets count may go to very low levels in case of Dengue infection, a continuous monitoring is the key factor for survival. National Rural Health Mission (NRHM) seeks to provide an equitable, affordable and quality healthcare to the rural population, especially the vulnerable groups. Hematology cellular analysis is a useful tool for these programs. The penetration of Complete Blood Count in rural areas will help to assess the prevalence of various anemia (which is one of the major concerns in India) among the rural population and its controls which is an objective of the NRHM. An affordable and accurate three-part hematology analyzer is the need of the hour which has been addressed by the Mispa Count X.

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Agappe MDâ&#x20AC;&#x2122;s Desk Mispa Count X has undergone tremendous validation protocol where the analyzer is validated against Sysmex systems from Japan and Beckman Coulter systems from US for correlation of the results. Hematology is the branch in the IVD where the morphology and count of the blood cells are analyzed for the diagnostic purpose. Blood morphology is depended on the races and India is a country of diversity with different races predominant in the south, north and north east. We have validated Mispa Count X against the different geographical population in India to have a unique algorithm which is well suited for the population in India and neighboring countries. This has helped to create an instrument that helps to address solution with an innovative, quality and affordable solution in hematology to the common man so that the healthcare needs of the masses can be addresses with ease. Agappe Joins the Covid 19 Battle Joining our ongoing fight against the COVID scenario, we at Agappe have equipped ourselves with the needed arsenal to stand our ground. Studies show that parameters like CRP, D DIMER and FERRITIN are used to indicate the prognosis of COVID-19 infection. The C-reactive protein (CRP), serves as an early inflammation or infection marker, a drastic increase in CRP values was observed in severely ill patients with COVID-19, by up to 50,000 times in acute inflammation. CRP starts exhibiting raised levels within 6 hours and peaks at 48 hours. Ferritin is an iron storage protein that represents the primary source of reserve iron in each cell. However, increased serum ferritin concentrations can also be suggestive of conditions not related to iron storage, such as severe inflammation. Therefore, IFCC has recommended monitoring of serum ferritin levels for COVID-19 management. D-

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Mispa-i series specific protein analysis with gold standard Rate Based Nephelometry is a leading solution provider for Covid-19 prognosis. Within a decade of time, our flagship models Mispa-i2 and Mispa-i3 changed the game for specific protein testing. dimer is one of the protein fragments produced when a blood clot gets dissolved in the body. D-dimer tests are used to help rule out the presence of an inappropriate blood clot (thrombus). The triggering of host inflammatory reactions also results in increased production of inflammatory cytokines that activates coagulation process. D-dimer levels correlate with disease severity and are a reliable prognostic marker for in-hospital mortality in patients admitted for COVID-19. We have taken the needful steps to cater to this large demand of these parameters for the Indian markets. Backed by our stateof-the art facility in Kochi we are able to produce 1,20,000 kits per shift per month which can cater to the reagents demand. The Mispa i-Series range of equipment is also a leading choice for the prognosis of COVID. Mispa i-series specific protein analysis with gold standard Rate Based Nephelometry is a leading solution provider for the COVID prognosis. Within a decade of time our flagship models Mispa i2 and Mispa i3 changed the game for specific protein testing. At present, we have more than 8500+ installations globally. With an assay panel that offers 25 parameters with bet-

LTTS - AGAPPE : PARTNERS IN AFFORDABLE HEALTHCARE

Healthcare technologies have continued to make

rapid strides over the last decade, but affordable healthcare services are yet to reach the masses in developing nations, such as India. One of the key areas that need greater coverage is hematology, and in particular, in-vitro diagnostics owing to the high cost of the devices. Currently such high-end equip ment is imported and hence very costly. The idea behind the Agappe-LTTS initiative was to make advanced healthcare affordable and accessible to all. It was important to understand the requirements, their inter-linkages, and complexities, and turn them into actionable design inputs. The plan was simple though – design a holistic yet compact blood analysis device that was affordable but didn’t compromise on quality. It may be noted that the need of the hour is to design and develop in India, state-of-the-art hematology devices that are highly accurate and affordable. The whole idea is to reduce the capital cost of acquiring and installing such devices for rural healthcare centers, and thereby, extend standard hematology diagnostic services to those regions.

Thomas John (Managing Director) and Meena Thomas (COO & Director) Agappe with Shri A.M. Naik, Group Chairman, L&T

ter sensitivity and linearity that ensures flexibility in laboratory testing with marginal investment. Mispa i2 and Mispa i3 comes with smart card calibration technology which avoids reagent wastage and calibration errors, thus offering reliable results. Product launch of Mispa CXL Pro in July is an answer to the COVID prognosis in the Clinical Chemistry with its focus on the CRP, Ferritin and D-Dimer parameters. It’s an entry level fully auto Biochemis-

The onset of large number of cases being reported, Kerala has recently started its first dedicated Covid-19 prognosis center at Government Covid Apex Centre PVS, Kochi to monitor the patients for a better screening and diagnosis. We have placed our Mispa Clinia Plus and Mispa Revo at this Centre for free of cost.

try analyzer, capable of a through-put of 180 tests per hour. A compact and sturdy instrument, this product is best suited in equipping our rural and sub-urban regions with the ability to cope with the increase in volumes of Covid 19 cases that may arise in this Pandemic Era. Let’s Fight it Together The onset of large number of cases being reported, Kerala has recently started its first dedicated COVID prognosis center at Government COVID Apex Centre PVS, Ernakulam to monitor the patients for a better screening and diagnosis. We have placed a Mispa Clinia Plus the clinical chemistry automation system in 400 test per hour segment and our Mispa Revo, animmunofluorescence based POC (point of care) testing device for assays like Procalcitonin (an assayused for Sepsis diagnosis), at the Govt. COVID Apex Centre PVS, Ernakulam, free of cost. We are also providing reagents free of cost, for our three-part haematology analyzer, BC 3000 plus, at the center. With these contributions to the nation’s battle against Covid 19, we are proud to say that we are holding to the infinite hope of a better tomorrow even as we are moving through one of our darkest days.

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Cover Story COVID-19 - Vaccine Development

COVID-19

VACCINE DEVELOPMENT Prof. Dr. D M Vasudevan,

CHALLENGES GALORE

MBBS, MD (Biochem), FRCPath, Technical Director, AGAPPE

In December 2019, a new disease, named as Covid-19 (abbreviation of Corona virus Disease 2019) emerged from Wuhan, China. It has been recognized as a pandemic by WHO, affecting almost all the countries of the world. The first case of the disease was reported in India from Kerala on 30 January 2020. This article presents an overview of this pandemic and discusses the various preventive measures and treatment procedures besides providing an update on the hectic efforts to find a vaccine for Covid-19.

The world continues to be under the grip of the Covid 19

pandemic even as efforts to develop an effective vaccine to fight the disease are on a fast track. However, the challenges to bring out a safe vaccine after proper clinical trials are many. However, such a vaccine is well on the way if the encouraging reports of the ongoing efforts by various countries and organizations are any indication. A new type of pneumonia was detected in the Wuhan Province of China, in December 2019 and the disease was named as Coronavirus 2019 (Covid-19). The virus producing this dis-

ease is named as Sars-CoV-2. The disease is a pandemic affecting all countries of the world. Since there are no effective drugs available, developing an effective vaccine to fight the new disease could be our only ray of hope. As on the last week of August 2020, there are 231 vaccines under various stages of development. About 19 are in phase 1 and 2 clinical trials, while 6 are in phase 3 trial. However, till the end of August, no vaccine has completed clinical trials. Of the candidate vaccines, about 70% are being developed by private companies, with the remaining projects under development by academic, government coalitions, and health organizations. It is hoped that vaccine may be available for the general public by the end of this year. Previous works to develop a vaccine against the coronavirus diseases (SARS and MERS) established considerable knowledge about the structure and function of coronaviruses. Further the genetic sequence of the Covid-19 virus was published in January 2020, which hastened the development of a vaccine.

Technology Platforms Ten different technology platforms are available to produce vaccine against Covid19. These are

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based on DNA, messenger RNA, non-replicating viral vectors, peptides, and recombinant proteins, live attenuated viruses, and inactivated viruses. When a vaccine is injected, a harmless virus or a part of that organism is introduced into the body. The bodyâ&#x20AC;&#x2122;s defence system (known as immunological system) recognises the invader and learns how to fight them. After a few months, when the natural virus enters, the body already knows how to fight it, and so virus could not produce the disease or it could generate only a mild disease.

A vaccine for an infectious disease will usually take many years to develop, as it has to undergo various stages. The preclinical study or the challenge study begins by testing a vaccine candidate for immunogenicity and safety in laboratory animals. If the animal studies are promising, then human studies can be started.

The main method of vaccination for decades has been to use the original virus. For example, the measles, mumps and rubella (MMR) vaccine is made by using weakened viruses that cannot cause a full-blown infection. Chinese scientists mainly adopted this approach. Because the genetic background of the new coronavirus, Sars-CoV-2 is already known, the researchers from Oxford have put small sections of its genetic material into a harmless virus that only infects chimpanzees. This is a safe virus that looks enough like the coronavirus to produce an immune response. Other groups are using pieces of genetic material (either DNA or RNA) which once injected into the body, should start producing bits of viral proteins which the immune system can learn to fight.

The Challenges Aplenty A vaccine for an infectious disease will usually take many years to develop, as it has to undergo various stages. The preclinical study or the challenge study begins by testing a vaccine candidate for immunogenicity and safety in laboratory animals. If the animal studies are promising, then human studies can be started. Hu-

The World Health Organization has established guidelines for conducting Covid19 vaccine studies in healthy people, including scientific and ethical evaluation, informed consent of the participants, and monitoring by independent experts.

man studies should undergo phases 1, 2 and 3 in that sequence. The phase 1 trials test safety and dosage in 10-15 healthy subjects. Following success in Phase 1, the phase 2 starts in a few hundred people, where dose levels and adverse effects of the candidate vaccine are studied. Phase 2 trials are typically randomized, placebo-controlled. If these tests are promising, the study proceeds to understand the effective dose into a large-scale Phase 3 trial in previously-uninfected, volunteers (young adults), who would then be deliberately infected with Covid19 for comparison with a placebo control group. Phase 3 trials will determine the effectiveness of the vaccine to prevent the disease while monitoring for adverse effects. Optimal dose is also studied. The World Health Organization has established guidelines for conducting Covid19 vaccine studies in healthy people, including scientific and ethical evaluation, informed consent of the participants, and monitoring by independent experts. Many vaccine candidates in preclinical development will not gain approval for human studies due to toxicity or ineffectiveness to induce immune responses in laboratory animals. The probability of success for an infectious disease vaccine candidate to pass preclinical barriers and reach Phase 1 of human testing is only 50%. The success rate of obtaining approval for Phase 3 trial was only 10% for vaccines. During the development process, various parameters such as the efficacy and toxicity of the vaccine, the duration of vaccination protection, route of vaccination (such as oral, nasal, subcutaneous, intramuscular), dose regimen, and storage characteristics, optimal manufacturing for scaling to billions of doses, and dissemination of the licensed vaccine are

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Cover Story COVID-19 - Vaccine Development to be studied. Further, population subgroups, such as the elderly, children, pregnant women, and people with existing weakened immune system are to be carefully evaluated. Host-related determinants that render a vaccine ineffective are genetics, underlying diseases, malnutrition, elderly (above age 65) and hypersensitivity. These persons may require separate vaccine technologies or repetitive booster vaccinations. Further, mutations of the virus can alter its structure targeted by the vaccine, thus making the vaccine ineffective.

Compressed Timelines In the haste to provide a vaccine, governments are under pressure to accept a high risk for the vaccine development process. In the case of Covid19, a vaccine efficacy of 70% may be enough to stop the pandemic. An efficacy of less than 60% will not provide enough herd immunity to stop the spread of the virus alone. Vaccine trials take a long time to develop before they are approved for use. Any vaccine which reaches us at this point would carry a certain level of ambiguity and a risk of danger. Much like the controversy that the Russian vaccine (Sputnik V) finds right now, an expedited vaccine approval would mean that there may be many side-effects when introduced to public consumption.

Funding Issues In July 2020, the WHO announced that 165 countries, representing up to 60% of the world population, had agreed to a WHOCOVAX plan for fair and equitable distribution of an eventual

licensed vaccine. The Coalition for Epidemic Preparedness Innovations (CEPI) further agreed to create US$ 8 billion fund to support research on 3 candidate vaccines. The Bill Gates Foundation is donating US$ 250 million in support of Covid19 vaccines. In June 2020, a summit was coordinated among governments of 52 countries, to raise US$ 8 billion to prepare an effective Covid19 vaccine.

Status of Covid Vaccines As of June 2020, six Covid19 vaccine candidates, developed by Chinese organizations are in early-stage human testing. Other promising vaccines are being studied at Pasteur Institute (France), Themis Bioscience (Austria), and CureVac (Germany). Vaccine development is also progressing within various companies such as Moderna, Johnson &amp; Johnson, and Sanofi in USA. The Moderna vaccine is now in phase 3 clinical trials. Large pharmaceutical companies with experience in making vaccines, including Johnson &amp; Johnson, Astra-Zeneca, and Glaxo-Smith-Kline (GSK), are forming alliances with governments and universities to accelerate progression to an effective vaccine. Russia, became the first country to grant regulatory approval to a Covid-19 vaccine, (Sputnik V, formerly known as Gam-CovidVac developed by the Gamaleya Research Institute in Moscow. After this announcement, experts have raised considerable concern about the safety and efficacy of the vaccine, as it has not yet entered Phase 3 clinical trials. Israel Institute for Biological Research (IIBR) has developed a vaccine found to be effective in animal models. This vaccine is developed on vesicular stomatitis virus (VSV) (an animal virus that does not cause disease in humans), and in which the spike protein was replaced with that of Covid virus. This vaccine is called recombinant-VSV-G-spike. Now they are beginning human trials for the vaccine candidate they developed. Israel is expected to have safe and effective vaccines by the end of the first quarter of 2021.

Indian scenario In June 2020, the Serum Institute of India (SII) reached a licensing agreement with Oxford-Astra-

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Zeneca to make 1 billion doses of vaccine for low-and-middle income countries including India. This vaccine has been developed by the University of Oxford (Imperial College of London) and distributed by the company Astra-Zeneca. The vaccine is now in phase 3 of clinical trials. The Oxford vaccine will be marketed as ‘Covishield’ in Ind ia. This phase 3 trials of the Oxford vaccine was started by the middle of August 2020 in India. About hundred people have been already vaccinated. The clinical trials will be conducted in 20 centres in India and 1600 persons will be injected. Those who have not been infected by the virus would likely be the first ones to get vaccinated. The healthcare workers and front-line workers should be given priority as initial vaccine candidates. The first batch of doses will be ready for deployment as early as December 2020. Three Indian vaccines are in different stages of development. Oxford vaccine has already been described. Other locally developed vaccines, Bharat BioTech’s Covaxin and Zydus Cadila’s ZyCOV-D, have entered in clinical trials in the month of July 2020. They are showing promising results.

WHO Solidarity Trial The WHO, with a multinational coalition of vaccine scientists, has developed the Global Target Product Profile (TPP), identifying attributes of safe and effective vaccines. The WHO vaccine coalition will prioritize which vaccines should go into Phase 3 clinical trials, and also to implement Phase 3 protocols for all vaccines. This will avoid duplication of research efforts, across its interna-

tional locations. Experts emphasize that licensed vaccines should be available and affordable for people at the frontline of healthcare and having the greatest need. As the elderly or impoverished people are at greater risk, they also get preferential availability for the vaccine. Nonspecific vaccines Assertions have been made that Covid19 mortality has been lower in countries having routine BCG vaccine administered against tuberculosis. But the World Health Organization (WHO) has not accepted this claim. In March 2020, a randomized trial of BCG vaccine began in the Netherlands, recruiting 1,000 healthcare workers, and another randomized trial in Australia enrolling 4,170 healthcare workers. Such works are going on in Columbia, Brazil, France, Greece and South Africa. In June 2020, a randomized placebo-controlled trial to test whether the measlesmumps-rubella vaccine (MMR) can protect healthcare workers from Covid19 began in Egypt.

When Will We Have the Vaccine?

A vaccine would normally take years, if not decades, to develop. Regarding the Covid infection, researchers hope to achieve the same amount of work within a few months. It is not yet known if it is possible to create a safe, reliable and affordable vaccine for this virus. It is possible that billions of dollars could be invested without any success. Similar to the development of the first polio vaccine that was never patented, an effective Covid-19 vaccine would be available for production and approval by a number of countries and pharmaceutical manufacturing centers worldwide, thereby allowing for a more even and cost-effective distribution on a global scale. Most experts hope that a vaccine is likely to become widely available by mid-2021, about 12-18 months after the new virus first emerged.

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Life Story Hari Krishnan

ADDING NEW DIMENSIONS TO SELFLESS SOCIAL SERVICE,

STORY OF A CHENNAI YOUTH Selfless service of a few individuals is a ray of hope for humanity during these pandemic days. Apart from the noble services of doctors, nurses and health care workers, a set of social workers and volunteers in different parts of the country helps to restore the faith in the humanity in this critical times. This is the story of 27 year old Hari Krishnan from Chennai who had been doing and still doing a remarkable job, volunteering to serve the migrant labourers and other destitute in the city of Chennai in India.

ll social workers are not born rich. A few are rich with a heart full of kindness to poor. Hari Krishnan belongs to that category. He hails from a middle class family. His father was a daily wager and Hari Krishnan and his sister did their studies mostly in government institutions. “Till Grade 12, my tuition fee per year was Rs.50 in that institute. But sometimes even to make it, we had to struggle. If you fail to pay the fee within the prescribed time, they wouldn’t allow you to sit in the class. Every year, it was ‘customary’ for me to attend the class from outside for a month or so. Yet that helped me to know the value of money. I started to work from Grade 5 onwards to make both ends meet. Also, I didn’t want to disturb my parents in their struggle to run the house. My first job was delivery of newspapers in the early morning. The monthly pay of Rs.150 helped me to buy other things like books, pencil or pen,” he recalls. In 2009, he finished his Grade 12 and it was the same time his father lost his job after the shop he worked had to close down. His mother who had certain health issues couldn’t go outside for a job. So, Hari had to take a break from his studies to run the family. He took up a marketing job with an insurance company. His salary was Rs.4500, provided he achieved the target. Out of this income he had to take care of his family and save enough to continue his studies from next year onwards. Aneesh K.K.

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The struggle for survival After one year when things at home become a bit more stable, Hari went back

to pursue his education. He joined a private institute for BSc Computer Science. His college timing was from 7AM to 1PM. “From 2PM to 7.30PM I worked with a courier company. From 8.30PM to 11.30PM I went to a parcel office as my second job. By early morning I returned home to get some sleep only to repeat the chain. When my friends say let’s go for a dinner outside or for a stroll in the beach, I had to excuse myself as I had to earn to support my education,” he says. Soon after completing college, he got a job with a tele marketing company. In a short span of time, he got promoted as a Team Leader. After a year, he joined an IT company as a BusiHari Krishnan giving training to social workers to manage Covid-19 in Chennai ness Development Manager which was mainly into developing websites. He was just 24 years ment against women. “To be frank, I went for the event only old when he became the Sales Head of the company. Even then he because so many people were going. I thought of posting about had been continuing his job as a newspaper delivery guy because it the social media after clicking a selfie. However at the event he knew the value of money. I realised the intensity of the situation. Harassment against women must not be tolerated. I was also inspired by the people Tryst with Social Service there,” he says. Hari Krishnan’s first brush of humanitarian service was durAfter that Hari began to involve more in social service acing the floods of 2015 that severely hit Chennai. By then they had tivities mostly during weekends. He used to participate in acshifted to Madipakam from Saidapet as they couldn’t afford the tivities like clean up and painting activities of a beach or public high rent at the latter. During the flood, the water level reached up spaces along with awareness programs. He was a Mime artist to the first floor of their flat in Madipakam and it was some unand it proved to be a helping hand in creating awareness among known people who came and saved them. the public and in the orphanages. For a brief tenure he was In 2016, Swathi murder case at Nugambakkam railway station also associated with an NGO. “I realised that even with an had received huge media attention. Weeks later, there was an eventorganisation or NGO for your support, you still have limitaa wal k organised to create awareness among people on harasstions in doing social service. So I focussed on creating leaders who can train people under them to take social service to more and needy people. Thus I started my journey as an inde“We stayed there for almost three pendent social worker in 2017,” he adds.

months. Within these three months, I had put all my savings for the rehabilitation process. My business was also suffering as I wasn’t available in Chennai. I realised the fact that you can serve the public only after taking care of your own family. That made me put the attire of an employee again’’.

Twists and Turns Back in 2016, Hari quit his job and started his own business venture as a branding and business consultant. In 2018, he launched Hasu Group of Companies- a branding and marketing firm. “We have trained more than 1000’s of entrepreneurs in Chennai along with 16,000 sales and marketing staffs. We have also developed more than 500+ brands in Chennai,” he says. In 2018, Gaja Cyclone hit Tamil Nadu. Since his team of volunteers was operating at Pudhupettai he went to check how they were progressing. But then he realised that several people had lost their lives and that they should help the people

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Life Story Hari Krishnan were very happy. Now his thought was about people who had no means to support themselves or their families especially those of differently abled persons. He contacted a few organisations and made a list of families that hadn’t received any help since the lock down began. From April 2020 onwards, he adopted some 254 families and supported them with his own savings. He still continues it even though it means he has to take a loan pledging his jewellery or spending his entire savings set apart for his marriage. Hari Krishnan had also wrote letters seeking attention of government officials for taking care of the people who lost jobs during the lock down Hari Krishnan on Covid-19 duty during lock down period especially people who are differently abled since he couldwith the rehabilitation process. “We stayed there for almost n’t take care of all. The letters got the attention of the government three months. Within these three months, I had put all my officials and they asked if he could volunteer to help the migrant savings for the rehabilitation process. My business was also labourers in the Chennai city. Hari Krishnan was more thanhappy suffering as I wasn’t available in Chennai. I realised the fact to do so and he was given one Zone of Chennai Corporation to that you can serve the public only after taking care of your own completely take care of. Within three days a volunteer team of 25 family. That made me put the attire of an employee again. This under Hari Krishnan distributed 890 government kits to the mitime it was a real estate portal and my designation was Senior grant labourers and families. Earlier the government officials could Manager for Chennai region. I still work with them and it helped distribute only 1000 kits that too taking a time of one month. So me to get a house of my own at my locality Saidapet. Although government officials asked me if he could take up the responsthe burden of housing loan still lingers on my head, I was ibility of all 15 zones of Chennai Corporation. “Thus I was appointed happy to get a home at my native place itself. I also began to as Chennai District Volunteer Coordinator. I could help more than save money for my marriage,” says Hari. 10,000 of migrant workers in Chennai during the lock down apart from the 2000 Tamil families,” says Hari brimming with proud.

The Challenging Days of Covid-19

The arrival of Covid 19 and the subsequent lock down announced by the Prime Minister made Hari to enter social service more enthusiastically. Like everyone, he too stayed indoors initially. His company allowed them to work from home. On March 26, 2020 he got a call from an orphanage. They told him that they were facing some medical emergency issues. Few of the kids were not well. They weren’t able to get medicines now. They shared the prescription online and he bought the medicines which cost around Rs.1500. The lockdown was in place and the only time they could go out was between 7AM1PM for emergency issues. When he went to deliver the medicine, he found out that they had scarcity of grocery items too. Immediately he went out and purchased few grocery and provisions for them. They

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AGAPPE DIAGNOSTICS SALUTE ALL THE COVID WARRIORS

We, Agappe Diagnostics, salute public health workers

who are playing an important role in responding to this pandemic. We appreciate essential frontline workers, including doctors, lab technicians and ASHA workers, who have been at the forefront of the battle against the coronavirus disease and the members from the police force that played a crucial role in the enforcement of lockdown restrictions and individuals from different organs of the public departments and the people keeping services like sanitation, food service, public transit, online schooling and many more, for their efforts in curbing the spread of Covid-19 in the country.

Another challenge they faced was the issue of migrant families who tried to wal k to their home towns after the trains were cancelled due to lock down. Hari and his team rescued more than 4000 migrant workers who were trying to wal k home during the lock down and provided them with shelter and food. Along with the Chennai Corporation, they were later able to send 1,40,000 migrant labourers back to their respective home towns in Shramik trains. It is estimated that more than 37,500 tonnes of rice and other provisional materials were distributed by Hari Krishnan and his volunteers in the 15 zones of Chennai Corporation to migrant families and needy people. This is also the first time the govern-

ment has appointed an individual for doing so. Usually NGO’s are given these kinds of responsibilities. “Our distribution was well appreciated by government officials after they had done a re-check on those who took the kits. Our mission including the coordination of sending them back in trains was hailed as a huge success. Deputy Commissioner congratulated me for my work. I was given a letter of appreciation from the government for my service. During all these time, in every 15 days I underwent Covid 19 test to make sure that I don’t spread the virus. I insisted my team of volunteers also to do the same,” he says.

Support of Family and Employer When asked about how his parents support his social service activities, he says: “no parents will support if their son is spending his savings to help the poor. My family had no idea that I had a wedding savings and I had spent it on my ‘adopted’ families. They are worried about me but I believe they are equally proud of my work. A few times they had come up with requests to help people around our neighbourhood during the lock down.” He is also quick to note the support provided by his company. “My current employer has been a huge blessing. Without their support, I wouldn’t have been to do any of these.”

Hari Krishnan on Covid -19 duty during lock down period

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Hari Krishnan wants to continue his social service activities in the future too. He doesn’t want to start a NGO for it. “I will continue to do independent social work until I could,” quips him in before signing off.

OCTOBER - DECEMBER 2020

Interview Dr. Soumya Swaminathan (WHO)

IF EVERYTHING GOES WELL,

VACCINE WILL BE READY BY EARLY 2021

A CHAT WITH DR. SOUMYA SWAMINATHAN People are anxious to know when wil l the drug/vaccine arrive. Wil l it be within next 6 months or another year?

Dr. Soumya Swaminathan was most recently WHO's Deputy Director-General for Programmes. A paediatrician from India and a globally recognized researcher on tuberculosis and HIV, she brings with her 30 years of experience in clinical care and research and has worked throughout her career to translate research into impactful programmes. Dr. Swaminathan was Secretary to the Government of India for Health Research and Director General of the Indian Council of Medical Research from 2015 to 2017. In that position, she focused on bringing science and evidence into health policy making, building research capacity in Indian medical schools and forging south-south partnerships in health sciences. From 2009 to 2011, she also served as Coordinator of the UNICEF/ UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases in Geneva.

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Normally a vaccine takes about 10 years for development. If we look historically, Ebola vaccine was developed in 5 years, the Zika in less than 2 years, but by that time the Zika problem was over. We are hoping to break that record also and try and develop a vaccine in under 12 months. That will be an astounding achievement if that happens. The only way it can happen is to have a global collaboration, rather than competition. There were over 100 candidates which were in various stages of development two months back. Of these, 7 were in Phase 1 human testing, including two each in China, USA and Germany and one in the UK. India also has a number of candidates in progressing development. Now, we have at least a few candidates which are in phase 2/3 trials. As this will be a new vaccine, safety is foremost and efficacy against COVID infection needs to be proved. If everything goes well, we may have a vaccine early in 2021. Right from the outset of the pandemic, WHO had started planning the R&D needed to promote the development of therapeutics, vaccines and diagnostics. As this is a new virus, we need to establish and standardize animal model and assays which will be used for vaccine testing. If everyone set up their own system of testing, they will not be comparable, so it is important to standardize that. We track the development of vaccine candidates and update the knowledge base regularly. We have also set up an expert group that looks at the criteria for prioritizing vaccine. You cannot bring 100 vaccines into phase 3. It can be say 2 to 5 at most â&#x20AC;&#x201C; so we have criteria to pick the most promising candidates. We have developed a protocol for a phase 3 vaccine trial which is ongoing now. Similar to the Solidarity trial for drugs, it would be a solidarity trial for vaccines. It would test multiple vaccine candidates against a placebo arm, and enrol in many countries at the same time, thus improving the efficiency and reducing the time needed . We also need to ensure that these vaccines are available to populations everywhere, regardless of their ability to pay. WHO will work with countries and developers to ensure a fair and equitable allocation system. Any prediction based on scientific data about when wil l the curve flatten global ly? There are many hypotheses on why infection rates are low in Africa and India, but there is no clear answer. We see flattening of

the curve in countries where there are robust public health measures like physical distancing etc. As countries lift lockdowns, we have to see how vigorously it rebounds again. That’s the risk, as we don’t know how this virus will behave. It is possible it goes down and stays at a low level, might flair up next winter or its possible that as soon as lockdown measures are lifted, it would increase. But what is clear is that the infection is going to stay with us, as it is already widespread. What the curves will look like, only time will tell. We Ex. Union Minister Sri. Ghulam Nabi Azad presenting the ICMR Kshanika Oration award to have to keep a close Dr. Soumya Swaminathan, at the ICMR awards presentation function, in New Del hi. watch on that. We can see what is happening in those countries which started early. For instance,China, also using digital technology and mobile phones to track people. South Korea and Hong Kong managed to keep new infections at a New infection rates are very low and most of them are travelvery low level. In Singapore, there was a spurt in cases, but it was ers. Those from outside the country are being quarantined for linked to a cluster of migrant workers living in dormitories. What 14 days. is encouraging is that China, South Korea, Taiwan and Hong Kong There have been tal ks that the virus is manufactured vicould bring the curve down and keep it low. They have lifted rus. Is it natural or man-made virus? lockdowns, but they have expanded testing, and still do isolation and quarantining . China used the zoning like India is doing of Available evidence strongly suggests that it had a natural anidividing the areas as red, yellow, green zones. In China, they are mal origin and is not a manipulated or constructed virus. By looking at the genetic sequence, scientists have been able to say this. Most likely it has come from bats as there is similarity between bat corona virus and covid 19. We don’t know if it Available evidence strongly suggests has come through an intermediate host and if so what that host was. Like for MERS we know it was camel for SARS 1, it that it had a natural animal origin and was the civet cat. Here it could be a domestic, wild or domesis not a manipulated or constructed ticated wild animal. We continue to collaborate with Chinese experts and have offered all support to work on identifying virus. By looking at the genetic sequewhat animal it came from and how it spread to humans and nce, scientists have been able to say whether it was one spillover incident or multiple. This understanding will help us for the future in prevention and control. this. Most likely it has come from bats

as there is similarity between bat corona virus and Covid-19.

Do you feel, India can lead the path in drug and vaccine development? Every country can decide how to use these drugs. Our position from the beginning has been that there is not enough

Courtesy to Shimona Kanwar, TOI

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Interview Dr. Soumya Swaminathan (WHO) evidence for prevention or treatment. So we advised conducting high quality research to find out. There are two big multicentric trials which will be done for pre and post exposure prophylaxis using HCQ amongst health care workers and high risk contacts. We propose to pool the data and make recommendations based on those results. As far as India is concerned, ICMR can still study the effectiveness of HCQ. Despite the fact that it has an advisory, there are ways of collecting data from healthcare workers which can give useful information about how effective it was. RCTs are ideal, but in a situation when you are already asking Award was presented at the hands of Shri D S Mehta, President Kasturba Health Society at a people to take it under exprogram organized by the Kasturba Health Society and Mahatma Gand hi Institute of panded use program, then Medical Sciences on 22nd September 2017. you have to col lect data from health care workers. is the response of the WHO? And examine if it was actually useful in preventing the infection. India has the capacity. It has academic centres and good pharmaceutical and vaccine manufacturers. But what it lacks is the capacity for phase 1 trials. Indian companies go out of the country to do those. So India should build that capacity. Even for animal models, many developers go outside India. WHO is providing all the SOPs for animal model. So it should be possible for facilities in India to actually be able to do that also. What is required is partnership between private and public sector and institutes with different capacities,infrastructure and expertise. How could WHO ensure access to protection equipment and overcoming its shortage worldwide? There was a huge global shortage of many of these products, including diagnostic kits and PPEs. What the WHO was doing to resolve the shortage as follows: The DG, WHO had appealed to the G20 trade ministers to ease the transportation of essential commodities including the PPEs and medical equipment and not to have any trade restrictions. The UN task force was looking at the supply chain mechanism that involves negotiating a price with the manufacturers and procuring large quantities. This was picked up by different agencies which sent it to those countries that need it. The WHO has been accused of mismanagement and as a fal lout the US withdrew its funds to the organization. What

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We regret the decision of the US. The US has been a long-standing supporter and generous friend to the WHO â&#x20AC;&#x201C; not only with financial resources, but also technical cooperation with agencies like the NIH and CDC. WHO has to continue its crucial work, as countries around the world depend on the organization. We hope the US will continue to support WHO in the future. We, Agappe Diagnostics, are a lead ing Indian Diagnostic Company serving mankind with more than 500 diagnostic products across globe. We have launched Covid-19 RNA Extraction kits in association with Sree Chitra Tirunal Institute of Medical Science, Trivandrum India which cut shortened the d iagnostic cost and many other Covid-19 Diagnostics Products are in pipeline. We appreciate the efforts taken by WHO to eradicate the d isease. Here we would like to have a few advices from you to improve our services to the general public. I toast all the healthcare entities highlighting the efforts and their augmented contributions towards eradicating this pandemic. The heads always need to mind that all we are public servants and this is the time to attest our accountability in ensuring public welfare. I trust more and more R&D activities are progressing globally to manage this pandemic and I wish all the best to do more better assignments in imminent days and make sure that every people will live healthily.

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Cover Story Current IVD Trends

COVID-19: CURRENT TRENDS IN

IN VITRO DIAGNOSTICS Article prepared and published in WHO’s COVID-19 Global literatures on coronavirus disease by R&D department (Reagent), Agappe.

R. Arun Krishnan, Rhema Elizabeth Thomas, Ajaikumar Sukumaran, Jofy K. Paul, Prof. Dr. D. M. Vasudevan

The novel coronavirus SARS-CoV-2 is the seventh known species of coronavirus, infectious to human beings. The pandemic COVID-19 spread all over the world with an unprecedented spreading rate after its first appearance in Wuhan, China. As a novel viral disease there in no antiviral treatment or vaccine for the COVID-19. At present, the early detection and the quarantine of infected patients are the ways to stop the spreading of the disease. This review will discuss about the current invitro diagnostic methods used worldwide for the early and accurate diagnosis of COVID-19. Currently the nucleic acidbased polymerase chain reaction is used as the reliable diagnostic platform and antigen/antibody detection immunoassays are playing the role of screening tests for early detection and prognosis in COVID-19 treatment.

The Coronavirus disease 2019 (COVID-19) is the latest pan-

demic gaoling the humanity, having very high spreading rate and approximately 5–6% of mortality worldwide. This novel beta coronavirus is an enveloped non-segmented positive sense RNA virus. The Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) genome structure comprises single stranded RNA with nucleocapsid protein which are enclosed by membrane proteins, envelope proteins and spike glycoproteins (Fig. 1). As a coronavirus, the SARS-CoV-2 has

Fig. 1

high similarity with other viruses like SARS-CoV and MERS-CoV. The entry of the novel coronavirus to host is through the interaction between the densely glycosylated spike proteins to the receptors on host cell membrane. The spike glycoprotein is a trimeric class I fusion protein consisting S1 and S2 domains. It is reported that there is 55% similarity in S1 domain of spike glycoproteins among SARS-CoV-2 and SARS-CoV and 91% similarity in case of S2 domain. It is evident that the SARS-CoV-2 can infect the human respiratory epithelial cells through interaction of spike protein with the human ACE2 receptor.

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The coronaviruses are large RNA viruses (65–125 nm in diameter) come under the Coronaviridae family in the Nidovirales order. Normally the coronavirus genome contains six open read ing frame (ORFs) which encodes for the structural as well as accessory proteins in the virus. The nucleocapsid protein (N-protein) in the coronavirus binds to RNA genome and forms a capsid around the enclosed nucleic acid. The function of N-

protein includes the interaction with membrane protein during viral assembly, assists in RNA synthesis/folding and affects host cell responses, including cell cycle and translation. The structural and accessory proteins are essential for viral replication, genome maintenance and pathogenesis of the virus.

Current Molecular Diagnostic Techniques for COVID-19 The currently available invitro diagnostic techniques can be broadly classified into (1) Nucleic acid-based assays and (2) Serological assays. These are described below. Nucleic Acid Based Assays At present the most widely used approved test for the diagnosis of COVID-19 is the Polymerase Chain Reaction (PCR). Two different strategies are in use for PCR based assays; the Reverse Transcriptase PCR (RT-PCR) and the Loop Mediated Isothermal Amplification PCR (LAMP PCR). Both methods offer high sensitivity (85– AGAPPE CHITRA MAGNA - RNA EXTRACTION KIT 90%) and specificity for the COVID-19 diagnosis as the methods are focusing on difacturers including Abbott, Bosch and Cepheid where a sperect amplification of the virus genetic material. The RT-PCR is quancific gene of SARS-CoV-2 is detected within few minutes. Altitative in nature whereas the LAMP PCR is qualitative. As comthough RT-PCR is the most widely used confirmatory test for pared to RT-PCR, LAMP PCR will be more cost effective and less COVID-19, this technique is not robust and can only be pertime consuming. High throughput screening is another nucleic formed by skilled analysts due to various biological safety acid detection technology. It is costly and has high equipment hazards making sample detection cumbersome in many cases. dependency making it less widely used. Even though the aforementioned methods can offer nearly 90% accurate result, the imEven though the RT-PCR is a robust technology there are proper sample collection, handling and transportation may lead many factors contributing to false-positive and false- negato false negative results, obviously decreasing the sensitivity of tive results. Mutations in primers targeting virus genome can the assay. lead to false negative results. Laboratory practices and safety Reverse Transcriptase PCR (RT-PCR) The RT-PCR is the most common and effective method used in the market to detect SARS-CoV-2. In RT-PCR, reverse transcriptase converts virus RNA into cDNA following amplification into millions of copies of DNA using a set of specific primers and probes. The amplification taking place in 3 steps: [1] denaturation [2] annealing and [3] elongation. These three steps take place at 95 °C for 30 s, 50° for 30 s and 72 °C for 60s respectively. The primers target and amplify different regions for SARS- CoV-2 such as nucleocapsid protein (N) gene, envelopeprotein (E) gene and ORF1ab gene regions which can be determined within the same cycle and separately for confirmatory testing. The turnaround time for sample analyses is 2.5–3.5 hr. One-step RT-PCR assay to detect E gene and RNA-dependent RNA polymerase (RdRp gene) regions of SARS-Cov-2 has been developed by Tib-Mol-boil. Predominantly, upper respiratory samples including nasopharyngeal swabs and oropharyngeal swabs are recommended for analysis. There are many breakthrough assays developed by various IVD manu-

procedures including collection, transportation and handling also contribute to false negative results. The sampling timing and optimum sample types play significant role in obtaining highly sensitive and highly specific results. In most PCR assays two different regions of genes are targeted. Hence the result interpretation will be positive, negative or inconclusive. If both genes are amplified the result is positive; If only one gene is positive, that is called inconclusive; and negative could be a false negative. So, inconclusive and negative persons should be treated as doubtful. Loop Mediated Isothermal Amplification (LAMP)

The efforts on minimizing length of the entire PCR process and practice of isothermal amplification has resulted in the development of loop-mediated isothermal amplification. The LAMP is a highly specific isothermal amplification technique with an analytical limit of detection of 75 copies per ul. In LAMP, conversion of RNA to DNA is followed by amplification of sample genome using 4–6 primers (forward inner

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Cover Story Current IVD Trends primer, forward outer primer, reverse inner primer and reverse outer primer) targeting different regions of the DNA. The LAMP has several advantages over RT-PCR. It is considered to be more user friendly with easy detection, speed and less background signal when compared to RT-PCR. In addition to its speed, LAMP shows high level of specificity and high amplification efficiency than RT-PCR. The recently developed Chitra Gene LAMP-N by Sree Chitra Thirunal Medical Institute and Technology in collaboration with Agappe Diagnostics Ltd. detects two different regions of N gene. The turnaround time of 20 min for the analysis of 30 samples is a remarkable achievement. However, stringent evaluations on commercial LAMP kits are needed for accuracy check and processing of large samples is an impetus for COVID-19 testing. Apart from RT-PCR and LAMP, United States Centers for Disease Control and Prevention (CDC) approved one- step real time reverse transcriptase polymerase chain reaction (rRTPCR) to quantitatively detect viral particles in more than 90 samples within 45 min. Recently, Specific High Sensitivity Enzymatic Reporter Unlocking (SHERLOCK) that allows multiplexed, portable, and ultra- sensitive detection of RNA is a detection strategy used to combat SARS-CoV-2. Cas13a ribonucleases used for RNA sensing binds to amplified RNA which when activated, cleaves fluorophore-quencher probes emitting fluorescence. SHERLOCK has previously been used to detect clinical samples for Zika Virus. Nevertheless, there is a need for further optimisation of this technique in larger samples to achieve large scale evaluation of SARS-CoV-2. Serological Assays Though the rRT-PCR is considered as the ‘Gold Standard’ in the clinical diagnosis of COVID-19, it has own limitations.

As a pandemic, screening and isolation of the infected patients is the only way to reduce the spread of COVID-19. In RT-PCR, the testing directly look for the presence of viral DNA but serological tests detect the presence of antibodies/antigens in human blood against the COVID-19. Hence RT-PCR will give the positive results in 3–7 days of infection but serological test will take 7–14 days to give positive results. The test cost and testing time of PCR based assays inevitably demands the development of rapid serology tests. Several immunoassays are developed by various IVD companies for detecting COVID-19 infection in serum, plasma and whole blood. Among these strategies Lateral flow immunoassays, ELISA and Chemiluminescence are most promising approaches. The limitation of rRT-PCR to detect COVID-19 past infection and the progress of the disease, increases the importance of serological assays. The serological tests can detect both active and past infections, if the tests are performed within the correct time frame after the onset of the disease. In case of antibody detection assay, both IgG and IgM antibodies against the COVID-19 are the target analytes where IgM appears in blood within a week of time and IgG expression will take more than 10 days. Apart from antibody detection, antigen detection against spike glycoprotein and nucleocapsid protein is also under development which offers early detection of COVID-19 infection. In case of RT-PCR one of the important reasons for false negative results is improper sampling (throat swab) and transport, whereas the sample of choice for serological test is serum/plasma/ whole blood which are easy to handle and transport. Serological tests like LFIA for antigen/antibody detection can be used as a rapid test or a point of care testing which offers quick screening of the patients with limited expertise. Detecting antibody titre is important for convalescent plasma therapy and the development of vaccines for COVID-19. Apart from that, serological testing would also provide valuable information regarding the course and degree of immune response as well as the durability of immunity in both infected individuals and participants in the vaccine clinical trials. Lateral Flow Immunoassay (LFIA) The LFIA can be utilized as a preliminary testing tool for COVID-19 in case of community spread or in mass population screening. At present the COVID-19 IgG/IgM antibody evaluation kits based on LFIA is widely available in market. Upon COVID-19 infection the IgM and IgG antibodies will start to develop in our body from 7–10 days and 14–20 days respectively. Though IgM can be detected earlier it also decreases and disappears earlier, but IgG can persist for a long time after the infection. Even though the antibody test kits are reliable for preliminary screening, the test cannot

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be used as a confirmatory test because of nonspecific interaction of antibodies and other proteins in the blood with capture and detector molecules in the membrane, which may results in false positive or false negative results.

The limitation of rRT-PCR to detect COVID-19 past infection and the progress of the dis ease, increases the importance of serological assays.

The main advantages of LFIA are that it can be used as a rapid POC test and it can be detected using finger-pricked blood or serum/ plasma. It does not require any instruments or expertise staff for carrying out the test and it gives result in 5â&#x20AC;&#x201C;30 min. The LFIA antibody test for COVID-19 can also be considered as a prognostic tool there by provides information about the immune status of the patient. Mostly the LFIA results are qualitative but can be made quantitative by the use of customized color readers. Currently COVID-19 antigen LFIA test is under development which will offer more sensitive and specific result for COVID19 diagnosis and will detect the viral antigen in 3 days of infection. Enzyme Linked Immunosorbent Assay (ELISA) and Chemiluminescence Immunoassay (CLIA)

The ELISA and CLIA platforms are widely using serology techniques for the quantitative detection of specific antigen or antibody in the samples. Zhang et al. have developed an enzyme linked immunosorbent assay for the detection of COVID-19 IgM and IgG antibody from serum sample. SARS-CoV-2 Rp3 nucleocapsid protein is adsorbed on the surface of a 96 well plate as capture molecule and anti-IgG antibody conjugated with horse radish peroxidase is used as the detector molecule. Manual ELISA kits for detecting COVID-19 have been developed by IVD manufactures like IBL International, DRG Diagnostics GmbH, Epitope Diagnostics and Euroimmun for detecting the IgG and IgM antibodies developed in response to COVID-19 infection. ELISA and CLIA based COVID-19 antigen detection kits are under development by IVD manufacturers worldwide. Automated CLIA method can also detect IgG and IgM antibody in serum or plasma. The advantages of automated CLIA analyzers compared to rapid LFIA tests is the very high throughput of samples and the ability to detect other biomarkers like C- reactive protein simultaneously. DZ-Lite SARS-CoV-2 CLIA developed by Diazyme, USA and MAGLUMI CLIA developed by Snibe, China are chemiluminescent analyzers which can detect IgG and IgM antibodies of COVID-19. Non-specific Tests for COVID-19 Besides the aforementioned specific tests, certain routine biochemical and haematological tests show abnormal results in COVID 19 patients. Upon COVID-19 infection the level of prothrombin time, lactate dehydrogenase (LDH), D-dimer, alanine transami-

nase (ALT), C-reactive protein (CRP), erythrocyte sedimentation rate (ESR) and creatine kinase are elevated. There is a marked lymphopenia with depletion of CD4 and CD8 lymphocytes in the early phase of the disease. As the disease progress patients show higher levels of interleukin-2 (IL-2), IL-7, IL-10, granulocyte colony-stimulating factor(GCSF), interferon gamma-induced protein, monocyte chemotactic protein 1 (MCP1), macrophage inflammatory protein alpha and tumour necrosis factor-a (TNF-a). Itâ&#x20AC;&#x2122;s also noted that patients in intensive care show significant increase in amylase and D-dimer. And in case of non survivors there is a marked elevation in the level of ferritin, blood urea, neutrophil count, and D-dimer and creatinine levels. But procalcitonin (PCT) is not elevated in COVID 19. So Procalcitonin level can be used for the differential diagnosis of COVID 19 from bacterial pneumonia. The level of CRP starts to rise at the time of mild pneumonia and reaches peak at severe pneumonia. The CRP is also used as a marker of inflammation and the rise correlates with the level of inflammation regardless of the factors such as age, sex and physical condition. It is reported that the CRP levels are positively correlated with lung lesions in early stage of COVID 19 cases and can be used as a key indicator for disease monitoring. Conclusion The nucleic acid-based diagnostics methods and serological assays described above are serving as strong diagnostics tools for the COVID-19 diagnosis. The assurance of quality of developed diagnostics kits is having prime importance at this scenario. Even though recently many developments happened in the field of serological diagnosis for COVID- 19, still there are many concerns regarding the sensitivity and specificity of the assays. The complexity, cost effectiveness and limitations of nucleic acid based diagnostic tools, impetus the innovative development of well standardized, highly sensitive, specific and low cost serological assays for COVID19 diagnosis.

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Promotion Covid-19 Biochemistry Diagnosis

ROLE OF LABORATORY TESTS IN

COVID-19 PROGNOSIS Bintu Lijo, Manager - Customer Technical Support, AGAPPE.

Several coronaviruses can infect humans, the globally endemic human coronaviruses HCoV-229E, HCoV-NL63, HCoVHKU1 and HCoV-OC43 that tend to cause mild respiratory disease, and the zoonotic Middle East respiratory syndrome coronavirus (MERS-CoV) and severe acute respiratory syndrome coronavirus (SARS-CoV) that have a higher case fatality rate. In December 2019, a cluster of patients with a novel coronavirus was identified in Wuhan, China. Initially tentatively named 2019 novel coronavirus (2019-nCoV), the virus has now been named SARS-CoV-2 by the International Committee of Taxonomy of Viruses (ICTV). This virus can cause the disease named coronavirus disease 2019 (COVID-19). WHO refers to the virus as COVID-19 virus in its current documentation. The purpose of this article is to provide interim guidance to laboratories and stakeholders involved in COVID-19 virus laboratory testing of patients

The International Federation of Clinical Chemistry and Labo-

ratory Medicine (IFCC) has recently posted a list of laboratory tests (Ref. Table 1) for monitoring patients with COVID-19. Besides hematology (i.e. Complete Blood Count) and coagulation

(i.e. D-Dimer and Prothrombin Time), the list also includes specific clinical chemistry tests for the biochemical monitoring of patients with COVID-19, which are supported by the initial clinical course of patients from Wuhan, China.

Table 1

Here I would like to discuss 4 important parameters in detail.

Laboratory Test

Abnormalities

*Complete Blood Count Increased WBC Increased Neutrophil Count

Potential Clinical Significance Bacterial infection Bacterial infection

Decreased Lymphocyte Count Decreased immunological response to virus Decreased Platelet Count

Disseminated Coagulopathy

Blood gases

Estimated modifications

Important in clinical care management

*Albumin

Decreased

Impaired liver function

*LDH

Increased

Pulmonary injury

*SGOT/SGPT

Increased

Liver injury

*Total Bilirubin

Increased

Liver injury

*Creatinine

Increased

Kidney injury

*Urea

Increased

Kidney injury

*Cardiac Troponin

Increased

Cardiac injury

*D -Dimer

Increased

Activation of coagulation/coagulopathy

*CRP

Increased

Severe viral infection

*Ferritin

Increased

Severe inflammation

*IgG/IgM

Increased

Valuable tool in combination with Ag testing

*Procalcitonin

Increased

An indicator of disease severity

*Available with Agappe

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1.CRP What is CRP? CRP (C â&#x20AC;&#x201C; Reactive Protein) is a cytokine -induced, acute phase protein that increases in concentration as a result of inflammation. Hence it is used as early marker or indicator of infections and inflammation. The assay of CRP is more sensitive than the erythrocyte sed imentation rate (ESR) and leukocyte count. The CRP levels rise and return to reference ranges more rapidly after the disease has subsided. Why CRP test is important in Covid-19 prognosis? Statistical studies among the COVID-19

patients shows that CRP levels are highly correlated with the inflammation in the lungs and an increased CRP level is suggestive of poor prognosis.

DID YOU KNO W KNOW

When a pathogen enters in body, inflammatory cytokines will be overproduced to fight against it and when it hyper activates it can damage lungs and other internal organs. CRP levels elevated in Silent Hypoxia (insufficient oxygen supply to body parts) results in Trauma, Stroke, Heart failure, Heart attack and Multiple organ failure.

Agappe Diagnostics Limited is the largest IVD Reagent Manufacturer in India who delivers quality reagents for testing CRP, D-Dimer, Ferritin, IgM/IgG to ensure precision results, worldwide. We ensure customerâ&#x20AC;&#x2122;s ultimate satisfaction in providing best patient service with accurate testing results.

During infectious or inflammatory disease states: z CRP levels rise rapidly within the first 6 to 8 hours z Peak at levels of up to 300â&#x20AC;&#x201C;350 mg/L after 48 hours z CRP is raised by up to 50,000 times in acute inflammation

ESR units

CRP serum concentration (% change)

CRP vs ESR

IFCC suggested CRP as one of the markers to evaluate the severity of infection, prognosis, and therapeutic monitoring. CRP is tested together with other clinical parameters for initial evaluation and follow up of Coronavirus infection. 2.D-DIMER What is D-Dimer?

Days post stimulation Rise in CRP level positively correlated with increase in diameter of lung lesions is il lustrated below. CRP levels are correlated with the level of inflammation, and its concentration level is not affected by factors such as age, sex and physical condition

D-Dimer is one of the protein fragments produced when a blood clot gets dissolved in the body. It is not normally present in human blood plasma. D-Dimer tests are used to help rule out the presence of an inappropriate blood clot (thrombus). Why D-Dimer test is important in Covid-19 prognosis? D-Dimer is commonly elevated in patients with COVID-19. In the disease condition, inflammatory reactions triggered which results in increased production of inflammatory cytokines (Cytokine storm) that activates coagulation process. When large numbers of clots are breaking down, D-dimer levels are elevated. Increased D-Dimer levels are also a predictor of developing acute respiratory distress in COVID-19, mentioning the probability of micro pulmonary embolism especially in severe forms of COVID-19. Recently performed autopsies on 12 patients with COVID-19 showed deep vein thrombosis in seven patients whereof four had pulmonary embolism (PE) as main pathological findings. In two of these cases PE was directly stated in the clinical cause of death. Studies on SARS-CoV-2 revealed that D-Dimer levels correlate with disease severity and are a reliable prognostic marker for in-hospital mortality in patients admitted for COVID-19.

CRP levels wer positively correlated with the diameter of lung lesion and severe presentation

3. Ferritin What is Ferritin? Body cannot synthesize iron of its own and it absorbs iron

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Promotion Covid-19 Biochemistry Diagnosis from diet. Most of the absorbed iron is used for RBC production and the remaining is stored in the form ferritin. Ferritin is a major intracellular iron storage protein in al l organisms. Why Ferritin test is important in Covid19 prognosis?

Test results RT-qPCR

Clinical Significance

IgM

lgG

+ + + +

+ + -

+ +

Patient may be in the window period of infection

Patient may be in the early stage of infection. RT-qPCR result may be false-negative.

When Corona virus + enters the body, body over produces cytok+ + ines to fight against virus. This Cytokine storm causes internal infection and inflammation which damage internal organs. When cells are damaged, Ferritin stored inside is released to blood and resulted Hyperferritinemia.

Patient may be in the early stage of infections Patients is in the active phase of infection Patient may be in the late or recurrent stage of infection

Patient may have had a past infection and has had recovered. Patient may be in the recovery stage of an infection, or the RT-qPCR result may be false-negative. As per the recent published guidelines longitudinal monitoring of ferritin during hospitalization may help to identify severe patients and predict the progression of COVID-19 towards a worse clinical prognosis. 4. Immunoglobulins (IgG and IgM) What is IgG and IgM? It also called Antibodies which are produced by WBC. 5 major classes are there and the below mentioned two are significant in Covid testing. IgM It is the largest antibody in the body, and it constitute 15 % of antibodies. It is the First Line of Defense against foreign invaders among the other 4 immunoglobulins. IgM antibodies appear early in the course of an infection therefore, it indicates recent infection.

WHEN VIRUS ENTERS BODY... Body overproduces cytokines (chemicals) quickly to fight against the virus. This is called cytokine storm – results in internal organs inflammation/ infection. The internal inflammation and infection cause CRP to shoot up rapidly within 6 to 8 hours of infection. Results HIGH LEVELS OF CRP The high inflammation and infection cause internal bleeding resulting in many internal clots. When these clots degrade, D-Dimer will be released. Results HIGH LEVELS OF D-DIMER The internal inflammation & infection causes cell damage. When cells are damaged the ferritin stored inside the cells will be released into blood. Results HIGH LEVELS OF FERRITIN

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IgG It is the dominant serum antibody constituting 85% Immunoglobulins. It is the 2nd antibody on arrival of any foreign invader and it remains in the body for a longer period. Why Immunoglobulins test is important in Covid-19 prognosis? IgM/ IgG Antibody estimation alone may not diagnose COVID 19, but it is a valuable diagnostic tool when used in combination with Ag testing methodologies. The corona virus Ag test, RT – qPCR detects the presence of Ag directly, but it requires successful swab for testing. IgM/IgG test offers below advantages over RT- qPCR • Serological tests hence more stable than viral RNA • Serum sample is less susceptible to spoilage during collection, transport, storage and testing than RT –qPCR specimen. • IgM /IgG antibodies are uniformly distributed in body hence prone to less variations when compared with Corona virus Ag.

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Cover Story Role of Laboratory Physicians

RACE AGAINST COVID-19 REDEFINES THE ROLE OF LABORATORY PHYSICIANS The role of laboratory physicians has been challenged many times in the past. Therefore, in the constant quest to develop and validate new laboratory biomarkers, it is essential to provide evidence of how the laboratory physicians (biochemists, microbiologists, clinical pathologists, hematologists, histopathologists,molecular biologists and geneticists) are playing crucial roles in improved clinical outcomes. In this article, I will emphasize the role of routine laboratory physicians. Dr. Barnali Das, MD, DNB, PGDHHM, Consultant, Laboratory Medicine, KokilabenDhirubhaiAmbani Hospital, Mumbai. Chair, American Association of Clinical Chemistry (AACC) India Section. Executive Member, Scientific Division, IFCC. College of American Pathologist Inspector & NABL Assessor

Coronavirus disease 2019 (COVID-19) is aglobal threat

tohealthcare and patient safety, caused bysevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Thisinfection originating from Wuhan in China, has infected over thirty-three mil lion people (WHO dashboard; 4:28 PM CEST, 30thSeptember, 2020: 33,502,430 confirmed cases) worldwide, and led toover 1,004,421 deathsacross the globe. In India, the total active cases estimated now is 9,40,705 and 98,678 people have already died from the highly contagious virus (1st October, 8:00 AM).As the morbidity and mortality statistics are alarming worldwide, as well as in India, it is clear thatthe laboratory physician will play an essential role in this crisis, contributing to patient admission, staging, monitoring, treatment protocol, as well as prognostication. Processes are now streamlined in Laboratory Medi-

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cine to ensure provision of reliable and timely test results, appropriate alliance with brain to brain loop, thus enhancing quality of care and patient safety. In recent decades, both International Fed-

eration of Clinical Chemistry and Laboratory Medicine and several other national and international societies of laboratory physiciansare playing an active role for standardization and harmonization of tests, methods, cut off and laboratory practices. The critical role of laboratory medicine in this pandemic extends far more than etiological d iagnosis of COVID-19, by rev-erse transcripase polymerase chain reaction (rRTPCR). Routine laboratory monitoring of COVID-19 patients through testing is critical, for assessing disease severity and progression, as well as monitoring therapeutic intervention. In addition to more common laboratory tests like, LFT, KFT, Blood Gas etc. patients with severe COVID-19 could be at risk of Macrophage Activation Syndrome (MAS) or Cytokine Storm. Therefore, routine biomarkers play an essential role in patient admission protocol, assessment of staging of disease according to severity, prognostication, patient monitoring and therapeutic guide. We have evaluated the role of laboratory biomarkers and observed statistically significant abnormal values of biochemical and immunoassay parameters: C Reactive Protein (CRP), Procalcitonin (PCT), Lactate Dehydrogenase (LDH), D-Dimer, Interleukin 6 (IL6), Ferritin, Blood Gases, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Serum Albumin,

Routine laboratory monitoring of COVID-19 patients through testing is critical, for assessing disease severity and progression, as well as monitoring therapeutic intervention.

Total Bilirubin (T Bil), Creatinine, WBC Count, Neutrophil Lymphocyte Ratio (NLR), Platelet Count, High sensitive Troponins (hSTnI or hsTnT) and B type Natriuretic Peptides (NT ProBNP or BNP) in COVID 19 patients; those who are admitted with rRT-PCR positive test results of SARS-CoV-2 in nasopharyngeal or oropharyngeal samples at Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute in Mumbai. We analyzed the retrospective routine laboratory data of around 528 COVID 19 cases admitted in KokilabenDhirubhai Ambani Hospital & Medical Research Institute. To explain the role of routine laboratory parameters in disease monitoring, letâ&#x20AC;&#x2122;s demonstrate the routine lab parameters of one case. An elderly male who is a known case of diabetes mellitus and hypertension, waspresented to the hospital, with a complain of breathlessness and dry cough since 4 to 5 days. The patient had no travel or contact history. The patient was tested positive for SARS-CoV-2by reverse transcriptase polymerase chain reaction (rRT-PCR) using nasopharyngeal swab. HRCT Chest showed extensive ground glass opacities in both lungs. The routine laboratory findings supported the diagnosis with elevated levels of Interleukin-6 (IL-6), C Reactive Protein (CRP), Procalcitonin, High Sensitive Troponin I (hsTnI), AST, ALT, Direct Bilirubin, D Dimer, Ferritin, LDH, Creatinine, Blood Urea Nitrogen (BUN), Neutrophil count, WBC Count, Lactate and decreased levels of Albumin and SO2% and Lymphocyte count (Table 1). The patient was diagnosed with Pneumonia, Multiorgan dysfunction syndrome, Acute respiratory distress syndrome, Viral myocarditis, Ischemic hepatitis and Acute

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Cover Story Role of Laboratory Physicians kidney Injury. Here, we have observed the importance of biomarker monitoring in admitted patients. For example, if we consider IL6, CRP, PCT, D-Dimer, Ferritin and LDH in one critical patient admitted patient, we can see sequential rise or fal l of the biomarkers. The ongoing pandemic of COVID-19 is characterized by respiratory il lness and d iverse systemic clinical presentations, which in turn are reflected by routine laboratory abnormalities, based on severity of disease presentation. The main laboratory changes encompass an array of increased inflammatory biomarkers, coagulation parameters, tissue-specific tissue injury indicators (liver, kidney, card iac) and derangementof the complete blood count. Based on se-

Table 1:

Parameters IL â&#x20AC;&#x201C; 6 (pg/ml) CRP (ng/ml) PCT (ng/ml) hsTroponin I (pg/ml) AST (U/L) ALT (U/L) TotalBil (mg/dl) DirectBil (mg/dl) IndirectBil (mg/dl) Total Protein (g/dl) Albumin (g/dl) D Dimer (ng/ml) Ferritin (ng/ml) LDH (U/L) CPK ( U/L) Creatinine (mg/dl) BUN (mg/dl) SO2% Lactate (mmol/L) WBC Count (103/microL) Neutrophil (%) WBC Count (103/microL) Neutrophil (%) Absolute Neutrophil (103/microL) Lymphocytes (%) Absolute Lymphocyte (103/microL) Platelet count (103/microL)

Biomarkers of inflammation, cardiac and muscle injury, liver and kidney function and coagulation measures were also significantly deranged in patients in the critical stage of COVID-19.

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Routine laboratory findings of Case 1:

OCTOBER - DECEMBER 2020

Reference Interval 0-7 below 0.5 below 0.5 MALE <34, FEMALE <16 10-50 below 41 0.3-1.2 below 0.3 0.1-0.9 6.6-8.3 3.97-4.95 below 500 21.8-274.66 135-225 10-171 0.67-1.17 6-20 95-98 0.7-2.5 4-11 40-80 4-11 40-80 2-7.5 20-40 1-3 150-410

Report Values 724.7 39.47 4.09 1128.1 104.3 48.4 0.59 0.50 0.09 6.75 3.79 6940.91 4110.76 857.1 137 4.55 48.4 77.8 3.2 13.11 87.6 13.11 87.6 11.5 7.5 1.0 356

verity of disease, host inflammatory response to virus may lead to cytokine storm that can cause multi-organ damage. Biomarkers of inflammation, cardiac and muscle injury, liver and kidney function and coagulation measures were also significantly deranged in patients in the critical stage of COVID-19. In hospitalized patients, there should be close monitoring ofCReactive Protein (CRP), Procalcitonin (PCT), Lactate Dehydrogenase (LDH), D-Dimer, Interleukin 6 (IL6), Ferritin, Blood Gases, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Albumin, Total Bilirubin (T Bil), Creatinine, WBC count, Neutrophil Count, Lymphocyte count and Platelet count, as markers for potential progression to critical stage ofthe illness and fatality.

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Live Story Rajesh Koyikkal

THE STORY OF A COVID-19

INFECTED JOURNALIST Being Covid-19 positive is the worst nightmare one expects these days. But nothing is in our hands. Just like health workers and police personnel, the journalists who bring us the grim realities of the pandemic from the worst affected areas round the clock are among the most vulnerable to the disease. Hereâ&#x20AC;&#x2122;s the true story of Rajesh Koyikkal, Senior Reporter at the Delhi Bureau of Mathrubhumi News, who turned Covid-19 positive and recovered after proper treatment.

he fast spread of Covid-19 cases could be one of the major news breaking ever since March 2020 in our print and electronic media. Apart from the deaths, we also hear the positive stories of people recovering from the disease. Few months back a memoir of a TV news reporter from Kerala who recov-

ered from Covid-19 and published in social media and in major news websites was well received by readers. It was the true story of Rajesh Koyikkal, Senior Reporter of the Del hi Bureau, Mathrubhumi News. Rajesh who hails from North Paravoor, Ernakulam district of Kerala joined Mathurbhumi News in 2013. As Covid-19 began to spread in the national capital, their job was rearranged and he was instructed to work from Kerala for a few months. As a result, Rajesh flew down to Ernakulam on June 16, 2020. His underwent mandatory home quarantine after his wife and kid moved to their ancestral home prior to his arrival. By then the news had begun to make rounds in the village that he had come from Del hi and is under home quarantine. Two days later he developed a cough. As instructed, he informed the health officials and on June 20th he was taken for the Covid 19 test. On 23rd the test results came in which he was Covid 19 positive.

Reactions Out of Ignorance Rajesh Koyikkal

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Even before the test results were out, the arrival of ambulance to the village to take him for Covid 19 test had made people around

the locality alert. Rajesh assumes that he might have infected during his flight from Del hi. The people around the locality were angry as why he had to come to the house now from Del hi. Rumours began to circulate in every direction. Mostly they were afraid that the virus may spread. Ignorance is fatal in some circumstances. Some even threatened the family members of Rajesh that they will beat the pulp out of them if any of them seen outside their house. “They were not real threats. In a village news spreads fast. So people were afraid. Many of them Rajesh Koyikkal with family were not aware of the real situation and got worried from rumours,” says Rajesh. “My first reaction was to ignore them. But the intensity increased with each day. Our local ward member and ASHA worker had hectic time as people were disturbing them with the rumours they heard about me and my family members. After a while I informed them such rumours will be legally handled if continued. Although poets say that villages are epitome of goodness, ignorance could be fatal. It is ok to be afraid of the disease but isolating the innocent family members is not acceptable,” he adds. Rajesh notes in his memoir that he indulged in reading several books of various genres during those days. He also tried cooking few items with the limited resources left at home for him by his wife. His brother regularly delivered snacks for him and occasionally non-veg meals. Rajesh also got in touch with many of his friends over his phone and social media. It helped a lot to get over the boredom.

“Once in a while we all have heard stories of arrogance from the part of doctors, nurses and staffs of government hospitals. That impression completely changed during my treatment days. I must say that from the junior doctors to the senior doctors, nurses to the hospital staff, all were cordial and helpful.” he says.

Hospital Days as a Covid 19 Victim The day after the test results were out he was moved to Government Medical College, Ernakulam (Kalamassery). There he was moved into a single room consisting of a toilet. One thing that had a positive impact during the period there was about the government hospital staffs, nurses and doctors. We all have heard about how some government hospitals function without even basic amenities not just in the state but in the entire country. “Once in a while we all have heard stories of arrogance from the part of doctors, nurses and staffs of government hospitals. That impression completely changed during my treatment days. I must say that from the junior doctors to the senior doctors, nurses to the hospital staff, all were cordial and helpful. In Del hi, we have personally witnessed how patients with low survival rate and old were left alone as they can’t attend them as the number of cases was high. Here they were trying to save everyone they could even if they had only slim chance. It really had a positive impact on me,” he says. In every three hours the nurses would knock on the door to either check the temperature or to enquire if they have any uneasiness. Of course, they are all in PPE kit and the only way to identify them is the name tag pasted on it. They were instructed to advise the patient to call them in case of an emergency. Rajesh had difficulty in breathing for two days and with the careful treatment it came to a halt. The room was cleaned twice a day and the food delivered at the doorstep along with boiled water for drinking. Doctors came regularly in the morning and evening.

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OCTOBER - DECEMBER 2020

Live Story Rajesh Koyikkal The Second Stage of Recovery After his symptoms subsided, Rajesh was moved to the temporary ward at Angamaly. Along with Rajesh there were four others including a woman moved to there in the Ambulance. As soon as they stepped out from the vehicle, health workers in PPE kit sanitized them and their luggage. A convention centre had been turned into hospital ward with a nurses’ station at the centre and a women section on the other side. Bed number ‘195’ was allotted to Rajesh along with a plate, spoon, glass and bathing amenities like bucket, cup and soap. Vitamin and Antibiotic medicines were provided to them. Those who had diabetes and BP were given special care along with the elderly people affected with Covid 19. To drink, boiled water was provided. Ginger, garlic and turmeric were mixed with hot water before drinking. Gargling with hot water and salt was another thing they did every now and then. They were allowed to get things from outside either through relatives or friends twice in a week. The items will have to be handed over at the gate in a cover with the name of the inmate. They were delivered within hours to the respective persons. Rajesh has also noted in his memoir in a sarcastic manner how the North Indians complained about the lack of better facilities

“I had told my family about the risk to which we are exposed each day. I told them to be prepared to hear that one day I might have turned Covid positive. Such was the nature of my job. During the intense situation of Covid 19 in Delhi we had to work and report,” he says. in the temporary care centre and how South Indians defended it. Some were successful enough to smuggle cigarettes to the bathroom. However health officials soon discovered and warned about the consequences which ended it. He recalls how his family stood with immense support during the time of disease. “I had told my family about the risk to which we are exposed each day. I told them to be prepared to hear that one day I might have turned Covid positive. Such was the nature of my job. During the intense situation of Covid 19 in Delhi we had to work and report,” he says. The discharge protocol by ICMR for Covid 19 patients changed during those days. At first only if two subsequent tests turned negative discharge was allowed. This was hard in most cases and there were people who spent almost 40 days to get two negative in consecutive tests. Rajesh recalls how a few people did tricks before the nasal swab tests. Since soap killed the virus, they took soap water into their nostrils. Few others tried salt water into their nostrils. “Desperate times, desperate measures!” Later the discharge protocol was changed by ICMR. One negative result was enough which will be conducted after 10 days of confirming the disease. The names of discharge patients will be exhibited in the ward. Rajesh's name came on the list on the 12th day along with 26 others. Rajesh is all grateful to the support extended by all the doctors, nurses and health officials in fighting the disease. He says he is proud about his state for its achievements made in Primary Health Care Sector. Also, he notes that people of Kerala are healthier than people of the national capital. “In Delhi you know the situation on how the air pollution has been affecting the lives of people. Most of them have respiratory problems associated with pollution and it could have played a role in raising the number of deaths at Del hi. Keralites are lucky as we don’t have such extreme air pollution,” he adds.

Rajesh Koyikkal during a news reporting

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OCTOBER - DECEMBER 2020

“I was very vigilant not to spread the disease to anyone. Although I was discharged from the treatment centre and asked to continue in home quarantine for seven more days after turning negative in two subsequent tests, I underwent 14 days home quarantine to make sure that I recovered completely. I’m currently

SAFETY GUIDELINES FOR JOURNALISTS WHO ARE MORE VULNERABLE TO COVID-19 1. Mantra Let us remember the Mantra: Our responsibilities are to cover news and not to become the news. We should not contribute to further spread ing the Coronavirus or COVID-19. We not only have a responsibility towards ourselves but also to our families and society in general.

technological platforms available to make this happen. If you are in a contaminated facility, do not place your equipment on the floor. Do a hand-held shoot. 4. On return On your return from reporting remove your clothes immediately and take a bath.

Wash your hands as often as you can with soap for at least 20 seconds. If there is no water, carry wet wipes and then use an alcohol based sanitizer.

6. Wear a mask & distant seating

Try and get as much information gathering done on the internet and by phone.

If a government spokesperson, senior official or minister is giving a statement, agree among yourselves to record them from at least six feet away. Try to stand without huddling. Better still, convince dignitaries to conduct digital press conferences with questions from journalists taken up live. There are plenty of

Before returning to Kerala from Delhi, one incident had deeply moved Rajesh. The number of deaths had been on the rise at Del hi during that time and he was there to report about the crematoriums. “At that time there were widespread reports that the government were not providing the actual death tolls due to Covid 19 so

If you are using public transportation, use sanitizer on your hands as soon as you get off.

7. Use phone, mobile data and the internet to gather information

3. Distant recording&avoid lapel mics

Grim Realities

5. Public transport

Wear a mask at all times when outside. At a press conference, try to get everyone to sit leaving two seats vacant between two people.

2. Hand washing

working at Kozhikode Mathurbhumi News Bureau and will have to return to Del hi in September,” says Rajesh.

Wash your clothes in hot water and soak in disinfectant.

8. If you develop infection symptoms If you experience onset of coronavirus infection symptoms, report this to your office, call a doctor and immediately self-isolate. as to reduce the number of official deaths. We were at a burial ground for Muslims to report while we found a youngster looking for something. We enquired what he was looking for and his reply shocked us. His father had passed away the day before due to Covid 19 and his dead body was cremated under Covid 19 protocol. Family members were not allowed to take part in the function. He was now looking for the place where his father was buried. Even the caretaker of the burial ground was helpless as more than 150 people were buried near the same place where his father was buried within the next day. Imagine the plight of that son who can’t even find his father’s grave. Such grim realities were taking place daily there,” says Rajesh. He also notes how responsibly our health officials including the ASHA workers are doing their job. “At Delhi near to our housing colony, one guy had turned positive and later all his six family members were Covid 19 positive. Health officials came to their house with all gear and told them not to get out for 28 days. They underwent home quarantine and after one month another health official came and told them that they were all now negative without even testing any one of them. Such is the ‘care’ given there. We are lucky. From the 12 days of hospital life, I've understood that you need not fear the disease. Even though there are minor flaws, our Health Department is wellequipped and moving things smoothly,” he adds.

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OCTOBER - DECEMBER 2020

Interview

Ameer Ali

SUTHARYA HEALTHCARE AND DIAGNOSTICS, A STRONG

ADVOCATE OF AGAPPE PRODUCTS E

Sutharya Healthcare and Diagnostics headquartered at Perinthalmanna, Malappuram and spread across central Kerala with several branches emphasises on providing quality, reliable and costeffective healthcare, and diagnostic service to the needy. Established in 2003 by Ameer Ali (Chairman and Managing Director, Sutharya Healthcare and Diagnostics), the group has now more than 25 branches in the central Kerala region. Sutharya Healthcare and Diagnostics aspires to be an iconic point in the field of laboratory diagnosis in a cost-effective manner uncompromising on quality. True to its tagline ‘redefining your diagnostic experience’, Sutharya Healthcare and Diagnostics provides premium facilities and infrastructure at its laboratories. Excerpts from an interview with its Chairman: Tech Agappe: Sutharya Healthcare and Diagnostics has now grown into a chain of laboratories from a single laboratory with a wide presence in central Kerala. You have now more than 20 years of experience in the diagnostic field. Now tell us, what made you enter into IVD industry?

Ameer Ali: I was very much inspired by my elder brother who was a pharmacist. I made my decision to pursue my higher education in the same and thus joined for B Pharm course at Mysuru, Karnataka. In 1994, I entered intothe diagnostic field. Our first lab was established in a place called Pulamanthole, Malappuram district in the year 2000 and then later with branches at Pattambi, Palakkad. A friend of mine, Mr.Ashraf E K who now works abroad helped me to establish the laboratory. Among other things, what inspired me to enter the diagnostic field was the unprofessional way in which laboratories were functioning till then. The amenities of most labs then were minimal and most often it had some side business apart from the laboratory like a photostat machine or a phone booth back in 2000. Semi Automatic machinery at labs was not even heard of. I thought, why we can’t bring some professional touch to it and introduce a new model. Our laboratory was the first in the region to do purely laboratorial service without any side business and in a professional manner with sophisticated equipments. Also, I found out that in Kerala, there is a dearth of genuine and authentic diagnostic centres.

Bibu B. Punnooran

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Mr. Ameer Ali

OCTOBER - DECEMBER 2020

While we established our first laboratory in 2000, it was named as Microlab and We had rebranded as Sudharma Specialty Laboratories when we went on expanding branches. However,we opened 27 branches in Malappuram, Palakkad, Calicut and Thrissur dis-

ASSOCIATION WITH AGAPPE

Mr. Ameer Ali receiving TechAgappe July-September edition from Majesh Mammen, Zonal Manager, Agappe. tricts. We now have total staff strength of around 250. None of our branches function as a mere collection centre. They are all ISO 9001:2015 certified laboratories with sophisticated equipments to do all tests other than the special tests. At our central laboratory at Perinthalmanna, we do the special tests. Besides me, there are two more partners from the beginning. Mr. Irshad Ahmad and Mr. Faizal P. Both are qualified lab technicians and joined hands with me to get Sutharya Healthcare and Diagnostics established in the Malappuram, Palakkad, Kozhikode and Thrissur districts. TA: What are the accreditations Sutharya Healthcare and Diagnostics possess? Ameer: At present we only have ISO 9001:2015 certification for

" I’m a strong advocate of Agappe products and my partners used to ask me whether I had any share in Agappe Company. Like I said, it is the sheer quality of the product and the fact that it is Indian, from Kerala is the basis of my love towards Agappe".

Ameer: Our association with Agappe starts from 2003 onwards with Agappe’s Mispa Plus. We were the first to introduce that machine in the vicinity. We referred Mispa Plus to many laboratories and clinics. Agappe was also very friendly in terms of business and service. Since Agappe was a company from Kerala, we had a particular interest in it. I haven’t found any company other than Agappe which does service of the machines so promptly. I believe it is the strength of Agappe. The executives of the company were also very encouraging and supportive. One machine which has left a lasting impression with us was Agappe’s Mispa Plus. Now we are using around sixty more modern machines from Agappe like Mispa Nano, Mispa Nano plus, BC 3000 and Mispa-i2. All are good machines and gives results matching our expectation. I’m also happy to hear about the launch of Agappe’s first indigenously developed 3-part Hematology Analyzer in the coming days. The highlight is that it is an Indian product and that too from Kerala. We might be able to get good offer price for imported machines but when it comes for service or spare parts, it is very costly. Agappe will change that scenario. We announce our cordial support to it. Tal king about the association with Agappe’s management, its Managing Director, Thomas John is one of my role models. He is a genius. I have heard several times how Agappe takes care of its employees like a family. We also follow same motto. I believe Agappe’s strength is its loyal employees. I’m a strong advocate of Agappe products and my partners used to ask me whether I had any share in Agappe Company. Like I said, it is the sheer quality of the product and the fact that it is Indian, from Kerala is the basis of my love towards Agappe.

TECHAGAPPE

OCTOBER - DECEMBER 2020

Interview

Ameer Ali

diagnosis services and medical support. We were on the verge of completing NABH (National Accreditation Board of Hospitals and Healthcare Providers) and NABL (National Accreditation Board for Testing and Calibration Laboratories) accreditation. Due to the pandemic situation, it has been got delayed. If it subsides, within two weeks, we will have those prestigious accreditations. The work for our molecular biology section is also progressing fast. We have ICMR approval for conducting Covid19 tests in our laboratory. TA: What are the changes you have observed in patients or customers for coming to laboratory for diagnostic service before and after Covid-19? Ameer: I have observed that people are now very much frightened to come to the laboratories. It is not just the labs but also the hospitals fearing that they might get infected. Even so, I think people are not now as cautious as they used to be in the initial stage of Covid-19 or during the lock down period. There is a sense of taking things not serious enough now. Considering the industry, I think Covid-19 has even affected the medical field. Diagnostic industry was also severely affected. Regular checkups have reduced drastically. I’m hopeful that by year end, we will be able to return to normalcy. We are also looking at Covid-19 testing facilities and approval from

"I’m also happy to hear about the launch of Agappe’s first indigenously developed 3-part Hematology Analyzer. The highlight is that it is an Indian product and that too from Kerala. We might be able to get good offer price for imported machines but when it comes for service or spare parts, it is very costly. Agappe will change that scenario. We announce our cordial support to it".

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OCTOBER - DECEMBER 2020

ICMR with the introduction of molecular biology section at our lab. TA: What are the special healthcare packages at Sutharya Healthcare and Diagnostics? Ameer: We have three kind of check-up package available for customers- General Health package, Total Health package and Master Executive package. Our departments include biochemistry, endocrinology, microbiology, serology, immunology, hematology, histopathology, ultrasound scan, ECG, X-ray and Orthopantomogram. We perform more than 3000 tests including cancer markers, cardiac marker, prenatal screens, autoimmune tests, fertility tests and many more. We handle more than 1000 samples daily. Sutharya Healthcare and Diagnostics is equipped with advanced technologies and machineries which promises reliable results on time. There is also mobile sample collection wing to take samples from home. Patients can also download their test results online. TA: About your family and who all are there behind your success? Ameer: My family consists of wife, two sons and three daughters. I am very much thanks to my loving team, they are : Noushad TK, Santhosh P, Hameed V, Ismail NV, Riyas PK, Najmal PK, Najeeb KT, Ibrahim KP, Noufal C, Ibrahim Panayappurath, Riyas PV, Ibrahim Kizhakkepallath, Riyas CK, Shereef KP, Latheef PV, Anees KH, Abhijith PV, Dilshad KM, Mansoor TA, Ishkender, Raouf P, Shaji P Joy, Abhilash, Shyju, Naseem CP, Ibrahim V. and all staffs who all are an important part of our Family. TA: What are the future plans for Sutharya Healthcare and Diagnostics? Ameer: Due to Covid-19, we are now a little behind our plans. We are hopeful that by December 2020 things will improve. Accordingly, we altered our plan and by next year, we are looking forward to opening more referral labs in every district of Kerala.

www.agappe.com

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OCTOBER - DECEMBER 2020

Cover Story Pregnancy & Covid-19

PREGNANCY DURING COVID-19 EFFECTS MOTHER AND BABY?

The COVID-19 pandemic has everyone anxious and in fear. If you are

pregnant, undoubtedly you have a lot of queries about whether coronavirus poses a threat to you and your baby. The answers are not crystal clear yet, due to the evolving nature of the disease. Knowledge from past epidemics due to similar respiratory illnesses help understand and manage viral infections during pregnancy. Here are the common queries among pregnant women answered. Dr. Lavanya Kiran, MBBS, MS,FRM,MBA,PGDMLE Senior Consultant-Obstetrics & Gynaecology, Narayana Multispeciality Clinic, Bangalore

What effect does coronavirus have on pregnant women? Generally, pregnant women do not appear to be more risky than healthy adults to develop a more serious disease or any complications if affected by coronavirus. Mostly, they will only experience mild to moderate flu-like symptoms.

If you are pregnant and your flu-like symptoms are getting worse, it could mean that your chest infection is getting more severe, and you may require hospitalization. If you develop more severe symptoms or your recovery is getting delayed, contact a first response hospital near you immediately.

It is not yet known if pregnant women are more susceptible to be infected by COVID-19 when compared to the normal population. Despite this, pregnant women are advised to reduce social contact by social distancing. It is an established fact that in some women, pregnancy alters how the body fights some viral infections. Though evidence for coronavirus is still insufficient, it is for this reason that pregnant women are advised to be extra cautious during this pandemic.

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OCTOBER - DECEMBER 2020

What effect wil l corona virus have on my baby if I test positive for COVID-19? As this is a very new virus, all the information and evidence is still not available to us. There is no evidence to suggest an increased risk of miscarriage if exposed to COVID-19. There is also no evidence of vertical transmission, which refers to the ability of the virus to pass to your unborn baby during pregnancy. In a study of nine pregnant women in China who tested positive for COVID-19, all nine babies tested negative for the virus and were healthy overal l. One pregnant lady in London tested positive for coronavirus and later her newborn also tested positive. However, it is unclear whether the baby con-

tracted the viral infection in utero or shortly after birth. Expert opinion is that the baby is unlikely to be exposed during pregnancy, and it is unlikely for the baby to have any defects in development as a result. As of now, there isnâ&#x20AC;&#x2122;t any new evidence that says otherwise.

WASH YOUR HANDS FREQUENTLY Hand hygiene can really protect you from exposure to Covid-19. You may hear this over and over but with a good reason.

What are the effects of Coro- na virus in the first trimester? Pregnant women who were part of The Lancet study were all in their second or third trimesters. There is still no data on pregnant women who tested positive for the virus in their first trimester. Patients who may get infected with symptoms like high fever may increase the risk of birth defects, though there is no evidence for this yet. Are pregnant women a vulnerable group for Corona virus? It is not yet known if pregnant women are more susceptible to be infected by COVID-19 when compared to the normal population. Despite this, pregnant women are advised to reduce social contact by social distancing. It is an established fact that in some women, pregnancy alters how the body fights some viral infections. Though evidence for coronavirus is still insufficient, it is for

Pregnant women who were part of The Lancet study were all in their second or third trimesters. There is still no data on pregnant women who tested positive for the virus in their first trimester. Patients who may get infected with symptoms like high fever may increase the risk of birth defects, though there is no evidence for this yet.

this reason that pregnant women are advised to be extra cautious during this pandemic. Wil l I be able to breastfeed my baby if I have suspected or confirmed coronavirus? Yes. The benefits of breastfeeding your infant far outweigh the risk of transmission of coronavirus through breastmilk. The main risk of breastfeeding is due to the close contact between you and your baby which can pose a risk of droplet infection that can spread to the baby while breathing. Discuss the risks and benefits with your treating doctor and family before you make a decision. Here are some steps to fol low to minimize the risk of transmission: z Wash your hands before feeding or touching the baby, breast pump or bottles z Try to avoid coughing or sneezing while you feed z Wear a face mask while feeding, if available. z If you are using a breast pump, follow instructions for cleaning and sterilising properly. z Consider asking one of your healthy family members to feed your baby if you are expressing milk. z Precautions for pregnant women against Coronavirus Here are some actions you can take to prevent getting the disease during pregnancy: Wash your hands frequently. Hand hygiene can really pro-

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OCTOBER - DECEMBER 2020

Cover Story Pregnancy & Covid-19

YOGA AND MEDITATION DURING PREGNANCY I tâ&#x20AC;&#x2122;s important for the mother to be and her baby to keep their anxiety levels down, even during this time. One way to help feelings of anxiety is through exercise, like going for a walk or doing yoga. Make sure to talk to your health care provider before taking part in any exercise.

Another option to reduce anxiety is meditation. Meditation is a way to clear your mind through breathing exercises. These exercises will help your mind slow down and ease worries. There are many meditation apps you can choose from and download to get started. During the time of the COVID-19

tect you from exposure to COVID-19. You may hear this over and over but with good reason. Practice social distancing. Always maintain a distance of at least 2 metres or 6 feet from others when you are in a public place. Avoid contact with others as much as possible. Get your flu vaccination on time. Though the flu vaccine

Do not ignore any respiratory symptoms. If you develop a cough or any respiratory distress, do not hesitate to call your doctor. After taking a detailed history, your doctor will decide if you need to get tested for COVID-19.

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OCTOBER - DECEMBER 2020

outbreak, itâ&#x20AC;&#x2122;s especially important to find ways to stay active virtually. There are many free yoga classes online and also meditation apps you can use your phone for. does not protect you from exposure to COVID-19, it does make you less susceptible to influenza, which can cause complications during pregnancy. Use a tissue when you cough or sneeze, throw the tissue in the dustbin. Wash your hands right after. Do not ignore any respiratory symptoms. If you develop a cough or any respiratory distress, do not hesitate to call your doctor. After taking a detailed history, your doctor will decide if you need to get tested for COVID-19. Go virtual. As much as possible, consider virtual consultations instead of prenatal visits to your gynaecologist. Try to minimize or altogether avoid spending time in the doctors waiting room or in the hospital. However, some tests will require you to be there in person such as the ultrasound, blood tests and fetal testing. Work from home whenever possible. Stay safe. Symptoms such as high fever with or without continuous cough may indicate a possible coronavirus infection. Avoid coming in close contact with anyone showing these symptoms.

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OCTOBER - DECEMBER 2020

Life Story

Mohammed Faras

THE AGONY AND ECSTASY OF A COVID-19 INFECTED NRI AND HIS EXPECTANT WIFE

Kerala’s Kasargod Kalanad native Mohammed Faras and his family consisting of wife and two children are Covid 19 survivors. What makes their story different is the fact that Mohammed Faras’ wife Fathimath Raseena is the first woman in Kerala who had successfully recovered from Covid 19 while she was carrying. Their new born kid Ayesha Mehra is now four months old unaware of all the worries related to her birth and the alarming pandemic situation in the world.

he story begins with Mohammed Faras’ return from Dubai on March 14, 2020 as his close relative had passed away on March 13th. He had been working at a perfume shop at Dubai Deira Naif. The body of the relative had been buried on the same day (March 13th) itself. He was supposed to attend the prayers on the following day. One of his relative was also travelling from Dubai with Faras and they were picked from Mangalore Airport by two other relatives in a car. But Faras got an uneasy feeling right after he got down at the airport and feared it might be a fever. Since he had a doubt, they went to a private hospital in Kasargod to check. However the doctor there was of the opinion that Faras had no fever.

When he informed that he was from Dubai, the doctor asked him to give sample for Covid-19 test at the General Hospital. Faras went to the General Hospital and the sample was taken. The instruction given from there was to go to his home. The agony begins His sole purpose for the journey was to attend the prayers and pay the respect to the deceased person. But Faras went to his home without attending the prayers keeping Covid-19 protocol and remained there for the next two days. It was after that the call came from Health Authorities informing him that he had turned positive in the Covid 19 test. There begins the struggle of a lifetime for the family of Mohammed Faras.

Mohammed Faras expressing his thanks notes to the health workers after his hospital d ischarge.

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OCTOBER - DECEMBER 2020

He was taken to the Kasargod District Hospital soon after that. Now the Health Authorities began tracing the people with whom he had contact. After testing them all, 20 of his relatives turned Covid 19 positive including his mother, his pregnant wife and two year old son. All of them have now recovered from the disease. Faras’ relative who had been accompanying him from Dubai and the two relatives who came to pick them from airport were negative. Faras assumes that the disease could have spread through his wife or mother as he had no direct contact with most of the relatives during these two days. Faras’ sister and father were however not affected by the disease despite being in primary contact with them.

“When I was d iagnosed with Covid 19, the mental trauma I went through was immense. People around the neighbourhood started to isolate al l our family members. Our family picture taken during my sister’s wedd ing was circulated through social media with my photo marked and asking people to isolate them,” recal ls Faras. “Few even speculated that I had come from Dubai knowing that I had the disease. I have a pregnant wife and a two year old kid at home. Do you think I would do so if I had known that I’m Covid 19 positive?” he asks.

Mohammed Faras with his two children. When Faras informed his employer at Dubai that he had turned Covid 19 posiWhile she was nine months pregnant, she began to expetive, other employees and 14 people residing in the same quarters rience pain. Although they requested authorities to make arwere moved to home quarantine. However all of them were negarangements at a hospital nearby, it wasn’t done. As her pain tive in the tests. Faras was discharged from the hospital after 25 increased, she badly wanted to get admitted in a hospital. days on April 10, 2020. However the authorities had given strict instructions not to get admitted in any other hospital without their permission. Fathimath Raseena’s Trauma When her husband had turned Covid 19 positive, Fathimath Raseena was seven months pregnant with their second baby. Since her husband had symptoms of fever upon the arrival from Dubai, she had kept distance and had not met him since his arriv al. She saw her husband only once when he reached for the prayers at the deceased relatives house. She had moved to her house and after two days she developed a fever along with her mother-in-law. Upon the instruction from her husband, she soon informed the Health Authorities. When the test results came they were positive along with their elder son. They were soon taken to Kannur Pariyaram Medical College Hospital. She was given special care as a pregnant mother by the doctors and nurses. After 22 days, they turned negative and got back home. They were asked to undergo home quarantine for a few more days.

When Faras informed his employer at Dubai that he had turned Covid 19 positive, other employees and 14 people residing in the same quar ters were moved to home quarantine. However all of them were negative in the tests. Faras was discharged from the hospital after 25 days on April 10, 2020.

TECHAGAPPE

OCTOBER - DECEMBER 2020

Life Story

Mohammed Faras

At last, an ambulance came to take her to Kannur Pariyaram Medical College Hospital which was more than 60 kms away from their home. Her husband was not allowed to accompany them as they were at home quarantine. The woes didn’t end there. At the hospital, the lift was kept aside for the use of Covid 19 patients. She was admitted in the ward on the 5th floor and had to climb all those steps to reach it under terrible pain. After two days, she was given a discharge. Although they had asked her to undergo a few tests after it, hospital facilities weren’t arranged. Since they were undergoing home quarantine, Faras couldn’t take his wife to the hospital and had to wait for the ambulance to do so. They had informed the authorities about it. However it elicited no response. Later some emergency tablets were delivered at home. Since her date was approaching and the pain increased, both Raseena and Faras contacted Health Officials and requested them to make arrangements at a hospital nearby for the delivery. They feared travelling such a long distance while the delivery date is approaching may be fatal. On May 4, 2020 her pain increased and soon they informed the Health Au-

“Doctors examined all the organs of the body and fixed treatment accordingly. Since, I was the patient after the first student from Wuhan who turned Covid 19 positive doctors had the experience of dealing it. I was provided counselling when the mental trauma began to affect me seriously,” adds him. thorities. But since the area had been under triple lockdown, vehicles couldn’t reach their house through the direct way. Faras was ready to take his wife in a car to the hospital for which the Health Authorities denied permission. By noon, she gave birth to a girl child at home itself. The ambulance to pick her up hadn’t still reached their home. Not even the neighbours were there for help as the place was under triple lockdown. Faras’ mother took care of her and the baby all that time. At last, an ambulance came with a group of emergency response team including nurses in it. She and the new born baby were taken to the nearby hospital from there. However they were denied permission at the hospital as she had been Covid 19 positive before. She had to wait alone awaiting permission from the authorities. Earlier Faras was not allowed to accompany his pregnant wife to hospital for delivery by the authorities. Later DMO intervened and gave emergency treatment and care. They were then taken to Kasargod General Hospital after making special arrangement. Smile of the Newborn The newborn was named Ayesha Mehra. The kid had undergone Covid 19 test soon after delivery and the result was negative. Apart from the handling of his wife’s delivery, Faras is of the opinion that the treatment and care he received while undergoing treatment was good. “Doctors examined all the organs of the body and fixed treatment accordingly. Since, I was the patient after the first student from Wuhan who turned Covid 19 positive doctors had the experience of dealing it. I was provided counselling when the mental trauma began to affect me seriously,” adds him. “Our newborn kid is now 4 months old. The elder one is two years old and survived Covid 19. Since we were one of the first in the locality to turn Covid 19 positive, most of the authorities had no idea what to do. That could be one reason why they weren’t able to effectively arrange us the facilities. We were lucky as it was my wife’s second delivery. If it was the first delivery, she and kid might not have survived without proper medical attention,” Faras says.

Ayesha Mehra

The life ahead Faras is now concerned about his job. “I came for a two day

TECHAGAPPE

OCTOBER - DECEMBER 2020

STOP FAKE NEWS SPREADING

Ever since the coronavirus outbreak was first reported in Wuhan, China, social media platforms have been flooded with posts on the disease. Beginning February, when awareness about the disease rose in India, social media platforms have seen numerous posts on Covid-19 ranging from information on the outbreak to false news about its origin and spread to offering untested treatment for the disease, and also prescribing strange diets. Now, after lockdown enforced across the country, still, such misleading posts not only amplify the menace of fake news, creating panic and frustration, but also result in privacy violations as medical records of tested individuals are being wilfully circulated online. In a few cases, false med ical reports have also been generated for random individuals and then people are suspecting them of having the diseases and socially boycotting them. Such overflow of content makes it difficult for the people to sift real news from the fakes. Despite the warnings and concerns, many vicious

leave and now it is almost six months. Although I tried to return, the shop owner said that the business is very low at the shop and they are managing with the two employees instead of four. They said they will inform when to join back and is waiting to the business to improve. I do have bank loans and is wondering how to repay it without the job. I had been working at Dubai for more than 12 years now. To find an income, I tried for a job here temporarily but most shops now run in half capacity as their business is very low,” he says. He had already paid a hefty amount for the visa. Even if he finds a new job at Dubai, the new visa needs will cost him again. Besides, organisations and business establishments are reducing the number of staff due to the pandemic situation. He is also unhappy about the absence of any financial aid from the government. He had earlier applied for a financial aid from NORKA Roots for expats. However even after six months, there hadn’t been any response. He enquired it at the office and was instructed to apply again despite successfully generating an application number. “I’m in a desperate state now. Inaction from the part of the authorities is annoying. Now even if I apply

minds continue to create and spread fake posts. A larger section forwards them across groups, often out of ignorance or the excitement of becoming a ‘news breaker’. In this context, we need a much wider awareness exercise, involving all stakeholders, to make every section of the

society aware of the laws and regulations as well as the harmful effects of fake posts. Stop spreading fake news. Think and understand well what is right and what is wrong before forwarding a message related to Covid-19. Let’s all work together to eradicate this dreadful disease.

Not even the neighbours were there for help as the place was under triple lockdown. Faras’ mother took care of her and the baby all that time. At last, an ambulance came with a group of emergency response team including nurses in it. for it, the time required for it to be processed will be long. Also, I’m jobless now. Not just jobless but a Covid 19 survivor with a newborn kid, wife and a son. How will I be able to find a livelihood now?” asks Faras. He hopes someone will be kind enough either to offer him a job abroad or a job temporarily here until the Covid 19 subsides. Readers of TechAgappe can contact him through mob: +91 9349011309

TECHAGAPPE

OCTOBER - DECEMBER 2020

Health Tips

EAT RIGHT FIGHT COVID As a pandemic, Covid-19 has universal presence and there are different approaches as to how to combat the deadly disease. One school of thought is that you can fight fairly with life style modification and right food, which provides proper immunity and antioxidant properties. Stress, strain, sleeplessness, hydration as well as mal nutrition can have adverse impact on recuperative mode of this pandemic.

Dr. C S Satheesh Kumar, Sr. Vice President-Supply Chain Management, AGAPPE., (Retd. Drugs Controller, Kerala)

eople who eat a well-balanced diet tend to be healthier with stronger immune systems and lower risk of chronic illnesses and infectious diseases. So, you should eat a variety of fresh and unprocessed or unrefined foods every day to get the vitamins, minerals, dietary fibre, protein and antioxidants your body needs. Drink enough water. Avoid sugar, fat and salt to

significantly lower your risk of overweight, obesity, heart disease, stroke, diabetes and certain types of cancer. Eat fresh and unprocessed foods every day like fruits, vegetables, legumes (e.g. lentils, beans), nuts and whole grains (e.g. unprocessed maize, millet, oats, wheat, brown rice or starchy tubers or roots such as potato). Do not overcook vegetables and fruit as this can lead to the loss of important vitamins. Avoid canned or dried vegetables and fruit if possible. Drink enough water every day. Water is essential for life. It transports nutrients and compounds in blood, regulates your body temperature, gets rid of waste, and lubricates and cushions joints. Drink 8â&#x20AC;&#x201C;10 cups of water every day. But be careful not to consume too much caffeine, and avoid sweetened fruit juices, syrups, fruit juice concentrates, fizzy and still drinks as they all contain sugar. Eat moderate amounts of fat and oil. Consume unsaturated fats (e.g. found in fish, avocado, nuts, olive oil, soy, canola, sunflower and corn oils) rather than saturated fats (e.g. fatty meat, butter, coconut oil, cream, cheese, ghee etc). Choose white meat (e.g. poultry) and fish, which are generally low in fat, rather than red meat. Avoid processed meats because they are high in fat and salt. Avoid industrially produced trans fats. These are often found in processed food, fast food, snack food, fried food, frozen pizza, pies, cookies, margarines and spreads.

TECHAGAPPE

OCTOBER - DECEMBER 2020

Eat less salt and sugar. When cooking and preparing food, limit the amount of salt and high-sodium condiments (e.g. soy sauce and fish sauce). Limit your daily salt intake to less than 5 g (approximately 1 teaspoon), and use salt pellets, not iodised powder. Avoid foods (e.g. snacks) that are high in salt and sugar. Limit your intake of soft drinks or sodas and other drinks that are high in sugar (e.g. fruit juices, fruit juice concentrates and syrups, flavoured mil ks and yogurt drinks). Choose fresh fruits instead of sweet snacks such as cookies, cakes and chocolate. Avoid eating out- Eat at home to reduce your instances of contact with other people and lower your chance of being exposed to COVID-19. We recommend maintaining a distance of at least 1 metre between yourself and anyone who is coughing or sneezing. That is not always possible in crowded social settings like restaurants and cafes. Droplets from infected people may land on surfaces and peopleâ&#x20AC;&#x2122;s hands (e.g. customers and staff), and with lots of people coming and going, you cannot tell if hands are being washed regularly enough. Eating a healthy diet is very important during the COVID-19 pandemic. What we eat and drink can affect our bodyâ&#x20AC;&#x2122;s ability to prevent, fight and recover from infections. While no foods or dietary supplements can prevent or cure COVID-19 infection, healthy diets are important for supporting immune systems. Good nutrition can also reduce the likelihood of developing other health problems, including obesity, heart disease, diabetes and some types of cancer. Do take fresh fruit juices, lemon water, coconut water/ hot water, herbal tea (containing polyphenols, flavonoids, and antioxidants). Include pulses and wholegrain foods (oats, brown pasta, mil let, and unrefined rice). Indian herbs: Coriander (Dhaniya), turmeric (contain Curcumin), fenugreek (methi), tulsi

Eating a healthy diet is very important during the COVID-19 pandemic. What we eat and drink can affect our bodyâ&#x20AC;&#x2122;s ability to prevent, fight and recover from infections. While no foods or dietary supplements can prevent or cure COVID-19 infection, healthy diets are important for supporting immune systems.

(Basil), cumin (jeera), fennel (sonph), cloves, black pepper (Kalimirch, contain Piperine), cinnamon (dalchini), ginger and curry leaves are good for health. These spices have antioxidant, antibacterial and anti-inflammatory properties, act as immune booster and may help to flush out any sinuses from the body. Rock salt (limit salt intake to 5 grams (equivalent to a teaspoon) a day. You can also eat supplements rich in omega 3 & 6 fatty acids for your daily dose, if stepping out to buy groceries is not an option during social distancing. Some natural immunity supplements include ginger, gooseberries (amla) and turmeric. Some of these superfoods are common ingredients in Indian dishes and snacks. There are several herbs that help in boosting immunity like garlic, Basel leaves and Black cumin. Certain seeds and nuts like sunflower seeds, Flax seed, pumpkin seeds and melon seeds are excellent sources of protein and vitamin E. Berry- Elderberries are full of nutrients including minerals like phosphorus, potassium, iron, copper and vitamins, such as vitamin A, B, and C, proteins and dietary fibre. Elderberries have antibacterial and antiviral qualities which help fight cold and influenza. Turmeric and Garlic- The bright yellow spice, Turmeric, contains a compound called curcumin, which boosts the immune function. Garlic has powerful anti-inflammatory and antiviral properties which enhances body immunity. Apart from maintaining a healthy lifestyle and taking supplements, the Indian health ministry is also suggesting few organic and natural ways to practise as preventive measures to fight COVID-19. The Ministry of AYUSH has recommended the following self-care guidelines as preventive measures and to

TECHAGAPPE

OCTOBER - DECEMBER 2020

Health Tips boost immunity with special reference to respiratory health. Drink warm water throughout the day. Practice Meditation, essential Yogasanas, and Pranayama. Again, Sitting and Breathing (Sukhasana and Pranayama), Half Lord of the Fishes (Ard ha Matsyendrasana), Supported Fish Pose (Matsyasana Variation), Forward Fold (Uttanasana), FourLimbed Staff Pose on El bows (Krupa Chaturanga Dandasana),n Legs Up the Wall (Viparita Karani) all can be practised to improve our immunity. Increase the intake of Turmeric, Cumin, Coriander and garlic. Drink herbal tea or decoction of Holy basil, Cinnamon, Black pepper, Dry Ginger and Raisin. Avoid sugar and replace it with jaggery if needed. Apply Ghee (clarified butter), Sesame oil, or Coconut oil in both the nostrils to keep the nostrils clean. Inhale steam with Mint leaves and Caraway seeds. The current guidelines of the Ministry of AYUSH, Government of India, recommend self-care guidelines for preventive health measures and boosting immunity. These guidelines recommend herbal tea and decoction (Kadha) made from Tulsi, Dalchini, Kalimirch, Shunthi (Dry Ginger) and Munakka (Raisin) with jaggery and/or fresh lemon juice to enhance the taste as immunity promoting measures against COVID-19. Guidelines also recommend avoiding cold, frozen, and heavy foods, which is a clear indication to avoid Rajasic and Tamsik food. Recommendations such as to take appropriate rest, timely sleep, exposure to sunlight, also help to balance our body, mind, and lifestyle. Don’t Compromise on Sleep- Good snooze time for 7-8 hours is the best way to help your body build immunity; lesser

Don’t Compromise on Sleep- Good snooze time for 7-8 hours is the best way to help your body build immunity; lesser sleep will leave you tired and impair your brain activity. The lack of sleep will prevent the body from resting and this will impair other bodily functions that will have a direct impact on your immunity.

TECHAGAPPE

OCTOBER - DECEMBER 2020

sleep will leave you tired and impair your brain activity. The lack of sleep will prevent the body from resting and this will impair other bodily functions that will have a direct impact on your immunity. Lack of sleep adversely affects the action of the flu vaccine. Don’t Skip on Exercise- A good diet should be followed by an exercise routine. Remember to exercise regularly; even light exercise will go a long way in releasing the toxins from your body. It is recommended to exercise for 30 to 45 minutes, depending on your stamina. If you have not started exercising yet, then it is a good time to start. There are several Youtube channels and apps to help you exercise at home. Regular exercise improves metabolism, which has a direct correlation with body immunity. Practice meditation- Too much stress releases the hormone known as cortisol, which impairs your response to immediate surroundings and makes your body susceptible to infections; you are left feeling constantly anxious. The best way to relieve stress is through meditation, it is a tried and tested activity to calm the nerves. If you need help meditating, then there are several channels on YouTube that have instructional resources to help you meditate. Avoid hazardous and harmful alcohol use- Alcohol is not a part of a healthy diet. Drinking alcohol does not protect against COVID-19 and can be dangerous. Frequent or excessive alcohol consumption increases your immediate risk of injury, as well as causing longer-term effects like liver damage, cancer, heart disease and mental illness. There is no safe level of alcohol consumption. It is recommended that in this time of uncertainties and nonavailability of treatment due to the greater number of patients, it is important to remain healthy and peaceful. Good food with other recommendations on life style, as explained in the above would help in building up our immunity as well as burst the stress for better management in combating against COVID-19.

Brand Reach Customer Speaks

Try MISPA-i3 & Feel The Difference

1 Sony George

Laboratory Manager, Little Flower Hospital & Research Centre, Kochi

I am Sony George, working at Little Flower Hospital & Research Centre as Laboratory Manager. My experience with Agappe started in 2012 & Mispa i2 laid foundation for that. Later when I joined this organisation I could experience the performance of Mispa i3.With Mispa i3 we could perform 3, 4 parameters which we were outsourcing economically. Major advantage of Mispa i3 is smart card calibration which avoids the need of lengthy manual calibration process. Every reagent kit comes with a smart card which help in error free calibration. The individual reagent cartridge system ensured zero reagent deterioration and also the smaller pack size of 10 T is really helpful for laboratories with lower volumes. Also results are highly reliable & inter lab comparison results are also highly correlating with less than 10% deviation. C3, C4 & hsCRP are the 3 parameters which we were outsourcing, Mispa i3 helped us to report these parameters faster. We am really satisfied with the service provided & reagent supply is also flawless. Even during COVID 19 pandemic Agappe coordinated really well without creating us any inconvenience. The service team used to visit periodically to ensure high performance of the equipment. We could work with Mispa i3 for the past 1.5 years without any inconvenience. We are highly satisfied with Mispa i3. You can also try Mispa i3 & feel the difference compared to other protein analysers in the market. We highly recommend Mispa i3.

Proud To Use A Made In India Product Hi friends, We have installed Mispa Count X in our hospital laboratory on 23rd September 2020 and happy to say that we are satisfied with the performance of the machine. Mispa Count X which is indigenously manufactured by Agappe Diagnostics provides quality test results. Proud to use a made in India product.

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Dr. Suresh Roy, Director, Purple Patch Hospital Bangalore

OCTOBER - DECEMBER 2020

Cover Story Good Laboratory Practices

ANTIGEN TEST USING LATERAL FLOW IMMUNOASSAY

Rapid screening of the masses is the key factor in controlling a pandemic. Generally, the screening is done using ready to use lateral flow immunoassay cards with visual reading. The lateral flow immunoassay (LFA) was developed in 1956 by Plotz and singer, which was originally derived from latex agglutination-based assay and was first used for rheumatoid arthritis. In the early stages the lateral flow systems are mainly used for human pregnancy test using urine samples based on the human gonadotropin. Let us see how it works for Covid-19. Sanjaymon K R, General Manager, Business Development, AGAPPE

The Global COVID-19 pandemic created new window in the IVD industry. This created a shift in the growth rate of classical segments in the industry and today Molecular diagnosis and rapid diagnostic market is moving at a faster rate than ever imagined.

Rapid screening of the masses is the key factor in controlling a pandemic. Generally, the screening is done using ready

to use lateral flow immunoassay cards with visual reading. The lateral flow immunoassay (LFA)was developed in 1956 by Plotz and singer, which was originally derived from latex agglutinationbased assay and was first used for rheumatoid arthritis. In the early stages the lateral flow systems are mainly used for human pregnancy test using urine samples based on the human gonadotropin. The technology is based on the capillary movement of fluids in a membrane (nitrocel lulose) coated with specific Antigen or Antibody conjugate. The proteins present in the sample gets attached to the coated membrane and gives a visual band which can be easily recognized by the user. The assay comes in the form of a card format with clearly marked sample d ispensing area, test reading area and sample ID area for ease of use. The test usual ly requires less than 30 minutes

TECHAGAPPE

OCTOBER - DECEMBER 2020

and does not require any specific instrument to perform. From the 1980s till date the technology was evolved into a bigger segment and become one of the major segment in the infectious disease control. Today LFA is used for testing pathogens, drugs of abuse, hormones, and metabolites etc. from human or veterinarysamples. With the introduction of high-resolution reflectance photometry systems, the LFA assays are now also used in quantitative detection of cardiac markers, sepsis markers using immunofluorescence technique. The LFA systems are now available in the form of Cards or dipsticks based on the application. The LFA was first used to detect a single pathogen and today there are LFA assays capable of detecting one to multiple pathogens in the same card itself making it one of the most competitive system for the mass screening of infectious diseases like HIV, HbsAg, Malaria , Dengue . Leptospira and Drugs of Abuse etc. Because of the above LFA systems has got wide acceptance in the industry. The importance of Rapid testing using the LFA based cards increased in this pandemic and the Antigen Testing cards are becoming the necessity of the day. Since the disease is highly contagious, care should be taken while performing the test. Protective devices: The laboratory should make sure that the

The importance of Rapid testing using the LFA based cards increased in the COVID-19 pandemic and the Antigen Testing cards are becoming the necessity of the day.Since the disease is highly contagious, care should be taken while performing the test.

persons performing the tests are strictly ad hering to the guidelines on the personnel protective equipmentâ&#x20AC;&#x2122;s and these equipmentâ&#x20AC;&#x2122;s are disposed off as per the guidelines Sensitivity of the test: The sensitivity of the test depends on the viral load in the sample. The nasal swab needs to be collected in the way as described by the manufacturer and should be treated immediately with reagents as per the kit insert. It is recommended to process the sample immediately upon collection of the swab to get good results. Area of testing: The area of testing needs to be disinfected as per the guideline to elude cross contamination between the samples. In case of any spillage of sample while testing the same needs to be disinfected immediately before taking other sample. Studies shows that the COVID-19 Antigen test is usually positive within 2 to 10 days after infection. After two weeks of infection, the antigen test may get negative result based on the patient and can show a positive report in the RT-PCR which confirms late infection. The technology of protein purification has evolved a lot in the last two decades and the highly specific and highly pure monoclonal antibodies are pawing a new road in the LFA segment. This helped to bring in other antigen assays to screen Dengue and Malaria the two most common infectious disease in the continent. Even though the LFA assays are simple to perform except the HCG tests, the testing cards used for testing other infectious diseases should be considered as highly contagious and should be disposed of as per the local government regulations.

TECHAGAPPE

OCTOBER - DECEMBER 2020

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Editorial Feedback 1. First indigenously manufactured hematology analyzer in India? ........................................ (Refer Pag No. 3) 2. The Agappe partner in Mispa Count X Development? ........................................(Refer Pag No. 11) 3. The common laboratory test used in diagnosing deep vein thrombosis? ........................................(Refer Pag No. 29) 4. The test used for diagnosing Cytokine storm? ........................................(Refer Pag No. 30) 5. The first patented nephelometric analyzer in India? ........................................(Refer Pag No. 31) 6. Early marker or indicator of infections and inflammations? ........................................(Refer Pag No. 28)

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Life Stories Good Laboratory Practices

OCTOBER - DECEMBER 2020

Health Tips Interviews

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Critically ill COVID-19 patients may be at high risk for developing renal failure, venous blood clots, and other complications associated with blood clots, such as stroke, researchers have emphasised on the need for early screening. LOW REAGENT VOLUME AUTO CUVETTE DETECTION OPEN SYSTEM

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LET’S FIGHT TOGETHER... Printed and Published by Ms. Meena Thomas on behalf of Agappe Diagnostics Limited and Printed at Five Star Offset Printers, Nettoor, Cochin-40 and published from Agappe Diagnostics Limited, “Agappe Hills”, Pattimattom P.O, Ernakulam district, Kerala-683 562. Editor is Ms. Meena Thomas. RNI No.: KERENG/2015/62113

Sharp for accuracy and smooth in procedure open to all and no closed loops bright as future and simple as present

Techagappe 25th Edition (October-December 2020) Ebook

Articles inside

Pregnancy During Covid-19: Affects Mother and Baby?

Adding New Dimensions to Selfless Social

Role of Laboratory Tests in Covid-19 Prognosis

Sutharya Healthcare and Diagnostics One of Kerala’s Pioneers in Professional Diagnostics - Interview

Covid-19: Current Trends in In-Vitro Diagnostics

If everything goes well, Vaccine will be ready by early 2021- Chat with Dr. Soumya Swaminathan -WHO

Covid-19: Vaccine Development