Labmedica International September 2017

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W O R L D ’ S C L I N I C A L L A B O R AT O R Y N E W S L E A D E R ISSN 1068-1760

Vol. 34 No. 5 • 8-9/ 2017

DAILY CLINICAL LAB NEWS

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Blood Test Predicts Vaccine Immunogenicity blood test early after vaccination can predict whether vaccines based on living, modified viruses have had the desired effect within seven days of vaccination.

A new study on systems analysis of immune responses induced by a highly promising vaccine against Ebola, as a couple of possible vaccines

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New Technique Tests Therapies For Cancer Metastasis new laboratory technique can rapidly test the effectiveness of treatments for life-threatening, breast cancer metastases in bone. Until now, there has not been an effective laboratory platform to study metastatic tumors in their new microenvironment.

In the clinic, primary breast tumors are usually surgically removed

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soon after diagnosis, leaving patients “tumor-free.” However, 20% to 40% of breast cancer survivors will eventually suffer metastasis to distant organs, sometimes years after surgery.

To mimic the interactions between metastatic breast cancer cells and bone cells in a living system, a test has been developed, called bone-in

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Image: Courtesy of Thermo Fisher Scientific

Clinical Mass Spectrometry Comes of Age: World's First Fully-Integrated Analyzer A

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novel rapid assay applies a nicking-enzyme amplification reaction to easily and rapidly detect respiratory syncytial virus (RSV) in children hospitalized with acute respiratory-tract infections.

Respiratory syncytial virus is a common

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DiaSorin to Acquire Siemens' ELISA Immunodiagnostics Business

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iaSorin S.p.A. (Saluggia, Italy; www.diasorin.com) has entered into an agreement to acquire Siemens Healthineers’ (Erlangen, Germany; www.healthcare. siemens.com) micro-titre-based ELISA immunodiagnostic business portfolio and related tangible and intangible assets, including customer

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here is an urgent need to develop biomarker strategies to a priori identify castration-resistant prostate cancer (CRPC) patients who will derive minimal benefit from androgen receptor (AR) targeting and offer them an alternative treatment paradigm.

The androgen receptor is known to play an important role in helping cancers to become resistant to treatment with abiraterone and enzalutamide, which are standard treatments for

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ealthcare professionals should consider a person’s blood group when assessing their cardiovascular risk as people with A, B, and AB blood types may be at greater risk of cardiovascular events, particularly heart attacks, than individuals with O blood types.

There are some risk factors for heart attack that can be addressed, such as a poor diet, lack of exercise, and smoking. However, some heart Cont’d on page 6

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Novel Assay Detects RSV in Children

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Test Predicts Benefit of Targeted Cancer Treatments

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Image: Product demonstration at AACC Clinical Lab Expo 2017

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Blood Group May Affect Heart Attack Risk

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next-generation diagnostic system brings together the convenience of clinical analyzers with the selectivity and sensitivity of liquid chromatography-tandem mass spectrometry (LC-MS/MS). The fullyautomated Cascadion SM clinical analyzer may be operated by lab staff with no special training in the technology.

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sales and distribution contracts, installed base of instruments and relevant intellectual property.

DiaSorin develops, produces and markets reagent kits for IVD worldwide, and offers a broad range of specialty tests in the immunodiagnostics Cont’d on page 33

Clinical News . . . . . . . . . 4-26 IFCC News . . . . . . . . . . . . . 27 Product News . . . . . . . 14-26 Industry News . . . . . . . . . .33 International Calendar . . . 34 PUBLISHED IN COOPERATION WITH

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Clinical Mass Spectrometry Comes of Age: World's First Fully-Integrated Analyzer next-generation diagnostic system, brings together the convenience of clinical analyzers with the selectivity and sensitivity of liquid chromatography-tandem mass spectrometry (LCMS/MS). The fully-automated Cascadion SM Clinical Analyzer system was developed by Thermo Fisher Scientific (Waltham, MA, USA; www.thermofisher.com) for use by non-experts in a variety of clinical settings including hospital laboratories, and to provide results for a range of frequently ordered clinical diagnostic tests.

The new Cascadion SM Clinical Analyzer (www. thermofisher.com/Cascadion) was presented to the European market at the EuroMedLab 2017 meeting last June in Athens, Greece, and unveiled to the US ciinical lab community at this year's AACC Clinical Lab Expo held in August at San Diego, CA. As a major benefit, the system can be operated by clinical laboratory staff without special training in LC-MS/MS technology.

Assays in development for the Cascadion system include those for 25OH Vitamin D, Total Testosterone, and a panel of Immunosuppressant drugs. Such diagnostic tests are projected to be launched once appropriate regulatory requirements for each country or region have been fulfilled. Development pipeline for the system includes tests for therapeutic drug monitoring, drugs of abuse, and endocrinology.

"This is a marvelous development, and it is really quite outstanding. It will fulfill the needs of many laboratories," said Prof. Brian Keevil, consultant clinical scientist and head of the Clinical Biochemistry Department, University Hospital of South Manchester NHS Foundation Trust, UK, after viewing a demonstration during EuroMedLab 2017.

James Nichols, PhD, medical director, Chemistry and Point of Care Testing, Vanderbilt University Medical Center, added, "For much of what we do in terms of chromatography and mass spectrometry, we need very highly skilled and experienced medical technologists. The Cascadion analyzer is relatively maintenance-free and because it includes specially designed reagent kits, there is not a

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lot of interaction required with the technology."

The Cascadion SM Clinical Analyzer system combines assays, software, accessories, consumables, support, and service in a stand-alone system designed to meet the regulatory requirements for routine and specialized clinical testing. The fully-automated sample-in and result-out system incorporates advanced development features including: gold standard mass spectrometry technology, complete assay kits for standardized results, traceability of results to reagent lots, automated sample preparation, LIS connectivity to maximize productivity, a turnkey solution from one supplier for easy implementation, and random access workflow for fast turnaround times.

The Cascadion system was designed and built using Thermo Fisher products and technologies combined with its industry-leading expertise in mass spectrometry. Tandem mass spectrometry, also known as MS/MS or MS2, involves multiple steps of mass spectrometry selection, with some form of fragmentation occurring in between the stages. In a tandem mass spectrometer, ions are formed in the ion source and separated by mass-to-charge ratio in the first stage of mass spectrometry (MS1). Ions of a particular mass-to-charge ratio (precursor ions) are selected and fragment ions (product ions) are created by collision-induced dissociation, ion-molecule reaction, photodissociation, or other process. The resulting ions are then separated and detected in a second stage of mass spectrometry (MS2).

After previewing the Cascadion analyzer, Michael Vogeser, senior physician and professor of laboratory medicine, University Hospital of Munich, stated "About 70% of all physician's decisions are based on laboratory tests, so the impact on laboratory testing is huge and this completely new technological approach is of enormous value to mankind."

While the instrument is still in final stages of development and not yet available for sale, CE marking and US FDA 510(k) clearance are currently being applied for by Thermo Fisher Scientific.

Novel Assay Detects RSV in Children cont’d from cover

respiratory virus that usually causes mild, cold-like symptoms and most people recover in a week or two, but RSV can be serious, especially for infants and older adults. RSV is the most important cause of acute respiratory-tract infection in neonates and young children.

Scientists at the University Hospital Heidelberg (Heidelberg, Germany; www.heidelberg-university-hospital. com) used the novel assay on 117 frozen nasopharyngeal swab samples obtained from children hospitalized with an acute respiratory-tract infection. The median age of the children whose samples were used in this study was 12 months (range: two weeks to 17.7 years).

The team used the Alere i RSV assay (Alere Inc, V

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Waltham, MA, USA; www.alere.com) and correctly identified all 49 samples positive for RSV. The assay demonstrated 100% sensitivity (95% confidence interval, CI: 93% to 100%), and 97% specificity (95% CI: 89% to 100%). Testing of 65 negative samples confirmed that 63 samples were true negatives; one falsepositive was incorrectly identified, and one sample was invalid. Positive test results were called after a median amplification time of 108 seconds (range: 102 to 234 seconds), with results obtained more quickly in samples with high viral load. The test results compared favorably with real-time reverse transcription polymerase chain reaction (RT-PCR) testing.

Sarah Valerie Schnee, a medical student and lead author of the study, “The total test duration, including three minutes for heating the lysis buffer, was five minutes for positive results and 13 minutes for negative results. The availability of sensitive, rapid RSV tests is critical to optimize care management, minimize unnecessary antibiotic use, and provide targeted infection control.” The study was presented at the 27th European Congress of Clinical Microbiology and Infectious Diseases on held April 22-25, 2017, in Vienna, Austria.

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Blood Group May Affect Heart Attack Risk cont’d from cover

attack risk factors cannot be changed, such as age, gender, and a family history of heart disease. A new study suggests that blood type should be added to the list. Scientists at the University Medical Centre Groningen (The Netherlands; www.umcg.nl) conducted a meta-analysis of studies that reported participants’ blood types and the incidence of cardiovascular events, including heart attack, heart disease, heart failure, and cardiovascular death. The data included more than 1.3 million adults who were a part of 11 cohorts across nine studies. The investigators used the data to assess how each blood group might impact the risk of coronary events, combined cardiovascular events, and fatal coronary events.

The team identified 771,113 individuals with a non-O blood group and 519,743 individuals with

an O blood group in the analysis of all coronary events. Among people with a non-O blood group, 1.5% (11,437) experienced a coronary event, compared with 1.4% (7,220) of people with an O blood group. In the analysis of combined cardiovascular events, they identified 708,276 people with a nonO blood group and 476,868 people with an O blood group. Among individuals with a non-O blood group, 2.5% (17,449) experienced a cardiovascular event, compared with 2.3% (10,916) who had an O blood group.

The scientists noted the that individuals with non-O blood types have higher concentrations of a blood-clotting protein called von Willebrand factor, which previous studies have linked to thrombotic events. Additionally, they point out that people with non-O blood groups, especially those with an A blood type, tend to have higher

cholesterol levels, which is a known risk factor for poor cardiovascular health. The odd ratio (OR) for combined cardiovascular events was significantly higher in non-O blood group carriers, at 1.09 (95% CI 1.06-1.11).

Tessa Kole, a Master’s degree student and lead author of the study said, “We demonstrate that having a non-O blood group is associated with a 9% increased risk of coronary events and a 9% increased risk of cardiovascular events, especially myocardial infarction. In future, blood group should be considered in risk assessment for cardiovascular prevention, together with cholesterol, age, sex, and systolic blood pressure.” The study was presented at the annual meeting of the European Society of Cardiology, held April 29 to May 2, 2017, in Paris, France.

Molecular Test Rapidly Diagnoses Sepsis apid diagnosis of sepsis in hospitalized patients is crucial because in severe cases, there is an average 7.6% decrease in survival rate per hour from the onset of low blood pressure without effective antimicrobial treatment.

Early identification of a pathogen increases the chance of targeting the correct agent and may avoid misuse of antibiotics. A molecular test has been developed that can rapidly and reliably diagnose sepsis, a potentially life-threatening complication of bacterial infections.

Scientists at the Tongde Hospital of Zhejiang Province (Hangzhou Shi, China; www.zj.gov.cn) designed primers and TaqMan probes that were to be complementary to conserved regions in the 16S rDNA gene of different kinds of bacteria. To evaluate accurately, sensitively, and specifically, the known bacteria samples (Standard strains, whole blood samples) are determined by TaqMan-Based Multiplex real-time polymerase chain reaction (PCR). In addition, 30 blood samples taken from patients with clinical symptoms of sepsis were tested

by TaqMan-Based Multiplex real-time PCR and blood culture.

The investigators found that the mean frequency of positive for Multiplex real-time PCR was 96% at a concentration of 100 colony-forming units (CFU)/mL, and it was 100% at a concentration greater than 1,000 CFU/mL. All the known blood samples and standard strains were detected positively by TaqMan-Based Multiplex PCR; no PCR products were detected when DNAs from other bacterium were used in the multiplex assay. Among the 30 patients with clinical symptoms of sepsis, 18 patients were confirmed positive by Multiplex realtime PCR and seven patients were confirmed positive by blood culture.

The authors concluded that TaqMan-Based Multiplex real-time PCR assay with highly sensitivity, specificity and broad detection range was a rapid and accurate method in the detection of bacterial pathogens of sepsis and should have a promising usage in the diagnosis of sepsis. The study was published on May 17, 2017, in the Journal of Clinical Laboratory Analysis.

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Tumor DNA Blood Test Predicts Advanced Breast Cancer Survival blood test that spots cancer-linked DNA correctly predicted that most of those patients with higher levels of the tumor markers died significantly earlier than those with lower levels.

Epigenetic alterations are among the most common molecular abnormalities in human cancers. DNA methylation does not change the genomic DNA sequence and is a form of epigenetic alteration that is heritable during DNA replication. Tumors commonly release aberrant DNA into the bloodstream, and this can now be detected.

A team of scientists led by those at Johns Hopkins University School of Medicine (Baltimore, MD, USA; www.hopkinsmedicine.org) prospectively analyzed blood samples collected from 141 women with advanced breast cancer that had spread to other organs who were beginning a new treatment at seven cancer centers in the USA, including The Johns Hopkins Hospital. The scientists collected the samples at the start of therapy, four weeks later and when the women’s cancers were “restaged,” usually after 12 weeks.

The investigators used the new quantitative multiplex assay (cMethDNA) to measure duplicate samples of a methylation panel from a previously published 10-gene panel in 300 mL of serum. In addition, a set of identical quality control pooled specimens from approximately 5% of the total samples was inserted into every batch to assess inter- and intrabatch reproducibility. The test searches for evidence of so-called hypermethylation, a type of chemical tag affixed to DNA in one or more of six breast cancer-specific genes. Biologically, hypermethylation often silences genes that keep runaway cell growth in check, and its appearance in the DNA code of breast cancer-related genes shed into the blood may indicate that a patient’s cancer growth is increasing and the disease has worsened.

Because progression-free and overall survival are distinct outcomes, the cutoff value for women with high versus low levels of cancer DNA in their blood in relation with the outcome was different for progression-free and overall survival. Among 128 of the 141 patients, the scientists found that the median progression-free survival of 71 patients identified with high levels of cancer DNA in their blood was 2.1 months, compared with 5.8 months for 57 patients with low levels. In 129 patients, median overall survival for 62 patients identified with high levels of cancer DNA in their blood was 12.3 months, compared with 21.7 for 67 patients with low levels. Median follow-up of the women in the study was 19.5 months (range 0.8-86.3 months). By the end of the seven-year study period, nearly all the women enrolled in the study had died of their metastatic cancer.

Sara Sukumar, PhD, a professor of Oncology, who helped develop the test, said, “What we see is an association between shorter periods of progression-free survival and overall survival in patients whose blood has higher levels of hypermethylated DNA, and we can see this very early on, after just four weeks of treatment.” The study was published in the February 2017 issue of the Journal of Clinical Oncology.

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Image: The new quantitative multiplex assay (cMethDNA) (Photo courtesy of Johns Hopkins Kimmel Cancer Center).

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Test Predicts Benefit of Targeted Cancer Treatments cont’d from cover

men whose cancer is resistant to traditional hormone blocking therapy and has spread round the body. A large international team of scientists collaborating with those at the Institute of Cancer Research (London, UK; www.icr.ac.uk) analyzed blood samples from 265 men with advanced prostate cancer who were being treated with abiraterone or enzalutamide, either before or after docetaxel chemotherapy. In two cohorts, patients were required to have histologically confirmed prostate adenocarcinoma without neuroendocrine differentiation, progressive disease despite ‘castration levels’ of serum testosterone of less than 50 ng/dL. Serum prostate-specific antigen (PSA) was assessed within one week of starting treatment and monthly thereafter. Circulating DNA was extracted from one to two mL of plasma with the QIAamp Circulating Nucleic Acid Kit (Qiagen, Hilden, Germany; www.qiagen.com).

Rare mutation detection assays were performed for the AR mutations. Emulsi-

fied polymerase chain reaction (PCR) reactions were run on a Mastercycler Nexus GSX1 (Eppendorf, Hamburg, Germany; www.eppendorf.com) and Droplet Digital PCR samples were read on a Bio-Rad QX200 droplet reader (Bio-Rad, Hercules, CA, USA; www.bio-rad.com).

In the primary trial of 171 patients, men in whom a blood test detected multiple copies of the gene that carries the instructions for making the androgen receptor were four times more likely to die over the course of the study than those who did not. The study included both patients who had previously received chemotherapy and those who did not. The findings were confirmed in a second group

of 94 patients where men with multiple copies had an eight-fold shorter response to treatment than men with one or two copies of the gene.

Gerhardt Attard, MD, PhD, a clinical scientist and team leader of the study said, “We have developed a robust test that can be used in the clinic to pick out which men with advanced prostate cancer are likely to respond to abiraterone and enzalutamide, and which men might need alternative treatments. Our method costs less than GBP 50, is quick to provide results, and can be implemented in hospital laboratories.” The study was published on May 3, 2017, in the journal Annals of Oncology.

Molecular Test Predicts Blood Cancer Patient Survival echnology that can detect the length of small DNA structures in cancer cells could hold the key to predicting the outcome of patients with two different types of blood cancer. The test, used in conjunction with current methods, may help doctors make better choices about the most appropriate and effective treatment option for individual patients.

Telomeres are protective stretches of DNA that cap the end of chromosomes, and act like plastic tips on shoelaces preventing chromosome ends from fraying and sticking to each other. Every time a cell divides the telomeres gradually shorten and eventually leave the chromosome ends exposed, triggering large-scale DNA damage that accelerates cancer progression and drug resistance.

A team of scientists led by those at Cardiff University (Cardiff, UK; www. cardiff.ac.uk) used high-resolution single telomere length analysis (STELA) to examine the potential role of telomere dysfunction in 80 myelodysplastic syndrome (MDS) and 95 de novo acute myeloid leukemia (AML) patients. After extracting chromosomes from the patients’ cancer cells, the team measured telomere length in each sample using the STELA technology they had previously developed. Telomere length was then checked against patients’ medical records to analyze its impact on disease progression and survival. The study was published on May 9, 2017, in the British Journal of Hematology.

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Genetic Test Determines Patients Sensitivity to Cancer Drug he identification of genetic biomarkers of synthetic lethal drug sensitivity effects provides one approach to the development of targeted cancer therapies. Testing for a gene commonly mutated in ovarian cancers could pick out patients who will respond well to a promising new class of cancer drugs.

Oncogene activation can induce replication stress and reliance upon an Ataxia-Telangiectasia protein (ATR) checkpoint function and this provides one rationale for the use of small molecule ATR inhibitors (ATRi) as cancer therapeutics.

A team of scientists at the Institute of Cancer Research (London, UK; www.icr.ac.uk) have demonstrated that defects in AT-Rich Interaction Domain 1A (ARID1A) sensitize tumor cells to clinical inhibitors of the DNA damage checkpoint kinase, ATR, both in vitro and in vivo. The team used a multiplicity of techniques including cell

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lines, ribonucleic acid screening, Western blots and antibodies, cellular viability assays, and immunofluorescence using a confocal microscope (Leica, Wetzlar, Germany; www.leica.com). Some samples were analyzed on a BD LSR II flow cytometer (BD Bioscience, Franklin Lakes, NJ, USA; www.bdbiosciences.com).

The scientists found that found that ATR inhibitors stopped cancer cells with ARID1A mutations from growing, both in culture dishes and in mice. They also found that switching off the ARID1A gene in breast and bowel cancer cells greatly increased their sensitivity to ATR inhibitors. They found the treatment killed cancer cells with ARID1A mutations through a process called ‘synthetic lethality’. Patients on clinical trials of ATR inhibitors could now start to be tested for ARID1A mutations in their tumors in order to assess whether those with the genetic defects are

particularly likely to benefit.

Justine Alford, PhD, a senior science information officer for Cancer research UK, said, “By identifying a potential way to exploit a specific genetic vulnerability in cancer this study could point the way to tailoring treatments to each patient, helping to make them kinder and more effective. The next steps will be to better understand the effects of targeting this weakness, and to find out whether this promising strategy will work in people.” The study was published on December 13, 2016, in the journal Nature Communications.

New Biomarker Reported for Severe Intracerebral Hemorrhage he association between high serum levels of vascular endothelial growth factor (VEGF) and clinical outcomes of intracerebral hemorrhage (ICH) patients has been investigated.

Although brain edema caused by ICH is more severe than cerebral ischemia and it is usually associated with poor prognostic results, few studies have been conducted on how VEGF influences brain edema resulted from ICH. Scientists at the Hebei Medical University (Hebei, China; www.hebmu.org) recruited a total of 82 patients including 56 males and 26 females with a mean age of 61.4 ± 4.7 (range: 41~80). A total of 78 healthy subjects, who participated in health examinations in the same hospital during the same period were recruited as the control group with a mean age of 60.2 ± 1.3, (range: 4578). Patients were divided into group A (less than 20 mL), group B (20-30 mL), and group C (greater than 30 mL) based on the bleeding amount. ICH patients were also categorized into the mild group (1-15) moderate group (16-30), and severe group (31-45).

The serum levels of VEGF in acute ICH patients detected at 24, 48, and 72 hours were obtained using an enzyme-linked immunosorbent assay (ELISA) kit (Jingmei BioTech, Shenzhen, China; www. jingmei.com), and then compared with the control group. Main clinical outcomes were evaluated using the modified Rankin scale at 90 days. The serum levels of VEGF were significantly higher than those in the control group.

The serum levels of VEGF in group C were specifically higher compared with those in other two groups. The severe group exhibited higher levels of VEGF than the other two groups. VEGF levels in patients with good outcomes were much higher than those in patients with poor outcomes. The results indicated that the optimal cut-off value of VEGF at 72 hours for predicting good outcomes was 111.2 pg/mL with 91.5% sensitivity and 98.7% specificity. The authors concluded that that the elevated serum levels of VEGF were associated with pathogenesis of ICH and because of which, VEGF could be a new marker in ICH for severity. The study was published on December 20, 2016, in the Journal of Clinical Laboratory Analysis.

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Blood Test Predicts Vaccine Immunogenicity cont’d from cover

have been proposed, and this can inform and accelerate rational development of other new vaccines based on living viruses. One of the vaccines, which is based on a recombinant vesicular stomatitis virus expressing the glycoprotein of the Zaire strain of the Ebola virus (VSV-ZEBOV), was recently shown to be extremely effective with 100% efficacy against the lethal Ebola virus disease in studies carried out in Guinea and Sierra Leone.

A large team of international scientists collaborating with those at the Geneva University Hospitals and Faculty of Medicine (Geneva, Switzerland; www.hug-ge.ch) examined plasma samples from 115 healthy volunteers from Geneva who received low-dose (LD) or high-dose (HD) vaccine or placebo. Fifteen plasma chemokines/cytokines were assessed at baseline and on days 1, 2 to 3, and 7 after injection.

Significant increases in monocyte-mediated MCP1/CCL2, MIP-1β/CCL4, IL-6, TNF-α, IL-1Ra, and IL-10 occurred on day one. The study includes 190 healthy individuals from Africa and Europe.

By longitudinal analysis blood samples retrieved from persons who have received the Ebola vaccine, the team could show that a group of cytokines measured in plasma within seven days of the vaccine injection correlates with antibody responses developed six months later. The cytokine signature was also shown to correlate with vaccine reactogenicity observed in some volunteers. A signature explaining 68% of cytokine/chemokine vaccine-response variability was

identified. Its score was higher in HD versus LD vaccinees and was associated positively with vaccine viremia and negatively with cytopenia. It was higher in vaccinees with injection-site pain, fever, myalgia, chills, and headache; higher scores reflected increasing severity. In contrast, HD vaccinees that subsequently developed arthritis had lower day one scores than other HD vaccinees.

This signature, which reveals monocytes’ critical role in rVSV-ZEBOV immunogenicity and safety across doses and continents, should prove useful in assessments of other vaccines. The study was published on April 12, 2017, in the journal Science Translational Medicine.

New Technique Tests Therapies for Cancer Metastasis cont’d from cover

culture array, by fragmenting mouse bones that already contain breast cancer cells. Scientists at the Baylor College of Medicine (Houston TX, USA; www.bcm.edu) and their colleagues determined that the bonein culture maintains the micro-environmental characteristics of bone metastasis in living animal models, and the cancer cells maintain the gene expression profile, the growth pattern and their response to therapies. Using the bone-in model, the investigators determined that the drug danusertib preferentially inhibits bone metastasis.

They also found that other drugs stimulate the growth of slow-growing cancer cells in the bone. In addition to determining the effect of drugs in the growth of metastasis in bone, the bone-in culture can be used to investigate mechanisms involved in bone colonization by cancer cells.

In the future, the scientists expect to develop this platform into a standardized system that can be used in the clinic to find specific drugs that can better treat metastatic cancer. Xiang Zhang, PhD, an associate professor of molecular and cellular biology and lead investigator said, “We have created a system in which we can mimic the interactions between cancer cells and bone cells, as bone is the place where breast cancer, and many other cancers too, disseminates most frequently.

We have developed a system that allows us to test many different drug responses simultaneously to discover the therapy that can selectively act on metastatic cancer cells and minimize the effect on the bone.” The study was published on April 21, 2017, in the journal Nature Communications.

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Titin Gene Mutation Increases Risk of Heart Failure reviously thought to affect only patients with dilated cardiomyopathy, researchers have discovered that truncating variants in the gene for the protein titin also adversely affect heart function in healthy individuals, placing them at higher risk under conditions of stress.

The finding, from a multinational study by researchers from Singapore, the UK, and Germany, may help understand a long observed paradox: that many people carry this mutation with no apparent effect. The key, the team now suggests, is that the hearts of such people may be “primed to fail” if they also suffer from a second relevant condition, whether a genetic or environmental stress.

The study was led by the National Heart Centre Singapore in collaboration with Duke-NUS Medical School, Medical Research Council (MRC) Clinical Sciences Centre, Imperial College London, and Max Delbrück Center for Molecular Medicine in the Helmholtz Association (MDC).

“We now know that the heart of a healthy individual with titin gene mutation lives in a compensated state and that the main heart pumping chamber is slightly bigger. Our next step is to find out the specific genetic factors or environmental triggers, such as alcohol or viral infection, that may put certain people with titin mutations at risk of heart failure,” said co-senior author Prof. Stuart Cook, of Sing Health Duke-NUS Academic Medical Centre.

Dr. Antonio de Marvao, clinical lecturer at Imperial College London (London, UK; www3.imperial. ac.uk) and MRC, added: “Our previous work showed that mutations in the titin gene are very common in people diagnosed with heart failure.

Around 1% of the general population also carries these mutations, but until now it wasn’t known if these are ‘silent’ gene changes or changes that can adversely affect the heart. Using state-of-the-art cardiac MRI, we created extremely detailed 3D “virtual hearts” from the scans of 1,409 healthy adults. We

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found that those with mutations have an enlarged heart, and in a pattern similar to that seen in heart failure patients.”

Dr James Ware, clinical senior lecturer at Imperial College London and MRC, said: “For patients with dilated cardiomyopathy, this study has improved our understanding of the disease, revealed possible new targets for drugs and other new therapies, and importantly has improved our ability to diagnose the condition confidently with genetic tests. This work required a very collaborative approach, with many institutions involved in assembling genetic data from tens of thousands of individuals. The finding that titin mutations are affecting the hearts of so many otherwise apparently healthy people worldwide, and potentially increasing their risk of heart failure, poses even pressing questions, such as why some people with these mutations seem to do well in the long term, while others do not. Fortunately, we are in a strong position to tackle these questions from lots of different angles, by analyzing aggregated genetic and clinical data from a network of collaborating units around the world.”

The researchers studied the effects of titin gene mutations in 2,495 patients with dilated cardiomyopathy. They also generated two rat models to understand the impact of these mutations on the molecular level and heart function. In addition, cardiac gene sequencing tests were performed in 1,409 healthy volunteers, coupled with 2D and 3D cardiac magnetic resonance imaging (MRI) that gave high-resolution information on the heart size and shape of the study subjects. The data collected gave major new insights allowing to better understand the variants that represent the commonest genetic cause of dilated cardiomyopathy, yet are prevalent in the general population.

First-author Prof. Sebastian Schäfer, National Heart Centre Singapore, explained: “We could directly show the impact of the mutations on the titin

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protein production which has an impact on the heart. Even though the heart appears healthy initially, it reacts to this genetic stress on many levels such as changes to its gene expression and energy source.

The heart can compensate and its cardiac function remains fine until an additional stressor occurs.

That’s when the heart fails, as it no longer has the capacity to react the same way a healthy heart does.”

Co-senior author Prof. Norbert Hübner, Max Delbrück Center, added: “By using a variety of genomic approaches we showed that the RNA that is produced from the actual titin allele which carries the mutation, is degraded in the cells of the heart.

This led to important insights on how these titin mutations operate.”

Currently, patients with inherited cardiac conditions can undergo a cardiac genetic test to screen for 174 genes in 17 such conditions, for diagnosis and thereby for prescribing effective treatment.

The study, by Schafer S, Marvao A, et al, was published online November 21, 2016, in the journal Nature Genetics.

Image: The discovery that carrying titin gene mutations also adversely affects heart function in apparently healthy individuals, suggests that the hearts of such people may be “primed to fail” if they also suffer from a second relevant condition (Photo courtesy of Imperial College London).

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PRODUCT NEWS ANAEROBIC JAR SYSTEM

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IMMUNOTURBIDIMETRIC TEST

LAB SAMPLE FREEZER

Advanced Instruments

DiaSys Diagnostic Systems

Eppendorf

The Anoxomat III features a new jar design that is easier to use and more secure, providing flexibility for lab techs, while maximizing incubator and lab space. The system can create exact and repeatable environmental conditions with low gas consumption, offering substantial cost savings.

The D-Dimer FS test can be used on any clinical chemistry analyzer. Its wide measuring range, high prozone security and excellent sensitivity/ specificity enable accurate exclusion of DVT and PE in individuals with signs or symptoms suggestive of thromboembolic phenomenon.

The CryoCube F740 series features increased capacity, improved energy efficiency, network compatibility, and a considerable noise reduction. Additional options include air-cooling or water-cooling, right-handed or left-handed doors, and three or five interior compartments.

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Point-of-Care System Evaluated for Measuring Cardiac Troponin I easurement of cardiac Troponin-I or Troponin-T (cTnI, cTnT) concentration in blood is required for assessment of patients suspected of Non ST-segment elevation acute myocardial infarction (NSTE-AMI) to support or exclude a diagnosis of acute myocardial infarc-

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tion (AMI).

The measurement of cTnI at the point of care with a short turnaround time (TAT) has the potential to improve patient flow in the emergency department (ED), enabling rapid clinical decision-making. A patient blood sample can be withdrawn and directly

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tested by a doctor, a nurse or a paramedic to provide cTnI concentration during clinical examination.

A European team of clinicians working with Philips Handheld Diagnostics (Eindhoven, The Netherlands; www.philips.nl) collected from patients at four European hospitals three sample types: capillary whole blood from finger stick, Li-heparin whole blood and Li-heparin plasma.

Samples were analyzed by trained users, nurses and research assistants within two hours after the blood was drawn. Frozen samples were sent to the core laboratory at Philips on dry ice for parallel testing on the Beckman Coulter AccuTnI + 3 assay (Beckman Coulter Life Sciences, Indianapolis IN, USA; www.beckmancoulter.com) and the Philips Minicare cTnI for the method comparison study.

The Philips Minicare cTnI consists of a handheld instrument and plastic disposable cartridge. The system makes use of the Philips Magnotech technology, which is based on the precisely controlled motion of magnetic particles (beads) in a small sample volume (typically 30 L). The same magnetic particles also serve as labels that are detected using frustrated total internal reflection (FTIR) imaging. The Minicare cTnI assay is a homogeneous sandwich immunoassay. The traditional liquid manipulation steps of an immunoassay have been replaced by magnetically controlled movements of magnetic nanoparticles within a stationary liquid.

The sample type comparison study

Image: The Minicare I-20 system point-of-care blood test for the rapid diagnosis of a heart attack (Photo courtesy of Philips Healthcare)

between capillary blood, Li-heparin whole blood and Li-heparin plasma samples demonstrated very high correlation coefficients between 0.99 and 1.00, and the method comparison between Minicare cTnI and Beckman Coulter Access, AccuTnI + 3 demonstrated a correlation coefficient of 0.973. No high-dose hook effect was found for samples up to and including a cTnI concentration of 2,000,000 ng/L. The limit of the blank, limit of detection and limit of quantitation at 20% coefficient of variation (CV) were determined to be 8.5 ng/L, 18 ng/L and 38 ng/L respectively. Total CV was found to be from 7.3% to 12% for cTnI concentrations between 109.6 ng/L and 6,135.4 ng/L. The authors concluded that the Minicare cTnI assay is a sensitive, fast and precise test for determination of cTnI that can be used as an aid in the diagnosis of AMI in a near-patient setting on capillary or Li-heparin venous whole blood sample. This offers for the Minicare cTnI test the potential for good clinical performance in the diagnosis of AMI. The study was published online on November 12, 2016, in the journal Clinical Biochemistry.

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PRODUCT NEWS HEMATOLOGY ANALYZER

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CYSTATIN C FS

RISK ASSESSMENT TOOL

Dymind Biotechnology

DiaSys Diagnostic Systems

Ortho Clinical Diagnostics

The DF50 5-Part hematology analyzer provides 23 reportable parameters and 4 research parameters. It also offers a throughput up to 60 tests/hour and supports capillary blood test mode, and the 10.4 inch touch screen display makes daily operation very convenient.

The Cystatin C FS is a particle-enhanced immunoturbidimetric test designed for the early detection of kidney failure. It features outstanding analytical sensitivity, high prozone security and excellent onboard and calibration stability.

The VITROS NephroCheck test is the first fully automated risk assessment tool for predicting Acute Kidney Injury (AKI). The simple urine test has received CE Mark clearance, provides lab results in 16 minutes, and can run on VITROS 3600/5600 immunodiagnostic systems.

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Novel Device May Provide Rapid POC Assessment of Clot Ability esearchers have developed a sensor that, on initial testing, accurately assessed blood-clotting ability 95 times faster than current methods, which uses only a single drop of blood. The device also provided more information than existing approaches.

The new device, “ClotChip,” was developed by researchers at Case Western Reserve University (CWRU; Cleveland, OH, USA; www.case.edu) to provide rapid and accurate assessments essential for providing appropriate care for patients with blood clotting problems. XaTek, a new Cleveland-based company, has licensed the technology for ClotChip with a goal of bringing it to market within three years.

“ClotChip is designed to minimize the time and effort for blood-sample preparation. [It can] be used at the doctor’s office or other points-of-care for patients on anticoagulation therapy, antiplatelet therapy, or who have suffered a traumatic injury causing bleeding,” said Pedram Mohseni, professor of electrical en-

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gineering and computer science (EECS) at CWRU, who led the development of ClotChip with Michael Suster, an EECS senior research associate.

Existing measures typically require patients to visit laboratories where expert technicians administer tests, an approach that typically is time-consuming and expensive. While a few methods exist to allow on-site testing, to date they have not been nearly as precise as laboratory-based methods.

In preliminary tests ClotChip provided results in 15 minutes, as compared to current measures that can take a day or even longer. It also provided more information about the coagulation process, including effects of a relatively new class of drugs – target-specific oral anticoagulants (TSOACs).

TSOACs block clots from forming in a different way than warfarin (e.g. brand name Coumadin). Warfarin can interact negatively with several medications and foods and also requires frequent blood tests to monitor the drug’s effects. The new medications, including rivaroxaban (Xarelto) and apixaban (Eliquis), have been marketed as a far more convenient alternative. To date, however, the US Food and Drug Administration (FDA) has not approved a device to determine the impact of the new drugs.

To monitor clotting, ClotChip uses an electrical technique called miniaturized dielectric spectroscopy, an approach that Prof. Mohseni, Dr. Suster, and team began developing six years ago. In essence, the technique applies an external electric field to the drop of blood, then quantitatively measures how the blood affects that field. The measurements reflect ability of the blood to clot. They then began collaborating with Evi Stavrou, assistant professor of hematology and oncology, Case Western Reserve School of Medicine.

The three researchers are also investigators at Advanced Platform Technology (APT) Research Center.

Image: The portable ClotChip will undergo clinical trials to further assess its ability to rapidly measure blood clotting at point-of-care with accuracy comparable to laboratory testing (Photo courtesy of Case Western Reserve University).

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PRODUCT NEWS CLINICAL ANALYZER

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CHEMISTRY ANALYZER

IMMUNOASSAY ANALYZER

Thermo Fisher Scientific

ELITech Group

BIOKIT

The Cascadion SM brings together the ease of use of clinical analyzers with the selectivity and sensitivity of LC-MS/MS. The fully automated analyzer features turnkey operation and is designed for use in various settings, including hospital labs, to provide results for a range of clinical tests.

The Microlab 400 can perform colorimetric, endpoint and kinetic assays, and is fully programmable for reliable results. It can be further enhanced with the addition of the optional incubator to increase standard productivity, making it suitable for primary, STAT or back-up needs.

The DS2 can process two microplates simultaneously with up to 24 tests per profile. Designed for small to medium labs, it features automated sample dispensing with disposable tips, reagent dispensing, microplate washing, time and temp incubations, photometric reading and data reduction.

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Mutation Linked to Impaired Physical and Cognitive Development inding the needle in a genomic haystack: genomic sequencing has revealed a de novo splice site mutation in the brain protein CASK as genetic cause of a child’s FG syndrome-4 and congenital nystagmus.

Researchers at the Translational Genomics Research Institute (TGen; Phoenix, AZ, USA; www.tgen.org) identified the mutation. Researchers from Barrow Neurological Institute and the University of Utah also contributed to the study. The child involved in this study, a 6-year-old boy, was seen at TGen’s Center for Rare

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Childhood Disorders, which helps families identify the genetic source of their children’s medical symptoms.

Upon analyzing the boys genome, the scientists identified a novel mutation that affects CASK, which is key to brain development and signals transmitted by neurons. The boy’s parents and older sister are unaffected.

“Identifying this new CASK mutation helps build our understanding of how these multifaceted disorders occur, and provides insight into how they might be treated in the future,” said the paper’s senior author Dr. Isabelle Schrauwen, assistant professor in TGen’s Neurogenomics Division.

According to the authors, the child’s constellation of symptoms included: developmental delay; feeding disorders, including severe gastro-intestinal and gastro-esophageal complications; and involuntary eye movement, a condition known as nystagmus, which can reduce or limit vision.

Although his IQ and language skills were normal, he had impaired motor development, behavior, and memory.

These clinical features are markers of the rare developmental syndrome FG syndrome-4 (FGS4), and this is the second CASK mutation known to the authors as a cause of FGS4.

More specifically, the boy is sensitive to loud noises, has a need to touch and examine objects intensely, exhibits impaired visual and motion abilities, and impaired memory.

TGen’s Center for Rare Childhood Disorders has sequenced the genomes

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of more than 440 children with rare conditions. This has resulted in a nearly 40% diagnosis rate, nearly 3 times the general rate of diagnosis among this patient population.

“By tracking down the genetic and genomic causes of these mutations, we hope to continue building a body of knowledge that will lead to improvements, for this patient and many others with rare medical disorders,” said co-author Dr. Vinodh Narayanan, medical director of TGen’s Center for Rare Childhood Disorders.

The study, by Dunn P et al, was published January 31, 2017, in the journal American Journal of Medical Genetics.

Image: Researchers have identified a mutation in brain protein responsible for a genetic cause of child-related disorders (Photo courtesy of iStock).

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PRODUCT NEWS PCR DETECTION KIT

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HEMATOLOGY ANALYZER

URINALYSIS SYSTEM

Certest Biotec

Abbott Diagnostics

Siemens Healthineers

The VIASURE MERS Coronavirus RT-PCR kit is designed for specific identification of MERS-CoV in clinical samples. The detection is done in a onestep real-time format where the reverse transcription and the subsequent amplification of specific target sequence occur in the same reaction well.

The Alinity hq is designed to streamline workflow and transform operational performance to help labs and hospitals achieve measurably better healthcare performance. It maximizes throughput and efficiency, and has been designed from the ground-up with user-focused design elements.

The Atellica 1500 combines the CLINITEK Novus and the Atellica UAS 800 into one automated unit for the highest accuracy and efficiency. It allows more samples to be managed using less staff in a shorter time, and streamlines detection of UTIs and early kidney disease.

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Fluorescent Sensor Provides Low-Cost Diagnosis of Cystic Fibrosis new diagnostic test has been developed for cystic fibrosis and the new device provides a cheaper, easier way to detect levels of chloride in sweat, which are elevated in cystic fibrosis patients. Chloride is an essential electrolyte that maintains homeostasis within the body, where abnormal chloride levels in biological fluids may indicate various diseases such as cystic fibrosis (CF).

However, current analytical solutions for chloride detection fail to meet the clinical needs of both high performance and low material or labor costs, hindering translation into clinical settings.

Bioengineers at the Pennsylvania State University (University Park, PA, USA; www.psu.edu) first developed a citrate-based dye that emits fluorescent light.

In the presence of chloride, however, the amount of light given off by the molecule diminishes: the more chloride, the less fluorescence. Sweat from eight healthy and five CF individuals were collected from each arm at a sweat clinic, where sweat from the

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right arm was analyzed by mercuric nitrate titration.

Absorbance spectra for the new test were recorded on an Infinite M200 Pro UV-vis spectroscopy (Tecan, Männedorf, Switzerland; www.tecan.com), and fluorescence spectra were recorded on a FluoroMax-4 fluorospectroscopy (Horiba, Kyoto, Japan; www.horiba.com) at concentrations below 0.1 optical density (OD). After creating a detection system based on this principle, the team compared it to the chloride-detection method currently used in the clinic and found both tests gave similar results. The new test can detect chloride over a wider range of concentrations and, because it’s automated, it avoids the problem of human error.

Seila Selimovic, PhD, program director of National Institute of Biomedical Imaging and Bioengineering (Bethesda, MD, USA; www.nibib.nih.gov), said, “This is an important step towards faster, more reliable diagnosis. The new sensing technology is cheap and easy to apply and, if used as part of a point-of-

care device may allow more clinics to provide early cystic fibrosis tests. That is a great thing for the developed world, but is a game changer for the economically developing world, since early intervention can save lives in dealing with this devastating and all too common disease.” The study was first published online on August 30, 2016, in the journal Chemical Science.

Image: Naturally fluorescing particles in body fluid samples were used to diagnose cystic fibrosis (Photo courtesy of Pennsylvania State University).

Identification of Gene Defects Helps Prostate Cancer Treatment he current method of treating prostate cancer involves identifying gene defects, which could help with the diagnosis of cancer and the development of individualized cancer treatments for patients.

The molecular biology of prostate cancer is now under scrutiny as the goal is to obtain a holistic picture of the disease’s mechanisms and use those mechanisms as a basis for developing new treatments.

Scientists at the University of Tampere (Finland; www.uta.fi) have been studying the molecular mechanisms in prostate cancer, which is the most common cancer among Finnish men and the second most common cancerous cause of death in males. The disease’s underlying mechanisms vary significantly from one individual to the next and therefore, prostate cancer treatments should be designed individually for each patient according to

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their personal clinical picture.

Several new treatments have been developed for prostate cancer in the past ten years. The same problem remains: the inability to predict which treatment will be most effective for each patient. It has been known for some time that prostate cancer growth is stimulated by male hormones called androgens. Hormonal therapy, which prevents the production or effects of androgens, has been the socalled gold standard in treating the advanced form of the disease.

However, prostate cancer can reactivate the androgen receptor-signaling pathway during treatment. Some types of prostate cancer eventually become independent of androgens. The scientists have found a new mechanism related to the activation of the transcription cofactor Hairy and Enhancer of Split 6 (HES6) as the result of gene fusion, which leads to this type of cancer cell devel-

opment. These types of prostate cancer need nonhormonal therapy.

Tapio Visakorpi, MD, PhD, a professor and lead investigator of the study, said, “Recent genome studies have shown that even though prostate cancer initiates in a single cell of origin, several cancer cell subpopulations with different genome types emerge as the disease progresses. This is not a single disease; several mechanisms lead to the emergence of the disease. Therefore, it’s important to identify those genome defects in each patient that occur in all cancer cells, that is, the so-called truncal mutations, and target the treatment to them.

This requires taking multiple samples from the patient. The processing of samples also needs to be improved to make them more suitable for molecular analysis than the current methods. We’ve developed a new processing method for cancerous tissue.”

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Novel Procalcitonin Immunoassay Analytically Evaluated he exact definition of sepsis has changed considerably over time, and remains controversial. This is probably due to the fact that sepsis develops as a continuum of severity, ranging from local infection, through bloodstream propagation to septic shock.

Due to the steadily increasing use of procalcitonin (PCT) measurement for diagnosis and management of bacterial infections, the number of PCT immunoassays available on the diagnostic market has increased in recent years, with automated immunoassays replacing the former manual techniques.

Clinical biochemists at the University of Verona (Italy; www.univr.it) carried out an analytical evaluation of a two-step sandwich immunoassay for PCT in human serum and plasma. This analytical evaluation encompassed the calculation of the limit of blank (LOB), limit of detection (LOD), functional sensitivity, intra- and inter-assay imprecision, confirmation of linearity and a comparison with the ELFA immunoassay Vidas BRAHMS PCT (bioMĂŠrieux, Marcy l Etoile, France; www. biomerieux.com).

The assay evaluated was the Lumipulse G BRAHMS PCT immunoassay (Fujirebio Diagnostics Inc., Tokyo, Japan; www. fdi.com) adapted to be used on the LUMIPULSE G1200 system. The assay is based on ChemiLuminescent Enzyme Immunoassay (CLEIA) technology. Briefly, the PCT molecules present in the test sample bind to monoclonal anti-PCT mouse antibodies and to capture anti-calcitonin mouse antibodies coated on polystyrene beads, thus generating stable immune complexes and the luminescence is monitored at 477 nm. The assay displays an analytical sensitivity of 0.0048 ng/mL, a functional sensitivity of 0.0079 ng/mL and linearity comprised between 0.02 to 85.1 ng/mL and results are available in 30 minutes.

The LOB, LOD and functional sensitivity were 0.001 ng/mL, 0.0016 ng/mL and 0.008 ng/mL, respectively. The total analytical imprecision was found to be 2.1% and the linearity was excellent in the range of concentrations between 0.006 to 75.5 ng/mL. The correlation coefficient with Vidas BRAHMS PCT was 0.995. The diagnostic agreement was 100% at 0.5 ng/mL, 97% at 2.0 ng/mL and 95% at 10 ng/mL, respectively.

The authors concluded that the results of the evaluation of Lumipulse G BRAHMS PCT demonstrate that this technique exhibits excellent analytical performance, among the best of the methods currently available on the diagnostic market for routine PCT measurement. However, the significant bias shown by comparing the two immunoassays studied emphasizes that longitudinal patient monitoring should be always performed using the same immunoassay. The study was published on December 1, 2016, in the journal Practical Laboratory Medicine.

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Image: The LUMIPULSE G1200 is a robust mid-sized fully automated immunoassay instrument (Photo courtesy of Fujirebio Diagnostics).

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PRODUCT NEWS RT-PCR SYSTEM

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HBA1C/VARIANT ANALYZER

CHEMISTRY ANALYZER

Streck Laboratories

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Tecom Science

The Zulu is designed to simplify and expedite the workflow of RT-PCR-based applications and offers unparalleled ramp rates. It combines precise thermal control and accuracy with a sensitive optical system and a 40-cycle PCR reaction completed in less than 20 minutes.

The HB-100 uses the ion-exchange HPLC method (Gold Standard) to deliver rapid and accurate results for HbA1c and HbF in just 90 seconds. It performs direct analysis from the collection tube, does not require any incubation time, and is compatible with LIS and other lab data systems.

The TC9080 features up to 90/120 onboard testing items capacity and 800 tests/hour throughput. It comes with a refrigerated reagent compartment and an 8-step auto washing system, and offers automatic probe cleaning, liquid level detection, clot detection and collision protection.

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Portable Breath Device Could Help Diagnose Diabetes new, portable breath analyzer has been developed that could someday help medical practitioners diagnose diabetes noninvasively without painful pinpricks, needles or other unpleasant methods.

Many studies examining the hallmarks of diabetes in exhaled breath have shown that elevated levels of acetone are strongly linked to diabetes. Detecting the concentrations of any given substance in breath in a simple way, however, is a major challenge as breath contains a complex mix of compounds, including water, carbon dioxide and methane that can throw results off.

Biochemists at the University of Oxford (UK; www.ox.ac.uk) working with the Oxford Medical Diagnostics, Ltd (Begbroke, UK; www.begbroke. ox.ac.uk) developed a portable and compact device for measuring acetone in breath samples. The device features a 7 cm long high finesse optical cavity as an optical sensor that is coupled to a miniature adsorption preconcentrator containing 0.5 g of

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polymer material. Acetone is trapped out of breath and released into the optical cavity where it is probed by a near-infrared diode laser operating at 1670 nm.

The scientists report that with an optical cavity mirror reflectivity of 99.994%, a limit of detection of 159 parts per billion by volume (ppbv) was demonstrated on samples from breath bags. Initial results on direct breath sampling are presented with a precision of 100 ppbv. The method is validated with measurements made using an ion–molecule reaction mass spectrometer. Data was presented on elevated breath acetone from two individuals following an overnight fast and exercise, and from a third individual during several days of routine behavior.

The measurements were a close match to those of the mass spectrometer and covered a wide range of concentrations, including those that would suggest a patient has undiagnosed type-1 diabetes, or have problems controlling their blood glucose.

Adding to the practicality of the device, the scientists say it could be re-used many times. The study was published online on October 18, 2016, in the journal Analytical Chemistry.

Image: A portable and compact breathalyzer device for measuring acetone in breath samples to diagnose diabetes (Photo courtesy of University of Oxford).

Costly Blood Clot Test Has Few Benefits t has been proposed that hospital patients, who have already been diagnosed with venous thromboembolisms or VTEs, do not need a positive genetic test to justify taking medication and making other changes to prevent future ones.

The hereditary thrombophilias are a group of inherited conditions that predispose to thrombosis. Heritable deficiencies of the endogenous anticoagulants protein C, protein S, and antithrombin have been recognized for some years, but their prevalence, even among patients with familial thrombosis, is low.

Scientists at the University of Michigan Medical School (Ann Arbor, MI, USA; www.med.umich.edu) have reviewed the ordering of inherited thromboembolism testing on inpatients. There are several tests for several traits, so patients often get them in com-

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bination, what’s called a hypercoagulable workup.

But if doctors are following guidelines grounded in evidence, the test result should rarely change a patient’s care. Often, it appears, the test gets ordered to satisfy curiosity about why a patient had a VTE, to see if they are among the 7% of Americans with a genetic mutation that makes blood more prone to clot.

So, except in very specific cases where such clots are highly likely, such as women with a family history of clots who are pregnant or getting hormone replacement therapy, there is little reason to do the test at all for inherited thrombophilia.

Ideally, genetic tests to find out whether someone carries a certain genetic trait should be used when there is clear information about the risks, benefits and costs of that test. However the team illustrated the situation by applying this information

to a hypothetical case of a young patient with a VTE but no family history who suffers a pulmonary embolism, a dangerous health emergency where clots form in the lower extremities and travel to the lungs, potentially cutting off oxygen to the body unless treatment starts quickly.

The scientists note the conclusions about VTE prevention and treatment that have been reached by several medical bodies that recommend against giving clot-prevention medication to people with the genetic trait but no VTE history. Lauren Heidemann, MD, an assistant professor of medicine and first co-author, said, “Physicians and patients should resist the temptation to perform costly search for an underlying genetic cause of venous thrombosis.”

The study was published on October 26, 2016, in the Journal of Hospital Medicine.

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Novel Point-Of-Care Test Kit For Procalcitonin Evaluated n response to inflammation, procalcitonin plasma concentrations increase more rapidly than other acute-phase reactants and higher values are associated with severe disease. Procalcitonin measurements assist in determining whether antibiotic therapy should be used.

For rapid diagnosis, point-of- Care test (POCT) is performed for early decision-making about additional testing or therapy. Despite being semi-quantitative, POCT results are helpful in situations when quantitative measurements are required quickly, such as within one to three hours.

Scientists at the Catholic University of Korea (Seoul, Korea; www.medicine. catholic.ac.kr) and their colleagues evaluated a total of 158 specimens, 115 specimens with procalcitonin levels ranging from 0 to 18.96 ng/mL were randomly selected for this study. Ages ranged from 15 to 90 years, with 51.7±19.9 (age mean ± SD) for the 158 samples, 77 males (54.4±19.9), and 81 females (49.1±19.4).

The team used the ABSOGEN PCT (Bumyoungbio, Inc., Suwon, Korea; www.genbionics.com), which is a novel, rapid, and semi-quantitative immunochromatographic POCT assay that analyses whole blood. The study compared patient quantitative test results using the Modular E170 analyzer (Roche Diagnostics, Mannheim, Germany; www.roche. com) to ABSOGEN PCT test results. ABSOGEN PCT Analysis was performed using fresh whole blood sample remnants collected in EDTA tubes for routine complete blood count assays.

The investigators found that the concordance rate between ABSOGEN PCT using the reader and quantitative assay, between ABSOGEN PCT using naked eyes and quantitative assay and between ABSOGEN PCT using the reader and naked eyes for the same category was 83.5%, 78.5%, and 82.3%, respectively. The concordance rates for the ±1 categories were all 100%. Since high procalcitonin levels indicate the immediate need for sepsis therapy, a bedside test that yields results quickly can be critically important. In this situation, the present novel POCT could be useful.

The authors concluded that The ABSOGEN PCT blood procalcitonin test is a very simple and rapid test. The turnaround time is rapid because it uses whole blood; centrifugation is not required and the reaction is rapid. Serum or plasma also can be used. Sample volume for the test is small and no need for dilution. Even though the reaction band is narrow and faint, there is no difficulty in differentiating positive and nega-

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tive, but some effort is needed to differentiate the grades using the naked eye and therefore a reader is recommended. The study was published on December 13, 2016, in the Journal of Clinical Laboratory Analysis.

Image: The ABSOGEN PCT assay: control line (C) and test line (T) of the semi-quantitative kit for the procalcitonin analysis. Negative (<0.1 ng/mL), low (0.1 to <1.0 ng/mL), middle (1.0-2.0 ng/mL), and high (>2.0 ng/mL) (Photo courtesy of the Catholic University of Korea).

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LABORATORY SOFTWARE

ESR ANALYZER

Rayto Life and Analytical Sciences

BioFire Diagnostics

ELITech Group

The RAC-1800 random access analyzer offers a comprehensive test speed of 180 tests per hour using the clotting, chromogenic, and immunologic measuring methods. Other features include auto loader for cuvettes, user-friendly operation software and bidirectional LIS system.

The FilmArray Link Software allows the FilmArray System to interface with an LIS, allowing test results to be electronically transferred. The LIS-interfacing capabilities enable faster turnaround and increased accuracy, while the software optimizes workflow and ensures efficient data management.

The Excyte Mini comes with 10 positions and 30minute test time, and can perform up to 20 sed rate tests per hour. Other features, such as random access and closed tube testing, make the sed rates and quality control easier to run, and ensures safety of laboratory staff.

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Performance of Second Generation Cortisol Assay Evaluated ntreated disorders of the adrenocortical system, such as Cushing’s or Addison’s disease, can be fatal, and accurate quantification of a patient’s cortisol levels is vital for diagnosis. A straightforward diagnostic approach is of essential importance, and accurate quantification of cortisol levels plays a key role in the diagnosis of patients with suspected disease. Cortisol levels are often measured from a patient’s serum or plasma, which reflects total cortisol, both free and bound. However, in patients with liver disease, and for those receiving estrogen treatments or with critical illness, total serum cortisol levels may be difficult to interpret because of the variation in binding proteins.

Laboratory scientists at the Hospital of the University of Munich (Munich, Germany; www. uni-muenchen.de) and their colleagues performed a technical evaluation of the Elecsys Cortisol II assay (Roche Diagnostics GmbH, Mannheim, Germany; www.roche.com) between June and November

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2014 at four European investigational sites: three in Germany (Munich, Heidelberg, and Leipzig) and one in Belgium (Ghent). All sites used cobas e 411 analyzers (Roche Diagnostics Limited, Rotkreuz, Switzerland; www.cobas.com) for the Cortisol II assay experiments and in addition to a cobas e 411 system, the Leipzig site utilized a cobas e 601 analyzer.

The Cortisol II assay was also compared with inhouse isotope dilution liquid chromatography-tandem mass spectrometry (LC-MS/MS) assays.

The team reported that for the method comparison studies, the serum samples covered a measuring range of 1.7 to 1,735 nmol/L and the saliva samples from 1.5 to 209.5 nmol/L. For the 405 serum samples, the agreement between the Cortisol II assay and LC-MS/MS was high, and the mean bias for serum samples measured on the Cortisol II assay compared with LC-MS/MS was 14.55 nmol/L. The correlation coefficient for the relationship between the Cortisol II assays versus LC-MS/MS for 253 sali-

va samples was 0.993, and for these comparisons, the mean bias was 2.56 nmol/L. The authors concluded that for the Cortisol II assay, they observed a degree of between-laboratory and between-production lot reproducibility and agreement with several assays of higher metrological order that they consider compatible with the diagnostic use of this assay. The study was published on November 29, 2016, in the journal Clinical Chemistry and Laboratory Medicine.

Image: The cobas e 411 fully automated, random access system for immunoassay analysis (Photo courtesy of Roche Diagnostics).

DNA Microarray Detects 18 Important Human Blood Protozoan Species ccurate detection of blood protozoa from clinical samples is important for diagnosis, treatment and control of related diseases and developing a rapid, simple, and convenient detection method for protozoan detection is an urgent need. Blood protozoa are single-cell organisms that often have flagella, cilia or other structures that help them move. They sometimes form parasitic relationships with humans and cause diseases or infections.

The most common blood protozoa in humans, animals, and vectors include Plasmodium, Leishmania, Trypanosoma, Toxoplasma gondii and Babesia.

Scientists at Fudan University (Shanghai, PR China; www.fudan.edu.cn) and their colleagues collected a total of 438 samples from humans, animals and vectors from August 2012 to December 2014 as well as 100 blood samples from healthy individuals. Reference blood protozoan samples were either stored in the laboratory or kindly provided by

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different partner laboratories.

The whole blood that was suspected infected Leishmania from human and canine was also tested by the Kalazar Detect dipstick, a recombinant k39 antigen-based immunochromatographic strip, to detect anti-leishmanial antibodies (InBios International, Seattle, WA, USA; www.inbios.com). The team performed microarray assays simultaneously that identified 18 species of common blood protozoa based on the differences in respective target genes. A total of 20 specific primer pairs and 107 microarray probes were selected according to conserved regions, which were designed to identify 18 species in five blood protozoan genera.

The scientists found that the positive detection rate of the microarray assay was 91.8% (402/438).

Sensitivity and specificity for blood protozoan detection ranged from 82.4% to 100.0% and 95.1% to 100.0%, respectively. Positive predictive value

(PPV) and negative predictive value (NPV) ranged from 20.0% to 100.0% and 96.8% to 100.0%, respectively. Youden index varied from 0.82 to 0.98.

The detection limit of the DNA microarrays ranged from 200 to 500 copies/reaction, which was similar to the polymerase chain reaction (PCR) findings.

The concordance rate between microarray data and DNA sequencing results was 100%.

The authors concluded that overall, the microarray platform can provide a convenient, accurate and reliable diagnostic tool for the identification of 18 of the most common blood protozoan species.

The system should be widely used in future detection assay and management of blood protozoan infections in busy hospitals and research institutes, and would help in disease control and prevention plans. The study was published on December 2, 2016, in the Public Library of Science Neglected Tropical Diseases.

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To view this issue in interactive digital magazine format visit www.LinkXpress.com

Screening System Detects Four Metabolic Disorders ysosomal Storage Disorders (LSDs) are a group of rare, inherited metabolic disorders in which enzymes (proteins) that normally eliminate unwanted substances in the body’s cells are not at normal levels or functioning properly. If not detected and treated in a timely manner, these disorders may cause organ damage, neurological disability or death.

A screening test for newborns that is designed to detect Mucopolysaccharidosis Type I (MPS I), Pompe disease, Gaucher disease and Fabry disease has received permission for marketing for these four LSDs. These four LSDs occur in approximately 1 in 1,500 to no more than 1 in 185,000 newborns and children, depending on the disorder. The US Food and Drug Administration (FDA, Silver Springs, MD, USA; www.fda.gov) evaluated data from a clinical study of 154,412 newborns in Missouri whose dried blood samples were tested for protein activity associated with MPS I, Pompe, Gaucher and Fabry. Efficacy was determined because the system was able to accurately identify at least one of each of these four LSDs in 73 of the screened newborns.

The FDA reviewed the data for the Seeker System (Baebies, Durham, NC, USA; http://baebies.com) through the de novo premarket review pathway, a regulatory pathway for devices of a new type with low-to-moderate-risk that are not substantially equivalent to an already legally marketed device and for which special controls can be developed, in addition to general controls, to provide a reasonable assurance of safety and effectiveness of the devices.

The Seeker System, consisting of the Seeker LSD Reagent Kit- IDUA|GAA| GBA|GLA and Seeker Instrument, works by measuring the activity level of proteins required for healthy lysosomal storage found in dried blood samples collected from the prick of a newborn’s heel 24 to 48 hours after birth. The Seeker Instrument is a device that automates the analysis of dried blood spots. Reduced enzyme activity of proteins associated with any of the four LSDs detected by the kit may indicate presence of a disorder. Results showing reduced enzyme activity must be confirmed using other testing methods, such as biopsies, genetic and other laboratory tests.

Alberto Gutierrez, Ph.D., director of the FDA Office of In Vitro Diagnostics and Radiological Health, said, “The Secretary of HHS recently added Pompe and MPS I to the list of routine recommended newborn screening programs and it is anticipated that additional states will begin requiring use of screening tests to detect these disorders. Accurate screening tests will help with early detection, treatment and control of these rare disorders in newborns, before permanent damage occurs. That’s why availability of LSD screening methods that have been assessed for accuracy and reliability by the FDA are so important.”

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Image: The Seeker workstation, a high throughput laboratory solution that measures enzymatic activity from dried blood spot specimens (Photo courtesy of Baebies).

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The Laura M features an evaluation time of 60 seconds, and a capacity of 600 strips per hour. Additional benefits include a memory capable of saving the last 2,000 measurements, making it ideal for use in clinical laboratories.

The GENESIS M2400 DNA/RNA extraction system offers the flexibility of processing 1-24 samples per run, making it ideal for laboratories requiring nucleic acid purification of small- to middlesized sample throughputs.

The Evidence Evolution can process any required workflow including batch analysis, STAT samples, and can run 2,640 tests/hour. Features include continuous sample and reagent loading, automated on-board sample dilution, sample data entry, and a walkaway time of two hours.

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Simple Saliva Test May Help Diagnose Kidney Disease preliminary study suggests that a dipstick test for salivary urea nitrogen could be accurate for diagnosing kidney disease and may help predict patients’ risk of early death. The test would be especially helpful in developing countries where simple and inexpensive tools for diagnosing kidney disease are most needed.

The study was highlighted at the American Society of Nephrology’s (Washington, DC, USA; www. asn-online.org) Kidney Week 2016 (November 1520, Chicago, IL, USA), and summarized in Abstract 5710 under the title “Saliva Urea Nitrogen Dipstick: a simple tool to detect and stratify risk of renal disease in low resource settings.”

Viviane Calice-Silva, MD, PhD, of the Pro-Kidney Foundation in Brazil, and colleagues evaluated the diagnostic performance of a salivary urea nitrogen (SUN) dipstick in Malawi, Africa, a low-re-

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source country. Among 742 adult individuals who were studied, investigators diagnosed 146 patients with kidney disease using standard tests.

High SUN levels were associated not only with the standard diagnostic tests, but also with a higher risk of early death.

“Our data suggest that SUN can improve the detection of kidney disease, increasing the awareness to this devastating complication,” said Dr. Calice-Silva, “Also, higher awareness and detection of kidney disease in low-resource settings may increase the number of patients who are diagnosed and referred, therefore providing appropriate treatment and improving outcomes.”

Image: The saliva test uses the dipstick technique to diagnose kidney diseases (Photo courtesy of Shutterstock).

Cytomegalovirus Infection Predicted in High-Risk Pregnant Women ongenital cytomegalovirus (CMV) infection can cause serious complications such as hearing difficulties and mental delay in affected infants. A new method for predicting congenital CMV infection during the prenatal period has been discovered. This method is safe for both mothers and fetuses, and could potentially be adopted for general use.

In the USA over 8,000 children a year suffer from the long-term complications of congenital CMV infection and the annual costs of caring for these children are estimated at USD 1-2 billions. To facilitate this, early diagnosis is vital; however, tests to identify the infection in infants, such as molecular tests that detect virus DNA in infants’ urine, are not widely carried out, and would incur huge financial costs if they were carried out for all infants.

Scientists affiliated with the Kobe University Graduate School of Medicine (Kobe, Japan; www.kobe-u.ac.jp) surveyed 300 pregnant women

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who tested positive for CMV immunoglobulin M (IgM) antibodies and were classified as high-risk for congenital infection. The team carried out clinical interviews, blood tests, ultrasounds, and DNA polymerase chain reaction (PCR) tests for CMV using samples of the subjects’ blood, urine and uterine cervical secretion. The maternal clinical and laboratory findings, including serum CMV IgM and IgG, IgG avidity index (AI), direct immunoperoxidase staining of leukocytes with peroxidase-labeled monoclonal antibody (C7-HRP test) testing, and PCR for the detection of CMV-DNA in the maternal serum, urine, and uterine cervical secretion, and prenatal ultrasound findings were evaluated.

The team reported that in 22 of the 300 women, congenital infection was confirmed using PCR for CMV-DNA in newborn urine. Univariate analyses demonstrated that the presence of maternal flu-like symptoms, presence of ultrasound fetal abnormalities, serum titers of CMV IgM, positive

results for C7-HRP, CMV IgG AI less than 40%, and positive PCR results in the uterine cervical secretion were statistically associated with the occurrence of congenital CMV infection. Multivariable analysis revealed that the presence of ultrasound fetal abnormalities and positive PCR results in the uterine cervical secretion were independent predictive factors of congenital CMV infection in CMV IgM-positive women.

The authors concluded that both ultrasound and PCR tests for uterine cervical secretion are non-invasive procedures, and using them can offer a safer method to test high-risk pregnant women and predict the occurrence of congenital infection.

Accurately identifying the affected infants enables doctors to start antiviral treatment early, and could improve the neurological prognosis of infants infected by CMV. The study was published online on October, 20, 2016, in the journal Clinical Infectious Diseases.

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Edited by Tahir Pillay MBChB, PhD, FRCPath(Lon), FCPath(SA) IFCC members may send news to: Tahir Pillay MBChB, PhD, Head, Dept of Chemical Pathology, Faculty of Health Sciences, University of Pretoria, Private Bag Bag x323, Arcadia, 0007, South Africa Tel: (27) 012-319-2114; Fax: (27) 012-328-3600; Email: enews@ifcc.org

IFCC WorldLab 2017: New App Provides Access To Posters One Week Prior to Conference

By Prof. Tahir Pillay, e-NewsLetter Editor oster presentations are an integral part of many conferences and in the case of the IFCC conferences are the mainstay of delegate presentations and are accompanied by scheduled poster presentation sessions where the author may be required to be present at the poster and be available to answer questions. There are many challenges with this approach. Depending on the number of posters, the posters may only appear for a day. Often the author may be available or present at the poster. Another major constraint is time. If posters are being judged for the award of a prize, the judges often have to go around and view the posters.

In the now countless times that I have either taken part as a poster presenter or been a judge of posters, it has proven difficult because of time constraints to either view the posters or be present at the posters at the scheduled time. There is almost always insufficient time to view all the posters and poster presenters are disadvantaged by this, especially if they have spent time and effort in producing firstly, the data for the poster and then assembling and printing the physical poster.

For the first time in the history of IFCC conferences, presenters will be asked to make their posters available as PDFs a week prior to the IFCC WorldLab 2017 conference. The PDFs will be available via the conference application/”app”. This will be in addi-

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Dr Rolf Hinzmann Elected IFCC Corporate Representative For 2018-2020 Term he IFCC Nominations Committee is happy to announce that the Corporate Representative in the Executive Board for the period 2018-2020 is Dr Rolf Hinzmann. The term of his position will commence on January 1st, 2018 until December 31th 2020. Thank you to the candidates who actively took part in the IFCC electoral process and best compliments to Dr Hinzmann for his reconfirmed position within the IFCC Executive Board. We wish him a fruitful term in the promotion of clinical chemistry and laboratory medicine world-wide.

The elections have been conducted via an electronic system in order to ensure wider participation in this important moment in the IFCC life.

As the re-elected Corporate Representative at the IFCC Executive Board I would like to give you some information about who I am, how I see my current role.

Cont’d on page 28

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tion to the conventional poster presentation schedule. This means that delegates and judges will be able to view the posters at their leisure and will be able read the posters on their devices or computers. They can also pose questions to the presenters via the “app”. Presenters who submit their posters for the “app” will be eligible for the prize draw. Prizes will be awarded to the three best posters as determined by the judges.

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NEWS

News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine Visit www.ifcc.org for more information

Dr Rolf Hinzmann Elected IFCC Corporate Representative for 2018-2020 Term Contâ&#x20AC;&#x2122;d from page 27

Who I Am: After having studied biochemistry and having completed my PhD in endocrinology I studied medicine and then specialized in what we call "laboratory medicine" in Germany which is something between clinical chemistry and clinical pathology, comprising microbiology as well.

After a period of time at the university lab I moved to the in vitro diagnostic industry in 1996 and worked as a Scientific Marketing Manager for Beckman Coulter. Later I was appointed Medical Director of Sysmex Europe and more than six years ago I moved to Roche Diabetes Care where I am now the Head of Global Medical & Scientific Affairs for Self-Monitoring of Blood Glucose and Continuous Glucose Monitoring.

I've been with the IFCC for sixteen years now, first serving as Corporate Representative in the Executive Committees of the Scientific Division and the Education & Management Division, later as a member of the Task Force on Point of Care Testing. For already more than 2 1/2 years I have been representing the Corporate Members in IFCC's Executive Board.

I've always had a strong interest in standardization, immunodiagnostics, metabolic diseases, evidence-based medicine, philosophy of science, and didactics of medicine.

How I see my role as Corporate Representative in the IFCC Executive Board: A couple of factors have dramatically changed the diagnostic landscape, e.g.: A shortage of money in public health systems and price pressure make it more challenging to find ways that the medical value provided by diagnos-

tic lab tests is adequately reimbursed.

At the same time hurdles for registration of new tests and devices are increasing and the procedures differ from country to country.

With the often very beneficial spread of testing from the central lab to the point of care quality assurance and training become more and more important.

In many countries the recognition of the importance of clinical chemists / clinical pathologists being in charge of lab testing, quality assurance and result interpretation is declining.

Data analytics will provide new opportunities for generation of medical value in laboratory diagnostics and might dramatically change the way we will conduct medicine in the future.

There are various ways how IFCC can support its Corporate Members to address these topics. At IFCC's General Conference in Madrid in April 2016 we had for the first time a session fully organized by the IVD industry. During this session I invited all delegates to submit proposals how IFCC could become more attractive for corporate members. We received around a hundred proposals which were later classified, consolidated, discussed by the IFCC Executive Board, and incorporated into IFCC's Strategic Action Plan. The following lists shows examples that are considered high priority from the Corporate Members' point of view: IFCC needs to better serve the needs of the Corporate Members instead of regarding Corporate Members mainly as a source of income.

IFCC must make it easier for employees of Corporate Members to actively participate in IFCC working groups and committees (and not only as corre-

sponding members).

IFCC needs to more strongly collaborate with clinical societies to harmonize guidelines and support medical claims leading to reimbursement for lab tests.

IFCC needs to align stronger with others (CLSI, FDA, clinical societies, etc.) to avoid inconsistency and duplication of regulatory guidelines and recommendations.

IFCC needs to embrace emerging technologies and data analytics.

IFCC needs to continue providing opportunities for exhibitions, industry symposia and networking with lab professionals during high-level academic conferences, thereby following the rules defined by the IVD industry in the MedTech Europe Code of Ethical Business Practice and other applicable codes to avoid that Corporate Members face challenges when sponsoring and exhibiting at congresses.

In all these areas IFCC and diagnostic manufacturers can achieve more if they collaborate strongly. Both lab professionals and Corporate Members share the final goal to improve the lives of patients worldwide.

In the past 2 1/2 years we have already reached a lot together. On the IFCC Executive Board I will continue being an active, impartial representative, facilitating the collaboration between lab professionals and the Corporate Members.

With kind regards Rolf HinzmannMD, PhD; Clinical Pathologist & Biochemist; Head of Global Medical & Scientific Affairs; Glucose Monitoring and Science. Roche Diagnostics GmbH. Diabetes Care. Sandhofer StraĂ&#x;e 116, 68305 Mannheim,Germany; Phone: +49 621 759 2254, Mobile: +49 173 348 5722, Fax: +49 621 759 78 2254; Email: rolf.hinzmann@roche.com

IFCC-Roche Travel Scholarship Recipients Attend EuroMedLab 2017 in Athens

Photo: (From left to right) Benjamin Chijioke Esogwah, University College Hospital, Ibadan, Nigeria; Santosh Pradhan, Samyak Diagnostics, Kathmandu, Nepal; Prof Vanessa Steenkamp, IFCC EB Liaison for Young Scientists; Padmavathi Parthasarathy, ACS Medical College & Hospital, Chennai, India; Aaron Tembo Konzani, Samfya District Hospital, Samfya, Lusaka, Zambia

FCC and Roche are happy to present the IFCC-Roche Travel Scholarship recipients. They were selected to attend the EuroMedLab IFCC Congress held in Athens. Congratulations to Padmavathi Parthasarathy (Chennai, India); Benjamin Chijioke Esogwah (Ibadan, Nigeria); Aaron Tembo Konzani (Lusaka, Zambia); Santosh Pradhan (Kathmandu, Nepal); Trilis Yulianti (Jakarta, Indonesia).

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IFCC-Roche Travel Scholarship programme enables Young Scientists from emerging countries to attend the major conferences of clinical chemistry and laboratory medicine. Watch the video to see the awardees express their views on the scholarship programme and share their experiences during EuroMedLab 2017, Athens, Greece and an interview with Prof Ferrari, IFCC President, and Dr Beastall, IFCC Past President.

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News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine Visit www.ifcc.org for more information

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THE WORLD OF IFCC

Pakistan Society Holds 8th Annual National Course akistan Society of Chemical Pathologists (PSCP) organized the 8th annual course in Chemical Pathology at CMH Lahore Medical College on 28-29 April 2017.The president and a dedicated team of chemical pathologists made a very successful endeavour of a very scientific and educational programme in these sessions. The inaugural session had a state of the art session on novel Cardiac Markers by Maj. General Ahmed Khan HI (R), Patron PSCP. After that very informative & innovative talks were delivered by our senior chemical pathologists in very well attended sessions covering following topics: Precocious Puberty Short stature and chemical analysis Laboratory safety Acid base balance and albuminuria update ADA recommendations of standard of medical care in diabetes Unveiling the secrets of cushingoid features in infants There were total of three sessions on the first day followed by mock objective structured practical examination (OSPE) exam for trainees. The second day had two sessions including a meet the expert session. The activity targeted the clinicians, pediatricians and post-graduate trainees of Chemical Pathology.

PSCP always keeps the tradition of promoting the academic and research culture in the country and keeps updating the guidelines according to international standards.

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IFCC Welcomes a New Member: Belarus!

By Dr Svetlana Bespalova, National Representative, Belarus Society of Clinical Laboratory Diagnosticians (BSCLD) ational Non-Governmental Organization â&#x20AC;&#x153;Society of Clinical Laboratory Diagnosticiansâ&#x20AC;? is the national professional organization in the sphere of laboratory medicine of the Republic of Belarus and existed from 8 November 2016.

Its main objectives and goals are as follows: Dr Svetlana Development and imBespalova provement of the laboratory service in the Republic of Belarus by uniting the clinical laboratory diagnosticians to provide for coordinated solution of scientific, practical and organizational tasks; Ensuring legal and social protection for the specialists, working in the field of clinical laboratory diagnostics.

Improving professional knowledge: In the professional sphere by additional education and using remote training technologies; In state and international legal fields on the matters of labour law, legal aspects of public procurement, issues of reclamation activities; Organization of expert activities under professional responsibilities with participation in public expertise of sectoral, national and international projects, related to the development and performance of the laboratory service of the Republic of Belarus; Integration of the laboratory service into the world community of specialists of laboratory medicine in order to expand international scientific and practical communication and promote a positive image of the Republic of Belarus.

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Photo: Participants at the 8th Annual Course

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News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine Visit www.ifcc.org for more information

Tosoh and Wako Research Scientists Win Japan Society's 2016 Technology Award

By Hideo Sakamoto, PhD and Shu-Ping Hui, PhD, International Exchange Committee of Japan Society of Clinical Chemistry he Japan Society of Clinical Chemistry (JSCC) has been the leading society in the field of Clinical Chemistry in Japan for more than fifty years. The JSCC Technology Award is given annually to companies who have made progress in clinical chemistry. In 2016, two winners received the JSCC Technology Award. The award presentation was held at the 56th Annual Meeting of JSCC in Kumamoto, Japan from 2-4 December 2016. At the presentation, the award recipient was congratulated by Dr. Masato Maekawa, president of JSCC for the contribution to the advancement in clinical chemistry.

In this issue, we would like to introduce two winners to celebrate their outstanding technology.

Daisuke MANITA, MS (Research and Development Department, Bioscience Division, Tosoh Corporation) is the winner of the 2016 JSCC Technology Award, entitled with “Development of new lipoprotein analyzer, HLC-729LP2”.

Dyslipidaemia is a risk factor for atherosclerosis, and is classified as either familial or acquired disorder of lipoprotein metabolism. World Health Organization (WHO) classification of hyperlipidaemia is a biochemical categorization based on raised lipoprotein patterns. Hence, analyzing lipoproteins in detail provides important clinical information for the prevention of atherosclerosis and the therapy of dyslipidaemia.

Major classes of lipoproteins can be isolated from serum with ultracentrifugation, but it is time-consuming and need large volume of serum. They have developed , for the measurement of cholesterol in the five major lipoprotein fractions [high density lipopro-

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tein (HDL), low density lipoprotein (LDL), intermediate density lipoprotein (IDL), very low density lipoprotein (VLDL), and other fraction which include chylomicron and lipoprotein(a)].

This new method can measure cholesterol concentrations of the five lipoprotein fractions within 5.2 minutes per test with an amount of serum as little as 0.2 mL. The cholesterol concentrations of serum lipoproteins (HDL, LDL, IDL, and VLDL + chylomicron) measured with LP2 had good correlation with those by ultracentrifugation method. HDL-C and LDL-C including IDL-C concentrations measured using LP2 agreed well with the concentrations using homogeneous assays or the Friedewald equation.

Kazuma HANAI, PhD (Diagnostics Research Laboratories, Wako Pure Chemical Industries, Ltd.) is the winner of the 2016 JSCC Technology Award, entitled with “Development of a new creatine kinase MB mass determination assay using a latex agglutination turbidimetric immunoassay”.

For diagnosis of myocardial infarction (MI), it is important to investigate changes in electrocardiograms and increases in blood cardiac biomarker levels. CK-MB is a suitable clinical biomarker of myocardial damage such as MI. They developed a reagent for CK-MB mass measurement, “L-type Wako CK-MB mass” (L-CKMB mass), that can be used to perform latex agglutination turbidimetric immunoassay (LTIA) with an automated biochemistry analyzer. During the development of L-CK-MB mass reagent, they made the following two improvements to CK-MB mass measurement. The first improvement is the high sensitivity of

IFCC Communications & Publications Division Announces 2017 Annual Survey Results

By Prof Edgard Delvin, Chair Committee on Public Relations (C-PR) he Communications and Publications Division (CPD) of IFCC and the Committee on Public Relations (CPR) initiated an annual survey last year to receive feedback from IFCC national

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representatives, IFCC divisions, committees, taskforces, working groups, as well as individual laboratory scientists around the world. The most recent survey, issued in March 2017, aimed at

the latex aggregation reaction. Although polyethylene glycol 6000 (PEG 6000) was used for conventional reagents for LTIA, this conventional reagent was not sensitive enough to measure low concentrations of CK-MB mass. However, the aggregation enhancer they developed can make reagents for LTIA more sensitive. The second improvement is the high specificity of their reagent for CK-MB. Serum samples containing CK-BB and macro CK type 1 (mainly IgG-bound CK-BB) caused a false positive result for CK-MB by LTIA, but not with electrochemiluminescence immunoassay（ECLIA. To resolve this cross reaction, they used anti-CK-B antibodies to inhibit cross reactions of anti-CK-MB antibodies with CK-BB and macro CK type 1.

In conclusion, L-CK-MB mass reagent was developed for the latex agglutination turbidimetric immunoassay method. This reagent is used with an automated biochemistry analyzer, and the CK-MB mass value determined using L-CK-MB mass assay was almost the same as that measured using ECLIA. These results suggest that L-CK-MB mass reagent is suitable for clinical routine measurement of CK-MB mass.

Photo: JSCC President Dr. Maekawa (on the left) and JSCC Technology Award winner Mr. Manita.

probing the laboratory scientists worldwide on their awareness, usage and perception of the IFCC Website and IFCC media including eNewsletter, eNewsflash, Electronic Journal of IFCC (eJIFCC), the eLearning program eAcademy, and the newly developed IFCC App. The present report highlights the 2017 survey findings and summarizes the key observations.

The survey was sent to all National Representatives as well as to National Society administrators, asking them to distribute the survey to their respective membership. A total of 831 responses were received from 63 countries, representing approximately 68% of IFCC member societies but only about 2% of the total number of society member scientists worldwide. Two out of three responders reported accessing the website with a minority (19%) accessing it through social media, with Facebook being the most frequently used and Twitter the least. It was reassuring that the responders unanimously found the website easy to navigate and useful.

The responses related to the eNewsletter, eNewsFlash and eJIFCC suggest significant interest in these publication and excellent readability.

Interestingly, 40 - 50% of responders

report receiving them, of which 75% were informed of these publications through their National Representatives. Here again, almost all responders reading them highly valued their content and format. With respect to the eJIFCC, it is interesting to note that 40% of the responders already knew it was recently indexed in PubMed. The eAcademy webpage content, although visited to a lesser extent, is mostly perceived as very good to excellent. The majority of those who visit the webpage commented that they would be interested in obtaining Continuing Education Credits (CEC) through the eAcademy program. Fortunately, these new features are already planned in phase 2 and phase 3 of the eAcademy program development and will be available later this year..

Finally, although the IFCC App has been released and promoted in the eNewsLetter only recently, a fair number of responders claim they have downloaded and accessed it.

In summary this survey shows that the IFCC tools are well appreciated by individual members. However, further efforts will have to be made to increase rate of survey responses to ensure that the results are more representative of the IFCC community.

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NEWS VIEWPOINT

Genomic Testing: The Dilemma of Disclosure

by Dr. Bernard Gouget Counselor for Public Health FHF; Chair-Human Health Care Committee-COFRAC; IFCC Chair-Nominations Committee; General Secretary of the International Francophone Federation Of Clinical Biology and Laboratory Medicine (FIFBCML) place in medical practice in the areas enomic medicine is no longer a of prevention, diagnosis, establishpromise. Recent technological ing prognosis and treatment in a progress in molecular biology and framework of precision medicine. the development of new ultra-highFollowing the example of UK, USA, throughput sequencers mean that it China, the France Genomic Mediis now possible to sequence whole cine 2025 Plan was launched last human genomes faster and more year under the leadership of Prof. cheaply. Analysis of whole genomes Yves Levy, President of Aviesan and is taking an ever-more important

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CEO of Inserm, to investigate current approaches to genetic diagnosis.

This is part of a ten-year vision to introduce precision medicine into the care pathway within the national healthcare system, in line with a similar process underway in Estonia, Slovenia and Netherlands. Genomic medicine is a stage for strong international competition, each country wanting to develop its own industry and attract scientific talent to bolster up its own advantages because it is a public health issue. While such a business opportunity is attracting major business concerns such as those collectively called the GAFAMS (Google, Apple, Facebook, Amazon, Microsoft and Samsung), in order to avoid the risk of technological dependence, it is fundamental that academic and public research do not to miss the opportunity to develop national frameworks The Healthcare system cannot be separated from innovation and requires close coordination with the world of research. Educational programs toward the development of clinical and medical lab professionals that are capable of meeting the challenges of analyzing and interpreting the data are key toward fostering a proper genomic health system. The demand is growing and there is a need to establish a generic care pathway with a clear common access to genomic medicine for patients affected by metastatic cancer, or a cancer that has been proven refractory to treatment or rare disease. Beyond 2020, the French system’s capacity will be grown also to cover common diseases. Specific measures include the setting up of a network of sequencing services, the establishment of a national center for intensive calculation, the generalization of standardized, interoperable electronic patient medical record and new regulatory frameworks according to Good Practices as well as judicial and ethical standards. It is also fundamental to ensure information, consultation and involvement of everyone in the society the general public, users and patient’s association concerned.

Genetic technologies enable more and more people to access their own personal genomic information. The genomic information creates a kind of transparency of the human body to ourselves and possibly to the others.

Genomics information changes the way to see the body and to embody

the life. Transparency is a threat to privacy. It is a revolution on the fields of prevention and healthcare but is not possible to develop personalized genomic medicine without answering to numerous questions asking by the patient on consent, on anonymization of the data, in access to and exploitation of health data, when we know that at the same time, the genome can be sequenced on demand through direct to consumer gene test companies and the data are directly communicated to the customers and are stored and used somehow.

This will also give rise huge ethical questions about what to do with the information. The fundamental relational feature of genetic knowledge shapes the questions of genetic responsibility and how to deal with genetic knowledge. The higher the impact of genetic knowledge on our own well-being, the greater is the responsibility we have in dealing with this knowledge. How to manage secondary discoveries and unwanted incidents when the entire genome of the patients and family members are sequenced? Do we have to inform a patient about a genetic risk that what happen to have detected if the incidental findings are of uncertain significance. The right not to know is recognized at international level in the UNESCO declaration on the human genome. “The right of every individual to decide whether or not to be informed of the results of genetic examination and the resulting consequences should be respected.

The right not to know is still heavily debated, some genetic professionals appear to think that to know is better than not to know, arguing that the progress in genomics make the right “not to know” obsolete because pathogenic mutations might be asymptomatic for long period of time and “to know” is better when information is actionable. Clinicians and labs professionals have also a fiduciary duty to prevent harm by warning patients and their families about certain incidental findings and this principle supersedes concerns about patient’ autonomy, just as it does in the reporting of incidental findings elsewhere in medical practice.

The question is still a controversial issue in various countries, but the evolution of knowledge in genomic medicine in particular in many cancers require definitively international guidelines. As Bjorn Hoffmann (NO) wrote, the question is: “Can I trust the results and will they make difference”. In the case of incidental findings with uncertain significance when nothing can be done to improve my health, there is no compelling reason to be informed ”ignorance is bliss” as the saying goes. When answering questions that are not asked, we need to think twice!

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DiaSorin to Acquire Siemens' ELISA Immunodiagnostics Business cont’d from cover

market and new tests in the molecular diagnostics markets. Siemens Healthineers offers a comprehensive portfolio of products and services in its core areas of diagnostic and therapeutic imaging and in laboratory diagnostics and molecular medicine. The company’s ELISA immunodiagnostic products are marketed in hospitals, private laboratories and blood banks.

DiaSorin will acquire the ELISA immunodiagnostic business portfolio and relevant assets from Siemens Healthineers, excluding the transfer of employees or manufacturing facility and capability, on a debt-free cashfree basis for a total consideration of up to Euro 47.5 million.

Siemens Healthineers will continue to manufacture and provide its

ELISA immunodiagnostic reagent kits exclusively to DiaSorin for up to three years, enabling continuous supply of its current ELISA immunodiagnostic products to customers.

The acquisition is in line with DiaSorin’s strategy to convert customers using ELISA products to its CLIA platforms and products solution, leveraging on the completeness of its CLIA menu and the features of its LIAISON platforms. Siemens Healthineers’ ELISA immunodiagnostic business portfolio will allow DiaSorin to access a significant customer base, mostly in Europe, thus providing it with the opportunity to further expand its global commercial presence to create new business opportunities for the promotion and marketing of its CLIA products.

Siemens to Acquire Blood Gas Subsidiary of Alere iemens Healthineers (Erlangen, Germany; www.health care.siemens.com), the separately managed healthcare business of Siemens AG, has entered into a definitive agreement to acquire Epocal Inc., a subsidiary of Alere Inc. (Waltham, MA, USA; www.alere.com) that develops and provides point-of-care (POC) blood diagnostic systems for healthcare enterprises.

Siemens Healthineers offers a comprehensive portfolio of products and services in its core areas of diagnostic and therapeutic imaging and in laboratory diagnostics and molecular

S

medicine. Epocal’s portfolio of POC blood diagnostic systems includes the epoc Blood Analysis System, a handheld, wireless testing solution that provides blood gas, electrolyte and metabolite results near the patient in approximately 30 seconds after sample introduction. With a complete offering for blood gas diagnostics from a low-volume, single-use handheld device up to a high-volume, multi-use benchtop solution, Siemens Healthineers aims to help customers improve their workflows and utilize the correct system for the needs of their particular settings.

Mexico IVD Market Valued at Over USD 400 Million for 2016 exico's in vitro diagnostic (IVD) market is valued at USD 405 million for 2016, making it the second largest in Latin America, and is considered moderate in its regulatory process and foreign investment opportunities. These are the latest findings of Kalorama Information, (New York, NY, USA; www. kaloramainformation.com), an independent medical market research firm.

Mexico is the world’s twelfth most populated country with 123.2 million people residing in the country in 2016 and is the second-largest country in Latin America in terms of population, accounting for 20% of the region's total. The World Health Organization (WHO) estimates Mexi-

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LabMedica International August-September/2017

co's healthy life expectancy at birth at 68 years, which is 9 years less than the total life expectancy for the country at birth. In spite of the increase in life expectancy and slight increase in healthy life expectancy, the Mexican population is likely to witness increasing chronic disease, disability and morbidity due to lifestyle trends resulting in obesity and diabetes.

Thus, Mexico’s IVD market is being supported by its growing population and its more rapidly increasing aging population.

Mexico's health sector is a mix of both private and public structures with the private sector responsible for a majority of the laboratory business in the country.

Industry News

Quidel to Buy Alere’s Triage Business uidel Corporation (San Diego, CA, USA; www.quidel. com), a provider of rapid diagnostic testing solutions, cellularbased virology assays and molecular diagnostic systems, has entered into definitive agreements to acquire the Triage MeterPro cardiovascular (CV) and toxicology assets (“Triage business”) and the B-type Naturietic Peptide (BNP) assay business run on Beckman Coulter analyzers (“BNP business”) from Alere Inc. (Waltham, MA, USA; www.alere.com). These products are being divested in order to obtain antitrust approvals required for Abbott’s pending acquisition of Alere.

Quidel develops diagnostic solutions and products which aid in the detection and diagnosis of many critical diseases and conditions, including, among others, influenza, respiratory syncytial virus, Strep A, herpes, pregnancy, thyroid disease and fecal occult blood. Quidel will acquire the Triage business, including real estate for the San Diego Triage facilities, and the BNP business for a total consideration of USD 400 million in addition to USD 40 million in contingent consideration. Quidel will distribute the Triage MeterPro products and BNP

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assays through a combination of direct sales force and distributors.

“We’ve been looking at acquisition opportunities in high-growth segments of the POC diagnostics market, such as cardiovascular, for several years, and believe that this strategic acquisition extends Quidel’s market leadership, adding an extensive cardiovascular and toxicology POC offering to our innovative medical diagnostics portfolio. The Triage acquisition significantly stabilizes our quarterly revenue profile and enhances our geographic and product diversity, with substantial expansion opportunities in new markets.

Further, while the installed base of Triage MeterPro instruments in the U.S. nicely complements the installed base of our Sofia and Solana platforms in the hospital segment, there will be new call points that our U.S. commercial organization can leverage as well. And internationally, the Triage MeterPro system gives us access to the rapidly evolving cardiac biomarker segment, one of the faster growing segments in the IVD market,” stated Douglas Bryant, president and chief executive officer of Quidel Corporation.

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