Medical Laboratory Observer CLR 2025

2025-2026

CLR-online.com

TM

FEATURING cross references of tests, equipment, products, services

+ REFERENCE GUIDES A SUPPLEMENT OF

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drug levels, toxicity levels, critical values, reference intervals

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IN THIS ISSUE...

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2025-2026

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Cover image: kirstypargeter / iStock / Getty Images Plus/ Getty Images

FEATURES

DEPARTMENTS 04 06

CLINICAL LABORATORY REFERENCE GUIDES

08 15 16 18 19

Table of Critical Limits Cutoff Concentrations for Drug Tests Critical Values for Therapeutic Drug Levels

From the editor Special Feature: Top trends in the clinical lab

By Erin Brady

34

Index of advertisers

Table of Reference Intervals Pediatric Reference Intervals

PRODUCT LISTINGS AND TESTS

20 26 32

Company Directory Product Categories

6

Product Categories Index

HOW TO USE CLR REFERENCE GUIDES

CLR is an annual supplement provided by MLO reflecting peer-reviewed clinical laboratory reference guides, as well as market resources available to clinical laboratorians.

PRODUCT INFORMATION

The product information section includes company descriptions, their essential laboratory products, and contact information for pricing and ordering.

INDEX OF TESTS, EQUIPMENT, AND SERVICES READER FEEDBACK

The alphabetical index conveniently categorizes and cross-references laboratory products by test names, equipment types, and ­services provided.

Visit CLR-online.com to access the digital version. Subscribe to receive future CLR supplements here: https://www.mlo-online.com/subscribe/.

CLR-ONLINE.COM | MLO | CLR 2025-2026 | 3

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F ROM T HE EDITOR

Our annual guide

M

edical Laboratory Observer’s annual reference guide, Clinical Laboratory Reference (CLR) is the industry’s only complete resource guide providing tables of critical values and high and low critical limits; cutoff concentrations for drug tests; critical values for therapeutic drug levels; adult reference intervals; and pediatric reference intervals.

CLR also provides an extensive, alphabetical guide to tests, equipment, and services for the clinical lab market, along with company descriptions and contact information for ordering and pricing.

The tables of critical limits, critical values, and referBy Christina Wichmann Editor in Chief ence intervals help laboratorians interpret test results.

Laboratory communication of abnormal test results is an essential aspect of patient care. Critical limits establish the upper and lower values that indicate when a patient’s medical condition may be precarious, requiring the immediate attention of the provider who ordered the test. A clinical laboratory critical value is a test result that falls significantly outside the normal reference interval and indicates a potentially life-threatening situation requiring immediate medical attention. Clinical laboratory reference intervals (also known as reference ranges) are the set of values used by healthcare providers to interpret laboratory test results. These intervals represent the expected range of values for a healthy population and help determine whether a patient’s test result is normal, low, or high. These decision tools assist in one of the top goals in healthcare: timely communication.

I want to thank our committed reviewers of these tables; without them this important resource would not be available: • The tables of critical limits and values were reviewed and updated by Gerald Kost, MD, PhD, MS, FADLM of the POCT•CTR, School of Medicine, UC Davis, and his UC Honors Program student team. A new point-of-care testing critical limits table is included this year based on their research published March 2025 in “Visualization of Critical Limits and Critical Values Facilitates Interpretation” in Diagnostics.

• The cutoff concentrations for drug tests table was reviewed by Suhash Harwani, PhD, Senior Director of Science for Workforce Health Solutions at Quest Diagnostics. Fentanyl is newly added this year based on the “Mandatory Guidelines for Federal Workplace Drug Testing Programs— Authorized Testing Panels” published January 16, 2025, in the Federal Register.

• The critical values for therapeutic drug values table was reviewed and updated by Rajasri Chandra, MS, MBA. • The table of reference intervals was reviewed and updated by Sean T. Campbell, PhD, DABCC, FADLM, Clinical Biochemist, Mount Sinai Hospital, Toronto, ON. • The pediatric reference intervals table was reviewed and updated by Khosrow Adeli, PhD, FCACB, DABCC, FADLM, Head, Clinical Biochemistry, Hospital for Sick Children and Principle Investigator – CALIPER Program, along with Erin Brady, MLO Managing Editor.

Lastly, I hope you enjoy reading “Top trends in the clinical lab” by Erin Brady.

Five laboratory industry professionals provided their insights on the top trends they are seeing in the lab world around topics such as artificial intelligence, automation, data analytics, staffing challenges in rural laboratories, continued growth of point-of-care testing, and lab safety challenges.

For the online version of CLR, please visit www.clr-online.com.

For comments or feedback on CLR, please feel to reach out to me at cwichmann@ mlo-online.com.

TM

Vol. 57, No. 7

PUBLISHER Chris Driscoll

cdriscoll@endeavorb2b.com EDITOR IN CHIEF Christina Wichmann

cwichmann@mlo-online.com

MANAGING EDITOR Erin Brady

ebrady@endeavorb2b.com

PRODUCTION MANAGER Edward Bartlett ART DIRECTOR Kelli Mylchreest AUDIENCE DEVELOPMENT/LIST RENTALS

Laura Moulton | lmoulton@endeavorb2b.com ADVERTISING SERVICES MANAGER

Karen Runion | krunion@endeavorb2b.com ADVERTISING DIRECTOR OF SALES EAST COAST/MIDWEST SALES, CLASSIFIEDS

Carol Vovcsko (941) 321-2873 | cvovcsko@mlo-online.com SOUTH/WEST COAST/ILLINOIS SALES

Lora Harrell (941) 328-3707 | lharrell@mlo-online.com MLO EDITORIAL ADVISORY BOARD John Brunstein, PhD, Biochemistry (Molecular Virology) President & CSO PathoID, Inc., British Columbia, Canada Lisa-Jean Clifford, COO & Chief Strategy Officer Gestalt, Spokane, WA Barbara Strain, MA, SM(ASCP), CVAHP Principal, Barbara Strain Consulting LLC, Formerly Director, Value Management, University of Virginia Health System, Charlottesville, VA Jeffrey D. Klausner, MD, MPH Professor of Preventive Medicine in the Division of Disease Prevention, Policy and Global Health, Department of Preventive Medicine at University of Southern California Keck School of Medicine.

Donna Beasley, DLM(ASCP), Director, Huron Healthcare, Chicago, IL Anthony Kurec, MS, H(ASCP)DLM, Clinical Associate Professor, Emeritus, SUNY Upstate Medical University, Syracuse, NY Suzanne Butch, MLS(ASCP)CM, SBBCM, DLMCM Freelance Consultant, Avon, OH Paul R. Eden, Jr., MT(ASCP), PhD, Lt. Col., USAF (ret.), (formerly) Chief, Laboratory Services, 88th Diagnostics/Therapeutics Squadron, Wright-Patterson AFB, OH Daniel J. Scungio, MT (ASCP), SLS, CQA (ASQ), Consultant at Dan the Lab Safety Man and Safety Officer at Sentara Healthcare, Norfolk, VA CORPORATE TEAM

CEO Chris Ferrell COO Patrick Rains CRO Paul Andrews CDO Jacquie Niemiec CALO Tracy Kane CMO Amanda Landsaw EVP HEALTHCARE, CITY SERVICES & DIGITAL INFRASTRUCTURE Kylie Hirko

30 Burton Hills Blvd., Suite 185 Nashville, TN 37215 800-547-7377 | www.mlo-online.com Medical Laboratory Observer USPS Permit 60930, ISSN 0580-7247 print, ISSN 2771-6759 online is published 10 times annually (Jan, Mar, Apr, May, Jul, Aug, Aug-CLR, Sep, Oct, Nov)

by Endeavor Business Media, LLC. 201 N Main St 5th Floor, Fort Atkinson, WI 53538. Periodicals postage paid at Fort Atkinson, WI, and additional mailing offices. POSTMASTER: Send address changes to Medical Laboratory Observer, PO Box 3257, Northbrook, IL 60065-3257. SUBSCRIPTIONS: Publisher reserves the right to reject non-qualified subscriptions. Subscription prices: U.S. $160.00 per year; Canada/Mexico $193.75 per year; All other countries $276.25 per year. All subscriptions are payable in U.S. funds. Send subscription inquiries to Medical Laboratory Observer, PO Box 3257, Northbrook, IL 60065-3257. Customer service can be reached toll-free at 877-382-9187 or at MLO@ omeda.com for magazine subscription assistance or questions.

Printed in the USA. Copyright 2025 Endeavor Business Media, LLC. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopies, recordings, or any information storage or retrieval system without permission from the publisher. Endeavor Business Media, LLC does not assume and hereby disclaims any liability to any person or company for any loss or damage caused by errors or omissions in the material herein, regardless of whether such errors result from negligence, accident, or any other cause whatsoever. The views and opinions in the articles herein are not to be taken as official expressions of the publishers, unless so stated. The publishers do not warrant either expressly or by implication, the factual accuracy of the articles herein, nor do they so warrant any views or opinions by the authors of said articles.

4 | CLR 2025-2026 | MLO | CLR-ONLINE.COM

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SPECIAL FEATURE :: CLINICAL LAB TRENDS

Special Feature :: Clinical lab trends

Top trends in the clinical lab

gobyg / DigitalVision Vectors / Getty Images

2025 has been an eventful year for the clinical laboratory industry with the overturning of the U.S. Food and Drug Administration’s (FDA) Laboratory Developed Test (LDT) rule, the U.S. Department of Health and Human Services (HHS) restructuring and cuts, and the continued rise of artificial intelligence (AI). On top of that, staffing shortages and burnout continue to burden labs.

By Erin Brady

MLO asked professionals what trends they’ve been observing in labs so far this year. Here is what they said:

AI and automation Lisa-Jean Clifford, President, Gestalt Diagnostics We are experiencing the advancement and increase in adoption of digital pathology solutions to enhance pathologists’ workflows. There is also a focus on incorporating AI to improve accuracy and reduce fatigue for pathologists in their interpretation of cases. This also provides faster turn around times.

Another trend in AI automation is that for workflow optimization within the organization; with AI being used in administrative functions and analysis in business process improvement. Generative AI is being used, or at least piloted for use, by many organizations to help improve non-diagnostic work – more as an assistant in items like note taking, reporting, communications, etc.

We are also seeing a big push for cross-specialty communication and collaboration on patients both in the diagnosis and the treatment decisions for patients. This area will continue to evolve as a focus on things like enterprise imaging and data value continues.

Adapting to workforce challenges in rural clinical laboratories Lynn Evans, Director of Human Resources, Interpath Laboratory A key trend we’re observing across clinical laboratories in 2025 is the growing emphasis on workforce flexibility and remote-enabled operations—an especially important evolution for rural labs like ours. Our core reference laboratory in Pendleton, Oregon, manages a high testing volume with

limited staff, requiring our medical laboratory scientists (MLS) to maintain deep specialization in their disciplines.

While this ensures accuracy and efficiency, it makes cross-training difficult, even though we recognize it as a best practice for long-term sustainability.

To help address these challenges, we’ve begun adopting digital imaging platforms that allow for remote review and analysis by qualified MLS professionals. This advancement has expanded our ability to recruit top-tier talent beyond our immediate geographic region—an enormous benefit in a rural setting where it can be difficult to attract and retain highly specialized laboratory staff. From an HR standpoint, this technology supports more flexible staffing models while maintaining the high standards required for diagnostic accuracy. As we continue to evolve, we’re focused on balancing specialization with gradual cross-training initiatives and leveraging technology to build a more agile, resilient workforce.

The 3 ‘As’ – Automation, Analytics, AI Kim Futrell, MLS(ASCP), BSHI, Senior Strategic Marketing Manager, Orchard Software In 2025, the push is for clinical laboratories to be more efficient than ever due to continued staffing shortages.

The good news is that there are advances in technology helping that efficiency along. For instance, laboratories can expect to see continued advancements in automation, AI, and data analytics. Automation systems are being deployed to handle manual aliquoting and pre-analytical steps in assay workflows. These systems improve the quality and reliability of results, reduce processing time, and enhance test turnaround time.

AI is revolutionizing laboratory information systems (LIS) by enabling advanced diagnostics, predictive insights, and workflow optimization. AI-powered algorithms assist in automating sample tracking, quality control, and anomaly

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Special Feature :: Clinical lab trends detection, providing actionable insights to improve diagnostic accuracy and laboratory efficiency.

Data analytics tools are being integrated into LIS platforms to unlock valuable insights from laboratory data, helping laboratories make informed decisions and drive continuous quality improvement. These trends highlight the growing importance of technology in clinical laboratories, driving improvements in efficiency, accuracy, and patient care.

gobyg / DigitalVision Vectors / Getty Images

Continued regulatory & billing uncertainty

Laboratories also continue to face challenges related to billing and reimbursement. Regulatory scrutiny of laboratory billing practices has increased, with a focus on compliance risks and the potential for financial penalties. Laboratories must stay abreast of evolving legal and compliance considerations to avoid violations and ensure the financial health of their operations. Overall, clinical laboratories navigate a multifaceted regulatory environment that includes compliance with CLIA, HIPAA, and other federal and state laws, while also addressing billing and reimbursement challenges.

Continued growth in POCT

Driven by many factors, point-of-care testing (POCT) continues to gain traction. The ability of POCT to provide immediate results is crucial for timely medical interventions. The need to care for a growing geriatric population, increasing prevalence of genetic disorders, and the need for rapid disease diagnosis and prevention are likely to continue to boost the POCT market. Overall, the continued growth in POCT reflects its importance in improving patient care, reducing healthcare costs, and enhancing the efficiency of diagnostics. This often means that laboratories have to oversee and manage POCT, which can be a challenge.

These items present an infection control risk, but many in lab leadership do not understand the risks or they feel unable to fight the use of this technology. Unfortunately, that is a dangerous pathwaythere are already cases of laboratorians who have been hospitalized for using such devices in the department and bringing them home. Since the addiction to social media and these devices is strong, perhaps leaders should look at e-breaks rather than allowing these devices to continue to generate infection risks for their staff.

Specimen transport

With the pandemic well behind us, many labs are now being pressured by other departments to allow all respiratory specimens to be sent to the lab via the pneumatic tube system (PTS). Although COVID-19 is not as great a concern as it once was, the use of the PTS is still a known aerosol generating process. That means that those who open the tube carriers in the lab are at risk for airborne exposure.

This includes influenza, tuberculosis, and even measles.

Perform a risk assessment to determine the best practice for transporting respiratory specimens to the lab.

A clinical laboratory trend continues: Data rich and information poor Barbara Strain, MA, CVAHP, Principal, Barbara Strain Consulting LLC

Two lab safety trends in 2025

Laboratory testing is central to healthcare, with ~70% of EMRs containing test results and at least 70% of medical decisions rely on them. As pathologists and technologists reexamine test methods, their priority remains delivering precise, easily interpretable, and actionable data.

All future predications reference AI and it is certainly transforming laboratory diagnostics today. Though still emerging, AI can utilize large data lakes with laboratory and other types of raw test results with patient demographics, symptoms, vital signs, diagnosis, and physiological patterns, to enhance triage in Emergency Departments. With AI likely to also be standard in procedural areas and nursing practice assisting but not taking the place of human trained decision making.

The future of lab AI depends on collaboration among pathologists, technologists, and manufacturers to streamline test validation and development of new test. An AI raw data-driven tool could analyze patient demographics, genetic profiles, disease states, as well as specimen collection methods to automate equipment selection or onboard new test modalities—optimizing efficiency and accelerating precision in healthcare diagnostics. Conversely one article proclaims that AI and machine learning could predict new tests in search to make new diagnoses.1

Dan Scungio, MLS (ASCP), SLS, CQA (ASQ), Owner, Dan The Lab Safety Man, Inc.

REFERENCE

Continued growth in personalized medicine

Personalized medicine is set to continue its rapid growth as well, transforming laboratories and the healthcare landscape.

Personalized medicine tailors medical treatment to the individual characteristics of each patient, leveraging advancements in genomics, bioinformatics, and data analytics. Laboratories are increasingly adopting next-generation sequencing (NGS) technologies, enabling faster and more precise genetic testing for disease detection and treatment. The integration of artificial intelligence (AI) and machine learning (ML) is further enhancing the ability to analyze vast amounts of patient data, providing insights that drive personalized treatment plans.

Additionally, the rise of mobile health apps and wearable devices is facilitating real-time data collection, improving the accuracy and effectiveness of personalized treatments. As personalized medicine continues to evolve, clinical laboratories will play a crucial role in delivering tailored diagnostics that ultimately improve patient outcomes.

Personal electronic devices

Labs continue to deal with the use of personal electronic devices such as cell phones, ear buds, and fitness trackers.

1. Cardozo G, Tirloni SF, Pereira Moro AR, Marques JLB. Use of artificial intelligence in the search for new information through routine laboratory tests: Systematic review. JMIR Bioinform Biotechnol.

2022;3(1):e40473. doi:10.2196/40473.

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TABLE OF CRITICAL LIMITS

CRITICAL LIMITS

By Gerald J. Kost, MD, PhD, MS, FADLM

C

ritical limits define the quantitative boundaries of life-threatening diagnostic test results. Critical results falling outside high and low critical limits must be reported to clinicians urgently, so the patient can be treated promptly if necessary. Critical value reporting was implemented by George Lundberg, MD, and published in MLO in 1972.1 Analysis of the impact of critical notifications on patient outcomes appeared in MLO in 1993 with follow-up articles calling for national harmonization and standards of care for critical notification practices. 2-4 These tables reflect research published in 2025 by Gerald Kost, MD, PhD, MS, FADLM of the POCT•CTR, School of Medicine, UC Davis, and his UC Honors Program student team. The research entailed a review of 50 critical limits/values lists from university hospitals, Level 1 trauma centers, centers of excellence, and high-performing hospitals across the U.S.5 with comparison to 1990-93 data compiled through the first three national surveys of critical limits used by 92 responding

U.S. medical centers, including 20 trauma centers and 39 children’s hospitals.6-8 Most hospital policies posted on the Web defined what a critical value is and stated that a licensed provider must be informed immediately.9 Statistically significant differences in 2024 versus 1990-93 critical limits were observed for glucose, calcium, magnesium, CO2 content, blood gas parameters, hematology, and coagulation tests. Ranges for critical limits narrowed for several tests, and new measurands were added. Point-of-care testing (POCT) listings were scarce and revealed notable differences from main lab values in the high median critical limit for glucose.5 The Joint Commission identifies timely reporting of critical tests results as a National Patient Safety Goal (NPSG.02.03.01) in its accreditation programs.10 Clinical laboratories can develop notification practices collaboratively with emergency physicians, hospitalists, and point-of-care specialists to achieve timely, effective, and focused patient care. For example, the statistically significant increase in the low critical limit for

Table 1: Clinical chemistry critical limits.5 Test

Listing Freq., % 2024 1990

Units

Low Mean (SD)

Low Median (Range)

High Mean (SD)

High Median (Range)

1990

2024

1990

2024

1990

2024

1990

2024

mmol/L

2.6 (0.4)

2.7 (0.3)

2.5 (1.7-3.9)

2.8** (2.2-3.3)

26.9 (8.0)

26.4 (2.8)

27.8 (6.1-55.5)

27.8 (22.1-33.3)

mg/dL

46 (7)

49 (5)

45 (30-70)

50** (39-60)

484 (144)

476 (51)

501 (110-1000)

500 (399-1000)

Glucose

100

100

Calcium

98

100

mmol/L mg/dL

1.65 (0.17) 6.6 (0.7)

1.55 (0.10) 6.2 (0.4)

1.62 (1.2-2.2) 6.5 (5.0-8.6)

1.50** (1.2-1.7) 6.0** (5.0-7.0)

3.22 (0.22) 12.9 (0.9)

3.24 (0.15) 13.0 (0.6)

3.24 (2.62-3.49) 13.0 (10.5-14.0)

3.24** (2.87-3.49) 13.0** (11.5-14.0)

Sodium

98

100

mmol/L

120 (5)

121 (2)

120 (110-137)

120 (119-125)

158 (6)

159 (2)

160 (145-170)

160 (153-165)

Potassium

96

100

mmol/L

2.8 (0.3)

2.8 (0.2)

2.7 (2.5-3.6)

2.8 (2.5-3.0)

6.2 (0.4)

6.1 (0.2)

6.0 (5.0-8.0)

6.0 (5.9-7.0)

Magnesium

88

33

mmol/L

0.41 (0.16)

0.41 (0.04)

0.41 (0.21-0.74)

0.41 (0.25-0.49)

2.02 (0.82)

2.3 (0.66)

1.75 (1.03-5.02)

2.02** (1.44-4.53)

lonized Calcium

82

57

mmol/L

0.82 (0.14)

0.78 (0.06)

0.80 (0.50-1.07)

0.80 (0.50-0.90)

1.55 (0.19)

1.59 (0.17)

1.50 (1.30-2.00)

1.58 (1.40-2.50)

Phosohorous

78

33

CO2 content

74

Lactate

62

Osmolality Cerebrospinal Fluid Glucose

mmol/L

0.39 (0.10)

0.36 (0.06)

0.32 (0.26-0.65)

0.32 (0.29-0.48)

2.87 (0.48)

3.13 (0.48)

3.22 (2.26-3.23)

2.91 (2.58-4.04)

mg/dL

1.2 (0.3)

1.1 (0.2)

1.0 (0.8-2.0)

1.0 (0.9-1.5)

8.9 (1.5)

9.7 (1.5)

10.0 (7.0-10.0)

9.0 (8.0-12.5)

75

mmol/L

11 (2)

11 (2)

10 (5-20)

10 (8-15)

40 (3)

42 (3)

40 (35-50)

40* (39-50)

5

mmol/L

—

—

—

—

3.4 (1.3)

3.9 (1.1)

3.0 (2.3-5.0)

4.0 (2.0-8.0)

40

20

mmol/kg

250 (13)

245 (14)

250 (230-280)

250 (190-260)

326 (18)

332 (18)

320 (295-375)

330 (308-390)

40

16

mmol/L

2.1 (0.6)

1.9 (0.4)

2.2 (1.1-2.8)

2.2 (1.1-2.5)

24.3 (11.4)

17.4 (3.5)

16.7 (13.9-38.9)

16.7 (13.9-25.0)

mq/dL

37 (10)

34 (8)

40 (20-50)

39 (20-50)

438 (206)

314 (63)

301 (250-700)

300 (250-450)

Ammonia

32

—

μmol/L

—

—

—

—

—

127 (57)

—

108 (50-250)

Chloride

22

20

mmol/L

75 (8)

77 (3)

80 (60-90)

75 (70-81)

126 (12)

125 (5)

120 (115-156)

125 (119-130)

Urea Nitrogen

12

20

Creatinine

12

10

Uric Acid

8

20

Bilirubin

0

25

mmol/L

—

—

—

—

37.1 (21.1)

32.5 (10)

33.9 (14.3-107.1)

36.1 (14.3-42.9)

mg/dL

—

—

—

—

104 (59)

91 (28)

95 (40-300)

101 (40-120)

μmol/L

—

—

—

—

654 (380)

636 (265)

884 (177-1326)

663 (177-884)

mg/dL

—

—

—

—

7.4 (4.3)

7.2 (3.0)

10 (2.0-15.0)

7.5 (2.0-10.0)

μmol/L

—

—

—

—

773 (119)

714 (59)

892 (595-892)

773 (595-773)

mg/dL

—

—

—

—

13 (2)

12 (1)

15 (10-15)

13 (10-13)

μmol/L

—

—

—

—

257 (86)

ACNL

257 (86-513)

ACNL

mg/dL

—

—

—

—

15 (5)

ACNL

15 (5-30)

ACNL

ACNL, Adult Critical limits Not Listed. *, Significant difference in medians at p < 0.05; **, Significant difference in medians at p < 0.01. Bold indicates statistically significant difference.

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TABLE OF CRITICAL LIMITS glucose, which increases the notification frequency, may reflect recognition of the level two threshold [54 mg/dL (3.0 mmol/L)] at which neuroglycopenic symptoms require immediate action.11 Hospitals are advised to review their notification practices, quantitative decision thresholds, and qualitative critical value notifications to assure that effective life-saving alerts improve patient outcomes without excessively burdening laboratory, bedside, critical care, or emergency staff.

4.

Kost GJ. Co-creating critical limits for enhanced acute care: proven need and web knowledge base. Part 2: Standard of care, what it means and how it is applied. MLO. 2016;48(1):28-29.

5. Shah A, Dohner J, Cheng K, Garcia M, Kost GJ. Visualization of Critical Limits and Critical Values Facilitates Interpretation. Diagnostics (Basel). 2025;15(5):604. doi:10.3390/diagnostics15050604.

6. Kost GJ. Critical limits for urgent clinician notification at U.S. medical centers.

JAMA. 1990;263:704-707.

7. Kost GJ. Critical limits for emergency clinician notification at U.S. children’s hospitals. Pediatrics. 1991;88:597-603.

8. Kost GJ. The significance of ionized calcium in cardiac and critical care. Availability and critical limits at U.S. medical centers and children’s hospitals. Arch Pathol Lab Med. 1993;117:890-896.

9. Kost GJ, Dohner J, Liu J, Ramos D, Haider N, Thalladi V. Web-accessible critical limits and critical values for urgent clinician notification. Clin Chem Lab Med. 2024;1-13. doi:10.1515/cclm-2024-0117.

10. Joint Commission. National Patient Safety Goal 02.03.01. Effective January 2025. https://www.jointcommission.org/-/media/tjc/documents/standards/ national-patient-safety-goals/2025/lab-npsg-chapter-2025.pdf. Accessed May 9, 2025.

11. American Diabetes Association. Glycemic targets: Standards of medical care in diabetes—2019. Diabetes Care. 2019;42(S1):S61-S70.

REFERENCES 1.

2.

Lundberg GD. When to panic over an abnormal value. MLO. 1972;4:47-54.

Kost GJ. Using critical limits to improve patient outcomes. MLO. 1993;25(3):22-27.

3.

Kost GJ. Co-creating critical limits for enhanced acute care: proven need and web knowledge base. Part 1: A call to action! MLO. 2015;47(12):34, 36-37.

Table 2: Blood gas and pH critical limits.5 Listing Freq., % 2024 1990

Units

1990

2024

1990

2024

1990

2024

1990

2024

pH

86

35

pH Units

7.21 (0.06)

7.20 (0.03)

7.20 (7.00-7.35)

7.20 (7.10-7.25)

7.59 (0.03)

7.59 (0.02)

7.60 (7.50-7.65)

7.60 (7.55-7.65)

Arterial pO2

78

26

mmHg

43 (6)

45 (6)

40 (30-55)

40* (39-60)

—

—

—

—

Measurand

Arterial pCO2 Carboxyhemoglobin Methemoglobin Venous pH Venous pCO2

Low Mean (SD)

Low Median (Range)

High Mean (SD)

High Median (Range)

kPa

5.7 (0.8)

6.0 (0.8)

5.3 (4.0-7.3)

5.3* (5.2-8.0)

—

—

—

—

mmHg

19 (3)

21 (6)

20 (9-25)

20* (9-44)

67 (6)

67 (5)

70 (50-80)

70 (55-80)

kPa

2.5 (0.4)

2.8 (0.8)

2.7 (1.2-3.3)

2.7* (1.2-5.9)

8.9 (0.8)

8.9 (0.7)

9.3 (6.7-10.7)

9.3 (7.3-10.7)

74

30

48

—

%

—

—

—

—

—

15.3 (5.7)

—

17.0 (5.1-25.0)

34

—

%

—

—

—

—

—

11.7 (10.4)

—

5.1 (3.0-30.0)

26

—

pH Units

—

7.20 (0.04)

—

7.20 (7.10-7.25)

—

7.59 (0.03)

—

7.60 (7.52-7.60)

mmHg

—

20 (6)

—

20 (9-28)

—

69 (6)

—

68 (60-75)

kPa

—

2.7 (0.8)

—

2.7 (1.2-3.7)

—

9.2 (0.8)

—

9.1 (8.0-10.0)

16

—

*, Significant difference in medians at p < 0.05. Bold indicates statistically significant difference.

Table 3: Hematology and coagulation critical limits.5 Test

Listing Freq., % 2024 1990

Units

Platelets

96

Hemoglobin

Low Mean (SD)

Low Median (Range)

High Mean (SD)

High Median (Range)

1990

1990

1990

2024

1990

2024

45

9

10 /L

37 (21)

25 (11)

30 (10-100)

20 (10-50)

894 (206)

984 (73)

1,000 (100-1,000)

96

42

g/dL

7.0 (2.2)

6.3 (0.6)

7.0 (4.0-15.0)

6.0 (5.0-7.0)

19.0 (4.4)

20.2 (0.9)

20.0 (20.0-30.0)

—

—

—

—

—

4.9 (0.6)

—

—

80 (33)

116 (25)

80 (40-150)

—

800 (500-1,000)

—

**

2024

2024 1,000 (600-1,000) 20.0 † (19.0-22.5)

INR

94

—

INR

Partial Thromboplastin Time

90

33

Sec

50

Fibrinogen

88

27

mg/dL

85 (26)

88 (19)

100 (8-10)

100 (50-120)

780 (260)

WBC Count

84

42

9

10 /L

2.2 (0.9)

1.3 (0.5)

2.0 (1-5)

1.4 (0.5-2.0)

37 (22)

57 (31)

30 (9.5-100)

50 (25-150)

Hematocrit

72

29

%

20 (8.1)

19 (2)

18 (41)

20 (15-21)

60 (12.8)

61 (5)

60 (20-80)

60 (54-75)

Absolute Neutrophil Count

34

—

109/L

—

0.6 (0.2)

—

0.5 (0.3-1.0)

—

—

—

—

WBC Count in CSF

26

—

WBC/ mm3

—

—

—

—

—

39 (55)

—

20 (5-200)

Prothrombin Time

16

33

Sec

12 (2.4)

—

10 (10-15)

—

29 (8)

48** (5)

30 (14-40)

47 (40-58)

—

50

**

5.0 (4.0-7.0) 110** (69-200)

**

Band Count

12

—

%

—

—

—

—

—

23 (11)

—

20 (10-40)

Blast Cells

12

—

%

—

—

—

—

—

5.7 (2.2)

—

5 (4-10)

**, significant difference in medians at p < 0.01. †, 0.10 < p < 0.05. Bold indicates statistically significant difference.

CLR-ONLINE.COM | MLO | CLR 2025-2026 | 9

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TABLE OF CRITICAL LIMITS Table 4: Qualitative critical values.5 Measurand

Detection Method(s) (If Identified)

Listing Frequency (%)

A. Microbiology Positive culture from blood, cerebrospinal fluid, or sterile body fluid

Culture

82

Culture, Latex agglutination, PCR, RAgT

70

Acid-Fast Bacillus (AFB)

Culture, stain

68

Positive Gram stain from blood, cerebrospinal fluid, or sterile body fluid

Gram stain

60

Culture, PCR, smear, stain

44

Mycobacterium tuberculosis

Culture, PCR, stain

34

Dimorphic fungal pathogens (e.g., Histoplasma, Blastomyces, or Coccidioides species)

Culture, PCR, smear

32

Brucellosis (Brucella species)

Culture

26

Tularemia (Francisella tularensis)

Culture

26

Anthrax (Bacillus anthracis)

Culture

24

Antibiotic resistant bacteria

Culture

24

Eye and ocular cultures positive

Culture, Gram stain

24

Plague (Yersinia pestis)

Culture

24

Pneumocystis species

PCR, RAgT

24

Cryptococcus species (Cryptococcus neoformans or gattii)

Pathogenic fungus in a potentially invasive space (CSF, blood, or sterile body fluid)

Burkholderia mallei or pseudomallei

Culture

20

Culture, PCR

18

Escherichia coli O157:H7 or Shiga-toxin tests

Culture, PCR

18

Legionella

Culture, RAgT

18

Neisseria meningitidis from sterile sites

Culture, RAgT

18

Meningitis/Encephalitis panel

PCR

16

Syphilis

RPR

16

Bordetella pertussis

Botulism (Clostridium botulinum toxin) Candida auris Cholera (Vibrio cholerae) Corynebacterium diphtheriae Group A Streptococcus Listeria Methicillin-resistant Staphylococcus aureus (MRSA) Neisseria gonorrhea in the eye Salmonella species Vancomycin Resistant Enterococcus (VRE) Pseudomonas eye/ocular positive

Culture

14

Culture, PCR

14

-

14

Culture

14

Culture, RAgT

14

Culture

14

-

14

Culture, probe

14

Culture

14

-

14

Culture, probe

12

Streptococcus pneumoniae

Culture, PCR, RAgT

12

Group B Streptococci

Culture, PCR, RAgT

10

Culture

10

Shigella

-

10

Chlamydia

Vancomycin-resistant Staphylococcus aureus (VRSA)

Culture, PCR

8

Clostridium difficile

Culture, PCR

8

Nocardia

Culture, PCR

8

-

8

PCR

36

Culture, Pap, PCR

34

Ag/Ab combo, PCR, RAgT, Western blot

32

Q fever (Coxiella burnetii)

B. Virology Herpes simplex virus (HSV) in CSF Herpes simplex virus (HSV) in newborns or near-term pregnant mothers Human Immunodeficiency Virus (HIV)

10 | CLR 2025-2026 | MLO | CLR-ONLINE.COM

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TABLE OF CRITICAL LIMITS Table 4: Qualitative critical values.5 Measurands

Detection Method(s) (If Identified)

Listing Frequency (%)

B. Virology Varicella zoster virus (VZV)

PCR

18

Epstein–Barr Virus (EBV)

PCR

14

Cytomegalovirus (CMV)

Culture, PCR

12

Respiratory Syncytial Virus (RSV)

PCR

12

Enterovirus in blood/sterile sites

Culture, PCR

10

Hepatitis B surface antigen

-

8

Viral hemorrhagic fever

-

8

Smallpox (Variola major)

-

6

PCR, RagT

4

Malarial parasites

RAgT, smear

42

COVID-19 (SARS-CoV-2) Detected

C. Parasitology Parasites from sterile body sites

RAgT, smear

22

Babesia microti

PCR, smear

14

Plasmodium species

Smear, stain

10

Microfilaria

Smear, stain

8

D. Blood Bank Positive Direct Coombs test/Direct antiglobulin test (DAT)

-

28

Hemolytic transfusion reaction

-

22

Culture, Gram stain

20

Positive culture or Gram stain on a blood product associated with a transfusion reaction New positive antibody screen

-

20

Non-availability of ordered transfusion

-

18

Incompatible crossmatch

-

16

Fetal maternal hemorrhage

8

E. Hematology Presence of blasts in blood or CSF

Smear

26

Heparin induced platelet antibodies

-

10

New diagnosis or findings of leukemia

Smear

8

-

14

Significant disagreement between the frozen section and final diagnosis

-

14

Significant discrepancy between outside diagnosis and the review diagnosis

-

14

F. Anatomical/Surgical Pathology Fat in endometrial curettage

Unexpected diagnosis of malignancy

-

14

Amended report with a significant change in diagnosis

-

12

Absence of chorionic villi when clinically expected

-

10

Crescents in kidney biopsy specimen

-

8

Significant discrepancy between the fine needle aspiration (FNA) immediate interpretation and the final diagnosis

-

8

Transplant rejection

-

8

Unexpected fat in colonic endoscopic specimens

-

8

G. Urinalysis Positive urine glucose

-

18

Positive urine ketones

-

16

Microscope

8

RBC casts

Abbreviations (in addition to those in the table): COVID-19, coronavirus infectious disease-2019; CSF, cerebrospinal fluid; PCR, Polymerase Chain Reaction; RAgT, rapid antigen test; RBC, red blood cells; RPR, rapid plasma reagin; and SARS-CoV-2, severe acute respiratory syndrome-coronavirus-2.

CLR-ONLINE.COM | MLO | CLR 2025-2026 | 11

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TABLE OF CRITICAL LIMITS Table 5. Listing frequencies of critical pathogens.5 Pathogen

NIH

CDC

WHO

IDSA

Frequency (%)

Cryptococcus species (C. neoformans or gatti)

70

Herpes simplex virus (HSV)

50

Malarial parasites

42

Tuberculosis (Mycobacterium tuberculosis)

34

Human Immunodeficiency Virus (HIV)

32

Brucellosis (Brucella species)

26

Tularemia (Francisella tularensis)

26

Anthrax (Bacillus anthracis)

24

Plague (Yersinia pestis)

24

Pneumocystis species

24

Coccidiodes species

22

Burkholderia mallei or psuedomallei

20

Bordatellapertussis

18

Escherichia coli

18

Legionella

18

Neisseria meningitidis

18

Varicella Zoster Virus (VZV)

18

Syphilis

16

Botulism (Clostridium botulinum toxin)

14

Cholera (Vibrio cholerae)

14

Consensus

Methicillin-resistant Staphylococcus aureus (MRSA)

14

Salmonella species

14

Viral hemorrhagic fever

8

Influenza viruses

6

Consensus

Smallpox (Variola minor)

6

COVID-19 (SARS-CoV-2)

4

Consensus

Purple fill-ins indicated that the corresponding pathogen is deemed as demanding rapid detection by that agency.

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TABLE OF CRITICAL LIMITS Table 6. Newborn critical limits.5 Listing Freq., %

Test

Units

2024 1990

Low Mean (SD)

Low Median (Range)

High Mean (SD)

High Median (Range)

1990

2024

1990

2024

1990

2024

1990

2024

Clinical Chemistry µmol/L

…

…

…

…

239 (34)

257 (34)

257 (171–308)

257 (171–342)

mg/dL

…

…

…

…

14 (2)

15 (2)

15 (10–18)

15 (10–20)

mmol/L

1.8 (0.4)

2.2 (0.3)

1.7 (1.1–2.8)

2.2 ** (1.7–3.1)

18.1 (6.0)

14.7 (4.4)

16.7 (11.1–38.9)

13.9 (8.3–27.8)

mg/dL

32 (7)

40 (6)

31 (20–50)

40 ** (30–55)

326 (108)

265 (80)

301 (200–700)

250 (150–500)

32

mmol/L

2.6 (0.2)

2.8 (0.3)

2.5 (2.5–3.5)

2.9 ** (2.0–3.0)

7.7 (0.7)

6.8 (0.6)

8.0 (5.5–8.0)

6.9 ** (6.0–8.0)

18

…

mmol/L

…

125 (2)

…

125 (124–130)

…

154 (4)

…

155 (150–160)

Hemoglobin

44

7

g/dL

9.5 (3.5)

7.9 (1.8)

8.5 (5.0–15.0)

8.0 (6.0–12.0)

22.3 (2.3)

22.4 (1.5)

21.0 (21.0–25.0)

22.0 (20.0–25.0)

Hematocrit

32

7

%

33 (6)

24 (6)

30 (24–45)

21* (18–35)

71 (4)

66 * (3)

70 (65–75)

66 (60–70)

Platelets

28

…

109/L

…

44 (22)

…

45 (20–100)

…

950 (84)

…

1000 (800–1000)

pH Units

…

7.05 (0.09)

…

7.00 (7.00–7.25)

…

7.52 (0.03)

…

7.50 (7.50–7.55)

mm Hg

37 (7)

46 (5)

35 (30–50)

50 * (40–50)

92 (12)

120 (73)

100 (70–100)

95 (90–300)

kPa

4.9 (0.9)

6.1 (0.7)

4.7 (4.0–6.7)

6.7 * (5.3–6.7)

12.3 (1.6)

16.0 (9.7)

13.3 (9.3–13.3)

12.7 (12.0–40.0)

mm Hg

35 (7)

30

35 (30–40)

30

55 (7)

66 (11)

55 (50–60)

70 (50–80)

kPa

4.7 (0.9)

4.0

4.7 (4.0–5.3)

4.0

7.4 (0.9)

8.8 (1.5)

7.4 (6.7–8.0)

9.3 (6.7–10.7)

Bilirubin

94

9

Glucose

80

42

Potassium

30

Sodium

Hematology

Blood Gas and pH pH Cord Blood

28

…

Arterial pO2

16

8

Arterial pCO2

16

2

*, significant difference in medians and one mean at p < 0.05; **, significant difference in medians at p < 0.01. Bold indicates statistically significant difference.

Table 7: POCT critical limits5 Measurands

Listing Frequency (%)

Units

Low Mean (SD)

Low Median (Range)

High Mean (SD)

High Median (Range)

Clinical Chemistry Glucose

24.1

mg/dL

49.5 (4.4)

50 (40–55)

415.4 (87.5)

400 (200–500)

Newborn Glucose

9.3

mg/dL

40.8 (7.3)

40 (30–50)

220.0 (73.7)

200 (125-325)

Potassium

16.7

mmol/L

2.6 (0.3)

2.5 (2.0-3.0)

6.2 (0.2)

6.0 (6.0-6.5)

Ionized Calcium

14.8

mmol/L

0.81 (0.10)

0.77 (0.70-1.0)

1.57 (0.13)

1.50 (1.40-1.75)

Sodium

14.8

mmol/L

121.1 (2.1)

120 (120-125)

160.1 (2.4)

160 (156-165)

20 (3.2)

20 (15-25)

64.3 (7.9)

70 (50–70)

7.21 (0.04)

7.20 (7.2-7.3)

7.59 (0.019)

7.60 (7.55–7.6)

45.7 (6.1)

45 (0-55)

na

na

Blood Gas pCO2

13.0

pH

13.0

pO2

13.0

mm/Hg

mm/Hg

Hematology Hematocrit

11.1

%

18.2 (2.1)

18 (15-21)

63.3 (6.1)

60 (60–75)

Hemoglobin

11.1

g/dL

6.4 (0.5)

6.25 (6-7)

20.25 (0.5)

20 (20–21)

INR

9.3

4.9 (0.22)

5 (4.5–5.0)

INR, International normalized ratio.

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CUTOFF CONCENTRATIONS FOR DRUG TESTS This table was put together by MLO staff and reviewed by Suhash Harwani, PhD, Senior Director of Science for Workforce Health Solutions at Quest Diagnostics. The table refers to federal regulations at 42 CFR Chapter 1, HHS Drug Testing Panel—Urine and 49 CFR part 40, Section 40.85. New to the table this year is fentanyl and norfentanyl due to the prevalence of fentanyl use and overdoses.

The table follows:1,2 Initial test analyte

Common street name(s)3

Initial test cutoffA

Confirmatory test analyte

Confirmatory test cutoff concentration

Marijuana metabolites (Δ9THCC)

Marijuana (Pot)

50 ng/mL

Δ9THCC

15 ng/mL.

Cocaine metabolite (Benzoylecgonine)

Cocaine (Coke)

150 ng/mLB

Benzoylecgonine

100 ng/mL.

Codeine/ Morphine

Opiates

2000 ng/mL

Codeine Morphine

2000 ng/mL. 4000 ng/mL.

Hydrocodone/ Hydromorphone

Vicodin/ Dilaudid

300 ng/mL

Hydrocodone Hydromorphone

100 ng/mL. 100 ng/mL.

Oxycodone/ Oxymorphone

OxyContin/ Opana

100 ng/mL

Oxycodone Oxymorphone

100 ng/mL. 100 ng/mL.

6-Acetylmorphine

Heroin

10 ng/mL

6-Acetylmorphine

10 ng/mL.

Phencyclidine

PCP (Angel Dust)

25 ng/mL

Phencyclidine

25 ng/mL.

FentanylC

Fentanyl

1 ng/mL

Fentanyl Norfentanyl

1 ng/mL 1ng/mL

Amphetamine/ Methamphetamine

Meth

500 ng/mL

Amphetamine Methamphetamine

250 ng/mL. 250 ng/mL.

MDMA MDA

250 ng/mL. 250 ng/mL.

MDMA /MDA D

E

Ecstasy

500 ng/mL

REFERENCES 1.

Mandatory guidelines for Federal workplace drug testing programs-authorized testing panels. Federal Register. January 16, 2025. Accessed June 6, 2025. https://www.federalregister.gov/d/2025-00425.

2.

49 CFR part 40 -- procedures for transportation workplace drug and alcohol testing programs. Ecfr.gov. Accessed June 17, 2025. https://www.ecfr.gov/current/ title-49/subtitle-A/part-40.

3.

SAMHSA guidelines - US. Accessed May 2, 2025. https://www.thermofisher. com/us/en/home/clinical/diagnostic-testing/clinical-chemistry-drug-toxicologytesting/drugs-abuse-testing/drug-testing-overview/samhsa.html.

A. For grouped analytes (i.e., two or more analytes that are in the same drug class and have the same initial test cutoff): Immunoassay: The test must be calibrated with one analyte from the group identified as the target analyte. The cross-reactivity of the immunoassay to the other analyte(s) within the group must be 80 percent or greater; if not, separate immunoassays must be used for the analytes within the group.

Alternate technology: Either one analyte or all analytes from the group must be used for calibration, depending on the technology. For a technology that measures a response from the entire group without differentiating between analytes (e.g., an activity-based assay, a mass spectrometric assay that does not differentiate isobaric compounds), the laboratory must compare the result to the initial test cutoff. In the case of an alternate technology that differentiates and quantifies each analyte in the group, the laboratory must compare each analyte’s result to the confirmatory test cutoff and reflex specimens with a positive initial test result to confirmatory testing.

B. Alternate technology (BZE): The confirmatory test cutoff must be used for an alternate technology initial test that is specific for the target analyte (i.e., 100 ng/ mL for benzoylecgonine).

C. A fentanyl immunoassay must have at least 5% cross-reactivity to norfentanyl.

D. Methylenedioxymethamphetamine (MDMA).

E. Methylenedioxyamphetamine (MDA).

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2508MLO_CLR_15_CutoffConcentrations.indd 15

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CRITICAL VALUES FOR THERAPEUTIC DRUG LEVELS The concept of critical values for drug levels was originally developed by the late Daniel M. Baer, MD, and first published in the April 1982 issue of MLO. This table was reviewed by Rajasri Chandra, MS, MBA and lists the critical values for common therapeutic drugs updated in 2025 by reputed laboratories in the United States. Ranges are approximate and may vary by laboratory and/or assay. Proper interpretation of therapeutic drug concentrations requires that the specimen be drawn at an appropriate time in relation to drug administration.

Drug

Indication

Acetaminophen1

Analgesic

Amikacin1

Antimicrobial

Amiodarone1

Therapeutic Range

Critical values for therapeutic drugs are drug levels in a patient’s body that are dangerously high or low, potentially leading to serious or life-threatening effects. These values fall outside the therapeutic ranges and often require immediate clinical attention. The purpose of monitoring is as follows: • Efficacy (drug is at a high enough level to be effective) • Safety (not so high that it becomes toxic)

Critical Value

Method

10.0-30.0 µg/mL

>150.0 µg/mL 4 hrs. after ingestion

Peak: 20.0-35.0 µg/mL

Peak: >40.0 µg/mL

Trough: <8.0 µg/mL

Trough: >10. µg/mL

Antiarrhythmic

0.5-2.0 µg/mL

>2.5 µg/mL

Quantitative Liquid Chromatography-Tandem Mass Spectrometry

Amitriptyline1

Antidepressant/ analgesic (neuropathic pain)

80.0-200.0ng/mL

>500.0 ng/mL

Quantitative Liquid Chromatography-Tandem Mass Spectrometry

Carbamazepine1

Antiepileptic/ mood stabilizer

Free: 1.0-3.0 µg/mL

Free: >4.0 µg/mL

Free: Ultrafiltration Followed by Homogeneous Microparticle Agglutination Immunoassay

Total: 4.0-12.0 µg/mL

Total: >15.0 µg/mL

Total: Homogeneous Microparticle Agglutination Immunoassay

Cyclosporine A1

Immunosuppressant

2-hour post dose: Kidney transplant: 800-1700 ng/mL Liver transplant: 600-1000 ng/mL

None established

Quantitative Liquid Chromatography-Tandem Mass Spectrometry

Digoxin1

Antiarrhythmic

0.6-1.2 ng/mL

>4.0 ng/mL

Electrochemiluminescent Immunoassay

Doxepin + Nordoxepin1

Antidepressant

50-150 ng/mL

>500.0 ng/mL

Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS)

Ethosuximide1

Antiepileptic

40.0-100.0 µg/mL

>150.0 µg/mL

Enzyme-Multiplied Immunoassay Technique (EMIT)

Everolimus2

Immunosuppressant

3.0-8.0 ng/mL

>30.0 ng/mL

Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS)

Flecainide1

Antiarrhythmic

0.2-1.0 µg/mL

>1.0 µg/mL

Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS)

Fluconazole3

Antifungal

5.0-20.0 µg/mL

None established

Quantitative High Performance Liquid ChromatographyTandem Mass Spectrometry

Flucytosine1

Antifungal

Peak: >25 µg/mL

>100.0 µg/mL

Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS)

Gentamicin1

Antimicrobial

Peak: 3.0-12.0 µg/mL

Peak: >12.0 µg/mL

Trough: <2.0 µg/mL

Trough: <2.0 µg/mL

Itraconazole1

Antifungal

Trough: >0.5 µg/mL (localized) >1.0 µg/mL (systemic)

Not established

Quantitative High Performance Liquid ChromatographyTandem Mass Spectrometry

Lamotrigine1

Antiepileptic/mood stabilizer

3-15.0 µg/mL

>20.0 μg/mL

Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS)

Lidocaine1

Antiarrhythmic

1.0-5.0 µg/mL

>6.0 µg/mL

Enzyme-Multiplied Immunoassay Technique (EMIT)

Lithium1

Mood stabilizer

0.5-1.2 mmol/L

>1.6 mmol/L

Colorimetry

Nortriptyline1

Antidepressant/ analgesic (neuropathic pain)

70-170 ng/mL

>500.0 ng/mL

Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS)

Phenobarbital1

Antiepileptic

60-40 µg/mL in adults 15-30 µg/mL in children

>60.0 µg/mL

Kinetic Interaction of Microparticles in a Solution (KIMS)

Total: 10.0-20.0 µg/mL

Total: >30.0 µg/mL

Free: 1.0-2.0 µg/mL

Free: >2.5 µg/mL

>0.7 µg/mL (Trough)

Not established

Phenytoin1 Posaconazole1

Antiepileptic

Antifungal

Spectrophotometry Kinetic Interaction of Microparticles in Solution (KIMS)

Turbidimetric Immunoassay

Total: Kinetic interaction of Microparticles in a Solution (KIMS) Free: Membrane Separation/KIMS Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS)

16 | CLR 2025-2026 | MLO | CLR-ONLINE.COM

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CRITICAL VALUES FOR THERAPEUTIC DRUG LEVELS Drug

Indication

Therapeutic Range

Critical Value

Method

Primidone

Antiepileptic

5.0-12.0 µg/mL

>15.0 µg/mL

Enzyme Multiplied Immunoassay Technique (EMIT)

Procainamide (PA) + NAPA1

Antiarrhythmic

PA: 4.0-10.0 µg/mL NAPA: 12.0-18.0 µg/mL

>12.0 µg/mL >40.0 µg/mL

Homogeneous Enzyme Immunoassay

Protriptyline3

Antidepressant

70.0-240.0 ng/mL

>400.0 ng/mL

Quantitative Liquid Chromatography-Tandem Mass Spectrometry

Quinidine1

Antiarrhythmic

2-5 µg/mL

>6.0 µg/mL

Kinetic Interaction of Microparticles in Solution (KIMS)

Salicylate1

Analgesic, Anti-inflammatory

<30 mg/dL

≥50.0 mg/dL

Photometric

>25.0 ng/mL

Quantitative Liquid Chromatography-Tandem Mass Spectrometry

>25.0 ng/mL

Quantitative Liquid Chromatography-Tandem Mass Spectrometry

Neonatal apnea: <4 weeks old 6.0-13.0 µg/mL

>20.0 µg/mL

Kinetic Interaction of Microparticles in a Solution (KIMS)

Peak: 3.0 – 12 µg/mL Trough: < 2.0 µg/mL

> 12.0 µg/mL > 2.0 µg/mL

Immunoassay

Total: 50 (trough)-125 (peak) µg /mL

≥151.0 µg/mL

Immunoassay

Free: 5-25 µg/mL

>30 µg/mL

Ultrafiltration Followed by Immunoassay

Peak: 20.0-40.0 µg/mL

>60.0 µg/mL

Trough: 5.0-20.0 µg/mL

>20.1 µg/mL

Trough: 1.0-5.5 µg/mL

>6.0 µg/mL

1

Sirolimus3

Kidney transplant: (in combination with cyclosporine) 4.0-12.0 ng/mL

Immunosuppressant

Liver transplant: 12.0-20.0 ng/mL Post Kidney transplant: 0-3 months: 7.0-20.0 ng/mL 3 months & older: 5.0-15.0 ng/mL

Tacrolimus3

Post heart transplant: 0-3 months: 10.0-20.0 ng/mL 3 months & older: 5.0-15.0 ng/ml

Immunosuppressant

Post liver transplant: Over 1-12 months: 5.0-20.0 ng/mL Bronchodilation: 8.0-12.0 µg/mL Theophylline1

Bronchodilator

Tobramycin1

Antibacterial

Valproic acid

1

Antiepileptic/mood stabilizer

Vancomycin2

Antimicrobial

Voriconazole1

Antifungal

Kinetic Immunoassay Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS)

REFERENCES 1.

2.

3.

Mayo Clinic Laboratories. Test Catalog. Accessed April 23, 2025. https://www.mayocliniclabs.com/test-catalog/drug-book/therapeutic.

Michigan Medicine Laboratories. Order lab tests. Accessed April 23, 2025. https://mlabs.umich.edu/tests.

ARUP Laboratories. Therapeutic drug monitoring- TDM. Accessed April 23, 2025. https://arupconsult.com/content/therapeutic-drug-monitoring.

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CLR-ONLINE.COM | MLO | CLR 2025-2026 | 17

2508MLO_CLR_16-17_CriticalValues.indd 17

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TABLE OF REFERENCE INTERVALS Specimen

Conversion Factor (multiply by)

Test

Conventional Units

S

Albumin*

3.9-5.1

10

39-51 g/L

B

Base excess (men)

-3.3 to +1.2 mmol/L

1

-3.3 to +1.2 mmol/L

B

Base excess (women)

-2.4 to +2.3 mmol/L

1

-2.4 to +2.3 mmol/L

P

Bicarbonate

21-29 mmol/L

1

21-29 mmol/L

S

Bilirubin, conjugated*

<0.3 mg/dL

17.1

<5 µmol/L

S

Bilirubin, total*

0.1-1.2 mg/dL

17.1

2.0-19.9 µmol/L

S/P

Calcium, total

9.0-10.4 mg/dL

0.25

2.2-2.6 mmol/L

B

CO2 content (venous)

22-26 mEq/L

1

22-26 mmol/L

S/P

Chloride*

98-107 mEq/L

1

98-107 mmol/L

S

Cholesterol (NCEP recommendation)

<200 mg/dL

0.0259

<5.18 mmol/L

S

Cortisol (a.m., total)*

5-23 µg/dL

27.6

138-635 nmol/L 80-115 µmol/L

g/dL

SI Units

S

Creatinine (Jaffe, men)*

0.9-1.3 mg/dL

88.4

S

Creatinine (Jaffe, women)*

0.6-1.1 mg/dL

88.4

53-97 µmol/L

S

Ferritin (men)*

20-250 ng/mL

1

20-250 µg/L 10-120 µg/L

S

Ferritin (women)*

10-120 ng/mL

1

P

Fibrinogen

200-400 mg/dL

0.01

2-4 g/L

S

Folate

9.5-39.0 ng/mL

2.265

21.5-88.4 nmol/L

S

Glucose, fasting*

74-100 mg/dL

0.0555

4.1-5.6 mmol/L

S

Haptoglobin*

30-200 mg/dL

0.01

0.3-2.0 g/L

B

Hematocrit (men)*

40.0-52.0 %

0.01

0.40-0.52 Vol fraction

B

Hematocrit (women)*

35.0-47.0 %

0.01

0.35-0.47 Vol fraction

B

Hemoglobin (men)*

14-18 g/dL

10

140-180 g/L

B

Hemoglobin (women)*

12-16 g/dL

10

120-160 g/L

S

Iron, total

20-168 µg/dL

0.179

3.5-30.0 µmol/L

S

Iron binding capacity

250-400 µg/dL

0.179

44.8-71.6 µmol/L

B

Lactate (at bed rest)

5-12 mg/dL

0.111

0.56-1.39 mmol/L

B

Lead*

<25 µg/dL

0.048

<1.21 µmol/L

S

Magnesium (Atomic Absorption)

1.6-2.6 mg/dL

0.4114

0.66-1.07 mmol/L 28.0-32.0 pg/cell

B

MCH (RBC index)*

28.0-32.0 pg/cell

1

B

MCHC (RBC index)*

32.0-36.0 g/dL

10

320-360 g/L

B

MCV (RBC index)*

83.0-95.0 fL

1

83.0-95.0 fL 280-295 mmol/kg

S

Osmolality

280-295 m0sm/kg

1

B

pCO2 (arterial) (men)

35-48 mm Hg

0.133

4.7-6.4 kPa

B

pCO2 (arterial) (women)

32-45 mm Hg

0.133

4.3-6.0 kPa

B

pH (arterial)*

S/P

Phosphate (as P)*

B B

7.35-7.45

1

7.35-7.45

2.8-4.8 mg/dL

0.323

0.89-1.54 mmol/L

pO2 (arterial)

83-108 mm Hg

0.133

11.0-14.4 kPa

Platelet count

150-450 103/mm3

1

150-450 109/L 3.8-4.9 mmol/L

S

Potassium

3.8-4.9 mEq/L

1

S

Protein, total (recumbent)

6.0-7.8 g/dL

10

60-78 g/L

B

RBC count (men)*

4.5-5.9 106/mm3

1

4.5-5.9 1012/L

B

RBC count (women)*

4.5-5.1 106/mm3

1

4.5-5.1 1012/L

S

Sodium

136-145 mEq/L

1

136-145 mmol/L

S

Thyroxine, free*

0.8-2.7 ng/dL

12.9

10.3-34.7 pmol/L

S

Thyroxine (T4), total (men)*

4.6-10.5 µg/dL

12.9

59-135 nmol/L

S

Thyroxine (T4), total (women)*

5.5-11 µg/dL

12.9

65-138 nmol/L

S

Triglyceride (NCEP recommendation)

<150 mg/dL

0.0113

<1.7 mmol/L

S

Urea nitrogen (BUN)*

8-24 mg/dL

0.357

2.8-8.6 mmol/L

S

Uric acid (men)*

3.7-7.7 mg/dL

0.059

0.22-0.46 mmol/L

S

Uric acid (women)*

2.5-6.2 mg/dL

0.059

0.15-0.37 mmol/L

S

Vitamin B12 (WHO Recommendation)

>201 ng/L

0.733

>147 pmol/L

S

Vitamin D (25-OH)

10-65 ng/ml

2.50

25-162 nmol/L

B

WBC count

S

Zinc

4-11 103/mm3 80-120 µg/dL

1

4-11 109/L

0.153

12-18 µmol/L

Specimens: B, whole blood; P, plasma; S, serum. Reference intervals depend on test method and the demographics of the normal population used. *Adult intervals (18Y-60Y). Age specific ranges apply for pediatric and/or geriatric populations.

Source: Burtis CA, Bruns DE. Tietz Fundamentals of Clinical Chemistry and Molecular Diagnostics. 7th ed. St. Louis, MO; Elsevier; 2015 and Rifai, N, Horvath AR, Wittwer, CT. Tietz Textbook of Clinical Chemistry and Molecular Diagnostics, 6th ed. St. Louis, MO; Elsevier; 2018 McPherson RA, Pincus MR. Henry’s Clinical Diagnosis and Management by Laboratory Methods. 22nd ed. Philadelphia, PA: Elsevier Saunders; 22nd ed; 2011.

Revised 2025 by S. T. Campbell, PhD, DABCC, FADLM, Clinical Biochemist, Mount Sinai Hospital, Toronto, ON.

18 | CLR 2025-2026 | MLO | CLR-ONLINE.COM

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PEDIATRIC REFERENCE INTERVALS Carbon Dioxide CO21,2 Specimen Type: Serum Instrument/Reagent: Abbott Architect

Albumin G1,2 Specimen Type: Serum Instrument/Reagent: Abbott Architect Age

Male (g/dL)

Female (g/dL)

Age

Male (mEq/L)

Female (mEq/L)

0− < 15 days

3.3−4.5

3.3−4.5

0− <15 days

5−20

5−20

15 days− <1 year

10−24

10−24

15 days− < 1 year

2.8−4.7

2.8−4.7

1− < 8 years

3.8−4.7

3.8−4.7

1− <5 years

14−24

14−24

17−26

17−26

18−28

17−26

8− < 15 years

4.1−4.8

4.1−4.8

5− <15 years

15− < 19 years

4.1−5.1

4−4.9

15− <19 years

Chloride Specimen Type: Serum Instrument/Reagent: Siemens ADVIA XPT/1800

Age

Male (U/L)

Female (U/L)

0− <1 year

5−33

5−33

1− < 13 years

9−25

9−25

13− <19 years

9−24

8−22

ALP (Alkaline Phosphatase)1,2 Specimen Type: Serum Instrument/Reagent: Abbott Architect

0− <15 days

Male (U/L) 90−273

Magnesium1,2 Specimen Type: Serum Instrument/Reagent: Abbott Architect Age

Male and Female (mg/dL)

0- <15 days

1.99- 3.94

15 days to <1 year

1.97- 3.09

1 to <19 years

1,3

ALT (Alanine Aminotransferase)1,2 Specimen Type: Serum Instrument/Reagent: Abbott Architect

Age

The information in this chart was updated by MLO Staff based on the CALIPER database1 and reviewed by Khosrow Adeli, PhD, FCACB, DABCC, FADLM, Head, Clinical Biochemistry at The Hospital for Sick Children and Principle Investigator of the CALIPER Program. The reviewed chemistries are comparable to those listed in MLO's original Pediatric Reference Intervals chart, last updated in 2022. For reference intervals obtained by other lab instruments, see the CALIPER database.1

Female (U/L) 90−273

Age

Male and Female (mmol/L)

0- <19 years

104-109

C−Reactive Protein- High Sensitivity (hsCRP)1,2 Specimen Type: Serum Instrument/Reagent: Abbott Architect Age

Male and Female (mg/L)

0− <15 days

0.3−6.1

15 days− <15 years

0.1−1.0

15-<19 years

0.1-1.7

15 days− <1 year

134−518

134−518

1− <10 years

156−369

156−369

10− <13 years

141−460

141−460

13− <15 years

127−517

62−280

Age

Male (U/L)

Female (U/L)

15− <17 years

89−365

54−128

0− < 13 years

68-293

68-293

17− <19 years

59−164

48−95

13− <19 years

80-354

48-200

Bilirubin, total1 ,2 Specimen Type: Serum Instrument/Reagent: Abbott Architect

15−42

12−71

12−71

2.09- 2.84

1− <4 years

32−63

32−63

Potassium1,3 Specimen Type: Serum Instrument/Reagent: Siemens ADVIA XPT/1800

4- <13 years

36−73

36−73

13− <19 years

32−68

32−72

Age

Male (mmol/L)

Female (mmol/L)

0− <1year

4.3-6.7

4.2-6.2

1− <19 years

4.0-5.3

4.0-5.3

6− <9 years

6.4−7.7

0- <14 years

16-128

16-128

9− <19 years

6.5−8.1

14- <19 years

31-168

20-162

Age

Male and Female (µg/dL)

0− <19 years

139- 146

0− <19 years

300- 439

1− <9 years

0.1−0.4

2− <5 years

0.2−0.43

0.2−0.43

9− <12 years

0.1−0.6

2.

5− <12 years

0.31−0.61 0.31−0.61

12− <15 years

0.1−0.7

12− <15 years

0.45−0.81 0.45−0.81

15− <19 years

0.1−0.8

15− <19 years

0.62−1.08 0.49−0.84

0- <19 years

73-112

Total Iron Binding Capacity1,3 Specimen Type: Serum/Plasma Instrument/Reagent: Siemens ADVIA XPT/1800

Male and Female (mmol/L)

REFERENCES

9.2−10.5

Iron Specimen Type: Serum Instrument/Reagent: Abbott Architect 1,2

Age

0.1−0.36

1− <19 years

45.6-131

Female (µg/dL)

0.1−0.36

Male and Female (mg/dL)

58.8-128

45.6-131

Male (µg/dL)

15 days− <2 years

Age

47.2-121

Age

0.1−0.7

8.5−11.0

1− <10 years 10- <19 years

6.1−7.5

15 days− <1 year

0− <1 year

13.2-173

1− <6 years

0.32−0.92 0.32−0.92

Male and Female (mg/dL)

13.2-173

4.4−7.1

0− <15 days

Age

0− <1 year

15 days− <1 year

0.2−16.6

4.

Female (mg/dL)

5.3−8.3

0− <15 days

3.

Male (mg/dL)

0− <15 days

Age

1.

Age

Male and Female (g/dL)

Sodium Serum1,3 Specimen Type: Serum Instrument/Reagent: Siemens ADVIA XPT/1800

Female (mg/dL)

Low−Density Lipoprotein− Cholesterol (LDL−C)1,4 Specimen Type: Serum Instrument/Reagent: Abbott Architect

Age

Male and Female (mg/dL)

Glucose (Random)1,3 Specimen Type: Serum Instrument/Reagent: Siemens ADVIA XPT/1800

Female (mg/dL)

15−42

Age

Calcium1,2 Specimen Type: Serum Instrument/Reagent: Abbott Architect

Male (mg/dL)

0− <15 days

Creatine Kinase (CK)1,3 Specimen Type: Serum Instrument/Reagent: Siemens ADVIA XPT/1800

Male (mg/dL)

Age

15 − <1 year

Protein, Total1,2 Specimen Type: Serum Instrument/Reagent: Abbott Architect

Creatinine (Enzymatic)1,2 Specimen Type: Serum Instrument/Reagent: Abbott Architect

High−Density Lipoprotein Cholesterol (HDL−C)1,2 Specimen Type: Serum Instrument/Reagent: Abbott Architect

CALIPER Pediatric Reference Interval Database. CALIPER. Accessed May 20, 2025. https://caliper.research.sickkids.ca/#/.

Colantonio DA, Kyriakopoulou L, Chan MK, et al. Closing the gaps in pediatric laboratory reference intervals: a CALIPER database of 40 biochemical markers in a healthy and multiethnic population of children. Clin Chem.

2012;58(5):854-868. doi:10.1373/clinchem.2011.177741.

Tahmasebi H, Higgins V, Woroch A, Asgari S, Adeli K. Pediatric reference intervals for clinical chemistry assays on Siemens ADVIA XPT/1800 and Dimension EXL in the CALIPER cohort of healthy children and adolescents.

Clin Chim Acta. 2019;490:88-97. doi:10.1016/j.cca.2018.12.011.

Higgins V, Asgari S, Chan MK, Adeli K. Pediatric reference intervals for calculated LDL cholesterol, non-HDL cholesterol, and remnant cholesterol in the healthy CALIPER cohort. Clin Chim Acta. 2018;486:129-134. doi:10.1016/j. cca.2018.07.028.

CLR-ONLINE.COM | MLO | CLR 2025-2026 | 19

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TM

COMPANY DIRECTORY The following section includes company descriptions with their essential laboratory products and contact information for ordering and pricing.

Also available online at: CLR-online.com

20 | CLR 2025-2026 | MLO | CLR-ONLINE.COM

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COMPANY DIRECTORY

Company Directory

ARKRAY USA 801 S Marquette Ave, #200 Minneapolis, MN, 55402, US

laboratories in emergency departments, urgent care, and oncology practices. CLC offers a complete laboratory solution that also includes hematology and immunoassay analyzers. CLC continues to sell bar coded reagents for use on AU480® and AU680® analyzers along with affordable service contracts. CLC is veteran-owned.

TEL: 952-646-3200 CORELAB@ARKRAYUSA.COM HTTPS://www.arkrayusa.com

ARKRAY is a leader in the blood glucose monitoring market with a dominant market share in long term care. ARKRAY continues to evolve and innovate its product lines and programs to meet the changing needs of the industry including oral wellness innovations that benefit patients and provide health care professionals with new tools to care for them. For healthcare providers, this means access to cutting edge and reliable products combined with superior customer support. With products and programs that reach throughout the industry, ARKRAY has become the trusted source across the healthcare continuum.

CAROLINA LIQUID CHEMISTRIES CORP. 313 Gallimore Dairy Rd Greensboro, NC, 27409, US

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There’s nothing that gives us more pleasure than helping our client facilities become more successful by helping them manage their laboratory and patient information. We pride ourselves in the “personal touch” and try to go above and beyond to provide software and support that is unrivaled in the healthcare industry.

With over 30 years of experience, we still delight in building innovative, intuitive software to keep our clients on the cutting edge of clinical software technology.

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syndromic panels and will allow clinical laboratory staff to overcome the constraint of the “one size fits all” approach for infectious disease syndromic diagnostics. This fully automated, easy to use, sample-toanswer system has a streamlined workflow and a room-temperature consumable. The operational handson time is only two minutes per sample and results are produced in less than two hours.

The LIAISON PLEX® Respiratory Flex Assay is the first assay cleared for use on our new LIAISON PLEX System. Testing for 19 pathogens commonly associated with respiratory infections—including 14 viral and 5 bacterial targets—the LIAISON PLEX Respiratory Flex Assay gives users the choice to process and pay for a specific subset of customized results based on patient needs. Compared to standard panel testing, this method can improve clinical utility while decreasing cost burdens on patients and healthcare systems. Through the application of panel testing, patient care and treatment can be optimized in support of diagnostic stewardship efforts, thus enabling proper patient therapies and reducing costly over-testing.

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Carolina Liquid Chemistries (CLC) offers high quality, low-cost clinical chemistry analyzers for laboratories of all sizes along with a menu of over 80 different reagents for use on a variety of instruments.

The CLC floor models consist of the CLC800, CLC1600, and the ultra-high-speed CLC6410. CLC also offers two benchtop chemistry analyzers: The EasyRA® performs urine drug screens and general chemistry tests, while the DZ-Lite™ c270 offers general chemistries, urine drug screens including fentanyl, and special chemistries including procalcitonin. Both are excellent for

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CLR-ONLINE.COM | MLO | CLR 2025-2026 | 21

2508MLO_CLR_20-34.indd 21

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Company Directory fungi. Hardy Diagnostics is headquartered in Santa Maria, California, and services over 10,000 laboratories across the nation. Hardy Diagnostics exports products to over 80 foreign distributors and maintains nine distribution centers nationwide. Hardy Diagnostics’ mission is to produce and distribute the finest products for the detection of microorganisms and partner with its laboratory customers to diagnose and prevent disease. For more information on products and services, visit www.HardyDiagnostics.com.

For over 35 years, KRONUS has provided specialized immunoassay test kits to medical professionals at the world’s most respected laboratory facilities. Please contact us directly with any questions, requests or comments that you may have. We welcome the opportunity to learn how KRONUS can be of assistance in meeting your laboratory’s immunoassay test kit needs.

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HEALTH CARE LOGISTICS PO Box 25 Circleville, OH, 43113, US TEL: 740-477-3755 HCL@GOHCL.COM HTTPS://gohcl.com

See ad on page 34

Health Care Logistics® is an industry leader specializing in manufacturing, packaging and distributing unique and hard-to-find products.

Top inventory lines include Lab Equipment, Biohazard Supplies and Specimen Handling Materials. The company’s commitment to customer satisfaction sets it apart with services such as free samples, small package quantities and sameday shipping on most items. HCL® has spent more than 40 years tailoring its products and services to the needs of its customers and will scout non-inventory items at no extra charge or manufacture custom solutions based on individual requests.

INSULIN AUTOANTIBODY (IAA) • Radioimmunoassay Kit, 100 Tubes NEUROIMMUNOLOGY AQUAPORIN-4 AUTOANTIBODY (AQP4Ab) • ELISA Kit, 96 Wells ACETYLCHOLINE RECEPTOR AUTOANTIBODY (AChRAb): BINDING; BLOCKING • Radioimmunoassay Kits, 100 Tubes VOLTAGE-GATED CALCIUM CHANNEL AUTOANTIBODY (VGCCAb): P/Q-TYPE • Radioimmunoassay Kits, 12 and 24 Tubes THYROID AUTOIMMUNITY TSH RECEPTOR AUTOANTIBODY (TRAb) • ELISA Kit, 96 Wells • Coated-Tube (CT) Radioimmunoassay Kits, 60 and 120 Tubes ADRENAL AUTOIMMUNITY STEROID 21-HYDROXYLASE AUTOANTIBODY (21-OHAb) • ELISA Kit, 96 Wells FOR RESEARCH USE 3 SCREEN ISLET CELL (GAD/IA-2/ ZnT8) AUTOANTIBODY SCREEN • ELISA Kit, 96 Wells†

KRONUS, INC.

MUSCLE SPECIFIC TYROSINE KINASE AUTOANTIBODY (MuSKAb) • Radioimmunoassay Kit, 25 Tubes†

170 S Seneca Springs Way, Suite 105 Star, ID, 83669, US

TITIN AUTOANTIBODY • ELISA Kit, 48 Wells†

TEL: 207-377-4800 KRONUS@KRONUS.COM HTTPS://www.kronus.com

See ad on inside front cover

ACETYLCHOLINE RECEPTOR AUTOANTIBODY (AChRAb) – BINDING • ELISA Kit, 96 Wells†

LGP LAB AUTOMATION PO Box 18 Woodriver, IL, 62095, US SALES@LGPLABAUTOMATION.COM HTTPS://lgplabautomation.com

Is safet y your concern? Then Pluggo Decapper(s) and KapSafe Recapper(s) are your solutions. Both are benchtop proven, reliable and affordable. Eliminate possible injury during manual decapping and recapping. Serving labs since 2002.

ORCHARD SOFTWARE CORPORATION 701 Congressional Blvd, Suite 360 Carmel, IN, 46032, US SALES@ORCHARDSOFT.COM HTTPS://orchardsoft.com

For three decades, Orchard has offered development, support, and service for existing products while continuing to design new products that support the laboratory in the ever-changing healthcare market.

Orchard Software Corporation is a leader in the laboratory information system industry and offers

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Company Directory a variety of laboratory system solutions and services that improve patient care. Orchard serves more than 2,400 laboratories across the country, helping them improve efficiency, reduce errors, and enhance integration. Orchard’s cloud-based solutions are installed in physician groups and clinics, hospitals, independent reference labs, student health centers, veterinary labs, public health organizations, universities, and retail facilities.

Our Vision, Mission, & Values Our team of expert employees are dedicated to making Orchard the LIS market leader in the physician office lab, public health lab, and reference lab markets, as well as a point-ofcare market leader in the ambulatory and hospital markets.

PROLINE LABORATORY FURNITURE 10 Avco Rd Haverhill, MA, 01835, US BENCH@1PROLINE.COM HTTPS://www.1proline.com

Proline Laboratory Furniture and Tables offers a modular design that al lows you to configure laboratory to meet your requirement. Offering multiple work surface choices including but not limited to Epoxy Res in, Stainless Steel and economical Chem-Guard chemical resistant work surfaces. Cabinets offer 90 percent ex tension slides with 150 pounds capacity. Economical laboratory tables with hanging cabinets and casters offering a truly modular ergonomic design.

A tradition of excellence Puritan is now in our 106th year of business. We founded our company on the principles of pride in achieving excellence and determination to succeed. Our customers know us as the swab experts, with a focus on quality, consistency, outstanding customer service, and our commitment to partnering with them in their pursuit of these same principles.

When you’ve been around since 1919, change is inevitable. While we’ve certainly grown, one thing that’s never changed at Puritan is our incredibly high standards. This commitment and attention to detail are why we have a worldwide reputation for consistent quality.

In fact, we regularly go beyond for our own QC satisfaction because it is extremely important to us that every product we make is the best of its kind.

Our manufacturing facility is ISO certified and CE mark registered, so you can be certain we adhere to the strictest quality guidelines.

We’ll deliver excellent products and services across our organization every time, on time. That’s our promise to you.

Order with confidence, knowing our products are manufactured, packaged, and shipped from our state-of-the-art facilities in Maine, USA.

1 Wall Street Burlington, MA, 01803, US TEL: 781-652-7800 HTTPS://www.sekisuidiagnostics.com

See ad on back cover

31 School St, PO Box 149 Guilford, ME, 04443, US TEL: 207-876-3311 SALES@PURITANMEDPRODUCTS.COM HTTPS://www.puritanmedproducts.com

STAFFREADY 421 W Main Ave, Suite 201 Spokane, WA, 99201, US TEL: 877- 229-5230 SOLUTIONS@STAFFREADY.COM HTTPS://www.staffready.com

Healthcare leaders face increasing demands, strict regulations, and limited resources. StaffReady simplifies workforce operations with cloud-based solutions for scheduling, compliance, and document control, all customized to fit your organization’s needs.

With over 20 years of healthcare and laboratory expertise, StaffReady helps centralize schedules, competencies, documents, policies, tasks, alerts, and communication.

The result is streamlined operations and smoother inspections.

Our quality management tools help keep your teams efficient, compliant, and connected, regardless of your organization’s size or location.

With StaffReady, work doesn’t have to feel like labor.

SEKISUI DIAGNOSTICS LLC

QUESTIONS@SEKISUI-DX.COM

PURITAN MEDICAL PRODUCTS CO

tests, blood collection tube materials as well as enzymes and specialty biochemicals.

With over 40 years of experience, SEKISUI Diagnostics’ mission is to provide intelligent solutions to enhance life with science and improve the health of all people. We supply innovative medical diagnostics globally to physicians, hospitals, laboratories and alternate testing locations.

Our product lines include clinical chemistry reagents, point-of-care

SYSMEX AMERICA, INC. 577 Aptakisic Rd Lincolnshire, IL, 60069, US TEL: 888-879-7639 COMMUNICATIONS@SYSMEX.COM HTTPS://www.sysmex.com/us

See ad on page 5

A Portfolio of Solutions you need for the lab of tomorrow Hematology Solutions • As a global leader in hematology, we’re proud to offer labs of all sizes award-winning services and innovative solutions.

Hemostasis Solutions • Our innovative portfolio of

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hemostasis analyzers, reagents and controls are designed with quality and efficiency in mind. We provide advanced hemostasis technology across multiple platforms.

Urinalysis Solutions • With fluorescent flow cytometry technology at its core, the Sysmex UN-Series offers an innovative urinalysis solution for any size laboratory.

Flow Cytometry Solutions • Our comprehensive Flow Cytometry solutions include automated sample preparation, flow cytometers, filters, reagents, monoclonal antibodies and analytical software.

Informatics Solutions • From highly secure test results and impactful performance metrics to quality control management, our software is designed to help your lab streamline its clinical and operational workflows so you can provide optimal patient care.

For more information about Sysmex solutions, visit www.sysmex.com/us

NAVIGATE PROFICIENCY TESTING WITH

CONFIDENCE CONFIDENCE TECHCYTE 105 S State St, #401 Orem, UT, 84058, US SALES@TECHCYTE.COM HTTPS://www.techcyte.com

Techcyte is transforming the practice of pathology through a unifi ed, AI-powered digital platform that streamlines complex workfl ows, integrates with core lab systems, and enhances communication across the lab. Built to reduce ineffi ciencies and diagnostic variability, Techcyte aims to help pathologists and lab professionals deliver faster, more consistent diagnoses.

By partnering with leading laboratories, scanner manufacturers, diagnostic hardware providers, and AI developers, together, we deliver a unifi ed digital pathology and diagnostics platform to labs and clinics around the world, furthering our mission to positively impact the health of humans, animals, and the environment.

Visit CLR online all year at CLR-online.com

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REQUEST A QUOTE

wslhpt.org/mlo wslhpt.org/mlo

Let WSLH PT be your trusted guide Empower your laboratory with expertly designed programs and solutions, delivering the accuracy and insights you trust.

6/27/25 3:46 PM

TM

PRODUCT CATEGORIES The following section includes company tests, equipment, products, and services for the clinical lab market.

Also available online at: CLR-online.com

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PRoduct CATEGORIES PRODUCT Categories EQUIPMENT & SERVICES

Health Care Logistics

Automation & Workflow

Dry Baths

Automation Clinical Software Solutions Hardy Diagnostics See ad on page 15

LGP Lab Automation

Barcode Products

See ad on page 34

Health Care Logistics See ad on page 34

Incubators Hardy Diagnostics See ad on page 15

Health Care Logistics See ad on page 34

Clinical Software Solutions Health Care Logistics

Microscopes & Accessories

Decapping & Recapping

Mixers & Shakers

LGP Lab Automation

Health Care Logistics

See ad on page 34

Information Systems & Software

Hardy Diagnostics See ad on page 15

See ad on page 34

Sample Stirrers

Laboratory Supplies Hardy Diagnostics See ad on page 15

Health Care Logistics See ad on page 34

Puritan Medical Products Co

Needles Health Care Logistics See ad on page 34

Pipettes & Tips Hardy Diagnostics See ad on page 15

Health Care Logistics See ad on page 34

Reagents Carolina Liquid Chemistries Corp.

Diasorin See ad on inside back cover

Health Care Logistics

Hardy Diagnostics

Clinical Software Solutions

Slide Stainers

Health Care Logistics

Lab Software & Computer Systems

Hardy Diagnostics

Healthcare Information Systems

Clinical Software Solutions Orchard Software Corporation StaffReady Sysmex America, Inc. See ad on page 5

Laboratory Information Systems

See ad on page 34

See ad on page 15

Sysmex America, Inc. See ad on page 5

Staining Sysmex America, Inc. See ad on page 5

Clinical Software Solutions Orchard Software Corporation StaffReady Sysmex America, Inc.

Staining & Coverslipping

Next Generation Sequencing Software

Health Care Logistics

See ad on page 5

Orchard Software Corporation

Sample Management Systems

Sysmex America, Inc. See ad on page 5

Techcyte

Water Baths See ad on page 34

See ad on page 15 See ad on page 34

KRONUS, Inc.

See ad on inside front cover

SEKISUI Diagnostics LLC See ad on back cover

Sysmex America, Inc. See ad on page 5

Test Tube Racks Hardy Diagnostics See ad on page 15

Health Care Logistics See ad on page 34

Tubes Hardy Diagnostics See ad on page 15

Health Care Logistics

Lab Supplies & Consumables

See ad on page 34

Urinalysis, Controls

Clinical Software Solutions Sysmex America, Inc.

Apparel Hardy Diagnostics

Arkray USA Health Care Logistics

Specimen Management Systems

Health Care Logistics

Sysmex America, Inc.

Clinical Software Solutions Puritan Medical Products Co

Furniture & Storage

See ad on page 5

Lab Instruments & Analyzers Analyzers Arkray USA Carolina Liquid Chemistries Corp.

Hardy Diagnostics See ad on page 15

Sysmex America, Inc. See ad on page 5

Centrifuges

See ad on page 15 See ad on page 34

See ad on page 34 See ad on page 5

Health Care Logistics

Phlebotomy & Sample Collection

Proline Laboratory Furniture

Phlebotomy Products And Supplies

Glassware & Cleaning

Health Care Logistics

See ad on page 34

Hardy Diagnostics See ad on page 15

Health Care Logistics See ad on page 34

See ad on page 34

Specimens, Storage Equipment Health Care Logistics See ad on page 34

Labels Health Care Logistics See ad on page 34

Hardy Diagnostics See ad on page 15

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PRoduct CATEGORIES PRODUCT Categories Quality & Compliance Education, Proficiency & Accreditation Clinical Software Solutions StaffReady Sysmex America, Inc. See ad on page 5

Error Prevention Clinical Software Solutions Health Care Logistics See ad on page 34

HIPAA Compliance

Specialty Products & Services Biochemistry Products & Services Arkray USA Carolina Liquid Chemistries Corp.

Diasorin

Sysmex America, Inc. See ad on page 5

Blood Bank, Instrumentation Health Care Logistics See ad on page 34

Individualized Quality Control Plan (IQCP) Implementation Tools

Hardy Diagnostics

Quality Management Tools Clinical Software Solutions Health Care Logistics See ad on page 34

Orchard Software Corporation StaffReady Sysmex America, Inc. See ad on page 5

Safety & Environment Cleanrooms

See ad on inside back cover

Hardy Diagnostics See ad on page 15

Puritan Medical Products Co

TESTS

Blood Bank & Transfusion

Sysmex America, Inc.

Clinical Software Solutions

Diasorin

See ad on inside back cover

Clinical Software Solutions Health Care Logistics See ad on page 34

Virology Products & Services

See ad on page 5

Diagnostic Services & Products See ad on page 15

Puritan Medical Products Co Sysmex America, Inc. See ad on page 5

Kappa Light Chains Carolina Liquid Chemistries Corp.

Manufacturing Services Clinical Software Solutions Health Care Logistics See ad on page 34

Puritan Medical Products Co

Microbiology Products & Services Hardy Diagnostics See ad on page 15

Clinical Chemistry/Biochemistry Aldolase Carolina Liquid Chemistries Corp.

Alkaline Phosphatase (alp) Carolina Liquid Chemistries Corp.

SEKISUI Diagnostics LLC See ad on back cover

Alt (ifcc) SEKISUI Diagnostics LLC See ad on back cover

Amylase (amy), Serum Carolina Liquid Chemistries Corp.

SEKISUI Diagnostics LLC See ad on back cover

Aspartate Aminotransferase (ast) Carolina Liquid Chemistries Corp.

SEKISUI Diagnostics LLC See ad on back cover

Beta Hydroxybutyrate SEKISUI Diagnostics LLC See ad on back cover

Hardy Diagnostics

Health Care Logistics

Health Care Logistics

Puritan Medical Products Co

Carolina Liquid Chemistries Corp.

Puritan Medical Products Co

Molecular Biology, Products & Services

Cholesterol, total

Safety Products

Health Care Logistics

See ad on page 15 See ad on page 34

Health Care Logistics See ad on page 34

See ad on page 34

See ad on page 34

Puritan Medical Products Co

LGP Lab Automation

Pap Test Products

Temperature Monitoring, Automated

Puritan Medical Products Co Techcyte

Health Care Logistics See ad on page 34

Temperature Monitoring, Continuous Health Care Logistics See ad on page 34

Waste & Hazardous Material Health Care Logistics See ad on page 34

Water Health Care Logistics See ad on page 34

Pathology Products & Services Health Care Logistics See ad on page 34

Toxicology Products & Services Carolina Liquid Chemistries Corp.

Clinical Software Solutions Health Care Logistics See ad on page 34

Urinalysis, Automated Arkray USA Health Care Logistics See ad on page 34

Cardiac Risk Assessment

Carolina Liquid Chemistries Corp.

Cholinesterase SEKISUI Diagnostics LLC See ad on back cover

Clinical Free Fatty Acids (NEFA) SEKISUI Diagnostics LLC See ad on back cover

C-Reactive Protein Carolina Liquid Chemistries Corp.

SEKISUI Diagnostics LLC See ad on back cover

Creatine Kinase Assays (CK) Carolina Liquid Chemistries Corp.

SEKISUI Diagnostics LLC See ad on back cover

CSF Test Kits SEKISUI Diagnostics LLC See ad on back cover

Sysmex America, Inc. See ad on page 5

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PRoduct Categories Gamma-Glutamyl Transpeptidase (GGT) Carolina Liquid Chemistries Corp.

SEKISUI Diagnostics LLC See ad on back cover

Glycated Serum Protein (GSP) Assay SEKISUI Diagnostics LLC See ad on back cover

Total Bilirubin (TBIL)

Complete Blood Count

Carolina Liquid Chemistries Corp.

SEKISUI Diagnostics LLC

Sysmex America, Inc.

Triglyceride (TRIG)

Complete Blood Count & Diff

Carolina Liquid Chemistries Corp.

SEKISUI Diagnostics LLC

Sysmex America, Inc.

See ad on back cover

See ad on back cover

Haptoglobin Assays (HAPT)

Clinical

SEKISUI Diagnostics LLC See ad on back cover

High-Density Lipoprotein, Direct Carolina Liquid Chemistries Corp.

SEKISUI Diagnostics LLC

Beta-2 Microglobulin SEKISUI Diagnostics LLC See ad on back cover

See ad on back cover

Endocrinology

Homocyst(e)ine, Plasma Or Serum Carolina Liquid Chemistries Corp.

SEKISUI Diagnostics LLC See ad on back cover

Iron & Iron-Binding Protein Assays Carolina Liquid Chemistries Corp.

SEKISUI Diagnostics LLC See ad on back cover

Lactate (LAC) Carolina Liquid Chemistries Corp.

SEKISUI Diagnostics LLC See ad on back cover

Lipase, Serum (LIP) Carolina Liquid Chemistries Corp.

SEKISUI Diagnostics LLC See ad on back cover

Lipoprotein (a) Carolina Liquid Chemistries Corp.

SEKISUI Diagnostics LLC

Diabetes Mellitus KRONUS, Inc.

See ad on inside front cover

Diabetes Testing & Management Sysmex America, Inc. See ad on page 5

Glucose (GLU) Carolina Liquid Chemistries Corp.

HCG Ultra Combo SEKISUI Diagnostics LLC See ad on back cover

Carolina Liquid Chemistries Corp.

Hematology

See ad on inside back cover

Health Care Logistics See ad on page 34

Low-Density Lipoprotein Cholesterol (direct)

Sysmex America, Inc.

Carolina Liquid Chemistries Corp.

SEKISUI Diagnostics LLC

Techcyte

Phosphorus, Inorganic (PHOS) Carolina Liquid Chemistries Corp.

SEKISUI Diagnostics LLC See ad on back cover

Sysmex America, Inc. See ad on page 5

Hematology/Clinical Chemistry D-Dimer, Automated Carolina Liquid Chemistries Corp.

SEKISUI Diagnostics LLC See ad on back cover

Immunology/Serology Acetylcholine Receptor KRONUS, Inc.

See ad on inside front cover

Antibody Screen KRONUS, Inc.

See ad on inside front cover

SEKISUI Diagnostics LLC

Diasorin

See ad on back cover

Reagents - Coagulation Assay

Triiodothyronine (T3)

Carolina Liquid Chemistries Corp.

SEKISUI Diagnostics LLC

SEKISUI Diagnostics LLC

Arkray USA

KRONUS, Inc.

Blood

Microprotein

Hemoglobin A1c

Carolina Liquid Chemistries Corp.

Lipoproteins & Apolipoproteins

See ad on back cover

See ad on page 5

Techcyte

Autoantibody Testing

Insulin

See ad on back cover

See ad on back cover

See ad on page 5

Techcyte

See ad on page 5

Blood, Screening Sysmex America, Inc. See ad on page 5

Techcyte

Cell Count Health Care Logistics See ad on page 34

Sysmex America, Inc. See ad on page 5

Protein, total

Techcyte

Carolina Liquid Chemistries Corp.

Chloride, Serum or Urine

See ad on inside front cover See ad on back cover

Techcyte

Autoimmune & Complement Assays Carolina Liquid Chemistries Corp.

SEKISUI Diagnostics LLC See ad on back cover

Autoimmune Disease Testing KRONUS, Inc.

See ad on inside front cover

Complement, Components, Assays Carolina Liquid Chemistries Corp.

SEKISUI Diagnostics LLC See ad on back cover

Enzyme Immunoassays Diasorin

See ad on inside back cover

SEKISUI Diagnostics LLC See ad on back cover

Free Kappa & Lambda Light Chains Carolina Liquid Chemistries Corp.

SEKISUI Diagnostics LLC See ad on back cover

Carolina Liquid Chemistries Corp.

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PRoduct Categories Immunoassays

H. Pylori

Susceptibility Testing

Carolina Liquid Chemistries Corp.

Hardy Diagnostics

Hardy Diagnostics

Hardy Diagnostics

SEKISUI Diagnostics LLC

Trichomonas Vaginalis, Rapid Testing

See ad on page 15

Immunodiagnostic Kits & Reagents Hardy Diagnostics See ad on page 15

Neuroimmunological Disorders, Autoimmune KRONUS, Inc.

See ad on inside front cover

Microbiology Antimicrobials, Assays

See ad on page 15

See ad on back cover

Legionella Pneumophila Urine Antigen Hardy Diagnostics

Methicillin-Resistant Staphylococcus Aureus (MRSA) Culture Only Rare Hardy Diagnostics See ad on page 15

Microbial Strain Typing Hardy Diagnostics

Aspergillus

Microbiology & Culture

Hardy Diagnostics See ad on page 15

Bacterial Vaginosis (sialidase) Techcyte

Bacteriology Test Reports Puritan Medical Products Co Techcyte

Puritan Medical Products Co SEKISUI Diagnostics LLC See ad on back cover

See ad on page 15

Hardy Diagnostics See ad on page 15

See ad on page 15

See ad on page 15

Hardy Diagnostics See ad on page 15

Microbiology/Immunology Babesia Microti Antibody Profile Diasorin

See ad on inside back cover

Microbiology/Virology Bordetella Parapertussis Detection Diasorin

See ad on inside back cover

Puritan Medical Products Co

Bordetella Pertussis Detection

Mycoplasma Pneumoniae Culture

Diasorin

Hardy Diagnostics See ad on page 15

See ad on inside back cover

Infectious Disease

Organism Identification

Diasorin

Hardy Diagnostics

Hardy Diagnostics

Diasorin

Techcyte

Puritan Medical Products Co

Hardy Diagnostics

Reference Bacterial Culture Identification

Techcyte

Hardy Diagnostics

Cryptococcus

Techcyte

Candida See ad on inside back cover See ad on page 15

Techcyte

Enterohemorrhagic E. Coli (ehec) Shiga Toxin, Eia Techcyte

Escherichia Coli

See ad on page 15

See ad on page 15

Staphylococcus Identification, Methicillin Resistant Hardy Diagnostics See ad on page 15

Strep A Antigen

Techcyte

Hardy Diagnostics

Fungal/Mycology

SEKISUI Diagnostics LLC

Hardy Diagnostics See ad on page 15

Gram’s Stain Hardy Diagnostics See ad on page 15

Techcyte

Group A Streptococcus Hardy Diagnostics See ad on page 15

Group B Streptococcus Colonization Detection Culture Hardy Diagnostics See ad on page 15

See ad on page 15

See ad on back cover

Strep A, Ultra Hardy Diagnostics See ad on page 15

SEKISUI Diagnostics LLC See ad on back cover

See ad on inside back cover See ad on page 15

Molecular Diagnostics Nucleic Acid Amplification Products & Detection Systems Diasorin

See ad on inside back cover

Molecular Diagnostics/Genetics Congenital Disease Diasorin

See ad on inside back cover

Factor V Leiden Mutation Analysis Diasorin

See ad on inside back cover

Genetic & Genomic Testing Puritan Medical Products Co

Streptococcus (Group B) Culture, Genital

Molecular Diagnostics/Pathology

Hardy Diagnostics

Bladder Cancer, Fish

See ad on page 15

Puritan Medical Products Co

Streptococcus Pneumoniae Antigen Hardy Diagnostics

Techcyte

Urovysion(tm) FISH Techcyte

See ad on page 15

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PRoduct Categories Molecular Diagnostics/Virology Adenovirus Dna, Qualitative, Rt Pcr

Acetaminophen

Diasorin

SEKISUI Diagnostics LLC

See ad on inside back cover

Pathology/Cytology Cytology /Cytopathology Techcyte

Fecal Occult Blood (ifob) Carolina Liquid Chemistries Corp.

Hardy Diagnostics See ad on page 15

SEKISUI Diagnostics LLC See ad on back cover

Gynecologic Pap Smear

Sysmex America, Inc.

Toxicology

See ad on page 5

Techcyte

Virology

See ad on back cover

Alcohol Assays

COVID-19

Carolina Liquid Chemistries Corp.

SEKISUI Diagnostics LLC

Diasorin

See ad on inside back cover

See ad on back cover

Hardy Diagnostics

Carbamazepine, Serum

See ad on page 15

Puritan Medical Products Co SEKISUI Diagnostics LLC

Carolina Liquid Chemistries Corp.

Digitoxin, Serum

See ad on back cover

Carolina Liquid Chemistries Corp.

Cytomegalovirus (CMV)

Drugs-of-abuse testing, Urine

Diasorin

Carolina Liquid Chemistries Corp.

See ad on inside back cover

Fentanyl

Dengue Fever

SEKISUI Diagnostics LLC

Diasorin

Gabapentin, Serum

Enterovirus Testing

SEKISUI Diagnostics LLC

Diasorin

Lamotrigine Tdm Assay

Epstein-Barr Virus (EBV)

SEKISUI Diagnostics LLC

Diasorin

Techcyte

Lithium, Serum

Herpes Simplex Virus (HSV)

Gynecologic Pap Testing

Carolina Liquid Chemistries Corp.

SEKISUI Diagnostics LLC

Diasorin

Puritan Medical Products Co Techcyte

Gynecologic Pap Test (ImageGuided Or Non-Image Guided), Liquid-based Preparation Techcyte

Gynecologic Pap Test, Liquidbased Preparation

Puritan Medical Products Co Techcyte

Histology Puritan Medical Products Co Techcyte

Immunocyt Monitoring For Bladder Cancer Techcyte

Stool culture Carolina Liquid Chemistries Corp.

Puritan Medical Products Co

Specialized/Other Method Development & Validation Hardy Diagnostics See ad on page 15

Point-of-care Testing, Clia Waived Hardy Diagnostics

See ad on back cover

Specimens Puritan Medical Products Co

See ad on inside back cover

See ad on back cover

See ad on inside back cover

See ad on back cover

See ad on inside back cover

See ad on back cover

HHV6

Methotrexate Assays

Diasorin

See ad on inside back cover

SEKISUI Diagnostics LLC See ad on back cover

Theophylline, Assay And Therapeutic Drug Monitoring (theo)

Influenza Diasorin

See ad on inside back cover

Carolina Liquid Chemistries Corp.

Hardy Diagnostics

Topiramate, Serum

Puritan Medical Products Co SEKISUI Diagnostics LLC

See ad on page 15

SEKISUI Diagnostics LLC See ad on back cover

See ad on back cover

Tricyclic Antidepressants, Serum

Mononucleosis

Carolina Liquid Chemistries Corp.

Hardy Diagnostics

Valproic Acid, Assay And Therapeutic Drug Monitoring (VPA) Carolina Liquid Chemistries Corp.

Zonisamide Tdm Assay SEKISUI Diagnostics LLC See ad on back cover

See ad on page 15

Puritan Medical Products Co SEKISUI Diagnostics LLC

See ad on inside back cover

See ad on back cover

See ad on page 15

SEKISUI Diagnostics LLC See ad on back cover

Respiratory Syncytial Virus (RSV) Diasorin

See ad on inside back cover

Hardy Diagnostics See ad on page 15

Urinalysis Arkray USA Health Care Logistics See ad on page 34

Puritan Medical Products Co SEKISUI Diagnostics LLC See ad on back cover

West Nile Diasorin

See ad on inside back cover

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TM

PRODUCT CATEGORIES INDEX The following section includes tests, equipment, products, and services for the clinical lab market.

Also available online at: CLR-online.com

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PRoduct CATEGORIES PRODUCT Categories INDEX Index A

D

Acetaminophen............................. 31 Acetylcholine Receptor................. 29 Adenovirus Dna, Qualitative, Rt Pcr............................................ 31 Alcohol Assays.............................. 31 Aldolase.......................................... 28 Alkaline Phosphatase (alp)........... 28 Alt (ifcc).......................................... 28 Amylase (amy), Serum.................. 28 Analyzers........................................ 27 Antibody Screen............................ 29 Antimicrobials, Assays................. 30 Apparel........................................... 27 Aspartate Aminotransferase (ast)............................................... 28 Aspergillus..................................... 30 Autoantibody Testing.................... 29 Autoimmune & Complement Assays.......................................... 29 Autoimmune Disease Testing...... 29 Automation.................................... 27

D-Dimer, Automated..................... 29 Decapping & Recapping............... 27 Dengue Fever................................. 31 Diabetes Mellitus........................... 29 Diabetes Testing & Management............................... 29 Diagnostic Services & Products....................................... 28 Digitoxin, Serum............................ 31 Drugs-of-abuse testing, Urine...... 31 Dry Baths........................................ 27

B Babesia Microti Antibody Profile.30 Bacterial Vaginosis (sialidase)...... 30 Bacteriology Test Reports............ 30 Barcode Products.......................... 27 Beta-2 Microglobulin..................... 29 Beta Hydroxybutyrate................... 28 Biochemistry Products & Services....................................... 28 Bladder Cancer, Fish..................... 30 Blood.............................................. 29 Blood Bank, Instrumentation....... 28 Blood Bank & Transfusion............ 28 Blood, Screening........................... 29 Bordetella Parapertussis Detection..................................... 30 Bordetella Pertussis Detection..... 30

C Candida.......................................... 30 Carbamazepine, Serum................ 31 Cardiac Risk Assessment.............. 28 Cell Count....................................... 29 Centrifuges..................................... 27 Chloride, Serum or Urine.............. 29 Cholesterol, total........................... 28 Cholinesterase............................... 28 Cleanrooms.................................... 28 Clinical Free Fatty Acids (NEFA).. 28 Complement, Components, Assays.......................................... 29 Complete Blood Count.................. 29 Complete Blood Count & Diff....... 29 Congenital Disease....................... 30 COVID-19........................................ 31 C-Reactive Protein......................... 28 Creatine Kinase Assays (CK)........ 28 Cryptococcus................................. 30 CSF Test Kits.................................. 28 Cytology /Cytopathology............. 31 Cytomegalovirus (CMV)............... 31

E Education, Proficiency & Accreditation............................... 28 Enterohemorrhagic E. Coli (ehec) Shiga Toxin, Eia........................... 30 Enterovirus Testing....................... 31 Enzyme Immunoassays................ 29 Epstein-Barr Virus (EBV)............... 31 Error Prevention............................ 28 Escherichia Coli............................. 30

F Factor V Leiden Mutation Analysis....................................... 30 Fecal Occult Blood (ifob)............... 31 Fentanyl.......................................... 31 Free Kappa & Lambda Light Chains.......................................... 29 Fungal/Mycology........................... 30 Furniture & Storage....................... 27

G Gabapentin, Serum....................... 31 Gamma-Glutamyl Transpeptidase (GGT)............................................ 29 Genetic & Genomic Testing.......... 30 Glassware & Cleaning................... 27 Glucose (GLU)................................ 29 Glycated Serum Protein (GSP) Assay............................................ 29 Gram’s Stain.................................. 30 Group A Streptococcus................ 30 Group B Streptococcus Colonization Detection Culture.. 30 Gynecologic Pap Smear................ 31 Gynecologic Pap Test (ImageGuided Or Non-Image Guided), Liquid-based Preparation........... 31 Gynecologic Pap Testing.............. 31 Gynecologic Pap Test, Liquidbased Preparation....................... 31

H Haptoglobin Assays (HAPT)......... 29 HCG Ultra Combo.......................... 29 Healthcare Information Systems.27 Hemoglobin A1c............................ 29 Herpes Simplex Virus (HSV)......... 31 HHV6............................................... 31 High-Density Lipoprotein, Direct............................................ 29 HIPAA Compliance........................ 28

Histology........................................ 31 Homocyst(e)ine, Plasma Or Serum..................................... 29 H. Pylori.......................................... 30

I Immunoassays............................... 30 Immunocyt Monitoring For Bladder Cancer............................ 31 Immunodiagnostic Kits & Reagents........................... 30 Incubators...................................... 27 Individualized Quality Control Plan (IQCP) Implementation Tools..... 28 Infectious Disease......................... 30 Influenza......................................... 31 Insulin............................................. 29 Iron & Iron-Binding Protein Assays.......................................... 29

K Kappa Light Chains....................... 28

L Labels............................................. 27 Laboratory Information Systems....................................... 27 Laboratory Supplies...................... 27 Lab Software & Computer Systems....................................... 27 Lactate (LAC).................................. 29 Lamotrigine Tdm Assay................ 31 Legionella Pneumophila Urine Antigen......................................... 30 Lipase, Serum (LIP)....................... 29 Lipoprotein (a)............................... 29 Lipoproteins & Apolipoproteins.. 29 Lithium, Serum.............................. 31 Low-Density Lipoprotein Cholesterol (direct)..................... 29

M Manufacturing Services............... 28 Methicillin-Resistant Staphylococcus Aureus (MRSA) Culture Only Rare..................................... 30 Method Development & Validation..................................... 31 Methotrexate Assays.................... 31 Microbial Strain Typing................ 30 Microbiology & Culture................ 30 Microbiology Products & Services....................................... 28 Microprotein.................................. 29 Microscopes & Accessories......... 27 Mixers & Shakers.......................... 27 Molecular Biology, Products & Services....................................... 28 Mononucleosis.............................. 31 Mycoplasma Pneumoniae Culture.......................................... 30

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PRoduct Categories Index N Needles........................................... 27 Neuroimmunological Disorders, Autoimmune................................ 30 Next Generation Sequencing Software...................................... 27 Nucleic Acid Amplification Products & Detection Systems.. 30

O Organism Identification................ 30

P Pap Test Products.......................... 28 Pathology Products & Services... 28 Phlebotomy Products And Supplies....................................... 27 Phosphorus, Inorganic (PHOS)..... 29 Pipettes & Tips.............................. 27 Point-of-care Testing, Clia Waived......................................... 31 Protein, total.................................. 29

Q

Respiratory Syncytial Virus (RSV)............................................ 31

S Safety Products............................. 28 Sample Management Systems.... 27 Sample Stirrers.............................. 27 Slide Stainers................................. 27 Specimen Management Systems.......................................... 27 Specimens...................................... 31 Specimens, Storage Equipment.. 27 Staining.......................................... 27 Staining & Coverslipping.............. 27 Staphylococcus Identification, Methicillin Resistant................... 30 Stool culture.................................. 31 Strep A Antigen............................. 30 Strep A, Ultra................................. 30 Streptococcus (Group B) Culture, Genital.......................................... 30 Streptococcus Pneumoniae Antigen......................................... 30 Susceptibility Testing................... 30

Quality Management Tools.......... 28

T

R

Temperature Monitoring, Automated................................... 28 Temperature Monitoring, Continuous.................................. 28 Test Tube Racks............................. 27

Reagents......................................... 27 Reagents - Coagulation Assay..... 29 Reference Bacterial Culture Identification............................... 30

Theophylline, Assay And Therapeutic Drug Monitoring (theo)............................................ 31 Topiramate, Serum........................ 31 Total Bilirubin (TBIL)..................... 29 Toxicology Products & Services.. 28 Trichomonas Vaginalis, Rapid Testing.......................................... 30 Tricyclic Antidepressants, Serum.. 31 Triglyceride (TRIG)........................ 29 Triiodothyronine (T3).................... 29 Tubes.............................................. 27

U Urinalysis, Automated.................. 28 Urinalysis, Controls....................... 27 Urovysion(tm) FISH....................... 30

V Valproic Acid, Assay And Therapeutic Drug Monitoring (VPA)... 31 Virology Products & Services...... 28

W Waste & Hazardous Material........ 28 Water.............................................. 28 Water Baths.................................... 27 West Nile........................................ 31

Z Zonisamide Tdm Assay................. 31

INDEX OF ADVERTISERS Advertiser........................... Web........................................ Page Diasorin.............................diasorin.com...................................... C3

Hardy Diagnostics...........HardyDiagnostics.com/CTXM..........15

Health Care Logistics......GoHCL.com.........................................34

Kronus...............................kronus.com......................................... C2

Sekisui Diagnostics.........sekisuidiagnostics.com.................... C4

Sysmex America..............Sysmex.com/UA...................................5

WSLH Proficiency Testing / University of Wisconsin-Madison........wslhpt.org/mlo....................................25 This index is provided as a service.

The ­publisher does not assume liability for errors or omissions.

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MOLECULAR SOLUTIONS

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p: 562 240 6500 w: diasorin.com ©2025 Luminex Corporation. All rights reserved. Luminex and LIAISON PLEX are trademarks of Luminex Corporation and/or its affiliates, registered in the US and other countries.

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Speed + Reliability Point-of-Care Respiratory Solutions To Meet Your Needs Respiratory season can pose a real threat to your patients, especially the elderly. Fast, accurate diagnosis and treatment is one way to protect them and get them back to doing what they love. Having the right diagnostics in your office can help you deliver a higher level of patient satisfaction and improve efficiency.

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These tests have not been FDA cleared or approved. They are authorized by FDA under an EUA for use by authorized laboratories. The emergency use of these products is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b) (1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb 3(b)(1), unless the declaration is terminated, or authorization is revoked sooner. © 2025 SEKISUI Diagnostics, LLC. All rights reserved. OSOM® and QC Inside® are registered trademarks of SEKISUI Diagnostics, LLC. Because every result matters™ is a trademark of SEKISUI Diagnostics, LLC. Metrix® is a registered trademark of Aptitude Medical Systems Inc.

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