Medical Laboratory Observer CLR 2026

2026-2027

CLR-online.com

TM

FEATURING

cross references of tests, equipment, products, services

+ REFERENCE GUIDES

critical limits, drug levels, drug testing cutoffs, adult and pediatric reference intervals

A SUPPLEMENT OF

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IN THIS ISSUE...

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2026-2027

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Cover image: Adobe Stock | 1293934691

FEATURES

DEPARTMENTS 04 06

CLINICAL LABORATORY REFERENCE GUIDES

08 14 18 23 24 25

Table of Critical Limits Point-of-Care Testing Critical Limits Critical Limits for Therapeutic Drug Levels

From the editor Special Feature: Preparing labs for the near future

By Erin Brady

35

Index of advertisers

Cutoff Concentrations for Drug Tests Table of Reference Intervals Pediatric Reference Intervals

PRODUCT LISTINGS AND TESTS

26 27 30

Product Categories Index Company Directory

6

Product Categories

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 2026-2027 | 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 limits 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.

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 laboratory 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.

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 glucose critical limits table is included this year based on their research in press, “Critical Limits and Clinical Recommendations for Notification of Life-Threatening Glucose Test Results in the 21st Century” in Archives of Pathology & Laboratory Medicine.

• New this year, is Point-of-Care Testing Critical Limits by Kami Osher and Gerald J. Kost, MD, PhD, MS, FADLM, derived from their research published in Diagnostics (Basel) in 2026, “Critical Decision Thresholds for Urgent Physician Notification of Point-of-Care Testing Results.”

• Also new this year is Critical Limits for Therapeutic Drug Levels, from research by Elina Kuang, Yasmeen Ibrahim, Kyle Cheng, and Gerald J. Kost, MD, PhD, MS, FADLM. “Drug Critical Limits for Urgent Physician Notification” was published this year in Clinical Pharmacology & Therapeutics (CPT).

• The cutoff concentrations for drug tests table was reviewed by Jason Hudson, PhD, Scientific Director & Laboratory Director at Quest Diagnostics. A callout for the DOT was added regarding the morphine 4000 ng/mL cutoff.

• 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 “Preparing labs for the near future” by Erin Brady. Seven laboratory industry professionals provided their viewpoints on the changes they believe will have the largest impacts on labs over the next one to two years, such as artificial intelligence, automation, workflow redesigns, staffing challenges, and healthcare affordability and financial pressures.

We hope readers find this resource beneficial. For the online version of CLR, please visit www.clr-online.com.

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

TM

Vol. 58, No. 5

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

Terry Gann | tgann@endeavorb2b.com ADVERTISING SALES DIRECTOR OF HEALTHCARE Jennifer Hazen 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 CDO Jacquie Niemiec CALO Tracy Kane CMO Amanda Landsaw EVP INFRASTRUCTURE & PUBLIC SECTOR GROUP Kylie Hirko VP OF CONTENT STRATEGY, INFRASTRUCTURE & PUBLIC SECTOR GROUP Michelle Kopier

30 Burton Hills Blvd., Suite 185 Nashville, TN 37215 800-547-7377 | www.mlo-online.com Medical Laboratory Observer USPS Permit 60930, ISSN 05807247 print, ISSN 2771-6759 online is published 9 times annually (January, March, April, May, July, August, September, October, November) 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. $164.80 per year; Canada/Mexico $199.56 per year; All other countries $284.54 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 2026 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.

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SPECIAL FEATURE :: LABORATORY INSIGHTS

mathisworks/ DigitalVision Vectors/Getty Images

Special Feature :: Laboratory insights

Preparing labs for the near future

By Erin Brady

T

he clinical laboratory industry is rapidly changing and frequently asked to be resilient without always having the proper resources to adapt. Medical Laboratory Observer (MLO) asked seven industry experts which changes they believe will have the largest impact on labs over the next one-two years. They shared their insights on how labs should be preparing for continued staffing issues, regulatory pressures and changes, financial burdens, continued artificial intelligence (AI) rise, and other operational and diagnostic challenges. Here is what they said:

Operational improvements

LUIS CARVAJAL, Director, Business Operations UHealth Laboratories, University of Miami Health System, Miami, Florida The greatest transformation over the next 12 to 24 months will be the transition from labor-intensive operating models to more structured and scalable ways of running laboratory operations, built to sustain performance despite ongoing staffing pressure. This is not about implementing new technology. It is about redesigning how work actually flows through the lab in response to persistent workforce constraints, increasing testing complexity, tighter compliance expectations, and financial pressure.

Labs should be acting now. They should standardize workflows, clarify roles and ownership, strengthen operational governance, and use operational excellence as the foundation for targeted automation. Organizations that do this well will see clear improvements in turnaround time, quality, and workforce stability. Those that do not will continue to struggle, regardless of how much technology they deploy.

A need for expertise

YVES DUBAQUIE, Senior Vice President, Diagnostics, Revvity AI and automation are accelerating our understanding of increasingly complex biological systems and diseases, which in turn is driving demand for more advanced and efficient testing. At the same time, staffing shortages and reimbursement pressures are forcing laboratories to become more productive while operating with the same or fewer resources. In this environment, automation has become a critical strategic lever for maximizing investment and improving operational efficiency. AI is also making sophisticated technologies more accessible to less specialized operators, enabling laboratories to address growing complexity while easing workforce constraints. As these trends continue, the laboratory workforce of the future will increasingly require both familiarity with

AI and automation technologies, as well as strong research and clinical expertise.

Future lab insights

DARRYL ELZIE, PsyD, MHA, MLS (ASCP), CQA (ASQ), Manager, Regulatory Affairs, Inova Blood Donor Services One of the many changes likely to have a major impact on clinical laboratory operations over the next 12-24 months is the rapid convergence of artificial intelligence, automation, and workforce redesign. Laboratories are already managing persistent staffing shortages (documented in the ASCP vacancy survey), rising test complexity, expected shorter turnaround times, and heavier quality documentation demands.

The practical question is no longer whether or what technology will enter the laboratory workflow, but how well laboratories will integrate the technology without weakening professional identity, trust, or culture.

AI and automation may help stabilize operations by reducing repetitive manual work, improving data visibility, supporting test triage, and enabling laboratory professionals to focus on interpretive, quality, and patient-impacting responsibilities.

However, this transition has a psychological dimension that laboratory leaders should not underestimate. Despite a high vacancy rate,1,2 staff may reasonably wonder whether AI will eventually eliminate their jobs4, downgrade their job classifications, reroute tasks away from them, or create opportunities for administrators to reduce compensation. If these concerns are left unaddressed, technology adoption can be perceived less as support and more as a threat.

Laboratories should therefore prepare for AI implementation as both an operational and cultural change. In my paper, Reshaping Organizational Culture in Pathology,3 I emphasized that pathology and laboratory departments undergoing rapid transformation must move beyond traditional hierarchical models and intentionally build cultures grounded in collaboration, transparency, psychological safety, adaptability, and shared purpose. Those same principles apply to AI adoption. Staff are more likely to engage with new tools when leaders explain why the change is occurring, how patient care and quality will be protected, what work will remain human-centered, and how employees will be reskilled rather than simply displaced.

In the next two years, laboratories should prepare by developing clear governance around AI-enabled tools, including validation, competency, oversight, documentation, escalation pathways, and defined limits of use. They should also develop communication plans addressing the human side of implementation. This includes acknowledging uncertainty directly,

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Special Feature :: Laboratory insights involving frontline laboratory professionals in workflow redesign, identifying tasks appropriate for automation rather than human judgment, and creating training pathways that help staff move into higher-value analytical, quality, informatics, supervisory, and patient-safety functions.

Laboratories navigating this transition most effectively will be those that treat technology as an extension of laboratory expertise, not a substitute for it. AI may change how work is distributed, documented, and monitored, but it will not eliminate the need for professional judgment, regulatory discipline, quality oversight, ethical decision-making, and accountability.

Preparing now means strengthening both the technical infrastructure and the cultural infrastructure required for change.

Laboratories should be inspection-ready, data-driven, and digitally capable. Still, they must also remain psychologically safe places where staff understand their future role in an increasingly technology-enabled laboratory environment.

Leadership opportunities PATTY J. ESCHLIMAN, MHA, MLS(ASCP)CM, DLM(ASCP)CM Director of Laboratory Operations, NKC Health, The Lab Leader Coach, LLC In my MLO article New and current laboratory challenges that impact staffing: What you can do to overcome and reach success5 (April 7, 2026), I discuss the financial pressures facing medical laboratories under H.R.1 OBBB, commonly known as The One Big Beautiful Bill. Reduced healthcare affordability and tighter access are projected to leave as many as 14.2 million more Americans uninsured. Combined with lower Medicare and Medicaid reimbursement, these pressures could be the tipping point for already struggling rural hospitals.6 They may also prompt hospitals to view laboratory services as a loss leader and consider selling them to outside reference labs. Additionally, I highlighted workforce trends affecting laboratories: as Gen Z enters the workforce and baby boomers retire, staffing, recruitment, and retention are changing in ways laboratory leaders cannot afford to ignore.

Together, these changes point to what I see as the greatest opportunity for clinical laboratories: leadership development.

It is discouraging to visit almost any laboratory social media group and see the unchecked expression of negativity and hostility. Some of this may be driven by bots designed to boost engagement by imitating human emotion and, in the process, amplifying harmful beliefs. However, there is often an underlying theme regarding a lack of leadership for addressing issues. Some of what I wince while reading include team members that are bullied by co-workers or other problematic behavioral issues that are reported but ignored, unequal work expectations and favoritism, micromanagement and the refusal to support the team, safety concerns, and even unethical conduct or unprofessional behavior from the supervisors themselves. Many times, these posts end with the questions: “What should I do?”“Should I stay here?” Or even “Should I leave the field of laboratory medicine?” Is this because so many laboratories promote individuals that are high in technical skills without considering if they are strong in interpersonal skills? Is it because our profession is so short staffed that there is no one who will step up into leadership? Or is it a systemic issue within the organization that leadership training is not needed or unnecessary? I suspect all of these problems might be in play, but the bottom line is that without strong leadership, there is not a strong team.

I highly recommend that if not provided by their employer,

new leaders seek out leadership training that will ensure success. Become active in your professional organizations such as ASCLS or ASCP. Volunteerism is a great way to learn leadership skills in a nonjudgemental way that you can then take back to your organization and shine! There are a lot of resources within these organizations to tap into: read books, listen to podcasts, seek out a mentor, or hire a coach!

Insights from UAMS

DR. NATHAN JOHNSON, Chair of Laboratory Sciences at the University of Arkansas for Medical Sciences (UAMS) A challenge impacting clinical laboratories over the next 12–24 months will be the continued mismatch between testing volume and complexity and the available workforce to perform that testing. Laboratories are being asked to do more with fewer experienced personnel, while at the same time managing ever-changing regulatory expectations. We need to establish more University and College based training programs to supply the workforce. Our current programs are doing a great job, but even working at capacity are producing less than 50 percent of what is needed. In the short-term, laboratories may need to shift to non-traditional students and specialized training (e.g. categorical certification) to meet workforce needs.

MR. JASON KEY, Assistant Professor/Program Director for Online Studies at the University of Arkansas for Medical Sciences (UAMS) The workforce shortage is real. I have the opportunity to visit Medical Laboratory Technician (MLT) programs all over the United States and they are doing phenomenal work. To better support these students, our MLT programs need support from local hospitals to host students. There are willing students, but our future workforce pipeline depends on hospitals carving out the time to host them. It’s hard because these hospitals are understaffed, but it is something we must do.

MR. PAUL NELSON, Associate Professor/Program Director for Non-Degree Studies at the University of Arkansas for Medical Sciences (UAMS) As AI becomes a more affordable and commonplace tool adopted across medical professions, clinical laboratories will continue moving away from physical manipulation of samples and manual bench testing at a more rapid pace. Over the next 12-24 months, clinical laboratories and the role of the medical laboratory scientist will continue to shift towards more quality management oversight, including increased data analysis and result interpretations, along with increased attention on machine/automation troubleshooting and more interdisciplinary communication and data sharing across the healthcare facility. Labs can better prepare by focusing on creating guidelines for the use of effective AI tools, training department supervisors on how to incorporate such tools into their daily workflows while actively listening to the frontline laboratory staff regarding which tools are working and which are problematic, overly burdensome and/or reduce accuracy, precision and timeliness of test result release back to the ordering provider.

References are available online at mlo-online.com/55382855 CLR-ONLINE.COM | MLO | CLR 2026-2027 | 7

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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 Tables 1-6 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 Table 7 displays research by Dr. Kost, Kami Osher, Kyle Cheng, BS, Chloe Cota, and Tarini Guru that reveals 35-year changes in glucose critical limits and point-of-care testing.

Glucose critical limits were extracted from critical limit notification lists from 417 university hospitals, trauma centers, heart centers, network hospitals, and community hospitals across all 50 U.S. states and Washington, D.C.10 The Joint Commission identifies timely reporting of critical tests results as a National Patient Safety Goal (NPSG.02.03.01) in its accreditation programs.11 Clinical laboratories can develop notification practices collaboratively with emergency physicians, hospitalists, and point-of-care specialists to achieve timely, effective, and focused patient care.

Table 1: Clinical chemistry critical limits.5 Test

Listing Freq., %

Low Mean (SD)

Low Median (Range)

High Mean (SD)

High Median (Range)

1990

2024

1990

2024

1990

2024

1990

2024

mmol/L

1.65 (0.17)

1.55 (0.10)

1.62 (1.2-2.2)

1.50** (1.2-1.7)

3.22 (0.22)

3.24 (0.15)

3.24 (2.62-3.49)

3.24** (2.87-3.49)

Units

2024 1990 Calcium

98

100

mg/dL

6.6 (0.7)

6.2 (0.4)

6.5 (5.0-8.6)

6.0** (5.0-7.0)

12.9 (0.9)

13.0 (0.6)

13.0 (10.5-14.0)

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

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)

CO2 content

74

75

mmol/L

11 (2)

11 (2)

10 (5-20)

10 (8-15)

40 (3)

42 (3)

40 (35-50)

40* (39-50)

Lactate

62

5

mmol/L

—

—

—

—

3.4 (1.3)

3.9 (1.1)

3.0 (2.3-5.0)

4.0 (2.0-8.0)

Osmolality

40

20

mmol/kg

250 (13)

245 (14)

250 (230-280)

250 (190-260)

326 (18)

332 (18)

320 (295-375)

330 (308-390)

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)

Cerebrospinal Fluid Glucose

40

16

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 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.

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. Gerald J. Kost, et al. Critical Limits and Clinical Recommendations for Notification of Life-Threatening Glucose Test Results in the 21st Century. Arch Path Lab Med. 2026; in press.

11. Joint Commission. National Patient Safety Goal 02.03.01. Effective January 2026. https://digitalassets.jointcommission.org/api/public/content/3c7a110c2159 43bc80d9ce87e9d9ee9d?. Accessed June 1, 2026.

REFERENCES 1. Lundberg GD. When to panic over an abnormal value. MLO. 1972;4:47-54.

2. 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.

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.

Table 2: Blood gas and pH critical limits.5

Measurand

Listing Freq., %

Low Mean (SD)

Low Median (Range)

High Mean (SD)

High Median (Range)

1990

2024

1990

2024

1990

1990

pH Units

7.21 (0.06)

7.20 (0.03)

7.20 (7.00-7.35)

7.20 (7.10-7.25)

mmHg

43 (6)

45 (6)

40 (30-55)

40* (39-60)

—

—

—

—

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)

Units

2024 1990 pH

86

35

Arterial pO2

78

26

*

2024

7.59 (0.03) 7.59 (0.02)

2024

7.60 (7.50-7.65) 7.60 (7.55-7.65)

Arterial pCO2

74

Carboxyhemoglobin

48

—

%

—

—

—

—

—

15.3 (5.7)

—

17.0 (5.1-25.0)

Methemoglobin

34

—

%

—

—

—

—

—

11.7 (10.4)

—

5.1 (3.0-30.0)

Venous pH

26

—

pH Units

—

7.20 (0.04)

—

7.20 (7.10-7.25)

—

7.59 (0.03)

—

7.60 (7.52-7.60)

Venous pCO2

16

—

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)

30

*

*, 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

Low Mean (SD)

Low Median (Range)

High Mean (SD)

High Median (Range)

1990

1990

1990

1990

2024

2024

2024

2024

Platelets

96

45

109/L

37 (21)

25 (11)

30 (10-100)

20** (10-50)

894 (206)

984 (73)

1,000 (100-1,000)

1,000 (600-1,000)

Hemoglobin

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)

20.0 † (19.0-22.5)

—

—

—

—

—

4.9 (0.6)

—

5.0 (4.0-7.0)

—

80 (33)

116 (25)

80 (40-150)

—

800 (500-1,000)

—

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)

Band Count

12

—

%

—

—

—

—

—

23 (11)

—

20 (10-40)

Blast Cells

12

—

%

—

—

—

—

—

5.7 (2.2)

—

5 (4-10)

—

50

**

110** (69-200)

**

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

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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)

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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.

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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) COVID-19 (SARS-CoV-2)

6 4

Consensus

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

INSIGHT

for Clinical Laboratory Management and Professionals Visit www.mlo-online.com/subscribe to sign up today!

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TABLE OF CRITICAL LIMITS Table 6. Newborn critical limits.5 Test

Listing Freq., % 2024

Units

1990

Low Mean (SD)

Low Median (Range)

High Mean (SD)

High Median (Range)

1990

2024

1990

2024

1990

2024

1990

2024

…

…

…

…

239 (34)

257 (34)

257 (171–308)

257 (171–342)

Clinical Chemistry µmol/L

Bilirubin

94

9

mg/dL

…

…

…

…

14 (2)

15 (2)

15 (10–18)

15 (10–20)

Potassium

30

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)

Sodium

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)

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. Glucose critical limits — adults and newborns, 2025 versus 1990, and point-of-care testing.10 Number of Hospitals (%)

Units

Low Mean (SD, Range)

Low Median (IQR)

High Median (IQR)

High Mean (SD, Range)

All hospitals 2025

1990

417 (100)

92 (100)

1990

2025

1990

2025

1990

2025

1990

2025

mg/dL

46.0 (7.1, 30-70)

49.2 (6.0, 35-60)

45 (40-50.1)

50a (45-54)

484 (147.2, 110-1,000)

458.6 (71.1, 200-999)

500 (400-500.3)

450 (400-500)

mmol/ L

2.6 (0.4, 1.7-3.9)

2.7 (0.3,1.9-3.3)

2.5 (2.2-2.8)

2.8a (2.5-3.0)

26.9 (8.2, 6.1-55.5)

25.5 (3.9, 11.1-55.5)

27.8 (22.2-27.8)

25.0 (22.2-27.8)

1990

2025

1990

2025

Newborns (at adult hospitals) 2025

1990

Low: 341 (82) High: 336 (81)

Low: 38 (41) High: 37 (40)

1990

2025

1990

2025

mg/dL

32.2 (6.2, 20-50)

38.2 (6.6, 20-55)

30.1 40a (30.1-30.1) (35-40)

309.5 (86.5, 150-700)

238.5 (88.6,120-500)

300 (300-300)

200b (150-300)

mmol/ L

1.8 (0.3, 1.1-2.8)

2.1 (0.4, 1.1-3.1)

1.7 (1.7-1.7)

17.2 (4.8, 8.3-38.9)

13.2 (4.9, 6.7-27.8)

16.7 (16.7-16.7)

11.1b (8.3-16.7)

2.2a (1.9-2.2)

Point-of-care testing 2025 73 (17.5)

2025

2025

2025

2025

mg/dL

50.3 (4.9, 40-70)

50 (50-54)

467.7 (60.5, 200-600)

450 (450-500)

mmol/L

2.8

2.8

26.0

25.0

Abbreviation: IQR, interquartile range; and SD, standard deviation. Note: Statistical computations were performed using data in mg/dL. To convert units, mmol/L= mg/dL x 0.05551. SI units (Système 555international d’unités) are shown for reader convenience.

Footnotes a. For comparisons of 1990 versus 2025 critical limits, 35-year changes are boldfaced when median ranks differed significantly [Mann Whitney U statistical test, P <.001 or less, highly significant]. b. For the comparison of newborn high critical limits, P<.01. c.Point-of-care testing showed no significant differences in when comparing adult matched pairs.

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POINT-OF-CARE TESTING CRITICAL LIMITS

Point-of-Care Testing (POCT) Critical Limits

By Kami Osher and Gerald J. Kost MD, PhD, MS, FADLM

T

he urgent communication of life-threatening test results is vital for patient safety, enabling rapid, potentially life-saving interventions. Unlike traditional laboratory testing, point-of-care testing (POCT) delivers rapid diagnostic results directly at or near the patient’s site. Healthcare institutions set thresholds for dangerously abnormal results

to guide immediate treatment.

These tables display large-scale research by Kami Osher and Gerald J. Kost, MD, PhD, MS, FADLM, published in 2026 in Diagnostics (Basel), involving 417 hospitals across all 50 states and Washington, D.C., including university hospitals and affiliates, heart centers, and trauma centers.1

Table 1. Critical limits for point-of-care clinical chemistry tests.1 Measurand

Number of Hospitals (%)

Units

Low Mean (SD)

Low Median (Range)

High Mean (SD)

High Median (Range)

1.A. Adults Glucose

73 (17.5)

mg/dL

50.3 (4.9)

50 (40–70)

467.7 (60.5)

450 (200–600)

mmol/L

2.8 (0.3)

2.8 (2.2–3.9)

26 (3.4)

25 (11.1–33.3)

Ionized calcium

21 (5)

mmol/L

0.66 (0.17)

0.75 (0.50–1.00)

1.65 (0.10)

1.60 (1.40–1.75)

Potassium

20 (4.8)

mmol/L

2.9 (0.2)

3 (2.5–3)

6.1 (0.2)

6 (6–6.5)

Sodium

18 (4.3)

mmol/L

123.6 (3)

126 (120–126)

156.7 (2.4)

155 (155–160)

CO2 content

17 (4.1)

mmol/L

10.7 (0.6)

11 (10–12)

40 (1.9)

39 (39-45)

Lactic Acid

14 (3.4)

mmol/L

…

…

3.6 (0.6)

3.9 (2–4)

11 (2.6)

mg/dL

Calcium

6.5 (0.2)

6.6 (6–6.6)

13 (0.3)

12.9 (12.9–14)

mmol/L

1.64 (0.05)

1.65 (1.5–1.65)

3.25 (0.08)

3.23 (3.23–3.5)

…

…

3.9 (0)

3.9 (3.9–3.9)

Venous Lactic Acid

10 (2.4)

mmol/L

1.B. Newborns

Glucose

62 (14.9)

mg/dL

44.7 (5)

45 (40–54)

227.7 (87)

200 (125–500)

mmol/L

2.5 (0.3)

2.5 (2.2–3)

12.6 (4.8)

11.1 (6.9–27.8)

Ionized calcium

18 (4.3)

mmol/L

0.86 (0.05)

0.90 (0.80–0.90)

1.41 (0.14)

1.30 (1.30–1.60)

Potassium

15 (3.6)

mmol/L

3 (0.1)

3 (2.8–3)

6.8 (0.5)

7.1 (6–7.1)

Sodium

14 (3.4)

mmol/L

127.5 (4.3)

130 (120–130)

151.1 (2.9)

150 (150–160)

CO2 content

12 (2.9)

mmol/L

11 (0.4)

11 (10–12)

39.2 (0.4)

39 (39–40)

11 (2.6)

mg/dL

Calcium

6.9 (0.3)

7 (6–7)

13 (0.3)

12.9 (12.9–14)

mmol/L

1.73 (0.08)

1.75 (1.5–1.75)

3.25 (0.08)

3.23 (3.23–3.5)

10

mg/dL

…

…

17.9 (0)

17.9 (17.9–17.9)

(2.4)

µmol/L

…

…

306.1 (0)

306.1 (306.1–306.1)

Bilirubin Abbreviation: SD, standard deviation.

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POINT-OF-CARE TESTING CRITICAL LIMITS Table 2. Critical limits for point-of-care blood gas and pH tests.1 Measurand

Number of Hospitals (%)

Units

Low Mean (SD)

Low Median (Range)

High Mean (SD)

High Median (Range)

2.A. Adults pH

Low: 29 (7) High: 28 (6.7)

Arterial pO2

Low: 27 (6.5) High: 1 (0.2)

Arterial pCO2

Low: 20 (4.8) High: 21 (5)

pH Units

7.20 (0.06)

7.20 (7.00–7.30)

7.59 (0.04)

7.60 (7.50–7.65)

mm Hg

45 (5.9)

40 (40–55)

200 (…)

200 (200–200)

kPa

6 (0.8)

5.3 (5.3–7.3)

26.7 (…)

26.7 (26.7–26.7)

mm Hg

20.3 (1.1)

20 (20–25)

67.1 (5.1)

70 (50–70)

2.7 (0.1)

2.7 (2.7–3.3)

8.9 (0.7)

9.3 (6.7–9.3)

…

…

12.6 (4.4)

10 (10–20)

…

…

4.5 (1.8)

4 (3–10)

kPa

Carboxyhemoglobin

21 (5)

%

Methemoglobin

20 (4.8)

%

Venous pH

20 (4.8)

pH Units

7.21 (0.02)

7.20 (7.20–7.30)

7.58 (0.05)

7.60 (7.50–7.65)

Low: 15 (3.6) High: 17 (4.1)

mm Hg

Venous pCO2

30 (7.3)

35 (20–35)

68.5 (4.1)

71 (56–71)

kPa

4 (1)

4.7 (2.7–4.7)

9.1 (0.5)

9.5 (7.5–9.5)

Arterial O2 Saturation

11 (2.6)

%

76.8 (10.6)

80 (45–80)

…

…

Venous O2 Saturation

10 (2.4)

%

60 (0)

60 (60–60)

…

Arterial O2 Hemoglobin

10 (2.4)

%

79.5 (4)

82 (75–85)

…

…

mm Hg

Venous pO2

Low: 10 (2.4) High: 1 (0.2)

32 (0)

32 (32–32)

200 (…)

200 (200–200)

kPa

4.3 (0)

4.3 (4.3–4.3)

26.7 (…)

26.7 (26.7–26.7)

pH

Low: 25 (6) High: 20 (4.8)

Arterial pO2

Low: 23 (5.5) High: 1 (0.2)

Arterial pCO2

Low: 17 (4.1) High: 22 (5.3)

mm Hg kPa

Carboxyhemoglobin

20 (4.8)

Venous pH

19 (4.6)

Venous pO2

Low: 10 (2.4) High: 1 (0.2)

Arterial O2 Saturation

10 (2.4)

…

2.B. Newborns pH Units

7.19 (0.04)

7.20 (7.00–7.27)

7.59 (0.05)

7.60 (7.45–7.65)

mm Hg

45 (9.2)

40 (30–60)

200 (…)

200 (200–200)

kPa

6 (1.2)

5.3 (4–8)

26.7 (…)

26.7 (26.7–26.7)

23.8 (3.8)

25 (20–35)

70.9 (7.2)

70 (50.1–80)

3.2 (0.5)

3.3 (2.7–4.7)

9.5 (1)

9.3 (6.7–10.7)

%

…

…

11.5 (5.1)

9 (8–20)

pH Units

7.20 (0)

7.20 (7.20–7.20)

7.60 (0.04)

7.60 (7.55–7.65)

mmHg

32 (0)

32 (32–32)

200 (…)

200 (200–200)

kPa

4.3 (0)

4.3 (4.3–4.3)

26.7 (…)

26.7 (26.7–26.7)

%

80 (0)

80 (80–80)

…

… continued

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POINT-OF-CARE TESTING CRITICAL LIMITS Table 2. Critical limits for point-of-care blood gas and pH tests.1 Measurand

Number of Hospitals (%)

Low Mean (SD)

Units

Low Median (Range)

High Mean (SD)

High Median (Range)

…

…

2.B. Newborns Venous O2 Saturation

10 (2.4)

%

60 (0)

60 (60–60)

Methemoglobin

10 (2.4)

%

…

…

6 (1.5)

6 (5-10)

9 (2.2)

mmHg

Venous pCO2

22.8 (2.6)

25 (20–25)

62.2 (2.6)

60 (60–65)

kPa

3 (0.4)

3.3 (2.7–3.3)

8.3 (0.4)

8 (8–8.7)

Capillary pH

Low: 9 (2.2) High: 4 (1)

pH Units

7.20 (0)

7.2 (7.20–7.20)

7.65 (0)

7.65 (7.65–7.65)

Low: 4 (1) High: 9 (2.2)

mmHg

Capillary pCO2

20 (0)

20 (20–20)

73.3 (7.9)

80 (65–80)

kPa

2.7 (0)

2.7 (2.7–2.7)

9.8 (1.1)

10.7 (8.7–10.7)

Arterial O2 Hemoglobin

9 (2.2)

%

78.9 (3.7)

82 (75–82)

…

…

Low Median (Range)

High Mean (SD)

High Median (Range)

Abbreviation: SD, standard deviation.

Table 3. Critical limits for point-of-care hematology and coagulation tests.1 Measurand

Number of Hospitals (%)

INR

27 (6.5)

INR

…

…

4.6 (0.5)

5 (4–5)

Hematocrit

Low: 24 (5.8) High: 12 (2.9)

%

19.7 (1.5)

20 (15–21)

61.3 (3.1)

60 (55–65)

Hemoglobin

Low: 23 (5.5) High: 6 (1.4)

g/dL

6.8 (0.7)

6.6 (6–8)

19.1 (0.4)

18.9 (18.9–20)

Low Mean (SD)

Units

3.A. Adults

3.B. Newborns Hematocrit

Low: 21 (5) High: 10 (2.4)

%

25.3 (5.1)

25 (18–30)

68 (6.3)

65 (60–75)

Hemoglobin

Low: 18 (4.3) High: 7 (1.7)

g/dL

8.8 (1.5)

10 (6–10)

19.6 (1.5)

18.9 (18.9–23)

INR

12 (2.9)

INR

…

…

4.1 (0.3)

4 (4–5)

Abbreviation: SD, standard deviation.

Table 4. Statistically significant POC versus laboratory critical limit matched pairs.1 Measurand, High or Low Critical Limit

Number of Hospitals

Units

p-Value

POC Median (Range)

Laboratory Median (Range)

4.A. Adults INR, High

27

INR

0.003

5 (4–5)

5 (4–5)

Hemoglobin, Low

23

g/dL

0.048

6.6 (6–8)

6.6 (6–7)

Ionized calcium, Low

21

mmol/L

0.002

0.75 (0.50–1.00)

0.76 (0.75–0.85)

Ionized calcium, High

21

mmol/L

0.004

1.60 (1.40–1.75)

1.59 (1.40–1.62)

0.003

4 (4–4.5)

4.9 (4.9–5)

4.B. Newborns INR, High

10

INR

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POINT-OF-CARE TESTING CRITICAL LIMITS Table 5. POC versus laboratory matched pairs qualitative difference.1 Measurand

Number of Hospitals

POC < Laboratory

Low

POC = Laboratory

High

Low

High

POC > Laboratory

Low

High

5.A. Clinical Chemistry

Adults Glucose

73

2

4

64

67

7

2

Ionized calcium

21

13

3

7

8

1

10

Potassium

20

…

…

20

…

…

…

Sodium

18

…

1

18

16

…

1

CO2 content

Low: 16 High: 15

…

…

15

15

1

…

Lactic Acid

14

…

…

…

13

…

1

Calcium

11

…

…

11

10

…

1

Newborns Glucose

62

3

3

52

56

7

3

Ionized calcium

17

…

…

17

16

…

1

Potassium

14

…

1

14

13

…

…

Sodium

12

…

1

12

11

…

…

CO2 content

12

…

…

12

11

…

1

Calcium

11

…

…

11

10

…

1

Newborn Bilirubin

10

…

…

…

10

…

…

16

15

1

…

5.B. Blood Gas and pH

Adults pH

Low: 18 High:17

1

2

Arterial pO2

16

…

…

15

…

1

…

Carboxyhemoglobin

11

…

…

…

11

…

…

Arterial pCO2

10

…

1

…

9

…

…

Methemoglobin

10

…

…

…

10

…

…

Venous pH

10

…

1

9

9

1

…

pH

11

…

…

11

…

…

…

Arterial pO2

11

…

…

10

…

1

…

Arterial pCO2

11

…

…

11

…

…

…

Newborns

Carboxyhemoglobin

10

…

…

…

10

…

…

Methemoglobin

10

…

…

…

10

…

…

17

…

…

5.C. Hematology and Coagulation

Adults INR

27

…

10

…

18

…

5

…

15

…

…

…

17

…

…

…

Hemoglobin

23

…

Hematocrit

15

…

…

Hemoglobin

18

1

…

Newborns Hematocrit

13

1

…

12

…

…

…

INR

10

…

10

…

…

…

…

REFERENCE 1. Osher K, Kost GJ. Critical decision thresholds for urgent physician notification of point-of-care testing results. Diagnostics (Basel). 2026;16(8):1139. doi:10.3390/ diagnostics16081139.

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CRITICAL LIMITS FOR THERAPEUTIC DRUG LEVELS

Critical Limits for Therapeutic Drug Levels Elina Kuang, Yasmeen Ibrahim, Kyle Cheng, and Gerald J. Kost, MD, PhD, MS, FADLM

A

critical limit is an upper or lower numerical threshold of a diagnostic test that, when exceeded or fallen below, indicates a potentially life-threatening condition and requires immediate clinician notification. For drugs, critical limits represent concentrations associated with serious toxicity or loss of therapeutic effect. A critical value is defined as a qualitative result that also warrants urgent clinician notification. Critical values for drugs are commonly reported using qualitative notification phrases, indicating detection of a substance. An analyte is defined as a substance measured in a laboratory test.1 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. Tables 1-4 represent the first large- scale national analysis of critical limits for drugs, demonstrating variability between hospitals and offering a reference point for hospitals

to compare their practices. It consolidates and compares current practices to consensus recommendations for critical decision thresholds. Critical limits were collected

by Kuang et al from 417 hospitals from all 50 U.S. states and Washington D.C. 411 of those kept drug critical limits lists. The research was originally published in the journal Clinical Pharmacology & Therapeutics (CPT).

The generally accepted definition for trough concentrations is defined as the measured drug concentration obtained immediately before the next scheduled dose. Peak is defined as the measured drug concentration obtained at a specified time after drug administration. Random is defined as a drug concentration measured at an unspecified time relative to dosing.1 REFERENCE 1. Kuang E, Ibrahim Y, Cheng K, Kost GJ. Drug critical limits for urgent physician notification. Clin Pharmacol Ther. Published online 2026. doi:10.1002/cpt.70277.

Table 1. Cardiopulmonary critical limits1

Measurand

Listing frequency % (n = 411)

Units

Median (range)

25th Percentile

75th Percentile

Percent differencea

Quartile coefficient of dispersionb

99.8

ng/mL

2.5 (2–4)

2.4

2.6

100

4

nmol/L

3.2 (2.6–5.1)

3.1

3.3 80

14

60

8

33

14

100

9

300

14

100

0

0

0

400

11

Antiarrhythmic Digoxin

Lidocaine

Procainamide

28.5

15.8

Procainamide + N-Acetyl Procainamide (NAPA)

14.1

Quinidine

13.9

N-Acetyl Procainamide (NAPA)

10.2

Amiodarone +

2.9

Desethylamiodarone Flecainide

2.9

μg/mL

6 (5–9)

6

8

μmol/L

25.6 (21.3–38.4)

25.6

34.1

μg/mL

12 (10–16)

12

16

μmol/L

51 (42.5–68)

51

68

μg/mL

40 (30–40)

30

40

μmol/L

–

–

–

μg/mL

6 (5–10)

5

6

μmol/L

18.5 (15.4–30.8)

15.4

18.5

μg/mL

40 (10–40)

30

40

μmol/L

144.2 (36.1–144.2)

108.2

144.2

μg/mL

2.5 (2.5–5)

2.5

2.5

μmol/L

–

–

–

mg/L

1 (1–1)

1

1

μmol/L

2.4 (2.4–2.4)

2.4

2.4

μg/mL

20.1 (15–75)

20

25

μmol/L

111.6 (83.3–416.25)

111

138.8

Bronchodilator Theophylline

72.3

SI conversion factors are provided in Supplementary Table S3 of the original Clinical Pharmacology and Therapeutics article. n = number of hospitals.

Percent difference = [(maximum − minimum)/(minimum)] × 100. bQuartile coefficient of dispersion (QCD) = [(Q3 − Q1)/(Q3 + Q1)] × 100.

a

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CRITICAL LIMITS FOR THERAPEUTIC DRUG LEVELS

Table 2. Psychotropic critical limits1

Measurand

Listing frequency % (n = 411)

Units

Median (range)

25th Percentile

75th Percentile

Percent differencea

Quartile coefficient of dispersionb

125

9

82.7

0

300

6

122

9

230

0

Antiepileptic Phenytoin

Carbamazepine (total)

Valproic acid

Phenytoin (free)

Primidone

90.8

87.6

80.3

39.2

17.5

μg/mL

30 (20–45)

25

30

μmol/L

119 (79.4–178.6)

99.2

119

μg/mL

15 (11–20.1)

15

15

μmol/L

63.5 (46.6–85.1)

63.5

63.5

μg/mL

150 (100–400)

150

170

μmol/L

1040.1 (693.4–2773.6)

1040.1

1178.8

μg/mL

2.9 (1.8–4)

2.5

3

μmol/L

11.5 (7.14–15.9)

9.9

11.9

μg/mL

15 (12.1–40)

15

15

μmol/L

68.7 (55.4–183.3)

68.7

68.7

Ethosuximide

12.7

mg/L μmol/L

150 (100–150) 1062.6 (708.4–1062.6)

100 708.4

150 1062.6

50

20

Valproic (free)

9.5

μg/mL

30 (20.1–75)

22.6

30

273

14

μmol/L

208 (139.4–520)

156.7

208

Carbamazepine (free)

8.8

μg/mL

4 (3.5–5)

4

4

43

0

μmol/L

16.9 (14.8–21.2)

16.9

16.9

Levetiracetam

0.7

μg/mL

70 (45–100)

57.5

85

122

19

μmol/L

411.3 (264.4–587.5)

337.8

499.4

mmol/L

1.6 (1.1–3)

1.5

2

173

14

11

3

150

9

0

0

1100

0

0

0

Mood stabilizer Lithium

94.9

Antipsychotic Clozapine

0.7

ng/mL

900 (900–1000)

900

950

μmol/L

2.7 (2.7–3)

2.7

2.85

μg/mL

60 (40–100)

50

60

μmol/L

258.6 (172.4–431)

215.5

258.6

Barbiturate Phenobarbital

Butalbital Pentobarbital

Secobarbital

83.7

8.3 4.4

3.2

Amobarbital

2.9

Butabarbital

2.9

μg/mL

10 (10–10)

10

10

μmol/L

44.6 (44.6–44.6)

44.6

44.6

μg/mL

10 (5–60)

10

10

μmol/L

44.2 (22.1–265.1)

44.2

44.2

μg/mL

5 (5–5)

5

5

μmol/L

21 (21–21)

21

21

μg/mL

10 (10–10)

10

10

μmol/L

44.2 (44.2–44.2)

44.2

44.2

μg/mL

50 (10–50)

50

50

μmol/L

235.6 (47.1–235.5)

235.5

235.5

0

400

0 0

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CRITICAL LIMITS FOR THERAPEUTIC DRUG LEVELS Table 2. Psychotropic critical limits1

Measurand

Listing frequency % (n = 411)

Units

Median (range)

25th Percentile

75th Percentile

Percent differencea

Quartile coefficient of dispersionb

ng/mL

500 (500–700)

500

500

40

0

nmol/L

1898.5 (1898.5–2657.9)

1898.5

1898.5

ng/mL

450 (400–700)

400

500

75

11

nmol/L

1689.3 (1501.6–2627.8)

1501.6

1877

ng/mL

500 (400–500)

500

500

25

0

nmol/L

1789.5 (1431.6–1789.5)

1789.5

1789.5

ng/mL

500 (500–500)

500

500

0

0

nmol/L

1802.5 (1802.5–1802.5)

1802.5

1802.5 75

0

100

0

0

0

50

0

133

0

100

22

Tricyclic antidepressants Nortriptyline

Desipramine

Doxepin

10.9

10.7

10.5

Amitriptyline

10

Imipramine + Desipramine

5.8

Clomipramine + Norclomipramine

5.4

Trimipramine

5.4

Imipramine

Tricyclic screen

5.1

2.2

Amitriptyline + Nortriptyline

1

ng/mL

400 (400–700)

400

400

nmol/L

–

–

–

ng/mL

450 (450–900)

450

450

nmol/L

–

–

–

ng/mL

500 (500–500)

500

500

nmol/L

1698.2 (1698.2–1698.2)

1698.2

1698.2

ng/mL

500 (400–600)

500

500

nmol/L

1783 (1426.4–2139.6)

1783

1783

ng/mL

500 (300–700)

500

500

nmol/L

–

–

–

ng/mL

600 (500–1000)

500

775

–

nmol/L

–

SI conversion factors are provided in Supplementary Table S3 of the original Clinical Pharmacology and Therapeutics article. n = number of hospitals. a Percent difference = [(maximum − minimum)/(minimum)] × 100. bQuartile coefficient of dispersion (QCD) = [(Q3 − Q1)/(Q3 + Q1)] × 100.

Table 3. Analgesic, antimicrobial, and immunosuppressant critical limits1

Measurand

Listing frequency % (n = 411)

Units

Median (range)

25th Percentile

75th Percentile

Percent differencea

Quartile coefficient of dispersionb

2400

50

400

14

150

14

567

20

233

33

Analgesic Acetaminophen Salicylate

86.9 86.9

Acetaminophen (post 12 hours)

1

μg/mL

140 (20–500)

50

150

μmol/L

926 (132.3–3307)

330.7

992.1

mg/dL

30 (20–100)

30

40

mmol/L

2.2 (1.4–7.2)

2.2

2.9

μg/mL

50 (40–100)

47.5

62.5

μmol/L

330.7 (264.6–661.4)

314.2

413.4

μg/mL

25 (12–80)

20

30

μmol/L

17.3 (8.3–55.2)

13.8

20.7

μg/mL

50 (30–100)

40

80

μmol/L

34.5 (20.7–69)

27.6

55.2

Antimicrobials Vancomycin (Trough)

67.9

Vancomycin (Peak)

48.9

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CRITICAL LIMITS FOR THERAPEUTIC DRUG LEVELS Table 3. Analgesic, antimicrobial, and immunosuppressant critical limits1

Measurand

Listing frequency % (n = 411)

Units

Median (range)

25th Percentile

75th Percentile

Percent differencea

Quartile coefficient of dispersionb

350

9

900

20

304

11

2043

25

1100

18

900

11

2043

35

0

0

1500

30

1150

39

1150

39

9

2

567

11

233

54

67

25

0

0

329

11

233

11

150

0

Antimicrobials Vancomycin (Random) Gentamicin (Trough)

30.9 57.9

Gentamicin (Peak)

53.5

Gentamicin (Random)

29.7

Tobramycin (Trough)

54.7

Tobramycin (Peak)

44.3

Tobramycin (Random)

24.3

Tobramycin (Cystic fibrosis)

2.4

Amikacin (Trough)

37.2

Amikacin (Peak)

32.6

Amikacin (Random)

22.4

Voriconazole

0.7

μg/mL

50 (20–90)

50

60

μmol/L

34.5 (13.8–62.1)

34.5

41.4

μg/mL

2 (1–10)

2

3

μmol/L

4.2 (2.1–20.9)

4.2

6.3

μg/mL

12 (9.9–40)

12

15

μmol/L

25.1 (20.7–83.6)

25.1

31.4

μg/mL

12 (2.1–45)

12

20

μmol/L

25.1 (4.4–94.1)

25.1

41.8

μg/mL

2 (1–12)

2

2.9

μmol/L

4.3 (2.1–25.7)

4.3

6.2

μg/mL

12 (4–40)

12

15

μmol/L

25.7 (8.6–85.6)

25.7

32.1

μg/mL

12 (2.1–45)

12

25

μmol/L

25.7 (4.5–96.3)

25.7

53.5

μg/mL

30.1 (30.1–30.1)

30.1

30.1

μmol/L

64.4 (64.4–64.4)

64.4

64.4

μg/mL

10 (5–80)

8.1

15

μmol/L

17.1 (8.54–136.6)

13.8

25.6

μg/mL

40 (8–100)

35

80

μmol/L

68.3 (13.7–171)

59.6

136.6

μg/mL

40 (8–100)

35.1

80

μmol/L

68.3 (13.7–171)

60

136.6

μg/mL

5.6 (5.5–6)

5.6

5.8

μmol/L

16 (15.7–17.2)

16

16.6

ng/mL

450 (300–2000)

400

500

nmol/L

374.4 (249.6–1664)

332.8

416

ng/mL

450 (450–1500)

450

1500

nmol/L

374.4 (374.4–1248)

374.4

1248

Immunosuppressants Cyclosporine (unspecified)

37.5

Cyclosporine (peak)

2.9

Cyclosporine (trough)

1.5

Cyclosporine (random) Tacrolimus Sirolimus Everolimus

1 32.4 17.8 9.7

ng/mL

480 (360–600)

360

600

nmol/L

399.4 (299.5–499.2)

307

499.2

ng/mL

1500 (1500–1500)

1500

1500

nmol/L

1248 (1248–1248)

1248

1248

ng/mL

20 (14–60)

20

25

nmol/L

24.9 (17.4–74.4)

24.8

31.1

ng/mL

25 (12–40)

20

25

nmol/L

27.3 (13.1–43.8)

21.9

27.3

ng/mL

15 (12–30)

15

15

nmol/L

15.7 (12.5–31.3)

15.7

15.7

SI conversion factors are provided in Supplementary Table S3 of the original Clinical Pharmacology and Therapeutics article. n = number of hospitals. a Percent difference = [(maximum − minimum)/(minimum)] × 100. bQuartile coefficient of dispersion (QCD) = [(Q3 − Q1)/(Q3 + Q1)] × 100.

CLR-ONLINE.COM | MLO | CLR 2026-2027 | 21

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CRITICAL LIMITS FOR THERAPEUTIC DRUG LEVELS Table 4. Alcohol, toxins, and other clinically important critical limits1

Measurand

Listing frequency % (n = 411)

Units

Median (range)

25th Percentile

75th Percentile

Percent differencea

Quartile coefficient of dispersionb

Alcohol Ethanol

47.2

mg/dL mmol/L

399 (80–500) 86.6 (17.4–108.6)

300 65.1

86.8

400

525

14

Ethylene glycol

20.2

mg/dL mmol/L

20 (0–29) 3.2 (0–4.7)

10 1.6

20 3.2

–

33

Methanol

14.4

mg/dL mmol/L

19 (5–100) 5.9 (1.6–31.2)

10 3.1

20 6.2

1900

33

Isopropanol

13.4

mg/dL mmol/L

19 (5–340) 3.2 (0.8–56.4)

10 1.7

20 3.3

6700

33

Propylene glycol

3.7

mg/dL mmol/L

5 (5–100) 0.7 (0.7–13.1)

5 0.7

6.8

52

1900

82

Lead

20

mg/dL mmol/L

70 (9–79) 3.38 (0.43–3.82)

45 2.2

3.4

70

778

22

Cyanide

5.1

μg/mL μmol/L

2 (2–2) 76.8 (76.8–76.8)

2 76.8

0

0

76.8

Toxin

2

Thiocyanate

5.1

mg/dL mmol/L

50 (5–60) 8.6 (0.9–10.3)

50 8.6

50 8.6

1100

0

Iron

4.1

μg/dL μmol/L

300 (280–500) 53.7 (50.1–89.5)

300 53.7

62.7

350

79

8

μg/mL μmol/L

30 (20–50) 154.5 (103–257.5)

26 133.9

154.5

150

7

10 (1–200)

5

10.1

19,900

34

22,000 (2200–440,000)

11,000

22,220

Stimulant Caffeine

18.7

30

Antineoplastic Methotrexate

14.6

μg/mL nmol/L

Specific measurands Acetone

11.2

mg/dL mmol/L

19 (10–100) 3.3 (1.7–17.2)

19 3.3

3.4

20

900

3

Sweat chloride

1.0

– mmol/L

– 30 (29–60)

– 29.8

– 37.5

107

12

Vitamin D (25-Hydroxyvitamin)

1.0

ng/mL

100 (100–100) 249.6 (249.6–249.6)

100 249.6

100 249.6

0

0

nmol/L

SI conversion factors are provided in Supplementary Table S3 of the original Clinical Pharmacology and Therapeutics article. n = number of hospitals. a Percent difference = [(maximum − minimum)/(minimum)] × 100. bQuartile coefficient of dispersion (QCD) = [(Q3 − Q1)/(Q3 + Q1)] × 100.

22 | CLR 2026-2027 | MLO | CLR-ONLINE.COM

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CUTOFF CONCENTRATIONS FOR DRUG TESTS This table was put together by MLO staff and reviewed by Jason Hudson, PhD, Scientific Director & Laboratory Director 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. Fentanyl and norfentanyl were added to the table in 2025 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.

MDMAD/MDAE

Ecstasy

500 ng/mL

MDMA MDA

250 ng/mL. 250 ng/mL.

*The DOT has not yet approved the morphine 4000 ng/mL cutoff or testing for fentanyl.

REFERENCES 1. Mandatory guidelines for Federal workplace drug testing programs-authorized testing panels. Federal Register. January 16, 2025. Accessed June 5, 2026. 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 5, 2026. https://www.ecfr.gov/current/title-49/ subtitle-A/part-40.

3. SAMHSA guidelines - US. Accessed June 5, 2026. https://www.thermofisher.com/us/en/home/clinical/diagnostic-testing/clinical-chemistry-drug-toxicology-testing/drugsabuse-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).

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2607MLO_CLR_18-23_CriticalValues.indd 23

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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

60-150 µg/dL

0.179

10.7-26.9 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 in 2026 by S. T. Campbell, PhD, DABCC, FADLM, Clinical Biochemist, Mount Sinai Hospital, Toronto, ON.

24 | CLR 2026-2027 | 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 Male and Female (mg/dL)

Age

0− <15 days

0.2−16.6

0− <15 days

0.32−0.92 0.32−0.92

15 days− <1 year

0.1−0.7

15 days− <2 years

0.1−0.36

0.1−0.36

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

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

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

Male and Female (mg/dL)

0− <1 year

8.5−11.0

1− <19 years

9.2−10.5

Male (mg/dL)

Age

Male and Female (mg/dL)

0- <19 years

73-112

Female (mg/dL)

15−42

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

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

Male (mg/dL)

Female (mg/dL)

0− <1 year

13.2-173

13.2-173

1− <10 years

47.2-121

58.8-128

10- <19 years

45.6-131

45.6-131

Age

Male and Female (g/dL)

0− <15 days

5.3−8.3

15 days− <1 year

4.4−7.1

1− <6 years

6.1−7.5

Age

Male (µg/dL)

Female (µg/dL)

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

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

Female (mg/dL)

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

Male (mg/dL)

0− <15 days

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

Age

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

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

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

Age

Male and Female (mmol/L)

Age

Male and Female (µg/dL)

0− <19 years

139- 146

0− <19 years

300- 439

REFERENCES 1.

2.

3.

4.

CALIPER Pediatric Reference Interval Database. CALIPER. Accessed June 10, 2026. 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 2026-2027 | 25

2607MLO_CLR_25_PediatricTableV2.indd 25

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TM

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

COMPANY DIRECTORY.....................................27

HEMATOLOGY............................................................33

PRODUCT CATEGORIES....................................30

HEMATOLOGY/CLINICAL CHEMISTRY.......................33

EQUIPMENT & SERVICES.................................30

IMMUNOLOGY/SEROLOGY.........................................33

AUTOMATION & WORKFLOW....................................30

MICROBIOLOGY..........................................................33

INFORMATION SYSTEMS & SOFTWARE....................30

MICROBIOLOGY/IMMUNOLOGY................................34

LAB INSTRUMENTS & ANALYZERS...........................30

MICROBIOLOGY/VIROLOGY........................................34

LAB SUPPLIES & CONSUMABLES..............................30

MOLECULAR DIAGNOSTICS.......................................34

PHLEBOTOMY & SAMPLE COLLECTION.....................31

MOLECULAR DIAGNOSTICS/GENETICS.....................34

QUALITY & COMPLIANCE..........................................31

MOLECULAR DIAGNOSTICS/PATHOLOGY..................34

SAFETY & ENVIRONMENT.........................................31

MOLECULAR DIAGNOSTICS/VIROLOGY.....................34

SPECIALTY PRODUCTS & SERVICES...........................31

PATHOLOGY/CYTOLOGY.............................................34

TESTS..................................................................32 CLINICAL CHEMISTRY/BIOCHEMISTRY.....................32 CLINICAL....................................................................32 ENDOCRINOLOGY.......................................................33

SPECIALIZED/OTHER..................................................34 TOXICOLOGY..............................................................35 URINALYSIS................................................................35 VIROLOGY...................................................................35

Also available online at: CLR-online.com  All 6 reference guides, including the Table of Critical Limits  Product photos, videos, announcements, and educational resources  Regular updates throughout the year

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COMPANY DIRECTORY

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Modernize your respiratory testing with sample-to-customizable answer capabilities—discover how the LIAISON PLEX Respiratory Flex Assay will address your lab’s current and future needs while battling the rising cost of patient care.

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CLSI/Clinical Laboratory Standards Institute Wayne, PA, US https://clsi.org

Drucker Diagnostics Port Matilda, PA, US https://druckerdiagnostics.com

American Proficiency Institute (API) Traverse City, MI, US https://www.api-pt.com AP Visions, LLC Santa Clara, UT, US https://www.ap-visions.com Applied BioCode Santa Fe Springs, CA, US https://www.apbiocode.com Arkray USA Minneapolis, MN, US https://www.arkrayusa.com Arkstone Medical Solutions LLC Boca Raton, FL, US https://arkstone.ai Ascentry L’Union, France https://www.ascentry.com Asuragen Austin, TX, US https://asuragen.com AUDIT MicroControls Eatonton, GA, US https://www.auditmicro.com Barry University Miami Shores, FL, US https://www.barry.edu BD Diagnostics Franklin Lakes, NJ, US https://www.bd.com Beckman Coulter, Inc. Brea, CA, US https://www.beckmancoulter.com Bio-Rad Laboratories Inc Hercules, CA, US https://www.bio-rad.com Carolina Liquid Chemistries Corp.

Greensboro, NC, US https://www.carolinachemistries.com Cepheid Sunnyvale, CA, US https://www.cepheid.com Clinical Software Solutions Queen Creek, AZ, US https://www.clin1mobile.net Clinisys Tucson, AZ, US https://www.clinisys.com

ELITechGroup MDx Bothell, WA, US https://egmdx.com ELLKAY Elmwood Park, NJ, US https://www.ellkay.com

Diasorin 12112 Technology Blvd, Suite 130, Austin, TX, 78727, US TEL: 512-219-8020 SUPPORT@LUMINEXCORP.COM HTTPS://us.diasorin.com/en/moleculardiagnostics See ad on back cover

Sample-to-Customizable Answers for Your Respiratory Testing The LIAISON PLEX® System is uniquely designed to provide full flexibility in the customization of 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-to answer 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.

Fujirebio Diagnostics, Inc. Malvern, PA, US https://www.fujirebio.com Genomadix Kanata, ON, Canada https://genomadix.com Gestalt Spokane, WA, US https://gestaltdiagnostics.com Globe Scientific Mahwah, NJ, US https://www.globescientific.com Greiner Bio-One Monroe, NC, US https://www.gbo.com Grundium Ltd Tampere, Finland https://www.grundium.com Hardy Diagnostics Santa Maria, CA, US https://hardydiagnostics.com

Health Care Logistics PO Box 25, Circleville, OH, 43113, US 740-477-3755 HCL@GOHCL.COM HTTPS://gohcl.com

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

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COMPANY DIRECTORY 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.

Hologic, Inc. Marlborough, MA, US https://www.hologic.com IMMY Norman, OK, US https://www.immy.com Kamiya Biomedical Company, LLC Tukwila, WA, US https://www.kamiyabiomedical.com

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 • CoatedTube (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† MUSCLE SPECIFIC TYROSINE KINASE AUTOANTIBODY (MuSKAb) • Radioimmunoassay Kit, 25 Tubes† • TITIN AUTOANTIBODY • ELISA Kit, 48 Wells†

KRONUS, Inc. 170 S Seneca Springs Way, Suite 105, Star, ID, 83669, US TEL: 207-377-4800 KRONUS@KRONUS.COM HTTPS://www.kronus.com

See ad on page 5

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.

ISLET CELL AUTOIMMUNITY ZINC TRANSPORTER 8 AUTOANTIBODY (ZnT8Ab) • ELISA Kit, 96 Wells GLUTAMIC ACID DECARBOXYLASE AUTOANTIBODY (GADAb) • ELISA Kit, 96 Wells

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

and affordable. Eliminate possible injury during manual decapping and recapping. Serving labs since 2002.

Luminex, a DiaSorin Company Austin, TX, US https://www.luminexcorp.com MedPro Healthcare Staffing Sunrise, FL, US https://medprostaffing.com Microbiologics Saint Cloud, MN, US https://www.microbiologics.com MilliporeSigma Burlington, MA, US https://www.sigmaaldrich.com Northcentral Technical College Wausau, WI, US https://www.ntc.edu Nova Biomedical Waltham, MA, US https://www.novabiomedical.com Owen Mumford, Inc Marietta, GA, US https://www.owenmumford.com

ACETYLCHOLINE RECEPTOR AUTOANTIBODY (AChRAb) – GANGLIONIC • Radioimmunoassay Kit, 25 Tubes† VOLTAGE-GATED POTASSIUM CHANNEL AUTOANTIBODY (VGKCAb) • Radioimmunoassay Kit, 25 Tubes† VOLTAGE-GATED CALCIUM CHANNEL AUTOANTIBODY (VGCCAb): N-TYPE • Radioimmunoassay Kit, 25 Tubes† † For Research Use Only. Not For Use in Diagnostic Procedures Lab Savvy Falls Church, VA, US https://www.labsavvy.com LabOS Petah Tikva, Central District, Israel https://labos.co

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 allows you to configure laboratory to meet your requirement. Offering multiple work surface choices including but not limited to Epoxy Resin, Stainless Steel and economical Chem-Guard chemical resistant work surfaces. Cabinets offer 90 percent extension slides with 150 pounds capacity. Economical laboratory tables with hanging cabinets and casters offering a truly modular ergonomic design.

IA-2 AUTOANTIBODY (IA-2Ab) • ELISA Kit, 96 Wells 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

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

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

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COMPANY DIRECTORY A tradition of excellence.

Puritan is now in our 107th 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. Qiagen, Inc. Germantown, MD, US https://www.qiagen.com Quantimetrix Redondo Beach, CA, US https://www.quantimetrix.com QuidelOrtho San Diego, CA, US https://www.quidelortho.com

SEKISUI Diagnostics LLC 6659 Top Gun Street, San Diego, CA, 92121, US TEL: 781-652-7800 QUESTIONS@SEKISUI-DX.COM HTTPS://www.sekisuidiagnostics.com

See ad on inside front cover

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

Shimadzu Corp Kyoto, Japan https://www.shimadzu.com

Sarstedt, Inc. Nümbrecht, Germany https://www.sarstedt.com SCC Soft Computer Clearwater, FL, US https://www.softcomputer.com Sciteck Fletcher, NC, US https://sciteck.org Sebia, Inc Norcross, GA, US https://www.sebia.com

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 Techcyte Orem, UT, US https://www.techcyte.com

Siemens Healthineers Tarrytown, NY, US https://www.siemens-healthineers. com/en-us

TechLab Blacksburg, VA, US https://www.techlab.com

StaffReady Spokane, WA, US https://www.staffready.com Streck La Vista, NE, US https://www.streck.com

Thermo Fisher Scientific, Genetic Sciences Division Waltham, MA, US https://www.thermofisher.com

Swift Sensors, Inc Austin, TX, US https://www.swiftsensors.com

Tosoh Bioscience Inc. Grove City, OH, US https://www.tosohbioscience.com Visiun Inc Burlington, NC, US https://www.visiun.com

Randox Laboratories-US, Ltd. Kearneysville, WV, US https://www.randox.com Roche Diagnostics Corporation Indianapolis, IN, US https://diagnostics.roche.com

Hemostasis Solutions • Our innovative portfolio of hemostasis analyzers, reagents and controls are designed with quality and efficiency in mind. We provide advanced hemostasis technology across multiple platforms.

Werfen Bedford, MA, US https://www.werfen.com WSLH Proficiency Testing Madison, WI, US https://www.wslhpt.org

Sysmex America, Inc. 577 Aptakisic Rd, Lincolnshire, IL, 60069, US 888-879-7639

ZeptoMetrix Buffalo, NY, US https://www.zeptometrix.com

COMMUNICATIONS@SYSMEX.COM HTTPS://www.sysmex.com/us

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.

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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

EQUIPMENT & SERVICES AUTOMATION & WORKFLOW AUTOMATION Clinical Software Solutions Hardy Diagnostics LGP Lab Automation BARCODE PRODUCTS Clinical Software Solutions Health Care Logistics DECAPPING & RECAPPING LGP Lab Automation

INFORMATION SYSTEMS & SOFTWARE HEALTHCARE INFORMATION SYSTEMS Advanced Data Systems Corporation Arkstone Medical Solutions LLC Clinical Software Solutions LAB SOFTWARE & COMPUTER SYSTEMS Clinical Software Solutions Clinisys StaffReady Sysmex America, Inc. LABORATORY INFORMATION SYSTEMS AP Visions, LLC Ascentry Clinical Software Solutions CompuGroup Medical

Computer Service and Support ELLKAY Greiner Bio-One Lab Savvy LabOS Clinisys SCC Soft Computer StaffReady Sysmex America, Inc. Visiun Inc

Health Care Logistics

NEXT GENERATION SEQUENCING SOFTWARE Clinisys

MIXERS & SHAKERS Health Care Logistics

SAMPLE MANAGEMENT SYSTEMS Clinical Software Solutions Sysmex America, Inc. SPECIMEN MANAGEMENT SYSTEMS Clinical Software Solutions Puritan Medical Products Co

LAB INSTRUMENTS & ANALYZERS ANALYZERS Arkray USA Carolina Liquid Chemistries Corp.

Hardy Diagnostics Nova Biomedical Shimadzu Corp Sysmex America, Inc. CENTRIFUGES Drucker Diagnostics Hardy Diagnostics

DRY BATHS Health Care Logistics INCUBATORS Hardy Diagnostics Health Care Logistics MICROSCOPES & ACCESSORIES Grundium Ltd Hardy Diagnostics

SAMPLE STIRRERS Health Care Logistics SLIDE STAINERS Hardy Diagnostics Sysmex America, Inc. STAINING Sysmex America, Inc. STAINING & COVERSLIPPING Sysmex America, Inc. Techcyte WATER BATHS Health Care Logistics

LAB SUPPLIES & CONSUMABLES APPAREL Hardy Diagnostics Health Care Logistics

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PRODUCT CATEGORIES FURNITURE & STORAGE Health Care Logistics Proline Laboratory Furniture

SPECIMENS, STORAGE EQUIPMENT Health Care Logistics

GLASSWARE & CLEANING Hardy Diagnostics Health Care Logistics

QUALITY & COMPLIANCE

LABELS Health Care Logistics LABORATORY SUPPLIES Globe Scientific Hardy Diagnostics Health Care Logistics Puritan Medical Products Co Sarstedt, Inc. NEEDLES Health Care Logistics PIPETTES & TIPS Hardy Diagnostics Health Care Logistics REAGENTS Carolina Liquid Chemistries Corp.

Diasorin See ad on back cover

Hardy Diagnostics Health Care Logistics KRONUS, Inc. See ad on page 5

SEKISUI Diagnostics LLC

See ad on inside front cover

Sysmex America, Inc. TEST TUBE RACKS Hardy Diagnostics Health Care Logistics TUBES Hardy Diagnostics Health Care Logistics URINALYSIS, CONTROLS Arkray USA AUDIT MicroControls Health Care Logistics Sysmex America, Inc.

PHLEBOTOMY & SAMPLE COLLECTION PHLEBOTOMY PRODUCTS AND SUPPLIES Health Care Logistics Owen Mumford, Inc

EDUCATION, PROFICIENCY & ACCREDITATION American Proficiency Institute (API) Barry University Clinical Software Solutions CLSI/Clinical Laboratory Standards Institute Northcentral Technical College StaffReady Sysmex America, Inc. WSLH Proficiency Testing ERROR PREVENTION Clinical Software Solutions Health Care Logistics HIPAA COMPLIANCE Clinical Software Solutions Health Care Logistics INDIVIDUALIZED QUALITY CONTROL PLAN (IQCP) IMPLEMENTATION TOOLS Clinical Software Solutions QUALITY MANAGEMENT TOOLS Clinical Software Solutions Health Care Logistics Clinisys Quantimetrix StaffReady Sysmex America, Inc.

SAFETY & ENVIRONMENT CLEANROOMS Hardy Diagnostics Health Care Logistics Puritan Medical Products Co SAFETY PRODUCTS Health Care Logistics LGP Lab Automation TEMPERATURE MONITORING, AUTOMATED Health Care Logistics TEMPERATURE MONITORING, CONTINUOUS Health Care Logistics Swift Sensors, Inc

WASTE & HAZARDOUS MATERIAL Health Care Logistics WATER Health Care Logistics

SPECIALTY PRODUCTS & SERVICES BIOCHEMISTRY PRODUCTS & SERVICES Arkray USA Carolina Liquid Chemistries Corp.

Diasorin See ad on back cover

MilliporeSigma BLOOD BANK & TRANSFUSION Alba Bioscience, Inc. ALCOR Scientific, Inc. Sysmex America, Inc. BLOOD BANK, INSTRUMENTATION Health Care Logistics Sysmex America, Inc. DIAGNOSTIC SERVICES & PRODUCTS Abbott Diagnostics BD Diagnostics Beckman Coulter, Inc. Bio-Rad Laboratories Inc Diazyme Laboratories Fujirebio Diagnostics, Inc. Hardy Diagnostics Hologic, Inc. Kamiya Biomedical Company, LLC MedPro Healthcare Staffing Puritan Medical Products Co QuidelOrtho Randox Laboratories-US, Ltd. Roche Diagnostics Corporation Sebia, Inc Siemens Healthineers Streck Sysmex America, Inc. TechLab Thermo Fisher Scientific, Genetic Sciences Division Tosoh Bioscience Inc. Werfen ZeptoMetrix KAPPA LIGHT CHAINS Carolina Liquid Chemistries Corp.

MANUFACTURING SERVICES Clinical Software Solutions CLR-ONLINE.COM | MLO | CLR 2026-2027 | 31

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PRODUCT CATEGORIES Health Care Logistics Puritan Medical Products Co MICROBIOLOGY PRODUCTS & SERVICES Hardy Diagnostics Health Care Logistics Microbiologics Puritan Medical Products Co MOLECULAR BIOLOGY, PRODUCTS & SERVICES Applied BioCode Asuragen Cepheid ELITechGroup MDx Genomadix Health Care Logistics Qiagen, Inc. PAP TEST PRODUCTS Puritan Medical Products Co Techcyte PATHOLOGY PRODUCTS & SERVICES Gestalt Health Care Logistics TOXICOLOGY PRODUCTS & SERVICES Carolina Liquid Chemistries Corp.

Clinical Software Solutions Health Care Logistics URINALYSIS, AUTOMATED Arkray USA Health Care Logistics Sciteck Sysmex America, Inc. VIROLOGY PRODUCTS & SERVICES Diasorin See ad on back cover

Hardy Diagnostics Puritan Medical Products Co

TESTS CLINICAL CHEMISTRY/ BIOCHEMISTRY ALDOLASE Carolina Liquid Chemistries Corp.

AMYLASE (AMY), SERUM Carolina Liquid Chemistries Corp.

SEKISUI Diagnostics LLC

HIGH-DENSITY LIPOPROTEIN, DIRECT Carolina Liquid Chemistries Corp.

SEKISUI Diagnostics LLC

ASPARTATE AMINOTRANSFERASE (AST) Carolina Liquid Chemistries Corp.

SEKISUI Diagnostics LLC

HOMOCYST(E)INE, PLASMA OR SERUM Carolina Liquid Chemistries Corp.

SEKISUI Diagnostics LLC

BETA HYDROXYBUTYRATE SEKISUI Diagnostics LLC

IRON & IRON-BINDING PROTEIN ASSAYS Carolina Liquid Chemistries Corp.

SEKISUI Diagnostics LLC

See ad on inside front cover

See ad on inside front cover

See ad on inside front cover

CARDIAC RISK ASSESSMENT Carolina Liquid Chemistries Corp.

CHOLESTEROL, TOTAL Carolina Liquid Chemistries Corp.

CHOLINESTERASE SEKISUI Diagnostics LLC

See ad on inside front cover

CLINICAL FREE FATTY ACIDS (NEFA) SEKISUI Diagnostics LLC See ad on inside front cover

C-REACTIVE PROTEIN Carolina Liquid Chemistries Corp.

SEKISUI Diagnostics LLC See ad on inside front cover

CREATINE KINASE ASSAYS (CK) Carolina Liquid Chemistries Corp.

SEKISUI Diagnostics LLC See ad on inside front cover

CSF TEST KITS SEKISUI Diagnostics LLC

See ad on inside front cover

GAMMA-GLUTAMYL TRANSPEPTIDASE (GGT) Carolina Liquid Chemistries Corp.

SEKISUI Diagnostics LLC See ad on inside front cover

GLYCATED SERUM PROTEIN (GSP) ASSAY SEKISUI Diagnostics LLC See ad on inside front cover

HAPTOGLOBIN ASSAYS (HAPT) SEKISUI Diagnostics LLC See ad on inside front cover

ALKALINE PHOSPHATASE (ALP) Carolina Liquid Chemistries Corp.

SEKISUI Diagnostics LLC See ad on inside front cover

See ad on inside front cover

See ad on inside front cover

See ad on inside front cover

LACTATE (LAC) Carolina Liquid Chemistries Corp.

SEKISUI Diagnostics LLC See ad on inside front cover

LIPASE, SERUM (LIP) Carolina Liquid Chemistries Corp.

SEKISUI Diagnostics LLC See ad on inside front cover

LIPOPROTEIN (A) Carolina Liquid Chemistries Corp.

SEKISUI Diagnostics LLC See ad on inside front cover

LIPOPROTEINS & APOLIPOPROTEINS Carolina Liquid Chemistries Corp.

SEKISUI Diagnostics LLC See ad on inside front cover

LOW-DENSITY LIPOPROTEIN CHOLESTEROL (DIRECT) Carolina Liquid Chemistries Corp.

SEKISUI Diagnostics LLC See ad on inside front cover

MICROPROTEIN SEKISUI Diagnostics LLC

See ad on inside front cover

PHOSPHORUS, INORGANIC (PHOS) Carolina Liquid Chemistries Corp.

SEKISUI Diagnostics LLC See ad on inside front cover

PROTEIN, TOTAL Carolina Liquid Chemistries Corp.

TOTAL BILIRUBIN (TBIL) Carolina Liquid Chemistries Corp.

SEKISUI Diagnostics LLC See ad on inside front cover

TRIGLYCERIDE (TRIG) Carolina Liquid Chemistries Corp.

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PRODUCT CATEGORIES SEKISUI Diagnostics LLC

See ad on inside front cover

CLINICAL BETA-2 MICROGLOBULIN SEKISUI Diagnostics LLC See ad on inside front cover

ENDOCRINOLOGY DIABETES MELLITUS KRONUS, Inc. See ad on page 5

DIABETES TESTING & MANAGEMENT Sysmex America, Inc. GLUCOSE (GLU) Carolina Liquid Chemistries Corp.

REAGENTS - COAGULATION ASSAY Sysmex America, Inc.

HEMATOLOGY/CLINICAL CHEMISTRY D-DIMER, AUTOMATED Carolina Liquid Chemistries Corp.

SEKISUI Diagnostics LLC

IMMUNOLOGY/SEROLOGY

See ad on back cover

Health Care Logistics Sysmex America, Inc. Techcyte BLOOD, SCREENING Sysmex America, Inc. Techcyte

BACTERIAL VAGINOSIS (SIALIDASE) Techcyte

See ad on page 5

See ad on inside front cover

Techcyte

See ad on page 5

See ad on page 5

AUTOIMMUNE & COMPLEMENT ASSAYS Carolina Liquid Chemistries Corp.

SEKISUI Diagnostics LLC See ad on inside front cover

AUTOIMMUNE DISEASE TESTING KRONUS, Inc. See ad on page 5

COMPLEMENT, COMPONENTS, ASSAYS Carolina Liquid Chemistries Corp.

SEKISUI Diagnostics LLC See ad on inside front cover

CELL COUNT Health Care Logistics Sysmex America, Inc. Techcyte

ENZYME IMMUNOASSAYS Diasorin

CHLORIDE, SERUM OR URINE Carolina Liquid Chemistries Corp.

FREE KAPPA & LAMBDA LIGHT CHAINS Carolina Liquid Chemistries Corp.

SEKISUI Diagnostics LLC

COMPLETE BLOOD COUNT Sysmex America, Inc. Techcyte COMPLETE BLOOD COUNT & DIFF Sysmex America, Inc. Techcyte

ANTIMICROBIALS, ASSAYS Hardy Diagnostics

SEKISUI Diagnostics LLC

ANTIBODY SCREEN KRONUS, Inc.

BLOOD Diasorin

MICROBIOLOGY

ASPERGILLUS Hardy Diagnostics

INSULIN Carolina Liquid Chemistries Corp.

HEMATOLOGY

See ad on page 5

AUTOANTIBODY TESTING KRONUS, Inc.

ACETYLCHOLINE RECEPTOR KRONUS, Inc.

TRIIODOTHYRONINE (T3) Carolina Liquid Chemistries Corp.

NEUROIMMUNOLOGICAL DISORDERS, AUTOIMMUNE KRONUS, Inc.

See ad on inside front cover

HCG ULTRA COMBO SEKISUI Diagnostics LLC

See ad on inside front cover

IMMUNODIAGNOSTIC KITS & REAGENTS Hardy Diagnostics

See ad on back cover

SEKISUI Diagnostics LLC

See ad on inside front cover

See ad on inside front cover

IMMUNOASSAYS Carolina Liquid Chemistries Corp.

Hardy Diagnostics

BACTERIOLOGY TEST REPORTS Puritan Medical Products Co Techcyte CANDIDA Diasorin

See ad on back cover

Hardy Diagnostics Techcyte CRYPTOCOCCUS Techcyte ENTEROHEMORRHAGIC E. COLI (EHEC) SHIGA TOXIN, EIA Techcyte ESCHERICHIA COLI Techcyte FUNGAL/MYCOLOGY Hardy Diagnostics GRAM’S STAIN Hardy Diagnostics Techcyte GROUP A STREPTOCOCCUS Hardy Diagnostics GROUP B STREPTOCOCCUS COLONIZATION DETECTION CULTURE Hardy Diagnostics H. PYLORI Hardy Diagnostics SEKISUI Diagnostics LLC

See ad on inside front cover

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PRODUCT CATEGORIES LEGIONELLA PNEUMOPHILA URINE ANTIGEN Hardy Diagnostics METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) CULTURE ONLY RARE Hardy Diagnostics MICROBIAL STRAIN TYPING Hardy Diagnostics MICROBIOLOGY & CULTURE Hardy Diagnostics Puritan Medical Products Co MYCOPLASMA PNEUMONIAE CULTURE Hardy Diagnostics ORGANISM IDENTIFICATION Hardy Diagnostics Techcyte REFERENCE BACTERIAL CULTURE IDENTIFICATION Hardy Diagnostics Techcyte STAPHYLOCOCCUS IDENTIFICATION, METHICILLIN RESISTANT Hardy Diagnostics

MICROBIOLOGY/IMMUNOLOGY BABESIA MICROTI ANTIBODY PROFILE Diasorin See ad on back cover

MICROBIOLOGY/VIROLOGY BORDETELLA PARAPERTUSSIS DETECTION Diasorin See ad on back cover

BORDETELLA PERTUSSIS DETECTION Diasorin See ad on back cover

INFECTIOUS DISEASE Diasorin See ad on back cover

Hardy Diagnostics Puritan Medical Products Co

MOLECULAR DIAGNOSTICS NUCLEIC ACID AMPLIFICATION PRODUCTS & DETECTION SYSTEMS Diasorin See ad on back cover

MOLECULAR DIAGNOSTICS/GENETICS

STREP A ANTIGEN Hardy Diagnostics SEKISUI Diagnostics LLC

CONGENITAL DISEASE Diasorin

See ad on inside front cover

See ad on back cover

STREP A, ULTRA Hardy Diagnostics SEKISUI Diagnostics LLC

FACTOR V LEIDEN MUTATION ANALYSIS Diasorin

See ad on inside front cover

See ad on back cover

STREPTOCOCCUS (GROUP B) CULTURE, GENITAL Hardy Diagnostics Puritan Medical Products Co

GENETIC & GENOMIC TESTING Puritan Medical Products Co

MOLECULAR DIAGNOSTICS PATHOLOGY

STREPTOCOCCUS PNEUMONIAE ANTIGEN Hardy Diagnostics

BLADDER CANCER, FISH Techcyte

SUSCEPTIBILITY TESTING Hardy Diagnostics

UROVYSION(TM) FISH Techcyte

TRICHOMONAS VAGINALIS, RAPID TESTING Puritan Medical Products Co SEKISUI Diagnostics LLC See ad on inside front cover

MOLECULAR DIAGNOSTICS/VIROLOGY ADENOVIRUS DNA, QUALITATIVE, RT PCR Diasorin See ad on back cover

PATHOLOGY/CYTOLOGY CYTOLOGY /CYTOPATHOLOGY Techcyte FECAL OCCULT BLOOD (IFOB) Carolina Liquid Chemistries Corp.

Hardy Diagnostics SEKISUI Diagnostics LLC See ad on inside front cover

GYNECOLOGIC PAP SMEAR Puritan Medical Products Co Techcyte GYNECOLOGIC PAP TEST (IMAGEGUIDED OR NON-IMAGE GUIDED), LIQUID-BASED PREPARATION Techcyte GYNECOLOGIC PAP TEST, LIQUID-BASED PREPARATION Techcyte GYNECOLOGIC PAP TESTING 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 POINT-OF-CARE TESTING, CLIA WAIVED Hardy Diagnostics Puritan Medical Products Co

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PRODUCT CATEGORIES SEKISUI Diagnostics LLC

See ad on inside front cover

SPECIMENS Puritan Medical Products Co

TOXICOLOGY ACETAMINOPHEN SEKISUI Diagnostics LLC See ad on inside front cover

ALCOHOL ASSAYS Carolina Liquid Chemistries Corp.

SEKISUI Diagnostics LLC See ad on inside front cover

CARBAMAZEPINE, SERUM Carolina Liquid Chemistries Corp.

DIGITOXIN, SERUM Carolina Liquid Chemistries Corp.

DRUGS-OF-ABUSE TESTING, URINE Carolina Liquid Chemistries Corp.

FENTANYL SEKISUI Diagnostics LLC

See ad on inside front cover

THEOPHYLLINE, ASSAY AND THERAPEUTIC DRUG MONITORING (THEO) Carolina Liquid Chemistries Corp.

LAMOTRIGINE TDM ASSAY SEKISUI Diagnostics LLC See ad on inside front cover

LITHIUM, SERUM Carolina Liquid Chemistries Corp.

SEKISUI Diagnostics LLC See ad on inside front cover

METHOTREXATE ASSAYS SEKISUI Diagnostics LLC

See ad on back cover

ENTEROVIRUS TESTING Diasorin

TOPIRAMATE, SERUM SEKISUI Diagnostics LLC

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EPSTEIN-BARR VIRUS (EBV) Diasorin

TRICYCLIC ANTIDEPRESSANTS, SERUM Carolina Liquid Chemistries Corp.

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HERPES SIMPLEX VIRUS (HSV) Diasorin

VALPROIC ACID, ASSAY AND THERAPEUTIC DRUG MONITORING (VPA) Carolina Liquid Chemistries Corp.

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HHV6 Diasorin See ad on back cover

ZONISAMIDE TDM ASSAY SEKISUI Diagnostics LLC

INFLUENZA Diasorin

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Hardy Diagnostics Puritan Medical Products Co SEKISUI Diagnostics LLC

URINALYSIS Arkray USA Health Care Logistics Sysmex America, Inc. Techcyte

GABAPENTIN, SERUM SEKISUI Diagnostics LLC See ad on inside front cover

DENGUE FEVER Diasorin

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MONONUCLEOSIS Hardy Diagnostics SEKISUI Diagnostics LLC

VIROLOGY

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RESPIRATORY SYNCYTIAL VIRUS (RSV) Diasorin

COVID-19 Diasorin

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Hardy Diagnostics Puritan Medical Products Co SEKISUI Diagnostics LLC

Hardy Diagnostics Puritan Medical Products Co SEKISUI Diagnostics LLC

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CYTOMEGALOVIRUS (CMV) Diasorin

WEST NILE Diasorin

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r

INDEX OF ADVERTISERS Advertiser............................................................Web..................................................................Page Diasorin................................................................diasorin.com...................................................... C4 Kronus..................................................................kronus.com...........................................................5 Sekisui Diagnostics..............................................sekisuidiagnostics.com/respiratory-health...... C2 This index is provided as a service. The p­ ublisher does not assume liability for errors or omissions.

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MOLECULAR SOLUTIONS

Travel history? Foodborne illness?

Contact exposure? You pick the panel.

Order only what is clinically appropriate, pay only for what you use, and expand results instantly as needed.

LIAISON PLEX® Gastrointestinal Flex Assay delivers rapid, actionable results while helping to avoid one-size-fits-all broad testing and unnecessary patient out-of-pocket costs to support your diagnostic stewardship goals.

Expansive Target Menu

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Detect up to 24 targets and enhance diagnostic confidence across a broad patient population.

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A simple 2-minute hands-on setup, improves workflow efficiency and resource utilization.

Learn more at diasorin.com/GI-Flex

p: +1 (512) 219 8020 w: diasorin.com ©2026 Luminex Corporation. and/or its affiliates. All rights reserved. LIAISON PLEX is a trademark of Luminex Corporation and DIASORIN S.p.A., registered in the U.S. and other countries. All other trademarks are the property of their respective owners.

2026MLOCLRbg_LuminexCorp_FP.indd 1 2607MLO_CLR_C1-C4.indd 4

PRTA1232150.US.0526.2

Or contact your Diasorin Account Executive.

6/5/26 12:50 8:25 AM 6/12/26 PM