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Specialty Areas

Method Evaluation

Setting the Standard

Defining Best Practices in Method Evaluation


CLSI’s evaluation protocol standards provide detailed explanations and instructions for the evaluation of test method performance characteristics such as precision and accuracy.  These standards equip labs with the information needed to comply with the latest best practices and accreditation requirements. 
 
In addition to evaluation protocol standards, CLSI has developed implementation and establishment guides and tools designed for use by laboratory scientists when performing verification and validation testing. Minimum protocols are provided in the establishment and implementation guides, including how to select appropriate samples and analyze data. 
 

CLSI method evaluation guidance supports developers of both commercially available in vitro devices (IVDs) and laboratory developed tests (LDTs), and follows the life of a test through establishment and implementation. CLSI EP19 presents a framework that all CLSI evaluation protocol standards fall into.
 

CLSI Test Life Phases Model

 

CLSI Test Life Phases Model
Expertise

Protocols and Best Practices for all Stages and Types of Evaluation

CLSI EP standards and guidance are designed for test developers in laboratories and commercial manufacturing organizations. Teams of experts, including developers and regulators, come together to define best practices and procedures that can ensure quality test results.

Expert Panel on Method Evaluation
Working Groups on Methods Evaluation
Learn More about the CLSI Consensus Process
Method Evaluation Products

Guidance to Ensure Your Test Meets Requirements 

CLSI’s library of evaluation protocols is based on the framework in EP19 and designed to ensure each stage and type of testing is compliant with regulatory requirements. 

See Our Latest Guidance
Featured Product

CLSI Method Navigator™

CLSI’s newly updated Method Navigator helps developers of both commercially available IVDs and LDTs identify, understand, and meet regulatory requirements with ease.  This comprehensive resource includes regulatory requirements, checklists, and navigation to specific document guidance necessary for meeting requirements at each life phase of a test. Learn more about this interactive product! 

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Other Method Evaluation Resources

Prepare your Lab with these CLSI Resources

Crosswalk of Documents Referenced Within FDA Accreditation Checklists
Tools for Verifying Performance Claims

Latest Method Evaluation Insights

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Laboratory Developed Tests
International Standards: Advancing Laboratory Practice Through Translation
Through the power of translation, access to CLSI standards is advancing around the world, helping to create harmonization across the medical laboratory industry.
Method Evaluation
Purpose-Driven Content for EP Documents: A Strategic Update
The CLSI Expert Panel on Method Evaluation is leading a strategic initiative to restructure CLSI EP documents, using a modular, purpose‑driven framework. This approach maintains scientific rigor while improving usability and navigation. This initiative marks a significant evolution in how EP guidance is organized and delivered to better support its consistent and effective application in practice.
Standards Development
Why CLSI? Because Expertise is More Powerful than Algorithms
In an era of instant answers and AI-generated content, it’s tempting to believe that a quick search or chatbot response can replace the depth of expert consensus.

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Share Your Expertise

Join our community of industry leaders who volunteer their experience and knowledge to drive innovation and excellence in laboratory practices.

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Method Evaluation Projects in Progress

Please note, the publication dates are subject to change based on document development activities.

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Current Method Evaluation Working Groups

There are standing and ad hoc working groups devoted to supporting specific projects.

  • Toshiyuki Baba / Member / Sysmex Corporation - Japan, Japan
  • Eati Basal, PhD / Member / Mayo Clinic, United States
  • Miranda Brun, PhD, FCACB / Member / Alberta Precision Laboratories, University of Alberta, Canada
  • Michelle Renee Campbell, MS, MLS(ASCP)CM, MBCM, SCCM / Contributor / Mayo Clinic, United States
  • Marisol Castaneto, PhD, F-ABFT / Member / Department of Defense, United States
  • Elbethel Damtae, MS, MLS(ASCP)CM / Member, United States
  • Florian Dufey / Member / Roche GmbH - GERMANY, Germany
  • Priya Halvorsen, PhD, MPH / Member, United States
  • Snezana Jovicic, PhD, PharmD / Member / Greiner Bio-One GmbH, Austria
  • Zahra Khatami, MS, FRCPath / Member / Royal London Hospitals, United Kingdom
  • Paula Ladwig, MS, MLS(ASCP) / Vice-Chairholder / Mayo Clinic, United States
  • Jayson Pagaduan, PhD, DABCC / Member / Intermountain Central Laboratory, United States
  • Ronnie Pedersen, PhD / Member / Radiometer America, Inc., United States
  • Marco Pradella, MD / Member / SIPMeL, Italy
  • Sara Smith, MPS, PhD / Member / Revvity - Pittsburgh, United States
  • Mary Urbanski / Member / Fujirebio Diagnostics, Inc., United States
  • Richard Y. Wang, DO / Member / Centers for Disease Control and Prevention, United States
  • Natalya Benina, MSc / Member / Fujirebio Diagnostics, United States
  • Marvin Berman, PhD / Member / Abbott Laboratories, United States
  • Bipasa Biswas / Member / FDA Ctr. for Devices/Rad. Health (CDRH), United States
  • Kornelia Galior, PhD, DABCC / Member / Emory University, United States
  • Paula Ladwig, MS, MLS(ASCP) / Vice-Chairholder / Mayo Clinic, United States
  • Donna Roberts, MS, MT(ASCP) / Member / Baylor Scott and White Health, United States
  • Scott A. Ruetten, PhD / Member / World Health Organization, United States, Ended: Feb 27, 2026
  • Aleksei Tikhonov, PhD, MS / Member / Gustave Roussy, France
  • Benjamin Uphoff, MLS(ASCP) / Chairholder / Mayo Clinic, United States
  • Nicholas Burn, MS / Member / University of Ottawa, Canada
  • Florian Dufey / Member / Roche GmbH - GERMANY, Germany
  • Jesper V. Johansen, PhD, MS / Member / Radiometer Medical ApS, Denmark
  • Marianne Thuy Duong Le, MS / Chairholder / Qufora A/S, Denmark