Clinical & Laboratory Standards Institute: CLSI Guidelines

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Join CLSI's virtual training event on regulatory review!

Coming April 29!
Don't miss this unique opportunity to get prepared and stay ahead of regulatory changes. This event will address FDA oversight and regulatory requirements for LDTs as well as manufacturers.

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Stay Ready – Equip your team with the tools to navigate evolving regulations.
Learn from Experts – Get insider tips on evaluation and compliance.
Ensure Success – Master strategies to ace regulatory reviews.
Build Skills – Apply real-world case studies to strengthen expertise.

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Upcoming Webinar

CLSI M100 Update Webinar 2025: Implement CLSI M100 With Confidence

Date: Wednesday, 26 February  2025 at 1:00-2:30 ET

Receive the latest guidance for implementing new breakpoints and standards into your laboratory practices, including discussion of the major changes in this edition, including:

A significant addition of a new appendix
Expanded QC guidance
Removal of breakpoint
A new categorization of disk diffusion methods described in CLSI M02.

View All Webinars Here

Featured Products

CLSI LDT Stage 1 | LDT Regulatory Guidance

The US Food and Drug Administration (FDA) 21 CFR Parts 820.198, 803, and 806 requirements apply to enforcement discretion for laboratory-developed tests (LDTs), which begins on May 6, 2025. This document intends to provide guidance for preparing a laboratory to adhere to the FDA requirements when establishing and implementing LDTs.

CLSI EP35 | Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures, 2nd Edition

EP35 provides recommendations for assessing clinically equivalent performance for additional similar-matrix specimen types and suitable performance for dissimilar-matrix specimen types, such that the laboratory does not necessarily need to repeat the full measurement procedure validation for each specimen type. The recommendations in EP35 apply to both quantitative measurement procedures and qualitative examinations.

CLSI PRE02 | Collection of Diagnostic Venous Blood Specimens, 8th Edition

CLSI PRE02 provides procedures for the collection of diagnostic venous blood specimens, including line draws, blood culture collection, and venipuncture in children.

CLSI MM23 | Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms), 2nd Edition

CLSI MM23 covers the current state of molecular diagnostic methods intended for characterization of solid tumors and covers a range of clinical applications, including diagnosis, prognosis, therapeutic response prediction for available drugs and drugs still in clinical trials, monitoring, and presymptomatic and predisposition testing.

CLSI M100 | Performance Standards for Antimicrobial Susceptibility Testing, 35th Edition

CLSI M100-Ed35 includes updated tables for the Clinical and Laboratory Standards Institute antimicrobial susceptibility testing standards CLSI M02| Performance Standards for Antimicrobial Disk Susceptibility Tests, 14th Edition (2024), CLSI M07| Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically, 12th Edition (2024), and CLSI M11 | Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria, 9th Edition (2018).

CLSI GP40 | Preparations and Testing of Reagent Water in the Medical Laboratory, 5th Edition

CLSI GP40 provides guidelines on water purified for medical laboratory use, methods for monitoring water quality and testing for specific contaminants, and water system design considerations.

Learn More About CLSI

CLSI and our volunteer members actively identify and develop new guidance on standards that raise laboratory testing quality, safety, and efficiency. We are setting the bar for how that guidance is delivered.

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