Method Evaluation | Standards

CLSI’s Method Evaluation standards provide concise explanations and step-by-step instructions for evaluation of test method performance characteristics such as precision and accuracy. We provide your lab with the information needed to comply and keep up-to-date with the latest best practice guidelines and laboratory accreditation requirements.  

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CLSI LDT Webinar | LDT Foundations Webinar Series: Navigating Design Controls for LDTs

Join CLSI for this webinar series dedicated to the stages of FDA's Final Rule on Laboratory Developed Tests (LDTs). Register for this first webinar and receive access to the entire series that will provide practical guidance, resources, and vital information for laboratories. Once you are registered for the series, you will receive notifications about new webinars that are released, all on-demand recordings, and webinar slides. CLSI will update this series frequently with new webinar dates, topi

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CLSI QSRLDT | Quality System Regulations for Laboratory-Developed Tests: A Practical Guide for the Laboratory, 2nd Edition

This practical guide, compiled with the help of experts from the in vitro diagnostics industry, is intended for the laboratory that is creating laboratory developed tests that may be subject to the US Food and Drug Administration (FDA) regulations, specifically the Quality System Regulation (QSReg), 21 CFR Part

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CLSI EP47 | Evaluation of Reagent Carryover Effects on Test Results, 1st Edition

CLSI EP47 provides guidance for planning, performing, evaluating, and documenting reagent carryover experiments and guidance for ensuring that no significant reagent carryover occurs.

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CLSI EP30 | Characterization and Qualification of Commutable Reference Materials for Laboratory Medicine, 2nd Edition

This document provides information to help material manufacturers in the production and characterization of commutable reference materials, as well as to assist assay manufacturers and laboratorians in the appropriate use of these materials for calibration and trueness assessment of in vitro diagnostic medical devices.

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CLSI EP06EG | Developer Validation of Linearity Establishment Guide, 1st Edition

This establishment guide describes the minimum procedures necessary for a developer (either a manufacturer or an LDT developer) to validate the linearity of a measurement procedure’s analytical measuring interval (AMI). Guide should be used in conjunction with CLSI EP06 standard document.

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CLSI EP10 | Preliminary Evaluation of Quantitative Medical Laboratory Measurement Procedures, 4th Edition

CLSI EP10 provides experimental design and data analysis for preliminary evaluation of the performance of a measurement procedure or device.

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CLSI EP 2024 Webinar | What's New in Method Evaluation?

Participate in this CLSI webinar to gain knowledge about the latest method evaluation standards, get a sneak peek of EP47, and engage in a Q&A session addressing important topics in the industry.

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CLSI EPLDT Quick Guide | Validating Performance Claims for Laboratory-Developed Tests, 1st Edition

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CLSI On-Demand LDT Webinar 1 | LDT Foundations: An Overview of FDA's Final Rule on LDTs

Join CLSI for this webinar series dedicated to the stages of FDA's Final Rule on Laboratory Developed Tests (LDTs). Register for this first webinar and receive access to the entire series, which will provide practical guidance, resources, and vital information for laboratories. Once you are registered for the series, you will receive notifications about new webinars that are released, all on-demand recordings, and webinar slides. CLSI will update this series frequently with new webinar dates, to

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