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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.
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.
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.
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
Method Navigator is an online subscription product that provides users with quick and easy access to specific guidance from CLSI documents.
CLSI EP47 provides guidance for planning, performing, evaluating, and documenting reagent carryover experiments and guidance for ensuring that no significant reagent carryover occurs.
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.
