This document provides guidance for evaluating the commutability of processed samples by determining if they behave differently than unprocessed patient samples when two quantitative measurement procedures are compared.
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.
EP27 | Constructing and Interpreting an Error Grid for Quantitative Measurement Procedures, 2nd Edition
This guideline provides recommendations on constructing and using error grids to evaluate the clinical acceptability of quantitative measurement procedures, based on the potential harm that may be caused by erroneous measurements with clinical consequences.
This implementation guide describes the minimum procedures necessary for a medical laboratory to verify that new reagent lots, when received and implemented by the laboratory, will produce results consistent with previous reagent lots. Reagent lot performance is validated by the developer before release and distribution; however, the laboratory needs to verify each new reagent lot it receives.
This guideline includes recommendations for laboratories on evaluating a new reagent lot, based on a protocol that uses patient samples to detect clinically important changes from the current lot.
Date: Thursday, May 26, 2022 at 1:00 pm (EST)
This implementation guide describes the minimum procedures necessary for a medical laboratory to verify a developer’s linearity interval claim. It also includes a link to CLSI workbook EP06-Ed2-WB, User Verification of Linearity Workbook.