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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.
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.
This implementation guide describes the minimum procedures necessary for a medical laboratory to make a preliminary decision about a new measurement procedure’s acceptability before using the procedure for laboratory testing. It also includes a link to CLSI workbook EP10-Ed3-WB, Preliminary Evaluation of Quantitative Medical Laboratory Measurement Procedures Workbook.
This implementation guide describes the minimum procedures necessary for a medical laboratory to verify that a preestablished reference interval for quantitative tests (eg, from previous studies, literature, or developer’s information) is transferrable to the laboratory’s similar tests.
