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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 a manufacturer’s or laboratory-developed test’s precision claims. It also includes a link to CLSI workbook EP15-Ed3-WB, User Verification of Precision and Estimation of Bias Workbook.
This implementation guide describes the minimum procedures necessary for a medical laboratory to estimate bias (trueness) of a laboratory measurement procedure. It also includes a link to CLSI workbook EP15-Ed3-WB, User Verification of Precision and Estimation of Bias Workbook.
This implementation guide describes the minimum procedures necessary for a medical laboratory to verify that a measurement procedure’s detection capability is consistent with the claims established by the developer. It also includes a link to CLSI workbook EP17-Ed2-WB, Detection Capability Data Entry and Analysis Workbook.
This implementation guide describes the minimum procedures necessary for a medical laboratory to identify and control laboratory error sources using risk management techniques.
This implementation guide describes the minimum procedures necessary for a medical laboratory to determine total analytical error for quantitative measurement procedures. It also includes a link to CLSI workbook EP21-Ed2-WB, Evaluation of Total Analytical Error Workbook.
