CLSI EP21
Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures
This guideline offers manufacturers and end users a comprehensive understanding of concepts related to total analytical error (TAE) for quantitative measurement procedures. It includes an experimental protocol and data analysis method to estimate TAE by comparing methods using patient specimens. Additionally, it provides a way to assess TAE in relation to pre-established goals for clinical acceptability. This ensures that the accuracy and reliability of test results meet the necessary standards for clinical use.
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{{FormatPrice(nonMemberPrice)}} List PriceClinical and Laboratory Standards Institute guideline EP21—Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures provides manufacturers and end users with a means to estimate total analytical error (TAE) for a quantitative measurement procedure and to assess if it meets pre-established specifications. Error is defined in terms of observed bias, using patient specimens tested with either a reference or comparative measurement procedure as described in CLSI document EP09. This assessment incorporates multiple analytical error sources, including imprecision, bias, nonlinearity, interferences, specimen-to-specimen matrix differences, and others. EP21 can be used to judge acceptability of candidate measurement procedures relative to performance goals reflective of clinical utility.
Before an evaluation with EP21, the user selects the appropriate limits for allowable total error relative to a performance goal for clinical utility. Users also decide whether to measure TAE over the entire measuring interval, and/or at specific subintervals.
This revision of EP21 is based upon extensive discussions with its current and potential users. It follows the same basic testing protocol as the previous edition, and incorporates updates designed to promote its relevance and use by both manufacturers and laboratorians. These updates include:
-Greater clarity in developing the concepts of total error and TAE
-Expanded guidance on selection of suitable acceptance criteria
-Overview of the relationship between TAE and the Sigma metric
-Simplified data analysis
EP21 provides guidance for understanding, estimating, and evaluating total analytical error (TAE) for quantitative medical laboratory measurement procedures. This guidance is suitable for both commercial products as well as laboratory-developed tests (LDTs). It is particularly useful for medical laboratories to assess the performance of measurement procedures intended to be put into service, relative to goals for allowable measurement error.
Through EP21, users will learn the limitations of traditional estimates of TAE that added independent point estimates of bias and imprecision, accounting for all sources of error including those due to nonlinearity, nonspecificities, lot-to-lot variations in reagent performance, etc. Users will learn how to:
-Describe the difference between TAE and total error, which includes pre- and postexamination (pre- and postanalytical) components, and why EP21 focuses only on the former.
-Explain the various available sources for establishing allowable total error (ATE) goals, also called total error allowable.
-Discuss considerations for setting ATE limits, including selection of appropriate subintervals.
-Design an experiment to measure TAE and determine if performance goals were met.
The intended users of this guideline are developers of in vitro diagnostic (IVD) reagents, regulatory authorities, and medical laboratory personnel.
The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.
CLSI EP21IG
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Clinical and Laboratory Standards Institute guideline EP21—Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures provides manufacturers and end users with a means to estimate total analytical error (TAE) for a quantitative measurement procedure and to assess if it meets pre-established specifications. Error is defined in terms of observed bias, using patient specimens tested with either a reference or comparative measurement procedure as described in CLSI document EP09. This assessment incorporates multiple analytical error sources, including imprecision, bias, nonlinearity, interferences, specimen-to-specimen matrix differences, and others. EP21 can be used to judge acceptability of candidate measurement procedures relative to performance goals reflective of clinical utility.
Before an evaluation with EP21, the user selects the appropriate limits for allowable total error relative to a performance goal for clinical utility. Users also decide whether to measure TAE over the entire measuring interval, and/or at specific subintervals.
This revision of EP21 is based upon extensive discussions with its current and potential users. It follows the same basic testing protocol as the previous edition, and incorporates updates designed to promote its relevance and use by both manufacturers and laboratorians. These updates include:
-Greater clarity in developing the concepts of total error and TAE
-Expanded guidance on selection of suitable acceptance criteria
-Overview of the relationship between TAE and the Sigma metric
-Simplified data analysis
EP21 provides guidance for understanding, estimating, and evaluating total analytical error (TAE) for quantitative medical laboratory measurement procedures. This guidance is suitable for both commercial products as well as laboratory-developed tests (LDTs). It is particularly useful for medical laboratories to assess the performance of measurement procedures intended to be put into service, relative to goals for allowable measurement error.
Through EP21, users will learn the limitations of traditional estimates of TAE that added independent point estimates of bias and imprecision, accounting for all sources of error including those due to nonlinearity, nonspecificities, lot-to-lot variations in reagent performance, etc. Users will learn how to:
-Describe the difference between TAE and total error, which includes pre- and postexamination (pre- and postanalytical) components, and why EP21 focuses only on the former.
-Explain the various available sources for establishing allowable total error (ATE) goals, also called total error allowable.
-Discuss considerations for setting ATE limits, including selection of appropriate subintervals.
-Design an experiment to measure TAE and determine if performance goals were met.
The intended users of this guideline are developers of in vitro diagnostic (IVD) reagents, regulatory authorities, and medical laboratory personnel.
The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.