CLSI EP17

Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures, 2nd Edition

This document provides guidance for evaluation and documentation of the detection capability of clinical laboratory measurement procedures (ie, limits of blank, detection, and quantitation), for verification of manufacturers’ detection capability claims, and for the proper use and interpretation of different detection capability estimates.

This reaffirmed document has been reviewed and confirmed as suitable to remain published without revision to content, as of June 2017. The document’s next scheduled review is generally five years after the reaffirmation date.

This edition of the document was corrected in June 2020. Read the full correction notice here, and learn more about our corrections process here.

This document is available in electronic format only.

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Chairholder: James F. Pierson-Perry

Date of Publication: June 18, 2012

Order Code PDF: CLSI EP17A2E
ISBN Number: 1-56238-796-0

Order Code Print: print not available

Edition: Second

Pages: 80

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CLSI EP17 Abstract

Clinical and Laboratory Standards Institute document EP17-A2—Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline—Second Edition provides guidance for evaluating the detection capability of clinical laboratory measurement procedures (ie, limits of blank, detection, and quantitation), for verification of manufacturers’ detection capability claims, and for the proper use and interpretation of different detection capability estimates. EP17 is intended for use by manufacturers of in vitro diagnostic tests, regulatory bodies, and clinical laboratories.