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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.

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Publication Details

Chairholder: James F. Pierson-Perry

Date of Publication: June 18, 2012

ISBN Number: 1-56238-795-2

Order Code PDF: EP17A2E

Order Code Print: EP17A2

Edition: Second

Pages: 80

EP17 Additional Details

The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.