CLSI EP17
Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline
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| Organization: | CLSI |
| Publication Date: | 1 June 2012 |
| Status: | inactive |
| Page Count: | 80 |
scope:
This document provides guidelines for the evaluation and
verification of detection capability claims of clinical laboratory
measurement procedures (ie, limit of blank [LoB], limit of
detection [LoD], and limit of quantitation [LoQ]), as well as for
their proper use, documentation, and interpretation. This guidance
is suitable both for commercial products as well as
laboratory-developed
The intended users of this guideline are manufacturers of in vitro diagnostic (IVD) reagents, regulatory bodies, and clinical laboratory personnel.
Document History
June 1, 2012
Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline
This document provides guidelines for the evaluation and verification of detection capability claims of clinical laboratory measurement procedures (ie, limit of blank [LoB], limit of detection [LoD],...
CLSI EP17
June 1, 2012
Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline
This document provides guidelines for the evaluation and verification of detection capability claims of clinical laboratory measurement procedures (ie, limit of blank [LoB], limit of detection [LoD],...
October 20, 2004
Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline
NCCLS document EP17 specifies recommendations for determining the lower limit of detection of clinical laboratory methods, for verifying claimed limits, and for the proper use and interpretation of...