UNLIMITED FREE ACCESS TO THE WORLD'S BEST IDEAS

close

This is embarrasing..

An error occurred while processing the form. Please try again in a few minutes.

Customize Your Engineering360 Experience

close
Privacy Policy

This is embarrasing..

An error occurred while processing the form. Please try again in a few minutes.

CLSI EP17

Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline

active, Most Current
Buy Now
Organization: CLSI
Publication Date: 1 June 2012
Status: active
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 tests. It is particularly important for measurement procedures for which the associated measurand's medical decision level is low (ie, approaching zero).

The intended users of this guideline are manufacturers of in vitro diagnostic (IVD) reagents, regulatory bodies, and clinical laboratory personnel.

Document History

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],...
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...

References

Advertisement