CLSI EP28-A3C-2010 (R2016)
$48.10
Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory
| Published By | Publication Date | Number of Pages |
| CLSI | 2010 | 76 |
This document provides diagnostic laboratories and diagnostic
test manufacturers with updated guidelines for determining
reference intervals for quantitative laboratory tests. It includes
specific recommendations regarding procedures that can be used to
establish and verify reliable reference intervals for use in
clinical laboratory medicine. By following these recommendations,
laboratories can provide reference intervals that are adequate and
useful for clinical interpretation.
Issues related to the reference subject selection process, the
importance of preanalytical and analytical considerations, the
calculation methods and requirements for estimating valid reference
intervals, and the transference of reference intervals are
discussed. Examples of the recommended estimation and calculation
processes are provided. Finally, issues related to the presentation
and use of reference intervals are discussed, followed by a brief
section that examines a number of important but collateral
reference value topics not amenable to inclusion in this
document.
