Analytical Performance Specifications. Relating Laboratory Performance to Quality Required for Intended Clinical Use.

Daniel A. Dalenberg, Patricia G. Schryver, George G. Klee

Research output: Contribution to journalReview article

3 Scopus citations

Abstract

This article proposes analytic performance goals for five quality indicators: precision, trueness, linearity, detection limits, and consistency across instruments and time. We defined our goals using methods linked to clinical practice data. Goals for desirable precision and trueness are based on biological variation. Linearity goals are related to total error recommendations. Detection limit goals are derived from 0.1 percentile of patient values. Goals for consistency are derived from the variability of distributions of patient test values. Data were collected and evaluated for each of these quality indicators for 46 chemistry tests measured on the Roche cobas 8000 analyzer.

Original languageEnglish (US)
Pages (from-to)55-73
Number of pages19
JournalClinics in Laboratory Medicine
Volume33
Issue number1
DOIs
StatePublished - Mar 1 2013

Keywords

  • Analytical bias
  • Analytical performance goals
  • Analytical precision
  • Detection limit
  • Linearity
  • Roche cobas 8000

ASJC Scopus subject areas

  • Clinical Biochemistry
  • Biochemistry, medical

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