TY - JOUR
T1 - Analytical Performance Specifications. Relating Laboratory Performance to Quality Required for Intended Clinical Use.
AU - Dalenberg, Daniel A.
AU - Schryver, Patricia G.
AU - Klee, George G.
PY - 2013/3
Y1 - 2013/3
N2 - 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.
AB - 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.
KW - Analytical bias
KW - Analytical performance goals
KW - Analytical precision
KW - Detection limit
KW - Linearity
KW - Roche cobas 8000
UR - http://www.scopus.com/inward/record.url?scp=84872450429&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84872450429&partnerID=8YFLogxK
U2 - 10.1016/j.cll.2012.11.005
DO - 10.1016/j.cll.2012.11.005
M3 - Review article
C2 - 23331729
AN - SCOPUS:84872450429
SN - 0272-2712
VL - 33
SP - 55
EP - 73
JO - Clinics in Laboratory Medicine
JF - Clinics in Laboratory Medicine
IS - 1
ER -