European specifications for imprecision and inaccuracy compared with operating specifications that assure the quality required by US CLIA proficiency-testing criteria. 1994

J O Westgard, and J J Seehafer, and P L Barry
Department of Pathology and Laboratory Medicine, Medical School, University of Wisconsin, Madison 53792.

Proposed and interim European quality specifications for imprecision and inaccuracy have been compared with the US CLIA total error criteria for proficiency testing (PT). To assess the relative demands of separate imprecision and inaccuracy specifications vs total error criteria, we derived the imprecision and inaccuracy that would be allowable if a testing process were to provide 90% assurance of achieving the analytical quality required by CLIA PT criteria. Charts of operating specifications (OPSpecs charts) were prepared for commonly used single-rule and multi-rule quality control procedures with 2 and 4 control measurements per run. Of the 23 tests studied, the proposed European specifications for imprecision and inaccuracy were more demanding than the CLIA requirements for 12 tests (albumin, alkaline phosphatase, amylase, calcium, chloride, creatinine, lactate dehydrogenase, lithium, magnesium, total protein, sodium, and thyroxine). The CLIA total error criteria were more demanding than the proposed European specifications for nine tests (alanine aminotransferase, aspartate aminotransferase, total bilirubin, cholesterol, creatine kinase, iron, triglycerides, uric acid, and urea nitrogen). Two tests (glucose, potassium) showed different requirements at different decision levels. Manufacturers and laboratory analysts need to compare these different quality specifications on a test-by-test basis to guide the development, selection, evaluation, and control of laboratory measurement procedures.

UI MeSH Term Description Entries
D007753 Laboratories Facilities equipped to carry out investigative procedures. Laboratory
D011786 Quality Control A system for verifying and maintaining a desired level of quality in a product or process by careful planning, use of proper equipment, continued inspection, and corrective action as required. (Random House Unabridged Dictionary, 2d ed) Control, Quality,Controls, Quality,Quality Controls
D001774 Blood Chemical Analysis An examination of chemicals in the blood. Analysis, Blood Chemical,Chemical Analysis, Blood,Analyses, Blood Chemical,Blood Chemical Analyses,Chemical Analyses, Blood
D002624 Chemistry, Clinical The specialty of ANALYTIC CHEMISTRY applied to assays of physiologically important substances found in blood, urine, tissues, and other biological fluids for the purpose of aiding the physician in making a diagnosis or following therapy. Clinical Chemistry
D005060 Europe The continent north of AFRICA, west of ASIA and east of the ATLANTIC OCEAN. Northern Europe,Southern Europe,Western Europe
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D012680 Sensitivity and Specificity Binary classification measures to assess test results. Sensitivity or recall rate is the proportion of true positives. Specificity is the probability of correctly determining the absence of a condition. (From Last, Dictionary of Epidemiology, 2d ed) Specificity,Sensitivity,Specificity and Sensitivity
D014481 United States A country in NORTH AMERICA between CANADA and MEXICO.

Related Publications

J O Westgard, and J J Seehafer, and P L Barry
January 1995, Clinical chemistry,
J O Westgard, and J J Seehafer, and P L Barry
November 1991, Clinical chemistry,
J O Westgard, and J J Seehafer, and P L Barry
May 1992, European journal of clinical chemistry and clinical biochemistry : journal of the Forum of European Clinical Chemistry Societies,
J O Westgard, and J J Seehafer, and P L Barry
November 1999, Scandinavian journal of clinical and laboratory investigation,
J O Westgard, and J J Seehafer, and P L Barry
September 2013, MLO: medical laboratory observer,
J O Westgard, and J J Seehafer, and P L Barry
April 1992, Clinical chemistry,
J O Westgard, and J J Seehafer, and P L Barry
December 1992, MLO: medical laboratory observer,
Copied contents to your clipboard!