Proposed goals for analytical precision and accuracy in single-point diagnostic testing. Theoretical basis and comparison with data from College of American Pathologists proficiency surveys. 1988

E K Harris
Department of Pathology, University of Virginia Medical Center, Charlottesville.

Expressing total analytic variance as the sum of the squares of imprecision and inaccuracy, or bias, and applying the Cotlove rule recommended by the 1976 College of American Pathologists Conference on Analytical Goals in Clinical Chemistry, namely, that analytic variance should be less than one fourth of the appropriate biological variance, I derive a rule for maximum allowable imprecision in the context of single-point diagnostic testing that takes into account the bias of the test procedure. This rule may be expressed in terms of a population-based reference range (in particular, the range of test results shown in a group of healthy individuals) and the bias of the test method. The latter is required not to exceed one eighth (0.125) of the reference range. These concepts are applied to eight common analytes for which estimates of the biases of specific methods and of within-laboratory imprecision have been published for large numbers of laboratories participating in recent College of American Pathologists proficiency surveys. Results indicate that some methods widely used in 1978 fail to meet the minimum accuracy criterion, while others show negligible bias. Even neglecting bias, more recent data show that average within-laboratory imprecision is still too high for sodium, chloride, and calcium but acceptable for potassium, glucose, cholesterol, urea, and uric acid.

UI MeSH Term Description Entries
D007753 Laboratories Facilities equipped to carry out investigative procedures. Laboratory
D007755 Laboratories, Hospital Hospital facilities equipped to carry out investigative procedures. Hospital Laboratories,Hospital Laboratory,Laboratory, Hospital
D010338 Pathology, Clinical A subspecialty of pathology applied to the solution of clinical problems, especially the use of laboratory methods in clinical diagnosis. (Dorland, 28th ed.) Clinical Pathology
D012015 Reference Standards A basis of value established for the measure of quantity, weight, extent or quality, e.g. weight standards, standard solutions, methods, techniques, and procedures used in diagnosis and therapy. Standard Preparations,Standards, Reference,Preparations, Standard,Standardization,Standards,Preparation, Standard,Reference Standard,Standard Preparation,Standard, Reference
D012016 Reference Values The range or frequency distribution of a measurement in a population (of organisms, organs or things) that has not been selected for the presence of disease or abnormality. Normal Range,Normal Values,Reference Ranges,Normal Ranges,Normal Value,Range, Normal,Range, Reference,Ranges, Normal,Ranges, Reference,Reference Range,Reference Value,Value, Normal,Value, Reference,Values, Normal,Values, Reference
D003625 Data Collection Systematic gathering of data for a particular purpose from various sources, including questionnaires, interviews, observation, existing records, and electronic devices. The process is usually preliminary to statistical analysis of the data. Data Collection Methods,Dual Data Collection,Collection Method, Data,Collection Methods, Data,Collection, Data,Collection, Dual Data,Data Collection Method,Method, Data Collection,Methods, Data Collection
D003955 Diagnostic Tests, Routine Diagnostic procedures, such as laboratory tests and x-rays, routinely performed on all individuals or specified categories of individuals in a specified situation, e.g., patients being admitted to the hospital. These include routine tests administered to neonates. Admission Tests, Routine,Hospital Admission Tests,Physical Examination, Preadmission,Routine Diagnostic Tests,Admission Tests, Hospital,Diagnostic Test, Routine,Diagnostic Tests,Examination, Preadmission Physical,Preadmission Physical Examination,Routine Diagnostic Test,Test, Routine Diagnostic,Tests, Diagnostic,Tests, Hospital Admission,Tests, Routine Diagnostic,Admission Test, Hospital,Admission Test, Routine,Diagnostic Test,Examinations, Preadmission Physical,Hospital Admission Test,Physical Examinations, Preadmission,Preadmission Physical Examinations,Routine Admission Test,Routine Admission Tests,Test, Diagnostic,Test, Hospital Admission,Test, Routine Admission,Tests, Routine Admission
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000047 Academies and Institutes Organizations representing specialized fields which are accepted as authoritative; may be non-governmental, university or an independent research organization, e.g., National Academy of Sciences, Brookings Institution, etc. Institutes,Research Institutes,Academies,Academy and Institute,Institutes and Academies,Academy,Institute and Academy,Institute, Research,Institutes, Research,Research Institute
D013223 Statistics as Topic Works about the science and art of collecting, summarizing, and analyzing data that are subject to random variation. Area Analysis,Estimation Technics,Estimation Techniques,Indirect Estimation Technics,Indirect Estimation Techniques,Multiple Classification Analysis,Service Statistics,Statistical Study,Statistics, Service,Tables and Charts as Topic,Analyses, Area,Analyses, Multiple Classification,Area Analyses,Classification Analyses, Multiple,Classification Analysis, Multiple,Estimation Technic, Indirect,Estimation Technics, Indirect,Estimation Technique,Estimation Technique, Indirect,Estimation Techniques, Indirect,Indirect Estimation Technic,Indirect Estimation Technique,Multiple Classification Analyses,Statistical Studies,Studies, Statistical,Study, Statistical,Technic, Indirect Estimation,Technics, Estimation,Technics, Indirect Estimation,Technique, Estimation,Technique, Indirect Estimation,Techniques, Estimation,Techniques, Indirect Estimation

Related Publications

E K Harris
October 1982, American journal of clinical pathology,
E K Harris
January 2004, Laboratory hematology : official publication of the International Society for Laboratory Hematology,
E K Harris
March 2015, Genetics in medicine : official journal of the American College of Medical Genetics,
E K Harris
September 2011, Genetics in medicine : official journal of the American College of Medical Genetics,
Copied contents to your clipboard!