A fresh look at analytical performance specifications from biological variation

Clinica Chimica Acta

Volumn 421, Issue , 2013, Pages 191-192

  Stepman, Hedwig C M ^a   Stöckl, Dietmar ^b   Twomey, Patrick J ^c   Thienpont, Linda M ^a  

^a GHENT UNIVERSITY   (Belgium)

^b STT Consulting   (Belgium)

^c IPSWICH HOSPITAL   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ACCESS TO INFORMATION; ACCURACY; ANALYTICAL PARAMETERS; ANALYTICAL PERFORMANCE SPECIFICATION; ANALYTICAL VARIATION; BIOLOGICAL VARIATION; DISEASE SEVERITY; FALSE POSITIVE RESULT; HUMAN; INTERNAL BIAS; LABORATORY DIAGNOSIS; LABORATORY TEST; LETTER; MEDICAL DECISION MAKING; MEDICAL HISTORY; MEDICAL RECORD REVIEW; NORMAL DISTRIBUTION; PRIORITY JOURNAL; QUALITY CONTROL;

BIOLOGICAL ASSAY; CHEMISTRY TECHNIQUES, ANALYTICAL; FALSE NEGATIVE REACTIONS; FALSE POSITIVE REACTIONS; HUMANS; OBSERVER VARIATION; QUALITY CONTROL;

EID: 84876320581     PISSN: 00098981     EISSN: 18733492     Source Type: Journal    
DOI: 10.1016/j.cca.2013.03.018     Document Type: Letter

References (4)

1. Cotlove E., Harris E.K., Williams G.Z. Biological and analytic components of variation in long-term studies of serum constituents in normal subjects. 3. Physiological and medical implications. Clin Chem 1970, 16:1028-1032.
2. Klee G.G. Tolerance limits for short-term analytical bias and analytical imprecision derived from clinical assay specificity. Clin Chem 1993, 39:1514-1518.
3. Desirable specifications for total error, imprecision, and bias, derived from biologic variation [accessed January 2013]. http://www.westgard.com/biodatabase1.htm.
4. Van Houcke S.K., Stepman H.C., Thienpont L.M., et al. Long-term stability of laboratory tests and practical implications for quality management. Clin Chem Lab Med Jan 2013, 22:1-5. [Epub ahead of print]. 10.1515/cclm-2012-0820.