Quality control for qualitative assays: Quantitative QC procedure designed to assure analytical quality required for an ELISA of hepatitis B surface antigen

Clinical Chemistry

Volumn 43, Issue 9, 1997, Pages 1618-1621

  Green IV, George A ^a,c   Neill Carey, R ^a   Westgard, James O ^b   Carten, Tami ^a   Shablesky, Leeann ^a   Achord, Daniel ^a   Page, Eileen ^a   Van Anh, L E ^a  

^a Ortho McNeil Pharmaceutical Incorporated   (United States)

^b Peninsula Regional Medical Center   (United States)

^c UNIVERSITY OF WISCONSIN SCHOOL OF MEDICINE AND PUBLIC HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

HEPATITIS B SURFACE ANTIGEN;

ARTICLE; CLINICAL ARTICLE; CONTROLLED STUDY; DIAGNOSTIC ACCURACY; ENZYME LINKED IMMUNOSORBENT ASSAY; HEPATITIS B; HUMAN; QUALITATIVE DIAGNOSIS; QUALITY CONTROL;

EID: 0030774491     PISSN: 00099147     EISSN: None     Source Type: Journal    
DOI: 10.1093/clinchem/43.9.1618     Document Type: Article

References (8)

1. Clinical Laboratory Improvement Act of 1988; final rule. Fed Reg 1992:57:7164.
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4. Courouce A-M, Drouet J, LeMarrec N, Drouet A, Soulier JP. Blood donors positive for HBsAg and negative for anti-HBC antibody. Vox Sang 1985;49:26-33.
5. National Committee for Clinical Laboratory Standards. Evaluation of precision performance of clinical chemistry devices, 2nd ed. Tentative guideline. NCCLS document EP5-T2 (ISBN 1-56238-145-8). Villanova, PA: NCCLS, 1988;5:1992.
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7. Westgard JO, Groth T, Aronsson T, Falk H, de Verdier C-H. Performance characteristics of control rules for internal quality control: probabilities for false rejection and error detection. Clin Chem 1977;23:1857-67.
8. Westgard JO, Barry PL. Cost-effective quality control: managing the quality and productivity of analytical processes. Washington, DC: AACC Press, 1986:47-9.