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Clinical Chemistry 43: 1618-1621, 1997;
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(Clinical Chemistry. 1997;43:1618-1621.)
© 1997 American Association for Clinical Chemistry, Inc.

Articles

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

George A. Green, IV1,a, R. Neill Carey2, James O. Westgard3, Tami Carten1, LeeAnn Shablesky1, Daniel Achord1, Eileen Page1 and Anh Van Le1

1 Ortho Diagnostic Systems, 1001 US Hwy. 202, Raritan, NJ 08869.

2 Peninsula Regional Medical Center, 100 East Carroll St., Salisbury, MD 21801.

3 Department of Pathology and Laboratory Medicine, University of Wisconsin Medical School, Madison, WI 53792.
a Author for correspondence. Fax (908) 704-3153; e-mail ggreen{at}odsus jnj.com.

An assay for hepatitis B surface antigen (HBsAg) should reliably detect 0.2 µg/L, the lowest reported concentration in an asymptomatic blood donor. The difference between this concentration and the assay cutoff defines the analytical quality requirement in a total error format. The design of a statistical QC procedure is critically dependent on the precision of the assay. The precision of a developmental ELISA of HBsAg under study ranged from 17.5% to 9.6% for controls containing 0.07 to 1.50 µg/L, respectively. Use of one positive control with the 13s QC rule provided an 85% chance of detecting a critical loss of assay sensitivity; use of two positive controls increased the chance of detecting critical loss of assay sensitivity to nearly 100%. These rules are based on the precision of this developmental assay, and must be developed individually for other assays. The development of the proposed QC procedures illustrates how quantitative QC can be provided for qualitative assays.






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Copyright © 1997 by the American Association for Clinical Chemistry.