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Serological Assays - Hepatitis

"Quality Control Procedures for Qualitative Assays: Determining Optimal Concentrations for Positive Controls for an Enzyme Linked Immunosorbent Assay (ELISA) for Hepatitis B Surface Antigen (HBsAg RIG

Published in Hepatitis Weekly, August 7th, 1995

According to an abstract submitted by the authors to the 47th Annual Meeting of the American Association for Clinical Chemistry, held July 16-20, 1995, in Anaheim, California, "In typical clinical assays, analyte concentrations in control materials approximate medical decision level concentrations. HBsAg ELISA assays are qualitative in use, and commonly utilize moderately positive controls (PC) which are substantially above assay cutoff. In a previous study based on an HBsAg ELISA sensitive to <=0.1 ng/mL, we used a 'demolition' experiment to study the relationship of control performance and potency as conditions of the assay were varied to induce loss of sensitivity. PCs...

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