Comparative evaluation of radioimmunoassay kits used for testing blood for hepatitis B surface antigen

Abstract

A comparative evaluation of six licensed radioimmunoassay kits for the detection of hepatitis B surface antigen (HBsAg) has been performed. Each method met the federal licensure requirements for the test. The performance of the kits varied considerably, however, when they were challenged to the limits of their sensitivities. During the period December 1978 through March 1979, four kits were judged to be of equivalent high sensitivity, whereas two were less sensitive. Three of the kits, including two of those with high sensitivity, generated a high (6%--7%) proportion of false reactive results. The sensitivities of all kits decreased during the shelf lives of the reagents.