Numerous tests to detect anti-HBc IgM have been developed and shown to have different degrees of sensitivity and specificity. One of these assays, Corzyme@-M (Abbott Laboratories, North Chicago, Ill.), recently became commercially available. The present study was undertaken to evaluate the clinical utility of this anti-HBc IgM test in establishing the diagnosis of acute hepatitis B using sera from a group of 42 prospectively followed individuals who had been exposed to hepatitis B virus. The Corzymee-M test was highly sensitive in detecting recent hepatitis B virus infection. All 30 patients with symptomatic and 12 with asymptomatic acute hepatitis B virus infection developed anti-HBc IgM. However, the timing of sample testing relative to onset of symptoms in symptomatic patients was important, inasmuch as 2 of 23 patients were negative for anti-HBc IgM early in the symptomatic period, although all were HBsAg positive. The duration of anti-HBc IgM positivity after acute infection was variable, ranging from 2 to 134 weeks. In 14% of patients, anti-HBc IgM remained detectable for more than 1 year. From the data, recommendations are given regarding the usefulness of anti-HJ3c IgM testing in the diagnosis of acute hepatitis B virus infection.
A number of tests to detect anti-HBc IgM have been developed (1-7). These tests have demonstrated differing degrees of sensitivity and specificity. Depending on the assay used, persistence of anti-HBc IgM following acute hepatitis has been documented for periods ranging from months to years.
Recently, one of these assays, CorzymeB-M (Abbott Laboratories, North Chicago, Ill.) became commercially available. This test has rapidly become widely used in routine clinical situations. The present study was undertaken to evaluate the applicability of this anti-HBc IgM test in the diagnosis of acute hepatitis B virus infection.
The population studied had been infected during a point source outbreak related t o the use of a hepatitis B virus-contaminated immunotherapy vaccine; thus, sera were available from individuals before, during and after exposure.
MATERIALS AND METHODS Study Population.
Eighty-nine patients with solid tumors who were involved in an outpatient immunotherapy pro-