The diagnosis of acute viral hepatitis A or B by microparticle enzyme immunoassay.
The traditional approach to the diagnosis of viral hepatitis has been to collect a serum sample and to test it for the presence of hepatitis B surface antigen (HBsAg), IgM to the core of HBV (anti-HBc IgM) and IgM to HAV (anti-HAV IgM) by solid phase radio- or enzyme immunoassays. Microparticle enzyme immunoassay technology (IMx-Abbott Laboratories) has been introduced as an automated carousel system for the detection of these markers. A side-by-side, blinded comparison of IMx to current IA was performed for HBsAg on 659 specimens submitted from March to July 1990, of which 72 (10.8%) were positive by AUSRIA (Abbott RIA for HBsAg) and 2 of these were discordant in IMx. Both were near the cutoff and by confirmatory testing one was positive and the other negative. Forty three percent (25/58) of frozen stored sera tested for anti-HBc IgM, by IMx, were positive by EIA (Corzyme M). One specimen near the cutoff was negative by EIA but weakly positive by IMx. Anti-HAV IgM was found in 21.8% (46/211) of sera with 100% correlation by IMx. Thus IMx had the following percent sensitivies and specificities: HBsAg; 98.6, 99.9; anti-HBc IgM; 100, 99.9; anti-HAV IgM; 100, 100. The test set-up times for the 3 markers in the IMx were similar to the RIA and EIA. The turnover time was 45 min for a full IMx carousel compared to: AUSRIA-short incubation (4 h), or long incubation (14 h); Corzyme M-short (4.75 h) or long (20 h); anti-HAV IgM (23 h).(ABSTRACT TRUNCATED AT 250 WORDS)
Chernesky
M A
MA
McMaster University, Regional Virology and Chlamydiology Laboratory, St. Joseph's Hospital, Hamilton. Ont., Canada.
Crawford
J
J
Castriciano
S
S
Mahony
J B
JB
D001331:Automation; D005069:Evaluation Studies as Topic; D006506:Hepatitis A / Q000175:diagnosis*; D006508:Hepatitis Antibodies / Q000097:blood; D006509:Hepatitis B / Q000175:diagnosis*; D006510:Hepatitis B Antibodies / Q000097:blood / Q000276:immunology; D006512:Hepatitis B Core Antigens / Q000276:immunology; D006514:Hepatitis B Surface Antigens / Q000097:blood; D006801:Humans; D007124:Immunoenzyme Techniques; D007075:Immunoglobulin M / Q000032:analysis; D012680:Sensitivity and Specificity
D006508:Hepatitis Antibodies; D006510:Hepatitis B Antibodies; D006512:Hepatitis B Core Antigens; D006514:Hepatitis B Surface Antigens; D007075:Immunoglobulin M