A second generation ELISA for combined detection of antibodies to three hepatitis C virus (HCV) recombinant proteins, i.e. C100, C33c and core, was compared with a first generation anti‐HCV ELISA in which only antibodies to C100 are detected. The results of the ELISAs were evaluated in 225 haemophilia patients (panel A) and 44 patients with non‐A, non‐B (NANB) hepatitis (panel B). HCV infection was established by cDNA‐polymerase chain reaction (PCR) (in panel B only) and by studying the anti‐HCV reaction patterns in 4 separate ELISAs for detection of antibodies to the recombinant proteins C100, C33c, core and a combination of two synthetic peptides sp67/65 derived from the C100 region. The sensitivity for the detection of HCV infection had increased from 0.92 (95% confidence interval (CI): 0.87–0.95) to 1.00 (95% CI: 0.98–1.00) in haemophiliacs and from 0.84 (95% CI: 0.66–0.95) to 1.00 (95% CI: 0.89–1.00) in NANB hepatitis patients when the second generation ELISA was used instead of the first generation ELISA. Concurrently the chance of a false negative result was reduced in panel A and B from 0.37 to 0 and from 0.28 to 0, respectively. Analysis of anti‐HCV reaction patterns revealed that 172 of 206 (83.5%) anti‐HCV ELISA‐reactive haemophilia patients had antibodies to all 4 antigens tested. In the NANB hepatitis patients 18 of 31 (58.1%) anti‐HCV ELISA‐reactive subjects reacted with 4 antigens. In the PCR tested panel of NANB hepatitis patients 2 subjects who showed antibody reactivity to only one antigen and 5 patients with reactivity to 2 antigens were PCR‐positive. On the other hand, 1 NANB hepatitis patient showed antibody reactivities to all 4 antigens tested, but was PCR‐negative. Antibodies to core were the most prevalent in the two populations studied. We conclude that the introduction of the second generation anti‐HCV ELISA will significantly reduce the likelihood of unrecognized HCV infection.
Vox Sanguinis – Wiley
Published: May 1, 1992
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