Comparison of the enzyme-linked immunosorbant assay III, recombinant immunoblot third generation assay, and polymerase chain reaction method in the detection of hepatitis C virus infection in haemodialysis patients

Hepatitis C virus (HCV) serotyping assays have evolved from simple antibody screening tests to complex RNA-based qualitative and quantitative methods. The objective of this study was to compare the HCV screening results from 161 patients in long-term maintenance haemodialysis (HD) as assessed by the recently developed Enzyme Linked ImmunosorbantAssay III (ELISA III), confi rmed by the Recombinant Immunoblot 3(rd) generation assay (RIBA 3(rd)) and determined by the qualitative HCV reverse transcription polymerase chain re action (RT-PCR) method. One hundred sixty-one HD patients were tested for t he presence of anti-HCV antibodies by the ELISA III and confirmed by the RI BA 3(rd). HCV RNA was determined by an HCV RT-PCR method. All reported resu lts that were designated as discrepant, anti-HCV (+) and/or HCV RNA (+) wer e further investigated by means of a quantitative HCV RT-PCR assay. Reporte d results obtained from ELISA III and qualitative RT-PCR assays were HCV po sitive for 16/161 patients (9,93%) and these were designated as anti-HCV ()/HCV RNA (+). Subsequently, these 16 anti-HCV positive/161 HD patients wer e confirmed by the RIBA 3(rd). Three individuals anti-HCV (-)/RIBA (+)/HCV RNA (-)I, the viral load that was reported from the quantitative RT-PCR was less than the assay detection level (<2,000 viral copies/ml). In view of p revious observations, our findings suggest that ELISA III remains still a h ighly reliable and valuable assay. However, despite the cost, the combinati on of both ELISA III and qualitative RT-PCR allows a definitive classificat ion on HCV diagnosis. J. Clin. Lab. Anal. 13:122-125, 1999. (C) 1999 Wiley- Liss, Inc.