Laboratory diagnosis of viral hepatitis C: The Sultan Qaboos University Hospital experience.

OBJECTIVES

A retrospective study was carried out to assess the performance of hepatitis C diagnostic assays in our laboratory, and to determine the prevalence of hepatitis C among blood donors at the Sultan Qaboos University Hospital.

METHODS

From 1991 to 2001, approximately 55,000 serum samples collected from blood donors and patients were submitted to our laboratory for testing. All sera were screened for antibodies to hepatitis C virus (HCV) by three successive generations of the enzyme-linked immunosorbent assay (ELISA). Anti-HCV positive sera were further tested by recombinant immunoblot assay (RIBA). Reverse-transcriptase polymerase chain reaction (RT-PCR) for HCV RNA was carried out on a limited number (241) of ELISA positive samples.

RESULTS

Out of 30012 samples from blood donors that were screened for anti-HCV, 272 (0.91%) were positive. Of these, 46.5% were confirmed positive by RIBA. The proportion of patient sera that were confirmed positive varied from 95% among intravenous drug users to 81% in patients with hepatitis to 70% in those with haemoglobinopathies. HCV RNA was detected in 67%, 6%, and 0% of the RIBA positive, indeterminate and negative samples respectively.

CONCLUSIONS

Based on RIBA, the prevalence of anti-HCV among blood donors in Oman is close to 0.5%. In our experience, RIBA-positivity is predictive of HCV infection in two thirds of subjects, and HCV infection is highly unlikely in those who are RIBA-negative. The experience at SQUH with three types of HCV assays has enabled the laboratory to develop a test algorithm, starting with screening anti-HCV ELISA.