Diagnosis of hepatitis C virus infection by ELISA, RIBA and RT-PCR: a comparative evaluation.

Mohan, K V; Murugavel, K G; Rajanikanth,; Mathews, S; Raghuram, K; Rajasambandam, P; Murali, A; Srinivas, U; Mathiazhagan,; Palaniswamy, K R; Panda, S K; Thyagarajan, S P

Diagnosis of hepatitis C virus infection by ELISA, RIBA and RT-PCR: a comparative evaluation.

Date

1999-04-13

Authors

Abstract

OBJECTIVES: To evaluate the efficacy of second-generation ELISA (ELISA-2), third-generation ELISA (ELISA-3) and third-generation recombinant immunoblot assay (RIBA 3.0) for detection of antibodies to hepatitis C virus (anti-HCV) in comparison with reverse transcriptase-polymerase chain reaction (RT-PCR) to detect HCV RNA for the diagnosis of hepatitis C. METHODS: Sera of 108 patients with chronic liver disease (CLD) were analyzed by ELISA-2, ELISA-3, RIBA 3.0 and RT-PCR in the first part of the study; in the second part, sera of 105 patients with non-chronic liver disease were evaluated with ELISA-3, RIBA 3.0 and RT-PCR. RESULTS: In the CLD group, anti-HCV was positive in 4.6%, 14.8% and 16.6% by ELISA-2, ELISA-3 and RIBA 3.0, respectively. Among these anti-HCV positive cases, HCV RNA was positive in 100%, 58.9% and 64%, respectively. ELISA-2 did not give false-positive results, but missed substantial number of anti-HCV positive cases (p < 0.001). In the second group, anti-HCV was positive in 76.3% by ELISA-3 and 68.6% by RIBA 3.0 (p:ns). HCV-RNA was positive in 88.7% of ELISA- and RIBA-positive cases; in 60% of ELISA-positive, RIBA-indeterminate cases; and in 46.4% of ELISA-negative, RIBA-negative cases. CONCLUSIONS: ELISA-2 is not a suitable assay for routine screening. ELISA-3 was at par with RIBA 3.0 and it can be recommended for routine screening for anti-HCV. RT-PCR for HCV is of value in detecting early viremic, anti-HCV negative cases; this may be of importance in the treatment of hepatitis C.

Citation

Mohan KV, Murugavel KG, Rajanikanth , Mathews S, Raghuram K, Rajasambandam P, Murali A, Srinivas U, Mathiazhagan , Palaniswamy KR, Panda SK, Thyagarajan SP. Diagnosis of hepatitis C virus infection by ELISA, RIBA and RT-PCR: a comparative evaluation. Indian Journal of Gastroenterology. 1999 Apr-Jun; 18(2): 73-5