Comparison of Third-generation Enzyme-linked Immunosorbent Assays for Detection of Antibody to Hepatits C Virus / 대한임상병리학회지

ABSTRACT

BACKGROUND: Little Is known about the compared efficiency of different third generation enzyme-linked immunosorbent assays (ELISA) fort the detection of anti-HCV. We examine the relative sensitivity and specificity of three third-generation anti-HCV assays, and results of discrepant samples among the anti-HCV ELISA are compared with data of a third-generation recombinant immunoblot assay and reverse transcription polymerase chain reaction (RT-PCR) . METHODS:A total of 167 samples (61 positive and 106 negative), screened by a second-generation IMx(R) anti-HCV assay (Abbott 2.0; Abbott Laboratories, USA), weve tested with Innotest HCV 3.0(R) (Green Cross, Korea), LG HCD 3.0(R) (LG, Korea) and DONG-A HCV 3.0(R) (Dong-4, Korea). The discrepant specimens among the 4 anti-HCV ELISA were tested by LG HCD Confirm(R) (LG, Korea) and RT-PCR. RESULTS: The concordance rates of all 4 ansi-HCV ELISA were 80.2% (134/167) and 92.2% (154/167), respectively. The 28 and 31 of 33 specimens showing discrepancy among 4 anti-HCV ELISA were tested with LG HCD Confirm and RT-PCR, respectively. Serum HCV RNA was positive in 2 of 2 reactive and in 6 of 26 nonreactive on LG HCD Confirm. The sensitivity, specificity, positive predictive value, negative predictive value and concordance rate of 4 anti-HCV ELISA were 97.7%, 85.2%, 70.0%, 99.0% and 88.5% (Abbott 2.0) ; 81.4%, 96.7%, 89.7%, 93.7% and 92 7% (Innotest 3.0), 81.4%, 98.4%, 94.6%, 93.8% and 93.9% (LG 3.0), 86.0%, 95.7%, 88.1%, 95.1% and 93.3% (DONG-A 3.0), respectively. CONCLUSIONS: These data indicate that the sensitivity and specificity of 3 third-generation anti-HCV ELISA are comparable, and that these reagents demonstrate improved specificity compared to the second-generation ELISA.