Effectiveness of Second- and Third-Generation Immunoassays for the Detection of Hepatitis C Virus Infection in Pregnant Women

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Abstract
To compare the sensitivity and specificity of a third-generation anti-hepatitis C virus (anti-HCV) assay (HCV 3.0) with second-generation one (HCV 2.0), and correlate with HCV-RNA positivity by reverse-transcription polymerase chain reaction (RT-PCR).We enrolled 197 pregnant women without screening for alanine aminotransferase (ALT) (Group A) and 324 pregnant women with elevated ALT activity (> 45 IU/l) (Group B). Each serum sample was tested by second- and third-generation tests, and anti-HCV titer was determined by serial dilutions. Anti-HCV-positive samples were subjected to HCV-RNA assays.Three (1.5%) and 4 (2.0%) of the 197 group A subjects were anti-HCV-positive by the second- and third-generation methods, respectively, while 17 (5.3%) and 21 (6.5%) of group B were positive, respectively. Three (1.5%) in group A and 8 (2.5%) in group B were HCV 2.0-negative, but positive for HCV 3.0. The sensitivity, specificity, positive and negative predictive values of HCV 2.0 and HVC 3.0 for positive HCV-RNA in both groups were 67 vs 100%, 30 vs 75%, 67 vs 92%, and 30 vs 100%, respectively. The anti-HCV-positive samples with optical density (O.D.) < 1.0 either by second- or third-generation test were negative for HCV-RNA, whereas samples with O.D. > or = 1.0 were all HCV-RNA-positive.The performance of HCV 3.0 is better than that of HCV 2.0, and anti-HCV-positive samples with O.D. < 1.0 are negative for HCV-RNA.