Effectiveness of second- and third-generation immunoassays for the detection of hepatitis C virus infection in pregnant women
Journal
Journal of Obstetrics and Gynaecology Research
Journal Volume
26
Journal Issue
4
Pages
265-270
Date Issued
2000
Author(s)
Abstract
Objective: 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). Methods: 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. Results: 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. ? 1.0 were all HCV-RNA-positive. Conclusions: 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.
SDGs
Other Subjects
alanine aminotransferase; adult; article; biomedical technology assessment; clinical article; comparative study; diagnostic accuracy; diagnostic test; enzyme immunoassay; female; hepatitis C; Hepatitis C virus; human; pregnancy; reverse transcription polymerase chain reaction; Adult; Comparative Study; Female; Hepacivirus; Hepatitis C; Hepatitis C Antibodies; Human; Predictive Value of Tests; Pregnancy; Pregnancy Complications, Infectious; Reverse Transcriptase Polymerase Chain Reaction; RNA, Viral; Sensitivity and Specificity; Support, Non-U.S. Gov't
Type
journal article