第二代和第三代免疫测定法检测孕妇丙型肝炎病毒感染的有效性

Effectiveness of second- and third-generation immunoassays for the detection of hepatitis C virus infection in pregnant women.

作者信息

Lin H H, Kao J H

机构信息

Department of Obstetrics and Gynecology, College of Medicine and Hospital, National Taiwan University, Taipei, ROC.

出版信息

J Obstet Gynaecol Res. 2000 Aug;26(4):265-70. doi: 10.1111/j.1447-0756.2000.tb01320.x.

DOI:10.1111/j.1447-0756.2000.tb01320.x

PMID:11049236

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. > or = 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.

摘要

目的

比较第三代抗丙型肝炎病毒（抗-HCV）检测方法（HCV 3.0）与第二代检测方法（HCV 2.0）的敏感性和特异性，并与逆转录聚合酶链反应（RT-PCR）检测的HCV-RNA阳性结果进行相关性分析。

方法

我们纳入了197例未筛查丙氨酸氨基转移酶（ALT）的孕妇（A组）和324例ALT活性升高（>45 IU/l）的孕妇（B组）。每份血清样本均采用第二代和第三代检测方法进行检测，并通过系列稀释法测定抗-HCV滴度。抗-HCV阳性样本进行HCV-RNA检测。

结果

197例A组受试者中，分别有3例（1.5%）和4例（2.0%）通过第二代和第三代方法检测为抗-HCV阳性，而B组分别有17例（5.3%）和21例（6.5%）为阳性。A组有3例（1.5%）、B组有8例（2.5%）HCV 2.0检测为阴性，但HCV 3.0检测为阳性。两组中HCV 2.0和HVC 3.0检测HCV-RNA阳性的敏感性、特异性、阳性预测值和阴性预测值分别为67%对100%、30%对75%、67%对92%和30%对100%。通过第二代或第三代检测方法，光密度（O.D.）<1.0的抗-HCV阳性样本HCV-RNA检测为阴性，而O.D.>或=1.0的样本均为HCV-RNA阳性。