Dawson G J, Lesniewski R R, Stewart J L, Boardway K M, Gutierrez R A, Pendy L, Johnson R G, Alcalde X, Rote K V, Devare S G
Abbott Diagnostics Division, Abbott Laboratories, North Chicago, Illinois 60064.
J Clin Microbiol. 1991 Mar;29(3):551-6. doi: 10.1128/jcm.29.3.551-556.1991.
An enzyme immunoassay (EIA) which utilizes a solid phase coated with a recombinant antigen (c100-3) derived from the hepatitis C virus (HCV) genome was evaluated for efficacy in the detection of antibodies to HCV (anti-HCV). The sensitivity of the antibody test was demonstrated by the detection of anti-HCV in a well-characterized panel of human specimens known to contain the infectious agent of non-A, non-B hepatitis. The specificity of the anti-HCV test was evaluated by testing 6,118 serum specimens from volunteer blood donors considered to be at low risk for exposure to HCV. The specificity of the anti-HCV EIA was demonstrated to be 99.56%, since 6,069 of 6,096 specimens from this low-risk group were nonreactive. A total of 49 (0.80%) of the 6,118 specimens were repeatedly reactive in the test, and 22 (46.81%) of the 47 specimens available for additional testing were confirmed as positive for antibodies to HCV c100-3. Among commercial plasma donors, 390 (10.49%) of 3,718 specimens were repeatedly reactive in the EIA. A total of 375 (97.40%) of the 385 specimens available for further testing were confirmed as positive. These limited data indicate that the prevalence of antibodies to HCV is 0.36% (22 confirmed positives among 6,118 specimens) among volunteer blood donors and 10.08% (375 confirmed positives among 3,718 specimens) among commercial plasma donors. The importance of confirmatory testing is discussed.
评估了一种酶免疫测定法（EIA），该方法利用包被有源自丙型肝炎病毒（HCV）基因组的重组抗原（c100-3）的固相来检测抗HCV抗体（抗-HCV）。通过在一组特征明确的已知含有非甲非乙型肝炎感染因子的人类标本中检测抗-HCV，证明了该抗体检测方法的敏感性。通过检测6118份来自被认为感染HCV风险较低的志愿献血者的血清标本，评估了抗-HCV检测的特异性。抗-HCV EIA的特异性被证明为99.56%，因为来自这个低风险组的6096份标本中有6069份无反应。在6118份标本中，共有49份（0.80%）在该检测中反复出现反应，在可用于进一步检测的47份标本中，有22份（46.81%）被确认为抗HCV c100-3抗体阳性。在商业血浆捐献者中，3718份标本中有390份（10.49%）在EIA中反复出现反应。在可用于进一步检测的385份标本中，共有375份（97.40%）被确认为阳性。这些有限的数据表明，志愿献血者中抗HCV抗体的流行率为0.36%（6118份标本中有22份确诊阳性），商业血浆捐献者中为10.08%（3718份标本中有375份确诊阳性）。文中讨论了确证检测的重要性。
