Hsu H H, Gonzalez M, Foung S K, Feinstone S M, Greenberg H B
Department of Medicine, Stanford University Medical Center, Palo Alto, California.
Gastroenterology. 1991 Dec;101(6):1724-7. doi: 10.1016/0016-5085(91)90413-f.
The significance of antibodies to hepatitis C virus (HCV) found by screening enzyme-linked immunoassay testing in a low-risk blood donor population is unclear. The rate of false positivity in this group as well as the usefulness of supplemental testing were examined by correlating the results of two screening enzyme-linked immunoassays (Ortho Diagnostics, Raritan, NJ, and Abbott Laboratories, North Chicago, IL) with supplemental antibody testing by the recombinant immunoblot assays (1 and 2) (Ortho) and neutralization assay (Abbott). Polymerase chain reaction was used to detect HCV genomic RNA to confirm viremia. Among 11.243 volunteer donors who were screened for the presence of antibodies to HCV by enzyme-linked immunoassay, 60 (0.53%) sera were repeatedly reactive. Twenty-five of these 60 sera were available for further testing. Seven sera were reactive by both screening enzyme-linked immunoassays, as well as by both recombinant immunoblot and neutralization assays. Six of these seven sera had detectable HCV genomic RNA by polymerase chain reaction. Among the remaining 18 sera, none were reactive by either recombinant immunoblot assays, whereas two sera were reactive by the neutralization assay only. None of the 18 samples had detectable HCV genomic RNA. Five of the six sera with elevated aminotransferase levels were among the seven sera reactive by all immunoassays. It is concluded that there is a significant false positivity rate associated with screening enzyme-linked immunoassay testing in a low-risk blood donor population. Supplemental testing correlates well with detection of hepatitis C genomic material by polymerase chain reaction and identifies donors who are truly infected.
在低风险献血人群中，通过酶联免疫吸附试验筛查发现的丙型肝炎病毒（HCV）抗体的意义尚不清楚。通过将两种酶联免疫吸附试验（新泽西州拉里坦市的奥索诊断公司和伊利诺伊州北芝加哥的雅培实验室）的结果与重组免疫印迹试验（1和2）（奥索）和中和试验（雅培）的补充抗体检测结果相关联，来检查该组中的假阳性率以及补充检测的有用性。采用聚合酶链反应检测HCV基因组RNA以确认病毒血症。在11243名通过酶联免疫吸附试验筛查HCV抗体的志愿献血者中，60份（0.53%）血清反复呈反应性。这60份血清中的25份可用于进一步检测。7份血清在两种酶联免疫吸附试验以及重组免疫印迹和中和试验中均呈反应性。这7份血清中的6份通过聚合酶链反应可检测到HCV基因组RNA。在其余18份血清中，没有一份在重组免疫印迹试验中呈反应性，而只有两份血清仅在中和试验中呈反应性。这18份样本中均未检测到HCV基因组RNA。6份转氨酶水平升高的血清中有5份在所有免疫试验中均呈反应性的7份血清中。得出的结论是，在低风险献血人群中，酶联免疫吸附试验筛查存在显著的假阳性率。补充检测与通过聚合酶链反应检测丙型肝炎基因组物质相关性良好，并能识别真正感染的献血者。
