Evaluation of a third generation anti-HCV assay in predicting viremia in patients with positive HCV antibodies.
Evaluation of a third generation anti-HCV assay in predicting viremia in patients with positive HCV antibodies.
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评估第三代抗 HCV 检测预测 HCV 抗体阳性患者病毒血症的效果。
DOI：
10.1016/s1665-2681(19)32163-5
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发表时间：
2002
影响因子：
3.8
通讯作者：
G. Castaño
中科院分区：
文献类型：
--
作者：
S. Sookoian;G. Castaño
最实用的丙型肝炎病毒抗体筛查试验是第二代和第三代酶免疫测定。我们评估了第三代微粒子酶免疫分析（MEIA）在预测抗-HCV阳性患者中HCV病毒血症的有效性。收集106例抗-HCV阳性患者血清。为了评价MEIA试验在预测HCV病毒血症中的诊断价值，根据血清HCV-RNA的存在或不存在将抗-HCV阳性患者分为两组。106例患者中，26例血清HCV-RNA阴性，80例血清HCV-RNA阳性。检测试剂盒根据每个样本和质控品的采样率与截止率的比值（S/CO）自动计算结果。当分析可检出和不可检出HCV-RNA患者的S/CO值平均值时，发现具有统计学显著性差异（分别为79.3 SD 22.2 vs. 8.2 SD 6.4）（p <0.0001）。我们进一步分析了S/CO在区分病毒血症和非病毒血症患者中的最佳临界值。S/CO值为26时，对两类HCV感染者的敏感性为99%，特异性为96%。总之，我们的数据表明，病毒血症的HCV患者有较高的S/CO值在MEIA测试相比，非病毒血症患者。因此，该检测可用于预测抗HCV阳性个体中的HCV病毒血症。
The most practical screening test for hepatitis C virus antibodies are second and third-generation enzyme immunoassays. We evaluated the usefulness of the third generation microparticle enzyme immunoassay (MEIA) in predicting HCV viraemia in anti-HCV positive patients. Serum samples from 106 patients with positive anti-HCV were obtained. To evaluate the diagnostic value of the MEIA test in predicting HCV viraemia, anti-HCV positive patients were categorized in two groups according to the presence or absence of serum HCV-RNA. Among the 106 patients, 26 had non detectable serum HCV-RNA and 80 had detectable HCV-RNA by PCR. The assay automatically calculates a result based on the ratio of sample rate to the cut-of rate for each sample and control (S/CO). When the means of S/CO values for patients with detectable and non detectable HCV-RNA were analyzed, a statistically significant difference was found,(79.3 SD 22.2 vs. 8.2 SD 6.4, respectively)(p 0.0001). We further analyzed the best cut-off value of the S/CO in differentiating viremic from non viremic patients. The S/CO value of 26 showed a sensitivity of 99% and a specificity off 96% in discriminating both categories of HCV infected patients. In conclusion, our data demonstrate that viremic HCV patients had higher S/CO values in the MEIA test in comparison with non viremic patients. Hence, this assay may be used to predict HCV viraemia in anti-HCV positive individuals.