基于丙型肝炎病毒抗体检测的信号-截断比值的丙型肝炎感染自动反射性检测算法的改进。

Improved reflexive testing algorithm for hepatitis C infection using signal-to-cutoff ratios of a hepatitis C virus antibody assay.

机构信息

Southern California Research Center for Alcoholic Liver and Pancreatic Diseases and Cirrhosis, Department of Pathology, University of Southern California, Los Angeles, CA, USA.

出版信息

Clin Chem. 2011 Jul;57(7):1050-6. doi: 10.1373/clinchem.2010.158691. Epub 2011 May 12.

DOI:10.1373/clinchem.2010.158691

PMID:21566071

Abstract

BACKGROUND

Chemiluminescence immunoassay (CIA) is used to detect hepatitis C virus (HCV) antibody status on the basis of signal-to-cutoff (S/Co) ratios. Positive results of antibody to HCV (anti-HCV) are followed by either recombinant immunoblot assay (RIBA) to confirm anti-HCV positivity or reverse transcription (RT)-PCR to detect viremia. We hypothesized that by analyzing S/Co ratios, we could determine a strategy to reduce unnecessary supplementary testing in our population.

METHODS

CIA was performed to screen for anti-HCV, and positive results were followed up with RT-PCR testing. Negative RT-PCR results were followed up with RIBA, whereas positive RT-PCR results were assumed to be RIBA positive. ROC curves were analyzed to determine the optimal S/Co ratios to predict HCV infection.

RESULTS

We determined the S/Co ratios on 34 243 veteran patient samples. We found that with the CIA method 9.0% of patients had positive test results for anti-HCV. An S/Co ratio <3.0 ruled out active HCV infection and exposure with 100% negative predictive value. When the S/Co ratio was ≥20.0, positive predictive values were 98.5% compared with RIBA results, and 81.0% compared with RT-PCR results.

CONCLUSIONS

RIBA is not necessary to confirm negative or positive CIA anti-HCV if the S/Co ratio is <3.0 or ≥20.0, respectively. To confirm HCV exposure, samples with an S/Co ratio between 3.0 and 19.9 should be followed up with RIBA unless PCR testing has been performed and the result is positive. Samples with an S/Co ratio ≥20.0 or positive RIBA results should be further tested by RT-PCR to determine HCV viremia status.

摘要

背景

化学发光免疫分析（CIA）用于根据信号与临界值（S/Co）比值检测丙型肝炎病毒（HCV）抗体状态。抗 HCV（抗-HCV）的阳性结果随后进行重组免疫印迹分析（RIBA）以确认抗-HCV 阳性，或进行逆转录（RT）-PCR 以检测病毒血症。我们假设通过分析 S/Co 比值，可以确定在我们的人群中减少不必要的补充检测的策略。

方法

CIA 用于筛查抗-HCV，阳性结果随后进行 RT-PCR 检测。阴性 RT-PCR 结果随后进行 RIBA 检测，而阳性 RT-PCR 结果假定为 RIBA 阳性。ROC 曲线用于分析确定预测 HCV 感染的最佳 S/Co 比值。

结果

我们确定了 34243 名退伍军人患者样本的 S/Co 比值。我们发现，使用 CIA 方法，9.0%的患者抗-HCV 检测结果阳性。S/Co 比值<3.0 排除了 HCV 感染和暴露的可能性，阴性预测值为 100%。当 S/Co 比值≥20.0 时，与 RIBA 结果相比，阳性预测值为 98.5%，与 RT-PCR 结果相比为 81.0%。

结论

如果 S/Co 比值分别<3.0 或≥20.0，则无需 RIBA 确认 CIA 抗-HCV 的阴性或阳性。为了确认 HCV 暴露，S/Co 比值在 3.0 和 19.9 之间的样本应进行 RIBA 检测，除非已进行 PCR 检测且结果为阳性。S/Co 比值≥20.0 或 RIBA 结果阳性的样本应进一步进行 RT-PCR 检测以确定 HCV 病毒血症状态。