抗 HCV 筛查试验与线免疫测定阳性样本的比较及阈值的确定。

Comparison of samples found positive by anti-HCV screening test with line immunoassay and determination of threshold value.

机构信息

Erciyes University, School of Medicine, Department of Medical Microbiology - Kayseri, Turkey.

Izmir Kâtip Celebi University, School of Medicine, Department of Biostatistics - Izmir, Turkey.

出版信息

Rev Assoc Med Bras (1992). 2021 Oct;67(10):1480-1484. doi: 10.1590/1806-9282.20210668.

DOI:10.1590/1806-9282.20210668

PMID:35018979

Abstract

OBJECTIVE

This study aimed to compare the serum samples found reactive (≥1-≤20 signal-to-cutoff ratio) with Elecsys antibodies to hepatitis C virus screening test with innogenetics-line immunassay hepatitis C Virus Score test and to determine the most appropriate threshold value for our country, since positive results close to the cutoff value cause serious problems in routine diagnostic laboratories.

METHODS

Antibodies to hepatitis C virus-positive samples from 687 different patients were included in the study. Antibodies to hepatitis C virus antibody detection was performed using Elecsys antibodies to hepatitis C virus II kits (Roche Diagnostics, Germany), an electrochemiluminescence method based on the double-antigen sandwich principle, on the Cobas e601 analyzer (Roche Diagnostics) in accordance with the recommendations of the manufacturer. Samples that were initially identified as reactive were studied again. Samples with ≥1-≤20 signal-to-cutoff ratio reagents as a result of retest were included in the study to be validated with the third-Generation Line immunassay kit (innogenetics-line immunassay hepatitis C Virus, Belgium).

RESULTS

A total of 687 samples with antibodies to hepatitis C virus positive and levels between 1-20 S/Co were found to be 56.1% negative, 14.8% indeterminate, and 29.1% positive by innogenetics-line immunassay hepatitis C Virus confirmation test. When the cases with indeterminate innogenetics-line immunassay hepatitis C Virus test results were accepted as positive, the signal-to-cutoff ratio value for antibodies to hepatitis C virus was determined as 5.8 (95% confidence interval) in distinguishing the innogenetics-line immunassay hepatitis C Virus negative and positive groups.

CONCLUSION

It was concluded that with further studies on this subject, each country should determine the most appropriate S/Co value for its population, and thus it would be beneficial to reduce the problems such as test repetition and cost increase.

摘要

目的

本研究旨在比较 Elecsys 抗丙型肝炎病毒筛查试验与 innogenetics-line 免疫测定丙型肝炎病毒评分试验中发现的反应性（≥1-≤20 信号-临界比值）血清样本，并确定最适合我国的临界值，因为接近临界值的阳性结果会给常规诊断实验室带来严重问题。

方法

本研究纳入了 687 例不同患者的抗丙型肝炎病毒阳性样本。使用 Elecsys 抗丙型肝炎病毒 II 试剂盒（罗氏诊断公司，德国），基于双抗原夹心法的电化学发光法，在 Cobas e601 分析仪（罗氏诊断公司）上，按照制造商的建议，对丙型肝炎病毒抗体进行检测。最初被识别为反应性的样本被重新研究。重新检测结果为≥1-≤20 信号-临界比值的样本被纳入研究，与第三代 Line 免疫测定试剂盒（innogenetics-line 免疫测定丙型肝炎病毒，比利时）进行验证。

结果

共发现 687 例抗丙型肝炎病毒阳性且 S/Co 值在 1-20 之间的样本，其中 innogenetics-line 免疫测定丙型肝炎病毒确证试验阴性、不确定和阳性分别为 56.1%、14.8%和 29.1%。当 innogenetics-line 免疫测定丙型肝炎病毒不确定结果的病例被接受为阳性时，抗丙型肝炎病毒的临界值为 5.8（95%置信区间），可区分 innogenetics-line 免疫测定丙型肝炎病毒阴性和阳性组。