轮状病毒免疫检测试剂盒在实际应用中的灵敏度和特异性存在广泛差异。

Wide Variability in the Sensitivity and Specificity of Rotavirus Immunoassay Diagnostic Kits in Practice.

机构信息

Department of Pediatrics and Adolescent Medicine, American University of Beirut, Faculty of Medicine, Beirut, Lebanon.

Center for Infectious Diseases Research, American University of Beirut, Faculty of Medicine, Beirut, Lebanon.

出版信息

J Infect Dev Ctries. 2021 Nov 30;15(11):1701-1707. doi: 10.3855/jidc.11922.

DOI:10.3855/jidc.11922

PMID:34898499

Abstract

INTRODUCTION

Most hospitals rely on rapid antigen-detection kits for the diagnosis of rotavirus infection. Several small studies reviewed the sensitivity and specificity of some of these kits. These studies showed discrepancy in results obtained for sensitivity and specificity that varied according to the type of kit used, area of study, and type of test used as standard for diagnosis of rotavirus infection. The objective of the study is to determine the sensitivity and specificity of five commonly used rotavirus immunoassay kits in comparison to RT-PCR as standard.

METHODOLOGY

Stool samples (N = 1,414) collected from children under 5 years of age hospitalized with gastroenteritis were tested for rotavirus by immunoassay kits and RT-PCR in a prospective hospital-based surveillance study conducted at 7 centers in Lebanon. Concordance and discrepancy between the two methods was used to calculate sensitivity and specificity, using RT-PCR as the "gold standard".

RESULTS

The sensitivity and specificity were respectively 95.08% and 86.62% for the SD Bioline® (Standard Diagnostics, Inc, South Korea) kit calculated on 645 samples, 65.86% and 45.90% for the VIROTECT® (Trinity Biotech, Ireland) kit calculated on 327 samples, 83.9% and 64.2% for the Rota-Strip (C-1001) (Coris Bioconcept, Belgium) calculated on 95 samples, 52.3% and 10.9% for the Acon® (Acon Laboratories, Inc, California, USA) kit calculated on 122 samples, 68.1% and 20% for the VIKIA® Rota-Adéno (Biomerieux, France) kit calculated on 32 samples.

CONCLUSION

A wide discrepancy was detected between the calculated and advertised sensitivity and specificity for most of the kits.

摘要

简介

大多数医院依靠快速抗原检测试剂盒来诊断轮状病毒感染。有几项小型研究综述了其中一些试剂盒的敏感性和特异性。这些研究表明，敏感性和特异性的结果存在差异，其差异取决于所使用的试剂盒类型、研究区域以及用于诊断轮状病毒感染的标准测试类型。本研究的目的是确定五种常用轮状病毒免疫测定试剂盒与 RT-PCR 作为标准相比的敏感性和特异性。

方法

在黎巴嫩 7 个中心进行的一项前瞻性基于医院的监测研究中，对因肠胃炎住院的 5 岁以下儿童的粪便样本（N=1414）进行免疫测定试剂盒和 RT-PCR 检测轮状病毒。使用 RT-PCR 作为“金标准”，通过两种方法的一致性和差异来计算敏感性和特异性。

结果

在 645 个样本中，SD Bioline®（Standard Diagnostics，Inc，韩国）试剂盒的敏感性和特异性分别为 95.08%和 86.62%，在 327 个样本中，VIROTECT®（Trinity Biotech，爱尔兰）试剂盒的敏感性和特异性分别为 65.86%和 45.90%，在 95 个样本中，Rota-Strip（C-1001）（Coris Bioconcept，比利时）试剂盒的敏感性和特异性分别为 83.9%和 64.2%，在 122 个样本中，Acon®（Acon Laboratories，Inc，加利福尼亚，美国）试剂盒的敏感性和特异性分别为 52.3%和 10.9%，在 32 个样本中，VIKIA® Rota-Adéno（Biomerieux，法国）试剂盒的敏感性和特异性分别为 68.1%和 20%。