Implementation of rapid SARS-CoV-2 antigenic testing in a laboratory without access to molecular methods: Experiences of a general hospital
Implementation of rapid SARS-CoV-2 antigenic testing in a laboratory without access to molecular methods: Experiences of a general hospital
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DOI：
10.1016/j.jcv.2020.104472
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发表时间：
2020-08-01
影响因子：
8.8
通讯作者：
Tre-Hardy, Marie
中科院分区：
文献类型：
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作者：
Blairon, Laurent;Wilmet, Alain;Tre-Hardy, Marie
背景资料：COVID-19 Ag（Antigen）Respi-Strip assay是最近可用于SARS-CoV-2抗原诊断的新型免疫层析诊断工具。建议的灵敏度不高于60%，但其高特异性允许快速决定患者的管理和确认的分子诊断仅为阴性测试。材料和方法：在一个月的时间内，我们将COVID-19 Ag Respi-Strip试剂盒获得的阴性结果与在具有SARS-CoV-2分子诊断资格的实验室中进行的qRT-PCR获得的结果进行了比较。结果：在774例患者中，714例为阴性，其中159例为阳性。中位阳性百分比一致率为23.9%（95% CI：14.2%-38.2%）。Cohen's kappa评分为0.35。结论：使用该免疫层析检测作为分诊试验并没有显著减少通过qRT-PCR进行COVID-19确认的外包样本数量。此外，即使周转时间很短，分析也是完全手动的，不适合大量的常规样品。这种快速检测的灵敏度较差，需要改进以提高其性能。
Background: The COVID-19 Ag (Antigen) Respi-Strip assay is a new immunochromatographic diagnostic tool recently available for antigenic diagnosis of SARS-CoV-2. The proposed sensitivity is not higher than 60 %, but its high specificity allows both quick decisions for the management of patients and confirmation by molecular diagnosis for only negative tests. However, from the first tests performed, we suspected that the sensitivity observed with routine use was much lower than that announced by the manufacturer.Materials and methods: Over a period of one month, we compared the negative results obtained with the COVID-19 Ag Respi-Strip kit with those obtained from qRT-PCR performed in a laboratory qualified for the molecular diagnosis of SARS-CoV-2. All samples tested were naso-pharyngeal smears from UTM-RT medium.Results: Of 774 patients tested, 714 negative samples were sent for confirmation, and 159 were found to be positive by qRT-PCR. The median positive percentage agreement was 23.9 % (95 % CI: 14.2 %-38.2 %). The Cohen's kappa score was 0.35.Conclusion: Using this immunochromatographic assay as a triage test did not significantly reduce the number of samples outsourced for COVID-19 confirmation by qRT-PCR. In addition, even if the turn-around time is short, the assay is completely manual, which is not suitable for large volumes of routine samples. The sensitivity of this rapid test is poor, and improvements are needed to enhance its performance.