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四种市售检测试剂盒用于鉴定 SARS-CoV-2、甲型/乙型流感病毒和 RSV 的诊断性能。

Diagnostic performances of four commercially available assays for the identification of SARS-CoV-2, influenza type A/B virus and RSV.

机构信息

Star-shl Medical Diagnostic Center, Rotterdam, The Netherlands.

Star-shl Medical Diagnostic Center, Rotterdam, The Netherlands; Department of Medical Microbiology and Infectious Diseases, Erasmus Medical Center, Rotterdam, The Netherlands.

出版信息

Diagn Microbiol Infect Dis. 2023 Aug;106(4):115970. doi: 10.1016/j.diagmicrobio.2023.115970. Epub 2023 Apr 24.

Abstract

We evaluated the diagnostic performance of 4 commercially NAAT for detecting SARS-CoV-2 RNA, Influenza type A/B virus and RSV. Included tests were the Allplex™ SARS-CoV-2 fast PCR Assay (RNA extraction-free), Allplex™ RV Master Assay, Allplex™ SARS-CoV-2 fast MDx Assay (LAMP) and Aptima™ SARS-CoV-2/Flu Assay (RT-TMA). The assays' performance characteristics were determined using nasopharyngeal swabs from 270 patients with suspected SARS-CoV-2 infection. A total of 215 SARS-CoV-2 positive, 55 negative nasopharyngeal swabs and 19 bacteria strains were included. The sensitivities and specificities for detecting SARS-CoV-2, Influenza type A virus and RSV ranged between 81.8% and 100% with extremely good agreements (κ ≥ 86.8 %). The Aptima™ SARS-CoV-2/Flu Assay introduced a new result parameter, that is, TTime. Here, we showed that TTime may be used as a surrogate for Ct-value. We concluded that all assays assessed in this study can be used for routine detection of SARS-CoV-2, Influenza type A virus and RSV.

摘要

我们评估了 4 种市售 NAAT 检测 SARS-CoV-2 RNA、甲型/乙型流感病毒和 RSV 的诊断性能。包括 Allplex™ SARS-CoV-2 快速 PCR 检测试剂盒(无 RNA 提取)、Allplex™ RV 主检测试剂盒、Allplex™ SARS-CoV-2 快速 MDx 检测试剂盒(LAMP)和 Aptima™ SARS-CoV-2/Flu 检测试剂盒(RT-TMA)。使用 270 例疑似 SARS-CoV-2 感染患者的鼻咽拭子评估了这些检测方法的性能特征。共纳入 215 例 SARS-CoV-2 阳性、55 例阴性鼻咽拭子和 19 株细菌。检测 SARS-CoV-2、甲型流感病毒和 RSV 的灵敏度和特异性在 81.8%到 100%之间,具有极高的一致性(κ≥86.8%)。Aptima™ SARS-CoV-2/Flu 检测试剂盒引入了一个新的结果参数,即 TTime。我们发现 TTime 可作为 Ct 值的替代物。我们得出结论,本研究中评估的所有检测方法都可用于常规检测 SARS-CoV-2、甲型流感病毒和 RSV。

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