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抗原检测与 qPCR 在 SARS-CoV-2 病毒感染快速诊断中的比较。

Comparison of Antigen Tests and qPCR in Rapid Diagnostics of Infections Caused by SARS-CoV-2 Virus.

机构信息

Department of Molecular Biology, John Paul II Hospital, ul. Prądnicka 80, 31-202 Kraków, Poland.

Department of Microbiology, John Paul II Hospital, ul. Prądnicka 80, 31-202 Kraków, Poland.

出版信息

Viruses. 2021 Dec 23;14(1):17. doi: 10.3390/v14010017.

Abstract

Diagnostics of the coronavirus disease 2019 (COVID-19) using molecular techniques from the collected respiratory swab specimens requires well-equipped laboratory and qualified personnel, also it needs several hours of waiting for results and is expensive. Antigen tests appear to be faster and cheaper but their sensitivity and specificity are debatable. The aim of this study was to compare a selected antigen test with quantitative polymerase chain reaction (qPCR) tests results. Nasopharyngeal swabs were collected from 192 patients with COVID-19 symptoms. All samples were tested using Vitassay qPCR SARS-CoV-2 kit and the Humasis COVID-19 Ag Test (MedSun) antigen immunochromatographic test simultaneously. Ultimately, 189 samples were tested; 3 samples were excluded due to errors in taking swabs. The qPCR and antigen test results were as follows: 47 positive and 142 negative, and 45 positive and 144 negative, respectively. Calculated sensitivity of 91.5% and specificity of 98.6% for the antigen test shows differences which are not statistically significant in comparison to qPCR. Our study showed that effectiveness of the antigen tests in rapid laboratory diagnostics is high enough to be an alternative and support for nucleic acid amplification tests (NAAT) in the virus replication phase in the course of COVID-19.

摘要

使用从收集的呼吸道拭子标本中进行的分子技术对 2019 年冠状病毒病(COVID-19)进行诊断需要配备齐全的实验室和合格的人员,还需要数小时的等待结果,并且费用昂贵。抗原检测似乎更快,更便宜,但它们的敏感性和特异性存在争议。本研究的目的是比较选定的抗原检测与定量聚合酶链反应(qPCR)检测结果。从 192 例有 COVID-19 症状的患者中采集鼻咽拭子。所有样本均同时使用 Vitassay qPCR SARS-CoV-2 试剂盒和 Humasis COVID-19 Ag Test(MedSun)抗原免疫层析检测法进行检测。最终,对 189 个样本进行了测试;由于拭子采集错误,排除了 3 个样本。qPCR 和抗原检测的结果分别为:47 例阳性和 142 例阴性,45 例阳性和 144 例阴性。抗原检测的灵敏度为 91.5%,特异性为 98.6%,与 qPCR 相比,其差异无统计学意义。我们的研究表明,抗原检测在快速实验室诊断中的有效性足以作为核酸扩增检测(NAAT)在 COVID-19 病毒复制阶段的替代和支持。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9232/8779007/a45a58c1be17/viruses-14-00017-g001.jpg

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