Evaluation of rapid antigen test for detection of SARS-CoV-2 virus
Evaluation of rapid antigen test for detection of SARS-CoV-2 virus
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DOI：
10.1016/j.jcv.2020.104500
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发表时间：
2020-08-01
影响因子：
8.8
通讯作者：
Tsang, Dominic N. C.
中科院分区：
文献类型：
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作者：
Mak, Gannon C. K.;Cheng, Peter K. C.;Tsang, Dominic N. C.
背景：对冠状病毒病2019(新冠肺炎)患者的快速诊断对于减少疾病传播至关重要。目的：评价市售新冠肺炎抗原检测方法的性能，并与逆转录聚合酶链式反应检测SARS冠状病毒进行比较。以病毒培养和RT-PCR为参照物，确定RAD试验检测SARS-CoV-2病毒的分析灵敏度。使用从确诊的新冠肺炎患者那里收集的呼吸道样本进一步对RAD测试进行了评估。结果：RAD试验、病毒培养和RT-PCR的检出限相差很大。RAD的敏感性是病毒培养的103倍，而RAD的敏感性是RT-PCR的105倍。结论：由于存在假阴性结果，RAD检测仅能作为RT-PCR检测的辅助手段。
Background: The rapid diagnosis of Coronavirus Disease 2019 (COVID-19) patients is essential to reduce the disease spread. Rapid antigen detection (RAD) tests are available, however, there is scanty data on the performance of RAD tests.Objective: To evaluate the performance of the commercially available BIOCREDIT COVID-19 Ag test and compare it with RT-PCR for detecting Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) virus. Analytical sensitivity for the detection of SARS-CoV-2 virus was determined for the RAD test using viral culture and RT-PCR as reference methods. The RAD test was further evaluated using respiratory samples collected from confirmed COVID-19 patients. The results were compared with RT-PCR test.Results: The detection limits between RAD test, viral culture and RT-PCR varied hugely. RAD was 103 fold less sensitive than viral culture while RAD was 105 fold less sensitive than RT-PCR. The RAD test detected between 11.1 % and 45.7 % of RT-PCR-positive samples from COVID-19 patients.Conclusions: This study demonstrated that the RAD test serves only as adjunct to RT-PCR test because of potential for false-negative results.