Institute for Developing Science and Health Initiatives (ideSHi), Dhaka, Bangladesh.
Division of Experimental Medicine, Zuckerberg San Francisco General Hospital, San Francisco, California.
Am J Trop Med Hyg. 2022 Aug 15;107(4):845-849. doi: 10.4269/ajtmh.22-0068. Print 2022 Oct 12.
Early detection of SARS-CoV-2 infection is crucial to prevent its spread. This study aimed to document test sensitivity/specificity, correlation with cycle threshold value from polymerase chain reaction (PCR), fitness-for-use in different populations and settings, and user perspectives that could inform large-scale implementation. In this study, we evaluated the performance of a rapid antigen detection test, BD Veritor, and compared this (and another rapid test, Standard Q) against reverse transcription PCR (RT-PCR) in terms of sensitivity and specificity in 130 symptomatic and 130 asymptomatic adults. In addition, we evaluated the suitability and ease of use of the BD Veritor test in a subsample of study participants (n = 42) and implementers (n = 5). At 95% confidence interval, the sensitivity of the BD Veritor and Standard Q test were 70% and 63% in symptomatic and 87% and 73% in asymptomatic individuals, respectively, regarding positive SARS-CoV-2 RT-PCR results. Overall, the BD Veritor test was 78% sensitive and 99.5% specific compared with RT-PCR irrespective of the cycle threshold. This warrants large field evaluation as well as use of the rapid antigen test for quick assessment of SARS-CoV-2 for containment of epidemics in the country.
早期发现 SARS-CoV-2 感染对于防止其传播至关重要。本研究旨在记录检测的敏感性/特异性、与聚合酶链反应（PCR）的循环阈值的相关性、在不同人群和环境中的适用性以及用户观点，以为大规模实施提供信息。在这项研究中，我们评估了一种快速抗原检测试验（BD Veritor）的性能，并将其（和另一种快速检测试验 Standard Q）与 RT-PCR 在 130 名有症状和 130 名无症状成年人中针对敏感性和特异性进行了比较。此外，我们在研究参与者（n = 42）和实施者（n = 5）的亚样本中评估了 BD Veritor 测试的适用性和易用性。在 95%置信区间内，BD Veritor 和 Standard Q 试验在有症状个体中的敏感性分别为 70%和 63%，在无症状个体中的敏感性分别为 87%和 73%，阳性 SARS-CoV-2 RT-PCR 结果。总体而言，BD Veritor 试验与 RT-PCR 相比，无论循环阈值如何，其敏感性为 78%，特异性为 99.5%。这需要进行大规模现场评估，以及使用快速抗原检测试验快速评估 SARS-CoV-2，以控制该国的疫情。
