Southwest District Health, Caldwell, Idaho, United States of America.
Division of Public Health, Idaho Department of Health and Welfare, Boise, Idaho, United States of America.
PLoS One. 2021 Dec 2;16(12):e0260862. doi: 10.1371/journal.pone.0260862. eCollection 2021.
SARS-CoV-2 RT-PCR, the gold standard for diagnostic testing, may not be readily available or logistically applicable for routine COVID-19 testing in many rural communities in the United States. In this validation study, we compared the BinaxNOW™ COVID-19 Test Ag Card with SARS-CoV-2 RT-PCR in 214 participants who sought COVID-19 testing from a local public health district in Idaho, USA. The median age of participants was 35 and 82.7% were symptomatic. Thirty-seven participants (17.3%) had positive RT-PCR results. Results between the two tests were 94.4% concordant. The sensitivity of the BinaxNOW™ COVID-19 Test Ag Card was 67.6% (95% CI: 50.2-81.9%), and the specificity was 100.0% (95% CI: 97.9-100.0%). The positive predictive value (PPV) for the BinaxNOW™ COVID-19 Test Ag Card was 100.0% (95% CI: 86.2-100.0%), and the negative predictive value (NPV) was 93.6% (95% CI: 89.1-96.6%). Although the sensitivity of BinaxNOW™ COVID-19 Test Ag Card was lower than RT-PCR, rapid results and high specificity support its use for early detection of COVID-19, especially in settings where SARS-CoV-2 RT-PCR testing is not readily available. Rapid antigen tests, such as the BinaxNOW™ COVID-19 Test Ag Card, may be a more convenient tool in quickly identifying and preventing COVID-19 transmission, especially in rural settings.
SARS-CoV-2 RT-PCR 是诊断检测的金标准,但在美国许多农村社区,可能无法方便地获得或在物流上适用于常规 COVID-19 检测。在这项验证研究中,我们比较了 BinaxNOW™ COVID-19 Test Ag 卡与美国爱达荷州当地公共卫生区寻求 COVID-19 检测的 214 名参与者的 SARS-CoV-2 RT-PCR。参与者的中位年龄为 35 岁,82.7%有症状。37 名参与者(17.3%)的 RT-PCR 结果为阳性。两种检测方法的结果一致性为 94.4%。BinaxNOW™ COVID-19 Test Ag 卡的敏感性为 67.6%(95%CI:50.2-81.9%),特异性为 100.0%(95%CI:97.9-100.0%)。BinaxNOW™ COVID-19 Test Ag 卡的阳性预测值(PPV)为 100.0%(95%CI:86.2-100.0%),阴性预测值(NPV)为 93.6%(95%CI:89.1-96.6%)。虽然 BinaxNOW™ COVID-19 Test Ag 卡的敏感性低于 RT-PCR,但快速的结果和高特异性支持其用于 COVID-19 的早期检测,特别是在无法方便地进行 SARS-CoV-2 RT-PCR 检测的情况下。快速抗原检测,如 BinaxNOW™ COVID-19 Test Ag 卡,可能是一种更方便的工具,可用于快速识别和预防 COVID-19 传播,特别是在农村环境中。