CityMD/Summit Medical Group, New York, NY, United States.
Becton, Dickinson and Company, BD Life Sciences-Integrated Diagnostic Solutions, Sparks, MD, United States.
Front Public Health. 2022 Apr 5;10:836328. doi: 10.3389/fpubh.2022.836328. eCollection 2022.
Real-world data are needed to establish SARS-CoV-2 rapid antigen testing (RAT) as an effective and reliable approach for SARS-CoV-2 screening. This study included 1,952,931 individuals who provided upper respiratory specimens during SARS-CoV-2 screening at CityMD urgent care locations in the New York metropolitan area from October 2020 to March 2021. Positive and negative results, as determined by the BD Veritor™ System for Rapid Detection of SARS-CoV-2 antigen (Veritor), were obtained for all individuals, with reflex reverse transcriptase-polymerase chain reaction (RT-PCR) testing performed on a case-by-case basis, per standard of care. Using verification bias adjustment, two alternative model assumptions were utilized for RAT results with missing reflex RT-PCR results. The worst antigen diagnostic performance estimates asserted that missing RT-PCR results would show a distribution similar to those RT-PCR results actually obtained, based on symptom category. The best antigen diagnostic performance estimates asserted that individuals without RT-PCR results had a clinical presentation consistent with RAT results, and, therefore, missing RT-PCR results would agree with RAT results. For patients with symptoms or high-risk exposure, 25.3% ( = 86,811/343,253) of RAT results were positive; vs. 3.4% ( = 53,046/1,559,733) positive for asymptomatic individuals without high-risk exposure. Reflex RT-PCR results were obtained from 46.3% ( = 158,836/343,253) and 13.8% ( = 215,708/1,559,733) of symptomatic and asymptomatic individuals, respectively. RT-PCR confirmed 94.4% (4,265/4,518) of positive and 90.6% (139,759/154,318) of negative RAT results in symptomatic individuals; and confirmed 83.4% (6,693/8,024) of positive and 95.3% (197,955/207,684) of negative RAT results in asymptomatic individuals. Applied assumptions for missing reflex RT-PCR results led to worst performance sensitivity estimates of 77.2 and 38.5% in the symptomatic and asymptomatic populations, respectively; assumptions for best performance estimates led to sensitivity values of 85.6 and 84.2%, respectively. Specificity values, regardless of assumptions or symptom category, ranged from 97.9-99.9%. At 10% SARS-CoV-2 prevalence, RAT positive predictive value was 86.9 and 99.0% for worst and best performance estimates across the total population, respectively; negative predictive values were >95% regardless of the applied assumption. Veritor test performance was consistent with that listed in the manufacturer instructions for use for symptomatic individuals. Real-world evidence should be gathered on RATs to support their efficacy as SARS-CoV-2 persists.
需要真实世界的数据来确定 SARS-CoV-2 快速抗原检测（RAT）作为 SARS-CoV-2 筛查的有效和可靠方法。这项研究包括了 1952931 名个体，他们在 2020 年 10 月至 2021 年 3 月期间在纽约大都市区的 CityMD 急诊护理地点进行 SARS-CoV-2 筛查时提供了上呼吸道标本。所有个体的阳性和阴性结果均由 BD Veritor™ SARS-CoV-2 抗原快速检测系统（Veritor）确定，根据标准护理，对每例个体进行了反射式逆转录-聚合酶链反应（RT-PCR）检测。使用验证偏倚调整，对于缺失反射 RT-PCR 结果的 RAT 结果，利用两种替代模型假设。最糟糕的抗原诊断性能估计假设，缺失的 RT-PCR 结果将显示与实际获得的 RT-PCR 结果相似的分布，基于症状类别。最佳抗原诊断性能估计假设，没有 RT-PCR 结果的个体具有与 RAT 结果一致的临床表现，因此，缺失的 RT-PCR 结果将与 RAT 结果一致。对于有症状或高风险暴露的患者，25.3%（=86811/343253）的 RAT 结果为阳性；而无症状且无高风险暴露的个体中，阳性结果为 3.4%（=53046/1559733）。46.3%（=158836/343253）和 13.8%（=215708/1559733）的有症状和无症状个体分别获得了反射 RT-PCR 结果。RT-PCR 证实了 94.4%（4265/4518）的阳性和 90.6%（139759/154318）的阴性 RAT 结果在有症状个体中；并证实了 83.4%（6693/8024）的阳性和 95.3%（197955/207684）的阴性 RAT 结果在无症状个体中。对于缺失反射 RT-PCR 结果的应用假设导致了最糟糕的性能敏感性估计值，在有症状和无症状人群中分别为 77.2%和 38.5%；最佳性能估计假设导致了 85.6%和 84.2%的敏感性值。无论假设或症状类别如何，特异性值均在 97.9%-99.9%之间。在 SARS-CoV-2 流行率为 10%的情况下，RAT 的阳性预测值在总人群中分别为最差和最佳性能估计值的 86.9%和 99.0%；阴性预测值>95%，无论应用的假设如何。Veritor 测试性能与制造商使用说明中列出的性能一致，适用于有症状的个体。应收集 RAT 的真实世界证据，以支持其作为 SARS-CoV-2 持续存在的疗效。
