Objective To assess the diagnostic test accuracy of two rapid antigen tests in asymptomatic and presymptomatic close contacts of people with SARS-CoV-2 infection on day 5 after exposure. Design Prospective cross sectional study. Setting Four public health service covid-19 test sites in the Netherlands. Participants 4274 consecutively included close contacts (identified through test-and-trace programme or contact tracing app) aged 16 years or older and asymptomatic for covid-19 when requesting a test. Main outcome measures Sensitivity, specificity, and positive and negative predictive values of Veritor System (Beckton Dickinson) and Biosensor (Roche Diagnostics) rapid antigen tests, with reverse-transcriptase polymerase chain reaction (RT-PCR) testing as reference standard. The viral load cut-off above which 95% of people with a positive RT-PCR test result were virus culture positive was used as a proxy of infectiousness. Results Of 2678 participants tested with Veritor, 233 (8.7%) had a RT-PCR confirmed SARS-CoV-2 infection of whom 149 were also detected by the rapid antigen test (sensitivity 63.9%, 95% confidence interval 57.4% to 70.1%). Of 1596 participants tested with Biosensor, 132 (8.3%) had a RT-PCR confirmed SARS-CoV-2 infection of whom 83 were detected by the rapid antigen test (sensitivity 62.9%, 54.0% to 71.1%). In those who were still asymptomatic at the time of sampling, sensitivity was 58.7% (51.1% to 66.0%) for Veritor (n=2317) and 59.4% (49.2% to 69.1%) for Biosensor (n=1414), and in those who developed symptoms were 84.2% (68.7% to 94.0%; n=219) for Veritor and 73.3% (54.1% to 87.7%; n=158) for Biosensor. When a viral load cut-off was applied for infectiouness (≥5.2 log10 SARS-CoV-2 E gene copies/mL), the overall sensitivity was 90.1% (84.2% to 94.4%) for Veritor and 86.8% (78.1% to 93.0%) for Biosensor, and 88.1% (80.5% to 93.5%) for Veritor and 85.1% (74.3% to 92.6%) for Biosensor, among those who remained asymptomatic throughout. Specificities were >99%, and positive and negative predictive values were >90% and >95%, for both rapid antigen tests in all analyses. Conclusions The sensitivities of both rapid antigen tests in asymptomatic and presymptomatic close contacts tested on day 5 onwards after close contact with an index case were more than 60%, increasing to more than 85% after a viral load cut-off was applied as a proxy for infectiousness. Individual participant data collected during the study will be available, after deidentification, of all participants. Data will be available to researchers who provide a methodologically sound proposal to achieve the aims in the approved proposal. Proposals should be directed to the corresponding author to gain access to the data. Data requestors will need to sign a data access agreement.

中文翻译：

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快速抗原检测对确诊 SARS-CoV-2 感染者的无症状和症状前密切接触者的诊断准确性：横断面研究


目的 评估两种快速抗原检测对 SARS-CoV-2 感染者暴露后第 5 天的无症状和症状前密切接触者的诊断检测准确性。设计前瞻性横断面研究。在荷兰设置四个公共卫生服务 covid-19 测试点。 4274 名参与者在请求测试时连续纳入了年龄在 16 岁或以上且无 covid-19 症状的密切接触者（通过测试和追踪计划或接触者追踪应用程序确定）。主要结果衡量 Veritor 系统 (Beckton Dickinson) 和 Biosensor (Roche Diagnostics) 快速抗原检测的灵敏度、特异性以及阳性和阴性预测值，以逆转录酶聚合酶链反应 (RT-PCR) 检测作为参考标准。病毒载量截止值被用作传染性的指标，高于该值时，RT-PCR 检测结果呈阳性的人中 95% 的病毒培养呈阳性。结果 在使用 Veritor 进行测试的 2678 名参与者中，233 名 (8.7%) 经 RT-PCR 确诊为 SARS-CoV-2 感染，其中 149 名也通过快速抗原测试检测到（灵敏度 63.9%，95% 置信区间 57.4% 至 70.1%） ）。在使用 Biosensor 进行测试的 1596 名参与者中，132 名 (8.3%) 经 RT-PCR 确诊为 SARS-CoV-2 感染，其中 83 名通过快速抗原测试检测到（灵敏度分别为 62.9%、54.0% 至 71.1%）。在采样时仍无症状的患者中，Veritor (n=2317) 的敏感性为 58.7%（51.1% 至 66.0%），Biosensor（n=1414）的敏感性为 59.4%（49.2% 至 69.1%）。 Veritor 组出现症状的比例为 84.2%（68.7% 至 94.0%；n=219），Biosensor 组出现症状的比例为 73.3%（54.1% 至 87.7%；n=158）。当对传染性应用病毒载量截止值（≥5.2 log10 SARS-CoV-2 E 基因拷贝数/mL）时，总体敏感性为 90.1%（84.2% 至 94.2%）。在整个过程中保持无症状的人中，Veritor 为 4%），Biosensor 为 86.8%（78.1% 至 93.0%），Veritor 为 88.1%（80.5% 至 93.5%），Biosensor 为 85.1%（74.3% 至 92.6%）。所有分析中快速抗原检测的特异性均 >99%，阳性和阴性预测值均 >90% 和 >95%。结论 在与指示病例密切接触后第 5 天开始测试的无症状和症状前密切接触者中，快速抗原检测的敏感性均超过 60%，以病毒载量截止值作为替代指标后，敏感性增加至 85% 以上为了传染性。在研究期间收集的个人参与者数据将在所有参与者去识别化后提供。数据将提供给提供方法上合理的提案以实现已批准提案中的目标的研究人员。提案应直接发送给通讯作者以获得数据访问权限。数据请求者需要签署数据访问协议。