Microbiology Service, Hospital Clínico Universitario, INCLIVA Research Institute, Valencia, Spain.
Instituto Valenciano de Microbiología, Bétera, Valencia, Spain.
Clin Microbiol Infect. 2021 Mar;27(3):472.e7-472.e10. doi: 10.1016/j.cmi.2020.11.004. Epub 2020 Nov 13.
To our knowledge no previous study has assessed the performance of a rapid antigen diagnostic immunoassay (RAD) conducted at the point of care (POC). We evaluated the Panbio™ COVID-19 Ag Rapid Test Device for diagnosis of coronavirus 2019 disease (COVID-19) in symptomatic patients (n = 412) attending primary healthcare centres.
RAD was performed immediately after sampling following the manufacturer's instructions (reading at 15 min). RT-PCRs were carried out within 24 h of specimen collection. Samples displaying discordant results were processed for culture in Vero E6 cells. Presence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in cell cultures was confirmed by RT-PCR.
Out of 412 patients, 43 (10.4%) tested positive by RT-PCR and RAD, and 358 (86.9%) tested negative by both methods; discordant results (RT-PCR+/RAD-) were obtained in 11 patients (2.7%). Overall specificity and sensitivity of rapid antigen detection (RAD) was 100% (95%CI 98.7-100%) and 79.6% (95%CI 67.0-88.8%), respectively, taking RT-PCR as the reference. Overall RAD negative predictive value for an estimated prevalence of 5% and 10% was 99% (95%CI 97.4-99.6%) and 97.9% (95%CI 95.9-98.9), respectively. SARS-CoV-2 could not be cultured from specimens yielding RT-PCR+/RAD- results (n = 11).
The Panbio™ COVID-19 Ag Rapid Test Device performed well as a POC test for early diagnosis of COVID-19 in primary healthcare centres. More crucially, the data suggested that patients with RT-PCR-proven COVID-19 testing negative by RAD are unlikely to be infectious.
据我们所知，以前没有研究评估过在即时护理点（POC）进行的快速抗原诊断免疫测定（RAD）的性能。我们评估了 Panbio™ COVID-19 Ag 快速检测设备在出现症状的患者（n=412）中用于诊断 2019 年冠状病毒病（COVID-19）的性能。这些患者在初级保健中心就诊。
RAD 是按照制造商的说明（15 分钟读取结果）在采样后立即进行的。RT-PCR 是在标本采集后 24 小时内进行的。显示出不一致结果的样本被用于在 Vero E6 细胞中进行培养。通过 RT-PCR 确认细胞培养物中存在严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）。
在 412 名患者中，43 名（10.4%）经 RT-PCR 和 RAD 检测呈阳性，358 名（86.9%）两种方法均呈阴性；11 名患者（2.7%）检测结果不一致（RT-PCR+/RAD-）。快速抗原检测（RAD）的总体特异性和敏感性分别为 100%（95%CI 98.7-100%）和 79.6%（95%CI 67.0-88.8%），以 RT-PCR 为参照。RAD 阴性预测值在估计的 5%和 10%流行率下分别为 99%（95%CI 97.4-99.6%）和 97.9%（95%CI 95.9-98.9%）。从 RT-PCR+/RAD-结果的标本中无法培养出 SARS-CoV-2（n=11）。
Panbio™ COVID-19 Ag 快速检测设备在初级保健中心用于 COVID-19 的即时护理点早期诊断中表现良好。更重要的是，数据表明，经 RT-PCR 证实患有 COVID-19 且 RAD 检测呈阴性的患者不太可能具有传染性。
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