Field evaluation of a rapid antigen test (Panbio™ COVID-19 Ag Rapid Test Device) for COVID-19 diagnosis in primary healthcare centres.
Field evaluation of a rapid antigen test (Panbio™ COVID-19 Ag Rapid Test Device) for COVID-19 diagnosis in primary healthcare centres.
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DOI：
10.1016/j.cmi.2020.11.004
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发表时间：
2021-03
期刊：
影响因子：
--
通讯作者：
Navarro D
中科院分区：
文献类型：
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作者：
Albert E;Torres I;Bueno F;Huntley D;Molla E;Fernández-Fuentes MÁ;Martínez M;Poujois S;Forqué L;Valdivia A;Solano de la Asunción C;Ferrer J;Colomina J;Navarro D
据我们所知，之前没有研究评估过在护理点（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快速检测设备在初级医疗中心就诊的有症状患者（n = 412）中诊断2019冠状病毒病（COVID-19）的情况。按照制造商的说明书（在15分钟时阅读），在取样后立即进行RAD。在样本采集后24 h内进行RT-PCR。处理显示不一致结果的样品，用于在Vero E6细胞中培养。通过RT-PCR证实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例患者中，43例（10.4%）通过RT-PCR和RAD检测为阳性，358例（86.9%）通过两种方法检测为阴性;在11例患者（2.7%）中获得不一致的结果（RT-PCR+/RAD-）。以RT-PCR为参照，快速抗原检测（RAD）的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%）。估计患病率为5%和10%的总体RAD阴性预测值分别为99%（95%CI 97.4-99.6%）和97.9%（95%CI 95.9-98.9）。不能从产生RT-PCR+/RAD-结果的标本中培养SARS-CoV-2（n = 11）。Panbio™ COVID-19 Ag快速检测仪在初级医疗中心作为早期诊断COVID-19的POC检测中表现良好。更关键的是，数据表明，经RAD检测RT-PCR证实为COVID-19阴性的患者不太可能具有传染性。
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.
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影响因子：
9.4
作者：
Young S;Taylor SN;Cammarata CL;Varnado KG;Roger-Dalbert C;Montano A;Griego-Fullbright C;Burgard C;Fernandez C;Eckert K;Andrews JC;Ren H;Allen J;Ackerman R;Cooper CK
通讯作者：
Cooper CK
影响因子：
11.8
作者：
Bullard, Jared;Dust, Kerry;Poliquin, Guillaume
通讯作者：
Poliquin, Guillaume
DOI：
10.1016/j.jcv.2020.104659
发表时间：
2020-12
期刊：
Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology
影响因子：
--
作者：
Linares M;Pérez-Tanoira R;Carrero A;Romanyk J;Pérez-García F;Gómez-Herruz P;Arroyo T;Cuadros J
通讯作者：
Cuadros J
影响因子：
64.8
作者：
Woelfel, Roman;Corman, Victor M.;Wendtner, Clemens
通讯作者：
Wendtner, Clemens
影响因子：
8.8
作者：
Scohy, Anais;Anantharajah, Ahalieyah;Rodriguez-Villalobos, Hector
通讯作者：
Rodriguez-Villalobos, Hector