Real-life validation of the Panbio™ COVID-19 antigen rapid test (Abbott) in community-dwelling subjects with symptoms of potential SARS-CoV-2 infection.
Real-life validation of the Panbio™ COVID-19 antigen rapid test (Abbott) in community-dwelling subjects with symptoms of potential SARS-CoV-2 infection.
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DOI：
10.1016/j.eclinm.2020.100677
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发表时间：
2021-01
影响因子：
15.1
通讯作者：
Hofstra LM
中科院分区：
文献类型：
--
作者：
Gremmels H;Winkel BMF;Schuurman R;Rosingh A;Rigter NAM;Rodriguez O;Ubijaan J;Wensing AMJ;Bonten MJM;Hofstra LM
RT-qPCR 是识别活动性 SARS-CoV-2 感染的参考测试，但会导致诊断延迟。抗原检测分析可在 20 分钟内且在实验室环境之外生成结果。然而，它们在现实生活中的诊断测试性能尚未确定。使用同时获得的两份鼻咽拭子，确定了 Panbio™ COVID-19 Ag 快速检测 (Abbott) 与 RT-qPCR (Seegene Allplex) 对中等流行区（荷兰乌得勒支）和高流行区（阿鲁巴）社区居住的轻度症状受试者的诊断价值。结果：乌得勒支和阿鲁巴分别招募了 1367 名受试者和 208 名受试者。根据 RT-qPCR，乌得勒支和阿鲁巴的 SARS-CoV-2 患病率分别为 10.2% (n = 139) 和 30.3% (n = 63)。 Panbio™ COVID-19 Ag 快速检测的特异性在两种情况下均为 100%（95%CI：99.7–100%）。荷兰的测试敏感性为 72.6% (95% CI: 64.5–79.9%)，阿鲁巴岛的测试敏感性为 81.0% (95% CI: 69.0–89.8%)。假阴性结果的概率与 RT-qPCR Ct 值相关，但与症状持续时间无关。将 RT-qPCR 检测阳性限制在 Ct 值 <32 范围内，乌得勒支的检测灵敏度为 95.2% (95%CI: 89.3–98.5%)，阿鲁巴的检测灵敏度为 98.0% (95%CI: 89.2–99.95%)。在患有轻度呼吸道症状的社区居住受试者中，Panbio™ COVID-19 Ag 快速检测具有 100% 的特异性，并且当使用 Ct 值 <32 个循环作为 RT-qPCR 检测阳性的截止值时，鼻咽样本的敏感性高于 95%。考虑到周转时间短、用户友好、成本低和分散测试的机会，该测试可以改善我们控制 SARS-CoV-2 传播的努力。
RT-qPCR is the reference test for identification of active SARS-CoV-2 infection, but is associated with diagnostic delay. Antigen detection assays can generate results within 20 min and outside of laboratory settings. Yet, their diagnostic test performance in real life settings has not been determined. The diagnostic value of the Panbio™ COVID-19 Ag Rapid Test (Abbott), was determined in comparison to RT-qPCR (Seegene Allplex) in community-dwelling mildly symptomatic subjects in a medium (Utrecht, the Netherlands) and high endemic area (Aruba), using two concurrently obtained nasopharyngeal swabs. Findings: 1367 and 208 subjects were enrolled in Utrecht and Aruba, respectively. SARS-CoV-2 prevalence, based on RT-qPCR, was 10.2% (n = 139) and 30.3% (n = 63) in Utrecht and Aruba respectively. Specificity of the Panbio™ COVID-19 Ag Rapid Test was 100% (95%CI: 99.7–100%) in both settings. Test sensitivity was 72.6% (95%CI: 64.5–79.9%) in the Netherlands and 81.0% (95% CI: 69.0–89.8%) in Aruba. Probability of false negative results was associated with RT-qPCR Ct-values, but not with duration of symptoms. Restricting RT-qPCR test positivity to Ct-values <32 yielded test sensitivities of 95.2% (95%CI: 89.3–98.5%) in Utrecht and 98.0% (95%CI: 89.2–99.95%) in Aruba. In community-dwelling subjects with mild respiratory symptoms the Panbio™ COVID-19 Ag Rapid Test had 100% specificity, and a sensitivity above 95% for nasopharyngeal samples when using Ct-values <32 cycles as cut-off for RT-qPCR test positivity. Considering short turnaround times, user friendliness, low costs and opportunities for decentralized testing, this test can improve our efforts to control transmission of SARS-CoV-2.
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影响因子：
82.9
作者：
He, Xi;Lau, Eric H. Y.;Leung, Gabriel M.
通讯作者：
Leung, Gabriel M.
影响因子：
7.4
作者：
Grant, Benjamin D.;Anderson, Caitlin E.;Nichols, Kevin P.
通讯作者：
Nichols, Kevin P.
影响因子：
8.4
作者：
Hirotsu, Yosuke;Maejima, Makoto;Omata, Masao
通讯作者：
Omata, Masao
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
DOI：
10.1016/j.cmi.2016.08.007
发表时间：
2016-12
期刊：
Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases
影响因子：
--
作者：
van der Linden L;Bruning AH;Thomas XV;Minnaar RP;Rebers SP;Schinkel J;de Jong MD;Pajkrt D;Wolthers KC
通讯作者：
Wolthers KC