Diagnostic accuracy of Panbio rapid antigen tests on oropharyngeal swabs for detection of SARS-CoV-2.
Diagnostic accuracy of Panbio rapid antigen tests on oropharyngeal swabs for detection of SARS-CoV-2.
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DOI：
10.1371/journal.pone.0253321
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发表时间：
2021
期刊：
影响因子：
3.7
通讯作者：
Eckerle I
中科院分区：
文献类型：
--
作者：
Ngo Nsoga MT;Kronig I;Perez Rodriguez FJ;Sattonnet-Roche P;Da Silva D;Helbling J;Sacks JA;de Vos M;Boehm E;Gayet-Ageron A;Berger A;Jacquerioz-Bausch F;Chappuis F;Kaiser L;Schibler M;Renzoni A;Eckerle I
用于检测SARS-CoV-2的抗原检测快速诊断测试（Ag-RDTs）为COVID-19大流行背景下的测试提供了新的机会。鼻咽拭子（鼻咽拭子）是参考样本类型，但口咽拭子（OPS）可能是某些患者更可接受的样本类型。我们在一个筛查中心进行了一项前瞻性研究，以评估Panbio™ COVID-19 Ag Rapid Test（Abbott）在瑞士第二波大流行期间对OPS的诊断性能，并与使用COVID-19的逆转录定量PCR（RT-qPCR）进行比较。402名门诊患者入组COVID-19筛查中心，其中168名（41.8%）患者的RT-qPCR检测结果呈阳性。与鼻咽RT-qPCR相比，口咽Ag-RDT的临床敏感性为81%（95%CI：74.2-86.6）。在234例RT-qPCR阴性个体中观察到2例假阳性，导致Ag-RDT的临床特异性为99.1%（95%CI：96.9-99.9）。对于循环阈值≤ 26.7（≥ 1 E6 SARS-CoV-2基因组拷贝数/mL，感染性病毒的假定临界值），使用OPS的Ag-RDT获得了96.3%的灵敏度（95%CI：90.7-99.0%）。根据我们的研究结果，Panbio™ Covid-19 RDT与OPS样本的诊断性能，如果由经过培训的人员采集，并且对样本质量有很高的要求，则符合WHO对Ag-RDT的标准（灵敏度≥80%，特异性≥97%），适用于有症状个体的高发病率。
Antigen-detecting rapid diagnostic tests (Ag-RDTs) for the detection of SARS-CoV-2 offer new opportunities for testing in the context of the COVID-19 pandemic. Nasopharyngeal swabs (NPS) are the reference sample type, but oropharyngeal swabs (OPS) may be a more acceptable sample type in some patients. We conducted a prospective study in a single screening center to assess the diagnostic performance of the Panbio™ COVID-19 Ag Rapid Test (Abbott) on OPS compared with reverse-transcription quantitative PCR (RT-qPCR) using NPS during the second pandemic wave in Switzerland. 402 outpatients were enrolled in a COVID-19 screening center, of whom 168 (41.8%) had a positive RT-qPCR test. The oropharyngeal Ag-RDT clinical sensitivity compared to nasopharyngeal RT-qPCR was 81% (95%CI: 74.2–86.6). Two false positives were noted out of the 234 RT-qPCR negative individuals, which resulted in a clinical specificity of 99.1% (95%CI: 96.9–99.9) for the Ag-RDT. For cycle threshold values ≤ 26.7 (≥ 1E6 SARS-CoV-2 genomes copies/mL, a presumed cut-off for infectious virus), 96.3% sensitivity (95%CI: 90.7–99.0%) was obtained with the Ag-RDT using OPS. Based on our findings, the diagnostic performance of the Panbio™ Covid-19 RDT with OPS samples, if taken by a trained person and high requirements regarding quality of the specimen, meet the criteria required by the WHO for Ag-RDTs (sensitivity ≥80% and specificity ≥97%) in a high incidence setting in symptomatic individuals.
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DOI：
10.1016/j.jinf.2021.02.014
发表时间：
2021-03
期刊：
The Journal of infection
影响因子：
--
作者：
Bulilete O;Lorente P;Leiva A;Carandell E;Oliver A;Rojo E;Pericas P;Llobera J;COVID-19 Primary Care Research Group
通讯作者：
COVID-19 Primary Care Research Group
影响因子：
15.1
作者：
Gremmels H;Winkel BMF;Schuurman R;Rosingh A;Rigter NAM;Rodriguez O;Ubijaan J;Wensing AMJ;Bonten MJM;Hofstra LM
通讯作者：
Hofstra LM
影响因子：
3.9
作者：
Wang, Huan;Liu, Qian;Xu, Shu-yun
通讯作者：
Xu, Shu-yun
影响因子：
4.8
作者：
Vetter P;Eberhardt CS;Meyer B;Martinez Murillo PA;Torriani G;Pigny F;Lemeille S;Cordey S;Laubscher F;Vu DL;Calame A;Schibler M;Jacquerioz F;Blanchard-Rohner G;Siegrist CA;Kaiser L;Didierlaurent AM;Eckerle I
通讯作者：
Eckerle I
影响因子：
3.7
作者：
Berger A;Nsoga MTN;Perez-Rodriguez FJ;Aad YA;Sattonnet-Roche P;Gayet-Ageron A;Jaksic C;Torriani G;Boehm E;Kronig I;Sacks JA;de Vos M;Bausch FJ;Chappuis F;Renzoni A;Kaiser L;Schibler M;Eckerle I
通讯作者：
Eckerle I