Panbio™ rapid antigen test for SARS-CoV-2 has acceptable accuracy in symptomatic patients in primary health care.

Panbio™ rapid antigen test for SARS-CoV-2 has acceptable accuracy in symptomatic patients in primary health care.
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DOI:
10.1016/j.jinf.2021.02.014
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发表时间:
2021-03
期刊:
The Journal of infection
影响因子:
--
通讯作者:
COVID-19 Primary Care Research Group
COVID-19 Primary Care Research Group
中科院分区:
其他
文献类型:
--
作者:
Bulilete O;Lorente P;Leiva A;Carandell E;Oliver A;Rojo E;Pericas P;Llobera J;COVID-19 Primary Care Research Group

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我们的目的是评估Panbio™ Ag-RDT在初级卫生保健(PHC)中心和检测点对有症状患者和密切接触者的准确性,使用逆转录聚合酶链反应(RT-PCR)检测作为金标准。该研究在西班牙马略卡岛的四个PHC中心和两个测试点进行。纳入了年龄大于18岁的连续性患者,参加了RT-PCR检测。采集了两份鼻咽样本,一份用于RT-PCR,另一份使用Panbio™ SARS-CoV-2快速抗原检测试剂盒进行现场处理。以RT-PCR为参考计算灵敏度和特异性,并以每个分析组的预试验概率结果计算预测值。共纳入1369名受试者;平均年龄42.5 ± 14.9岁,54.3%为女性。总患病率为10.2%。大多数参与者(70.6%)在症状发作后5天内出现。总体敏感性为71.4%(95%CI:63.1%,78.7%),特异性为99.8%(95%CI:99.4%,99.9%),阳性预测值为98.0%(95%CI:93.0%,99.7%),阴性预测值为96.8%(95%CI:95.7%,97.7%)。在有症状的患者中,在症状发作后5天内到达的患者和病毒载量高的患者中,敏感性较高。Ag-RDT在症状出现后5天内的疑似症状患者中具有相对较好的性能特征。然而,我们的数据不支持Panbio™ Ag-RDT单独用于无症状个体。没有一
We aimed to evaluate the accuracy of the Panbio™ Ag-RDT at primary health care (PHC) centers and test sites in symptomatic patients and close contacts, using the Reverse-Transcription Polymerase Chain Reaction (RT-PCR) test as the gold standard. The study was conducted in four PHC centers and two test sites in Mallorca, Spain. Consecutive patients older than 18 years, attending the sites for RT-PCR testing were included. Two nasopharyngeal samples were collected, one for RT-PCR and the other was processed on-site using the Panbio™ rapid antigen test kit for SARS-CoV-2. The sensitivity and specificity were calculated using RT-PCR as the reference, and the predictive values using the pretest probability results for each analyzed group. A total of 1369 participants were included; mean age 42.5 ± 14.9 years and 54.3% women. The overall prevalence was 10.2%. Most participants (70.6%) presented within 5 days of the onset of symptoms. The overall sensitivity was of 71.4% (95% CI: 63.1%, 78.7%), the specificity of 99.8% (95% CI: 99.4%, 99.9%), the positive predictive value of 98.0% (95% CI: 93.0%, 99.7%) and a negative predictive value of 96.8% (95% CI: 95.7%, 97.7%). The sensitivity was higher in symptomatic patients, in those arriving within 5 days since symptom onset and in those with high viral load. Ag-RDT had relatively good performance characteristics in suspected symptomatic patients within five days since the onset of symptoms. However, our data do not support the sole use of Panbio™ Ag-RDT in asymptomatic individuals. None
DOI: 10.1038/s41579-020-00461-z
发表时间: 2021-03
期刊: Nature reviews. Microbiology
影响因子: --
作者:
Vandenberg O;Martiny D;Rochas O;van Belkum A;Kozlakidis Z
通讯作者: Kozlakidis Z
DOI: 10.37201/req/120.2020
发表时间: 2020-12
期刊: Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia
影响因子: --
作者:
Candel FJ;Barreiro P;San Román J;Abanades JC;Barba R;Barberán J;Bibiano C;Canora J;Cantón R;Calvo C;Carretero M;Cava F;Delgado R;García-Rodríguez J;González Del Castillo J;González de Villaumbrosia C;Hernández M;Losa JE;Martínez-Peromingo FJ;Molero JM;Muñoz P;Onecha E;Onoda M;Rodríguez J;Sánchez-Celaya M;Serra JA;Zapatero A
通讯作者: Zapatero A
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