Primary Health Care Research Unit, Balearic Public Health Service (Ib-Salut), Escola Graduada n9, 07002 Palma, Illes Balears, Spain; Balearic Islands Health Research Institute (IdISBa), Carretera de Valldemossa, 79, 07120 Palma, Illes Balears, Spain.
Primary Health Care Research Unit, Balearic Public Health Service (Ib-Salut), Escola Graduada n9, 07002 Palma, Illes Balears, Spain; Santa Ponça Primary Health Care Center, Balearic Public Health Service (Ib-Salut), Carrer del Riu Síl, 25, 07180 Santa Ponça, Illes Balears, Spain.
J Infect. 2021 Mar;82(3):391-398. doi: 10.1016/j.jinf.2021.02.014. Epub 2021 Feb 13.
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.
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我们旨在评估 Panbio™ Ag-RDT 在初级保健（PHC）中心和检测点的准确性，使用逆转录聚合酶链反应（RT-PCR）检测作为金标准，检测有症状的患者和密切接触者。
该研究在西班牙马略卡岛的四个 PHC 中心和两个检测点进行。纳入年龄大于 18 岁、前往检测点进行 RT-PCR 检测的连续患者。采集两个鼻咽样本，一个用于 RT-PCR，另一个在现场使用 Panbio™ 快速抗原检测试剂盒进行 SARS-CoV-2 检测。使用 RT-PCR 作为参考计算敏感性和特异性，并使用每个分析组的预测试概率结果计算预测值。
共纳入 1369 名参与者；平均年龄 42.5±14.9 岁，54.3%为女性。总体患病率为 10.2%。大多数参与者（70.6%）在症状出现后 5 天内就诊。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%）。在症状患者、症状出现后 5 天内就诊的患者和病毒载量较高的患者中，敏感性较高。
在症状出现后五天内，Ag-RDT 在疑似有症状患者中的表现特征相对较好。然而，我们的数据不支持单独使用 Panbio™ Ag-RDT 检测无症状个体。
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