Polvere Immacolata, Voccola Serena, D'Andrea Silvia, Zerillo Lucrezia, Varricchio Romualdo, Madera Jessica Raffaella, Stilo Romania, Vito Pasquale, Zotti Tiziana
Department of Science and Technologies, University of Sannio, 82100 Benevento, Italy.
Genus Biotech, University of Sannio, 82100 Benevento, Italy.
Diagnostics (Basel). 2022 Mar 7;12(3):650. doi: 10.3390/diagnostics12030650.
Molecular tests are the gold standard to diagnose severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection but are associated with a diagnostic delay, while antigen detection tests can generate results within 20 min even outside a laboratory. In order to evaluate the accuracy and reliability of the FAST COVID-19 SARS-CoV-2 Antigen Rapid Test Kit (Ag-RDT), two respiratory swabs were collected simultaneously from 501 patients, with mild or no coronavirus disease 2019 (COVID-19)-related symptoms, and analyzed with both the Reverse Transcriptase-quantitative Polymerase Chain Reaction (RT-qPCR) and the FAST COVID-19 SARS-CoV-2 Antigen Rapid Test. Results were then compared to determine clinical performance in a screening setting. We measured a precision of 97.41% (95% CI 92.42-99.15%) and a recall of 98.26% (95% CI 93.88-99.25%), with a specificity of 99.22% (95% CI 97.74-99.74%), a negative predictive value of 99.48% (95% CI 97.98-99.87%), and an overall accuracy of 99.00% (95% CI 97.69-99.68%). Concordance was described by a Kappa coefficient of 0.971 (95% CI 0.947-0.996). Considering short lead times, low cost, and opportunities for decentralized testing, the Ag-RDT test can enhance the efforts to control SARS-CoV-2 spread in several settings.
分子检测是诊断严重急性呼吸综合征冠状病毒2（SARS-CoV-2）感染的金标准，但存在诊断延迟问题，而抗原检测测试即使在实验室外也能在20分钟内得出结果。为了评估快速新冠病毒SARS-CoV-2抗原快速检测试剂盒（Ag-RDT）的准确性和可靠性，同时从501例有轻度或无2019冠状病毒病（COVID-19）相关症状的患者中采集两份呼吸道拭子，并分别采用逆转录定量聚合酶链反应（RT-qPCR）和快速新冠病毒SARS-CoV-2抗原快速检测进行分析。然后比较结果以确定筛查环境中的临床性能。我们测得其精确率为97.41%（95%置信区间92.42-99.15%），召回率为98.26%（95%置信区间93.88-99.25%），特异性为99.22%（95%置信区间97.74-99.74%），阴性预测值为99.48%（95%置信区间97.98-99.87%），总体准确率为99.00%（95%置信区间97.69-99.68%）。一致性用Kappa系数0.971（95%置信区间0.947-0.996）表示。考虑到检测时间短、成本低以及分散检测的机会，Ag-RDT检测可在多种环境中加强控制SARS-CoV-2传播的工作。
