Meyer Jakob, Gosert Rainer, Bingisser Roland, Nickel Christian H, Tschudin-Sutter Sarah, Leuzinger Karoline
Emergency Medicine, University Hospital Basel, Basel, Switzerland.
Clinical Virology, University Hospital Basel, Basel, Switzerland.
J Med Virol. 2025 Jul;97(7):e70493. doi: 10.1002/jmv.70493.
Rapid antigen diagnostic tests (RDTs) can rapidly detect respiratory pathogens, allowing for the prompt initiation of infection control measures and the prevention of nosocomial spread within hospital settings. In this study, we prospectively evaluated the diagnostic performance of a combined RDT from AllTest Biotech for the simultaneous detection of SARS-CoV-2, influenza virus (IV-A/B), and respiratory syncytial virus (RSV). We compared its diagnostic performance to the Xpert-Xpress-SARS-CoV-2/Flu/RSV molecular test using 100 naso-oropharyngeal swabs (Ct-values ≤ 35), collected from symptomatic patients with acute respiratory tract infections (RTIs) at our tertiary care hospital. The RDT showed a sensitivity of 60% (95%CI: 43.4%-74.7%) for SARS-CoV-2, with lower sensitivities for RSV at 60.0% (95%CI: 38.9%-78.2%) and IV-A/B at 54.3% (95%CI: 36.9%-70.8%). Higher sensitivities of 100% were achieved for all three viruses in respiratory samples with higher viral loads (Ct-values ≤ 25). The RDT demonstrated high specificity of > 99% for SARS-CoV-2, IV-A/B, and RSV. In conclusion, the Alltest-SARS-CoV-2/IV-A + B/RSV RDT is effective for detecting SARS-CoV-2, IV-A/B, and RSV in samples with high viral loads, but its sensitivity significantly declines at Ct-values above 25. Therefore, negative RDT results should be confirmed with nucleic acid testing in symptomatic patients with RTIs to prevent severe consequences for clinical management.
快速抗原诊断测试(RDTs)能够快速检测呼吸道病原体,有助于及时采取感染控制措施,防止医院环境中的医院内传播。在本研究中,我们前瞻性地评估了AllTest Biotech公司的一种联合RDT对严重急性呼吸综合征冠状病毒2(SARS-CoV-2)、流感病毒(IV-A/B)和呼吸道合胞病毒(RSV)的同时检测诊断性能。我们使用从我们三级护理医院有急性呼吸道感染(RTIs)症状的患者中采集的100份鼻-口咽拭子(Ct值≤35),将其诊断性能与Xpert-Xpress-SARS-CoV-2/流感/RSV分子检测进行比较。该RDT对SARS-CoV-2的敏感性为60%(95%CI:43.4%-74.7%),对RSV的敏感性较低,为60.0%(95%CI:38.9%-78.2%),对IV-A/B的敏感性为54.3%(95%CI:36.9%-70.8%)。对于病毒载量较高(Ct值≤25)的呼吸道样本中的所有三种病毒,敏感性均达到100%。该RDT对SARS-CoV-2、IV-A/B和RSV表现出>99%的高特异性。总之,Alltest-SARS-CoV-2/IV-A + B/RSV RDT在检测病毒载量高的样本中的SARS-CoV-2、IV-A/B和RSV方面是有效的,但其敏感性在Ct值高于25时显著下降。因此,对于有RTIs症状的患者,RDT阴性结果应通过核酸检测进行确认,以防止对临床管理造成严重后果。