Savolainen Laura E, Peltola Joanna, Hilla Risto, Åman Tapio, Broas Markku, Junttila Ilkka S
NordLab, Oulu, Finland.
NordLab, Rovaniemi, Finland.
Microbiol Spectr. 2025 Jan 7;13(1):e0163024. doi: 10.1128/spectrum.01630-24. Epub 2024 Nov 26.
Rapid antigen tests (RATs) might provide rapid, low-cost, and easy-to-perform choice to nucleic-acid amplification methods (NAAT) in point-of-care (POC) diagnostics of respiratory infections. The clinical performance of two commercial combo-RATs for influenza A and B, respiratory syncytial virus (RSV) and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) POC diagnostics, was assessed. RAT and real-time-PCR (RT-PCR) analysis were performed on 620 patients admitted to the emergency department due to respiratory symptoms. The sensitivity and specificity of the RATs compared with RT-PCR results were studied. The sensitivity of the RATs with respect to symptom duration was also estimated. The tested RAT1 showed sensitivities of 98.68%, 73,53%, and 44.44% for SARS-CoV-2, influenza A, and RSV, respectively, when the cycle threshold (Ct) values were <25 and 95.45%, 68.42%, 40.0% with Ct values <30. In RAT2 analysis, respective sensitivities for influenza A and RSV in samples with Ct <25 were 85% and 100% and in samples with Ct <30 respective sensitivities dropped to 69.23% and 66.67%. Positive SARS-CoV-2 cases during the RAT2 testing period and influenza B cases during both the RAT1 and RAT2 testing periods were scarce, so they were omitted from the statistical analysis. The specificity of both tested RATs was high and varied between 99.48% and 100%. The clinical use of RATs should be carefully considered due to the possibility of insufficient sensitivity. Because the specificity of the tests is high, the use of such tests might provide added value, for example, in emergency units, particularly when the prevalence of these infections is high. However, an option to confirm negative RAT by NAAT should be available.
Rapid diagnostics of respiratory viruses is essential for clinical management, infection control, and epidemiological surveillance. Our results showed that due to the high specificity and still inadequate sensitivity, rapid antigen tests (RATs) might be useful for influenza, respiratory syncytial virus, and severe acute respiratory syndrome coronavirus 2 point-of-care diagnostics when correctly used. The results provide useful information for laboratory and infectious disease control professionals to support decision-making when implementation of the RATs in clinical use is planned.
在呼吸道感染的即时检测（POC）诊断中，快速抗原检测（RAT）可能为核酸扩增方法（NAAT）提供快速、低成本且易于操作的选择。评估了两种用于甲型和乙型流感、呼吸道合胞病毒（RSV）和严重急性呼吸综合征冠状病毒2（SARS-CoV-2）POC诊断的商用组合RAT的临床性能。对620名因呼吸道症状入住急诊科的患者进行了RAT和实时荧光定量聚合酶链反应（RT-PCR）分析。研究了RAT与RT-PCR结果相比的敏感性和特异性。还估计了RAT对症状持续时间的敏感性。当循环阈值（Ct）值<25时，测试的RAT1对SARS-CoV-2、甲型流感和RSV的敏感性分别为98.68%、73.53%和44.44%，当Ct值<30时，敏感性分别为95.45%、68.42%、40.0%。在RAT2分析中，Ct<25的样本中甲型流感和RSV的敏感性分别为85%和100%，在Ct<30的样本中，敏感性分别降至69.23%和66.67%。RAT2检测期间的SARS-CoV-2阳性病例以及RAT1和RAT2检测期间的乙型流感病例较少，因此在统计分析中被省略。两种测试的RAT的特异性都很高，在99.48%至100%之间变化。由于可能存在敏感性不足的情况，应谨慎考虑RAT的临床应用。因为检测的特异性很高，所以使用此类检测可能会提供附加价值，例如在急诊科，特别是当这些感染的患病率很高时。然而，应该有通过NAAT确认RAT阴性结果的选项。
呼吸道病毒的快速诊断对于临床管理、感染控制和流行病学监测至关重要。我们的结果表明，由于特异性高但敏感性仍然不足，快速抗原检测（RAT）在正确使用时可能对流感、呼吸道合胞病毒和严重急性呼吸综合征冠状病毒2的即时诊断有用。这些结果为实验室和传染病控制专业人员在计划将RAT应用于临床时提供了有用信息，以支持决策。
