关键词: BA.2 BA.5 clinical specimens influenza A omicron variant simultaneous detection

来  源:   DOI:10.1089/vim.2024.0039

Abstract:
It is difficult to differentiate between coronavirus disease 2019 (COVID-19) and influenza based on the symptoms. In the present study, a newly developed antigen rapid diagnostic test (Ag-RDT) called Panbio™ COVID-19/Flu A&B that can simultaneously detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and influenza A/B virus was evaluated. Its accuracy was evaluated using 235 pairs of nasopharyngeal samples collected from patients with respiratory symptoms and fever (>37.5°C). Reverse transcription polymerase chain reaction was used as a reference method to evaluate the accuracy of the SARS-CoV-2 detection. We confirmed the accuracy of the developed Ag-RDT against the Omicron variant where the sensitivity and specificity were 94.8% and 100%, respectively. In addition, to identify the influenza A virus, a noninferiority test was conducted using a commercial Ag-RDT, which has a sensitivity and specificity in comparison with viral culture of 94.8% and 98.4%, respectively. The positive and negative predictive values for influenza A virus were 98.5% and 98.1%, respectively, for the Panbio COVID-19/Flu A&B test. The evaluation of this newly developed Ag-RDT using clinical samples suggests that it has a high efficacy in clinical settings.
摘要:
根据症状很难区分2019年冠状病毒病(COVID-19)和流感。在本研究中,评估了一种新开发的抗原快速诊断测试(Ag-RDT),称为Panbio™COVID-19/FluA&B,该测试可以同时检测严重急性呼吸道综合征冠状病毒2(SARS-CoV-2)和甲型/乙型流感病毒。使用从具有呼吸道症状和发烧(>37.5°C)的患者收集的235对鼻咽样本评估其准确性。使用逆转录聚合酶链反应作为参考方法来评估SARS-CoV-2检测的准确性。我们证实了开发的Ag-RDT对Omicron变体的准确性,其中灵敏度和特异性分别为94.8%和100%,分别。此外,为了识别甲型流感病毒,使用商业Ag-RDT进行了非劣效性测试,与病毒培养相比,其敏感性和特异性分别为94.8%和98.4%,分别。甲型流感病毒阳性预测值和阴性预测值分别为98.5%和98.1%,分别,用于PanbioCOVID-19/流感A&B测试。使用临床样品对这种新开发的Ag-RDT进行的评估表明,它在临床环境中具有很高的疗效。
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