Department of Laboratory Medicine, Korea University College of Medicine, Seoul, Korea.
Department of Diagnostic Immunology, Seegene Medical Foundation, Seoul, Korea.
Ann Clin Lab Sci. 2021 Jan;51(1):106-111.
Alere i Influenza A&B is an isothermal nucleic acid amplification-based integrated system used for detecting and differentiating between influenza virus A and influenza virus B. We evaluated the clinical performances of Alere i Influenza A&B compared to that of real-time PCR, multiplex real-time PCR, and two rapid influenza diagnostic kits.
Nasopharyngeal aspiration specimens (n=315) from patients with signs of acute respiratory infection were collected between 2015 and 2016. Samples were tested using real-time PCR, the multiplex RT-PCR Anyplex II RV16 Detection kit, Alere i Influenza A&B, BD Veritor™ System Flu A+B, and the Sofia Influenza A+B Fluorescence Immunoassay. Positive influenza specimens detected by the Anyplex II RV16 Detection kit were tested by real-time PCR.
Compared to that of multiplex RT-PCR (influenza A, n=88; influenza B, n=82; influenza-negative, n=145), the sensitivities of Alere i, Sofia, and Veritor for influenza A were 97.7%, 72.7%, and 71.6%, respectively, whereas for influenza B, the sensitivities were 96.3%, 80.4%, and 75.6%, respectively. The specificity of Alere i, Sofia, and Veritor was 100.0%.
The clinical performance of Alere i Influenza A&B is satisfactory, with the advantage of a significantly shorter test time than other molecular assays. It is suitable for point-of-care testing and rapid influenza diagnostic tests because of its high sensitivity and specificity.
Alere i 流感 A&B 是一种等温核酸扩增一体化系统，用于检测和区分流感病毒 A 和流感病毒 B。我们评估了 Alere i 流感 A&B 与实时 PCR、多重实时 PCR 和两种快速流感诊断试剂盒相比的临床性能。
2015 年至 2016 年间，收集了 315 例有急性呼吸道感染迹象的患者的鼻咽抽吸标本。使用实时 PCR、多重 RT-PCR Anyplex II RV16 检测试剂盒、Alere i 流感 A&B、BD Veritor™ System Flu A+B 和 Sofia 流感 A+B 荧光免疫分析试剂盒对样本进行检测。Anyplex II RV16 检测试剂盒检测到的阳性流感样本用实时 PCR 进行检测。
与多重 RT-PCR（流感 A，n=88；流感 B，n=82；流感阴性，n=145）相比，Alere i、Sofia 和 Veritor 对流感 A 的灵敏度分别为 97.7%、72.7%和 71.6%，而对流感 B 的灵敏度分别为 96.3%、80.4%和 75.6%。Alere i、Sofia 和 Veritor 的特异性均为 100.0%。
Alere i 流感 A&B 的临床性能令人满意，其测试时间明显短于其他分子检测方法。由于其高灵敏度和特异性，它适合用于即时检测和快速流感诊断测试。
