a Division of Infectious Diseases , Shenzhen Children Hospital , Shenzhen , China.
b Departments of Laboratory Medicine and Internal Medicine , Memorial Sloan-Kettering Cancer Center , New York , NY , USA.
Expert Rev Mol Diagn. 2018 May;18(5):403-409. doi: 10.1080/14737159.2018.1466703. Epub 2018 Apr 24.
The Alere i Influenza A & B assay incorporates the Nicking Enzyme Amplification Reaction technique on the Alere i instrument to detect and differentiate influenza virus (Flu) A and B nucleic acids in specific specimens. Areas covered: The Alere i Influenza A & B assay was cleared by the US Food and Drug Administration for use with nasal swabs (NS) and nasopharyngeal swabs, either directly or in viral transport medium. Notably, direct use on NS was the first ever CLIA-waived nucleic acid-based test. Previously published evaluations have reported sensitivities and specificities of 55.2-100% and 62.5-100% for Flu A and 45.2-100% and 53.6-100% for Flu B, respectively. Expert commentary: The Alere i Influenza A & B assay provides a rapid and simple platform for detection and differentiation of Flu A and B. Efforts are expected to further improve sensitivity and user-friendliness for effective and widespread use in the true point-of-care setting.
Alere i 流感 A&B 检测试剂盒采用了 Nicking 酶扩增反应技术，在 Alere i 仪器上检测并区分特定样本中的流感病毒（Flu）A 和 B 核酸。
美国食品和药物管理局已批准 Alere i 流感 A&B 检测试剂盒用于鼻腔拭子（NS）和鼻咽拭子，可直接使用或在病毒运输介质中使用。值得注意的是，直接使用 NS 是首个获得 CLIA 豁免的基于核酸的检测。先前发表的评估报告分别报告了 Flu A 的灵敏度和特异性为 55.2-100%和 62.5-100%，以及 Flu B 的灵敏度和特异性为 45.2-100%和 53.6-100%。
Alere i 流感 A&B 检测试剂盒为检测和区分 Flu A 和 B 提供了一个快速简单的平台。预计将进一步提高灵敏度和用户友好性，以便在真正的即时护理环境中有效且广泛地使用。
