Ryu Sook Won, Suh In Bum, Ryu Se-Min, Shin Kyu Sung, Kim Hyon-Suk, Kim Juwon, Uh Young, Yoon Kap Jun, Lee Jong-Han
Department of Laboratory Medicine, Kangwon National University School of Medicine, Chuncheon, Gangwon-do, Korea.
Department of Thoracic and Cardiovascular Surgery, Kangwon National University School of Medicine, Chuncheon, Gangwon-do, Korea.
J Clin Lab Anal. 2018 Feb;32(2). doi: 10.1002/jcla.22234. Epub 2017 Apr 13.
Rapid influenza diagnostic tests (RIDTs) show variable sensitivities in clinical settings. We aimed to compare three digital RIDTs and one conventional RIDT.
We assessed 218 nasopharyngeal swabs from patients between neonates and 90 years old in 2016. Three digital RIDTs were BUDDI, Sofia Influenza A+B Fluorescence Immunoassay, Veritor System Flu A+B assay. One conventional test was the SD Bioline Influenza Ag A/B/A(H1N1/2009). All test results were compared with those from the Anyplex Flu A/B Typing Real-time Detection real-time PCR. The four RIDTs were tested with diluted solutions from the National Institute for Biological Standards and Control (NIBSC) to compare lower detection limit. Cross-reactivity of four RIDTs within other respiratory viruses was identified.
For influenza A, BUDDI, Sofia, Veritor, and Bioline showed 87.7%, 94.5%, 87.7%, and 72.6% sensitivity, and 100%, 97.7%, 96.5%, and 100% specificity. For influenza B, BUDDI, Sofia, Veritor, and Bioline showed 81.7%, 91.7%, 81.7%, and 78.3% sensitivity, and 100%, 95.3%, 100%, and 100% specificity, respectively. Each RIDT could detect diluted NIBSC solution, according to the level of dilution and specific influenza subtypes. Cross-reactivity of four RIDTs with other respiratory viruses was not noted.
Sofia showed the highest sensitivity for influenza A and B detection. BUDDI and Veritor showed higher detection sensitivity than a conventional RIDT for influenza A detection, but similar results for influenza B detection. Further study is needed to compare the test performance of RIDTs according to specific, prevalent influenza subtypes.
快速流感诊断检测(RIDTs)在临床环境中显示出不同的敏感性。我们旨在比较三种数字RIDTs和一种传统RIDT。
2016年,我们评估了218例年龄在新生儿至90岁之间患者的鼻咽拭子。三种数字RIDTs分别为BUDDI、Sofia甲型/乙型流感荧光免疫测定法、Veritor系统甲型/乙型流感检测法。一种传统检测方法是SD Bioline甲型/乙型流感抗原检测试剂盒(A/B/A(H1N1)/流感2009)。所有检测结果均与Anyplex甲型/乙型流感分型实时检测实时聚合酶链反应的结果进行比较。用来自英国国家生物标准与控制研究所(NIBSC)的稀释溶液对这四种RIDTs进行检测,以比较最低检测限。确定了四种RIDTs在其他呼吸道病毒中的交叉反应性。
对于甲型流感,BUDDI、Sofia、Veritor和Bioline的敏感性分别为87.7%、94.5%、87.7%和72.6%,特异性分别为100%、97.7%、96.5%和100%。对于乙型流感,BUDDI、Sofia、Veritor和Bioline的敏感性分别为81.7%、91.7%、81.7%和78.3%,特异性分别为100%、95.3%、100%和100%。根据稀释水平和特定流感亚型,每种RIDT均可检测NIBSC稀释溶液。未发现四种RIDTs与其他呼吸道病毒的交叉反应性。
Sofia对甲型和乙型流感检测的敏感性最高。对于甲型流感检测,BUDDI和Veritor的检测敏感性高于传统RIDT,但对于乙型流感检测结果相似。需要进一步研究根据特定的、流行的流感亚型比较RIDTs的检测性能。