Nam Myung-Hyun, Jang Jin Woo, Lee Jong-Han, Cho Chi Hyun, Lim Chae Seung, Kim Woo Joo
Department of Laboratory Medicine, Korea University Medical School, Korea University Guro Hospital, Guro 2 Dong, GuroGu, Seoul 152-703, Republic of Korea.
Department of Laboratory Medicine, Korea University Medical School, Korea University Guro Hospital, Guro 2 Dong, GuroGu, Seoul 152-703, Republic of Korea.
J Virol Methods. 2014 Aug;204:86-90. doi: 10.1016/j.jviromet.2014.04.009. Epub 2014 Apr 18.
Early identification of influenza is important for optimal patient management and infection control. Rapid influenza antigen tests have been used routinely in clinical settings to confirm clinical suspicion, despite their low sensitivity. To improve sensitivity, various influenza point-of-care test reader systems have been developed. This study evaluated the clinical performance of a digital readout rapid influenza diagnostic test (RIDT), the BD Veritor™ System Flu A+B assay (BD). Nasopharyngeal swabs taken from 250 patients (influenza A positive, n=75; influenza B positive, n=75; and influenza negative, n=100) were analyzed using the BinaxNOW® Influenza A/B antigen kit (BN), SD Influenza Ag A/B kit (SD), BD, real-time reverse transcriptase polymerase chain reaction (RT-PCR), and an influenza virus culture. Compared to RT-PCR, the sensitivities of BN, SD, and BD were 56.0, 53.3, and 72.0%, respectively, for influenza A and 57.3, 65.3, and 69.3%, respectively, for influenza B. No false-positive results were noted with the three rapid antigen tests. For influenza A, the average RT-PCR threshold cycle (Ct) for specimens that tested positive using BD was higher than that for specimens that tested positive using BN and SD. BD is a sensitive and easy method for the early detection of influenza A and B.
早期识别流感对于优化患者管理和感染控制至关重要。尽管快速流感抗原检测灵敏度较低，但在临床环境中已常规用于确认临床怀疑。为提高灵敏度，已开发出各种流感即时检测读取系统。本研究评估了一种数字读出快速流感诊断检测（RIDT）——BD Veritor™ 系统甲型/乙型流感检测试剂（BD）的临床性能。使用BinaxNOW® 甲型/乙型流感抗原试剂盒（BN）、SD甲型/乙型流感抗原试剂盒（SD）、BD、实时逆转录聚合酶链反应（RT-PCR）和流感病毒培养法，对从250名患者（甲型流感阳性，n = 75；乙型流感阳性，n = 75；流感阴性，n = 100）采集的鼻咽拭子进行分析。与RT-PCR相比，BN、SD和BD对甲型流感的灵敏度分别为56.0%、53.3%和72.0%，对乙型流感的灵敏度分别为57.3%、65.3%和69.3%。三种快速抗原检测均未发现假阳性结果。对于甲型流感，使用BD检测呈阳性的标本的平均RT-PCR阈值循环数（Ct）高于使用BN和SD检测呈阳性的标本。BD是早期检测甲型和乙型流感的一种灵敏且简便的方法。
