Hassan Ferdaus, Nguyen Ashley, Formanek Ashley, Bell James J, Selvarangan Rangaraj
Department of Pathology and Laboratory Medicine, Children's Mercy Hospitals and Clinics, Kansas City, Missouri, USA.
J Clin Microbiol. 2014 Mar;52(3):906-10. doi: 10.1128/JCM.02484-13. Epub 2014 Jan 3.
The performance characteristics of two commercially available rapid tests for influenza, the BD Veritor System for Flu A+B (BD) and the Alere BinaxNOW influenza A&B card (BN), were evaluated using 200 frozen clinical specimens collected from January 2011 to June 2012 from pediatric patients. Real-time reverse transcriptase PCR (RT-PCR) was used as the gold standard to evaluate the results obtained by the two different assays. Of the 200 specimens tested, real-time RT-PCR assay detected influenza A or B virus in 116 samples, while BD detected 104 samples and BN detected 84 samples as positive. The overall sensitivity and specificity for detection of both influenza A and B virus in comparison to those of real-time RT-PCR were 89.6% (95% confidence interval [CI], 82.2 to 94.3) and 98.8% (95% CI, 92.6 to 99.9) for BD Veritor and 72.4% (95% CI, 63.2 to 80.0) and 100% (95% CI, 94.5 to 100.0) for BinaxNOW. Workflow analysis indicated that overall processing times for a batch size of 10 specimens were virtually identical between both systems. Overall, these results indicate that the BD Veritor assay was more sensitive than the BinaxNOW assay in detection of influenza A and B viruses in respiratory specimens from pediatric patients.
使用从2011年1月至2012年6月收集的200份儿科患者的冷冻临床标本,对两种市售流感快速检测方法——BD Veritor甲型/乙型流感检测系统(BD)和Alere BinaxNOW甲型/乙型流感检测卡(BN)的性能特征进行了评估。实时逆转录聚合酶链反应(RT-PCR)用作金标准,以评估这两种不同检测方法获得的结果。在检测的200份标本中,实时RT-PCR检测在116份样本中检测到甲型或乙型流感病毒,而BD检测到104份样本呈阳性,BN检测到84份样本呈阳性。与实时RT-PCR相比,BD Veritor检测甲型和乙型流感病毒的总体敏感性和特异性分别为89.6%(95%置信区间[CI],82.2至94.3)和98.8%(95%CI,92.6至99.9),BinaxNOW分别为72.4%(95%CI,63.2至80.0)和100%(95%CI,94.5至100.0)。流程分析表明,两种系统处理10份标本批次的总体处理时间几乎相同。总体而言,这些结果表明,在检测儿科患者呼吸道标本中的甲型和乙型流感病毒方面,BD Veritor检测比BinaxNOW检测更敏感。