Berry Gregory J, Oladipo Olajumoke, Wittnebert Debbie, Loeffelholz Michael J, Petersen John R
Department of Pathology, University of Texas Medical Branch, Galveston, TX.
Current affiliation: Northwell Health, Department of Pathology and Laboratory Medicine, Lake Success, NY.
J Appl Lab Med. 2017 May 1;1(6):735-739. doi: 10.1373/jalm.2016.022350.
The use of point-of care testing (POCT) in patient management decisions is becoming increasingly common. Our goal was to evaluate the diagnostic performance of 2 commercially available rapid POCT devices for influenza viruses A and B: the Alere™ i Instrument (Alere, Scarborough) and the BD Veritor™ System (BD Diagnostics).
Paired nasopharyngeal swabs were collected from patients (18-71 years) presenting with influenza-like symptoms at 3 outpatient clinics. A total of 65 samples were obtained. The Alere i and BD Veritor were performed according to the manufacturers' instructions. Discordant results were resolved using real-time reverse transcription PCR (RT-PCR).
In a head-to-head comparison involving symptomatic adult patients visiting outpatient clinics during the 2014-2015 and 2015-2016 influenza seasons, the Alere i and BD Veritor had 90.63% agreement in the detection of influenza A virus and a statistically significant observed κ coefficient of 0.754 (P <0.0001). Discordant results between the Alere i and BD Veritor were further investigated using RT-PCR, showing that the BD Veritor missed 5 positive influenza A virus results (false negatives) and detected 1 false positive, while the Alere i results agreed with all RT-PCR results. There were no discordant results between the Alere i and BD Veritor in the detection of influenza B virus.
Our data suggest that the Alere i has higher sensitivity and specificity than the BD Veritor in the detection of influenza A virus. Both assays showed equal performance in the detection of influenza B virus.
即时检验(POCT)在患者管理决策中的应用越来越普遍。我们的目标是评估两种市售的甲型和乙型流感病毒快速POCT设备的诊断性能:Alere™ i仪器(Alere,士嘉堡)和BD Veritor™系统(BD诊断)。
从3家门诊诊所出现流感样症状的患者(18 - 71岁)中采集配对的鼻咽拭子。共获得65份样本。Alere i和BD Veritor按照制造商的说明进行检测。不一致的结果通过实时逆转录聚合酶链反应(RT-PCR)解决。
在2014 - 2015年和2015 - 2016年流感季节对门诊有症状成年患者进行的直接比较中,Alere i和BD Veritor在甲型流感病毒检测中的一致性为90.63%,观察到的κ系数具有统计学意义,为0.754(P <0.0001)。使用RT-PCR进一步研究Alere i和BD Veritor之间不一致的结果,结果显示BD Veritor漏检了5份甲型流感病毒阳性结果(假阴性)并检测到1例假阳性,而Alere i的结果与所有RT-PCR结果一致。在乙型流感病毒检测中,Alere i和BD Veritor之间没有不一致的结果。
我们的数据表明,在甲型流感病毒检测中,Alere i比BD Veritor具有更高的灵敏度和特异性。两种检测方法在乙型流感病毒检测中表现相当。