Department of Pathology, University of Texas Medical Branch, Galveston, Texas, USA
Department of Pathology, University of Texas Medical Branch, Galveston, Texas, USA.
J Clin Microbiol. 2018 Feb 22;56(3). doi: 10.1128/JCM.01310-17. Print 2018 Mar.
Rapid detection of group A (GAS) is an integral component of treatment decisions in the clinic, especially in the pediatric population. We prospectively collected 216 specimens from symptomatic, predominantly pediatric patients and evaluated the performance of the Alere i Strep A test (Alere i; Alere Inc., Scarborough, ME) and the BD Veritor system (BD Veritor; Becton, Dickinson and Company, Sparks, MD), with culture results being used as a comparator. Real-time PCR (RT-PCR) was performed as an arbiter in discordant cases. Comprehensive chart review was also done to determine the hypothetical impact of the results on antibiotic use. Alere i had a sensitivity and a specificity of 100% and 91.3%, respectively, and BD Veritor had a sensitivity and a specificity of 76.2% and 93.6%, respectively, when the results were compared to those of GAS culture. Further analysis of discordant results using RT-PCR revealed that while BD Veritor missed 13 confirmed positive cases, Alere i detected 100% ( = 13) of the same cases. Analysis of assay agreement showed that Alere i and BD Veritor had only moderate agreement (agreement = 0.888 [95% confidence interval {CI}, 0.838 to 0.927]; kappa index = 0.689 [95% CI, 0.91 to 0.974]). We also found both the underutilization and the overutilization of antibiotics based on the results of molecular testing. Overall, Alere i showed superior performance over BD Veritor in the detection of GAS pharyngitis and could potentially assist in better antibiotic utilization.
快速检测 A 组链球菌(GAS)是临床治疗决策的重要组成部分,特别是在儿科人群中。我们前瞻性地收集了 216 份来自有症状的、主要是儿科患者的标本,并评估了 Alere i Strep A 试验(Alere i;Alere Inc.,斯卡伯勒,ME)和 BD Veritor 系统(BD Veritor;Becton,Dickinson and Company,斯帕克斯,MD)的性能,以培养结果为比较。实时 PCR(RT-PCR)作为仲裁者用于解决不一致的情况。还进行了全面的图表审查,以确定结果对抗生素使用的假设影响。当将结果与 GAS 培养结果进行比较时,Alere i 的灵敏度和特异性分别为 100%和 91.3%,BD Veritor 的灵敏度和特异性分别为 76.2%和 93.6%。使用 RT-PCR 进一步分析不一致的结果显示,虽然 BD Veritor 错过了 13 例确认的阳性病例,但 Alere i 检测到 100%(= 13)相同的病例。分析测定一致性显示,Alere i 和 BD Veritor 的一致性仅为中度(一致性= 0.888[95%置信区间{CI},0.838 至 0.927];kappa 指数= 0.689[95%CI,0.91 至 0.974])。我们还发现,根据分子检测结果,抗生素的使用既不足也过度。总的来说,Alere i 在检测 GAS 咽炎方面的表现优于 BD Veritor,可能有助于更好地利用抗生素。