Microbiology Department, Hospital Universitario 12 de Octubre, Madrid, Spain.
Biomedical Research Institute imas12, Hospital Universitario 12 de Octubre, Madrid, Spain.
PLoS One. 2019 Dec 27;14(12):e0226403. doi: 10.1371/journal.pone.0226403. eCollection 2019.
Respiratory viral infections are the most frequent clinical syndrome affecting both children and adults, and early detection is fundamental to avoid infection-related risks and reduce the healthcare costs incurred by unnecessary antibiotic treatments. In this study, performance characteristics of two commercial methods, the Panther Fusion® assay (Hologic Inc., San Diego, CA, USA) were compared to Allplex™ respiratory panels (Seegene, Seoul, South Korea) for the detection of influenza A (Flu A), influenza B (Flu B), respiratory syncytial virus (RSV), parainfluenza virus (PIV), human metapneumovirus (hMPV), rhinovirus (RV) and adenovirus (AdV) targets. A total of 865 specimens collected prospectively and retrospectively were included, and discordant results were further examined using another commercial product, R-GENE™ respiratory kits (bioMérieux, Marcy l'Etoile, France). There was high agreement between both methods, with 98.6% concordance and a kappa (k) value of 0.9 (95% CI: 0.89-0.92). A specific analysis of both methods for each viral agent demonstrated comparable sensitivity and specificity, both ranging from 0.83 to 1 with good predictive values for the prospective part of the study. Good agreement between both methods was also found for the κ values obtained (ranging from 97.55% to 98.9%), with the lowest for hMPV (k = 0.83, 95% CI: 0.75-0.91) and RV (k = 0.73, 95% CI: 0.65-0.81). Amplification efficiency, measured according to the value of the cycle threshold (Ct) obtained in each of the amplifications in both tests, was significantly better with Panther Fusion for Flu A, Flu B, hMPV and RV. Regarding discordant results, R-GENE showed higher agreement with Panther Fusion-positive specimens (negative for Allplex; n = 28/71, 34.9%) than with Allplex-positive samples (negative for Panther Fusion; n = 7/49, 14.3%). In summary, Panther Fusion proved to be a more efficient fully-automated methodology, requiring shorter hands-on and turnaround times than Allplex.
呼吸道病毒感染是影响儿童和成人的最常见临床综合征,早期检测对于避免感染相关风险和降低不必要抗生素治疗的医疗保健费用至关重要。在这项研究中,比较了两种商业方法的性能特征,即 Panther Fusion® 检测试剂盒(Hologic Inc.,圣地亚哥,加利福尼亚州,美国)和 Allplex™ 呼吸道检测试剂盒(Seegene,首尔,韩国),用于检测甲型流感(Flu A)、乙型流感(Flu B)、呼吸道合胞病毒(RSV)、副流感病毒(PIV)、人偏肺病毒(hMPV)、鼻病毒(RV)和腺病毒(AdV)。总共纳入了 865 份前瞻性和回顾性采集的标本,对不一致的结果使用另一种商业产品 R-GENE™ 呼吸道试剂盒(bioMérieux,马西勒埃托勒,法国)进一步检查。两种方法之间具有高度一致性,一致性为 98.6%,kappa(k)值为 0.9(95%置信区间:0.89-0.92)。对两种方法针对每种病毒的特异性分析表明,敏感性和特异性均相当,均在 0.83 到 1 之间,对前瞻性研究部分具有良好的预测值。两种方法的 κ 值也具有良好的一致性(范围为 97.55%至 98.9%),其中 hMPV 的 κ 值最低(k = 0.83,95%置信区间:0.75-0.91)和 RV(k = 0.73,95%置信区间:0.65-0.81)。根据在两种检测中每个扩增获得的循环阈值(Ct)值, Panther Fusion 在 Flu A、Flu B、hMPV 和 RV 的扩增效率显著更高。关于不一致的结果,R-GENE 与 Panther Fusion 阳性标本(Allplex 阴性;n = 28/71,34.9%)的一致性高于与 Allplex 阳性样本(Panther Fusion 阴性;n = 7/49,14.3%)。总之, Panther Fusion 被证明是一种更有效的全自动方法,与 Allplex 相比,所需的手动操作和周转时间更短。