Division of Infectious Diseases, The Miriam Hospital, Providence, Rhode Island, USA
Department of Medicine, Warren Alpert School of Medicine, Brown University, Providence, Rhode Island, USA.
J Clin Microbiol. 2018 Jul 26;56(8). doi: 10.1128/JCM.00787-18. Print 2018 Aug.
Accurate and rapid diagnosis is needed for timely intervention and clinical management of acute respiratory infections. This study evaluated performance characteristics of the Panther Fusion assay for the detection of influenza A virus (Flu A), influenza B virus (Flu B), respiratory syncytial virus (RSV), parainfluenza viruses 1 to 3 (Para 1 to 3), human metapneumovirus (hMPV), rhinovirus (RV), and adenovirus (Adeno) targets in comparison to those of the eSensor and Lyra assays using 395 nasopharyngeal (NP) and 104 lower respiratory tract (LRT) specimens. Based on the consensus positive result established (positive result in 2 of the 3 assays), the NP specimens for the Fusion and eSensor assays had 100% positive percent agreement (PPA) for all the analytes and the Lyra assays had 100% PPA for Flu A and Adeno analytes. A 100% negative percent agreement (NPA) was observed for all the Lyra analytes, whereas those for the Fusion targets ranged from 98.4 to 100% and those for the eSensor ranged from 99.4 to 100% for all the analytes except RV. For the LRT specimens, Fusion had 100% PPA and 100% NPA for all the targets except hMPV. There was a 100% PPA for eSensor analytes; the NPA ranged from 98 to 100%, except for RV. For the Lyra assays, the PPA ranged between 50 and 100%, while the NPA was 100% for all the targets except Adeno. The Fusion assay performed similarly to the eSensor assay for majority of the targets tested and provides laboratories with a fully automated random-access system to test for a broad array of viral respiratory pathogens.
为了及时进行干预和临床管理急性呼吸道感染，需要准确和快速的诊断。本研究评估了 Panther Fusion 检测试剂盒用于检测流感 A 病毒（Flu A）、流感 B 病毒（Flu B）、呼吸道合胞病毒（RSV）、副流感病毒 1 到 3（Para 1 到 3）、人偏肺病毒（hMPV）、鼻病毒（RV）和腺病毒（Adeno）与 eSensor 和 Lyra 检测试剂盒的性能特征，使用了 395 份鼻咽（NP）和 104 份下呼吸道（LRT）标本。基于建立的共识阳性结果（3 种检测方法中有 2 种为阳性），Fusion 和 eSensor 检测试剂盒的 NP 标本对所有分析物的阳性百分符合率（PPA）为 100%，Lyra 检测试剂盒对 Flu A 和 Adeno 分析物的 PPA 为 100%。所有 Lyra 分析物的阴性百分符合率（NPA）均为 100%，而 Fusion 检测的所有目标的 NPA 范围为 98.4%至 100%，eSensor 的 NPA 范围为 99.4%至 100%，除了 RV 之外，所有分析物的 NPA 范围均为 99.4%至 100%。对于 LRT 标本，Fusion 对所有目标的 PPA 为 100%，NPA 为 100%，除了 hMPV 之外。eSensor 分析物的 PPA 为 100%，NPA 范围为 98%至 100%，除了 RV 之外。对于 Lyra 检测试剂盒，PPA 范围在 50%至 100%之间，而除了 Adeno 之外，所有目标的 NPA 均为 100%。Fusion 检测试剂盒的性能与大多数测试目标的 eSensor 检测试剂盒相似，为实验室提供了一个全自动的随机存取系统，用于检测广泛的病毒呼吸道病原体。
