Department of Pulmonary and Critical Care Medicine, Laboratory of Clinical Microbiology and Infectious Diseases, China-Japan Friendship Hospital, China; Clinical Center for Pulmonary Infections, Capital Medical University, Beijing, China.
Department of Pulmonary and Critical Care Medicine, Laboratory of Clinical Microbiology and Infectious Diseases, China-Japan Friendship Hospital, China.
Int J Infect Dis. 2019 Mar;80:92-97. doi: 10.1016/j.ijid.2018.12.014. Epub 2019 Jan 8.
The Xpert Xpress Flu/RSV assay is released by FDA for rapid detection of influenza A (FluA), influenza B (FluB), and respiratory syncytial virus (RSV). This study aimed to evaluate its clinical performance in comparison to that of the RT-PCR assay cleared by China FDA (CFDA-PCR).
Nasopharyngeal specimens were collected from patients and tested by the two assays side by side. Discordant results were tested with a laboratory-developed real-time PCR for resolution. Viral load in the sample was quantified with a droplet digital PCR.
A total of 658 specimens were involved and gave 94.7%-99.1% agreement between the two assays. The Xpert assay showed higher sensitivity for FluA (100% vs. 89.8%) and FluB detection (100% vs. 95.3%), and also higher accuracy (98.9% vs. 95.7%) for FluA than the CDFA-PCR. The positive and negative predictive values (NPV) for the three viruses ranged from 90.5% to 100% in the two assays, with higher NPV for FluA and FluB in Xpert assay. Moreover, the Xpert Ct values showed a linear correlation with virus titer in specimens tested.
Overall, the Xpert assay is a reliable and sensitive tool for the detection of FluA, FluB and RSV in our clinical settings.
Xpert Xpress Flu/RSV assay 经美国食品药品监督管理局（FDA）批准用于快速检测甲型流感（FluA）、乙型流感（FluB）和呼吸道合胞病毒（RSV）。本研究旨在评估其与中国食品药品监督管理局（CFDA-PCR）批准的 RT-PCR 检测相比的临床性能。
采集患者的鼻咽拭子标本，同时用两种方法进行检测。对不一致的结果采用实验室开发的实时 PCR 检测进行解析。采用数字液滴 PCR 定量检测样本中的病毒载量。
共涉及 658 份标本，两种方法的一致性为 94.7%-99.1%。Xpert 检测法对 FluA（100% vs. 89.8%）和 FluB 检测（100% vs. 95.3%）的敏感性更高，对 FluA 的准确性（98.9% vs. 95.7%）也更高。两种方法对三种病毒的阳性和阴性预测值（NPV）范围为 90.5%-100%，Xpert 检测法对 FluA 和 FluB 的 NPV 更高。此外，Xpert Ct 值与检测标本中的病毒滴度呈线性相关。
总体而言，Xpert 检测法是一种可靠、敏感的工具，可用于我们临床环境中检测 FluA、FluB 和 RSV。
