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Comparison of the Cepheid Xpert Xpress Flu/RSV assay and commercial real-time PCR for the detection of influenza A and influenza B in a prospective cohort from China

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单位: [1]Department of Pulmonary and Critical Care Medicine, Laboratory of Clinical Microbiology and Infectious Diseases, China-Japan Friendship Hospital, China [2]Clinical Center for Pulmonary Infections, Capital Medical University, Beijing, China [3]Tsinghua University-Peking University Joint Center for Life Sciences, Beijing, China
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关键词: Xpert Xpress Flu/RSV RT-PCR Digital PCR Sensitivity

摘要:
Background: 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). Methods: 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. Results: 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. Conclusion: Overall, the Xpert assay is a reliable and sensitive tool for the detection of FluA, FluB and RSV in our clinical settings. (c) 2019 The Authors. Published by Elsevier Ltd on behalf of International Society for Infectious Diseases. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

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出版当年[2018]版:
大类 | 3 区 医学
小类 | 3 区 传染病学
最新[2025]版:
大类 | 2 区 医学
小类 | 2 区 传染病学
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出版当年[2017]版:
Q2 INFECTIOUS DISEASES
最新[2023]版:
Q1 INFECTIOUS DISEASES

影响因子: 最新[2023版] 最新五年平均[2021-2025] 出版当年[2017版] 出版当年五年平均[2013-2017] 出版前一年[2016版] 出版后一年[2018版]

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第一作者单位: [1]Department of Pulmonary and Critical Care Medicine, Laboratory of Clinical Microbiology and Infectious Diseases, China-Japan Friendship Hospital, China [2]Clinical Center for Pulmonary Infections, Capital Medical University, Beijing, China
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通讯机构: [1]Department of Pulmonary and Critical Care Medicine, Laboratory of Clinical Microbiology and Infectious Diseases, China-Japan Friendship Hospital, China [2]Clinical Center for Pulmonary Infections, Capital Medical University, Beijing, China [3]Tsinghua University-Peking University Joint Center for Life Sciences, Beijing, China [*1]Department of Pulmonary and Critical Care Medicine, China-Japan Friendship Hospital, No. 2, East Yinghua Road, Chaoyang District, Beijing 100029, China
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