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Abstract：
Influenza virus is known to cause respiratory tract infections of varying severity in individuals of all ages. The EasyNAT Rapid Flu assay is a newly developed in vitro diagnostic test that employs cross-priming isothermal amplification (CPA) to detect and differentiate influenza A and B viruses in human nasopharyngeal (NP) swabs. The aim of this study is to determine the performance characteristics of the EasyNAT Rapid Flu assay for rapid detection of influenza virus. The limit of detection (LOD) and cross-reactivity of the EasyNAT Rapid Flu assay were assessed. The clinical performance of the assay was evaluated using NP swab samples that were tested with real-time reverse-transcription polymerase chain reaction (RT-PCR) and Xpert Xpress Flu/RSV assay. The LOD for the detection of influenza A and B using the EasyNAT Rapid Flu assay was found to be 500 copies/mL. Furthermore, the assay exhibited no cross-reactivity with other common respiratory viruses tested. For the 114 NP swab samples tested for influenza A using both the EasyNAT Rapid Flu assay and real-time RT-PCR, the two assays demonstrated a high level of agreement (κ = 0.963, P < 0.001), with a positive percentage agreement (PPA) of 97.7% and a negative percentage agreement (NPA) of 98.6%. Similarly, for the 43 NP swab samples tested for influenza A and B using both the EasyNAT Rapid Flu assay and Xpert Xpress Flu/RSV assay, the two assays showed a high level of agreement (κ = 0.933, P < 0.001), with the overall rate of agreement (ORA) of 97.7% for influenza A and 100% for influenza B. The EasyNAT Rapid Flu assay demonstrates excellent performance in the detection of influenza A, highlighted by its strong agreement with RT-PCR-based assays.IMPORTANCEThe newly developed EasyNAT Rapid Flu assay is an innovative cross-priming isothermal amplification-based method designed for detecting influenza A and B viruses at point-of-care settings. This study aims to thoroughly assess the analytical and clinical performance of the assay, offering valuable insights into its potential advantages and limitations. The findings of this research hold significant implications for clinical practice.
摘要：
已知流感病毒在所有年龄的个体中引起不同严重程度的呼吸道感染。EasyNAT快速流感测定法是一种新开发的体外诊断测试，它采用交叉引发等温扩增（CPA）来检测和区分人鼻咽（NP）拭子中的甲型和乙型流感病毒。这项研究的目的是确定EasyNAT快速流感测定法用于流感病毒快速检测的性能特征。评估了EasyNAT快速流感测定的检测限（LOD）和交叉反应性。使用用实时逆转录聚合酶链反应(RT-PCR)和XpertXpressFlu/RSV测定测试的NP拭子样品评估测定的临床性能。发现使用EasyNAT快速流感测定法检测甲型和乙型流感的LOD为500拷贝/mL。此外，该试验与其他常见呼吸道病毒无交叉反应.对于使用EasyNAT快速流感测定和实时RT-PCR测试甲型流感的114个NP拭子样品，两种检测方法具有较高的一致性(κ=0.963,P<0.001),正百分比协议（PPA）为97.7%，负百分比协议（NPA）为98.6%。同样，对于使用EasyNAT快速流感测定法和XpertXpress流感/RSV测定法测试甲型和乙型流感的43个NP拭子样品，两种检测方法具有较高的一致性(κ=0.933,P<0.001),甲型流感的总体一致性（ORA）为97.7%，乙型流感的总体一致性（ORA）为100%。突出的是其与基于RT-PCR的测定的强烈一致性。IMPORTANCE新开发的EasyNAT快速流感检测是一种创新的基于交叉引发等温扩增的方法，旨在检测甲型和乙型流感病毒在护理点设置。这项研究旨在彻底评估分析和临床表现的分析，提供对其潜在优势和局限性的宝贵见解。这项研究的结果对临床实践具有重要意义。
