Accurate detection of influenza A virus by use of a novel cross-priming isothermal amplification-based point-of-care assay
ABSTRACTInfluenza 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 vir...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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American Society for Microbiology
2024-03-01
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| Series: | Microbiology Spectrum |
| Subjects: | |
| Online Access: | https://journals.asm.org/doi/10.1128/spectrum.03074-23 |
| _version_ | 1797276765018652672 |
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| author | Jiankai Deng Hongji Zhu Shu An Hao Huang Ruizhi Wang Yaoming Chen Peisong Chen Xuegao Yu |
| author_facet | Jiankai Deng Hongji Zhu Shu An Hao Huang Ruizhi Wang Yaoming Chen Peisong Chen Xuegao Yu |
| author_sort | Jiankai Deng |
| collection | DOAJ |
| description | ABSTRACTInfluenza 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. |
| first_indexed | 2024-03-07T15:33:59Z |
| format | Article |
| id | doaj.art-b1d78d8f16924e5686a263d2e5dc630f |
| institution | Directory Open Access Journal |
| issn | 2165-0497 |
| language | English |
| last_indexed | 2024-03-07T15:33:59Z |
| publishDate | 2024-03-01 |
| publisher | American Society for Microbiology |
| record_format | Article |
| series | Microbiology Spectrum |
| spelling | doaj.art-b1d78d8f16924e5686a263d2e5dc630f2024-03-05T14:04:36ZengAmerican Society for MicrobiologyMicrobiology Spectrum2165-04972024-03-0112310.1128/spectrum.03074-23Accurate detection of influenza A virus by use of a novel cross-priming isothermal amplification-based point-of-care assayJiankai Deng0Hongji Zhu1Shu An2Hao Huang3Ruizhi Wang4Yaoming Chen5Peisong Chen6Xuegao Yu7Department of Laboratory Medicine, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, ChinaDepartment of Laboratory Medicine, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, ChinaDepartment of Laboratory Medicine, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, ChinaDepartment of Laboratory Medicine, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, ChinaDepartment of Laboratory Medicine, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, ChinaDepartment of Laboratory Medicine, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, ChinaDepartment of Laboratory Medicine, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, ChinaDepartment of Laboratory Medicine, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, ChinaABSTRACTInfluenza 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.https://journals.asm.org/doi/10.1128/spectrum.03074-23influenza viruspoint-of-carecross-priming isothermal amplificationreal-time RT-PCRXpert Xpress Flu/RSV assay |
| spellingShingle | Jiankai Deng Hongji Zhu Shu An Hao Huang Ruizhi Wang Yaoming Chen Peisong Chen Xuegao Yu Accurate detection of influenza A virus by use of a novel cross-priming isothermal amplification-based point-of-care assay Microbiology Spectrum influenza virus point-of-care cross-priming isothermal amplification real-time RT-PCR Xpert Xpress Flu/RSV assay |
| title | Accurate detection of influenza A virus by use of a novel cross-priming isothermal amplification-based point-of-care assay |
| title_full | Accurate detection of influenza A virus by use of a novel cross-priming isothermal amplification-based point-of-care assay |
| title_fullStr | Accurate detection of influenza A virus by use of a novel cross-priming isothermal amplification-based point-of-care assay |
| title_full_unstemmed | Accurate detection of influenza A virus by use of a novel cross-priming isothermal amplification-based point-of-care assay |
| title_short | Accurate detection of influenza A virus by use of a novel cross-priming isothermal amplification-based point-of-care assay |
| title_sort | accurate detection of influenza a virus by use of a novel cross priming isothermal amplification based point of care assay |
| topic | influenza virus point-of-care cross-priming isothermal amplification real-time RT-PCR Xpert Xpress Flu/RSV assay |
| url | https://journals.asm.org/doi/10.1128/spectrum.03074-23 |
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