Jing Ma, Yan Zhe Hao, Mei Ling Hou, Xiao Shan Zhang, Jing Duan Liu, Hao di Meng, Jiang Bo Chang, Xue Jun Ma, Ji Hua Liu, Qing Jie Ying, Xian Hua Wang, Hong Xia Li, Yu Xi Cao, Xiao Guang Zhang
{"title":"开发用于 SARS-CoV-2 核酸提取和检测的一次性集成装置。","authors":"Jing Ma, Yan Zhe Hao, Mei Ling Hou, Xiao Shan Zhang, Jing Duan Liu, Hao di Meng, Jiang Bo Chang, Xue Jun Ma, Ji Hua Liu, Qing Jie Ying, Xian Hua Wang, Hong Xia Li, Yu Xi Cao, Xiao Guang Zhang","doi":"10.3967/bes2024.070","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>To develop a highly sensitive and rapid nucleic acid detection method for the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).</p><p><strong>Methods: </strong>We designed, developed, and manufactured an integrated disposable device for SARS-CoV-2 nucleic acid extraction and detection. The precision of the liquid transfer and temperature control was tested. A comparison between our device and a commercial kit for SARS-Cov-2 nucleic acid extraction was performed using real-time fluorescence reverse transcription polymerase chain reaction (RT-PCR). The entire process, from SARS-CoV-2 nucleic acid extraction to amplification, was evaluated.</p><p><strong>Results: </strong>The precision of the syringe transfer volume was 19.2 ± 1.9 μL (set value was 20), 32.2 ± 1.6 (set value was 30), and 57.2 ± 3.5 (set value was 60). Temperature control in the amplification tube was measured at 60.0 ± 0.0 °C (set value was 60) and 95.1 ± 0.2 °C (set value was 95) respectively. SARS-Cov-2 nucleic acid extraction yield through the device was 7.10 × 10 <sup>6</sup> copies/mL, while a commercial kit yielded 2.98 × 10 <sup>6</sup> copies/mL. The mean time to complete the entire assay, from SARS-CoV-2 nucleic acid extraction to amplification detection, was 36 min and 45 s. The detection limit for SARS-CoV-2 nucleic acid was 250 copies/mL.</p><p><strong>Conclusion: </strong>The integrated disposable devices may be used for SARS-CoV-2 Point-of-Care test (POCT).</p>","PeriodicalId":93903,"journal":{"name":"Biomedical and environmental sciences : BES","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2024-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Development of an Integrated Disposable Device for SARS-CoV-2 Nucleic Acid Extraction and Detection.\",\"authors\":\"Jing Ma, Yan Zhe Hao, Mei Ling Hou, Xiao Shan Zhang, Jing Duan Liu, Hao di Meng, Jiang Bo Chang, Xue Jun Ma, Ji Hua Liu, Qing Jie Ying, Xian Hua Wang, Hong Xia Li, Yu Xi Cao, Xiao Guang Zhang\",\"doi\":\"10.3967/bes2024.070\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>To develop a highly sensitive and rapid nucleic acid detection method for the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).</p><p><strong>Methods: </strong>We designed, developed, and manufactured an integrated disposable device for SARS-CoV-2 nucleic acid extraction and detection. The precision of the liquid transfer and temperature control was tested. A comparison between our device and a commercial kit for SARS-Cov-2 nucleic acid extraction was performed using real-time fluorescence reverse transcription polymerase chain reaction (RT-PCR). The entire process, from SARS-CoV-2 nucleic acid extraction to amplification, was evaluated.</p><p><strong>Results: </strong>The precision of the syringe transfer volume was 19.2 ± 1.9 μL (set value was 20), 32.2 ± 1.6 (set value was 30), and 57.2 ± 3.5 (set value was 60). Temperature control in the amplification tube was measured at 60.0 ± 0.0 °C (set value was 60) and 95.1 ± 0.2 °C (set value was 95) respectively. SARS-Cov-2 nucleic acid extraction yield through the device was 7.10 × 10 <sup>6</sup> copies/mL, while a commercial kit yielded 2.98 × 10 <sup>6</sup> copies/mL. The mean time to complete the entire assay, from SARS-CoV-2 nucleic acid extraction to amplification detection, was 36 min and 45 s. The detection limit for SARS-CoV-2 nucleic acid was 250 copies/mL.</p><p><strong>Conclusion: </strong>The integrated disposable devices may be used for SARS-CoV-2 Point-of-Care test (POCT).</p>\",\"PeriodicalId\":93903,\"journal\":{\"name\":\"Biomedical and environmental sciences : BES\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-06-20\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Biomedical and environmental sciences : BES\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.3967/bes2024.070\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Biomedical and environmental sciences : BES","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.3967/bes2024.070","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Development of an Integrated Disposable Device for SARS-CoV-2 Nucleic Acid Extraction and Detection.
Objective: To develop a highly sensitive and rapid nucleic acid detection method for the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Methods: We designed, developed, and manufactured an integrated disposable device for SARS-CoV-2 nucleic acid extraction and detection. The precision of the liquid transfer and temperature control was tested. A comparison between our device and a commercial kit for SARS-Cov-2 nucleic acid extraction was performed using real-time fluorescence reverse transcription polymerase chain reaction (RT-PCR). The entire process, from SARS-CoV-2 nucleic acid extraction to amplification, was evaluated.
Results: The precision of the syringe transfer volume was 19.2 ± 1.9 μL (set value was 20), 32.2 ± 1.6 (set value was 30), and 57.2 ± 3.5 (set value was 60). Temperature control in the amplification tube was measured at 60.0 ± 0.0 °C (set value was 60) and 95.1 ± 0.2 °C (set value was 95) respectively. SARS-Cov-2 nucleic acid extraction yield through the device was 7.10 × 10 6 copies/mL, while a commercial kit yielded 2.98 × 10 6 copies/mL. The mean time to complete the entire assay, from SARS-CoV-2 nucleic acid extraction to amplification detection, was 36 min and 45 s. The detection limit for SARS-CoV-2 nucleic acid was 250 copies/mL.
Conclusion: The integrated disposable devices may be used for SARS-CoV-2 Point-of-Care test (POCT).
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