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恢复期血浆中新型冠状病毒核酸的提取试剂盒效率比较和检测方法适用性考察
引用本文:姜晓 周桥胜 董德梅 董科成 孙勇 梁雪,秦婷婷 林涛 谢一舟 丁亚凌.恢复期血浆中新型冠状病毒核酸的提取试剂盒效率比较和检测方法适用性考察[J].国际生物制品学杂志,2021,44(1):13-16.
作者姓名:姜晓 周桥胜 董德梅 董科成 孙勇 梁雪  秦婷婷 林涛 谢一舟 丁亚凌
作者单位:成都蓉生药业有限责任公司质量检定部 610041;北京天坛生物制品股份有限公司血源管理中心 100024;武新单采血浆站有限公司,监利 433300;成都蓉生药业有限责任公司科研开发部 610041;成都蓉生药业有限责任公司血浆检测部 610041
摘    要:目的:通过比较提取效率选择新型冠状病毒核酸提取试剂盒,并考察方法对血浆的核酸检测适用性。方法:采用3种不同厂家核酸提取试剂盒对血浆中新型冠状病毒核酸进行提取,使用1种核酸检测试剂盒进行扩增和核酸检测。结果:核衣壳蛋白(nucleocapcid, N)基因片段和开放阅读框1a/b(open reading f...

关 键 词:新型冠状病毒肺炎  恢复期血浆  核酸提取  定量聚合酶链反应

Efficiency comparison of extraction kits and suitability study of detection method for 2019 novel corona virus nucleic acid in convalescent plasma #br#
Institution:Quality Control Department, Chengdu Rongsheng Pharmaceuticals Company, Chengdu 610041, China;  Plasma Test Department, Chengdu Rongsheng Pharmaceuticals Company, Chengdu 610041, China; Plasma Management Center, Beijing Tiantan Biological Products Company, Beijing 100050, China; Wu Xin Blood Station, Jianli 433300, China; Research and Development Department, Chengdu Rongsheng Pharmaceuticals Company, Chengdu 610041, China;
Abstract:Objective  To choose 2019 novel coronavirus (2019-nCoV)nucleic acid extraction kits by comparing their extraction efficiency and to investigate the suitability of detection method for nucleic acid in plasma sample. Methods  The 2019-nCoV nucleic acid in plasma was extracted using 3 different nucleic acid extraction kits. The open reading frame 1a/b (ORF1ab) and nucelocapcid (N) genes were amplified and detected using same nucleic acid detection kit. Results  The correlation coefficients of ORF1ab and N gene fragments standard curve were both ≥ 0.999. Extraction kit A had a recovery rate of 91% for ORF1ab and  38% for N. Kit B had a recovery rate of 104% for ORF1ab and 44% for N. Kit C had a recovery rate of 0% for ORF1ab and 12% for N. The accuracies of kits A and B were both 100%, while kit C was 62.5% attributing to false negative results. Conclusion  Except for kit C, both kits A and B can be used with 2019-nCoV nucleic acid detection kit for virus nucleic acid detection in COVID-19 convalescent plasma.
Keywords:COVID-19  Convalescent plasma  Nucleic acid extraction  Quantitative polymerase chain reaction  
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