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| 白喉棒杆菌核酸检测试剂用国家参考品的研制 |
| Development of national reference for Corynebacterium diphtheriaeNucleic Acid Test Kit |
| 投稿时间：2022-02-17 修订日期：2023-12-22 |
| DOI： |
| 中文关键词: 白喉棒杆菌 国家参考品 均匀性 稳定性 |
| 英文关键词: Corynebacterium diphtheriae National reference materials Uniformity Stability |
| 基金项目:“艾滋病和病毒性肝炎等重大传染病防治科技重大专项” (2018ZX10102-001; 2018ZX10734404); 国家科技基础条件平台--国家菌种资源库(国家菌种资源库-NMRC-2021-2) |
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| 中文摘要: |
| 目的 研制白喉棒杆菌核酸检测试剂用国家参考品。方法 将6株白喉棒杆菌和10株非白喉棒杆菌代表性菌株在各自适宜的环境下培养,经菌株鉴定后,制备灭活菌液,对候选参考品进行均匀性和稳定性的评估以及准确性、特异性、重复性和最低检出限的验证研究,并组织3家实验室进行协作标定。结果 研制了由6个阳性参考品、10个阴性参考品、最低检出限参考品和重复性参考品组成的白喉棒杆菌核酸检测试剂用候选参考品。并证实该候选参考品均匀性及稳定性良好, 准确性、特异性及重复性好,最低检出限可达1.0×103~1.0×104个菌/mL。协作标定结果也进一步表明阳性、阴性、重复性和最低检出限候选参考品均符合国家参考品的各项要求。结论 成功研制白喉棒杆菌核酸检测试剂参考品,可用于相关试剂盒的质量控制和评价。 |
| 英文摘要: |
| Objective To develop national reference for Corynebacterium diphtheriae Nucleic Acid Test Kit. Methods Six strains of C. diphtheriae and 10 strains of non-C. diphtheriae were cultured in the suitable environments. After identification and prepared the inactivated bacterial sotion, The reference samples were evaluated for uniformity and stability. And the accuracy, specificity, repeatability and minimum detection limit of the reference were verified with C.diphtheriae nucleic acid detection reagent. 3 laboratories were organized to carry out collaborative calibration. Results A national reference for Corynebacterium diphtheriae Nucleic Acid Test Kit were developed, of which included six 6 positive references,10 negative references, minimum detection limit references and repetitive references. There were good uniformity and stability of the reference materials, and the minimum detection limit can reach 1.0×103~1.0×104 bacteria /mL. The results of collaborative calibration also showed that the candidate reference materials of positive, negative, repeatability and minimum detection limit met the requirements of national reference materials.Conclusion The developed reference materials was successfully developed,which can be used for the quality evaluation of Corynebacterium diphtheriae nucleic acid detection reagent. |
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