Preparation and validation of a national reference for nucleic acid test reagent of Streptococcus pneumoniae
LI Kang* HUANG Yang* WANG Chun’e LI Jiangjiao LIANG Li CHEN Chi LIU Rufeng YE Qiang
Division of Bacterial Polysaccharide and Conjugate Vaccines, Institute for Biological Product Control, National Institutes for Food and Drug Control, Beijing 102629, China
Abstract：Objective To prepare a national reference for nucleic acid test reagent of Streptococcus pneumoniae and validate its applicability. Methods Ten strains of Streptococcus pneumoniae and ten strains of non-Streptococcus pneumoniae were selected to prepare positive reference, negative reference, repeatable reference and minimum detection limit reference. The uniformity and stability of the reference package was evaluated. The accuracy, specificity, reproducibility and minimum detection limit of the prepared national reference of Streptococcus pneumoniae were validated by using nucleic acid detection kits of Streptococcus pneumoniae produced by four enterprises. Results The packing uniformity of the reference was good, and the coefficient of variation of the cycle threshold values were all within 5.00%. The stability of the reference was not affected by being placed for three or seven days at 2-8℃，room temperature (25℃) and 37℃ and repeated freezing-thawing for three or five times. The accuracy, specificity and reproducibility of the kits from the four enterprises were all in line with the requirements. The minimum detection limit of the kits from one enterprise was 1.0×104/mL, and the minimum detection limit of the kits from the other three enterprises was 1.0×103/mL. Conclusion A set of national reference reagents for nucleic acid test reagent of Streptococcus pneumoniae has been prepared, which can be used for the quality control and evaluation of Streptococcus pneumoniae nucleic acid detection kits.
李康* 黄洋* 王春娥 李江姣 梁丽 陈驰 刘茹凤 叶强. 肺炎链球菌核酸检测试剂国家参考品的研制及验证[J]. 中国医药导报, 2021, 18(15): 141-144.
LI Kang* HUANG Yang* WANG Chun’e LI Jiangjiao LIANG Li CHEN Chi LIU Rufeng YE Qiang. Preparation and validation of a national reference for nucleic acid test reagent of Streptococcus pneumoniae. 中国医药导报, 2021, 18(15): 141-144.
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