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目的建立标准化的针对肺炎链球菌荚膜多糖特异性抗体的多型调理吞噬试验(multiplexed opsonophagocytic killing assay,MOPA)方法,并进行验证。方法参照有关组织研究和发布的MOPA实验操作规范(UAB-MOPA),通过菌种鉴定、HL60细胞分化规律的确定、补体筛选、质控血清质控范围的确定,建立本实验室的MOPA实验方法,并对方法进行特异性、线性、精密性、准确性以及耐受性验证。结果工作菌种的所有指标均符合UAB-MOPA操作规范的要求;HL60细胞在分化后3~6 d均可作为工作细胞使用;27531和84321N两批补体可作为工作补体使用;建立了09CS、QC2、B、C和F 5个质控血清的质控范围。方法的特异性、线性、精密性、准确性及耐受性均符合预定指标。结论成功建立了标准化的13价肺炎球菌多型MOPA方法,并进行了验证。
Objective To establish and validate a multiplexed opsonophagocytic killing assay (MOPA) against S. pneumoniae capsular polysaccharide-specific antibodies. Methods According to the MOPA protocol (UAB-MOPA) which was researched and published by the relevant organizations, the method of MOPA was established through the identification of strains, the determination of HL60 cell differentiation, the screening of complement and the quality control of serum quality control. , And the method for specificity, linearity, precision, accuracy and tolerance verification. Results All the indicators of the working strains were in accordance with the requirements of UAB-MOPA. HL60 cells could be used as working cells 3 ~ 6 days after differentiation. 27531 and 84321N two batches of complement could be used as working complement. , B, C and F 5 quality control serum quality control range. The specificity, linearity, precision, accuracy and tolerability of the method are in line with the predetermined target. Conclusion The standard 13-valent pneumococcal polytype MOPA was successfully established and validated.