cTnI-C质控物制备与评价

Preparation and Performance Evaluation of Control Material for cTnI-C

目的:研制人心肌肌钙蛋白I-C(cTnI-C)质控物,并评价cTnI-C质控物的免疫反应性、均一性和稳定性。方法:使用重组的cTnI-C复合蛋白制备质控品,筛选合适基质和冻干保护剂,获得稳定的cTnI-C质控物。结果:胎牛血清基质更有利于cTnI-C质控物的稳定,添加3%海藻糖可显著提高cTnI-C质控物的热稳定性,质控物瓶间均一性无显著差异(F<2.39),37℃加速条件下可保存14 d,2~8℃贮存有效期为13个月,复溶后在2~8℃下可保存7 d。结论:本研究制备的cTnI-C质控物的免疫反应性、均一性和稳定性良好,可作为cTnI检测系统的校准物和质控物原料,提高临床实验室cTnI检测质量。

Objective:To prepare a lyophilized control material for cardiac troponin I-C(cTnI-C),and evaluate its performance including immunoassay,homogeneity,stability.Methods:Recombinant cTnI-C polypeptides was used to prepare control material.The suitable matrix and lyophilized protective agent were selected to obtain the stable cTnI-C control material.Results:Fetal bovine serum is the more conducive to the stability of cTnI-C quality control material.The addition of 3%trehalose could significantly improve the thermal stability of cTnI-C control material.There was no significant difference in the homogeneity between bottles(F<2.39).It could be stored for 14 days under accelerated conditions at 37℃,the storage validity period was 13 months at 2~8℃,and it can be stored for 7 days at 2~8℃after reconstituted.Conclusion:the cTnI-C control material prepared in this study has good immunoassay,homogeneity and stability,and it can be used as the calibrated material and control material for cTnI detection system,so as to improve the quality of cTnI detection in clinical laboratories.