肺炎衣原体IgG抗体检测试剂用国家参考品的制备和标定

目的：制备肺炎衣原体（Chlamydia pneumonia，CP）IgG抗体检测试剂的国家参考品。方法：利用国内外9个厂家ELISA试剂和免疫印迹法试剂对候选血浆样本进行筛选和确认，确定肺炎衣原体检测试剂国家参考盘。通过5家试剂生产厂家的协作标定最终确定国家参考品的质量标准，用一种试剂盒对确定的参考品盘的均匀性和稳定性进行全面考察。结果：参考品由10份支阴性参考品、10份阳性参考品、5份最低检测限参考品和1份重复性参考品组成。质量标准为：阴性参考品符合率至少为9/10；阳性参考品符合率至少为9/10；检出下限样本稀释度不低于1：4；连续检测重复性参考品10次，其A值的RSD不高于10.0%。该参考盘均匀性较好，-20℃长期保存稳定性较好，37℃保存影响其稳定性。结论：建立一套适用于ELISA方法的肺炎衣原体IgG抗体检测试剂用国家参考品，可用于该类试剂盒的质量评价。

Objective: To prepare a national reference for detection reagents of IgG antibody against Chlamydia pneumonia (CP). Methods: Candidate plasma samples were screened and confirmed by ELISA reagents and by immunoblotting kits of 9 manufacturers at home and abroad to determine the national reference plates for detection reagents against CP. The quality standard for national references was determined by collaborative calibration of 5 reagent manufacturers. The uniformity and stability of the reference plates were further studied using an ELISA kit. Results: The national reference consisted of 10 negative samples,10 positive samples,5 limit-detecting samples and 1 reproducibility sample,of which the quality standard were as follows:the compliance rate of test results of negative samples was no less than 9/10,the compliance rate of test results of positive samples was no less than 9/10, the dilution of limit-detecting samples was no less than 1:4, and RSD of A values of 10 reproducibility samples was no more than 10.0%. The reference plates had good uniformity and were stable kept at -20℃ and unstable kept at 37℃. Conclusion: A set of national reference for detection reagents of IgG antibody against CP is successfully established,which can be used for the quality evaluation of such kits.

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