人C-肽第1次国际标准品协作标定Ⅲa期研究

目的：评价人C-肽第1次国际候选标准品（批号13/146）的免疫反应性。方法：采用放射免疫法、酶联免疫法、化学发光免疫法和时间分辨免疫荧光法分析人C-肽第1次国际候选标准品（批号13/146）的效价。结果：本实验室测定人C-肽第1次国际候选标准品（批号13/146）效价均值为9.98μg·安瓿^-1（95%可信限为8.60~11.36），WHO报告中汇总均值为9.78μg·安瓿^-1（95%可信限为9.31~10.25）。分别高出经WHO生物标准专家委员会审核通过的最终效价8.64μg·安瓿^-1（Ⅱ期研究中采用HPLC标定的结果）约15.5%和13.1%。试剂生产厂商应了解引入通过理化方法而非免疫学方法赋值的C-肽国际标准品（批号13/146）对其校准系统的潜在影响。结论：人C-肽第1次国际候选标准品（批号13/146）具有适宜的免疫活性，适合作为人C-肽免疫分析用国际标准品。

Objective: To evaluate the immunoreactivity of the first international candidate standard for human C-peptide, lot No. 13/146. Methods: The content of the first international candidate standard for human C-peptide (lot No.13/146)was tested by radioimmunoassay, immunoenzymetric assay, time-resolved fluoroimmunometric assay and chemiluminescence immunoassay. Results: The first international candidate standard for human C-peptide(lot No. 13/146)was detected in this laboratory, and the mean content of immunoreactivity was 9.98 μg per ampoule(95% confidence limits 8.60~11.36). WHO reports gave a mean content of 9.78 μg per ampoule (95% confidence limits 9.31~10.25). These were approximately 15.5% and 13.1% higher than the final estimated content(8.64 μg per ampoule, assigned by HPLC in Phase Ⅱ study)released by WHO Expert Committee on Biological Standardization, respectively. Manufacturers should be aware of the potential impact on their calibration system when utilizing human C-peptide(lot No.13/146), which has been calibrated using physicochemical methods instead of the immunological method. Conclusion: The human C-peptide candidate standard(lot No. 13/146)has appropriate immunological activity and is thus suitable to serve as a human C-peptide international standard for immuno-analysis.