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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 immunological reactivity of the first international candidate human C-peptide (lot 13/146). Methods: The titers of the first international candidate human C-peptide (lot 13/146) were analyzed by radioimmunoassay, enzyme-linked immunosorbent assay, chemiluminescence immunoassay and time-resolved immunofluorescence. RESULTS: The first international candidate standard (Lot 13/146) for human C-peptide in our laboratory was 9.98 μg · ampoule -1 (95% confidence interval 8.60 ~ 11.36). The WHO mean value 9.78 μg · ampule-1 (95% confidence interval 9.31-10.25). Respectively, higher than the final titer of 8.64 μg · ampoule (-1) (as determined by HPLC in the phase Ⅱ study) approved by the WHO Biological Standards Committee of Experts, about 15.5% and 13.1%, respectively. Reagent manufacturers should be aware of the potential impact of introducing a C-peptide international standard (Lot 13/146) assigned by physical and chemical methods rather than immunological methods to their calibration system. Conclusion: The first international candidate of human C-peptide (lot 13/146) has suitable immunological activity and is suitable as an international standard for human C-peptide immunoassay.