人C-肽第1次国际标准品协作标定Ⅲa期研究

发布时间：2018-11-19 14:48

【摘要】：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。
[Abstract]:Aim: to evaluate the immunoreactivity of the first international candidate standard for human C-peptide (batch 13 / 146). Methods: radioimmunoassay, enzyme-linked immunosorbent assay (Elisa), chemiluminescence immunoassay (CLIA) and time-resolved immunofluorescence (TSR) were used to analyze the titers of the first international candidate standard for human C- peptide (batch 13 / 146). Results: the average titer of the first international standard for human C- peptide (batch 13 / 146) was 9.98 渭 g ampoule-1 (95% confidence limit 8.60% 11.36). The average aggregate value in WHO report was 9.78 渭 g ampoul (95% confidence limit of 9.31 渭 g). The final titers of 8.64 渭 g ampoule ~ (-1) approved by WHO Biological Standards expert Committee (the results of HPLC calibration in stage 鈪，

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