【摘要】：目的:評價人C-肽第1次國際候選標準品(批號13/146)的免疫反應性。方法:采用放射免疫法、酶聯(lián)免疫法、化學發(fā)光免疫法和時間分辨免疫熒光法分析人C-肽第1次國際候選標準品(批號13/146)的效價。結果:本實驗室測定人C-肽第1次國際候選標準品(批號13/146)效價均值為9.98μg·安瓿-1(95%可信限為8.60~11.36),WHO報告中匯總均值為9.78μg·安瓿-1(95%可信限為9.31~10.25)。分別高出經WHO生物標準專家委員會審核通過的最終效價8.64μg·安瓿~(-1)(Ⅱ期研究中采用HPLC標定的結果)約15.5%和13.1%。試劑生產廠商應了解引入通過理化方法而非免疫學方法賦值的C-肽國際標準品(批號13/146)對其校準系統(tǒng)的潛在影響。結論:人C-肽第1次國際候選標準品(批號13/146)具有適宜的免疫活性,適合作為人C-肽免疫分析用國際標準品。
[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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