【摘要】：目的:評(píng)價(jià)人C-肽第1次國際候選標(biāo)準(zhǔn)品(批號(hào)13/146)的免疫反應(yīng)性。方法:采用放射免疫法、酶聯(lián)免疫法、化學(xué)發(fā)光免疫法和時(shí)間分辨免疫熒光法分析人C-肽第1次國際候選標(biāo)準(zhǔn)品(批號(hào)13/146)的效價(jià)。結(jié)果:本實(shí)驗(yàn)室測定人C-肽第1次國際候選標(biāo)準(zhǔn)品(批號(hào)13/146)效價(jià)均值為9.98μg·安瓿-1(95%可信限為8.60~11.36),WHO報(bào)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(jīng)WHO生物標(biāo)準(zhǔn)專家委員會(huì)審核通過的最終效價(jià)8.64μg·安瓿~(-1)(Ⅱ期研究中采用HPLC標(biāo)定的結(jié)果)約15.5%和13.1%。試劑生產(chǎn)廠商應(yīng)了解引入通過理化方法而非免疫學(xué)方法賦值的C-肽國際標(biāo)準(zhǔn)品(批號(hào)13/146)對其校準(zhǔn)系統(tǒng)的潛在影響。結(jié)論:人C-肽第1次國際候選標(biāo)準(zhǔn)品(批號(hào)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(biāo)準(zhǔn)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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