血吸蟲(chóng)病時(shí)間分辨免疫熒光檢測(cè)試劑盒的研制和效能評(píng)價(jià)
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本文關(guān)鍵詞:血吸蟲(chóng)病時(shí)間分辨免疫熒光檢測(cè)試劑盒的研制和效能評(píng)價(jià) 出處:《中國(guó)血吸蟲(chóng)病防治雜志》2017年01期 論文類(lèi)型:期刊論文
更多相關(guān)文章: 日本血吸蟲(chóng) 重組蛋白SjP 雙抗體夾心 時(shí)間分辨免疫熒光分析
【摘要】:目的研制日本血吸蟲(chóng)SjP38的時(shí)間分辨免疫熒光分析(Time-resolved fluoroimmunoassay,TRFIA)試劑盒,并評(píng)價(jià)其效能。方法將抗SjP38的9G7單克隆抗體作為捕獲抗體包被96孔板,Eu~(3+)標(biāo)記1A6單克隆抗體作為檢測(cè)抗體,研制SjP38 TRFIA試劑盒,并評(píng)價(jià)試劑盒的準(zhǔn)確度、靈敏度、精密度、穩(wěn)定性以及與病原學(xué)檢測(cè)方法的符合率等指標(biāo)。結(jié)果自制試劑盒準(zhǔn)確度好,線性范圍為2~1 250 ng/ml,最低檢出濃度為0.14 ng/ml;精密度良好,分析內(nèi)精密度為3.6%~4.6%,分析間精密度為5.1%~6.7%。定性試驗(yàn)表明該試劑盒可在4℃穩(wěn)定半年,37℃穩(wěn)定7 d。自制試劑盒與病原學(xué)檢測(cè)方法的陽(yáng)性符合率為95%,陰性符合率為100%。結(jié)論所研制試劑盒的各項(xiàng)性能及檢測(cè)指標(biāo)均達(dá)到臨床檢驗(yàn)的要求,但臨床推廣使用還有待進(jìn)一步的驗(yàn)證。
[Abstract]:Objective to develop a time-resolved fluoroimmunofluorescence assay (TRFIA) kit for SjP38 of Schistosoma japonicum. Methods 1A6 monoclonal antibody was labeled with 9G7 monoclonal antibody (McAb) of SjP38 as a capture antibody coated with a 96-well plate (Eufon 3) as the detection antibody. SjP38 TRFIA kit was developed, and its accuracy, sensitivity, precision, stability and coincidence rate with etiological detection method were evaluated. The linear range is 1 250 ng / ml and the lowest detectable concentration is 0. 14 ng / ml; The precision was good, the analytical precision was 3.6 and 4.6, and the precision was 5.1 and 6.7.The qualitative test showed that the kit could be stabilized at 4 鈩,
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