【摘要】 目的:血清超敏C-反应蛋白(CRP)时间分辨荧光免疫分析(TRFIA)法的建立.方法:采用双抗体夹心法检测血清CRP水平(1株抗CRP的单抗用于包被微孔板,另1株抗CRP的单抗用于Eu3+标记).结果:TRFIA的线性测量范围为1~1000mg/L,灵敏度为0.06mg/L,批内和批间精密度分别为4.0%~7.2%,6.7%~10.8%.与人IgG和白蛋白未见明显的交叉反应.109份血清标本用本方法与国外试剂盒同时检测,其相关系数为0.916.结论:CRP-TRFIA各项指标均达到临床检测要求,可替代国外产品试剂盒,用于临床血清CRP的测定.更多还原

【Abstract】 AIM: To establish two-site time-resolved fluoroimmunoassay (TRFIA) of high sensitive C-reactive protein (CRP) in serum based on direct sandwich technique. METHODS: The sandwich technique was used to detect serum CRP level (One mAb was immobilized on the surface of microtiter plate wells, and the other mAb was labelled with Eu3+). RESULTS: The linear measurement range of CRP-TRFIA was 1-1000 mg/L. The sensitivity was 0.06 mg/L. The intra- and inter-assay coefficients of variation were 4.0%-7.2% and 6.7%-10.8%, respectively. There was no cross reactivity with human IgG and albumin. The correlation coefficient of 109 blood samples detection results between CRP-TRFIA and commercially available CRP-ELISA kit(IBL) was 0.916. CONCLUSION: CRP-TRFIA is a new immunoassay which has several advantages including high sensitivity, specificity, and wide working range. It is suitable for routine clinical use instead of hs-CRP kit produced by IBL company.更多还原