初步建立了人复制蛋白变体(CIZ1-V)的胶乳增强免疫比浊检测方法,用于早期肺癌的检测。用制备的CIZ1-V多克隆抗体(兔抗)与0.13μm粒径的胶乳微球颗粒进行化学偶联,研制CIZ1-V试剂盒,并对试剂盒性能进行鉴定。结果表明,CIZ1-V试剂盒标准曲线呈线型,相关系数R2=0.998 8;检测范围为0.20~8.00μg/m L,灵敏度为0.11μg/m L,检测限为0.20μg/m L。试剂盒对表达纯化所得目的蛋白的回收率范围为98.92%~104.00%,平均100.91%;平均批内及批间变异系数均小于5%,符合国家检测试剂盒标准。试剂盒和Elisa方法对于表达纯化所得目的蛋白的回收率无显著差异(P>0.05),对1 L菌液的CIZ1-V表达量测定结果也无显著差异(P>0.05),为早期肺癌的血清检测做了充分准备。 A latex-enhanced immunoassay method for the detection of early-stage lung cancer was initially established for human replication protein variants (CIZ1-V). The prepared CIZ1-V polyclonal antibody (rabbit anti-rabbit) was chemically coupled with 0.13 μm particle size latex microspheres particles to develop CIZ1-V kit, and the performance of the kit was identified. The results showed that the standard curve of CIZ1-V kit was linear and the correlation coefficient was R2 = 0.998 8. The detection range was 0.20-8.00μg / ml, the sensitivity was 0.11μg / ml and the detection limit was 0.20μg / ml. The recovery rate of the target protein expressed and purified by the kit ranged from 98.92% to 104.00% with an average of 100.91%. The average intra-assay and intra-assay CVs were all less than 5%, which met the national test kit standard. There was no significant difference (P> 0.05) between the kit and Elisa assay for the recovery rate of the target protein (P> 0.05). There was no significant difference in the CIZ1-V expression level in 1 L Serum testing has been fully prepared.