甲胎蛋白定量标记免疫分析试剂盒行业标准的实验验证

Experimental verification of the industry standard for alpha-fetoprotein quantitative labelling immunoassay kit

目的:对甲胎蛋白定量标记免疫分析试剂盒行业标准进行实验验证。方法:选择酶联免疫分析法(ELISA)、化学发光免疫分析法(CLIA)、时间分辨荧光免疫分析法(TRFIA)对甲胎蛋白定量标记免疫分析试剂盒行业标准中规定的最低检出限、准确性和精密度等指标进行比较分析,验证行业标准各条款的可行性。结果:行业标准各指标的规定具有一定的合理性,可操作性强,TRFIA原理的试剂盒各指标均能满足行业标准规定的要求,ELISA和CLIA原理的试剂盒准确性指标不能满足要求,尤其是低浓度样品的准确性。结论:甲胎蛋白定量标记免疫分析试剂盒行业标准的制定,有助于该产品质量标准的统一,对该产品的生产、检验、流通等领域的监管提供了依据。

Objective：To verify the efficacy of industry standard for alpha-fetoprotein quantitative labelling immunoassay kit.Methods： Three kinds of kits were used,which included different principle of method such as enzyme-linked immunosorbent assay（ELISA）,chemiluminescent immunoassay（CLIA） and time-resolved fluoroimmuno assay（TRFIA）.The standard was assessed by testing items of lowest detection limit,accuracy,precision et al.Results： Provisions of the industry standard was reasonable and workable.The TRFIA kit could meet all requirements,while accuracy of ELISA and CLIA kits was just partly qualified at high concentration of the sample and was not good at low concentration.Conclusion： The establishment of the industry standard will contribute to the unity of the product quality,and provide a basis for the regulation of production,inspection,distribution and other areas.