国产AFP,CEA,β_2-m和TSH RIA kit对比测定研究

Comparison of Results of Radioimmunoassay Performed with NationwideDifferent Commercial Kits for AFP, CEA, β_2-m and TSH

目的:使用国家质控血清和临床未知血清样品对国产甲胎蛋白、癌胚抗原、β2-微球蛋白和促甲状 腺素放射免疫分析试剂盒进行对比测定研究。方法:采用放射免疫分析和免疫放射分析。结果:实验数据来自 本实验室和13个生产商实验室。CEA:7组样品测定均值变异系数在10%～30%之间;β2-m:7组样品测定 均值变异系数在10%～20%之间;AFP:6组质控血清样品测定均值变异系数在15%左右;提示试剂盒之间的 可比性较好。TSH:7组样品测定均值变异系数在20%～40%之间;提示试剂盒之间的可比性较差。结论:本 实验提示CEA、β2-m及AFP试剂盒质量满意,而TSH试剂盒间差异较大,须加强质控。

Objective Study on an external quality assessment program with national quality control sera as standard for the comparison of the radioimmunoassay results obtained with different kits for AFP, CEA, β 2-m and TSH. Methods National quality control sera as well as pooled “unknown” clinical sera specimens were assigned to the national laboratory and different manufacturers’ laboratories (n=13) to be assayed for AFP, CEA, β 2-m and TSH and the results cross-checked. Results With CEA, the coefficient variation (CV) of different sets (n=7) assayed in the national and manufacturers’ laboratories ranged from 10~30%; with β 2-m, the CV ranged 10~20% (sets n=7); with AFP, CV ranged 15%±(n=6). The above data suggested fairly good comparability and reproducibility. However, the results were less satisfactory with TSH assays (CV 20~40%, n=7). Conclusion Present study revealed fairly satisfactory quality with CEA, β 2-m and AFP kits. With TSH kits, the comparability was less satisfactory; the clinical normal ranges in different laboratories should be individualized and internal quality control enforced.