自制铕标记Free β-hCG—TRFIA试剂盒的临床应用研究

Clinic Study β-hCG Quantitative of Home-made Free Diagnostic Kit with TRFIA

目的对自制铕标记Freeβ—hCG—TRFIA定量测定试剂盒进行临床应用研究，为该试剂盒的临床应用提供科学依据。方法收集血清样本1000份，用自制试剂盒进行测定，对照试剂盒选用PE公司钐标记Free β-hCG TRFIA试剂盒，复核试剂选用美国Diognastic Automation公司ELISA试剂盒，获取相关目标实验数据，进行“符合率”、“相关性”等统计学分析。结果以PE公司钐标记法为对照实验，自制试剂盒的高值符合率为78．4％；低值符合率为100％，正常值符合率为95．1％，总符合率为93．8％；两种试剂盒测定值相关性良好，相关系数为0．985。结论自制试剂盒临床检测性能与现行临床广泛应用的方法相仿，可以满足临床应用的需要。

Objective To study the clinical evaluation of home-made quantitative diagnostic kit for human chorionic gonadotropin free β subunit （TRFIA） labeled with Eu. Methods 1 000 serum samples were detected by two kinds of kit. Results Comparing to the Free hCG β labeled with Sm of PerkinElmer（PE） company,the accordant ratio of high value was 84.7% ,the accordant ratio of low value was 100% ,the accordant ratio of normal value was 95.1% and the total accordant ratio was 93. 8% ;The correlation coefficient of two diagnostic kits was 0. 985. Conclusion The developed Free β-hCG- TRFIA kit could meet the need of the clinical application.