2009年度甲胎蛋白(AFP)体外诊断试剂抽验质量分析

The Quality Analysis of the AFP Reagent of In Vitro Diagnostic Kit in 2009

目的对14家企业的19批次的甲胎蛋白(AFP)体外诊断试剂进行评价,考察我国该类试剂的质量。方法依据产品注册标准和自拟标准对所有试剂进行检测。结果与结论 18批次试剂符合产品注册标准,自拟标准检测16批次试剂符合关于剂量反应曲线的线性相关系数的要求,16批次试剂符合准确性的要求,15批次试剂检测4份临床质控血结果差别显著(P<0.05)。各企业AFP体外诊断试剂产品注册标准存在差异,直接影响产品质量,建议加强该类标准的制修订工作,对三类体外诊断试剂的注册检验实行统一管理。

Objective To evaluate 19 batches AFP reagent produced by 14 companies.Methods To test all the reagents according to the product registration standards and the proposed criteria.Results and Conclusion The results showed that 18 batches of reagents complied with product registration standards,16 batches of reagents complied with dose-response curve of the linear correlation coefficient,another 16 batches of reagents complied with accuracy of the proposed standards,and 15 batches of reagents showed siginicant difference by testing 4 clinical samples（P0.05）.Because the product registration standards of each company varied greatly and affected the quality of the reagent,it was necessary to strengthen the standards-setting and revision,to practice unified management of registration testing on types three of in vitro diagnostic reagents.