国产甘油三酯和高密度脂蛋白胆固醇检测试剂质量的调查和评价

Evaluation of the Quality of Home-made Triglyceride and HDL-cholesterol Detection Reagents

为了解国产TG检测试剂和HDL-C检测试剂的批内精密度和准确度,对国内生产的61个TG检测试剂和44个HDL-C检测试剂,分别与厂家指定的校准品、质控品和日立7180全自动生化分析仪组成检测系统,用新鲜混合血清和国家标准物质对各试剂进行批内精密度、准确度评价。结果表明,61个TG试剂的CV均<5%,其中16个试剂的偏倚<±5%,48个试剂的总误差<15%;44个HDL-C试剂的CV均<4%,其中11个试剂的偏倚<±5%,22个试剂的总误差<13%。国产TG检测试剂和HDL-C检测试剂的批内精密度可以接受,然而在检测同一个样品时,可比性差,国产TG和HDL-C试剂整体上还无法做到准确可比。因此,国内体外诊断试剂的生产厂家应利用已获公认的参考测量系统,以建立检测系统的溯源性。

To evaluate the analytical performance of home-made Triglyceride（TG） and HDL-cholesterol（HDL-C） detection reagents,all the reagents with the calibrators and controls were performed following manufactures＇ instruction on a Hitachi 7180 automatic chemistry analyzer to analysis the repeatability and accuracy.The results showed that all TG reagents demonstrated CV5%,the bias of 16 Reagents±5%,and the total error of 48 Reagents 15%.All HDL-cholesterol reagents demonstrated CV4%,the bias of 11 reagents ±5%,and the total error of 22 reagents13%.The TG and HDL-C home-made reagents have been shown to be reasonably precise,but with poor comparable.Therefore manufactures of in vitro diagnostic reagents should apply reference measurement systems and construct the traceability in clinical medicine.