自建与配套检测系统生化结果一致性探讨

目的探讨实现国产科美试剂在贝克曼LX20生化分析仪上与原装试剂测定结果一致性的方法。方法以贝克曼原装试剂测定混合血清作为量值传递载体,用其校准科美试剂后对RANDOX校准品赋值,并以赋值后的RANDOX校准品、科美试剂组成自建系统,与原装试剂系统进行检测结果的比对分析。结果在总蛋白(TP)、白蛋白(A lb)、血糖(G lu)、尿素(Urea)、胆固醇(Chol)、三酰甘油(TG)、尿酸(UA)7个项目中,除UA在低水平处与原装试剂差异较大外,其余各项目在其可报告范围内与原装试剂具有较好的一致性。结论通过量值传递后,在贝克曼生化分析仪上国产科美试剂具有与原装试剂临床意义一致的测定结果。

The coincidence of the results from Beckman automatic biochemical analyzer using Kemei reagent and Beckman reagent

Objective To study the coincidence of the results from Beckman LX20 automatic biochemical analyzer using Kemei reagent and Beckman reagent. Methods Fresh mixed patient sera used as temporary calibrator was determined by Beckman reagent and Kemei reagent.The value of RANDOX calibrator was gotten from the calibrated Kemei reagent system and applied in it.Glucose(Glu),triglyceride(TG),cholesterol(Chol),urea,total protein(TP),albumin(Alb) and uric acid(UA) were detected in 40 samples with the two reagents at the same time. Results In comparison with the results using Beckman reagent,the results using Kemei reagent was lower for UA,the other six items coincided with the Beckman reagent system.Conclusions The fresh mixed patient sera can transmit the traceability of Beckman regeat system to the Kemei reagent.