新鲜血清赋值传递提高不同生化检测系统检验结果的可比性

目的通过新鲜血清赋值传递给日常血清校准品的研究,探讨地区性生化检测的量值溯源性和结果可比性的方法。方法选择本地区6家三级综合性医院,检定生化分析仪后,用配套检测系统的校准品的定值和新鲜血清赋值传递校正后的校正值,分别校准仪器,检测患者新鲜混合血清ALT、TC、Urea、TBil等4个项目并与目标系统进行比对,分析不同系统间溯源校准的效果和结果的可比性。结果虽然本研究所用仪器均处于良好状态和较高精密度,但各被测系统对ALT、TC、Urea、TBil等项目的测试结果与目标系统所获结果的可比性较低,结果之间存在较大差异(P<0.01)。经用新鲜血清进行可溯源的准确度传递后,被测系统与目标系统间的可比性提高,所获结果间的差异减小(P>0.05)。结论用新鲜血清进行可溯源的准确度传递,是解决地区性临床化学检测的溯源性和可比性问题的简便实用的方法。

Improvement of testing results from various biochemical analytical systems by transfer of value assignment with fresh sera

Objective To explore a practical way for traceability and comparability of the value obtained from clinical biochemical examination in regional medical organizations by transferring the assigned value in fresh serum to daily serum calibrator.Methods Six local comprehensive hospitals with Grade III were chosen to analyze the effects of calibration by traceability and the comparability of examined results.The definite values of standard panel in matching analytical system were transferred to fresh sera for value assignment.Verified biochemical analyzers were used to examine the values of alaninetransaminase(ALT),total cholesterol(TC),urea and total bilirubin(TBil) in mixed fresh sera and intercomparison with target system was performed to analyze the effect of traceable calibration and the comparability among various analytical systems.Results Although all the applied instruments in the present study were in good conditions with high precision,the comparability of obtained results of ALT,TC,Urea and TBil between tested system and target system was low and the differences were significant(P<0.01).After traceable precision transfer with fresh serum,the comparability increased and the differences of results were reduced(P>0.05).Conclusion Traceable precision transfer by using fresh serum is a simple,practical,feasible way to realize the traceability and comparability of regional clinical biochemical examination.