血清总甘油测定基质效应的研究

摘要

Objective To evaluate the matrix effect of processed materials in serum total glycerol measurement and to assess the accuracy of routine test systems.Methods With an isotope dilution liquid chromatography tandem mass spectrometry method as the comparative method，matrix effects of 28 processed materials on 8 routine test systems were evaluated ccording to the NCCLS EP 14 protocol.The processed materials and 20 flesh patient specimens were analyzed with both the comparative method and each of the evaluated methods and results obtained with the two methods were plotted.Two-tailed 95% prediction intervals for the mean of the flesh patient specimen were computed and results on the processed aterials were compared with these intervals for evaluation of matrix effect.Results with the two methods on fresh samples were also compared for assessment of the accuracy of the routine test systems.Results Some of the processed samples showed matrix effects on some of the routine test systems.The observed matrix effects were system-specific and aused either positive or negative biases.Calibration biases were also observed on some test systems.Conclusion Matrix effect and calibration bias have been observed in serum total glycerol measurements.Continued efforts are needed for improving the accuracy of serum total glycerol measurements.%目的 评价28种质控血清或校准物在8种总甘油常规检测系统下的基质效应,并评价常规系统校准的准确性.方法 以同位素稀释液相色谱串联质谱测定m清总甘油的方法为对比方法,用甘油氧化酶法的8种常规测定系统为待评价方法,测定20份人新鲜血清和28种制备物中的总甘油.将两法测定人新鲜血清的结果作直线回归,求得Y值双侧95%的预测区问,评价制备物的基质效应.通过分析新鲜血清样本的测定结果评价常规系统校准的准确性.结果 制备物在进口A、B、C系统和国产D系统巾表现正基质效应,进口D系统正、负基质效应均有以正效应为主,国产A、B系统正、负基质效应均以负效应为主,只有1个制备物对国产C系统有较弱的基质效应.同对比方法相比,国产A、D系统存在正校准偏差,进口A、B、C、D和国产B系统1竽在负偏差,国产C系统不存在校准偏差.结论 我国血清总甘油的部分常规检测系统存在校准偏差,部分质控物和校准物存在基质效应.为实现检验结果的准确性和实验室问的可比性,临床标准化工作势在必行.