目的总结并回顾性分析同位素稀释质谱法在美国疾病预防控制中心(CDC)胆固醇参考方法实验室网络(CRMLN)中的比对结果,为我国血脂测定提供质量保证。方法采用我国建立的同位素稀释液相色谱串联质谱(ID-LC/MS/MS)测定血清总胆固醇(TC)和三酰甘油(TG)的方法参加CRMLN比对。2016年之前每3个月1次,每次4种样品,测定2批。2016年之后每半年比对1次,每次4种样品,测定2批。每次测定中至少同时测定2个有证标准物质作为质控品。结果 15次TC比对结果显示,本血脂参考实验室(以下简称"本室")平均CV为0.43%,CDC各参加实验室间CV为0.42%,本室与实验室间总体均值的偏移为0.22%,与CDC靶值的偏移为0.58%。15次TG比对结果显示,本室平均CV为0.62%,本室测定TG的结果与实验室间均值的偏移为-0.98%,与CDC靶值的偏移为-0.80%。TC和TG各60个比对结果中,98%(59/60)的TC测定CV满足CDC的精密度要求,70%(42/60)的测定满足TC准确度要求(TC:CV≤1%,偏移≤1%);92%(55/60)的TG测定准确度满足CDC的要求(TG:偏移≤2.55%)。结论 ID-LC/MS/MS测定血清TC和TG的方法在CRMLN比对中数据良好,与CDC及各网络实验室测定结果一致,有望在我国血脂标准化中发挥重要作用并为参考测量比对计划提供经验和技术支持。
Objective To summarize and review the comparative results of the isotope dilution mass spectrometry in Cholesterol Reference Method Laboratory Network (CRMLN) project of the Centers for Disease Control and Prevention (CDC) of the United States in order to provide quality controls for determination of blood lipid.Methods The isotope dilution liquid chromatography tandem mass spectrometry (ID-LC/MS/MS) methods for determination of serum total cholesterol (TC) and triglycerides (TG) were developed to participate in the comparison of CRMLN.The survey was conducted every three months before 2016 and every half year from 2016.Four kinds of reference materials with two parallel tubes for each material and each tube in duplicate were determined in every survey.At least two certified reference materials used as quality control samples were analyzed simultaneously in each determination.Results In the 15 comparisons the CV of the TC determination method in our laboratory was 0.43% while the CV of all the participated laboratories in CRMLN was 0.42%.The bias from the overall mean value in our laboratory was 0.22% while the bias from the CDC target values was 0.58%.The CV of the TG determination method in 15 tests of our laboratory was 0.62% and the bias was-0.98% from the overall mean value and-0.80% from the target values of CDC.Among the 60 results for comparison,98% (59/60) of CV in the TC determination met with CDC requirement for precision (CV≤1%),and 70% of bias (42/60) of the results met with CDC requirement for accuracy (bias≤1%).For the 60 results in comparison of TG determination,92% (55/60) of bias of the results met with the accuracy requirement of CDC (bias≤2.55%).Conclusion In CRMLN comparison the results of TC and TG determined by ID-LC/MS/MS method were consistent with the values which were certified by CDC and determined by other network laboratories.The comparative surveys may play an important role in the standardization of lipid determination,and should be