中文摘要：

目的 探讨不同储存条件下高密度脂蛋白胆固醇（HDL-C）和低密度脂蛋白胆固醇（LDL-C）参考物质用4种常规检测系统测定的稳定性.方法 方法学评价.采用同步实验设计对HDL-C和LDL-C参考物质进行稳定性研究.共设计13种“温时”,不同温时的样品在储存时间到期时转移至液氮中,至稳定性试验结束时将样品取出,同时分析所有样本.选择罗氏、和光、协和和第一化学4种不同检测原理的试剂盒同日立7170组成4种检测系统.4种系统分别对不同温时下储存的HDL-C和LDL-C冰冻血清参考物质进行测定,各测定39份样本.计算检测系统的精密度,并分别采用单因素方差分析和t检验进行均匀性和稳定性检验,评价不同温时下储存的HDL-C和LDL-C参考物质在4种常规检测系统上的稳定性变化趋势及同参考值的相对偏差,评估不稳定性产生的不确定度.稳定性分析采用线性回归系数的t检验.结果 4种检测系统的精密度和参考物质的均匀性良好,可以满足稳定性分析的要求.稳定性分析结果显示：-70℃保存12个月的HDL-C和LDL-C参考物质在4个系统上均显示出很好的稳定性,相对偏差小于1％.HDL-C在其他温时下不稳定,-20℃下12个月和4℃下2个月均发生明显的降低,常温保存的HDL-C在各系统上稳定性变化趋势不同.-20℃保存12个月及4℃保存2个月的LDL-C在罗氏和和光系统上显示稳定性良好,其他温时保存的LDL-C在各系统上均不稳定,且表现出不同的变化趋势.HDL-C和LDL-C在4种检测系统下由不稳定性产生的不确定度分别为,HDL-C：0.003、0.005、0.005和0.005 mmol/L; LDL-C：0.012、0.011、0.009和0.009 mmol/L.结论 HDL-C和LDL-C血清参考物质在-70℃保存至少稳定1年,其他温时下储存的HDL-C和LDL-C在不同系统上表现出不同的稳定性.

英文摘要：

Objective To evaluate the and low-density lipoprotein cholesterol （LDL-C） stability of high-density lipoprotein cholesterol （HDL-C） serum reference material measured by four different routine methods under different storage conditions. Methods This is a methodological evaluation. A detailed research was made on the stability of HDL-C and LDL-C reference material. Isochronous design was used, which is based on a storage design （different storage points： storing samples at different temperatures for different time periods）. Zero point （reference point） means storing in liquid nitrogen （at - 196 ~C ,reference temperature）. In this study,there were 13 storage points. Until the preset storage end time the samples were transferred into the liquid nitrogen. At the end of the study all samples were taken out and analyzed at the same time. Four different routine methods were used to measure the HDL-C and LDL-C under different storage points. Precision of the four routine methods, homogeneity and stability of the material wereanalyzed. The changing trend of stability and the relative deviation with zero point were calculated. At last, the uncertainty of the inhomogeneity and instability were evaluated. Results Four routine methods had good precision and the reference material had good homogeneity, which could meet the requirement of the stability analysis. The HDL-C and LDL-C were tested to be stable for at least 12 months at - 70℃, with small relative deviation less than 1%. For HDL-C, it was unstable at other storage points, with lower results at -20 ℃ for 12 months and 4 ℃ for 2 months ,and 4 methods exhibited somewhat different stability trends at room temperature on different methods. For LDL-C, it was also stable at -20 ℃ for 12 months on Roche and Wako methods, but it was unstable on other storage points, and it exhibited different stability trend on different methods. The uncertainty due to instability for the four measurement methods were：HDL-C,0. 003, 0. 005,0. 005 and 0. 005 mmol