中文摘要：

目的评价血清高密度脂蛋白胆固醇（HDL—C）常用参考物质、校准品、质控物质等制备物在HDL—C测定中的基质效应。方法方法学比较。根据美国临床实验室标准化委员会（NCCLS）EP14-A2方案进行基质效应评价。以超速离心／化学沉淀／HPLC（小体积B-定量法）测定血清HDL—C的方法为比对方法，12个厂家的HDL—C匀相法为待评方法，分别测定40份新鲜人血清及13种制备物的HDL—C水平；将两种方法测定结果的均值作直线回归，求得Y值双侧95％的预测区间，评价制备物的基质效应。通过测定经过一次冻融和两次冻融的血清样本，评价冻融对HDL—C测定的影响。结果各制备物的基质效应依制备物的种类而异。冻干质控物质和校准物在绝大多数系统中表现出明显的基质效应；新鲜冰冻人血清和冰冻猪血清未表现出明显的基质效应；无添加新鲜血清冻融1～2次不造成明显的HDL—C变化。结论冻干血清存在明显的基质效应问题，在标准化计划和临床应用中，应选择新鲜冰冻血清作为校准物质和质控物质，以提高HDL—C测定的准确性和量值溯源的有效性。

英文摘要：

Objective To evaluate the matrix effects of the processed materials, including reference materials, calibrators, and quality control materials, in the measurement of high-density lipoprotein cholesterol （HDL-C）. Methods This was a method comparison study. Matrix effect was evaluated according to the NCCLS EP 14-A2 protocol. Ultraeentrifugation/chemieal precipitation/HPLC method （ small volume β- quantification） was used as the comparison method, and the 12 homogeneous direct methods were used as the routine methods. 40 fresh serum samples and 13 processed materials were measured simultaneously by these two methods and the results were plotted. According to the man results of fresh samples by these two methods, two-tailed 95% predicted intervals were calculated. Then the results of the processed materials were compared with these intervals to evaluate the matrix effect. Effect of freeze thaw on the measurement of HDL-C was also evaluated by analyzing samples. Results The observed matrix effects were varied for different processed materials. Frozen human serum and pig serum samples showed good commutability and almost had no matrix effects. In contrast, the lyophilized calibrator and quality control materials showed significant matrix effects on most of the routine systems. Furthermore, once or twice freeze and thaw process did not cause significant changes of HDL-C concentrations. Conclusions The matrix effects of the processed materials affect the evaluation of routine methods and traceability, which need to be understood and carefully studied. To increase the accuracy and comparability of HDL-C measurement, fresh frozen serum is recommended as calibrators arid quality control materials.