作者：丁敏, 孟娇然, 夏娃

作者单位：上海市计量测试技术研究院，上海 201203

关键词：血清乳酸;标准物质;同位素稀释质谱法;临床量值溯源

摘要：

为满足临床血清乳酸测量结果量值溯源需求，研制血清中乳酸标准物质。标准物质以人血清为基质，加入与人体构型相同的高纯乳酸，制备为3个浓度水平的标准物质候选物，采用同位素稀释高效液相色谱-串联质谱法进行多家实验室定值，采用酶膜法对标准物质均匀性、稳定性进行评价。实验结果表明，该系列血清中乳酸标准物质均匀性稳定性良好，在−80 ℃条件下可保存9个月以上，3个浓度水平标准物质定值结果分别为(5.53±0.14) mmol/L、(10.22±0.09) mmol/L、(15.76±0.27) mmol/L，包含因子k=2。该标准物质作为血清中乳酸量值溯源的载体，可以有助于临床乳酸参考系统的建立，应用于临床乳酸测定仪的校准、乳酸检测方法评价以及相应质量控制。

Development of reference materials of lactic acid in serum
DING Min, MENG Jiaoran, XIA Wa
Shanghai Institute of Measurement and Testing Technology, Shanghai 201203, China
Abstract: In order to meet the requirements of traceability of clinical serum lactic acid measurement results, reference materials of lactic acid in serum were developed. Human serum was used as the matrix, high purity lactic acid with the same configuration as lactic acid in human body was added to prepare reference material candidates at three concentration levels. The value of the reference materials were evaluated by isotope dilution high performance liquid chromatography-tandem mass spectrometry in several laboratories, the homogeneity and stability of the reference materials were evaluated by enzyme membrane method. The result indicated that the series of reference materials were sufficient homogeneity and had good stability, could be stored for more than 9 months at −80 ℃. The certified values of the three levels were (5.53±0.14) mmol/L, (10.22±0.09) mmol/L, (15.76±0.27) mmol/L respectively, coverage factor k=2. As the carrier of serum lactic acid value traceability, these reference materials of lactic acid in serum can contribute to the establishment of clinical lactic acid reference system, be used in the calibration of clinical lactic acid analyzer, method evaluation and quality control of clinical lactic acid measurement.
Keywords: lactic acid in serum;reference material;isotope dilution mass spectrometry;clinical traceability
2022, 48(8):60-67  收稿日期: 2022-03-12;收到修改稿日期: 2022-05-07
基金项目: 国家市场监督管理总局科技计划项目（2020MK026）
作者简介: 丁敏（1979-），女，贵州贵阳市人，高级工程师，主要从事化学计量和标准物质的研究
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