液相色谱-串联质谱法检测25-羟维生素D标准化专家共识

Expert consensus on the standardization of liquid chromatography-tandem mass spectrometry method for the measurement of 25-hydroxyvitamin D

液相色谱-串联质谱法(LC-MS/MS)是临床生化小分子检测的首选方法,常用于血清25-羟维生素D[25(OH)D]的检测。其虽有高灵敏度、高特异性、线性范围宽等优势,但因仪器、色谱柱、试剂、校准物、方法学及性能验证等因素的影响,也会造成同一个实验室内部及不同实验室之间的LC-MS/MS检测结果存在较大偏差。标准化是确保在不同实验室、不同质谱仪器及不同时间,获得一致性和可比性结果的必要条件。为规范LC-MS/MS检测25(OH)D的方法,该共识基于目前现有的临床质谱相关指导文件和临床实践,针对同位素稀释LC-MS/MS的标准物质和内标物选择、方法验证、色谱质谱参数选择、质量控制、人员要求及参考区间等方面提出建议,旨在提高检验结果的准确性及可靠性。

Liquid chromatography-tandem mass spectrometry(LC-MS/MS)is the preferred testing method for measurement of clinical biochemical small molecule,it is often used for measuring serum level of 25-hydroxyvitamin D[25(OH)D].However,due to various influence factors including instrumentation,chromatographic conditions,reagents,calibrators,methodology,and method validation,obtained 25(OH)D results might differ significantly.25(OH)D measured by LC-MS/MS assays may generate high intra-and inter-laboratory variations,despite known advantages of high sensitivity,high specificity,and wide linear range of LC-MS/MS.Standardization is the key point to ensure consistent and comparable results obtained from different laboratories,mass spectrometers and testing times.Here we form the consensus to standardize the LC-MS/MS method for the measurement of serum 25-hydroxyvitamin D.The consensus is developed based on the current clinical mass spectrometry-related guidance documents and clinical practice.For assay based on isotope-labeled dilution LC-MS/MS method,recommendations are focused on selection of standard substances,internal standards,method validation,parameters for LC and MS/MS,quality control,personnel requirements,and reference intervals to improve the accuracy and reliability of the test results.