不同品牌标准品对LC-MS/MS法检测血浆25(OH)D_(3) 结果的影响  

Effects of Different Brands of Standard Products on the Determination ofPlasma 25(OH)D_(3) by LC-MS/MS

作　　者：李敏 杨越屹 赵光轮 邵燕[1] 于洪远[1] LI Min;YANG Yueyi;ZHAO Guanglun;SHAO Yan;YU Hongyuan(Beijing Aerospace General Hospital,Beijing 100076,China;Civil aviation General Hospital,Beijing 100123,China)

机构地区：[1]北京航天总医院检验科,北京100076 [2]民航总医院检验科,北京100123

出　　处：《标记免疫分析与临床》2023年第11期1934-1938,共5页Labeled Immunoassays and Clinical Medicine

摘　　要：目的评估不同品牌的标准品对LC-MS/MS法检测血浆25-羟基维生素D_(3)[25(OH)D_(3)]结果的影响。方法收集北京航天总医院2023年1月至4月住院患者剩余血浆作为研究对象,选择美国国家标准与技术研究院(NIST)生产的SRM2972a标准品(记为系统A)和Cerilliant公司的25(OH)D_(3)标准品(记为系统B)分别作为校准品,采用LC-MS/MS法分别检测45例单人份血浆样本和2022年国际参考实验室间质量评价样本(2022RELA),参考美国临床和实验室标准化协会(CLSI)EP9-A3文件,评估两种不同标准品对25(OH)D_(3)测量结果的影响。结果两个系统对RELA样本的测量值均在其等效范围内,偏倚小于7.5%。系统A、B的批内重复性分别为2.17%~3.04%、2.35%~3.38%,总不精密度分别为2.56%~3.85%、2.74%~4.05%。两个系统对应的标准曲线方程分别为Y=0.0866 X+0.0302(r=0.9992)、Y=0.0827 X+0.0429(r=0.9998),线性良好。45例血浆标本测量结果可比,Passing-Bablok回归分析方程为Y=1.019 X+0.232,斜率的95%CI为1.0000~1.0455,截距的95%CI为-0.3818~0.7000。将医学决定水平12、20、30带入方程,得到的相对偏倚为3.76%、3.01%和2.64%。结论这2种品牌的标准品对LC-MS/MS法检测血浆25(OH)D_(3)结果的影响差异没有统计学意义,均适用于临床实验室血浆25(OH)D_(3)的定量分析。Objective To evaluate effects of different brands of standard substances on the determination of plasma 25 hydroxyvitamin D3[25(OH)D_(3)]by LC-MS/MS.Methods The remaining plasma of hospitalized patients from January to April,2023 in Beijing Aerospace General Hospital was collected as the study object.SRM2972a(System A)produced by the National Institute of Standards and Technology(NIST)and 25(OH)D_(3) standard from Cerilliant(System B)were selected as calibration products respectively.A total of 45 individual plasma samples and the 2022 International Reference Laboratory Quality Assessment sample(22RELA)were examined by LC-MS/MS method and effects of two different standards on the measurement results of 25(OH)D_(3) were evaluated with reference to CLSI EP9-A3 document.Results Both systems were able to measure RELA samples within their equivalent range with a bias of less than 7.5%.The in-batch repeatability of system A and B were 2.17%-3.04%and 2.35%-3.38%.The total imprecisions were 2.56%-3.85%and 2.74%-4.05%,respectively.The standard curve equations corresponding to the two systems were Y=0.0866 X+0.0302(r=0.9992)and Y=0.0827 X+0.0429(r=0.9998)with a good linearity.The measurements of plasma samples from 45 cases were comparable.The equations of Passing-Bablok regression analysis was Y=1.019 X+0.232,while the 95%CI of slope was 1.0000-1.0455 and the 95%CI of intercept was-0.3818-0.7000.When medical decision levels 12,20 and 30 were introduced into the equation,the relative bias were 3.76%,3.01%,and 2.64%,respectively.Conclusion There is no significant difference in the effect of these two brands of standard products on the determination of plasma 25(OH)D_(3) by LC-MS/MS and they are suitable for the quantitative analysis of plasma 25(OH)D_(3) in clinical laboratories.

关 键 词：25-羟基维生素D_(3) 标准品 NIST Cerilliant 溯源 

分 类 号：R446[医药卫生—诊断学] R714[医药卫生—临床医学]