两种化学发光法检测25-羟基维生素D的性能差异及结果一致性评价  

Difference and agreement of two chemiluminescence methods for measuring 25-hydroxyvitamin D

作　　者：常丽 冯苏 赵东兰 王超 程丽姗 宋国威 李立新 CHANG Li;FENG Su;ZHAO Donglan(Department of Laboratory,Shijiazhuang People’s Hospital,Hebei,Shijiazhuang 050000,China)

机构地区：[1]河北省石家庄市人民医院检验科,050000

出　　处：《河北医药》2023年第18期2798-2801,共4页Hebei Medical Journal

摘　　要：目的 研究直接化学发光法和电化学发光法2种方法检测25-羟基维生素D进行性能验证,并对收集的血清标本进行2种检测方法的结果一致性评价。方法 应用国产新产业M4000P(直接化学发光法)和德国罗氏Cobas e411(电化学发光法)分别进行精密度、正确度、线性范围和参考区间的性能验证,并对收集的145例血清标本分别在两个检测平台检测后进行数据一致性分析。结果 国产新产业M4000P直接化学发光法25-羟基维生素D精密度1水平2.49%,2水平1.63%;德国罗氏Cobas e411电化学发光法25-羟基维生素D的1水平精密度5.37%,2水平3.64%;国产新产业M4000P直接化学发光法平均偏倚5.67%和3.43%,德国罗氏Cobas e411电化学发光法平均偏倚3.34%和6.59%。2种方法在各自的线性区间国产新产业M4000P(10 ng/ml~150 ng/ml)和德国罗氏Cobas e411(3 ng/ml~70 ng/ml)内线性良好,国产新产业M4000P和德国罗氏Cobas e411r2分别为0.9997和0.9996;国产新产业M4000P直接化学发光法和德国罗氏Cobas e411电化学发光法两个平台25-羟基维生素D参考区间均可通过验证。将收集的血清标本用这2种化学发光法的检测结果进行一致性分析,组内相关系数ICC=0.925,提示一致性极好;Bland-Altman偏差分析显示2种方法25-羟基维生素D检测结果在检测均值偏低范围(7.65 ng/ml~20 ng/ml)表现出极佳的一致性,随检测值增大,偏差增大的可能性增大。结论 2种检测方法25-羟基维生素D性能参数正确度、精密度、线性区间、稀释倍数和参考区间均符合临床检测需求。新产业M4000P直接化学发光法和德国罗氏Cobas e411电化学发光法检测25-羟基维生素D在检测均偏低范围表现出极好的一致性,随25-羟基维生素D浓度增大,偏差可能性越大。Objective To verify the performance of direct chemiluminescence and electrochemiluminescence for measuring 25-hydroxyvitamin D and to evaluate the agreement in detecting it in serum samples.Methods The performance of precision,accuracy,linear range and reference interval of the MAGLUMI 4000 Plus(direct chemiluminescence method)versus Roche Cobas e411 analyzer(electrochemiluminescence method)were compared.The consistency evaluation was performed by the two methods for measuring 25-hydroxyvitamin D of collected 145 serum samples.Results The precision level of 25-hydroxyvitamin D detected by the MAGLUMI 4000 Plus(direct chemiluminescence method)was 2.49%at level 1 and 1.63%at level 2,which,detected by the Roche Cobas e411 analyzer(electrochemiluminescence method)was 5.37%at level 1 and 3.64%at level 2,respectively.The mean bias of the MAGLUMI 4000 Plus(direct chemiluminescence method)in measuring 25-hydroxyvitamin D at level 1 and 2 was 5.67%and 3.43%,respectively,which,of the Roche Cobas e411 analyzer(electrochemiluminescence method)was 3.34%and 6.59%,respectively.The linear range of the MAGLUMI 4000 Plus(direct chemiluminescence method)and Roche Cobas e411 analyzer(electrochemiluminescence method)was 10~150ng/ml and 3~70ng/ml,respectively,both showing a good linearity.Their R2 was 0.9997 and 0.9996,respectively.Hence,the reference range of the MAGLUMI 4000 Plus(direct chemiluminescence method)and Roche Cobas e411 analyzer(electrochemiluminescence method)in measuring 25-hydroxyvitamin D could be verified.Serum samples were collected for analyzing the agreement of measuring 25-hydroxyvitamin D by the two chemiluminescence methods.The intraclass correlation coefficient(ICC)was 0.925,indicating a great agreement.The Bland-Altman plot showed a great agreement by the two methods in measuring a low range of 25-hydroxyvitamin D at 7.65~20ng/ml.The possibility of deviation increased with the increase in the detection value.Conclusion The accuracy,precision,linear range,dilution ratio and reference range of measuring 25-hyd

关 键 词：25-羟基维生素D 性能验证 化学发光法 精密度 正确度 线性范围 生物参考区间 一致性评价 

分 类 号：R917[医药卫生—药物分析学]