两种全自动免疫分析系统检测25-羟基维生素D的一致性评价

Comparison of two automatic immunoassays for measuring 25-hydroxyvitamin D

背景全球范围内维生素D检测受到越来越多的关注,全自动免疫分析系统是临床实验室最常用的维生素D分析设备,然而不同免疫分析法结果之间的可比性是困扰临床解读的一个现实问题。目的比较新产业(Snibe,Maglumi 4000 Plus)与索灵(DiaSorin,LIAISON XL)全自动免疫分析系统检测25-羟基维生素D[25(OH)D]的一致性。方法选取解放军总医院2019年5-6月810例健康查体者血清样本,分别由新产业和索灵免疫分析系统检测25(OH)D。以索灵为比对标准,分析新产业与索灵全自动免疫分析系统的检测偏差随25(OH)D浓度增加的变化趋势;通过Passing-bablok回归、组内相关系数(intra-class correlation coefficient,ICC)分析两种方法的相关性和一致性;Kappa检验分析两种方法用于临床判断维生素D营养状况的一致性。结果二者的平均偏差为-1.39 ng/mL(-1.06%),在一定范围内检测偏差随25(OH)D浓度的增加而增加。新产业与索灵的Passing-bablok回归方程斜率为0.650(95%CI:0.623~0.680),截距为4.871(95%CI:4.396~5.338),ICC为0.766(95%CI:0.700~0.814)。新产业判断维生素D充足、不足、缺乏与索灵的符合率为68.77%,Kappa值为0.479。结论新产业与索灵全自动免疫分析系统检测25(OH)D的相关性、一致性较好,但仍然存在一定的检测偏差。免疫法检测结果用于临床判定维生素D营养状况应注意建立针对本方法的参考范围。

Background Vitamin D detection has attracted more and more attention worldwide.Automatic immunoassays are the most widely used methods for clinical 25-hydroxyvitamin D(25(OH)D)testing.However,the comparability between the results of different immunoassays is a practical problem that perplexes clinical interpretation.Objective To evaluate the consistency of Snibe(Maglumi 4000 plus)and DiaSorin(Liaison XL)in automatic 25(OH)D immunoassays.Methods A total of 810 serum samples were collected from healthy subjects in the Second Medical Center of Chinese PLA General Hospital from May to June in 2019,and25(OH)D was detected by Snibe and DiaSorin immunoassays,respectively.DiaSorin was performed as the comparative method,the variation trend of detection deviation of Snibe and DiaSorin with the increase of 25(OH)D concentration was analyzed.The correlation and consistency of the two methods were analyzed by passing-bablok regression and intraclass correlation coefficient(ICC),and the consistency of the two methods in clinical judgment of vitamin D nutritional status was analyzed by Kappa test.Results The average deviation between the two methods was-1.39 ng/mL(-1.06%).Within a certain range,the detection deviation increased with the increase of 25(OH)D concentration.Slope from regression of the two methods was 0.650(95%CI:0.623-0.680),while the intercept was 4.871(95%CI:4.396-5.338),and the ICC was 0.766(95%CI:0.700-0.814).The concordance rate in judgment of vitamin D nutritional status was 68.77%,and the Kappa value was 0.479.Conclusion Snibe and DiaSorin automatic 25(OH)D immunoassays show good correlation and agreement.A specific reference range for each 25(OH)D immunoassay is needed in clinical judgment of vitamin D status.