化学发光免疫法与液相色谱-串联质谱法检测人血清维生素B_(12)的一致性评价

The consistency of chemiluminescence immunoassay and liquid chromatography-tandem mass spectrometry for the determination of vitamin B_(12) in human serum

目的 比较化学发光免疫分析法(CLIA)和高效液相色谱-串联质谱法(LC-MS/MS)测定人血清中维生素B_(12)的一致性。方法 收集不同浓度维生素B_(12)血清标本50例,分别采用CLIA和LC-MS/MS法进行测定。采用配对样本t检验评价两系统检测结果的差异性,用Passing-Bablok回归、Bland-Altman图、组内相关系数(ICC)分析2种检测方法的相关性,加权Kappa检验分析2种检测方法用于临床判断维生素B_(12)营养状况的一致性。结果 配对样本t检验结果提示2种检测方法差异有统计学意义(P<0.001)。Passing-Bablok回归方程的斜率为0.958(95%CI:0.939~0.984),95%置信区间接近于1但不包含1,表明2种方法可能存在些许比例系统误差;截距为14.563(95%CI:-9.255~24.823),95%置信区间包含0,提示2种方法不存在恒定系统误差。Bland-Altman分析结果显示2种方法的平均偏差为4.19%,94%的点的偏差位于95%一致限内,且均在允许误差范围内(25%)。ICC=0.996(P<0.001),一致性较好。两方法判断维生素B_(12)缺乏、边缘缺乏、正常与偏高的总符合率为94%(47/50),加权Kappa=0.936(95%CI:0.865~1),一致性优秀。结论 2种方法的测定结果具有良好的可比性,均可用于血清维生素B_(12)的检测。

Objective This paper aims to compare the consistency of the results of quantitative determination of vitamin B_(12) in human serum by chemiluminescence immunoassay(CLIA) and liquid chromatography-tandem mass spectrometry(LC-MS/MS). Methods A total of 50 serum samples with different levels were selected, and the concentrations of vitamin B_(12) were determined by CLIA and LC-MS/MS. Paired t-test, Passing-Bablok regression, Bland-Altman plots, intraclass correlation coefficient(ICC) and Kappa test were used to analyze the correlation and consistency of the two methods. Results The paired sample t-test result indicated that the difference between the two detection methods was statistically significant(P<0.001). The slope of the Passing-Bablok regression equation was 0.958(95%CI: 0.939-0.984), and the 95% confidence interval was close to but did not contain 1, indicating that there might be some proportional systematic error between the two methods. While the intercept was 14.563(95%CI:-9.255-24.823), and the 95% confidence interval contained 0, indicating that there was no constant systematic error between the two methods. The Bland-Altman analysis results showed that the average deviation of the two methods was 4.19%, and the 94% points were within the 95% agreement limit, and both were within the allowable error range(25%). ICC was 0.996(P<0.001). The consistency was good. The total consistency rate of vitamin B_(12) deficiency, marginal deficiency, normal and high total agreement rate was 94%(47/50), and the weighted Kappa value was 0.936(95%CI:0.865-1). The consistency of two methods was excellent. Conclusion The measurement results of the two methods were well comparable. Both of them can be used for the detection of serum vitamin B_(12).