2种检测系统检测尿轻链K-Ig、λ-Ig 的方法学比对及偏移评估
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Comparison of measurement procedure in two instruments for detecting urine K-Ig and λ-Ig light chains and bias estimation
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    摘要:

    摘要:目的分析2个检测 系统尿轻链K-lg、λ-Ig结果,评价可比性、一致性及偏移。方法分别用 BNII(参比方法,X)与BA400(待评方法,Y)检测162例尿k-Ig与132例尿入-Ig水平各1次。采用ESD法剔除离群值。散点图、偏差图及Bland-Alt-man图用于分析Y随X变化的大致趋势、方法间差值潜在变化特征及一致性。根据方法间差值分布状态使用平均值或中位数初步估算偏移。2组间比较采用配对样本Wilcoxon符号秩和检验。选择Deming和Passing-Bablok回归模型拟合散点图,计算医学决定水平处的偏移及可信区间,以≤+12.5%为可接受标准。结果经ESD检验和散点图、偏差图分析筛选出146 对尿k-Ig与122对尿λ-g测量结果。散点图显示2种方法间测量值大致呈线性关系,偏差图显示方法间差值呈混合变化(SD和CV)。尿K-Ig 在低浓度与高浓度处估算偏移及其95%CI分别为-1.47(-1.89~-0.97)mg/L.5.98%(3.20% ~8.76%);尿入-Ig在低浓度与高浓度处估算偏移及其95%CI分别为1.70( 1.26~2.15)mg/L、18.87%( 14.03%~23.70%)。尿k-Ig、λ-Ig测量结果呈非正态分布,经Wilcoxon 检验方法间尿k-Ig测量值差异无统计学意义(P>0.05),尿入-Ig测量值差异有统计学意义(P<0.05)。一致性评价表明,2种方法间尿k-Ig λ-Ig的测量值差异有统计学意义(P<0.05);位于LoA范围内的点占94.52% ~ 96.46% ,但LoA及其95%CI均超出+12.5%,尚不能认为2种方法一致性良好。回归分析表明,尿K-g、λ-Ig医学决定水平14.40 mg/L、7.80 mg/L处偏移的可信区间均符合可接受标准;回归方程截距和斜率95%CI表明2种方法间尿k-Ig测定存在系统差异和比例差异,尿入-lg测定存在比例差异。结论2种方法检测尿轻链存在差异,不能相互替代。 一致性界限范围相差幅度在临床不可接受,尚不能认为2种方法一致性良好。

    Abstract:

    Abstract : Objective To analyze and evaluate the comparabilty ,consistency and bias of measurement results for urine K-Ig and λ-_lg from two measurement procedures. Methods The levels of k-Ig in 162 cases and λ-Ig in 132 cases of urine specimens were measured once by BN II ( comparative measurement procedure, X) and BA400 ( candidate measurement procedure, Y) respectively. ESD method was used to eliminate outliers, scatter plots, difference plots. Bland-Altman plots were applied to analyze the general trend of Y value changing with X value, the characteristics of underlying difference between two measurement procedures, and evaluate their consistency. Arithmetic mean or median were applied to estimate bias preliminary according to the distribution states of different values between the two measurement procedures. The comparison between the two groups of paired samples was performed by Wilcoxon signed rank test. Derming and Passing- Bablok regression models were selected to fit scatter plots and calculate the biases and confidence intervals at medical decision levels. The values of less than or equal to +12.5% was considered as the acceptable criteria. Results The measured results of 146 pairs of urine k-Ig and 122 pairs of urine λ-Ig were screened respectively by ESD test, scatter plots and difference plots. An approx imately linear relationship of the measured values between the two procedures was seen in scatter plots, but mixed variability ( standard deviation and cefficient of variation ) appeared in difference plots. The biases with 95%CI of urine K-Ig were estimated as -1.47 (-1.89 to -0.97) mg/L in low concentration and 5.98% (3.20% to 8.76%) in high concentration respectively. The biases with 95% CI of urine λ-g were estimated as 1.70 (1.26 to2.15) mg/L in low concentration and 18.87% ( 14.03% to 23.70%)in high concentration respectively. The measured results of urine K-Ig and λ-Ig showed abnormal distribution. Wilcoxon test suggested that the measured results of urine k-Ig showed no significant difference between the two procedures ( P>0.05) , however the difference of the measured results of urine λ入-Ig was statistically significant ( P>0.05). The consistency analysis showed that differences in the measured results of urine k-Ig and λ-g between the two procedures were statistically significant ( P<0.05). The points within LoA ran-ges were accounted for 94.52% to 96.46%,but LoA with 95%CI exceeded +12.5%,so it could not be considered that the two measurement procedures were in good consisteney. Regression analysis showed that the confidence intervals of biases of urine K-Ig and λ-g at 14.40 mg/L and 7. 80 mg/L of the medical decision level respectively met the acceptable criteria. The intercepts and slopes of regression equation with 95%CI indicated that the measured results of urine K-Ig showed systermatic and proportional differences between the two measurement procedures, while the the measured results of urine λ-Ig showed only proportional difference. Conclusion The results of two measurement procedures were different in detecting urine light chains, so they could not be replaced each other. The margins of LoA from the two procedures were not acceptable in clinical practice. It was not considered that the two measurement procedures were in good consistency.

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连丽丽,王莹,张天骄,许建成.2种检测系统检测尿轻链K-Ig、λ-Ig 的方法学比对及偏移评估[J].临床检验杂志,2023,41(01):50-55

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  • 收稿日期:2022-06-15
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  • 在线发布日期: 2023-05-22
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