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目的对Afinion AS100和自研HbA1c床旁检测系统这两种HbA_1c检测方法进行方法学比对和偏倚评估,以验证自研HbA_1c床旁检测系统检测结果的可比性。方法以Afinion AS100为参考系统(X),以自研HbA_1c床旁检测系统为待比较系统(Y)。依据美国临床实验室标准协会(CLSI)EP9-A2文件要求,分别采用上述两种检测系统测定标本中HbA_1c浓度,依据检验结果,检查离群点,计算线性方程、相关系数和直线回归方程,以临床实验室改进规范88(CLIA’88)规定的室间质量评价允许误差范围的1/2为标准,在不同医学决定水平判断不同检测系统的偏差于临床是否可以接受。结果微粒子色谱法和显色型亲和层析法的批内CV<5%,日间CV<6.67%,已达到CLSI要求。两种检测方法均未发现离群点,对数据统计得到回归方程Y=1.0075X-0.0693,R~2=0.9982。结论实验方法与参考方法相关性良好,偏差在临床允许误差内。
Objective To compare the methodological and biased assessments of two HbA_1c detection methods, the Afinion AS100 and the self-developed HbA1c bedside detection system, to verify the comparability of self-developed HbA_1c bedside detection system test results. Methods Afinion AS100 as a reference system (X), to study HbA_1c bedside detection system to be compared to the system (Y). According to the CLSI EP9-A2 document, the HbA1c concentrations in the specimens were determined by the above two detection systems. Outliers were examined according to the test results, and linear equations, correlation coefficients and linear regression equations were calculated According to the Clinical Laboratory Improvement Specification 88 (CLIA’88), one-half of the allowable error range of the inter-laboratory quality evaluation is used as a criterion to determine whether clinical deviations of different detection systems are acceptable at different medical decision levels. Results The intracritical CV <5% and the intraday CV <6.67% were achieved by the method of particle chromatography and colorimetric affinity chromatography, which met the CLSI requirement. No outliers were found in the two methods. The regression equation was Y = 1.0075X-0.0693, R ~ 2 = 0.9982. Conclusion The correlation between experimental method and reference method is good, the deviation is within the allowable clinical error.