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目的应用美国临床实验室标准化委员会(NCCLS)EP10-A2文件初步评价荧光免疫层析法测定尿液中β_2-微球蛋白(β_2-MG)的多方面性能。方法按照NCCLS颁布的EP10-A2文件,按中、高、低、中、中、低、低、高、高、中的顺序连续测定各浓度样本5 d。计算测定结果的偏差、总不精密度、截距、斜率、非线性、携带污染和漂移。结果低、中、高浓度β_2-MG样本偏差分别为-1、1和4μg/L;总不精密度分别为4.12%、0.83%和0.44%;非线性、携带污染、漂移差异均无统计学意义(P>0.01)。结论荧光免疫层析法检测尿液中β_2-MG,准确度、精密度均较好,线性良好,携带污染率低,稳定性好,试剂性能可满足临床应用需求。
OBJECTIVE: To evaluate the multidimensional properties of β_2-microglobulin (β_2-MG) in urine by fluorescent immunochromatography assay using the American College of Clinical Laboratory Standardization Committee (NCCLS) EP10-A2. Methods According to the EP10-A2 document promulgated by NCCLS, each concentration sample was continuously measured in the order of medium, high, low, medium, medium, low, low, high, high and medium for 5 days. Calculate deviations in measurement results, total imprecision, intercept, slope, non-linearity, carry contamination and drift. Results The deviations of low, medium and high concentration β_2-MG samples were -1, 1 and 4 μg / L, respectively. The total inaccuracy was 4.12%, 0.83% and 0.44% respectively. There was no statistical difference in non-linear, Significance (P> 0.01). Conclusion The fluorescence immunochromatography assay of β_2-MG in urine shows good accuracy and precision, good linearity, low carryover rate and good stability. The reagent performance can meet the needs of clinical application.