摘要
目的评价免疫透射比浊法检测尿清蛋白（Alb）的性能,探讨尿Alb/肌酐（Cr）比值（ACR）联合估算肾小球滤过率（e GFR）在2型糖尿病（T2DM）患者肾损伤评价中的诊断价值。方法对免疫透射比浊法检测尿Alb的精密度、正确度、分析测量范围（AMR）、检测限、参考区间进行验证,并分析其与免疫散射比浊法的相关性和偏差。选取220例T2DM住院患者,检测尿Alb、尿Cr、血Cr,计算ACR和e GFR并进行分析。结果尿Alb在11.11~298.76 mg/L范围内批内、批间不精密度均小于厂家声明的标准。正确度验证显示两种诊断系统尿Alb校准品测定结果符合验证要求;CAP室间质评物（U-A、U-B）、校准验证/线性评价物（LN20-B）结果符合CAP校准验证/线性评价误差界限所规定的标准,相对偏倚小于基于生物学变异设定质量规范中的适当允许偏倚（〈16.4%）。AMR验证显示尿Alb在5.08~347.93 mg/L范围内线性良好。方法学比对显示透射比浊法与散射比浊法检测尿Alb结果相关性较好,平均绝对偏差为8.6 mg/L,平均相对偏差为14.52%,在医学决定水平处的预期偏差在可接受范围内。220例T2DM患者按照正常Alb、微量Alb、大量Alb尿分组,分别有10.9%、45.7%、66.7%的患者e GFR〈60m L·min^-1·1.73 m^-2;在e GFR≥90 m L·min^-1·1.73 m^-2的患者中,15.7%有微量Alb尿,7.1%有大量Alb尿。结论免疫透射比浊法检测尿Alb的各项性能指标基本满足实验室要求,联合应用ACR和e GFR有助于评估T2DM患者肾脏损伤状况。
Objective To evaluate the performance of immunoturbimetry in determination of urinary albumin （Alb） and investigate the diagnostic value of urinary albumin/creatinine ratio （ACR） combined with estimated glomerular filtration rate （eGFR） for type 2 dia- betes mellitus （T2DM）. Methods The performance of immunoturbimetry method was validated, including precision, accuracy, ana- lytical measuring range （AMR）, biological reference interval and compared with the nephelometric immunoassay. The correlation and deviation between the two methods were analyzed. The levels of urine albumin, urine creatinine and serum creatinine of 220 patients with T2DM were determined and ACR and eGFR were calculated. Results The variations of precision in both within-run and between- run tests were below the standard of manufacturer statement in the range of 11.11 to 298.16 mg/L of urine albumin. The results of urine albumin calibrators from the two diagnostic systems met the allowable range of the target value in the validation for accuracy. The results of external quality assessment （EQA） samples of CAP （U-B, U-A and LN20-B） from the two systems met the linear evaluation error lim- its of CAP calibration and validation. The relative bais was below the given desirable specifications derived from intra- and inter-individu- al biologic variation （bias of target value less than 16.4 percent）. AMR validation showed that the results of urine albumin inhibited per- fect linear equation in the concentration ranged from 5.08 to 347.93 mg/L. Bland-Altman plot showed that the average absolute deviation was 8.6 mg/L, and the average relative deviation was 14.52% indicating a preferable correlation for the results of urine albumin between the determinations of immunoturbimetry and immunonephelometry. The expected bias was within the acceptable limits at the medical deci- sion level. Among the 220 patients who were grouped as normal albuminuria, microalbuminuria and nephrotie albuminuria the percentage of patients with
出处
《临床检验杂志》
CAS
CSCD
2015年第4期253-257,273,共6页
Chinese Journal of Clinical Laboratory Science
基金
国家科技支撑计划(2012BAH24F01)
关键词
尿清蛋白
免疫透射比浊法
免疫散射比浊法
估算肾小球滤过率
2型糖尿病
urinary albumin
turbidimetric immunoassay
nephelometric immunoassay
estimated glomerular filtration rate
type 2 diabetes mellitus
