尿微量清蛋白干化学法测定的可靠性探讨

The reliability study of urinary microalbumin test by dry hemical method

目的用微量清蛋白尿的定量检验方法验证干化学法测试尿液中微量清蛋白以及微量清蛋白/肌酐比值(M/C)的可靠性。方法 80例临床确诊的糖尿病患者尿液分别用生化定量和干化学定性作双份平行微量清蛋白测定。干化学法定性采用桂林华通公司所生产的HT2000尿液分析仪及其配套测试带。尿微量清蛋白定量测定方法为免疫透射比浊法。肌酐定量测定使用肌氨酸氧化酶法。去除10例离群检测样本后,以定量测定M/C的结果为参考标准,与微量清蛋白定量法和于化学法以及干化学法M/C检测微量清蛋白尿的结果进行比较分析。结果以定量测定M/C为参考标准,微量清蛋白定量法、微量清蛋白干化学法、干化学法M/C的灵敏度、准确度、约登指数依次降低。干化学法M/C与定量测定M/C的结果之间差异具有统计学意义(P<0.01)。干化学法M/C的误诊率、漏诊率显著高于定量测定M/C的结果。结论干化学法微量清蛋白半定量测定的灵敏度较高,建议作为微量清蛋白的筛查方法。干化学法M/C不宜作为即刻尿中微量清蛋白的过筛指标。

Objective The quantitation measurement of microalbuminuria was adopted to verify the feasibility of urinary microalbumin and ratio of microalbumin to creatinine （M/C） detection with dry heroical method. Methods Totally 80 urine samples from the patients with clinically diagnosed diabetes were tested by the immune quantitation method （immunoturbidimetric assay） and dry hemical method （HT2000 urine analyzer and test paper, Guilin Huatong Company） simultaneously. Sarcosine oxidase method was applied to measuring creatinine level. Ten cases of outliers were removed. With the quantitation result of M/C as the reference standard, immune quatilyzation of the M/C as reference, we compared and analyzed the results of the immune quantilization of urine microalbumin, those of the dry chemistry method and of the dry chemistry system detecting M/C. Results There was significant differences in test results of urinary microalbumin with the dry chemistry method and the immune quantitation method （P〈0.01）. The sensitivity, accuracy and Youden index of the microalbuminuria testing had been observed to decrease in order in immune the dry chemistry method, the im mune quantitation method and M/C quantitation detection method. Conclusion The sensitivity of semi-quantitation dry chemical method is satisfactory in detecting microalbumin, which may be used as a means of microalbumin screening. M/C detection with the dry chemical method isn＇t suitable for screening microalbumin in instant urine samples.