UA-5800和AE-4020尿液分析仪尿蛋白试纸条结果的一致性及其与尿蛋白/肌酐比值的相关性研究

The Consistency of Dipstick Tests for Proteinuria Detected by UA-5800 or AE-4020 Urinalysis Analyzers and Their Correlations with Albumin-Creatine Ratio

目的比较迈瑞公司UA-5800和日本爱科来公司AE-4020尿液分析仪试纸条检测尿蛋白的一致性并验证其测定的灵敏度和特异性。方法随机收集2016年10月某肿瘤专科医院门诊及住院尿液标本共721例,同时采用UA-5800和AE-4020尿液分析仪行尿蛋白定性检测,其后采用生化分析仪检测尿白蛋白含量和肌酐水平,计算尿白蛋白/肌酐比值(ACR)。以ACR≥30 mg/g Cr作为尿蛋白阳性的诊断标准,以尿试纸条阴性组ACR<30 mg/g Cr的阴性率作为特异性,以尿试纸条结果微量、1+、2+和3+组ACR≥30 mg/g Cr的阳性率作为灵敏度。结果UA-5800和AE-4020的尿蛋白定性结果具有一致性(κ=0.65),两者检测尿蛋白的特异性分别为85.19%和83.41%。UA-5800和AE-4020检出蛋白尿的灵敏度在尿蛋白微量组、1+组、2+组和3+组分别为35.53%和34.27%、86.79%和73.69%、100%和100%、100%和92.31%。结论国产UA-5800和日本AE-4020尿分析仪尿蛋白干化学检测具有较高的一致性和良好的诊断蛋白尿的特异性和灵敏度。二者均具有良好的蛋白尿筛查性能。

Objective To investigate the consistency of dipstick tests for proteinuria detection by the use of Mindray UA-5800 or Arkray AE-4020 urine auto-analyzers,and to validate the sensitivity and the specificity of the tests’qualitative determination for proteins in urine.Methods A total of 721 urine samples were collected in October 2016 from outpatient and inpatient cohorts in a cancer hospital and their urinary proteins were tested by UA-5800 and AE-4020 urine analyzers.At the same time,the levels of albumin and creatinine in urine were detected by the biochemical analyzer.The ratio of urinary albumin to creatinine(ACR)was calculated and reported.The criterion of albuminuria was defined as ACR≥30 mg/g Cr.The rate of ACR<30 mg/g Cr in the urinary dipstick negative group was considered as the specificity.The rates of ACR≥30 mg/g Cr in the urinary dipstick groups of trace,1+,2+and 3+,were calculated as the sensitivity.Results The qualitative urine protein results of UA-5800 and AE-4020 were consistent(κ=0.65).The specificity of UA-5800 and AE-4020 was 85.19%and 83.41%,respectively.The sensitivity of UA-5800 and AE-4020 were 35.53%and 34.27%,86.79%and 73.69%,100%and 100%,and 100%and 92.31%in the proteinuria trace group,1+group,2+group,and 3+group,respectively.Conclusion UA-5800 and AE-4020 urinalysis analyzers have a high consistency and same specificity and sensitivity for the diagnosis of proteinuria,and both of them are qualified for proteinuria screening.