| Background and Objective: Microalbuminuria is the key indicators of diagnosis of early diabetic nephropathy(Diabetic Nephropathy, DN), screening the amount of microalbumin in urine in diabetic patients(microalbuminuria, MA) is important. The currently accepted method of evaluation of urinary MA is the determination of 24 hour urine or night time urinary MA excretion rate, but the operation is very complicated, and the strict requirements and procedures of the technology makes it difficult for the ordinary people to operate. Research shows that urinary albumin/creatinine ratio(ACR) can be used to monitor the urinary excretion of MA and ACR was in high correlation with urinary albumin excretion rate. Immunoturbidimetric method is the most commonly used in large clinical laboratory for measuring amount of urinary MA, which has strong sensitivity and specificity. AS100 special protein analyzer produced by Afinion company in Norway is a real-time detection device, the device is designed for the instant detection of urinary MA with dry immune scattering quantitative method. The operation is very simple and quick.Our study collects morning urine samples from patients with type 2 diabetes, and then the samples are detected the urine albumin using immuno-turbidimetric method and dry immune markers scattered quantitative method respectively.The urine creatinine were measured using enzyme method of synchronization. Our study aims to compare the results of two methods to show whether the results are consistent and to evaluate the clinical value of AS100 protein analyzer methods.Methods: We collected 60 cases of type 2 diabetic patients hospitalized in the first hospital affiliated of Dalian Medical University from 2014 November to 2015 February. All of cases have(-),(±) or(+)qualitative urine protein results. We collected patients’ urine 20 ml in the fasting state, the sample was divided into 2 parts, then the sample was detected respectively using immuno-turbidimetric method and dry immune scattering quantitative method. Immuno-turbidimetric method using SIEMENS BN II automatic protein analyzer is conducted by Department of clinical laboratory in the First Hospital affiliated of Dalian Medical University. Dry immune markers scattered quantitative method using the Afinion AS100 special protein analyzer is conducted in the diabetic laboratory. Determination of creatinine concentration was used enzyme method, then calculating the value of ACR, comparing two detection methods rusults and evaluation of dry immune markers scattered quantitative method.Results:1. We have recruited 60 patients:qualitative urine protein(-)group 23 cases, qualitative urinary protein(±)group 21 cases, qualitative urinary protein(+) group of 16 cases.2. Analysis of complete data: according to the data of urine routine examination results all cases were divided into 3 groups:qualitative urine protein(-)group 18 cases, qualitative urinary protein(±)group 13 cases, qualitative urinary protein(+) group of 14 cases. The ACR value was compared in each group, the results shows within group differences were no statistical significance(P>0.05); the two detection methods of urinary MA determination compared in each group showed no statistical significance value difference(P>0.05); and there is no statistical difference in the creatinine concentrations between the two instruments measured using enzymatic(P>0.05).3. Analysis of non complete data information: a total of 15 patients using Afinion AS100 special protein analyzer detected urine specimens which did not show specific ACR value, then we divided into these cases into 3 groups and compared with the clinical laboratory results. Urinary MA < 5.0mg/L(7 cases)using, immune- turbidimetry results shows average MA 2.71mg/L, the average is below 5.0mg/L and consistent with the dry immune markers scattering quantitative method; Urinary MA > 200mg/L(5 cases) using dry immune markers scattering quantitative method, immune-turbidimetry shows average MA 564.88mg/L, only 1 cases with specific value is 85.7mg/L, the other 4 cases were more than 200mg/L,the majority cases results was consistent between two methods; the Afinion AS100 analyzer for determination of creatinine 3 cases < 16.4mg/dl, synchronous inspection department Hitachi 7600-110 automatic biochemical analyzer enzymatic method for the determination of the 3 cases of urinary creatinine the mean of 21.44mg/dl; and no significant difference in the average m Alb concentration(48.23 mg/L vs 41.53mg/L).4. Linear equation for two kinds of method for the determination of ACR: qualitative urine protein(-) group, y=0.6193x+3.8869, r=0.9358,P=0.646; qualitative urine protein(±) group, y=0.7606 x + 1.1171, r=0.9956,P=0.457; qualitative urine protein(+) group, y=0.9883x-5.5, r=0.9847,P=0.550; the results show a good correlation between the two methods of measuring ACR value.5. Linear equation for two kinds of method for the determination of MA: qualitative urine protein(-) group, y=0.8036 x +0.3142, r=0.9781, P=0.591; qualitative urine protein(±) group, y=0.9976x-3.385, r=0.9889,P=0.628; qualitative urine protein(+) group, y=1.4693x-22.493, r=0.8806,P=0.646; the results show a good correlation between the two methods of measuring MA value.6. Linear equation for two kinds of method for the determination of Cre: qualitative urine protein(-) group, y=0.8857 x +11.988, r=0.9689, P=0.255;qualitative urine protein(±) group, y=0.6866x+26.114, r=0.9213, P=0.457; qualitative urine protein(+) group, y=0.4646x+50.937,r=0.7489,P=0.927; the results show a good correlation between the two methods of measuring Cre value.Conclusions:Our study shows that the results of dry immune scattering quantitative method and immune-turbidimetry is consistent, and dry immune scattering quantitative method for the detection of urinary microalbumin and ACR is suitable for clinical application. |
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