BACKGROUND: High albuminuria is defined as albumin excretion of >30 mg/24 hr or an albumin-to-creatinine ratio of 30 mg/g in a random urine sample. We assessed the analytical performance of the Albumin in Urine/CSF FS kit (DiaSys Inc., UK) using a BioMajesty JCA-6010/C analyzer (JEOL Inc., Japan). METHODS: Urine albumin concentrations were measured by the Albumin in Urine/CSF FS kit using a BioMajesty JCA-BM6010/C analyzer. Imprecision, linearity, and carry-over were measured according to the Clinical Laboratory and Standards Institute documents EP10 and EP9. The assay was compared with the ALB-T TQ Gen.2 (Roche, Germany) assay on a Cobas8000 C702 (Roche, Germany), the Tina-Quant Albumin (Roche, Switzerland) assay on a Hitachi7600-210 (Hitachi, Japan), and an Abbott urine albumin assay (Abbott Laboratories, USA) on a TBA 200FR (Toshiba, Japan) using 50 random urine samples. RESULTS: Within-run and total imprecision were 0.551-1.023% and 0.551-1.214%, respectively. Linearity ranged from 6.31 to 30.60 mg/dL, and functional sensitivity was 0.5 mg/dL. Results from the Albumin in Urine/CSF FS kit showed good correlation with the ALB-T TQ Gen.2 (r=0.987) and the Tina-Quant Albumin assays (r=0.991). However, the four assays categorized 18 of 50 urine samples into different albuminuria groups. CONCLUSIONS: Albumin in Urine/CSF FS testing on a BioMajesty JCA-BM6010/C analyzer showed good linearity, functional sensitivity, precision, and correlation with the ALB-T TQ Gen.2 and Tina-Quant Albumin assays. However, because some samples were categorized into different albuminuria groups by the different assays, further studies on the standardization of albuminuria assays are needed.
Albuminuria

No abstract available.
Albuminuria ; Glomerular Filtration Rate

Researchers at Central Army Hospital No 108, who studied 62 patients with primary hypertension, with average age is 66,9 and average determined times is 5,4 years. The results showed that positive microalbuminuria patients are 58%, this is early sign of kidney damage in patients with primary hypertention. Microalbuminuria closely related with time of hypertesion, systolic hypertension and according to creatine and specially sign of left ventricle in patients with hypertension.
Hypertension ; Heart Ventricles ; Albuminuria

BACKGROUND: The urinary albumin/creatinine ratio (ACR) is an important indicator of albuminuria. We aimed to estimate ACR uncertainty and its impact on test results and proposed imprecision quality goals based on the estimated uncertainty. METHODS: The combined ACR uncertainty was calculated using the individual uncertainties of urinary albumin and creatinine. ACR confidence intervals (CIs) were estimated based on the expanded uncertainty. When the CI contained the ACR category boundary (30 or 300 mg/g), the cases were considered ambiguous. Quality goals for ACR were suggested using the number of ambiguous cases among actual patient results. RESULTS: The number of ambiguous cases resulting from the combined ACR uncertainty was higher than expected based on biological variation (BV) quality goals. When the ACR met BV quality specifications, we estimated that 4.8–15.5% of the results may have been misclassified. To minimize the number of ambiguous results, the minimum, desirable, and optimum quality goals were set at 34.0%, 18.0%, and 4.5%, respectively. CONCLUSIONS: We expressed ACR uncertainty using the uncertainties of urinary albumin and creatinine and assessed the impact of this combined uncertainty on the test results. Subsequently, we proposed imprecision quality goals for ACR based on ambiguous results.
Albuminuria ; Creatinine ; Humans ; Uncertainty

No abstract available.
Albuminuria/*epidemiology ; Female ; Humans ; Male

OBJECTIVE: Albumin creatinine ratio (ACR) in a spot urine is replacing albumin excretion rate (AER) in 24 hour-collected urine as screening test for microalbuminuria because of simplicity and reliance. There are some controversies about the most relevant ACR value in detecting microalbuminuria. Most commonly recommended cut-off value is 30 mg/gm. Some recommends sex-specific ACR cut-off value: 17 mg/gm for men, 25 mg/gm for women. In this report, we evaluated diagnostic characteristics of ACR according to above different cut-off values and estimated most relevant ACR cut-off value for microalbuminuria in patients with type 2 diabetes. METHODS: Urine was collected for 24hours for the measurement of microalbumin in type 2 diabetes who admitted in SNUH. The next day, first morning urine was obtained for microalbumin and creatinine concentration in patients with albumin excretion rate (AER) below 300 mg/day. RESULTS: 33% of total 156 patients had microalbuminuria. ACR correlated positively with AER. According to regression equations of AER and ACR, an AER of 30 mg/day corresponded to an ACR of 32 mg/gm. Positive and negative predictive values of ACR 30 mg/gm for microalbuminuria were 81% and 84% in men. In women, these were 80% and 86% respectively. Using recommended sex-specific ACR cutoff values, these were 52% and 94% in men, 68% and 91% in women. The most relevant ACR cutoff from receiver operating characteristics curve was 32 mg/gm in our study. CONCLUSION: Using ACR 30 mg/gm as cut-off values of microalbuminuria, positive and negative predictive value were above 80% in both men and women. In patients visiting SNUH, ACR 32 mg/gm may be more relevant in screening microalbuminuria in type 2 diabetes.
Albuminuria ; Creatinine* ; Female ; Humans ; Male ; Mass Screening* ; Proteinuria ; ROC Curve

BACKGROUND: Diagnosing albuminuria by measuring the urinary albumin-creatinine ratios (UACR) is important for the early detection of kidney diseases in patients with diabetes or hypertension. Currently, a few point-of-care testing (POCT) systems exist for estimating the UACR. Here, we evaluated the performance characteristics of two semi-quantitative UACR POCT assays. METHODS: Albumin and creatinine levels were quantified for 219 randomly acquired urine samples with the Toshiba TBA-200FR NEO analyzer, and the UACR were calculated. The results were compared to UACR measured using the CLINITEK Microalbumin 2 Strip (Siemens, USA) and URiSCAN 2 ACR Strip (YD diagnostics, Korea) POCT assays. RESULTS: Semi-quantitative results from the CLINITEK and URiSCAN UACR assays showed that the sensitivity and specificity of each test were, respectively, 96.7% and 62.7%, and 45.9% and 84.8%. Positive and negative predictive values of the CLINITEK and URiSCAN tests were, respectively, 50.0% and 98.0%, and 53.8% and 80.2%. The rate of agreement between URiSCAN test and CLINITEK test was 91.1% in the normal UACR range (<30 mg/g), but it was as low as 36.4% in the abnormal UACR range (> or =30 mg/g). CONCLUSIONS: The URiSCAN test showed higher specificity than did the CLINITEK test owing to the lower false positive results. However, the high rate of false negatives for the URiSCAN test significantly lowered its sensitivity and negative predictive values. Therefore, the sensitivity of the URiSCAN device in detecting urine albumin needs to be improved before its adoption as a reliable rule-out testing system.
Albuminuria ; Creatinine ; Humans ; Hypertension ; Kidney Diseases ; Sensitivity and Specificity

BACKGROUND: Early detection of moderately increased albuminuria using the albumin-creatinine ratio (ACR) test is very important for preventing renal insufficiency and cardiovascular disease in patients with diabetes. The purpose of this study was to analyse the clinical usefulness of the Afinion AS100 Analyzer (Alere Technologies AS, Norway) for determining the ACR by evaluating its precision and linearity and comparing it with another conventional device. METHODS: Urine samples of patients and quality control materials were used for evaluation. The Afinion AS100 was used to measure albumin and creatinine, and the ACR was automatically calculated. The Cobas Integra 800 (Roche Diagnostics, Germany) was used as a reference instrument for correlation analysis. In accordance with the Clinical and Laboratory Standards Institute guidelines, precision, linearity, and turnaround time were evaluated, and the Afinion AS100 was compared with another device. RESULTS: The total coefficients of variation of albumin and creatinine were 2.8% and 2.9% for high concentration and 2.9% and 2.5% for low concentration, respectively. Both albumin and creatinine showed coefficients of determination of 0.999 or higher in linearity. Correlation coefficients of albumin, creatinine, and ACR were higher than the Clinical and Laboratory Standards Institute recommended value of 0.975, suggesting a high correlation as well as showing significant correlation with a 24-hour urinary albumin level obtained using the Cobas Integra 800. Mean turnaround time was 5 minute 35 seconds. CONCLUSIONS: The albumin, creatinine, and ACR tests performed with the Afinion AS100 showed satisfactory performance in terms of precision and linearity and showed good correlation with the central laboratory instrument and a 24-hour urine albumin quantitative test using a conventional instrument.
Albuminuria ; Cardiovascular Diseases ; Creatinine* ; Humans ; Quality Control ; Renal Insufficiency

OBJECTIVE: To develop a rapid detection method for microalbuminuria with size-exclusion high performance liquid chromatography. METHODS: With a new mobile phase, samples were injected onto an Agilent Zorbax GF-250 size exclusion chromatographic column. The method was evaluated and urine albumin of 56 diabetic patients was analyzed. RESULTS: The mobile phase containing 0.1% formic acid and acetonitrile, with 20 μL sample size, 1 mL/min flow rate, 205 nm detection wavelength. The retention time of albumin both in human serum and urine was 1.7 min. The linear range was 5-2000 mg/L. The lower limit of measurement was 2 mg/L. The intra-assay coefficient of variation and the inter-assay coefficient of variation were 3.98% and 4.05% (20 mg/L), 3.55% and 3.60% (200 mg/L), 4.65% and 4.74% (2000 mg/L), respectively. Recovery rates were 95.3%, 98.1%, and 97.2%. Microalbuminuria was detected in 30 samples by high performance liquid chromatography and 15 samples by immunoturbidimetry from 56 patients with diabetic mellitus. CONCLUSION A fast and high sensitivity method, namely size-exclusion high performance liquid chromatography, with mobile phase containing 0.1% formic acid and acetonitrile has been established to analyze microalbuminuria, which can detect more microalbuminuria than other methods and is suitable for clinical routine measurement.
Albuminuria ; diagnosis ; Chromatography, High Pressure Liquid ; Diabetes Mellitus ; urine ; Humans

Two types of urine dipstick assays, Multistix-SG and Comber-9-Test RL, were compared for compatibility, accuracy, specificity and predictive values of a positive and negative test in 501 patients' urine and artificially prepared specimen. We found that the results of semiquantitative tests of Multistix-SG and Comber-9-Test RL performed were statistically similar in patients' specimen. The urinary leukocyte esterase tests of Comber-9-Test RL assays compared with urine sediment microscopy in regard to compatibility, sensitivity, specificity, and predictive values of a positive and negative test 83.7%, 48.1%, 90.3%, 47.4% and 90.1%, respectively. The urinary nitrite tests of Comber-9-Test RL assays compared with urine culture tests, in regard to compatibility, sensitivity, specificity, and predictive values of a positive and negative test were 90.3%, 19.4%, 84.7%, 53.8% and 94.1, respectively. For the urinary protein, the sulfosalicylic acid method was the most sensitive test for any kinds of protein, and Multistix-SG appeared more sensitive than Comber-9-Test RL for the albuminuria. For the urinary bilirubin and glucose, two dipstick assays were similar in their diagnostic efficiency. Finally in the urinary occult blood tests, Comber-9-Test RL assays was more sensitive than Multistix-SG.
Albuminuria ; Bilirubin ; Glucose ; Leukocytes ; Methods ; Microscopy ; Occult Blood ; Sensitivity and Specificity ; Urinalysis