In 2018, external quality assessment trials for urinalysis and fecal occult blood (FOB) were performed using 1,590 participants. Urine chemistry tests were performed thrice while urine sediment and FOB tests twice. Urine chemistry tests comprised of pH, protein, glucose, ketone body, bilirubin, blood, urobilinogen, nitrite, leukocyte, and specific gravity analyses. The results of urine chemistry and specific gravity tests showed accuracy rates >95%, except for the pH test. The accuracy rate of urine sediments was low, especially for atypical calcium oxalate crystal and red blood cell cast. In the FOB quality test, reagents showed accuracy rates >90%, except for SD and GC Genedia FOB reagents. In the FOB quantitative test, Alfresa NS-Plus C instrument showed falsely high values in the FOB negative specimens.
Bilirubin ; Calcium Oxalate ; Chemistry ; Erythrocytes ; Glucose ; Hydrogen-Ion Concentration ; Indicators and Reagents ; Leukocytes ; Occult Blood ; Quality Control ; Specific Gravity ; Urinalysis ; Urobilinogen

In 2017, external quality assessment trials for urinalysis and fecal occult blood (FOB) were performed with 1,544 participants. Urine chemistry tests were performed three times and urine sediment and FOB tests were evaluated 2 times. Urine chemistry tests consisted of pH, protein, glucose, ketone, bilirubin, blood, urobilinogen, nitrite, leukocyte, and specific gravity analyses. The results of the urine chemistry and specific gravity tests showed accuracy rates >95%. The accuracy rate of urine sediments was low, especially for fat droplets and atypical uric acid crystals. In the FOB quality test, all reagents showed accuracy rates >82%, which suggested the persistent improvement of false-positive reactions. In the FOB quantitative test, discrepant results depending on the instrument used were observed. To compensate for the result differences caused by the amounts of stool samples, the results should be reported using another unit (µg/g of stool).
Bilirubin ; Chemistry ; Glucose ; Hydrogen-Ion Concentration ; Indicators and Reagents ; Korea* ; Leukocytes ; Occult Blood* ; Quality Control ; Specific Gravity ; Uric Acid ; Urinalysis* ; Urobilinogen

In 2016, external quality assessment trials for urinalysis and faecal occult blood (FOB) were performed with 1,487 participants in Korea. Urine chemistry and FOB tests were performed three and two times, respectively, whereas urine sediment was evaluated once using photography. Urine chemistry tests consisted of pH, protein, glucose, ketone, bilirubin, blood, urobilinogen, and nitrite levels; leukocyte count; specific gravity. The results of the urine chemistry and specific gravity tests showed accuracy rates of >95%. The accuracy rate of urine sediments was low, especially that for transitional epithelial cells and atypical crystals. In the FOB quality test, all reagents showed accuracy rates of >90%, which suggested the improvement of false-positive reaction. In the FOB quantitative test, discrepant results depending on the instrument used was observed. To compensate for the result differences caused by the stool samples, the results should be reported using another unit (µg/g of stool).
Bilirubin ; Chemistry ; Epithelial Cells ; Glucose ; Hydrogen-Ion Concentration ; Indicators and Reagents ; Korea* ; Leukocyte Count ; Occult Blood* ; Photography ; Specific Gravity ; Urinalysis* ; Urobilinogen

In Korea, external quality assessment trials for urinalysis and faecal occult blood (FOB) were performed for 1,250 participants. Urine chemistry and FOB tests were evaluated three times, whereas urine sediment by photography was evaluated twice. Urine chemistry tests consisted those for pH, protein, glucose, ketone, bilirubin, blood, urobilinogen, nitrite, leukocyte, and specific gravity. The results of the urine chemistry and specific gravity tests showed accuracy rates >95%. In the FOB quality test, all reagents showed false-positive results. These reagents showed positive results in stool specimens containing >11 ng/mL haemoglobin. In the FOB quantitative test, the results were significantly different, based on the instrument used for the measurements. The average accuracy rate of urine sediments was 90.8%, whereas those for renal epithelial cells and cholesterol crystals were 83%.
Bilirubin ; Chemistry ; Cholesterol ; Epithelial Cells ; Glucose ; Hydrogen-Ion Concentration ; Indicators and Reagents ; Korea* ; Leukocytes ; Occult Blood* ; Photography ; Specific Gravity ; Urinalysis* ; Urobilinogen

In 2014, external quality assessment trials for urinalysis and faecal occult blood (FOB) were performed of 1,270 participants. Urine chemistry and FOB tests were evaluated three times, while urine sediment examination by photography was evaluated one time. Urine chemistry tests consisted of pH, protein, glucose, ketone, bilirubin, blood, urobilinogen, nitrite, leukocyte, and specific gravity (SG). The urine chemistry test results showed accuracy rates >95%, while those of the SG test by using a refractometer had accuracy rates <95%. In the FOB quality test, the Bio Focus reagent (BIO FOCUS Co., Korea) disclosed low positive rates (87%). The result of the FOB quantity test showed different values according to the instruments used, and the Kyowa instrument (Kyowa Chemical Industry Co., Japan) revealed the lowest values. In a urinary sediment examination, it is necessary to increase the frequency of the quality assessment trials due to low accuracy rates.
Bilirubin ; Chemical Industry ; Chemistry ; Glucose ; Hydrogen-Ion Concentration ; Korea* ; Leukocytes ; Occult Blood* ; Photography ; Specific Gravity ; Urinalysis* ; Urobilinogen

BACKGROUND: We evaluated the recently marketed UriDoctor analyser (DFI Co., Ltd., Korea) for urinalysis and measurement of microalbumin and creatinine in urine. METHODS: The precision within and betweenruns was evaluated using commercial control materials. The comparison evaluations were performed using patient urine samples. Urine dipstick tests for blood, bilirubin, urobilinogen, ketones, protein, nitrite, glucose, pH, specific gravity, and leukocyte esterase were performed with UriDoctor using CYBOW10 strips (DFI Co., Ltd., Korea) and with AX4030 using Aution Sticks 10EA (Arkray Inc., Japan), and the results were compared. Additionally, tests for microalbumin and creatinine were performed with UriDoctor using CYBOW2AC strips and with the Cobas c501 system (Roche Diagnostics, Germany), and the results were compared. RESULTS: The within-run and between-run precisions for urinalysis using UriDoctor were both 100%. The concordance rates and concordance rates including +/-1 grade between UriDoctor and AX4030 were as follows: blood (90%, 100%); bilirubin (97%, 100%); urobilinogen (98%, 100%); ketones (92%, 100%); protein (83%, 100%); nitrite (100%, 100%); glucose (85.0%, 100%); pH (58%, 94%); specific gravity (32%, 80%); leukocyte esterase (89%, 93%). The concordance rates between UriDoctor and the Cobas c501 system were as follows: microalbumin (71%); creatinine (46%); albumin-creatinine ratio (65%). CONCLUSIONS: UriDoctor showed good precision. There was significant agreement between the results of UriDoctor and AX4030, except for pH and specific gravity. The albumin-creatinine ratio showed relatively low specificity and high sensitivity; therefore, it would be more suitable for screening patients. The performance of UriDoctor when used with CYBOW10 and CYBOW2AC strips was satisfactory for clinical application.
Albuminuria ; Bilirubin ; Creatinine ; Glucose ; Humans ; Hydrogen-Ion Concentration ; Ketones ; Kidney Diseases ; Leukocytes ; Mass Screening ; Sensitivity and Specificity ; Specific Gravity ; Urinalysis ; Urobilinogen

The urinalysis is an essential part of the diagnostic work-up for kidney disease and other renal system disorders. The dipstick test allows rapid and simultaneous chemical analyses of urine, including factors such as pH, specific gravity, protein, glucose, ketones, occult blood, bilirubin, urobilinogen, nitrite, and leukocyteesterase. The chemical reactions on dipstick are complicated and can be affected by oxidizing, reducing, and discoloring substances in the urine. Therefore, false positive and false negative results are common in dipstick testing. To obtain reliable results with the dipstick, it is necessary to collect urine cleanly and examine the urine carefully. It is mandatory to clearly understand the principles of dipstick testing to evaluate abnormal findings. If the urine dipstick results suggest hematuria, proteinuria, or urinary tract infection, microscopy of the urine should be performed to confirm the findings.
Bilirubin ; Glucose ; Hematuria ; Hydrogen-Ion Concentration ; Ketones ; Kidney Diseases ; Microscopy ; Occult Blood ; Proteinuria ; Specific Gravity ; Urinalysis* ; Urinary Tract Infections ; Urobilinogen

Three external quality assesment trials which composed of 16 control materials(12 chemical materials and four sets of microscopic photograph of urinary sediment) for interlaboratory quality control assesment in urinalysis were performed with 796, 823, and 841 participants, in each, in the year of 2009. The response rate were 97.1% (796/820), 95.5% (823/862) and 97.1% (841/866), in the first, the second and the third trials, in each. The test items include pH, glucose, protein, ketone, bilirubin, blood, urobilinogen, nitrite, leukocyte estrase, specific gravity and four microscopic photographs of urinary sediment. The survey results are summarized as follows: 1. The chemical quality control test in urinalysis revealed generally good concordance. 2. The percentage of using urinalysis analyzer was slightly decreased as 82.3% and the distribution of using reagent strip was similar to the previous year. 3. The percentage of response rate of microscopic photographs of urinary sediment was 83.5% (702/841) and the percentage of good performance of these tests ware 83.6% to 99.1%.
Bilirubin ; Equidae ; Glucose ; Hydrogen-Ion Concentration ; Korea ; Leukocytes ; Quality Control ; Reagent Strips ; Specific Gravity ; Urinalysis ; Urobilinogen

Three external quality assesment trials which composed of 16 control materials (12 chemical materials and four sets of microscopic photograph of urinary sediment) for interlaboratory quality control assesment in urinalysis were performed with 699, 718, and 732 participants, in each, in the year of 2008. The response rate were 95.4% (699/733), 96.6% (718/743) and 95.3% (732/767), in the first, the second and the third trials, in each. The test items include pH, glucose, protein, ketone, bilirubin, blood, urobilinogen, nitrite, leukocyte estrase, specific gravity and four microscopic photographs of urinary sediment. The survey results are summarized as follows: 1. The chemical quality control test in urinalysis revealed generally good concordance. 2. The percentage of using urinalysis analyzer was slightly decreased as 83.0% and the distribution of using reagent strip was similar to the previous year. 3. The percentage of response rate of microscopic photographs of urinary sediment was 81.3% (571/732) and the percentage of good performance of these tests ware 32.9% to 80.5%.
Bilirubin ; Equidae ; Glucose ; Hydrogen-Ion Concentration ; Korea ; Leukocytes ; Quality Control ; Reagent Strips ; Specific Gravity ; Urinalysis ; Urobilinogen

Three external quality assesment trials which composed of 16 control materials (12 chemical materials and four microscopic photographs of urinary sediment) for interlaboratory quality control assesment in urinalysis were performed with 638, 645, and 662 participants, in each, in the year of 2007. The response rate were 95.5% (638/668), 96.7% (645/667) and 97.1% (662/682), in the first, the second and the third trials, in each. The test items include pH, glucose, protein, ketone, bilirubin, blood, urobilinogen, nitrite, leukocyte esterase, specific gravity and four microscopic photographs of body fluid and urinary sediment. The survey results are summarized as follows: 1. The chemical quality control test in urinalysis revealed generally good concordance. 2. The percentage of using urinalysis analyzer was slightly increased as 87.5% and the distribution of using reagent strip was similar to the previous year. 3. The percentage of response rate of microscopic photographs of urinary sediment was 80.7% (536/662) and the percentage of good performance of these tests was 60.6% to 99.1%.
Bilirubin ; Body Fluids ; Carboxylic Ester Hydrolases ; Equidae ; Glucose ; Hydrogen-Ion Concentration ; Korea ; Leukocytes ; Quality Control ; Reagent Strips ; Specific Gravity ; Urinalysis ; Urobilinogen