Annual Report of the Korean Association of External Quality Assessment Service on Urinalysis and Fecal Occult Blood Testing (2018)

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.

Annual Report on the External Quality Assessment Scheme for Urinalysis and Fecal Occult Blood Testing in Korea (2017)

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).

Annual Report on the External Quality Assessment Scheme for Urinalysis and Faecal Occult Blood Testing in Korea (2016)

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).

Annual Report on the External Quality Assessment Scheme for Urinalysis and Faecal Occult Blood Testing in Korea (2015)

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%.

Annual Report on External Quality Assessment Scheme for Urinalysis and Faecal Occult Blood Testing in Korea (2014)

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.

Evaluation of an Automated Dipstick Device for Urinalysis-UriDoctor / 임상검사와정도관리

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.

Urinalysis: The Usefulness and Limitations of Urine Dipstick Testing

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.

Annual Report on External Quality Assessment in Urinalysis in Korea (2009) / 임상검사와정도관리

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%.

Annual Report on External Quality Assessment in Urinalysis in Korea (2008) / 임상검사와정도관리

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%.

Annual Report on External Quality Assessment in Urinalysis in Korea (2007) / 임상검사와정도관리

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%.

Annual Report on External Quality Assessment in Urinalysis in Korea (2007) / 임상검사와정도관리

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%.

Annual Report on External Quality Assessment in Urinalysis in Korea (2005) / 임상검사와정도관리

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 451, 452, and 476 participants, in each, in the year of 2005. The response rate were 95.6% (451/472), 91.9% (452/492) and 95.6% (476/498), 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 increased as 91.2% 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 76.5%(387/498) and the percentage of good performance of these tests ware 63.6% to 86.5%.

Annual Report on External Quality Assessment in Urinalysis in Korea (2004) / 임상검사와정도관리

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 446, participants, in each, in the year of 2004. The response rate were 93.4% (422/452), 91.7% (411/448) and 91.7% (410/447), 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 increased as 87.9% 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% and the percentage of good performance of these tests ware 85.8% to 95.8%.

Annual Report on External Quality Assessment in Urinalysis in Korea (2003) / 임상검사와정도관리

Three external quality assesment trials which composed of 12 control materials(12 chemical materials) for interlaboratory quality control assesment in urinalysis were performed with 446, participants, in each, in the year of 2003. The response rate were 92.4% (414/448), 91.9% (419/456) and 91.3% (408/447), 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 and specific gravity. 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 86.8% and the distribution of using reagent strip was similar to the previous year.

Annual Report on External Quality Assessment in Urinalysis in Korea (2002) / 임상검사와정도관리

Three external quality assesment trials which composed of 12 control materials(12 chemical materials) for interlaboratory quality control assesment in urinalysis were performed with 446, participants, in each, in the year of 2002. The response rate were 91.5% (408/446), 90.8% (405/445) and 90.4% (403/446), 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 and specific gravity. 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 79.0% and the distribution of using reagent strip was similar to the previous year.

El segundo bienio del Programa de Evaluación Externa de Calidad en Uroanálisis (PEECU) / The second biennial of the External Quality Evaluation Program in Urinalysis (PEECU)

OBJECTIVE: To characterize the participation of clinical laboratories in the second biennial of an external quality assurance scheme for urinalysis in Mexico. METHODS: The participants received 32 control samples in 8 shipments of 4 controls each during the biennial 1999-2000. The controls were in the form of tablets to be dissolved in 12 mL of water to mimic urine. The participants performed dipstick assays of pH, specific gravity (SG) and 8 analytes (proteins, glucose, ketones, blood, bilirubin, nitrites, urobilinogen, leukocytes) in the controls. Expected control values were assigned by 10-15 replicate automated assays using dipsticks and apparatus of a single provider (Bayer). Participants' results were transformed to scores ranging from zero (perfect result) to 400 (worst possible). Score differences were analyzed using nonparametric methods (Kruskal-Wallis and Mann-Whitney). RESULTS: The best results were seen for nitrites, ketones and proteins (mean global scores = 3-5) and the worst for SG (score = 45) with intermediate scores of 10-13 for the other six. CONCLUSIONS: The scores improved for the second biennial from a grand mean of 17 in the first significantly down to 12 in the second. The number of participants has been increasing yearly and there has been a decrease of participants who do not report at least 3 out of 4 yearly shipments. We confirmed that automated readings yield better scores than visual readings.

The Performance Evaluation of Yeongdong URiSCAN GEN 10SGL Urine Dipstick Strip Using Other Quantitative, Microscopic, and Culture Methods / 대한임상병리학회지

BACKGROUND: The previous performance tests of URiSCAN GEN 10SGL dipstick reagent strip (Yeongdong pharmaceutical Co., Seoul, Korea) were mainly done by comparison with the approved urine strips. However, adequate comparison was inavailable because the grading systems were different among the manufacturers. We evaluated the correlation of new generation URiSCAN GEN 10SGL urine strip with known quantitative, microscopic, and culture methods. METHODS: We used urine specimens which were collected for the urinalysis and culture from November 2000 to Mars 2001. We evaluated the correlation between the results of URiSCAN GEN 10SGL and the quantitative methods by comparing the mean of change of reflectance rate (change %R) with the result of the corresponding quantitative method for protein, glucose, bilirubin, urobilinogen, pH, and specific gravity. To calculate the sensitivity and specificity, we used microscopic examination for leukocytes and erythrocytes, and used urine culture for nitrite test. RESULTS: The correlation coefficients between the change %R of URiSCAN GEN 10SGL and the corresponding quantitative method exceeded 0.81, except bilirubin and specific gravity (P<0.01; respectively). The agreements of identical or neighboring concentration block were more than 90%, except urobilinogen and specific gravy. The sensitivity and specificity of URiSCAN GEN 10SGL were 63.6% and 94.2% for leukocytes; 92.8% and 74.1% for erythrocytes; 74.4% and 85.0% for nitrite producing organisms. CONCLUSTIONS: URiSCAN GEN 10SGL had acceptable accuracy and agreement compared with the corresponding quantitative methods and culture result. Also, it had improved sensitivity and specificity of leukocytes and erythrocytes detection compared with previous URiSCAN urine dipstick strip.

Sensibilidad, especificidad, valor predictivo y eficiencia de las tiras reactivas para uroanálisis a los parámetros bilirrubina, hemoglobina y urobilinógeno / Sensibility, especifity, predictive value and efficience for urinalisys dipsticks to bilirubin, blood and urobilinogen

Se comparó la sensibilidad, especificidad, valor predictivo y eficiencia de las tiras reactivas marcas: combur, combina, chroma, combi 9, self stick y uriscan a los parámetros hemoglobina, bilirrubina y urobilinógeno. Resultados: hemoglobina: en muestra biológicas combur es 100 por ciento sensible, especifica, valor de predicción y eficiencia. Combi 9 presentó alto porcentaje de falsos positivos. La marca self stick mostró 96,4 por ciento de eficiencia, en función del 100 por ciento de sensibilidad y valor predictivo negativo, y 80 por ciento especificidad. Bilirrubina: combur y self stick reaccionaron 100 por ciento al patrón de 0,4 mg/dL, y 100 por ciento sensibles, especificas, predictivas y eficientes. Las marcas chroma y uriscan mostraron baja eficiencia. Se apreció sobrestimación del valor real de urobilinógeno. Uriscan arrojó 100 por ciento de falsos positivos

A Study on the Status of Preemployment Health Examination / 대한산업의학회지

Preemployment health examination, stipulated by the Occupational Safety and Health Regulations, plays an important role in workers' health management. Recently, employers are getting more aware of the importance of screening recruits before employment to decrease the development of occupational disorders and work loss due to health problems. Accordingly, additional test items are being included and selection criteria for preemployment health examination is getting more strict. However, studies and. data on preemployment health examination are scarce until now. Authors reviewed preemployment health certificates of 3,261 recruits issued by a university hospital in Pohang from January 3 to December 31, 1993, analyzed regulations on preemployment health examination of 16 companies in the Pohang area, and surveyed 80 health and safety personnel with questionnaire to evaluate the present status of preemployment health examination. Of 3,261 recruits 125 (3.8 %) failed to recruit. Main causes of. failure were chronic liver disease, tuberculosis of undetermined activity. The regulations of 16 companies on preemployment health examination were reviewed. Most companies adopted additional test items in addition to basic test items listed on the Regulation; test of physical strength, pulmonary function test, pure tone audiometer (2000 Hz and 4000 Hz in addition to 1000 Hz), exercise provocation test, urine erythrocyte and urobilinogen, complete blood count, stool examination, VDRL, arid sputum examination for acid fast bacilli In most companies, obesity, hearing disturbance, color vision disturbance was included in the selection criteria. Hepatitis B carrier was not accepted in 4 companies, accepted conditionally in 2, and accepted in 5 companies. Of 80 health and safety personnel of companies in the Pohang area, 56 (70. 0 %) perceived preemployment health examination as a tool for selection of recruits and 14(17.5%) as a procedure for job fitting. Most of them were against the acceptance of recruits with hepatitis B carrier, lumbar spine deformity, and hearing disturbance. In conclusion, preemployment health examination is performed mainly for the purpose of selection of healthier employee, but test items and selection creteria is not seem to be adequate. Authors suggest that further studies are needed to select the test items for specific job, and application of selection criteria be restricted only to some specified jobs. Consecutive filling of preemployment health examination to the periodic health examination was also suggested.