BACKGROUND: The ComboStick Reader 720(R)(DFI Co., Ltd. Korda) is a newly developed automated urine analyzer. The objective of this analysis was to evaluate the analytical performance of the Combostick Reader 720 and ComboStick 10 reagent strips and to compare the results using the Uriscan Pro II and Uriscan Gen 10 SGL strips (YD Diagnostics, Korea). METHODS: The Dipstick urinalyses were performed on a ComboStick Reader 720(R) using ComboStick 10 strips and on a Uriscan Pro II(R) using Uriscan 10 SGL strips. Precision was evaluated with commercial control materials. The sets of results were analyzed for concordance with weighted kappa values or intraclass correlation coefficients (ICCs). The microscopic urine analysis was carried out to confirm the results from both automated urine analyzers. Agreement between the dipstick methods and the microscopic method was evaluated by kappa values and the McNemar test. RESULTS: Within and between-run precisions of the ComboStick Reader 720(R) were 90.0% to 100%. A comparison of results from 1,700 urine samples using the ComboStick Reader 720(R) and Uriscan Pro II(R) revealed a very high concordance rate of > or = 91.0% on consideration of neighboring blocks for all analytes of the dipstick urinalysis. There was a good association between the microscopic method and the dipstick methods of the two automated urine analyzers. The ComboStick Reader 720(R) revealed a statistically higher degree of agreement for leukocytes. CONCLUSIONS: The ComboStick Reader 720(R) and ComboStick 10 strips showed good precisions and revealed a statistically significant agreement with the Uriscan Pro II(R) and Uriscan 10 SGL strips. For leukocytes, the ComboStick Reader 720(R) was superior to the Uriscan Pro II(R) in comparing the agreement between the microscopic and dipstick methods. The overall performance of the ComboStick Reader 720(R) and ComboStick 10 strips were satisfactory.
Leukocytes ; Reagent Strips ; Urinalysis

A strip reader based lateral flow immunoassay (LFIA) was established for the rapid and quantitative detection of ractopamine (RAC) in swine urine. The ratio of the optical densities (ODs) of the test line (AT) to that of the control line (AC) was used to effectively minimize interference among strips and sample variations. The linear range for the quantitative detection of RAC was 0.2 ng/mL to 3.5 ng/mL with a median inhibitory concentration (IC50) of 0.59 ± 0.06 ng/mL. The limit of detection (LOD) of the LFIA was 0.13 ng/mL. The intra-assay recovery rates were 92.97%, 97.25%, and 107.41%, whereas the inter-assay rates were 80.07%, 108.17%, and 93.7%, respectively.
Animals ; Immunoassay ; Phenethylamines ; urine ; Reagent Strips ; Swine ; urine

BACKGROUND: Although bacteriologic culture remains the gold standard for detecting bactriuria, leukocyte esterase, nitrite and urine microscopy are also widely used. However, it is not uncommon to be presented with a discrepancy between these tests. METHODS: We performed leukocyte esterase and nitrite tests by urine reagent strip testing (Combur 10 Test, Roche, Germany), microscopic urinalysis, and by bacteriologic urine culture on 290 persons. RESULTS: The number of pathogens and non-pathogens were 51 (17.6%) and 87 (30.0%) respectively. The number of cases in which no microorganism was isolated (NMI group) was 152 (52.4%). The concordance rate between leukocyte esterase and microscopic leukocytes (leukocyturia) was 70.7%. The sensitivities and specificities of leukocyte esterase, microscopic leukocyte and microscopic bacteria were 72.5%/61.8%, 76.5%/44.1 % and 80.4%/92.1% respectively, and their positive predictive values and negative predictive values were 24% (62.3%)/69.1% (89.7%), 21.3% (53.6%)/62.6% (88.8%) and 51.9% (84.8%)/66.4% (95.3%), respectively. Although the nitrite test showed higher positive rates in the pathogen groups (37.2%) than in the non-pathogen group (2.2%) and NMI group (1.3%), this was only marginally significant. CONCLUSION: The microscopic estimation of bacteria is more a predictable marker of bacteriuria, rather than leukocyte esterase, nitrite, and microscopic leukocytes, in urine.
Bacteria ; Bacteriuria* ; Humans ; Leukocytes* ; Microscopy ; Reagent Strips ; Urinalysis

BACKGROUND: Although bacteriologic culture remains the gold standard for detecting bactriuria, leukocyte esterase, nitrite and urine microscopy are also widely used. However, it is not uncommon to be presented with a discrepancy between these tests. METHODS: We performed leukocyte esterase and nitrite tests by urine reagent strip testing (Combur 10 Test, Roche, Germany), microscopic urinalysis, and by bacteriologic urine culture on 290 persons. RESULTS: The number of pathogens and non-pathogens were 51 (17.6%) and 87 (30.0%) respectively. The number of cases in which no microorganism was isolated (NMI group) was 152 (52.4%). The concordance rate between leukocyte esterase and microscopic leukocytes (leukocyturia) was 70.7%. The sensitivities and specificities of leukocyte esterase, microscopic leukocyte and microscopic bacteria were 72.5%/61.8%, 76.5%/44.1 % and 80.4%/92.1% respectively, and their positive predictive values and negative predictive values were 24% (62.3%)/69.1% (89.7%), 21.3% (53.6%)/62.6% (88.8%) and 51.9% (84.8%)/66.4% (95.3%), respectively. Although the nitrite test showed higher positive rates in the pathogen groups (37.2%) than in the non-pathogen group (2.2%) and NMI group (1.3%), this was only marginally significant. CONCLUSION: The microscopic estimation of bacteria is more a predictable marker of bacteriuria, rather than leukocyte esterase, nitrite, and microscopic leukocytes, in urine.
Bacteria ; Bacteriuria* ; Humans ; Leukocytes* ; Microscopy ; Reagent Strips ; Urinalysis

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.
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 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%.
Bilirubin ; Equidae ; Glucose ; Hydrogen-Ion Concentration ; Korea* ; Leukocytes ; Quality Control ; Reagent Strips ; Specific Gravity ; Urinalysis* ; Urobilinogen

BACKGROUND: Microscopic examinations are usually performed to confirm urine sediments in samples flagged in automated urinalysis. The aim of this study was to analyze the review rates and the difference in urinalysis results according to review rules. METHODS: A total of 1,408 urine samples submitted for health screening were collected. The urine chemistry test and urine sediment test were performed using EikenUS 3100 (Eiken Chemical Co. Ltd., Japan) and Sysmex UF-1000i (Sysmex Co., Japan), respectively. We assessed the rate of agreement between the 2 analyses and the kappa values for white blood cells (WBCs) and red blood cells (RBCs). Microscopic examinations were performed for all cases of discordant results between the urine strip and automated sediment analysis, some cases of concordant results, and cases of albuminuria. RESULTS: The review rate was 14.3%. Microscopic examinations were additionally performed on 77 samples (77/1,207, 6.4%) including 29 and 56 samples flagged for WBCs and RBCs, respectively. Based on the results of microscopic examination, the false-positive and the false-negative results of the urine chemistry test and automatic sediment analysis were corrected. Among concordant results between two methods, a clinically significant number of false-negatives were identified (6 results of WBC detection [6/125, 4.8%] and 4 of RBC detection [4/145, 2.8%]). Among the 22 unflagged cases of albuminuria, pathologic casts were detected in 21 cases (21/22, 95.5%). CONCLUSIONS: Microscopic examination based on the combined results of the two analyses improved the quality of the test.
Albuminuria ; Chemistry ; Erythrocytes ; Flow Cytometry ; Leukocytes ; Mass Screening ; Microscopy ; Quality Improvement* ; Reagent Strips ; Urinalysis*

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 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%.
Bilirubin ; Equidae ; Glucose ; Hydrogen-Ion Concentration ; Korea* ; Leukocytes ; Quality Control ; Reagent Strips ; Specific Gravity ; Urinalysis* ; Urobilinogen