Performance Evaluation of Three URiSCAN Devices for Routine Urinalysis

Ko, Kiwoong; Kwon, Min‐Jung; Ryu, Seungho; Woo, Hee‐Yeon; Park, Hyosoon

doi:10.1002/jcla.21874

Cited by 10 publications

(13 citation statements)

References 15 publications

(17 reference statements)

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“…It has been demonstrated that some urine dipsticks have poor ability to accurately detect proteinuria due to their low sensitivity ( 4 ). Various dipsticks may differ in their diagnostic performance regarding leukocyte and erythrocyte detection ( 5 ). There is also evidence that urine dipstick pH analysis shows insufficient accuracy ( 6 ).…”

Section: Introductionmentioning

confidence: 99%

Analytical verification of 12 most commonly used urine dipsticks in Croatia: comparability, repeatability and accuracy

Vuljanić¹,

Dojder²,

Špoljarić³

et al. 2018

Biochem. med. (Online)

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IntroductionVariability among manufacturers of urine dipsticks, respective to their accuracy and measurement range, may lead to diagnostic errors and thus create a serious risk for the patient. Our aims were to determine the level of agreement between 12 most commonly used urine dipsticks in Croatia, examine their accuracy for glucose and total protein and to test their repeatability.Materials and methodsA total of 75 urine samples were used to examine comparability and accuracy of 12 dipstick brands (Combur 10 TestM, ChoiceLine 10, Combur 10 TestUX, ComboStik 10M, ComboStik 11M, CombiScreen 11SYS, CombiScreen 10SL, Combina 13, Combina 11S, Combina 10M, UriGnost 11, Multistix 10SG). Agreement between each dipstick and the reference (Combur 10 TestM) was expressed as kappa coefficient (acceptable κ ≥ 0.80). Accuracy for glucose and total protein was tested by comparison with quantitative measurements on analysers: AU400 (Beckman Coulter, USA), Cobas 6000 c501 (Roche Diagnostics, Germany) and Architect plus c4000 (Abbott, USA). Repeatability was assessed on 20 replicates (acceptable > 90%).ResultsBest agreement was achieved for glucose, total protein and nitrite (11/11, k > 0.80) and the lowest for bilirubin (5/5, k < 0.60). Sensitivities for total protein were 41-75% (AU400) and 56-92% (Cobas and Architect); while specificities were 41-75% (AU400, Cobas, Architect). Dipsticks’ sensitivity and specificity for glucose were 68-98%. Most of the dipsticks showed unacceptable repeatability (6/12, < 90%) for one parameter, most prominently for pH (3/12, < 90%).ConclusionsMost commonly used dipsticks in Croatia showed low level of agreement between each other. Moreover, their repeatability varies among manufacturers and their accuracy for glucose and proteins is poor.

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Section: Introductionmentioning

confidence: 99%

Analytical verification of 12 most commonly used urine dipsticks in Croatia: comparability, repeatability and accuracy

Vuljanić¹,

Dojder²,

Špoljarić³

et al. 2018

Biochem. med. (Online)

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“…In previous studies on URSTs using quantitative data, the readout values from a grade were compared with the analyte concentrations obtained from a chemistry analyzer, or with the blood cell count obtained from a urine particle analyzer or microscope [ 6 , 22 – 26 , 29 , 32 , 33 ]. This is the first study to use URST quantitative readout data for statistical IQC.…”

Section: Discussionmentioning

confidence: 99%

“…URiSCAN Super Plus is one of a series of URST systems that is commonly used in Korea [ 29 ]. On reaction with a urine specimen, the degree of color development of the pads on a reagent strip is measured by a charge-coupled device (CCD) color image sensor under illumination with a light-emitting diode.…”

Section: Methodsmentioning

confidence: 99%

“…The CCD takes a reading at each wavelength for red (630 nm), green (540 nm), and blue (460 nm). The difference in the reflectance rate before and after the reaction is then converted to the change in the reflectance rate (change %R) value, from which a grade on an ordinal scale (e.g., −, ±, +, 2+, and 3+) is generated as the test result based on a range that is predefined by the manufacturer [ 29 ].…”

Section: Methodsmentioning

confidence: 99%

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Internal Quality Control Data of Urine Reagent Strip Tests and Derivation of Control Rules Based on Sigma Metrics

Park

2021

Ann Lab Med

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Background: Urine reagent strip test (URST) results are semi-quantitative; therefore, the precision of URSTs is evaluated as the proportion of categorical results from repeated measurements of a sample that are concordant with an expected result. However, URSTs have quantitative readout values before ordinal results challenging statistical monitoring for internal quality control (IQC) with control rules. This study aimed to determine the sigma metric of URSTs and derive appropriate control rules for IQC.Methods: The URiSCAN Super Plus fully automated urine analyzer (YD Diagnostics, Yongin, Korea) was used for URSTs. Change in reflectance rate (change %R) data from IQC for URSTs performed between November 2018 and May 2020 were analyzed. Red blood cells, bilirubin, urobilinogen, ketones, protein, glucose, leukocytes, and pH were measured from 2-3 levels of control materials. The total allowable error (TEa) for a grade was the difference in midpoints of a predefined change %R range between two adjacent grades. The sigma metric was calculated as TEa/SD. Sigma metric-based control rules were determined with Westgard EZ Rules 3 software (Westgard QC, Madison, WI, USA).Results: Seven out of the eight analytes had a sigma metric > 4 in the control materials with a negative grade (−), which were closer to the cut-offs. Corresponding control rules ranged from 12.5s to 13.5s. Conclusions:Although the URST is a semi-quantitative test, statistical IQC can be performed using the readout values. According to the sigma metric, control rules recommended for URST IQC in routine clinical practice are 12.5s to 13.5s.

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“…Dipstick or diagnostic reagent strips are commonly used in colorimetric analysis for blood or urine samples [ 79 , 80 ]. However, several concerns such as time-dependent variation and uncontrolled reaction volume caused by the dipping of a strip into biofluid, impair their detection accuracy.…”

Section: Smartphone-based Optical Sensing Of Metabolic Biomarkersmentioning

confidence: 99%

Smartphone-based mobile biosensors for the point-of-care testing of human metabolites

Zhang

Cui

2022

Materials Today Bio

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Performance Evaluation of Three URiSCAN Devices for Routine Urinalysis

Abstract: There were well correlated results between those of the three URiSCAN devices and those obtained using the corresponding Roche analyzers, quantitative assays, and manual microscopy. URiSCAN series devices are therefore suitable for routine urinalysis in clinical laboratories.

Cited by 10 publications

References 15 publications

Analytical verification of 12 most commonly used urine dipsticks in Croatia: comparability, repeatability and accuracy

Analytical verification of 12 most commonly used urine dipsticks in Croatia: comparability, repeatability and accuracy

Internal Quality Control Data of Urine Reagent Strip Tests and Derivation of Control Rules Based on Sigma Metrics

Smartphone-based mobile biosensors for the point-of-care testing of human metabolites

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