Internal Quality Control Data of Urine Reagent Strip Tests and Derivation of Control Rules Based on Sigma Metrics
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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.
Abstract
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.
참고문헌 (34)
- 조선영, "Advances in Automated Urinalysis Systems, Flow Cytometry and Digitized Microscopy", Annals of Laboratory Medicine, 39(1), pp.1~2 (2019), 대한진단검사의학회[DOI]
- Young Eun Kwon, "Prevalence and Clinical Characteristics of Asymptomatic Pyuria in Chronic Kidney Disease", Annals of Laboratory Medicine, 40(3), pp.238~244 (2020), 대한진단검사의학회[DOI]
- 김현지, "Age-Specific Cutoffs of the Sysmex UF-1000i Automated Urine Analyzer for Rapid Screening of Urinary Tract Infections in Outpatients", Annals of Laboratory Medicine, 39(3), pp.322~326 (2019), 대한진단검사의학회[DOI]
- 김현정, "Small Red Blood Cell Fraction on the UF-1000i Urine Analyzer as a Screening Tool to Detect Dysmorphic Red Blood Cells for Diagnosing Glomerulonephritis", Annals of Laboratory Medicine, 39(3), pp.271~277 (2019), 대한진단검사의학회[DOI]
- Matthijs Oyaert, M.Sc.,, "Progress in Automated Urinalysis", Annals of Laboratory Medicine, 39(1), pp.15~22 (2019), 대한진단검사의학회[DOI]
- Vuljanić D, "Analytical verification of 12 most commonly used urine dipsticks in Croatia: comparability, repeatability and accuracy", Biochem Med (Zagreb), 29, pp.010708~ (2019)
- Rota C, "Evaluation of Aution Max AX-4030 and 9UB Uriflet, 10PA Aution Sticks urine dipsticks in the automated urine test strip analysis", Clin Chem Lab Med, 50, pp.139~146 (2011)
- Hoffmann P, "Evaluation of the iChem® Velocity™ urine chemistry analyzer in a hospital routine laboratory", Clin Chem Lab Med, 49, pp.509~513 (2011)
- European Confederation of Laboratory Medicine, "European urinalysis guidelines", Scand J Clin Lab Invest Suppl, 231, pp.1~86 (2000)
- Kouri T, "Quality specifications for ordinal scale measurements with multiproperty (multiple) urine test strips", Scand J Clin Lab Invest, 59, pp.523~526 (1999)
- Pum JKW, "Evaluation of analytical performance of qualitative and semi-quantitative assays in the clinical laboratory", Clin Chim Acta, 497, pp.197~203 (2019)
- Lim S, "Evaluation of the URiSCAN 2 ACR Strip to estimate the urine albumin", creatinine ratios, 2018, pp.32, e22289~
- Xia J, "Quality specifications of routine clinical chemistry methods based on sigma metrics in performance evaluation", J Clin Lab Anal, 32, pp.e22284~ (2018)
- Cao S, "Application of Sigma metrics in assessing the clinical performance of verified versus non-verified reagents for routine biochemical analytes", Biochem Med (Zagreb), 28, pp.020709~ (2018)
- Zeng Y, "Practical application of the sigma-metric run size nomogram for multistage bracketed statistical quality control analysis of eight enzymes", Clin Chim Acta, 492, pp.57~61 (2019)
- Đido V, "Determination of Six Sigma metric in control of enzymes determination in human serum", Clin Lab, 65 (2019)
- Li R, "Comparative analysis of calculating sigma metrics by a trueness verification proficiency testing-based approach and an internal quality control data inter-laboratory comparison-based approach", J Clin Lab Anal, 33, pp.e22989~ (2019)
- 박해일, "Comparison of Method Group Precision in Proficiency Testing of Clinical Chemistry Tests Before and After Two Major Changes: Reorganization of Proficiency Testing and Implementation of the Differential Benefit for the Quality of Laboratory Tests", Annals of Laboratory Medicine, 39(3), pp.333~339 (2019), 대한진단검사의학회[DOI]
- 허희진, "Sigma-Metrics of Electrolyte Tests From a Recently Launched New-Generation Proficiency Testing Program of the Korean Association of Quality Assurance for Clinical Laboratory", Annals of Laboratory Medicine, 37(4), pp.339~342 (2017), 대한진단검사의학회
- Zhou B, "Practical application of Six Sigma management in analytical biochemistry processes in clinical settings", J Clin Lab Anal, 34, pp.e23126~ (2020)
- Hens K, "Sigma metrics used to assess analytical quality of clinical chemistry assays: importance of the allowable total error (TEa) target", Clin Chem Lab Med, 52, pp.973~980 (2014)
- Oyaert M, "Semiquantitative, fully automated urine test strip analysis", J Clin Lab Anal, 33, pp.e22870~ (2019)
- Oyaert MN, "Quantitative urine test strip reading for leukocyte esterase and hemoglobin peroxidase", Clin Chem Lab Med, 56, pp.1126~1132 (2018)
- Delanghe JR, "Sensitive albuminuria analysis using dye-binding based test strips", Clin Chim Acta, 471, pp.107~112 (2017)
- Cho MC, "Evaluation of the URiSCAN super cassette ACR semiquantitative urine dipstick for microalbuminuria screening", J Clin Lab Anal, 28, pp.281~286 (2014)
- Decavele AS, "A sensitive quantitative test strip based point-of-care albuminuria screening assay", Clin Chem Lab Med, 50, pp.673~678 (2012)
- Westgard S, "Analytical Sigma metrics: a review of Six Sigma implementation tools for medical laboratories", Biochem Med (Zagreb), 28, pp.020502~ (2018)
- Park HI, "LEGO plot for simultaneous application of multiple quality requirements during trueness verification of quantitative laboratory tests", J Clin Lab Anal, 28, pp.147~156 (2014)
- Ko K, "Performance evaluation of three URiSCAN devices for routine urinalysis", J Clin Lab Anal, 30, pp.424~430 (2016)
- Farrance I, "ISO", TS 20914:2019 - a critical commentary, 2019, pp.58, 1182~1190
- Westgard JO, "The quality of laboratory testing today: an assessment of sigma metrics for analytic quality using performance data from proficiency testing surveys and the CLIA criteria for acceptable performance", Am J Clin Pathol, 125, pp.343~354 (2006)
- Penders J, "Quantitative measurement of ketone bodies in urine using reflectometry", Clin Chem Lab Med, 43, pp.724~729 (2005)
- Penders J, "Quantitative evaluation of urinalysis test strips", Clin Chem, 48, pp.2236~2241 (2002)
- Ceriotti F, "Criteria for assigning laboratory measurands to models for analytical performance specifications defined in the 1st EFLM Strategic Conference", Clin Chem Lab Med, 55, pp.189~194 (2017)