Proposed Imprecision Quality Goals for Urinary Albumin/Creatinine Ratio
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Background: The urinary albumin/creatinine ratio (ACR) is an important indicator of albuminuria. We aimed to estimate ACR uncertainty and its impact on test results and proposed imprecision quality goals based on the estimated uncertainty. Methods: The combined ACR uncertainty was calculated using the individual uncertainties of urinary albumin and creatinine. ACR confidence intervals (CIs) were estimated based on the expanded uncertainty. When the CI contained the ACR category boundary (30 or 300 mg/g), the cases were considered ambiguous. Quality goals for ACR were suggested using the number of ambiguous cases among actual patient results. Results: The number of ambiguous cases resulting from the combined ACR uncertainty was higher than expected based on biological variation (BV) quality goals. When the ACR met BV quality specifications, we estimated that 4.8–15.5% of the results may have been misclassified. To minimize the number of ambiguous results, the minimum, desirable, and optimum quality goals were set at 34.0%, 18.0%, and 4.5%, respectively. Conclusions: We expressed ACR uncertainty using the uncertainties of urinary albumin and creatinine and assessed the impact of this combined uncertainty on the test results. Subsequently, we proposed imprecision quality goals for ACR based on ambiguous results.
Abstract
Background: The urinary albumin/creatinine ratio (ACR) is an important indicator of albuminuria. We aimed to estimate ACR uncertainty and its impact on test results and proposed imprecision quality goals based on the estimated uncertainty. Methods: The combined ACR uncertainty was calculated using the individual uncertainties of urinary albumin and creatinine. ACR confidence intervals (CIs) were estimated based on the expanded uncertainty. When the CI contained the ACR category boundary (30 or 300 mg/g), the cases were considered ambiguous. Quality goals for ACR were suggested using the number of ambiguous cases among actual patient results. Results: The number of ambiguous cases resulting from the combined ACR uncertainty was higher than expected based on biological variation (BV) quality goals. When the ACR met BV quality specifications, we estimated that 4.8–15.5% of the results may have been misclassified. To minimize the number of ambiguous results, the minimum, desirable, and optimum quality goals were set at 34.0%, 18.0%, and 4.5%, respectively. Conclusions: We expressed ACR uncertainty using the uncertainties of urinary albumin and creatinine and assessed the impact of this combined uncertainty on the test results. Subsequently, we proposed imprecision quality goals for ACR based on ambiguous results.
참고문헌 (18)
- Lambers Heerspink HJ, "Albuminuria is an appropriate therapeutic target in patients with CKD: the Pro View", Clin J Am Soc Nephrol, 10, pp.1079~1088 (2015)[DOI]
- Currie G, "Proteinuria and its relation to cardiovascular disease", Int J Nephrol Renovasc Dis, 7, pp.13~24 (2013)
- Rodby RA, "Timed urine collections for albumin and protein: "The King Is Dead, Long Live the King!"", Am J Kidney Dis, 68, pp.836~838 (2016)[DOI]
- Talreja H, "Predicting kidney transplantation outcomes using proteinuria ascertained from spot urine samples versus timed urine collections", Am J Kidney Dis, 64, pp.962~968 (2014)[DOI]
- American Diabetes Association, "Standards of medical care in diabetes-2017: summary of revisions", Diabetes Care, 40(S1), pp.S4~S5 (2017)[DOI]
- Farrance I, "Uncertainty of measurement: a review of the rules for calculating uncertainty components through functional relationships", Clin Biochem Rev, 33, pp.49~75 (2012)
- Sandberg S, "Defining analytical performance specifications: consensus Statement from the 1st Strategic Conference of the European Federation of Clinical Chemistry and Laboratory Medicine", Clin Chem Lab Med, 53, pp.833~835 (2015)
- 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)
- Shephard MD, "An innovative Australian point-of-care model for urine albumin: creatinine ratio testing that supports diabetes management in indigenous medical services and has international application", Ann Clin Biochem, 42, pp.208~215 (2005)[DOI]
- Miller WG, "Standardization of urine albumin measurements: status and performance goals", J Appl Lab Med, 2, pp.423~429 (2017)[DOI]
- Levin A, "Summary of KDIGO 2012 CKD Guideline: behind the scenes, need for guidance, and a framework for moving forward", Kidney Int, 85, pp.49~61 (2014)[DOI]
- Cavalier E, "Measurement uncertainty of creatinine in low values: another good reason not to use the MDRD formula with low creatinine values", Clin Biochem, 40, pp.285~286 (2007)[DOI]
- Ricos C, "Current databases on biological variation: pros, cons and progress", Scand J Clin Lab Invest, 59, pp.491~500 (1999)[DOI]
- Fraser CG, "Proposals for setting generally applicable quality goals solely based on biology", Ann Clin Biochem, 34, pp.8~12 (1997)[DOI]
- de Boer IH, "Renal outcomes in patients with type 1 diabetes and macroalbuminuria", J Am Soc Nephrol, 25, pp.2342~2350 (2014)[DOI]
- de Boer IH, "Long-term renal outcomes of patients with type 1 diabetes mellitus and microalbuminuria: an analysis of the Diabetes Control and Complications Trial", Epidemiology of Diabetes Interventions and Complications cohort, 2011, pp.171, 412~420
- Perkins BA, "Regression of microalbuminuria in type 1 diabetes", N Engl J Med, 348, pp.2285~2293 (2003)[DOI]
- Parry D, "Measurement uncertainty of eGFR at low creatinine levels: be careful to not overestimate", Clin Biochem, 43, pp.349~350 (2010)[DOI]