Harmonization of urine albumin/creatinine ratio (ACR) results: a study based on an external quality assessment program in Polish laboratories
-
Agnieszka Ćwiklińska
,
Hanna Dąbrowska
Abstract
Background:
The ratio of albumin to creatinine (ACR) is an important parameter used for detection of albuminuria in patients with early kidney damage. The aim of the study was to evaluate the harmonization of ACR results among Polish participants in an international external quality assessment (EQA) program, and to evaluate the impact of albumin and creatinine analytical performance on the harmonization of ACR results.
Methods:
We analyzed 182 results of albumin, 202 of creatinine, and 180 of ACR obtained from Polish laboratories in an EQA program organized by Labquality. The dispersion of the results in surveys and percentage differences between the results and target values were calculated. Moreover, differences between method groups were assessed.
Results:
The inter-laboratory coefficient of variation (CV) for ACR was 36%. Only 74% of results of Polish laboratories were within the target limits; for 11% of the results, an incorrect albuminuria category would have been reported. The inter-laboratory CV for albumin was 20%, 2.6-fold higher than for creatinine. Significant differences between method groups for albumin determination have been observed, even when the same measurement technique was used. The greatest difference between two groups was 23%, 2.5-fold greater in comparison to creatinine.
Conclusions:
There is an insufficient harmonization of ACR values among Polish laboratories, caused mainly by urine albumin analytical performance. Given the important role of ACR in the classification, monitoring and treatment of kidney damage, the harmonization of albumin measurements is crucial and urgently needed.
Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: None declared.
Employment or leadership: Aleksandra Fijalkowska and Gabriela Bednarczuk are full-time employees of SOWA-med, Polish distributor of Labquality EQA programs. Agnieszka Ćwiklińska and Barbara Kortas-Stempak cooperates with SOWA-med as experts in clinical chemistry.
Honorarium: None declared.
Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
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©2018 Walter de Gruyter GmbH, Berlin/Boston
Artikel in diesem Heft
- Frontmatter
- Editorials
- Harmonization in laboratory medicine: Blowin’ in the wind
- Standardization and harmonization of autoimmune diagnostics
- On the complexity of hemostasis and the need for harmonization of test practice
- Harmonization of laboratory hematology: a long and winding journey
- Section 1: Current Harmonization Activities at Global Level
- Harmonization in laboratory medicine: more than clinical chemistry?
- Harmonization of External Quality Assessment Schemes and their role – clinical chemistry and beyond
- An overview of EFLM harmonization activities in Europe
- Metrological traceability and harmonization of medical tests: a quantum leap forward is needed to keep pace with globalization and stringent IVD-regulations in the 21st century!
- Assessment of bone turnover in osteoporosis: harmonization of the total testing process
- Recent initiatives in harmonization of hemostasis practice
- EASI – European Autoimmunity Standardisation Initiative: facing the challenges of diagnostics in autoimmunity
- Harmonization of microbiology processes and standards: work in progress
- Harmonization initiatives in the generation, reporting and application of biological variation data
- Harmonization of accreditation to ISO15189
- External quality assessment programs in the context of ISO 15189 accreditation
- Section 2: Pre-Pre and Pre-Analytical Phase
- Laboratory testing in the emergency department: an Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC) and Academy of Emergency Medicine and Care (AcEMC) consensus report
- The EFLM strategy for harmonization of the preanalytical phase
- Section 3: The Analytical Phase
- The roadmap for harmonization: status of the International Consortium for Harmonization of Clinical Laboratory Results
- The quest for equivalence of test results: the pilgrimage of the Dutch Calibration 2.000 program for metrological traceability
- Current state and recommendations for harmonization of serum/plasma 17-hydroxyprogesterone mass spectrometry methods
- International normalized ratio (INR) testing in Europe: between-laboratory comparability of test results obtained by Quick and Owren reagents
- Detecting molecular forms of antithrombin by LC-MRM-MS: defining the measurands
- A design for external quality assessment for the analysis of thiopurine drugs: pitfalls and opportunities
- Harmonization of PCR-based detection of intestinal pathogens: experiences from the Dutch external quality assessment scheme on molecular diagnosis of protozoa in stool samples
- Harmonization of urine albumin/creatinine ratio (ACR) results: a study based on an external quality assessment program in Polish laboratories
- Standardization of autoimmune testing – is it feasible?
- Diagnostic laboratory tests for systemic autoimmune rheumatic diseases: unmet needs towards harmonization
- Clinically relevant discrepancies between different rheumatoid factor assays
- An international survey on anti-neutrophil cytoplasmic antibodies (ANCA) testing in daily clinical practice
- Predictive autoimmunity using autoantibodies: screening for anti-nuclear antibodies
- Harmonization in autoimmune thyroid disease diagnostics
- International consensus on antinuclear antibody patterns: definition of the AC-29 pattern associated with antibodies to DNA topoisomerase I
- Reference standards for the detection of anti-mitochondrial and anti-rods/rings autoantibodies
- International Consensus on Antinuclear Antibody Patterns: defining negative results and reporting unidentified patterns
Artikel in diesem Heft
- Frontmatter
- Editorials
- Harmonization in laboratory medicine: Blowin’ in the wind
- Standardization and harmonization of autoimmune diagnostics
- On the complexity of hemostasis and the need for harmonization of test practice
- Harmonization of laboratory hematology: a long and winding journey
- Section 1: Current Harmonization Activities at Global Level
- Harmonization in laboratory medicine: more than clinical chemistry?
- Harmonization of External Quality Assessment Schemes and their role – clinical chemistry and beyond
- An overview of EFLM harmonization activities in Europe
- Metrological traceability and harmonization of medical tests: a quantum leap forward is needed to keep pace with globalization and stringent IVD-regulations in the 21st century!
- Assessment of bone turnover in osteoporosis: harmonization of the total testing process
- Recent initiatives in harmonization of hemostasis practice
- EASI – European Autoimmunity Standardisation Initiative: facing the challenges of diagnostics in autoimmunity
- Harmonization of microbiology processes and standards: work in progress
- Harmonization initiatives in the generation, reporting and application of biological variation data
- Harmonization of accreditation to ISO15189
- External quality assessment programs in the context of ISO 15189 accreditation
- Section 2: Pre-Pre and Pre-Analytical Phase
- Laboratory testing in the emergency department: an Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC) and Academy of Emergency Medicine and Care (AcEMC) consensus report
- The EFLM strategy for harmonization of the preanalytical phase
- Section 3: The Analytical Phase
- The roadmap for harmonization: status of the International Consortium for Harmonization of Clinical Laboratory Results
- The quest for equivalence of test results: the pilgrimage of the Dutch Calibration 2.000 program for metrological traceability
- Current state and recommendations for harmonization of serum/plasma 17-hydroxyprogesterone mass spectrometry methods
- International normalized ratio (INR) testing in Europe: between-laboratory comparability of test results obtained by Quick and Owren reagents
- Detecting molecular forms of antithrombin by LC-MRM-MS: defining the measurands
- A design for external quality assessment for the analysis of thiopurine drugs: pitfalls and opportunities
- Harmonization of PCR-based detection of intestinal pathogens: experiences from the Dutch external quality assessment scheme on molecular diagnosis of protozoa in stool samples
- Harmonization of urine albumin/creatinine ratio (ACR) results: a study based on an external quality assessment program in Polish laboratories
- Standardization of autoimmune testing – is it feasible?
- Diagnostic laboratory tests for systemic autoimmune rheumatic diseases: unmet needs towards harmonization
- Clinically relevant discrepancies between different rheumatoid factor assays
- An international survey on anti-neutrophil cytoplasmic antibodies (ANCA) testing in daily clinical practice
- Predictive autoimmunity using autoantibodies: screening for anti-nuclear antibodies
- Harmonization in autoimmune thyroid disease diagnostics
- International consensus on antinuclear antibody patterns: definition of the AC-29 pattern associated with antibodies to DNA topoisomerase I
- Reference standards for the detection of anti-mitochondrial and anti-rods/rings autoantibodies
- International Consensus on Antinuclear Antibody Patterns: defining negative results and reporting unidentified patterns
