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Performance of Afinion HbA1c measurements in general practice as judged by external quality assurance data

  • Anne Stavelin EMAIL logo , Kristine Flesche , Mette Tollaanes , Nina Gade Christensen and Sverre Sandberg
Published/Copyright: December 11, 2019
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 58 Issue 4

Abstract

Background

It has been debated whether point-of care (POC) glycated hemoglobin (HbA1c) measurements methods can be used for diagnosing persons with diabetes mellitus. The aim of this study was to evaluate the analytical performance of the POC Afinion HbA1c system in the hands of the users, and to investigate which predictors that were associated with good participant performance.

Methods

External quality assurance (EQA) data from seven surveys in 2017–2018 with a total of 5809 Afinion participants from a POC total quality system in Norway were included in this study (response rate 90%). The control materials were freshly drawn pooled EDTA whole blood. Each participant was evaluated against the analytical performance specification of ±6% from the target value, while the Afinion system was evaluated against the pooled within-laboratory CV <2%, the between-laboratory CV <3.5%, and bias <0.3%HbA1c. Logistic regression analyses were used to investigate which factors were associated with good participant performance.

Results

The participant pass rates for each survey varied from 98.2% to 99.7%. The pooled within-laboratory CV varied from 1.3% to 1.5%, the between-laboratory CV varied from 1.5% to 2.1%, and bias varied between −0.17 and −0.01 %HbA1c in all surveys. Reagent lot was the only independent factor to predict good participant performance.

Conclusions

Afinion HbA1c fulfilled the analytical performance specifications and is robust in the hands of the users. It can therefore be used both in diagnosing and monitoring persons with diabetes mellitus, given that the instrument is monitored by an EQA system.

Keywords: analytical performance specifications; diabetes mellitus; external quality assurance; glycated hemoglobin; point-of-care testing

Acknowledgments

We thank Abbott for a grant to support this study.

  1. Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

  2. Research funding: Abbott Laboratories.

  3. Employment or leadership: None declared.

  4. Honorarium: None declared.

  5. 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.

References

1. Schnell O, Crocker JB, Weng J. Impact of HbA1c testing at point of care on diabetes management. J Diabetes Sci Technol 2017;11:611–7.10.1177/1932296816678263Search in Google Scholar PubMed PubMed Central

2. Florkowski C, Don-Wauchope A, Gimenez N, Rodriguez-Capote K, Wils J, Zemlin A. Point-of-care testing (POCT) and evidence-based laboratory medicine (EBLM) – does it leverage any advantage in clinical decision making? Crit Rev Clin Lab Sci 2017;54:471–94.10.1080/10408363.2017.1399336Search in Google Scholar PubMed

3. Lenters-Westra E, English E. Investigating the quality of POCT devices for HbA1c: what are our next Steps? J Diabetes Sci Technol 2019;13:1154–7.10.1177/1932296819850838Search in Google Scholar PubMed PubMed Central

4. Stavelin A, Sandberg S. Harmonization activities of Noklus – a quality improvement organization for point-of-care laboratory examinations. Clin Chem Lab Med 2018;57:106–14.10.1515/cclm-2018-0061Search in Google Scholar PubMed

5. Stavelin A, Riksheim BO, Christensen NG, Sandberg S. The importance of reagent lot registration in external quality assurance/proficiency testing schemes. Clin Chem 2016;62:708–15.10.1373/clinchem.2015.247585Search in Google Scholar PubMed

6. Bukve T, Stavelin A, Sandberg S. Effect of participating in a quality improvement system over time for point-of-care C-reactive protein, glucose, and hemoglobin testing. Clin Chem 2016;62:1474–81.10.1373/clinchem.2016.259093Search in Google Scholar PubMed

7. Solvik UO, Roraas T, Christensen NG, Sandberg S. Diagnosing diabetes mellitus: performance of hemoglobin A1c point-of-care instruments in general practice offices. Clin Chem 2013;59:1790–801.10.1373/clinchem.2013.210781Search in Google Scholar PubMed

8. ISO13528. Statistical methods for use in proficency testing by interlaboratory comparison, 2nd ed. Geneva, Switzerland: International Organization for Standardization, 2015.Search in Google Scholar

9. Hoelzel W, Weykamp C, Jeppsson JO, Miedema K, Barr JR, Goodall I, et al. IFCC reference system for measurement of hemoglobin A1c in human blood and the national standardization schemes in the United States, Japan, and Sweden: a method-comparison study. Clin Chem 2004;50:166–74.10.1373/clinchem.2003.024802Search in Google Scholar PubMed

10. NGSP. College of American Pathologists (CAP) survey data [cited 2019 19th June]. http://www.ngsp.org/CAPdata.asp.Search in Google Scholar

11. Sacks DB, Arnold M, Bakris GL, Bruns DE, Horvath AR, Kirkman MS, et al. Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus. Clin Chem 2011;57:e1–47.10.1373/clinchem.2010.161596Search in Google Scholar PubMed

12. Lenters-Westra E, English E. Evaluation of four HbA1c point- of-care devices using international quality targets: are they fit for the purpose? J Diabetes Sci Technol 2018;12:762–70.10.1177/1932296818785612Search in Google Scholar PubMed PubMed Central

13. Price CP, Smith I, Van den Bruel A. Improving the quality of point-of-care testing. Fam Pract 2018;35:358–64.10.1093/fampra/cmx120Search in Google Scholar PubMed

14. Nordin G. Accuracy of HbA1c as monitored by external quality assessment and compared with patient mean values. J Diabetes Sci Technol 2018;12:771–9.10.1177/1932296818785622Search in Google Scholar PubMed PubMed Central

15. Weykamp C. The EurA1c Trial Group: the European HbA1c trial to investigate the performance of HbA1c assays in 2166 laboratories across 17 countries and 24 manufacturers by use of the IFCC model for quality targets. Clin Chem 2018;64:1183–92.10.1373/clinchem.2018.288795Search in Google Scholar PubMed

Supplementary Material

The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2019-0879).

Received: 2019-08-20
Accepted: 2019-11-15
Published Online: 2019-12-11
Published in Print: 2020-03-26

©2020 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2019-0879
Keywords for this article
analytical performance specifications; diabetes mellitus; external quality assurance; glycated hemoglobin; point-of-care testing

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. New insights on the analytical performances for detecting and quantifying monoclonal proteins
  4. Reviews
  5. Vitamin C measurement in critical illness: challenges, methodologies and quality improvements
  6. Early predictors of perinatal brain damage: the role of neurobiomarkers
  7. Opinion Paper – Point
  8. Mixing studies for lupus anticoagulant: mostly yes, sometimes no
  9. Opinion Paper – Counterpoint
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  11. EFLM Consensus Paper
  12. Quantifying atherogenic lipoproteins for lipid-lowering strategies: consensus-based recommendations from EAS and EFLM
  13. Guidelines and Recommendations
  14. PREDICT: a checklist for preventing preanalytical diagnostic errors in clinical trials
  15. Genetics and Molecular Diagnostics
  16. Plasma vs. serum in circulating tumor DNA measurement: characterization by DNA fragment sizing and digital droplet polymerase chain reaction
  17. General Clinical Chemistry and Laboratory Medicine
  18. An international multi-center serum protein electrophoresis accuracy and M-protein isotyping study. Part I: factors impacting limit of quantitation of serum protein electrophoresis
  19. An international multi-center serum protein electrophoresis accuracy and M-protein isotyping study. Part II: limit of detection and follow-up of patients with small M-proteins
  20. Use of clinical data and acceleration profiles to validate pneumatic transportation systems
  21. National survey on delta checks in clinical laboratories in China
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  26. Influence of ethnicity on biochemical markers of health and disease in the CALIPER cohort of healthy children and adolescents
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  32. Corrigendum to: Pediatric reference intervals for 29 Ortho VITROS 5600 immunoassays using the CALIPER cohort of healthy children and adolescents
  33. Letters to the Editor
  34. Potential risks in fecal microbiota transplantation
  35. Macro-aspartate aminotransferase syndrome: a case report
  36. Factitious severe acidosis in a patient, preanalytical considerations and prevention
  37. Methods for quick, accurate and cost-effective determination of the type 1 diabetes genetic risk score (T1D-GRS)
  38. Anti-adalimumab and anti-certolizumab antibodies titers after discontinuation of adalimumab: two case reports
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  42. Carryover issues with UF-5000 urine flow cytometry – how did we miss it?
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