Home Medicine Lot variation and inter-device differences contribute to poor analytical performance of the DCA Vantage™ HbA1c POCT instrument in a true clinical setting
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Lot variation and inter-device differences contribute to poor analytical performance of the DCA Vantage™ HbA1c POCT instrument in a true clinical setting

  • Anders Abildgaard ORCID logo EMAIL logo , Cindy Søndersø Knudsen , Lise Nørkjær Bjerg , Sten Lund and Julie Støy
Published/Copyright: September 6, 2021
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 60 Issue 1

Abstract

Objectives

The glycated haemoglobin fraction A1c (HbA1c) is widely used in the management of diabetes mellitus, and the Siemens DCA Vantage™ point-of-care testing (POCT) instrument offers rapid HbA1c results even far from a clinical laboratory. However, the analytical performance has been questioned, and not much is known about effects of changing reagent lot, instrument and operator. We therefore compared the analytical performance of the DCA Vantage™ with established routine methods (Tosoh G8/G11 ion exchange HPLC) in a true clinical setting at two Danish hospitals.

Methods

We extracted all routine clinical HbA1c results incidentally drawn from the same patient within 48 h (n=960 pairs) and evaluated the effect of reagent lot, operator and instrument. We also performed a prospective method comparison in our diabetes out-patient clinic (n=97).

Results

The critical difference (CD) between two POCT results varied between 5.14 and 6.61 mmol/mol (0.47–0.55%), and the analytical imprecision of the DCA Vantage™ (CVA) was >3%. Significant effect of reagent lot and inter-instrument differences were found, whereas no effect of operator was seen.

Conclusions

The DCA Vantage™ HbA1c analysis does not fulfil the prevailing analytical performance specifications, but rigorous validation of new reagent lots and continuous recalibration of instruments may potentially improve the precision substantially. Our findings, therefore, clearly emphasise the necessity of a close collaboration between clinicians and laboratory professionals in the POCT field. Finally, POCT HbA1c results should always be interpreted together with other measures of glycaemic control to avoid inappropriate change of patient treatments due to measurement uncertainty.

Keywords: clinical laboratory techniques; glycated haemoglobin A; point-of-care testing
Corresponding author: Anders Abildgaard, MD, PhD, Department of Clinical Biochemistry, Regional Hospital Horsens, Sundvej 30, 8700 Horsens, Denmark; and Steno Diabetes Center Aarhus, Aarhus University Hospital, Aarhus N, Denmark, E-mail:

  1. Research funding: None declared.

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

  3. Competing interests: Authors state no conflict of interest.

  4. Informed consent: Not applicable.

  5. Ethical approval: Not applicable.

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Supplementary Material

The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2021-0720).

Received: 2021-06-21
Accepted: 2021-08-25
Published Online: 2021-09-06
Published in Print: 2022-01-26

© 2021 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2021-0720
Keywords for this article
clinical laboratory techniques; glycated haemoglobin A; point-of-care testing

Articles in the same Issue

  1. Frontmatter
  2. Editorials
  3. EU health policy is on the brink of a spectacular own-goal that will harm patients and hamper innovation
  4. Theranos revisited: the trial and lessons learned
  5. Reviews
  6. Review and evolution of guidelines for diagnosis of COVID-19 vaccine induced thrombotic thrombocytopenia (VITT)
  7. High-sensitivity cardiac troponins in pediatric population
  8. Opinion Papers
  9. Implementation of the new EU IVD regulation – urgent initiatives are needed to avert impending crisis
  10. Exploration of novel biomarkers for hypertensive disorders of pregnancy by comprehensive analysis of peptide fragments in blood: their potential and technologies supporting quantification
  11. General Clinical Chemistry and Laboratory Medicine
  12. Total lab automation: sample stability of clinical chemistry parameters in an automated storage and retrieval module
  13. Instability of corticotropin during long-term storage – myth or reality?
  14. External quality assessment of serum indices: Spanish SEQC-ML program
  15. Comparison of two LC-MS/MS methods for the quantification of 24,25-dihydroxyvitamin D3 in patients and external quality assurance samples
  16. Isotope dilution LC-MS/MS quantification of the cystic fibrosis transmembrane conductance regulator (CFTR) modulators ivacaftor, lumacaftor, tezacaftor, elexacaftor, and their major metabolites in human serum
  17. Hematology and Coagulation
  18. The development of autoverification system of lymphocyte subset assays on the flow cytometry platform
  19. Cancer Diagnostics
  20. Comparison of the QuikRead go® point-of-care faecal immunochemical test for haemoglobin with the FOB Gold Wide® laboratory analyser to diagnose colorectal cancer in symptomatic patients
  21. Evaluation of circulating Dickkopf-1 as a prognostic biomarker in ovarian cancer patients
  22. Cardiovascular Diseases
  23. Soluble CD40 ligand and outcome in patients with coronary artery disease undergoing percutaneous coronary intervention
  24. Diabetes
  25. Lot variation and inter-device differences contribute to poor analytical performance of the DCA Vantage™ HbA1c POCT instrument in a true clinical setting
  26. Infectious Diseases
  27. Lipase elevation in serum of COVID-19 patients: frequency, extent of increase and clinical value
  28. Acknowledgment
  29. Acknowledgment
  30. Letters to the Editors
  31. Presepsin value predicts the risk of developing severe/critical COVID-19 illness: results of a pooled analysis
  32. Measuring accuracy of the neutralizing activity of COVID-19 convalescent plasma
  33. Evaluation of reference intervals for classical and alternative pathway functional complement assays
  34. Reference values for plasma neurofilament light chain in healthy Chinese children
  35. Cerebrospinal fluid neurogranin in Alzheimer’s disease studies: are immunoassay results interchangeable?
  36. Pepsin pretreatment corrects underestimation of 25-hydroxyvitamin D measurement by an automated immunoassay in subjects with high vitamin D binding protein levels
  37. A conspicuous reduced plasma creatinine: the first presenting sign of Waldenstrom macroglobulinemia
  38. Effect of non-linearity on rheumatoid factor assay in Beckman system IMMAGE800
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