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Accuracy of the Precision® point-of-care ketone test examined by liquid chromatography tandem-mass spectrometry (LC-MS/MS) in the same fingerstick sample

  • Marcel J.W. Janssen , Ben H.E. Hendrickx , Carin D. Habets-van der Poel , Joop P.W. van den Bergh , Anton A.M. Haagen and Jaap A. Bakker
Published/Copyright: August 24, 2010
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Clinical Chemistry and Laboratory Medicine
From the journal Clinical Chemistry and Laboratory Medicine Volume 48 Issue 12

Abstract

Background: The Precision® (Abbott Diabetes Care) point-of-care biosensor test strips are widely used by patients with diabetes and clinical laboratories for measurement of plasma β-hydroxybutyrate (β-HB) concentrations in capillary blood samples obtained by fingerstick. In the literature, this procedure has been validated only against the enzymatic determination of β-HB in venous plasma, i.e., the method to which the Precision® has been calibrated.

Methods: In this study, the Precision® Xceed was compared to a methodologically different and superior procedure: determination of β-HB by liquid chromatography tandem-mass spectrometry (LC-MS/MS) in capillary blood spots. Blood spots were obtained from the same fingerstick sample from out of which Precision® measurements were performed. Linearity was tested by adding varying amounts of standard to an EDTA venous whole blood matrix.

Results: The Precision® was in good agreement with LC-MS/MS within the measuring range of 0.0–6.0 mmol/L (Passing and Bablok regression: slope=1.20 and no significant intercept, R=0.97, n=59). Surprisingly, the Precision® showed non-linearity and full saturation at concentrations above 6.0 mmol/L, which were confirmed by a standard addition experiment. Results obtained at the saturation level varied between 3.0 and 6.5 mmol/L.

Conclusions: The Precision® β-HB test strips demonstrate good comparison with LC-MS/MS. Inter-individual variation around the saturation level, however, is large. Therefore, we advise reporting readings above 3.0 as >3.0 mmol/L. The test is valid for use in the clinically relevant range of 0.0–3.0 mmol/L.

Clin Chem Lab Med 2010;48:1781–4.

Keywords: β-hydroxybutyrate; fingerstick; ketone; liquid chromatography tandem-mass spectrometry; point-of-care; Precision®
Corresponding author: Marcel J.W. Janssen, Laboratory of Clinical Chemistry and Haematology, VieCuri Medical Center, P.O. Box 1926, 5900 BX Venlo, The Netherlands Phone: +31-77-3205201, Fax: +31-77-3205216,
Received: 2010-5-28
Accepted: 2010-6-25
Published Online: 2010-08-24
Published in Print: 2010-12-01

©2010 by Walter de Gruyter Berlin New York

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https://doi.org/10.1515/CCLM.2010.351
Keywords for this article
β-hydroxybutyrate; fingerstick; ketone; liquid chromatography tandem-mass spectrometry; point-of-care; Precision®

Articles in the same Issue

  1. Editorial
  2. Biomarkers of cardiovascular risk – matters of prediction and precision
  3. Reviews
  4. Inflammatory markers, cholesterol and statins: pathophysiological role and clinical importance
  5. C-reactive protein and venous thromboembolism: causal or casual association?
  6. Perspectives
  7. Statistical methods for assessment of added usefulness of new biomarkers
  8. Genetics and Molecular Diagnostics
  9. ThalassoChip, an array mutation and single nucleotide polymorphism detection tool for the diagnosis of β-thalassaemia
  10. General Clinical Chemistry and Laboratory Medicine
  11. Glycated hemoglobin vs. the oral glucose tolerance test for the exclusion of impaired glucose tolerance in high-risk individuals
  12. Impact of glucuronide interferences on therapeutic drug monitoring of posaconazole by tandem mass spectrometry
  13. Evaluation of D-dimer in the diagnosis of suspected aortic dissection
  14. Quantification of coagulation factor XIII activity by a thio-NADH based assay using factor XIII immuno-depleted plasma as a diluent for calibration
  15. Qualitative detection of the Marburg I alloenzyme of factor VII-activating protease by an immunoassay and its comparison to PCR testing
  16. Fatty acid composition of serum phospholipids in cystic fibrosis (CF) patients with or without CF related liver disease
  17. Development and validation of a combined method for the biomonitoring of omega-3/-6 fatty acids and conjugated linoleic acids in different matrices from human and nutritional sources
  18. Evaluation of the Sysmex UF-1000i® urine flow cytometer in the diagnostic work-up of suspected urinary tract infection in a Dutch general hospital
  19. Association between coffee consumption and the estimated glomerular filtration rate in the general Japanese population: preliminary data regarding C-reactive protein concentrations
  20. Lactic acid is of low predictive value for the diagnosis of bacterial infection in ventricular cerebrospinal fluid samples containing residual blood
  21. Accuracy of the Precision® point-of-care ketone test examined by liquid chromatography tandem-mass spectrometry (LC-MS/MS) in the same fingerstick sample
  22. Cancer Diagnostics
  23. Combination of polymorphisms within the HDAC1 and HDAC3 gene predict tumor recurrence in hepatocellular carcinoma patients that have undergone transplant therapy
  24. Global DNA methylation: comparison of enzymatic- and non-enzymatic-based methods
  25. Determination of biological variation of α-fetoprotein and choriogonadotropin (β chain) in disease-free patients with testicular cancer
  26. Infectious Diseases
  27. Investigation of the relationship between apolipoprotein E gene polymorphisms and hepatitis B virus infection in northern China
  28. Helicobacter pylori infection and the severity of gastritis are not associated with iron deficiency in a group of Brazilian patients
  29. Cardiovascular Diseases
  30. Proatrial natriuretic peptide is a better predictor of 28-day mortality in septic shock patients than proendothelin-1
  31. The relationship between aminoterminal propeptide of type III procollagen and heart rate variability parameters in heart failure patients: a potential serum marker to evaluate cardiac autonomic control and sudden cardiac death
  32. Relationship of hepatic steatosis and alanine aminotransferase with coronary calcification
  33. Letters to the Editor
  34. Novel mutation at codon 110 of the human APOE gene: impact on genotyping with fluorescent hybridization probes
  35. A simple, fast and inexpensive automated technique for measurement of plasma nitrite
  36. Development of an innovative serological test for detection of antibodies to Treponema pallidum
  37. Erratum
  38. Controversies on quotient reporting to standardise laboratory results
  39. Acknowledgement
  40. Acknowledgement
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