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

Clin Chem Lab Med. 2010 Dec;48(12):1781-4. doi: 10.1515/CCLM.2010.351. Epub 2010 Aug 24.

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.

Publication types

  • Evaluation Study

MeSH terms

  • Biosensing Techniques / methods*
  • Blood Specimen Collection / methods
  • Chromatography, Liquid
  • Diabetes Mellitus / diagnosis*
  • Humans
  • Ketones / blood*
  • Point-of-Care Systems / standards*
  • Reagent Kits, Diagnostic / standards*
  • Reproducibility of Results
  • Tandem Mass Spectrometry

Substances

  • Ketones
  • Reagent Kits, Diagnostic