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.