Evaluation of a new handheld biosensor for point-of-care testing of whole blood beta-hydroxybutyrate concentration

Hong Kong Med J. 2002 Jun;8(3):172-6.


Objectives: To evaluate performance characteristics of the newly available handheld combined glucose and ketone meter for beta-hydroxybutyrate measurement.

Design: Laboratory method evaluation.

Main outcome measures: Accuracy of beta-hydroxybutyrate measurement and effect of acetoacetate interference at clinically important beta-hydroxybutyrate levels.

Results: Deming regression analysis of beta-hydroxybutyrate measurements assessed by the ketone sensor and a laboratory enzymatic method revealed a coefficient of determination of 0.989 (P<0.001). Passing-Bablok regression analysis showed a linear relationship between the two methods, ie Y= -0.32+1.13X. The 95% confidence interval of the slope and y-intercept were: slope=1.13 (95% confidence interval, 1.04 to 1.22); intercept= -0.32 (95% confidence interval, -0.59 to -0.06). The Bland-Altman plot showed a small proportional bias between the two methods. The mean bias +/-2 standard deviations was between -0.53 and 0.67 mmol/L. Beta-hydroxybutyrate measurements made by the sensor were linear up to 6 mmol/L. Replicate analysis of two samples spiked with 3.6 mmol/L and 0.8 mmol/L of beta-hydroxybutyrate resulted in coefficients of variation of 3.3% and 13%, respectively. The presence of acetoacetate caused a negative interference in beta-hydroxybutyrate measurement. Beta-hydroxybutyrate recovery was 97.0% and 90.7% when the ketone body ratios were 6:1 and 3:1, respectively.

Conclusion: The analytical performance of the sensor, when operated according to manufacturer's instructions, could meet the needs of point-of-care beta-hydroxybutyrate measurement. Additional clinical studies are needed to assess the benefits of introducing such an assay in a clinical setting.

Publication types

  • Evaluation Study

MeSH terms

  • 3-Hydroxybutyric Acid / blood*
  • Autoanalysis / instrumentation*
  • Biosensing Techniques / standards*
  • Computer Peripherals
  • Diabetic Ketoacidosis / diagnosis
  • Humans
  • Point-of-Care Systems / standards*


  • 3-Hydroxybutyric Acid