Evaluation of a new handheld biosensor for point-of-care testing of whole blood beta-hydroxybutyrate concentration.
OBJECTIVE
To evaluate performance characteristics of the newly available handheld combined glucose and ketone meter for beta-hydroxybutyrate measurement.


METHODS
Laboratory method evaluation.


METHODS
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.


CONCLUSIONS
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.
Chiu
R W K
RW
Department of Chemical Pathology, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong.
Ho
C S
CS
Tong
S F
SF
Ng
K F
KF
Lam
C W
CW
D020155:3-Hydroxybutyric Acid / Q000097:blood*; D001322:Autoanalysis / Q000295:instrumentation*; D015374:Biosensing Techniques / Q000592:standards*; D016287:Computer Peripherals; D016883:Diabetic Ketoacidosis / Q000175:diagnosis; D006801:Humans; D019095:Point-of-Care Systems / Q000592:standards*
D020155:3-Hydroxybutyric Acid