Lab Med Online.  2014 Jan;4(1):22-27.

Evaluation of the T-KB-H and 3-HB Kits for the Measurement of Serum Ketone and beta-Hydroxybutyric Acid

• Lee K
• Jun SH
• Lee KW
• Han M
• Song SH
• Park KU
• Song J

Abstract

BACKGROUND
Diabetes mellitus and alcohol consumption are the most common causes of ketoacidosis in adults. Recently, beta-hydroxybutyric acid (betaHBA) was reported to be a potential serum biomarker in the diagnosis and monitoring of ketoacidosis. We evaluated the performance of T-KB-H and 3-HB kits for the measurement of ketone bodies [acetoacetate (AcAc)+betaHBA] and betaHBA, respectively.
METHODS
Quantitative enzymatic assays were performed using the T-KB-H and 3-HB kits (Nittobo Medical Co., Japan) and the Architect ci16200 Integrated System (Abbott Laboratories, USA). Simultaneously, the ketone body levels in these serum samples were determined by gas chromatography-mas spectrometry (GC-MS). We evaluated precision and linearity of these kits and correlation with GC-MS, and established reference intervals in children and adults.
RESULTS
The coefficients of variation for the T-KB-H and 3-HB kits were less than 4.0% at analyte levels of 50, 100, and 400 micromol/L. Linearity was observed for AcAc and betaHBA over a 0-1,000 micromol/L range (R2<0.99). Results from the T-KB-H and 3-HB kits were in good agreement with those from the GC-MS analysis, with correlation coefficients of 0.94 for AcAc and 0.96 for betaHBA. Reference intervals determined for the T-KB-H kit were 9.8-270.1 micromol/L and 18.5-531.8 micromol/L in children and adults, respectively. For the 3-HB kit, the reference intervals were 6.4-234.0 micromol/L and 16.0-437.2 micromol/L in children and adults, respectively.
CONCLUSIONS
The T-KB-H and 3-HB kits displayed good precision, clinically acceptable linearity, and reliable correlation with an established assay. This indicates that the kits can be used clinically for measuring serum ketone bodies.

Keyword

Ketone bodies; Diabetic ketoacidosis; Acetoacetate; 3-hydroxybutyric acid; Gas chromatography-mass spectrometry

MeSH Terms

3-Hydroxybutyric Acid*
Adult
Alcohol Drinking
Child
Diabetes Mellitus
Diabetic Ketoacidosis
Diagnosis
Enzyme Assays
Gas Chromatography-Mass Spectrometry
Humans
Ketone Bodies
Ketosis
Spectrum Analysis
3-Hydroxybutyric Acid
Ketone Bodies

Figure

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  Fig. 1 Linearity of concentrations measured by the T-KB-H kit. (A) β-hydroxybutyric acid, (B) acetoacetate.

• 

  Fig. 2 Linearity of concentrations measured by the 3-HB kit for β-hydroxybutyric acid.

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  Fig. 3 Comparison of acetoacetate (AcAc) and β-hydroxybutyric acid (βHBA) measurements obtained with the T-KB-H kit, the 3-HB kit, and gas chromatography-mass spectrometry (GC-MS). (A) and (C), Scatter plots with ordinary linear fit with the Passing-Bablock regression analysis for AcAc and βHBA. (B) and (D), Bland-Altman plots for AcAc and βHBA.

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