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KMID : 1100820140040010022
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Laboratory Medicine Online
2014 Volume.4 No. 1 p.22 ~ p.27
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Evaluation of the T-KB-H and 3-HB Kits for the Measurement of Serum Ketone and β-Hydroxybutyric Acid
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Lee Kyung-Hoon
Chun Sun-Hee
Lee Kwang-Woo
Han Min-Je
Song Sang-Hoon
Park Kyoung-Un
Song Jung-Han
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Abstract
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Background: Diabetes mellitus and alcohol consumption are the most common causes of ketoacidosis in adults. Recently, β-hydroxybutyric acid (βHBA) 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)+βHBA] and βHBA, 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 μmol/L. Linearity was observed for AcAc and βHBA over a 0-1,000 μmol/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 βHBA. Reference intervals determined for the T-KB-H kit were 9.8-270.1 μmol/L and 18.5-531.8 μmol/L in children and adults, respectively. For the 3-HB kit, the reference intervals were 6.4-234.0 μmol/L and 16.0-437.2 μmol/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.
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KEYWORD
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Ketone bodies, Diabetic ketoacidosis, Acetoacetate, 3-hydroxybutyric acid, Gas chromatography-mass spectrometry
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