T-KB-H와 3-HB 키트를 이용한 혈중 총 케톤과 베타-히드록시부틸산 측정법 평가 = Evaluation of the T-KB-H and 3-HB Kits for the Measurement of Serum Ketone and β-Hydroxybutyric Acid

다국어 초록 (Multilingual Abstract)

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 chromato-graphy-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.

국문 초록 (Abstract)

배경: 성인에서 케톤산증의 가장 많은 원인은 당뇨병과 알코올의 섭취에 의한 것이다. 이러한 케톤산증을 진단 및 치료 효과의 모니터링을 하는데 혈중 베타-히드록시부틸산(βHBA)의 측정을 권장하고 있다. 본 연구는 총케톤체[아세토아세테이트(AcAc)+βHBA]와 βHBA를 각각 측정할 수 있는 T-KB-H와 3-HB 키트의 유용성을 평가하고자 하였다.
방법: 효소법을 이용한 혈중 케톤 정량은 Nittobo 사의 T-KB-H와 3-HB 키트와 Abbott사의 Architect ci16200 기기를 사용하여 측정하였으며, 동시에 가스크로마토그래피-질량분석법(GC-MS)으로 측정하였다. CLSI의 지침에 따라서 정밀도, 직선성, 기존 장비와의 상관성과 소아 및 성인의 참고범위를 설정하였다.
결과: 각 키트마다의 측정한 두가지 농도에 대한 모든 정밀도는 4.00% 미만이었다. 직선성은 0-1,000 mol/L 범위에서 우수하였다(R2<0.99). GC-MS 결과와 비교하였을 때 AcAc의 경우 상관계수가 0.94, βHBA의 경우 0.96으로 양호한 상관관계를 보였다. 그리고 각각의 키트에서 구한 참고범위는 T-KB-H 키트의 경우 소아는 9.8-270.1 mol/L, 성인은 18.5-531.8 mol/L, 3-HB 키트의 경우 소아는 6.4-234.0 mol/L, 성인은 16.0-437.2 mol/L이었다.
결론: T-KB-H와 3-HB 키트는 정밀도 및 직선성이 우수하였고 기존 방법과의 상관성이 양호하므로, 임상적으로 혈중 케톤체의 농도를 측정하는데 유용하게 사용할 수 있을 것으로 생각된다.

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