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
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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.
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.
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