Development and Validation of a Novel Saliva Beta-hydroxy-butyrate Point-of-care Test for Children Receiving Ketogenic Diet Therapy for Epilepsy
Abstract number :
2.006
Submission category :
10. Dietary Therapies (Ketogenic, Atkins, etc.)
Year :
2024
Submission ID :
694
Source :
www.aesnet.org
Presentation date :
12/8/2024 12:00:00 AM
Published date :
Authors :
Presenting Author: Neha Kaul, BNutrDiet(Hons), APD, PhD – Monash University/Alfred Hospital
Jing Duan, BSci – Shenzhen Children’s Hospital
Dong Cui, PhD – Shenzhen Children’s Hospital
Michael Erlichster, PhD – MX3 Diagnostics Inc
Zhibin Chen, PhD – Monash University
Dovile Anderson, PhD – Monash University
Jian Xiong Chan, PhD – Monash University
Ingrid Scheffer, MBBS, PhD, FRACP, FRS – University of Melbourne, Austin Hospital and Royal Children's Hospital, Florey and Murdoch Children’s Research Institutes
Efstratios Skafidas, PhD – MX3 Diagnostics Inc
Jianxiang Liao, MD, PhD – Shenzhen Children’s Hospital
Patrick Kwan, MD PhD – Monash University
Rationale: Monitoring of ketosis is crucial to ensure ketogenic diet therapy is safe and effective. Current practice for measuring ketones varies between centers. Capillary blood beta-hydroxy-butyrate (BHB) testing is accurate, but causes discomfort to the child. Urine aceto-acetate testing is a cheaper and less invasive alternative, but correlates poorly with capillary BHB concentration. In this study the primary aim was to determine if saliva BHB testing could be an accurate, non-invasive alternative to capillary BHB testing by first establishing the if there was a biological correlation between serum and saliva BHB concentration. The secondary aim was to validate the MX3 LAB Pro, a novel point-of-care device for saliva BHB testing.
Methods: This was a prospective single center cohort study. Children aged less than 18 years, admitted to Shenzhen Children’s Hospital in Shenzhen, China for commencement of ketogenic diet therapy were invited to take part in this study. Children were admitted to the neurology ward for seven days for initiation of ketogenic diet therapy as per standard of care. A paired serum blood and saliva sample was taken on the first and last day of the admission. Serum BHB concentration was measured using a BHB Colorimetric Assay Kit (Cayman, Michigan, USA). Each child also provided a saliva test paired with a capillary BHB measurement performed on the ward using a blood ketone meter (Yicheng Bioelectronics Technology, Beijing, China) twice daily. Saliva BHB concentration was measured using liquid chromatography mass spectrometry (LCMS) and the MX3 LAB Pro. The primary outcome was the correlation between serum BHB concentration and saliva BHB concentration measured using LCMS. The secondary outcomes included correlation of capillary BHB compared with saliva BHB measured using LCMS and the MX3 LAB Pro, and degree of agreement between saliva BHB concentration measured by LCMS and the MX3 LAB Pro.
Results: Forty-two children, median age 4.5 years (IQR:1-8 years) took part in the study. A total of 71 serum and 334 capillary blood samples with paired saliva samples were available for analysis. Saliva BHB measured using LCMS strongly correlated with serum BHB (Spearman’s ρ=0.910) and capillary blood BHB concentrations (Spearman’s ρ=0.865). Saliva BHB concentration was 6% of serum BHB and 7% capillary BHB concentration (Fig 1). The MX3 LAB Pro demonstrated excellent test-retest reliability when compared with LCMS (ICC(A,k)=0.983, 95% CI: 0.980 – 0.986) (Fig 2).
Conclusions: Saliva BHB concentration has a strong correlation with both serum and capillary BHB concentration. The MX3 LAB Pro can accurately measure saliva BHB concentration. Saliva BHB testing may be suitable alternative method to monitor ketosis for children requiring ketogenic diet therapy.
Funding: Sanming Project, Shenzhen, China
Dietary Therapies (Ketogenic, Atkins, etc.)