A simple saliva test could transform the lives of millions of children and adults worldwide who are on the keto diet to manage their epilepsy, and who currently endure uncomfortable finger prick tests.
Monash researchers, in collaboration with China's Shenzhen Children's Hospital and the global biotech firm MX3 Diagnostics, found that MX3's handheld test was comparable in accuracy to existing blood tests. Urine and breath testing are also less invasive, but much less accurate.
The device, called the MX3 LAB, utilises a test strip to non-invasively measure salivary levels of ketones - acids that are released when the body burns fat instead of carbohydrates for energy.
People living with epilepsy and other conditions – especially children with drug-resistant epilepsy – are often prescribed the ketogenic diet, which has been proven to reduce seizures. Knowing their ketone levels allows them to adjust the composition and timing of their food intake to help further reduce symptoms.
Joint first author Dr Neha Kaul, a neuroscience researcher at Monash University's School of Translational Medicine, said the test would be a game changer for parents, especially of younger children.
"All that's needed is for the tongue to touch the test strip for just a few seconds, and you can see the results in 30 seconds, without having to endure a painful finger prick test," Dr Kaul said. "Being able to manage not only your kids' diet but also eliminate some of the discomfort of living with the condition is going to really help."
"Parents could administer the test in the morning and use the information for their menu planning the same day."
The study was published in the journal Epilepsia. Blood and saliva samples from some 40 children (with a median age of four and a half years) were taken on day one and day seven of a week-long admission to the SCH to start ketogenic diet therapy for the first time. The researchers found that the results correlated with ketone levels in the blood.
MX3 CEO Michael Luther said, "Nobody likes to give blood. Even a finger prick can be painful, especially when done every day. The breakthrough biomarker testing system that the MX3 team has developed will significantly improve quality of life for these brave kids who are really just interested in leading a normal, pain-free life."
Further research is needed to determine whether the test has similar accuracy in infants, and its accuracy for people who have been on the ketogenic diet for a prolonged period.
The project was undertaken as part of a larger collaborative program, the Shenzhen Sanming Project, with Professor Ingrid Scheffer from The University of Melbourne, and other researchers.
The clinical benefits of the test are now being validated in a telehealth clinical trial conducted by Monash University through Alfred Health, via a Medical Research Future Fund (MRFF) grant, which will conclude in 2027.
