"We have developed a method for measuring cortisol in saliva using a smartphone and a disposable test strip. This innovation enables anyone with a smartphone to measure their salivary cortisol level quickly, accurately, and affordably," said lead study author Joel R. L. Ehrenkranz, MD, director of diabetes and endocrinology of the Department of Medicine at Intermountain Healthcare in Murray, Utah.
Cortisol is a hormone made by the adrenal glands that's essential for the body’s response to stress, and measuring cortisol can help diagnose adrenal diseases and monitor stress levels. Current testing for salivary cortisol levels involves collecting a saliva sample and sending it to a clinical lab for analysis.
"A lab charges about $25 to $50 for a quantitative salivary cortisol test and has a turnaround time of days to a week. This test, taken in a medical office or at home, will cost less than $5 and take less than 10 minutes," Dr. Ehrenkranz said. "The device is a reader that includes a case, a light pipe, and a lens and costs about a dollar to make. There is no battery power and it's unbreakable, passive and reusable."
Doctors worldwide can use the smartphone test to help them diagnose adrenal insufficiency and hypercortisolism and monitor physiologic variations in cortisol concentration; and individuals can monitor their own cortisol levels whenever they like.
The software is "operating-system-agnostic," he explained, meaning that the device can be used on all platforms, including iOS, Android, Windows, and BlackBerry, and it has a universal form factor that works with all smartphones.
The person being tested inserts a straw-like saliva collector under the tongue. The collector wicks the saliva by capillary action to an immunoassay strip housed in a cassette and the cassette is inserted into the reader. The smartphone uses its camera and flash to take a picture of the saliva-coated strip and an algorithm converts the image's pixel density to a cortisol value.
Marketing this test as a cortisol assay would make it a class 2 medical device, Dr. Ehrenkranz explained. He and his research team are now collecting clinical data for the FDA submission, and hope to attain approval in 2015.
This study was privately funded.
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