Urine analysis app uChek is about to launch a six-month, 375-patient trial with Merck for Mothers, a Merck-sponsored initiative to reduce global maternal mortality.
Researchers will test the feasability of providers using uChek to detect preeclampsia and eclampsia in pregnant women in Bangladesh, with usability of the app for healthcare professionals as a secondary outcome measure.
Each woman in the study will be given both a traditional urine analysis, with a visually inspected test strip, and an analysis using uChek.Pre-eclampsia and eclampsia are dangerous pregnancy complications that manifest as sudden weight gain and high blood pressure during pregnancy and seizures after pregnancy.
The study will be conducted at the Hope Hospital for Women on women who are at least 22 weeks into their pregnancy. Each woman in the study will be given both a traditional urine analysis, with a visually inspected test strip, and an analysis using uChek.
At the end of the study, healthcare workers will be given a questionnaire asking them (1) whether they believe uChek is accurate, (2) whether they find it easier to use than the standard of care, and (3) whether they consider it useful in a low-resource setting. Researchers will do a data analysis on the responses.
uChek health app is made by Thane, India-based Biosense Technologies. The app uses the smartphone camera to analyze existing, FDA-cleared urine test strips and return results to the user.
A fixed funding campaign on Indiegogo raised only $15,700 of its $40,000 goal. As of now, the app is not available in the App store and uChek does not have FDA clearance as a class II medical device, but a large sample size study like this can bring company back to life, and eventually get it the FDA 510(k) clearance.