Clinical Research Directory

A novel sweat test method, using a device that includes a microneedle pilocarpine patch and a microchannel with a sweat chloride sensor. µSTP sweat testing device that operates without electrical current, eliminating the risk of burns and the need for specialized equipment. Like the SOC method, the µSTP stimulates sweating with pilocarpine nitrate and measures sweat chloride concentration but differs from the current method by: 1. Utilizing microneedles to painlessly and rapidly administer pilocarpine to the skin (without the complexities and risks of iontophoresis) 2. Requiring only 0.5 µL of sweat to measure sweat chloride (instead of the 15 µL currently required) 3. Wirelessly communicating the result to a tablet or other device 4. Completing the POC measurement to provide immediate results without sending any samples to the laboratory.

The study team will place two pilocarpine gel discs into the corresponding electrodes and place them on the participant's arm. The SOC method takes 5 minutes to induce sweating. After sweat has been induced by the SOC method, a sweat collector will be placed on the location of the red electrode to collect the sweat. At the end of the sweat collection period, the sweat collection device will be removed, and the study visit will be completed. For newborns undergoing evaluation for CF, the study team will perform the µSTP method on their thigh instead of the forearm. Since newborns will undergo sweat testing for their clinical diagnosis, the study team will use the sweat data from SOC testing to minimize burden. The sweat chloride concentration will be assessed by a laboratory chloridometer.