Novel Point-of-care Sweat Chloride Testing Device for Monitoring CFTR Function

Novel Point-of-care Sweat Chloride Testing Device for Monitoring CFTR Function

This study is being done to test a device called micro Sweat Test Patch (mSTP or µSTP).

The study team will compare the standard of care (SOC) method of sweat testing with a novel sweat test technique using an integrated micro Sweat Test Patch (µSTP) with microneedle assembly made out of Pilocarpine nitrate, microfluidic channels, and a chloride sensor for point-of-care (POC) measurements of sweat chloride concentrations in newborns being evaluated for cystic fibrosis (CF) diagnosis and in pediatric and adult people with CF (pwCF).

The procedures involve performing a SOC sweat test (if they are not a neonate) and the novel sweat test developed by the research team.

Recruitment for the study will take place at Children's Healthcare of Atlanta and Emory Healthcare cystic fibrosis clinics.

The current SOC sweat testing method, using pilocarpine iontophoresis and Macroduct collectors, results in inconsistent sweat production, leading to inadequate collection, delays in CF diagnosis, longer testing times, skin discomfort, and a risk of skin burns. It requires trained personnel and expensive equipment, limiting patient access, and repeating sweat tests after inadequate collection causes delays in starting therapies and stress for parents. In developing countries where CF remains underdiagnosed, access to sweat testing is a major barrier, and the need for refrigeration of the pilogel discs adds cost.

There is an unmet clinical need to improve access to sweat testing worldwide without expensive supplies and laboratory equipment.

Inclusion Criteria:

• Age 0-90 years old
• Signed a written informed consent
• Confirmed CF diagnosis via genetic test or elevated Immunoreactive Trypsinogen (IRT) level in newborn screen

Exclusion Criteria:

• History of skin disorders (eczema, psoriasis, etc.) that could prevent sweat testing on the forearms