THE LONG-TERM OBJECTIVES OF THIS PROGRAM ARE TO DEVELOP AND MANUFACTURE A LOW-COST, IN SITU SWEAT DETERMINATION SYSTEM FOR CYSTIC FIBROSIS SCREENING IN CHILDREN AND INFANTS.

THE LONG-TERM OBJECTIVES OF THIS PROGRAM ARE TO DEVELOP AND MANUFACTURE A LOW-COST, IN SITU SWEAT DETERMINATION SYSTEM FOR CYSTIC FIBROSIS SCREENING IN CHILDREN AND INFANTS. USING THE PROPRIETARY TECHNOLOGY OF INTEGRATED IONICS, INC.,AN ACCURATE, TEMPERATURE-CORRECTED SODIUM AND CHLORIDE DETERMINATION CAN BE PERFORMED BY PLACING A MINIATURIZED COMBINED SWEAT COLLECTION/SENSOR UNIT ONTO THE SKIN OF THE SUBJECT. THE SENSORS WILL BE MASS FABRICATED USING SEMI- CONDUCTOR-BASED ELECTROCHEMICAL SENSORS WITH INTEGRATED ELECTRONICS. THE AIM IN THIS PHASE I PROGRAM IS TO DETERMINE THE FEASIBILITY OF SUCH A SYSTEM, PREFERABLY WITH-OUT THE NEED FOR SWEAT INDUCTION. A PHASE II EFFORT WILL THEN DEVELOP THE SENSOR UNIT AND PORTABLE RECORDING UNIT TO A POINT WHERE THE SYSTEM CAN BE MANUFACTURED AND MARKETED. THE STUDY WILL USE THE GIBSON-COOK PILOCARPINE IONTOPHORESISDETERMINATION AS A REFERENCE METHOD. THE PROPOSED TEST WILLUSE 1 UL OF SWEAT IN A DETERMINATION LASTING FIVE MINUTES AND REQUIRING LESSER-SKILLED STAFF; THIS WILL MAKE IT APPROPRIATE FOR EVEN NEONATAL SCREENING.