The primary objective is to evaluate the diagnostic accuracy of a new sweat test method in both normal individuals and individuals with CF or cystic fibrosis related metabolic syndrome (CRMS).
Subject participation is for one day and duration of study for each subject is one day. No follow-up will be required.
Number of subjects; 300 split evenly between subjects with previously diagnosed CF or CRMS (cystic fibrosis related metabolic syndrome) and subjects referred to the sweat test lab for clinical reasons.
Number of sites = 6, U of WI-Madison, U of WI-Milwaukee, U of MI-Ann Arbor, Dayton Children's Hospital (OH), U of MN, and Children's of Alabama.
Primary endpoints:
* Clinical and analytical sensitivity of the new test method
* Clinical and analytical sensitivity of the standard-of-care methods
Statistics Sensitivity and specificity will be calculated and reported along with the corresponding 95% confidence intervals. Bias assessment will be conducted according to the Clinical and Laboratory Standards Institute (CLSI) guidelines for method comparison and bias estimation. Pearson's correlation analysis will be conducted to test for adequate range of the replicate values for the new test method.
