Clinical evaluation of a new sweat test system in the diagnosis of cystic fibrosis after newborn screening

A high chloride concentration determined in sweat is still the gold standard to
confirm the diagnosis Cystic Fibrosis (CF). Validated methods for performing a
sweat test are the Quantitative Pilocarpine Iontophoresis (QPIT) method and the
Macroduct collection system. In young infants, for example neonates with a
positive newborn screening test for CF (under 2 months of age), their often is
an insufficient sweat sample. This may lead to a diagnostic delay and longer
stressful period for the parents. The nanoduct is a new system for performing a
sweat test, especially designed for neonates, but this method is not yet
validated as a diagnostic instrument.

To determine the succes rate of the Nanoduct sweat test system.

A prospective comparing study tot determine the success rate of the Nanoduct
versus the QPIT/Macroduct.

QPIT or Macroduct sweat test ('gold standard' test) and Nanoduct.

All infants undergo two tests instead of one, one on each arm at the same time.
The sweat test is not painful nor distressing. the risk for complications is
negligible, the only reported risk is redness of the skin when the test is not
performed according to protocol or performed by non-skilled personell.