A Study of Sweat Testing Using a Quantitative Patch
| Status: | Completed |
|---|---|
| Conditions: | Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 8/31/2018 |
| Start Date: | January 2012 |
| End Date: | October 2013 |
The primary aim of the study is to determine if the CF Quantum Sweat Test provides sweat
chloride results that are equivalent to the results from traditional sweat testing. The
secondary aim of the study is to assess the quantity not sufficient rate of the CF Quantum
Sweat Test compared to traditional sweat testing.
chloride results that are equivalent to the results from traditional sweat testing. The
secondary aim of the study is to assess the quantity not sufficient rate of the CF Quantum
Sweat Test compared to traditional sweat testing.
All 50 states and the District of Columbia are performing newborn screening for cystic
fibrosis (CF). Infants who have a positive newborn screen require follow-up with a sweat
test. Gibson-Cooke Quantitative Pilocarpine Iontophoresis (GCQPIT) requires collecting sweat
in microbore tubing or on gauze/filter paper and analyzing sweat using a chloridometer. This
test has many difficulties including specimens that are quantity not sufficient (QNS), many
steps of pipetting solutions in the laboratory, and the need for a chloridometer to analyze
sweat chloride concentration. The only manufacturer of a chloridometer has ceased production
of this instrument. The CF Quantum® Sweat Test System (CFQT) overcomes all of the
difficulties of GCQPIT. This pilot study will determine if the CFQT provides results that are
equivalent to GCQPIT.
fibrosis (CF). Infants who have a positive newborn screen require follow-up with a sweat
test. Gibson-Cooke Quantitative Pilocarpine Iontophoresis (GCQPIT) requires collecting sweat
in microbore tubing or on gauze/filter paper and analyzing sweat using a chloridometer. This
test has many difficulties including specimens that are quantity not sufficient (QNS), many
steps of pipetting solutions in the laboratory, and the need for a chloridometer to analyze
sweat chloride concentration. The only manufacturer of a chloridometer has ceased production
of this instrument. The CF Quantum® Sweat Test System (CFQT) overcomes all of the
difficulties of GCQPIT. This pilot study will determine if the CFQT provides results that are
equivalent to GCQPIT.
Inclusion Criteria:
- clinical diagnosis of cystic fibrosis
- patients who require a sweat test
Exclusion Criteria:
- Infants less than 48 hours of age
- Patient is receiving oxygen by open delivery
- collection site has diffuse inflammation or rash
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