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| ID | Type | Description | Link |
|---|---|---|---|
| CFQuantum001 | Other Identifier | PolyChrome Medical, Inc. |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cystic fibrosis patients | cystic fibrosis patients | ||
| non-cystic fibrosis patients | non-cystic fibrosis patients |
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| Measure | Description | Time Frame |
|---|---|---|
| sweat chloride value | Sweat chloride measurements obtained by GCQPIT and CFQT | once, at enrollment (baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| QNS rate | QNS rate of CFQT compared to GCQPIT | once, at enrollment (baseline) |
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Inclusion Criteria:
Exclusion Criteria:
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pediatric pulmonology clinic
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| Name | Affiliation | Role |
|---|---|---|
| Michael J Rock, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States | ||
| University of Utah |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Salt Lake City |
| Utah |
| 84012 |
| United States |
| American Family Children's Hospital | Madison | Wisconsin | 53792 | United States |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |