Protocol - Sweat Chloride Test
Description
Quantitative pilocarpine iontophoresis is the procedure also known as the sweat chloride test. It involves stimulation of sweat, collection of sweat onto gauze or filter paper, measurement of the weight or volume of sweat collected, and analyses to determine the sweat chloride concentration.
Specific Instructions
The Cystic Fibrosis Foundation (CFF) accredits cystic fibrosis centers to perform sweat testing. The CFF strongly recommends that any laboratory that performs sweat testing be accredited by their organization.
The Rare Genetic Conditions Working Group indicates that normally this test is performed on infants and young children and may be less accurate when performed on adults. Also the Working Group acknowledges, sweat testing is exclusively performed in relation to cystic fibrosis.
Availability
Protocol
The following description is a summary. See Clinical and Laboratory Standards Institute (CLSI) document C34-A2 for the full protocol. The test should be performed at a CFF accredited laboratory. In addition, the CFF has also provided testing guidelines (LeGrys et al., 2007) that should be followed.
- Pilocarpine is applied to gauze or filter paper.
- Electrodes are attached to the gauze or filter paper.
- The electrodes are attached to the newborn’s lower arm or upper leg for about 5 minutes. Sweat collection should not occur longer than 30 minutes.
- Collect a minimum of 75 mg of sweat.
- Quantitatively analyze the sweat for chloride concentration by coulometric titration using a chloridometer, or using the Schales and Schales mercuric nitrate procedure or an automated analyzer that has been validated against the other methods.
- It is recommended but not required that the test be repeated on the newborn.
Reference values
Sweat chloride concentrations < 40 mmol/L are negative; 40 to 60 mmol/L are borderline/intermediate; > 60 mmol/L are positive.
Personnel and Training Required
Trained laboratory staff at a Cystic Fibrosis Foundation-accredited laboratory.
Equipment Needs
Iontophoresis equipment (battery powered)
Requirements
| Requirement Category | Required |
|---|---|
| Major equipment | Yes |
| Specialized training | Yes |
| Specialized requirements for biospecimen collection | No |
| Average time of greater than 15 minutes in an unaffected individual | No |
Mode of Administration
Bioassay
Lifestage
Infant, Toddler, Child, Adolescent, Adult, Senior, Pregnancy
Participants
Infants 48 hours old to adults
Selection Rationale
The sweat chloride test is considered the gold standard for the diagnosis of cystic fibrosis.
Language
English
Standards
| Standard | Name | ID | Source |
|---|---|---|---|
| caDSR Form | PhenX PX221701 - Sweat Chloride Test | 6200813 | caDSR Form |
Derived Variables
None
Process and Review
This section will be completed when reviewed by an Expert Review Panel.
Protocol Name from Source
LeGrys, V.A., et al. Diagnostic sweat testing: The Cystic Fibrosis Foundation guidelines. J Pediatr, 2007
Source
CLSI. Sweat Testing: Sample Collection and Quantitative Chloride Analysis; Approved Guideline-Third Edition. CLSI document C34-A3. Wayne, PA: Clinical and Laboratory Standards Institute; 2009.
LeGrys, V. A., Yankaskas, J. R., Quittell, L. M., Marshall, B. C., & Mogayzel, P. J., Jr. (2007). Diagnostic sweat testing: The Cystic Fibrosis Foundation guidelines. Journal of Pediatrics, 151(1), 85-89.
General References
Farrell, P. M., Rosenstein, B. J., White, T. B., Accurso, F. J., Castellani, C., Cutting, G. R., Durie, P. R., Legrys, V. A., Massie, J., Parad, R. B., Rock, M. J., & Campbell, P. W.; Cystic Fibrosis Foundation. (2008). Guidelines for diagnosis of cystic fibrosis in newborns through older adults: Cystic Fibrosis Foundation consensus report. Journal of Pediatrics, 153(2), S4-S14.
Mishra, A., Greaves, R., & Massie, J. (2005). The relevance of sweat testing for the diagnosis of cystic fibrosis in the genomic era. Clinical Biochemist Reviews, 26, 135-53.
Protocol ID
221701
Variables
Export Variables| Variable Name | Variable ID | Variable Description | dbGaP Mapping | |
|---|---|---|---|---|
| PX221701_SweatTest_Borderlien | ||||
| PX221701010000 | Negative Sweat test - Cystic Fibrosis | N/A | ||
| PX221701_SweatTest_Negative | ||||
| PX221701020000 | Borderline Sweat test - Cystic Fibrosis | N/A | ||
| PX221701_SweatTest_Positive | ||||
| PX221701030000 | Positive Sweat test - Cystic Fibrosis | N/A | ||
Measure Name
Sweat Chloride Test
Release Date
April 30, 2015
Definition
An assay to determine if a person has cystic fibrosis.
Purpose
The sweat chloride test is the gold standard test used to diagnose cystic fibrosis. It is recommended after a newborn screens positive for cystic fibrosis or when a patient of any age is suspected of having cystic fibrosis.
Keywords
Cystic fibrosis, sweat chloride, sweat test, Cystic Fibrosis Foundation, CFF, quantitative pilocarpine iontophoresis, newborn screening
Measure Protocols
| Protocol ID | Protocol Name |
|---|---|
| 221701 | Sweat Chloride Test |
Publications
There are no publications listed for this protocol.