Module CC-23 · Version 1.0
The Laboratory Role in Cystic Fibrosis Testing
Use newborn-screening, sweat chloride, and CFTR molecular results as distinct evidence streams while protecting sweat specimen adequacy and reporting uncertainty clearly.
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Who this module is for
Medical laboratory professionals with electrolyte methods and genetics basics who support newborn screening referrals, sweat chloride testing, or CFTR result interpretation.
Learning objectives
- Differentiate screening, diagnostic sweat testing, and CFTR molecular analysis.
- Identify sweat-collection adequacy, contamination, evaporation, and analytical requirements.
- Explain why age, phenotype, genotype, and repeat or confirmatory testing matter.
How completion works
Mark every required section done and answer every knowledge check in those sections correctly. The final save completes the module automatically.
Sources
12 sources
1. Farrell PM, White TB, Ren CL, et al. Diagnosis of Cystic Fibrosis: Consensus Guidelines from the Cystic Fibrosis Foundation. J Pediatr. 2017;181S:S4-S15.e1. doi:10.1016/j.jpeds.2016.09.064. PMID 28129811. Summarized on CFF's current guideline page.
Source note · professional society guidance
2. Green DM, Lahiri T, Raraigh KS, et al. Cystic Fibrosis Foundation Evidence-Based Guideline for the Management of CRMS/CFSPID. Pediatrics. 2024;153(5):e2023064657. PMCID PMC11781860.
Source note · professional society guidance
3. Cystic Fibrosis Foundation. Sweat Test Clinical Care Guidelines.
Source note · professional society guidance
4. Cystic Fibrosis Foundation. Newborn Screening for CF.
Source note · professional society guidance
5. Cystic Fibrosis Foundation. Cystic Fibrosis Newborn Screening: A Toolkit for Care Center Collaboration and Action.
Source note · professional society guidance
6. Clinical and Laboratory Standards Institute. Sweat Testing: Sample Collection and Quantitative Chloride Analysis. CLSI guideline C34, 5th ed. Wayne, PA: CLSI; 2024.
Source note · consensus standard
7. Clinical and Functional Translation of CFTR (CFTR2) database. Johns Hopkins University, US CF Foundation, European CF Society.
Source note · consensus standard
8. Deignan JL, Astbury C, Cutting GR, et al. CFTR variant testing: a technical standard of the American College of Medical Genetics and Genomics. Genet Med. 2020.
Source note · professional society guidance
9. Code of Federal Regulations, Title 42, Part 493, Section 493.1253. Standard: Establishment and verification of performance specifications. US CMS/CLIA.
Source note · federal regulation
10. Code of Federal Regulations, Title 42, Part 493, Sections 493.1255 and 493.1256. Calibration and control procedures. US CMS/CLIA.
Source note · federal regulation
11. College of American Pathologists. Chemistry and Toxicology Checklist, CHM.30150 Sweat Rejection Incidence Rate (Phase I). CAP Accreditation Program, 12.09.2025 edition.
Source note · accreditation standard
12. College of American Pathologists. Surveys and Anatomic Pathology Education Programs Catalog, Sweat Analysis Survey listing.
Source note · laboratory reference