PERFORMANCE WHITE PAPER:
CFTR 100+ Panel
More Variants. More Populations. Better Insight.
Proven performance for confident CFTR detection.
The iPlex Pro® CFTR 100+ Panel was developed to support evolving cystic fibrosis research with broader variant coverage. This technical white paper documents the analytical
validation and verification studies performed to assess the panel’s accuracy, robustness, and reproducibility across multiple laboratories utilizing the MassARRAY® System workflow.
Designed to detect all 100 CFTR variants recommended by the American College of Medical Genetics and Genomics (ACMG) plus 23 additional variants of interest, the CFTR 100+ Panel reflects both current guidance and direct feedback from researchers working across diverse populations.
What this white paper covers:
This performance white paper provides a detailed look at how the CFTR 100+ Panel performs under real-world laboratory conditions, including:
- Accuracy and analytical performance: How concordance, sensitivity, and specificity were assessed across external evaluation sites
- Robustness and stability: How the assay performs across instruments, operators, workflow parameters, and routine shipping and storage conditions
- Reference materials and controls: Which characterized samples and controls were used—and how gaps were addressed when reference materials were unavailable
Who should read this:
- Public health and state laboratories conducting cystic fibrosis–related research or population studies
- Newborn screening laboratories evaluating CFTR variant detection strategies and assay performance characteristics
- Research laboratories supporting CF programs that require validated, scalable workflows with expanded variant coverage
- Existing MassARRAY® System users assessing CFTR assay performance for research applications
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