Cystic Fibrosis Detection 
CPT 81220
Test Code 7000106
Synonyms CF 60, CFTR
Test Includes Detection of 60 Cystic Fibrosis mutations in the CFTR gene
Specimen Whole Blood
Volume 4.0 mL
Container Lavender Top (EDTA) Tube
Special Instructions Completed Cystic Fibrosis Questionnaire must accompany the specimen. Testing cannot be performed without the Questionnaire. Whole blood is required for this test. Do NOT centrifuge specimen.
Specimen Prep  
Storage Refrigerated
Transport Temp Refrigerated
Stability Rm Temp 24 hours
Stability Refrig 14 days
Stability Frozen Unacceptable
Methodology Polymerase Chain Reaction (PCR)
Rejection Criteria Hemolyzed specimen, plasma, serum, frozen specimen. 
Reference Value Descriptive Report  
Performed/TAT Two times per week   Up to 5 days    
Comments Testing is performed using the Luminex xTAG Cystic Fibrosis 60 v2 (CF 60 panel) to simultaneously detect and identify a panel of 60 mutations and variants in the Cystic Fibrosis transmembrane conductance regulator (CFTR) gene in human blood specimens. The panel consists of mutations and variations currently recommended by the American College of Medical Genetics and American College of Obstetricians and Gynecologists (ACMG/ACOG), plus some of the world's most common and North American-prevalent mutations. The CF 60 panel is a qualitative genotyping test that provides information intended to be used for carrier testing in adults of reproductive age, as an aid in newborn screening, and in confirmatory testing in newborns and children. The kit is not indicated for use in fetal diagnostic or pre-implantation testing. This kit is also not indicated for stand-alone diagnostic purposes.