Update Type: Test Code Change
Test Updated: 04/20/2022
Test Overview
Test Methodology

Multiplex Polymerase Chain Reaction (PCR)

Test Usage

Cystic Fibrosis mutation panel for general population screening. This assay may be used for determination of carrier status in individuals who have a family history of cystic fibrosis, and refinement of carrier risk for those individuals who do not have a family history of cystic fibrosis. This panel includes genotyping for 60 mutations and variants within the CFTR gene. See http://www.pathology.med.umich.edu/handbook/Tables/INPLX_Mutations.pdf for complete listing of the tested mutations and variants.

Reference Range *

Interpretive report provided.

Test Limitations

This test will not detect mutations other than the 60 described above. The accuracy of reported probabilities are contingent upon the accuracy of the history provided. This test is intended only for carrier screening, not for the diagnosis of cystic fibrosis.

Test Details
Days Set Up
Tuesday
Analytic Time

3 - 10 days

Soft Order Code
INPLX
MiChart Code
Cystic Fibrosis Carrier Screening
Synonyms
  • CFINPLEX
  • CYSTIC FIBROSIS CARRIER SCREEN
  • Sweat Chloride
  • CFINV
  • CFINVS
  • CFDX
  • Cystic Fibrosis Mutation
  • MLABEL
  • INPLX
  • CF Carrier Screening Mutation Detection
  • CFTR Mutation Screening
Laboratory
Molecular Diagnostics
Section
Molecular Diagnostics
Specimen Requirements
Collection Instructions

Collect blood in a lavender top tube. Refrigerate and send intact blood specimen within 48 hours of collection.

Alternate Specimen
The preferred specimen is whole blood collected in EDTA (lavender top). However, ACD (yellow top) will also be accepted.
Contraindications
In the absence of specific information regarding advances in the knowledge of mutation characteristics for a particular disorder, the current literature indicates that genetic tests for inherited disease need only be conducted once per lifetime.
Normal Volume
5 mL EDTA (lavender) whole blood. Extracted DNA is also acceptable if extracted in a CLIA certified laboratory.
Additional Information

By ordering this test the clinician acknowledges that informed consent has been obtained from the patient as required by applicable state or federal laws and the ordering clinician has authorization from the patient permitting MLabs to report the test results to the ordering clinician. Test includes pathologist interpretation of results billed as a separate additional charge. This test is not available without interpretation.

Billing
CPT Code
81220
Fee Code
21659
Pro Fee CPT
G0452-26
LOINC
21654-9
NY State Approved
No