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Test Code CF97V / 481025-LC Cystic Fibrosis (CF), 97 Variants

Important Note

This test may require pre-authorization or have limited coverage.  Please check with your appropriate insurance carrier to determine any specific requirements.

Additional Codes

Software Test Code

SCC

CF97V
EPIC LAB20646
LabCorp 481025

 

Performing Laboratory

Laboratory Corporation of America (LabCorp)

Useful For

 

This test is used for cystic fibrosis carrier screening for 97 CFTR variants.

Specimen Type

4 mL whole blood (3 mL minimum) - Lavender-top (EDTA) tube, yellow-top (ACD-A) tube, pink-top (EDTA) tube, tan-top (EDTA) tube

LabCorp buccal swab kit (LabCorp clients only)

* Yellow top ACD-B tubes are unacceptable **

 

Specimen Collection and Handling

Maintain at room temperature or refrigerate at 4°C.

Do not eat, drink, smoke or chew gum 30 minutes prior to collection.

Causes for Rejection are Frozen or hemolyzed whole blood specimen; quantity not sufficient for analysis; one buccal swab; improper container; wet buccal swab

 

CPT Code Information

CPT Code CPT Code Description CPT Code Disclaimer
81220 Cftr gene com variants  

 

Additional Notes and Limitations

Technologies used do not detect germline mosaicism and do not rule out the presence of large chromosomal aberrations including rearrangements and gene fusions, or variants in regions or genes not included in this test, or possible inter/intragenic interactions between variants, or repeat expansions. Variant classification and/or interpretation may change with time if more information becomes available. False positive or false negative results may occur for reasons that include: rare genetic variants, sex chromosome abnormalities, pseudogene interference, blood transfusions, bone marrow transplantation, somatic or tissue-specific mosaicism, mislabeled samples or erroneous representation of family relationships. This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.

Methodology

Next-generation sequencing to identify 97 variants in the CFTR gene