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Test Code LAB3024 CYSTIC FIBROSIS, CFTR GENE, VARIANT PANEL, VARIES

Additional Codes


EPIC order name: Cystic Fibrosis 106-Mutation Panel  (EPIC Test# LAB3024)
Cerner order name: Cystic Fibrosis (CFTR) expanded variant panel

Performing Laboratory

St. Louis Children's Hospital - Blood Bank

Specimen Requirements

Patient Preparation: A previous bone marrow transplant from an allogenic donor will interfere with testing.

Container/Tube  
Preferred: Lavender-top (EDTA) tube
Collection Volume: 3.0 mL (minimum 1.0 mL)

Special Instructions:

Immediately invert tube gently 8-10 times after collection to ensure proper mixing of blood and anticoagulant (this will avoid specimen clotting). Send specimen in original vacutainer to lab at ambient temperature.

Send a completed "Patient History Form for Cystic Fibrosis (CF) Testing" with specimen. If there is a family history of cystic fibrosis, the known variant in the family should be supplied for best interpretation of results.

Sample Rejection

Specimens collected in NaHep, Yellow (ACD) soln, or LiHep tubes
Clotted specimens.

Mislabeled or unlabeled specimens.

Logistics

Test Availability: Daily
Turnaround Time: 6-10 days

Test set-up: Sunday-Saturday

Lab Testing Section:

Send-outs

Referred to:

BJN Molecular Diag Lab to ARUP  / Test ID: CF VAR

Reference Values

Reference Range:

An interpretive report will be provided

Critical Values:

None established

Limitations:

NA

Methodology:

Matrix-Assisted Laser Desorption Ionization-Time of Flight (MALDI-TOF)

Test Classification:

This test was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the US Food and Drug Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes.

 

 

Additional Information

For SLCH Laboratory use only

Lab Processing instructions:

DO NOT CENTRIFUGE. Send specimen in original vacutainer

 

Processed Volume:

3.0 mL (minimum 1.0 mL) whole blood

 

Transport Temperature:

Ambient

 

Analyte Stability:

Ambient: 72 hours

Refrigerated: 1 week

Frozen: 1 month

LOINC

CF Allele 1: 42938-1
CF Allele 2: 42939-9
CF 5T Variant: 21654-9
CF Expanded Variant Pnl Interp: 21656-4

Last Reviewed

10/22