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Test Code LAB4314 Factor V Leiden Mutation, Whole Blood

Important Note

The performance of the Xpert Factor II & Factor V test has not been evaluated with samples from pediatric patients.

Additional Codes

Test Name in EPIC EPIC Test Code  Mnemonic
Factor V Leiden Mutation, Whole Blood LAB4314 EH F5DNA

 

Useful For/Utility

Aid in the diagnosis of suspected thrombophilia 

Performing Laboratory

SMDC Clinical Lab

Specimen Type

EDTA Whole Blood in original collection tube

Specimen Required


4.0 mL EDTA whole blood  (Minimum: 0.5 mL EDTA whole blood)

Specimen Stability Information

Do not centrifuge or concentrate the whole blood sample by plasma removal.


Samples should be stored at 2-8C if transport to performing laboratory is longer than 24 hours.

Whole blood is stable up to 15 days when stored at 2-8C.

Whole blood samples may be stored at -20C or -80C for up to 3 months (use of freezer compatible storage vial is recommended).


Refrigerate - 15 days

Method and Method Description

Cepheid GeneXpert System by real-time polymerase chain reaction (PCR)

This test uses the Cepheid Xpert FII & FV assay to detect Factor V Leiden (G1691A) mutations using real-time polymerase chain reaction (PCR) on the Cepheid GeneXpert Instrument System. The primers and probes in the Xpert FII & FV assay determine the genotype of the Factor V gene (at position 1691). Factor V Leiden (G1691A) refers to the G to A transition at nucleotide position 1691 of the Factor V gene, resulting in the substitution of amino acid arginine by glutamine in the Factor V protein, causing resistance to cleavage by Activated Protein C (APC). Factor V Leiden (G1691A) mutations are present in 5% of the general population. The Cepheid Xpert FII & FV assay is FDA-cleared; its performance was verified by Essentia Health-SMDC Clinical Laboratory.

Day(s) Test Set Up

Monday-Friday

CPT/LOINC

CPT: 81241

LOINC:

Factor V Leiden Mutation:  91712-0

Factor V Leiden Method Comment: 85069-3

Factor V Leiden Limitations: 77202-0

Reference Values

Normal (No mutation detected)