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Test Code LAB6150 F5 (FVL) and  F2 (Prothrombin) Mutations

Important Note

***IMPORTANT***  Specimen must remain ambient.  Must arrive within 24 hours of collection.

Performing Laboratory

Barnes-Jewish Hospital Molecular Diagnostic Laboratory

Methodology

This assay utilizes the Cepheid Xpert® FII & FV qualitative in vitro diagnostic genotyping test, as described in the FDA approved assay package insert, for the detection of Factor V (F5) and Prothrombin (F2) alleles from sodium citrate or EDTA anticoagulated whole blood. This test is performed on the Cepheid GeneXpert® Dx System which automates and integrates sample purification, nucleic acid amplification, and detection of the target sequence in whole blood using real-time Polymerase Chain Reaction (PCR) assays based on Scorpion® PCR technology. Note: F5 (NM_000130​.4):c.1601G>A, R534Q or Factor V Leiden is also referred to as c.1691G>A, p.R506Q in the literature.  F2 (NM_000506.3):c.*97G>A is also referred to as G20210A and g.20210G>A in the literature.

Specimen Requirements

Form: Molecular Diagnostics Requisition

 

Specimen Type: Whole blood
Container/Tube: Lavender-top (EDTA)
Specimen Volume: 1 -2 mL
Specimen Minimum Volume: 0.5 mL
Collection Instructions: Invert several times to mix blood. Clotted blood is not acceptable.
Additional Information: Specimen cannot be frozen.

Day(s) Test Set Up

Tuesday, Thursday
Turnaround Time:
STAT: Director approval required
Routine: 3 to 7 business days

Reference Values

An interpretive report will be provided.

Test Classifications and CPT Coding

81240 - F2 (prothrombin, coagulation factor II), (eg, hereditary hypercoagulability) gene analysis, 20210G>A variant

81241 - F5 (coagulation factor V), (eg, hereditary hypercoagulability) gene analysis, Leiden variant

Additional Information

For BJH Laboratory Use Only
Alternate Tube:

1 blue-top (sodium citrate) tube

Analyte Stability:

Blood is stable 24 hours at ambient temperature, up to 15 days refrigerated.

Laboratory Processing Instructions:
Test performed in BJH Molecular Diagnostics.

Specimen Transport Temperature

Specimen should be sent at Ambient temperature or kept refrigerated

Specimen cannot be frozen