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

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.

Specimen Transport Temperature

Specimen should be sent at Ambient temperature or kept refrigerated

Specimen cannot be frozen

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.

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