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Test Code F25L Factor II (Prothrombin G20210A) and Factor V Leiden Genotype

Performing Laboratory

Bronson Laboratory Services-Microbiology

Reference Values



Note: Factor II (G20210A) and Factor V Leiden mutations are
present in 2% and 5% of the general population, respectively


Please note:  Factor II (Prothrombin G20210A) and Factor V
Leiden mutation testing are both performed in this panel. The tests
are not offered individually. 


This test should only performed once in a patient’s


Methodology: Cepheid  Xpert Hemosil Factor II and Factor V

Chain Reaction (PCR) and Multiplexing Micro-Chip Array


Specimen Requirements

Specimen Type: Whole blood
Lavender top (EDTA)
Acceptable: Sodium citrate
Specimen Volume: Full tube
Specimen Minimum Volume: 500 ul  peripheral
blood drawn in an EDTA microtainer
Collection Instructions:
1. Invert several times to mix blood.
2. Send specimen in original tube.
Additional Information:

1. Molecular coagulation test requested must have its own

2. To avoid co-mingling and cross contamination: If
specimen is to be shared with another department, the
molecular testing must take an aliquot of the specimen first or
perform their testing prior to routing to additional testing


Reject Due To:
Hemolysis: Mild OK; Gross OK
Lipemia: Mild OK; Gross OK
Icterus: NA
Other: Green-top (heparin) tube; previously performed (this test is
only performed once in a patient’s lifetime)

Specimen Transport Temperature

Stable 24 hours when stored at room temperature (22-28°

Stable 15 days when stored at 2-8° C

Stable 3 months when stored at -20° C or -80° C

Day(s) Test Set Up

Monday through Friday on day shift

Test Classification and CPT Coding





This test has been approved by the U.S. Food and Drug
Administration and is used per manufacturer’s

Clinical Utility


Factor V Leiden is Useful for:

Direct mutation analysis should be reserved for patients with
clinically suspected thrombophilia and:

- Activated protein C (APC)-resistance proven or suspected by a
low APC-resistance ratio

-Family history of the factor V (FV Leiden) mutation


It may be appropriate to screen those women contemplating oral
contraceptive use or pregnancy, with consideration of an
alternative form of contraceptive therapy or venous thromboembolism
(VTE) prophylaxis during pregnancy or the postpartum state for
women with FV Leiden allele


Knowledge of the FV Leiden allele status may alter
anticoagulation management of VTE patients.


Factor II Prothombin is useful for:

Direct mutation analysis for the prothrombin (PT) G20210A allele
in patients with documented venous thromboembolism, deep vein
thrombosis, or pulmonary embolism.