The detection and genotyping of the Factor V Leiden G1691A mutation as an aid in diagnosis of patients with personal or family history of thrombosis (especially venous) or risk factors for thrombosis.

Lavender (EDTA), 4mL

• Only one (1) tube needs to be drawn for any combination of the following tests:
  • Calreticulin Exon 9 Assay
  • Factor V Leiden Mutation
  • Factor 2 Mutation
  • Hereditary Hemochromatosis
  • JAK2 V617F Mutation Detection
  • MTHFR C677T assay
• Immediately following collection, mix sample thoroughly by gentle inverting 8 - 10 times, to prevent clotting

Submit entire tube, unspun

Lavender (EDTA), 4mL

 Lt blue Sodium citrate (Na Cit) - 2.7mL 

Yellow ACD (A or B)

Lt blue Sodium citrate (NaCit) or

Yellow ACD (A or B)

Molecular Medicare billing request

Hospital clients submitting a request for this assay on an outpatient with Medicare should complete and submit a Molecular Medicare billing request form to notify us of the need for Allina Health Laboratory to bill insurance.

Ambient (preferred)

Refrigerated (OK)

• Improper label (unlabeled or mislabeled)
• Wrong container (anticoagulant or solution)
• Improper blood/anticoagulant ratio
• Delay in transport
• Improper storage
• Inappropriate timing of collection
• Interfering substances
• Leaking container

Cobas Factor II and Factor V Test

Thrombophilia is a condition with a predisposition to develop thrombosis (e.g., blood clots) due to either an inherited or acquired defect in the coagulation system. Blood clots may form in either the venous or arterial vascular system and can lead to Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE), which are the third most common cause of cardiovascular death after acute coronary syndrome and stroke.

Inherited thrombophilia is most frequently caused by a Factor V or Factor II (Prothrombin) gene mutation. The Factor V Leiden mutation is a single point mutation (G to A at position 1691, or G1691A) of the human Factor V gene that results in substitution of arginine to glutamine at position 506 (R506Q) in the Factor V protein. Factor V Leiden mutation renders the protein partially resistant to inactivation by activated protein C (APC). Factor V Leiden mutation has a relatively high prevalence in the general population (e.g. about 5% in Caucasians). In addition to the Factor V G1691A mutation, molecular genetic testing for Factor II G20210A (G to A at position 20210) is recommended as this mutation is present in 1-3% of the general population. Evaluation of a patient’s risk for hereditary thrombophilia through a Factor II and Factor V genotyping test is critical for diagnosis and clinical management of patients with thrombophilia.

Medical necessity

Hospital clients submitting a request for this assay on an outpatient with Medicare should complete and submit a Molecular Medicare billing request form to notify us of the need for Allina Health Laboratory to bill insurance.

Molecular Medicare billing request