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Test Code LAB10967 Factor V Leiden (G1691A) & Prothrombin Factor II(G20210A) Mutation

Important Note

1.    Patients on heparin therapy and blood transfusion patients may have blood specimens that potentially interfere with the PCR results and lead to invalid or erroneous results.
2.    Rare Factor V mutations (A1696G, G1689A, and A1692C) and any additional  single nucleotide polymorphisms (SNPs) in the probe binding region may interfere with the target detection and yield an INVALID result.
3.    Other rare Factor II mutations in the probe binding region may interfere with the target detection and could yield an INVALID result, or a false HOMOZYGOUS mutant result when occurring concordantly with the Factor II c.*97G>A (G20210A) mutation.
4.    Performance of the Xpert Factor II & Factor V test has not been evaluated with samples from pediatric patients.
5.    Patients receiving allogenic stem cell transplant prior to DNA based testing may have false normal or abnormal results depending on the genotype of the stem cell donor. 
 

Intended Use

This test is intended to provide results for Factor II (G20210A) and Factor V Leiden (G1691A)mutations as an aid in the diagnosis in individuals with suspected thrombophilia.

The association of Factor II (G20210A) and Factor V Leiden (G1691A) mutations with an increased risk for venous thrombosis has been well documented. Factor II c.*97G>A was previously designated as G20210A or 20210G>A4 and is commonly referred to as prothrombin or, as in the Xpert Factor II & Factor V test, as Factor II (G20210A). The Factor II (G20210A) mutation refers to the G to A transition at nucleotide 20210 in the 3' untranslated region of the gene and is associated with increased plasma levels of prothrombin. Factor V c.1601G>A (p.Arg534Gln) was previously designated as G1691A or Arg506Gln and is commonly referred to as Factor V Leiden or FVL5, or as in the Xpert Factor II & Factor V test, as Factor V (G1691A). 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 the amino acid arginine by glutamine in the Factor V protein, causing resistance to cleavage by Activated Protein C (APC). Factor II (G20210A) and Factor V Leiden (G1691A) mutations are present in 2% and 5% of the general population, respectively.

Specimen Collection and Handling

Collect Whole Blood in EDTA or Sodium Citrate Tube
    24 hours when stored at room temperature (22-28 °C)
    Samples should be stored at 2-8 °C if stored longer than 24 hours. Blood is stable up to 15 days when stored at 2-8 °C

 Shared Specimen or add on not allowed