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Test Code FV Leiden PCR Factor V Leiden Mutation by PCR

Important Note

This test is orderable under the Genetic Testing PowerOrder.  After selecting the order, right click on the test and select, "modify".  Please provide detailed information to allow for insurance prior-authorization. 

Useful For

The eSensor® Thrombophilia Risk Test is an in vitro diagnostic for the detection and genotyping of Factor II (Prothrombin) 20210G>A, Factor V (Factor V Leiden) 1691G>A and MTHFR (5,10 methylenetetrahydrofolate reductase gene) 677C>T and 1298A>C mutations in patients with suspected Thrombophilia from isolated genomic DNA obtained from whole blood samples. The test is intended to be used in the eSensor® XT-8 System.

Patient Preparation

No special patient preparation required

Collection Method

Venous collection

Minimum Volume

3 mL


Note: May be combined with PT by PCR without additional volume needed.

Container

Pink Top EDTA

Preferred Specimen

Pink Top EDTA – Whole Blood

Acceptable Specimens

  • Pink Top EDTA whole blood
  • Lavender Top EDTA whole blood
  • Lt Blue Top Sodium Citrate whole blood

Reference or Target Ranges

No Mutations Detected


Note: The limit of detection for the eSensor Thrombophilia Risk Test was determined to be 1.0 ng of gDNA, and reproducibility was 100% correlation with DNA sequencing.

Reportable Units

Homozygous/Heterozygous/Not Detected

Critical Value

Not defined for this assay

Reasons for Rejection

Hemolysis Threshold N/A
Icterus Threshold N/A
Lipemia Threshold N/A
Interfering Subtances/Other
  • Specimens rejected if plasma has been separated from cells.
  • Leakage or contamination of specimen, improper collection, container or transport, questionable patient or specimen identification, insufficient quantity

Specimen Stability

Ambient 3 Days
Refrigerated (4°C to 8°C) 7 Days
Frozen(-70°C to 0°C) 6 weeks

Performance Information

Days and Time Performed Batched once weekly
Expected Turn Around Time 7 – 14 Days
Stat Availabilty No
Performing Bench Molecular Pathology
Methodology/Method Description GenMark XT-8 – The eSensor® Technology uses a solid-phase electrochemical method for determining the genotyping status of a defined panel of mutations. Purified genomic DNA is isolated from the patient specimen according to defined laboratory procedures. Following multiplex PCR, single stranded target DNA is generated from the genomic DNA by exonuclease digestion. This specimen is combined with a signal buffer containing a pair of allele-specific oligonucleotide signal probes for each polymorphism, where each pair of signal probes is labeled with a genotype-specific ferrocene derivative. The mixture of amplified sample and signal buffer is loaded onto a cartridge containing single-stranded oligonucleotide capture probes bound to gold-plated electrodes. The cartridge is inserted into the XT-8 instrument where the single stranded targets hybridize to the complementary sequences of the capture probes and signal probes. The genotype of each polymorphism is determined by voltammetry, which generates specific electrical signals from the allele-specific signal probes.

Additional Information/Important Notes

This test is considered Genetic Testing and may be subject to insurance limitations.

CPT Codes

81241