Test Code LAB8455 Factor V Leiden and Prothrombin Mutations
Performing Section
PRECISION DIAGNOSTICS
Purpose/Principle
The Xpert® Factor II & Factor V Assay is a qualitative in vitro diagnostic genotyping test for the detection of Factor II and Factor V alleles from EDTA anticoagulated whole blood. The assay is performed on the Cepheid GeneXpert® Dx System software version 4.0 or higher. This assay is intended to provide results for Factor II (20210G>A) and Factor V Leiden (c.1691G>A) mutations as an aid in the
diagnosis in individuals with suspected thrombophilia.
Special Collection Notes
Collect specimen according to standard operating procedure.
Specimen Type
Whole Blood/Bone Marrow:
Purple Top Tube-EDTA
Specimen Volume
Whole Blood
Preferred: 4.0 mL
Minimum: 0.5 mL
Processing Instructions
Store and ship ambient. If transport is longer than 4 hours send refrigerated on cold pack.NOTE: Samples should be received within 72 hours of collection if possible – maximum 5 days. Our recommendation is to use FedEx or UPS for shipping and obtain a tracking number to ensure safe delivery. Samples that are received on a Friday afternoon, Saturday, Sunday or before a major holiday will not be processed until the next business day. If samples need to be stored in your laboratory prior to shipping, they should be stored at room temperature or refrigerate until you send; do not freeze. Local couriers may be used to deliver specimens within the Denver metropolitan area.
Temperature
Ambient/Refrigerated
Test Components
Factor V Mutation
Factor II Mutation
Reference Range
Factor V MutationNot Detected
Factor II Mutation
Not Detected
TAT
5 days
Aliases
G1691A
20210A
Factor 2 Mutation
Factor II Mutation
F2 Mutation
Factor 5 Mutation
F5 Mutation
CPT
81241
81240