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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 Mutation

Not 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