Test Code JAK2V 
Methodology Qualitative Real-time Polymerase Chain Reaction (PCR). (PCR is used pursuant to a license agreement with Roche Molecular Systems, Inc.) Genomic DNA is extracted from whole blood and allele-specific real-time polymerase chain reaction (PCR) is performed to detect the 1848G>T (V617F) point mutation in exon 14 of the JAK2 gene. Other mutations are not detected. 
Description Indications:
Use this test to differentiate P.vera and other chronic myeloproliferative disorders from reactive processes. Indications for testing are reviewed in: Steensma DP. JAK2 V617F in Myeloid Disorders: Molecular Diagnostic Techniques and Their Clinical Utility. J Mol Diagn. 2006;8:397-411.

Performance Characteristics:
The sensitivity of this assay is 5% mutant DNA in a background of normal DNA. This mutation is not detected in healthy individuals.

This test was developed and its performance characteristics determined by NorDx. It has not been cleared or approved by the U.S. Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not required. The diagnostic utility for this test has been validated by NorDx. This test is used for clinical purposes, and should not be regarded as investigational or for research use only. 

Specimen Draw 4 mL (minimum volume 0.5mL) blood or bone marrow in a lavender-top (EDTA) blood collection tube. Invert several times to mix. Clotted blood is not acceptable. Transport at room temperature. Do not freeze. 
Reference Values Jak2 mutation is detected or not detected. 
Analytic Time 1 Day; Maximum Laboratory Time - 8 Days 
Day(s) Test Set Up Tuesdays 
CPT Code(s) 81270