JAK2_Exon 12-16

Minimum of 1 mL whole blood in a purple (EDTA) or pink top tube (EDTA); minimum of 1 mL of bone marrow aspirate in a purple, pink, or green (heparin) top tube.

JAK2 mutation analysis is primarily used for differential diagnosis of malignant erythrocytosis and secondary or reactive erythrocytosis. According to the World Health Organization (WHO) diagnostic guidelines for myeloproliferative neoplasms (MPNs), documenting a JAK2 exon 12 mutation serves as an alternative major criterion for establishing a definitive diagnosis of polycythemia Vera (PV) when JAK2_V617F is absent.

Copy of the referring client's requisition form to accompany specimen.

Refrigerated: 5 days
Ambient (Room Temperature): 3 days
Specimen must be received by laboratory within 7 days of collection.

Frozen specimen; clotted or grossly hemolyzed specimens; serum; specimens without 2 patient identifiers; serum or plasma, aliquots (previously open containers); specimen that were received >7 days after collection.

Whole blood and bone marrow - 1 week.

This test was developed, and its performance characteristics determined by CellNetix Labs LLC. The U.S. Food and Drug Administration (FDA) has not approved or cleared this test. However, FDA approval or clearance is currently not required for clinical use of this test. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions. CellNetix is authorized under Clinical Laboratory Improvement Amendments (CLIA) to perform high-complexity testing.

55300-8; 80186-0