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The quantitative real-time PCR assay detects V617F mutation (c.1849 G>T) observed in approximately 95% polycythemia vera (pv), 55% essential thrombocythemia (ET), and 55% primary myelofibrosis (PMF). It is also infrequently present (3% to 5%) in myelodysplastic syndrome, chronic myelomonocytic leukemia, and other atypical chronic myeloid disorders. The results should be interpreted in the context of all clinical and laboratory findings. No therapeutic action should be taken based solely on these results.
Please provide indications for JAK2 testing and specimen type. Direct any questions regarding this test to customer service at 800-345-4363.
This assay detects only the JAK2V617F point mutation. Other mutations that may occur in the JAK2 gene will not be detected. In vitro studies have indicated that this assay has an analytical sensitivity of 1%. This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.
Total genomic DNA was extracted and subjected to TaqMan® real-time PCR amplification/detection. Two amplification products per sample were monitored by real-time PCR using primers/probes specific to JAK2 wild type (WT) and JAK2 mutant V617F. The ABI7900 Absolute Quantitation software will compare the patient specimen values to the standard curves and generate percent values for wild type and mutant type. The numerical values of sample Mutant Quantity/(Sample Mutant Quantity + Sample Wild Type Quantity) X100 is reported as a percentage.
Information on collection, storage, and volume
Whole blood, bone marrow or cell pellet
3 to 5 mL whole blood or 1 to 2 mL bone marrow
3 mL whole blood or 1 mL bone marrow
Lavender-top (EDTA) tube, green-top (sodium heparin) tube, tan-top (K2-EDTA) tube or pink-top (K2-EDTA) tube
Ship at room temperature. If specimen is to be stored prior to shipment, store at 2°C to 8°C.
Specimen does not meet collection criteria; frozen whole blood, marrow, or cell pellet; leaking tube; clotted blood or marrow; grossly hemolyzed specimen or otherwise visibly degraded; contamination by another specimen; specimens containing suspicious foreign material.
Submit at room temperature. Specimen should arrive at the testing laboratory within 48 hours of collection. Indicate the date and time of collection on the test request form.
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