Name: JAK2 Mutation V617F, Quantitative, PCR, Blood
Test Name: JAK2 Mutation V617F, Quantitative, PCR, Blood
Health Link Test Code: HCJAK2MD
LIS Test Code: JAK2MD
CPT Code(s): 81270
Methodology: Real-Time PCR followed by Melting Point Analysis
Days Performed: Once a week.
In-Lab Turnaround Time: 10 days.
Stat In-Lab Turnaround Time: Not available stat.
Collection Container: Lavender top
For bone marrow specimens, order JAK2 Gene,V617F Mutation, Qualititative on bone marrow order form UWH#HEMATOREQ at time of collection.
Contact UWHC Test Referral office at (608)262-6388 prior to blood collection. Ordering source must fill out the Referral Screening Flow Sheet prior to specimen collection.
Collection Volume: 4 mL
Pediatric Collection Volume: 2 mL
Sample Analyzed: Whole Blood
Testing Volume: 2 mL
Pediatric Testing Volume: 1.2 mL
Do not centrifuge sample.
Transport specimen to laboratory immediately. Refrigerate specimen if not delivered immediately. Do not freeze sample.
Interpretation Type: Expected Results
Analytical measurement range for this test is 2.5 to 50.0% Jak2 V617F allele burden. Detection range is 2.5% allele burden and above.
For whole blood samples in which the Jak2 V617F allele is detected and within the analytical measurement range (AMR), a quantitative value for the mutant allele burden will be reported. If the Jak2 V617F allele burden is detected (>50.0%), a result of "Detected >50% allele burden" will be reported. If the Jak2 V617F allele is not detected or the result is below the detection range of 2.5%, a result of "Not detected" will be reported.
A result of 'Not detected" does not rule out the presence of the Jak2 V617F allele. False negative results may be due to inhibitory substances that may be present in the specimen. Inadequate specimen collection, processing and storage may invalidate test results. This test should not be used as the only criterion to form a clinical conclusion. Instead, results should be correlated with other test results, patient symptoms and clinical presentation.
The performance characteristics of this test were validated by UWHC Clinical Laboratories. 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. The UWHC Clinical Laboratories is authorized under Clinical Laboratory Improvement Amendments (CLIA) to perform high-complexity testing.
A written interpretive report is provided by the laboratory.
A professional fee is associated with this test.