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 (≥1.0%) but below 2.5%, a result of "Detected" will be reported. If the Jak2 V617F allele is not detected or the result is below the detection range of 1.0%, 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.
Referral Screening Flow Sheet