/clinical/,/clinical/tools-resources/,/clinical/tools-resources/lab-test-directory/,/clinical/tools-resources/lab-test-directory/molecular-diagnostics/,

/clinical/tools-resources/lab-test-directory/molecular-diagnostics/name-68405-en.labtest

Mar 16, 2016

page

100

UWHC,UWMF,

Clinical Hub,Tools & Resources,UWHC Lab Test Directory,Molecular Diagnostics

JAK2 Mutation V617F, Quantitative, PCR, Blood

JAK2 Mutation V617F, Quantitative, PCR, Blood (HCJAK2MD) Molecular Diagnostics Lab Test

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.

Specimen: Blood

Collection Container: Lavender top

Collection Instructions:

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

Stability Ambient:

24 hours

Stability Refridgerated:

10 days

Stability Frozen:

Not acceptable

Sample Analyzed: Whole Blood

Testing Volume: 2 mL

Pediatric Testing Volume: 1.2 mL

Specimen Processing:

Do not centrifuge sample.

Specimen Transport:

Transport specimen to laboratory immediately. Refrigerate specimen if not delivered immediately. Do not freeze sample.

Interpretation:

Not detected

Interpretation Type: Expected Results

Test Limitations:

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.

Additional Information:

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.