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HelpTest Code IN16Q CBFB::MYH11 Inversion(16), Quantitative Detection and Minimal Disease Risk Monitoring, qRT-PCR, Varies
Shipping Instructions
1. Refrigerated specimens must arrive within 5 days of collection, and ambient specimens must arrive within 3 days of collection.
2. Collect and package specimen as close to shipping time as possible.
Necessary Information
The following information is required:
1. Pertinent clinical history
2. Date of collection
3. Specimen source (blood or bone marrow)
Specimen Required
Submit only 1 of the following specimens:
Specimen Type: Blood
Container/Tube: Lavender top (EDTA) or yellow top (ACD-B)
Specimen Volume: 10 mL
Collection Instructions:
1. Invert several times to mix blood.
2. Send whole blood specimen in original tube. Do not aliquot.
3. Label specimen as blood.
Specimen Type: Bone marrow
Container/Tube: Lavender top (EDTA) or yellow top (ACD-B)
Specimen Volume: 4 mL
Collection Instructions:
1. Invert several times to mix bone marrow.
2. Send bone marrow specimen in original tube. Do not aliquot.
3. Label specimen as bone marrow.
Forms
1. Hematopathology Patient Information (T676)
2. If not ordering electronically, complete, print, and send an Hematopathology/Cytogenetics Test Request (T726) with the specimen.
Useful For
Detection of CBFB::MYH11 gene fusion in patients recently diagnosed with acute myeloid leukemia (AML)
Minimal residual disease monitoring during the clinical and therapeutic course of patients with AML
Method Name
Quantitative Real-Time Reverse Transcription Polymerase Chain Reaction (qRT-PCR)
Reporting Name
Inv(16); CBFB-MYH11, Quant, VSpecimen Type
VariesSpecimen Minimum Volume
Blood: 8 mL; Bone marrow: 2 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Varies | Refrigerated (preferred) | 5 days | |
| Ambient | 72 hours |
Reject Due To
| Gross hemolysis | Reject |
| Bone marrow core biopsies Paraffin-embedded bone marrow clots Slides Paraffin shavings Moderately to severely clotted |
Reject |
Clinical Information
CBFB::MYH11 minimal residual disease (MRD) monitoring in patients with acute myeloid leukemia (AML) with inv(16) or t(16;16) is useful for evaluating disease response after therapy and identifying individuals with increased risk of relapse. Quantitative real-time reverse transcription polymerase chain reaction testing in neoplasms with known clonal genetic markers can achieve highly sensitive detection of neoplastic cells in peripheral blood or bone marrow specimens. It is one of the most mature technologies available for this purpose. In this assay, inversion or translocation of chromosome 16 resulting in fusion of two genes, CBFB and MYH11, will be evaluated. Quantitative results will provide physicians with an accurate and precise measurement of disease burden to guide patient intervention decisions. This assay can be used for post-therapy MRD monitoring as well as detection of CBFB::MYH11 fusion in AML patients at the time of diagnosis.
Reference Values
An interpretive report will be provided.
Day(s) Performed
Monday through Saturday
Report Available
4 to 8 daysPerforming Laboratory
Mayo Clinic Laboratories in Rochester
Test Classification
This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.CPT Code Information
81401-CBFB-MYH11