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Test Code PMLR PML/RARA Quantitative, PCR, Varies

Reporting Name

PML/RARA Quantitative, PCR

Useful For

Diagnosis of acute promyelocytic leukemia (APL)

 

Detection of residual or recurrent APL

 

Monitoring the level of promyelocytic leukemia/retinoic acid receptor alpha (PML/RARA) in APL patients

Testing Algorithm

See Acute Promyelocytic Leukemia: Guideline to Diagnosis and Follow-up in Special Instructions.

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Specimen Type

Varies


Advisory Information


This assay may not detect rare, unusual PML/RARA fusions. Therefore, if the assay is going to be used for monitoring after treatment, the test should be performed at the time of diagnosis to ensure that the test gives a positive result.



Shipping Instructions


Refrigerated specimen must arrive within 5 days (120 hours of draw), and ambient specimens must arrive within 3 days (72 hours) of draw. Draw 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: Whole blood

Container/Tube:

Preferred: EDTA (lavender top)

Acceptable: ACD (yellow top)

Specimen Volume: 10 mL

Collection Instructions:

1. Invert several times to mix blood.

2. Send specimen in original tube.

3. Label specimen as blood.

 

Specimen Type: Bone marrow

Container/Tube:

Preferred: EDTA (lavender top)

Acceptable: ACD (yellow top)

Specimen Volume: 4 mL

Collection Instructions:

1. Invert several times to mix bone marrow.

2. Send specimen in original tube.

3. Label specimen as bone marrow.


Specimen Minimum Volume

Peripheral blood: 4 mL
Bone Marrow: 2 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Varies Refrigerated (preferred) 5 days PURPLE OR PINK TOP/EDTA
  Ambient  72 hours PURPLE OR PINK TOP/EDTA

Reference Values

An interpretive report will be provided.

 

If positive, a value representing a ratio of PML-RARA fusion transcript to the control gene ABL1 expressed as a percentage will be reported.

Day(s) and Time(s) Performed

Monday through Friday

Test Classification

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the U.S. Food and Drug Administration.

CPT Code Information

81315-PML/RARalpha (t(15;17)), (PML-RARA regulated adaptor molecule 1) (eg promyelocytic leukemia) translocation analysis; all breakpoints (eg, intron 3, intron 6 and variable in exon 6), qualitative or quantitative

LOINC Code Information

Test ID Test Order Name Order LOINC Value
PMLR PML/RARA Quantitative, PCR In Process

 

Result ID Test Result Name Result LOINC Value
39469 PMLR Result No LOINC Needed
MP012 Specimen Type 31208-2
19449 Interpretation 69047-9

Reject Due To

Gross hemolysis Reject
Other Moderately to severely clotted

Method Name

Quantitative, Real-Time Polymerase Chain Reaction (PCR)

Secondary ID

84114

Forms

1. Hematopathology Patient Information (T676) in Special Instructions

2. If not ordering electronically, complete, print, and send a Hematopathology/Cytogenetics Test Request (T726) with the specimen.