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HelpOrder Code PMLR PML::RARA Quantitative, PCR, Varies
Reporting Name
PML/RARA Quantitative, PCRUseful For
Diagnosis of acute promyelocytic leukemia (APL)
Detection of residual or recurrent APL
Monitoring the level of PML::RARA (promyelocytic leukemia/retinoic acid receptor alpha) in APL patients
Testing Algorithm
For more information see Acute Promyelocytic Leukemia: Guideline to Diagnosis and Follow-up
Performing Laboratory
Mayo Clinic Laboratories in Rochester
Specimen Type
VariesOrdering Guidance
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
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: Whole blood
Container/Tube:
Preferred: Lavender top (EDTA)
Acceptable: Yellow top (ACD)
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:
Preferred: Lavender top (EDTA)
Acceptable: Yellow top (ACD)
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.
Specimen Minimum Volume
Blood: 8 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 |
Special Instructions
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) Performed
Monday through Saturday
CPT Code Information
81315-PML/RAR-alpha (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
Method Description
Total RNA is extracted from blood or bone marrow and reverse transcribed to generate complementary DNA. Quantitative real-time polymerase chain reaction is performed using the LightCycler instrument platform (Roche) and the data analyzed using the dedicated software for relative quantification with calibrator normalization. Results are provided as a normalized relative value of PML::RARA/ABL1 messenger RNA (mRNA) with a reproducible analytical sensitivity of 0.003%(Unpublished Mayo method).
The normalized ratio is a relative quantification calculation as follows:
|
Normalized ratio*= |
PML::RARA (sample) ABL1 (sample) |
|
PML::RARA (calibrator) ABL1 (calibrator) |
*Where ABL1 mRNA is used to normalize variations in RNA quality and calibrator mRNA from a PML::RARA-positive cell line is used to normalize variations in run conditions.
Reject Due To
| Gross hemolysis | Reject |
| Moderately to severely clotted | Reject |
Method Name
Quantitative, Real-Time Polymerase Chain Reaction (PCR)
Forms
1. Hematopathology Patient Information (T676)
2. If not ordering electronically, complete, print, and send a Hematopathology/Cytogenetics Test Request (T726) with the specimen.