PML-RARA t(15;17), Quantitative RT-PCR [14994]

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Test Code

PMLRAQ

Alias/See Also

14994

CPT Codes
81315

Preferred Specimen

5 mL whole blood or 3 mL bone marrow collected in an EDTA (lavender-top) tube

Minimum Volume

3 mL whole blood • 1 mL bone marrow • 20 uL of 10 ng/uL extracted RNA

Other Acceptable Specimens

Whole blood or bone marrow collected in: sodium heparin (green-top) tube, or ACD-B solution (yellow-top) tube • 50 uL of 10 ng/uL extracted RNA submitted in a microcentrifuge tube

Instructions

Do not reject specimens, send to laboratory for screening.

Collect 5 mL of whole blood or 3 mL bone marrow in an EDTA (lavender-top) tube. Whole blood or bone marrow is shipped at room temperature or refrigerated (cold packs). Do not freeze whole blood or bone marrow.
After collection of the sample, draw date and time, as well as sample type, must be written on the tube and included as requested information.
If the stability of the sample cannot be determined, delay in result or cancelation of test may occur. Clotted specimens are unacceptable.

Only accept extracted RNA when extraction or isolation is performed in an appropriately qualified laboratory such as a CLIA-certified laboratory or a laboratory meeting equivalent requirements as determined by the CAP and/ or CMS.

Transport Temperature

Whole blood or bone marrow: Room temperature
Extracted RNA: Refrigerated (cold packs)

Specimen Stability

Whole blood and bone marrow
Room temperature: 5 days
Refrigerated: 5 days
Frozen: Unacceptable

Extracted RNA
Room temperature: Unacceptable
Refrigerated: Preferred
Frozen: Acceptable

Methodology
Real-Time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)

FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by the FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule

Set up: Daily; Report available: 5 days

Reference Range

See Laboratory Report

Clinical Significance

This assay detects the short form (bcr3), long form (bcr1) and the variant exon 6 (bcr2) PML-RARA transcripts associated with the t(15; 17) chromosomal translocation. PML-RARA transcript levels are expressed as normalized copy number (NCN) of PML-RARA using ABL1 as internal control. The lower limit of PML-RARA + leukemia detection in this assay is dependent on the quality of RNA obtained and the cellularity of the sample. Analytic assay sensitivity is determined at 1:100,000.

Various clinical regimens combining all-trans retinoic acid (ATRA), arsenic trioxide (ATO) and anthracyclines now cure the majority of APL patients. ATRA induces APL differentiation and transient remissions. ATO targets PML through oxidation-triggered disulphide bond formation and direct binding, resulting in PML-RARA sumoylation, ubiquitylation and proteasome-mediated degradation (Lallemand-Breitenbach et al. 2012).

Performing Laboratory
Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly, VA 20153

Last Updated: December 6, 2021

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.