PML-RARA t(15;17), Quantitative, Real Time-PCR

Message

WHOLE BLOOD - DO NOT CENTRIFUGE

Test Code

14994

Alias/See Also

LAB00988

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 extracted RNA

Other Acceptable Specimens

Whole blood or bone marrow collected in: ACD-B (yellow-top) tube or sodium heparin (green-top) tube

50 uL of 10 ng/uL extracted RNA submitted in a microcentrifuge tube

Instructions:
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.

Instructions

Do not reject specimens, send to laboratory for screening. Collect 5 mL 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 cancellation of test may occur. Clotted specimens are unacceptable.

Transport Container

EDTA (lavender-top) tube

Transport Temperature

Room temperature

Specimen Stability

Whole blood & 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

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-San Juan Capistrano, CA

33608 Ortega Highway

San Juan Capistrano, CA 92675-2042

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.