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Specimen Collection Manual and Test Catalog

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PML-RARA T(15;17), QUANTITATIVE RT-PCR

Geisinger Epic Procedure Code:  LAB1046    Geisinger Epic ID:  52109

SPECIMEN COLLECTION
Specimen type: 

Whole blood (preferred) OR bone marrow


Preferred collection container: 
Alternate collection container: 
4 mL green/green-top (sodium heparin) tube
Specimen required: 

5 mL whole blood (minimum 4 mL) collected in an EDTA (lavender-top) tube (preferred) OR 3mL bone marrow (minimum 1 mL) in EDTA or sodium heparin tube


Special notes: 

BONE MARROW MUST BE FIRST ASPIRATE! Expel excess heparin from syringe before aspirate collection to prevent dilution of sample. 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.



SPECIMEN PROCESSING
Transport temperature: 

Room temperature.


Specimen stability: 

Room temperature:5 days. Refrigerated: 5 days. Frozen: Unacceptable. Do not reject specimens. Send to laboratory for screening.


Rejection criteria: 

Clotted specimens are unacceptable.



TEST DETAILS
Additional information: 

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.


CPT code(s):  81315
Note: The billing party has sole responsibility for CPT coding.  Any questions regarding coding should be directed to the payer being billed.
The CPT codes provided by GML are based on AMA guidelines and are for informational purposes only.

Methodology: 
Real-time Reverse Transcription Polymerase Chain Reaction (RT-PCR)
Synonyms: 

Quest test code 14994, PML Qnt PCR, PML/RARA, Quantitative RT-PCR,APL,Translocation (15;17),Acute Promyelocytic Leukemia,AML(M3)


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).


Doctoral Director(s): 
Randin Nelson MD
Review Date:  11/07/2023

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