Unique Identifier:
ML-H027
Name on Requisition:
PML-RARA, Quant.
Product Line:
HEME
Panel Group:
PCR
Methodology
Molecular
PCR
Test Description and clinical significance
Genes
PML-RARA, Quant.
Disease:
Acute promyelocytic leukemia (APL)
PML-RARA is a fusion gene resulting from the t(15;17)(q24;q21) translocation, the hallmark of acute promyelocytic leukemia (APL). This rearrangement leads to production of the oncogenic PML-RARA fusion transcript, which blocks normal myeloid differentiation. Quantitative detection of PML-RARA transcripts by PCR is essential for diagnosis, baseline assessment, and monitoring of minimal residual disease (MRD) in APL. This assay measures PML-RARA transcript levels, enabling sensitive detection and longitudinal monitoring of treatment response and relapse.
Specimen Requirements
Preparation:
PB, BM
Collection:
At least 0.5 ml EDTA, citrate (ACD) or Heparinized whole blood or bone marrow aspirates for DNA mutations
Stability:
96hours/4 to 7 days refrigerated
Unacceptable Conditions:
Specimen submitted is in the incorrect fixative or anticoagulant. Specimen received after the stability date. Gross hemolysis. Frozen specimen. Insufficient specimen. Unlabeled. Left un-refrigerated for an extended period.
Storage & Transport
Blood or bone marrow specimens should be kept at room temperature and preferably received within 96 hrs of drawing. Samples that are 4 to 7 days old should be refrigerated. Sufficient quantity of previously extracted DNA is acceptable if stored at appropriate temperature (short term at 2–8oC or long term at -15 to -25 oC) and should be transported on ice.
CPT(s)
81315
New York Approved
NA
TAT
5
Requisition Type
Heme
Levels of Service
Full
DexS Code
Z05C3
Prefix
MI
*The CPT codes provided are for informational purposes only and are based on AMA guidelines The billing party is solely responsible for correct CPT coding.
With core values rooted in service and integrity, our leadership team sets the bar high.
We consistently strive to set the model for exactly how a reference laboratory should engage with both physicians and patients.
siParadigm is accredited by CLIA (Clinical Laboratory Improvement Amendments) and certified by CAP (College of American Pathologists).
We also hold select state licensure where required.