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PML-RARA Transcript Detection for Acute Promyelocytic Leukemia, Quantitative

CPT: 81315
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Synonyms

  • 15;17 Translocation Detection by RT-PCR
  • APL

Special Instructions

Specimens must arrive in laboratory within 48 hours of collection. Indicate date and time of collection on test request form. Please direct any questions regarding this test to customer service at 800-345-4363.


Expected Turnaround Time

4 - 7 days



Specimen Requirements


Specimen

Whole blood, bone marrow, or cell pellet


Volume

3 to 5 mL whole blood or 1 to 2 mL bone marrow


Minimum Volume

3 mL whole blood or 1 mL bone marrow


Container

Lavender-top (EDTA) tube, green-top (sodium heparin) tube, or yellow-top (ACD-A) tube


Storage Instructions

Ship at room temperature. If specimen is to be stored prior to shipment, store at 2°C to 8°C.


Causes for Rejection

Specimen does not meet collection criteria; frozen whole blood, marrow, or cell pellet; leaking tube; clotted blood or marrow; grossly hemolyzed specimen or otherwise visibly degraded; contamination by another specimen; specimens containing suspicious foreign material


Test Details


Use

The translocation t(15;17) (q22;q21) is the prototype rearrangement found in the vast majority of acute promyelocytic leukemia (APL), being found in >95% of APL cases. In this chromosomal rearrangement, the retinoic acid receptor (RARA) gene on chromosome 17 is fused with the PML gene on chromosome 15. There are three common breakpoints within the PML gene, bcr1 (intron 6), bcr2 (exon 6), and bcr3 (intron 3). All breakpoints fuse a portion of the PML gene to a consistent breakpoint region within the RARA gene. This assay will detect the PML-RARA transcripts associated with the bcr1, bcr2, and bcr3 breakpoints using real-time RT-PCR in order to assist in the diagnosis and monitoring of APL. The results are reported as a normalized ratio of %PML-RARA copies/ABL1 copies. In vitro studies have indicated that this assay has an analytical sensitivity that allows for the detection of 0.001% PML-RARA/ABL1.


Limitations

Absence of a detectable rearrangement does not exclude the possibility of the presence of low levels of transcript below the level of detection of this assay, or a rearrangement outside the analyzed breakpoint regions. Fluorescence in situ hybridization (FISH) is recommended to detect rare variant breakpoints or other translocations associated with APL.


Methodology

TaqMan® quantitative polymerase chain reaction (Q-PCR)


References

Lo Coco F, Diverio D, Falini B, et al. Genetic diagnosis and molecular monitoring in the management of acute promyelocytic leukemia. Blood. 1999; 94(1):12-22.10381493

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
510840 APL(PML-RARA) Quant 510841 PML bcr1-RARA transcript % 72216-5
510840 APL(PML-RARA) Quant 510842 PML bcr2-RARA transcript % 72215-7
510840 APL(PML-RARA) Quant 510846 PML bcr3-RARA transcript % 72214-0
510840 APL(PML-RARA) Quant 510843 Interpretation: 62365-2
510840 APL(PML-RARA) Quant 510859 Background: 77202-0
510840 APL(PML-RARA) Quant 510845 Methodology: 49549-9
510840 APL(PML-RARA) Quant 510847 References: n/a
510840 APL(PML-RARA) Quant 510848 Director Review: 72486-4
510840 APL(PML-RARA) Quant 511958 PDF 80563-0

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CPT Statement/Profile Statement

The LOINC® codes are copyright © 1994-2021, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee. Permission is granted in perpetuity, without payment of license fees or royalties, to use, copy, or distribute the LOINC® codes for any commercial or non-commercial purpose, subject to the terms under the license agreement found at https://loinc.org/license/. Additional information regarding LOINC® codes can be found at LOINC.org, including the LOINC Manual, which can be downloaded at LOINC.org/downloads/files/LOINCManual.pdf