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PML-RARA Transcript Detection for Acute Promyelocytic Leukemia, Quantitative

CPT 81315
Synonyms
  • 15;17 Translocation Detection by RT-PCR
  • APL

Test Details

Methodology

TaqMan® quantitative polymerase chain reaction (Q-PCR)

Result Turnaround Time

4 - 7 days

Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.

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.

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.

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.

This test was developed and its performance characteristic determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.

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

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, yellow-top (ACD-A) tube, tan-top (K2-EDTA) tube or pink-top (K2-EDTA) 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

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
510840 APL(PML-RARA) Quant 72104-3 510841 PML bcr1-RARA transcript % 72216-5
510840 APL(PML-RARA) Quant 72104-3 510842 PML bcr2-RARA transcript % 72215-7
510840 APL(PML-RARA) Quant 72104-3 510846 PML bcr3-RARA transcript % 72214-0
510840 APL(PML-RARA) Quant 72104-3 510843 Interpretation: 62365-2
510840 APL(PML-RARA) Quant 72104-3 510859 Background: 77202-0
510840 APL(PML-RARA) Quant 72104-3 510845 Methodology: 49549-9
510840 APL(PML-RARA) Quant 72104-3 510847 References: N/A
510840 APL(PML-RARA) Quant 72104-3 510848 Director Review: 72486-4
510840 APL(PML-RARA) Quant 72104-3 511958 PDF 80563-0
Order Code510840
Order Code NameAPL(PML-RARA) Quant
Order Loinc72104-3
Result Code510841
Result Code NamePML bcr1-RARA transcript
UofM%
Result LOINC72216-5
Order Code510840
Order Code NameAPL(PML-RARA) Quant
Order Loinc72104-3
Result Code510842
Result Code NamePML bcr2-RARA transcript
UofM%
Result LOINC72215-7
Order Code510840
Order Code NameAPL(PML-RARA) Quant
Order Loinc72104-3
Result Code510846
Result Code NamePML bcr3-RARA transcript
UofM%
Result LOINC72214-0
Order Code510840
Order Code NameAPL(PML-RARA) Quant
Order Loinc72104-3
Result Code510843
Result Code NameInterpretation:
UofM
Result LOINC62365-2
Order Code510840
Order Code NameAPL(PML-RARA) Quant
Order Loinc72104-3
Result Code510859
Result Code NameBackground:
UofM
Result LOINC77202-0
Order Code510840
Order Code NameAPL(PML-RARA) Quant
Order Loinc72104-3
Result Code510845
Result Code NameMethodology:
UofM
Result LOINC49549-9
Order Code510840
Order Code NameAPL(PML-RARA) Quant
Order Loinc72104-3
Result Code510847
Result Code NameReferences:
UofM
Result LOINCN/A
Order Code510840
Order Code NameAPL(PML-RARA) Quant
Order Loinc72104-3
Result Code510848
Result Code NameDirector Review:
UofM
Result LOINC72486-4
Order Code510840
Order Code NameAPL(PML-RARA) Quant
Order Loinc72104-3
Result Code511958
Result Code NamePDF
UofM
Result LOINC80563-0