PML-RARA Detection by RT-PCR, Quantitative

2002871
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Example Reports
Detected
Not Detected

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Time Sensitive

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Additional Technical Information
Ordering Recommendation

Detect and quantitate PML-RARA fusion transcripts in patients with acute promyelocytic leukemia. Monitor minimal residual disease and assess the risk of disease relapse.

Mnemonic
PML QNT
Methodology

Reverse Transcription Polymerase Chain Reaction

Performed

RNA isolation: Sun-Sat
Assay: Sun, Tue, Thu

Reported

2-7 days

New York DOH Approval Status
This test is New York DOH approved.
Specimen Required
Patient Preparation
Collect

Lavender (EDTA) or bone marrow (EDTA). Also acceptable: RNA extracted by CLIA certified lab.

Specimen Preparation

Whole Blood: Transport 5 mL whole blood. (Min: 1 mL)
Bone Marrow: Transport 3 mL bone marrow. (Min: 1 mL)
Specimens must be received within 48 hours of collection due to lability of RNA.
Extracted RNA: Transport 40uL RNA with at least 40 ng/uL concentration (Min: 40uL). Transport RNA in a tissue transport kit (ARUP Supply #47808) available online through eSupply using ARUP Connect™ or contact ARUP Client Services at (800) 522-2787.

Storage/Transport Temperature

Whole Blood and Bone Marrow: CRITICAL REFRIGERATED. Separate specimens must be submitted when multiple tests are ordered.
Extracted RNA: CRITICAL FROZEN. Separate specimens must be submitted when multiple tests are ordered.

Unacceptable Conditions

Serum, plasma, CSF, extracted DNA, RNA extracted by a non-CLIA lab, bone core, or FFPE tissue. Specimens collected in anticoagulants other than EDTA. Severely hemolyzed or clotted specimens.

Remarks
Stability

Ambient: 1 hour; Refrigerated: 48 hours; Frozen: Unacceptable
Extracted RNA: Ambient: Unacceptable; Refrigerate: Unacceptable; Frozen: Indefinitely

Reference Interval

By report

Interpretive Data

Refer to report.

Compliance Statement B: For laboratory developed tests not using a RUO kit, and for FDA approved, cleared or 510(k) exempt assays with alterations. This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.

Note
Hotline History

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Hotline History

Date of Change
Test Name Change
Methodology
Performance/Reported Schedule
Specimen Requirements
Reference Interval
Interpretive Data
Note
CPT Code
Component Change
Other Interface Change
New Test
Inactive
02/18/2020
X
X
08/19/2019
X
X
N/A
CPT Codes

81315

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Components
Component Test Code* Component Chart Name LOINC
2002872 PML-RARA Translocation 21551-7
2002874 PML-RARA Translocation Quant 21785-1
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.
Aliases
  • AMPL' APL
  • APL MRD
  • APL Post-consolidation therapy testing
  • PML-RARA fusion types, A, B, B variant
  • PML-RARA long, short, variable types
  • PML-RARA S, L, V forms
  • PML_RARA fusion types
  • Quantitative PML
  • t(15;17)
PML-RARA Detection by RT-PCR, Quantitative