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NPM1 Mutation for MRD, Quantitative PCR
Test Code13694
CPT Codes
81310
Preferred Specimen
5 mL whole blood or 3 mL bone marrow collected in an EDTA (lavender-top) tube
Minimum Volume
3 mL whole blood • 1 ml bone marrow • 20 uL of 10 ng/uL extracted RNA
Other Acceptable Specimens
Whole blood or bone marrow collected in: Sodium heparin (green-top) tube • 50 uL of 10 ng/uL extracted RNA submitted in a microcentrifuge tube
Instructions
Extracted RNA: In addition, only accept extracted DNA when extraction or isolation is performed in an appropriately qualified laboratory such as a CLIA-certified laboratory or a laboratory meeting equivalent requirements as determined by the CAP and/or CMS.
Transport Temperature
Blood and bone marrow: Room temperature
RNA: Frozen
RNA: Frozen
Specimen Stability
Specimen viability decreases during transit. Send specimen to testing lab for viability determination. Do not reject.
Methodology
Polymerase Chain Reaction (PCR)
FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
Set up: Daily; Report available: 5-7 days
Clinical Significance
NPM1, encoding the nucleophosmin protein, is mutated in about 30% of the AML patients and the mutations are predominantly a 4-base insertion which causes a frameshift of the NPM1 protein to amino acid sequence 288 near the C-terminus. NPM1, Quantitative for MRD is an allele-specific qPCR assay designed to quantitatively detect the presence of the NPM1 mutation found previously as a way to assess the minimal/measurable residual disease (MRD) status after initial induction therapy for prognosis of disease progression and consideration of consolidation treatment selection.
