NPM (Exon 12) Mutation Analysis, Cell-based

NPM (Exon 12) Mutation Analysis, Cell-based

Test Code

16158
81310
CPT Code is subject to a Medicare Limited Coverage Policy and may require a signed ABN when ordering.
16158
81310
CPT Code is subject to a Medicare Limited Coverage Policy and may require a signed ABN when ordering.
Not offered in Quest Diagnostics Nichols Institute (IFD) – San Juan Capistrano. Please provide SERVICE AREA INFORMATION to find available tests you can order.
In-home collection may be available in your area for purchase through Quest Mobile.

Clinical Significance

NPM (Exon 12) Mutation Analysis, Cell-based - Acute Myeloid Leukemia (AML) is a clinically heterogeneous disease. Recurrent cytogenetic abnormalities help define subgroups with different prognosis and identify patients whom might benefit from targeted therapies. However, almost half adults AML cases display a normal karyotype by conventional cytogenetics, and the clinical and molecular features of this large subgroup of patients are poorly understood. The NPM exon 12 mutation can serve as predictor in AML cases with a normal karyotype, good response to induction chemotherapy and as a marker for monitoring of minimal residual disease. NPM exon 12 mutations are AML-specific since they are not detected in normal cells or other neoplasms.

Test Resources

None found for this test
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Test Details

Methodology

Next Generation Sequencing

Assay Category

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.

Reference Range(s)

Not detected

Alternative Name(s)

Acute Myeloid Leukemia (AML),Nucleophosmin

LOINC® Codes, Performing Laboratory

Service Area must be determined

Methodology

Next Generation Sequencing
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.

Reference Range(s)

Not detected

Alternative Name(s)

Acute Myeloid Leukemia (AML),Nucleophosmin
Service Area must be determined

Preferred Specimen(s)

3 mL whole blood collected in an EDTA (lavender-top) tube

Alternative Specimen(s)

3 mL bone marrow submitted in an EDTA (lavender-top) tube • Formalin-fixed paraffin embedded tissue • Cell pellet

Minimum Volume

1 mL

Collection Instructions

Whole blood (preferred): Collect 3-5 mL whole blood samples in EDTA tube. Blood samples are shipped at room temperature or 4° C. Do not freeze whole blood. Record the draw time and date on the tube. Ship immediately to maintain sample stability.

Cell Pellet: This assay is also designed for the remnant cell pellet from Cytogenetics. The cell pellet usually fixed should be transported at room temperature or refrigerated to the laboratory as soon as possible. Please provide a copy of the Cytogenetics report.

Transport Container

EDTA (lavender-top) tube

Transport Temperature

Whole blood, bone marrow and formalin-fixed paraffin embedded tissue: Room temperature
Cell pellet: Refrigerated

Specimen Stability

  • Whole blood or bone marrow
  • Room temperature: 7 days
  • Refrigerated: 7 days
  • Frozen: Do not freeze
  •  
  • Formalin-fixed paraffin embedded tissue
  • Room temperature: Indefinite
  • Refrigerated: Indefinite
  • Frozen: Do not freeze
  •  
  • Cell pellet
  • Room temperature: 7 days
  • Refrigerated: 30 days
  • Frozen: 30 days

Reject Criteria

Received frozen

Setup Schedule

Service Area must be determined
3 mL whole blood collected in an EDTA (lavender-top) tube
3 mL bone marrow submitted in an EDTA (lavender-top) tube • Formalin-fixed paraffin embedded tissue • Cell pellet
1 mL
Whole blood (preferred): Collect 3-5 mL whole blood samples in EDTA tube. Blood samples are shipped at room temperature or 4° C. Do not freeze whole blood. Record the draw time and date on the tube. Ship immediately to maintain sample stability.

Cell Pellet: This assay is also designed for the remnant cell pellet from Cytogenetics. The cell pellet usually fixed should be transported at room temperature or refrigerated to the laboratory as soon as possible. Please provide a copy of the Cytogenetics report.
EDTA (lavender-top) tube
Whole blood, bone marrow and formalin-fixed paraffin embedded tissue: Room temperature
Cell pellet: Refrigerated
Whole blood or bone marrow
Room temperature: 7 days
Refrigerated: 7 days
Frozen: Do not freeze

Formalin-fixed paraffin embedded tissue
Room temperature: Indefinite
Refrigerated: Indefinite
Frozen: Do not freeze

Cell pellet
Room temperature: 7 days
Refrigerated: 30 days
Frozen: 30 days
Received frozen
Service Area must be determined
Not offered in Quest Diagnostics Nichols Institute (IFD) – San Juan Capistrano. Please provide SERVICE AREA INFORMATION to find available tests you can order.
In-home collection may be available in your area for purchase through Quest Mobile.
Test Details

Clinical Significance

Test Resources

Reference ranges are provided as general guidance only. To interpret test results use the reference range in the laboratory report.

The CPT codes provided are based on AMA guidance and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

This material contains content from LOINC® (http://loinc.org). The LOINC Table, LOINC Table Core are copyright © 1995-2019, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and is available at no cost under the license at http://loinc.org/license.

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