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Heme Gene Panel by NGS

Important Note

This test is under Utilization Management and therefore must be ordered as a MISCELLANEOUS GENETIC TEST. All requests are reviewed and must be approved by a pathologist as part of the lab stewardship program.

Clinical System Name

Miscellaneous Genetic Test

Description

This assay is a multiplexed gene sequencing panel designed to detect mutations associated with hematologic myeloid and lymphoid disorders. Purified genomic DNA is enzymatically sheared and targeted sequences are isolated by hybrid capture probes and sequenced by using an Illumina NGS platform.

 

This assay will not detect variants if present in only a small proportion of cells in the sample. If indicated, additional testing for FLT3-ITD and CEBPA mutations for new evaluation of acute myeloid leukemia should be separately ordered.

 

This assay is not intended for post-treatment disease monitoring nor comprehensive germline evaluation and is not validated to detect all classes of genomic alterations, such as large structural events including fusions and copy alterations.

 

Single gene testing can also be ordered as a MISC genetic test.

 

Sample Requirements


Blood: 6mL in Lavender Top (EDTA); Minimum 1mL EDTA

Bone Marrow: 1-2mL in Lavender Top (EDTA); Minimum  0.5mL EDTA

Tissue, Fluids or Sorted cells: Sterile container in RPMI

Formalin-fixed paraffin embedded tissue (FFPE/PET) block

Slides: 10 unstained; Minimum 5 curls/Slides

 

Accepted:
Green Tops (Heparin), while green tops are accepted for testing, there is documentation that heparin can interfere with some PCR assays.

Extracted DNA from CLIA certified laboratory.

Formalin-fixed paraffin embedded tissue (FFPE/PET)

Tissue from curls cut from FFPE/PET blocks or stained cover-slipped slides


Unacceptable:
Specimens received beyond stability limit.
Specimens with low volume or inadequate WBC
Decalcified or unacceptable fixatives

 

Processing Instructions

Reject due to:

Spin: N

Aliquot: N

Temp: RT or 2 - 4 C (see Storage Location instructions)

Storage Location: During business hours, call Send Outs for special handling. If received after hours or on weekends, place sample in the CPA 1 refrigerator's Send Outs rack.

Optimal results are achieved when samples are received within 48 hours of collection for bone marrow and peripheral blood.

Stability

Specimen Type Temperature Time
Bone Marrow Room temp 3 d
  Refrigerated 7 d
  Frozen  

 

Availability

STAT Performed TAT
N Weekly 10 - 12 d

 

Performing Laboratory

UW / Seattle Cancer Care Alliance

Hematopathology Laboratory

825 Eastlake Avenue E., G7-800

Seattle, WA 98109

 

Phone Number: (206) 288-7060

Intake Hours: Monday - Friday 08:00 - 18:30 PST

Department

Department: Send Outs/Genetics

Phone Number: (206) 987-2563

Reference Ranges

Interpretive report provided.

Methodology

Method: Amplification of the stated genetic regions followed by sequencing using an Illumina instrument

Analytical Volume: 1.0 mL Bone Marrow

Limitations:

Send Out Instructions

Reference Test Name:

Heme Gene Panel by NGS

Reference Test Code: HCAPA
Instructions: During business hours, call Send Outs for special handling. If received after hours or on weekends, place sample in the CPA 3 refrigerator's Send Outs rack. Send Monday through Friday via Delivery Express.