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Test Code LAB3725 clonoSEQ

Important Note

This test is under Utilization Management.  All requests are reviewed and must be approved by a Hematopathologist as part of the lab stewardship program. 

There are two ordering options:  1) Send immediately, or 2) Send only if flow cytometry results MRD negative.  If testing needs to be sent without waiting for flow cytometry results, please make this selection in Epic and email the SCH Hematopathologists (hematopathologists@seattlechildrens.org) to request the sample be sent immediately.”

Clinical System Name

clonoSEQ

Sample Requirements

Preferred Specimen: Bone Marrow

Container(s): Lavender/EDTA

Preferred Vol: >2.0 mL

Minimum Vol: >1.0 mL

 

Specimen: Fresh Peripheral Blood

Container(s): Lavender/EDTA

Preferred Vol: 2.0 mL

Minimum Vol: >2.0 mL

 clonoSEQ Test Specimen Requirements

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.

 

Off-site collection:

Stability

Specimen Type Temperature Time
Bone Marrow Room temp 4 d
  Refrigerated 7 d
  Frozen  
Peripheral Blood Room temp 4d
  Refrigerated 7d
  Frozen  

 

Availability

STAT Performed TAT
N M - F 7 - 14 d

 

Performing Laboratory

Adaptive Biotechnologies Corporation

Attention: Clinical Services

1165 Eastlake Avenue East

Seattle, WA 98109

 

Phone Number: (888) 552-8988

Intake Hours: Monday - Friday 08:00 - 17:00 PST

Department

Department: Send Outs/Genetic

Phone Number: (206) 987-2563

Methodology

Method: PCR and Next-Generation Sequencing

Analytical Volume: >2.0 mL Bone Marrow

Limitations:

Send Out Instructions

Reference Test Name: clonoSEQ
Reference Test Code: N/A
Instructions: 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. Send Monday through Friday via Delivery Express. Adaptive Biotechnologies can receive samples up until 1700 PST.

 

Description

The clonoSEQ® Clonality (ID) Test determines the clonal diversity of a sample and can also be used to identify the trackable immune receptor sequence(s) of a lymphoid clone. Diagnostic samples are typically used, but other samples with high disease load (e.g., relapse) are also acceptable.

 

clonoSEQ is an FDA-cleared in vitro diagnostic (IVD) test service for use in B-cell acute lymphoblastic leukemia and multiple myeloma patients to detect and monitor measurable residual disease (MRD) in bone marrow samples. clonoSEQ is also available for use in other lymphoid cancers and validated
sample types as a CLIA-regulated laboratory developed test (LDT) service provided by Adaptive Biotechnologies.

Reference Ranges

Interpretive report provided.