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Test Code 76479997 BCR/ABL t(9;22) major (p210) IS, Quantitative

Performing Laboratory

Barnes-Jewish Hospital Laboratory

Methodology

The quantitative BCR/ABL assay is performed on the GeneXpert (Cepheid) platform.  RNA is extracted, converted to cDNA, and BCR/ABL and ABL cDNA targets are quantified by real-time PCR amplification. 

 

The analytical sensitivity of this assay is 0.01% BCR/ABL:ABL.  The reproducibility of this assay is such that results within 0.5 log should be considered equivalent.  

 

Testing Algorithm:

For patients who are clinically and pathologically suspected to have chronic myeloid leukemia (CML) or acute lymphoblastic leukemia (ALL) at diagnosis but have Negative results for the major (p210) BCR/ABL fusion transcript will reflex to testing for the minor (p190) BCR/ABL fusion transcript.

 

 

 

Specimen Requirements

Call Barnes-Jewish Hospital Molecular Diagnostics Laboratory at 314-454-8685 for collection instructions.
 

Forms: Molecular Diagnostic Laboratory Request for DNA Studies-Oncology in Special Instructions.

 

Specimen Type: Whole blood

Container/Tube: Lavender top

Specimen Volume: Full tube

Specimen Minimum Volume: 5 mL

Collection Instructions: Invert several times to mix blood. Clotted blood is not acceptable.

Additional Information:

1. RNA is extremely liable and subject to degradation, delay in shipping may compromise RNA viability and results.

2. Specimen cannot be frozen.

 

Specimen Type: Bone marrow

Container/Tube: Lavender top (EDTA)

Specimen Volume: 2 mL

Specimen Minimum Volume: 1 mL

Collection Instructions: Invert several times to mix bone marrow. Clotted sample is not acceptable.

Addiontional Information:

1. RNA is extremely liable and subject to degradation, delay in shipping may compromise RNA viability and results.

2. Specimen cannot be frozen.

 

 

 

 

Day(s) Test Set Up

Monday, Wednesday, and Friday

Turnaround Time:
STAT: not available
Routine: 3 to 5 business days

Reference Values

An interpretive report will be provided.

 

Literature Reference:

Branford S, Fletcher L, Cross N, et al. Desirable performance characteristics for BCR-ABL measurement on an international reporting scale to allow consistent interpretation of individual patient response and comparison of response rate between clinical trials. Blood 2008;113:3330-3338.

 

White HE, Matejschuk P, Rigsby P, et al. Establishment of the first World Health Organization International Genetic Reference Panel for quantification of BCR-ABL mRNA. Blood 2010;116:e111-117.

Test Classification and CPT Coding

81206, major (p210) fusion transcript

 

81207, minor (p190) fusion transcript—only used for patients that reflex to minor testing.  See Methodology section for details.

 

Additional Information

For BJH Laboratory Use Only
Analyte Stability:

Blood and bone marrow are stable 0 to 4 hours at ambient temperature and up to 120 hours refrigerated (72 hours for minor).

Laboratory Processing Instructions:

BCR/ABL major (p210) test performed in BJH Molecular Diagnostics

BCR/ABL minor (p190) test performed at Mayo Medical Laboratories

 

 

 

Specimen Transport Temperature

Samples must be sent at ambient or refrigerated temperatures. Do Not send frozen.