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Genetic Labs

Houston, Texas

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Medical Genetics Test Details

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BCR/ABL1 - Quantitative Analysis
Test Information: Detection and quantification of BCR/ABL1 major fusion gene transcripts resulting from t(9;22) translocation in patients with CML. This test is used for monitoring response to treatment in CML patients known to carry b2a2 or b3a2 BCR/ABL1 fusion transcripts.

Test Details
Test Code: 9065
Special Notes: For initial diagnosis or patients with no previous BCR/ABL1 testing performed, BCR/ABL1-Qualitative test (#9070) should be ordered with reflex to the BCR/ABL1-Quantitative test (#9065). Specimen must arrive in the laboratory within 24 hrs of collection.

Technical Limitations:

The analytical sensitivity is equivalent to the detection of 1 fusion transcript positive cell in a background of 1,000,000 fusion transcript negative cells.

Results of this test must always be interpreted in the context of relevant clinical and pathological data, and should not be used alone for a diagnosis of malignancy. This test is not intended to detect minimal residual disease.

Technical Information
Methodology: Total RNA was extracted from the patient's sample and reverse transcribed to cDNA. Fluorescent real-time quantitative PCR was used to measure BCR/ABL fusion transcript b2a2 and b3a2. An additional amplification of ABL gene was performed to serve as an endogenous control for RNA quality and a reference for relative quantification. IS-MMR Calibrator was used to convert the BCR/ABL1 to ABL1 relative quantification to International Scale (IS). This test can only detect BCR-ABL1 P210 transcript BCR/ABL1 (b2a2) and BCR/ABL1 (b3a2). The limit of this assay is one fusion transcript positive cell in 1,000,000 normal cells.
Sample & Shipping Information
Test Requisition: Tumor Analysis
Specimen Type: Bone Marrow
Requirements: 2-5 mL Bone Marrow (Min: 1 mL) in a EDTA (purple-top) tube(s).

Transport Temperature: Ship at ambient temperature (18-25C/64-77F).

Unacceptable Conditions: Frozen specimens.

Stability: Ambient: 24 hours; Frozen: Unacceptable

Shipping Conditions: Ship at ambient temperature (18-25C/64-77F) in an insulated container by overnight courier. Specimen should arrive in the laboratory within 24 hrs of collection. Do not heat or freeze.



Specimen Type: Leukemic Blood
Requirements: 5-10 mL Leukemic Blood (Min: 1 mL) in a EDTA (purple-top) tube(s).

Transport Temperature: Ship at ambient temperature (18-25C/64-77F).

Unacceptable Conditions: Frozen specimens.

Stability: Ambient: 24 hours; Frozen: Unacceptable

Shipping Conditions: Ship at ambient temperature (18-25C/64-77F) in an insulated container by overnight courier. Specimen should arrive in the laboratory within 24 hrs of collection. Do not heat or freeze.



Turn Around Time: 3 - 5 days
Billing Information
List Price: *For Insurance or Institutional Prices, please call.
CPT Codes: 81206x1


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