t(9;22)(q34;q11.2);BCR-ABL1, Transcript Analysis
Real-Time (Quantitative), Alternate BCR/ABL Transcript (Qualitative)
Real-Time (Quantitative), Alternate BCR/ABL Transcript (Qualitative)
Indication
This test is for the detection of the t(9;22)(q34;q11.2);BCR-ABL1 fusion transcript for diagnosis and monitoring of residual disease in patients with chronic myelogenous leukemia (CML), B-lymphoblastic leukemia (B-ALL) with t(9;22) and a small subset of patients with acute myeloid leukemia (AML).
Methodology
RNA is extracted from white blood cells in bone marrow and/or peripheral blood and reverse transcribed to cDNA. Real-time PCR is performed to amplify the BCR-ABL1 fusion transcripts as well as ABL1 transcripts. Common transcript types also known as major (e13a2 (b2a2), e14a2 (b2a2)) and minor (e1a2) are detected in single tube reaction by real-time quantitative PCR. When an alternate transcript (e13a3 (b2a3), e14a3 (b3a3), e1a3, e6a2 and e19a2) is suspected, a qualitative multiplex PCR is performed, followed by capillary electrophoresis.
Test Parameters
Sensitivity is approximately 1 in 100,000 for real-time PCR and 1 in 1000 for qualitative multiplex PCR. Levels detected in peripheral blood and bone marrow samples are generally equivalent.
Turnaround Time
Five to 10 working days (Quantitative)
Five to 15 working days (Qualitative)
Sample Requirements
10–30 ml peripheral blood in lavender top (EDTA) tube, sent on wet ice
or
2–5 ml of bone marrow aspirate in lavender top (EDTA) tube, sent on wet ice
CPT Codes
81206, 81207, 81208
The CPT codes provided are based on AMA guidelines 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.
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