Detection of BCR ABL Minor Fusion Transcripts

The t(9;22)(q34;q11.2) translocation resulting in BCR::ABL1 fusion transcripts is seen in nearly all cases of chronic myelogenous leukemia (CML) and in a subset of acute lymphoblastic leukemia/lymphoma (ALL). This assay detects and quantifies e1a2 BCR::ABL1 transcript (p190) arising from BCR breakpoints in the minor breakpoint cluster region. The assay can be used for diagnosis, classification, post-treatment monitoring and minimal residual disease detection. The test results must be interpreted in conjunction with clinical findings, hematologic data and other laboratory studies.

Total RNA is extracted from the provided sample and reverse-transcribed into complementary DNA (cDNA). Quantitative real-time multiplex PCR amplification is performed using primers designed to t(9;22)(q34;q11.2)/BCR::ABL1 fusion transcripts in leukemia. Specifically, the assay is designed to detect e1a2 involving the minor breakpoint region. Standard curves for BCR::ABL1 and the ABL1 control are included in each assay to quantify the transcripts. A normalized copy number (NCN) is calculated for each sample as #BCR::ABL1 cDNA molecules/#ABL1 cDNA molecules. The results are reported as percentage NCN also known as percentage ratio relative to the control transcript.

1. Limit of Quantification: 0.0036 %  
2. Limit of Detection: 0.0025 %
3. Analytical measurement range- BCR::ABL1 %ratio of 0.0036%–25%

Five to 10 working days 

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

81207
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