b'Gel & Capillary | RUO AssaysGel and CapillaryBCR/ABL t(9;22) Translocation Assays Research Use Only (RUO) AssayBCR/ABL t(9;22) Translocation AssaysAssay Use Specimen RequirementsThis Research Use Only assay identifies BCR/ABL t(9;22) translocations. This assay tests complementary DNA (cDNA) template.Summary and Explanation of the TestReferencesThe master mixes are included in these assay kits used to amplify1.R Kurzrock et al., Ann. Intern. Med. 138: 819-30 (2003).complementary DNA (cDNA) produced from specimen(s), and positive2. JV Melo. Blood 88: 2375-2384 (1996).and negative RNA controls (included). Primers target an internal3. JP Radich et al., Blood 85: 2632-2638 (1995).control transcript (Abl) and p190-, p210-, and p230-type transcripts expressed from BCR-ABL1 translocations. Amplicon products can be analyzed by capillary electrophoresis or standard gel electrophoresis with ethidium bromide staining. A BCR-ABL1 translocation is indicated if just one of the 2nd round master mixes (Mix 2b, Mix 2c, Mix 3b, Mix 3c, or Mix 3d) generates product(s) of the valid size. Reagents for RNA extraction and reverse transcription are not included. This assay is compatible with all standard RNA extraction and cDNA synthesis methods. This is a qualitative assay and has not been validated for quantitative use.Background BCR/ABL translocations are associated with a variety of hematologic malignancies. The Philadelphia chromosome (Ph1) is a specific chromosomal abnormality that results from reciprocal t(9;22)(q34;ql1) chromosomal rearrangements fuse coding regions of the BCR gene, located on chromosome 22, with the ABL receptor-independent tyrosine kinase gene on chromosome 9. This assay detects and identifies the variety of p190-, p210- and p230-type transcripts produced from all known BCR/ABL translocations.Figure Legend: This figure shows the genomic organization of the BCR and ABLBCRgenes on chromosomes 22 and 9, respectively. Boxes represent exon regions ofChromosome 22the ABL (red boxes) and BCR encoding exons (other colors). The solid black line represents intron regions, which have been left incompletely spliced to assist in demarcation of the exon segments. The location of exon regions targeted by labeled and unlabeled primers are indicated by arrows. A p210-type BCR-ABL1ABLtranslocation (b3a2 junction) is depicted in the lower portion of the figure alongChromosome 9with the control ABL transcript control.BCR/ABL t(9;22) Translocationp210 Type, b3a2 junctionABL cDNA Control122'