Oncology

CE IVD diagnostic kit enables detection and quantification of b2a2 (e13a2) and b3a2 (e14a2) BCR-ABL1 MAJOR fusion gene transcript variants. The detection is based on one-step RT-qPCR using fluorescently labelled probes. The quantification is evaluated as the copy number percentage ratio of BCR-ABL1 fusion transcripts to ABL1 reference gene transcripts. The detection and quantification of both fusion and reference gene transcripts is performed in one tube.

• kit contents – Assay BCR-ABL MAJOR/ABL, Master Mix BCR-ABL, series of calibration standards, negative control
• reverse transcriptase and quantification PCR (detection) is performed in one step in one tube
• detection of the BCR-ABL1 fusion gene in the FAM channel, ABL1 reference gene in HEX
• reaction volume 25 µl
• conversion to the International Scale (IS) using STANDARD MMR BCR-ABL MAJOR (cat. no. 3280-004)
• the calculator (MS Excel) for data evaluation facilitation provided