The TRUPCR® INV16 Qualitative PCR Testing Kit is a PCR‑based in vitro diagnostic assay designed for the qualitative detection of the CBFB–MYH11 fusion transcript generated by inv(16)(p13q22) or t(16;16)(p13q22) in patients with suspected or confirmed acute myeloid leukaemia (AML). The assay uses RNA extracted from EDTA whole blood or bone marrow, which is reverse‑transcribed to cDNA prior to amplification.
The kit uses a two‑step workflow consisting of reverse transcription followed by real‑time PCR using specific primers and probes targeting CBFB–MYH11 and the internal control ABL1. Amplification is monitored in real time to determine the presence or absence of the fusion transcript.
The CBFB–MYH11 fusion results from rearrangements involving chromosome 16 and is a defining genetic abnormality in a subset of AML (particularly AML‑M4Eo). This fusion disrupts core‑binding factor function and is associated with characteristic clinical and morphological features. Although generally linked to a favourable prognosis, 30–40% of patients may relapse, making rapid molecular identification clinically important.
The TRUPCR® INV16 Qualitative Kit detects the following transcript variants:
- Type A
- Type D
- Type E
