TRUPCR® PIK3CA mutatiedetectiekit

• CE-IVD • Reliable and sensitive detection of hotspot PIK3CA mutations (exons 7, 9, and 20) • Dual-channel detection: Mutant alleles (FAM) and Reference control (JOE/VIC) • Includes all reagents and positive/negative controls for the assay • Based on allele-specific amplification (ARMS-PCR) for high specificity • Limit of detection as low as 2.5% mutant alleles (depending on mutation) • Compatible with multiple Real-time PCR instruments:

TRUPCR® PIK3CA Kit is an in vitro diagnostic test intended for the qualitative detection of somatic mutations in exons 7, 9, and 20 of the PIK3CA gene from tumor tissue DNA (fresh, frozen, or formalin-fixed paraffin-embedded tissue) using Real-time PCR. The kit is based on allele-specific amplification (ARMS-PCR) combined with fluorescent probe detection, allowing selective amplification of mutant alleles even in a background of predominantly wild-type DNA. It can reliably detect mutations with a sensitivity as low as 2.5% mutant alleles depending on the mutation. Each reaction includes a reference control (exon 15, no known polymorphisms or mutations) to monitor DNA quality and PCR performance, ensuring accurate detection and minimizing the risk of false negatives.