APIS PIK3CA qPCR Kit (RUO*)
The APIS PIK3CA Mutations Kit is a real-time qualitative PCR test for the detection of the five most prevalent activating mutations in the PIK3CA gene, using DNA extracted from either formalin-fixed, paraffin-embedded (FFPE) breast tumour tissue (gDNA) or blood plasma (cfDNA).
The kit includes mutation-specific probes to enable highly sensitive detection of the target mutations. Additionally, it uses PCR clamp and blocker technology, which ensures specific amplification of the mutant sequence, even in the presence of a high wild-type background.
*APIS PIK3CA qPCR Kit is distributed by Biocartis NV for Research Use Only (RUO), not for use in diagnostic procedures. Data and conclusions have not been validated by Biocartis NV.
Benefits of Using APIS PIK3CA qPCR Kit
- Detects 5 PIK3CA mutations, covering > 95% of actionable mutations
- Highly sensitive detection at ≤ 0.5% mutant allele frequency (MAF)
- Designed for FFPE tumour tissue (gDNA) or plasma (cfDNA)
Assay Mutations and Analytical Sensitivity
Synthetic DNA samples were prepared at ≤ 0.5% mutant allele frequency (MAF), with a total input of 5000 copies per reaction. A total of 24 replicates were generated per target, across 2 instruments and 2 kit lots. The Limit of Detection (LoD) is based on the highest MAF with ≥ 95% correct calls observed for each target. The LoD was established at ≤ 0.5% MAF for all targets.
