APIS ESR1 dPCR Kit (RUO*)
03302
The APIS ESR1 dPCR Kit is a digital PCR (dPCR) workflow allowing for reliable detection of mutations within the oestrogen receptor (ESR1) gene. The kit detects eleven ESR1 mutations across three exons: exon 5 (E380Q), exon 7 (S463P) and exon 8 (P535H, L536R, L536Q, L536H, L536P, Y537C, Y537S, Y537N and D538G).
*For Research Use Only (RUO), not for use in diagnostic procedures, developed by APIS and distributed by Biocartis NV. Data and conclusions have not been validated by Biocartis NV.
Benefits of using APIS ESR1 dPCR Kit
- Wide target coverage – designed to cover 11 ESR1 Mutations
- High sensitivity – all mutations are detected at ≤ 0.1% MAF
- High specificity – clamp & blocking technology to ensure no WT detection
- Instrument agnostic – compatible with most digital PCR systems
Analytical Sensitivity
The Limit of Detection (LoD) was established for each target using samples contrived with wild-type (WT) and mutant DNA at 0.1% mutant allele frequency (MAF). A total of 6 replicates were generated per target, across one instrument and two kit lots. The LoD was defined as the highest MAF with 100% correct calls.