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APIS ESR1 dPCR Kit (RUO*)

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).

*APIS ESR1 dPCR 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.

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Benefits of using APIS ESR1 dPCR Kit

  1. Wide target coverage – designed to cover 11 ESR1 Mutations
  2. High sensitivity – all mutations are detected at ≤ 0.1% MAF
  3. High specificity – clamp & blocking technology to ensure no WT detection
  4. 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.

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