APIS ESR1 qPCR Kit
The APIS ESR1 qPCR Kit is an advanced qPCR-based assay designed for the sensitive and precise detection of mutations in the oestrogen receptor (ESR1) gene. This qualitative test identifies 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).
The kit includes mutation-specific probes to enable highly sensitive detection of the target mutations. Additionally, it utilises PCR clamp and blocker technology, which ensures specific amplification of the mutant sequence, even in the presence of a high wild-type background.
It is suitable for use in both centralised and decentralised settings, especially for those facilities that require a testing solution without the need for additional specialised equipment e.g. NGS.
Assay Mutations and Analytical Sensitivity
The APIS ESR1 qPCR Kit detects 11 ESR1 mutations. Synthetic DNA samples were prepared at 0.5% mutant allele frequency (MAF), with a total input of 10,000 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 (Table 1).
Table 1. 11 ESR1 mutations detected by the APIS ESR1 qPCR Kit. LoD in % MAF
APIS ESR1 qPCR Kit Specifications
The kit has undergone testing as part of APIS’ unique RUO assay development pipeline, including both in silico and wet laboratory testing. As a result, researchers can depend on the kit for consistent and high-quality detection of ESR1 mutations. A positive and negative control (PC and NTC), which monitor assay set up and assay performance, are also supplied with the kit.
Table 2. Kit specification for the APIS ESR1 qPCR Kit
APIS ESR1 and PIK3CA qPCR Kits Bundle - Achieve ≤ 0.5% MAF Detection
Discover the advanced capabilities of the APIS ESR1 and PIK3CA qPCR Kits, both designed to achieve a ≤ 0.5% Limit of Detection (LoD).
The APIS ESR1 qPCR Kit is an advanced qPCR assay for the sensitive and precise detection of mutations within the oestrogen receptor gene (ESR1). The APIS ESR1 qPCR Kit is a qualitative test, detecting eleven ESR1 mutations from DNA extracted from plasma (cfDNA).
The APIS PIK3CA qPCR Kit is a real-time qualitative PCR test for the detection of the five most prevalent activating mutations in the PIK3CA gene, from DNA extracted from formalin-fixed, paraffin-embedded (FFPE) breast tumour tissue (gDNA) or blood plasma (cfDNA).
Mutations Detected by the APIS ESR1 qPCR Kit and APIS PIK3CA qPCR Kit
Table 3. The different mutations detected by both the ESR1 qPCR Kit and the PIK3CA qPCR Kit
APIS ESR1 qPCR Kit
The APIS ESR1 qPCR Kit is available as a Research Use Only (RUO) product. Not for use in diagnostic procedures.
For more information on this product please contact us and select ‘ESR1 qPCR Kit’
Ordering Information
| Product | Test Type | Kit Size | Catalogue Number | Price |
|---|---|---|---|---|
| APIS ESR1 qPCR Kit | RUO | 24 samples plus controls | 03201 (distributed by APIS) | Available upon request |
| APIS ESR1 qPCR Kit | RUO | 24 samples plus controls | 03202 (distributed by Biocartis) | Available upon request |
| APIS ESR1 Mutations Controls | RUO | 24 reactions | 02801 (distributed by APIS) | Available upon request |
| APIS ESR1 Mutations Controls | RUO | 24 reactions | 02802 (distributed by Biocartis) | Available upon request |
Biocartis distributes directly to the following countries: Austria, Belgium, Denmark, France, Germany, Greece, Hungary, Italy, Liechtenstein, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of Cyprus, Republic of Ireland, Slovenia, Spain, Sweden, Switzerland, United Kingdom, United States of America.
Biocartis distributes via local distributors to the following countries: Australia, Brazil, Bulgaria, Chile, Colombia, Croatia, Czechia, Ecuador, Estonia, Finland, Hong Kong, Israel, Jordan, Latvia, Lebanon, Lithuania, Malaysia, Mexico, New Zealand, Philippines, Qatar, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Thailand, Turkey, United Arab Emirates
Shiva Scientific is the distributor in India.
GLOBAL BIORAY TEKNOLOGI is the distributor for Indonesia.
APIS is the distributor for all other countries.
To order the APIS ESR1 qPCR Kit or to learn more about how our assay can elevate your breast cancer research capabilities, please contact us by clicking below.