EGFR StripAssay
The Viennalab EGFR XL StripAssay identifies 30 mutations in the EGFR gene, in exons 18, 19, 20 and 21, by PCR followed by reverse hybridisation on a test strip. The EGFR mutation status determines the treatment of non-small cell lung cancer. Deletions in exon 19 and the substitution p.L858R in exon 21 predict a response to tyrosine kinase inhibitors, while p.T790M in exon 20 is the classic resistance mutation that appears during such treatment.
Automate on
DYNABLOT Heat
See the instrument that automates this assay
Quote-based, no public pricing. Add to your quote and our specialists put together a proposal with the right documentation, typically within 24 hours.
This kit in detail
- 30 EGFR mutations across exons 18, 19, 20 and 21
- Includes the exon 19 deletions, p.L858R, p.L861Q and p.T790M
- Reverse hybridisation on a test strip, read by eye
- Two-tube PCR with Amplification Mix A and B, each with its own positive control
- Taq DNA Polymerase supplied (125 U)
- 20 tests per kit, REF 5-630
The Viennalab EGFR XL StripAssay determines the EGFR mutation status of a tumour sample. The assay covers 30 mutations in exons 18, 19, 20 and 21.
Clinical background
In non-small cell lung cancer, activating EGFR mutations predict a response to tyrosine kinase inhibitors. The deletions in exon 19 and the substitution p.L858R in exon 21 together account for most activating mutations. Exon 18 contributes the p.G719 substitutions, and p.T790M in exon 20 is the resistance mutation that appears under treatment with a first or second generation inhibitor. p.L861Q in exon 21 completes the picture.
Method
The PCR is set up in two tubes, with Amplification Mix A and Amplification Mix B, so each sample yields two amplification products. Biotinylated products are hybridised to allele-specific probes immobilised as parallel lines on a test strip, detected with streptavidin-alkaline phosphatase and a colour substrate, and read by eye against the supplied Collector sheet. A positive control is supplied for each of the two mixes, along with negative controls for exons 18, 19, 20 and 21.
Sample requirements
Taq DNA Polymerase is supplied (125 U). DNA extraction reagents are not supplied; the DNA concentration has to be adjusted to 1 to 10 ng/µl. For DNA from formalin-fixed paraffin-embedded tissue, the IFU advises fluorometric quantification rather than UV photometry, which overestimates the amount of amplifiable DNA.
- Amplification Mix A (yellow cap)
- Amplification Mix B (green cap)
- Taq Dilution Buffer (transparent cap)
- Taq DNA Polymerase (5 U/µl) (red cap)
- DNAT (blue cap)
- Typing Trays
- Test Strips
- Hybridization Buffer (white cap)
- Wash Solution A (white cap)
- Conjugate Solution
- Wash Solution B
- Color Developer
- Collector™ Sheet
Datasheets and regulatory documentation
Everything your quality team needs for evaluation and procurement.
Instructions for Use
Brochure StripAssays
Frequently paired with this kit
Other assays and instruments lab teams add alongside the EGFR StripAssay.
Add this kit to your quote
Tell us the platforms and throughput you’re planning for and our specialists will put together a clear proposal with the right documentation, no public pricing, just a considered answer.
