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Detects reliably below 0.1% mutant DNA by real-time PCR

QClamp® EGFR Mutation Test

The QClamp® EGFR Mutation Test in Codons Ex19 Del, Codons 719, 790, 858, & 861 is a real-time PCR assay for the detection of somatic mutations in and near EGFR codon 719 in Exon 18, Exon 19 deletions, codon 790 in Exon 20 and codon 858 and codon 861 in Exon 21, in the human EGFR (epidermal growth factor receptor) gene, using purified DNA extracted from FFPE (formalin fixed paraffin embedded), cells or tissue. The kit identifies the presence or absence of mutations in the targeted regions but does not specify the exact nature of the mutation. The codon specific detection kits are designed to detect any mutation at or near the stated codon site without specifying the exact nucleotide change.

HIGHLIGHTS

• Sample Ready: Suitable FFPE, cell or tissue
• Ultra-Sensitive: Detects below 0.1% mutant DNA by real-time PCR
• Rapid: Streamlined workflow with less than 4 hours turnaround time
• Versatile: Works with most PCR machines
• Reproducible: Robust XNA-PCR technology minimizing variability

List of mutations and cosmic identities found in EGFR

Exon Amino Acid Change Nucleotide change Cosmic No.
2 G719>A c.2156G>C 6239
G719>S c.2155G>A 6252
G719>C c.2155G>T 6253
19 E746_A750del c.2235_2249 del 15 6223
E746_T751>I c.2235_2252 > AAT 13551
E746_T751del c.2236_2253 del 18 12728
E746_T751>A  c.2237_2251 del 15 12678
E746_S752>A c.2237_2254 del 18 12367
E746_S752>V c.2237_2255>T 12384
E746_A750del c.2236_2250 del 15 6225
E746_S752>D c.2238_2255 del 18 6220
L747_A750>P c.2238_2248 >GC 12422
L747_T751>Q c.2238_2252 >GCA 12419
L747_E749del c.2239_2247 del 9 6218
L747_T751del c.2239_2253 del 15 6254
L747_S752del c.2239_2256 del 18 6255
L747_ A750>P c.2239_2248 TTAAGAGAAG>C 12382
L747_P753>Q  c.2239_2258 >CA 12387
L747_T751>S c.2240_2251 del 12 6210
L747_P753>S c.2240_2257 del 18 12370
L747_T751del  c.2240_2254 del 15 12369
L747_T751>P c.2239_2251>C 12383
K745_E749del  2233_2247del15 26038
S752_I759del  2253_2276del24 13556
E746_A750>IP 2235_2248>AATTC 13550
E746_T751>V  2237_2252>T 12386
E746_T751>IP  2235_2251>AATTC 13552
E746_S752>I 2235_2255>AAT 12385
E746_T751>VA 2237_2253>TTGCT 12416
E746_P753>VS  2237_2257>TCT 18427
L747_T751del 2238_2252del15 23571
L747_S752>Q  2239_2256>CAA 12403
20 T790>M c.2369C>T  6240
21 L858R2303 G>T 2573_2574TG>GTS768I 124296241
L858>R c.2573T>G  6224
L861>Q c.2582T>A 6213

Product specifications

Specification QClamp® EGFR Codon Specific Mutation Test
Intended UseFor In Vitro Diagnostic Use (CE/IVD) or For Research Use
Sample TypeFFPE, Cells or Tissues
Pack Size10 Samples, 30 Samples and 60 Samples
Validated InstrumentsABI 7500, ABI 7500FAST, ABI 7900, ABI StepOnePlus, Qiagen Rotor-Gene Q, Roche LightCycler LC96, Roche LightCycler 480 II
Detection ChannelFAM; HEX
Turnaround TimeLess than 4 hours
StabilityStable for 12 months at -25 ℃ to -15 ℃

Ordering information

Product NameCatalog # (RUO)Catalog # (CE/IVD)
QClamp® EGFR Codon Specific Mutation in Codons 719, Ex19Del, 790, 858 & 861 (10 Samples) DC-10-1038R DC-10-1038
QClamp® EGFR Codon Specific Mutation in Codons 719, Ex19Del, 790, 858 & 861 (30 Samples) DC-10-0012R DC-10-0012
QClamp® EGFR Codon Specific Mutation in Codons 719, Ex19Del, 790, 858 & 861 (60 Samples) DC-10-0011R DC-10-0011

Note: RUO (Research Use Only) products are not for use in diagnostic procedures. CE/IVD products are intended for use in diagnostic procedures.