PMID- 27029725
OWN - NLM
STAT- MEDLINE
DCOM- 20170109
LR  - 20191210
IS  - 1950-6112 (Electronic)
IS  - 0003-3898 (Linking)
VI  - 74
IP  - 2
DP  - 2016 Mar-Apr
TI  - [Validation steps for the detection of L858R mutation in EGFR gene by real time 
      quantitative PCR].
PG  - 196-202
LID - 10.1684/abc.2016.1130 [doi]
AB  - Since January 16(th) 2010, the French legislation requires that the medical 
      laboratories must be accredited according to ISO 15189 standards. This concerned 
      all the biological medical technics, including molecular biology technics. In 
      this work, we described the validation steps by real time quantitative PCR of 
      L858R mutation in EGFR gene, frequently detected in non-small lung cancers 
      (NSCLC). Epidermal growth factor - tyrosine kinase inhibitors (EGFR-TKIs) are 
      authorized in Europe for the treatment of metastatic NSCLC after failure of, at 
      least one, prior chemotherapy. Thus, in view of accreditation of this analysis, 
      we have used the recommendation of the COFRAC (Comite francais d'accreditation) 
      and INCa (Institut national du cancer). Several parameters have been tested, such 
      as the primers, the limit of detection, and the sensitivity and specificity of 
      the method. In addition, a risk study has been evaluated. Although long and 
      fastidious, the method of validation is required to perform analysis in optimal 
      conditions to guaranty optimal results for the patients.
FAU - Saitta, Emeline
AU  - Saitta E
AD  - Unite de biologie, Departement de biologie et pathologie des tumeurs, Centre GF 
      Leclerc, Dijon, France.
FAU - Brasselet, Astrid
AU  - Brasselet A
AD  - Unite de biologie, Departement de biologie et pathologie des tumeurs, Centre GF 
      Leclerc, Dijon, France.
FAU - Cadouot, Muriel
AU  - Cadouot M
AD  - Unite de biologie, Departement de biologie et pathologie des tumeurs, Centre GF 
      Leclerc, Dijon, France.
FAU - Gibeaud, Anne
AU  - Gibeaud A
AD  - Unite de biologie, Departement de biologie et pathologie des tumeurs, Centre GF 
      Leclerc, Dijon, France.
FAU - Jourdain, Marine
AU  - Jourdain M
AD  - Unite de biologie, Departement de biologie et pathologie des tumeurs, Centre GF 
      Leclerc, Dijon, France.
FAU - Bozonnet, Didier
AU  - Bozonnet D
AD  - Unite de biologie, Departement de biologie et pathologie des tumeurs, Centre GF 
      Leclerc, Dijon, France.
FAU - Goussot, Vincent
AU  - Goussot V
AD  - Unite de biologie, Departement de biologie et pathologie des tumeurs, Centre GF 
      Leclerc, Dijon, France.
FAU - Riedinger, Jean-Marc
AU  - Riedinger JM
AD  - Unite de biologie, Departement de biologie et pathologie des tumeurs, Centre GF 
      Leclerc, Dijon, France.
FAU - Lizard, Sarab
AU  - Lizard S
AD  - Unite de biologie, Departement de biologie et pathologie des tumeurs, Centre GF 
      Leclerc, Dijon, France.
LA  - fre
PT  - Journal Article
PT  - Validation Study
TT  - Validation de methode de la recherche de la mutation L858R par PCR en temps reel 
      utilisant les sondes fluorescentes Taqman(R) dans les cancers bronchiques non a 
      petites cellules.
PL  - France
TA  - Ann Biol Clin (Paris)
JT  - Annales de biologie clinique
JID - 2984690R
RN  - 94ZLA3W45F (Arginine)
RN  - EC 2.7.10.1 (EGFR protein, human)
RN  - EC 2.7.10.1 (ErbB Receptors)
RN  - GMW67QNF9C (Leucine)
SB  - IM
MH  - Amino Acid Substitution/genetics
MH  - Arginine/genetics
MH  - Carcinoma, Non-Small-Cell Lung/genetics
MH  - Cells, Cultured
MH  - DNA Mutational Analysis/*methods/standards
MH  - ErbB Receptors/*genetics
MH  - Humans
MH  - Leucine/genetics
MH  - Limit of Detection
MH  - Lung Neoplasms/genetics
MH  - MCF-7 Cells
MH  - *Mutation, Missense
MH  - Real-Time Polymerase Chain Reaction/*methods/standards
MH  - Reproducibility of Results
MH  - Sensitivity and Specificity
OTO - NOTNLM
OT  - EGFR-TKIs
OT  - L858R mutation
OT  - method validation
OT  - non-small lung cancer
EDAT- 2016/04/01 06:00
MHDA- 2017/01/10 06:00
CRDT- 2016/04/01 06:00
PHST- 2016/04/01 06:00 [entrez]
PHST- 2016/04/01 06:00 [pubmed]
PHST- 2017/01/10 06:00 [medline]
AID - abc.2016.1130 [pii]
AID - 10.1684/abc.2016.1130 [doi]
PST - ppublish
SO  - Ann Biol Clin (Paris). 2016 Mar-Apr;74(2):196-202. doi: 10.1684/abc.2016.1130.