title: Results of the First Italian External Quality Assurance Scheme for somatic EGFR mutation testing in non-small-cell lung cancer.
abstract: BACKGROUND
  The Italian Association of Medical Oncology (AIOM) and the Italian Society of Pathology and Cytology organized an external quality assessment (EQA) scheme for EGFR mutation testing in non-small-cell lung cancer.
  
  
  METHODS
  Ten specimens, including three small biopsies with known epidermal growth factor receptor (EGFR) mutation status, were validated in three referral laboratories and provided to 47 participating centers. The participants were requested to perform mutational analysis, using their usual method, and to submit results within a 4-week time frame. According to a predefined scoring system, two points were assigned to correct genotype and zero points to false-negative or false-positive results. The threshold to pass the EQA was set at higher than 18 of 20 points. Two rounds were preplanned.
  
  
  RESULTS
  All participating centers submitted the results within the time frame. Polymerase chain reaction (PCR)/sequencing was the main methodology used (n = 37 laboratories), although a few centers did use pyrosequencing (n = 8) or real-time PCR (n = 2). A significant number of analytical errors were observed (n = 20), with a high frequency of false-positive results (n = 16). The lower scores were obtained for the small biopsies. Fourteen of 47 centers (30%) that did not pass the first round, having a score less than or equal to 18 points, used PCR/sequencing, whereas 10 of 10 laboratories, using pyrosequencing or real-time PCR, passed the first round. Eight laboratories passed the second round. Overall, 41of 47 centers (87%) passed the EQA.
  
  
  CONCLUSIONS
  The results of the EQA for EGFR testing in non-small-cell lung cancer suggest that good quality EGFR mutational analysis is performed in Italian laboratories, although differences between testing methods were observed, especially for small biopsies.
authors.affiliation: Research Department, Cell Biology and Biotherapy Unit, INT Fondazione G.Pascale, Via M. Semmola, Naples, Italy. nicnorm@yahoo.com
authors.forename: Nicola
authors.initials: N
authors.lastname: Normanno
authors.forename: Carmine
authors.initials: C
authors.lastname: Pinto
authors.forename: Gianluigi
authors.initials: G
authors.lastname: Taddei
authors.forename: Marcello
authors.initials: M
authors.lastname: Gambacorta
authors.forename: Francesca
authors.initials: F
authors.lastname: Castiglione
authors.forename: Massimo
authors.initials: M
authors.lastname: Barberis
authors.forename: Claudio
authors.initials: C
authors.lastname: Clemente
authors.forename: Antonio
authors.initials: A
authors.lastname: Marchetti
mesh_terms: D002289:Carcinoma, Non-Small-Cell Lung / Q000235:genetics* / Q000473:pathology; D066246:ErbB Receptors / Q000235:genetics*; D005500:Follow-Up Studies; D005820:Genetic Testing; D006801:Humans; D008175:Lung Neoplasms / Q000235:genetics* / Q000473:pathology; D009154:Mutation / Q000235:genetics*; D059645:Mutation Rate; D009367:Neoplasm Staging; D016133:Polymerase Chain Reaction; D011379:Prognosis; D011785:Quality Assurance, Health Care / Q000458:organization & administration*; D011786:Quality Control
chemical_list: C512478:EGFR protein, human; D066246:ErbB Receptors