title: [ALK fusion gene assessment by fully automatic immunohistochemistry in non-small cell lung cancer].
abstract: OBJECTIVE
  To evaluate the sensitivity and specificity of fully automated immunohistochemistry (IHC), with comparison to FISH, in the detection of EML4-ALK rearrangement in lung adenocarcinoma (ADC); and the use of IHC as a pre-screening tool.
  
  
  METHODS
  A total of 404 paraffin-embedded NSCLC samples from surgical resections were tested by IHC with Ventana anti-ALK rabbit monoclonal antibody (D5F3) and ultrasensitive detection kit. ALK rearrangement was further confirmed by FISH.
  
  
  RESULTS
  Twenty-nine of 404 lung ADCs (7.2%) were positive for ALK by IHC. ALK positive tumor cells demonstrated strong and diffused granular cytoplasmic staining. All the ALK IHC-positive cases were confirmed to harbor ALK rearrangement by FISH. None of the ALK IHC-negative cases was FISH-positive.
  
  
  CONCLUSIONS
  IHC can effectively detect ALK rearrangement in lung cancer. It may provide a reliable and cost-effective diagnostic approach in routine pathologic laboratories for the identification of suitable candidates for ALK-targeted therapy.
authors.affiliation: Department of Pathology, Cancer Institute & Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100021, China.
authors.forename: Lei
authors.initials: L
authors.lastname: Guo
authors.affiliation: Department of Pathology, Cancer Institute & Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100021, China.
authors.forename: Xiuyun
authors.initials: X
authors.lastname: Liu
authors.affiliation: Department of Pathology, Cancer Institute & Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100021, China.
authors.forename: Tian
authors.initials: T
authors.lastname: Qiu
authors.affiliation: Department of Pathology, Cancer Institute & Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100021, China.
authors.forename: Yun
authors.initials: Y
authors.lastname: Ling
authors.affiliation: Department of Pathology, Cancer Institute & Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100021, China.
authors.forename: Ling
authors.initials: L
authors.lastname: Shan
authors.affiliation: Department of Pathology, Cancer Institute & Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100021, China. E-mail: xyq_cn@126.com.
authors.forename: Yongqiang
authors.initials: Y
authors.lastname: Xie
mesh_terms: D000230:Adenocarcinoma / Q000235:genetics* / Q000378:metabolism; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002289:Carcinoma, Non-Small-Cell Lung / Q000235:genetics* / Q000378:metabolism; D005260:Female; D015321:Gene Rearrangement; D006801:Humans; D007150:Immunohistochemistry; D017404:In Situ Hybridization, Fluorescence; D008175:Lung Neoplasms / Q000235:genetics* / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D015514:Oncogene Proteins, Fusion / Q000235:genetics* / Q000378:metabolism; D012680:Sensitivity and Specificity
chemical_list: C522504:EML4-ALK fusion protein, human; D015514:Oncogene Proteins, Fusion