title: [Value of Immunohistochemical Methods in Detecting EML4-ALK Fusion Mutations: A Meta-analysis].
abstract: OBJECTIVE
  The fusion between echinoderm microtubule-associated protein 4 (EML4) and anaplastic lymphatic tumor kinase (ALK) rearrangement is present in approximately 5% of non-small cell lung cancer (NSCLC) patients. It has been regarded as another new target gene after epidermal growth factor receptor (EGFR) and K-ras. Figures showed that the disease control rate could reach up to 80% in NSCLC patients with EML4-ALK fusion gene after treated with ALK inhibitors. Thus, exploring an accurate and rapid detecting method is the key in screening NSCLC patients with EML4-ALK expressions. The aim of this study is to analyze the specificity and sensitivity of IHC in detecting EML4-ALK fusion mutations. To evaluate the accuracy and clinical value of this method, and then provide basis for individual molecular therapy of NSCLC patients.
  
  
  METHODS
  Using Pubmed database to search all documents required. The deadline of retrieval was February 25, 2015. Then further screening the articles according to the inclusion and exclusion criteria. Using diagnostic test meta-analysis methods to analyze the sensitivity and specificity of the immunohistochemistry (IHC) method compared with fluorescence in situ hybridization (FISH) method.
  
  
  RESULTS
  Eleven literatures were added into the meta analysis, there were 3,234 of total cases. The diagnostic odds ratio (DOR) was 1,135.00 (95%CI: 337.10-3,821.46); the area under curve (AUC) of summary receiver operating characteristic curve (SROC) curve was 0.992,3 (SEAUC=0.003,2), the Q* was 0.964,4 (SEQ*=0.008,7).
  
  
  CONCLUSIONS
  Immunohistochemical detection of EML4-ALK fusion gene mutation with specific antibody is feasible. It has high sensitivity and specificity. IHC can be a simple and rapid way in screening EML4-ALK fusion gene mutation and exhibits important clinical values.
authors.affiliation: Department of Medical Oncology, Tianjin Medical University General Hospital, Tianjin 300052, China.
authors.forename: Chang
authors.initials: C
authors.lastname: Liu
authors.affiliation: Department of Medical Oncology, Tianjin Medical University General Hospital, Tianjin 300052, China.
authors.forename: Lu
authors.initials: L
authors.lastname: Cai
authors.affiliation: Department of Medical Oncology, Tianjin Medical University General Hospital, Tianjin 300052, China.
authors.forename: Diansheng
authors.initials: D
authors.lastname: Zhong
authors.affiliation: Tianjin Lung Cancer  Institute, Tianjin Medical University General Hospital, Tianjin 300052, China.
authors.forename: Jing
authors.initials: J
authors.lastname: Wang
mesh_terms: D006801:Humans; D007150:Immunohistochemistry / Q000379:methods*; D017404:In Situ Hybridization, Fluorescence; D008175:Lung Neoplasms / Q000235:genetics* / Q000378:metabolism / Q000473:pathology; D009154:Mutation; D015514:Oncogene Proteins, Fusion / Q000235:genetics* / Q000378:metabolism; D012680:Sensitivity and Specificity
chemical_list: C522504:EML4-ALK fusion protein, human; D015514:Oncogene Proteins, Fusion