PMID- 26551338
OWN - NLM
STAT- MEDLINE
DCOM- 20160830
LR  - 20181202
IS  - 1533-4058 (Electronic)
IS  - 1533-4058 (Linking)
VI  - 23
IP  - 10
DP  - 2015 Nov-Dec
TI  - Developing ALK Immunohistochemistry and In Situ Hybridization Proficiency Testing 
      for Non-Small Cell Lung Cancer in Canada: Canadian Immunohistochemistry Quality 
      Control Challenges and Successes.
PG  - 677-81
LID - 10.1097/PAI.0000000000000267 [doi]
AB  - Intrachromosomal rearrangements involving the ALK gene are found in 3% to 5% of 
      non-small cell lung cancers. Crizotinib is a tyrosine kinase inhibitor that has 
      been shown to prolong progression-free survival in patients with advanced 
      non-small cell lung cancer harboring ALK gene rearrangements. In Canada, ALK 
      immunohistochemistry (IHC) is used as a screening test before confirmation by 
      fluorescence in situ hybridization (FISH). Canadian Immunohistochemistry Quality 
      Control (CIQC) provides ALK (Lung Cancer) proficiency testing (PT) for Canadian 
      IHC laboratories. Samples included 32 previously characterized cases (IHC and 
      FISH) either from the Canadian ALK (CALK) project or from CIQC reference 
      laboratories. The same design was used for both runs. A total of 20 laboratories 
      participated in Run 1 and 22 in Run 2. Some laboratories participated in the 
      anticipation of future need and used the PT exercise as a part of test 
      development and validation. Results of the IHC testing were first self-reported 
      using the CIQC TMA Scorer and then evaluated by expert assessment. FISH results 
      were self-reported only. Participants also reported details about IHC and FISH 
      protocols. The kappa-values were calculated, for which values >0.80 were used as 
      acceptable results, respectively. The pass rate between the 2 runs and between 
      different primary antibodies were compared. Six of the 22 protocols (27%) in Run 
      1 and 15 of the 22 (68%) protocols in Run 2 passed the CIQC PT criteria for IHC 
      testing. The increase in the pass rate for Run 2 was significant (P=0.03, 
      Wilcoxon signed-rank test). All reported FISH results were correct. CALK 
      laboratories had significantly higher kappa-values than non-CALK laboratories 
      (P=0.002, t test). PT for IHC for rare diseases such as ALK-positive lung cancer 
      is feasible, but challenging. The academic nature of the CIQC program and 
      collaboration on a national level facilitated the development of appropriate PT 
      samples. Participating laboratories made use of the PT exercise either to confirm 
      that their testing was properly calibrated or to improve their protocols, which 
      was confirmed by the achievement of significantly better results in Run 2. They 
      also used CIQC's PT program for new test development and optimization.
FAU - Cheung, Carol C
AU  - Cheung CC
AD  - *Laboratory Medicine Program, University Health Network, University of Toronto, 
      Toronto double daggerDepartment of Pathology and Molecular Medicine, McMaster University, 
      Hamilton, ON daggerCanadian Immunohistochemistry Quality Control  section signDepartment of 
      Pathology, Vancouver General Hospital, University of British Columbia, Vancouver, 
      BC, Canada.
FAU - Garratt, John
AU  - Garratt J
FAU - Won, Jennifer
AU  - Won J
FAU - Cutz, Jean-Claude
AU  - Cutz JC
FAU - Gilks, Blake C
AU  - Gilks BC
FAU - Tsao, Ming
AU  - Tsao M
FAU - Torlakovic, Emina E
AU  - Torlakovic EE
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Appl Immunohistochem Mol Morphol
JT  - Applied immunohistochemistry & molecular morphology : AIMM
JID - 100888796
RN  - EC 2.7.10.1 (ALK protein, human)
RN  - EC 2.7.10.1 (Anaplastic Lymphoma Kinase)
RN  - EC 2.7.10.1 (Receptor Protein-Tyrosine Kinases)
SB  - IM
MH  - Anaplastic Lymphoma Kinase
MH  - Carcinoma, Non-Small-Cell Lung/*enzymology/*pathology
MH  - Female
MH  - Humans
MH  - Immunohistochemistry/standards
MH  - In Situ Hybridization/standards
MH  - Lung Neoplasms/*enzymology/*pathology
MH  - Male
MH  - Quality Control
MH  - Receptor Protein-Tyrosine Kinases/*metabolism
EDAT- 2015/11/10 06:00
MHDA- 2016/08/31 06:00
CRDT- 2015/11/10 06:00
PHST- 2015/11/10 06:00 [entrez]
PHST- 2015/11/10 06:00 [pubmed]
PHST- 2016/08/31 06:00 [medline]
AID - 00129039-201511000-00001 [pii]
AID - 10.1097/PAI.0000000000000267 [doi]
PST - ppublish
SO  - Appl Immunohistochem Mol Morphol. 2015 Nov-Dec;23(10):677-81. doi: 
      10.1097/PAI.0000000000000267.