PMID- 15034001
OWN - NLM
STAT- MEDLINE
DCOM- 20040503
LR  - 20170214
IS  - 0022-1554 (Print)
IS  - 0022-1554 (Linking)
VI  - 52
IP  - 4
DP  - 2004 Apr
TI  - The use of TMA for interlaboratory validation of FISH testing for detection of 
      HER2 gene amplification in breast cancer.
PG  - 501-7
AB  - HER2 fluorescence in situ hybridization (FISH) testing for breast cancer is 
      largely limited to academic centers and commercial laboratories. As testing 
      demands increase, methods for rapid and cost-effective technical validation and 
      quality assessment will be required. Tissue microarray (TMA), a technique for 
      high-throughput biomarker evaluation, could help facilitate these needs. Our 
      objective was to assess the usefulness of TMA technology for validation of HER2 
      FISH testing. Two TMA blocks containing paired cores from 41 breast cancers were 
      constructed. HER2 FISH was performed in parallel at two institutions and the 
      results compared. One institution, with considerable HER2 FISH experience, served 
      as the reference laboratory. HER2 chromogenic in situ hybridization (CISH) and 
      immunohistochemistry (IHC) were compared to the FISH results. For positive and 
      negative results, the concordance rate between laboratories was 100%. Using kappa 
      statistical analysis to determine interobserver agreement, HER2 to chromosome 17 
      gene copy ratios showed strong agreement between laboratories with kappa = 0.85 
      (perfect agreement = 1.0). Four cases displaying low-level amplification by CISH 
      contained chromosome 17 polysomy and gene copy ratios of <2.0 by FISH. Good 
      concordance was observed between HER2 IHC and in situ hybridization testing. TMA 
      is a robust and effective method for the technical validation of HER2 FISH 
      testing and should be considered for use by quality assessment programs.
FAU - Diaz, Leslie K
AU  - Diaz LK
AD  - Department of Pathology, Feinberg School of Medicine, Northwestern University, 
      Chicago, Illinois 60611, USA. l-diaz@northwestern.edu
FAU - Gupta, Rohit
AU  - Gupta R
FAU - Kidwai, Noman
AU  - Kidwai N
FAU - Sneige, Nour
AU  - Sneige N
FAU - Wiley, Elizabeth L
AU  - Wiley EL
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PL  - United States
TA  - J Histochem Cytochem
JT  - The journal of histochemistry and cytochemistry : official journal of the 
      Histochemistry Society
JID - 9815334
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
SB  - IM
MH  - Breast Neoplasms/*metabolism
MH  - Female
MH  - Humans
MH  - Immunohistochemistry
MH  - In Situ Hybridization, Fluorescence/methods/*standards
MH  - Laboratories/*standards
MH  - Observer Variation
MH  - Receptor, ErbB-2/genetics/*metabolism
MH  - Reproducibility of Results
EDAT- 2004/03/23 05:00
MHDA- 2004/05/05 05:00
CRDT- 2004/03/23 05:00
PHST- 2004/03/23 05:00 [pubmed]
PHST- 2004/05/05 05:00 [medline]
PHST- 2004/03/23 05:00 [entrez]
AID - 10.1177/002215540405200408 [doi]
PST - ppublish
SO  - J Histochem Cytochem. 2004 Apr;52(4):501-7. doi: 10.1177/002215540405200408.