PMID- 21512768
OWN - NLM
STAT- MEDLINE
DCOM- 20120522
LR  - 20220309
IS  - 1573-7217 (Electronic)
IS  - 0167-6806 (Linking)
VI  - 132
IP  - 1
DP  - 2012 Feb
TI  - Digital image analysis of membrane connectivity is a robust measure of HER2 
      immunostains.
PG  - 41-9
LID - 10.1007/s10549-011-1514-2 [doi]
AB  - The purpose of this study was to develop and validate a new software, 
      HER2-CONNECT(TM), for digital image analysis of the human epidermal growth factor 
      receptor 2 (HER2) in breast cancer specimens. The software assesses 
      immunohistochemical (IHC) staining reactions of HER2 based on an algorithm 
      evaluating the cell membrane connectivity. The HER2-CONNECT algorithm was aligned 
      to match digital image scorings of HER2 performed by 5 experienced assessors in a 
      training set and confirmed in a separate validation set. The training set 
      consisted of 167 breast carcinoma tissue core images in which the assessors 
      individually and blinded outlined regions of interest and gave their HER2 score 
      0/1+/2+/3+ to the specific tumor region. The validation set consisted of 86 core 
      images where the result of the automated image analysis software was correlated 
      to the scores provided by the 5 assessors. HER2 fluorescence in situ 
      hybridization (FISH) was performed on all cores and used as a reference standard. 
      The overall agreement between the image analysis software and the digital 
      scorings of the 5 assessors was 92.1% (Cohen's Kappa: 0.859) in the training set 
      and 92.3% (Cohen's Kappa: 0.864) in the validation set. The image analysis 
      sensitivity was 99.2% and specificity 100% when correlated to FISH. In 
      conclusion, the Visiopharm HER2 IHC algorithm HER2-CONNECT(TM) can discriminate 
      between amplified and non-amplified cases with high accuracy and diminish the 
      equivocal category and thereby provides a promising supplementary diagnostic tool 
      to increase consistency in HER2 assessment.
FAU - Brugmann, Anja
AU  - Brugmann A
AD  - Institute of Pathology, Aalborg Hospital, Aarhus University Hospital, 
      Ladegaardsgade 3, 9100 Aalborg, Denmark. ahb@rn.dk
FAU - Eld, Mikkel
AU  - Eld M
FAU - Lelkaitis, Giedrius
AU  - Lelkaitis G
FAU - Nielsen, Soren
AU  - Nielsen S
FAU - Grunkin, Michael
AU  - Grunkin M
FAU - Hansen, Johan D
AU  - Hansen JD
FAU - Foged, Niels T
AU  - Foged NT
FAU - Vyberg, Mogens
AU  - Vyberg M
LA  - eng
PT  - Journal Article
PT  - Validation Study
DEP - 20110422
PL  - Netherlands
TA  - Breast Cancer Res Treat
JT  - Breast cancer research and treatment
JID - 8111104
RN  - EC 2.7.10.1 (ERBB2 protein, human)
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
SB  - IM
MH  - Algorithms
MH  - Area Under Curve
MH  - Breast Neoplasms/*diagnosis/metabolism
MH  - Carcinoma, Ductal, Breast/*diagnosis/metabolism
MH  - Cell Membrane/*metabolism
MH  - Female
MH  - Humans
MH  - *Image Processing, Computer-Assisted
MH  - Immunohistochemistry
MH  - In Situ Hybridization, Fluorescence
MH  - Observer Variation
MH  - Receptor, ErbB-2/*metabolism
MH  - Sensitivity and Specificity
MH  - *Software
MH  - Tissue Array Analysis
EDAT- 2011/04/23 06:00
MHDA- 2012/05/23 06:00
CRDT- 2011/04/23 06:00
PHST- 2011/02/18 00:00 [received]
PHST- 2011/04/08 00:00 [accepted]
PHST- 2011/04/23 06:00 [entrez]
PHST- 2011/04/23 06:00 [pubmed]
PHST- 2012/05/23 06:00 [medline]
AID - 10.1007/s10549-011-1514-2 [doi]
PST - ppublish
SO  - Breast Cancer Res Treat. 2012 Feb;132(1):41-9. doi: 10.1007/s10549-011-1514-2. 
      Epub 2011 Apr 22.