PMID- 21571957
OWN - NLM
STAT- MEDLINE
DCOM- 20110712
LR  - 20141120
IS  - 1943-7722 (Electronic)
IS  - 0002-9173 (Linking)
VI  - 135
IP  - 6
DP  - 2011 Jun
TI  - A comparison of equivocal immunohistochemical results with anti-HER2/neu 
      antibodies A0485 and SP3 with corresponding FISH results in routine clinical 
      practice.
PG  - 845-51
LID - 10.1309/AJCPIP5LOO3NGDJG [doi]
AB  - HER2/neu status in breast cancer is determined by immunohistochemical analysis 
      and/or fluorescence in situ hybridization (FISH). Previous studies have found 
      widely varying sensitivities and specificities for anti-HER2/neu antibodies, 
      including recently developed rabbit monoclonal antibodies. The current 
      prospective study compared rabbit monoclonal antibody SP3 and rabbit polyclonal 
      antibody A0485 immunostaining on routinely processed consecutive cases of breast 
      carcinoma. Of 1,610 cases tested, 261 (16.2%) equivocal (2+) cases were evaluated 
      by FISH. Of 253 cases equivocal with A0485 results, 125 (49.4%) were negative 
      with SP3. In 22 (8.7%) of 253 cases equivocal with A0485, there was amplification 
      by FISH, and 3 of these cases were SP3- (0/1+). Of the 20 (14.8%) of 135 
      SP3-equivocal cases amplified by FISH, 1 case was A0485-. The reported 
      false-negative rate with A0485 is 2.8%, and the American Society of Clinical 
      Oncology/College of American Pathologists guidelines recommend a rate of less 
      than 5%. Compared with A0485, the false-negative rate with SP3 is only 0.3% 
      (3/1,156) higher, but it shows about a 50% reduction in equivocal scores, 
      reducing the need for reflex FISH testing.
FAU - Manion, Elizabeth
AU  - Manion E
AD  - Dept. of Pathology, Brigham and Women's Hospital, 75 Francis St., Boston, MA 
      02115, USA.
FAU - Hornick, Jason L
AU  - Hornick JL
FAU - Lester, Susan C
AU  - Lester SC
FAU - Brock, Jane E
AU  - Brock JE
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PL  - England
TA  - Am J Clin Pathol
JT  - American journal of clinical pathology
JID - 0370470
RN  - 0 (Antibodies)
RN  - 0 (Antibodies, Monoclonal)
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
SB  - IM
MH  - Animals
MH  - Antibodies/immunology
MH  - Antibodies, Monoclonal/immunology
MH  - Breast Neoplasms/*metabolism/pathology
MH  - Carcinoma/*metabolism/pathology
MH  - False Negative Reactions
MH  - Female
MH  - Gene Dosage
MH  - Humans
MH  - Immunohistochemistry/*methods
MH  - *In Situ Hybridization, Fluorescence
MH  - Neoplasm Invasiveness
MH  - Prospective Studies
MH  - Rabbits
MH  - Receptor, ErbB-2/genetics/immunology/*metabolism
MH  - Staining and Labeling
EDAT- 2011/05/17 06:00
MHDA- 2011/07/13 06:00
CRDT- 2011/05/17 06:00
PHST- 2011/05/17 06:00 [entrez]
PHST- 2011/05/17 06:00 [pubmed]
PHST- 2011/07/13 06:00 [medline]
AID - 135/6/845 [pii]
AID - 10.1309/AJCPIP5LOO3NGDJG [doi]
PST - ppublish
SO  - Am J Clin Pathol. 2011 Jun;135(6):845-51. doi: 10.1309/AJCPIP5LOO3NGDJG.