PMID- 11848614
OWN - NLM
STAT- MEDLINE
DCOM- 20020806
LR  - 20141120
IS  - 0091-7370 (Print)
IS  - 0091-7370 (Linking)
VI  - 32
IP  - 1
DP  - 2002 Winter
TI  - A testing algorithm for determination of HER2 status in patients with breast 
      cancer.
PG  - 3-11
AB  - The HER2 gene is amplified and overexpressed in 25-30% of breast carcinomas. 
      Assessment of HER2 status for prognosis and treatment of breast cancer patients 
      can be performed by immunohistochemistry and/or fluorescence in situ 
      hybridization (FISH). To develop a testing algorithm for HER2 in breast cancers, 
      we used FISH analysis to determine the HER2 gene copy number and immunostaining 
      to detect the p185 protein. Interlaboratory, interobserver, and intermethod 
      variabilities of immunohistochemistry were assessed. In 24 invasive breast 
      carcinomas, the indices of HER2 status obtained by FISH and by a reference 
      laboratory's DAKO HercepTest (immunostain) gave an overall concordance of 96%. 
      The reference laboratory's stained slides were re-interpreted by an in-house 
      panel of pathologists; the interpretation differed in one case. The panel's 
      interpretations were concordant with the FISH results in all 24 cases. 
      Interobserver variability for the panel's immunohistochemistry interpretations 
      was assessed using three different immunostaining methods on 70 slides. The 
      numerical (0-1+, 2+, 3+) scores showed greater variability among observers than 
      did the overall positive/negative results. One pathologist reported inconsistent 
      results in >30% of the slides evaluated. Borderline scoring of 1-2+ was reported 
      in 18 slides (23%) by at least one observer. Incongruent interobserver 
      immunohistochemistry scores, leading to different positive and negative 
      interpretations, were obtained with 5 slides (7%). The majority of consensus 
      positive cases exhibited strong membrane staining (3+). The majority of consensus 
      negative cases scored as 0. Based on these observations, we developed a testing 
      algorithm that maximizes the benefits of FISH and immunohistochemistry, providing 
      physicians with accurate results for appropriate clinical care.
FAU - Nichols, Dawn W
AU  - Nichols DW
AD  - Department of Pathology and Laboratory Medicine, Medical University of South 
      Carolina, Charleston 29425, USA.
FAU - Wolff, Daynna J
AU  - Wolff DJ
FAU - Self, Sally
AU  - Self S
FAU - Metcalf, John S
AU  - Metcalf JS
FAU - Jacobs, Donna
AU  - Jacobs D
FAU - Kneuper-Hall, Rayna
AU  - Kneuper-Hall R
FAU - Cate, John C 4th
AU  - Cate JC 4th
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Ann Clin Lab Sci
JT  - Annals of clinical and laboratory science
JID - 0410247
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
SB  - IM
MH  - *Algorithms
MH  - Breast Neoplasms/*genetics/*metabolism
MH  - Female
MH  - *Gene Dosage
MH  - *Genes, erbB-2
MH  - Humans
MH  - Immunohistochemistry
MH  - In Situ Hybridization, Fluorescence
MH  - Observer Variation
MH  - Receptor, ErbB-2/*metabolism
MH  - Single-Blind Method
EDAT- 2002/02/19 10:00
MHDA- 2002/08/07 10:01
CRDT- 2002/02/19 10:00
PHST- 2002/02/19 10:00 [pubmed]
PHST- 2002/08/07 10:01 [medline]
PHST- 2002/02/19 10:00 [entrez]
PST - ppublish
SO  - Ann Clin Lab Sci. 2002 Winter;32(1):3-11.