PMID- 15976096
OWN - NLM
STAT- MEDLINE
DCOM- 20050816
LR  - 20190722
IS  - 0009-9147 (Print)
IS  - 0009-9147 (Linking)
VI  - 51
IP  - 7
DP  - 2005 Jul
TI  - Evaluation of the quantitative analytical methods real-time PCR for HER-2 gene 
      quantification and ELISA of serum HER-2 protein and comparison with fluorescence 
      in situ hybridization and immunohistochemistry for determining HER-2 status in 
      breast cancer patients.
PG  - 1093-101
AB  - BACKGROUND: HER-2 status is generally determined by immunohistochemistry (IHC) or 
      fluorescence in situ hybridization (FISH). Both methods are only 
      semiquantitative, require a tumor sample, and can be difficult to reproduce. We 
      compared these methods with 2 quantitative approaches, one measuring HER-2 gene 
      copy number in tissue by real-time quantitative PCR (qPCR), and the other 
      measuring shed HER-2 protein in serum by ELISA in patients with metastatic 
      disease. METHODS: We analyzed 52 cases of metastatic breast cancer for which both 
      serum collected at the diagnosis of metastasis and stored primary breast tumor 
      specimens were available. The within- and between-run imprecision of real-time 
      qPCR and ELISA were evaluated according to Clinical and Laboratory Standards 
      Institute (formerly known as NCCLS) recommendations. Concordance among the 4 
      methods was assessed by calculating the kappa statistic and its 95% confidence 
      interval (95% CI). RESULTS: The CVs for within- and between-run imprecision were 
      both <10% with qPCR and ELISA. There was good agreement of results between qPCR 
      and IHC (kappa = 0.81; 95% CI, 0.64-0.99), qPCR and FISH (kappa = 0.77; 95% CI, 
      0.58-0.96), ELISA and IHC (kappa = 0.65; 95% CI, 0.41-0.89); and ELISA and FISH 
      (kappa = 0.69; 95% CI, 0.46-0.92). CONCLUSIONS: Measurements of HER-2 gene 
      expression by qPCR and of serum HER-2 protein by ELISA are highly reproducible 
      approaches for determining HER-2 status in metastatic breast cancer. In addition, 
      ELISA eliminates the need for biopsy.
FAU - Tse, Chantal
AU  - Tse C
AD  - Laboratoire de Biochimie, Hopital Tenon, Paris, France. chantal.tse@wanadoo.fr
FAU - Brault, Didier
AU  - Brault D
FAU - Gligorov, Joseph
AU  - Gligorov J
FAU - Antoine, Martine
AU  - Antoine M
FAU - Neumann, Rainer
AU  - Neumann R
FAU - Lotz, Jean-Pierre
AU  - Lotz JP
FAU - Capeau, Jacqueline
AU  - Capeau J
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Clin Chem
JT  - Clinical chemistry
JID - 9421549
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Breast Neoplasms/blood/*genetics/pathology
MH  - Cell Line, Tumor
MH  - Enzyme-Linked Immunosorbent Assay
MH  - Female
MH  - Gene Dosage
MH  - Genes, erbB-2
MH  - Humans
MH  - Immunohistochemistry
MH  - In Situ Hybridization, Fluorescence
MH  - Middle Aged
MH  - Neoplasm Metastasis
MH  - Receptor, ErbB-2/blood/*genetics
EDAT- 2005/06/25 09:00
MHDA- 2005/08/17 09:00
CRDT- 2005/06/25 09:00
PHST- 2005/06/25 09:00 [pubmed]
PHST- 2005/08/17 09:00 [medline]
PHST- 2005/06/25 09:00 [entrez]
AID - clinchem.2004.044305 [pii]
AID - 10.1373/clinchem.2004.044305 [doi]
PST - ppublish
SO  - Clin Chem. 2005 Jul;51(7):1093-101. doi: 10.1373/clinchem.2004.044305.