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Leica Biosystems Bond Oracle HER2 IHC System Instructions for Use TA9145 EN-CE-Rev_E 18/06/2013
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5. Lewis GD, Figari I, Fendly B, Wong WL, Carter P, Gorman C, et al. Differential responses of human
tumor cell lines to anti-p185HER2 monoclonal antibodies. Cancer Immunology and Immunotherapy
1993; 37: 255-63.
6. Baselga J, Norton L, Albanell J, Kim Y-M, Mendelsohn J. Recombinant humanized anti-HER2
antibody (Herceptin
®
) enhances the antitumor activity of paclitaxel and doxorubicin against HER2/neu
overexpressing human breast cancer xenografts. Cancer Research 1998; 58: 2825-31.
7. Nakane PK and Pierce GB. Enzyme labeled antibodies: Preparations and applications for the
localization of antigens. Journal of Histochemistry and Cytochemistry. 1967; 14: 929-931.
8. Tsutsumi Y, Serizawa A and Kawai K. Enhanced polymer one-step staining (EPOS) for proliferating
cell nuclear antigen and Ki-67 antigen-applications to intraoperative frozen diagnosis. Pathology
International. 1995; 45(2): 108-115.
9. Walker RA, Bartlett JMS Dowsett M, Ellis IO, Hanby AN, Jasani B, Miller K and Pinder SE. HER2
Testing in the UK- Further Update To Recommendations. Journal of Clinical Pathology 2008
10. Dickson, RB and Lippman, ME. Genes, Oncogenes, and Hormones. Boston, Kluwer Academic Publishers, 1992.
11. Keatings, L. et al. c-erbB-2 oncoprotein expression in mammary and extramammary Paget’s disease:
an immunohistochemical study. Histopathology. 1990; 17: 234-247.
12. The National Committee for Clinical Laboratory Standards (NCCLS). Quality assurance for
immunocytochemistry; Approved guideline. NCCLS document MM4-A (1-56238-396-5) NCCLS, 940 West
Valley Road, Suite 1400, Wayne, Pennsylvania 1999; 19087-1898: USA
13. Elias JM, Gown AM, Nakamura RM, Wilbur DC, Herman GE, Jaffe ES, et al. Special Report: Quality
control in immunohistochemistry. American Journal of Clinical Pathology 1989 ;92: 836-43.
14. Press MF, Cordon-Cardo C, Slamon DJ. Expression of the HER-2/neu proto-oncogene in normal
human adult and fetal tissues. Oncogene 1990; 5: 953-62.
15. Nadji, M. and Morales, A. R. Immunoperoxidase, part I: the techniques and its pitfalls. Laboratory
Medicine 1983; 14: 767.
16. Jackson P. 2007. Quality Assurance in Immunohistochemistry. In: Immunohistochemistry, 2007
(ed. Renshaw S), PP 205-237. Scion Publishing Ltd.
17. Omata M, Liew C-T, Ashcavai M, Peters RL. Nonimmunologic binding of horseradish peroxidase to
hepatitis B surface antigen: a possible source of error in immunohistochemistry. American Journal of
Clinical Pathology 1980; 73: 626-32.
18. Bartlet JMS, Ibrahim M, et al External Quality Assurance of HER2 FISH Testing: Results of a UK
NEQAS Pilot Scheme. Journal of Clinical Pathology. 2006.
Amendments to previous issue
Branding, Additional Product Codes, Reproducibility Study.
Date of issue
18 June 2013
Symbol Identication
LOT
Batch Code
Storage
REF
Catalog number
IVD
In vitro
diagnostic
medical device
Manufacturer
Fragile
Consult
instructions for
use
Contains sufficient
for <n> tests
Use by YYYY-MM-DD
SN
Serial Number
HercepTest
™
is a trademark of, and subject to, licences held by DakoCytomation, Denmark A/S
Herceptin
®
is a trademark of Genentech, Inc. and F. Hoffmann-La Roche Ltd.