Leica Biosystems Bond Oracle HER2 IHC System - Manual (Page 23)

Page 23 of 23
English
Leica Biosystems Bond Oracle HER2 IHC System Instructions for Use TA9145 EN-CE-Rev_E 18/06/2013
English
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 Identification
LOT
Batch Code Storage
REF
Catalog number
IVD
In vitro
diagnostic
medical device Manufacturer Fragile
Consult
instructions for
use Contains sufficient
for 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.