For in vitro diagnostic use. Membrane Others HER2 neu 4B5 VENTANA IVD Breast Carcinoma VENTANA® anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody RTD001197 CE-IVD Rabbit 4B5 05999570001 VEN anti-HER2/neu (4B5) RM PAB-US EXPORT VENTANA anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody 04015630984237 Reagents, kits 790-4493 50 tests Not Available true VENTANA anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody is intended for the semi-quantitative detection of HER2 antigen in sections of formalin-fixed, paraffin-embedded normal and neoplastic breast and gastric tissue stained on a BenchMark IHC/ISH instrument.This product is indicated as an aid in the assessment of breast and gastric cancer patients for whom Herceptin® (trastuzumab) treatment is considered and for breast cancer patients for whom KADCYLA® (ado-trastuzumab emtansine) or PERJETA® (pertuzumab) treatments are being considered.This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls.This antibody is intended for in vitro diagnostic (IVD) use. en VENTANA anti-HER2 (4B5) antibody is a rabbit monoclonal antibody, which binds to HER2 in formalin-fixed, paraffin-embedded (FFPE) tissue sections. The specific antibody can be localized by either a biotin conjugated secondary antibody formulation that recognizes rabbit immunoglobulins followed by the addition of a streptavidin-horseradish peroxidase (HRP) conjugate (iVIEW DAB Detection Kit) or a secondary antibody-HRP conjugate (ultraView Universal DAB Detection Kit). The specific antibody-enzyme complex is then visualized with a precipitating enzyme reaction product. Each step is incubated for a precise time and temperature. At the end of each incubation step, the instrument washes the sections to stop the reaction and to remove unbound material that would hinder the desired reaction in subsequent steps. The instrument also applies Liquid Coverslip, which minimizes evaporation of the aqueous reagents from the specimen slide.Clinical cases should be evaluated within the context of the performance of appropriate controls. The inclusion of a positive tissue control fixed and processed in the same manner as the patient specimen is recommended (for example, a weakly positive breast or gastric carcinoma). In addition to staining with VENTANA anti-HER2 (4B5) antibody, a second slide should be stained with CONFIRM Negative Control Rabbit Ig. For the test to be considered valid, the positive control tissue should exhibit membrane staining of the tumor cells. These components should be negative when stained with CONFIRM Negative Control Rabbit Ig. In addition, it is recommended that a negative tissue control (for example, a HER2 negative breast or gastric carcinoma) be included for every batch of samples processed and run on the BenchMark IHC/ISH instrument. This negative tissue control should be stained with VENTANA anti-HER2 (4B5) antibody to ensure that the antigen enhancement and other pretreatment procedures did not create false positive staining. en