For in vitro diagnostic use. Others VENTANA HER2 4B5 Rabbit Monoclonal Primary Antibody RxDx CE IVD VENTANA® HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx PID00000679 CE-IVD 09670564001 VEN HER2 (4B5) RM PAB RxDx-US EXPORT2 VEN HER2 (4B5) RM PAB RxDx-US EXPORT2 07613336208021 Reagents, kits 790-7167 Not Available Not Available Le VENTANA HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx est destiné à être utilisé en laboratoire pour la détection semi-quantitative de l’antigène HER2 par immunohis- tochimie (IHC) dans des coupes de tissus de carcinomes mammaires et gastriques fixés au formol et inclus en paraffine colorées sur un appareil BenchMark IHC/ISH.Ce dispositif IHC est indiqué comme diagnostic compagnon pour identifier les patientes atteintes d’un cancer du sein éligibles à un traitement par trastuzumab (IHC 3+ ou IHC 2+/ISH amplifié), pertuzumab (IHC 3+ ou IHC 2+/ISH amplifié), trastuzumab emtansine (IHC 3+ ou IHC 2+/ISH amplifié) ou trastuzumab deruxtecan (IHC 1+ ou IHC 2+/ISH non amplifié). Par ailleurs, ce dispositif IHC est indiqué comme diagnostic compagnon pour identifier les patients atteints de cancer gastrique pour lesquels un traitement par trastuzumab est envisagé (IHC 3+ ou IHC 2+/ISH amplifié).Ce produit doit être interprété par un anatomopathologiste qualifié, en complément d’examens histologiques, d’informations cliniques pertinentes et de contrôles adaptés. Cet anticorps est conçu pour une utilisation en diagnostic in vitro (IVD). fr VENTANA HER2 (4B5) Assay contains a rabbit monoclonal antibody, which binds to HER2 in FFPE tissue sections. The specific antibody can be localized using 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 carcinoma). In addition to staining with VENTANA HER2 (4B5) Assay, 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 a BenchMark IHC/ISH instrument. This negative tissue control should be stained with VENTANA HER2 (4B5) RxDx to ensure that the antigen enhancement and other pretreatment procedures did not create false positive staining. en