For in vitro diagnostic use. Others ultraView SISH DNP Detection Kit IVD ultraView SISH DNP Detection Kit RTD000631 CE-IVD 05 907 136 001 5 907 136 001 05907136001 5907136001 05907136001 ULTRAVIEW SISH DNP DETECTION KIT ultraView SISH DNP Detection Kit 04015630972500 Reagents, kits 800-098 100 Tests Not Available true Ventana Medical Systems Inc’s, (Ventana) ultraView SISH DNP Detection Kit is an indirect, biotin-free system for detecting DNP labeled probes. The kit is intended to identify targets by silver in situ hybridization (ISH) in sections of formalin fixed, paraffin embedded tissue that are stained on BenchMark IHC/ISH instruments. The clinical interpretation of any staining, or the absence of staining, must be complemented by histological examination and evaluation of proper controls. Evaluation must be made by a qualified reader within the context of the patient’s clinical history and other diagnostic tests. This detection kit is intended for in vitro diagnostic (IVD) use. en The ultraView SISH DNP Detection Kit detects specific dinitrophenyl (DNP) labeled probes bound to target sequences using silver in situ hybridization (SISH) in formalinfixed, paraffin-embedded (FFPE) tissue sections. First, the section is hybridized with a DNP-labeled probe, followed by incubation with a rabbit anti-DNP antibody, which binds to the DNP hapten on the probe. A multimer solution, a goat anti-rabbit secondary antibody with a horseradish peroxidase (HRP) enzyme, is applied to detect the rabbit anti-DNP antibody. The visualization of the bound secondary antibody is accomplished with enzyme (HRP) catalyzed deposition of silver which produces a black precipitate. Silver ions (Ag+) from the Silver ISH DNP Chromogen A (Silver A) solution are reduced by hydroquinone from the Silver ISH DNP Chromogen B (Silver B) solution to metallic silver ions (Ag0). This reaction is fueled by the substrate for HRP, hydrogen peroxide (Silver C). The silver precipitate is deposited in the nuclei and the target sequence is visualized as a black dot, which is readily visualized by light microscopy. The specimen is then counterstained with Hematoxylin II for interpretation by light microscopy. The staining protocol consists of numerous steps in which reagents are incubated for predetermined times at specific temperatures. At the end of each incubation step, the BenchMark IHC/ISH instrument washes the sections to remove unbound material and applies a liquid coverslip, which minimizes the evaporation of the aqueous reagents from the slide.1 Results are interpreted using a light microscope and aid in the differential diagnosis of pathophysiological processes. For more detailed information on instrument operation, refer to the appropriate User Guide. 1. Elias JM, Gown AM, Nakamura RM, et al. Quality control in immunohistochemistry. Report of a workshop sponsored by the Biological Stain Commission. Am J Clin Pathol. 1989;92(6):836-843. en

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