For in vitro diagnostic use. Others ultraView SISH DNP Detection Kit US IVD ultraView SISH DNP Detection Kit RTD001183 US-FDA 05 572 037 001 5 572 037 001 05572037001 5572037001 05572037001 ULTRAVIEW SISH DNP DETECTION KIT US ultraView SISH DNP Detection Kit 04015630970384 Reagents, kits 760-098 100 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 VENTANA Benchmark XT automated slide stainer or VENTANA BenchMark ULTRA automated slide stainer 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 dinitrophenyl (DNP) labeled probes bound to target sequences using silver in situ hybridization (SISH) in paraffin embedded 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. Figure 1 illustrates the SISH reaction. The specimen is then counterstained with Hematoxylin II for interpretation by light microscopy. en

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