CHROMOGENIC HER-2/NEU GENE AMPLIFICATION ASSAY

描述：(改编自申请人的摘要)自动金字学 增强的纳米金探针已被证明对直接检测具有高度的敏感性 原位杂交探针，当与催化的 报告沉积(CARD，又称酪胺信号放大或TSA)。 将该方法用于检测SiHA细胞中的HPV-16型 已知只包含1-2个拷贝的病毒基因组比 酶检测。我们提出了一种纳米金原位显色分析方法。 乳腺癌组织中原癌基因HER-2/neu扩增的检测 标本。这是最被广泛接受的侵袭性恶性疾病的指标。 行为；拟议的化验将用于早期检测潜在的 恶性程度和单抗或赫赛汀治疗的适应证。不像 荧光原位杂交(FISH)不需要荧光光学元件 在许多病理实验室中，纳米金检测通常会产生 一种密集的黑色信号，很容易用传统的光学方法观察到 显微镜。新的试剂和程序将结合高灵敏度 利用纳米金获得限制性抗原的能力进行扩增， 只有金才有的大分子空间分辨率 探头：可以对相同的样本进行处理以定位目标 如果需要，可以在大分子水平上进行测序。 建议的商业应用：不可用

DESCRIPTION: (adapted from applicant's abstract) Autometallographically enhanced Nanogold probes have proved highly sensitive both for direct detection of in situ hybridization probes, and when used in conjunction with Catalyzed Reporter Deposition (CARD, also known as Tyramide Signal Amplification or TSA). This method was used to detect Human Papilloma virus type 16 in SiHa cells known to contain only 1-2 copies of the viral genome more reliably than enzymatic detection. We propose a Nanogold chromogenic in situ assay for the detection of amplification of the proto-oncogene Her-2/neu in breast carcinoma specimens. This is the most widely accepted indicator of aggressive malignant behavior; the proposed assay will be used for early detection of potential malignancy and indication for monoclonal antibody or Herceptin therapy. Unlike fluorescent in situ hybridization (FISH) which requires fluorescent optics not routinely available in many pathology laboratories, Nanogold detection produces a dense black signal that is readily visualized by conventional optical microscopy. The new reagents and procedures will combine the high sensitivities of amplification with the ability of Nanogold to access restricted antigens, and the macromolecular spatial resolution which is only available with gold probes: the same sample may be processed for localization of the target sequence at the macromolecular level if desired. PROPOSED COMMERCIAL APPLICATION: NOT AVAILABLE