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    • 2. 发明授权
    • Process and materials for the rapid detection of streptococcus pneumoniae employing purified antigen-specific antibodies
    • 使用纯化抗原特异性抗体快速检测肺炎链球菌的方法和材料
    • US06824997B1
    • 2004-11-30
    • US09397110
    • 1999-09-16
    • Norman James MooreMary Kathleen FentVladimir Andrei KoulchinElena Valentin Molokova
    • Norman James MooreMary Kathleen FentVladimir Andrei KoulchinElena Valentin Molokova
    • A61K39085
    • G01N33/56944C07K16/1275G01N21/78G01N2021/752G01N2021/757G01N2021/7759G01N2333/3156G01N2400/10G01N2469/10
    • A process is disclosed for obtaining a C-polysaccharide cell wall antigen containing not more than about 10% protein from Streptococcus pneumoniae bacteria. The antigen thus obtained is conjugated to a spacer molecule, and the free end of the latter is then conjugated to a chromatographic affinity column. The column is then utilized to purify raw antibodies to S. pneumonia bacteria, thereby producing antigen-specific antibodies. A portion of such antibodies is conjugated to a labeling agent which displays a visible color change upon reaction of the antibodies with their antigenic binding partner and embedded in a first zone of an immunochromatographic assay device. Another portion of such antibodies is bound to the reaction zone of the device which has a view window. When a liquid sample, such as patient urine, cerebrospinal fluid or blood is applied to the first zone, the conjugate of antibodies and labeling agent and the sample move along a flow strip of bibulous material to the reaction zone wherein, if the sample contains S. pneumoniae or its cell wall antigen, a sandwich is formed among the labeled conjugate, the antigen and the bound antibodies and a color change is observed. The immunochromatographic assay thus performed is completed within about 15 minutes. This assay affords a basis for rapid and reliable diagnosis of various pathogenic states caused by S. pneumoniae including pneumonia, bronchitis, otitis media, sinusitis, meningitis, and secondary disease states that commonly occur when primary pneumonic infection caused by this bacterium persists undiminished over a time period of 3-5 days.
    • 公开了一种从肺炎链球菌细菌获得含有不超过约10%蛋白质的C-多糖细胞壁抗原的方法。 由此获得的抗原与间隔分子缀合,然后将后者的自由末端与色谱亲和柱结合。 然后将柱用于纯化对肺炎链球菌细菌的原始抗体,从而产生抗原特异性抗体。 这种抗体的一部分与标记试剂缀合,所述标记试剂在抗体与其抗原结合配偶体反应并在免疫色谱测定装置的第一区域中显示可见的颜色变化。 这种抗体的另一部分结合到具有视窗的装置的反应区。 当将液体样品(例如患者尿液,脑脊液或血液)施加到第一区时,抗体和标记试剂的结合物和样品沿着吸水材料的流动条移动到反应区,其中如果样品含有S 肺炎支原体或其细胞壁抗原,在标记的缀合物,抗原和结合的抗体之间形成夹心,并观察到颜色变化。 由此进行的免疫色谱测定在约15分钟内完成。 该测定为快速可靠地诊断由肺炎链球菌引起的各种致病状态的基础,包括肺炎,支气管炎,中耳炎,鼻窦炎,脑膜炎,以及通常在由该细菌引起的原发性肺炎感染持续不减退时发生的继发性疾病状态 时间为3-5天。