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    • 9. 发明授权
    • Integrated assay device and methods of production and use
    • 综合检测装置及生产和使用方法
    • US06663833B1
    • 2003-12-16
    • US09263183
    • 1999-03-05
    • James W. StaveGeorge B. Teaney, IIIWerner Kroll
    • James W. StaveGeorge B. Teaney, IIIWerner Kroll
    • G01N2100
    • G01N33/54366G01N33/5302G01N33/538G01N33/54313G01N33/558Y10T436/255
    • An assay device for the detection of analyte in a sample, methods and immunoassay formats for performing an assay with or without the device, and methods for manufacturing the device are provided. The device is a continuous liquid flow channel having a proximal and a distal end, with a detection membrane in fluid communication with the distal end of the flow channel. Interspersed between the assay buffer and detection membrane, and continuous with the liquid flow channel, are a sample delivery means, one or more reservoirs containing the reagents necessary for conducting the assay, and, optionally, mixing or incubation reservoirs for combining the sample and reagents. The geometry of the liquid flow channel regulates the flow rate of the liquids through the channel, thereby controlling incubation, mixing and reaction time. The preferred detection membrane is an immunochromatographic test strip containing immobilized reagents. The detection of labeled reagent in a particular area of the detection membrane reflects the presence or relative amount of analyte in the sample. Detection may be achieved visually. One or more liquid flow channels may be contained within a single housing for simultaneous, consecutive, or comparative sample analysis.
    • 提供了用于检测样品中分析物的测定装置,用于进行具有或不具有该装置的测定的方法和免疫测定形式以及用于制造该装置的方法。 该装置是具有近端和远端的连续液体流动通道,其中检测膜与流动通道的远端流体连通。 分散在测定缓冲液和检测膜之间并且与液体流动通道连续的是样品递送装置,一个或多个含有进行测定所必需的试剂的储存器,以及任选地混合或孵育用于组合样品和试剂的储存器 。 液体流动通道的几何形状调节通过通道的液体的流速,从而控制孵育,混合和反应时间。 优选的检测膜是含有固定化试剂的免疫色谱试纸。 在检测膜的特定区域中的标记试剂的检测反映了样品中分析物的存在或相对量。 可以在视觉上实现检测。 一个或多个液体流动通道可以包含在单个壳体内用于同时,连续或对比的样品分析。