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1. 发明授权

US06312888B1 Diagnostic assay for a sample of biological fluid 失效
标题翻译：生物流体样本的诊断测定
公开(公告)号：US06312888B1
公开(公告)日：2001-11-06
申请号：US09688636
申请日：2000-10-16
申请人： Sie Ting Wong , Robert G. Hiltibran , Tung-Ming Huang , Brenda B. Calfin , Mark R. Pope , Thomas G. Schapira , Eric B. Shain , Douglas F. Young
发明人： Sie Ting Wong , Robert G. Hiltibran , Tung-Ming Huang , Brenda B. Calfin , Mark R. Pope , Thomas G. Schapira , Eric B. Shain , Douglas F. Young
IPC分类号： C12Q100
CPC分类号： G01N33/558 , G01N33/525
摘要： An article and a method for monitoring the concentration of an analyte, e. g., glucose, in blood. In one aspect, the invention involves an article comprising a multiple-layer element. In one embodiment, the article comprises: a multiple-layer element comprising: (a) a base layer (b) a cover layer, the cover layer having a first opening for venting the multiple-layer element and a second opening for receiving a biological sample; and (c) a core layer having a first major surface and a second major surface, the core layer disposed between the base layer and the cover layer, the core layer comprising a sample introduction chamber and a optical reading chamber, the first major surface of the core layer in face-to-face contact with the base layer, the second major surface of the core layer in face-to-face contact with the cover layer. The multiple-layer element of this invention allows the use of samples of blood or other biological fluids, such as interstitial fluid, to provide extremely sensitive assay results. The device has been shown to provide accurate and reproducible results with samples having volumes ranging from about 5 &mgr;L to about 20 &mgr;L. In another aspect, the invention involves a method for using the aforementioned article.
摘要翻译：用于监测分析物浓度的文章和方法，例如血糖中的葡萄糖。一方面，本发明涉及包含多层元件的制品。在一个实施例中，所述制品包括：多层元件，包括：（a）基层（b）覆盖层，所述覆盖层具有用于排出所述多层元件的第一开口和用于接收生物样品; 和（c）具有第一主表面和第二主表面的芯层，所述芯层设置在所述基底层和所述覆盖层之间，所述芯层包括样品引入室和光学读取室，所述芯层的第一主表面芯层与基层面对面接触，芯层的第二主表面与覆盖层面对面接触。本发明的多层元件允许使用血液样品或其他生物流体，例如间质液，以提供极敏感的测定结果。该装置已被证明可以提供具有约5至20微米的体积的样品的准确和可重复的结果。另一方面，本发明涉及使用上述制品的方法。

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