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    • 2. 发明授权
    • Diagnostic assay requiring a small sample of biological fluid
    • 诊断测定需要一小部分生物液样品
    • US6077660A
    • 2000-06-20
    • US095683
    • 1998-06-10
    • Sie Ting WongRobert G. HiltibranTung-Ming Huang
    • Sie Ting WongRobert G. HiltibranTung-Ming Huang
    • G01N33/52C12Q1/32C12Q1/54G01N33/53G01N33/543G01N33/66G01N37/00C12Q1/00A01N1/02
    • G01N33/54373G01N33/5304
    • An article and a method for monitoring the concentration of glucose in blood. In one aspect, the invention involves an article comprising a multiple-layer element utilizing reagents capable of reacting with an analyte of interest. In a preferred embodiment, the element comprises:(a) a core layer having two major surfaces, an optical reading chamber extending from a first opening in one of the two major surfaces to a second opening in the other of the two major surfaces, the core layer further having a third opening therein and a flow channel, one end of which flow channel communicates with the third opening and the other end of which flow channel communicates with the optical reading chamber;(b) a base layer in face-to-face contact with one major surface of the core layer; and(c) a cover layer in face-to-face contact with the other major surface of the core layer, the cover layer having an opening therein to vent the element.In another aspect, the invention involves a method comprising the steps of:(a) obtaining a sample of biological fluid, e.g., interstitial fluid, from the body of a patient;(b) introducing the sample to an article comprising a multiple-layer element having an optical reading chamber;(c) allowing reagents to react with an analyte of interest in the sample; and(d) measuring the concentration of analyte in the sample by means of an optical instrument.
    • 一种用于监测血液中葡萄糖浓度的文章和方法。 一方面,本发明涉及一种包含多层元件的制品,该多层元件利用能够与感兴趣的分析物反应的试剂。 在优选实施例中,元件包括:(a)具有两个主表面的芯层,从两个主表面中的一个主表面中的一个中的第一开口延伸到两个主表面中另一个中的第二开口的光学读取室, 芯层还具有第三开口和流动通道,其一端的流动通道与第三开口连通,另一端与光学读取室连通。 (b)与芯层的一个主表面面对面接触的基层; 和(c)与所述芯层的另一个主表面面对面接触的覆盖层,所述覆盖层在其中具有用于排出所述元件的开口。 在另一方面,本发明涉及一种方法,包括以下步骤:(a)从患者的身体获得生物流体样品,例如间质液; (b)将样品引入包含具有光学读取室的多层元件的制品; (c)允许试剂与样品中感兴趣的分析物反应; 和(d)通过光学仪器测量样品中分析物的浓度。
    • 5. 发明授权
    • Diagnostic assay for a sample of biological fluid
    • 生物流体样本的诊断测定
    • US06312888B1
    • 2001-11-06
    • US09688636
    • 2000-10-16
    • Sie Ting WongRobert G. HiltibranTung-Ming HuangBrenda B. CalfinMark R. PopeThomas G. SchapiraEric B. ShainDouglas F. Young
    • Sie Ting WongRobert G. HiltibranTung-Ming HuangBrenda B. CalfinMark R. PopeThomas G. SchapiraEric B. ShainDouglas F. Young
    • C12Q100
    • G01N33/558G01N33/525
    • 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.
    • 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。