公开(公告)号：WO03023371A9

公开(公告)日：2003-09-04

申请号：PCT/US0228846

申请日：2002-09-10

Applicant: QUIDEL CORP

Inventor： JEROME JEREMY ,  DAQUIPA MARK ,  JACONO BRUCE ,  BOEHRINGER HANS ,  LAMBOTTE PAUL ,  LAWRENCE PAUL J

IPC: G01N21/86 ,  G01N33/543 ,  G01N33/558 ,  G01N21/00 ,  C12M1/34

CPC classification number: G01N21/8483 ,  B01L3/5023 ,  G01N33/54386 ,  G01N33/558 ,  Y10S435/805 ,  Y10S435/823 ,  Y10S436/807 ,  Y10S436/81 ,  Y10S436/823 ,  Y10T436/25125

Abstract: A test device and method for determining the presence or absence of one or more analytes in a fluid sample, the test device including a support (14) or member bearing a mark (46)thereon, and a matrix (18) or member containing a capture zone (40). In operation, an observation area (38) in the test device becomes transparent, thereby allowing the user to view a mark that is present on a support that is disposed beneath the observation area. Typically, the mark on the underlying support is configured as a minus (-) sign. In the absence of analyte in the sample, the test device presents a negative result as a minus (-) signal. In the presence of analyte in the sample, however, the mark operates in concert with a perpendicular test line on the observation area to present a positive result as a plus (+) signal that is visible to the user.

Abstract translation: 一种用于确定流体样品中一种或多种分析物的存在或不存在的测试装置和方法，所述测试装置包括支撑件（14）或在其上具有标记（46）的构件，以及基体（18）或包含 捕获区（40）。 在操作中，测试装置中的观察区域（38）变得透明，从而允许用户观看存在于设置在观察区域下方的支撑体上的标记。 通常，底层支持上的标记被配置为减号（ - ）。 在样品中没有分析物的情况下，测试装置呈负值（-1）信号。 然而，在样品中存在分析物的情况下，标记与观察区域上的垂直测试线一致，以将正的结果呈现为使用者可见的加号（+）信号。