Inverness Medical Switzerland Gmbh

Alere Switzerland Gmbh

Zuifen Tang

Shujiang Wu

DengFeng Xiong

Zhumin Guan

The present invention provides devices, methods and kits for detecting the presence of an analyte in a liquid sample and indicating to the user the presence or absence of the analyte through the formation of a recognizable symbol during the assay. In one embodiment, the present invention provides test strips having a matrix including a sample application zone, a reagent zone, and a detection zone. Within the detection zone are located positive and negative control areas, and an analyte binding area. The positive control area contains one or more components that exhibit a first color when dry and a second color when wetted. When the assay is conducted, the positive control area is wetted by the assay fluids and turns to a second color, thereby functioning as a positive procedural control. When analyte is present in the sample, it binds at the analyte binding area, which interacts with the positive control area to form a second recognizable symbol at the detection zone.

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Hangzhou, China

Zuifen Tang