Alcon Laboratories, Inc.

Inverness Medical Switzerland Gmbh

Oakville Hong Kong Company Limited

Alere Switzerland Gmbh

Zhumin Guan

Shujiang Wu

Ying Yang

Yuchang Wu

DengFeng Xiong

Robert Thomas Hudak

Lorraine Bautista

Zuifen Tang

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.

Devices and methods for analyte assays with built-in result reporting using recognizable symbols

The present invention recognizes that sample handling devices, particularly those used for testing for substances of abuse, do not allow for a separation of the bulk sample from a sample thereof to be tested. The present invention provides such a device and methods of use. The present invention includes but is not limited to a specimen collection device that includes a chamber such that the chamber is capable of collecting a specimen. The device also includes a reservoir such that the reservoir is capable of receiving a portion of the specimen from the chamber and optionally so that the reservoir is capable of receiving a test device. The device includes a valve including a valve body and a valve plunger functionally interposed between the chamber and the reservoir that is capable of transferring at least a portion of the specimen from the chamber to the reservoir such that the chamber and the reservoir are not in direct fluid communication. The device includes a detachable handle able to engage the valve plunger. The device optionally includes a means for fluidic communication between the chamber, the valve and the reservoir.

Specimen collection container

The present invention recognizes that it can be desirable to have a sample receiving chamber integral to or engageable with a test platform, such as a test platform that includes a test strip. The sample receiving chamber is preferably separate or separable from the test platform, but that need not be the case. Preferably, a fluid flow actuating device or structure, such as a valve separates the sample receiving chamber from the test platform. The present invention provides such a device and methods of use. A first aspect of the present invention is a test device that includes a sample receiving chamber and a test platform that preferably includes a test element. The sample receiving chamber preferably engages the test platform and is optionally separable therefrom. A second aspect of the present invention is a method of detecting an analyte in a sample, including: providing a sample, contacting the sample with a test device and detecting the analyte in the sample. The test device preferably includes a sample receiving chamber and a test platform that includes a test element. Preferably, the sample receiving chamber engages the test platform and optionally the sample receiving chamber is separable from the test platform.

In line test device and methods of use

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Hangzhou, China

Zhumin Guan