Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: The present invention includes but is not limited to an analysis device having a housing, an assay strip and a seal attachable to the housing. The present invention is inserted into a specimen collection and assay container such as a urine collection and analysis cup. The housed assay strip is sealed within the collection container. If the container has a separate reservoir for testing a portion of the sample, the housed assay strip may be sealed inside the reservoir. The housing of the assay device is attachable to the seal by a variety of means, for example, by prongs, clips or glue.

Abstract: 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.

Abstract: 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.