Abstract: The present invention provides biosensor test devices for measuring the presence or amount of an analyte in a biological fluid. The devices have a base plate that has an electrode system embedded therein, and a hydrophilic porous material situated on the base plate. A hydrophobic protective layer is situated on the hydrophilic porous material, and a cover is placed on the hydrophobic protective layer to complete the device. Some embodiments also use an insulating layer, which can be situated between the base layer and the hydrophilic porous material. The cover of the device has an opening present therein, situated over the electrodes, so that the electrodes communicate with the exterior of the device through the groove. The insulating layer can also have a groove situated therein, which in one embodiment is placed to align with the groove in the cover. The invention also provides methods of manufacturing the devices, and methods of using them.

Abstract: The present invention is directed novel lateral flow devices for analyzing liquid samples. The devices contain chemical test strips and are useful for testing liquids for physical properties, such as pH, specific gravity, contamination or adulteration, the presence of proteins or blood, and the like. The test strips contain a bibulous material, a filter element, a reagent pad, and in some embodiments also contain a hydrophobic member and a cover. Any fluid can be tested, for example, urine or other body fluids, environmental samples, biological samples, clinical samples, or food and beverage samples.

Abstract: Medical and environmental diagnostic devices are described and claimed. Preferred embodiments feature cup within cup configurations wherein one cup is dedicated, for the most part, to sample collection and another cup is dedicated, for the most part, to assay performance. Communication between the cups is afforded by what is believed to be a unique valve assembly and lid tandem.

Abstract: The present invention provides test devices for detecting an analyte suspected of being present in a liquid sample. The devices contain a reservoir compartment, a test compartment, and a port for a sample collection well. The devices also have a rotatable sample collection well located in the port. The device has an upper chamber for insertion of a sample applicator, an expression plate for wringing out the sample applicator and applying sample to the device, a lower chamber, and an aliquot outlet and a reservoir outlet for the movement of sample through the device. The device also contains test elements for detecting the analyte of interest. By rotating the sample collection well, the operator is able to direct distribution of collected sample in the device. Methods of using the devices and kits containing the devices are also provided.

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. The invention provides devices having a positive control area covered with an opaque, movable material, such as an ink, dye, or other material, that is moved on the device by the flow of liquid sample, thereby exposing the positive control area underneath. Using the interaction of colored signals from the positive control area and the analyte binding area, a recognizable symbol is revealed on the device that correlates with the test results, and appears as the test is conducted.

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 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.