Abstract: Medical and environmental diagnostic devices are described and claimed. Preferred embodiments feature cup (1) within cup configurations wherein one cup is dedicated, for the most part, to sample collection and another cup (2) 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 (3) and lid (7) tandem.

Abstract: The present invention is directed to devices and methods for determining the presence of analyte in a fluid sample. The devices utilize a sample collection well, an expression plate for expressing sample into the sample collection well, a plunger that drives a lance, and a test compartment containing test elements. The devices also preserve an aliquot of fluid sample in a reservoir for later confirmation testing. When the plunger is lowered into the sample collection well, a lance on the device punctures a frangible material that covers a sample outlet. When the sample outlet is thus opened, fluid sample flows from the sample collection cup to the test compartment. In one embodiment the plunger is lowered as a cap is applied to the device. The devices are useful for detecting the presence of analyte in a wide variety of fluid samples, such as saliva, oral fluids, and more. The invention also provides methods of using the devices, and kits containing the devices.

Abstract: The present invention is directed to devices and methods for determining the presence of analyte in a fluid sample. The devices utilize a sample collection well, an expression plate for expressing sample into the sample collection well, a plunger that drives a lance, and a test compartment containing test elements. The devices also preserve an aliquot of fluid sample in a reservoir for later confirmation testing. When the plunger is lowered into the sample collection well, a lance on the device punctures a frangible material that covers a sample outlet. When the sample outlet is thus opened, fluid sample flows from the sample collection cup to the test compartment. In one embodiment the plunger is lowered as a cap is applied to the device. The devices are useful for detecting the presence of analyte in a wide variety of fluid samples, such as saliva, oral fluids, and more. The invention also provides methods of using the devices, and kits containing the devices.

Abstract: Medical and environmental diagnostic devices are described and claimed. Preferred embodiments feature cup (1) within cup configurations wherein one cup is dedicated, for the most part, to sample collection and another cup (2) 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 (3) and lid (7) tandem.