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: 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 seal, and a test compartment containing test elements. The devices also contain a reservoir for preserving an aliquot of sample for later confirmation testing. When the plunger is lowered into the sample collection well, an aliquot of sample is sealed in the reservoir. 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. The invention also provides methods of using the devices, and kits containing the devices.

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 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 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 is directed to devices and methods for collecting liquid samples and of testing the sample for the presence of an analyte of interest and/or a physical property. In one embodiment the device is a urine cup having an interior for containing a liquid sample, a lid, and a chamber for holding liquid. The device contains a test component for determining the presence of an analyte in the liquid sample and/or a physical property. A tube is immersed in liquid sample when the device is filled with liquid sample to be tested. When the lid is applied to the device (e.g., by screwing or snapping on), liquid sample is forced through the tube and into the chamber holding the test component.

Abstract: Disclosed is a device for collecting a fluid specimen. The device comprises a container that can receive a fluid specimen; a plunger movably positioned within the container, wherein the plunger can move from an initial position at an upper region of the container to a secondary position below the first position; a fluid segregation chamber that can receive a portion of the fluid specimen from the container, wherein any fluid in the segregation chamber is segregated from the fluid specimen in the container; a fluid flow lumen that provides a passageway for at least a portion of the fluid specimen to flow into the fluid segregation chamber, wherein a first end of the passageway has a first opening that opens into the fluid segregation chamber and a second end of the passageway has a second opening that can receive at least a portion of the fluid specimen; and a seal member that covers the first opening or the second opening to prevent fluid from flowing therethrough.

Abstract: A biological sample collection and test kit and a method of using the kit are disclosed in the application. The kit includes a swab, having a sample collection portion, a cover for covering the sample collection portion of the swab for hygienic purpose. Also disclosed is a package for the swab and the cover.

Abstract: The present disclosure includes but is not limited to an assay or test device, such as an immunological assay device, with positive and negative controls for each analyte of interest. In general, the device has a bi-fold, tri-fold or quarter-fold cassette, each folded side having one or more test strips contained therein. The device is compact and easily used by the worker. The present device is particularly useful in a clinical drug of abuse testing setting, in which the use of internal quality controls is regulated by the USCMS and the College of American Pathologists. In addition, the present device provides the advantages of ease of use, small size and reduced cost compared to other devices currently available on the market.