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.

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: 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: 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 invention is a device for conveniently collecting and storing liquid samples, as well as applying an aliquot of the sample to a test device, such as a lateral flow immunoassay. The present invention comprises an absorbent swab and a dropper container containing an expression means for expressing the collected sample from the swab. After the collected sample has been expressed into the reservoir of the device, the device is capped. The device can be inverted over a test device, the sides of the reservoir squeezed and an aliquot of the sample applied, in a drop-wise manner, to the sample application well of the test device. The present invention is particularly useful for collecting viscous samples, such as saliva or oral fluid, in a drug of abuse testing setting.

Abstract: The present disclosure includes but is not limited to a device for collecting samples, especially liquid samples to be tested for the presence of an analyte, especially for drugs of abuse, antibodies, antigens and biological moieties such as steroids and glucose. In particular, the disclosure describes improvements in collection device design that provide a simple, non-invasive, non-hazardous method of collecting samples from a subject or patient, especially liquid samples such as saliva, oral fluid and urine. The collected sample can be stored in the disclosed device and the device can be used to apply, in a drop-wise manner, an aliquot of the sample directly to a test device.

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.

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 invention is a device for conveniently collecting and storing liquid samples, as well as applying an aliquot of the sample to a test device, such as a lateral flow immunoassay. The present invention comprises an absorbent swab and a dropper container containing an expression means for expressing the collected sample from the swab. After the collected sample has been expressed into the reservoir of the device, the device is capped. The device can be inverted over a test device, the sides of the reservoir squeezed and an aliquot of the sample applied, in a drop-wise manner, to the sample application well of the test device. The present invention is particularly useful for collecting viscous samples, such as saliva or oral fluid, in a drug of abuse testing setting.

Abstract: The present invention is a device for collecting and testing a liquid sample, for example a viscous sample, such as oral fluid or saliva. The present invention provides a simple and sanitary means of collecting a sample, testing a portion of the sample for one or more analytes of interest, and storing the remaining sample. The stored sample may be used at a later time for confirmation of the test results. In certain embodiments of the present invention, the reservoir of stored sample may be removed from the device prior to storage. The present invention is particularly useful of drug of abuse testing, as well as indicators of health and/or disease state.

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 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.