Diagnostic devices for performing diagnostic tests are provided, as well as methods that utilize the diagnostic devices, methods for manufacturing the diagnostic devices, and test kits for performing the diagnostic tests. The diagnostic devices include a vial, a rupturable container disposed in an internal cavity of the vial and containing a fluid, and a test and readout device in fluid communication with the internal cavity of the vial. The rupturable container is configured to rupture during a test procedure of the diagnostic test to enable the fluid to flow into the internal cavity of the vial. The rupturable container may include a rupturable ampoule or a frangible seal. The rupturable container may be ruptured by deformation of the vial or by piercing caused by a sharp object in the vial or a sample swab inserted in the vial.

Devices and methods used collect and transport a biological specimen are disclosed. The devices include a vial defining a specimen chamber to retain a specimen, a collection member to collect a specimen, and a cap containing a liquid medium to treat the specimen for transport. The cap includes a puncture member to puncture a seal to release the liquid medium from the cap.

A biological sample collection system can include a sample collection vessel having a sample collection chamber with an opening configured to receive a biological sample into the sample collection chamber. The biological sample collection system can additionally include a selectively movable sleeve valve configured to associate with the opening of the sample collection chamber. The biological sample collection system can additionally include a sealing cap that is configured to associate with the selectively movable sleeve valve and with the sample collection vessel. The sealing cap can include a reagent chamber having reagent(s) stored therein, and when the sealing cap is associated with the sample collection vessel, the selectively movable sleeve valve opens, dispensing the reagent(s) into the sample collection chamber.

Separation of the cellular components of whole blood, or other biological fluid, from plasma or serum can be achieved for assay analysis. A device for facilitating separation can include, for example, a capillary tube that accurately draws target blood volume, a pad that chemically interacts with red-blood cells, such that the red blood cells become chemically and/or physically trapped within pad material, a mechanism for plasma recovery from the pad upon diffusion or active mixing, and a dropper tip that facilitates dispensing the mixture onto a test device. The treatment of the cellular components can be performed prior to contact with a buffer solution, so release of the cellular components into the buffer solution is reduced or prevented. Additional filtration can be provided to filter any remaining cellular components in the mixture.

A multi-chamber saliva-collection device is configured to segregate a saliva sample into at least two aliquots, each of the at least two aliquots being contained within a distinct chamber of the multi-chamber device, wherein the multi-chamber device is useful for performing an instant analyte test and a subsequent DNA confirmation to validate the identity of the tested individual. Related methods for using the device to obtain each of: an analyte test result, and a DNA confirmation of the identity of the individual from which the tested saliva sample, are also disclosed.

Cartridges for the voltammetric detection of fluid parameters in a fluid sample are provided. The cartridges contain a sample reservoir containing two compartments fluidically separated by a barrier. Each compartment contains a chemical compound to facilitate voltammetric detection of a fluid parameter. A fluid collection device containing a fluid sample can be received by the sample reservoir, and the barrier can be penetrated by the fluid collection device, to thereby cause contact between the fluid sample and both chemical compounds. Upon introduction of the fluid sample in the sample reservoir a fluid parameter can be voltammetrically detected. Related assemblies including the cartridges, as well as methods for operating the cartridges are also described.

The present disclosure provides a cartridge and method to move fluids within the cartridge that simplifies the design and removes the need for any internal valves or metering devices. The design is amenable to injection molded manufacturing lowering cost for large volume manufacturing. The design can be adapted to carry out both sample preparation and detection of biological substances including nucleic acids and proteins.

The present technology provides for an apparatus for detecting polynucleotides in samples, particularly from biological samples. The technology more particularly relates to microfluidic systems that carry out PCR on nucleotides of interest within microfluidic channels, and detect those nucleotides. The apparatus includes a microfluidic cartridge that is configured to accept a plurality of samples, and which can carry out PCR on each sample individually, or a group of, or all of the plurality of samples simultaneously.

The presently disclosed subject matter provides devices and methods for sample extraction from a swab during biological sample processing. In particular embodiments, the devices and methods are configured for use in conjunction with microfluidic devices for sample processing.

The technology described herein generally relates to systems for extracting polynucleotides from multiple samples, particularly from biological samples, and additionally to systems that subsequently amplify and detect the extracted polynucleotides. The technology more particularly relates to microfluidic systems that carry out PCR on multiple samples of nucleotides of interest within microfluidic channels, and detect those nucleotides.