Described herein is a device for collecting and drying and protecting oral or nasal swab samples that can then be submitted for antibody and/or molecular testing.

A receptacle for detecting a targeted pathogen is provided. The receptacle includes a main body configured to accommodate reagent containing ampoules and a specimen collector, a reservoir provided at a distal end side of the main body, and a support extending through the main body in an extending direction of the receptacle. The support includes an inlet that permits passage of the specimen collector into the main body and an outlet that restrictively permits passage of the specimen collector into and out of the reservoir.

A method of verifying proper functionalization of a sensor and a negative test result obtained by exposing a sensing element functionalized to detect a target analyte to a test sample is described. The method may include, subsequent to or simultaneously with the exposing the sensing element to the test sample, exposing the sensing element to a test confirmation sample, the test confirmation sample comprising at least one of the target analyte in an amount greater than a detection limit of the sensing element and a recombinant protein of the target analyte in an amount greater than a detection limit of the sensing element and performing a measurement using the sensing element to obtain a subsequent test result.

Disclosed is a lateral flow assay device useful for useful for detecting a variety of analytes in samples. Also disclosed are methods of using the device and other lateral flow assay sampling and detection methods. In general, the devices and methods allow for a lateral flow assay test to be conducted within a single, closed environment, thus minimizing risks of sample contamination as well as other potential hazards to the user.

A lateral flow assay (LFA) device includes a capillary pad and a sample port that holds the sample fluid before a hole is made in a cavity surface of the sample port. The LFA device includes a breaker with a tip to make a hole in the cavity wall of the sample port causing the sample fluid held inside the compartment to be applied to the capillary pad after the start of a test.

Assay cartridges are described that have a detection chamber, preferably having integrated electrodes, and other fluidic components which may include sample chambers, waste chambers, conduits, vents, bubble traps, reagent chambers, dry reagent pill zones and the like. In certain embodiments, these cartridges are adapted to receive and analyze a sample collected on an applicator stick. Also described are kits including such cartridges and a cartridge reader configured to analyze an assay conducted using an assay cartridge.

A blister assembly comprises at least one collapsible blister adapted, as it is collapsed, to eject a liquid contained therein. The blister assembly comprises a first layer (130) having at least one blister chamber (150) and a second layer (131) sealed to the first layer at least around a periphery of the at least one blister chamber such that a liquid is contained between the first layer and the second layer. The seal between the first and second layers comprises a first planar portion having a first peel strength and a second planar portion having a second peel strength, wherein the first peel strength is greater than the second peel strength, such that when pressure is applied to the blister, the second portion of the seal breaks to release the liquid contained within the chamber into the liquid inlet. The blister assembly further comprises at least one discontinuity (142) formed in the first and second layers in the region of the first portion of the seal, such that a shear force is required to delaminate the first and second layers in that region.

Devices and associated methods for analyzing patient samples are disclosed herein. In some embodiments, a device includes a housing base configured to retain a test strip, and a housing cover configured to couple to the housing base to at least partially enclose the test strip. The housing cover can include a fluid reservoir configured to hold a solution for hydrating a sample swab. The housing can further include an aperture configured to permit transfer of a sample from the sample swab onto the test strip.

Embodiments include assay devices within a single use, disposable cassette for biochemical assays with at least one fluid well and at least one capillary valve. The capillary valve in combination with motion of porous sheets within the assay leads to addition of liquid reagents at different times to the assay although a user adds the liquid reagents to the cassette simultaneously.

This system takes in raw cellular material collected using a provided swab, blood collection device, urine collection device, or other sample collection device and transforms that biological material into a digital result, identifying the presence, absence and/or quantity of nucleic acids, proteins, and/or other molecules of interest.