Methods and devices to capture and analyze aerosolized particles such as protein biomarkers and their truncated proteoforms characteristic of a disease, including a respiratory disease, in exhaled breath to enable rapid detection of diseases are disclosed. The disclosed methods and systems selectively capture aerosolized particles using a packed bed column. The captured particles are then eluted using one or more solvents and analyzed using devices including mass spectrometry.

Disclosed are methods and devices for analyzing non-volatile organics in exhaled breath and other aerosols using various diagnostic tools that enable rapid, low cost point of care assays for several diseases including respiratory tract diseases such as COVID-19. The disclosed methods and systems selectively capture non-volatile organics in exhaled breath and other aerosols in a packed bed column. The non-volatile organics are eluted and samples are analysis using diagnostic devices including MALDI-TOFMS. The disclosed systems and methods provide for a diagnostic test result in less than about 20 minutes and provides for autonomous operation with minimal human intervention.

A rapid testing mechanism for respiratory viral pathogens includes a filter material positioned to capture exhaled breath particles from a respiratory tract. At least a portion of the filter material includes a pathogen binding adsorptive reagent, wherein the pathogen binding adsorptive reagent is a sulfated cellulose membrane. When the exhaled breath particles pass through the filter material, the following occur: when the binding adsorptive reagent reacts, a positive test for respiratory viral pathogens is indicated by the filter material; and when the pathogen binding adsorptive reagent does not react, a negative test for respiratory viral pathogens is individuated by the filter material.

A system and method of monitoring sobriety using a hand-held breath testing device that, on receipt of a user's breath, generates a breath test signal comprising substance content data and user identification data, and wirelessly transmits the breath test signal to a breath test signal receiving station.

Disclosed herein are compositions, devices and methods for detecting analytes in air samples obtained from a subject. Compositions can be included on inanimate surfaces such as masks to be worn by an individual having a test substrate for capturing analytes.

A mask-based diagnostic apparatus is provided for detecting a biomarker contained in exhaled breath of a test subject. An exhaled breath condensate (EBC) collector converts breath vapor received from the lungs and airways of the test subject into a fluid biosample. The EBC collector including a thermal mass, a condensate-forming surface and a fluid conductor disposed on the condensate-forming surface. A fluid transfer system receives the fluid biosample from the EBC collector. A biomarker testing unit receives the fluid biosample from the fluid transfer system and tests the fluid biosample for a target biomarker. A testing system support is provided for supporting the EBC collector, the fluid transfer system and the biomarker testing unit. The testing system support is configured and dimensioned to fit inside a face mask. A face mask is provided forming an exhaled breath vapor containment volume to hold the exhaled breath vapor in proximity to the EBC collector to enable the condensate-forming surface cooled by the thermal mass to coalesce the exhaled breath vapor into the fluid biosample.

An apparatus for testing for streptococcal pharyngitis includes a tube having an open first end and a second end, and an opening on a side thereof, a dipstick inserted into the tube through the side opening, and an insert with a hole that can receive the dipstick and sized to nest the dipstick into the side opening of the tube. A swab at the end of the dipstick inside the tube receives microbes in a breath exhaled by a patient holding the first end of the tube to the patient's mouth. After being exhaled upon by the patient, the dipstick is removed for testing for the presence of microbes that cause streptococcal pharyngitis.

Methods and devices are provided for analyzing acetone in breath. One such method comprises disposing a reactant in a reaction zone within the breath analysis device, wherein the reactant comprises a primary amine disposed on a surface, and wherein the reaction zone has an optical characteristic that is at a reference level. It also comprises pre-storing a liquid nitroprusside solution within the breath analysis device separately from the reactant. The method further comprises using the breath analysis device to cause the breath to contact the reactant in the reaction zone so that the acetone in the breath reacts with the reactant to form a reaction product and, after the reaction product has been formed, using the breath analysis device to cause the nitroprusside solution to contact and react with the reaction product and to facilitate a change in the optical characteristic of the reaction zone relative to the reference level. The method also comprises using the breath analysis device to detect the change in the optical characteristic to sense the acetone in the breath. Apparatuses that use these methods are also described.

This disclosure provides a breath microbe collection assembly. The assembly receives both an upper respiratory breath and a lower respiratory breath of a user. The assembly includes a housing having a first chamber and a second chamber. A portion of the first chamber is configured to receive the upper respiratory breath and the lower respiratory breath. The second chamber is configured to receive the lower respiratory breath. A stop is mounted within the first chamber. A valve is mounted to the housing and has a pivoting part and a diverting part. The pivoting part is adjacent one side of the stop when the valve is in an initial position. The diverting part is adjacent another side opposite the one side of the stop when the valve is in an activated position. The valve automatically returns to the initial position when a volume of an initial breath of said user is dissipated.

A method of using an electrochemical device includes at least first and second electrodes; a chamber for receiving a fluid sample and defining a volume partially bounded by a first portion of the first electrode and a second portion of the second electrode, the first portion having a first characteristic for influencing an electrochemical reaction at the first portion, the second portion having a second characteristic for influencing an electrochemical reaction at the second portion, the first and second characteristics having a predetermined relationship. The method also includes receiving a fluid sample in the chamber; measuring first and second electrical outputs at least one of the first and second electrodes; and determining whether the first and second electrical outputs are related according to the predetermined relationship.