Abstract: The present disclosure relates to enhancements in diagnostic assays for detection of analytes. The improved assays are suitable for management of infections and pandemics in humans and animal reservoirs, including but not limited to SARS-CoV-2 (CoV2), and for measurement of biomarkers of disease (both human and veterinary).

Abstract: A system for mixing a sample with a combined buffer includes a sampler body, the sampler body including a first reservoir and a second reservoir. The system further includes a first separator forming a first enclosure with the sampler body for the first reservoir. The system further includes a second separator forming a second enclosure with the sampler body for the first reservoir. The system further includes a third separator, in conjunction with the second separator, forming a third enclosure and a fourth enclosure, respectively, both in conjunction with the sampler body, for the second reservoir.

Abstract: A system for mixing a sample with a combined buffer includes a sampler body, the sampler body including a first reservoir and a second reservoir. The system further includes a first separator forming a first enclosure with the sampler body for the first reservoir. The system further includes a second separator forming a second enclosure with the sampler body for the first reservoir. The system further includes a third separator, in conjunction with the second separator, forming a third enclosure and a fourth enclosure, respectively, both in conjunction with the sampler body, for the second reservoir.

Abstract: A structure for controlling fluid flow from a sample receiving pad into a lateral flow assay test strip, including: a lateral flow assay test strip; a sample pad abutting the lateral flow assay test strip; a pinch wall positioned to direct fluid flow from the sample pad to the lateral flow assay test strip; a top support structure positioned on top of the test strip; and a bottom support structure positioned underneath the test strip, wherein each of the top and bottom support structures comprise a plurality of separate spaced-apart support ribs positioned along the length of the test strip.

Abstract: A structure for controlling fluid flow from a sample receiving pad into a lateral flow assay test strip, including: a lateral flow assay test strip; a sample pad abutting the lateral flow assay test strip; a pinch wall positioned to direct fluid flow from the sample pad to the lateral flow assay test strip; a top support structure positioned on top of the test strip; and a bottom support structure positioned underneath the test strip, wherein each of the top and bottom support structures comprise a plurality of separate spaced-apart support ribs positioned along the length of the test strip.

Abstract: A device for preparing a fluid sample for use in a fluid analyte meter, including: a first portion, comprising: a septum piercing projection, a capillary channel, and a vent on an outer surface of the first portion; and a second portion, comprising: a treatment solution chamber, and a septum sealing the treatment solution chamber, wherein the vent is open when the first portion of the device is initially inserted into the second portion of the device, and wherein the vent is closed when the first portion of the device is fully inserted into the second portion of the device.

Abstract: A method of preparing a fluid sample for use in a fluid analyte monitor, the method including drawing a fluid sample into a capillary channel in a body having a septum piercing projection; piercing a first septum covering a treatment solution chamber with the septum piercing projection, thereby exposing the fluid sample in the capillary channel to the contents of the treatment solution chamber; mixing the fluid sample with the contents of the treatment solution chamber; and piercing a second septum covering the treatment solution channel such that the mixed fluid and treatment solution chamber contents are received into a fluid analyte meter. The method may also include shaking the treatment solution chamber with the capillary channel therein, thereby mixing the fluid sample with the contents of the treatment solution chamber.

Abstract: A structure for controlling fluid flow from a sample receiving pad into a lateral flow assay test strip, including: a lateral flow assay test strip; a sample pad abutting the lateral flow assay test strip; a pinch wall positioned to direct fluid flow from the sample pad to the lateral flow assay test strip; a top support structure positioned on top of the test strip; and a bottom support structure positioned underneath the test strip, wherein each of the top and bottom support structures comprise a plurality of separate spaced-apart support ribs positioned along the length of the test strip.

Abstract: A method of preparing a fluid sample for use in a fluid analyte monitor, the method including drawing a fluid sample into a capillary channel in a body having a septum piercing projection; piercing a first septum covering a treatment solution chamber with the septum piercing projection, thereby exposing the fluid sample in the capillary channel to the contents of the treatment solution chamber; mixing the fluid sample with the contents of the treatment solution chamber; and piercing a second septum covering the treatment solution channel such that the mixed fluid and treatment solution chamber contents are received into a fluid analyte meter. The method may also include shaking the treatment solution chamber with the capillary channel therein, thereby mixing the fluid sample with the contents of the treatment solution chamber.

Abstract: A device for preparing a fluid sample for use in a fluid analyte meter, including: (a) a first portion, comprising: a capillary channel dimensioned to receive a fluid sample therein, an internal nozzle in communication with the capillary channel, a mixing chamber in communication with both the capillary channel and the internal nozzle, and a dispensing nozzle in communication with the mixing chamber; (b) a treatment solution chamber covered by a septum; and (c) a second portion that is moveable with respect to the first portion to pierce the septum such that contents of the treatment solution chamber mix with contents of the capillary channel in the mixing chamber and are ejected through the dispensing nozzle when the second portion is moved with respect to the first portion.

Abstract: A device for preparing a fluid sample for use in a fluid analyte meter, including: a first portion, comprising: a septum piercing projection, a capillary channel, and a vent on an outer surface of the first portion; and a second portion, comprising: a treatment solution chamber, and a septum sealing the treatment solution chamber, wherein the vent is open when the first portion of the device is initially inserted into the second portion of the device, and wherein the vent is closed when the first portion of the device is fully inserted into the second portion of the device.

Abstract: A system for controlling fluid flow movement between a sample receiving pad and a test strip, including: a sample receiving pad having first and second portions separated by a narrowed portion; an absorbent pad in contact with the first portion of the sample receiving pad; and a test strip in contact with the second portion of the sample receiving pad.

Abstract: A structure for controlling fluid flow from a sample receiving pad into a lateral flow assay test strip, including: a lateral flow assay test strip; a sample pad abutting the lateral flow assay test strip; a pinch wall positioned to direct fluid flow from the sample pad to the lateral flow assay test strip; a top support structure positioned on top of the test strip; and a bottom support structure positioned underneath the test strip, wherein each of the top and bottom support structures comprise a plurality of separate spaced-apart support ribs positioned along the length of the test strip.

Abstract: A combination body fluid analyte meter and cartridge system, having: (a) a body fluid analyte meter, with: a housing; a logic circuit disposed within the housing; a visual display disposed on the housing; and a measurement system disposed within the housing; and (b) a cartridge, having: at least one lateral flow assay test strip, the lateral flow assay test strip having: (i) a lateral flow transport matrix; (ii) a specific binding assay zone on the transport matrix for receiving a fluid sample and performing a specific binding assay to produce a detectable response, and (iii) a general chemical assay zone on the transport matrix for receiving the fluid sample and performing a general chemical assay to produce a detectable response; wherein the cartridge is dimensioned to be receivable into the body fluid analyte meter such that the measurement system is positioned to detect the responses in the specific binding assay zone and the general chemical assay zone in the lateral flow assay test strip.

Abstract: A device for preparing a fluid sample for use in a fluid analyte meter, including: (a) a first portion, comprising: a capillary channel dimensioned to receive a fluid sample therein, an internal nozzle in communication with the capillary channel, a mixing chamber in communication with both the capillary channel and the internal nozzle, and a dispensing nozzle in communication with the mixing chamber; (b) a treatment solution chamber covered by a septum; and (c) a second portion that is moveable with respect to the first portion to pierce the septum such that contents of the treatment solution chamber mix with contents of the capillary channel in the mixing chamber and are ejected through the dispensing nozzle when the second portion is moved with respect to the first portion.

Abstract: A lancet device includes a body within which is slidably located a trigger and fixedly located a base. The base contains, in an armed position, the lance with its needle and a spring affixed to the lance. The trigger includes a mechanism to release the lance during use.In a preferred embodiment, the lancet device of the present invention is self-activated by the finger (or other body part) to be pierced. Depression of the trigger with the finger releases the lance and the spring so that the needle protrudes through an orifice in the end of the trigger and pierces the tissue. Because the spring is held in a pre-armed position, release of the spring is consistent, and reproducibility of incision is well controlled.

Abstract: A lancet device includes a body within which is slidably located a trigger and fixedly located a base. The base contains, in an armed position, the lance with its needle and a spring affixed to the lance. The trigger includes a mechanism to release the lance during use.In a preferred embodiment, the lancet device of the present invention is self-activated by the finger (or other body part) to be pierced. Depression of the trigger with the finger releases the lance and the spring so that the needle protrudes through an orifice in the end of the trigger and pierces the tissue. Because the spring is held in a pre-armed position, release of the spring is consistent, and reproducibility of incision is well controlled.

Abstract: A self-contained assay device is provided, where an analyte may be detected or be quantitated by measuring the distance of a detectable signal from a predetermined site. The device employs two strips separated by a gap, where a flow path is completed by movement of a sample receiving pad into the gap. The movement of the sample receiving pad also results in release of a reagent solution which is then transported through the pad into the quantitation area where the amount of analyte may be determined. Various chemistries may be employed for providing a detectable signal.