Abstract: Provided are methods and systems that relate to configuring a diagnostic analyzer. The diagnostic analyzer may receive an identifier from a dual design test cartridge. The parameter module disposed within the diagnostic analyzer may determine parameters corresponding to the received test cartridge identifier.

Abstract: Provided are methods and systems that relate to configuring a handheld analyzer. The handheld analyzer may receive an identifier from a dual design test cartridge. The parameter module disposed within the handheld analyzer may determine parameters corresponding to the received test cartridge identifier. The parameter module may then configure the handheld analyzer to perform a test with the dual designed test cartridge using the determined parameters. In an embodiment, the diagnostic test module may determine the test corresponding to the received cartridge identifier and the diagnostic test module configures the handheld analyzer to perform the determined test with the test cartridge. In another embodiment, the dual test cartridge comprises an outer enclosure and an inner enclosure. The outer enclosure comprises a parameter module capable of storing test cartridge identification and may be reused to store new test identifications.

Abstract: Methods and systems directed towards a single use nasopharyngeal aspirate collection device comprising, a reservoir capable of contracting and expanding in a lineal motion at least one time, a nozzle comprising an at least one orifice at a distal end of the nozzle, a fastening means capable of coupling a proximal end of the reservoir with a proximal end of the nozzle, a guard disposed about a portion of an outer wall of the reservoir adjacent to the proximal end of the reservoir, and an internal cavity extending from the reservoir through the nozzle.

Abstract: The methods and systems disclosed herein may relate to a testing cartridge. A system may include, a test cartridge comprising: a body comprising an upper component and a lower component, an inner cavity at least partially enclosed by the body, a sample port disposed in the upper component, a structural member disposed within the upper component relative to the sample port capable of controlling the contact between a sample and the sample pad, an assay coupled to the lower component, wherein the assay comprises a sample pad, and a membrane coupled to a portion of the structural member capable of pretreating the sample.

Abstract: The present disclosure may provide a system and method for using a viral respiratory infection detection device, a method comprising: obtaining a biological sample from a subject; preparing the biological sample for testing; placing at least a portion of the prepared biological sample into a sample port of a viral respiratory infection detection device thereby contacting a sample pad with the prepared biological sample thus initiating a first test strip and a second test strip, wherein the first testing strip is formed to detect the binding of a respiratory virus to a recombinant human receptor protein, wherein the second testing strip is formed to detect the binding of a specific respiratory virus to a specific recombinant spike glycoprotein; and analyzing the results of the first test strip and the second test strip.

Abstract: A method for determining total hemoglobin concentration in a blood sample comprising spectrophotometric analysis of a blood sample at two wavelengths and determining a ratio of the detected radiation at a first wavelength to the detected radiation at a second wavelength; and determining a concentration of total hemoglobin in the blood sample based on the ratio.

Abstract: The present invention provides apparatus and methods for performing assays for determining the time required for a sample of blood to coagulate. The apparatus comprises reaction chambers coated with one or more clotting agent. A drop of blood or equivalent is placed at the sample application port, diluted, and contacted with the clotting agents in the reaction chambers. The diluted blood sample can be moved back and forth through the reaction chambers until blood clots. The blood clotting process forms fibrin stands that prevent the flow of the blood sample in the reaction chambers. The clotting time is the total time from the sample entering the reaction chambers to the time at which the waveform in the reaction chambers change, or the motion or flow of the sample ceases, and can be measured by turbidity.

Abstract: A method and system for configuring an analyzer is disclosed. The analyzer receives a strip identifier from a strip or a vial identifier from a vial. The parameter module in the analyzer determines the parameters corresponding to the received strip identifier or the vial identifier. The parameter module then configures the analyzer to perform a test with the strip using the determined parameters. In one embodiment, the diagnostic test module determines the test corresponding to the received strip identifier or the vial identifier and the diagnostic test module configures the analyzer to perform the determined test with the strip. In another embodiment, the association determination module determines if the received strip identifier and vial identifier are associated with each other. If not, the analyzer renders an error requesting a correct strip.

Abstract: The present invention provides apparatus and methods for performing assays for determining the presence of and/or quantifying an analyte in a sample. The analyte and a label preferably immobilized on a particle are mixed to provide a homogenous solution. The homogeneous solution can be optionally made to flow through a filter. The homogenous solution or the filtrate can be metered through the read zone at a controlled flow rate and the presence of the label or the presence of the particle can be detected. The methods and apparatus of the invention do not require the use of a capture zone.

Abstract: The present invention provides apparatus and methods for performing assays for determining the time required for a sample of blood to coagulate. The apparatus comprises reaction chambers coated with one or more clotting agent. A drop of blood or equivalent is placed at the sample application port, diluted, and contacted with the clotting agents in the reaction chambers. The diluted blood sample can be moved back and forth through the reaction chambers until blood clots. The blood clotting process forms fibrin stands that prevent the flow of the blood sample in the reaction chambers. The clotting time is the total time from the sample entering the reaction chambers to the time at which the waveform in the reaction chambers change, or the motion or flow of the sample ceases, and can be measured by turbidity.

Abstract: An assay device, analytical instrument and assay method for determining the presence or amount of an analyte in a fluid is disclosed. The device is a one-step lateral flow dry reagent immunoassay with one, two or more zones along a transverse axis of the device, each zone can contain or be preceded by diffusively or non-diffusively bound reagents. The invention measures an indicator in one or two test zones for each analyte to determine its presence or concentration. The signal reagent (indicator) may be a particle such as a colored latex or colloidal gold. The assay quantitation may be read by an instrument.

Abstract: The present invention provides an assay composition for producing a physically detectable change upon contact with a sample which correlates with the amount of selected analyte in the sample. The composition includes a support matrix pervious to optical radiation and a chemical reagent yielding a physically detectable change which correlates with the amount of selected analyte in the sample. The support matrix has at least one detection zone for detecting the physical change with a cross-sectional area and depth profile. The composition includes an opacifier present in an amount sufficient to increase the resolution of the physically detectable change. The opacifier is distributed uniformly across the cross-sectional area of the detection zone and is distributed through at least a portion of the depth profile of the support matrix within the detection zone. The chemical reagent is substantially immobilized relative to the opacifier when detecting the physical change.