The invention encompasses a real time, point of care, diagnostic system, including a lateral flow test cassette, a data reader, and an application for processing test results and methods of diagnosis of a disease or virus.

Systems and methods to analyzes images of lateral flow assays are disclosed herein. An example image analysis system includes processor circuitry to (a) determine whether a format of an image of a lateral flow assay device satisfies a format threshold, (b) in response to determining the format of the image satisfies the format threshold, determine whether the lateral flow assay device in the image is authentic, (c) in response to determining the lateral flow assay device is authentic, determine whether a position of the lateral flow assay device in the image satisfies a position threshold, (d) in response to determining the position of the lateral flow assay device satisfies the position threshold, analyze the image to determine the result of the diagnostic test, and (e) abort the sequence of the operations during performance of the sequence of operations at the time any one of operations fails.

A pancreatic cancer detection device, including: a solid surface comprising an antibody bound to the solid surface, the solid surface configured to indicate selective binding between the antibody and one or more target protein(s); and wherein the antibody is configured to selectively bind to the target protein(s). In some examples, the target protein(s) include one or more protein(s) selected from the group consisting of Alpha-1 antitrypsin (A1AT), Alpha-1-acid glycoprotein 1 (AGP1), Apolipoprotein A1 (ApoA1), C1-inhibitor, Complement C2, Complement component 3, Carbohydrate antigen 19-9, Calprotectin, caspase-cleaved cytokeratin-18 (CCK18), Ceruloplasmin, cartilage oligomeric matrix protein, gamma-glutamyl transpeptidase, Haptoglobin, Insulin-like growth factor 1, Insulin-Like Growth Factor Binding Protein 3, Properdin, Serum amyloid A, and Tumor necrosis factor alpha (TNF alpha).

The technology described in this document can be embodied in a test strip for use in measuring a level of an ST2 cardiac biomarker in a blood plasma sample. The test strip includes a base, and a plurality of conjugates, wherein each conjugate includes a reporter group bound to a first antibody that binds to ST2. A conjugate pad disposed along a length of the base and is configured to hold the plurality of conjugates that bind with ST2 to produce conjugate-ST2 complexes. The conjugate pad is further configured to receive the blood plasma sample. The test strip also includes a plurality of second and third antibodies that bind to ST2, and the conjugate-ST2 complexes, respectively. The plurality of second antibodies are bound to a membrane in a test location and the plurality of third antibodies are bound to the membrane in a control location.

A lateral flow assay (“LFA”) strip for receiving a test sample from a domain. The LFA strip includes a test line on the LFA strip that indicates a positive result in the presence of a chemical-of-interest being tested for in the domain and a negative result in the absence of the chemical-of-interest being tested for in the domain. The strip also includes a verification line on the LFA strip that indicates a positive result when a target marker present in the domain is on the LFA strip.

Systems, methods, and apparatus are disclosed for determining quantitative hormone and chemical analyte results from qualitative test results. An image is taken of an ovulation test device. The image is analyzed to identify a color intensity ratio (T/C ratio) between a color density of a test-line to a color density of a control-line. Additionally, a quantitative substance level may be determined using the T/C ratio, by identifying the type of test device and referencing a data structure that relates quantitative substance levels to T/C ratios for the identified type of test device.

CRISPR-based diagnostic methods and compositions are provided. One embodiment provides the use of DNA-barcoded antibodies or peptide-MHC (pMHC) tetramers (e.g., Kb-OVA.sub.257-264, Db-GP100.sub.25-33, Db-GP.sub.33-41) and CRISPR-Cas protein, and a guided DNA endonuclease, to achieve ultrasensitive detection of soluble and cell surface proteins. The disclosed embodiments can use type V: Cas12a; type VI: Cas13a, or Cas13b. Combining DNA encoding with CRISPR-Cas protein recognition is a sensitive system because barcodes can be isothermally amplified and Cas, for example Cas12a, enzymatically cleaves DNA reporters upon barcode detection, providing two rounds of amplification and enabling measurement of protein concentration by sample fluorescence or using by paper-based assays. This platform enables monitoring of protein and cellular biomarkers and further expands the toolbox of CRISPR/Cas-based technologies

A device for receiving a digital reader and a lateral flow assay (LFA) cartridge and systems incorporating the same are provided. Aspects of the device include a body having a frame configured to receive the digital reader and a base plate having one or more LFA cartridge receiving positions for positioning one or more LFA cartridges at a fixed orientation relative to a planar space defined by the frame. Also provided are methods for using the device to read a result indicative of the presence or absence of an analyte in a sample.

Embodiments described herein generally relate to: sensing and/or authentication using luminescence imaging; diagnostic assays, systems, and related methods; temporal thermal sensing and related methods; and/or to emissive species, such as those excitable by white light, and related systems and methods.

A lateral flow assay device comprises a test strip to receive a quantity of fluid comprising a quantity of exosomes and detect the presence of a target analyte on the surface of the exosomes. The test strip comprises a conjugate pad that contains a set of one or more types of tetraspanin binding reagents conjugated with a label. Each type of tetraspanin binding reagent is configured to bind with a corresponding type of exosome tetraspanin and form an immunocomplex comprising an exosome. The conjugate pad is fluidly connected to a membrane. The membrane comprises a test line comprising an immobilized binding reagent to the target analyte. The immobilized binding reagent to the target analyte is configured to bind to a protein of the target analyte on the surface of an exosome in an immunocomplex comprising the exosome.