Provided herein, in some embodiments, are rapid diagnostic tests to detect one or more target nucleic acid sequences (e.g., a nucleic acid sequence of one or more pathogens). In some embodiments, the pathogens are viral, bacterial, fungal, parasitic, or protozoan pathogens, such as SARS-CoV-2 or an influenza virus. Further embodiments provide methods of detecting genetic abnormalities. Diagnostic tests comprising a sample-collecting component, one or more reagents (e.g., lysis reagents, nucleic acid amplification reagents), and a detection component (e.g., a component comprising a lateral flow assay strip and/or a colorimetric assay) are provided.

Embodiments of the invention provides methods and devices which enable a quick, easy, and cost-effective test for detecting the presence of coagulation factor (CF) inhibitors and platelet (P) inhibitors within small volumes of patient-derived liquid samples. The inventive approach reduces the need for elaborate and time-consuming sample testing or larger quantities of a sample to be collected. The inventive approach overcomes further limitations by providing a detection method that is suitable for measuring antiplatelet drugs, as well as methods for detecting CF inhibitors which are not dependent on competition between CF inhibitors and chromogenic substrates and enzymatic cleaving, but instead relies on non-competitive configurations involving the use of sequential binding moieties with specificity toward CF/P inhibitors and subsequent complexes and/or competitive configurations involving the use of binding moieties that will compete for CF inhibitors against either modified CF inhibitors or other competing moieties.

A device and method for performing a diagnostic test, including determining presence or absence of antibodies to a virus. The device displays the results on a display, and includes a retractable needle and an enclosure that houses the retractable needle, a vessel for collecting or storing a bodily liquid sample collected from the subject, an enclosure containing a diluent fluid that is mixed with the collected sample, and at least one area for mixing and performing analysis.

A pressure sensor checks for pressure being applied by the test subject's finger during the test, and stops the test or disables display if it does not sense pressure of the test subject's finger during testing. A processor performs identification testing by scanning a digital fingerprint of the test subject by a digital scanner prior to evaluation, stores the data and evaluates the test results to determine whether the results exceed or reach a threshold value. The testing and evaluation are performed only after a successful identification of the test subject. The device keeps the test information and identification information about the test subject anonymous, and does not communicate the identity of the test subject and the test results to an external device.

The present invention provides a highly sensitive immunochromatography measurement method in which a labeling substance for labeling an object to be detected in a specimen undergoing immunochromatography is quantified by being identified with precision, high resolution, and increased contrast using an electron microscope. An immunochromatography measurement method according to an embodiment of the present invention is characterized in that measurement is performed by an electron microscope after applying an auxiliary liquid other than a specimen in the immunochromatography.

A lateral flow assay device for testing a biological sample includes housing, a sample receiving pad, a conjugate test pad, and a nitrocellulose membrane. The sample receiving pad and conjugate test pad, as well as the nitrocellulose membrane, are enclosed within an interior portion of the housing. The sample receiving pad is in fluid communication with an opening defined in an outer surface of the housing for receiving the biological sample. At least a portion of the conjugate test pad is in contact with the sample receiving pad and is configured to test the biological sample. At least one window is defined in the outer surface of the housing adjacent the conjugate test pads such that the results of the test performed on the conjugate test pads are visible from outside of the housing.

The invention relates to a combination of biomarkers and their use in brain injury or mild traumatic brain injury (mTBI) detection. The invention also relates to methods of treating the individual diagnosed with a traumatic brain injury (TBI) or a mild traumatic brain injury (mTBI) using such biomarkers.

Molecules, test kits, test kit components and methods for detecting and measuring different first and second antibodies in a test sample using a single test are provided herein. A method includes the steps of obtaining the test specimen from a subject, transferring the test specimen to a sample receiving portion of an assay of a test kit, and reading the results from the assay. The test kit includes a first molecule comprising a first portion of a protein, wherein the first antibody has a first affinity to bind to the first portion, and a second molecule comprising a second portion of the protein different from the first portion, wherein the second antibody has a second affinity to bind to the second portion.

Disclosed are methods for detecting analytes using combined sample collection types. In particular, a first sample is combined with a bio-aerosol sample. Also disclosed are kits that include components for collecting and combining a first sample with a bio-aerosol sample.

A generic point of care based portable device and method thereof as a platform technology for detecting pathogenic infection via nucleic acid based testing achieving sample-to-result integration, comprising the following interconnected stand-alone modules: a thermal unit for executing piece-wise isothermal reactions in a pre-programmable concomitant fashion without necessitating in-between operative intervention; a colorimetric detection unit seamlessly interfaced with smartphone-app based analytics for detecting the target analyte. The said platform technology is thus capable of detecting targeted pathogen-associated RNA by coupling additional complementary DNA probe hybridization combined with isothermal reaction purposed for reverse transcription of RNA followed by amplification of the resulting c-DNA as well as subsequent specific binding of the same in a single user-step in a concomitant fashion and its smartphone-enabled interpretation, in a generic modular format that renders operative suitability outside controlled laboratory environment in a user-friendly manner, with predictive accuracy favorably comparable with gold standard RT-PCR tests.

The disclosed embodiments are generally directed to improving feature detection of rapidly acquired images using camera-enabled mobile devices involving a 2-D decal code, such as a QR code, for improving the reading accuracy of a rapid diagnostic antigen or antibody or enzymatic colorimetric directed test, such as for COVID-19 diagnosis. One primary issue with evaluating a Covid-19 rapid test is detecting and quantifying positive test lines from sampled test strips based on digital images of the test strip. Aspects of the present invention contemplate masking a QR code to improve the sample image resolution and contrast. Other aspects of the present invention contemplate methods and techniques to evaluate a test line on the sample image by enhancing an intensity curve along the test line and control line containing area by way of calculating the instantaneous change in pixel intensity and evaluating the position and intensity of those signals.