The present invention relates to a chromatography strip for diagnosing pregnancy having multiple test lines, a pregnancy diagnosis kit having the chromatography strip, and a method for diagnosing pregnancy using the same.

The present invention overcomes the problem of false negatives due to hCG variants such that pregnancy can be determined more accurately and conveniently by the naked eye. Furthermore, there is an effect of improving the concentration measurement range of hCG or a variant thereof by using a chromatography strip for diagnosing pregnancy which is constituted by multiple test lines and control lines.

Systems are described, based on a primary binding compound and a secondary binding compound used in combination with a support to detect a target in a sample. The systems includes at least one support structure, at least one small primary support portion containing at least one molecule covalently bound to a visual colloidal marker, a plurality of secondary support portions comprising secondary binding compounds that are covalently bound to the support portions and chemically active, at least one pH litmus indicator, at least one pH strip, a buffer for lateral flow on the porous membrane support that allows preservation and activity of binding compounds.

Methods and systems for the diagnosis, treatment, and management of gastroesophageal diseases including gastroesophageal reflux disease, reflux laryngitis, nonerosive reflux disease and gastric cancer using saliva based biomarkers are presented herein. The biomarkers may include E-cadherin, TGF-α, EGF, IL-6, pepsin, MOB kinase activator 1A, EphA1, MOB kinase Activator 1B, integrin alpha 5, Golgi resident protein GCP 60, FR-beta, protein SEC13 homolog, epiregulin, FGF-12, inhibitor of nuclear factor kappa B kinase catalytic subunit, vimentin, annexin A1, protein S100-A6, malate dehydrogenase, proteasome activator complex subunit 2, cathepsin D light chain, MMP-1, MMP-2, MMP-3, MMP-7, MMP-8, MMP-9, MMP-10, MMP-13, MMP-14, mucin-1, alpha-1-acid glycoprotein, antithrombin, serpin peptidase inhibitor, CTSF, HMGB1, TLR7, COPS2, NT5E, TERF1, TIMP-1, TIMP-2, TIMP-4, XPNPEP2, TGFR2, SIGLEC6, CPE, GHR, GPNMB, SLAMF8, TNFRSF19, TWEAK, IFNGR1, Notch-3, TNFRSF19L, annexin A6, α-defensin-1, caveolin 1, EGF receptor, integrin beta 4, S100A6, S100A8, S100A9, and/or haptoglobin.

Described are assays, associated assay kits, and associated methods for diagnosing an infection in a subject. The assay includes a first binding molecule that specifically binds an inflammatory marker (i.e., neutrophil gelatinase-associated lipocalin (NGAL) homodimer) in a sample taken from the subject, and a second binding molecule that binds a marker indicative of the presence of a pathogen in the sample. The assay and methods are for the diagnosis of peritonitis in peritoneal dialysis patients.

A reacting device of dual path synchronous immunochromatographic platform includes a seat, an upper housing, and a fluid dividing funnel. The seat contains two immunochromatographic carriers. The hollow pipe portion has two sloped structures. A force bearing portion of the fluid dividing funnel can be pressed down, so two fluid exits of the fluid dividing funnel move towards these two sloped structures. The specimen drops and is guided into these two immunochromatographic carriers respectively. A reaction result can be observable. The fluid dividing funnel can divide the specimen into two immunochromatographic carriers evenly. The sloped structure can increase the accuracy of specimen supply. Excess specimen can be scraped off for enhancing the solving accuracy. In addition, it can decrease the possibility of false positive problem.

Provided is a membrane carrier for a test kit for detecting a substance to be detected in a liquid sample, the membrane carrier including: a flow channel having a detection zone, in which the flow channel has a rough structure A having protrusions, at least in the detection zone, a rough microstructure B is formed on a surface of the protrusion, a silane coupling agent is attached to a surface of the rough microstructure B, and a maximum peak height Rp of a roughness curve of a protrusion at which the rough microstructure B is formed, as measured according to JIS B0601: 2013 using a three-dimensional roughness analysis scanning electron microscope, is equal to or more than 0.005 μm and equal to or less than 10 μm, and an average length RSm of a roughness curve element is equal to or more than 0.01 μm and equal to or less than 15 μm.

Test cells with first and second sorbent materials defining a first flow path for a solution, a second flow path distinct from the first flow path for a sample, and a test site with immobilized antigens or antibodies or other ligand-binding molecules located at the junction of the sorbent materials for identifying one or more ligands. In one embodiment, a single highly sensitive immunoassay device is provided that detects the presence in a body fluid sample of two or more COVID-19 (Coronavirus disease 2019) antibodies including immunoglobulin M (IgM) and/or immunoglobulin G (IgG) antibodies to nucleocapsid protein (NP) and spike protein receptor binding domain (RBD), and optionally spike protein S1 subunit (S1) COVID-19 virus antigens. The immunoassay device is sensitive in detecting early infection using IgM antibody detection and continuing infection using IgG antibody detection. Additionally, successful inoculation is distinguished from infection after inoculation by comparing NP and RBD results.

A method for providing variable function medical tests, comprising providing by a mobile device application a plurality of selectable medical test functions, receiving information from the mobile device application regarding test results from a test performed using a testing device, wherein the testing device includes an alignment target disposed on the testing device and a plurality of immunoassay test strips receiving at the server an image of the testing device from the mobile device application, determining by the server RGB values for a plurality of pixels of the image, normalizing by the server the RGB values into a single value, comparing by the server the single value to a control value stored on the server, and providing by the server a risk indicator, wherein the risk indicator indicates a likelihood of a presence of a medical condition.

An assay system for detecting the presence or absence of at least a first analyte and a second analyte in a sample is disclosed. The assay system comprises an assay device and a separate label solution comprising a detection molecule. The assay device comprises: a first detection region for receiving the sample in a vertical direction perpendicular to a longitudinal axis; a second detection region for receiving the sample from the first detection region in a horizontal direction parallel to the longitudinal axis; a first immobilized molecule in one of the first and second detection regions configured to bind to either the detection molecule or the first analyte; and a second immobilized molecule in the other one of the first and second detection regions and configured to bind to the second analyte to generate a complex, wherein the detection molecule is configured to bind to the complex.

The present invention relates to a test system or an assay system (detection system) and test method preferably for use in the Point-of-Care (PoC) field.