Abstract: A method for performing a lateral flow assay is provided. The method includes inserting a sample cartridge in a dark chamber and activating a light emitter in the dark chamber. The method includes focusing an optical coupling mechanism in an image-capturing device to optimize an image of a sensitive area in the sample cartridge and capturing, with an image capturing device, an image of a sensitive area in the sample cartridge after a selected period of time. The method also includes providing the image of the sensitive area to a processor, wherein the processor comprises an image-capturing application. A system and a computer-implemented method to perform at least partially the above method are also provided.

Abstract: A method for performing a lateral flow assay is provided. The method includes inserting a sample cartridge (201) in a dark chamber (220) and activating a light emitter (251) in the dark chamber (220). The method includes focusing an optical coupling mechanism (115a, 115b) in an image-capturing device (100a, 100b) to optimize an image of a sensitive area (202) in the sample cartridge (201) and capturing, with an image capturing device (100a, 100b), an image of a sensitive area (202) in the sample cartridge (201) after a selected period of time. The method also includes providing the image of the sensitive area (202) to a processor, wherein the processor comprises an image-capturing application (122). A system and a computer-implemented method to perform at least partially the above method are also provided.

Abstract: Methods, devices and kits for rapid identification of individuals previously infected with, or vaccinated for, a bacterial or viral pathogen, such as SARS CoV-2 virus. Pathogen specific memory T cells, such as SARS CoV-2 specific memory T cells, provide indication of prior infection, if detected. Memory T cells are assayed by exposure to specific bacterial and/or viral antigens and then tested for activation by analysis of nucleotide content.

Abstract: Methods for determining bacterial identity and susceptibility or resistance to antibiotic or antimicrobial agents are provided. In one embodiment, the bacteria is cultured in the presence or absence or the antibiotic agent to generate a plurality of primary cultures, which are then cultured in the presence or absence of transforming phages to generate a first secondary culture that comprise transformed bacteria that have been treated with the antibiotic agent and a second secondary culture that comprises transformed bacteria that have not been treated with the antibiotic agent. The recombinant phages are specific to the bacteria and comprise a heterologous marker. The susceptibility or resistance of the bacteria to the antibiotic or antimicrobial agent is determined by comparing a level or activity of the marker in the first and second secondary cultures.

Abstract: Lateral flow immunoassays that reliably detect human antibodies, including IgG and/or IgM antibodies, specific for severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) are described herein. Devices, methods and kits for analysis of samples, such as liquid blood, serum or plasma, for the presence of human antibodies, such as IgG and/or IgM antibodies, specific for SARS CoV-2 proteins, such as SARS CoV-2 N and/or S proteins are provided.

Abstract: A method for performing a lateral flow assay is provided. The method includes inserting a sample cartridge (201) in a dark chamber (220) and activating a light emitter (251) in the dark chamber (220). The method includes focusing an optical coupling mechanism (115a, 115b) in an image-capturing device (100a, 100b) to optimize an image of a sensitive area (202) in the sample cartridge (201) and capturing, with an image capturing device (100a, 100b), an image of a sensitive area (202) in the sample cartridge (201) after a selected period of time. The method also includes providing the image of the sensitive area (202) to a processor, wherein the processor comprises an image-capturing application (122). A system and a computer-implemented method to perform at least partially the above method are also provided.

Abstract: A system for analysis of a sample to aid in diagnosis and/or detection of the presence or absence, and/or the identity of, an analyte in the sample is provided. A cartridge with reagents to isolate nucleic acid from a sample inserted in the cartridge and to amplify the isolated nucleic acid, and an instrument that interacts with the cartridge, together provide a self-contained sample to answer system for detection, identification, differentiation and/or quantification of a target nucleic acid in a sample.

Abstract: Antibody fusions comprising any antibody or fragment thereof, operably linked, and expressed as a fusion with a label of interest are provided. Plasmids, vectors, host cells, methods, and kits related to the described antibody fusions are also provided. The antibody fusions are useful at least in the diagnostic and reagent setting.

Abstract: Methods for determining bacterial identity and susceptibility or resistance to antibiotic or antimicrobial agents are provided. In one embodiment, the bacteria is cultured in the presence or absence or the antibiotic agent to generate a plurality of primary cultures, which are then cultured in the presence or absence of transforming phages to generate a first secondary culture that comprise transformed bacteria that have been treated with the antibiotic agent and a second secondary culture that comprises transformed bacteria that have not been treated with the antibiotic agent. The recombinant phages are specific to the bacteria and comprise a heterologous marker. The susceptibility or resistance of the bacteria to the antibiotic or antimicrobial agent is determined by comparing a level or activity of the marker in the first and second secondary cultures.

Abstract: The present invention relates, in part, to methods for determining a prognosis of early stage lung cancer in an individual using one or more biomarkers.

Abstract: The invention provides diagnostic methods, kits, and systems, and related computer-readable media, which use multiple blood marker values, including serum and plasma marker values, to aid in the diagnosis of the status or progress of a liver disease in a patient. The invention also provides methods and systems, and related computer-readable media, that use blood marker values, including serum and plasma marker values: (1) to screen for active ingredients useful in the treatment of a liver disease; (2) to aid in the selection of treatment regimens for patients that are predisposed to, or suffer from, liver disease; and (3) to aid in the design of clinical programs useful in monitoring the status or progress of liver disease in one or more patients.

Abstract: The present invention relates to monoclonal antibodies binding to the N-terminal procollagen (III) propeptide (PIIINP) molecule which is a proteolytic fragment emanating from the specific cleavage of procollagen (III) by N-proteinase after exocytosis and to an assay using these antibodies.

Abstract: The present invention provides SNPs, polymorphic variants, and haplotypes associated with cardiovascular disease. The invention also provides methods for detecting the SNPs, polymorphic variants, and haplotypes. The invention also provides methods for determining an individual's genotype with respect to one or more polymorphisms and/or haplotypes associated with cardiovascular disease. The invention further provides methods of determining whether an individual has or is susceptible to development or occurrence of a cardiovascular disease or event. The methods are useful for providing diagnostic and/or prognostic information, selecting therapeutic regimens, etc. The invention further provides reagents and kits for practicing the methods.

Abstract: The invention provides diagnostic methods, kits, and systems, and related computer-readable media, which use multiple blood marker values, including serum and plasma marker values, to aid in the diagnosis of the status or progress of a liver disease in a patient. The invention also provides methods and systems, and related computer-readable media, that use blood marker values, including serum and plasma marker values: (1) to screen for active ingredients useful in the treatment of a liver disease; (2) to aid in the selection of treatment regimens for patients that are predisposed to, or suffer from, liver disease; and (3) to aid in the design of clinical programs useful in monitoring the status or progress of liver disease in one or more patients.

Abstract: The present invention concerns a method for diagnosing liver fibrosis wherein two or more diagnostic markers are measured and the measurements are correlated by a mathematic algorithm characterized in that the diagnostic markers are selected from the group N-terminal procollagen III propeptide (PIIINP), Collagen IV, Collagen VI, Tenascin, Laminin, Hyaluronan, MMP-2, TIMP-1 and MMP-9/TIMP-1 complex. The algorithm can be used to predict the histological score of a liver biopsy.

Abstract: The present invention concerns a method for diagnosing liver fibrosis wherein two or more diagnostic markers are measured and the measurements are correlated by a mathematic algorithm characterized in that the diagnostic markers are selected from the group N-terminal procollagen III propeptide (PIIINP), Collagen IV/, Collagen VI, Tenascin, Laminin, Hyaluronan, MMP-2, TIMP-1 and MMP-9/TIMP complex. The algorithm can be used to predict the histological score of a liver biopsy.

Abstract: An assay device for the detection of analyte in a sample, methods and immunoassay formats for performing an assay with or without the device, and methods for manufacturing the device are provided. The device is a continuous liquid flow channel having a proximal and a distal end, with a detection membrane in fluid communication with the distal end of the flow channel. Interspersed between the assay buffer and detection membrane, and continuous with the liquid flow channel, are a sample delivery means, one or more reservoirs containing the reagents necessary for conducting the assay, and, optionally, mixing or incubation reservoirs for combining the sample and reagents. The geometry of the liquid flow channel regulates the flow rate of the liquids through the channel, thereby controlling incubation, mixing and reaction time. The preferred detection membrane is an immunochromatographic test strip containing immobilized reagents.

Abstract: The invention relates to a kit comprising a pharmaceutical composition containing repinotan or a physiologically acceptable salt of repinotan, and a means for the determination of the concentration of repinotan or its metabolites in body fluids, and also new pharmaceutical compositions containing repinotan or a physiologically acceptable salt of repinotan, and processes for their preparation.

Abstract: The invention relates to a kit comprising a pharmaceutical composition containing repinotan or a physiologically acceptable salt of repinotan, and a means for the determination of the concentration of repinotan or its metabolites in body fluids, and also new pharmaceutical compositions containing repinotan or a physiologically acceptable salt of repinotan, and processes for their preparation.

Abstract: The invention relates to a kit comprising a pharmaceutical composition containing repinotan or a physiologically acceptable salt of repinotan, and a means for the determination of the concentration of repinotan or its metabolites in body fluids, and also new pharmaceutical compositions containing repinotan or a physiologically acceptable salt of repinotan, and processes for their preparation.