The invention features methods, systems, and panels for rapid detection of tick-borne pathogens in a sample (including Borrelia spp. such as B. burgdorferi, B. afzelii, and B. garinii) and for diagnosis and monitoring of tick-transmitted diseases, including Lyme disease, Rocky Mountain spotted fever, Q-fever, babesiosis, ehrlichiosis, tularemia, and anaplasmosis.

Disclosed herein is a method of detecting and identifying antigens that are shed into human bodily fluids during infection. The disclosed method allows circulating antigens associated with a particular infection to be detected within minutes or hours from testing as compared to days required with the current methods. Methods of identifying diagnostic indicators/targets for a given condition or disease are disclosed which include immunizing a veterinary subject with biological fluids obtained from a human infected with particular antigens to identify diagnostic targets for immunoassay. Also disclosed are methods of diagnosing and monitoring a B. burgdorferi-associated condition, such as Lyme disease. Point-of-care immunoassays are also provided that can be used to diagnose or monitor the efficacy of a B. burgdorferi-associated condition treatment. These immunoassays can also be used for rapid diagnosis of infection produced by B. burgdorferi, such as Lyme disease.

The present invention is directed to a method for making a solid substrate for conducting biological and chemical assays and to the solid substrate made by the method.

Disclosed herein is a panel comprising one or more MHC multimers; and a panel comprising one or more pools of MHC multimers, wherein each pool comprises one or more MHC multimers; wherein said MHC multimers comprise an antigenic peptide P derived from a Borrelia antigenic polypeptide selected from the group consisting of OppA, DbpA, FlhF, FlaB and P37-42; as well as uses thereof in the detection of Borrelia-specific T cells and the diagnosis, treatment and monitoring of Borrelia disease in an individual.

The disclosure, in some aspects, provides antigen-specific amino acid sequences for Borrelia burgdorferi sensu lato species.

A device for determining presence or absence of infection due to an infectious agent is described. The device comprises a sample receiving zone configured to receive a liquid sample from a subject suspected of having an infection due to an infectious agent, the sample receiving zone positioned to distribute the sample along a first fluid flow path to a first label zone and along a second fluid flow path to a second label zone. Test lines in each fluid flow path capture a mobile detectable species as an indicator of presence or absence of the infectious agent. The device also comprises a reference line positioned in the one of the fluid flow paths. The bidirectional fluid flow paths emanate from a common sample zone and provide an efficient approach to detection and differentiate two species as indicators of the same infectious agent or as indicators of two different infectious agents.

The invention provides compositions (e.g., peptide compositions) useful for the detection of antibodies that bind to Borrelia antigens. The peptide compositions comprise polypeptide sequences comprising variants in the IR6 domain of the Borrelia VlsE protein. The invention also provides devices, methods, and kits comprising such peptide compositions and useful for the detection of antibodies that bind to Borrelia antigens and the diagnosis of Lyme disease.

Provided herein are multiplex assays for detecting antibodies indicative of presence and stage of syphilis infection in an individual. Individuals infected with syphilis produce antibodies directed to syphilis components and the lipid cellular debris associated with the infection. The present disclosure represents the first combination of these diverse antibody targets in a single assay.

The present invention provides compositions and methods that can be used to determine a peptide signature for an antibody repertoire in a sample comprising multiple antibodies. The method can be used to characterize a phenotype in a sample, such as providing a diagnosis, prognosis or theranosis of a medical condition.

The subject matter disclosed herein provides a method and a device for detection of one or more bacteria in a sample.