Abstract: Methods and compositions for treating or preventing C. difficile infection (CDI) through TcdB or TcdA holotoxins. The compositions feature immunogens or binding agents, such as antibodies, nanobodies (VHHs), single-domain antibodies (sdAbs), etc., based on one or a combination of neutralizing epitopes of TcdB or TcdA. Where immunogens inhibit the conformational changes necessary for pore formation by TcdB at an endosomal pH. Additionally, immunogens inhibit the movement of the scissile bond into the CPD cleavage side and a proper orientation of GTD relative to CPD, thus inhibiting cleavage of the GTD, which is required to activate the toxin. The present invention also describes vaccines for treatment of CDI, e.g., vaccines that target TcdB or TcdA.

Abstract: The illustrated embodiments of the invention include an automated method of assaying a viral and antibody analyte in a sample in a portable, handheld microfluidic reader having a SAW detector with a minimal mass sensitivity limitation. The automated method includes the steps of automatically performing the assay with the SAW detector with enhanced sensitivity as in Optikus I, but also includes the steps of automatically disposing a second portion of the sample on a microarray, selectively automatically probing the second portion of the sample for antibodies corresponding to the at least one selected virus using the microarray, and automatically reading the microarray using a fluorescent camera to identify antibodies in the second portion of the sample.

Abstract: The illustrated embodiments of the invention include an automated method of assaying a viral and antibody analyte in a sample in a portable, handheld microfluidic reader having a SAW detector with a minimal mass sensitivity limitation. The automated method includes the steps of automatically performing the assay with the SAW detector with enhanced sensitivity as in Optikus I, but also includes the steps of automatically disposing a second portion of the sample on a microarray, selectively automatically probing the second portion of the sample for antibodies corresponding to the at least one selected virus using the microarray, and automatically reading the microarray using a fluorescent camera to identify antibodies in the second portion of the sample.

Abstract: Contemplated microfluidic devices and methods are drawn to protein arrays in which distinct and detergent-containing antigen preparations are deposited onto an optical contrast layer in a non-specific and non-covalent manner. Detection of binding a is carried out using a dye that precipitates or agglomerates to so form a visually detectable signal at a dynamic range of at least three orders of magnitude.

Abstract: Disclosed herein are diagnostic methods and compositions for identifying individuals that are protected against Plasmodium falciparum caused malaria. Such methods are particularly useful for determining not only the protective efficacy of Pf whole parasite vaccines for individual subjects, but also within populations of vaccinated subjects. Also disclosed herein are subunit vaccines comprising at least one Pf immunologic determinant for protection against Plasmodium-caused malaria.

Abstract: Contemplated compositions, devices, and methods comprise immunodominant antigens from selected human pathogens (Burkholderia pseudomallei, Borrelia burgdorferi, Brucella melitensis, Chlamydia muridarum, Coxiella burnetii, Francisella tularensis, human Herpes virus 1 and 2, Mycobacterium tuberculosis, Plasmodium falciparum, and Vaccinia virus) can be used as a vaccine, as diagnostic markers, and as therapeutic agents. In particularly preferred aspects, the antigens have quantified and known relative reactivities with respect to sera of a population infected with the pathogen, and have a known association with a disease parameter.

Abstract: Contemplated compositions, devices, and methods are drawn to various antigens from the pathogen M. tuberculosis and their use in vaccines, therapeutic agents, and various diagnostic tests. In particularly preferred aspects, the antigens are immunodominant and have quantified and known relative reactivities with respect to sera of a population infected with the pathogen, and/or have a known association with a disease parameter.

Abstract: Disclosed herein are diagnostic methods and compositions for identifying individuals that are protected against Plasmodium falciparum caused malaria. Such methods are particularly useful for determining not only the protective efficacy of Pf whole parasite vaccines for individual subjects, but also within populations of vaccinated subjects. Also disclosed herein are subunit vaccines comprising at least one Pf immunologic determinant for protection against Plasmodium-caused malaria.

Abstract: Methods to obtain expression systems and proteins in a high-throughput protocol by utilizing mixtures of cells cultured from those transformed with a desired nucleotide sequence permit rapid production of protein for use in arrays to assess activity. In one embodiment, the proteins (or peptides) in the array are assessed for their immunological activity with regard to an infectious agent.

Abstract: Contemplated compositions, devices, and methods comprise immunodominant antigens from selected human pathogens (Burkholderia pseudomallei, Borrelia burgdorferi, Brucella melitensis, Chlamydia muridarum, Coxiella burnetii, Francisella tularensis, human Herpes virus 1 and 2, Mycobacterium tuberculosis, Plasmodium falciparum, and Vaccinia virus) can be used as a vaccine, as diagnostic markers, and as therapeutic agents. In particularly preferred aspects, the antigens have quantified and known relative reactivities with respect to sera of a population infected with the pathogen, and have a known association with a disease parameter.

Abstract: Contemplated compositions, devices, and methods are drawn to various antigens from the pathogen M. tuberculosis and their use in vaccines, therapeutic agents, and various diagnostic tests.

Abstract: Contemplated compositions, devices, and methods are drawn to various antigens from the pathogen M. tuberculosis and their use in vaccines, therapeutic agents, and various diagnostic tests. In particularly preferred aspects, the antigens are immunodominant and have quantified and known relative reactivities with respect to sera of a population infected with the pathogen, and/or have a known association with a disease parameter.

Abstract: Disclosed herein are diagnostic methods and compositions for identifying individuals that are protected against Plasmodium falciparum caused malaria. Such methods are particularly useful for determining not only the protective efficacy of Pf whole parasite vaccines for individual subjects, but also within populations of vaccinated subjects. Also disclosed herein are subunit vaccines comprising at least one Pf immunologic determinant for protection against Plasmodium-caused malaria.

Abstract: Disclosed herein are diagnostic assays for identifying individuals that are protected against Plasmodium falciparum caused malaria. Such assays are particularly useful for determining not only the protective efficacy of Pf whole parasite vaccines for individual subjects, but also within populations of vaccinated subjects. The assays comprise the use of proteomes representing at least 50% of Pf, preferably coupled to a solid phase as a fixed array. The arrays are used to probe the sera of human subjects, particularly subjects of human clinical trials of whole parasite malaria vaccines as well as public health vaccination campaigns. Serum samples with antibody profiles most strongly reactive in multiplex to CSP and MSP5 demonstrate a sensitivity of from 92% to 100% and a specificity of from 84% to 89%.

Abstract: Contemplated compositions, devices, and methods are drawn to various antigens from Herpes Simplex Virus type 1 (HSV-1) and Herpes Simplex Virus type 2 (HSV-2) and their use in vaccines, therapeutic agents, and various diagnostic tests. In particularly preferred aspects, the antigens are immunodominant and have quantified and known relative reactivities with respect to sera of a population infected with the pathogen, and/or have a known association with a disease parameter.

Abstract: Contemplated compositions, devices, and methods comprise immunodominant antigens from selected human pathogens (Burkholderia pseudomallei, Borrelia burgdorferi, Brucella melitensis, Chlamydia muridarum, Coxiella burnetii, Francisella tularensis, human Herpes virus 1 and 2, Mycobacterium tuberculosis, Plasmodium falciparum, and Vaccinia virus) can be used as a vaccine, as diagnostic markers, and as therapeutic agents. In particularly preferred aspects, the antigens have quantified and known relative reactivities with respect to sera of a population infected with the pathogen, and have a known association with a disease parameter.

Abstract: Novel immunodominant antigenic proteins and peptides associated with associated with leptospirosis were identified using a proteome array based on expression of ORFs from a Leptospira genome. Compositions, methods, and uses of such antigenic proteins and peptides in the diagnosis and staging of leptospirosis infection and in compositions, methods, and uses of such antigenic is proteins and peptides in prophylactic and therapeutic vaccines are disclosed.

Abstract: Contemplated compositions, devices, and methods are drawn to various antigens from the pathogen M. tuberculosis and their use in vaccines, therapeutic agents, and various diagnostic tests. In particularly preferred aspects, the antigens are immunodominant and have quantified and known relative reactivities with respect to sera of a population infected with the pathogen, and/or have a known association with a disease parameter.

Abstract: Contemplated compositions, devices, and methods comprise immunodominant antigens from selected human pathogens (Burkholderia pseudomallei, Borrelia burgdorferi, Brucella melitensis, Chlamydia muridarum, Coxiella burnetii, Francisella tularensis, human Herpes virus 1 and 2, Mycobacterium tuberculosis, Plasmodium falciparum, and Vaccinia virus) can be used as a vaccine, as diagnostic markers, and as therapeutic agents. In particularly preferred aspects, the antigens have quantified and known relative reactivities with respect to sera of a population infected with the pathogen, and have a known association with a disease parameter.

Abstract: Contemplated compositions, devices, and methods are drawn to various antigens from Herpes Simplex Virus type 1 (HSV-1) and Herpes Simplex Virus type 2 (HSV-2) and their use in vaccines, therapeutic agents, and various diagnostic tests. In particularly preferred aspects, the antigens are immunodominant and have quantified and known relative reactivities with respect to sera of a population infected with the pathogen, and/or have a known association with a disease parameter.