Abstract: Compositions and methods are provided for detection, diagnosis and prognosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) disease (COVID-19) and for characterization of SARS-CoV-2 antigen-specific T-cell immune responsiveness in COVID-19 patient samples, including in secondary in vitro immune response assays for long-lived anamnestic (memory) T-cell responses. Disclosed compositions and methods include a method that comprises contacting, in vitro, whole blood samples from subjects suspected of having COVID-19 or who have previously been exposed to SARS-CoV-2, with synthetic peptides comprising T-cell epitope-containing regions derived from SARS-CoV-2 Spike proteins; and indirectly detecting SARS-CoV-2-specific activated T-cells by determining production of a T-cell immune response indicator (e.g., interferon-?) in response to stimulation by the Spike protein-derived peptides.

Abstract: This disclosure relates generally to the field of immunological-based diagnostic assays including an assay to measure cell-mediated immunoresponsiveness. The present disclosure teaches determination of the state, progression and/or severity of disease conditions based on a subject's cell-mediated immunoresponsiveness. The assay contemplated herein is capable of integration into standard pathology architecture to provide a diagnostic reporting system and to facilitate point of care clinical management.

Abstract: Compositions and methods are provided for detection, diagnosis and prognosis of Lyme disease (LD), including a method for confirming Borrelia spp. infection by contacting, in vitro, whole blood samples from subjects suspected of having LD with synthetic peptides comprising T-cell epitope-containing regions derived from Borrelia proteins that are expressed at different stages of Lyme disease, and indirectly detecting LD-specific activated T-cells by determining production of a T-cell immune response indicator (e.g., interferon-Y) in response to stimulation by the peptides.

Abstract: Subject of the invention is a composition comprising at least one fragment of the peptide ESAT-6 and at least one fragment of the peptide CFP-10. Preferably, the fragments comprise at least two sets of peptides, a first set comprising at least one peptide of from about 7 to 14 amino acid residues in length and a second set comprising at least one peptide of from 16 amino acid residues or greater. The invention also relates to diagnostic methods using the composition.

Abstract: Compositions and methods are disclosed that relate to protecting biological activity of a biologically active molecule, including a biologically active protein or biological response modifier such as an immune response modifier, against radiation damage during radiation sterilization. Inclusion of at least one radio-protectant compound, for example, cysteine, reduced glutathione, melatonin, and/or histidine, in an exemplary mitogenic lectin formulation during spray-drying onto surfaces of immunoassay tubes, surprisingly protected the lectin against loss of biological (mitogenic) activity that would otherwise result from electron beam radiation sterilization. The radioprotectant compound also protected other biologically active molecules and stabilized their biological activities, permitting them to retain biological activity after extended storage following the radiation treatment.

Abstract: Compositions and methods are provided for detection, diagnosis and prognosis of Lyme disease (LD), including a method for confirming Borrelia spp. infection by contacting, in vitro, whole blood samples from subjects suspected of having LD with synthetic peptides comprising T-cell epitope-containing regions derived from Borrelia proteins that are expressed at different stages of Lyme disease, and indirectly detecting LD-specific activated T-cells by determining production of a T-cell immune response indicator (e.g., interferon-Y) in response to stimulation by the peptides.

Abstract: This disclosure relates generally to the field of immunological-based diagnostic assays including an assay to measure cell-mediated immunoresponsiveness. The present disclosure teaches determination of the state, progression and/or severity of disease conditions based on a subject's cell-mediated immunoresponsiveness. The assay contemplated herein is capable of integration into standard pathology architecture to provide a diagnostic reporting system and to facilitate point of care clinical management.

Abstract: This disclosure relates generally to the field of immunological-based diagnostic assays including an assay to measure cell-mediated immunoresponsiveness. The present disclosure teaches diagnosis of a subject's exposure to an antigen based on cell-mediated immunoresponsiveness with enhanced sensitivity which is achieved by adding a non-reducing sugar during incubation of the sample with the antigen.

Abstract: The present disclosure relates generally to the field of immunological-based diagnostic assays. Particularly, a method is contemplated herein for measuring cell-mediated immune response reactivity. The present disclosure further provides a method to reduce incidence of non-specific immune response reactivity in a cell-mediated immune response-based assay, comprising contacting a sample with a basic peptide structure capable of binding to lipopolysaccharides, such as polymyxin B or a sushi peptide.

Abstract: This disclosure relates generally to the field of immunological-based diagnostic assays including an assay to measure cell-mediated immunoresponsiveness. The present disclosure teaches diagnosis of a subject's exposure to an antigen based on cell-mediated immunoresponsiveness with enhanced sensitivity which is achieved by adding a non-reducing sugar during incubation of the sample with the antigen.

Abstract: This disclosure relates generally to the field of immunological-based diagnostic assays including an assay to measure cell-mediated immunoresponsiveness. The present disclosure teaches determination of the state, progression and/or severity of disease conditions based on a subject's cell-mediated immunoresponsiveness. The assay contemplated herein is capable of integration into standard pathology architecture to provide a diagnostic reporting system and to facilitate point of care clinical management.

Abstract: Compositions and methods are provided for detection, diagnosis and prognosis of Lyme disease (LD), including a method for confirming Borrelia spp. infection by contacting, in vitro, whole blood samples from subjects suspected of having LD with synthetic peptides comprising T-cell epitope-containing regions derived from Borrelia proteins that are expressed at different stages of Lyme disease, and indirectly detecting LD-specific activated T-cells by determining production of a T-cell immune response indicator (e.g., interferon-Y) in response to stimulation by the peptides.

Abstract: This disclosure relates generally to the field of immunological-based diagnostic assays including an assay to measure cell-mediated immunoresponsiveness. The present disclosure teaches diagnosis of a subject's exposure to an antigen based on cell-mediated immunoresponsiveness with enhanced sensitivity. The assay contemplated herein is capable of integration into standard pathology architecture to provide a diagnostic reporting system and to facilitate point of care clinical management.

Abstract: This disclosure relates generally to the field of immunological-based diagnostic assays including an assay to measure cell-mediated immunoresponsiveness. The present disclosure teaches diagnosis of a subject's exposure to an antigen based on cell-mediated immunoresponsiveness with enhanced sensitivity. Lymphocytes from a subject are contacted with at least a first set of peptides comprising at least one peptide of from 7 to 14 amino acid residues in length and a second set comprising at least one peptide of 16 amino acid residues or greater and the presence or elevation of an immune molecule is detected. The assay contemplated herein is capable of integration into standard pathology architecture to provide a diagnostic reporting system and to facilitate point of care clinical management.

Abstract: Subject of the invention is a composition comprising at least one fragment of the peptide ESAT-6 and at least one fragment of the peptide CFP-10. Preferably, the fragments comprise at least two sets of peptides, a first set comprising at least one peptide of from about 7 to 14 amino acid residues in length and a second set comprising at least one peptide of from 16 amino acid residues or greater. The invention also relates to diagnostic methods using the composition.

Abstract: The present invention relates generally to the field of immunological-based diagnostic assays. More particularly, the present invention contemplates a method for measuring cell-mediated immunoresponsiveness. The present invention further enables determination of the immunosuppressive effects of disease conditions, therapeutic agents and environmental contaminants. The assay of the present invention is also capable of integration into pathology architecture to provide a diagnostic reporting system and to facilitate point of care clinical management.

Abstract: This disclosure relates generally to the field of immunological-based diagnostic assays including an assay to measure cell-mediated immunoresponsiveness. The present disclosure teaches diagnosis of a subject's exposure to an antigen based on cell-mediated immunoresponsiveness with enhanced sensitivity which is achieved by adding a non-reducing sugar during incubation of the sample with the antigen.

Abstract: This disclosure relates generally to the field of immunological-based diagnostic assays including an assay to measure cell-mediated immunoresponsiveness. The present disclosure teaches diagnosis of a subject's exposure to an antigen based on cell-mediated immunoresponsiveness with enhanced sensitivity. Lymphocytes from a subject are contacted with at least a first set of peptides comprising at least one peptide of from 7 to 14 amino acid residues in length and a second set comprising at least one peptide of 16 amino acid residues or greater and the presence or elevation of an immune molecule is detected. The assay contemplated herein is capable of integration into standard pathology architecture to provide a diagnostic reporting system and to facilitate point of care clinical management.

Abstract: This disclosure relates generally to the field of immunological-based diagnostic assays including an assay to measure cell-mediated immunoresponsiveness. The present disclosure teaches determination of the state, progression and/or severity of disease conditions based on a subject's cell-mediated immunoresponsiveness. The assay contemplated herein is capable of integration into standard pathology architecture to provide a diagnostic reporting system and to facilitate point of care clinical management.

Abstract: The present disclosure relates generally to the field of immunological-based diagnostic assays. Particularly, a method is contemplated herein for measuring cell-mediated immune response reactivity. The present disclosure further provides a method to reduce incidence of non-specific immune response reactivity in a cell-mediated immune response-based assay, comprising contacting a sample with a basic peptide structure capable of binding to lipopolysaccharides, such as polymyxin B or a sushi peptide.