Described is an assay for diagnosing an infection such as peritonitis in a subject. The assay includes a binding molecule, such as an antibody that specifically binds to an inflammatory marker in a sample from the subject, and a second binding molecule that binds to a marker indicative of a pathogen in the sample. For diagnosing peritonitis in a subject, the pathogen will be at least one bacterium and/or fungus. Typically, the assay will be incorporated into a lateral flow device and may include a binding molecule that specifically binds to an antigen indicative of the presence of a specific pathogen species. The described assay(s) may further include filter(s), enriching antigen(s), and buffer(s). Also described are methods of diagnosing and treating peritonitis in a subject who is a peritoneal dialysis patient that include utilizing the herein described assay(s) or assay kit(s) to analyze the subject's peritoneal dialysis effluent.

The subject invention pertains to systems and methods diagnosing, monitoring and treating women for successful embryo implantation and establishment of pregnancy using peripheral blood cytokine profiling and administration of immune-modulators to establish an implantation-promoting microenvironment in the uterus.

A method of immune phenotyping (evaluating adaptive and innate immune status) a subject is disclosed that includes providing a biological sample comprising diluted whole blood or isolated peripheral blood mononuclear cells (PBMCs), quantitating T cell interferon-gamma (IFN-γ) and monocyte TNF-α production using ELISpot in the biological sample comprising diluted whole blood, and determining that the subject has an immunosuppressive immunological endotype if T cell interferon-gamma (IFN-γ) and/or monocyte TNF-α production are decreased or low compared to a healthy subject. The disclosed method may be used to evaluating drug efficacy by measuring immune function in a subject after administering a drug to the subject to determine changes in the immune function of the subject in response to the drug.

Disclosed are compositions and methods to detect proteins associated with non-coeliac gluten sensitivity (NCGS). Such markers may be useful to allow individuals susceptible to NCGS to manage their food intake to avoid symptoms and further progression of disease.

It has been demonstrated that certain compounds bind to TNF and stabilise a conformation of trimeric TNF that binds to the TNF receptor. Antibodies which selectively bind to complexes of such compounds with TNF superfamily members are disclosed. These antibodies may be used to detect further compounds with the same activity, and as target engagement biomarker.

The invention relates to a method for obtaining APRIL-binding peptides. With this method APRIL-binding peptides may be obtained and/or selected. Further aspects of the invention relate to a cell comprising a nucleotide sequence coding for an APRIL-binding peptide according to the invention, a process for producing an APRIL-binding peptide and the APRIL-binding peptide obtainable in the production process and/or the selection method. In view of the possible utility of the APRIL-binding peptides according to the invention, further aspects of the invention relate to diagnostic uses of an APRIL binding peptide of the invention.

The present disclosure provides antibodies that specifically bind to human OX40 receptor (OX40) and compositions comprising such antibodies. In a specific aspect, the antibodies specifically bind to human OX40 and modulate OX40 activity, e.g., enhance, activate, or induce OX40 activity, or diminish, deactivate, or suppress OX40 activity. The present disclosure also provides methods for treating disorders, such as cancer, by administering an antibody that specifically binds to human OX40 and modulates OX40 activity, e.g., enhances, activates, or induces OX40 activity. Also provided are methods for treating autoimmune or inflammatory diseases or disorders, by administering an antibody that specifically binds to human OX40 and modulates OX40 activity, e.g., diminishes, deactivates, or suppresses OX40 activity.

The present disclosure relates to methods of detecting free (active) LIGHT in biological samples to diagnose conditions associated with elevated free LIGHT, as well as to predict the effectiveness of anti-LIGHT therapies. The disclosure also relates to treating such conditions with anti-LIGHT antibodies. Conditions include acute lung injury (ALI) and acute respiratory distress syndrome (ARDS), optionally wherein the ALI and ARDS are associated with viral infection, including coronavirus infection. Conditions also include Crohn's Disease or an inflammatory condition associated with Crohn's Disease.

Methods for predicting pharmacokinetics of an Immunoglobulin G (IgG) therapeutic protein based on a patient's level of rheumatoid factor (RF), anti-citrullinated protein antibodies (ACPA), or RF and ACPA. Methods disclosed herein also relate to methods for determining the therapeutically effective dose of an IgG therapeutic protein based on the levels of RF, ACPA, or RF and ACPA.

The present disclosure provides a rapid test for determining state of an infection (e.g., a coronavirus such as Covid-2019) in a subject. The test may include the steps of detecting of an antibody specific to the pathogen in a blood sample from the subject, and detecting and quantitating the level of at least one inflammatory biomarker in the same subject.