The present invention relates to a kit of parts and methods for determining the presence and quantity of one or more TNF-α inhibitor drugs and/or anti-TNF-α inhibitor drug antibodies in one or more biological samples each comprising less than 200 μl, the method comprising the steps of providing a reaction liquid comprising the sample, a first TNF-α conjugate comprising TNF-α and a first conjugated moiety and a second TNF-α conjugate comprising TNF-α and a second conjugated moiety, said second moiety being capable of generating or ameliorating a detectable signal in the presence of a molecular complex comprising a TNF-α inhibitor, followed by detecting the change in signal when the complex between the TNF-α inhibitor drug, the first TNF-α conjugate and a the second TNF-α conjugate forms.

This disclosure relates to methods of diagnosing and predicting renal disease, using one, two, or more biomarkers, including sTN-FR1, sTNFR2, sFAS, TNF, and IL-6.

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.

Provided is a method for diagnosing a subject having or at risk of having mild cognitive impairment (MCI), including stimulating T cells in a biological sample obtained from the subject with an amyloid β peptide or a fragment thereof and evaluating a magnitude of a T cell response toward the amyloid β peptide or the fragment thereof. Also provided is a kit for diagnosing MCI by using the method.

A method for assessing the potency of MSCs to produce anti-inflammatory cytokines in response to a pro-inflammatory stimulus. The method comprises stimulating the MSCs with one or more proinflammatory cytokines, such as TNF-α, for a duration of time and then identifying and quantifying the production of anti-inflammatory cytokines. MSCs that produce potent levels of anti-inflammatory cytokines in response to TNF-α can be used in treatments for aging-related conditions, including aging frailty and Alzheimer's disease, and can also be used to treat corona virus infections. The method shows that TNF-α induced MSCs robustly secrete several anti-inflammatory cytokines, including IL-1 receptor antagonist (IL-1RA), IL-10, and granulocyte colony stimulating factor (G-CSF).

Epileptic seizures are difficult to diagnose and are often difficult to distinguish from several conditions with similar presentations, and therefore, diagnosis of seizures is often a long, expensive, and unreliable process. This invention provides biomarkers for identifying seizures and epilepsy, assays for measuring and assessing biomarker concentration, predictive models based on biomarkers and computational systems for detecting, assessing and diagnosing phasic and tonic changes associated with seizures and epilepsy in all clinical and healthcare settings. Diagnostic and treatment methods, systems, kits, and predictive models provided herein, provide quantitative and/or qualitative assessment in order to allow patients to proceed immediately to diagnostic and/or treatment protocols, and assess therapeutic treatment effectiveness.

A molecule capable of binding to human 4-1BB includes the amino acid sequences of HCDR1, HCDR2 and HCDR3 in the heavy chain variable region of the antibody provided by present invention are shown sequentially at positions 31-35, positions 50-64, and positions 98-106 in SEQ ID No.1 from the N-terminus. The amino acid sequences of LCDR1, LCDR2 and LHCDR3 in the light chain variable region are shown sequentially at positions 24-34, positions 50-56, and positions 89-97 in SEQ ID No.2 from the N-terminus. The antibodies provided by the present invention can bind to human and monkey 4-1BB, exhibit high affinity to human 4-1BB and effectively enhance T cell responses; they can be used to regulate the immune responses mediated by T cells and antibodies; as immune modulators, they have a wide range of therapeutic uses in diseases such as cancer, autoimmune diseases, inflammatory diseases, and infectious diseases, etc.

The invention relates to a method for the diagnosis and/or risk stratification of invasive fungal infections (IFI)/invasive fungal diseases (IFD) and in particular associated with sepsis or septic shock, wherein a determination of the marker proadrenomedullin (proADM) or a partial peptide or fragment thereof, in particular midregional proadrenomedullin (MR-proADM), or contained in a marker combination (panel, cluster), is carried out from a patient to be examined. Furthermore, the invention relates to a diagnostic assay and a kit for carrying out the method.

Disclosed are methods for conducting diagnostic tests for the detection of the inflammatory bowel diseases, such as Crohn’s disease and ulcerative colitis. Also described are methods for monitoring a patient by administering tests of the present invention. Also described are methods for monitoring patient’s treatment by administering tests of the present invention. Also described are methods for evaluating the effectiveness of a drug or a drug candidate by administering tests of the present invention to samples from patients, animal models, and cell cultures treated with a drug or a drug candidate. Also disclosed are methods for determining the usefulness of analytes, e.g. cytokines, for acting as diagnostic and monitoring markers for inflammatory bowel disease in the various methods of the invention.

Methods and kits for screening, diagnosing, detecting or predicting a patient outcome/risk in a patient with a respiratory illness, the method comprising: a. obtaining a sample obtained from the patient; b. quantitatively measuring in the sample a polypeptide level of one or more biomarkers selected from: IL-6, CXCL8, IL-10, IL-IRA, IL-2, IL-4, IL-7, IL-9, IL-13, IL-17, IFN-g, IP-10, MCP-1, G-CSF, GM-CSF, FGF-basic, SCGF-β, GRO-α, MIP1-α, MIP1-β, CK-18, PDGF-bb, caspase 3, HMGB-1, TNF α, VEGF, sTNFR1 and sTREM1; and c. i) comparing the level of the one or more biomarkers in the sample with a control or cut-off level, wherein the differential level is indicative of patient outcome risk; or ii) using the polypeptide level of several of the biomarkers in combination, as inputs for an algebraic calculation or machine learning model of patient outcome risk.