Described are assays, associated assay kits, and associated methods for diagnosing an infection in a subject. The assay includes a first binding molecule that specifically binds an inflammatory marker (i.e., neutrophil gelatinase-associated lipocalin (NGAL) homodimer) in a sample taken from the subject, and a second binding molecule that binds a marker indicative of the presence of a pathogen in the sample. The assay and methods are for the diagnosis of peritonitis in peritoneal dialysis patients.

The present disclosure provides, in part, a method of treating an autoimmune disease in a subject by reducing the number of pDCs through administration of a human interleukin-3 (IL-3)-diphtheria toxin conjugate (DT-IL3). The disclosure also generally relates to methods of monitoring the effectiveness of therapy in subjects receiving DT-IL3 for treating an autoimmune disease, and methods of determining continuing treatment of subjects receiving DT-IL3 for treating an autoimmune disease. The disclosure also provides pharmaceutical compositions of DT-IL3 for use in such methods.

Methods of diagnosing infections are disclosed. In one embodiment, the method comprises measuring the amount of each of the polypeptides TRAIL, CRP, IP10 and at least one additional polypeptide selected from the group consisting of IL-6 and PCT.

Biomarker panels for the prediction of patient response to immunotherapy, and methods of use thereof.

Diagnostic screening tests that can be used to identify if a patient is a good candidates for an implantable vagus nerve stimulation device. One or more analyte, such as a cytokine or inflammatory molecule, can be measured from a blood sample taken prior to implantation of a vagus nerve stimulator to determine the patient's responsiveness to VNS for treatment of an inflammatory disorder.

Disclosed is a method for evaluating the ability of a chemical substance or a chemical composition to prevent muscle fatigue and damage induced by physical exertion in humans by comparing the effect the chemical substance or a chemical composition has on a combination of three biological markers in cultured human primary skeletal muscle cells.

A method for determining the risk of acute kidney injury (AKI) in a mammal following cardiac surgery is provided. The method comprises determining the sample value of IL-6 or hFABP concentration, or the ratio of IL-6 to IL-10, in a biological sample from the mammal, either prior to cardiac surgery or within 6 hours following surgery; comparing the sample value to a corresponding reference value; and determining that the mammal is at risk of acute kidney injury following cardiac surgery if the sample value is greater than the corresponding reference value.

Provided herein are vertical flow assay devices for detecting presence or an amount of cytokines in a sample. Also provided herein are immunoassay methods for detecting presence or an amount of cytokines in a sample, using the vertical flow assay devices.

The present inventors discovered that problems of existing antibody pharmaceuticals can be solved by producing antigen-binding molecules that contain an antigen-binding domain whose antigen-binding activity varies depending on the concentration of a target tissue-specific compound. Use of antigen-binding molecules of the present invention enables various diseases that originate from a target tissue to be treated in a manner specific to the target tissue.

Provided herein are methods for reducing risk of severe symptoms and outcomes associated with Coronavirus Disease 2019 (COVID-19) and Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection by measuring levels of interleukin 6 (IL-6), IL-8, IL-22, and serum ferritin in a subject. Also provided are methods for treating a subject exposed to or at elevated risk of expose to SARS-CoV-2 based on levels of IL-6, IL-8, IL-22, and ferritin in the serum of the subject.