The disclosure provides biomarker proteins, a change in the concentration or activity level of which are associated with atypical hemolytic uremic syndrome (aHUS) or clinically meaningful treatment of aHUS with a complement inhibitor. Also provided are compositions and methods for interrogating the concentration and/or activity of one or more of the biomarker proteins in a biological fluid. The compositions and methods are useful for, among other things, evaluating risk for developing aHUS, diagnosing aHUS, determining whether a subject is experiencing the first acute presentation of aHUS, monitoring progression or abatement of aHUS, and/or monitoring response to treatment with a complement inhibitor or optimizing such treatment.

The present invention is directed to methods for using a plurality of particles comprising surfaces each independently comprising a capture moiety to isolate and characterize biomarkers (e.g., for obstructive sleep apnea).

The present disclosure relates to methods and compositions for treating traumatic brain injury (TBI) and TBI-associated impairments and improving outcome in subjects that have sustained traumatic brain injury comprising administering to the subject a sgp130 or an agent that promotes the binding of sgp130 and sIL-6R and/or reduces sIL-6R mediated trans-signaling. The present disclosure also relates to methods and kits for identifying a subject that is at risk of developing a TBI-associated impairment (e.g., headache, depression, cognitive deficits, and seizure) or monitoring the responsiveness to a treatment regimen for a TBI-associated impairment in the subject, using biomarkers (e.g., white blood cells indices (e.g., Neutrophil-Lymphocyte Ratio (NLR), absolute lymphocyte counts), sIL-6R, sgp130, IL-6, sgp130:sIL-6R ratio, sIL-2Ra, IL-2, sIL-2Ra:IL-2 ratio, TNFα, TNFRI, and TNFRI:TNFα ratio).

A method of determining a management course for treating a subject showing symptoms of a disease is disclosed. The method comprises measuring the TRAIL protein level in a blood sample of the subject, wherein when the TRAIL level is above a predetermined amount, the subject is treated as a low-risk patient.

Methods, systems, and kits for detection, diagnosis, monitoring, and/or treatment of viral infections such as represented by the COVID-19 disease are described. The methods, systems, and kits are capable of detection of salivary biomarkers which correlate with, and are indicative of, COVID-19 in a subject. Detection of the biomarkers in a saliva sample provides opportunities for a COVID-19 or other viral detection assay which is non-invasive, produces rapid results, and can be implemented in the field on a wide geographic basis for individualized screening or mass screenings for COVID-19 or other viral infections.

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), IL8, IL22, 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 IL6, IL8, IL22, and ferritin in the serum of the subject.

An injectable formulation, comprising: poly(lactic-co-glycolic (PLGA) microsphere encapsulating siltuximab, wherein microspheres are sized to release siltuximab over a period of hours, days and weeks, where the biocompatible polymer releases antibody at an absorption rate which is characterized by an absorption rate constant (Ka (h.sup.−1) in the range of (0.001 to 2.048)+/−20%, or +/−10%, or +/−5%. for use and treating human patients with infections. The invention includes treating patients with viral infections of SARS-Cov-2 using siltuximab.

Multiplexed test measurements are conducted using an assay module having a plurality of assay domains. In preferred embodiments, these measurements are conducted in assay modules having integrated electrodes with a reader apparatus adapted to receive assay modules, induce luminescence, preferably electrode induced luminescence, in the wells or assay regions of the assay modules and measure the induced luminescence.

Disclosed is a system, a kit, a use and an in vitro method for assessing whether a human patient suffering from periodontitis has mild periodontitis or advanced periodontitis. The system and method are based on the insight to apply a clustering technique to a reference set of patient data, and then further discriminating the sets of bio markers to be applied. The clusters are determined on the basis of the biomarkers Hepatocyte Growth Factor (HGF), Matrix metalloproteinase 8 (MMP8), and Matrix metalloproteinase 9 (MMP9). The actual classification of the patient is done on the basis of the measurement of the concentrations of either of two sets of biomarkers. For one cluster these are Interleukin-1β (IL1β), Interleukin-6 (IL6), and Collagen Telopeptide. For the other cluster, these are HGF and metallopeptidase inhibitor 1 (TIMP1).

Provided herein are methods for assessing risk of infection or cardiovascular disease (CVD) in a subject with an inflammatory disease, e.g., rheumatoid arthritis. The methods include performing immunoassays to generate scores based on quantitative data for expression of biomarkers relating to inflammatory biomarkers with or without additional clinical variables to assess infection and CVD risk. Also provided are uses of inflammatory biomarkers for guiding treatment decisions.