The present invention relates to a method for analyzing a biological sample obtained from a subject, comprising analyzing components contained in a biological sample by an assay using a first molecule selected from the group consisting of a molecule binding to a sugar chain bindable with BC2LCN, a molecule binding to SerpinA3, and a molecule binding to Gal3BP, and a second molecule that is BC2LCN.

Provided is an immunoassay for detection of anti-drug antibodies (ADAs), such as anti-C1-Inhibitor antibodies (C1INH-ADA in a test sample. The immunoassay provides a means for testing the immunogenicity and efficacy of drug treatment protocols.

Methods for treatment and diagnosis of pervasive developmental disorders in humans are described.

Disclosed herein are methods of treating and making prognostic prediction of, monitoring of therapeutic outcome for treatment of cervical carcinoma in a patient in need thereof by quantifying gene expression in a sample, wherein the genes include 10 high risk genes; calculating the subject's survival risk score by determining the protein expression levels and their relationships using machine learning (ML) and artificial intelligence. The survival risk category of a patient is determined by the consensus or plurality voting of a large number of ML models that individually have excellent predictive potential, thus providing a very robust prognostic biomarker for cervical carcinoma.

The invention provides assay methods of detecting last protease CI inhibitor (C1-INH) that binds plasma kallikreir, Factor XII, or both, and uses thereof for identifying subjects at risk for or suffering from a pKal-me-diated or bradykinin-mediated disorder. Provided methods permit analysis of patients with plasma kallikrein-mediated angioedema (KMA), or other diseases mediated by pKal useful in the evaluation and treatment.

A device for detecting and/or quantifying functional C1-esterase inhibitor (fC1-INH), the device comprising: (i) a conjugate pad comprising a first zone and a second zone, on which a first agent and a second agent are immobilized, respectively, and (ii) a membrane, which is in communication with the conjugate pad, wherein the membrane comprises a third zone, on which a third agent is immobilized. The conjugate pad may further comprise a fourth zone for placing a biological sample, which flows through the device in the order of the first zone, the second zone, and the third zone.

Coagulation and fibrinolysis assays and related compositions, systems, methods, and kits are provided. In some embodiments, a coagulation and fibrinolysis assay may utilize one or more biological molecules. For instance, the assay may comprise combining a blood or blood-derived patient sample with the biological molecule(s) and measuring one or more properties of the sample associated with coagulation and/or fibrinolysis. The biological molecules may serve to shorten the assay duration and/or enhance the sensitivity of the assay relative to certain conventional assays. In certain embodiments, the biological molecules may allow pathological coagulation and/or fibrinolysis phenotypes to be elucidated. The coagulation and fibrinolysis assays described herein may be used for a wide variety of clinical and/or laboratory applications, including the diagnosis of certain coagulation and/or fibrinolysis disorders, such as trauma-induced coagulopathy and hyperfibrinolysis.

The invention provides assay methods of detecting plasma protease CI inhibitor (Cl-INH) that binds plasma kallikrein, Factor XII, or both, and uses thereof for identifying subjects at risk for or suffering from a pKal-mediated or bradykinin-mediated disorder. Provided methods permit analysis of patients with plasma kallikrein-mediated angioedema (KMA), or other diseases mediated by pKal useful in the evaluation and treatment.

The present invention relates to the determination of protein markers associated with extracellular vesicles present in sub-fractions of plasma samples taken from people that experience chest pain and are suspected to experience ischemic heart disease. The invention relates to the use of the markers in the identification of subjects suffering from, or at risk of suffering from, an ischemic heart disease, in particular stable angina and unstable angina. Especially preferred markers are SerpinC1, SerpinG1, CD14, Cystatin C and SerpinF2.

The invention provides assay methods of detecting plasma protease CI inhibitor (C1-INH) that binds plasma kallikrein, Factor XII, or both, and uses thereof for identifying subjects at risk for or suffering from a pKal-me-diated or bradykinin-mediated disorder. Provided methods permit analysis of patients with plasma kallikrein-mediated angioedema (KMA), or other diseases mediated by pKal useful in the evaluation and treatment.