The present invention relates to the field of immunotherapeutics, in particular to a method for characterization and/or quality control of immunotherapeutics. It provides a method of testing potency of an immunoglobulin composition, e.g., plasma or a plasma-derived immunoglobulin composition such as an intravenous immunoglobulin composition (IVIG), as well as to use of a bead coated with an antigen and an antibody specifically bound to said antigen for testing po-tency of an immunoglobulin composition. Said immunoglobulin composition, or immunoglobulin test composition can be an IVIG, particularly and IgA- and/or IgM enriched (also sometimes re-ferred to as IVIG-AM). The potency is tested by the capability of the composition to inhibit an ef-fector function of an Fc-receptor expressing immune effector cell, such as a neutrophil, e.g., a HL60 cell, preferably, production of an inflammatory cytokine such as IL-8. The invention also relates to a method of preparing a standardized immunoglobulin composition, to a kit for carry-ing out the method, as well as a composition. The immunoglobulin compositions obtainable from said method may be used, e.g., in the treatment of inflammation, e.g., in the context of COVID-19 or pneumonia, e.g., severe community-acquired pneumonia.

Provided are methods for determining the presence or absence of donor specific antibodies in a biological sample. The methods include mixing a cellular sample from a donor with a biological sample from a recipient under conditions sufficient for recipient immune antibodies, if present, to bind to donor cell surface antigen (Ag) to form an immune antibody-Ag complex, contacting the mixture with beads comprising an antibody that specifically binds the immune antibody-Ag complex (e.g., the Ag or immune antibody) on a surface thereof, adding under lysis conditions a detectably-labeled antibody that specifically binds the immune antibody-Ag complex bound to the beads, and detecting the presence or absence of the detectably-labeled antibody bound to the immune antibody-Ag complex to determine the presence or absence of donor specific antibodies in the biological sample from the recipient. Systems and kits for practicing the subject methods are also provided.

Disclosed is a method for detecting an analyte in a sample, including the steps of: (A) forming a first complex comprising: an analyte; a first trapping body which specifically binds to the analyte; a second trapping body which specifically binds to a site of the analyte, the site being different from a site to which the first trapping body specifically binds; and a third trapping body which specifically binds to the second trapping body; (B) separating a part comprising the analyte and the first trapping body from the third trapping body; (C) allowing a fourth trapping body to trap the part to form a second complex; and (D) detecting the analyte of the second complex, wherein the second trapping body comprises a binding substance which binds to the analyte, a support, and a linker which links the binding substance and the support with each other.

A target analysis kit includes: a sample holder including: a reagent chamber containing a first reagent; a sample holding portion; and a liquid transfer portion; and an analysis container including: a first chamber containing a second reagent; and a second chamber with a labeling substance contained in the first or second reagent to be detected. A combination of the first and second reagents is any of the combinations (1) to (3) and (4): (1) first reagent is the immobilized second binding substance and second reagent is the labeled first binding substance; (2) first reagent is the labeled first binding substance and second reagent is the immobilized second binding substance; (3) first reagent is the immobilized first binding substance and second reagent is the labeled second binding substance; and (4) first reagent is the labeled second binding substance and second reagent is the immobilized first binding substance.

The present disclosure relates to the finding that thymidine kinase 1 (TK-1) represents a valuable biomarker in a method for determining a Prognostic Index (PI) for risk stratification of a patient with aggressive B-cell lymphoma, especially diffuse large B-cell lymphoma (DLBCL), to the use of TK-1 in such PI and to a PI comprising the marker TK-1.

Hydrogel-based or aerogel-based devices and methods for pretreatment of a sample. The devices and method may include an aerogel-based device for pretreating a sample comprising at least one aerogel; a hydrogel-based device for pretreating a sample comprising at least one hydrogel; or a combination aerogel-based and hydrogel-based device for pretreating a sample comprising at least one aerogel in fluid communication with at least one hydrogel.

An autonomous bioaerosol sampling and detection system and method adapted to provide real-time detection and identification of bio-organisms in aerosols without human intervention.

The present system and method are useful for the removal of immune inhibitors such as soluble TNF receptors from the body fluid of cancer patients. In some embodiments, soluble TNF-Receptors 1 and 2 are selectively removed from plasma at 80% or more efficiency. In some embodiments, the system includes an immobilized capture ligand of a single chain TNFα. The system and method are useful for the treatment of different cancer types, stages and severity.

The invention described herein is directed to methods of isolation and detection of target analytes in a sample. The target analytes are coupled to analyte detection particles which comprise base particles having labels and affinity agents coupled thereto by linker arms. The linker arms form bonds with the labels and target analytes and are cleavable under different label and affinity cleavable conditions. Systems and methods for preparing and using the analyte detection particles are also disclosed.

Test strip devices, assemblies, systems, and methods for the analysis of a sample are shown and described. In one embodiment, a test strip includes a nitrocellulose membrane, a filtration conjugate pad with a fibrous labeled receptor bottom side, and an overlay tape enclosing the nitrocellulose membrane and a portion of the filtration conjugate pad. An assembly may include a delivery device for delivering sample to the test strip.