The present disclosure relates to compositions, kits, and methods to perform peptide exchange on MHC class II molecules, such as quantified peptide exchange.

Described herein are blocking agents that can be used in diagnostic assays to prevent false positive results.

The present invention relates to a method of detecting the presence of Cytomegalovirus and measuring antigenicity through detection and quantification of a pentameric complex by an indirect sandwich ELISA assay which ensures an appropriate concentration of this critical glycoprotein complex is present in the vaccine.

Provided herein are systems, devices and methods for the rapid and accurate measurement of analytes by assay of binding events, by direct, digital measurement of individually resolved analyte/reporter binding events. The digital molecular assay systems, devices and methods disclosed herein are capable of particle-by-particle readout using optical reporter molecules that detect and report the binding of a single analyte molecule, and report each such binding in binary format. Such digital molecular assay systems, devices and methods are useful in a variety of applications, such as on mobile electronic devices for use in the field.

The present invention provides an anti-APOA4 monoclonal antibody or an antibody fragment thereof capable of accurately measuring apolipoprotein A-IV (APOA4) in a specimen, a measurement method for immunologically measuring APOA4 using the antibody or the antibody fragment thereof, and a kit for measuring APOA4 containing the antibody or the antibody fragment thereof.

The present invention provides methods and immunoassays kits for the improved detection of cytomegalovirus (CMV) in a subject. In some embodiments, the methods and immunoassays kits differentiate between subjects who have developed a serological response to vaccination against CMV and subjects who have had a natural infection. In some embodiments, the methods and immunoassays kits differentiate between serological responses to different CMV serotypes.

A method of measuring APP669-711, including involving immobilizing, to a support, a first antibody capable of immunospecifically binding to an N terminus of APP669-711; blocking the support to which the first antibody is immobilized, with a blocking agent; bringing APP669-711 in the sample into contact with the first antibody thus immobilized, and thereby allowing APP669-711 to bind to the first antibody; removing the sample that is not bound; bringing a second antibody capable of immunospecifically binding to a C terminus of APP669-711, into contact with APP669-711 bound to the first antibody thus immobilized, and thereby allowing the second antibody to bind to APP669-711; removing the second antibody that is not bound; and detecting the presence of the second antibody bound to APP669-711.

A high-throughput high sensitivity and high selectivity ELISA-based method is provided that can detect human IgA, IgM, and IgG directed against SARS-CoV-2 with minimum false positive results. Simultaneous use of SARS-CoV-2-specific antigens derived from SARS-CoV-2 spike and nucleocapsid proteins provides greater sensitivity and selectivity compared to current methods for the detection of SARS-CoV-2-induced human immunoglobulin A, M, and G serum antibodies.

The present invention relates to an in vitro method for assessing cholangiocarcinoma in a patient sample, comprising the steps of: a) determining the level of tissue inhibitor of metalloproteinase-1 (TIMP1) in the patient sample, wherein the patient sample is selected from a group consisting of serum, plasma and whole blood sample from an individual, b) comparing the level of TIMP1 determined in step (a) with a reference level of TIMP1, and c) assessing cholangiocarcinoma in the patient sample by comparing the level determined in step (a) to the reference level of TIMP1, wherein an increased level of TIMP1 compared to the reference level of TIMP1 is indicative for cholangiocarcinoma in the patient sample. Further, the present invention relates to an in vitro method for assessing cholangiocarcinoma comprising TIMP1 and MMP2, the use of TIMP1 and optionally MMP2 in the in vitro assessment of CCA, and a kit for performing the said methods.

Methods and kits for detection of presence, absence, or amount of an analyte in a biological sample are provided. In the methods and kits, kinetics of the detection is modulated my adjusting concentrations of a reporter binding moiety and a reporter.