Disclosed herein are methods, reagents and devices for the rapid detection of SARS-CoV-2 nucleocapsid antigens in clinical samples using high throughput methods.

The present invention teaches an apparatus for consistent and accurate on-site readings of fluorescence signals of coronavirus test result, with which a user directly reads a fluorescent light qualitatively instead of using electronic sensors. The fluorescent light is excited from a fluorescent source in a site of interest in a target assay. The device comprises a light source for generating an excitation light for exciting the fluorescent source of the target assay to generate a fluorescent light, a component for accurately transmitting the excitation light and the fluorescent light with less noise or reflection, a component for consistent detecting of the fluorescent source by bare eyes with minimal health risks, and a user control system that requires minimal training.

The disclosure concerns a polypeptide suitable for detecting antibodies against Zika virus in an isolated biological sample having a Zika virus NS1 wing domain specific amino acid sequence and variants thereof, wherein no further Zika virus specific amino acid sequences are present in the polypeptide. This polypeptide does not immunologically cross-react with antibodies raised against structurally related antigens from tick-borne encephalitis virus, Dengue virus 1-4, West Nile virus, yellow fever virus or Japanese encephalitis virus, but immunologically reacts with antibodies raised against full length Zika virus NS1 antigen. Also disclosed is a method of producing a soluble and immunoreactive Zika virus NS1 polypeptide as well as methods and kits for detecting antibodies specific for Zika virus in an isolated sample.

Two or more upconverting particles are attached to each unit of one or more units of a chemical component in a sample, to form, for each unit of the chemical component, a multi-particle complex including the unit of the chemical component and two or more corresponding upconverting particles. The sample is illuminated by input light having a first wavelength. Light is received at an imaging sensor, the received light including output light generated by at least a portion of the upconverting particles attached to the units of the chemical component, the output light having a second wavelength that is shorter than the first wavelength. One or more images of the sample are captured from the received light. Based on the captured one or more images, a presence or a level of the chemical component in the sample is determined.

The present invention provides an antibody including a structural domain represented by the following amino acid sequence, in an N- to C-direction, N-FR1-CDR1-FR2-CDR2-FR3-CDR3-FR4-C
wherein the antibody further includes a protein molecule bound to the structural domain; the structural domain is capable of binding to a norovirus; FR denotes a framework region amino acid sequence and CDR denotes a complementary determining region amino acid sequence; any one of the following requirements (i)-(iii) is satisfied. Requirement (i): the CDR1 includes an amino acid sequence having a sequence identity of not less than 60% with any one of the amino acid sequences represented by SEQ ID NO: 1-SEQ ID NO: 6, the CDR2 includes an amino acid sequence having a sequence identity of not less than 60% with any one of the amino acid sequences represented by SEQ ID NO: 7-SEQ ID NO: 12, and the CDR3 includes an amino acid sequence having a sequence identity of not less than 60% with any one of the amino acid sequences represented by SEQ ID NO: 13-SEQ ID NO: 17; Requirement (ii): the CDR1 includes an amino acid sequence in which one-three amino acid(s) of any one of the amino acid sequence represented by SEQ ID NO: 1-SEQ ID NO: 6 has/have been substituted, deleted, or added, the CDR2 includes an amino acid sequence in which one-three amino acid(s) of any one of the amino acid sequence represented by SEQ ID NO: 7-SEQ ID NO: 12 has/have been substituted, deleted, or added, and the CDR3 includes an amino acid sequence in which one-three amino acid(s) of any one of the amino acid sequence represented by SEQ ID NO: 13-SEQ ID NO: 17 has/have been substituted, deleted, or added; and Requirement (iii): the CDR1 includes any one of the amino acid sequence represented by SEQ ID NO: 1-SEQ ID NO: 6, the CDR2 includes any one of the amino acid sequence represented by SEQ ID NO: 7-SEQ ID NO: 13, and the CDR3 includes any one of the amino acid sequence represented by SEQ ID NO: 13-SEQ ID NO: 17.

The present invention relates to methods for producing an exosome enriched fraction from a sample. The method comprises the steps of contacting a first binding agent that specifically binds to the extra-vesicular part of Rab11 or a second binding agent that specifically binds to the extra-vesicular part of Rab4, or a combination thereof, to the sample under conditions allowing binding of said first binding agent and/or second binding agent to exosomes; and separating exosomes to which the first binding agent and/or the second binding agent is bound from the sample. Further provided are methods for diagnosing cancer and viral diseases, methods for quantifying and/or qualifying tumor-related and virus-related exosomes in a sample, methods for monitoring tumor growth and viral diseases. Also provided is a kit comprising means for carrying out the methods.

Provided are novel human-derived monoclonal antibodies as well as antigen-binding fragments thereof which specifically recognize and preferably neutralize severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). The anti-SARS-CoV-2 antibodies provided herein are useful in treating and diagnosis of COVID-19.

The present disclosure relates to biofragment compositions that comprise bioparticle fragments and at least one heterologous antigen-binding molecule. In some embodiments, the biofragment is typically derived from a larger, intact bioparticle that express the at least one heterologous antigen-binding molecule at the surface, and the biofragment has increased solubility to facilitate assays for antigen detection. The disclosure also relates the related methods of using and making the biofragment compositions, as well as systems and devices implementing the biofragment compositions. In some embodiments, the related methods, systems and devices do not require additional detection reagents, such as animal derived detection antibodies.

Disclosed herein are methods for treating patients that may develop or already have pre-existing gene therapy neutralizing antibodies by administering an agent that blocks, inhibits or reduces the interaction between immunoglobulin G (IgG) and the neonatal Fc receptor (FcRn), such as an anti-FcRn antibody, to reduce IgG recycling and enhance IgG clearance in vivo. Also disclosed are methods for utilizing agents that reduce interaction of IgG with FcRn for gene therapy treatment of a disease in a patient in need thereof.

The present is directed to compositions comprising regulatory T cell epitopes, wherein said epitopes comprises a polypeptide comprising at least a portion of SEQ ID NOS: 4-370, 391-440, and 448-833 (and/or fragments and variants thereof), and optionally 1 to 12 additional amino acids distributed in any ratio on the N-terminus and/or C-terminus of the polypeptide of SEQ ID NOS: 4-370, 391-440, and 448-833, as well as methods of producing and using the same. The present is further directed to detolerized antigens to the regulatory T cell epitopes, including proteins or polypeptides of SARS-CoV-2 wherein one or more of the identified T cell epitopes are deleted, partially deleted and/or mutated.