Described herein are IgG epitope peptides that bind rheumatoid factors in rheumatoid arthritis (RA) and COVID-19. The IgG epitope peptides may be conjugated to a ligand, a detectable label, or a combination thereof. Also, the IgG epitope peptides are particularly useful in assays to detect antibodies in blood samples from subjects with RA risk factors, for example. The COVID-19 IgG epitope peptides are particularly useful in screening convalescent plasma.

The invention provides adeno-associated virus (AAV) Factor VIII (FVIII)-encoding/expressing vectors and virus, including AAV FVIII vectors with high expression activity and AAV FVIII vectors that express full-length or truncated functional FVIII protein. The invention also relates to methods of making the herein described AAV FVIII vectors, recombinant AAV FVIII virus particles comprising or expressing such vectors, associated pharmaceutical formulations comprising the same and therapeutic uses thereof.

A method for characterizing or quantifying one or more proteins in visible and/or sub-visible particles formed in a sample by detecting the at least one visible or sub-visible particle in the sample, isolating and capturing the at least one visible or sub-visible particle to identify a presence of a protein, and using a mass spectrometer to characterize the protein.

Described herein are methods and systems for detecting and/or distinguishing irritable bowel syndrome (IBS) from inflammatory bowel disease (IBD) and celiac disease. The methods and systems can utilize the detection of anti-CdtB antibodies and/or anti-vinculin antibodies to detect IBS, distinguish IBS from IBD and/or celiac disease. Further described are methods for selecting a therapy to treat IBS, IBD or celiac disease.

The present disclosure provides compositions and methods for detecting the presence of neutralizing antibodies in a sample. Unlike conventional assays, the methods provided herein do not require the use of live virus or virus pseudoparticles to identify neutralizing antibodies.

A screening method is provided. Cells secreting target antibodies are screened by mixing candidate cells labeled with a first fluorescent molecule, a capture antigen and a labeled antibody against a target antibody and incubating, labeling using a high content cell imager and sorting using flow cytometry so as to screen cells secreting target antibodies. The screening method disclosed in the present application can automatically complete the labeling and sorting of target candidate cells in high throughput by labeling with a fluorescent molecule in combination with high-content cell imager and flow cytometer, so as to provide sufficient quantity of cells for subsequent amplification to obtain their antibody sequences and screen affinity antibodies. This method greatly improves the screening efficiency.

In various embodiments methods are provided for identifying a mammal having an elevated risk for an adverse cardiac event (e.g. an MI) and/or determining the prognosis for the mammal. In certain embodiments the methods comprise determining, or causing to be determined, the presence and/or level of antibodies that bind a malondialdehyde acetaldehyde adduct (MAA adduct) in a biological sample from the mammal, where an elevated level of anti-MAA adduct antibodies, as compared to the level found in a normal healthy mammal is an indicator that that said mammal has one or more atherosclerotic lesions and/or is at elevated risk for a myocardial infarction.

The invention provides methods of testing food for antigens that are more stable to food processing than more clinically problematic allergens from the same food. When clinically-significant allergens are disproportionately broken down by common preparation methods, the presence of certain food ingredients may be “masked” to some tests yet may still be allergenic. To prevent false negative results due to food preparation, the invention provides tests that test for specific food antigens that are selected on the basis of their stability under processing. Antigens are selected for inclusion in the test not because they are the most clinically relevant allergens, but rather because they are robust to processing (e.g., and do not denature during cooking). Tests of the invention may also test for the most clinically relevant allergens, but importantly, by testing for stable protein products/antigens, the tests report the presence of food residues even after commercial processing.

Described herein are compositions that comprise one or more Babesia microti antigens, one or more Babesia microti nucleic acid molecules, or one or more anti-Babesia microti antibodies and uses thereof in methods for the prophylaxis of babesiosis, the treatment of babesiosis and the monitoring of individuals undergoing prophylactic or therapeutic administration of the compositions of the invention.

Therapeutic antibodies having binding specificity for ROR-1 expressed on cancer cells (particularly leukemic and lymphomic cells) and pharmaceutical compositions containing one or more such antibodies for use in treating cancer. Methods for diagnosing such cancers through in vitro detection of binding to ROR-1 protein expressed on putative cancer cells are also provided.