Disclosed herein are methods and reagents for determining immunoglobulin gamma (IgG) antibody isotype concentration from biological samples, and for analyzing a plurality of cell samples for IgG antibody production.

A transgenic mouse expressing inactivated human iduronate-2-sulphatase (IDS) and a method for improving agents for treating Hunter syndrome using the transgenic mouse are provided. The transgenic mouse expressing the inactivated human IDS, which has immune tolerance to IDS, does not cause an immune response to IDS which is an active component of the agents for treating Hunter syndrome, and thus the transgenic mouse may be effectively used to identify immunogenic factors other than the immunogenicity of the protein components of the agents.

The present invention concerns methods for treating progressive multiple sclerosis (MS) in a patient, and an article of manufacture with instructions for such use.

The present invention provides antibodies and fragments thereof that specifically detect the complex of a specific cognate antigen-binding moiety, in particular antibodies, and its antigen. The antibodies of the present disclosure do not bind either said cognate antigen binding moiety or said antigen alone and this can be used e.g. to directly detect antigen-bound antigen-binding moieties. Further disclosed are methods for production and use of said antibodies and antibody fragments.

The invention relates to methods and products for the identification of a clinically significant immune response in subjects treated with a therapeutic protein. Aspects of the invention relate to methods and compositions for identifying a clinically significant immune response in patients treated with therapeutic amounts of a VLA4 binding antibody (e.g., natalizumab).

Isolated antigen binding molecules that specifically bind to an anti-CD19 scFv comprising SEQ ID NO: 1 are provided. The antigen binding molecules can be used in the methods provided herein.

Provided is a method of providing an effective means as a countermeasure for handling a pandemic of an influenza virus. The resistance to a type A influenza virus is determined using, as an indicator, the presence or otherwise of antibodies using the VH1-69 gene in a biological sample originating from a subject.

Methods and products for diagnosing, treating and/or delaying onset of chronic allograft rejection, including cardiac allograft vasculopathy. In an exemplary embodiment of a noninvasive method of screening a cardiac allograft recipient for being at-risk for developing cardiac allograft vasculopathy of the present disclosure, the method comprises the steps of withdrawing at least one biological sample from a cardiac allograft recipient; and analyzing the at least one biological sample for one or more biomarkers indicative of the presence of fibrin deposits within the cardiac allograft microvasculature; wherein detection of the one or more biomarkers indicates that the cardiac allograft recipient is at-risk for or developing cardiac allograft vasculopathy.

The present invention provides a panel of at least five clinical analyses or tests (using serum samples) to determine the risk of pediatric acute-onset neuropsychiatric syndrome (PANS) and/or pediatric autoimmune neuropsychiatric disorder associated with streptococcal infection (PANDAS) in an individual. These include enzyme linked immunosorbent assays (ELISAs) to measure antibody titers against neuronal antigens present in the brain; the neuronal antigens include lysoganglioside, tubulin, dopamine receptor D1, dopamine receptor D2, serotonin receptor 5HT2A, and serotonin receptor 5HT2C. Antibody titers against at least four of these neuronal antigens are required in the present methods; preferably antibody tiers against all of these neuronal antigens are measured. A final assay is used to quantify calcium/calmodulin-dependent protein kinase activity using a neuronal cell line. The results of these analyses or tests are then combined using an algorithm to determine whether a PANS or PANDAS diagnosis is appropriate for the individual. Depending on the diagnosis, an appropriate treatment can be determined.

The invention provides methods of identifying bacteria comprising binding polypeptides. The invention also provides methods of identifying bacteria with improved expression of binding polypeptides. The invention also provides methods of identifying binding polypeptides with improved expression. The invention also provides engineered bacteria suitable for use in the methods of the invention. The invention also provides compositions that can be obtained using the methods, for example, anti-interleukin-13 (IL-13) antibodies with improved expression and/or stability. The invention also provides libraries comprising binding polypeptide (e.g., antibody) variants.