Siemens Healthcare Diagnostics Gmbh

James Vincent Freeman

Ramon A Evangelista

Niver Panosian Sahakian

Bruce A Campbell

Qimu Liao

Spencer Hsiang-Hsi Lin

Eddine Merabet

Mariah Arcuri

Cheryl Krumm

Ken Yokoyama

Spencer H Lin

Disclosed herein are immunoassays for detecting an antibody in a biological sample from a subject and/or diagnosing an autoimmune disease in a subject. The disclosed immunoassays use a single, direct step to assess the level of antibody in a biological sample from the subject by simultaneously binding the antibody to a capture antigen (e.g. an unlabeled antigen bound to a solid support) and a labeled antigen not bound to the solid support.

Direct immunoassay measurement of autoantibodies

Provided herein are antigenic molecules that can be used to generate antibodies capable of binding to a vitamin D derivative, such as 25-hydroxyvitamin D2 and/or 25-hydroxyvitamin D3, or a 25-hydroxyvitamin D analog, such as a vitamin D-C22 immunogenic molecule or compound. Antibodies produced using these antigenic molecules, and related antigenic compounds, are also described. In addition, disclosed herein are methods for detecting vitamin D deficiency in a subject, methods for treating a subject suspected of having a vitamin D deficiency, methods for monitoring progression of vitamin D deficiency in a subject, and methods for monitoring treatment of vitamin D deficiency in a subject in need thereof. The methods involve the detection or quantification of 25-hydroxyvitamin D2 and D3. Also provided are methods and reagents for the detection or quantification of 25-hydroxyvitamin D2 and D3, methods for stabilizing vitamin D analogs, and methods for separating 25-hydroxyvitamin D2 and D3 from vitamin D binding protein in a biological sample.

Antibodies to 25-hydroxyvitamin D2 and D3 for detecting total 25-hydroxyvitamin D

Antibodies to 25-hydroxyvitamin D2 and D3

Method for detecting total 25-hydroxyvitamin D using antibodies to 25-hydroxyvitamin D2 and D3

Provided herein are antigenic molecules that can be used to generate antibodies capable of binding to a vitamin D derivative, such as 25-hydroxyvitamin D2 and/or 25-hydroxyvitamin D3, or a 25-hydroxyvitamin D analog, such as a vitamin D-C22 immunogenic molecule or compound. Antibodies produced using these antigenic molecules, and related antigenic compounds, are also described. In addition, disclosed herein are methods for detecting vitamin D deficiency in a subject, methods for treating a subject suspected of having a vitamin D deficiency, methods for monitoring progression of vitamin D deficiency in a subject, and methods for monitoring treatment of vitamin D deficiency in a subject in need thereof. Also provided are methods and reagents for the detection or quantification of 25-hydroxyvitamin D2 and D3, methods for stabilizing vitamin D analogs, and methods for separating 25-hydroxyvitamin D2 and D3 from vitamin D binding protein in a biological sample.

Antibodies to 25-hydroxyvitamin D2 and D3 and uses thereof

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Sandy Hook, CT, United States of America

James Vincent Freeman