Metra Biosystems, Inc.

Dade Behring Marburg Gmbh

Mary J Cerelli

Robert F Zuk

Viola T Kung

Thomas D Kempe

Yuri Daniloff

Hsin-Shan Julia Ju

Suzanna S Pedersen

Zafrira Avnur

This invention relates to novel monoclonal antibodies XI-4G6, XII-10E3 and XII-3B2, which are capable of recognizing bone alkaline phosphatase and not liver alkaline phosphatase. Methods and kits for using these antibodies in the determination of bone alkaline phosphatase are also described.

Assay for bone alkaline phosphatase

A method of assaying bone collagen degradation activity in a human subject. In the method, a human urine sample is reacted with an antibody which (i) is capable of reacting immunospecifically with pyridinium crosslinks selected from the group consisting of native free pyridinoline and native free deoxypyridinoline, and (ii) has a ratio of reactivity toward the selected pyridinium crosslinks and urinary pyridinium peptides larger than 1,000 daltons in molecular weight, of greater than about 5:1. An immunocomplex forms between the antibody reagent and the selected pyridinium crosslinks which are present in the sample, and the amount of immunocomplex is measured. Also disclosed are antibody reagents and kits which can be used in the method.

Method and kit for pyridinium crosslink assay

A method of assaying a human urine sample, by measuring a concentration of pyridinium crosslinks from which the concentration of total hydrolysed pyridinoline in the sample can be determined, is disclosed. In the method, a urine sample is reacted with an anti-Pyd antibody reagent which preferably has a ratio of reactivity toward native free pyridinoline and urinary pyridinoline peptides larger than 1,000 daltons in molecular weight, of greater than 10:1. By measuring the extent of immunocomplex formed by the reaction, the concentration of total hydrolysed pyridinoline in the sample can be calculated. Also disclosed are an antibody reagent and kit which can be used in the method.

Method and kit for pyridinoline assay

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Burlingame, CA, United States of America

Mary J Cerelli