Abbott Laboratories Corporation

Vincent T Yue

John C Russell

Dominique P Bridon

Catherine A Brennan

Grant A Krafft

Elaine Marie Brate

Robert G Parsons

Wlodzimierz Mandecki

Steven C March

Keeve D Jaffe

Robert Kowal

This invention relates to genetically engineered enzymes, their ligand conjugates, their manufacture, and their use in qualitative or quantitative assays. A hybrid enzyme, such as an AP-epitope, has a foreign amino acid moiety (an epitope) inserted near the active site of the starting AP enzyme. The foreign amino acid moiety binds with an analyte, and, as a consequence of this binding, the enzymatic activity of the hybrid enzyme, AP-epitope, is modified. The changes in the enzymatic activity are dependent upon the presence, or the amount, of the analyte. In another embodiment, the hybrid enzyme consists of a cysteine introduced near the active site of an AP to give a hybrid enzyme. The cysteine on the hybrid enzyme serves as a point of conjugation of a ligand, such as theophylline, ferritin, thyroxine, or digoxigenin, to form the hybrid enzyme-ligand conjugate. The ligand binds with an antibody, an analyte or a binding molecule to an analyte and as a result of this binding, the enzymatic activity of the hybrid enzyme-ligand conjugate is modified or modulated.

Genetically engineered enzymes and their conjugates for diagnostic assays

The present invention relates to immunoassay methods for detecting and measuring the amount of an analyte in a sample by means of generic anti-hapten antibodies. Also disclosed are multi-analyte immunoassay methods. Reagents, devices, and kits using the anti-hapten antibodies are also disclosed. The present invention also relates to dyed erythrocytes, preferably fixed, which are coated with antibodies. Also disclosed is the use of these dyed erythrocytes in agglutination assays to detect and measure the presence of an analyte in a sample. The analyte can be a hapten, an antigen, or an antibody. Also included are agglutination assays, compositions and kits using these dyed and coated erythrocytes.

Immunoassays employing generic anti-hapten antibodies and materials for

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Deerfield, IL, United States of America

Vincent T Yue