Siemens Healthcare Diagnostics Gmbh

Dade Behring Inc.

Yi Feng Zheng

Hshiou-ting Liu

Yali Yang

Tie Q Wei

Carsten Schelp

Pratap Singh

Manoj Sharma

Roland Janzen

Liping Geng

Nihmat Morjana

Jian Chen

Holger Keim

Johnny Jose Valdez

Mae W Hu

Zhu Teng

Zhijian Zhao

Khaled A Yamout

Donald E Berger, Jr

William D Bedzyk

Richard F Parrish

Tatiana Mareeva

Yuriy Smirnov

Deb K Vickery

Susan C Swann

Cathy K Worley

Guoping Wang

Linda Hudson

Bogdan Draghici

Tatiana Lebedeva

Heungyeung Yau

Allison Dominowski

Patrick Donovan

John Driscoll

Lauren Parker

Johnny Valdez

Antibodies that specifically bind naloxone or naltrexone are disclosed. Also disclosed are conjugates used in the production of the antibodies, as well as methods of producing the antibodies. Also disclosed are methods of using the antibodies in direct assays for naloxone or naltrexone. Further disclosed are methods of reducing naloxone or naltrexone interference in opiate assays using the antibodies.

Anti-naloxone and anti-naltrexone monoclonal antibodies and methods of production and use thereof

Methods are disclosed of designing antibodies for a sandwich assay for a small molecule having a molecular weight of about 500 to about 2,000. The method comprises preparing a first antibody that binds to the small molecule, and preparing a second antibody that binds to the small molecule at a portion of the small molecule other than a portion to which the first antibody binds. The second antibody is prepared from an immunogen that comprises a predetermined portion of the small molecule. The antibodies may be employed in sandwich assays for the small molecule.

Sandwich assay design for small molecules

The present invention relates to multi-hapten mutant G6PDH conjugates, methods of their preparation and their use for detection of multiple analytes. The compositions of the invention comprise different types of haptens (molecules) require to be immobilized into the G6PDH to make one multi-hapten-G6PDH conjugate. Both thiol and amine functional groups on G6PDH are utilized for immobilization of different haptens.

Preparation of multi-hapten mutant G6PDH conjugates and their use for detection of multiple analytes

Compositions, methods, and kits are disclosed directed at haptens, immunogens and immunoassays for oxycodone and metabolites thereof. The compounds are exemplified by compounds of the Formula I. The method comprises providing in combination in a medium (i) a sample suspected of containing oxycodone and/or oxycodone metabolites, a compound of the Formula I wherein Ror Ris a label, and an antibody for oxycodone or a metabolite thereof. The medium is examined for the presence of a complex comprising the labeled compound of Formula I where the presence of such as complex indicates the presence of oxycodone or oxycodone metabolite in the sample.

Conjugates for assays for oxycodone and oxymorphone

Methods and reagents are disclosed for conducting assays. Embodiments of the present methods and reagents are concerned with chemiluminescent reagents for determining the presence and/or amount of an analyte in a sample suspected of containing the analyte. The reagent is non-particulate and comprises a binding partner for the analyte and a chemiluminescent composition comprising an olefinic compound and a metal chelate. In embodiments of an assay, a combination is provided that comprises a sample suspected of containing the analyte, a chemiluminescent reagent as described above and a sensitizer reagent capable of generating singlet oxygen. The combination is subjected to conditions for binding of the analyte to the binding partner for the analyte. The sensitizer is activated and the amount of luminescence generated by the chemiluminescent composition is detected wherein the amount of luminescence is related to the amount of the analyte in the sample.

Immunoassays employing non-particulate chemiluminescent reagent

Compositions are disclosed for releasing an FKBP-binding immunosuppressant drug from endogenous binding substances in a sample suspected of containing the FKBP-binding immunosuppressant drug. The compositions include sirolimus derivatives that are modified with a bulky organic radical in the triene portion of the sirolimus molecule. The compositions may be employed in conjunction with assays for an FKBP-binding immunosuppressant drug in a sample suspected of containing the drug.

Compounds and methods for determination of FKBP-binding immunosuppressant drugs

Methods and reagents are disclosed for determining the presence and/or amount of cyclosporin A in a medium suspected of containing cyclosporin A. In the method a combination is provided in a medium. The combination comprises (i) the sample, (ii) a first member of a signal producing system (sps) associated with a first support wherein the first sps member is capable of activating a second member of the sps and wherein the first support is associated with a first member of a specific binding pair, and (iii) the second sps member associated with a second support wherein the second sps member is activatable by the first sps member. The second support comprises either (I) cyclosporin C or cyclosporin A and the combination further comprises a conjugate of an antibody for cyclosporin A and a second member of the specific binding pair or (II) antibody for cyclosporin A and the combination further comprises a conjugate of cyclosporin A and a second member of the specific binding pair. The combination is subjected to conditions for binding of cyclosporin A to the antibody for cyclosporin A. The first sps member is activated and the amount of signal generated by the second sps member is detected. The amount of signal is related to the presence and/or amount of cyclosporin A in the sample.

Methods for detection of cyclosporin A

Reagents are disclosed for use in assays for analytes. The reagents are dry assay reagents that may be readily reconstituted for use in the assays. The dry assay reagents comprise a solid support and one or more molecules of a receptor immobilized on the solid support. The receptor comprises one or more binding sites for a ligand. A portion of a total number of the binding sites is bound to a conjugate comprising the ligand linked to a specific binding pair member and a portion of the total number of the binding sites is free. In use in an assay, a combination is provided in an aqueous medium comprising the sample and reagents for detecting the analyte wherein at least one of the reagents comprises the dry assay reagent mentioned above. The combination is incubated under conditions for binding of the analyte to one or more of the reagents. The presence and/or amount of binding of the analyte to one or more of the reagents is detected where the presence and/or amount of the binding is related to the presence and/or amount of the analyte in the sample.

Stabilization of solid support assay reagents

Compounds are disclosed comprising a moiety, such as a poly(amino acid), a non-poly(amino acid) label moiety, or a non-poly(amino acid) immunogenic carrier, linked to a sirolimus compound at position 26 or at position 32. Such sirolimus compounds comprising an immunogenic carrier can be employed to raise both polyclonal and monoclonal antibodies to the sirolimus compound. Polyclonal antibodies are also disclosed, which are raised against a compound wherein a moiety, such as a poly(amino acid), a non-poly(amino acid) label moiety, or a non-poly(amino acid) immunogenic carrier, is linked to a sirolimus compound at position 32. The above antibodies and sirolimus compounds comprising a label can be used in assays for the detection of sirolimus compounds.

Compositions and methods for detection of sirolimus

Methods, compositions and kits are disclosed. The compounds disclosed comprise an amphetamine moiety and a methamphetamine moiety linked together by a first linking group. A second linking group depends from the first linking group and comprises a functional group. The distance of the amphetamine moiety and the methamphetamine moiety from the point of linkage of the second linking group to the first linking group is approximately the same. The compounds may be linked to labels and used in assays for the detection of amphetamine and/or methamphetamine in samples suspected of containing these drugs.

Assays for amphetamine and methamphetamine

Methods, compositions and kits are disclosed. Enzyme conjugates of Formula I may be employed in assays for the determination of an amphetamine and/or a methamphetamine. Immunogenic conjugates of Formula I may be employed to prepare antibodies for an amphetamine and/or for a methamphetamine for use in assays for the determination of an amphetamine and/or a methamphetamine. The enzyme conjugates may also be employed to screen antibodies for use in such methods.

Assays for amphetamine and methamphetamine using stereospecific reagents

Methods, compositions and kits are disclosed. Enzyme conjugates of Formula I are employed in assays for the determination of an methylenedioxyamphetamine, a methylene-dioxyethamphetamine, and/or a methylenedioxymethamphetamine. Immunogenic conjugates of Formula I are employed to prepare antibodies for an methylenedioxyamphetamine, a methylenedioxyethamphetamine, and/or for a methylene-dioxymethamphetamine for use in assays for the determination of an methylenedioxyamphetamine, a methylenedioxyethamphetamine, and/or a methylene-dioxymethamphetamine. The enzyme conjugates may also be employed to screen antibodies for use in such methods.

Ecstasy haptens and immunogens

Methods, compositions and kits are disclosed. The methods are directed to determining the presence of entactogen analytes such as, for example, 3,4-methylenedioxyamphetamine (MDA), 3,4-methylenedioxy-methamphetamine (MDMA), 3,4-methylenedioxy-ethylamphetamine (MDEA) and 4-hydroxy-3-methoxy-methamphetamine (HMMA). The method comprises providing in combination in a medium (i) a sample suspected of containing the compound and (ii) an antibody raised against a compound of Formula I that comprises a protein. The medium is examined for the presence a complex comprising the compound and the antibody where the presence of such as complex indicates the presence of the compound in the sample. In one aspect of the above embodiment, the combination further comprises a label conjugate of the compound Formula I.

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Wilmington, DE, United States of America

Yi Feng Zheng