Dade Behring Marburg Gmbh

Siemens Healthcare Diagnostics Gmbh

Siemens Healthcare Diagnostics Products Gmbh

Behringwerke Aktiengesellschaft

Dade Behring Inc.

Carsten Schelp

Andreas Wiegand

Michael Kraus

Hrair Kirakossian

Alan Robert Craig

Zhu Teng

Roland Janzen

Tie Q Wei

Pratap Singh

Yi Feng Zheng

Paul Meller

Norbert Madry

Jeffrey L Moore

Gary Hickey

Michael Trier

Liping Geng

Marcel R Pirio

Norbert F Zander

John S Pease

Hans-Erwin Pauly

Stefan Teigelkamp

Andreas Kappel

Wilhelm Schuy

Andrea Lichte

Andrzej Grzegorzewski

Jason Snyder

Uwe Stöhr

Michael Mohlen

Christine Moran

Sabine Teigelkamp, Legal Representative

Tie Quan Wei

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

The invention relates to a kit for a homogenous detection method for the quantitative or qualitative detection of an analyte in an assay and adequate reagents therefor, particularly a homogenous binding test. According to the invention, an analyte-specific binding partner R1 comprises more than one specific binding point for a specific binding partner X that is associated with a component of a signal-forming system while a second analyte-specific binding partner R2 comprises more than one specific binding point for a specific binding partner Y which is also associated with a component of a signal-forming system.

Homogeneous detection method

The invention relates to methods for the quantitative or qualitative detection of an analyte in an assay and adequate reagents therefor, particularly a homogeneous binding test. According to the invention, an analyte-specific binding partner R1 comprises more than one specific binding point for a specific binding partner X that is associated with a component of a signal-forming system while a second analyte-specific binding partner R2 comprises more than one specific binding point for a specific binding partner Y which is also associated with a component of a signal-forming system.

The invention relates to methods for determining the activity of a proteolytic coagulation factor of the blood coagulation cascade in a body fluid such as whole blood or plasma. A combination is provided in a reaction mixture. The combination comprises the sample and an activation agent for activating a proteolytic coagulation factor of the blood coagulation cascade or for activating the blood coagulation cascade. The effect of the activating on a reagent system comprising a cleavable moiety is evaluated. The cleavable moiety is or becomes bound to a chemiluminescent agent or a sensitizer agent or both. The chemiluminescent agent and the sensitizer agent are related in that, when in close proximity, energization of the sensitizer agent results in energization of the chemiluminescent agent. The effect of the activating is related to the activity of a proteolytic coagulation factor of the blood coagulation cascade wherein the effect is the extent of cleavage of the cleavable moiety.

Blood coagulation assays

The invention relates to methods and compositions for removing a dissociated species from a fluid medium solution during and after it has detached from a solid-phase immersed in said medium, thereby allowing the concentration of free species to remain close to zero, and for improving the signal to noise ratio in assays. This is achieved by employing a substrate, such as a scavenging solid-phase, having an attached binding partner or partners ('scavenger') for the specifically binding species and which is present during storage. This substrate may also contain regions for binding signal generating components attached to the solid-phase. This substrate binds any free species bleeding off the solid phase, increasing the reliability and sensitivity of assays. A subset of the substrates in the invention additionally forms cross-linked networks of solid-phase particles that further increase the sensitivity of assays.

Method and composition for stabilizing liquid reagents

Methods and reagents are disclosed for conducting assays. Embodiments of the present methods and reagents are concerned with a solid support such as, for example, a particle. The support includes a chemiluminescent composition that includes a metal chelate. The present inventors observed that, when such support such as, e.g., particles, were employed in assays for the determination of an analyte, stability of signal output by the chemiluminescent composition associated with the particle was unacceptably reduced as compared to particles including other chemiluminescent compositions. In accordance with embodiments of the present invention, the stability of signal output from such particles is enhanced by including in a medium that contains the particles a sufficient amount of one or more stabilizing agents, which may be a chelating agent and/or a metal chelate such as, for example, the metal chelate that is associated with the particle.

Stabilization of signal generation in particles used in assays

The invention relates to a method for quantitatively or qualitatively detecting an analyte in a sample, with the sample being incubated, for the purpose of avoiding, diminishing and/or detecting the high-dose hook effect, with an analyte-specific binding partner R1, which is associated with a solid phase, an analyte-specific binding partner R2, which is associated with a label L1, and an analyte-specific binding partner R3, which is associated with a label L2, and the L1-dependent measurement signal being determined either at a different time from the L2-dependent or L1 plus L2-dependent measurement signal or using a different measurement method.

Detection methods

Methods and compositions are disclosed for reducing non-specific binding in a binding assay for the determination of an analyte in a sample where one of the reagents for conducting the binding assay comprises a solid support comprising a polysaccharide. The method comprises including in an assay medium for conducting the binding assay a soluble compound comprising a protein linked to a polysaccharide. Also disclosed are methods and compositions for determining the presence and/or amount of an analyte in a sample suspected of containing the analyte. The methods include as reagents a solid support comprising a polysaccharide and a soluble compound comprising a protein linked to a polysaccharide.

Reduction of non-specific binding in assays

A polysaccharide coated carrier having a coating of at least two successive layers of polysaccharide. The first polysaccharide layer spontaneously associates with a second polysaccharide layer and, optionally, the carrier. Each successive layer of polysaccharide spontaneously associates with a preceding layer. Spontaneous association occurs due to the presence of oppositely charged functional groups on each layer of polysaccharide or due to a spontaneous reaction between the functional groups the layers. The carrier may be any surface such as a tube, microtitration plate, bead, particle or the like and is suitable for use in diagnostic or therapeutic methods.

Carriers coated with polysaccharides, their preparation and use

The invention relates to a method and to a diagnostic agent for detecting hemostasis disturbances, wherein, as a consequence of blood platelet aggregation, clot formation and/or clot dissolution, substances are brought to a distance from each other which permits or prevents an interaction, in particular an energy transfer, between the substances, and the extent of the interaction is measured.

Method and diagnostic agent for hemostasis diagnosis

The present invention relates to procedures for the detection or for the determination of solid phase-associated factors, which are multiply associated with the same solid phase. According to the invention, the sample is brought into contact with a transmitter particle, on which at least one ligand having binding affinity for a solid phase-associated factor and a transmitter are immobilized, and a receiver particle, on which at least one ligand having binding affinity for said solid phase-associated factor and a receiver is immobilized, and then the signal is determined which results when transmitter and receiver are brought sufficiently close to one another. In particular, the invention relates to the detection of cell surface receptors which can be used for the typing of cells or for the determination of cell activation states. It is thus possible to replace the hitherto widely customary flow cytometry by a more simple procedure.

Detection and determination of solid phase-associated factors

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Hockessin, DE, United States of America

Carsten Schelp