Roche Diagnostics Operations, Inc.

Roche Diagnostics Gmbh

Indiana University

F. Hoffmann-la Roche Ag

Barbara Upmeier

Toralf Zarnt

Ralf Bollhagen

Christoph Seidel

Ursula-Henrike Wienhues

Urban Schmitt

Elke Faatz

Manfred Motz

Erwin Soutschek

Michael Wiedmann

Frederic Donie

Dieter Roessler

Christian Scholz

Johannes Polz

Peter Schaarschmidt

Alfred Engel

Dittmar Schlieper

Peter Muench

Andreas Woeste

Manfred Ginter

Hans-Peter Josel

Marie-Ange Buyse

Eva Hoess

Eric Saman

Christine Markert-Hahn

Martin Burri

Beatus Ofenloch-Hahnle

Ursula Klause

Veit Peter Grunert

Jürgen Schäffler

Bernhard Eckert

Sascha Antoni

Pavel Kubalec

Werner Naser

Matthias Rothfuss

Thomas Mock

Vanessa Balassa

Werner Doeppen

Elena Pfaffenrot

Martina Bronold

Peter MÜNCH

The present invention relates to a method for determining an analyte in a sample, comprising a) contacting said sample with at least a first and a second detector compound; b) determining the amount of complexes comprising at least one detector compound; and, c) determining said analyte in a sample based on the result of step b), wherein said first detector compound comprises a first binding moiety and a first label, and said second detector compound comprises a second binding moiety and a second label, and wherein the first label and the second label are non-identical. The present invention further relates to a kit for detecting an analyte in a sample, comprising at least a first and a second detector compound for said analyte, wherein said first detector compound comprises a first binding moiety and a first label, and said second detector compound comprises a second binding moiety and a second label, and wherein the first label and the second label are non-identical; and to a device for determining an analyte in a sample, comprising at least a first and a second detector compound for said analyte, wherein said first detector compound comprises a first binding moiety and a first label, and said second detector compound comprises a second binding moiety and a second label, and wherein the first label and the second label are non-identical; and means for determining at least one signal obtained from said first label and said second label; and to the use of a composition comprising at least a first and a second detector compound for detecting an analyte, wherein said first detector compound comprises a first binding moiety and a first label, and said second detector compound comprises a second binding moiety and a second label, and wherein the first label and the second label are non-identical.

Reduction of interferences in immunoassays

A method for determining an analyte in a sample suspected to comprise the analyte, includes a) contacting with said sample at least a first and a second capture compound for the analyte; b) contacting the capture compounds contacted with the sample with a specifier; c) determining the amount of complexes comprising the specifier and a capture compound; and d) determining the analyte in a sample based on the result of step c). Additionally, a method for improving the specificity of an indirect immunoassay for determining an analyte, kits, devices, and uses related to the aforementioned methods are also disclosed.

Methods for reducing interferences

An automated analyzer system for biological samples is provided and includes a sample processing system and a controller configured to receive a selection of one of multiple workflows for determining a presence and/or concentration of an analyte in a biological sample and prompt the automated analyzer system to automatically carry out the selected workflow using the sample processing system and output a result classifying the biological sample.

Systems and methods for classifying a biological sample regarding the presence of an analyte

The present disclosure relates to a method for detecting a core polypeptide of a hepatitis C virus (HCV) in a sample from a subject with the steps of (a) contacting the sample with a surfactant comprising a cationic detergent; (b) contacting the sample with a binding compound; and (c) detecting a core polypeptide of the HCV in the sample; wherein step a) is immediately followed by step b). The present disclosure further relates to a method for pre-processing a sample from a subject for detection of an HCV core polypeptide, involving (a) contacting the sample with a surfactant comprising a cationic detergent and, optionally, with an agent inducing a pH shift, immediately followed by (b) contacting the sample with a binding compound. Moreover, the present disclosure further relates to uses, devices, and analytical systems related to aforesaid methods.

Pretreatment method for rapid detection of HCV core antigen

Disclosed is an immunoassay method for detecting an analyte such as an antigen or an antibody in an isolated sample suspected to contain the analyte by incubating the sample with a plurality of binding partners, one of which carries a detectable label, wherein a label-specific binding partner is added that does not carry a label but binds to the detectable label. The method is applicable for a large variety of analytes and has proven particularly useful for analyte antibodies of the IgG and IgM class present in samples due to infections by pathogens. Also disclosed is a reagent kit useful for the method comprising at least two analyte-specific binding partners one of which carries a detectable label and a label-specific binding partner that binds to said detectable label but itself does not carry a detectable label.

Method for reduction of interferences in immunoassays

Described is a method for determining an analyte in a sample suspected to contain the analyte, by a) contacting the sample with a first and a second capture compound for the analyte, wherein the first and second capture compounds are non-identical capture compounds, and the capture compounds compete in binding to the analyte; b) contacting the capture compounds contacted with the sample with a specifier, wherein the specifier competes in binding to the capture compounds with the analyte; c) determining the amount of complexes having the specifier and a capture compound; and d) determining the analyte in a sample based on the result of step c). Also disclosed is a method for improving the specificity of an indirect immunoassay for determining an analyte, as well as kits, devices, and uses related to the methods.

The present disclosure relates to a method for detecting a core polypeptide of a hepatitis C virus (HCV) in a sample from a subject involving (a) contacting said sample with a base and with a surfactant having a cationic detergent, and (b) detecting a core polypeptide of the HCV in the sample. The present invention further relates to a method for pre-processing a sample from a subject for detection of HCV, involving contacting the sample with a base and with a surfactant having a cationic detergent; and to a pre-processing reagent for detecting HCV in a sample, having a base and a surfactant including a cationic detergent, wherein the surfactant also has a nonionic detergent. Moreover, the present disclosure further relates to kits, uses, and devices related to the methods disclosed.

Method for serological detection of viral antigens

The disclosure concerns a method and kits for measurement of an analyte in a microparticle-based analyte-specific binding assay. In the assay, the microparticles are coated with the first partner of a binding pair, mixing the coated microparticles and at least two analyte-specific binding agents, each conjugated to the second partner of the binding pair, and a sample suspected of containing the analyte. The second partner of the binding pair is bound to each of the analyte-specific binding agents via a linker comprising from 12 to 30 ethylene glycol units (PEG 12 to 30), thereby binding the analyte via the conjugated analyte-specific binding agents to the coated microparticles. The method also entails separating the microparticles having the analyte bound via the binding pair and the analyte-specific binding agent from the mixture and measuring the analyte bound to the microparticles.

Immunoassay using at least two pegylated analyte-specific binding agents

The disclosure relates to a multi-epitope fusion protein as well as to its use as calibrator and/or control in an in vitro diagnostics immunoassay for detecting HCV core antigen. The multi-epitope fusion protein has two to six different non-overlapping linear peptides present in the amino acid sequence of hepatitis C virus (HCV) core protein, wherein each of the peptides is separated from the other peptides by a spacer consisting of a non-HCV amino acid sequence and having a chaperone amino acid sequence. No further HCV specific amino acid sequences are present in the polypeptide. A further aspect relates to a reagent kit for detecting HCV core antigen containing said multi-epitope fusion protein as calibrator or control or both.

Multi-epitope fusion protein of an HCV antigen and uses thereof

The invention concerns variants of JL7 antigens that are suitable for detecting antibodies against(causing Chagas disease) in an isolated biological sample. These antigens comprise a JL7 specific amino acid sequence, said JL7 specific sequence consisting of two copies of SEQ ID NO. 2, wherein each of said two copies has an amino acid identity of at least 90% to SEQ ID NO.2 and wherein no furtherspecific amino acid sequences are present in said polypeptide. The invention also concerns a composition of polypeptides useful for the detection of antibodies againstthat comprises the above characterized JL7 antigen along with at least one ofpolypeptides 1F8, Cruzipain, KMP-11 and PAR-2. Moreover, it relates to a method for producing JL7 antigen as well as to diagnostic methods for detectingantibodies using the JL7 polypeptide. In addition, the invention concerns a reagent kit comprising said JL7 polypeptides or composition ofpolypeptides.

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A test management system is presented. The system comprises an analyzer to perform tests a sample according to a first set of instructions, a manager module connected to the analyzer, and a first order interface connected to the manager module. The manager module directs activity of the analyzer according to a second set of instructions. The first order interface receives an order for a first analytical test and a second analytical test and transmits the order to the manager module. If the order is for the first analytical test, the test manager module forwards the order directly to the analyzer and the sample is analyzed by the analyzer according to the first set of instructions. If the order is for the second analytical test, the manager module handles the order according to the second set of instructions and generates and transmits secondary test requests to the analyzer.

Analytical test management system and method

The present invention concerns a composition of polypeptides suitable for detecting antibodies against() in an isolated biological sample consisting of three polypeptides 1F8, JL7 and Cruzipain. A method of producing a soluble and immunoreactive composition of polypeptides suitable for detecting antibodies againstusing said composition of polypeptides is also part of the invention. Moreover, the invention concerns a method for detecting antibodies specific forin an isolated sample wherein a composition of saidpolypeptides is used as well as a reagent kit comprising said composition ofpolypeptides.

Antigen composition for detecting Chagas disease

Methods for determining an analyte in a sample by immunoassay in a one-step format without performing washing steps are described. The method includes a first analyte-specific receptor that contains at least two binding sites for the analyte, and a second analyte-specific receptor that selectively binds to an aggregate arrangement of at least two analyte molecules bound to the first receptor.

Method for detection of specific immunoglobulin class G antibodies

Methods and system for determination of an anti-&#x3c;therapeutic monoclonal antibody&#x3e; antibody (anti-&#x3c;TmAB&#x3e;AB) in vitro in a sample from a patient treated with a therapeutic monoclonal antibody (TmAB). Also, methods and systems for the determination of antigen specific antibodies of a particular immunoglobulin class and for the identification of a patient who is at risk of developing an adverse drug reaction (ADR) during treatment with a TmAB.

Assay for measurement of antibodies binding to a therapeutic monoclonal antibody

The invention relates to soluble rubella E1 antigens and variants of these antigens. The antigens contain amino acids 201 to 432 or 169 to 432 and are lacking amino acids 453 to 481 as well as at least the amino acids 143 to 164. They further contain a region spanning two disulfide-bridges. The invention also relates to a recombinant DNA molecule encoding the rubella E1 antigens, the expression of rubella E1 antigens as chaperone fusion proteins and their use in a method of detecting antibodies against rubella in a sample.

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Iffeldorf, Germany

Barbara Upmeier