Biosite Diagnostics, Inc.

Biosite Incorporated

Alere San Diego, Inc.

Vermillion Corporation

Alere International

Kenneth Francis Buechler

Paul H McPherson

Gunars E Valkirs

Joseph Barry Noar

Richard R Anderson

Lema Tadesse

Jeffrey R Dahlen

Joseph Anderberg

Howard J Kirchick

Mariusz Banaszczyk

Si S Moi

Mark R Nowakowski

Joseph M Anderberg

Richard Roger Batt

Alfred R Sundquist

Theodore T Lee

Tai-Tung Yip

Mark A Reynolds

Eric Thomas Fung

Scott Harold Rongey

Jason Christopher Briggs

J Barry Noar

Violeta Dinauer

Michael A Whittaker

Alan Maisel

Michael Whittaker

Christopher A Scott

Paul H Mcpherson

Richard Ray Anderson

Mark Reynolds

Methods for improving immunoassays, and in particular, assays for B-Type natriuretic peptide analogues resistant to prolyl-specific dipeptidyl degradation are provided wherein one or more antibodies are selected such that the one or more antibodies detect a biologically active form of a natriuretic peptide of interest.

Assays for B-type natriuretic peptide analogues resistant to prolyl-specific dipeptidyl degradation

Assay systems and specialized antibodies for the detection and quantitation of troponin I and troponin T in body fluids as an indicator of myocardial infarction are disclosed. Troponin I and T exist in various conformations and the ratios of monomeric troponin I and T and the binary and ternary complexes, as well as which form of troponin present in the blood, may be related to the metabolic state of the heart. Disclosed are systems to determine the presence of a troponin form or a group of troponin forms in whole blood, serum or plasma samples. Disclosed is a method for improving the recovery of troponin I or T from a surface used in immunoassays. Also disclosed are antibodies which recognize unbound troponin forms, the forms of troponin in binary complexes, the ternary complex of troponin I, T and C, and the conformations of troponin I having intramolecularly oxidized and reduced cysteines.

Methods for the assay of troponin I and T and complexes of troponin I and T and selection of antibodies for use in immunoassays

A method to facilitate recovery troponin I and/or troponin T from a sample comprising addition of troponin C to the sample or to a surface from which the troponin I and/or troponin T are recovered.

Methods for improving the recovery of troponin I and T in membranes, filters and vessels

The present invention relates to novel arginine analogs, and methods for their synthesis and use. Such analogs are designed to provide a protected or free thiol (&#x2014;SH) group, thereby providing a convenient linkage chemistry for coupling to a suitable group on a target such as a protein, polypeptide, detectable label or solid phase, and at a site distal to the guanidino group. Arginine analog conjugates are useful for generating antibodies that can bind specifically with dimethylarginine, which can be detected using such antibodies in immunoassays.

Arginine analogs, and methods for their synthesis and use

The assay devices, assay systems and device components of this invention comprise at least two opposing surfaces disposed a capillary distance apart, at least one of which is capable of immobilizing at least one target ligand or a conjugate in an amount related to the presence or amount of target ligand in the sample from a fluid sample in a zone for controlled fluid movement to, through or away the zone. The inventive device components may be incorporated into conventional assay devices with membranes or may be used in the inventive membrane-less devices herein described and claimed. These components include flow control elements, measurement elements, time gates, elements for the elimination of pipetting steps, and generally, elements for the controlled flow, timing, delivery, incubation, separation, washing and other steps of the assay process.

Diagnostic devices and apparatus for the controlled movement of reagents without membranes

The present invention provides methods for the identification and use of diagnostic markers for differential diagnosis of diseases. In a various aspects, the invention relates to methods and compositions able to determine the presence or absence of one, and preferably a plurality, of diseases that exhibit one or more similar or identical symptoms. Such methods and compositions can be used to provide assays and assay devices for use in determining the disease underlying one or more non-specific symptoms exhibited in a clinical setting.

Markers for differential diagnosis and methods of use thereof

The invention relates in part to the use of independent assay controls (IACs) for the optical communication between an assay device and an instrument in monitoring and performing assays, preferably immunoassays.

Methods for monitoring the status of assays and immunoassays

The present invention relates to materials and procedures for evaluating the prognosis of patients suffering from acute coronary syndromes. In particular, the level of BNP, or a marker related to BNP, in a patient sample, alone or in combination with one or more other prognostic markers, provides prognostic information useful for predicting near-term morbidity and/or mortality across the entire spectrum of acute coronary syndromes, including unstable angina, non-ST-elevation non-Q wave myocardial infarction, ST-elevation non-Q wave MI, and transmural (Q-wave) MI.

Use of B-type natriuretic peptide as a prognostic indicator in acute coronary syndromes

The present invention relates to methods for the diagnosis and evaluation of stroke and transient ischemic attacks. A variety of markers are disclosed for assembling a panel for such diagnosis and evaluation. In various aspects, the invention provides methods for early detection and differentiation of stroke types and transient ischemic attacks, for determining the prognosis of a patient presenting with stroke symptoms, and identifying a patient at risk for cerebral vasospasm. Invention methods provide rapid, sensitive and specific assays to greatly increase the number of patients that can receive beneficial stroke treatment and therapy, and reduce the costs associated with incorrect stroke diagnosis.

Diagnostic markers of stroke and cerebral injury and methods of use thereof

Assay systems and specialized antibodies for the detection and quantitation of troponin I and troponin T in body fluids as an indicator of myocardial infarction. Since troponin I and T exist in various conformations in the blood, the ratios of the monomeric troponin I an T and the binary and ternary complexes, as well as which form of troponin present in the blood, may be related to the metabolic state of the heart. Disclosed is a system to determine the presence of a troponin form or a group of troponin forms in a sample of whole blood, serum or plasma. Disclosed is a stabilized composition of troponin; the stabilized composition can comprise a stabilized composition of troponin I, wherein the troponin I is oxidized, the troponin I can be unbound or the troponin I can be in a complex. Disclosed is a method for improving the recovery of troponin I or T from a surface used in immunoassays Also disclosed are antibodies which recognize, unbound troponin forms, the forms of troponin in binary complexes, the ternary complex of troponin I, T and C, and the conformations of troponin I having intramolecularly oxidized and reduced cysteines.

Disclosed is a fluorescent conjugate comprising a biological reagent, a fluorescent molecule, and a means for impeding phototoxic degradation of the biological reagent. The impeding means can be a cross-linking substance having a long molecular distance, whereby the cross-linking substance links the fluorescent molecule and the biological reagent; a quencher of singlet oxygen; a quencher of a free radical; or a combination thereof. Also disclosed is a solution comprising a fluorescent conjugate of a biological reagent and a fluorescent molecule together with an oxygen depleting system.

Compositions and methods for inhibiting light-induced inactivation of biological reagents

Devices and use thereof, the device comprising a filter and a means for region specific compression of the filter. Alteratively, the device comprises a filter; a region containing the filter; a fluid access port to the region containing the filter; a fluid egress port from the region containing the filter; and a lateral fluid flow path through the filter connecting the fluid access port to the fluid egress port. Alternatively, a single step assay device whereby fluid movement through the device occurs substantially solely due to action of capillary force, the device comprising a filter; a region containing the filter; a fluid access port to the region containing the filter; a means for retarding movement of particles through a peripheral filter surface; a fluid egress port from the region containing the filter; a lateral fluid flow path through the filter connecting the fluid access port to the fluid egress port, whereby sample fluid substantially devoid of particulate matter is released from the filter through the egress port; and, an exit region fluidly connected to the egress port. Use of the device optionally comprises means for a producing an assay result in an exit region of the device.

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San Diego, CA, United States of America

Kenneth Francis Buechler