Idexx Laboratories, Inc.

Biocontrol Systems, Inc.

Charles R Carpenter

Ali Naqui

Mark Weston Pierson

Michael P Finnerty

Thomas R Weschler

Stephen C Wardlaw

Haoyi Gu

Chun-Ming Chen

Genevieve Clark

Melanie Tornberg

Thomas Patrick O'Connor, Jr

Giosi Farace

Paul Scott MacHenry

Katherine Jean Esty

Elizabeth Ehrenfeld

Brian John Foster

Mirolee Blue Zieba

Michael Ryan D'Angelo

Gary Madsen

Diana N Sands

Brent M Nelson

Karen E Plante

Brian Eckenroth

Steven C Wardlaw

A method and a kit for determining the presence or amount of analytes in samples over a broad potential concentration range for the analyte. The method and kit incorporate chemiluminescent and fluorescent labels conjugated to a specific binding partner for the analyte for sandwich assays, or to the analyte or an analog of the analyte for competitive assays. The conjugates are mixed with the sample and the labels are detected simultaneously or sequentially.

Dual standard curve immunoassay

The present invention provides devices and methods for determining the presence or absence of pathogens in a biological sample and for the concurrent determination of the antimicrobial susceptibility of pathogens present. The devices and methods of the present invention are able to make the determinations without pre-selection of target bacteria. Instead, all organisms from the sample are applied to the device. In wells where one or more antimicrobial agents are present only pathogens resistant to the antimicrobial agent grow. This allows the user to determine the presence of target pathogens and concurrently determine the resistance patterns of the organisms without the need to subculture the organisms. The present invention also provides methods of performing a business service of performing the determinations described above, and kits containing the devices and descriptions of the methods.

Methods and devices for the detection of pathogenic microorganisms and their antimicrobial susceptibility

The present invention relates to a method of detecting the presence of target microorganisms in a biological sample and of simultaneously determining the susceptibility of the microorganisms to antimicrobial agents. The target microbial organisms may be urinary pathogens. The methods include the steps of providing a multicompartment assay device with at least one compartment containing a medium capable of sustaining the growth of total viable microorganisms, at least one compartment containing a medium capable of sustaining the growth of target microorganisms, and at least one compartment containing an antimicrobial susceptibility interpretation medium. A biological sample is placed in each compartment and the presence and antimicrobial susceptibility of the target microorganisms which may be present is determined by analyzing which compartments exhibit microbial growth.

Method and apparatus for concurrently detecting pathogenic organisms and antimicrobial susceptibility

The present invention provides a method and a device that utilizes capillarity-mediated, chromatographic transport, for the qualitative or semi-quantitative analysis of selected analytes in liquid samples. The device utilizes an applicator/collection device for collecting and administering the sample to the flow path such that reagent(s) flow through the applicator/collection device, washing the sample into the reaction pathway. The device further utilizes an air gap between the initial location of the reagent and the reaction pathway to funnel the reagent efficiently through the sample so as to collect all or substantially all of the sample and make it available for the reaction(s).

Analyte assays and devices

A disposable, dry chemistry analytical system is disclosed which is broadly useful for the detection of a variety of analytes present in biological fluids such as whole blood, serum, plasma, urine and cerebral spinal fluid. The invention discloses the use of the reaction interface that forms between two liquids converging from opposite directions within a bibulous material. The discovery comprises a significant improvement over prior art disposable, analytical reagent systems in that the detectable reactant zone is distinct and separate from the unreacted reagents allowing for the use of reaction indicators exhibiting only minor changes as well as extremely high concentrations of reactants. In addition, staged, multiple reagents can be incorporated. Whole blood can be used as a sample without the need for separate cell separating materials. Finally, the invention is useful for the detection of analytes in a broad variety of materials such as milk, environmental samples, and other samples containing target analytes.

Method and device for detecting analytes in fluids

The present invention provides methods for the calibration of detection and/or quantification assays for a wide variety of analytes in wet or dry chemistry assay systems. The invention involves the use of a reagent and calibrator, which provide a detectable signal after reacting with the analyte to be assayed for. In preferred embodiments the calibrator is provided in gross excess. A mathematical relationship is provided that relates a reaction measurement of the analyte sample with the reagent and a reaction measurement of the calibrator with the reagent as an equation that defines a three dimensional surface. This relationship may be used to calibrate the detection and/or quantification assay.

Methods for the calibration of analyte assays

A self-contained signal generating device and methods for using and making the same are provided. The device and methods may detect the presence of a number of different substances, such as proteins, and utilizes a target material binding dye, which may precipitate a target material as well as stain it, and/or undergo a detectable change, e.g., an absorption or emission frequency shift, on binding of the substance to be detected.

Detection of contaminants using self-contained devices employing target material binding dyes

A disposable, dry chemistry analytical system is disclosed which is broadly useful for the detection of a variety of analytes present in biological fluids such as whole blood, serum, plasma, urine and cerebral spinal fluid. The invention discloses the use of the reaction interface that forms between two liquids converging from opposite directions within a bibulous material. The discovery comprises a significant improvement over prior art disposable, analytical reagent systems in that the detectable reactant zone is visually distinct and separate from the unreacted reagents allowing for the use of reaction indicators exhibiting only minor changes as well as extremely high concentrations of reactants. In addition, staged, multiple reagents can be incorporated. Whole blood can be used as a sample without the need for separate cell separating materials. Finally, the invention is useful for the detection of analytes in a broad variety of materials such as milk, environmental samples, and other samples containing target analytes.

Methods for the detection and identification of crystals in biological fluids

The present invention provides a method and a device that utilizes capillarity-mediated, chromatographic transport, for the qualitative or semi-quantitative analysis of selected analytes in liquid samples. The device utilizes an applicator/collection device for collecting and administering the sample to the flow path such that reagent(s) flow through the applicator/collection device, washing the sample into the reaction pathway. The device farther utilizes an air gap between the initial location of the reagent and the reaction pathway to funnel the reagent efficiently through the sample so as to collect all or substantially all of the sample and make it available for the reaction(s).

An article adapted for holding a liquid sample for quantification of biological material in the liquid sample. The article includes a bag having an upper surface sheet and a lower surface sheet enclosing a volume therebetween. The bag has an upper opening through which the liquid sample can be poured into the volume in the bag. The bag also has a plurality of partitions configured to separate one or more portions of adequate sample in the bag. Also provided is a passage through which a liquid sample can be distributed throughout the volume in the bag. The bag is made of material which can be caused to form discreet non-permeable compartments for holding separate aliquots of the liquid sample.

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Scarborough, ME, United States of America

Charles R Carpenter