Abstract: The present invention relates to a method and reagents for determining the presence of or the amount of an analyte in a sample.

Abstract: Devices, methods and kits for the detection of analytes in liquid samples. A device for conducting an assay to determine the presence or amount of an analyte in a fluid sample having a flow path matrix that facilitates fluidic flow and a fluid impermeable barrier. The flow path includes a first region on a top side of the barrier that facilitates fluid flow in a first direction and comprises a sample entry area and a second region on a bottom side of the barrier that facilitates fluid flow in a second direction substantially opposite the first direction and comprises a detection zone. Methods using the devices. Kits including the devices and various reagents necessary for conducting the methods.

Abstract: Assays are provided for rapid detection, with high specificity of the pathogenic form of prion protein responsible for neurodegenerative diseases affecting humans and animals, such as transmissible spongiform encephalopathy in bovine, sheep, and cats. Also provided are assays for testing animal feedstock, such as animal feed, for the presence or concentration of pathogenic prion protein. Results are available in from about 0.5 to about 20 minutes and preferably within from about 5 to about 10 minutes. The assays employ proteinase-K to remove normal prion protein from a biological sample, so that the sample may be analyzed by immunochromatography to determine the presence and concentration of pathogenic prion protein. Because the proteinase-K is immobilized on a solid support for in situ removal of interfering components, the present invention obviates the need for subsequent extraction of the desired analyte.

Abstract: Assays are provided for rapid detection, with high specificity of the pathogenic form of prion protein responsible for neurodegenerative diseases affecting humans and animals, such as transmissible spongiform encephalopathy in bovine, sheep, and cats. Also provided are assays for testing animal feedstock, such as animal feed, for the presence or concentration of pathogenic prion protein. Results are available in from about 0.5 to about 20 minutes and preferably within from about 5 to about 10 minutes. The assays employ proteinase-K to remove normal prion protein from a biological sample, so that the sample may be analyzed by immunochromatography to determine the presence and concentration of pathogenic prion protein. Because the proteinase-K is immobilized on a solid support for in situ removal of interfering components, the present invention obviates the need for subsequent extraction of the desired analyte.

Abstract: Assays are provided for rapid detection, with high specificity of the pathogenic form of prion protein responsible for neurodegenerative diseases affecting humans and animals, such as transmissible spongiform encephalopathy in bovine, sheep, and cats. Also provided are assays for testing animal feedstock, such as animal feed, for the presence or concentration of pathogenic prion protein. Results are available in from about 0.5 to about 20 minutes and preferably within from about 5 to about 10 minutes. The assays employ proteinase-K to remove normal prion protein from a biological sample, so that the sample may be analyzed by immunochromatography to determine the presence and concentration of pathogenic prion protein. Because the proteinase-K is immobilized on a solid support for in situ removal of interfering components, the present invention obviates the need for subsequent extraction of the desired analyte.

Abstract: A sensor (10,110) is provided for determination of various concentrations of one or more components within a fluid sample. The sensor (10,110) includes an injection molded body (12,112), at least two electrodes (30,31,32,130,131,132), an enzyme (57,157), and, if desired, an electron transfer mediator. The body includes a reaction zone (24,124) for receiving a fluid sample. The electrodes (30,31,32,130,131,132) are at least partially embedded within the plastic body (12,112) and extend into the reaction zone (24,124). Also contained within the reaction zone is an enzyme (57,157) capable of catalyzing a reaction involving a compound within the fluid sample.

Abstract: Test devices, systems, and test kits are provided for rapid detection with high specificity of the pathogenic form of prion protein responsible for neurodegenerative diseases affecting humans and animals, such as transmissible spongiform encephalopathy in bovine, sheep, and cats. The present invention is also useful for testing animal feedstock made from animal parts. Results are available in from about 0.5 to about 20 minutes and preferably from about 5 to about 10 minutes after the sample is introduced to the device and system. The devices, systems, and test kits employ proteinase-K to remove noninfectious prion protein from a biological sample, so that the sample may be analyzed by immunochromatography to determine the presence and concentration of pathogenic prion protein. Because the proteinase-K is immobilized on a solid support for in-situ removal of interfering components, the present invention obviates the need for subsequent extraction of the desired analyte.

Abstract: A disc (200) having integral therewith a plurality of electrochemical sensors (10) therein to be used with a motorized meter for rapidly detecting and quantifying concentration of analytes in a fluid sample. The disc and sensors may be produced by injection molding manufacturing methods.

Abstract: A disc (200) having integral therewith a plurality of electrochemical sensors (10) therein to be used with a motorized meter for rapidly detecting and quantifying concentration of analytes in a fluid sample. The disc and sensors may be produced by injection molding manufacturing methods.

Abstract: A sensor is provided for the determination of various concentrations of one or more components within a fluid sample. The sensor includes an injection molded body, at least two electrodes, an enzyme, and if desired, an electron transfer mediator. The body includes a reaction zone for receiving a fluid sample. The electrodes are at least partially embedded within the plastic body and extend into the reaction zone. Also contained within the reaction zone is an enzyme capable of catalyzing a reaction involving a compound within the fluid sample. Additionally, the sensor incorporates fill detection which activates a meter, attached to the sensor, for measuring the electrochemical changes occurring in the reaction zone.

Abstract: A sensor is provided for the determination of various concentrations of one or more components within a fluid sample. The sensor includes an injection molded body, at least two electrodes, an enzyme, and if desired, an electron transfer mediator. The body includes a reaction zone for receiving a fluid sample. The electrodes are at least partially embedded within the plastic body and extend into the reaction zone. Also contained within the reaction zone is an enzyme capable of catalyzing a reaction involving a compound within the fluid sample. Additionally, the sensor incorporates fill detection which activates a meter, attached to the sensor, for measuring the electrochemical changes occurring in the reaction zone.

Abstract: A disposable device, a method of sample preparation, and a business method are provided for collecting and preparing a sample for subsequent direct analysis of a particular analyte. The device includes a sampling assembly for collecting a sample, a homogenizing body for comminuting the sample, and a container with a buffer. The homogenizing body has two sites for attachment—one site being attachable to the sampling assembly and the other, being attachable to the container. The device includes a first reagent and a second reagent to facilitate sample preparation, which may respectively be proteinase-K and proteinase-K inhibitor for preparing a sample for analysis of pathogenic prion protein. One embodiment includes a delivery apparatus for dispensing the second reagent into the treated homogenate.

Abstract: Devices and methods are provided for collecting a sample, diluting the sample in a buffer, and dispensing it for analysis by a method of choice. The devices comprise a dropper top dispensing component having a housing and an elongated swab member inserted in the dropper top and having a swab end with an absorbent for collecting a sample. Also included is a vial that contains a buffer and is attachable to the dropper top so as to immerse the absorbent in the buffer after the absorbent has been used to collect the sample. One embodiment incorporates a dispensing chamber within the dropper top for controlling the amount of sample dispensed from the device, so the device is capable of dispensing sample in drop-sized increments.

Abstract: A disposable device, a method of sample preparation, and a business method are provided for collecting and preparing a sample for subsequent direct analysis of a particular analyte. The device includes a sampling assembly for collecting a sample, a homogenizing body for comminuting the sample, and a container with a buffer. The homogenizing body has two sites for attachment—one site being attachable to the sampling assembly and the other, being attachable to the container. The device includes a first reagent and a second reagent to facilitate sample preparation, which may respectively be proteinase-K and proteinase-K inhibitor for preparing a sample for analysis of pathogenic prion protein. One embodiment includes a delivery apparatus for dispensing the second reagent into the treated homogenate.

Abstract: A sensor is provided for the determination of various concentrations of one or more components within a fluid sample. The sensor includes an injection molded body, at least two electrodes, an enzyme, and if desired, an electron transfer mediator. The body includes a reaction zone for receiving a fluid sample. The electrodes are at least partially embedded within the plastic body and extend into the reaction zone. Also contained within the reaction zone is an enzyme capable of catalyzing a reaction involving a compound within the fluid sample. Additionally, the sensor incorporates fill detection which activates a meter, attached to the sensor, for measuring the electrochemical changes occurring in the reaction zone.

Abstract: A sensor is provided for the determination of various concentrations of one or more components within a fluid sample. The sensor includes an injection molded body, at least two electrodes, an enzyme, and if desired, an electron transfer mediator. The body includes a reaction zone for receiving a fluid sample. The electrodes are at least partially embedded within the plastic body and extend into the reaction zone. Also contained within the reaction zone is an enzyme capable of catalyzing a reaction involving a compound within the fluid sample. Additionally, the sensor incorporates fill detection which activates a meter, attached to the sensor, for measuring the electrochemical changes occurring in the reaction zone.

Abstract: A sensor (10,110) is provided for determination of various concentrations of one or more components within a fluid sample. The sensor (10,110) includes an injection molded body (12,112), at least two electrodes (30,31,32,130,131,132), an enzyme (57,157), and, if desired, an electron transfer mediator. The body includes a reaction zone (24,124) for receiving a fluid sample. The electrodes (30,31,32,130,131,132) are at least partially embedded with in the plastic body (12,112) and extend into the reaction zone (24,124). Also contained within the reaction zone is an enzyme (57,157) capable of catalyzing a reaction involving a compound within the fluid sample.

Abstract: A sensor is provided for the determination of various concentrations of one or more components within a fluid sample. The sensor includes an injection molded body, at least two electrodes, an enzyme, and if desired, an electron transfer mediator. The body includes a reaction zone for receiving a fluid sample. The electrodes are at least partially embedded within the plastic body and extend into the reaction zone. Also contained within the reaction zone is an enzyme capable of catalyzing a reaction involving a compound within the fluid sample. Additionally, the sensor incorporates fill detection which activates a meter, attached to the sensor, for measuring the electrochemical changes occurring in the reaction zone.

Abstract: Test devices, systems, and test kits are provided for rapid detection with high specificity of the pathogenic form of prion protein responsible for neurodegenerative diseases affecting humans and animals, such as transmissible spongiform encephalopathy in bovine, sheep, and cats. The present invention is also useful for testing animal feedstock made from animal parts. Results are available in from about 0.5 to about 20 minutes and preferably from about 5 to about 10 minutes after the sample is introduced to the device and system. The devices, systems, and test kits employ proteinase-K to remove noninfectious prion protein from a biological sample, so that the sample may be analyzed by immunochromatography to determine the presence and concentration of pathogenic prion protein. Because the proteinase-K is immobilized on a solid support for in-situ removal of interfering components, the present invention obviates the need for subsequent extraction of the desired analyte.

Abstract: Methods are provided for rapid detection with high specificity of the pathogenic form of prion protein responsible for neurodegenerative diseases affecting humans and animals, such as transmissible spongiform encephalopathy in bovine, sheep, and cats. Methods are also provided for testing animal feedstock for pathogenic prio protein. Results are available in from about 0.5 to about 20 minutes and preferably within from about 5 to about 10 minutes. The methods employ proteinase-K to remove normal prion protein from a biological sample, so that the sample may be analyzed by immunochromatography to determine the presence and concentration of pathogenic prion protein. Because the proteinase-K is immobilized on a solid support for in-situ removal of interfering components, the present invention obviates the need for subsequent extraction of the desired analyte. All aspects of the present invention are suitable for quantifying the minimal detectable amount of pathogenic prion protein in a test sample.