Abstract: The invention relates to, among other things, a method for performing electrophoresis with in-situ calibration. The method includes combining a volume of a test sample with a volume or quantity of a calibrating sample to form a final volume, where the volume of the calibrating sample includes a known concentration of a calibrator and the final volume includes a known ratio of test sample to calibrating sample. The method also includes depositing a loading fraction in a receiving well of an electrophoretic gel, in which the loading fraction is a fraction of the final volume, and separating the loading fraction along a common separation lane of the electrophoretic gel such that components of the test sample and the calibrator are separated from one another along the common separation lane.

Abstract: A fluid applicator device includes an applicator body having a surface that is generally planar. A plurality of aligned applicator teeth extend from said applicator body. Each applicator tooth extends longitudinally from said applicator body along a length from a base of the applicator tooth proximate to the applicator body to a tip of the applicator tooth distal to the applicator body. At least one applicator tooth of the plurality of aligned applicator teeth has a width that is greater at the base than at the tip. A method for depositing a liquid sample on a substrate using the fluid applicator device is also disclosed.

Abstract: The application describes methods for determining the particle number and/or molar mass of lipoprotein(a) subform(s) in a biological sample using enzyme linked immunosorbent assay (ELISA). The methods described herein significantly improve lipoprotein ELISA methods and devices capable of quantifying particle numbers and population mass of Lp(a) particles. This technology offers a method for the efficient and cost-effective measurement of specific Lp(a) in a rapid, low-cost format, rather than limited measurement of Lp(a) concentration in patient tissues. The ability to measure the particle number and/or molar mass of lipoprotein(a) subform(s) in a biological sample also provides a useful diagnostic tool for assessing cardiovascular risk in a subject.

Abstract: The application describes methods for determining the concentration and/or particle number of a lipoprotein(a) subform in a biological sample using capillary isotachophoresis laser induced fluorescence (CE-ITP-LIF) and compositional analysis of lipoprotein(a) particles. The ability to measure the concentration and/or particle number of a lipoprotein(a) subform in a biological sample provides a useful diagnostic tool for assessing cardiovascular risk in a subject.

Abstract: This application discloses methods for assessing quantities of spherical or substantially spherical lipoprotein particles or portions thereof present in a biological sample based on the measurement of free cholesterol and/or phospholipid content in the lipoprotein particles. Methods of treating a subject at increased risk for cardiovascular disease and/or cardiodiabetes are also disclosed.

Abstract: A fluid applicator device includes an applicator body having a surface that is generally planar. A plurality of aligned applicator teeth extend from said applicator body. Each applicator tooth extends longitudinally from said applicator body along a length from a base of the applicator tooth proximate to the applicator body to a tip of the applicator tooth distal to the applicator body. At least one applicator tooth of the plurality of aligned applicator teeth has a width that is greater at the base than at the tip. A method for depositing a liquid sample on a substrate using the fluid applicator device is also disclosed.

Abstract: A fluid applicator device includes an applicator body having a surface that is generally planar. A plurality of aligned applicator teeth extend from said applicator body. Each applicator tooth extends longitudinally from said applicator body along a length from a base of the applicator tooth proximate to the applicator body to a tip of the applicator tooth distal to the applicator body. At least one applicator tooth of the plurality of aligned applicator teeth has a width that is greater at the base than at the tip. A method for depositing a liquid sample on a substrate using the fluid applicator device is also disclosed.

Abstract: The present disclosure relates to, among other things, systems for detecting the level of specific lipoprotein-bound level of PCSK9, and optionally free PCSK9, lipoprotein or portions thereof and/or PCSK9 unbound lipoproteins present in a biological sample. The present invention also relates to methods of assessing the level of specific lipoprotein-bound level of PCSK9, and optionally free PCSK9, Apo B and/or PCSK9 unbound lipoproteins present in a biological sample, determining whether a subject is at increased risk for cardiovascular disease and monitoring the risk for developing cardiovascular disease.

Abstract: The present invention relates to, among other things, a gel electrophoresis system for detecting the level of specific Apolipoproteins and/or lipoprotein particles present in intact lipid particles in a biological sample. The system includes a gel substrate to receive a biological sample, at least two lipoprotein-binding complexes. Each complex includes an antibody that binds a lipoprotein particle or a portion thereof, which is bound to a signal producing molecule capable of producing or causing production of a detectable signal. The system also includes a device for detecting the detectable signal. The present invention also relates to methods of assessing the level of specific Apolipoproteins and/or lipoprotein particles present in a biological sample, determining whether a subject is at increased risk for cardiovascular disease, and monitoring the risk for developing cardiovascular disease.

Abstract: A fluid applicator device (10) includes an applicator body (14) having a surface that is generally planar. A plurality of aligned applicator teeth (16) extend from said applicator body. Each applicator tooth (16) extends longitudinally from said applicator body (14) along a length from a base (18) of the applicator tooth proximate to the applicator body to a tip (20) of the applicator tooth distal to the applicator body. At least one applicator tooth of the plurality of aligned applicator teeth has a width that is greater at the base than at the tip. A method for depositing a liquid sample on a substrate using the fluid applicator device is also disclosed. The applicator teeth (16) may comprise perforations. The applicator teeth (16) may comprise a hydrophobic flash border surrounding the main applicator tooth body to prevent premature deposition of the sample fluid.

Abstract: The present invention relates to, among other things, a gel electrophoresis system for detecting the level of specific Apolipoproteins and/or lipoprotein particles present in intact lipid particles in a biological sample. The system includes a gel substrate to receive a biological sample, at least two lipoprotein-binding complexes. Each complex includes an antibody that binds a lipoprotein particle or a portion thereof, which is bound to a signal producing molecule capable of producing or causing production of a detectable signal. The system also includes a device for detecting the detectable signal. The present invention also relates to methods of assessing the level of specific Apolipoproteins and/or lipoprotein particles present in a biological sample, determining whether a subject is at increased risk for cardiovascular disease, and monitoring the risk for developing cardiovascular disease.

Abstract: The application describes methods for determining the particle number and/or molar mass of lipoprotein(a) subform(s) in a biological sample using enzyme linked immunosorbent assay (ELISA). The methods described herein significantly improve lipoprotein ELISA methods and devices capable of quantifying particle numbers and population mass of Lp(a) particles. This technology offers a method for the efficient and cost-effective measurement of specific Lp(a) in a rapid, low-cost format, rather than limited measurement of Lp(a) concentration in patient tissues. The ability to measure the particle number and/or molar mass of lipoprotein(a) subform(s) in a biological sample also provides a useful diagnostic tool for assessing cardiovascular risk in a subject.

Abstract: The application describes methods for determining the concentration and/or particle number of a lipoprotein(a) subform in a biological sample using capillary isotachophoresis laser induced fluorescence (CE-ITP-LIF) and compositional analysis of lipoprotein(a) particles. The ability to measure the concentration and/or particle number of a lipoprotein(a) subform in a biological sample provides a useful diagnostic tool for assessing cardiovascular risk in a subject.

Abstract: This application describes a method for measuring the molar concentrations of lipoprotein particles and lipoprotein subclass particles in bodily fluid by Multipixel Capillary Isotachophoresis Laser Induced Fluorescence (MPCE-ITP-LIF) and compositional analysis of spherical lipoprotein particles. The ability to measure several kinds of lipoproteins and particles in one unified system provides a useful diagnostic tool for predicting the risk of developing metabolic diseases such as cardiovascular disease and cardiodiabetes.

Abstract: A method for determining the molar concentration of specific lipoprotein particles present in a bodily fluid is presented. Multipixel Capillary Isotachophoresis Laser Induced Fluorescence is applied to fluorescently-labeled lipoproteins or immunologically-labeled apolipoproteins, facilitating quantification of lipoproteins and/or lipid particles and/or their associated apolipoproteins in a sample. The measurements are used to predict the risks of developing, progressing in severity of diseases related to lipoprotein particles, including cardiovascular and metabolic disorders.

Abstract: A fluid applicator device includes an applicator body having a surface that is generally planar. A plurality of aligned applicator teeth extend from said applicator body. Each applicator tooth extends longitudinally from said applicator body along a length from a base of the applicator tooth proximate to the applicator body to a tip of the applicator tooth distal to the applicator body. At least one applicator tooth of the plurality of aligned applicator teeth has a width that is greater at the base than at the tip. A method for depositing a liquid sample on a substrate using the fluid applicator device is also disclosed.

Abstract: The invention relates to, among other things, a method for performing electrophoresis with in-situ calibration. The method includes combining a volume of a test sample with a volume or quantity of a calibrating sample to form a final volume, where the volume of the calibrating sample includes a known concentration of a calibrator and the final volume includes a known ratio of test sample to calibrating sample. The method also includes depositing a loading fraction in a receiving well of an electrophoretic gel, in which the loading fraction is a fraction of the final volume, and separating the loading fraction along a common separation lane of the electrophoretic gel such that components of the test sample and the calibrator are separated from one another along the common separation lane.

Abstract: This invention relates to methods for assessing quantities of spherical or substantially spherical lipoprotein particles or portions thereof present in a biological sample based on the measurement of free cholesterol and/or phospholipid content in the lipoprotein particles. The invention also relates to the use of the assessed quantities of the lipoprotein particles or portions thereof to determine whether a subject is at increased risk for cardiovascular diseases and cardiodiabetes.

Abstract: In one aspect, a method for determining the composition of individual Lp(a) subforms in a test sample is provided. The method involves providing a test sample comprising Lp(a) subforms obtained from a subject; separating the Lp(a) subforms in the test sample along an electrophoretic gel; measuring the migration velocity of the individual Lp(a) subforms along the electrophoretic gel; comparing, based on said measuring, the migration velocity of the individual Lp(a) subforms to a reference value; and determining, based on said comparing, the molar mass of the individual Lp(a) subforms. Methods for predicting cardiovascular health are also provided.

Abstract: The invention relates to, among other things, a method for performing electrophoresis with in-situ calibration. The method includes combining a volume of a test sample with a volume or quantity of a calibrating sample to form a final volume, where the volume of the calibrating sample includes a known concentration of a calibrator and the final volume includes a known ratio of test sample to calibrating sample. The method also includes depositing a loading fraction in a receiving well of an electrophoretic gel, in which the loading fraction is a fraction of the final volume, and separating the loading fraction along a common separation lane of the electrophoretic gel such that components of the test sample and the calibrator are separated from one another along the common separation lane.