Helena Laboratories Corporation

True Health IP LLC

Health Diagnostic Laboratory, Inc.

True Health Diagnostics LLC

Philip A Guadagno

Robert J Sarrine

Henry A Garsee

Charles D Kelley

Eric H Petersen

Tipton L Golias

Earl W Boone

Michael T Everitt

Janine P Burrows

Subphong Tansamrit

Mark E Merchant

Terry L McNeely

Erin Summers

Suzan Robinson

James R Markus

James R Sanford

Aungnapa Tansamrit

James Robert Markus Sanford

Daniel M Hoefner

Joseph Paul McConnell

Mohmed Ashmaig

Erin Grace Bellin

Erin Grace Summers Bellin

Erin Grace (Summers) Bellin

William S Harris

Rajani Rayachoti

Debra Linn Hicks

Joseph Paul Mcconnell

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. The method also includes detecting the calibrator and separated components of the test sample within the common separation lane and measuring the level of the calibrator and separated components of the test sample based on the detecting, thereby performing electrophoresis with in-situ calibration.

Composition and method for gel electrophoresis with in-situ calibration

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.

Applicator comb for gel electrophoresis

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.

Lp(a) subform size identification using elisa

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.

Lp(a) subform size identification by capillary isotachophoresis electrophoresis with laser-induced-fluorescence

An assembly, method, system, and apparatus for the assessment of the level of specific lipoprotein particles present in a bodily fluid are disclosed. The levels determined may be used to predict the risk of developing various diseases related to lipoprotein particles.

Assay for determination of levels of lipoprotein particles in bodily fluids

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.

Flourescent in-situ detection of lipid particle apolipoproteins within primary electrophoretic matrix

A process for making a support for an electrophoretic medium comprising the steps of: applying an agarose coating to a corona treated polymeric film by transferring a layer of agarose solution onto a surface of the corona treated polymeric film. The pH of the agarose solution can be generally maintained between about 8 and about 11 and the concentration of the agarose solution can be generally maintained between about 0.1 and about 0.4% agarose by weight. The agarose powder used to make the agarose solution can be pre-treated by introducing a fresh reducing atmosphere above the agarose powder and exposing the agarose powder to a reducing atmosphere. The reducing atmosphere treatment may be repeated at least three times.

Process for manufacturing a flexible support for an electrophoretic medium

An improved fecal occult blood test having a matrix such as paper that is treated, imprinted or impregnated with a test reagent capable of undergoing a chromogen reaction is disclosed. The improvement relates to a novel developing solution in which the water to alcohol ratio is adjusted to enhance the sensitivity of the test.

Occult blood test enhancer

Novel apparatuses and methods for depositing or placing substances on substrates or plates are described. The invention relates to automated and semiautomated apparatuses and methods for controlled volume and precise placement of substances on substrates. Combinations of applicator tips, applicator tip assemblies, applicator reservoirs, applicator holders and movable racks precisely and accurately place samples and testing chemicals on substrates. Applicator tips particularly useful for dunk transfer and deposit processes and for carrying substances are disclosed. Apparatuses for precisely moving applicator holders, applicator reservoirs and tips are disclosed. The methods and apparatuses also have features for pre-loading substances on applicators and applicator reservoirs and precisely delivering the preloaded substances to substrates.

System for the application of samples on a substrate

An improvement in the immunofixation electrophoresis procedure for detecting proteins in serum, urine or cerebral spinal fluids. Samples are placed on a gel and subjected to electrophoresis for resolving or separating proteins. Thereafter, antisera are applied to the sample areas through openings located on a template. The template includes projections and, the template substantially precludes cross-contamination and the adverse effects of ambient conditions on the integrity of the fluid, such as by the projections contacting, depressing or cutting into the gel to form closed cavities.

Gel-template interface and method for depositing liquid on a gel

An electrophoresis apparatus for automatically performing medical assays includes an electrophoresis platform which cooperates with a gantry assembly. The electrophoresis platform and the gantry assembly are movable along paths that are perpendicular to each other. An applicator assembly includes pipettes which transfer fluid samples from a specimen tray to an electrophoresis plate mounted on the electrophoresis platform. The electrophoresis platform then moves to a position into the gantry assembly, where electrophoresis is conducted to separate the samples into different fractions. The electrophoresis platform then moves beneath a reagent pouring station where a reagent is applied to make the separated fractions fluoresce under ultraviolet light. The electrophoresis platform is then moved beneath the gantry assembly again, and an air knife in the gantry assembly spreads the reagent. After incubation and drying of the electrophoresis plate, the electrophoresis platform and gantry assembly are moved relative to one another while the electrophoresis plate is read with the aid of ultraviolet lamps and a photomultiplier tube mounted in the gantry assembly. The gain of the photomultiplier tube is automatically adjusted and the data gathered is automatically edited to remove background noise. The edited results can be printed or displayed on a video monitor. Techniques for calibrating the electrophoresis apparatus are also disclosed.

Automatic electrophoresis method and apparatus

An improved chromogen-reagent test system for a slide, test kit or the like has particular utility in the testing of fecal specimens for occult blood. The chromogen-reagent system may include the use of colorless guaiac which, in the presence of a developing solution and a catalyst, is oxidized to yield a predetermined color such as blue. Hydrogen peroxide is used as the developing solution and hemoglobin in the fecal specimen functions as the catalyst. The chromogen-reagent test system includes an indicator area for determining if the guaiac and the developing solution are functioning properly, i.e., the test system of the present invention verifies that the guaiac has not lost its activity nor been improperly catalyzed and that the hydrogen peroxide has not lost its activity. The indicator area includes a catalyst which has a greater stability than blood, in respect to adverse environmental conditions, such that a determination can be made if the reagents are functioning properly.

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Vidor, TX, United States of America

Philip A Guadagno