Abbott Laboratories Corporation

Peter A Lagocki

William J Kanewske, Iii

David A Yost

James E Mitchell

Richard R Martin

James A Vaught

Apparao Tayi

B Jane Smith

Kendall B Hendrick

Edna S Walker

Charles D Pennington

Gilbert Clift

Larry W Moore

Richard L Vickstrom

William J Raymoure

John M Clemens

Frederic L Clark

William D Rumbaugh

Donny R Walker

Kevin M Cloonan

Richard A Merriam

Douglas D McDowell

Gary E Winter

William E Watkins, Iii

Linda S Schmidt

Robert A Wohlford

David B Hills

Alyn K Stanton

Adrian M Spronk

Robert B Hance

Carl M Oleksak

Paul R Schrier

Frederick L Clark

Roger C Hu

Yi-Her Jou

Larry E Moore

Gibert Clift

William J Iii Kanewske

William E Iii Watkins

Donny Ray Walker

Jane B Smith

A sample container segment assembly for use in an automated, continuous, and random access analytical system is disclosed. The assembly includes a sample container which is received by a sample container segment, and the sample container segment is received on a carousel of the automated analytical instrument. The test sample container includes an upper skirt and a body having a reservoir for receipt of the test sample. The segment includes a base, a frame, and a handle. The frame has a shelf for which the upper skirt of the test sample container rests on, and has openings for receipt of the body of the sample container. The carousel has a carousel trough for receipt of the base of the sample container segment, and has a plurality of alignment pins disposed in the carousel trough. The base of the sample container segment has a circular slot and an elongated slot for receiving the alignment pins and positioning the sample container segment relative to the carousel. The sample container segment can include a liquid level sensing sleeve which is made of a conductive material and surrounds the reservoir of the test sample container inserted therein. Alternatively, the test sample container can have a conductive core which surrounds the reservoir and extends therebelow. The container sample segment can also include various sleeves, or springs and arms, for securing and positioning the test sample container within the sample container segment.

Sample container segment assembly

A method for verifying that an assay methodology is properly performed, that assay reagents employed possess the necessary potency for accurately performing such assay methodology, and whether or not test samples or assay reagents have been tampered with or are adulterated, is described. The method is performed by employing an assay verification sample, comprising a positive analyte component and the test sample under analysis, wherein the assay verification sample is analyzed employing the same assay reagents and essentially the same assay methodology employed to analyze the test sample. The method is particularly useful for performing heterogeneous immunoassays on an automated continuous and random access analytical system.

Assay verification control for an automated analytical system

A method and apparatus for washing clinical apparatus is disclosed. The apparatus is a device for washing clinical apparatus, wherein the clinical apparatus is employed, at different times, to contain a first test substance during a first testing step and a second test substance during a second testing step subsequent to the first testing step. The apparatus comprises a device for supplying a wash solution to the apparatus, and for varying the quantity of the wash solution supplied to the apparatus. The apparatus further comprises a control unit for controlling the device for varying quantity to vary the quantity of the wash solution in proportion to the potential for contamination between the first test substance and the second test substance contained in the apparatus.

Apparatus and method for washing clinical apparatus

The present invention is a method for opening and closing a cap pivotally mounted on a container for storing reagents for use in an automated analytical instrument. The cap has one end for sealing the container and a tab extending from the other end for pivoting the cap. The method comprises the steps of positioning a closed container adjacent an actuating device mounted on the analytical system. The method further comprises the steps of projecting the actuating device against the top of the tab to pivotally open the cap to a position sufficiently vertical for aspirating reagent from the container, and retracting the actuating device from the cap to a position above the pivotal mounting thereof. The method comprises the final step of causing relative motion between the cap and the actuating device so that the actuating device drags along the top of the cap pivotally closing the cap to provide a sufficient seal on the container preventing evaporation of the reagent therefrom.

Cap actuator for opening and closing a container

An automated, continuous and random access analytical system, having apparatus and methodology capable of simultaneously performing multiple assays of liquid samples using different assay methodologies, and providing continuous and random access while performing a plurality of different assays on the same or different samples during the same time period, is disclosed. A method is also disclosed of operating an automated continuous and random access analytical system capable of simultaneously effecting multiple assays of a plurality of liquid samples wherein scheduling of various assays of the plurality of liquid samples is followed by creating a unit dose disposable and separately transferring a first liquid sample and reagents to a reaction vessel without initiation of an assay reaction sequence, followed by physical transfer of the unit dose disposable to a processing workstation, whereby a mixture of the unit dose disposable reagents and sample are achieved during incubation. The system is capable of performing more than one scheduled assay in any order, and assays where more than such scheduled assays are presented. The automated, continuous and random access analytical system is also capable of analyzing the incubated reaction mixtures independently and individually by at least two assay procedures.

Automated continuous and random access analytical system

A method for modifiying a liquid assay reagent to provide prolonged homogeneity thereof, particularly where the liquid assay reagent comprises microparticles for performing a heterogeneous immunoassay, is provided wherein the addition of an inert material to a liquid assay reagent achieves neutral density to thereby prolong the homogeneity thereof for extended periods of time. A method for the automated agitation of assay reagents to maintain the homogeneity thereof with an automated, continuous and random access analytical instrument is also provided. The automated mixing is accomplished by a back and forth motion of a carousel onto which assay reagent containers or packs are mounted with asymmetric pauses which can be completed within a short period of time. The carousel acceleration, velocity, distance moved, and pause-asymmetry are optimized to provide rapid assay reagent resuspension without foaming or bubble formation. Accordingly, periodic removal of assay reagent packs by an operator in order to mix the reagents is not necessary.

Methods for providing homogeneous reagents

A plastic assay cuvette having the desired optical properties for the analysis of a test sample or reaction mixture thereof, and a method for making such plastic assay cuvette, are described. The optical properties of the plastic assay cuvette are substantially the same as the optical properties of glass wherein low birefringence throughout the optical read region thereof is provided. When used for the analysis of a test sample or reaction mixture thereof, such as in fluorescence polarization assays and absorbance assays, the plastic assay cuvette provides accurate and reproducible results while, at the same time, provides a low-cost disposable assay cuvette which can be used in place of conventional glass assay cuvettes.

Injection molding a plastic assay cuvette having low birefringence

The present invention provides for novel homogeneous immunoassay systems involving complement-mediated lysis of marker-encapsulating lipid vesicles (liposomes) for detection of analyte in a fluid sample. These systems do not require the separation of unbound antigens and/or antibody conjugates yet provide highly sensitive procedures for analyte detection. Liposomes containing a marker, are coupled to antibody fragments in a way which confers the liposomes with immunological specificity yet avoids sensitizing the liposomes to complement mediated lysis in the absence of analyte. Antibody sensitized liposomes (the first reagent) are sequentially incubated with an analyte-containing sample, and optionally 'dummy' liposomes, which do not contain encapsulated marker, a second antibody (the second reagent), and finally with a complement source such as plasma. Complement is activated by the liposome-antibody-antigen-second antibody complex causing liposome lysis and a concomitant release of marker. Also provided are methods for preparing antibody sensitized liposomes in the presence of a polysaccharide capable of forming a reversible gel and methods for preparing derivatized Fab' antibody fragments for coupling to lipid vesicles.

Process for coupling antibodies or antibody fragments to liposomes

Liposome based homogeneous immunoassay for diagnostic tests

Growing community of inventors

Park Ridge, IL, United States of America

Peter A Lagocki