Abbott Laboratories Corporation

Thomas F Zurek

Omar S Khalil

Charles F Hanna

Curtis J Pepe

Kathleen A Hanley

Helen H Lee

A David Hofferbert

Yi-Her Jou

Kevin R Genger

Denise G Huff

Denise A Grigalauski

Stephen M Cotter

Timothy J Perko

A disposable reaction vessel for performing nucleic acid amplification assay. The disposable reaction vessel has a penetrable cap that can be penetrated by an automated pipettor to aspirate a portion of an amplified reaction product. The disposable reaction vessel contains the reagents necessary to perform a nucleic acid amplification assay. A patient specimen is added to the unit dose reagents in the disposable reaction vessel and the penetrable cap is closed. The disposable reaction vessel containing the reaction mixture and the specimen undergoes amplification, typically by placing it in a thermal cycler. After amplification the intact disposable reaction vessel is transferred to an automated analyzer where an automated pipettor penetrates the closure membrane and aspirates a portion of the amplified sample for further processing, without removal of the reaction vessel cap. This avoids the generation of potentially contaminating aerosols or droplets.

Reaction tube with a penetrable membrane to minimize contamination

Method of minimizing contamination in amplification reactions using a

The method for thermal cycling of nucleic acid assays includes a blended fluid stream produced from a plurality of constant velocity, constant volume, constant temperature fluid streams wherein to provide a variable temperature, constant velocity, constant volume fluid stream which is introduced into a sample chamber for heating and cooling samples contained therein. By diverting and altering the ratio of the constant temperature fluid streams relative to one another, the blended fluid stream is rapidly variable in temperature, providing for almost instantaneous temperature change within the environment defined by the sample chamber.

Method for thermal cycling nucleic acid assays

A disposable device suitable for performing automated solid-phase diagnostic assays which employs microparticles to complex an analyte and where the microparticle complex becomes retained and immobilized on a fibrous matrix such that the presence of analyte on the microparticles can be detached by optical means. A device is disclosed having a plurality of well pairs comprising a sample well for receiving a sample and reagents for forming a reaction mixture, a read well comprising (a) an entrance port and holder for receiving and holding a quantity of sample and assay reagents, (b) a fibrous matrix for retaining and immobilizing microparticle/analyte complexes for detection, said fibrous matrix positioned below said holder, and having an average spatial separation of fibers greater than the average diameter of said microparticles, (c) absorbent material positioned below said fibrous matrix for assisting the flow of sample and assay reagents through said fibrous matrix, (d) walls or ribs for creating a substantially light-tight real surrounding the wells, (e) a vent for venting air entrapped in the absorbent material and which is displaced by fluids absorbed therein, and (f) a passage between the sample well and the read well whereby sample and reaction mixtures can be transferred and washed from said sample well into said read well without being contacted by any apparatus.

Device for performing solid-phase diagnostic assay

A method for performing a microparticle diagnostic assay in a device having a shallow sample well for receiving a sample and reagents for forming a reaction mixture, a read well positioned adjacent to said sample well and separated from said sample well by a wall which is constructed and arranged such that when wash fluid is injected into said sample well, sample and reaction mixtures are washed from said shallow sample well, over the wall and into said read well. The steps of the method comprise forming microparticle analyte complexes in said shallow sample well; washing said microparticle analyte complexes from said shallow sample well over the wall and into said read well where a fibrous matrix retains and immobilizes said microparticle analyte complexes; adding to said read well an indicator substance capable of forming an assay signal when said microparticle analyte complexes are present; and detecting said assay signal produced by said indicator substance.

Methods for performing a solid-phase immunoassay

Disposable immunoassay reaction tray

Apparatus and method for performing a chemiluminescence assay involving the immobilization of a chemiluminescent reaction complex to a solid, porous element. The solid, porous element is preferably treated to provide an immobilizing interaction with the chemiluminescent reaction complex wherein the chemiluminescent reaction complex is thereby immobilized to the solid, porous element. The activating and reading of the chemiluminescent reaction are separately performed by evenly distributing a concentrated chemiluminescent activating solution to form a puddle on the surface of the porous element to which the chemiluminescent reaction complex is immobilized.

Method and apparatus for heterogeneous chemiluminescence assay

A disposable device suitable for performing automated solid-state diagnostic assays which employs microparticles to complex an analyte and where the microparticle complex becomes retained and immobilized on a fibrous matrix such that the presence of analyte on the microparticles can be detected by an optical device. A device is disclosed having a shallow sample well for receiving a sample and reagents for forming a reaction mixture, a read well having (a) an entrance port and wash receiving structure for receiving a quantity of sample and assay reagents, (b) a fibrous matrix for retaining and immobilizing microparticle/analyte complexes for detection, the fibrous matrix positioned below the wash receiving structure, and having an average spatial separation of fibers greater than the average diameter of the microparticles and (c) a structure below the fibrous matrix for assisting the flow of sample and assay reagents through the fibrous matrix, such as an absorbent material or vacuum below the fibrous matrix and a passage means communicating between the shallow sample well and the read well where the sample and reaction mixtures can be transferred and washed from the shallow sample well into the read well without being contacted by any apparatus.

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River Forest, IL, United States of America

Thomas F Zurek