Gen-probe, Inc.

Cheryl A Jakub

Glenn A Horner

Robert Edwin Schneider

Kelly G Ammann

Robert J Smith

Ralph E Burns

Ernest V Hansberry

John E Kling

Donald J Nieglos

An automated analyzer for performing multiple diagnostic assays simultaneously includes multiple stations, or modules, in which discrete aspects of the assay are performed on fluid samples contained in reaction receptacles. The analyzer includes stations for automatically preparing a specimen sample, incubating the sample at prescribed temperatures for prescribed periods, performing an analyte isolation procedure, and ascertaining the presence of a target analyte. An automated receptacle transporting system moves the reaction receptacles from one station to the next. The analyzer further includes devices for carrying a plurality of specimen tubes and disposable pipette tips in a machine-accessible manner, a device for agitating containers of target capture reagents comprising suspensions of solid support material and for presenting the containers for machine access thereto, and a device for holding containers of reagents in a temperature controlled environment and presenting the containers for machine access thereto. A method for performing an automated diagnostic assay includes an automated process for isolating and amplifying a target analyte. The process is performed by automatically moving each of a plurality of reaction receptacles containing a solid support material and a fluid sample between stations for incubating the contents of the reaction receptacle and for separating the target analyte bound to the solid support from the fluid sample. An amplification reagent is added to the separated analyte after the analyte separation step and before a final incubation step.

Automated analyzer for performing a nucleic acid-based assay

An automated method for detecting the presence of a nucleic acid in a sample, where the method is performed within a housing of a self-contained, stand-alone analyzer. The method includes purifying the nucleic acid after it has been immobilized on a magnetically-responsive solid support. A pipette of the analyzer is used to form a reaction mixture comprising the purified nucleic acid and all reagents required to perform a nucleic acid amplification. Amplification products are synthesized that include a nucleotide sequence contained in the nucleic acid or the complement of the nucleic acid. The amplification products are exposed to a probe in a mixture, where the probe forms a hybrid with one of the amplification products. The formation of the hybrid in the mixture provides an indication of the presence of the nucleic acid in the sample.

Method for detecting the presence of a nucleic acid in a sample

An automated process for isolating and amplifying a target nucleic acid in a self-contained analyzer.

Method for performing an assay with a nucleic acid present in a specimen

An automated method for performing multiple nucleic acid amplification procedures in multiple receptacles of a set of receptacles contained in an analyzer.

Method for simultaneously performing multiple amplification reactions

An automated method for preparing and amplifying a sequence contained in a nucleic acid present in a sample, the nucleic acid being prepared in a receptacle that is part of a unit that includes a plurality of receptacles and holds a removable contact-limiting element for aspirating a fluid component of the sample from the receptacle.

An automated process for detecting the presence of a target nucleic acid in a sample. The process includes contacting a sample with a magnetically-responsive solid support and immobilizing a target nucleic acid present in the sample on the solid support. At a first station of an analyzer, the solid support is subjected to a magnetic field and the immobilized target nucleic acid is separated from a non-immobilized component of the sample. A solution comprising the separated target nucleic acid is moved to an incubator of a second station of the analyzer, where the separated target nucleic acid is subjected to an amplification procedure and an amplification product is formed. The amplification product is detected as an indication of the presence of the target nucleic acid in the sample.

Automated process for detecting the presence of a target nucleic acid in a sample

An automated process for detecting the presence of a target nucleic acid in a sample. The process includes separating the target nucleic acid from other material present in the sample at a first station, transferring the separated target nucleic acid from the first station to a second station using a rotatable transport mechanism, combining the transferred target nucleic acid and reagents for performing an amplification reaction at the second station, and performing an amplification reaction. A product of the amplification reaction is detected as an indication of the presence of the target nucleic acid in the sample.

An automated process performed in an analyzer for detecting the presence of a target nucleic acid in a sample. The process includes separating the target nucleic acid from other material present in the sample, performing an amplification reaction to produce an amplification product indicative of the presence of the target nucleic acid in the sample, and detecting the amplification product. The amplification reaction can be performed in an open receptacle vessel, such as a test tube.

An automated process for detecting the presence of a target nucleic acid in a sample. The process is performed in a stand-alone unit and includes separating the target nucleic acid from other material present in the sample, engaging a robotic pipettor to combine the separated target nucleic acid and reagents for performing an amplification reaction, and performing an amplification reaction. A product of the amplification reaction is detected as an indication of the presence of the target nucleic acid in the sample.

An automated process for preparing and amplifying a target nucleic acid sequence within a stand-alone unit.

Automated process for preparing and amplifying a target nucleic acid sequence

An automated analyzer for performing multiple diagnostic assays simultaneously includes multiple stations, or modules, in which discrete aspects of the assay are performed on fluid samples contained in reaction receptacles. The analyzer includes stations for automatically preparing a specimen sample, incubating the sample at prescribed temperatures for prescribed periods, preforming in analyte isolation procedure, and ascertaining the presence of a target analyte. An automated receptacle transporting system moves the reaction receptacles from one station to the next. The analyzer further includes devices for carrying a plurality of specimen tubes and disposable pipette tips in a machine-accessible manner, a device for agitating containers of target capture reagents comprising suspensions of solid support material and for presenting the containers for machine access thereto, and a device for holding containers of reagents in a temperature controlled environment and presenting the containers for machine access thereto. A method for performing an automated diagnostic assay includes an automated process for isolating and amplifying a target analyte. The process is performed by automatically moving each of a plurality of reaction receptacles containing a solid support material and a fluid sample between stations for incubating the contents of the reaction receptacle and for separating the target analyte bound to the solid support from the fluid sample. An amplification reagent is added to the separated analyte after the analyte separation step and before a final incubation step.

Automated system for isolating and amplifying a target nucleic acid sequence

An automated analyzer for performing multiple diagnostic assays simultaneously includes multiple stations, or modules, in which discrete aspects of the assay are performed on fluid samples contained in reaction receptacles. The analyzer includes stations for automatically preparing a specimen sample, incubating the sample at prescribed temperatures for prescribed periods, preforming an analyte isolation procedure, and ascertaining the presence of a target analyte. An automated receptacle transporting system moves the reaction receptacles from one station to the next. The analyzer further includes devices for carrying a plurality of specimen tubes and disposable pipette tips in a machine-accessible manner, a device for agitating containers of target capture reagents comprising suspensions of solid support material and for presenting the containers for machine access thereto, and a device for holding containers of reagents in a temperature controlled environment and presenting the containers for machine access thereto. A method for performing an automated diagnostic assay includes an automated process for isolating and amplifying a target analyte. The process is performed by automatically moving each of a plurality of reaction receptacles containing a solid support material and a fluid sample between stations for incubating the contents of the reaction receptacle and for separating the target analyte bound to the solid support from the fluid sample. An amplification reagent is added to the separated analyte after the analyte separation step and before a final incubation step.

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Golden, CO, United States of America

Cheryl A Jakub