Abstract: A method of determining whether one or more forms of a nucleic acid analyte are present in a sample. The method includes dissolving an amplification reagent with a first solvent, where the amplification reagent contains oligonucleotides sufficient to amplify and detect a first region of a first form of the analyte, where the first solvent contains one or more oligonucleotides which, in combination with the oligonucleotides of the amplification reagent, are sufficient to amplify and detect a second region of a second form of the analyte, where the one or more oligonucleotides of the first solvent are insufficient to amplify and detect the first or second form of the analyte, and where the first and second regions each comprise a different nucleotide base sequence.

Abstract: An automated system for performing nucleic acid amplification assays on samples provided to the system, where the system includes data input components configured to enable input specifying one or more user-defined assay parameters; data storage media storing a first set of assay parameters, the first set of assay parameters consisting of system-defined parameters, and a second set of assay parameters, the second set of assay parameters including the one or more user-defined parameters; and command input components configured to enable input specifying (i) that a first nucleic acid amplification assay be performed on a first sample in accordance with the first set of assay parameters, and (ii) that a second nucleic acid amplification assay be performed on a second sample in accordance with the second set of assay parameters.

Abstract: A method of performing a lab developed test for detecting a nucleic acid analyte on an automated analyzer. The method includes a first step of using a computer to select, define or modify one or more user-defined parameters of a protocol for performing the lab developed test on the analyzer, where each user-defined parameter of the protocol defines a step to be performed by the analyzer during the lab developed test. The method further includes a second step of performing the lab developed test with the protocol of the first step, where the analyzer stores one or more system-defined parameters for performing the lab developed test, the one or more system-defined parameters being installed on the analyzer prior to performing first step.

Abstract: A diagnostic system is configured to perform first and second, different nucleic acid amplification reactions. The system includes a bulk reagent container compartment configured to store first bulk reagent container containing a first bulk reagent for performing sample preparation processes with a first subset and a second subset of a plurality of samples and a second bulk reagent container containing a second bulk reagent for performing the first nucleic acid amplification reaction. The system includes a unit-dose reagent compartment storing a unit-dose reagent pack including unit-dose reagents for performing the second nucleic acid amplification reaction.

Abstract: A diagnostic system is configured to perform first and second, different nucleic acid amplification reactions. The system includes a bulk reagent container compartment configured to store first bulk reagent container containing a first bulk reagent for performing sample preparation processes with a first subset and a second subset of a plurality of samples and a second bulk reagent container containing a second bulk reagent for performing the first nucleic acid amplification reaction. The system includes a unit-dose reagent compartment storing a unit-dose reagent pack including unit-dose reagents for performing the second nucleic acid amplification reaction.

Abstract: A processing module is configured to extend the capabilities of an analyzer configured to process substances within each of a plurality of receptacles. The module includes a container transport configured to transport a container from a location within the processing module to a location within the analyzer that is accessible to a substance transfer device of the analyzer. A receptacle distribution system is configured to receive a receptacle from the analyzer, transfer the receptacle into the processing module, and to move the receptacle between different locations within the analyzer. A substance transfer device of the module is configured to dispense substances into or remove substances from the receptacle within the processing module. A reagent card exchanger provides an input device for inserting reagent cards into and removing reagent cards from the module, stores reagent cards within the module, and transfers reagent cards to different location within the module.

Abstract: Systems and methods for performing a plurality of nucleic acid amplification assays in an automated analyzer. A first nucleic acid amplification assay of the plurality is performed in accordance with a first set of assay parameters which consist of system-defined parameters. And a second nucleic acid amplification assay of the plurality is performed in accordance with a second set of assay parameters which includes one or more user-defined parameters.

Abstract: One or more temperature cycles are applied to the contents of a processing vial closed by an interlocked cap within a thermal cycler. The processing vial and the interlocked cap are transferred from the thermal cycler to a storage compartment within the instrument with a transfer mechanism with a probe engaged with the cap. In the storage compartment, the processing vial and interlocked cap are moved to an access opening in the instrument and are removed from the instrument through the access opening.

Abstract: A system, method and computer readable medium enabling a user to specify user-defined assay parameters of an assay protocol for processing a sample and causing a computer-controlled analyzer to perform an assay in accordance with the assay protocol.

Abstract: An automated method for analyzing a plurality of samples within a housing of a self-contained system. The system is loaded with a plurality of samples, after which a first assay is performed on a first sample subset and a second assay performed on a second sample subset. The two assays include exposing the samples to a target capture reagent having a solid support for directly or indirectly immobilizing a target nucleic acid that may be present in one or more of the samples. The two assays may be performed with the same or different target capture reagents and target nucleic acids, but the receptacles for performing the exposing step have substantially identical geometries. Following the exposing step, an amplification reaction for amplifying a region of the target nucleic acid is performed with each sample. The amplification reactions of the two assays are performed in receptacles having different geometries.

Abstract: An automated method for analyzing a plurality of samples within a housing of a self-contained system. The system is loaded with a plurality of samples, after which a first assay is performed on a first sample subset and a second assay performed on a second sample subset. The two assays include exposing the samples to a target capture reagent having a solid support for directly or indirectly immobilizing a target nucleic acid that may be present in one or more of the samples. The two assays may be performed with the same or different target capture reagents and target nucleic acids, but the receptacles for performing the exposing step have substantially identical geometries. Following the exposing step, an amplification reaction for amplifying a region of the target nucleic acid is performed with each sample. The amplification reactions of the two assays are performed in receptacles having different geometries.

Abstract: One or more temperature cycles are applied to the contents of a processing vial closed by an interlocked cap within a thermal cycler. The processing vial and the interlocked cap are transferred from the thermal cycler to a storage compartment within the instrument with a transfer mechanism with a probe engaged with the cap. In the storage compartment, the processing vial and interlocked cap are moved to an access opening in the instrument and are removed from the instrument through the access opening.

Abstract: A processing module is configured to extend the capabilities of an analyzer configured to process substances within each of a plurality of receptacles. The module includes a container transport configured to transport a container from a location within the processing module to a location within the analyzer that is accessible to a substance transfer device of the analyzer. A receptacle distribution system is configured to receive a receptacle from the analyzer, transfer the receptacle into the processing module, and to move the receptacle between different locations within the analyzer. A substance transfer device of the module is configured to dispense substances into or remove substances from the receptacle within the processing module. A reagent card exchanger provides an input device for inserting reagent cards into and removing reagent cards from the module, stores reagent cards within the module, and transfers reagent cards to different location within the module.

Abstract: An automated method for analyzing a plurality of samples within a housing of a self-contained system. The system is loaded with a plurality of samples, after which a first assay is performed on a first sample subset and a second assay performed on a second sample subset. The two assays include exposing the samples to a target capture reagent having a solid support for directly or indirectly immobilizing a target nucleic acid that may be present in one or more of the samples. The two assays may be performed with the same or different target capture reagents and target nucleic acids, but the receptacles for performing the exposing step have substantially identical geometries. Following the exposing step, an amplification reaction for amplifying a region of the target nucleic acid is performed with each sample. The amplification reactions of the two assays are performed in receptacles having different geometries.

Abstract: A diagnostic system performs a first nucleic acid amplification reaction and a second, different nucleic acid amplification reaction. The diagnostic system includes a compartment configured to store at least a first bulk reagent container comprising a first bulk reagent for performing a sample preparation process, and a second bulk reagent container comprising a second bulk reagent for performing the first reaction. The system including a compartment configured to store at least one unit-dose pack comprising a plurality of unit-dose reagents for performing the second reaction. The diagnostic system is configured to perform the sample preparation process using the first bulk reagent on each of a plurality of samples provided to the diagnostic system. The system is configured to perform the first reaction using the second bulk reagent on a first sample subset, and perform the second reaction using the plurality of first unit-dose reagents on a second sample subset.

Abstract: A diagnostic system performs a first nucleic acid amplification reaction and a second, different nucleic acid amplification reaction. The diagnostic system includes a compartment configured to store at least a first bulk reagent container comprising a first bulk reagent for performing a sample preparation process, and a second bulk reagent container comprising a second bulk reagent for performing the first reaction. The system including a compartment configured to store at least one unit-dose pack comprising a plurality of unit-dose reagents for performing the second reaction. The diagnostic system is configured to perform the sample preparation process using the first bulk reagent on each of a plurality of samples provided to the diagnostic system. The system is configured to perform the first reaction using the second bulk reagent on a first sample subset, and perform the second reaction using the plurality of first unit-dose reagents on a second sample subset.

Abstract: A processing module is configured to extend the capabilities of an analyzer configured to process substances within each of a plurality of receptacles. The module includes a container transport configured to transport a container from a location within the processing module to a location within the analyzer that is accessible to a substance transfer device of the analyzer. A receptacle distribution system is configured to receive a receptacle from the analyzer, transfer the receptacle into the processing module, and to move the receptacle between different locations within the analyzer. A substance transfer device of the module is configured to dispense substances into or remove substances from the receptacle within the processing module. A reagent card exchanger provides an input device for inserting reagent cards into and removing reagent cards from the module, stores reagent cards within the module, and transfers reagent cards to different location within the module.