SINGLE-TUBE, READY-TO-USE ASSAY KITS, AND METHODS USING SAME
First Claim
Patent Images
1. A method for facilitating genetic analysis, comprising:
- providing a user with software adapted to run on an operating system that controls operation of a sequence detection system in performing an assay;
receiving from the user a request for one or more genetic-analysis assays;
providing to the user (i) one or more homogeneous assays, each homogeneous assay comprising a container and a reaction mixture in the container, the reaction mixture comprising at least one primer and at least one probe, the at least one primer comprising a sequence that is complementary to a target polynucleotide and the at least one probe being reactive with the same target polynucleotide in an allelic discrimination or expression analysis assay when admixed with the target polynucleotide, (ii) a plate rack defining a plurality of locations, wherein each container of the one or more homogeneous assays is disposed in a respective one of the plurality of locations, and (iii) information relating to the one or more homogeneous assays, the information being in electronic form and comprising an assay information file, the assay information file comprising position validation information identifying a predetermined one or more of the plurality of locations defined by the plate rack in which each respective container should be disposed to correspond with the predetermined one or more of the plurality of locations thereof, wherein the position validation information is formatted to be used by the software to control operation of the sequence detection system in performing the one or more homogeneous assays using the reaction mixture of each of the one or more homogeneous assays;
determining whether each respective container is in the respective plate rack location identified by the position validation information; and
controlling operation of the sequence detection system based on what is determined in the determining step.
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Abstract
An assay kit is provided that includes assay reagents stored in a single-tube container, and a data storage medium containing information about the contents of the container. Methods are provided for using the data provided with the kit to direct instruments and/or processes, for example, to control an instrument to perform amplification and/or sequencing reactions.
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Citations
31 Claims
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1. A method for facilitating genetic analysis, comprising:
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providing a user with software adapted to run on an operating system that controls operation of a sequence detection system in performing an assay; receiving from the user a request for one or more genetic-analysis assays; providing to the user (i) one or more homogeneous assays, each homogeneous assay comprising a container and a reaction mixture in the container, the reaction mixture comprising at least one primer and at least one probe, the at least one primer comprising a sequence that is complementary to a target polynucleotide and the at least one probe being reactive with the same target polynucleotide in an allelic discrimination or expression analysis assay when admixed with the target polynucleotide, (ii) a plate rack defining a plurality of locations, wherein each container of the one or more homogeneous assays is disposed in a respective one of the plurality of locations, and (iii) information relating to the one or more homogeneous assays, the information being in electronic form and comprising an assay information file, the assay information file comprising position validation information identifying a predetermined one or more of the plurality of locations defined by the plate rack in which each respective container should be disposed to correspond with the predetermined one or more of the plurality of locations thereof, wherein the position validation information is formatted to be used by the software to control operation of the sequence detection system in performing the one or more homogeneous assays using the reaction mixture of each of the one or more homogeneous assays; determining whether each respective container is in the respective plate rack location identified by the position validation information; and controlling operation of the sequence detection system based on what is determined in the determining step. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 23, 28, 29)
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22. A method for facilitating genetic analysis, comprising:
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providing a user with software adapted to run on an operating system that controls operation of a sequence detection system in performing an assay; receiving from a user a request for one or more genetic-analysis assays; providing to the user (i) the one or more genetic-analysis assays, each of the one or more genetic-analysis assays provided in a single-tube format, wherein the single-tube format is suitable for use in a fluorescence detection instrument and comprises a container and a reaction mixture in the container, the reaction mixture comprising at least one primer and at least one probe, the at least one primer comprising a sequence that is complementary to a target polynucleotide and the at least one probe being reactive with the same target polynucleotide when admixed with the target polynucleotide, (ii) a plate rack defining a plurality of locations, wherein each container of the one more genetic-analysis assays is disposed in a respective one of the plurality of locations, and (iii) information relating to the one or more genetic-analysis assays, the information being in electronic form and comprising an assay information file, the assay information file comprising position validation information identifying a predetermined one or more of the plurality of locations defined by the plate rack in which each respective container should be disposed to correspond with the predetermined one or more of the plurality of locations thereof, wherein the position validation information is formatted to be used by the software to control operation of the sequence detection system in performing the one or more genetic-analysis assays using the reaction mixture of each of the one or more genetic-analysis assays; determining whether each respective container is in the respective plate rack location identified by the position validation information; and controlling operation of the sequence detection system based on what is determined in the determining step.
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24. A method for facilitating genetic analysis comprising:
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providing a user with software adapted to run on an operating system that controls operation of a sequence detection system in performing an assay; receiving from a user a request for one or more genetic-analysis assays; providing to the user (i) the one or more genetic-analysis assays, each assay being provided in a single-tube format and comprising a container and a reaction mixture in the container, the reaction mixture comprising at least two target primers and at least one probe, the at least two target primers each comprising a sequence that is complementary to a target polynucleotide and the at least one probe being reactive with the same target polynucleotide when admixed with the target polynucleotide, (ii) a plate rack defining a plurality of locations, wherein each container of the one or more genetic-analysis assays is disposed in a respective one of the plurality of locations, and (iii) information relating to the one or more genetic-analysis assays, the information being in electronic form and comprising an assay information file, the assay information file comprising position validation information identifying a predetermined one or more of the plurality of locations defined by the plate rack in which each respective container should be disposed to correspond with the predetermined one or more of the plurality of locations thereof, wherein the position validation information is formatted to be used by the software to control operation of the sequence detection system in performing the one or more genetic-analysis assays using the reaction mixture of each of the one or more genetic-analysis assays; determining whether each respective container is in the respective plate rack location identified by the position validation information; and controlling operation of the sequence detection system based on what is determined in the determining step. - View Dependent Claims (25, 26, 27, 30)
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31. A method for facilitating genetic analysis comprising:
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providing a user with software adapted to run on an operating system that controls operation of a sequence detection system in performing an assay; receiving from a user a request for one or more genetic-analysis assays; providing to the user (i) the one or more genetic-analysis assays, each assay being provided in a single-tube format and comprising a container and a reaction mixture in the container, the reaction mixture comprising at least two target primers and at least one probe, the at least two target primers each comprising a sequence that is complementary to a target polynucleotide and the at least one probe comprising a dye and being reactive with the same target polynucleotide when admixed with the target polynucleotide, and (ii) information relating to the one or more genetic-analysis assays, the information being in electronic form and comprising an assay information file, the assay information file comprising dye information identifying the dye of the probe, the dye information being formatted to be used by the software to control operation of the sequence detection system in performing the one or more genetic-analysis assays using the reaction mixture of each of the one or more genetic-analysis assays; and controlling operation of the sequence detection system based on the dye information.
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Specification