SINGLE-TUBE, READY-TO-USE ASSAY KITS, AND METHODS USING SAME

• US 20090239233A1
• Filed: 03/23/2009
• Published: 09/24/2009
• Est. Priority Date: 01/25/2002
• Status: Abandoned Application

• Current Assignee: Applied Biosystems LLC (Thermo Fisher Scientific Incorporated)
• Original Assignee: Applera Corporation (Thermo Fisher Scientific Incorporated)
• Inventors: Livak, Kenneth J., Lucero, Michael, Stevens, Junko, Hunkapiller, Michael W., Eddins, Susan K., Gilbert, Dennis A.
• Application Number:
  US12/408,870
• Publication Number:
  US 20090239233A1
• Time in Patent Office: Days
• US Class Current: 435/6
• CPC Class Codes: G01N 35/00732 Identification of carriers, materials or components in automatic analysers
• CPC Class Codes: G01N 35/1002 Reagent dispensers

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.

Claims

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.

2. The method of claim 1, wherein the one or more homogeneous assays comprise components for conducting a fluorogenic 5′

nuclease assay.

3. The method of claim 1, wherein the information is provided on a disk.

4. The method of claim 3, wherein the disk is a compact disk (CD).

5. The method of claim 1, wherein the information is provided via a computer network.

6. The method of claim 5, wherein the information is transmitted to the user via electronic mail.

7. The method of claim 5, wherein the information is provided via a file transfer protocol (FTP).

8. The method of claim 1, wherein the information is comprised, at least in part, of American Standard Code for Information Interchange (ASCII) formatted text.

9. The method of claim 1, wherein at least one of the one or more assays and the information are shipped to the user together in a single package.

10. The method of claim 1, wherein the information comprises information about an exon-exon junction.

11. The method of claim 1, wherein the information comprises information about the at least one probe and the at least one primer.

12. The method of claim 1, wherein the information comprises information about one or more nucleic acid sequences to be used in a homogeneous assay.

13. The method of claim 1, wherein the information comprises information about a marker dye.

14. The method of claim 1, wherein the one or more homogeneous assays comprise a homogeneous ligand binding assay.

15. The method of claim 1, wherein a component in the one or more homogeneous assays comprises a minor groove binding probe.

16. The method of claim 1, wherein a component in the one or more homogeneous assays comprises a non-fluorescent quencher.

17. The method of claim 16, wherein the non-fluorescent quencher is at the 3′

end of a polynucleotide.

18. The method of claim 1, wherein a component in the one or more homogeneous assays comprises two target primers and a probe.

19. The method of claim 1, wherein the single-tube format is suitable for use in a sequence detection system instrument.

20. The method of claim 1, wherein the information in electronic form comprises an electronic assay workbook.

21. The method of claim 1, wherein the information comprises at least one of an electronically readable or printable copy of instructions for an assay protocol, an electronically readable or printable copy of protocols for submitting requests for assays, or an electronically readable copy of a product insert.

23. The method of claim 19, wherein the sequence detection system instrument is a fluorescence detection instrument.

28. The method of claim 1, further comprising controlling a sequence detection system based on the assay information file to perform an assay using the reaction mixture.

29. The method of claim 23, further comprising controlling a sequence detection system based on the assay information file to perform an assay using the reaction mixture.

22. 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 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.

24. 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 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.

25. The method of claim 24, wherein the assay comprises a minor groove binding probe.

26. The method of claim 25, wherein the minor groove binding probe comprises a quencher.

27. The method of claim 24, wherein each assay comprises a reaction mixture for a homogeneous assay.

30. The method of claim 24, further comprising controlling a sequence detection system based on the assay information file to perform an assay using the reaction mixture.

31. 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 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.