Diagnostic systems and methods

Patent metadata

Field	Value
Publication number	US-11840722-B2
Application number	US-202117146110-A
Country	US
Kind code	B2
Filing date	Jan 11, 2021
Priority date	Mar 14, 2013
Publication date	Dec 12, 2023
Grant date	Dec 12, 2023

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. The system is configured to perform the sample preparation process using the first bulk reagent on the first and second subsets of the samples, perform the first nucleic acid amplification reaction using the second bulk reagent on the first subset of the samples, and perform the second nucleic acid amplification reaction using the unit-dose reagents on the second subset of the samples.

First claim

The invention claimed is:

1. A diagnostic system configured to perform a first nucleic acid amplification reaction and a second nucleic acid amplification reaction different than the first nucleic acid amplification reaction, the diagnostic system comprising:
at least one bulk reagent container compartment configured to store
at least one first bulk reagent container comprising at least one first bulk reagent for performing sample preparation processes with a first subset and a second subset of a plurality of samples provided to the diagnostic system, and
at least one second bulk reagent container comprising a second bulk reagent for performing the first nucleic acid amplification reaction;

a unit-dose reagent compartment configured to store at least one unit-dose reagent pack comprising a plurality of unit-dose reagents for performing the second nucleic acid amplification reaction;
wherein the diagnostic system is configured to
perform the sample preparation process using the at least one first bulk reagent on the first subset and the second subset of the plurality of samples;
perform the first nucleic acid amplification reaction using the second bulk reagent on the first subset of the plurality of samples; and
perform the second nucleic acid amplification reaction using the plurality of unit-dose reagents on the second subset of the plurality of samples.

2. The diagnostic system of claim 1 , wherein a first module performs the first nucleic acid amplification reaction and a second module performs the second nucleic acid amplification reaction.

3. The diagnostic system of claim 2 , wherein the first module is integral with the second module.

4. The diagnostic system of claim 2 , wherein the second module is configured to be selectively and operably coupled to the first module.

5. The diagnostic system of claim 4 , wherein the at least one bulk reagent container compartment comprises a first bulk reagent container compartment in the first module that is configured to store the at least one first bulk reagent container, and wherein the unit-dose reagent compartment is in the second module.

6. The diagnostic system of claim 5 , wherein the first bulk reagent container compartment stores the at least one first bulk reagent container, and wherein the at least one first bulk reagent comprises a target capture reagent.

7. The diagnostic system of claim 2 , wherein the at least one bulk reagent container compartment comprises a first bulk reagent container compartment in the first module that is configured to store the at least one first bulk reagent container.

8. The diagnostic system of claim 7 , wherein the first bulk reagent container compartment stores the at least one first bulk reagent container, and wherein the at least one first bulk reagent comprises a target capture reagent.

9. The diagnostic system of claim 7 , wherein the at least one bulk reagent container compartment further comprises a second bulk reagent container compartment in the first module that is configured to store the second bulk reagent container.

10. The diagnostic system of claim 7 , wherein the second bulk reagent container compartment stores the second bulk reagent container.

11. The diagnostic system of claim 7 , wherein the at least one bulk reagent container compartment further comprises a second bulk reagent container compartment in the second module that is configured to store a third bulk reagent container comprising a third bulk reagent.

12. The diagnostic system of claim 11 , wherein the third bulk reagent container compartment stores the third bulk reagent container, and wherein the third bulk reagent comprises a reconstitution reagent.

13. The diagnostic system of claim 1 , wherein the unit-dose reagent compartment stores a first unit-dose reagent pack comprising a plurality of first unit-dose reagents for targeting a first nucleic acid, and wherein the unit dose reagent compartment stores a second unit-dose reagent pack comprising a plurality of second unit-dose reagents for targeting a second nucleic acid different than the first nucleic acid.

14. The diagnostic system of claim 13 , wherein the first unit-dose reagents comprise at least one of a polymerase and nucleoside triphosphates for performing the second nucleic acid amplification reaction, and wherein the second unit-dose reagents comprise at least one of a polymerase and nucleoside triphosphates.

15. The diagnostic system of claim 1 , further comprising a distributor configured to move a unit-dose reagent pack stored in the unit-dose reagent compartment to a location accessible to a substance transfer device configured to aspirate a reconstituted form of at least one of the plurality of unit-dose reagents.

16. The diagnostic system of claim 1 , wherein the first nucleic acid amplification reaction is an isothermal reaction, and wherein the second nucleic acid amplification reaction involves temperature cycling.

17. The diagnostic system of claim 1 , wherein the unit-dose reagent compartment stores at least one unit-dose reagent pack comprising a plurality of lyophilized unit-dose reagents.

18. The diagnostic system of claim 1 , wherein the at least one first bulk reagent comprises a magnetically-responsive solid support for directly or indirectly immobilizing a target nucleic acid.

19. The diagnostic system of claim 1 , wherein the at least one first bulk reagent comprises first and second sample processing reagents and wherein the diagnostic system is configured to perform (i) a first sample preparation process using the first sample processing reagent on the first subset of the plurality of samples and (ii) a second sample preparation process using the second sample processing reagent on the second subset of the plurality of samples.

20. The diagnostic system of claim 1 , wherein the diagnostic system is configured to simultaneously perform the first nucleic acid amplification reaction and the second nucleic acid amplification reaction.

Assignees

• Gen Probe Inc

Inventors

• Buse David A
• Opalsky David
• Rhubottom Jason F
• Hagen Norbert D
• Tidd Jennifer L

Classifications

• C12Q1/6806 Primary

  Preparing nucleic acids for analysis, e.g. for polymerase chain reaction [PCR] assay (C12Q1/6804 takes precedence) · CPC title

• B01L3/50825 Primary

  Closing or opening means, corks, bungs · CPC title

• B01L3/565

  Seals · CPC title

• B01L7/5255

  by moving sample containers · CPC title

• C12Q1/686

  Polymerase chain reaction [PCR] · CPC title