Method for analyzing a plurality of samples

Patent metadata

Field	Value
Publication number	US-9732374-B2
Application number	US-201414213900-A
Country	US
Kind code	B2
Filing date	Mar 14, 2014
Priority date	Mar 14, 2013
Publication date	Aug 15, 2017
Grant date	Aug 15, 2017

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.

First claim

The invention claimed is:

1. An automated method for analyzing a plurality of samples, the method comprising performing within a housing of a self-contained diagnostic system the steps of:
(a) loading the diagnostic system with the plurality of samples;
(b) after step (a), performing a first assay on a first sample subset of the plurality of samples, the first assay comprising:
(i) preparing each of a plurality of samples of the first sample subset using an aliquot of a first bulk reagent contained in a first bulk reagent container, wherein the first bulk reagent comprises a solid support for directly or indirectly binding and immobilizing a first target nucleic acid that may be present in one or more samples of the first sample subset; and
(ii) after step (b)(i), performing in each sample of the first sample subset a first amplification reaction for amplifying a region of the first target nucleic acid, wherein a unit-dose reagent comprising a polymerase is used to perform the first amplification reaction in each sample of the first sample subset, the unit does reagent being in an amount sufficient to perform only one amplification reaction; and

(c) after step (a), performing a second assay on a second sample subset of the plurality of samples, the second assay comprising:
(i) preparing each of a plurality of samples of the second sample subset using an aliquot of a second bulk reagent contained in a second bulk reagent container, wherein the second bulk reagent comprises a solid support for directly or indirectly binding and immobilizing a second target nucleic acid that may be present in one or more samples of the second sample subset; and
(ii) after step (c)(i), and simultaneous with step (b)(ii), performing in each sample of the second sample subset a second amplification reaction for amplifying a region of the second target nucleic acid, wherein an aliquot of a third bulk reagent contained in a third bulk reagent container and comprising a polymerase is used to perform the second amplification reaction in each sample of the second sample subset wherein the first assay does not use a bulk reagent comprising a polymerase for performing an amplification reaction, and wherein the second assay does not use a unit-dose reagent comprising a polymerase for performing an amplification reaction, the unit-dose reagent being in an amount sufficient to perform only a single amplification reaction,

wherein the diagnostic system stores the unit-dose reagent for each of the first amplification reactions and the bulk reagents prior to performing the first and second assays.

2. The automated method of claim 1 , wherein the first bulk reagent and the second bulk reagent are the same bulk reagent, and wherein the first bulk reagent container and the second bulk reagent container are the same bulk reagent container.

3. The automated method of claim 1 , wherein preparing the first sample subset comprises isolating and purifying the first target nucleic acid of the first assay, provided the first target nucleic acid is present in the first sample subset, and wherein preparing the second sample subset comprises isolating and purifying the second target nucleic acid of the second assay, provided the second target nucleic acid is present in the second sample subset.

4. The automated method of claim 1 , wherein the solid support of each of the first and second bulk reagents is magnetically-responsive.

5. The automated method of claim 1 , wherein the first bulk reagent does not comprise a component necessary for performing the first amplification reaction, and wherein the second bulk reagent does not comprise a component necessary for performing the second amplification reaction.

6. The automated method of claim 1 , further comprising coordinating a first schedule for performing the first assay with a second schedule for performing the second assay such that use of resources of the diagnostic system is maximized and that the time to perform the first and second assays is minimized.

7. The automated method of claim 1 , wherein the first and second sample subsets comprise different samples.

8. The automated method of claim 1 , wherein the first and second sample subsets comprise the same samples.

9. The automated method of claim 1 , wherein the first amplification reaction involves temperature cycling.

10. The automated method of claim 1 , wherein the first unit-dose reagent further comprises nucleoside triphosphates.

11. The automated method of claim 1 , wherein the second amplification reaction involves temperature cycling.

12. The automated method of claim 9 , wherein the second amplification reaction is an isothermal reaction.

13. The automated method of claim 1 , wherein the first and second amplification reactions are different types of amplification reactions.

14. The automated method of claim 1 , wherein the third bulk reagent further comprises nucleoside triphosphates.

15. The automated method of claim 1 , wherein step (b)(ii) is performed in a first set of receptacles and step (c)(ii) is performed in a second set of receptacles, the receptacles of the first set of receptacles having a different geometry than the receptacles of the second sets of receptacles.

16. The automated method of claim 15 , wherein the receptacles of the second set of receptacles are components of multiple receptacle devices, and wherein the receptacles of the first set of receptacles are not components of multiple receptacle devices.

17. The automated method of claim 15 , wherein steps (b)(i) and (c)(i) are performed in receptacles that are identical to each other.

18. The automated method of claim 17 , wherein the receptacles used to perform step (c)(i) are the same receptacles used to perform step (c)(ii), and wherein the receptacles used to perform step (b)(i) are different than the receptacles used to perform step (b)(ii).

19. The automated method of claim 1 , wherein steps (c)(ii) and (b)(ii) are performed in first and second modules of the diagnostic system, respectively, and wherein the first and second modules are at distinct locations of the diagnostic system.

20. The automated method of claim 19 , wherein the first module is detachably coupled to the second module of the diagnostic system.

21. The automated method of claim 19 , wherein steps (b)(i) and (c)(i) are performed in the first module of the diagnostic system.

22. The automated method of claim 1 , wherein the unit-dose reagent is a lyophilized pellet, and wherein the method further comprises reconstituting the lyophilized pellet prior to performing step (b)(ii).

Assignees

• Gen Probe Inc

Inventors

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

Classifications

• B01L2300/046

  Function or devices integrated in the closure · CPC title

• C12Q1/686

  Polymerase chain reaction [PCR] · CPC title

• G01N35/04

  Details of the conveyor system {(G01N35/021 - G01N35/028 take precedence)} · CPC title

• B01L2200/026

  Fluid interfacing between devices or objects, e.g. connectors, inlet details · CPC title

• B01L3/565

  Seals · CPC title