SAMPLE PREPARATION DEVICE AND ASSOCIATED METHOD

• US 20120100557A1
• Filed: 04/27/2010
• Published: 04/26/2012
• Est. Priority Date: 04/27/2009
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Fox, William Alan, Williams, Ryan Carl, Langhoff, Brian Reuben
• Granted Patent: US 9,528,919 B2
• Time in Patent Office: Days
• US Class Current: 435/7.1
• CPC Class Codes: G01N 1/30 Staining; Impregnating ; Fixation; Dehydration; Multistep processes for preparing samples of tissue, cell or nucleic acid material and the like for analysis
• CPC Class Codes: G01N 1/312 for samples mounted on planar substrates
• CPC Class Codes: G01N 1/44 Sample treatment involving radiation, e.g. heat
• CPC Class Codes: G01N 2035/00168 Manufacturing or preparing test elements
• CPC Class Codes: G01N 2035/00346 Heating or cooling arrangements
• CPC Class Codes: G01N 35/00029 provided with flat sample substrates, e.g. slides G01N35/028 takes precedence

Abstract

A sample preparation device and associated method is provided for preparing samples according to an assay protocol. A cell deposition module deposits a sample on each a plurality of assay devices supported by a support device. An epitope retrieval module deposits a reagent on each of the samples. Each of the samples is brought to a selected temperature. A heating device, corresponding to each of the assay devices, directly interacts with the corresponding assay device may be used to heat each assay device to the selected temperature, in conjunction with the epitope retrieval module depositing the reagent on each of the samples. A staining module deposits a staining reagent on each of the samples, and removes excess staining reagent. The staining, epitope retrieval, and cell deposition modules cooperate with the support device and heating devices to form a unitary sample preparation device.

Claims

1. A sample preparation device for preparing a sample according to an assay protocol, comprising:

a support device configured to support a plurality of assay devices;

a cell deposition module operably engaged with the support device and configured to deposit a sample on each of the plurality of assay devices supported by the support device;

an epitope retrieval module operably engaged with the support device and the cell deposition module, and configured to deposit at least one reagent on each of the samples according to the assay protocol;

a staining module operably engaged with the support device, the cell deposition module, and the epitope retrieval module, the staining module being configured to deposit a staining reagent on each of the samples according to the assay protocol, and to remove excess staining reagent therefrom upon staining of the samples, the staining module, the epitope retrieval module, and the cell deposition module cooperating with the support device to form a unitary sample preparation device for preparing the sample without movement of the assay devices via the support device; and

a heating source for heating the samples corresponding to each of the plurality of assay devices to a selected temperature.

2. A device according to claim 1, wherein the sample is a cytological sample.

3. A device according to claim 2, wherein the assay protocol is an immunocytochemistry assay protocol.

4. A device according to claim 1, wherein the assay device is a slide.

5. A device according to claim 1, further comprising a control system in communication with at least one of the cell deposition module, the epitope retrieval module, and the staining module, the control system being responsive to the assay protocol to automatically control and perform at least one of the sample deposition, the reagent deposition, and the staining reagent deposition and removal.

6. A device according to claim 1, wherein the heating source is the at least one reagent.

7. A device according to claim 1, the heating source comprises at least one heating device, wherein the staining module, the epitope retrieval module, and the cell deposition module cooperate with the support device and the at least one heating device to form a unitary sample preparation device for preparing the sample without movement of the assay devices via the support device.

8. A device according to claim 7, wherein the at least one heating device corresponds to and is operably engaged with the support device and is configured to attain compliance with the support device so as to heat the plurality of assay devices to the selected temperature, in conjunction with the epitope retrieval module depositing the at least one reagent on each of the samples, according to the assay protocol.

9. A device according to claim 7, the heating source further comprising a plurality of heating devices, each heating device corresponding to each of the plurality of assay devices, each heating device being operably engaged with the support device and configured to attain compliance with the corresponding assay device so as to heat each of the plurality of assay devices to the selected temperature, in conjunction with the epitope retrieval module depositing the at least one reagent on each of the samples, according to the assay protocol.

10. A device according to claim 7, further comprising a control system in communication with at least one of the cell deposition module, the epitope retrieval module, the at least one heating device, and the staining module, the control system being responsive to the assay protocol to automatically control and perform at least one of the sample deposition, the reagent deposition, the assay device heating, and the staining reagent deposition and removal.

11. A device according to claim 7, wherein the support device is further configured to support the assay devices in an array having at least one row and at least one column, and wherein each of the cell deposition module, the epitope retrieval module, the heating devices, and the staining module is configured to substantially simultaneously interact with the assay devices disposed in at least one of one of the rows and one of the columns of the array.

12. A device according to claim 7, further comprising an actuating device configured to receive the support device and to actuate the assay devices into engagement with the heating device.

13. A method of preparing a sample according to an assay protocol, using a unitary sample preparation device, said method comprising:

supporting a plurality of assay devices with a support device;

depositing a sample on each of the plurality of assay devices supported by the support device in a cell deposition module operably engaged therewith;

depositing at least one reagent on each of the samples, according to the assay protocol, in an epitope retrieval module operably engaged with the cell deposition module and the support device;

depositing a staining reagent on each of the samples, according to the assay protocol, and removing excess staining reagent therefrom upon staining of the samples, in a staining module operably engaged with the epitope retrieval module, the cell deposition module, and the support device, the staining module, the epitope retrieval module, and the cell deposition module cooperating with the support device for preparing the sample without movement of the assay devices via the support device; and

bringing each of the samples to a selected temperature.

14. A method according to claim 13, wherein the sample is a cytological sample.

15. A method according to claim 13, further comprising the step of heating each of the plurality of assay devices to the selected temperature with a heating device corresponding to each of the plurality of assay devices, each heating device being operably engaged with the support device and configured to attain compliance with the corresponding assay device, in conjunction with depositing the at least one reagent on each of the samples, according to the assay protocol, wherein the staining module, the epitope retrieval module, and the cell deposition module cooperating with the support device and the heating devices for preparing the sample without movement of the assay devices via the support device.

16. A method according to claim 13, wherein supporting a plurality of assay devices with a support device further comprises supporting a plurality of slides with a support device.

17. A method according to claim 15, further comprising automatically controlling and performing at least one of the cytological sample deposition, the reagent deposition, the assay device heating, and the staining reagent deposition and removal, in response to the assay protocol, using a control system in communication with at least one of the cell deposition module, the epitope retrieval module, the heating devices, and the staining module.

18. A method according to claim 15, wherein supporting a plurality of assay devices further comprises supporting a plurality of assay devices in an array having at least one row and at least one column such that each of the cell deposition module, the epitope retrieval module, the heating devices, and the staining module is capable of substantially simultaneously interacting with the assay devices disposed in at least one of one of the rows and one of the columns of the array.