Sample collection and analysis devices

• US 10,093,918 B2
• Filed: 06/03/2015
• Issued: 10/09/2018
• Est. Priority Date: 06/04/2014
• Status: Active Grant

• Current Assignee: Edan Instruments, Inc.
• Original Assignee: Lucigen Corporation (3M Company)
• Inventors: Mielke, Cindy, Williamson, Kyle, Koelbl, James, Ceriani, Dylann, da Costa, Chris, Kahatt, Espir
• Primary Examiner(s): WARDEN, JILL ALICE
• Application Number:
  US14/729,760
• Publication Number:
  US 20150353919A1
• Time in Patent Office: 1,224 Days
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 10/0096 Casings for storing test samples A61B10/0038 and A61B10/0045 take precedence; preservation of living parts of the human or animal body A01N1/02; containers for retaining a material to be analysed B01L3/50; containers for enzymology or microbiology C12M1/16; swab-sampler being part of enzymology or microbiology container C12M1/30
• CPC Class Codes: A61B 10/02 Instruments for taking cell samples or for biopsy A61B10/0038 and A61B10/0045 take precedence; needle locating or guiding means A61B17/3403; samplers for enzymology or microbiology C12M1/26; sampling or preparing biological specimens G01N33/48
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: B01L 2200/0689 Sealing
• CPC Class Codes: B01L 2200/10 Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
• CPC Class Codes: B01L 2300/042 Caps; Plugs
• CPC Class Codes: B01L 2300/043 Hinged closures
• CPC Class Codes: B01L 2300/0681 Filter
• CPC Class Codes: B01L 2300/087 Multiple sequential chambers
• CPC Class Codes: B01L 2300/123 Flexible; Elastomeric
• CPC Class Codes: B01L 2400/0481 squeezing of channels or chambers
• CPC Class Codes: B01L 2400/0487 fluid pressure, pneumatics
• CPC Class Codes: B01L 2400/06 Valves, specific forms thereof
• CPC Class Codes: B01L 2400/0655 pinch valves
• CPC Class Codes: B01L 3/502738 characterised by integrated valves microvalves F16K99/0001
• CPC Class Codes: B01L 3/5029 using swabs
• CPC Class Codes: B01L 7/00 Heating or cooling apparatus autoclaves B01J3/04; Heat insulating devices
• CPC Class Codes: B01L 7/52 with provision for submitting samples to a predetermined sequence of different temperatures, e.g. for treating nucleic acid samples amplification or hybridisation processes per se C12Q1/68; controlling sequential reactions for synthesis B01J19/0046
• CPC Class Codes: C12N 15/1017 by filtration, e.g. using filters, frits, membranes
• CPC Class Codes: C12Q 1/6806 : Preparing nucleic acids for analysis, e.g. for polymerase chain reaction [PCR] assay C12Q1/6804 takes precedence
• CPC Class Codes: G01N 1/38 : Diluting, dispersing or mixing samples

Abstract

Devices and methods for collecting, processing, and analyzing a sample. A sample collection module is configured for collecting, mixing diluting, and filtering a sample for analysis. A reaction cartridge is configured for processing a sample, mixing it with dried reagents, and conducting a chemical reaction for detecting target analytes.

Claims

1. A reaction cartridge comprising:

a pressurizable first chamber;

a first pressure actuator in fluid communication with the first chamber;

a first valve in fluid communication with the first chamber;

a second valve in fluid communication with the first valve;

a reversibly pressurizable second chamber in fluid communication with the first valve and the second valve;

a second pressure actuator in fluid communication with the second chamber;

a reversibly pressurizable third chamber in fluid communication with the second valve;

a third pressure actuator in fluid communication with the third chamber;

a third valve in fluid communication with the second valve and the third chamber; and

a fourth chamber in fluid communication with the third valve, wherein;

pressurizing the first chamber through the first pressure actuator with the first valve open and with the second valve closed moves liquid from the first chamber to the second chamber;

pressurizing the second chamber through the second pressure actuator with the second valve open and with the first valve and the third valve closed moves liquid from the second chamber to the third chamber;

pressurizing the third chamber through the third pressure actuator with the second valve open and with the first valve and the third valve closed moves liquid from the third chamber to the second chamber; and

pressurizing the third chamber through the third pressure actuator with the second valve closed and the third valve open moves liquid from the third chamber to the fourth chamber.

2. The reaction cartridge of claim 1 wherein a valve selected from the group consisting of the first valve, the second valve, and the third valve is a pneumatically controlled valve.

3. The reaction cartridge of claim 1 wherein the second chamber comprises a dried component selected from the group consisting of a detergent, a reducing agent, and a cell-wall lysis enzyme.

4. The reaction cartridge of claim 1 wherein at least one of the third chamber and the fourth chamber comprises a dried DNA polymerase.

5. The reaction cartridge of claim 1 wherein the fourth chamber comprises a dried component selected from the group consisting of a primer and a DNA detection reagent.

6. The reaction cartridge of claim 1 wherein the fourth chamber comprises multiple fourth chambers.

7. The reaction cartridge of claim 1 wherein the fourth chamber comprises multiple fourth chambers wherein at least one of the fourth chambers comprises a primer not included in another of the fourth chambers.

8. A method of detecting an analyte in a sample with the reaction cartridge of claim 1 comprising:

introducing the sample in the first chamber;

pressurizing the first chamber through the first pressure actuator with the first valve open and with the second valve closed to transfer the sample to the second chamber wherein the sample undergoes a first change in composition or constitution;

pressurizing the second chamber through the second pressure actuator with the second valve open and with the first valve and the third valve closed to transfer the sample to the third chamber wherein the sample undergoes a second change in composition or constitution; and

pressurizing the third chamber through the third pressure actuator with the second valve closed and the third valve open to transfer the sample to the fourth chamber; and

detecting the analyte in the fourth chamber.

9. The method of claim 8 further including pressurizing the third chamber through the third pressure actuator with the second valve open and with the first valve and the third valve closed to transfer the sample from the third chamber to the second chamber prior to transferring the sample to the fourth chamber.

10. The method of claim 8 wherein the analyte is a nucleic acid.

11. The method of claim 8 wherein the analyte is a nucleic acid and the detecting the analyte comprises amplifying the nucleic acid.

12. The method of claim 8 wherein the analyte is a nucleic acid and the detecting the analyte comprises isothermally amplifying the nucleic acid.

13. The method of claim 8 wherein the sample comprises a cell or a virion.

14. The method of claim 8 wherein the sample comprises a cell or a virion and the first change in composition or constitution comprises lysis of the cell or virion.

15. A reaction cartridge comprising:

a pressurizable first chamber;

a first pressure actuator in fluid communication with the first chamber;

a first valve in fluid communication with the first chamber;

a second valve in fluid communication with the first valve;

a reversibly pressurizable second chamber in fluid communication with the first valve and the second valve;

a second pressure actuator in fluid communication with the second chamber;

a reversibly pressurizable third chamber in fluid communication with the second valve;

a third pressure actuator in fluid communication with the third chamber;

a third valve in fluid communication with the second valve and the third chamber; and

a fourth chamber in fluid communication with the third valve, wherein;

the first valve is in fluid connection with the second valve via a channel that does not pass through the second chamber;

the second valve is in fluid connection with the third valve via a channel that does not pass through the third chamber;

or

the first valve is in fluid connection with the second valve via a channel that does not pass through the second chamber and the second valve is in fluid connection with the third valve via a channel that does not pass through the third chamber.

16. The reaction cartridge of claim 15 wherein the first valve is in direct fluid connection with the second valve, the second valve is in direct fluid connection with the third valve, or the first valve is in direct fluid connection with the second valve and the second valve is in direct fluid connection with the third valve.

18. The reaction cartridge of claim 15 wherein a valve selected from the group consisting of the first valve, the second valve, and the third valve is a pneumatically controlled valve.

19. The reaction cartridge of claim 15 wherein the second chamber comprises a dried component selected from the group consisting of a detergent, a reducing agent, and a cell-wall lysis enzyme.

20. The reaction cartridge of claim 15 wherein at least one of the third chamber and the fourth chamber comprises a dried DNA polymerase.

21. The reaction cartridge of claim 15 wherein the fourth chamber comprises a dried component selected from the group consisting of a primer and a DNA detection reagent.

22. The reaction cartridge of claim 15 wherein the fourth chamber comprises multiple fourth chambers.

23. The reaction cartridge of claim 15 wherein the fourth chamber comprises multiple fourth chambers wherein at least one of the fourth chambers comprises a primer not included in another of the fourth chambers.

24. A method of detecting an analyte in a sample with the reaction cartridge of claim 15 comprising:

introducing the sample in the first chamber;

pressurizing the first chamber through the first pressure actuator with the first valve open and with the second valve closed to transfer the sample to the second chamber wherein the sample undergoes a first change in composition or constitution;

pressurizing the second chamber through the second pressure actuator with the second valve open and with the first valve and the third valve closed to transfer the sample to the third chamber wherein the sample undergoes a second change in composition or constitution; and

pressurizing the third chamber through the third pressure actuator with the second valve closed and the third valve open to transfer the sample to the fourth chamber; and

detecting the analyte in the fourth chamber.

25. The method of claim 24 further including pressurizing the third chamber through the third pressure actuator with the second valve open and with the first valve and the third valve closed to transfer the sample from the third chamber to the second chamber prior to transferring the sample to the fourth chamber.

26. The method of claim 24 wherein the analyte is a nucleic acid.

27. The method of claim 24 wherein the analyte is a nucleic acid and the detecting the analyte comprises amplifying the nucleic acid.

28. The method of claim 24 wherein the analyte is a nucleic acid and the detecting the analyte comprises isothermally amplifying the nucleic acid.

29. The method of claim 24 wherein the sample comprises a cell or a virion.

30. The method of claim 24 wherein the sample comprises a cell or a virion and the first change in composition or constitution comprises lysis of the cell or virion.

17. A reaction cartridge comprising:

a pressurizable first chamber;

a first pressure actuator in fluid communication with the first chamber;

a first valve in fluid communication with the first chamber;

a second valve in fluid communication with the first valve;

a reversibly pressurizable second chamber in fluid communication with the first valve and the second valve;

a second pressure actuator in fluid communication with the second chamber;

a reversibly pressurizable third chamber in fluid communication with the second valve;

a third pressure actuator in fluid communication with the third chamber;

a third valve in fluid communication with the second valve and the third chamber; and

a fourth chamber in fluid communication with the third valve, wherein;

the first valve is in fluid connection with the second valve via a channel that does not pass through the second chamber;

the second valve is in fluid connection with the third valve via a channel that does not pass through the third chamber;

or

the first valve is in fluid connection with the second valve via a channel that does not pass through the second chamber and the second valve is in fluid connection

with the third valve via a channel that does not pass through the third chamber, wherein;

pressurizing the first chamber through the first pressure actuator with the first valve open and with the second valve closed moves liquid from the first chamber to the second chamber;

pressurizing the second chamber through the second pressure actuator with the second valve open and with the first valve and the third valve closed moves liquid from the second chamber to the third chamber;

pressurizing the third chamber through the third pressure actuator with the second valve open and with the first valve and the third valve closed moves liquid from the third chamber to the second chamber; and

pressurizing the third chamber through the third pressure actuator with the second valve closed and the third valve open moves liquid from the third chamber to the fourth chamber.