Cartridge, system and method for automated medical diagnostics

• US 9,568,424 B2
• Filed: 06/16/2006
• Issued: 02/14/2017
• Est. Priority Date: 06/23/2005
• Status: Active Grant

• Current Assignee: Biocartis NV (Biocartis Group NV)
• Original Assignee: Biocartis NV (Biocartis Group NV)
• Inventors: Van Haag, Chris, Jongerius, Michiel Johannes, Schaefer, Danny Genius Aldegonda, Van Den Bijgaart, Adrianus Wilhelmus Dionisius Maria, De Gier, Ronald, De Jong, Michiel, Pross, Gerhard, Bacher, Johannes, Boos, Andreas, Luedke, Gerd, Seher, Jens-Peter
• Primary Examiner(s): FORMAN, BETTY J
• Application Number:
  US11/917,955
• Publication Number:
  US 20100047774A1
• Time in Patent Office: 3,896 Days
• Field of Search: 435/287.1, 435/6
• US Class Current: 1/1
• CPC Class Codes: B01L 2200/027 for microfluidic devices
• CPC Class Codes: B01L 2200/028 Modular arrangements
• 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 2300/02 Identification, exchange or storage of information
• CPC Class Codes: B01L 2300/087 Multiple sequential chambers
• CPC Class Codes: B01L 2300/1805 Conductive heating, heat from thermostatted solids is conducted to receptacles, e.g. heating plates, blocks
• CPC Class Codes: B01L 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: B01L 3/502738 characterised by integrated valves microvalves F16K99/0001
• CPC Class Codes: B01L 3/545 for laboratory containers
• 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: G01N 2035/00158 Elements containing microarrays, i.e. "biochip"
• CPC Class Codes: G01N 21/6428 Measuring fluorescence of fluorescent products of reactions or of fluorochrome labelled reactive substances, e.g. measuring quenching effects, using measuring "optrodes" in vivo A61B5/00; immunoassay G01N33/53
• CPC Class Codes: G01N 35/00069 whereby the sample substrate is of the bio-disk type, i.e. having the format of an optical disk

Abstract

Cartridge and method for the detection of the presence, absence and/or amount of a target nucleotide sequence in a sample comprising one or more nucleic acid sequences. The cartridge comprises a one or more nucleic acid sequences, and the cartridge includes a generic part and one or more separate application-specific parts, which are connectable to the generic part.

Claims

1. A cartridge for the detection of the presence, absence and/or amount of a target nucleotide sequence in a sample comprising one or more nucleic acid sequences, comprising:

a generic part;

the generic part comprising a click-fit connector, pumps, valves, process chambers, and fluid and waste rooms;

one or more separate application-specific parts, each being specifically configured for a specific application;

the one or more application-specific parts being separately connectable to the generic part; and

at least one of the one or more separate application-specific parts being a PCR body comprising one or more thermocycling chambers and plural primers,

wherein the one or more thermocycling chambers of the PCR body contains the plural primers for PCR amplification prior to the sample being introduced into the cartridge,

wherein at least one of the one or more application-specific parts is click-fit connected to the generic part via the click-fit connector,

wherein at least one of the primers is spotted on the PCR body, and

wherein the cartridge is configured to be removably connected to an apparatus comprising one or more actuation devices that can actuate one or more elements of the generic part.

2. A cartridge for the detection of the presence, absence and/or amount of a target nucleotide sequence in a sample comprising one or more nucleic acid sequences, comprising:

a generic part;

the generic part comprising a releasable click-fit connector, pumps, valves, process chambers, and fluid and waste rooms;

plural separate application-specific parts, each being specifically configured for a specific application;

the application-specific parts being separately connectable to the generic part;

at least one of the separate application-specific parts being a detection device connectable to the generic part, and

at least one of the separate application-specific parts being a circular, disc-shaped PCR body comprising one or more thermocycling chambers and plural primers,

wherein the one or more thermocycling chambers of the PCR body contains the plural primers for PCR amplification prior to the sample being introduced into the cartridge,

wherein at least one of the one or more application-specific parts is click-fit connected to the generic part via the click-fit connector,

wherein the PCR body comprises one or more thermal masses, and wherein the cartridge is configured to be removably connected to an apparatus comprising one or more actuation devices that can actuate one or more elements of the generic part.

3. A cartridge for the detection of the presence, absence and/or amount of a target nucleotide sequence in a sample comprising one or more nucleic acid sequences, comprising:

a generic part;

the generic part comprising at least one click-fit connector, pumps, valves, process chambers, and fluid and waste rooms;

one or more separate application-specific parts, each being specifically configured for a specific application;

the one or more application-specific parts being separately connectable to the generic part;

at least one of the one or more separate application-specific parts being a PCR body comprising one or more thermocycling chambers and plural primers; and

a detection device,

wherein the one or more thermocycling chambers of the PCR body contains the plural primers for PCR amplification prior to the sample being introduced into the cartridge and prior to the PCR body being connected to the generic part,

wherein a releasable click-fit connection is provided between the PCR body and the generic part,

wherein the detection device is specifically configured to perform detection with the primers in the PCR body, and

wherein the cartridge is configured to be removably connected to an apparatus comprising one or more actuation devices that can actuate one or more elements of the generic part.

4. A cartridge for the detection of the presence, absence and/or amount of a target nucleotide sequence in a sample comprising one or more nucleic acid sequences, the cartridge comprising:

a generic part;

the generic part comprising a click-fit connector, pumps, valves, process chambers, and fluid and waste rooms;

plural different application-specific parts separate from the generic part;

the plural different application-specific parts being separately connectable to different portions of the generic part; and

at least one of the plural different application-specific parts being a PCR body comprising one or more thermocycling chambers and plural primers,

wherein the one or more thermocycling chambers of the PCR body contains the plural primers for PCR amplification prior to the PCR body being connected to the generic part, and

wherein the cartridge is configured to be removably connected to an apparatus comprising one or more actuation devices that can actuate one or more elements of the generic part.

5. A cartridge according to claim 4, wherein at least one of the primers is spotted on the PCR body.

6. A cartridge according to claim 4, wherein the PCR body is disc-shaped.

7. A cartridge according to claim 4, wherein the PCR body comprises one or more thermal masses.

8. A cartridge according to claim 4, wherein one of the plural different application-specific parts is a detection device.

9. A cartridge according to claim 8, wherein the detection device is selected on the basis of the primers in the PCR body.

10. A cartridge according to claim 4, wherein one of the plural different application-specific parts is a sample introduction device configured to prepare a sample to a specific state.

11. A cartridge according to claim 10, wherein the sample introduction device is a pre-lysis device configured to prepare a sample to a specific state.

12. A cartridge according to claim 4, further comprising spaces for holding a sample or part thereof arranged in each of the generic part and the plural different application-specific parts, wherein each space for holding the sample or part thereof is air-tight.

13. A cartridge according to claim 4, wherein at least one of the plural different application-specific parts comprises an identification device.

14. A cartridge according to claim 4, wherein each of the plural different application-specific parts and the generic part comprises an identification device.

15. A cartridge for detecting a presence, absence and/or amount of a target nucleotide sequence in a sample comprising one or more nucleic acid sequences, the cartridge comprising:

a generic cartridge part comprising a click-fit connector, an identification and a plurality of different devices arranged inside a body of the generic part;

a first application-specific cartridge part comprising an identification and being connectable to the generic part;

a second application-specific cartridge part comprising an identification and being connectable to the generic part;

the first application-specific part being different from the second application-specific part and the first application-specific part comprising a PCR body containing amplification chambers and primers contained in the amplification chambers for PCR amplification; and

the primers being contained within the amplification chambers prior to the first application-specific part being connected to the generic part,

wherein the first part is connected to the generic part via the click-fit connector arranged on the generic part and the second part is connected to the generic part at a location on the generic part that is spaced from the click-fit connector, and

wherein the cartridge, with the first part connected to the generic part via the click-fit connector, is configured to be removably connected to an apparatus comprising one or more actuation devices that can actuate one or more elements of the generic part.

16. The cartridge of claim 15, wherein the cartridge is structured and arranged to receive a sample, perform DNA isolation and amplification, and detect amplified DNA, wherein the plurality of different devices comprises at least one of:

pumps;

valves;

process chambers; and

fluid and waste rooms.