Method for operating a system for the integrated and automated analysis of DNA or protein

1. A method for operating a control device in a biochip analysis device comprising:

a cartridge in the form of a plastic card which contains a system of microfluidic channels that form a reservoir that contains a reaction substance, a sample chamber and flow channels, a fluid input and a deformable means for covering the system of microfluidic channels,

a control device having a cartridge receptacle for receiving, locking, unlocking and releasing the cartridge, the control device comprising:

a power supply connected to the cartridge receptacle,

at least one first sensor adapted for identifying whether or not a cartridge located in the cartridge receptacle is a correct cartridge or correctly located therein,

a microcontroller adapted for control and data acquisition, and having means for transmitting data to an evaluation unit or computer, and

a pump controlled by the microcontroller and adapted to direct a flow of liquid through a cartridge located in the cartridge receptacle,

wherein the cartridge receptacle is comprised of upper and lower parts that are movable apart for insertion of a cartridge and together for locking an inserted cartridge in the cartridge receptacle, the method comprising the steps of:

introducing a sample into said cartridge;

opening the cartridge receptacle;

using a means for moving to move a part of the cartridge receptacle upon insertion of the cartridge into the cartridge receptacle, such that the cartridge is correctly received in the cartridge receptacle;

transferring the sample to a PCR chamber;

dissolving dry PCR reagents;

closing off valves of the PCR chamber;

starting thermocycling;

carrying out a set number of thermocycles at defined temperatures;

opening the valves of the PCR chamber after conclusion of the PCR;

transferring the PCR product from the PCR chamber to a detection chamber;

carrying out an DNA analysis of constituents to be detected in the sample in an integrated process; the carrying out the DNA analysis comprising actively changing the temperature in the detection chamber, such that hybridization of the PCR product with catcher molecules can take place;

pumping dissolved enzyme into the detection chamber;

pumping dissolved substrate into the detection chamber;

starting electrical detection; and

evaluating measurement signals resulting from the analysis or transmitting data to an external device or computer.

2. The method as claimed in claim 1 , wherein an SNP analysis is carried out by recording melting curves.

3. The method as claimed in claim 1 , wherein the control device comprises said means for moving a part of the cartridge receptacle and further comprising a means for locking a cartridge inserted into the cartridge receptacle.

4. Method as claimed in claim 1 , wherein the control device comprises fill level sensors adapted for monitoring of the flow of fluid in the cartridge.

5. Method as claimed in claim 1 , wherein a thermostatic regulation device is provided that has thermal coupling plates at positions adapted for transferring heat to a cartridge in the cartridge receptacle, one of the thermal coupling plates on a side facing the film of an inserted cartridge.

6. Method as claimed in claim 1 , further comprising bringing two parts of the cartridge receptacle together by said means for moving.

7. Method as claimed in claim 1 , further comprising bringing a Peltier element into position by said means for moving.

8. Method as claimed in claim 1 , further comprising performing redox cycling in the detection chamber for detection of DNA.

9. Method as claimed in claim 1 , wherein the closing of the valves of the PCR chamber is performed by actuators pressing onto the deformable means for covering the system of microfluidic channels of the cartridge.

10. A method for controlling an integrated and automated analysis of DNA or protein in a system comprising a cartridge containing various reagents for the analysis and to receive a sample to be analyzed and comprising a control device for controlling an analysis process, the method comprising:

introducing a sample into the cartridge;

determining, using a capacitive filling level sensor, a liquid level in a channel of the cartridge;

actively influencing the temperature in a detection chamber of the cartridge by a Peltier element of the control device which is thermally coupled to a chip module;

carrying out an analysis of constituents to be detected in the sample in an integrated process;

recording measurement data from the analysis process via a computing unit;

transmitting the measurement data to an evaluation unit via a wireless module; and

evaluating the measurement data; and

representing the results of the analysis on a display,

further comprising using a means for moving for bringing the Peltier element into position for said influencing of the temperature in the detection chamber.

11. Method according to claim 10 , further comprising: controlling all components of the control device involved in the analysis process via a microcontroller.

12. Method according to claim 11 , wherein the microcontroller is connected to the computing unit via a serial interface.

13. Method according to claim 10 , further comprising: controlling a pump for pumping a fluid through channels of the cartridge.

14. Method according to claim 10 , further comprising: controlling at least one valve arranged in a channel of the cartridge.

15. Method according to claim 10 , further comprising: controlling valves of a PCR chamber via a servomotor and a signal processing unit.

16. Method according to claim 10 , further comprising: monitoring the movement of a fluid in the cartridge.

17. Method according to claim 10 , wherein carrying out the analysis includes performing a DNA analysis, and the DNA analysis includes cell disruption and PCR.

18. Method as claimed in claim 17 , wherein an SNP analysis is carried out by recording melting curves.

19. Method according to claim 10 , further comprising: carrying out a thermocycling process for PCR, wherein dry PCR reagents are dissolved.

20. Method as claimed in claim 10 , wherein a protein analysis is carried out.

21. Method as claimed in claim 10 , further comprising closing valves of a PCR chamber by actuators pressing onto a deformable means for covering the cartridge.

22. Method as claimed in claim 10 , further comprising actively influencing the temperature in the detection chamber by a Peltier element which is thermally coupled to a chip module in order to support a hybridization between the replicated DNA and corresponding capture molecules that takes place at a surface of a chip module of the cartridge.

23. A method for controlling an integrated and automated analysis of DNA or protein in a system comprising a cartridge containing various reagents for the analysis and to receive a sample to be analyzed and comprising a control device for controlling an analysis process, the method comprising:

introducing a sample into the cartridge;

carrying out an analysis of constituents to be detected in the sample in an integrated process;

closing off a PCR chamber of the cartridge by closing two valves by actuators pressing onto a film of the cartridge;

pressing a device for transferring heat to the PCR chamber against a plastic body of the cartridge when a PCR is carried out, wherein said device comprises two Peltier units which are arranged on opposite sides of the PCR chamber;

carrying out a thermocycling process for PCR, wherein dry PCR reagents which are stored in the cartridge are dissolved;

carrying out a predetermined number of thermocycles at defined temperatures;

recording measurement data from the analysis process via a computing unit;

transmitting the measurement data to an evaluation unit via a wireless module; and evaluating the measurement data,

further comprising using a means for moving to bring the device for transferring heat into position against the plastic body.

24. Method as claimed in claim 23 , further comprising inserting the cartridge into a cartridge receptacle and bringing two parts of the cartridge receptacle together by said means for moving.

25. Method as claimed in claim 23 , further comprising actively influencing the temperature in a detection chamber of the cartridge by a Peltier element which is thermally coupled to a chip module in order to support a hybridization between replicated DNA and corresponding capture molecules that takes place at a surface of a chip module of the cartridge.

26. Method as claimed in claim 25 , further comprising performing redox cycling in the detection chamber for detection of DNA.

27. Method as claimed in claim 23 , further comprising electrically detecting the PCR product by means of a sensor array.

28. A method for controlling an integrated and automated analysis of DNA in a system comprising a cartridge containing various reagents for analysis and receiving a sample to be analyzed and comprising a control device for controlling an analysis process and having Peltier elements, the method comprising:

introducing a sample to be analyzed into the cartridge;

opening a cartridge receptacle of the control device;

using a motor means for moving a part of a cartridge receptacle upon insertion of the cartridge and/or bringing two parts of the cartridge receptacle together when the cartridge has been completely introduced;

upon insertion of the cartridge, bringing Peltier elements of the control device into position by another motor means;

transferring a sample to be analyzed to a PCR chamber of the cartridge;

closing off the PCR chamber using actuators by pressing two valves onto a film of the cartridge;

performing PCR by carrying out a predetermined number of thermocycles;

opening the PCR chamber after conclusion of the PCR;

transferring the PCR product from the PCR chamber to a detection chamber of the cartridge;

actively influencing the temperature in the detection chamber using a Peltier element which is thermally coupled to a chip module in order to support hybridization between the PCR product and corresponding capture molecules that takes place at a surface of the chip module of the cartridge;

performing redox cycling in the detection chamber for detection of DNA;

electrically detecting the PCR product by means of a sensor array;

recording measurement data from the analysis process with a computing unit;

evaluating the measurement data; and

representing the results of the analysis on a display.

29. Method as claimed in claim 28 , further comprising transmitting the measurement data to an evaluation unit via a wireless module.

30. Method as claimed in claim 28 , further comprising interrupting the movement of the cartridge by a limit switch when the cartridge has been completely introduced.

31. Method as claimed in claim 28 , further comprising marking DNA linked to catcher molecules by a label enzyme.

32. Method as claimed in claim 28 , further comprising pressing Peltier units, which are arranged on opposite sides of the PCR chamber for transferring heat to the PCR chamber, against a plastic body of the cartridge when PCR is carried out.

33. Method as claimed in claim 28 , wherein a Peltier element for actively influencing the temperature in the detection chamber is pressed against the cartridge.

34. Method as claimed in claim 28 , wherein the sensor array comprises a CMOS sensor chip.