Analysis device

• US 20040115094A1
• Filed: 09/09/2003
• Published: 06/17/2004
• Est. Priority Date: 03/09/2001
• Status: Active Grant

• Current Assignee: Boehringer Ingelheim Vetmedica GmbH (C.H. Boehringer Sohn AG & Co. KG)
• Original Assignee: Boehringer Ingelheim Vetmedica GmbH (C.H. Boehringer Sohn AG & Co. KG)
• Inventors: Gumbrecht, Walter, Stanzel, Manfred
• Granted Patent: US 8,597,574 B2
• Time in Patent Office: Days
• US Class Current: 422/58
• CPC Class Codes: B01L 2200/027 for microfluidic devices
• CPC Class Codes: B01L 2200/16 Reagents, handling or storing thereof
• CPC Class Codes: B01L 2300/0645 Electrodes
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/0867 Multiple inlets and one sample wells, e.g. mixing, dilution
• CPC Class Codes: B01L 2300/1822 using Peltier elements
• CPC Class Codes: B01L 2400/0487 fluid pressure, pneumatics
• CPC Class Codes: B01L 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: B01L 3/52 Containers specially adapted for storing or dispensing a reagent B01L3/02 takes precedence; containers for medical or pharmaceutical purposes A61J1/00; containers in general B65D; storing or dispensing test elements G01N33/4875; automated reagent dispensing G01N35/1002
• 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: B01L 9/527 for microfluidic devices, e.g. used for lab-on-a-chip
• CPC Class Codes: G01N 27/416 Systems G01N27/27 takes precedence

Abstract

A microfluidic diagnosis kit used in biochemical analysis obtains a premeasured amount of reagents in an applicator for an analysis system. The required reagents are proportioned as non-volatile agents and a microfluidic system is provided, whereby the reagents are automatically dissolved in a solvent and fed to a sensor module to carry out measurement.

Claims

1. An analysis device for use in biochemical analytics, with an applicator for decentralized use, containing a first housing, a microfluidic system and a sensor module, which together with a second housing forms a measuring and analysis system, the sensor module having a microfluidically accessible, sensitive area, characterized in that in the fluidic system (11, 12, 13;

110) of the applicator (10, 60, 70) with the sensor module (15) reagents are present in a pre-portioned amount as solid, non-volatile substances and in that the fluidic system (11, 12, 13;

110) has a connection to a solvent reservoir (29, 39) for the purpose of automatic provision of solvent and dissolving of the portioned amount of solid reagent, it being possible for at least one reagent solution prepared from the reagent and the solvent to be fed to the sensitive area (2) of the sensor module (15).

2. The analysis device as claimed in claim 1, characterized in that the sensor module (15) has on the rear side an electrical contacting zone for feeding in and tapping electrical signals.

3. The analysis device as claimed in claim 1, characterized in that the solvent reservoir (39) is arranged in the second housing (20, 80), assigned [lacuna] applicator (10, 60, 70), with the reader.

4. The analysis device as claimed in claim 1, characterized in that the solvent reservoir (39) is arranged in the applicator (10, 60, 70).

5. The analysis device as claimed in claim 1, characterized in that in the applicator (10, 60, [lacuna]

6. The analysis device as claimed in claim 1, characterized in that the reagents are stored in a stable form.

7. The analysis device as claimed in claim 1, characterized in that at least one reagent is stored as a pure solid substance.

8. The analysis device as claimed in claim 1, characterized in that at least one reagent is stored in a dissolved or mixed form in an adjuvant.

9. The analysis device as claimed in claim 8, characterized in that the adjuvant is solid or liquid.

10. The analysis device as claimed in claim 9, characterized in that the adjuvant is a water-soluble polymer.

11. The analysis device as claimed in claim 8, characterized in that the adjuvant is used for diluting the reagent and/or placing it in a container of the applicator (10, 60, 70) in such a way that it is geometrically defined and has good adhesion.

12. The analysis device as claimed in claim 11, characterized in that the container in the applicator (10, 60, 70) has a defined geometry, for example as a microchannel (11) with a defined cross section and defined length.

13. The analysis device as claimed in claim 12, characterized in that the reagent dissolved in an adjuvant is placed in a defined quantitative gradient along the microchannel (11).

14. The analysis device as claimed in claim 1, characterized in that the applicator (10, 60, 70) with the first housing is a plastic card provided with microfluidic components.

15. The analysis device as claimed in claim 14, characterized in that the plastic card (10, 60, 70) is a chip card.

16. The analysis device as claimed in claim 15, characterized in that the second housing (20, 80) realizes a reader with an evaluation unit, into which the applicator (10, 60, 70), containing the first housing and the sensor module (15), can be introduced.

17. The analysis device as claimed in claim 16, characterized in that, with the prescribed operating mode, the applicator (10, 60, 70) in conjunction with the reader (20, 80) allows reagent and solvent to be brought together.

18. The analysis device as claimed in one of the preceding claims, characterized in that the applicator (10, 60, 70) is connected to the reader (20, 80) by means of at least one microchannel (11).

19. The analysis device as claimed in claim 18, characterized in that the solvent reservoir (29) in the reader (20, 80) is formed for receiving the solvent, for example water, for a number of analyses.

20. The analysis device as claimed in claim 18, characterized in that there is a container (28) for the disposal of sample material and used reagents.

21. The analysis device as claimed in claim 20, characterized in that the container (28) for the disposal of sample material and used reagents is arranged in the first housing of the applicator (10, 60, 70) and/or in the second housing of the reader (20, 80).

22. The analysis device as claimed in claim 18, characterized in that the reader (20, 80) contains means (25) for conveying the solvent through the microchannels to the sensor module and to the waste container in the applicator (10, 60, 70) and/or reader (20, 80).

23. The analysis device as claimed in one of the preceding claims, characterized in that the solvent is passed over the geometrically placed reagent-adjuvant mixture (16, 16′

, . . . ), so that a defined solution is produced.

24. The analysis device as claimed in claim 23, characterized in that the solvent is kept at a defined temperature.

25. The analysis device as claimed in one of claims 1 to 24, characterized in that there are means for setting a defined temperature at the sensor module (15), in particular for cooling.

26. The analysis device as claimed in claim 25, characterized in that in the second housing (20, 80) there is a Peltier element (30), which exerts a thermostatically controlling effect, in particular a cooling effect, on the sensor module (15).

27. The analysis device as claimed in one of the preceding claims, characterized by use in biochemical analytics.

28. The analysis device as claimed in claim 27, characterized in the application for DNA analysis.

29. The analysis device as claimed in claim 27, characterized in the application for speeding up the cooling phase in the PCR technique.

30. The analysis device as claimed in one of claims 1 to 24, characterized by use in food monitoring.

31. The analysis device as claimed in one of claims 1 to 24, characterized by use in environmental measuring technology.

32. The analysis device as claimed in one of claims 1 to 24, characterized by use in forensics.

33. The analysis device as claimed in one of claims 1 to 24, characterized by use in medical diagnostics.

34. The analysis device as claimed in claim 33, characterized by use in blood gas/blood electrolyte analysis.

35. The analysis device as claimed in claim 33, characterized by use in the diagnosis of infectious diseases.

36. The analysis device as claimed in claim 33, characterized by use in therapy control.

37. The analysis device as claimed in. Claim 33, characterized by use for early detection of diseases.