Cartridge and analysis system for testing a sample

• US 10,346,653 B2
• Filed: 10/05/2017
• Issued: 07/09/2019
• Est. Priority Date: 10/07/2016
• 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: Schoeder, Heinz, Niemeyer, Axel, Wuerz, Kai
• Primary Examiner(s): Labaze, Edwyn
• Application Number:
  US15/725,372
• Publication Number:
  US 20180101706A1
• Time in Patent Office: 642 Days
• Field of Search: 235375, 235487
• CPC Class Codes: B01L 2200/14 Process control and prevention of errors
• CPC Class Codes: B01L 2300/021 Identification, e.g. bar codes
• CPC Class Codes: B01L 2300/022 Transponder chips
• CPC Class Codes: B01L 2300/0645 Electrodes
• CPC Class Codes: B01L 3/5027 by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip B01L3/5023 takes precedence; micromixers B01F33/30; microreactors for synthesis B01J19/0093; microcapillary devices in general B81B1/00
• CPC Class Codes: G01N 2035/00742 Type of codes
• CPC Class Codes: G01N 2035/00792 Type of components bearing the codes, other than sample carriers
• CPC Class Codes: G01N 35/00732 Identification of carriers, materials or components in automatic analysers
• CPC Class Codes: G06K 19/06028 using bar codes
• CPC Class Codes: G06K 19/0723 the record carrier comprising an arrangement for non-contact communication, e.g. wireless communication circuits on transponder cards, non-contact smart cards or RFIDs
• CPC Class Codes: G06K 7/10366 the interrogation device being adapted for miscellaneous applications
• CPC Class Codes: G06K 7/1413 1D bar codes

Abstract

A cartridge, an analysis system, a method and a computer program product for testing a sample, such as, environmental, food or biological sample, wherein the cartridge has two memory means that are different and/or can be read out by different methods and which correspond to the cartridge or to the batch thereof.

Claims

1. A cartridge for an analysis system for testing a sample, comprising:

a fluid system having a plurality of channels, cavities and valves for controlling the flow through the channels and cavities,

a sensor apparatus for detecting at least one analyte of the sample, wherein the sensor apparatus comprises a chip having electrodes for electrochemical detection,

contacts via which measurement results of a test can be read out or transmitted,

two readable memory means, each of which is readable in different manner, and

two different cartridge identifiers,

wherein a first of the two readable memory means is formed on or by the chip and is electronically readable in a wired manner via the contacts of the cartridge and comprises a first of the two cartridge identifiers, wherein the first of the two cartridge identifiers identifies the cartridge, and

wherein a second of the two readable memory means is readable wirelessly and comprises a second of the two of the cartridge identifiers, wherein the second of the two of the cartridge identifies a batch of cartridges with which the cartridge is associated.

2. The cartridge according to claim 1, wherein the second of the two memory means is optically readable.

3. The cartridge according to claim 1, wherein at least one sensor field is formed on or by the chip.

4. The cartridge according to claim 1, wherein the cartridge identifiers comprise an identification code that uniquely identifies the cartridge or a batch with which the cartridge is associated.

5. The cartridge according to claim 1, further comprising a pump apparatus which creates a pumping force, transporting the fluid through the fluid system.

6. An analysis system, comprising:

a cartridge for testing a sample comprising two memory means that can be read out by different methods and each of which comprises a cartridge identifier, one of the cartridge identifiers identifying the cartridge or and another of cartridge identifiers identifying a batch of cartridges with which the cartridge is associated; and

an analysis device for receiving the cartridge and subsequently carrying out a test using the received cartridge, the test being performed based on received control information, and

an operating instrument that can be at least one of physically separated or disconnected from the analysis device, from a data connection, or wirelessly connected to the analysis device,

the operating instrument forming a user interface for controlling the test,

wherein a first of the two memory means can be read out by means of the operating instrument in order to retrieve control information for carrying out the test using the cartridge, and

wherein a second of the two memory means can be read out by means of the analysis device so that the analysis system can verify the control information.

7. The analysis system according to claim 6, wherein the second of the two memory means is electronically readable by means of the analysis device.

8. The analysis system according to claim 7, wherein the second of the two memory means is electronically readable in a wired manner.

9. The analysis system according to claim 6, wherein the first of the two memory means is optically readable.

10. The analysis system according to claim 6, wherein the first of the two memory means is readable only by the operating instrument and the second of the two memory means is readable only by the analysis device.

11. The analysis system according to claim 6, wherein the analysis system comprises a database containing at least one of control information or evaluation information for carrying out a test using the cartridge, the database being controllable by the cartridge identifier.

12. The analysis system according to claim 11, wherein the at least one of the control information or evaluation information being at least one of identifiable or retrievable from the database by means of the cartridge identifier.

13. The analysis system according to claim 6, wherein the analysis system is adapted to determine or retrieve at least one of control information for carrying out a test or evaluation information for evaluation of measurement results using one of said cartridge identifiers and to at least one of verify the at least one of the control information or evaluation information or enable, unblock or start testing using another one of said cartridge identifiers.

14. The analysis system according to claim 13, wherein the cartridge identifier for determining or retrieving at least one of the control information or the evaluation information is a cartridge identifier that is wirelessly readable.

15. The analysis system according to claim 13, wherein the cartridge identifier for verifying at least one of the control information or evaluation information or enabling, unblocking or starting testing is electronically readable.

16. The analysis system of claim 6, wherein the operating instrument forms a user interface for evaluating measurement results determined during the test.

17. The analysis system of claim 6, wherein one of the memory means is optically readable by means of the operating instrument.

18. The analysis system of claim 6, wherein one of the memory means is optically readable by means of the operating instrument and the other memory means is electronically readable in a wired manner by means of the analysis device.

19. The analysis system of claim 6, wherein the cartridge further comprises:

a fluid system having a plurality of channels cavities and valves for controlling the flow through the channels and cavities,

a sensor apparatus for detecting at least one analyte of the sample, wherein the sensor apparatus comprises a chip having electrodes for electrochemical detection, and

contacts via which measurement results of the test can be read out or transmitted,

wherein the second of the two readable memory means is formed on or by the chip and is electronically readable in a wired manner via the contacts of the cartridge, and

wherein the first of the two readable memory means is readable wirelessly.

20. The analysis system of claim 6, wherein

wherein the second of the two readable memory means comprises the cartridge identifier which identifies the cartridge, and

wherein the first of the two readable memory means comprises the cartridge identifier which identifies a batch of cartridges with which the cartridge is associated.

21. A method for carrying out a test on an in particular biological sample using a cartridge that can be inserted into an analysis device for carrying out the test, comprising:

reading out a first cartridge identifier from a first memory means of the cartridge by means of an operating instrument that forms a user interface for controlling the test, wherein the operating instrument can be at least one of physically separated or disconnected from the analysis device at least with respect to a data connection or can be wirelessly connected to the analysis device,

using the operating instrument for retrieving, by means of the first cartridge identifier, control information for carrying out the test,

reading out a second cartridge identifier by means of the analysis device from a second memory means of the cartridge that is different from the first memory means,

verifying the control information by means of the second cartridge identifier,

transmitting the control information to the analysis device by means of the operating instrument, and

using the analysis device for carrying out the test with the control information.

22. The method according to claim 21, comprising the further step of verifying the control information when a cartridge is loaded in the analysis device.

23. The method according to claim 21, comprising the further steps of:

the operating instrument retrieving, by means of the first cartridge identifier, evaluation information for evaluating measurement results,

the analysis device obtaining measurement results by means of the test,

the analysis device transmitting the measurement results to the operating instrument, and

the operating instrument evaluating the measurement results by means of the evaluation information.

24. The method according to claim 23, comprising the further step of verifying the evaluation information by means of the second cartridge identifier.

25. The method according to claim 21, wherein one of the cartridge identifiers corresponds to the cartridge and the other cartridge identifier corresponds to a batch of cartridges associated with the cartridge.