MULTIPLE- ANALYTE ASSAY DEVICE AND SYSTEM

• US 20120282602A1
• Filed: 05/02/2012
• Published: 11/08/2012
• Est. Priority Date: 05/02/2011
• Status: Active Grant

• Current Assignee: Ibis Biosciences Incorporated
• Original Assignee: Ibis Biosciences Incorporated
• Inventors: Collier, Gordon Bruce, Hofstadler, Steven A., Drader, Jared J.
• Granted Patent: US 8,614,087 B2
• Time in Patent Office: Days
• US Class Current: 435/6.1
• CPC Class Codes: B01L 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: G01N 2035/00158 Elements containing microarrays, i.e. "biochip"
• CPC Class Codes: G01N 27/26 by investigating electrochemical variables; by using electrolysis or electrophoresis
• CPC Class Codes: G01N 27/3273 Devices therefor, e.g. test element readers, circuitry details not specific to biochemical electrodes G01N33/4875
• CPC Class Codes: G01N 33/5302 Apparatus specially adapted for immunological test procedures
• CPC Class Codes: G01N 33/54306 Solid-phase reaction mechanisms

Abstract

Provided herein is technology relating to testing biological samples and particularly, but not exclusively, to devices, systems, and kits for performing multiple, simultaneous real-time assays on a sample in a single-use disposable format. For example, the technology relates to an apparatus that finds use, for example, for point-of-care diagnostics, including use at accident sites, emergency rooms, in surgery, in intensive care units, as well as for non-medical applications.

Claims

1. A cartridge for sensing an analyte in a sample, the cartridge comprising:

a) a plurality of analyte sensors;

b) a multiplexer electronically connected to the plurality of analyte sensors; and

c) a data output electronically connected to the multiplexer.

2. The cartridge of claim 1 wherein an analyte sensor is an electrochemical analyte sensor or a light sensor that detects light and outputs an electrical signal.

3. The cartridge of claim 1 further comprising an interface for connecting the cartridge to a reading apparatus, wherein the interface transmits signals between the cartridge and the reading apparatus.

4. The cartridge of claim 1 wherein an output signal from the data output comprises a sampled portion of a data signal from an analyte sensor.

5. The cartridge of claim 1 wherein a data signal is sampled during a timeslot for 0.01-10 seconds.

6. The cartridge of claim 1 comprising 10-100 analyte sensors.

7. The cartridge of claim 1 comprising 48 analyte sensors and 6 analog measurement channels, wherein each analog measurement channel carries the multiplexed signals from 8 analyte sensors.

8. The cartridge of claim 1 configured to acquire 2 measurements per second.

9. The cartridge of claim 1 comprising a screen-printed silver/silver chloride electrode.

10. The cartridge of claim 1 wherein a printed circuit board comprises the plurality of analyte sensors.

11. The cartridge of claim 1 wherein the analyte is selected from the group consisting of:

a nucleic acid, an antigen, an enzyme, a protein, a toxin, a biochemical metabolite, a biological ion, and a respiratory gas.

12. The cartridge of claim 1 wherein the analyte sensors produce a signal that is, or is a combination of, a type selected from the group consisting of:

amperometric, conductimetric, and potentiometric.

13. The cartridge of claim 1 wherein a sensor of the plurality of analyte sensors comprises a nucleic acid capture element.

14. The cartridge of claim 1 wherein a sensor of the plurality of analyte sensors detects an electrogenic species derived from an enzyme reaction associated with nucleotide capture.

15. A system for sensing an analyte in a sample, the system comprising:

a) the cartridge of claim 1; and

b) a reading apparatus.

16. The system of claim 15 wherein the cartridge comprises:

1) an analyte sensor configured to analyze a sample;

2) a multiplexer configured to receive a data signal and output an output signal; and

3) a first interface component configured to mate with the reading apparatus and communicate with the reading apparatus; and

wherein the reading apparatus comprises;

1) a second interface component configured to mate with the cartridge and communicate with the cartridge; and

2) a microprocessor configured to decode the output signal.

17. A kit comprising the cartridge according to claim 1.

18. A method for detecting one or more analytes in a sample, comprising:

exposing the cartridge of claim 1 to a sample and detecting one or more analytes in said sample.

19. The cartridge of claim 1 comprising:

a) Nanalyte sensors for assaying the sample;

b) Mmeasurement channels electrically coupled to the first plurality of analyte sensors; and

c) a C-channel shift register electrically coupled to the first plurality of analyte sensors, wherein N, M and Care integers and N=M×

C.

20. The cartridge of claim 19 wherein the shift register controls the ON/OFF state of each analyte sensor of the plurality of analyte sensors.

21. The cartridge of claim 19 wherein the shift register simultaneously controls the ON/OFF state of Manalyte sensors.

22. The cartridge of claim 19 wherein the shift register simultaneously controls the ON/OFF state of Manalyte sensors, 1 in each measurement channel.

23. The cartridge of claim 19 wherein one measurement channel carries the multiplexed signals from Canalyte sensors.

24. The cartridge of claim 19 wherein N=48, M=6, and C=8.