Systems, devices and methods for multiplexed diagnostics

• US 9,488,613 B2
• Filed: 08/30/2013
• Issued: 11/08/2016
• Est. Priority Date: 03/02/2011
• Status: Active Grant

• Current Assignee: Massachusetts Institute of Technology
• Original Assignee: Massachusetts Institute of Technology
• Inventors: Linnes, Jacqueline, Bosch, Irene, Hamad-Schifferli, Kimberly S., Gehrke, Lee, Hanumara, Nevan Clancy, Wood, David, Gomez-Marquez, Jose F.
• Primary Examiner(s): Warden, Jill
• Assistant Examiner(s): Kingan, Timothy G
• Application Number:
  US14/014,864
• Publication Number:
  US 20140246334A1
• Time in Patent Office: 1,166 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: B01L 2300/021 Identification, e.g. bar codes
• CPC Class Codes: B01L 2300/025 Displaying results or values with integrated means
• CPC Class Codes: B01L 2300/126 Paper
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: G01N 27/3275 Sensing specific biomolecules, e.g. nucleic acid strands, based on an electrode surface reaction
• CPC Class Codes: G06F 2218/00 Aspects of pattern recognition specially adapted for signal processing
• CPC Class Codes: G06K 7/015 Aligning or centering of the sensing device with respect to the record carrier
• CPC Class Codes: G06K 7/10 by electromagnetic radiation, e.g. optical sensing; by corpuscular radiation

Abstract

Exemplary embodiments provide diagnostic devices, systems and methods for determining the presence or absence of one or more markers or characteristics in one or more samples. An exemplary diagnostic device may display a first two-dimensional machine-readable output to indicate the presence or absence of a first characteristic in a sample. Similarly, the exemplary diagnostic device may display a second two-dimensional machine-readable output to indicate the presence or absence of a second characteristic in a sample. An image capture device may be used to automatically detect the two-dimensional machine-readable output appearing in the diagnostic device. A computational device may be used to automatically determine whether the presence or absence of the first characteristic and/or the second characteristic based on the two-dimensional machine-readable output displayed in the diagnostic device.

Claims

1. A diagnostic device for detecting a presence or absence of one or more substances in one or more samples, the diagnostic device comprising:

a microfluidic network layer, including;

a first set of input nodes for introduction of the one or more samples to the diagnostic device;

an output region, including

a first set of output nodes arranged to detect the presence or absence of a first substance in the one or more samples,

a second set of output nodes arranged to detect the presence or absence of a second substance in the one or more samples, and

a two-dimensional machine-readable pattern with one or more apertures and one or more solid portions overlaid over the first set of output nodes and the second set of output nodes to provide a machine-readable output indicating the presence or absence of the first substance and/or the second substance in the one or more samples; and

a plurality of microfluidic channels extending between the first set of input nodes and the first and second sets of output nodes.

2. The diagnostic device of claim 1, wherein an indicator appearing at the first set of output nodes within the machine-readable output indicates the presence of the first substance in the one or more samples.

3. The diagnostic device of claim 1, wherein an indicator appearing at the second set of output nodes within the machine-readable output indicates the presence of the second substance in the one or more samples.

4. The diagnostic device of claim 1, wherein a first indicator appearing at the first set of output nodes and a second indicator appearing at the second set of output nodes within the machine-readable output indicates the presence of the first and second substances in the one or more samples.

5. The diagnostic device of claim 1, wherein the first set of output nodes is arranged to detect the presence or absence of the first substance in a first sample, and wherein the second set of output nodes is arranged to detect the presence or absence of the second substance in a second, different sample.

6. The diagnostic device of claim 1, wherein the machine-readable output is a matrix pattern.

7. The diagnostic device of claim 1, wherein the two-dimensional machine-readable pattern is imprinted on a stencil, and wherein the stencil comprises a set of the apertures aligned with the first and second sets of output nodes to enable viewing of the first and second sets of output nodes.

8. The diagnostic device of claim 1, wherein the first set of output nodes include a first reagent, and wherein interaction of a sample with the first reagent causes the presence or absence of a first indicator at the first set of output nodes.

9. The diagnostic device of claim 1, wherein one or more microfluidic channels include a first reagent, and wherein interaction of a sample with the first reagent causes the presence or absence of a first indicator at the first set of output nodes.

10. The diagnostic device of claim 1, further comprising:

an image capture device for detecting the machine-readable output at the output region.

11. The diagnostic device of claim 1, further comprising:

a computational device programmed to automatically determine the presence or absence of the first substance in the one or more samples based on the machine-readable output including or excluding a first indicator at the first set of output nodes.

12. The diagnostic device of claim 11, wherein the computational device is further programmed to automatically determine that the one or more samples includes the first substance if the machine-readable output includes the first indicator at the first set of output nodes.

13. The diagnostic device of claim 11, wherein the computational device is further programmed to automatically determine a quantitative determination of the first substance in the one or more samples.

14. The diagnostic device of claim 11, wherein the computational device is further programmed to automatically determine that the one or more samples exclude the first substance if the machine-readable output does not include the first indicator at the first set of output nodes.

15. The diagnostic device of claim 11, wherein the computational device is further programmed to automatically determine a diagnostic condition based on the machine-readable output including or excluding the first indicator at the first set of output nodes.

16. The diagnostic device of claim 1, wherein the one or more samples is blood, blister exudate, urine, sweat, saliva, food, water, a soil component, oil, or fuel.

17. The diagnostic device of claim 1, wherein the first substance is a biomarker, tracer, metabolite, protein, nucleic acid, biological organism, pathogen, oil, fuel, or chemical additive.

18. The diagnostic device of claim 1, wherein the machine-readable output includes one or more colors appearing at the first set of output nodes.

19. The diagnostic device of claim 1, wherein the machine-readable output includes one or more alphanumeric symbols appearing at the first set of output nodes.

20. The diagnostic device of claim 1, wherein the machine-readable output includes one or more pictorial symbols appearing at the first set of output nodes.

21. The diagnostic device of claim 1, further comprising:

an electrochemical reader for detecting electrochemical activity at the first set of output nodes and/or the second set of output nodes, electrochemical activity at the first set of output nodes indicating the presence or absence of the first substance in the one or more samples, electrochemical activity at the second set of output nodes indicating the presence or absence of the second substance in the one or more samples.

22. The diagnostic device of claim 1, further comprising:

a top layer disposed above the microfluidic network layer for covering the plurality of microfluidic channels from view of a user.

23. The diagnostic device of claim 1, wherein the first and second sets of output nodes are provided in a scattered arrangement within the scope of the two-dimensional machine-readable pattern.

24. The diagnostic device of claim 1, wherein the first and second sets of output nodes are provided in a matrix arrangement within the scope of the two-dimensional machine-readable pattern.

25. The diagnostic device of claim 1, wherein a first input node is coupled to two or more output nodes.

26. The diagnostic device of claim 1, wherein a first output node is coupled to two or more input nodes.

27. The diagnostic device of claim 1, wherein a first input node is not coupled to any output node.

28. The diagnostic device of claim 1, wherein a first output node is not coupled to any input node.

29. The diagnostic device of claim 1, wherein the number of input nodes is the same as the number of output nodes in the microfluidic network layer.

30. The diagnostic device of claim 1, wherein the number of input nodes is different from the number of output nodes in the microfluidic network layer.

31. The diagnostic device of claim 1, further comprising:

a radio frequency identification (RFID) tag associated with the first and second sets of output nodes in the microfluidic network layer, the RFID tag configured to transmit a radio frequency (RF) signal in response to detection of the machine-readable output.

32. A method for forming a diagnostic device for detecting a presence or absence of one or more substances in one or more samples, the method comprising:

providing a microfluidic network layer;

forming a set of input nodes in the microfluidic network layer;

forming an output region, comprising;

a first set of output nodes arranged to detect the presence or absence of a first substance in the one or more samples,

a second set of output nodes arranged to detect the presence or absence of a second substance in the one or more samples, and

a two-dimensional machine-readable pattern with one or more apertures and one or more solid portions overlaid over the first set of output nodes and the second set of output nodes to provide a machine-readable output indicating the presence or absence of the first substance and/or second substance in the one or more samples; and

forming a plurality of microfluidic channels extending between the first set of input nodes and the first and second sets of output nodes.