Test card for assay and method of manufacturing same

• US 10,214,772 B2
• Filed: 06/17/2016
• Issued: 02/26/2019
• Est. Priority Date: 06/22/2015
• Status: Active Grant

• Current Assignee: Fluxergy, LLC
• Original Assignee: Fluxergy, LLC
• Inventors: Revilla, Ryan Alan, Heltsley, Roy James, Lee, Steve Hoe, Patel, Tej Rushikesh
• Primary Examiner(s): Merkling, Sally A
• Application Number:
  US15/185,661
• Publication Number:
  US 20160369323A1
• Time in Patent Office: 984 Days
• CPC Class Codes: B01L 2200/04 Exchange or ejection of cartridges, containers or reservoirs
• CPC Class Codes: B01L 2200/0684 Venting, avoiding backpressure, avoid gas bubbles
• CPC Class Codes: B01L 2200/0689 Sealing
• 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 2300/087 Multiple sequential chambers
• CPC Class Codes: B01L 2300/0887 Laminated structure
• CPC Class Codes: B01L 2300/161 Control and use of surface tension forces, e.g. hydrophobic, hydrophilic
• CPC Class Codes: B01L 2400/049 vacuum
• 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: 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: C12Q 1/686 Polymerase chain reaction [PCR]

Abstract

A disposable test card configured to accept a fluid sample for an assay, and a method of manufacturing same, is disclosed herein. In a general example embodiment, a test card for analyzing a fluid sample includes a first substrate layer including an inlet port and an outlet port, a channel layer bonded to the first substrate layer, the channel layer including a microchannel placing the inlet port in fluid communication with the outlet port, and a second substrate layer bonded to the channel layer, the second substrate layer having electrodes printed adjacent to a target zone of the microchannel of the channel layer, wherein the electrodes are configured to raise the temperature of the fluid sample within the target zone of the microchannel when a current is applied thereto.

Claims

1. A method of manufacturing a test card for analysing a fluid sample, comprising:

cutting at least a microchannel into a first polymer material to form a channel layer;

cutting a first aperture and a second aperture into a second polymer material to form a first substrate layer;

bonding the first substrate layer to a first side of the channel layer and a second substrate layer to a second side of the channel layer to form a single bonded layer with the microchannel passing therethrough and placing the first aperture and the second aperture in fluid communication with each other;

forming a third substrate layer to be thicker than the first substrate layer and the second substrate layer;

printing a conductive ink onto a first side of the bonded layer; and

adhering the third substrate layer to a second side of the bonded layer opposite the first side to form the test card, wherein the formed test card has a first surface formed by third substrate layer and an opposite second surface with the conductive ink exposed for contact with an outside source of current.

2. The method of claim 1, which includes diffusion bonding the first substrate layer to the first side of the channel layer and the second substrate layer to the second side of the channel layer.

3. The method of claim 1, which includes filling the microchannel with a surfactant solution.

4. The method of claim 1, which includes filling the microchannel with a surfactant solution including water and then allowing the water to evaporate to leave behind a layer of surfactant molecules on a surface of the microchannel.

5. The method of claim 1, which includes cutting a third aperture and a fourth aperture into the third substrate layer, and aligning the third aperture with the first aperture and the fourth aperture with the second aperture when adhering the third substrate layer to the bonded layer.

6. The method of claim 5, which includes cutting the third aperture to have two different cross-sectional areas, a first cross sectional area forming an inlet port on one side of the third substrate layer, and a second cross-sectional area forming at least part of a mixing chamber on an opposite side of the third substrate layer.

7. The method of claim 1, which includes cutting an analysis port aperture into the third substrate layer, and aligning the analysis port aperture with a target zone of the microchannel when adhering the third substrate layer to the bonded layer.

8. The method of claim 1, which includes printing a layer of dielectric ink over at least a portion of the conductive ink on the one first side of the bonded layer.

9. The method of claim 7, wherein the target zone is aligned with electrodes formed by the conductive ink, and wherein the electrodes are aligned within borders of the analysis port aperture when the test card is formed.

10. The method of claim 7, which includes aligning the analysis port aperture with both the target zone and a fluid detection zone of the microchannel when adhering the third substrate layer to the bonded layer.

11. The method of claim 10, wherein the fluid detection zone is a first fluid detection zone upstream of the target zone along the microchannel, and which includes aligning the analysis port aperture to further surround a second fluid detection zone downstream of the target zone along the microchannel.

12. The method of claim 1, which includes cutting an analysis port aperture into the third substrate layer, and aligning the analysis port aperture so that the first aperture aligns outside of borders of the analysis port aperture when the test card is formed.

13. The method of claim 1, which includes cutting an analysis port aperture into the third substrate layer, and aligning the analysis port aperture so that the second aperture aligns outside of borders of the analysis port aperture when the test card is formed.

14. The method of claim 1, which includes cutting an analysis port aperture into the third substrate layer, and aligning the analysis port aperture so that at least one electrical contact formed by the conductive ink and exposed for contact with the outside source of current aligns outside of borders of the analysis port aperture when the test card is formed.

15. The method of claim 1, which includes cutting an analysis port aperture into the third substrate layer, wherein a length of the analysis port aperture taken along a direction of the test card from the first aperture to the second aperture is more than half of a length of the third substrate layer in a same direction.

16. The method of claim 1, which includes cutting an analysis port aperture into the third substrate layer, wherein a width of the analysis port aperture taken approximately perpendicular to a direction of the test card from the first aperture to the second aperture is more than half of a width of the third substrate layer in a same direction.

17. The method of claim 1, wherein the conductive ink on the first side of the bonded layer is the only component of the test card intended to contact the outside source of current.