Integrated microchip genetic testing system

• US 6,303,288 B1
• Filed: 02/07/2000
• Issued: 10/16/2001
• Est. Priority Date: 05/08/1996
• Status: Expired due to Term

• Current Assignee: Regents of The University of Minnesota (University of Minnesota)
• Original Assignee: Regents of The University of Minnesota (University of Minnesota)
• Inventors: Furcht, Leo T., Polla, Dennis L., McGlennen, Ronald C.
• Primary Examiner(s): Redding, David A.
• Application Number:
  US09/499,202
• Time in Patent Office: 617 Days
• Field of Search: 435/4, 435/6, 435/287.2, 435/287.3, 435/287.6, 435/287.7, 435/287.8, 435/810, 435/970, 422/56, 422/61, 935/77, 935/78, 935/87
• US Class Current: 435/4
• CPC Class Codes: B01J 2219/00495 Means for heating or cooling the reaction vessels
• CPC Class Codes: B01J 2219/00529 DNA chips
• CPC Class Codes: B01J 2219/00585 Parallel processes
• CPC Class Codes: B01J 2219/00596 Solid-phase processes
• CPC Class Codes: B01J 2219/00608 DNA chips
• CPC Class Codes: B01J 2219/0061 The surface being organic
• CPC Class Codes: B01J 2219/00612 the surface being inorganic
• CPC Class Codes: B01J 2219/00617 by chemical means
• CPC Class Codes: B01J 2219/00626 Covalent
• CPC Class Codes: B01J 2219/0063 Other, e.g. van der Waals forces, hydrogen bonding
• CPC Class Codes: B01J 2219/00637 by coating it with another layer
• CPC Class Codes: B01J 2219/00659 Two-dimensional arrays
• CPC Class Codes: B01J 2219/00689 using computers
• CPC Class Codes: B01J 2219/00702 Processes involving means for analysing and characterising the products
• CPC Class Codes: B01J 2219/00722 Nucleotides
• CPC Class Codes: B01L 2200/147 Employing temperature sensors
• CPC Class Codes: B01L 2200/16 Reagents, handling or storing thereof
• CPC Class Codes: B01L 2300/0636 Integrated biosensor, microarrays
• CPC Class Codes: B01L 2300/0663 Whole sensors
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/0825 : Test strips
• CPC Class Codes: B01L 2300/1827 : using resistive heater
• CPC Class Codes: B01L 2300/1838 : using fluid heat transfer medium
• CPC Class Codes: B01L 2400/0406 : capillary forces
• CPC Class Codes: B01L 2400/0439 : ultrasonic vibrations, vibrating piezo elements
• CPC Class Codes: B01L 2400/0442 : thermal energy, e.g. vaporisation, bubble jet
• CPC Class Codes: B01L 2400/0481 : squeezing of channels or chambers
• CPC Class Codes: B01L 2400/0683 : mechanically breaking a wall or membrane within a channel or chamber
• 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: B01L 9/527 : for microfluidic devices, e.g. used for lab-on-a-chip
• CPC Class Codes: C40B 40/06 : Libraries containing nucleotides or polynucleotides, or derivatives thereof
• CPC Class Codes: C40B 60/14 : for creating libraries
• CPC Class Codes: Y10S 435/97 : Test strip or test slide

Abstract

A genetic testing system includes a miniaturized thermal cycling device and an integrated, unitary microchip based detection device with microfluidic controls, on chip electronics. The genetic testing system further uses dipped or coated polymeric materials on processed silicon as a means to facilitate amplification chemistry.

Claims

1. A genestrip comprising:

a support strip;

a reaction cocktail pouch affixed to the support strip and coupled to a sample collection pad by a cocktail fluid tube capped by a pressure sensitive membrane; and

an assembly mounted on the support strip, the assembly is operable for sliding and rupturing the reaction cocktail pouch containing a fluid and forcing the fluid into the cocktail fluid tube.

2. The genestrip of claim 1, wherein the support strip is operable for coupling to an integrated nucleic amplifier and detector.

3. The genestrip of claim 1, wherein the support strip is a flexible plastic support strip.

4. The genestrip of claim 3, wherein the flexible plastic support strip includes an area for receiving a sample identifier mark.

5. The genestrip of claim 1, wherein the sample collection pad is fabricated from paper.

6. The genestrip of claim 1, wherein the sample collection pad is fabricated from a synthetic material.

7. The genestrip of claim 1, wherein the sample collection pad is impregnated with FTA™

.

8. The genestrip of claim 1, wherein the reaction cocktail pouch is a sealed reservoir.

9. The genestrip of claim 8, wherein the sealed reservoir is fabricated from a plastic.

10. The genestrip of claim 1, wherein the reaction cocktail pouch contains buffers, oligonucleotide primers and reaction additives used in an amplification reaction.

11. The genestrip of claim 1, wherein the membrane is a pressure sensitive valve.

12. The genestrip of claim 1, wherein the assembly comprises:

a sliding ferrule affixed to a collar.

13. The genestrip of claim 1, wherein the support strip has an area for receiving a sample identifier mark.

14. A method comprising:

inserting a genestrip including a cocktail pouch and a sample collection pad into a genetic test card;

rupturing the cocktail pouch containing a fluid and forcing the fluid into contact with the sample collection pad including a nucleic acid; and

amplifying the nucleic acid to form amplified nucleic acid.

15. The method of claim 14, wherein rupturing the cocktail pouch containing a fluid and forcing the fluid into contact with a sample collection pad including a nucleic acid comprises:

moving a sliding assembly along the genestrip to rupture the cocktail pouch containing the fluid and to force the fluid through a cocktail fluid tube and into contact with a sample collection pad.