Device and method for analyte detection

• US 7,381,571 B2
• Filed: 02/24/2006
• Issued: 06/03/2008
• Est. Priority Date: 04/03/1996
• Status: Expired due to Fees

• Current Assignee: Applera Corporation (Thermo Fisher Scientific Incorporated)
• Original Assignee: Applera Corporation (Thermo Fisher Scientific Incorporated)
• Inventors: Kowallis, Reid B., Albin, Michael, Winn-Deen, Emily S., Ragusa, Robert P., Raysberg, Yefim, Woudenberg, Timothy M.
• Primary Examiner(s): Le; Long V.
• Assistant Examiner(s): DIRAMIO, JACQUELINE A
• Application Number:
  US11/362,475
• Publication Number:
  US 20060166352A1
• Time in Patent Office: 830 Days
• Field of Search: 422/50, 422/55, 422/57, 422/58, 422/68.1, 422/102, 422/82.05, 422/82.08, 435/6, 435/7.1, 435/287.2, 435/288.5, 435/288.4, 435/288.7, 236/164, 236/501, 236/807
• US Class Current: 436/518
• CPC Class Codes: B01J 2219/00317 Microwell devices, i.e. having large numbers of wells
• CPC Class Codes: B01J 2219/00599 Solution-phase processes
• CPC Class Codes: B01J 2219/00722 Nucleotides
• CPC Class Codes: B01L 2200/027 for microfluidic devices
• CPC Class Codes: B01L 2200/0642 Filling fluids into wells by specific techniques
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/0864 comprising only one inlet and multiple receiving wells, e.g. for separation, splitting
• CPC Class Codes: B01L 2300/1827 using resistive heater
• 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 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: B01L 3/50851 specially adapted for heating or cooling samples laboratory heating apparatus B01L7/00; incubators C12M
• 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 1/08 using multifield media
• CPC Class Codes: C12Q 1/6816 characterised by the detection means C12Q1/6804 takes precedence
• CPC Class Codes: C12Q 2565/631 being a biochannel or pore
• CPC Class Codes: C40B 40/06 Libraries containing nucleotides or polynucleotides, or derivatives thereof
• CPC Class Codes: C40B 50/08 Liquid phase synthesis, i.e. wherein all library building blocks are in liquid phase or in solution during library creation; Particular methods of cleavage from the liquid support
• CPC Class Codes: C40B 60/14 for creating libraries
• CPC Class Codes: G01N 2035/00148 Test cards, e.g. Biomerieux or McDonnel multiwell test cards
• CPC Class Codes: G01N 21/6452 : Individual samples arranged in a regular 2D-array, e.g. multiwell plates
• CPC Class Codes: Y10S 436/805 : Optical property
• CPC Class Codes: Y10S 436/807 : Apparatus included in process claim, e.g. physical support structures
• CPC Class Codes: Y10S 436/808 : Automated or kit
• CPC Class Codes: Y10S 436/809 : Multifield plates or multicontainer arrays
• CPC Class Codes: Y10T 436/143333 : Saccharide [e.g., DNA, etc.]
• CPC Class Codes: Y10T 436/25 : including sample preparation

Abstract

The invention is directed to a method and device for simultaneously testing a sample for the presence, absence, and/or amounts of one or more of a plurality of selected analytes. The invention includes, in one aspect, a device for detecting or quantitating a plurality of different analytes in a liquid sample. Each chamber may include an analyte-specific reagent effective to react with a selected analyte that may be present in the sample, and detection means for detecting the signal. Also disclosed are methods utilizing the device.

Claims

1. A device comprising:

a multi-layered substrate, the multi-layered substrate comprising a first layer and a coated metal layer, the coated metal layer comprising a heat-conducting metal layer and a plastic polymer coating on the heat-conducting metal layer for preventing corrosion of the heat-conducting metal layer, wherein the first layer and the coated metal layer are sealably bonded together;

a sample-distribution network defined by the multi-layered substrate and comprising (i) a sample inlet, (ii) two or more detection chambers, each of the two or more detection chambers being defined by the coated metal layer such that the plastic polymer coating separates the heat-conducting metal layer from the detection chamber, (iii) at least one sample delivery channel in fluid communication with the sample inlet, and (iv) a plurality of dead-end fluid connections, each of the dead-end fluid connections providing a dead-end communication between a respective one of the two or more detection chambers and the at least one sample delivery channel; and

detection reagents in the detection chambers.

2. The device of claim 1, wherein the heat-conducting metal layer comprises copper or aluminum.

3. The device of claim 1, wherein the substrate layers are sealably bonded together with glue or epoxy resin.

4. The device of claim 1, wherein the substrate layers have been sealably bonded together by pressure-sealing, ultrasonic welding, or heat curing.

5. The device of claim 1, wherein the detection reagents comprise selected-sequence polynucleotides effective to react with selected target analytes.

6. The device of claim 1, wherein at least one of the two or more detection chambers is pre-loaded with at least one oligonucleotide primer pair suitable for polymerase chain reaction.

7. The device of claim 1, wherein the substrate comprises an optically transparent window through which a reaction product of the detection reagents can be detected.

8. The device of claim 1, wherein each detection chamber comprises an upper wall that is optically clear.

9. The device of claim 1, wherein the detection reagents are pre-loaded and dried down in the detection chambers.

10. The device of claim 1, wherein the at least one sample delivery channel comprises three sample delivery channels.

11. A system comprising:

a device, the device comprising

a multi-layered substrate, the multi-layered substrate comprising a first layer and a coated metal layer, the coated metal layer comprising a heat-conducting metal layer and a plastic polymer coating on the heat-conducting metal layer for preventing corrosion of the heat-conducting metal layer, wherein the first layer and the coated metal layer are sealably bonded together,

a sample-distribution network defined by the multi-layered substrate and comprising (i) a sample inlet, (ii) two or more detection chambers, each of the two or more detection chambers being defined by the coated metal layer such that the plastic polymer coating separates the heat-conducting metal layer from the detection chamber, (iii) at least one sample delivery channel in fluid communication with the sample inlet, and (iv) a plurality of dead-end fluid connections, each of the dead-end fluid connections providing a dead-end communication between a respective one of the two or more detection chambers and the at least one sample delivery channel, and

detection reagents in the detection chambers;

a temperature-controller adapted to heat the two or more detection chambers; and

a detector configured to detect signals from the two or more detection chambers.

12. The system of claim 11, wherein the detector comprises a non-optical sensor for signal detection.

13. The system of claim 11, wherein the detector comprises a fluorescence sensor for signal detection.

14. The system of claim 11, wherein the temperature-controller comprises a thermal cycle for modulating the temperature of the two or more detection chambers to effect thermal cycling of a liquid sample within each detection chamber.

15. The system of claim 11, wherein at least one of the two or more detection chambers is pre-loaded with at least one oligonucleotide primer pair suitable for polymerase chain reaction.

16. The system of claim 11, wherein the detection reagents are pre-loaded and dried down in the detection chambers.

17. The system of claim 11, wherein the heat-conducting metal layer comprises copper or aluminum.

18. The system of claim 11, wherein the substrate layers are sealably bonded together with glue epoxy resin.

19. The system of claim 11, wherein the substrate layers have been sealably bonded together by pressure-sealing, ultrasonic welding, or heat curing.

20. The system of claim 11, wherein each detection chamber comprises an upper wall that is optically clear.