Device for extracting nucleic acid from a sample

• US 20080057572A1
• Filed: 10/24/2007
• Published: 03/06/2008
• Est. Priority Date: 05/28/1999
• Status: Active Grant

• Current Assignee: Cepheid (Danaher Corporation)
• Original Assignee: Cepheid (Danaher Corporation)
• Inventors: Belgrader, Phillip, Taylor, Michael, Petersen, Kurt, Dority, Douglas, Sakai, Stanley, Northrup, M., Chang, Ronald, Pourahmadi, Farzad, Ching, Jesus, McMillan, William
• Granted Patent: US 9,789,481 B2
• Time in Patent Office: Days
• US Class Current: 435/306.1
• CPC Class Codes: B01L 2200/10 Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
• CPC Class Codes: B01L 2300/0654 Lenses; Optical fibres
• CPC Class Codes: B01L 2300/0681 Filter
• CPC Class Codes: B01L 2300/0809 rectangular shaped
• CPC Class Codes: B01L 2300/087 Multiple sequential chambers
• CPC Class Codes: B01L 2400/0487 fluid pressure, pneumatics
• CPC Class Codes: B01L 2400/0622 distribution valves, valves having multiple inlets and/or outlets, e.g. metering valves, multi-way valves
• CPC Class Codes: B01L 2400/0644 rotary valves
• CPC Class Codes: B01L 3/502 with fluid transport, e.g. in multi-compartment structures centrifugal-type cuvettes G01N21/07; analysis by separation into components G01N30/00; automatic analysers G01N35/00
• 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: C12N 1/066 by physical methods
• CPC Class Codes: C12N 13/00 Treatment of microorganisms or enzymes with electrical or wave energy, e.g. magnetism, sonic waves
• CPC Class Codes: Y10S 435/81 Packaged device or kit
• CPC Class Codes: Y10S 436/805 Optical property
• CPC Class Codes: Y10S 436/806 Electrical property or magnetic property
• CPC Class Codes: Y10S 436/807 Apparatus included in process claim, e.g. physical support structures
• CPC Class Codes: Y10S 436/809 Multifield plates or multicontainer arrays
• CPC Class Codes: Y10S 436/829 Liposomes, e.g. encapsulation
• CPC Class Codes: Y10T 137/87716 For valve having a flexible diaphragm valving member
• CPC Class Codes: Y10T 137/88046 Biased valve with external operator
• CPC Class Codes: Y10T 436/255 : including use of a solid sorbent, semipermeable membrane, or liquid extraction

Abstract

The present invention provides a cartridge for analyzing a fluid sample. The cartridge provides for the efficient separation of cells or viruses in the sample from the remaining sample fluid, lysis of the cells or viruses to release the analyte (e.g., nucleic acid) therefrom, and optionally chemical reaction and/or detection of the analyte. The cartridge is useful in a variety of diagnostic, life science research, environmental, or forensic applications for determining the presence or absence of one or more analytes in a sample.

Claims

1. A device for extracting nucleic acid from a sample, the sample containing cells or viruses, the device comprising a cartridge having:

a) a lysing chamber for lysing the cells or viruses to release the nucleic acid therefrom, wherein the lysing chamber contains capture material for capturing the cells or viruses as the sample flows through the lysing chamber, and wherein the lysing chamber further contains removal material for holding unwanted material in the lysing chamber while the nucleic acid is eluted from the lysing chamber;

b) at least one waste chamber for receiving used sample fluid that has flowed through the lysing chamber;

c) a third chamber for receiving the nucleic acid eluted from the lysing chamber; and

d) at least one flow controller for directing the used sample fluid, that has flowed through the lysing chamber, to flow into the at least one waste chamber and for directing the eluted nucleic acid to flow into the third chamber.

5. The device of claim 1, wherein the third chamber comprises a reaction chamber for amplifying the nucleic acid and holding the nucleic acid for optical detection, and wherein the cartridge is in combination with an instrument having a heater for heating the reaction chamber and having at least one optical detector for detecting the nucleic acid.

6. The device of claim 1, wherein the third chamber comprises a reaction chamber for amplifying the nucleic acid.

7. The device of claim 1, wherein the lysing chamber is defined by at least one wall having an external surface to which an ultrasonic transducer may be coupled, and wherein the wall is sufficiently deflectable to deflect in response to vibratory movements of the transducer to generate pressure waves or pressure pulses in the lysing chamber.

8. The device of claim 7, further comprising beads in the lysing chamber for rupturing the cells or viruses.

9. The device of claim 1, wherein the cartridge includes a sample chamber having a port for introducing a sample into the cartridge and further includes a sample flow path extending from the sample chamber, the lysing chamber being in the sample flow path.

10. The device of claim 1, wherein the at least one flow controller comprises at least one valve for directing the used sample fluid to flow into the waste chamber via a first flow path in the cartridge and for directing the nucleic acid to flow into the third chamber via a second flow path in the cartridge.

11. The device of claim 1, wherein the capture material comprises at least one filter.

12. The device of claim 1, wherein the capture material comprises beads.

13. The device of claim 12, wherein the beads are coated with antibodies or receptors for binding the cells or viruses.

14. The device of claim 1, wherein the removal material comprises beads.

15. The device of claim 14, wherein the beads are capable of binding proteins or peptides.

16. The device of claim 14, wherein the beads are capable of binding salts, metal ions, or detergents in the sample.

17. The device of claim 14, wherein the beads are ion exchange beads.

18. The device of claim 14, wherein the beads have metal ion chelators.

19. The device of claim 1, wherein the capture material comprises a first set of beads for capturing the cells or viruses, and wherein the removal material comprises a second set of beads for binding the unwanted material.

2. The device of claim 2, wherein the third chamber comprises a mixing chamber for mixing the nucleic acid with one or more reagents.

3. The device of claim 2, wherein the cartridge further includes a reaction chamber in fluid communication with the mixing chamber for holding the nucleic acid for chemical reaction or optical detection.

4. The device of claim 2, wherein the cartridge further includes:

i) a reaction chamber in fluid communication with the mixing chamber for amplifying the nucleic acid; and

ii) a capillary electrophoresis area in communication with the reaction chamber.