Disposable Device for Analyzing a Liquid Sample Containing a Nucleic Acid With a Nucleic Acid Amplification Apparatus

• US 20100003683A1
• Filed: 07/05/2007
• Published: 01/07/2010
• Est. Priority Date: 07/14/2006
• Status: Active Grant

• Current Assignee: Roche Molecular Systems (Roche Holding AG)
• Original Assignee: Roche Molecular Systems Inc (Roche Holding AG)
• Inventors: Kopp, Martin, Wahl, Hans-Peter, Elsenhans, Olivier, Sarofim, Emad
• Granted Patent: US 8,642,293 B2
• Time in Patent Office: Days
• US Class Current: 435/6
• 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 2300/0809 rectangular shaped
• CPC Class Codes: B01L 3/502707 characterised by the manufacture of the container or its components by shaping or joining plastic parts B29C59/00, B29C65/00; by laminating B32B37/00; manufacture of microstructural devices in general B81C
• CPC Class Codes: B01L 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces

Abstract

The invention is directed to a disposable sample holding and processing device (1) dimensioned for being operated in a nucleic acid amplification apparatus for analyzing a liquid sample containing a nucleic acid by a nucleic acid amplification technique. The device (1) comprises chambers (15, 16) and channels (44) designed to perform the steps of capturing, amplification and detection of the nucleic acid within the device (1), and optionally also a lysis chamber (3). The binding chamber (15) contains a solid phase (14) for immobilization of a component of the sample to be analyzed, and the amplification chamber (16) is connected to the binding chamber (15) by a fluid channel (44). The device (1) comprises a rigid body (42) and at least one channel (44), the binding chamber (15) and the amplification chamber (16) are situated on side-surfaces (50) of the body (42), each of those side-surfaces (50), on which a channel (44), the binding chamber (15) or the amplification chamber (16) is situated, is covered by at least one wall (41) and these side-surfaces (50) are substantially vertical planes when the device (1) is operated in the nucleic acid amplification apparatus.

Claims

1-25. -25. (canceled)

26. A disposable device capable of holding and processing samples for being operated in a nucleic acid amplification apparatus, comprising:

a rigid body,

a binding chamber, said binding chamber being located on a side-surface of said rigid body and containing a solid phase for solid phase extraction of a component of a sample to be analyzed,

an amplification chamber, said amplification chamber being located on a side-surface of said rigid body,

a fluid channel, connecting said amplification chamber to said binding chamber,

at least one channel, and

at least one fluid interface connected by a fluid channel to at least one of the binding chamber and the amplification chamber, wherein the fluid interfaces are situated on at least one of the top and bottom-surfaces of the rigid body when the device is operated in the nucleic acid amplification apparatus,

wherein;

each of said side-surfaces, on which a channel, the binding chamber or the amplification chamber is situated, is covered by at least one wall, and

the side-surfaces are oriented along substantially vertical planes when the device is operated in the nucleic acid amplification apparatus.

27. The device according to claim 26, wherein the channels, the binding chamber and the amplification chamber are formed by cavities, said cavities being recesses on the side-surfaces of the rigid body and being covered by the at least one wall.

28. The device according to claim 26, wherein the binding chamber, the fluid channel and the amplification chamber are located on one side-surface of the rigid body and are covered by a common wall.

29. The device according claim 26, wherein at least one fluid interface is effective to contact fluid delivery and/or fluid removal means of the nucleic acid amplification apparatus.

30. The device according to claim 29, wherein at least one fluid supply interface of the device is constructed such that a fluid is supplied to the device from above in a downward direction when the device is operated in the nucleic acid amplification apparatus.

31. The device according to claim 26, wherein the rigid body has a structured surface on which the cavities are formed, and a sealing cover which covers the structured surface thereby forming a wall covering a side-surface of the device,

wherein:

a first layer of the sealing cover is made of a material which is inert with respect to the sample liquid, and

a second layer of the sealing cover is made of a metal.

32. The device according to claim 26, wherein the amplification chamber is covered on one side with a heat transfer wall for providing a thermal contact between a temperature control means of the nucleic acid analysis apparatus and the amplification chamber for heating and cooling of a sample in the amplification chamber of the device when it is operated in the nucleic acid amplification apparatus.

33. The device according to claim 32, wherein the effective direction of the heat flow between the temperature control means and the amplification chamber is horizontal and perpendicular in regard to the plane of the heat transfer wall.

34. The device according to claim 31, wherein a transparent optical measurement window of the amplification chamber and the heat transfer wall are arranged on opposite sides of the amplification chamber.

35. The device according to claim 26, wherein a fluidic filling measurement means is provided in the outlet channel of the amplification chamber close to the outlet of the amplification chamber for detecting a moment when the amplification chamber (16) has been filled or emptied completely.

36. The device according the claim 35, wherein the fluidic filling measurement means is an optical transparent window enabling optical detection of fluid in the outlet channel by a corresponding optical sensor of the nucleic acid amplification apparatus or an electric sensor placed in or close to the outlet channel.

37. The device according to claim 26, further comprising a sample preparation chamber suitable for performing the step of lysis of the nucleic amplification analysis within the device.

38. The device according to claim 37, comprising a sample preparation chamber with an opening adapted to receive a sample transfer tip for transferring liquid into the device.

39. The device according to claim 37, wherein the volume of the sample preparation chamber is much larger than the volume of the amplification chamber, the sample is kept and located in the lower end of the sample preparation chamber by gravity and may be transported through the binding chamber, the fluid channel and the amplification chamber upon use of the device in a nucleic acid amplification apparatus by a pressure difference between an inlet of the device, particularly the sample preparation chamber, and an outlet of the device, the pressure difference being applied to the device by the nucleic acid amplification apparatus.

40. The device according to claim 26, wherein the volume of the amplification chamber is larger than about the volume of the binding chamber and not larger than about twice the volume of the binding chamber.

41. The device according to claim 26, wherein the body of the device comprises at least one sealing point located close to a channel of the device, said channel leading from a chamber of the device to an inlet port, outlet port or venting port of the device, or leading from a first chamber to a second chamber, wherein the channel located close to the sealing point is sealed by a sealer of the nucleic acid amplification apparatus in order to close said channel for interrupting a flow of liquid or gas through said channel.

42. The device according to claim 26, comprising at least one waste chamber integrated into the device for taking up waste material resulting in a process performed with the device, wherein the waste chamber is situated on a side-surface of the body and is formed by a cavity being a recess in the body, and that side-surface being covered by a wall, which wall is substantially a vertical plane when the device is operated in the nucleic acid amplification apparatus.

43. A system comprising at least one device according to claim 26 and a nucleic acid amplification apparatus for analyzing said device.

44. A method for analyzing a liquid sample containing a nucleic acid with a nucleic acid amplification technique comprising the step of using a system according to claim 43.