Apparatus and processes for facilitating reaction between analyte and test reagent system

• US 4,902,629 A
• Filed: 10/06/1987
• Issued: 02/20/1990
• Est. Priority Date: 10/06/1987
• Status: Expired due to Fees

• Current Assignee: Personal Diagnostics, Inc.
• Original Assignee: Personal Diagnostics, Inc.
• Inventors: Palmieri, Thomas, Bernstein, Philip, Meserol, Peter M., Prodell, Rita C.
• Primary Examiner(s): Richman, Barry S.
• Assistant Examiner(s): Johnston, Jill
• Application Number:
  US07/106,573
• Time in Patent Office: 868 Days
• Field of Search: 422/55, 422/58, 422/61, 422/68, 422/100, 436/164, 436/165, 435/805
• US Class Current: 436/165
• CPC Class Codes: B01L 2300/0838 Capillaries
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 2400/065 sliding valves
• CPC Class Codes: B01L 3/502738 characterised by integrated valves microvalves F16K99/0001
• CPC Class Codes: G01N 33/5302 Apparatus specially adapted for immunological test procedures
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: Y10S 435/805 Test papers

Abstract

Apparatus for and process of facilitating reaction between analyte contained in a sample and test reagent system at least one of which sample and test reagent system is a liquid, wherein the liquid one of the sample and test reagent system is placed in a reservoir, the other of the analyte and test reagent system is placed in capillary means dimensioned for entry into the reservoir, the reservoir and capillary means being mounted for at least relative movement towards each other and entry of the capillary means into the reservoir to draw by capillary attraction the liquid one of the sample and test reagent system from the reservoir into the capillary means and to bring the analyte and test reagent system into contact in the capillary means and facilitate the reaction.

Claims

1. An apparatus for facilitating reaction between test reagent system and analyte contained in a sample, wherein one of said test reagent system and sample is a liquid and the other of said test reagent system and sample is either a liquid or a non-liquid, comprising:

a first capillary tube provided with a first bore having a non-circular cross-section for receiving said other of said test reagent system and sample,

reservoir means for receiving said one of said test reagent system and sample,

said first capillary tube dimensioned for entry into said reservoir means and said first capillary tube and said reservoir means mounted for at least relative movement towards each other and entry of said first capillary tube into said reservoir means to draw by capillary attraction said one of said test reagent system and sample from said reservoir means into said bore and to bring said test reagent system and sample into turbulent contact in said bore and facilitate said reaction.

2. The apparatus according to claim 1 wherein said other of said test reagent system and sample is a liquid and wherein said capillary tube bore receives said other of said test reagent system and sample by capillary attraction.

3. The apparatus according to claim 2 wherein said bore is for providing turbulent flow by said capillary attraction to said one of said test reagent system and sample to bring said test reagent system and analyte into said turbulent contact in said bore of said first capillary tube and enhance facilitation of said reaction.

4. The apparatus according to claim 2 wherein said bore is for providing turbulent flow to said one of said test reagent system and sample by said capillary attraction and for bringing said test reagent system and analyte into contact in said first capillary tube with capillary attraction driven turbulence generating a contact gradient therebetween increasing in the direction of turbulent flow to enhance facilitation of said reaction.

5. The apparatus according to claim 1 wherein said reservoir means are second capillary means comprising a second capillary tube for receiving said one of said test reagent system and sample by capillary attraction.

6. The apparatus according to claim 1 wherein said reservoir means comprise opposed, spaced apart members providing a reservoir therebetween for receiving said one of said test reagent system and sample by pipetting.

7. The apparatus according to claim 1 wherein said first capillary tube has a first longitudinal axis, wherein said reservoir means comprises a second capillary tube having a second longitudinal axis, and wherein said apparatus includes mounting means for mounting said first and second capillary tubes in generally coaxial, opposing and spaced apart end-to-end relationship and wherein said first capillary tube is mounted slidably on said mounting means for at least sliding relative movement towards and entry into said second capillary tube.

8. The apparatus according to claim 7 wherein said other of said test regent system and sample is a liquid and wherein said mounting means is provided with a cavity which upon said first capillary tube being in a rearward position resides intermediate the opposed ends of said first capillary tube and said reservoir means, said cavity for receiving said other of said test reagent system and sample and wherein said slidably mounted first capillary tube upon said sliding relative movement from said rearward position towards said second capillary tube engages said other of said test reagent system and sample residing in said cavity to cause said other to be drawn by capillary attraction into said first capillary tube before entry thereof into said reservoir means.

9. The apparatus according to claim 8 wherein said mounting means are provided with second barrier means intermediate said cavity and said second capillary tube for preventing the other of said test reagent system and sample from being drawn into said second capillary tube by capillary attraction.

10. The apparatus according to claim 8 wherein said mounting means are provided with first barrier means which upon said first capillary tube being in said rearward position resides intermediate said first capillary tube and said cavity, said first barrier means for preventing premature entry of said other of said test reagent system and sample into said first capillary tube by capillary attraction.

11. The apparatus according to claim 10 or 9 wherein each of said barrier means comprise an additional cavity formed in said mounting means.

12. The apparatus according to claim 1 wherein said bore non-circular cross-section has mutually perpendicular major and minor axes having a major to minor axis ratio of approximately 10 to 1.

13. The apparatus according to claim 12 wherein said major axis is approximately 1000-2000 microns in length and wherein said minor axis is approximately 100-200 microns in length, with said 10:

1 ratio being maintained.

14. The apparatus according to claim 1 wherein said bore is defined by opposed flat surfaces interconnected by opposed generally circular, outwardly extending surfaces.

15. The apparatus according to claim 1 wherein said bore non-circular cross-section is generally oval.

16. The apparatus according to claim 1 wherein said bore non-circular cross-section is generally lemniscate.

18. The apparatus according to claim 1 or 17 wherein said capillary means is provided with at least an optically transparent portion enabling optical determination of said reaction.

17. An apparatus for facilitating reaction between a first liquid test reagent system and analyte contained in a liquid sample, and for facilitating reaction between an admixture of said first liquid test reagent system and liquid sample and a second liquid test reagent system, comprising:

mounting means;

reservoir means provided on said mounting means, said reservoir means having an entrance and for receiving said second liquid test reagent system;

capillary means mounted slidably on said mounting means and for advancement from a rearward position towards and entry into said reservoir means through said entrance thereof;

first and second cavities provided in said mounting means and upon said capillary means being in said rearward position said cavities residing intermediate said capillary means and said reservoir means with said capillary means, cavities and reservoir means being aligned linearly with said first cavity adjacent said capillary means and with said second cavity adjacent said reservoir means;

said first cavity for receiving said liquid sample and said second cavity for receiving said first liquid test reagent system; and

upon said capillary means being advanced from said rearward position towards said reservoir said capillary means engaging said liquid sample to draw said sample therein by capillary attraction, upon continued advancement of said capillary means said capillary means engaging said first liquid test reagent system to draw said first liquid test reagent system therein by capillary attraction to provide an admixture of said first liquid test reagent system and said sample and and to bring said analyte and said first liquid test reagent system into contact in said capillary means and facilitate said reaction therebetween, and upon further continued advancement of said capillary means said capillary means entering said reservoir means and engaging said second liquid test regent system to draw said second liquid test reagent therein by capillary attraction and to bring said second liquid test reagent system and said admixture into contact in said capillary means to facilitate said reaction therebetween.

19. The apparatus according to claim 7 or 17 wherein said capillary means comprises a capillary tube provided with at least an optically transparent portion enabling optical determination of said reaction and wherein said mounting means is provided with a magnifying portion for magnifying the view of said reaction in said capillary tube to enhance visual perception thereof by the human eye.

20. The apparatus according to claim 17 wherein said capillary means comprise a capillary tube provided with a bore having a non-circular cross-section for providing turbulent flow by said capillary attraction respectively to said first and second liquid test reagent systems to bring said systems into turbulent contact in said capillary means respectively with said sample an said admixture and enhance facilitation of said reactions.

21. The apparatus according to claim 17 wherein said capillary means is a capillary tube provided with a bore having a non-circular cross-section for providing turbulent flow to said first liquid test reagent system by said capillary attraction and for bringing said first liquid test reagent system into contact with said analyte in said capillary tube with capillary attraction driven turbulence generating a contact gradient therebetween increasing in the direction of turbulent flow to enhance facilitation of said reaction therebetween, and for providing turbulent flow to said second liquid test reagent system by said capillary attraction and for bringing said second liquid test reagent system into contact with said admixture of said sample and said first liquid test reagent system in said capillary tube with capillary attraction driven turbulence generating a contact gradient therebetween increasing in the direction of turbulent flow to enhance facilitation of said reaction therebetween.

22. The apparatus according to claim 17 wherein said reservoir means are second capillary means for receiving said second liquid test reagent system by capillary attraction.

23. The apparatus according to claim 17 wherein said reservoir means comprising opposed, spaced apart members providing a reservoir therebetween for receiving said second liquid test reagent system by pipetting.

24. An apparatus for facilitating reaction between analyte contained in a liquid sample and an analytical test reagent system, and for providing a control test between said sample and a control test reagent system for comparison with said reaction to determine the validity thereof, comprising:

first capillary means for receiving said analytical test reagent system;

second capillary means for receiving said control test reagent system;

reservoir means for receiving said liquid sample; and

said first and second capillary means dimensioned for entry into said reservoir and said first and second capillary means and said reservoir means mounted for at least relative movement toward each other and entry of said first and second capillary means into said reservoir means to draw by capillary attraction respective portions of said sample into said first capillary means and said second capillary means to bring said analyte and analytical test reagent system into contact in said first capillary means and facilitate said reaction therebetween and to bring a portion of said sample and said control test reagent system into contact in said second capillary means to provide said control test.

25. The apparatus according to claim 24 wherein each of said first and second capillary means are each a capillary tube provided with a bore having a non-circular cross-section for providing turbulent flow by said capillary attraction to said portions of said liquid sample and to bring said analyte into turbulent contact with said analytical test reagent system in said first capillary tube and to bring a portion of said liquid sample into turbulent contact with said control test reagent system in said second capillary tube.

26. The apparatus according to claim 24 wherein each of said first and second capillary means are a capillary tube provided with a bore having a non-circular cross-section for providing turbulent flow to said portions of said sample by said capillary attraction and for bringing said analyte into contact with said analytical test reagent system in said first capillary means with capillary attraction driven turbulence generating a contact gradient therebetween increasing in the direction of turbulent flow to enhance facilitation of said reaction and for bringing a portion of said sample into contact with said control liquid test reagent system in said second capillary means with capillary attraction driven turbulence generating a contact gradient therebetween increasing in the direction of turbulent flow to enhance said control test.

27. The apparatus according to claim 24 wherein said analytical and control test reagent systems are each a liquid and wherein said first and second capillary means comprise first and second capillary tubes and wherein said analytical liquid test reagent system and said control liquid test reagent system are received, respectively, in said first and second capillary tubes by capillary attraction.

28. The apparatus according to claim 24 wherein said reservoir means are third capillary means for receiving said sample by capillary attraction.

29. The apparatus according to claim 24 wherein said reservoir means comprises opposed, spaced apart members providing a reservoir therebetween for receiving said analyte by pipetting.

30. The apparatus according to claim 24 wherein each of said first and second capillary means are provided with at least an optically transparent portion for enabling optical determination respectively of said reaction and said control test.

31. The apparatus according to claim 24 wherein said apparatus further comprises mounting means and a slide member mounted slidably on said mounting means for sliding advancement toward said reservoir means, wherein said reservoir means are provided on said mounting means, and wherein said first and second capillary means comprise first and second capillary tubes disposed substantially parallel and secured to said slide member for sliding advancement therewith and upon advancement of said slide member toward said reservoir means, said first and second capillary tubes are advanced concurrently into said reservoir means.

32. The apparatus according to claim 31 wherein said first and second capillary tubes are each provided with at least an optically transparent portion enabling optical determination respectively of said reaction and said control test, and wherein said mounting means is provided with a magnifying portion for magnifying the views of said reaction and control test to enhance visual perception and comparison thereof by the human eye.

33. In an apparatus for facilitating reaction between analyte contained in a sample and test reagent system, wherein at least one of said sample and test reagent system is a liquid

WHEREIN THE IMPROVEMENT COMPRISES:

means comprising a capillary tube including a bore of non-circular cross-section for providing turbulent flow to said liquid one of said sample and test reagent system and for flowing said liquid one into turbulent contact with the other of said sample and test reagent system to bring said analyte and test regent system into turbulent contact and enhance facilitation of said reaction.

34. In an apparatus for facilitating reaction between analyte contained in a sample and test regent system, wherein at least one of said sample and test regent system is a liquid

WHEREIN THE IMPROVEMENT COMPRISES:

means comprising a capillary tube including a bore of non-circular cross-section for providing turbulent flow to said liquid one of said sample and test reagent sample and bringing said analyte and test reagent system into contact with capillary attraction driven turbulence generating a contact gradient therebetween increasing in the direction of turbulent flow to enhance facilitation of said reaction.

35. A process of facilitating reaction between analyte contained in a sample and test reagent system, wherein at least one of said sample and test reagent system is a liquid, comprising the steps of:

placing said liquid one of said sample and test reagent system in reservoir means;

placing the other of said sample and test reagent system in a bore of non-circular cross-section provided in a capillary tube, said capillary tube dimensioned for entry into said reservoir means;

mounting said reservoir means and said capillary tube for at least relative movement towards each other and entry of said capillary tube into said reservoir means; and

providing said relative movement towards each other and entry of said capillary tube into said reservoir means to draw by capillary attraction said one of said sample and test reagent system from said reservoir means into said bore and to bring said analyte and test reagent system into turbulent contact in said bore and facilitate said reaction.

36. The process according to claim 35 including the further steps of drawing by said capillary attraction said one of said sample and test reagent system from said reservoir into said capillary tube with turbulent flow to bring said analyte and test reagent system into turbulent contact in said capillary tube and enhance facilitation of said reaction.

37. The process according to claim 36 including the further steps of providing turbulent flow to said one of said sample and test reagent system by said capillary attraction and bringing said analyte and test reagent system into contact in said capillary tube with capillary attraction driven turbulence generating a contact gradient therebetween increasing in the direction of turbulent flow to enhance facilitation of said reaction.

38. The process according to claim 35 wherein the other of said sample and test reagent system is a liquid and wherein said process includes the further step of placing said other of said sample and test reagent system in said capillary means by capillary attraction.

39. The process according to claim 35 wherein said reservoir means are capillary means and wherein said process includes the further step of placing said one of said sample and test reagent system in said reservoir means by capillary attraction.

40. The process according to claim 35 wherein said capillary tube has a first longitudinal axis, wherein said reservoir means is provided with a second longitudinal axis and wherein said mounting step comprises the step of mounting said capillary tube and said reservoir means in generally coaxial, opposing and spaced apart end-to-end relationship and mounting said capillary tube slidably on mounting means for at least sliding relative movement towards and entry into said reservoir means.

41. The process according to claim 40 wherein the other of said sample and test reagent system is a liquid and wherein said process includes the further step of providing a cavity for receiving said other of said sample and test reagent system and which cavity, upon said capillary tube being in a rearward position, resides intermediate the opposed ends of the capillary tube and said reservoir means and wherein the process includes the further step of advancing said capillary tube from said rearward position towards said reservoir means to engage said other of said sample and test reagent system residing in said cavity to cause said other of said sample and test reagent system to be drawn by capillary attraction into said capillary tube before entry thereof into said reservoir means.

42. The process according to claim 41 wherein said process includes the further step of providing a first barrier intermediate said capillary tube and said cavity to prevent premature entry of said other of said sample and test reagent system into said capillary tube by capillary attraction.

43. The process according to claim 42 wherein said process includes the further step of providing a second barrier intermediate said cavity and said reservoir means to prevent the other of said sample and test reagent system from being drawn into said reservoir means by capillary attraction.

45. The process according to claim 40 or 44 wherein said capillary means are a capillary tube, and wherein said process includes the further steps of providing said capillary tube with at least an optically transparent portion enabling optical determination of said reaction, mounting said capillary tube on mounting means and providing said mounting means with a magnifying portion for magnifying the view of said reaction in said capillary tube to enhance visual perception thereof by the human eye.

44. A process of facilitating reaction between analyte contained in a liquid sample and a first liquid test reagent system and of facilitating reaction between an admixture of said sample and said first liquid test reagent system and a second liquid test reagent system, comprising the steps of:

placing said second liquid test reagent system in a reservoir provided with an entrance;

mounting capillary means slidably for advancement from a rearward position towards and entry into said reservoir through said entrance;

placing said sample and said first liquid test reagent system, respectively, in first and second cavities residing intermediate said capillary means upon said capillary means being in a rearward position and said reservoir; and

advancing said capillary means from said rearward position towards said reservoir to cause said capillary means to engage said liquid sample in said first cavity and draw said sample into said capillary means by capillary attraction, continuing advancement of said capillary means to cause said capillary means to engage said first liquid test reagent system residing in said second cavity to draw said first liquid test reagent system into said capillary means by capillary attraction and to bring said analyte and said first liquid test reagent system into contact in said capillary means and facilitate said reaction therebetween, and further continuing advancement of said capillary means to cause said capillary means to enter said reservoir through said entrance and engage said second liquid test reagent system to draw said second liquid test reagent system into said capillary means by capillary attraction and to bring said second liquid test reagent system and said admixture of said sample and said first liquid test reagent system into contact in said capillary means to facilitate said reaction therebetween.

46. The process according to claim 44 wherein said process includes the further steps of and providing turbulent flow by capillary attraction respectively to said first and second liquid test reagent systems to bring said systems into turbulent contact in said capillary means respectively with said analyte and said admixture of said sample and said first liquid test reagent system to enhance facilitation of said reactions.

47. The process according to claim 44 wherein said capillary means comprise a capillary tube having a bore provided with a non-circular cross-section wherein said process includes the further steps of providing turbulent flow to said first liquid test reagent system by said capillary attraction and bringing said first liquid test reagent system into contact with said analyte in said capillary tube with capillary attraction driven turbulence generating a contact gradient therebetween increasing in the direction of turbulent flow to enhance facilitation of said reaction therebetween, and providing turbulent flow to said second liquid test reagent system by said capillary attraction and bringing said second liquid test reagent system into contact with said admixture of said sample and said first liquid test reagent system in said capillary tube with capillary attraction driven turbulence generating a contact gradient therebetween increasing in the direction of turbulent flow to enhance facilitation of said reaction therebetween.

48. The process according to claim 44 wherein said reservoir comprises capillary means and wherein said process includes the further step of placing said second liquid test reagent system in said capillary vessel by capillary attraction.

49. The process according to claim 44 wherein said said reservoir comprises opposed, spaced apart members providing said reservoir therebetween and wherein said process includes the further step of placing said second liquid test reagent system in said reservoir by pipetting.

50. The process according to claim 44 wherein said process includes the further step of providing said capillary means with at least an optically transparent portion enabling optical determination of said reaction.

51. A process of facilitating reaction between analyte contained in a liquid sample and an analytical test reagent system and for providing a control test between said ample and a control test reagent system for comparison with said reaction to determine the validity thereof, comprising the steps of:

placing said analytical test reagent system in first capillary means;

placing said control test reagent system in second capillary means;

placing said liquid sample containing said analyte in a reservoir;

providing said first and second capillary means with cross-sectional dimensions permitting entry thereof into said reservoir;

mounting said first and second capillary means and said reservoir for at least relative movement towards each other and entry of said first and second capillary means into said reservoir; and

providing said relative movement and entry of said first and second capillary means into said reservoir and drawing by capillary attraction respective portions of said sample into said first capillary means and said second capillary means to bring said analyte and analytical test reagent system into contact in said first capillary means and facilitate said reaction and to bring a portion of said sample and said control test reagent system into contact in said second capillary means to provide said control test.

52. The process according to claim 51 wherein said process includes the further steps of providing turbulent flow by said capillary attraction to said portions of said sample to bring said portions of said sample respectively into turbulent contact in said first capillary means with said analytical test reagent system and in said second capillary means with said control test regent system.

53. The process according to claim 51 wherein said process includes the further steps of providing turbulent flow to said portions of said sample by said capillary attraction and bringing said portions of said sample respectively into contact with said analytical test reagent system in said first capillary means with capillary attraction driven turbulence generating a contact gradient therebetween increasing in the direction of turbulent flow to enhance facilitation of said reaction and into contact with said control test reagent system in said second capillary means with capillary attraction driven turbulence creating a gradient contact therebetween increasing in the direction of turbulent flow to enhance said control test.

54. The process according to claim 51 wherein said analytical and control test reagent systems are each a liquid and wherein said steps of placing said analytical and control test reagent systems in said first and second capillary means comprise the steps of drawing said analytical and control test reagent systems respectively into said first and second capillary means by capillary attraction.

55. The process according to claim 51 wherein said reservoir comprises capillary means and wherein the step of placing said sample in said reservoir means comprises the step of drawing said sample into said reservoir by capillary attraction.

56. The process according to claim 51 wherein said process includes the further step of providing each of said first and second capillary means with at least an optically transparent portion for enabling optical determination respectively of said reaction and said control test.

57. The process according to claim 51 wherein said first and second capillary means comprise first and second capillary tubes and wherein said process comprises the further steps of disposing said first and second capillary tubes substantially parallel, securing said first and second capillary tubes to a slide member mounted slidably on mounting means, advancing said slide member towards said reservoir means and advancing said first and second capillary tubes concurrently into said reservoir means.

58. The process according to claim 57 wherein said step of advancing said first and second capillary tubes concurrently into said reservoir means comprises the step of advancing said first and second capillary tube simultaneously into said reservoir means.

59. The process according to claim 57 wherein said process includes the further steps of providing each of said first and second capillary tubes with at least an optically transparent portion enabling optical determination respectively of said reaction and said control test and providing said mounting means with a magnifying portion for magnifying the views of said reaction and control test to enhance visual perception and comparison thereof by the human eye.

60. A process of facilitating reaction between analyte contained in a sample and test reagent system, at least one of said sample and test reagent system being a liquid, comprising the step of providing turbulent flow by capillary attraction through a bore of non-circular cross-section to said liquid one of said sample and test reagent system and turbulently flowing said liquid one into turbulent engagement with the other of said sample and test reagent system to bring said analyte and test reagent system into turbulent contact in said bore thereby facilitating said reaction.

61. A process of facilitating reaction between analyte contained in a sample and test reagent system, at least one of said sample and test reagent systems being a liquid, comprising the step of bringing said analyte and test reagent system into contact in a bore of non-circular cross-section with capillary attraction driven turbulence generating a contact gradient therebetween.