ANALYTE COLLECTION AND DETECTION DEVICES

• US 20090202388A1
• Filed: 02/04/2009
• Published: 08/13/2009
• Est. Priority Date: 03/04/2004
• Status: Abandoned Application

• Current Assignee: Beckman Coulter Incorporated (Danaher Corporation)
• Original Assignee: Beckman Coulter Incorporated (Danaher Corporation)
• Inventors: Doherty, John, Hay-Kaufman, Martha L., Jaseph, Corey L., Goulden, Leslie, Kalbag, Geeta S., Matusewicz, Richard S.
• Application Number:
  US12/365,828
• Publication Number:
  US 20090202388A1
• Time in Patent Office: Days
• US Class Current: 422/58
• CPC Class Codes: B01L 2200/026 Fluid interfacing between devices or objects, e.g. connectors, inlet details
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: B01L 3/5025 for parallel transport of multiple samples
• CPC Class Codes: B01L 3/5055 Hinged, e.g. opposable surfaces
• CPC Class Codes: G01N 33/54388 based on lateral flow
• CPC Class Codes: G01N 33/54389 with bidirectional or multidirectional lateral flow, e.g. wherein the sample flows from a single, common sample application point into multiple strips, lanes or zones
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: G01N 33/72 involving blood pigments, e.g. haemoglobin, bilirubin or other porphyrins; involving occult blood

Abstract

A system for collecting biological samples, such as fecal specimens, and testing such samples for the presence of an analyte is disclosed. The system comprises a sample collection device that includes a removably secured tab for retaining and transferring a portion of the sample to be tested to the test device. The tab is preferably configured so that it can be received in the test device in only a pre-selected orientation so as to put the portion of the tab carrying the sample in communication with a chromatographic material in the test device.

Claims

1-40. -40. (canceled)

41. A sample test device comprising:

a test device body;

a receptacle in the test device body adapted to receive a sample carrying member which is bilaterally asymmetrical, wherein the receptacle is sized and shaped so that the sample carrying member can be received in only a pre-selected orientation; and

chromatographic material for performing a test, wherein the chromatographic material cooperates with the receptacle so as to place the chromatographic material in communication with a sample carried by the sample carrying member when the sample carrying member is contained in the receptacle in the pre-selected orientation.

42. The device of claim 41, further comprising a cover adapted to be secured to the test device body, wherein the chromatographic material is attached to the cover.

43. The device of claim 42, wherein the cover is hingedly attached to the body.

44. The device of claim 42, wherein the cover is adapted to be reversibly secured to the body.

45. The device of claim 42, wherein the cover further includes a window, and wherein the chromatographic material extends across the window.

46. The device of claim 45, wherein the chromatographic material includes an immobilized capture reagent which binds an analyte of interest, and wherein the capture reagent is present in a portion of the chromatographic material located in the window.

47. The device of claim 41, wherein the chromatographic material is attached to the test device body.

48. The device of claim 47, further including a cover adapted to be secured to the test device body.

49. The device of claim 48, wherein the cover is hingedly attached to the body.

50. The device of claim 41, wherein the test device body comprises an upper layer of material, and wherein the receptacle comprises an opening in the upper layer of material.

51. The device of claim 41, further including the sample carrying member in the receptacle in the pre-selected orientation.

52. The device of claim 41, wherein the sample is a fecal sample, and wherein the chromatographic material is adapted to detect the presence of blood in the fecal sample.

53. A sample test device for testing a sample, said sample test device comprising:

a test device body;

a receptacle in the test device body adapted to receive a sample carrying member having a first side, wherein the receptacle is sized and shaped to receive the sample carrying member in a pre-selected orientation; and

a chromatographic material for performing a test,

wherein the chromatographic material is arranged in fluid communication with the first side of the sample carrying member when the sample carrying member is contained in the receptacle in the pre-selected orientation.

54. The sample test device of claim 53, wherein the receptacle is asymmetrical to receive the sample carrying member in the pre-selected orientation.

55. The sample test device of claim 53, wherein the sample carrying member has a sample collection end and a handle, wherein the chromatographic material is arranged to extend from the sample collection end to the handle of the sample carrying member when the sample carrying member is contained in the receptacle in the pre-selected orientation such that fluid flows through the chromatographic material towards the handle of the sample carrying member when testing a sample in the sample test device.

56. The sample test device of claim 53, wherein the receptacle is sized and shaped to receive the sample carrying member in a pre-selected orientation so that the first side of the sample carrying member faces a pre-selected direction.

57. The sample test device of claim 53 further comprising a cover adapted to be secured to the test device body, wherein the chromatographic material is attached to the cover and is in fluid communication with the first side of the sample carrying member when said cover is secured to the test device body.

58. A system for collecting and testing a fecal sample, comprising:

(a) a sample collection device including,

(i) a sample collection device body having first and second opposed surfaces;

(ii) a sample carrying member removably secured to the first opposed surface of the sample collection device body, the sample carrying member having a first side suitable for receiving and carrying a fecal sample; and

(b) a sample test device including,

(i) a sample test device body;

(ii) a receptacle in the sample test device body adapted to receive the sample carrying member, wherein the receptacle is configured to receive the sample carrying member in a pre-selected orientation; and

(iii) chromatographic material suitable for detecting the presence of an analyte of interest in the fecal sample, wherein the chromatographic material is arranged to fluidly communicate with the fecal sample on the sample carrying member when the sample carrying member is contained in the receptacle in the pre-selected orientation.

59. The system of claim 58, wherein the sample collection device further includes a flap attached to the first opposed surface of the sample collection device body, the flap having a proximal edge covering at least a portion of the sample carrying member when the sample carrying member is removably secured to first opposed surface of the sample collection device body.

60. The system of claim 59, wherein the proximal edge of the flap is adapted to extend away from the first opposed surface of the sample collection device body to provide clearance for the sample carrying member when the sample carrying member is removed from the first opposed surface of the sample collection device body.

61. The system of claim 58, wherein the sample carrying member is asymmetrical so that the sample carrying member is received by the receptacle in the pre-selected orientation.

62. The system of claim 58, wherein the sample carrying member is configured to remove a portion of the fecal sample received by the sample collection device when the sample carrying member is removed from the first opposed surface of the sample collection device body.

63. The system of claim 58, wherein the sample carrying member is adapted to release from the first opposed surface of the sample collection device body when said first opposed surface is flexed convexly.