Diagnostic test apparatus

• US 6,241,689 B1
• Filed: 05/13/1998
• Issued: 06/05/2001
• Est. Priority Date: 11/13/1995
• Status: Expired due to Fees

• Current Assignee: Provalis UK Ltd. (Provalis Plc)
• Original Assignee: Provalis UK Ltd. (Provalis Plc)
• Inventors: Woolston, Robert, Smith, Christopher John, Chard, Michael John, Goodwin, Philip Robert, Sams, Bernard
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US09/076,825
• Time in Patent Office: 1,119 Days
• Field of Search: 600/573, 600/578, 600/584, 604/51, 604/52
• US Class Current: 600/584
• CPC Class Codes: B01L 2300/042 Caps; Plugs
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: B01L 3/5029 using swabs

Abstract

Sample collection apparatus is provided which allows for fast, accurate, repeatable sample collection, particularly of blood and saliva samples. This apparatus is adapted to interconnect with a device designed to carry out analyte detection. Kits comprising the sample collection apparatus are also provided.

Claims

1. Sample collection apparatus comprising:

a collector adapted to receive and retain a sample volume of biological fluid, said collector comprising at least two elongate members forming a comb arrangement; and

engagement meads configured to engage counterpart means on a device or housing incorporating analyte detection means and a test result visualization area, said engagement means further being configured to hold said sample collection apparatus in place with respect to the device or housing;

wherein upon interconnection with the device or housing at least a part of any sample in said sample collection apparatus will be transferred to the device or housing from said sample collection apparatus for an analyte detection process to be performed within the device or housing and for the process results to be visualized in the test result visualization area.

2. Sample collection apparatus as claimed in claim 1, further comprising a first portion adapted to be held by a user and coupled to said collector.

3. Sample collection apparatus as claimed in claim 2, wherein said collector is detachable from said first portion.

4. Sample collection apparatus as claimed in any one of claims 1 or 3, wherein said engagement means presents said collection apparatus correctly for interconnection with the device or housing for the analyte detection process to begin within the device or housing.

5. Sample collection apparatus as claimed in claim 4, wherein said alignment means also form interconnection means.

6. Sample collection apparatus as claimed in claim 1, wherein said collector is configured to contact, over a substantial proportion of its surface area, means within a device or housing for transferring the sample from said collector to the device or housing.

7. Sample collection apparatus as claimed in claim 1, wherein a fixed sample volume is taken up by said collector by capillary action.

8. Sample collection apparatus as claimed in claim 1, wherein said elongate members are formed by plates.

9. Sample collection apparatus as claimed in claim 1, wherein said comb is formed from four, five or six elongate members, providing three, four or five spaces therebetween, respectively, to receive the sample volume.

10. Sample collection apparatus as claimed in claim 1, wherein said collector comprises a two-dimensional array of members with spaces formed therebetween.

11. Sample collection apparatus as claimed in claim 1, wherein said collector comprises absorbent material formed into a pad.

12. Sample collection apparatus as claimed in claim 11, wherein said absorbent material has been treated to increase its hydrophilicity.

13. Sample collection apparatus as claimed in claim 12, wherein the treatment involves treatment with a wetting agent such as SDS or Sodium Lauroyl Sarcosinate.

14. Sample collection apparatus as claimed in claim 1, wherein said collection apparatus is shaped to interlock with a device or housing incorporating an analyte detection means such that once connected with the device incorporating the analyte detection means said apparatus cannot be disconnected therefrom.

15. Sample collection apparatus comprising at least two substantially coplanar elongate members spaced apart to receive a sample volume of biological fluid therebetween upon bringing said at least two members into contact with a biological fluid.

16. Sample collection apparatus as claimed in claim 15, wherein a fixed sample volume is taken up between said elongate members by capillary action.

17. Sample collection apparatus as claimed in claim 15 or claim 16, further comprising a first portion adapted to be held by the user and coupled to said elongate members.

18. Sample collection apparatus as claimed in claim 15, wherein said elongate members are formed by plates.

19. Sample collection apparatus as claimed in claim 18, wherein said elongate members form a comb arrangement.

20. Sample collection apparatus as claimed in claim 19, wherein said comb is formed from four, five or six elongate members, providing three, four or five spaces therebetween, respectively, to receive the sample.

21. Sample collection apparatus as claimed in claim 15, wherein said elongate members form a two-dimensional array of members with spaces formed therebetween.

22. Sample collection apparatus as claimed in claim 15, wherein said sample collection apparatus is configured to be brought into contact with an analyte detection means.

23. Sample collection apparatus as claimed in claim 22, wherein said sample collection apparatus is configured such that once connected with a device incorporating the analyte detection means said sample collection apparatus cannot be disconnected therefrom.

24. Sample collection apparatus adapted to interconnect with a device or housing which incorporates analyte detection means, said sample collection apparatus comprising absorbent material treated with a wetting agent selected from the group consisting of Sodium Dodecyl Sulphate and Sodium Lauroyl Sarcosinate to increase its hydrophilicity, wherein upon interconnection with the device or housing at least a part of any sample in said sample collection apparatus will be transferred to the device or housing from said sample collection apparatus.

25. Sample collection apparatus as claimed in claim 24, wherein said absorbent material is formed into a pad.

26. Sample collection apparatus as claimed in claim 24, wherein said pad is formed from sintered polymer powders.