Integrated device for analyte testing, confirmation, and donor identity verification

• US 8,940,527 B2
• Filed: 12/22/2010
• Issued: 01/27/2015
• Est. Priority Date: 03/31/2006
• Status: Active Grant

• Current Assignee: Lamina Equities Corp., Sonabank (432804) (Primis Financial Corp.)
• Original Assignee: Lamina Equities Corp.
• Inventors: Guirguis, Raouf A.
• Primary Examiner(s): Chin, Chris L
• Application Number:
  US12/975,471
• Publication Number:
  US 20110144535A1
• Time in Patent Office: 1,497 Days
• Field of Search: 422/400, 422/401, 422/420, 422/425, 422/430, 435/287.2, 435/287.7, 435/287.9, 435/810, 435/970, 435/973, 436/514, 436/810
• US Class Current: 435/287.7
• CPC Class Codes: A61B 10/0038 Devices for taking faeces samples; Faecal examination devices anal receptacles A61F5/451
• CPC Class Codes: A61B 10/0051 for taking saliva or sputum samples devices for receiving spittle A61J9/00
• CPC Class Codes: A61B 10/007 for taking urine samples measuring urological functions A61B5/20; genital receptacles A61F5/451; urinals for bed-ridden persons A61G9/006
• CPC Class Codes: A61B 2010/0006 involving a colour change
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 90/90 Identification means for patients or instruments, e.g. tags
• 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 33/94 involving narcotics or drugs or pharmaceuticals, neurotransmitters or associated receptors
• CPC Class Codes: Y10S 435/81 Packaged device or kit
• CPC Class Codes: Y10S 435/97 Test strip or test slide
• CPC Class Codes: Y10S 435/973 Simultaneous determination of more than one analyte
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick

Abstract

The present invention provides an apparatus for fluid sample collection and analyte testing, including a sample receiving member and at least one membrane test strip, and optionally a sample retention member, fingerprint acquisition pad, and/or fluid collector. It also provides a fluid collection apparatus having an absorbent material, compression element, and closure element, and optionally a lid that allows the apparatus to be used in conjunction with a fluid container. Also provided are methods of collecting, testing, and retaining a fluid sample and verifying the identity of one or more individuals associated with the sample, such as the test subject, test administrator, and/or witnesses.

Claims

1. An apparatus comprising:

a sample receiving member having an opening for receiving a fluid sample;

a sample retention member in fluid communication with the sample receiving member to retain a portion of the fluid sample;

at least one membrane test strip in fluid communication with the sample receiving member to indicate the presence or absence of at least one analyte in the fluid sample; and

a fluid collector to collect the fluid sample and convey the fluid sample into the sample receiving member,

wherein the fluid collector comprises an absorbent material to absorb the fluid sample;

a compression member operatively associated with the absorbent material; and

a closure member capable of sealing the open end of the sample receiving member when the fluid collector is inserted in the sample receiving member.

2. The apparatus of claim 1, wherein the closure member is capable of creating an airtight seal in the open end of the sample receiving member.

3. The apparatus of claim 1, further comprising means for securing the fluid collector within the sample receiving member after the fluid collector has been inserted into the sample receiving member.

4. The apparatus of claim 3, wherein the means for securing the fluid collector within the sample receiving member comprise at least one annular projection within the sample receiving member.

5. The apparatus of claim 1, wherein the fluid collector further comprises a handle removably attached to the upper surface of the closure member.

6. The apparatus of claim 1, further comprising a saliva-producing substance.

7. The apparatus of claim 6, wherein the saliva-producing substance is sugar, salt, acid, or any combination thereof.

8. The apparatus of claim 7, wherein the saliva-producing substance is sodium chloride, citric acid, or any combination thereof.

9. The apparatus of claim 1, further comprising a fingerprint acquisition pad.

10. The apparatus of claim 9, wherein the fingerprint acquisition pad is enclosed by a cover attached to the housing.

11. The apparatus of claim 9, wherein the fingerprint acquisition pad is an ink-based fingerprint acquisition pad.

12. The apparatus of claim 11, further comprising a dispenser able to dispense an ink that can elicit a signal in the ink-based fingerprint acquisition pad.

13. The apparatus of claim 9, wherein the fingerprint acquisition pad is an inkless fingerprint acquisition pad.

14. The apparatus of claim 13, further comprising a dispenser able to dispense an activator that can elicit a signal in the inkless fingerprint acquisition pad.

15. The apparatus of claim 13, wherein the inkless fingerprint acquisition pad is an immunoassay-based fingerprint acquisition pad.

16. The apparatus of claim 15, wherein the immunoassay-based fingerprint acquisition pad is in fluid communication with the sample receiving member.

17. The apparatus of claim 16, wherein a channel provides the fluid communication between the sample receiving member and the at least one membrane test strip and the fluid communication between the sample receiving member and the immunoassay-based fingerprint acquisition pad.

18. The apparatus of claim 17, further comprising a dispenser able to dispense a signal-producing agent that can elicit a signal in the immunoassay-based fingerprint acquisition pad.

20. The apparatus of claim 1, wherein the compression member is configured for selective compression of the absorbent material against a surface of the sample receiving member to cause the absorbent material to expel at least a portion of the fluid sample when the fluid collector is inserted in the sample receiving member.

19. An apparatus for testing a fluid sample comprising at least one test strip in combination with a sample receiving member having an open end and a fluid collector, the fluid collector including:

an absorbent material, to absorb a fluid sample;

a compression member operatively associated with the absorbent material,

wherein the compression member is configured for selective compression of the absorbent material against a surface of the sample receiving member to cause the absorbent material to expel at least a portion of the fluid sample when the fluid collector is inserted in the sample receiving member; and

a closure member, capable of sealing the open end of the sample receiving member

when the fluid collector is inserted into the sample receiving member, wherein the at least one test strip is configured to indicate the presence or absence of at least one analyte in the at least a portion of the fluid sample upon expulsion of the at least a portion of the fluid sample from the absorbent material.