Sampling and testing device for the human or animal body

• US 9,877,672 B2
• Filed: 01/27/2011
• Issued: 01/30/2018
• Est. Priority Date: 01/28/2010
• Status: Active Grant

• Current Assignee: Ellume Pty. Ltd.
• Original Assignee: Ellume Pty. Ltd.
• Inventors: Dahl, Steven David, Parsons, Sean Andrew, Maschmann, Jennifer, Wong, Kon Euan Gerard, Spink, Tim Ian, Wilson, Stephen Robert
• Primary Examiner(s): Winakur, Eric
• Assistant Examiner(s): Fardanesh, Marjan
• Application Number:
  US13/575,999
• Publication Number:
  US 20130096400A1
• Time in Patent Office: 2,560 Days
• Field of Search: None
• CPC Class Codes: A61B 10/0038 Devices for taking faeces samples; Faecal examination devices anal receptacles A61F5/451
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 10/0048 for taking amniotic fluid samples
• CPC Class Codes: A61B 10/0051 for taking saliva or sputum samples devices for receiving spittle A61J9/00
• CPC Class Codes: A61B 10/0058 for taking sperm samples artificial insemination A61B17/43; for animals A61D19/021; genital receptacles for the male member A61F5/453; massage of the genitals A61H19/00
• CPC Class Codes: A61B 10/0064 for taking sweat or sebum samples measuring sweat production A61B5/4266
• CPC Class Codes: A61B 2010/0003 including means for analysis by an unskilled person
• CPC Class Codes: A61B 5/0071 by measuring fluorescence emission
• CPC Class Codes: A61B 5/15 Devices for taking samples of blood hypodermic syringes A61M5/178
• CPC Class Codes: A61B 5/207 Sensing devices adapted to collect urine
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis

Abstract

A device (1) is provided that is configured to indicate the presence or absence of one or more biological entities in a biological sample. The device comprises a sampling portion (11), the sampling portion comprising flexible material adjustably conformable to a part of a human or animal body, at least a portion of the sampling portion being absorbent and configured to receive a biological sample directly from the body; and a test portion (12) in fluid engagement with the sampling portion, the test portion comprising one or more test zones (14). The sampling portion and test portion are configured such that at least a portion of the sample received by the sampling portion is transferable to the test portion such as to contact one or more of the test zones, and wherein each test zone is configured to indicate the presence or absence of one or more biological entities in the sample.

Claims

1. A device for testing a biological sample, the device comprising:

a rigid housing;

a sampling portion located outside of the housing, the sampling portion comprising flexible sheet material that projects from and is bendable independently of the housing and is adjustably conformable to a part of a human or animal body, the flexible sheet material having a surface area of at least 20 cm² and at least a portion of the flexible sheet material being an absorbent target portion configured to receive a biological sample directly from the body;

a test portion located at least partially inside the rigid housing, the test portion being spaced from the absorbent target portion, the test portion comprising one or more label-holding areas including labels that form labelled complexes with one or more biological entities present in the biological sample and comprising one or more test zones configured to immobilize the labelled complexes to indicate the presence or absence of one or more biological entities in the sample, and

a fluid flow path, connected between the absorbent target portion and the test portion, that transfers biological sample received at the absorbent target portion to the test portion by capillary action.

2. The device of claim 1, wherein the biological sample comprises any one or more of the following:

blood, serum, plasma, saliva, sputum, urine, ocular fluid, tears, semen, vaginal discharge, nasal secretions and droplets, ear secretions, perspiration, mucus, stool, and amniotic, spinal, wound, and abscess fluid.

3. The device of claim 1, wherein the flexible sheet material of the sampling portion is conformable to a nasal region of the body to permit a nasal discharge sample to be provided directly to the absorbent portion.

4. The device of claim 3, wherein the flexible sheet of material of the sampling portion is conformable to contact portions adjacent-an ala or an alar groove on opposite sides of a nose and configured to extend from these contact points on opposite sides of the nose and across a tip of the nose.

5. The device of claim 1, wherein the flexible sheet material of the sampling portion is conformable to an intergluteal cleft to permit a stool sample to be provided directly to the absorbent portion.

6. The device of claim 1 comprising a test layer, wherein the sampling portion and the test portion are comprised in the test layer.

7. The device of claim 6, further comprising a cover layer attached to the test layer, the cover layer defining an opening through which the biological sample is deliverable to a target region of the sampling portion of the test layer.

8. The device of claim 6, further comprising a backing layer attached to the test layer.

9. The device of claim 8, wherein the backing layer is fluid resistant.

10. The device of claim 1 wherein the housing comprises one or more windows through which a reaction at one or more of the test zones to indicate a presence or absence of one or more biological entities in the biological sample is observable.

11. The device of claim 1 wherein the device is foldable to enclose the sampling portion.

12. The device of claim 11 further comprising one or more fixation devices to maintain the device in a folded configuration, the one or more fixation devices comprising:

hook and loop fasteners, clips or adhesive.

13. The device of claim 1 further comprising a sealed reservoir, the reservoir containing a liquid releasable from the reservoir to increase fluidity of a biological sample received at the absorbent portion of the sampling portion.

14. The device of claim 13, wherein the device is foldable to enclose the sampling portion, and wherein the reservoir releases the liquid automatically during folding of the device.

15. The device of claim 13, wherein the device is foldable to enclose the sampling portion, and wherein the device comprises a mechanism to release the liquid from the reservoir after folding of the device.

16. The device of claim 13, wherein the reservoir is breakable or burstable to release the liquid.

17. The device of claim 13 wherein the reservoir is at least partially enclosed in the housing.

18. The device of claim 17, wherein the housing comprises an actuation mechanism to break or burst the reservoir to release the liquid.

19. The device of claim 1, wherein the test portion comprises a label-holding zone including a labelling substance configured to bind a fluorescent structure to a biological entity in the biological sample;

and the device further comprises one or more light sources operable to emit light at a wavelength suitable for causing the fluorescent structure to fluoresce.

20. The device of claim 19, wherein the one or more light sources are configured to backlight the one or more test zones.

21. The device of claim 1, wherein the test portion comprises at least one lateral flow test strip.

22. The device of claim 1, wherein the sampling portion comprises two flexible wings, each wing extending from, and being pivotable relative to, the housing.

23. A test device for receiving and testing a nasal discharge sample from a nose, the test device comprising:

a housing;

a sampling portion projecting from the housing, the sampling portion comprising flexible sheet material defining two flexible wings, the two flexible wings being pivotable relative to the housing and configured to be positioned on opposite sides of the nose, the flexible sheet material having a surface area of at least 20 cm² and comprising an absorbent target portion to receive a nasal discharge sample from the nose; and

a test portion located at least partially inside the housing, the test portion being spaced from the absorbent target portion, the test portion comprising one or more label-holding areas including labels that form labelled complexes with one or more biological entities present in the biological sample and comprising one or more test zones configured to immobilize the labelled complexes to indicate the presence or absence of one or more biological entities in the sample,

a sealed reservoir containing liquid, the sealed reservoir located at least partially inside the housing;

a mechanism operable to break or burst the reservoir to release the liquid from the reservoir, wherein the released liquid is transferred to the absorbent portion by capillary action to increase the fluidity of nasal discharge sample received at the absorbent portion; and

a fluid flow path, connected between the absorbent target portion and the test portion, that transfers nasal discharge sample received at the absorbent portion to the test portion by capillary action.