Self-contained test sensor

• US 9,383,351 B2
• Filed: 07/15/2014
• Issued: 07/05/2016
• Est. Priority Date: 12/13/2004
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Inventors: Fleming, Roger
• Primary Examiner(s): WHITE, DENNIS MICHAEL
• Application Number:
  US14/331,671
• Publication Number:
  US 20140329258A1
• Time in Patent Office: 721 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 10/007 for taking urine samples measuring urological functions A61B5/20; genital receptacles A61F5/451; urinals for bed-ridden persons A61G9/006
• CPC Class Codes: B01L 2200/0684 Venting, avoiding backpressure, avoid gas bubbles
• CPC Class Codes: B01L 2200/141 Preventing contamination, tampering
• CPC Class Codes: B01L 2300/041 Connecting closures to device or container
• CPC Class Codes: B01L 2300/044 pierceable, e.g. films, membranes
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 3/502 with fluid transport, e.g. in multi-compartment structures centrifugal-type cuvettes G01N21/07; analysis by separation into components G01N30/00; automatic analysers G01N35/00
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: B01L 3/502707 characterised by the manufacture of the container or its components by shaping or joining plastic parts B29C59/00, B29C65/00; by laminating B32B37/00; manufacture of microstructural devices in general B81C
• CPC Class Codes: B01L 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: C12Q 1/54 involving glucose or galactose
• CPC Class Codes: C12Q 1/60 involving cholesterol
• CPC Class Codes: C12Q 1/61 involving triglycerides
• CPC Class Codes: G01N 33/521 Single-layer analytical elements
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: G01N 35/00 Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor

Abstract

A test strip to assist in determining the concentration of an analyte in a fluid sample comprises a base, at least one tab and a break line. The base includes a capillary channel and a test element. The capillary channel is in fluid communication with the test element. The test element is adapted to receive the fluid sample. The at least one tab is removably attached to the base. The capillary channel extends from the base into a portion of the tab. The break line intersects the capillary channel in which an inlet to the capillary channel is exposed along the break line when the tab is separated from the base.

Claims

1. A test strip to assist in determining the concentration of an analyte in a fluid sample, comprising:

a base of the test strip including a first portion of a capillary channel therein and at least one interior surface with a reagent deposited thereon, the reagent being located to contact the fluid sample in response to the fluid sample being introduced into the first portion of the capillary channel via an inlet of the first portion of the capillary channel and traveling along the first portion of the capillary channel due to capillary action;

a tab including a second portion of the capillary channel therein, the tab being removably attached to an end of the base and adjacent to the inlet of the first portion of the capillary channel; and

a break line separating the first portion of the capillary channel and the second portion of the capillary channel, the break line including (i) a scored line, (ii) a thinned line, or (iii) a thinned area, wherein the inlet to the first portion of the capillary channel is formed along the break line in response to the tab being at least partially separated from the base.

3. The test strip of claim 1, wherein the tab includes a cavity having a desiccant located therein, the cavity being in communication with the capillary channel and the reagent when the tab is attached to the base.

2. A test strip to assist in determining the concentration of an analyte in a fluid sample, comprising:

a base of the test strip including a first portion of a capillary channel therein and at least one interior surface with a reagent deposited thereon, the reagent being located to contact the fluid sample in response to the fluid sample being introduced into the first portion of the capillary channel via an inlet of the first portion of the capillary channel and traveling along the first portion of the capillary channel due to capillary action;

a tab including a second portion of the capillary channel therein, the tab being removably attached to an end of the base and adjacent to the inlet of the first portion of the capillary channel,;

a break line separating the first portion of the capillary channel and the second portion of the capillary channel, wherein the inlet to the first portion of the capillary channel is formed along the break line in response to the tab being at least partially separated from the based; and

at least one recess located in an outer surface of the base and the tab, the at least one recess being adapted to facilitate the separation of the tab from the base along the break line.

4. A test strip to assist in determining the concentration of an analyte in a fluid sample, comprising:

a base of the test strip including (i) a first portion of a capillary therein, (ii) a vent channel in communication with the capillary channel, (ii) and at least one interior surface with a reagent deposited thereon, the reagent being located to contact the fluid sample in response to the fluid sample being introduce into the first portion of the capillary channel via an inlet of the first portion of the capillary channel and traveling along the first portion of the capillary channel due to capillary action;

a first tab including a second portion of the capillary channel therein, the first tab being removably attached to a first end of the base and adjacent to the inlet of the first portion of the capillary channel;

a break line separating the first portion of the capillary channel and the second portion of the capillary channel, wherein the inlet to the first portion of the capillary channel is formed along the break line in response to the first tab being at least partially separated from the base; and

a second tab removably attached to an opposing second end of the base, the vent channel extending from the base into a portion of the second tab such that the second tab includes a portion of the vent channel.

5. A method for using a test strip to determine a concentration of an analyte in a fluid sample, the method comprising the acts of:

providing a test strip including

(i) a base of the test strip including a first portion of a capillary channel therein and at least one interior surface with a reagent deposited thereon,

(ii) a tab including a second portion of the capillary channel therein, the tab being removably attached to an end of the base, and

(iii) a break line intersecting the capillary channel, the break line including (i) a scored line, (ii) a thinned line, or (iii) a thinned area;

exposing an inlet to the first portion of the capillary channel by at least partially separating the tab from the base; and

receiving the fluid sample via the inlet such that the fluid sample flows through the first portion of the capillary channel due to capillary action and contacts the reagent.

6. The method of claim 5, wherein the tab is at least partially separated from the base by:

(i) moving the base within a meter having projections positioned to apply pressure to the tab, (ii) twisting the tab relative to the base, (iii) tearing the test strip along the break line, (iv) bending the test strip at the break line, or (v) pulling the tab away from the base.

7. The method of claim 5, further comprising determining the concentration of the analyte in the fluid sample.

8. A test strip to assist in determining the concentration of an analyte in a fluid sample, comprising:

a base including a capillary channel having at least one interior surface with a reagent deposited thereon, the reagent being located to contact the fluid sample in response to the fluid sample being introduced into the capillary channel and traveling along the capillary channel due to capillary action; and

a tab having a body, a first extension, and a second extension, the first and the second extensions being separate and distinct from each other, the first and the second extensions extending from the body of the tab in substantially the same direction, the first and the second extensions removably attaching the body of the tab to the base, the first and the second extensions being configured to separate from the base when the body of the tab is rotated relative to the base, the first and the second extensions being connedted to each other only the body of the tab.

9. The test strip of claim 8, wherein the base further includes a vent channel, the vent channel being in communication with the capillary channel, wherein the first extension is attached to the base such that the first extension seals the capillary channel and wherein the second extension is attached to the base such that the second extension seals the vent channel, and wherein the separation of the tab from the base exposes an inlet to the capillary channel and an inlet to the vent channel.

10. A test strip for use in determining a concentration of an analyte in a fluid sample, the test strip comprising:

a base including a capillary channel and a reagent, the capillary channel being configured to receive the fluid sample and to cause the fluid sample to travel therein due to capillary action;

a tab removably attached to an end of the base, the capillary channel extending from the base into a portion of the tab such that the tab includes a portion of the capillary channel;

a break line intersecting the capillary channel, an inlet to the capillary channel is configured to be exposed along the break line in response to the tab being at least partially separated from the base; and

at least one recess located in outer surface of the base and the tab, the at least one recess being adapted to facilitate the separation of the tab from the base along the break line.

11. The test strip of claim 10, wherein the tab includes a cavity having a desiccant located therein, the cavity being in communication with the capillary channel and the reagent when the tab is attached to the base.

12. The test strip of claim 10, wherein the base includes a vent channel in communication with the capillary channel.

13. The test strip of claim 12, further comprising a second tab removably attached to an opposing end of the base, the vent channel extending from the base into a portion of the second tab such that the second tab includes a portion of the vent channel.

14. The test strip of claim 10, wherein the break line is (i) a scored line,(ii) a thinned line, or (iii)a thinned area.

15. The test strip of claim 10, wherein the tab is at least partially separated from the base by:

(i) moving the base within a meter having projections positioned to apply pressure to the tab, (ii) twisting the tab relative to the base, (iii) tearing the test strip along the break line, (iv) bending the test strip at the break line, or (v) pulling the tab away from the base.