Analytical test strip

• US 4,965,047 A
• Filed: 02/17/1988
• Issued: 10/23/1990
• Est. Priority Date: 02/17/1987
• Status: Expired due to Term

• Current Assignee: Carnaud Metalbox Plc (Crown Holdings Incorporated)
• Original Assignee: Carnaud Metalbox Plc (Crown Holdings Incorporated)
• Inventors: Hammond, John M.
• Primary Examiner(s): NOT, DEFINED
• Assistant Examiner(s): Vassilatos, Thalia P.
• Application Number:
  US07/156,837
• Time in Patent Office: 979 Days
• Field of Search: 422/58, 422/57, 422/56, 422/61, 422/86, 422/87, 422/88, 436/805
• US Class Current: 422/413
• CPC Class Codes: G01N 33/528 Atypical element structures, e.g. gloves, rods, tampons, toilet paper

Abstract

An analytical test strip has a flexible blister (12) thermoformed in a sheet plastics member (22), and a diaphragm (34) which closes the blister to create a reservoir for holding a reagent and/or carrier liquid (32). The sheet plastics member (22) is further formed with one or two spikes (28) the or each of which is disposed within the blister and extends in a reentrant manner towards the diaphragm where it terminates at a point. For use of the dispenser the blister is pinched by finger pressure applied by the user to cause the spike or spikes to puncture the diaphragm and release the reagent and/or carried liquid which then soaks along an absorbent layer (40) until it reaches a viewing window (20). The test substance, particularly a liquid, is applied to the absorbent layer at a cavity (16), and combines with the reagent and/or carrier liquid as it moves to the viewing window. If required, the absorbent layer may include one or more discrete areas or bands (44) of an absorbed reagent substance through which the reagent and/or carrier liquid and the test substance pass. The medical (or other) condition for which the test is being made is shown as a color or tone change of the absorbent layer as seen through the viewing window.

Claims

1. An analytical test strip comprising

an elongated layer of absorbent material along which liquid may pass,

upper and lower layers of liquid impermeable material sandwiching the absorbent layer therebetween, said liquid impermeable material being interrupted to enable a test substance to be brought into contact with the absorbent layer at a predetermined position therealong, and said liquid impermeable material including a viewing window through which the absorbent layer is visible for detecting a color or tone change indicating a predetermined condition of a test substance introduced at said predetermined position and having passed along the absorbent layer with one or more reagent or carrier liquids to said viewing window or region,

a deformable blister defined by said liquid impermeable material in a position overlying the absorbent layer and holding at least one reagent or carrier liquid, and

a liquid impermeable but rupturable diaphragm separating the blister from the absorbent layer and closing the blister with each said reagent or carrier liquid therein,

said blister, said viewing window and said predetermined position for introducing the test substance being spaced apart along the test strip with said viewing window being nearest one end of the test strip, the blister having at least one integral spike formed on said liquid impermeable material and defining an inner surface portion of said blister and extending to a free end adjacent the diaphragm, whereby the diaphragm is rupturable by each spike on deformation of the blister to allow the reagent or carrier liquid to leave the blister through the opening thus formed in the diaphragm and to contact the absorbent layer.

2. A test strip as claimed in claim 1, wherein the upper and lower layers of impermeable material form a plastic enclosure of the strip.

3. A test strip as claimed in claim 2, wherein the enclosure is formed by first and second sheet plastics members which are peripherally sealed together, the blister and the or each spike being formed in the first sheet plastics member by a thermoforming operation.

4. A test strip according to claim 2, where the viewing window or region is formed by a transparent area of the enclosure, through which the absorbent layer is visible.

5. A test strip according to claim 4, wherein the material forming the diaphragm is opaque and extends from the diaphragm to and beyond the viewing window or region, the said diaphragm material being formed with an opening defining the viewing window or region.

6. A test strip according to claim 2, wherein the enclosure has an opening for the test substance to be applied to the absorbent layer, which opening longitudinally of the strip is located between the blister and the viewing window or region.

7. An analytical test strip according to claim 2, wherein the enclosure has an opening for the test substance to be applied to the absorbent layer, which opening in longitudinally of the strip is located beyond the blister in relation to the viewing window or region.

8. A test strip according to claim 2, which has an opening in the enclosure remote from the viewing window or region, the strip being arranged to be dipped into the test substance to bring the substance into contact with the absorbent layer through the said opening.

9. A test strip according to claim 6, which has the said opening thereof temporarily closed by a removable cover which is peelably adhered to the enclosure.

10. A test strip according to claim 2, wherein the absorbent layer has one or more discreet bands or regions of an absorbed reagent substance through which the reagent and/or carrier liquid and the test substance pass.

11. A test strip according to claim 2, wherein two said spikes are provided and located in spaced relation within the blister so as each to rupture the diaphragm on deformation of the blister.

12. A test strip according to claim 11, wherein the blister has an outwardly convex top from which the spikes are carried, the top requiring inversion for causing the spikes to rupture the diaphragm and thereafter remaining permanently in its inverted condition.

13. A test strip according to claim 12, wherein the blister is generally rectangular and comprises an upstanding peripheral wall, and said top is supported by said peripheral wall at upper edges thereof which are upwardly bowed.

14. A test strip according to claim 11, wherein each spike is arranged to rupture the diaphragm with a swinging motion so that the opening formed in the diaphragm by the spike is enlarged.

15. An analytic test strip comprising:

a viewing window;

holding means for storing a reagent or carrier liquid comprising;

(i) a liquid impermeable, deformable blister and

(ii) a liquid impermeable, rupturable diaphragm, wherein the blister and the diaphragm together form a storage chamber for the reagent or carrier liquid;

a layer of absorbent material positioned to receive the reagent or carrier liquid from the storage chamber and to carry the reagent or carrier liquid together with a test substance to said viewing window, wherein a predetermined condition of the test substance is indicated by the color or tone of said layer of absorbent material visible through said viewing window; and

at least one spike formed of said liquid impermeable material and defining an inner surface portion of said blister and extending into the storage chamber toward the diaphragm, wherein the reagent or carrier liquid in the storage chamber is brought into contact with said layer of absorbent material by rupturing the diaphragm with said at least one spike.

16. An analytic test strip according to claim 15 further comprising:

an opening in said test strip, including the diaphragm, to permit the test substance to be contacted with said layer of absorbent material.

17. An analytic test strip according to claim 16, wherein said opening is positioned on said test strip either between the blister and said viewing window or at a location separated from said viewing window by the blister.

18. A test strip according to claim 17, wherein said layer of absorbent material has one or more discreet bands or regions of an absorbed reagent substance positioned on said test strip between said viewing window and both said opening and the blister.

19. A test strip according to claim 16 further comprising:

a cover over said opening, said cover being peelably adhered to said test strip.

20. An analytic test strip comprising:

a viewing window;

holding means for storing a reagent or carrier liquid comprising;

(i) a liquid impermeable, deformable blister and

(ii) a liquid impermeable, rupturable diaphragm, wherein the blister and the diaphragm together form a storage chamber for the reagent or carrier liquid;

a layer of absorbent material positioned to receive the reagent or carrier liquid from the storage chamber and to carry the reagent or carrier liquid together with a test substance to said viewing window, wherein a predetermined condition of the test substance is indicated by the color or tone of said layer of absorbent material visible through said viewing window;

an opening in said test strip, including the diaphragm, to permit the test substance to be contacted with said layer of absorbent material, wherein said opening is positioned on said test strip either between the blister and said viewing window or at a location separated from said viewing window by the blister;

a cover over said opening, said cover being peelably adhered to said test strip;

one or more discreet bands or regions of an absorbed reagent substance positioned on said test strip between said viewing window and both said opening and the blister; and

at least one spike formed of said liquid impermeable material and defining an inner surface portion of said blister and extending into the storage chamber toward the diaphragm, wherein the reagent for carrier liquid in the storage chamber is brought into contact with said layer of absorbent material by rupturing the diaphragm with said at least one spike.