Reagent test strip

• US 5,047,206 A
• Filed: 03/11/1987
• Issued: 09/10/1991
• Est. Priority Date: 03/11/1987
• Status: Expired due to Fees

• Current Assignee: Wayne State University
• Original Assignee: Wayne State University
• Inventors: Dombrowski, Mitchell P.
• Primary Examiner(s): WARDEN, JILL ALICE
• Application Number:
  US07/024,573
• Time in Patent Office: 1,644 Days
• Field of Search: 422/56, 422/57, 422/58, 436/165, 427/2, 156/73.1
• US Class Current: 422/412
• CPC Class Codes: G01N 33/525 Multi-layer analytical elements
• CPC Class Codes: G01N 33/528 Atypical element structures, e.g. gloves, rods, tampons, toilet paper

Abstract

A reagent test strip (10,10'"'"') includes a support medium (12,12'"'"') having a handle portion (14,14'"'"') and a reagent support portion (16,16'"'"'). A reagent (18,18'"'"') is fixedly adhered to the reagent support portion (16,16'"'"'). A cover (20,20'"'"') is mounted on the support medium (12,12'"'"') and over the reagent (18,18'"'"'). The cover (20,20'"'"') defines a capillary chamber (28,28'"'"') having two open ends (30,30'"'"') and a predetermined volume only over the reagent surface (19) for drawing a predetermined amount of liquid (32,32'"'"') into the capillary chamber (28,28'"'"') to quantitatively react all of the liquid with the reagent (18,18'"'"'). The cover (20,20'"'"') is the only structure over the reagent surface (19,19'"'"') and is spaced thereover only sufficiently to establish the predetermined volume for acting as a capillary. Methods of using and manufacturing the reagent test strip (10,10'"'"') are also disclosed.

Claims

1. A reagent test strip (10,10'"'"') comprising a support medium (12,12'"'"') including a handle portion (14,14'"'"') and a reagent support portion (16,16'"'"');

an insoluble reagent (18,18'"'"') fixedly adhered to said reagent support portion (16,16'"'"') defining a reagent surface (19,19'"'"') capable of quantitatively changing reflectance in the presence of a reactant to be quantitatively determined; and

a cover (20,20'"'"') mounted on said support medium (12,12'"'"') and only over said reagent (18,18'"'"'), said cover (20,20'"'"') defining capillary chamber means (28,28'"'"') having two open ends (30,30'"'"') and a predetermined volume only over said reagent surface (19,19'"'"') for drawing a predetermined amount of liquid (32,32'"'"') into said capillary chamber means (28,28'"'"') and only over said reagent surface (19,19'"'"') to quantitatively react all of the liquid with said reagent (18,18'"'"') and quantitatively change the reflectance of the reagent surface, said cover (20,20'"'"') being the only structure over said reagent surface (19,19'"'"') and being spaced thereover only sufficiently to establish said predetermined volume for acting as a capillary.

2. A test strip as set forth in claim 1 wherein said cover (20) is removably adhered to said support medium (12).

3. A test strip as set forth in claim 2 including tab means for being gripped to remove said cover (20) from said support medium.

4. A test strip as set forth in claim 3 wherein said cover (20,20'"'"') includes two spaced upstanding wall portions (22,22'"'"',24,24'"'"') adjacent opposite ends of said reagent (18,18'"'"') defining closed ends of said capillary chamber means (28,28'"'"') and a ceiling portion (26,26'"'"') extending therebetween.

5. A test strip as set forth in claim 4 wherein each of said wall portions (22,24) have an end portion (34,36) removably adhered to said support medium (12) and perfecting a seal therebetween.

6. A test strip as set forth in claim 5 wherein said tab means includes a tab portion (38) extending from one of said end portions (36) adjacent to said support medium (12), said tab portion (38) being independent of said support medium (12).

7. A test strip as set forth in claim 6 wherein said tab portions (38) are spaced from said support medium (12).

8. A test strip as set forth in claim 1 wherein said cover (20,20) includes two spaced upstanding wall portions (22,22'"'"',24,24'"'"') adjacent opposite ends of said reagent (18,18'"'"') defining closed ends of said capillary chamber means (28,28'"'"') and a ceiling portion (26,26'"'"') extending therebetween.

9. A test strip as set forth in claim 8 wherein each of said wall portions (22,24'"'"') includes an end portion (42,44), one of said end portions (42) being integrally connected to said support medium (12'"'"'), said other end portion (44) being fixedly adhered to said support medium (12'"'"').

10. A test strip as set forth in claim 8 wherein said cover (20,20'"'"') is an optically clear material.

11. A test strip as set forth in claim 1 wherein said support medium (12) comprises a thin and flat polymeric film.

12. A test strip as set forth in claim 1 wherein said capillary chamber (28) has a height from said reagent surface (19,19'"'"') to said cover (20) of 0.25 to 1.00 millimeters.

13. A test strip as set forth in claim 1 wherein said support medium (12,12'"'"') is an optically clear material.

14. A test strip as set forth in claim 1 including filter means (48) disposed over said reagent (18'"'"') for filtering solid components from the liquid (32'"'"') drawn into said capillary chamber means (28'"'"') prior to the liquid (32'"'"') contacting and reacting with said reagent (18'"'"').

15. A test strip as set forth in claim 14 wherein said filter means (48) includes a fibrous material.

16. A test strip as set forth in claim 14 wherein said filter means (48) includes a polymeric microporous material.

17. A method of making a reagent test strip (10,10'"'"') including the steps of:

cutting a predetermined length of a support medium (12);

embossing a first depression (50) at a predetermined distance proximate to one end (52) of the support medium (12) and a second depression (54) between the first depression and the end (52) of the support medium (12);

fixedly adhering an insoluble reagent (18) on the support medium (12) at a distance from the first depression (50) that is equal to the distance of the second depression (54) from the first depression (50) in the opposite direction;

folding over the support medium at the first depression (50) so that the second depression (50) forms a covered chamber (28) directly over the reagent (18) with two open sides; and

adhering the folded over portion to the support medium (12).

18. A method as set forth in claim 17 wherein the step of adhering the cover (20) to the support medium (12) is further defined as depositing an adhesive on the support medium (12) adjacent each end of the reagent (18) and forcing the folded over portion into contact with the adhesive.

19. A method as set forth in claim 18 wherein the first depression (50) forms a U-shaped fold between the cover (20) and the remainder of the support medium (12), the method further including the step of shearing off the U-shaped fold after the cover (20) is adhered to the remainder of the support medium (12).

20. A method as set forth in claim 17 further including the step of embossing the end (60) of the support medium (12) adjacent to the second embossment (54) whereby folding over of the support medium (12) at the first embossment (50) forms the covered chamber (28) from the second embossment (54) and a tab (38) spaced from the remainder of the support medium (12) from the embossed end (60).

21. A method of making a quantitative analytical determination of a soluble constituent in a liquid sample (32,32'"'"') comprising the steps of:

contacting a lateral open aspect of a chamber (28,28'"'"') with a liquid (32,32'"'"') wherein the chamber (28,28'"'"') is defined between a reagent surface (19,19'"'"') of an insoluble reagent (18,18'"'"') fixedly deposited thereon and a cover (20,20'"'"');

drawing a known quantity of the liquid (32,32'"'"') into the chamber (28,28'"'"') by capillary action of the chamber (28,28'"'"') to only cover the reagent surface (19,19'"'"');

saturating the reagent (18,18'"'"') with the liquid while completely reacting a soluble constituent of the liquid (32,32'"'"') with the reagent (18,18'"'"') to form a reaction product on the reagent surface (19,19'"'"'); and

reflecting a light beam (33) off of the reagent (18,18'"'"') to quantitatively determine the amount of the reaction product by reflectance photometry.

22. A method as set forth in claim 21 further including the steps of removing the cover (20) and removing the liquid (32) from the reagent surface (19,19'"'"') and reflecting the light beam (33) off of the blotted reagent surface (19,19'"'"').

23. A method as set forth in claim 21 wherein the liquid (32,32'"'"') is whole blood, said method further including the steps of lancing the skin, drawing blood (32,32'"'"') out from the lanced skin, and contacting the chamber (28,28'"'"') with the drawn blood (32,32'"'"').

24. A method as set forth in claim 23 further including the step of separating the serum from the whole blood in the chamber (28'"'"') and reacting the serum with the reagent (18'"'"').

25. A method as set forth in claim 24 wherein the support medium (12,12'"'"') is a clear material, the determining step being further defined as photometrically determining the amount of reaction product by reflecting the light beam (33) against the reagent surface (19,19'"'"') through the clear support medium (12,12'"'"') whereby it is not necessary to remove the liquid from the reagent surface.