Methods for applying a reagent to an analytical test device

• US 6,121,011 A
• Filed: 12/04/1998
• Issued: 09/19/2000
• Est. Priority Date: 01/09/1997
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Amira Medical (Roche Holding AG)
• Inventors: Douglas, Joel S., Gleisner, John M.
• Primary Examiner(s): Leary, Louise N.
• Application Number:
  US09/205,556
• Time in Patent Office: 655 Days
• Field of Search: 435/28, 435/25, 435/4, 435/283.1, 435/968, 422/50, 422/68.1
• US Class Current: 435/28
• CPC Class Codes: C12Q 1/26 involving oxidoreductase
• CPC Class Codes: C12Q 2326/32 3-Methyl-2-benzothiazolinone hydrazone hydrochloride hydrate, i.e. MBTH
• CPC Class Codes: G01N 33/521 Single-layer analytical elements
• CPC Class Codes: Y10S 435/968 High energy substrates, e.g. fluorescent, chemiluminescent, radioactive

Abstract

This invention provides methods and apparatus for applying a reagent to an analytical test device. The methods and apparatus employ a nozzle and a flexible restrictor to accurate control the amount of reagent applied to the test device. The analytical test devices prepared by the methods of this invention are used to determine the presence or the quantity of an analyte in a liquid sample, such as whole blood.

Claims

1. A method for applying a reagent to a test device comprising:

(a) providing a test device comprising a substrate and a test pad attached to the substrate;

(b) providing a fluid delivery system comprising a nozzle and a flexible restrictor attached to the nozzle for delivery of a reagent from the nozzle to the test pad;

(c) applying a reagent comprising an indicator system and glucose oxidase in a predetermined amount and at a predetermined pressure through the nozzle and the flexible restrictor to the test pad, wherein the indicator system comprises 3-methyl-6-(M sulfonate)-benzothiazolinone-(2)-hydrazone where M is sodium, potassium or ammonium and a second dye component capable of forming a dye couple with 3-methyl-6-(M sulfonate)-benzothiazolinone-(2)-hydrazone.

2. The method of claim 1 wherein the fluid delivery system further comprises a pressure delivery system.

3. The method of claim 1 wherein the fluid delivery system further comprises a positive displacement system.

4. The method of claim 1 wherein a brush is attached to the underside of the nozzle and the reagent is applied through the nozzle and then through the brush to the test pad.

5. The method of claim 1 wherein the reagent is applied continuously to the test pad.

6. The method of claim 5 wherein the nozzle has an internal diameter ranging from about 0.005 to about 0.150 inches and a length ranging from about 0.2 to about 2.0 inches, and the flexible restrictor has an internal diameter ranging from about 0.002 to about 0.200 inches and a length of about 0.5 to about 12 feet.

7. The method of claim 1 wherein the reagent is applied in a discrete amount to the test pad.

8. The method of claim 7 wherein the nozzle has an internal diameter which is less than or equal to 0.032 inches and a length ranging from about 0.2 to about 2.0 inches, and the flexible restrictor has an internal diameter ranging from about 0.002 to about 0.200 inches and a length of about 0.5 to about 12 feet.

9. The method of claim 1 wherein the indicator system is selected from the group consisting of 3-methyl-6-(sulfonate)-benzothiazolinone-(2)-hydrazone sodium salt and 3-dimethylaminobenzoic acid;

3-methyl-6-(sulfonate)-benzothiazolinone-(2)-hydrazone sodium salt and 8-anilino-1-naphthalenesulfonate; and

3-methyl-6-(sulfonate)-benzothiazolinone-(2)-hydrazone sodium salt and N-(3-sulfopropyl)aniline.

10. The method of claim 1 wherein the fluid delivery system comprises a plurality of nozzles and flexible restrictors.

11. The method of claim 10 wherein each of the plurality of nozzles and flexible restrictors applies a different concentration of reagent to the test pad.

12. An apparatus for applying a reagent to a test device comprising a substrate and a test pad, said apparatus comprising:

(a) a fluid delivery system comprising a nozzle and a flexible restrictor for delivery of the reagent to the test pad;

(b) a support positioned under the fluid delivery system for supporting the test device; and

(c) means for moving the test device under the fluid delivery system;

wherein the reagent comprises an indicator system and glucose oxidase and further wherein the indicator system comprises 3-methyl-6-(M sulfonate)-benzothiazolinone-(2)-hydrazone where M is sodium, potassium or ammonium and a second dye component capable of forming a dye couple with 3-methyl-6-(M sulfonate)-benzothiazolinone-(2)-hydrazone.

13. The apparatus of claim 12 wherein the fluid delivery system further comprises a pressure delivery system.

14. The apparatus of claim 12 wherein the fluid delivery system further comprises a positive displacement system.

15. The apparatus of claim 12 wherein a brush is attached to the underside of the nozzle and the reagent is applied through the nozzle and then through the brush to the test pad.

16. The apparatus of claim 12 wherein the nozzle has an internal diameter ranging from about 0.005 to about 0.150 inches and a length ranging from about 0.2 to about 2.0 inches, and the flexible restrictor has an internal diameter ranging from about 0.002 to about 0.200 inches and a length of about 0.5 to about 12 feet.

17. The apparatus of claim 12 wherein the nozzle has an internal diameter which is less than or equal to 0.032 inches and a length ranging from about 0.2 to about 2.0 inches, and the flexible restrictor has an internal diameter ranging from about 0.002 to about 0.200 inches and a length of about 0.5 to about 12 feet.

18. The apparatus of claim 12 wherein the means for moving the test device is a conveyor.

19. The apparatus of claim 12 wherein the fluid delivery system comprises a plurality of nozzles and flexible restrictors.