Test strip and measurement device for its evaluation

• US 6,441,898 B1
• Filed: 02/25/2000
• Issued: 08/27/2002
• Est. Priority Date: 09/15/1999
• Status: Expired due to Fees

• Current Assignee: Markart, Ernst
• Original Assignee: Markart, Ernst
• Inventors: Markart, Ernst
• Primary Examiner(s): Pham, Hoa Q.
• Application Number:
  US09/513,701
• Time in Patent Office: 914 Days
• Field of Search: 356/244, 356/246, 356/440, 356/319, 356/326, 250/339.07, 250/343, 422/102, 422/99, 422/100, 422/104, 422/61, 422/82.05, 422/58, 436/164, 436/172, 436/165, 435/14
• US Class Current: 356/244
• CPC Class Codes: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04
• CPC Class Codes: Y10S 435/808 Optical sensing apparatus

Abstract

In a test strip for the optical determination of the concentration of a substance in a liquid, especially for blood sugar determination, including a strip-shaped carrier with a reaction field, defined by opaque material on the carrier, containing a reagent carrying medium, which reagent carrying medium upon wetting with the fluid to be investigated changes in regard to its reflectivity or transmissivity, the carrier consists of an optically transparent material onto which a thin-layered carrying medium containing the reagent is applied.

Claims

1. A test strip for optically determining the concentration of a substance in a liquid, said test strip comprising a strip-shaped transparent carrier with upper and lower faces;

opaque material on and covering a portion of one of said faces of the carrier, said opaque material defining a reaction field on said carrier free of said opaque material and with said opaque material being located on at least two sides of said reaction field, a layer of reagent carrying medium carried by said carrier which layer of reagent carrying medium is located above said upper face of the carrier and covers said reaction field, which layer of reagent carrying medium upon wetting with the liquid to be investigated changes in regard to its optical reflectivity or transmissivity.

2. A test strip according to claim 1, wherein the reagent carrying medium is a paint.

3. A test strip according to claim 1, wherein the reagent carrying medium is a paste.

4. A test strip according to claim 1, wherein the reagent carrying medium is a piece of thin strip material.

5. A test strip according to claim 1, wherein the opaque material located on at least two sides of the reaction field is provided by two diaphragm strips of opaque material running along the longitudinal edges of the carrier.

6. A test strip according to claim 5, wherein the opaque material is provided on the side of the carrier which is opposite from the side carrying the reagent carrying medium.

7. A test strip according to claim 1, wherein the opaque material surrounds the reaction field.

8. A test strip according to claim 1, wherein the opaque material is printed onto the carrier.

9. A test strip according to claim 1, wherein the layer of reagent carrying medium covers at least a portion of the opaque material.

10. A test strip according to claim 1, wherein a layer of reference material is carried by the carrier and covers a small area of the carrier to provide an optical reference surface which can be sensed by an optical sensor located below the carrier.

11. A test strip according to claim 10, wherein the reference material is printed onto the upper face of the carrier so that the reference surface can be sensed through the transparent carrier by a sensor located below the carrier.

12. A test strip according to claim 10, wherein the opaque material and the reference surface are provided on the same side of the carrier as the reagent carrying medium.

13. A measuring device for optically determining the concentration of a substance in a liquid, by means of a test strip according to claim 10, said measuring device including a housing with a strip support surface, a measuring optic system arranged below the strip support surface, an indicator apparatus, an operating field and an evaluation and control circuit, said measuring optic system having at least three optical sensors of which two are directed onto the reaction field and one of which is directed onto the reference surface.

14. A measuring device according to claim 13, wherein the sensors directed onto the reaction field are arranged behind one another in the longitudinal direction of a test strip lying on the strip support surface.

15. A measuring device according to claim 13, wherein a reference surface is provided above the strip support surface for balancing the optical sensors.

16. A measuring device according to claim 15, wherein the evaluation and control circuit is so formed that it automatically carries out the balancing process at pre-given time intervals.

17. A measuring device according to claim 15, wherein the measuring device has a temperature sensor and the evaluation and control circuit is so formed that the balancing process is carried out in dependence on a pre-given temperature change.

18. A measuring device according to claim 15, wherein the reference surface is provided on a cover fixed relative to the housing and extending over the strip support surface.

19. A measuring device according to claim 13, wherein a key is arranged on the housing above the strip support surface, which key is movable between a first position in which it clamps the test strip against the strip support surface and a position at which the test strip is freed.

20. A measuring device according to claim 19, wherein at least a part of the key is transparent.

21. A measuring device according to claim 19, wherein the reference surface is formed on the key.

22. A measuring device according to claim 13, said device further comprising three optical sensors for respectively sensing a part of said reaction field, said reference surface, and one other area of said test strip different from said part of the reference field and the reference surface, and wherein the evaluation and control circuit is so formed that the reflectivity/transmissivity of each of said part of the reaction field, the reference surface, and the other area of the test strip is recognizable by the evaluation and control circuit.

23. method for the calibration of the measuring optic system of a measuring device according to claim 20, wherein the evaluation and control circuit stores a functional relationship between the reflectivity/transmissivity sensed by the measuring optic system and the concentration value of the substance to be investigated, and wherein a card is arranged over the strip support surface with calibration fields associated with the individual optical sensors, with each of the calibration fields having a reflectivity/transmissivity corresponding to a given concentration of the substance to be investigated, the actually measured reflectivity/transmissivity values of the calibration fields being compared with the corresponding values according to the stored functional relationship and upon the appearance of a difference determining a corresponding correction factor by means of which the measured reflectivity/transmissivity value of the test strip is corrected.

24. A method according to claim 23, wherein the card carries a code evaluatable by the evaluation and control circuit.

25. A method according to claim 24, wherein the code is formed by the calibration fields.

26. A method according to claim 23, wherein the card has further color fields each of which corresponds to a given concentration of the substance to be investigated, and which can be visually compared with the reaction field of a test strip wetted by the liquid to be investigated.

27. A test strip according to claim 1, wherein the reaction field is covered by a hydrophilic material for uniformly distributing over the reaction field the liquid to be investigated.

28. A test strip according to claim 27, wherein the hydrophilic material is a finely woven textile.

29. A test strip according to claim 27, wherein the hydrophilic material is surrounded by a hydrophobic material which absorbs essentially none of the liquid.

30. A test strip according to claim 1, wherein the surface area of the test strip containing the reaction field is provided with a hydrophobic covering having a drop application opening.

31. A test strip according to claim 30, wherein the drop application opening is arranged adjacent to a longitudinal end of the test strip.

32. A test strip according to claim 30, wherein the hydrophobic covering is a plastic foil.