Device for rapid determination of disease-associated thiol compounds

1. A single-use disposable article for determining the concentration of thiol compounds in a sample of fluid, the article comprising:

(a) a matrix comprising at least one absorbent material comprising a polyamide material, the matrix being capable of absorbing the sample;

(b) an amount of a detection reagent, the amount of the detection reagent being capable of providing, during a period of time after at least a portion of the amount of the detection reagent has been contacted with at least a portion of the sample, a signal indicating the concentration of thiol compounds in the sample; and

(c) a comparator region,

wherein the detection reagent comprises 10 mg/L to 150 mg/L 5,5′-dithiobis-(2-nitrobenzoic acid) (DTNB), 20 mM to 150 mM imidazole or phosphate buffer, about 0.1 mM manganese chloride, 0.1% to 5.0% by volume glycerol, and 2% to 10% by weight xylitol.

2. The article of claim 1 , wherein the detection reagent further comprises at least one of: 5-(2-aminoethyl)-dithio-2-nitrobenzoic acid; N,N′-bis (4-nitrobenzylidene)-4,4′-dithiodianiline; N,N′-bis (3-nitrobenzylidene)-4,4′-dithiodianiline; N,N′-bis (2-nitrobenzylidene)-4,4′-dithiodianiline; N,N′-bis (2,4-dinitrobenzylidene)-4,4′-dithiodianiline; or N,N′-bis (4-nitrocinnamalylidene)-4,4′-dithiodianiline.

3. A single-use disposable test strip for determining the concentration of thiol compounds in a sample of a fluid from a mammalian subject, the test strip comprising:

(a) a matrix comprising at least one absorbent fiber material comprising a polyamide material, the matrix being capable of absorbing the sample;

(b) an amount of a detection reagent comprising 10 mg/L to 150 mg/L 5,5′-dithiobis-(2-nitrobenzoic acid) (DTNB), 20 mM to 150 mM imidazole or phosphate buffer, about 0.1 mM manganese chloride, 0.1% to 5.0% by volume glycerol, and 2% to 10% by weight xylitol, the amount of the detection reagent being capable of providing, during a period of time after at least a portion of the amount of the detection reagent has been contacted with at least a portion of the sample, a signal indicating the concentration of thiol compounds in the sample; and

(c) a comparator region.

4. The test strip of claim 3 , wherein the detection reagent further comprises at least one of: 5-(2-aminoethyl)-dithio-2-nitrobenzoic acid; N,N′-bis (4-nitrobenzylidene)-4,4′-dithiodianiline; N,N′-bis (3-nitrobenzylidene)-4,4′-dithiodianiline; N,N′-bis (2-nitrobenzylidene)-4,4′-dithiodianiline; N,N′-bis (2,4-dinitrobenzylidene)-4,4′-dithiodianiline; or N,N′-bis (4-nitrocinnamalylidene)-4,4′-dithiodianiline.

5. The test strip of claim 3 , wherein the period of time begins about one second after the at least a portion of the amount of the detection reagent has been contacted with the at least a portion of the sample and ends about ten minutes after the at least a portion of the amount of the detection reagent has been contacted with the at least a portion of the sample.

6. The test strip of claim 3 , wherein the period of time begins about five seconds after the at least a portion of the amount of the detection reagent has been contacted with the at least a portion of the sample and ends about five minutes after the at least a portion of the amount of the detection reagent has been contacted with the at least a portion of the sample.

7. The test strip of claim 3 , wherein the signal comprises an electromagnetic signal.

8. The test strip of claim 7 , wherein the electromagnetic signal comprises a visible signal.

9. The test strip of claim 3 , further comprising a humectant.

10. A single-use disposable test strip for determining the risk that a mammalian subject is suffering from a particular malady, the test strip comprising:

(a) a matrix comprising at least one absorbent material comprising a polyamide material, the matrix being capable of absorbing a sample from the subject;

(b) an amount of a detection reagent comprising 10 mg/L to 150 mg/L 5,5′-dithiobis-(2-nitrobenzoic acid) (DTNB), 20 mM to 150 mM imidazole or phosphate buffer, about 0.1 mM manganese chloride, 0.1% to 5.0% by volume glycerol, and 2% to 10% by weight xylitol, the amount of the detection reagent being capable of providing, during a period of time after at least a portion of the amount of the detection reagent has been contacted with at least a portion of the sample, a signal indicating the risk that the subject is suffering from the particular malady, and wherein

the particular malady is at least one of: periodontitis, gingivitis, halitosis, cardiovascular disease, type II diabetes, or preterm delivery; and

(c) a comparator region.

11. The test strip of claim 10 , wherein the particular malady is periodontitis.

12. The test strip of claim 11 , wherein the signal indicates that the concentration of thiol compounds in the sample is at least about 160 micromolar.

13. The test strip of claim 12 , wherein the signal indicates that the concentration of thiol compounds in the sample is at least about 200 micromolar.

14. The test strip of claim 13 , wherein the signal indicates that the concentration of thiol compounds in the sample is at least about 240 micromolar.

15. The test strip of claim 10 , wherein the particular malady is gingivitis.

16. The test strip of claim 15 , wherein the signal indicates that the concentration of thiol compounds in the sample is at least about 80 micromolar.

17. The test strip of claim 16 , wherein the signal indicates that the concentration of thiol compounds in the sample is at least about 100 micromolar.

18. The test strip of claim 17 , wherein the signal indicates that the concentration of thiol compounds in the sample is at least about 120 micromolar.

19. The test strip of claim 10 , wherein the particular malady is halitosis.

20. The test strip of claim 19 , wherein the signal indicates that the concentration of thiol compounds in the sample is at least about 40 micromolar.

21. The test strip of claim 20 , wherein the signal indicates that the concentration of thiol compounds in the sample is at least about 50 micromolar.

22. The test strip of claim 21 , wherein the signal indicates that the concentration of thiol compounds in the sample is at least about 60 micromolar.

23. The test strip of claim 10 , wherein the particular malady is cardiovascular disease.

24. The test strip of claim 10 , wherein the particular malady is type II diabetes.

25. The test strip of claim 10 , wherein the particular malady is preterm delivery.

26. The test strip of claim 10 , further comprising a humectant.

27. The article of claim 1 , wherein the glycerol is present at a concentration of about 0.5% by volume.

28. The article of claim 1 , wherein the xylitol is present at a concentration of about 4% by weight.

29. A single-use disposable article for determining the concentration of thiol compounds in a sample of fluid, the article comprising:

(a) a matrix comprising at least one absorbent material comprising a polyamide material, the matrix being capable of absorbing the sample;

(b) an amount of a detection reagent, the amount of the detection reagent being capable of providing, during a period of time after at least a portion of the amount of the detection reagent has been contacted with at least a portion of the sample, a signal indicating the concentration of thiol compounds in the sample; and

(c) a comparator region,

further comprising a flavoring or scent.

30. A single-use disposable article for determining the concentration of thiol compounds in a sample of fluid, the article comprising:

(a) a matrix comprising at least one absorbent material comprising a polyamide material, the matrix being capable of absorbing the sample;

(b) an amount of a detection reagent, the amount of the detection reagent being capable of providing, during a period of time after at least a portion of the amount of the detection reagent has been contacted with at least a portion of the sample, a signal indicating the concentration of thiol compounds in the sample; and

(c) a comparator region,

wherein the dried detection reagent is stable for more than one year at room temperature.

31. A single-use disposable article for determining the concentration of thiol compounds in a sample of fluid, the article comprising:

(a) a matrix comprising at least one absorbent material, the matrix being capable of absorbing the sample;

(b) an amount of a detection reagent comprising 10 mg/L to 150 mg/L 5,5′-dithiobis-(2-nitrobenzoic acid) (DTNB), 20 mM to 150 mM imidazole or phosphate buffer, about 0.1 mM manganese chloride, 0.1% to 5.0% by volume glycerol, and 2% to 10% by weight xylitol, the amount of the detection reagent being capable of providing, during a period of time after at least a portion of the amount of the detection reagent has been contacted with at least a portion of the sample, a signal indicating the concentration of thiol compounds in the sample; and

(c) a comparator region.