Estimation of active infection by heliobacter pylori

5,989,840

08/865,089

May 29, 1997

Disclosed is a diagnostic apparatus for estimating an active Heliobacter pylori infectious agent in saliva, comprising in combination an immunoassay chamber in which a first portion of said saliva is subjected to serological test for antibody to said infectious agent and a chemical reaction chamber in which a second portion of said saliva is subjected to chemical analysis for an ammonia constituent thereof.

D'Angelo, Joseph P. (Miami, FL); Zhe, Jin (Miami, FL)

Americare International Diagnostics, Inc. (Miami, FL)

We claim

1. A diagnostic apparatus for estimating an active Helicobacter pylori infectious agent in human saliva, comprising in combination an immunoassay chamber comprising a reaction membrane with immobilized antigen to said Helicobacter pylori, an absorbance layer, and a sample reservoir; a chemical reaction chamber in which said saliva is subjected to chemical analysis for an ammonia constituent thereof selected from the group consisting of ammonia, ammonium ion, and ammonium hydroxide, said chemical reaction chamber comprising a solid porous support impregnated with at least one chemical reagent indicating the presence of said ammonia constituent by a detectable change in electrical potential, in color, or in fluorescence, and said analysis comprising performing a reaction to release ammonia, whereby active Helicobacter pylori infection is diagnosed by a positive reaction of said antigen with antibody in said saliva and greater than normal level of ammonia constituent in said saliva.

2. A diagnostic apparatus according to claim 1, in which at least one chamber comprises a hollow container with one open end.

3. A diagnostic apparatus according to claim 1, in which the reaction membrane comprises nitrocellulose.

4. A diagnostic apparatus according to claim 1, in which the absorbance layer comprises porous hydrophilic material.

5. A diagnostic apparatus according to claim 1, in which said chemical reagent is a pH indicator capable of giving rise to a visible change in color at a pH in the range from 4 to 12.

6. A diagnostic apparatus according to claim 7, in which said pH indicator is selected from the group consisting of 2-(2,4-Dinitrophenylazo)-1-naphthol-3,6-disulfonic acid, 4,4'-bis(4-amino-1-naphthylazo)-2,2'-stilbenedisulfonic acid, 6,8-dinitro-2,4-(1H)qunizaolinedione, alizarin, brilliant yellow, bromothymol blue, cresol red, m-nitrophenol, metacresol purple, neutral red, phenol red, phenolphthalein, rosolic acid, thymol blue, turmeric, and xylenol blue.

7. A diagnostic apparatus according to claim 1, in which said chemical reagent responds to the presence of an ammonia constituent by the Berthelot reaction.

8. A diagnostic apparatus according to claim 7, in which said chemical reagent comprises alkali metal hydroxide, alkali metal salicylate, and alkali metal nitroprusside.

9. A diagnostic apparatus according to claim 1, in which said chemical reagent responds to the presence of an ammonia constituent by giving rise to a fluorescent product.

10. A diagnostic apparatus according to claim 9, in which said chemical reagent comprises 4-fluoro-7-nitrobenzo-2-oxa-1,3-diazole.

11. A diagnostic apparatus according to claim 1, in which said porous support comprises an organic polymer.

12. A diagnostic apparatus according to claim 11, in which said porous support comprises cellulose.

13. A diagnostic apparatus according to claim 12, in which said porous support comprises filter paper or cellulose membrane.

14. A diagnostic apparatus according to claim 1, in which the chemical reaction chamber is used to mix saliva with at least one reagent selected from the group consisting of sodium hydroxide, sodium hypochlorite, sodium nitroprusside, and sodium salicylate.

15. A diagnostic apparatus according to claim 1, in which the chemical reaction chamber is used to mix saliva with a reagent for the formation of fluorescent compounds.

16. A diagnostic apparatus according to claim 1, in which the chemical reaction chamber is used to carry out ammonia analysis in saliva using ammonia electrodes.

17. A diagnostic apparatus according to claim 15, in which the reagent for the formation of fluorescent compounds is 4-fluoro-7-nitrobenzo-2-oxo-1,3-diazole.

435/732; 422/101; 422/56; 422/50; 436/113; 436/518; 435/12; 435/6

G01N 33554

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