Test kit for analyzing body fluids and analysis method

• US 5,981,300 A
• Filed: 05/29/1997
• Issued: 11/09/1999
• Est. Priority Date: 12/16/1994
• Status: Expired due to Fees

• Current Assignee: M & M Dental-Medizin GmbH
• Original Assignee: M & M Dental-Medizin GmbH
• Inventors: Moll, Claus-Jurgen, Althoff, Jorg, Paessens, Theodor
• Primary Examiner(s): ALEXANDER, LYLE
• Application Number:
  US08/849,659
• Time in Patent Office: 894 Days
• Field of Search: 422/58, 422/61, 422/56, 422/57, 436/810-811
• US Class Current: 422/411
• CPC Class Codes: A61B 10/0051 for taking saliva or sputum samples devices for receiving spittle A61J9/00
• CPC Class Codes: A61B 2010/0003 including means for analysis by an unskilled person
• CPC Class Codes: C12Q 1/04 Determining presence or kind of microorganism; Use of selective media for testing antibiotics or bacteriocides; Compositions containing a chemical indicator therefor C12Q1/6897 takes precedence
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick
• CPC Class Codes: Y10S 436/811 Test for named disease, body condition or organ function

Abstract

A test kit is disclosed for analyzing a patient'"'"'s saliva to determine the patient'"'"'s risk of tooth decay, which contains: (a) a support; (b) an absorbent material in contact with said support and capable of removing saliva from the mouth and of absorbing the saliva; (c) a composition coated on said absorbent material, said composition soluble in saliva and capable of reaction inside the mouth of the patient with the saliva to reduce the pH of the saliva; and (d) a color scale for determining outside of the mouth of the patient the pH of the saliva absorbed by the absorbent material in which the composition is dissolved to measure the reaction of the composition with the saliva in the patient'"'"'s mouth to determine the patient'"'"'s risk of tooth decay.

Claims

1. A test kit for analyzing a patient'"'"'s saliva to determine the patient'"'"'s risk of tooth decay, which comprises:

(a) a support;

(b) an absorbent material in contact with said support and capable of removing saliva from the mouth and of absorbing the saliva;

(c) a composition coated on said absorbent material, said composition soluble in saliva and capable of reaction inside the mouth of the patient with the saliva to reduce the pH of the saliva; and

(d) means for determining outside of the mouth of the patient the pH of the saliva reacted with the composition and absorbed by the absorbent material to determine the patient'"'"'s risk of tooth decay.

2. The test kit defined in claim 1 wherein the composition coated on said absorbent material completely surrounds the absorbent material.

3. The test kit defined in claim 1 wherein the composition is so selected that by the time the composition has been completely dissolved in the body fluid, a minimum time required to provoke the reaction of the composition and the saliva in the patient'"'"'s mouth has elapsed.

4. The test kit defined in claim 1 therein the composition is in the form of a glaze which consists of an ingredient which reacts with the microorganisms in the saliva in the patient'"'"'s mouth and fat as a binder.

5. The test kit defined in claim 1 wherein the composition consists essentially ofto 45% by weight of glucose;

8 to 45% by weight of gelatine;

0 to 70% by weight of a preservative;

2 to 10% by weight of sucrose; and

a flavoring.

6. The test kit defined in claim 1 wherein the support is a stick consisting essentially of wood.

7. The test kit defined in claim 1 wherein the absorbent material consists of individual fibers of surgical cottonwool, and is surrounded by a cotton cloth, on which is coated the composition soluble in saliva.

8. The test kit defined in claim 1 wherein the absorbent material is in the shape of an animal or an animal'"'"'s head.

9. The test kit defined in claim 1 wherein the composition contains at least one ingredient which reacts with the saliva in the patient'"'"'s mouth.

10. The test kit defined in claim 9 wherein the composition contains a carbohydrate and a sugar substitute.

11. The test kit defined in claim 11 wherein the composition dissolves in the saliva in the patient'"'"'s mouth in 1 to 10 minutes.

12. The test kit defined in claim 11 wherein the composition dissolves in the saliva in the patient'"'"'s mouth in 2 to 5 minutes.

13. The test kit defined in claim 11 wherein the composition is in the form of a coating on the absorbent material with a thickness of 0.1 to 0.5 mm.

14. The test kit defined in claim 13 wherein the thickness of the composition coated on the absorbent material is 0.1 to 0.2 mm.

15. The test kit defined in claim 11 wherein the means for determining outside of the mouth of the patient the pH of the saliva absorbed by the absorbent material is a test paper for determining pH value which is arranged on or in the kit pack.

16. The test kit defined in claim 15 wherein the means for determining outside of the mouth of the patient the pH of the saliva absorbed by the absorbent material further includes a color scale.

17. A process for analyzing a patient'"'"'s saliva to determine the patient'"'"'s risk of tooth decay, which comprises the steps of:

(a) absorbing saliva and removing the saliva from the patient'"'"'s mouth by placing in the patient'"'"'s mouth a test kit which comprises;

(1) a support;

(2) an absorbent material in contact with said support and capable of removing saliva from the patient'"'"'s mouth and of absorbing the saliva; and

(3) a composition coated on said absorbent material, said composition soluble in saliva and capable of reaction inside the mouth of the patient with the saliva to reduce the pH of the saliva;

(b) allowing a reaction within the patient'"'"'s mouth of said composition and the saliva;

(c) following step (b), determining outside of the mouth of the patient the pH of the saliva reacted with the composition and absorbed by the absorbent material during step (b); and

(c) analyzing the patient'"'"'s risk of tooth decay based upon the pH of the saliva determined in step (b).