Diagnostic test for vaginal infections

• US 6,019,734 A
• Filed: 12/04/1997
• Issued: 02/01/2000
• Est. Priority Date: 12/04/1996
• Status: Expired due to Term

• Current Assignee: KPH Diagnostics Inc.
• Original Assignee: Chris Parkinson
• Inventors: Parkinson, Chris
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US08/985,233
• Time in Patent Office: 789 Days
• Field of Search: 600/562, 600/572, 600/573, 600/584
• US Class Current: 600/572
• CPC Class Codes: G01N 33/56911 Bacteria
• CPC Class Codes: G01N 33/56961 Plant cells or fungi
• CPC Class Codes: G01N 33/84 involving inorganic compounds or pH

Abstract

An apparatus, method and diagnostic kit for assessing the presence or absence of a vaginal infection including bacterial vaginosis which includes a pH indicator means and a KOH patch for detecting bacterially derived amines. A method, apparatus and test kit for diagnosing vaginosis in a simple test series which can be readily performed in a doctor'"'"'s office at the time a vaginal fluid sample is taken.

Claims

1. An apparatus for testing vaginal fluid for assessing the presence or absence of a vaginal infection, the apparatus comprising:

one or more carrier means,

a patch impregnated with an effective amount of potassium hydroxide applied at least one carrier means, and

a first pH indicator means applied to at least one carrier means, whereby the apparatus is adapted to receive one or more vaginal fluid samples on each of the potassium hydroxide patch and the first pH indicator means.

2. The apparatus of claim 1 wherein the first pH indicator means is capable of indicating a pH of 4.5 or greater.

3. The apparatus of claim 1 wherein the vaginal infection is selected from the group comprising bacterial vaginosis or yeast.

4. The apparatus of claim 1 wherein the vaginal fluid is tested for presence of bacterially-derived amines.

5. The apparatus of claim 1 wherein the potassium hydroxide patch comprises a potassium hydroxide concentration of 10% to 20%.

6. The apparatus of claim 1 further comprising a second pH indicator means capable of indicating a specific pH value within a pH range, the second pH indicator means applied to one of the carrier means.

7. The apparatus of claim 6 wherein the pH range is 3.0 to 6.0.

8. The apparatus of claim 1 wherein the carrier means is selected from the group comprising a stick, a disc or a card.

9. The apparatus of claim 1 wherein the carrier means is a stick, the stick having a first end and a second end, wherein the potassium hydroxide patch and the first pH indicator means are located at opposite ends of the stick.

10. The apparatus of claim 6 wherein the carrier means is a stick, the stick having a first end and a second end, wherein the potassium hydroxide patch is located near the first end of the stick and the first pH indicator means and the second pH indicator means are located near the second end of the stick.

11. The apparatus of claim 6 wherein the second pH indicator means is located near the first pH indicator means.

12. An apparatus for testing vaginal fluid for assessing the presence or absence of a vaginal infection, the apparatus comprising:

a carrier means, and

a patch impregnated with an effective amount of potassium hydroxide applied to the carrier means whereby the apparatus is adapted to receive one or more vaginal fluid samples on the potassium hydroxide patch.

13. The apparatus of claim 12 wherein the vaginal infection is selected from the group comprising bacterial vaginosis or yeast.

14. The apparatus of claim 12 wherein the vaginal fluid is tested for the presence of bacterially-derived amines.

15. The apparatus of claim 12 wherein the potassium hydroxide patch comprises a potassium hydroxide concentration of 10% to 20%.

16. The apparatus of claim 12 wherein the carrier means is selected from the group comprising a stick, a disc or a card.

17. In a method for testing a vaginal fluid for the presence or absence of a vaginal infection, the steps that include:

providing a first pH indicator means and a potassium hydroxide patch on one or more carrier means,

first applying the vaginal fluid to the first pH indicator means,

subsequently applying the vaginal fluid to the potassium hydroxide patch,

and then visually observing a colour change on the first pH indicator means and smelling the potassium hydroxide patch.

18. The method of claim 17 further comprising:

providing a second pH indicator means on a carrier means,

applying the vaginal fluid to the second pH indicator means,

subsequently visually observing a colour on the second pH indicator means, and subsequently visually matching the colour on the second pH indicator means with a pH colour comparison chart.

19. The method of claim 17 wherein the potassium hydroxide patch is smelled for the presence of bacterially-derived amines.

20. The method of claim 17 wherein the vaginal infection is selected from the group comprising bacterial vaginosis or yeast.

21. The method of claim 17 wherein the potassium hydroxide patch is smelled within 20 to 40 seconds of application of the vaginal fluid to the potassium hydroxide patch.