WO2009121079A2 - Test device and method for testing for vaginal infections - Google Patents
Test device and method for testing for vaginal infections Download PDFInfo
- Publication number
- WO2009121079A2 WO2009121079A2 PCT/ZA2009/000013 ZA2009000013W WO2009121079A2 WO 2009121079 A2 WO2009121079 A2 WO 2009121079A2 ZA 2009000013 W ZA2009000013 W ZA 2009000013W WO 2009121079 A2 WO2009121079 A2 WO 2009121079A2
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- WIPO (PCT)
- Prior art keywords
- test
- area
- indicator
- leucocyte count
- vaginal
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Classifications
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N31/00—Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroup; Apparatus specially adapted for such methods
- G01N31/22—Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroup; Apparatus specially adapted for such methods using chemical indicators
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/52—Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
- G01N33/6893—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids related to diseases not provided for elsewhere
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2800/00—Detection or diagnosis of diseases
- G01N2800/36—Gynecology or obstetrics
Definitions
- This invention relates to a test device for testing for vaginal infections and, more particularly, to a device and a method of using the device for making a presumptive diagnosis for three different types of vaginal infections.
- Bacterial vaginal infections or bacterial vaginosis can be diagnosed using the Amsel test which involves the evaluation of four criteria of a vaginal fluid sample, namely: an elevated pH (over 4.7), a positive whiff test (caused by alkaline volatilisation of amines), vaginal fluid homogeneity, and the presence of clue cells.
- vaginal fluid homogeneity and clue cell identification requires evaluation of a sample of vaginal fluid under a microscope by a skilled microscopist.
- Bacterial vaginosis is however only one of three common vaginal infections, the other two being protozoal infections (e.g. Trichomonas Vaginalis) and fungal infections (e.g. Candida Albicans). In rural areas in South Africa as well as in other developing areas, laboratory equipment and skilled medical practitioners are not readily available to test for vaginal infections so that many infections go undiagnosed and untreated.
- protozoal infections e.g. Trichomonas Vaginalis
- fungal infections e.g. Candida Albicans
- the inventor believes that a need exists for providing a device and a method for allowing a presumptive diagnosis for three different types of vaginal infections to be made, which device and method do not involve laboratory examination of samples and which do not rely on a skilled medical practitioner for evaluation.
- a device for making a presumptive diagnosis for three or more different types of vaginal infections including three or more test areas for receiving a sample of vaginal fluid thereon, the test areas including:- - a pH indicator area for indicating the pH of the vaginal fluid sample, the indicator covering a pH range of from 3.5 to 8;
- a leucocyte count indicator area for indicating the leucocyte count of the vaginal fluid sample, the indicator covering a leucocyte count range from zero to three; and - an amine test area impregnated with a ten percent potassium hydroxide solution.
- the vaginal infections may be selected from the group including: a bacterial infection, a protozoal infection, and a fungal infection.
- the device may be in the form of a card with the test areas arranged thereon.
- the card may be elongate in shape.
- the pH indicator area may include a conventional pH indicator covering a pH range of from 3.5 to 8.
- the colour of the pH indicator area after application of the vaginal fluid sample thereto may indicate a particular pH or pH range.
- a pH colour chart may be provided together with the device to assist in establishing the pH of the vaginal fluid sample.
- the pH indicator applied to the area may be an EMD colorpHast® indicator (catalogue number 9582-3) covering a pH range of from 4 to 7. Colour changes are visible every 0.2 to 0.3 pH units.
- the leucocyte count indicator area may include a conventional leucocyte count indicator covering a leucocyte count range of from 0 to 3.
- the colour of the leucocyte count indicator area after application of the vaginal fluid sample thereto may indicate a particular leucocyte count.
- a leucocyte count colour chart may be provided together with the device to assist in establishing the leucocyte count of the vaginal fluid sample.
- the leucocyte indicator applied to the area may be a Teco Urine reagent strip, a Multistix ® 10 SG reagent strip by Bayer, a Combur 9 -Test reagent strip by Roche, or a Uristix ® reagent strip by Bayer.
- the amine test area may be any suitable absorbent material impregnated with a ten percent potassium hydroxide solution. After application of the vaginal fluid sample to the amine test area, this area may immediately be subjected to an olfactory test to determine the presence of volatilised amines.
- the vaginal fluid sample may be applied to the test areas of the device using a conventional swab.
- the device may be inserted directly into the vagina of the patient to be tested to achieve application of a sample of vaginal fluid to the test areas of the device.
- the device may include more than three test areas to permit testing of additional parameters for making presumptive diagnoses for various vaginal infections.
- a method of making a presumptive diagnosis for three or more different types of vaginal infections using a device as described above including at least the steps of:- - applying a vaginal fluid sample to test areas of the device, the test areas including a pH test area, a leucocyte count test area, and an amine test area; - subjecting the amine test area to an olfactory test immediately after the sample has been applied to said area; and - visually establishing the colour of the pH and leucocyte count test areas to establish the pH and leucocyte count of the vaginal fluid sample.
- the diagnosis is most likely a bacterial infection.
- the diagnosis may be confirmed by a sample pH 4.7 or higher (typically between 5 and 6) and a sample leucocyte count of between one and two or more.
- a sample leucocyte count of three or more and a pH of 4.7 or higher may be indicative of a protozoal infection.
- a sample leucocyte count of from zero to two or more and a pH of less than 4.5 may be indicative of a fungal infection.
- the vaginal fluid sample may be applied to the test areas of the device using a conventional swab.
- the device may be inserted directly into the vagina of the patient to be tested to achieve application of a sample of vaginal fluid to the test areas of the device.
- the method may be applied to patients complaining of symptoms of vaginal infections such as an abnormal vaginal discharge and/or itching.
- the diagnostic method describe above may find particular application in rural and/or developing areas where the method may be used by clinic staff, family practitioners, and medical practitioners requiring an immediate presumptive diagnosis without the use of laboratory equipment.
- Figure 1 shows a schematic plan view of a device for making a presumptive diagnosis for three or more different types of vaginal infections.
- reference numeral 10 generally indicates an embodiment of a device in accordance with the present invention.
- the device 10 includes three test areas 12, 14 and 16 for receiving a sample of vaginal fluid thereon.
- Test area 12 is a pH indicator area for indicating the pH of the vaginal fluid sample, the indicator covering a pH range of from 3.5 to 8.
- Test area 14 is a leucocyte count indicator area for indicating the leucocyte count of the vaginal fluid sample, the indicator typically covering a leucocyte count range from zero to three.
- Test area 16 is an amine test area impregnated with a ten percent potassium hydroxide solution.
- vaginal infections that the device 10 can be used to test for are: a bacterial infection, a protozoal infection, and a fungal infection.
- the device 10 is in the form of an elongate card 18 with the test areas 12, 14 and 16 arranged thereon.
- the pH indicator area 12 includes a conventional pH indicator covering a pH range of from 3.5 to 8, typically from 4 to 7.
- the colour of the pH indicator area 12 after application of the vaginal fluid sample thereto indicates a particular pH or pH range.
- a pH colour chart (not shown) is provided together with the device 10 to assist in establishing the pH of the vaginal fluid sample.
- the leucocyte count indicator area 14 includes a conventional leucocyte count indicator covering a leucocyte count range of from 0 to 3.
- the colour of the leucocyte count indicator area 14 after application of the vaginal fluid sample thereto indicates a particular leucocyte count.
- a leucocyte count colour chart is provided together with the device 10 to assist in establishing the leucocyte count of the vaginal fluid sample.
- the colour charts for the pH and leucocyte count indicator areas typically form part of the packaging of the device 10.
- the amine test area 16 is any suitable absorbent material impregnated with a ten percent potassium hydroxide solution. After application of the vaginal fluid sample to the amine test area 16, this area 16 is immediately be subjected to an olfactory test to determine the presence of volatilised amines.
- the vaginal fluid sample can be applied to the test areas of the device 10 using a conventional swab.
- the device 10 can be inserted directly into the vagina of the patient to be tested to achieve application of a sample of vaginal fluid to the test areas 12, 14 and 16 of the device 10.
- a sample of vaginal fluid is applied to the test areas 12, 14 and 16 of the device 10.
- the amine test area 16 is immediately subjected to an olfactory test after the sample has been applied to said area.
- the diagnosis is most likely a bacterial infection.
- the diagnosis can be confirmed by a sample pH 4.7 or higher and a sample leucocyte count of between one and two or more.
- the colour of the pH and leucocyte count test areas 12 and 14 is established visually to establish the pH and leucocyte count of the vaginal fluid sample.
- a sample leucocyte count of three and a pH of 4.7 or higher is indicative of a protozoal infection.
- a sample leucocyte count of from zero to two and a pH of less than 4.5 is indicative of a fungal infection.
- the method is applied to patients complaining of symptoms of vaginal infections such as an abnormal vaginal discharge and/or itching.
- the device 10 can be developed further to include more than three test areas to permit testing of additional parameters for making presumptive diagnoses for various vaginal infections.
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- Urology & Nephrology (AREA)
- General Health & Medical Sciences (AREA)
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Abstract
The device (10) includes three test areas (12)(14) and (16) for receiving a sample of vaginal fluid thereon. Test area (12) is a PHjndicator area for indicating the PH of the vaginal fluid sample, the indicator covering a pH range of from 3, 5 to 8. Test area (14) is a leucocyte count indicator area for indicating the leucocyte count of the vaginal fluid sample, the indicator typically covering a leucocyte count range from zero to three. Test area (16) is an amine test area impregnated with a ten percent potassium hydroxide solution. The vaginal infections that the device (10) can be used to test for are: a bacterial infection, a protozoal infection, and a fungal infection.
Description
TEST DEVICE AND METHOD FOR TESTING FOR VAGINAL INFECTIONS
Field of the Invention
This invention relates to a test device for testing for vaginal infections and, more particularly, to a device and a method of using the device for making a presumptive diagnosis for three different types of vaginal infections.
Background to the Invention
Bacterial vaginal infections or bacterial vaginosis can be diagnosed using the Amsel test which involves the evaluation of four criteria of a vaginal fluid sample, namely: an elevated pH (over 4.7), a positive whiff test (caused by alkaline volatilisation of amines), vaginal fluid homogeneity, and the presence of clue cells.
The inspection of vaginal fluid homogeneity and clue cell identification requires evaluation of a sample of vaginal fluid under a microscope by a skilled microscopist.
Tests using only two of the abovementioned criteria, namely pH and the whiff test, have been developed as these do not require laboratory evaluation and are therefore convenient and inexpensive. Such tests rely on a pH elevated to above 4.7 as well as a positive whiff test to arrive at a positive diagnosis of bacterial vaginosis.
Bacterial vaginosis is however only one of three common vaginal infections, the other two being protozoal infections (e.g. Trichomonas Vaginalis) and fungal infections (e.g. Candida Albicans). In rural areas in South Africa as well as in other developing areas, laboratory equipment and skilled medical practitioners
are not readily available to test for vaginal infections so that many infections go undiagnosed and untreated.
The inventor believes that a need exists for providing a device and a method for allowing a presumptive diagnosis for three different types of vaginal infections to be made, which device and method do not involve laboratory examination of samples and which do not rely on a skilled medical practitioner for evaluation.
Summary of the Invention
According to the invention, there is provided a device for making a presumptive diagnosis for three or more different types of vaginal infections, the device including three or more test areas for receiving a sample of vaginal fluid thereon, the test areas including:- - a pH indicator area for indicating the pH of the vaginal fluid sample, the indicator covering a pH range of from 3.5 to 8;
- a leucocyte count indicator area for indicating the leucocyte count of the vaginal fluid sample, the indicator covering a leucocyte count range from zero to three; and - an amine test area impregnated with a ten percent potassium hydroxide solution.
The vaginal infections may be selected from the group including: a bacterial infection, a protozoal infection, and a fungal infection.
The device may be in the form of a card with the test areas arranged thereon. The card may be elongate in shape.
The pH indicator area may include a conventional pH indicator covering a pH range of from 3.5 to 8. The colour of the pH indicator area after application of the vaginal fluid sample thereto may indicate a particular pH or pH range. A pH
colour chart may be provided together with the device to assist in establishing the pH of the vaginal fluid sample.
In particular, the pH indicator applied to the area may be an EMD colorpHast® indicator (catalogue number 9582-3) covering a pH range of from 4 to 7. Colour changes are visible every 0.2 to 0.3 pH units.
The leucocyte count indicator area may include a conventional leucocyte count indicator covering a leucocyte count range of from 0 to 3. The colour of the leucocyte count indicator area after application of the vaginal fluid sample thereto may indicate a particular leucocyte count. A leucocyte count colour chart may be provided together with the device to assist in establishing the leucocyte count of the vaginal fluid sample.
In particular, the leucocyte indicator applied to the area may be a Teco Urine reagent strip, a Multistix ® 10 SG reagent strip by Bayer, a Combur9-Test reagent strip by Roche, or a Uristix ® reagent strip by Bayer.
The amine test area may be any suitable absorbent material impregnated with a ten percent potassium hydroxide solution. After application of the vaginal fluid sample to the amine test area, this area may immediately be subjected to an olfactory test to determine the presence of volatilised amines.
The vaginal fluid sample may be applied to the test areas of the device using a conventional swab. Alternatively, the device may be inserted directly into the vagina of the patient to be tested to achieve application of a sample of vaginal fluid to the test areas of the device.
The device may include more than three test areas to permit testing of additional parameters for making presumptive diagnoses for various vaginal infections.
According to a further aspect of the invention, there is provided a method of making a presumptive diagnosis for three or more different types of vaginal infections using a device as described above, the method including at least the steps of:- - applying a vaginal fluid sample to test areas of the device, the test areas including a pH test area, a leucocyte count test area, and an amine test area; - subjecting the amine test area to an olfactory test immediately after the sample has been applied to said area; and - visually establishing the colour of the pH and leucocyte count test areas to establish the pH and leucocyte count of the vaginal fluid sample.
Should the olfactory test of the amine test area be positive by virtue of the detection of a fishy amine odour, the diagnosis is most likely a bacterial infection. The diagnosis may be confirmed by a sample pH 4.7 or higher (typically between 5 and 6) and a sample leucocyte count of between one and two or more.
Should the olfactory test of the amine test area be negative, a protozoal or fungal infection may be present.
A sample leucocyte count of three or more and a pH of 4.7 or higher (typically between 6 and 7) may be indicative of a protozoal infection.
A sample leucocyte count of from zero to two or more and a pH of less than 4.5 may be indicative of a fungal infection.
The vaginal fluid sample may be applied to the test areas of the device using a conventional swab. Alternatively, the device may be inserted directly into the vagina of the patient to be tested to achieve application of a sample of vaginal fluid to the test areas of the device.
The method may be applied to patients complaining of symptoms of vaginal infections such as an abnormal vaginal discharge and/or itching.
Once a presumptive diagnosis has been made using the method described above, further tests may be used to definitively identify the type of vaginal infection present.
The diagnostic method describe above may find particular application in rural and/or developing areas where the method may be used by clinic staff, family practitioners, and medical practitioners requiring an immediate presumptive diagnosis without the use of laboratory equipment.
Detailed Description of the Invention
The invention will now be described by way of the following, non-limiting example with reference to the accompanying drawing.
Figure 1 shows a schematic plan view of a device for making a presumptive diagnosis for three or more different types of vaginal infections.
In the drawing, reference numeral 10 generally indicates an embodiment of a device in accordance with the present invention.
The device 10 includes three test areas 12, 14 and 16 for receiving a sample of vaginal fluid thereon.
Test area 12 is a pH indicator area for indicating the pH of the vaginal fluid sample, the indicator covering a pH range of from 3.5 to 8.
Test area 14 is a leucocyte count indicator area for indicating the leucocyte count of the vaginal fluid sample, the indicator typically covering a leucocyte count range from zero to three.
Test area 16 is an amine test area impregnated with a ten percent potassium hydroxide solution.
The vaginal infections that the device 10 can be used to test for are: a bacterial infection, a protozoal infection, and a fungal infection.
The device 10 is in the form of an elongate card 18 with the test areas 12, 14 and 16 arranged thereon.
The pH indicator area 12 includes a conventional pH indicator covering a pH range of from 3.5 to 8, typically from 4 to 7. The colour of the pH indicator area 12 after application of the vaginal fluid sample thereto indicates a particular pH or pH range. A pH colour chart (not shown) is provided together with the device 10 to assist in establishing the pH of the vaginal fluid sample.
The leucocyte count indicator area 14 includes a conventional leucocyte count indicator covering a leucocyte count range of from 0 to 3. The colour of the leucocyte count indicator area 14 after application of the vaginal fluid sample thereto indicates a particular leucocyte count. A leucocyte count colour chart is provided together with the device 10 to assist in establishing the leucocyte count of the vaginal fluid sample.
The colour charts for the pH and leucocyte count indicator areas typically form part of the packaging of the device 10.
The amine test area 16 is any suitable absorbent material impregnated with a ten percent potassium hydroxide solution. After application of the vaginal fluid
sample to the amine test area 16, this area 16 is immediately be subjected to an olfactory test to determine the presence of volatilised amines.
The vaginal fluid sample can be applied to the test areas of the device 10 using a conventional swab. Alternatively, the device 10 can be inserted directly into the vagina of the patient to be tested to achieve application of a sample of vaginal fluid to the test areas 12, 14 and 16 of the device 10.
In use, a sample of vaginal fluid is applied to the test areas 12, 14 and 16 of the device 10. The amine test area 16 is immediately subjected to an olfactory test after the sample has been applied to said area.
Should the olfactory test of the amine test area 16 be positive by virtue of the detection of a fishy amine odour, the diagnosis is most likely a bacterial infection. The diagnosis can be confirmed by a sample pH 4.7 or higher and a sample leucocyte count of between one and two or more.
Accordingly, the colour of the pH and leucocyte count test areas 12 and 14 is established visually to establish the pH and leucocyte count of the vaginal fluid sample.
Should the olfactory test of the amine test area 16 be negative, a protozoal or fungal infection could be present.
A sample leucocyte count of three and a pH of 4.7 or higher is indicative of a protozoal infection.
A sample leucocyte count of from zero to two and a pH of less than 4.5 is indicative of a fungal infection.
The method is applied to patients complaining of symptoms of vaginal infections such as an abnormal vaginal discharge and/or itching.
Once a presumptive diagnosis has been made using the method described above, further tests are used to definitively identify the type of vaginal infection present.
The device 10 can be developed further to include more than three test areas to permit testing of additional parameters for making presumptive diagnoses for various vaginal infections.
It is to be appreciated, that the invention is not limited to any particular embodiment or configuration as hereinbefore generally described or illustrated.
Claims
1. A device for making a presumptive diagnosis for three or more different types of vaginal infections, the device including three or more test areas for receiving a sample of vaginal fluid thereon, the test areas including:-
- a pH indicator area for indicating the pH of the vaginal fluid sample, the indicator covering a pH range of from 3.5 to 8;
- a leucocyte count indicator area for indicating the leucocyte count of the vaginal fluid sample, the indicator covering a leucocyte count range from zero to three; and
- an amine test area impregnated with a ten percent potassium hydroxide solution.
2. A device as claimed in claim 1 , wherein the vaginal infections identifiable using the device are selected from the group including: a bacterial infection, a protozoal infection, and a fungal infection.
3. A device as claimed in claim 1 or claim 2, wherein device is in the form of a card with the test areas arranged thereon.
4. A device as claimed in any one of claims 1 to 3, wherein the pH indicator area includes a conventional pH indicator covering a pH range of from 3.5 to 8.
5. A device as claimed in claim 4, wherein the pH indicator applied to the pH indicator area is an EMD colorpHast® indicator (catalogue number 9582-3) covering a pH range of from 4 to 7.
6. A device as claimed in any one of the preceding claims, wherein the leucocyte count indicator area includes a conventional leucocyte count indicator covering a leucocyte count range of from 0 to 3.
7. A device as claimed in claim 6, wherein the leucocyte indicator applied to the leucocyte count indicator area is selected from the group including: a Teco Urine reagent strip, a Multistix ® 10 SG reagent strip by Bayer, a Combur9- Test reagent strip by Roche, and a Uristix ® reagent strip by Bayer.
8. A device as claimed in any one of the preceding claims, wherein the amine test area is any suitable absorbent material impregnated with a ten percent potassium hydroxide solution.
9. A method of making a presumptive diagnosis for three or more different types of vaginal infections using a device as claimed in any one of claims 1 to 8, the method including at least the steps of:-
- applying a vaginal fluid sample to test areas of the device, the test areas including a pH test area, a leucocyte count test area, and an amine test area;
- subjecting the amine test area to an olfactory test immediately after the sample has been applied to said area; and
- visually establishing the colour of the pH and leucocyte count test areas to establish the pH and leucocyte count of the vaginal fluid sample.
10. A method as claimed in claim 9, wherein, if the olfactory test of the amine test area is positive by virtue of the detection of a fishy amine odour the presumptive diagnosis is a bacterial infection.
11. A method as claimed in claim 10, wherein the presumptive diagnosis is confirmed by a sample pH 4.7 or higher and a sample leucocyte count of between one and two or more.
12. A method as claimed in claim 9, wherein, if the olfactory test of the amine test area is negative the presumptive diagnosis is a a protozoal or fungal infection.
13. A method as claimed in claim 12, wherein the presumptive diagnosis of a protozoal infection is confirmed by a sample leucocyte count of three or more and a pH of 4.7 or higher.
14. A method as claimed in claim 12, wherein the presumptive diagnosis of a fungal infection is confirmed by a sample leucocyte count of from zero to two or more and a pH of less than 4.5.
15.A method as claimed in any one of claims 9 to 14, wherein the vaginal fluid sample is applied to the test areas of the device using a conventional swab.
16. A method as claimed in any one of claims 9 to 14, wherein the vaginal fluid sample is applied to the test areas of the device by inserting the device directly into the vagina of the patient to be tested.
17.A test kit including a device as claimed in any one of claims 1 to 8 and instructions for carrying out the method as claimed in any one of claims 9 to
16.
18.A test kit as claimed in claim 17, wherein the kit includes a pH colour chart to assist in establishing the pH of the vaginal fluid sample.
19.A test kit as claimed in claim 17 or claim 18, wherein the kit includes a leucocyte count colour chart to assist in establishing the leucocyte count of the vaginal fluid sample.
20. A device for making a presumptive diagnosis for three or more different types of vaginal infections according to the invention, substantially as hereinbefore described or exemplified.
21. A device for making a presumptive diagnosis for three or more different types of vaginal infections as specifically described with reference to or as illustrated in any one of the accompanying drawings.
22.A device for making a presumptive diagnosis for three or more different types of vaginal infections including any new and inventive integer or combination of integers, substantially as herein described.
23.A method according to the invention for making a presumptive diagnosis for three or more different types of vaginal infections substantially as hereinbefore described or exemplified.
24.A method of making a presumptive diagnosis for three or more different types of vaginal infections including any new and inventive integer or combination of integers, substantially as herein described.
25.A device as claimed in any one of claims 1 to 8 whenever supplied with instructions for the use thereof in the making of a presumptive diagnosis for three or more different types of vaginal infections.
26. A device as claimed in claim 25 when the instructions are in printed or written form.
27.A device as claimed in claim 26 supplied in a package or container having said instructions provided thereon or therein.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| ZA2009/09095A ZA200909095B (en) | 2008-03-26 | 2009-12-21 | Test device and method for testing for vaginal infections |
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| ZA2008/2660 | 2008-03-26 | ||
| ZA200802660 | 2008-03-26 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| WO2009121079A2 true WO2009121079A2 (en) | 2009-10-01 |
| WO2009121079A3 WO2009121079A3 (en) | 2009-11-19 |
Family
ID=41114836
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/ZA2009/000013 WO2009121079A2 (en) | 2008-03-26 | 2009-02-20 | Test device and method for testing for vaginal infections |
Country Status (2)
| Country | Link |
|---|---|
| WO (1) | WO2009121079A2 (en) |
| ZA (1) | ZA200909095B (en) |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA2192004C (en) * | 1996-12-04 | 2006-05-02 | Chris Parkinson | Diagnostic test for bacterial vaginosis |
| US20050112547A1 (en) * | 2003-09-22 | 2005-05-26 | Florida Atlantic University | Vaginal infection test system and method |
| US7504235B2 (en) * | 2005-08-31 | 2009-03-17 | Kimberly-Clark Worldwide, Inc. | Enzyme detection technique |
| US7476201B2 (en) * | 2005-09-26 | 2009-01-13 | Femteck Llc | Digital type color comparisons in vaginal moisture pH determination |
-
2009
- 2009-02-20 WO PCT/ZA2009/000013 patent/WO2009121079A2/en active Application Filing
- 2009-12-21 ZA ZA2009/09095A patent/ZA200909095B/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| WO2009121079A3 (en) | 2009-11-19 |
| ZA200909095B (en) | 2010-11-24 |
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