WO2009121079A2 - Dispositif et procédé d'essai relatif à des infections vaginales - Google Patents

Dispositif et procédé d'essai relatif à des infections vaginales Download PDF

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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
Authority
WO
WIPO (PCT)
Prior art keywords
test
area
indicator
leucocyte count
vaginal
Prior art date
Application number
PCT/ZA2009/000013
Other languages
English (en)
Other versions
WO2009121079A3 (fr
Inventor
John Kapp
Original Assignee
Kapp John
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Kapp John filed Critical Kapp John
Publication of WO2009121079A2 publication Critical patent/WO2009121079A2/fr
Publication of WO2009121079A3 publication Critical patent/WO2009121079A3/fr
Priority to ZA2009/09095A priority Critical patent/ZA200909095B/en

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Classifications

    • 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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  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Chemical & Material Sciences (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Urology & Nephrology (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Biochemistry (AREA)
  • Analytical Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Medicinal Chemistry (AREA)
  • Food Science & Technology (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Cell Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)

Abstract

Le dispositif selon l'invention comporte trois zones d'essai (12, 14 et 16) destinées à recevoir un échantillon de liquide vaginal. La zone d'essai (12) est une zone indicateur de pH qui indique le pH de l'échantillon de liquide vaginal, l'indicateur couvrant une plage de pH allant de 3,5 à 8. La zone d'essai (14) est un indicateur de comptage de leucocytes de l'échantillon de liquide vaginal, l'indicateur d'ordinaire couvrant une plage de comptage de leucocytes allant de zéro à trois. La zone d'essai (16) est une zone d'essai d'amines imprégnée de 10% d'une solution d'hydroxyde de potassium. Les infections vaginales que le dispositif (10) permet de soumettre à essai sont : infection bactérienne, infection protozoaire et infection fongique.
PCT/ZA2009/000013 2008-03-26 2009-02-20 Dispositif et procédé d'essai relatif à des infections vaginales WO2009121079A2 (fr)

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
ZA200802660 2008-03-26
ZA2008/2660 2008-03-26

Publications (2)

Publication Number Publication Date
WO2009121079A2 true WO2009121079A2 (fr) 2009-10-01
WO2009121079A3 WO2009121079A3 (fr) 2009-11-19

Family

ID=41114836

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/ZA2009/000013 WO2009121079A2 (fr) 2008-03-26 2009-02-20 Dispositif et procédé d'essai relatif à des infections vaginales

Country Status (2)

Country Link
WO (1) WO2009121079A2 (fr)
ZA (1) ZA200909095B (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6019734A (en) * 1996-12-04 2000-02-01 Parkinson; Chris Diagnostic test for vaginal infections
US20050112547A1 (en) * 2003-09-22 2005-05-26 Florida Atlantic University Vaginal infection test system and method
US20070048815A1 (en) * 2005-08-31 2007-03-01 Kimberly-Clark Worldwide, Inc. Enzyme detection technique
US20070073190A1 (en) * 2005-09-26 2007-03-29 Caillouette James C Digital type color comparisons in vaginal moisture pH determination

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6019734A (en) * 1996-12-04 2000-02-01 Parkinson; Chris Diagnostic test for vaginal infections
US20050112547A1 (en) * 2003-09-22 2005-05-26 Florida Atlantic University Vaginal infection test system and method
US20070048815A1 (en) * 2005-08-31 2007-03-01 Kimberly-Clark Worldwide, Inc. Enzyme detection technique
US20070073190A1 (en) * 2005-09-26 2007-03-29 Caillouette James C Digital type color comparisons in vaginal moisture pH determination

Also Published As

Publication number Publication date
WO2009121079A3 (fr) 2009-11-19
ZA200909095B (en) 2010-11-24

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