Bacterial vaginosis screening technique and a diagnostic kit for use therein
First Claim
1. A method for screening for the presence of bacterial vaginosis, the method comprising the steps of:
- (a) combining a sample of vaginal fluid with a developer reagent selected from the group consisting of phenol, derivatives thereof, and mixtures thereof to form a first reaction medium;
(b) combining the first reaction medium with a water soluble base and a halogen-containing oxidizing agent to form a second reaction medium having a pH of at least about 9.5;
(c) observing the color of the second reaction medium, where the concentration of the halogen-containing oxidizing agent in the second reaction medium is about 0.12 or greater, on a molar basis, than the concentration of the developer reagent in the second reaction medium.
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Abstract
A screening test for bacterial vaginosis is performed by (a) combining a sample of vaginal fluid with a developer reagent selected from the group consisting of phenol, derivatives thereof, and mixtures thereof to form a first reaction medium; (b) combining the first reaction medium with a water soluble base and a halogen-containing oxidizing agent to form a second reaction medium having a pH of at least about 9.5; and (c) observing the color of the second reaction medium. The concentration of the halogen-containing oxidizing agent in the second reaction medium is about 0.12 or greater (on a molar basis) than the concentration of the developer reagent in the second reaction medium. The foregoing procedure can be used to test for the presence of amines in any aqueous fluid as well as for synthesizing various dyes.
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Citations
47 Claims
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1. A method for screening for the presence of bacterial vaginosis, the method comprising the steps of:
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(a) combining a sample of vaginal fluid with a developer reagent selected from the group consisting of phenol, derivatives thereof, and mixtures thereof to form a first reaction medium;
(b) combining the first reaction medium with a water soluble base and a halogen-containing oxidizing agent to form a second reaction medium having a pH of at least about 9.5;
(c) observing the color of the second reaction medium, where the concentration of the halogen-containing oxidizing agent in the second reaction medium is about 0.12 or greater, on a molar basis, than the concentration of the developer reagent in the second reaction medium. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35)
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36. A method for detecting the presence of an amine in a sample of fluid, the method comprising the steps of:
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(a) combining the sample of fluid with a developer reagent selected from the group consisting of phenol, derivatives thereof, and mixtures thereof and an amine to form a first reaction medium;
(b) combining the first reaction medium with a water soluble base and a halogen-containing oxidizing agent to form a second reaction medium having a pH of at least about 9.5;
(c) observing the color of the second reaction medium, where the concentration of the halogen-containing oxidizing agent in the second reaction medium is about 0.12 or greater, on a molar basis, than the concentration of the developer reagent in the second reaction medium. - View Dependent Claims (37)
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38. A diagnostic kit comprising:
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(a) a developer reagent selected from the group consisting of phenol, derivatives thereof, and mixtures thereof;
(b) water soluble base; and
(c) a halogen-containing oxidizing agent, where (i) the concentration of the halogen-containing oxidizing agent in a reaction medium formed by combining the developer reagent, the water soluble base, and the halogen-containing oxidizing agent is about 0.12 or greater, on a molar basis, than the concentration of the developer reagent in the reaction medium and (ii) the pH of the reaction medium is at least about 9.5.
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39. A method for synthesizing 2,6-dichloroindophenol or a salt thereof, the method comprising the steps of:
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(a) reacting a phenol with an amine to form a first reaction medium; and
(b) combining the first reaction medium with a halogen-containing oxidizing agent and a water soluble dye to form a second reaction medium, where step (b) is conducted under reaction conditions such that the second reaction medium comprises 2,6-dichloroindophenol or a salt thereof.
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40. A method for synthesizing a dye, the method comprising the steps of:
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(a) reacting a phenol derivative selected from the group consisting of 2-phenylphenol, 3-phenylphenol, 4-phenylphenol, the alkali metal salts thereof, and mixtures thereof with an amine to form a first reaction medium; and
(b) combining the first reaction medium with a halogen-containing oxidizing agent and a water soluble base to form a second reaction medium, where step (b) is conducted under reaction conditions such that the second reaction medium comprises the dye. - View Dependent Claims (41, 42)
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43. A method for preparing a dye comprising the steps of:
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(a) reacting a developer reagent selected from the group consisting of phenol, 2-phenylphenol, 3-phenylphenol, 4-phenylphenol, the alkali metal salts thereof, and mixtures thereof with an amine selected from the group consisting of methylamine, isobutylamine, putrescine, cadaverine, histamine, tyramine, phenylethylamine, and mixtures thereof to form a first reaction medium; and
(b) combining the first reaction medium with an alkali metal salt selected from the group consisting of sodium hydroxide, potassium hydroxide, sodium carbonate, potassium carbonate, trisodium phosphate, tripotassium phosphate, and mixtures thereof and an oxidizing agent selected from the group consisting of sodium hypochlorite, trichloroisocyanuric acid, and mixtures thereof to form a second reaction medium in which the dye is formed, where the concentration of the oxidizing agent in the second reaction medium is about 0.12 or greater, on a molar basis, than the concentration of the developer reagent in the second reaction medium and the pH of the second reaction medium is at least about 9.5. - View Dependent Claims (44, 45)
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46. A method for preparing a dye comprising the steps of:
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(a) reacting a developer reagent selected from the group consisting of phenol, derivatives thereof, and mixtures thereof with an amine to form a first reaction medium; and
(b) combining the first reaction medium with a water soluble base and an halogen-containing oxidizing agent to form a second reaction medium having a pH of at least about 9.5 and comprising the dye, where the concentration of the oxidizing agent in the second reaction medium is about 0.12 or greater, on a molar basis, than the concentration of the developer reagent in the second reaction medium.
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47. A method for screening for the presence of bacterial vaginosis, the method comprising the steps of:
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(a) combining a sample of vaginal fluid simultaneously or in any desired order with (i) a developer reagent selected from the group consisting of phenol, derivatives thereof, and mixtures thereof, (ii) a water soluble base, and (iii) a halogen-containing oxidizing agent to form a reaction medium having a pH of at least about 9.5;
(b) observing the color of the reaction medium, where the concentration of the halogen-containing oxidizing agent in the reaction medium is about 0.12 or greater, on a molar basis, than the concentration of the developer reagent in the reaction medium.
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Specification