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Kit used for detecting bacterial vaginosis

A kit and vaginosis technology, applied in the field of medical testing, can solve the problems of lack of specificity, elevated enzyme level, not very clear, etc., and achieve the effect of good specificity and simple operation

Active Publication Date: 2015-09-16
SHENZHEN AIRUI BIO TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In vitro experiments have proved that many bacteria and fungi can produce proline aminopeptidase, but the reason for the increased enzyme activity in BV patients is not yet clear
There are some serious problems with this method: First, some studies have shown that there is crossover between the diagnosis of BV and Trichomonas vaginalis infection by using this method. The result is positive, the reason is that Trichomonas is an anaerobic protozoa that can multiply in anaerobic environment, and it has a particulate matter that can produce hydrogen. Oxygen in the vagina combines to form water, which exacerbates the anaerobic condition in the vagina and stimulates and accelerates the growth of other anaerobic microorganisms, leading to the development of some of the clinical signs of BV, which include increased vaginal pH and increased discharge with detection Metabolite-based diagnostic tests of BV-associated flora: odorous, elevated anaerobic counts, elevated levels of enzymes associated with the corresponding bacteria, etc.
[0013] The test methods for detecting other metabolites include the detection of ammonia substances that produce peculiar smell, and the application of gas-chromatography technology to detect the ratio of succinic acid / lactic acid in vaginal secretions, etc., but the former lacks specificity, while the latter requires Uses instruments that are not readily available in laboratories and are therefore not suitable for widespread use

Method used

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  • Kit used for detecting bacterial vaginosis

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Preparation of reaction solution: Weigh 2,6-dichloro-4-aminophenol-α-D-N-acetylneuraminic acid sodium salt and dissolve it in 0.5mol / L sodium acetate solution to make the concentration 8mg / ml; Weigh 3,5-dihydroxy-2-naphthoic acid and dissolve it in the above solution to make the final concentration 2g / L; weigh PVA and dissolve it in the above solution to make the final concentration 2g / L; pH to 5.6. Aliquot into 0.5ml / reaction tube. The reaction tube is made of transparent plastic or glass.

[0034] Preparation of stop solution: Weigh sodium hydroxide and dissolve it in pure water to make the concentration 1mol / L.

[0035] The use of the kit of the present invention: first soak the swab that has taken a good sample into the reaction solution, and react it in a 37°C thermostat for 5 minutes; after the reaction is completed, add 1-2 drops of stop solution, and observe the color change of the sample swab. If the color is light brown and yellow, it is judged as negative,...

Embodiment 2

[0040] Preparation of reaction solution: Weigh 2,6-dichloro-4-aminophenol-α-D-N-acetylneuraminic acid sodium salt and dissolve it in 0.25mol / L sodium acetate solution to make the concentration 10mg / ml; Take 3,5-dihydroxy-2-naphthoic acid and dissolve in the above solution with a final concentration of 4.5g / L; weigh PVP and dissolve in the above solution with a final concentration of 2.8g / L; adjust the pH to 5.4 with glacial acetic acid. Aliquot into 0.5ml / reaction tube. The reaction tube is made of transparent plastic or glass.

[0041] Preparation of stop solution: Weigh sodium hydroxide and dissolve it in pure water to make the concentration 0.8mol / L.

[0042] The use of the kit of the present invention: first soak the swab that has taken a good sample into the reaction solution, and react it in a 37°C thermostat for 5 minutes; after the reaction is completed, add 1-2 drops of stop solution, and observe the color change of the sample swab. If the color is light brown and y...

Embodiment 3

[0044] Preparation of reaction solution: Weigh 2,6-dichloro-4-aminophenol-α-D-N-acetylneuraminic acid sodium salt and dissolve it in 0.25mol / L sodium acetate solution to make the concentration 10mg / ml; Take 3,5-dihydroxy-2-naphthoic acid and dissolve in the above solution with a final concentration of 4.5g / L; weigh PVP and dissolve in the above solution with a final concentration of 2.8g / L; adjust the pH to 5.4 with glacial acetic acid. Aliquot into 0.5ml / reaction tube. The reaction tube is made of transparent plastic or glass.

[0045] Preparation of stop solution: Weigh sodium hydroxide and dissolve it in pure water to make the concentration 0.8mol / L.

[0046] Preparation of negative control substance: prepare phosphate buffer solution so that the concentration of phosphate is 0.1mmol / L, and adjust the pH value to 7.4.

[0047] Preparation of positive control substance: configure phosphate buffer solution containing sialidase so that the concentration of sialidase is 5.0 U...

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Abstract

The invention provides a kit used for detecting bacterial vaginosis, which comprises a reaction solution and a stopping solution. The reaction solution comprises a sialidase specific substrate and an acetate-potassium acetate buffer of a developer, the sialidase specific substrate is phenol dye-based acetyl neuraminide or its pharmaceutically acceptable salt; and the stopping solution is a sodium hydroxide solution. The kit has the advantages of simple, rapid and sensitive operation, and good specificity, can be widely used for medical examination places at all levels, especially basic medical units, and has great important meaning for prevention, treatment and rehabilitation of bacterial vaginosis.

Description

technical field [0001] The invention belongs to the field of medical testing, and in particular relates to a test kit for detecting bacterial vaginosis and the application of acetylneuraminic acid glycoside based on phenol dye in preparing articles for checking bacterial vaginosis. Background technique [0002] Bacterial vaginosis (BV for short) refers to a type of bacteriologically normal flora of the reproductive tract (producing H 2 o 2 Lactobacilli) are reduced and replaced by a clinical syndrome of increased anaerobic flora. Due to the limited knowledge of it, many names have been reported, such as non-specific vaginitis, Gardnerella vaginitis, vaginal haemophilus vaginitis, etc. In order to unify the name, the 1984 Swedish special international academic conference officially named "bacterial vaginosis". [0003] BV is one of the most common diseases in obstetrics and gynecology, the infection rate is 15%-50%, and it is easy to relapse. 50% of women suffering from B...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12Q1/34C12Q1/04
Inventor 谢爱武陶克美
Owner SHENZHEN AIRUI BIO TECH
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