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Detection kit for bacterial vaginosis (BV) and sialidase detection method

A detection kit and technology for vaginosis, applied in biochemical equipment and methods, microbial determination/inspection, etc., can solve the problems of increased vaginal pH, cumbersome results, and limited promotion and application, so as to reduce the misoperation rate, The effect of saving experimental time and simplifying the experimental method

Inactive Publication Date: 2011-11-23
泰普生物科学(中国)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, Amsel diagnostic criteria are not easy to grasp and are easily affected by human factors. However, the use of bacterial culture is cumbersome and time-consuming, which is not conducive to timely diagnosis and treatment of patients, and limits the popularization and application.
[0005] In the diagnosis of BV, the most commonly used clinical method is the traditional Amsel method (as mentioned above), but it is not easy to implement it accurately in practice
First of all, some factors not related to infection, such as recent sexual intercourse, vaginal douching, menstruation, or the presence of a large amount of cervical mucus, can also lead to an increase in vaginal pH or odor of secretions; the identification of odor in the amine test depends on the individual. However, the identification of clue cells, which are the best markers for BV diagnosis, is affected by many factors such as the quality of microscopic equipment, sample collection, and operator experience, and is highly subjective, so it is difficult to judge the results. Statistics and Comparisons

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] In order to better illustrate the performance of the reagents, the following implementation data are provided for reference: 200 patient samples were selected for the detection of the kit of the present invention and the clinical "gold standard" diagnostic method.

[0023] Kit preparation of the present invention:

[0024] Preparation of reaction solution (500ml): Weigh 0.46g of potassium acetate and dissolve it in 300ml of distilled water, add 1g of sucrose, add water to 500ml after the solute is completely dissolved, and adjust the pH to 6.2-6.5 with glacial acetic acid. Quickly weigh 50 mg of acetylneuraminic acid salt, dissolve it in 500 ml of potassium acetate buffer and mix well. Aliquot into 500ul per reaction tube. The reaction tube is a tube with high permeability, which can be a glass tube or a plastic tube.

[0025] Chromogenic solution preparation: Weigh 2g of sodium hydroxide and dissolve in 500ml of distilled water, pH > 10, dissolve and dispense.

[00...

Embodiment 2

[0042] In order to further illustrate the bacterial vaginosis detection kit of the present invention is as follows:

[0043] Preparation of reaction solution (1L): Weigh 1g of potassium acetate and dissolve it in 500ml of distilled water, add 5g of trehalose, after it is completely dissolved, add water and adjust the volume to 1000ml, and adjust the pH to 6.0-6.7 with glacial acetic acid. Quickly weigh 200 mg of 5-bromo-4-chloro-3-indolyl acetylneuraminic acid sodium salt, dissolve it in 1000 ml of potassium acetate buffer, mix well, and distribute into 500 ul reaction tubes. The reaction tube is a tube with high permeability, which can be a glass tube or a plastic tube.

[0044] Chromogenic solution preparation: Weigh 5g of sodium hydroxide and dissolve in 500ml of distilled water, and dispense after dissolving, pH>9.

Embodiment 3

[0046]Preparation of reaction solution (500ml): Weigh 3g of potassium acetate and dissolve it in 300ml of distilled water, add 6g of sucrose, add water to 500ml after the solute is completely dissolved, and adjust the pH to 6.2-6.5 with glacial acetic acid. Quickly weigh 150 mg of acetylneuraminic acid salt, dissolve it in 500 ml of potassium acetate buffer and mix well. Aliquot into 500ul per reaction tube. The reaction tube is a tube with high permeability, which can be a glass tube or a plastic tube.

[0047] Chromogenic solution preparation: Weigh 10g of sodium hydroxide and dissolve in 500ml of distilled water, pH > 10, dissolve and pack.

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Abstract

The purpose of the invention is to provide a detection kit for BV, and the detection kit has the advantages of a simple testing process, strong pertinency, high accuracy and fast and convenient operation. The technical scheme for the invention is that a detection kit for BV is provided and comprises a reaction solution and a colored solution, wherein the reaction solution comprises specific zymolytes, carbohydrates and a potassium acetate buffer, and the zymolytes are n-acetylneuraminic acid and salts thereof. The beneficial effect of the invention is simplification of testing methods and result interpretation of BV diagnosis. Discrimination with the sialidase detection method has the following advantages: 1, testing time is substantially saved, all the testing operation is finished with ten minutes or more, no other complex equipment is needed, and only a baking box or a culture case at a temperature of 37 DEG C is needed to provide; 2, the interpretation step is rapid and visual, and the rate of misoperation and misdiagnosis are greatly reduced; 3, the detection card is sensitive, accurate and convenient, and has a high accordance rate with the detection of BV by golden standard the Amsel method.

Description

technical field [0001] The invention relates to the detection of bacterial vaginosis, in particular to a detection kit and a sialidase detection method of bacterial vaginosis. Background technique [0002] Bacterial vaginosis (BV) is one of the most common lower genital tract infections among married women. It is a clinical syndrome caused by an increase in the number of a group of anaerobic bacteria (Bacteroides, Gardnerella, Mobilonia, Mycoplasma hominis, and Peptostreptococcus, etc.). BV is one of the common gynecological diseases, the infection rate is 15-50%, and it is easy to recur. 50% of women suffering from BV are prone to premature delivery or low birth weight babies, and their babies are also likely to have various sequelae. More and more evidence shows that BV is a risk factor for organizing choriovitis, amniotic fluid infection, post-cesarean endometritis, and other adverse pregnancy and pregnancy complications. In addition, in gynecology, BV is mainly relate...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12Q1/34C12Q1/04
Inventor 陈宁阳卫超胡守旺谢佐福周晓强姚铭锋
Owner 泰普生物科学(中国)有限公司
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