Quality control product of AV/BV combined test kit and preparation method thereof

Abstract

The invention provides a five-item quality control product of an AV / BV combined test kit and a preparation method thereof, belonging to quality control products for controlling the quality of kits used during female gynecological clinical detection. The quality control product comprises a vaginal discharge five-item positive quality control product and a vaginal discharge five-item negative quality control product, and the two types of quality control products are stored in the states of dry powder. The quality control product is used to carry out quality detection of a vaginitis test kit and can carry out quality control on five biochemical indexes including hydrogen peroxide, neuraminidase, leucocyte esterase, beta-glucuronidase and coagulase. By means of taking biological enzymes as active ingredients of the quality control product and preparing a dry powder quality control product by adopting a freezing-drying technology, the deactivation of a liquid quality control product in transportation and storage processes is avoided. The quality control product does not contain any human vaginal discharge, and does not cause infection to the environment and operators.

Description

technical field [0001] The invention belongs to the technical field of biological products, and in particular relates to a quality control product of an AV / BV combined detection kit and a preparation method thereof. Background technique [0002] Studies in recent years have found that female bacterial vaginal infections can be divided into two types, one is caused by anaerobic bacteria and facultative anaerobic bacteria, and its main preformed enzyme is sialidase; the other is caused by aerobic bacteria. The main preformed enzymes are β-glucuronidase and coagulase. At the same time, white blood cell esterase is used clinically to evaluate whether there is inflammation in the female vagina, and the vaginal micro-ecological environment is judged according to the concentration of hydrogen peroxide. Application of relevant kits (such as ZL200910244266.X) can diagnose whether women are infected with aerobic vaginitis and bacterial vaginosis, and this technology is widely used in ...

AI Technical Summary

Problems solved by technology

[0003] The quality inspection of the kit is related to the definite diagnosis and condition monitoring of the patient. In the screening of female vaginitis, due to the special composition of vaginal secretions and large individual differences, it is difficult to use the tested specimens as preparation quality control products. The matrix, and leukocyte esterase and β-glucuronidase are extremely poor in stability and are very easy to be inactivated. Liquid quality control products can be stored for a long time at -20°C, but can only be stored for 3 days at 4°C

[0004] At present, there are many kinds of kits for female vaginitis detection on the market, but no quality control products are provided for matching kits. Due to the special composition of vaginal secretions and large individual differences, one of the sources of mixed normal secretions is medical testing. For the remaining specimens in daily work, since the volume of each remaining specimen is only a few hundred microliters or even less, it is not suitable for commercial production requiring more than thousands of milliliters. At the same time, the cost of testing each specimen for pathogenic pathogens is very high

Images