Vaginal micro-ecological environment sensor and manufacturing method thereof

Abstract

The invention discloses a human body pathological change sensing device belonging to the technical field of clinical diagnosis instruments. Actual operation of diagnosing flora imbalance bacterial vaginosis with Amsel and Nugent standards is difficult; although certain new technology applications exist, the bacterial vaginosis is actually caused by a plurality of intricately interweaved factors; the methods are rough; and the operation is complicated and overloaded. The invention provides a complete, precise and convenient diagnosis method. The device comprises a vaginal chemoreception chip and a handle, wherein the chip consists of a substrate and a tunica; one surface of the substrate is combined with specific detection reagents to form detection units; the detection units are arrayed; the substrate is covered with a thin film; the handle consists of a handle head and a handle tail; the handle head is provided with a groove for placing the chemoreception chip; pits are formed in the middle parts of the two side wings of the substrate; and bulges are arranged at the middle parts of the inner faces on the two sides of the groove. The device and the method have the beneficial effects that more pathogenic factor changes in a vagina can be detected directly; the device is small in size; vaginal secretions are collected without swabs; elution and dilution are avoided; and the device is suitable for bedside operation by an outpatient doctor of a hospital or household use by a patient.

Description

technical field [0001] The invention relates to a human body pathological change sensing device, in particular to a vaginal micro-ecological environment change sensing device, which belongs to the technical field of clinical diagnostic instruments. Background technique [0002] For women of normal reproductive age, under the action of estrogen secreted by the ovary, the squamous epithelial cells of the cervix and vagina absorb glycogen and gradually mature, and the glycogen in the cells is released after shedding, which is conducive to the growth of lactobacillus and reduces the pH value of the vagina. It inhibits the growth of other pathogenic bacteria and forms a normal micro-ecological balance in the vagina. In addition, the secretion of cervical glands forms a specific micro-ecological environment that resists the invasion of pathogenic microorganisms and maintains a healthy state. When the human estrogen level drops, a large number of antibiotics or excessive vaginal wa...

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Problems solved by technology

[0007] In clinical practice, the Amsel standard has the following deficiencies: 1. It is inconvenient to measure the pH value. 2. Judging the characteristics of vaginal secretions is highly subjective. 3. The compliance and objectivity of the sniffing test staff are poor; 4. Clue cells are indirect evidence; the Nugent standard also requires smears, Gram staining, and identification, counting, and integration of individual bacterial species under an oil microscope, which requires strong professional experience, is tedious, and time-consuming

[0008] With the continuous in-depth understanding of the pathogenesis of BV, diagnostic methods based on the detection of metabolites of microorganisms unique to the vaginal secretions of BV patients have emerged and some commercial kits have emerged. For example, the publication number of the China Intellectual Property Office is CN201247244 "Gynecological Multi-item Dry Chemistry Joint Detection Test Strip" and "A Bacterial Vaginosis Rapid Detection Device, Detection Test Strip and Detection Method" with the publication number CN101975852A, these methods are more objective than the above methods and suitable for batch operation , but it is still necessary to take the specimen to the laboratory for inspection and operation. To judge the color change with the naked eye, it is necessary to use a test to collect vaginal secretions, elute and dilute, and then add it to the reaction dish or test strip to develop color. pH Value determination requires direct contact with secretions for color development observation, while other reactions cannot be uniformly operated after elution and dilution. At the same time, the detection after dilution is relatively indirect, which will also reduce sensitivity, many operating steps, and poor accuracy. For bedside doctors , there are multiple operation steps and judgment indicators, which is very time-consuming and cumbersome. For the laboratory, it takes a long time to transfer to the laboratory for experimental operation, and the transfer and handover in the middle will take a long time. The enzymes are easy to degrade and change, which will affect the authenticity of the results. sex and accuracy

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