A rapid detection kit for Helicobacter pylori

Abstract

The present application provides a breathalyzer for detecting Helicobacter pylori. During the test, the inspector only needs to rinse his mouth with about 5 ml of water with a pH value of about 4.0 for about 2 minutes, and then blow the rinse liquid into the test kit from the A end of the test kit, and judge the severity of Helicobacter pylori infection by the color change of the test kit observation window.

Description

Technical Field

[0001] The present application relates to the field of medical devices, and is a breath-blowing kit for rapid detection of Helicobacter pylori, belonging to the field of medicine. Background Art

[0002] Helicobacter pylori lives in the pyloric part of the human stomach and the oral cavity and is one of the most common bacterial pathogens. More than half of the world's population has been infected with Helicobacter pylori, and in some countries almost 90% of the people have been infected with this bacterium. People are usually infected in childhood, reaching 50% under the age of 5. This bacterial infection first causes chronic gastritis, and leads to gastric ulcers and gastric atrophy, and in severe cases, it develops into gastric cancer. According to statistics, the incidence of atrophic gastritis and gastric cancer is high in people who are first infected with Helicobacter pylori at an early age, and the mortality rate of Helicobacter pylori infection is parallel to the high and low mortality of gastric cancer. Helicobacter pylori parasitizes in the gastric mucosal tissue, and 67% to 80% of gastric ulcers and 95% of duodenal ulcers are caused by Helicobacter pylori. The common symptoms of patients with chronic gastritis and gastrointestinal ulcers are: fullness, discomfort or pain in the upper abdomen after eating, often accompanied by other adverse symptoms, such as belching, bloating, acid reflux and loss of appetite. Some patients may also experience recurrent severe abdominal pain and a small amount of upper gastrointestinal bleeding. Based on this, experts believe that early detection of Helicobacter pylori infection and timely and effective use of antibiotics to kill Helicobacter pylori are of great significance for the prevention and control of gastric cancer. Since Krajden successfully isolated and cultured Hp from the dental plaque of gastritis patients in 1989, the oral cavity has been basically confirmed as another gathering place for Hp. Current literature shows that Hp is transmitted in three ways: oral-oral, fecal-oral, and gastric-oral. It can be seen that Hp in the oral cavity plays a very important role in the transmission of gastric Hp.

[0003] There are many methods for detecting Helicobacter pylori infection, such as biopsy, isolation and culture of Helicobacter pylori, rapid urease test, urea breath test, urine ammonia excretion test, serological test and polymerase chain reaction. In comparison, the most widely used detection method in clinical practice is mainly based on the urea breath test based on the rapid urease test. This detection method is mainly based on the production of urease by Helicobacter pylori, which decomposes urea to produce CO 2 and NH 3 . The existing methods are mainly used for clinical testing in hospitals and are not suitable for home use. Therefore, Helicobacter pylori testing for ordinary people is the key to eliminating Helicobacter pylori and preventing cancer. For ordinary people to use the reagent, it must be simple and easy to operate. They can operate independently by reading the instructions or diagrams, just like early pregnancy test strips. Based on this goal and starting point, the present application provides a breathalyzer kit for detecting Helicobacter pylori. Its entire structure is as follows Figure 1 As shown in the figure, it consists of a rod body and a balloon. From the A-end section, the rod body is composed of two half elliptical long rods. Figure 2 , the section is expanded as Figure 3 From the B-end balloon section, the section is as follows Figure 4 , the section is expanded as Figure 5 . The absorbent pad is the most important part of the entire test kit, and the entire key reaction process of the test must be completed here. Urease can be dissolved in water and is also more active under acidic conditions. The tester only needs to rinse his mouth with about 5ml of water with a pH value of about 4.0 for about 2 minutes, because Helicobacter pylori exists transiently in the mouth. Helicobacter pylori in the mouth may have entered the stomach, but the urease secreted by Helicobacter pylori is still in the mouth and remains active for a certain period of time. At the same time, some Helicobacter pylori in the stomach can also enter the mouth through the esophagus, which may leave the secreted urease in the mouth. The person to be tested rinses his mouth with about 5ml of water for 2 minutes to ensure that the urease is fully dissolved in water. At the same time, 5ml of water can ensure the concentration of urease, so that the concentration is not too low and the reaction time is too long. The person to be tested blows the mouthwash liquid into the test kit from the A end of the test kit. The mouthwash water containing urease is adsorbed by the absorbent pad, and urea can decompose the urea to produce ammonia, which increases the pH value of the entire environment of the absorbent pad and changes the color of the indicator. Because the size of each absorbent pad is fixed, when the first absorbent pad is saturated with adsorption, the excess liquid will continue to flow forward to the next absorbent pad. With the blowing of the person to be tested, the flow can be accelerated. The next absorbent pad will have the same reaction as the previous one. By analogy, you only need to add different doses of urea and indicators that change color at different pH values ​​to the absorbent pad, and the severity of Helicobacter pylori infection can be reflected according to the color change. Finally, the excess liquid is blown into the balloon and adsorbed by the sponge in the balloon. The entire device is used to detect Helicobacter pylori. It is simple and easy to operate, and is more suitable for patients to self-examine at ordinary times. Summary of the invention

[0004] The purpose of this application is to provide a rapid Helicobacter pylori detection breathalyzer kit. This kit can greatly improve the work efficiency of detection personnel in medical insurance institutions and expand the user population, such as children and pregnant women who cannot be detected by breathalyzer. When used in non-medical institutions, people can test themselves.

[0005] The invention discloses a rapid Helicobacter pylori detection air blowing kit, which mainly comprises 1 card shell, 2 liquid guide film, and 3 liquid absorption pad.

[0006] As mentioned above, the rapid detection kit for Helicobacter pylori is characterized in that the cartridge is composed of a rod body and a balloon, the balloon is composed of two elliptical hemispheres, and a liquid-absorbing sponge is installed. The rod body is composed of two semi-elliptical long tubes, one of which has an observation window, and its structural schematic diagram is shown as follows Figure 1 Figure 2 Figure 3 Figure 4 Figure 5shown.

[0007] As mentioned above, the rapid detection kit for Helicobacter pylori is characterized in that the liquid absorption pad is adhered to the liquid conduction bottom film, and its structural schematic diagram is as follows Figure 6 shown.

[0008] As mentioned above, the rapid detection kit for Helicobacter pylori is characterized in that the liquid-conducting bottom sheet and the liquid-absorbing pad are in the rod body, and the liquid-absorbing pad is just located in the observation window of the rod body. The schematic diagram of its structure is shown in FIG. Figure 7 shown.

[0009] As described above, the rapid detection of Helicobacter pylori air blowing kit is characterized in that the substrate urea and the indicator are adsorbed on the absorbent pad, and the color change point of the indicator contained in the absorbent pad in the observation window position at the A end of the rod body to the absorbent pad in the observation window position at the B end changes from low to high.

[0010] As described above, the rapid detection of Helicobacter pylori by blowing kit is characterized in that during the test, the patient rinses his mouth with about 5 ml of water with a pH value of about 4.0 for about 2 minutes, and then blows the rinse liquid from the A end of the rod into the balloon for about 3 to 5 minutes, and observes the color change of the absorbent pad in the observation window. Specified colors appear in sequence from the A end to the B end. The more the number of specified colors, the more serious the Helicobacter pylori infection. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] Figure 1 Schematic diagram of the structure of the Helicobacter pylori rapid detection breath test kit

[0012] Figure 2 Schematic diagram of the cross-section structure of the rod body viewed from end A

[0013] Figure 3 Schematic diagram of the expanded structure of the cross section of the rod viewed from end A

[0014] Figure 4 Schematic diagram of the cross-sectional structure of the balloon viewed from the B end

[0015] Figure 5 Schematic diagram of the expanded structure of the balloon section viewed from the B end

[0016] Figure 6 Schematic diagram of the structure of the liquid-absorbing pad attached to the liquid-conducting bottom film

[0017] Figure 7 Schematic diagram of the cross-sectional structure of the liquid-absorbing pad and the liquid-conducting bottom plate in the rod body as viewed from end A

[0018] The following is a further explanation of the specific implementation scheme of this application in conjunction with the figures DETAILED DESCRIPTION

[0019] In the figure, 1 is the rod body and balloon as a whole, 2 is the liquid absorbing pad, 3 is the liquid guiding film, 101 is the observation window on the rod body, 102 is the rod body, and 103 is the balloon. The balloon is filled with a water absorbing sponge or other liquid absorbing material. Figure 2 is the cross-section of the rod, Figure 3 It is a cross-sectional expansion diagram of the rod body. From the cross-sectional and expansion diagrams, it can be seen that the rod body is composed of two semi-elliptical materials, which are connected by a slot, and can just fix the absorbent pad containing urea and indicator and the liquid-conducting film in the rod body, forming a flat conduit with an absorbent pad and a liquid-conducting film. There is an observation window on one side of the flat surface for observing color changes. The size of the absorbent pad 2 is consistent with the size of the observation window, and the size can be partially extended from the observation window. There is no urea and indicator on the liquid-conducting film, which serves to connect the various absorbent pads. The liquid-conducting pad is connected to the absorbent pad as shown in FIG. Figure 6 When the tester blows in a solution containing oral urease from end A, it can be quickly guided to each absorbent pad through the liquid guide film until the absorbent pad is saturated. The excess liquid will be absorbed by the absorbent material in the balloon. The cross-section diagram and the expanded cross-section diagram of the balloon are shown in Figure 4 Figure 5 . Figure 7 This is a cross-sectional picture of the absorbent pad and the liquid guide film installed in the rod body. When the patient is tested, rinse the mouth with about 5ml of water with a pH value of about 4.0 for about 2 minutes, and then blow the rinse liquid from the A end of the rod into the balloon for about 3 to 5 minutes. Observe the color change of the absorbent pad in the observation window. The specified colors appear from the A end to the B end in sequence. The more colors that meet the requirements, the more serious the infection with Helicobacter pylori. In order to eliminate the interference of the pH value of saliva itself, the pH value of the water used for rinsing the mouth is about 4.0. The pH value increases slightly after rinsing the mouth, but it will be lower than the color change point of the indicator in the first absorbent pad at the A end of the rod body. The amount of mouthwash liquid is controlled at about 5ml, so as to ensure that it is dissolved into the concentration of the mouthwash solution. Look at the color of the absorbent pad in the observation window about 3 to 5 minutes after blowing into the rod, so as to ensure that the urease in the mouthwash liquid fully reacts with the urea in the absorbent pad.

Claims

1. A rapid detection kit for Helicobacter pylori. It is characterized in that The invention comprises a casing, a liquid-conducting film and a liquid-absorbing pad; the casing is composed of a rod body and a balloon, the balloon is composed of two elliptical hemispheres and is provided with a liquid-absorbing sponge, the rod body is composed of two semi-elliptical long tubes, one of which has an observation window, the rod body comprises an A end and a B end, the B end is connected to the balloon, the liquid-absorbing pad is adhered to the liquid-conducting film, the liquid-conducting film has no urea and an indicator and is used to connect the liquid-absorbing pads, the liquid-conducting film and the liquid-absorbing pad are inside the rod body, and the liquid-absorbing pad is just located in the observation window of the rod body, the substrate urea and the indicator are adsorbed on the liquid-absorbing pad, and the color change point of the indicator contained in the liquid-absorbing pad at the observation window position of the A end of the rod body changes from low to high.

2. The rapid detection kit for Helicobacter pylori according to claim 1, It is characterized in that During the test, the patient rinses his mouth with 5 ml of water with a pH value of 4.0 for 2 minutes, and then blows the rinse liquid into the balloon from the A end of the stick for 3 to 5 minutes. The color change of the absorbent pad in the observation window is observed. The specified colors appear in sequence from the A end to the B end. The more specified colors there are, the more serious the Helicobacter pylori infection is.

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