A saliva exosome-based rapid diagnostic kit for pediatric autoimmune encephalitis

Abstract

The application discloses the technical field of diagnostic reagent and discloses a rapid diagnostic kit for children's autoimmune encephalitis based on saliva exosome, which comprises a collector body, an L-shaped rod, a secretion mechanism and a quantitative mechanism, wherein the secretion mechanism comprises an O-shaped cover, the top of the collector body is provided with the O-shaped cover, the outer part of the O-shaped cover is fixedly provided with a gas delivery pipe, the free end of the gas delivery pipe is provided with a squeeze air pump, and the bottom of the squeeze air pump is provided with a placing box. When the device is used to collect saliva of a patient, the patient holds the oral ball, the clamping groove on the outer part of the oral ball stimulates the inside of the patient's oral cavity, saliva of the patient is secreted, and when the oral ball is held, the squeeze air pump is squeezed, the stimulating gas in the placing box enters the inside of the collector body through the gas delivery pipe to stimulate the patient, and saliva of the patient is secreted.

Description

Technical Field

[0001] This invention relates to the field of diagnostic reagent technology, specifically to a rapid diagnostic kit for childhood autoimmune encephalitis based on salivary exosomes. Background Technology

[0002] Autoimmune encephalitis (AE) is an inflammatory encephalopathy caused by abnormal activation of the body's immune system, leading to the production of autoantibodies against antigens in the central nervous system. In recent years, with the development of neuroimmunology, various autoantibodies related to AE on the surface of neurons or synaptic proteins have been discovered, such as anti-NMDAR (N-methyl-D-aspartate receptor), LGI1, CASPR2, and GABABR antibodies. Children are one of the high-risk groups for AE, and their clinical manifestations are often atypical, including behavioral abnormalities, seizures, cognitive impairment, motor disorders, and even decreased level of consciousness. This makes them highly susceptible to misdiagnosis as viral encephalitis, mental illness, or epilepsy syndromes, thus delaying treatment.

[0003] Currently used saliva collection devices are relatively simple in structure, typically using only disposable sampling cups for collection. However, in practical applications, especially in pediatric patients, factors such as tension, anxiety, or physiological dry mouth often lead to insufficient saliva secretion or slow secretion rates, making it difficult to obtain a sufficient sample in a short time. This not only prolongs the sampling time but may also affect the reliability of subsequent exosome extraction and detection due to insufficient sample volume. Furthermore, these simple collectors lack quantitative functions and cannot accurately control or label the volume of collected saliva, easily causing inconsistent sample volumes, which in turn introduces detection bias and reduces the repeatability and accuracy of diagnostic results. Based on this, the present invention designs a rapid diagnostic kit for pediatric autoimmune encephalitis based on salivary exosomes to solve the above problems. Summary of the Invention

[0004] The purpose of this invention is to provide a rapid diagnostic kit for childhood autoimmune encephalitis based on salivary exosomes, in order to solve the problems mentioned in the background art.

[0005] To achieve the above objectives, the present invention provides the following technical solution: This invention provides a rapid diagnostic kit for childhood autoimmune encephalitis based on salivary exosomes, comprising a collector body, an L-shaped rod, a secretion mechanism, and a quantification mechanism; The secretion mechanism includes an O-shaped cover, which is set on the top of the collector body. An air supply tube is fixedly installed on the outside of the O-shaped cover. A squeeze air pump is installed at the free end of the air supply tube, and a placement box is installed at the bottom of the squeeze air pump. When the device is needed to collect the patient's saliva, the patient holds the oral bulb in his mouth and squeezes the squeeze air pump to allow the stimulating gas inside the placement box to enter the inside of the collector body through the air supply tube to stimulate the patient and promote saliva secretion. The quantitative mechanism includes a guide tube disposed inside the collector body, an isolation plate below the guide tube, several support rods symmetrically arranged inside the guide tube, and a circular baffle at the top of the guide tube. A suspended ball is movably disposed between the support rods and the circular baffle. When the saliva inside the isolation plate reaches a certain amount, the suspended ball rises under the buoyancy of the saliva and blocks the circular baffle, preventing saliva from entering the isolation plate and achieving precise control of the collected saliva volume.

[0006] Preferably, the diameter of the suspended ball is larger than the inner diameter of the circular baffle, which is used to automatically block the guide pipe when the liquid level rises.

[0007] Preferably, the isolation plate has a through groove inside, and a test strip is installed between the isolation plate and the collector body for rapid testing of the collected saliva samples.

[0008] Preferably, the external part of the guide tube is equipped with an adjustment plate to adjust the saliva inflow rate to adapt to the saliva secretion rate of children of different ages.

[0009] Preferably, an L-shaped rod is installed on one side of the inner side of the guide tube, a mouth-holding ball is installed on the top of the L-shaped rod, and a number of slots are provided on the outside of the mouth-holding ball.

[0010] Preferably, the slot contains a vitamin C tablet, which is used to stimulate the oral mucosa and promote saliva secretion when the child holds the ball in their mouth.

[0011] Preferably, the placement box is equipped with food-grade acetic acid gel, which is used to release irritating gas under the action of a squeeze pump, thereby further promoting saliva secretion through odor stimulation.

[0012] Preferably, a sealing ring is provided at the connection between the gas delivery tube and the O-ring to prevent gas leakage and ensure that the stimulating gas is effectively delivered to the patient's mouth.

[0013] Preferably, the bottom of the collector body is provided with an anti-slip base for stable placement during collection and to prevent tipping and sample loss.

[0014] Preferably, the flow guide tube and the isolation plate are detachably connected, facilitating cleaning and replacement of components after use and improving the reusability of the reagent kit.

[0015] Compared with the prior art, the beneficial effects of the present invention are: 1. The present invention can stimulate the patient to secrete saliva through a secretion mechanism. The secretion mechanism includes a slot, a squeezing pump, and a placement box. When the device is needed to collect the patient's saliva, the patient holds the oral bulb in their mouth. The slot on the outside of the oral bulb stimulates the inside of the patient's mouth, causing the patient to secrete saliva. When the oral bulb is held in the mouth, the squeezing pump causes the stimulating gas inside the placement box to enter the inside of the collector body through the gas delivery tube to stimulate the patient to secrete saliva.

[0016] 2. This invention enables the quantitative measurement of saliva entering the device through a quantitative mechanism. The quantitative mechanism includes a support rod, a suspended ball, and a circular baffle. When collecting saliva using the device, the patient's secreted saliva enters through the circular baffle and the support rod in sequence. When the amount of saliva inside the isolation plate reaches a certain level, the suspended ball is suspended by the saliva and blocks the circular baffle, preventing saliva from entering the isolation plate. This avoids the inability to accurately control or label the volume of collected saliva, which can easily lead to inconsistent sample amounts, introduce detection bias, and reduce the repeatability and accuracy of diagnostic results. Attached Figure Description

[0017] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0018] Figure 1 This is a schematic diagram of the first three-dimensional structure of the present invention; Figure 2 This is a schematic diagram of the second three-dimensional structure of the present invention; Figure 3 This is a schematic diagram of the internal structure of the present invention; Figure 4 This is an enlarged structural diagram of part A of the present invention; Figure 5 This is an enlarged structural diagram of part B of the present invention.

[0019] The attached diagram lists the components represented by each number as follows: 1. Collector body; 2. O-ring; 201. Gas supply pipe; 202. Compressed air pump; 203. Placement box; 3. Isolation plate; 301. Through groove; 302. Test paper; 4. Guide pipe; 401. Support rod; 402. Suspension ball; 403. Circular baffle; 404. Adjustment plate; 5. L-shaped rod; 501. Oral ball; 502. Slot. Detailed Implementation

[0020] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0021] Please see Figure 1-5 The present invention provides a technical solution: a rapid diagnostic kit for childhood autoimmune encephalitis based on salivary exosomes, comprising a collector body 1, an L-shaped rod 5, a secretion mechanism and a quantitative mechanism.

[0022] like Figure 1 , Figure 2 As shown, the collector body 1 is a transparent cylindrical structure made of medical-grade polypropylene material, facilitating observation of the saliva collection process. The bottom of the collector body 1 has a non-slip base (not shown in the figure) to stably place the reagent kit on the work surface during collection, preventing tipping and sample loss. An O-ring 2 is detachably mounted on the top of the collector body 1. The O-ring 2 has a ring-shaped hollow structure and a sealing ring between it and the collector body 1 to ensure airtightness at the connection point.

[0023] like Figure 1 , Figure 2 , Figure 5 As shown, the secretion mechanism includes an O-shaped cover 2, an air supply tube 201, a squeeze pump 202, and a placement box 203. The air supply tube 201, a flexible medical silicone tube, is fixedly mounted on the outside of the O-shaped cover 2, with its free end connected to the air outlet of the squeeze pump 202. The squeeze pump 202 is a manually squeezed airbag made of elastic rubber material, with the placement box 203 mounted at its bottom. The placement box 203 is a transparent plastic box, threadedly connected to the squeeze pump 202 for easy disassembly and addition of stimulating materials. The placement box 203 contains food-grade acetic acid gel, which is stable in a static state but releases acetic acid gas with a pungent odor when disturbed by the airflow from the squeeze pump 202, thus promoting saliva secretion through olfactory stimulation.

[0024] like Figure 3 , Figure 5As shown, the quantitative mechanism includes a flow guide tube 4, a partition plate 3, support rods 401, a suspension ball 402, and a circular baffle 403. The partition plate 3 is fixedly installed inside the collector body 1, dividing the interior of the collector body 1 into upper and lower chambers. The upper chamber is the saliva flow guide area, and the lower chamber is the sample collection and detection area. A flow guide tube 4 is installed on the top of the partition plate 3. The flow guide tube 4 is a vertically arranged transparent tube and is detachably connected to the partition plate 3 for easy cleaning and replacement. Several support rods 401 are symmetrically installed inside the flow guide tube 4, arranged in a cross shape, to support the suspension ball 402 and restrict its lateral movement. A circular baffle 403 is installed on the top of the flow guide tube 4, with a through hole in the center of the circular baffle 403 for saliva inflow. A suspended ball 402 is movably disposed between the support rod 401 and the circular baffle 403. The suspended ball 402 is a hollow, lightweight sphere made of food-grade polyethylene material. Its diameter is larger than the diameter of the central through hole of the circular baffle 403, ensuring that the suspended ball 402 can completely block the through hole after it rises.

[0025] like Figure 3 , Figure 4 As shown, the partition plate 3 has multiple vertically arranged narrow channels 301 inside, which are used to evenly distribute the saliva discharged from the guide tube 4 into the lower chamber. A test strip 302 is installed between the partition plate 3 and the collector body 1. The test strip 302 is a rapid test strip based on immunochromatography technology, and its surface is coated with detection lines of autoimmune encephalitis-related antibodies such as NMDAR, LGI1, and CASPR2, which are used for qualitative or semi-quantitative detection of target substances in salivary exosomes.

[0026] like Figure 3 , Figure 5 As shown, an adjusting plate 404 is movably fitted onto the outside of the drainage tube 4. The adjusting plate 404 is an annular plate that can slide up and down along the outer wall of the drainage tube 4 and be positioned by friction. The adjusting plate 404 is used to adjust the gap between the drainage tube 4 and the isolation plate 3, thereby controlling the speed at which saliva flows into the lower chamber to accommodate the differences in saliva secretion rates among children of different ages.

[0027] like Figure 3 , Figure 5As shown, an L-shaped rod 5 is installed on one side of the inner side of the drainage tube 4. The L-shaped rod 5 is a rigid plastic rod with an L-shaped structure. One end is fixedly connected to the inner wall of the drainage tube 4, and the other end extends upward to the outside of the drainage tube 4. A mouth ball 501 is installed at the top of the L-shaped rod 5. The mouth ball 501 has an ellipsoidal hollow structure and is made of food-grade silicone material with a smooth surface and no sharp corners to ensure the comfort and safety of children when they put it in their mouths. Several slots 502 are provided on the outside of the mouth ball 501. The slots 502 have a recessed structure for embedding vitamin C tablets. When the vitamin C tablets come into contact with the oral mucosa, they slowly dissolve, releasing acidic substances that stimulate taste buds and salivary glands, promoting saliva secretion.

[0028] The working principle and usage process of this invention are as follows: When using the device for saliva collection and testing, the following preparations are made: A vitamin C tablet is embedded inside the slot 502; an appropriate amount of food-grade acetic acid gel is added inside the placement box 203; and the placement box 203 is screwed tightly onto the bottom of the squeeze pump 202. The test strip 302 is pre-loaded into the gap between the separator 3 and the collector body 1, ensuring that the sample-absorbing end of the test strip faces the through-slot 301.

[0029] At the start of sampling, the patient (child) places a mouth bulb 501 in their mouth. At this time, the vitamin C tablet inside the slot 502 on the outside of the mouth bulb 501 comes into contact with the oral mucosa, gradually dissolving and releasing an acidic substance. This chemically stimulates the inside of the patient's mouth, prompting the salivary glands to secrete saliva. Simultaneously, medical staff or the patient intermittently squeezes the air pump 202. The airflow generated by squeezing the air pump 202 enters the placement box 203, agitating the food-grade acetic acid gel inside and causing it to release acetic acid gas with a pungent odor. This gas enters the O-ring 2 through the gas delivery tube 201, and then into the patient's mouth, further promoting saliva secretion through olfactory stimulation. Through the synergistic effect of physical, chemical, and olfactory stimulation, the problem of insufficient saliva secretion in children caused by tension, anxiety, or physiological dry mouth can be effectively solved, significantly improving sampling efficiency.

[0030] The patient's saliva enters the mouth bulb 501 through small holes on its surface, and is then guided into the guide tube 4 by the L-shaped rod 5. The saliva inside the guide tube 4 flows downwards under gravity, passing sequentially through the central through-hole of the circular baffle 403 and the gap between the support rod 401, finally entering the collection and detection area below the isolation plate 3 through the through-groove 301, where it contacts the sample suction end of the test strip 302.

[0031] As saliva continuously flows in, the liquid level below the separator 3 gradually rises. When the liquid level rises to a certain height, the suspended ball 402 gradually rises under the buoyancy of the saliva. Since the diameter of the suspended ball 402 is larger than the diameter of the central through hole of the circular baffle 403, when the suspended ball 402 rises to the top, it will fit tightly against the lower surface of the circular baffle 403, completely blocking the through hole, preventing saliva from entering the collection and detection area below the separator 3. By adjusting the position of the adjusting plate 404 on the guide tube 4, the speed at which saliva flows into the lower chamber can be changed, thereby achieving precise control of the collection volume and avoiding detection deviations caused by inconsistent sample volume.

[0032] After the suspended ball 402 blocks the circular baffle 403, the patient's mouth leaves the ball 501, and the sampling process ends. At this time, gently shake the collector body 1 to ensure that the saliva sample below the isolation plate 3 fully contacts the test strip 302 and undergoes chromatographic development. After standing for 5-10 minutes, observe the color development of the test line and control line on the test strip 302 through the transparent sidewall of the collector body 1. Based on the color development results, determine whether the target autoantibodies are present in the patient's saliva, thereby achieving rapid auxiliary diagnosis of autoimmune encephalitis in children.

[0033] After use, the guide tube 4 can be removed from the isolation plate 3, and the used test strip 302 can be taken out for compliant disposal. The collector body 1, guide tube 4, mouth bulb 501 and other components can be rinsed with clean water and disinfected, dried and reassembled. After replacing with new test strip 302 and stimulation material, it can be reused, which improves the reusability of the kit and reduces the cost of use.

[0034] In the description of this specification, references to terms such as "an embodiment," "example," "specific example," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of the invention. In this specification, illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples.

[0035] The preferred embodiments of the present invention disclosed above are merely illustrative of the invention. These preferred embodiments do not exhaustively describe all details, nor do they limit the invention to any specific implementation. Clearly, many modifications and variations can be made based on the content of this specification. This specification selects and specifically describes these embodiments to better explain the principles and practical applications of the invention, thereby enabling those skilled in the art to better understand and utilize the invention. The invention is limited only by the claims and their full scope and equivalents.

Claims

1. A rapid diagnostic kit for childhood autoimmune encephalitis based on salivary exosomes, comprising a collector body (1), an L-shaped rod (5), a secretion mechanism, and a quantitative mechanism; characterized in that: The secretion mechanism includes an O-shaped cover (2) which is set on the top of the collector body (1). An air supply pipe (201) is fixedly installed on the outside of the O-shaped cover (2). A squeeze air pump (202) is installed at the free end of the air supply pipe (201). A placement box (203) is installed at the bottom of the squeeze air pump (202). The quantitative mechanism includes a flow guide tube (4) which is located inside the collector body (1). A partition plate (3) is provided below the flow guide tube (4). Several support rods (401) are symmetrically arranged inside the flow guide tube (4). A circular baffle (403) is provided at the top of the flow guide tube (4). A suspended ball (402) is movably arranged between the support rods (401) and the circular baffle (403).

2. The rapid diagnostic kit for childhood autoimmune encephalitis based on salivary exosomes according to claim 1, characterized in that: The diameter of the suspended ball (402) is larger than the inner diameter of the circular baffle (403), which is used to automatically block the guide pipe (4) when the liquid level rises.

3. The rapid diagnostic kit for childhood autoimmune encephalitis based on salivary exosomes according to claim 1, characterized in that: The isolation plate (3) has a through groove (301) inside, and a test paper (302) is installed between the isolation plate (3) and the collector body (1).

4. The rapid diagnostic kit for childhood autoimmune encephalitis based on salivary exosomes according to claim 1, characterized in that: The externally movable part of the guide tube (4) is equipped with an adjustment plate (404) for adjusting the saliva inflow rate.

5. The rapid diagnostic kit for childhood autoimmune encephalitis based on salivary exosomes according to claim 1, characterized in that: An L-shaped rod (5) is installed on one side of the inside of the guide tube (4), and a mouth ball (501) is installed on the top of the L-shaped rod (5). Several slots (502) are provided on the outside of the mouth ball (501).

6. The rapid diagnostic kit for childhood autoimmune encephalitis based on salivary exosomes according to claim 5, characterized in that: The slot (502) contains a vitamin C tablet to stimulate saliva secretion.

7. The rapid diagnostic kit for childhood autoimmune encephalitis based on salivary exosomes according to claim 1, characterized in that: The placement box (203) is equipped with food-grade acetic acid gel, which is used to release irritating gas under the action of the squeeze pump (202).

8. The rapid diagnostic kit for childhood autoimmune encephalitis based on salivary exosomes according to claim 1, characterized in that: A sealing ring is provided at the connection between the gas supply pipe (201) and the O-ring (2) to prevent gas leakage.

9. A rapid diagnostic kit for childhood autoimmune encephalitis based on salivary exosomes according to claim 1, characterized in that: The collector body (1) is provided with an anti-slip base at the bottom for stable placement.

10. A rapid diagnostic kit for childhood autoimmune encephalitis based on salivary exosomes according to claim 1, characterized in that: The guide pipe (4) and the isolation plate (3) are detachably connected, which facilitates cleaning and replacement.

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