Saliva collection and detection integrated device

Abstract

The utility model discloses a saliva collection and detection integrated device, a saliva collection and detection integrated device, including the funnel for the collection saliva and the detection card, the detection card includes the cavity and sets up the detection component in the cavity, the drainage port of funnel has the thread of mutual cooperation with detection card, to make the funnel with the cavity intercommunication, the drainage port of funnel is provided with check valve membrane, the utility model discloses the collector sets up the funnel type entrance, and the user directly spits saliva and can inject the detection card through the flow guide channel, exempts the user to need to contain into the cotton stick collection step. The detection card built-in test strip and maintain hydraulic stability through the overflow hole, have convenient operation, the advantages such as anti -pollution, detection reliable.

Description

Technical Field

[0001] This utility model relates to the field of medical in vitro diagnostic device technology, and in particular to an integrated saliva collection and testing device. Background Technology

[0002] Saliva testing, as a non-invasive and easy-to-use in vitro diagnostic method, has been widely used in various fields such as virus screening, hormone level analysis, and gene testing. Current saliva collection methods typically involve physical contact sampling of the oral cavity using cotton swabs or swabs, followed by manual transfer of the collected saliva sample to a testing container for reaction analysis. However, this method has several problems in practical use.

[0003] First, traditional cotton swab sampling requires contact with the inside of the mouth, followed by exposure to air, before being inserted into the testing kit. This creates a "triple contamination window," easily introducing external contaminants and affecting the accuracy of test results. Clinical data shows a relatively high contamination rate. Second, saliva samples have a certain viscosity (typically in the range of 1.5–5.4 mPa·s), resulting in low transfer efficiency in capillaries or simple drainage devices, high sample residue, and reduced detection sensitivity. Finally, cotton swab collection generally causes discomfort by stimulating the mouth and triggering the gag reflex, especially for children, the elderly, or those with oral sensitivities, leading to a poor user experience.

[0004] Therefore, there is an urgent need for an integrated saliva collection and testing device that is simple in structure, avoids contamination, has high transfer efficiency, and provides a more user-friendly experience, in order to meet the needs of home testing, rapid screening, and other application scenarios. Utility Model Content

[0005] To address the problems existing in the prior art, this utility model proposes an integrated saliva collection and detection device. Through a threaded connection structure, saliva is directly introduced into the detection area. This utility model device establishes a closed sample path, eliminating operational contamination; it achieves active saliva flow control, improving transfer efficiency; and it eliminates the need for users to insert cotton swabs, enhancing the user's saliva collection experience.

[0006] The technical solution adopted in this utility model is to design an integrated saliva collection and detection device, including a funnel for collecting saliva and a detection card. The detection card includes a cavity and a detection component disposed in the cavity. The drain port of the funnel and the detection card have mutually mating threads, thereby enabling the funnel to communicate with the cavity. The drain port of the funnel is provided with a one-way valve diaphragm.

[0007] In some embodiments, the funnel's drain port is provided with an external thread, and the detection card is provided with an internal thread that mates with the external thread.

[0008] In some embodiments, the internal thread diameter is 5-8 mm.

[0009] In some implementations, the diameter of the funnel inlet port is 15-25 mm.

[0010] In some embodiments, the detection component includes a sample cell containing a test strip, one end of which corresponds vertically to the drain port of the funnel.

[0011] In some embodiments, the sample slots are arranged side by side, and each sample slot contains the test strip.

[0012] In some embodiments, the detection card is provided with an observation window corresponding to the test strip inside the cavity.

[0013] In some embodiments, an overflow hole is provided on the end sidewall of the sample tank.

[0014] In some embodiments, the overflow hole is located on the side wall at the end of the sample tank.

[0015] In some embodiments, the funnel and the detection card are each housed in separate sealed packages.

[0016] Compared with the prior art, the present invention has the following beneficial effects:

[0017] This novel sampler features a funnel-shaped inlet, allowing users to directly spit saliva into the test card via the guide channel, eliminating the need for a cotton swab. The test card contains a built-in test strip and maintains hydraulic stability through an overflow hole, offering advantages such as convenient operation, contamination prevention, and reliable detection. Attached Figure Description

[0018] The present invention will now be described in detail with reference to specific embodiments and accompanying drawings. To illustrate the details and facilitate understanding of its principles, the drawings are not necessarily to scale, and similar reference numerals may describe similar components in different views. The accompanying drawings generally illustrate the embodiments discussed herein by way of example and not limitation. Wherein:

[0019] Figure 1 This is a cross-sectional diagram of the funnel and the detection card connected together by threads.

[0020] Figure 2 This is a schematic diagram of the cross-section of the funnel.

[0021] Figure 3 This is a schematic diagram of the test card.

[0022] In the diagram, 1 is the funnel; 11 is the external thread; 2 is the test card; 21 is the internal thread opening; 3 is the cavity; 5 is the one-way valve diaphragm; 6 is the sample slot; 7 is the test paper; 8 is the observation window; and 9 is the overflow hole. Detailed Implementation

[0023] The following are specific embodiments of this utility model, and the technical solution of this utility model will be further described with reference to the accompanying drawings. However, this utility model is not limited to these embodiments, and the following embodiments do not limit the utility model involved in the claims. In addition, all combinations of features described in the embodiments are not necessarily necessary for the solution of the utility model.

[0024] The principle and structure of this utility model will be described in detail below with reference to the accompanying drawings and embodiments.

[0025] Example

[0026] like Figure 1 , 2 As shown in Figure 3, an integrated saliva collection and detection device includes a funnel 1 for collecting saliva and a detection card 2. The detection card 2 includes a cavity 3 and a detection component disposed within the cavity 3. The drain port of the funnel 1 and the detection card 2 have mating threads, thereby enabling communication between the funnel 1 and the cavity 3. The drain port of the funnel 1 is provided with a one-way valve diaphragm 5. The detection card 2 includes an elongated shell, the inner cavity of which is the cavity.

[0027] The core of this invention lies in: by designing a threaded connection structure and a one-way valve membrane 5 between the saliva collection funnel 1 and the detection card 2, the sealed conduction, directional control and zero-contact transfer of saliva from collection to detection are achieved, so as to solve the key problems of high contamination risk, low transfer efficiency and poor user experience in the prior art.

[0028] The funnel 1 and the detection card 2 are equipped with matching threaded structures, allowing for a sealed connection via screwing before use. Once connected, they form an integrated, sealed sampling system. Saliva remains enclosed within the device throughout the sampling, transfer, and detection processes, preventing exposure to air after collection. This achieves a fully sealed sampling path, improving system sealing and mechanical stability, and ensuring reliable detection.

[0029] A one-way valve membrane 5 is installed at the drain port of funnel 1, allowing saliva to flow unidirectionally into the cavity 3 of test card 2 under pressure or gravity, while preventing backflow or leakage. This directional saliva flow within the sealed channel prevents saliva leakage and contamination of the testing environment or user; it also ensures accurate sample introduction and improves testing reliability. After connecting funnel 1 to test card 2, the user spits out saliva, which automatically enters the testing cavity 3 under gravity through the one-way valve. This achieves a fully enclosed operation process of "zero exposure, zero contact" from collection to testing, eliminating the need for manual sample transfer, simplifying operation, avoiding human contamination, and automatically completing sample transfer, thus improving saliva utilization and testing consistency. The funnel 1 collection method is more natural and gentle than swab or cotton swab collection, avoiding contact with deep oral tissues. It reduces the risk of gag reflex, enhances sampling comfort, simplifies sampling actions, and allows users to complete the process by following the diagram, improving the universality and acceptance of home self-testing, especially suitable for children, the elderly, and people with oral sensitivities.

[0030] Furthermore, the funnel 1 has an external thread 11 on its discharge port, and the detection card 2 has an internal thread 21 that mates with the external thread 11. Before use, the user only needs to screw the funnel 1 into the detection card 2 in a rotating manner to ensure that the external thread 11 and the internal thread are tightly engaged, forming a reliable mechanical connection and a sealing channel.

[0031] This design features a forward-screw connection, aligning with intuitive user operation habits and allowing for control over connection strength and sealing performance through structural parameters. Compared to snap-fit ​​or plug-in methods, threaded connections offer stronger axial locking force and sealing performance. After screwing, a seamless connection is formed between the funnel and the detection card, effectively preventing saliva leakage at the connection point. This is particularly suitable for applications with high fluid viscosity (e.g., saliva 1.5–5.4 mPa·s), maintaining a long-term sealed state and preventing micro-leakage from affecting test results. The combination of external and internal threads has a self-locking function, preventing loosening or detachment. Even during shaking, inversion, or transportation, the saliva collection device maintains a stable connection, improving the product's disposable safety and portability, making it ideal for home users or field testing environments. Users simply need to tighten clockwise to complete the connection. The external thread is on one side of the funnel, facilitating hand-held rotation and conforming to ergonomic design. This structure can be combined with a torque stop design to provide a "tightened in place" indication, enhancing user experience and operational accuracy. Both external and internal threads can be integrally molded using injection molding, avoiding the need for additional connecting parts or sealing rings. This results in a simple structure, reduced manufacturing costs, and facilitates large-scale, low-cost production of the device.

[0032] Furthermore, the internal thread diameter is 5-8 mm. The internal thread diameter refers to the diameter of the through hole at the liquid inlet port of the detection card that is threaded to the liquid outlet end of the funnel, that is, the inlet opening size through which saliva flows into the detection chamber.

[0033] This orifice diameter range (5–8 mm) represents a comprehensive balance between saliva properties, flow efficiency, sealing performance, and user experience. This setting ensures smooth saliva flow and improves transfer efficiency. Saliva is a highly viscous non-Newtonian fluid with a viscosity typically between 1.5 and 5.4 mPa·s, significantly higher than water (approximately 1 mPa·s). If the internal thread orifice diameter is too small, it will severely impair saliva flow, easily causing blockages or residue buildup at the orifice, reducing sample utilization. A diameter of ≥5 mm is sufficient to allow a normal volume of saliva to flow smoothly into the detection chamber under natural gravity, improving saliva transfer rate, preventing residue buildup, and enhancing the consistency and accuracy of test results.

[0034] To prevent loosening or leaks at the connection between the funnel and the detection card, if the orifice diameter is too large (>8mm), the thread pitch will become correspondingly coarser, potentially shortening the spiral connection section and affecting the locking force and sealing performance. Maintaining a diameter of ≤8mm helps keep the number of thread turns within the effective engagement range, forming a stable and reliable connection. After tightening the thread, the funnel will not wobble or loosen, improving the overall assembly stability. An orifice diameter that is too small will result in slow flow, longer usage time, longer user wait times, and may be mistaken for blockage. An orifice diameter that is too large may lead to splashing, leakage, or risks of misoperation.

[0035] Furthermore, the diameter of the funnel's inlet port is 15-25mm. The diameter of the funnel's inlet port refers to the maximum cross-sectional diameter of the uppermost part of the funnel (i.e., the opening through which the user directly spits saliva). Its size directly affects the user's sampling convenience, flow efficiency, and hygiene safety. Limiting the diameter to 15-25mm is an optimal design range derived by comprehensively considering factors such as human mouth shape, saliva flow rate, the possibility of accidental spitting, visual positioning, and structural stability.

[0036] The maximum mouth width for adults is typically 30–45 mm, while the natural opening range for spitting saliva is 20–35 mm. If the funnel opening is too small, the user needs to aim carefully, and saliva is prone to spillage. If it is too large, it increases material waste and the risk of misoperation. A 15–25 mm opening is within the "comfortable aiming range" of the human body's natural spitting action. Users can accurately spit saliva in without special guidance, improving comfort and naturalness of action. This is especially suitable for children, the elderly, and other people with weaker coordination abilities, reducing saliva dripping or splashing outside the funnel and improving sampling cleanliness and success rate. Saliva is a viscous non-Newtonian fluid. If the inlet opening is narrow, it is easy to form "liquid column" or "liquid clump" phenomena, resulting in slow flow rate and more residue. The wide-mouth design facilitates natural saliva convergence and gravity introduction. A 15–25 mm opening ensures that saliva quickly flows into the center of the funnel without accumulation, reducing sample residue at the funnel edge, improving sample collection rate and detection accuracy, increasing overall flow efficiency, and reducing waiting time. The liquid naturally converges in the middle of the funnel, reducing adhesion and residue, thereby increasing the flow rate and improving the overall flow efficiency. This helps to control the flow stability of the sample entering the detection chamber and prevents sudden liquid inflow that could cause back pressure or splashing.

[0037] Furthermore, the detection component includes a sample slot 6, in which a test strip 7 is disposed, and one end of the sample slot 6 corresponds vertically to the drain port of the funnel 1.

[0038] The sample slot 6 is located inside the test card 2, directly below the outlet of the funnel 1. Once saliva flows out of the outlet of the funnel 1, it is guided by a one-way valve and immediately falls into the test strip 7 area within the sample slot 6. Through capillary reaction, it moves towards the top of the test strip without the need for transfer, tilting, or shaking. This shortens the response time from sample collection to detection, achieving a rapid response of "instant color development upon drop." Saliva directly contacts the test strip 7, improving sample utilization and reducing waste. It also prevents saliva from flowing or spreading within the cavity 3 of the test card 2, reducing errors and improving the specificity and accuracy of the test. Through the corresponding vertical arrangement of the outlet of the funnel 1 and the sample slot 6, saliva falls "vertically" into the sample slot 6 under gravity, without needing to flow through other parts or channels. This design reduces the probability of sample contact with air and material interfaces during the flow path, preventing cross-contamination and avoiding sample turbulence, spillage, or adhesion to other areas within cavity 3. It also improves the system's sealing and hygiene, simplifies the internal flow channel structure of test card 2, and reduces manufacturing complexity and product failure rate. Sample slot 6 is a pre-positioned detection area where test strip 7 is located. The modular integration of "sample slot 6 + test strip" into test card 2 facilitates assembly, testing, and packaging during production.

[0039] Furthermore, it includes a plurality of sample slots 6 arranged side by side, each of which is provided with a test strip 7.

[0040] By collecting saliva in a single sample, multiple sample slots 6 are simultaneously introduced. The test strips 7 in each sample slot 6 can react independently for different detection items or target substances, or the same target substance can be repeatedly tested on multiple test strips, improving the reliability of the results. This is a multi-channel parallel detection structure that achieves expanded detection capabilities and parallel analysis of multiple indicators without increasing sampling complexity. Obtaining multiple detection data points from a single saliva spitting operation improves detection throughput and information efficiency, making it suitable for various rapid screening scenarios, such as comprehensive home self-testing, school epidemic prevention testing, and pre-competition testing for athletes, demonstrating the systemic advantages of the device's "integrated detection."

[0041] Even if the test strips 7 are configured identically in multiple sample slots 6, repeated testing can be achieved for comparison, correction, or validity assessment. This enables repeated testing at multiple sites on the same sample, reducing the impact of occasional errors on the final result. It provides a multi-channel data source for recognition or image comparison algorithms, enhancing reliability, and is particularly suitable for home users or non-professional operating scenarios, improving the reliability of the final judgment.

[0042] The sample slots 6 are arranged in parallel within the detection card 2, and a reasonable guide channel or diversion structure is designed to allow saliva to naturally distribute into multiple sample slots 6 upon inflow. Utilizing capillary action, automatic sample diversion without power is achieved, ensuring consistent saliva content in each detection zone, improving reaction condition uniformity, optimizing sample utilization, and reducing invalid reactions caused by flow deviation. The modular parallel sample slot structure 6 allows for flexible addition or reduction of the number of detection channels and configuration of detection items as needed.

[0043] Furthermore, the test card 2 is provided with an observation window 8 corresponding to the test strip 7 inside the cavity 3. The observation window 8 is located in the middle of the upper shell of the test card.

[0044] Test strips 7 typically display results through color development (such as red / blue lines, fluorescence, color intensity, etc.). Without the observation window 8, users cannot determine whether the test is complete or valid. The observation window 8 allows users to see the color reaction area of ​​the test strip immediately without disassembling the cartridge or opening any part. For strip-type test strips that do not require specialized instruments for reading (such as gold-labeled colorimetric strips, pH colorimetric strips, etc.), results can be quickly determined, clearly distinguishing between "not detected," "positive," and "invalid" states, improving ease of use and accuracy. The test card 2 remains completely sealed, and users observe only through the transparent area, avoiding contact with the saliva sample area. This enhances biosafety, reduces detection interference, and ensures sample integrity and the validity of the test strip 7, especially in infectious sample scenarios such as virus testing. The observation window 8 is made of transparent or semi-transparent material, such as transparent plastic or thin glass, allowing light to pass through and making it suitable for applications such as visual recognition and image acquisition.

[0045] Furthermore, an overflow hole 9 is provided on the side wall of the sample tank 6. Excess saliva is discharged through the overflow hole 9 to avoid siphon interference.

[0046] During saliva sampling, when the volume of saliva in the sample trough 6 exceeds the expected upper limit, the excess saliva can be automatically discharged or directed through the overflow hole 9, thereby preventing liquid from overflowing from the sample trough 6 or submerging the color development area of ​​the test strip 7, ensuring the accuracy of the detection reaction and the readability of the strips.

[0047] After being soaked in liquid, the test strip needs to maintain a suitable capillary migration rate and reaction distance. If there is too much saliva, the test strip will be over-soaked, and the bands may become blurred, diffused, or misaligned, affecting the interpretation of the results. The overflow hole 9 can automatically drain excess saliva, preventing the test strip from becoming saturated or drifting, ensuring a constant liquid content in the reaction zone, and maintaining the clarity and positional accuracy of the chromatographic bands. This is especially important for protecting moisture-sensitive materials such as fluorescent strips and colorimetric membranes. Individual differences exist in the amount of saliva users spit out; some people may far exceed the absorbency of the test strip, causing the sample chamber 6 to overflow and even contaminate other functional areas. The overflow hole 9 automatically drains excess saliva before the sample chamber 6 reaches saturation, preventing saliva from spilling into other sample chambers 6 or observation windows 8, avoiding cross-contamination or interference with test results, and improving the overall safety, cleanliness, and reliability of the product. By designing the overflow hole 9 to connect with the guide channel (or absorbent cotton), excess saliva can be diverted to a specific waste liquid area or absorption area, rather than spreading freely. It enables internal liquid path management, ensuring that each functional area does not interfere with each other. It can be linked with the closed structure to prevent liquid from leaking outside the detection card 2, which is beneficial for liquid isolation between independent detection areas in the multi-channel sample tank 6.

[0048] Furthermore, the overflow hole is located on the side wall at the end of the sample well. The reaction zone of the test strip should generally not be completely submerged. The overflow hole on the side wall is typically located at the end of the sample well, below the drain port of the funnel. When the saliva level rises close to the set height, the overflow hole on the side wall promptly removes excess saliva, preventing excessive liquid from soaking the color development area of ​​the test strip and maintaining accurate and clear color development.

[0049] Furthermore, the funnel 1 and the detection card are respectively housed in separate sealed packages.

[0050] Before use, funnel 1 and the detection housing are in separate, non-contact, clean encapsulated environments to prevent cross-contamination or interface damage during transportation, storage, and distribution. Users assemble both components as instructed before spitting saliva, ensuring the biosafety, sealing, and operational reliability of the entire sampling-detection pathway.

[0051] The packaging consists of a plastic bag and an aluminum foil bag. Users tear open the packaging of the saliva collector and the test card, assemble the external threaded interface of the saliva collector with the internal threaded interface of the test card, and then directly spit out saliva (≥0.5ml) into the funnel of the saliva collector. After the saliva breaks through the one-way valve membrane and enters the sample pad of the test strip on the test card, the liquid wets the test strip and begins to develop color. At the same time, excess saliva is discharged through the overflow hole to avoid siphon interference.

[0052] The specific embodiments described herein are merely illustrative examples illustrating the spirit of this utility model. Those skilled in the art to which this utility model pertains may make various modifications or additions to the described specific embodiments or use similar methods to replace them, without departing from the spirit of this utility model or exceeding the scope defined by the appended claims.

Claims

1. A saliva collection and detection integrated device, comprising a funnel for collecting saliva and a detection card, wherein the detection card includes a cavity and a detection component disposed within the cavity, characterized in that, The drain port of the funnel has a thread that mates with the detection card, thereby allowing the funnel to communicate with the cavity. The drain port of the funnel is provided with a one-way valve diaphragm. The detection assembly includes a sample tank, in which a test strip is placed. One end of the sample tank corresponds vertically to the drain port of the funnel. An overflow hole is provided on the side wall of the sample tank, located on the side wall at the end of the sample tank.

2. The integrated saliva collection and detection device according to claim 1, characterized in that, The funnel has an external thread at its drain port, and the detection card has an internal thread that mates with the external thread.

3. The integrated saliva collection and detection device according to claim 2, characterized in that, The diameter of the internal thread is 5-8mm.

4. The integrated saliva collection and detection device according to claim 2, characterized in that, The diameter of the inlet port of the funnel is 15-25mm.

5. The integrated saliva collection and detection device according to claim 1, characterized in that, It includes multiple sample slots arranged side by side, and each sample slot contains the test strip.

6. The integrated saliva collection and detection device according to claim 1, characterized in that, The test card is provided with an observation window corresponding to the test strip inside the cavity.

7. The integrated saliva collection and detection device according to claim 5, characterized in that, The test card is provided with an observation window corresponding to the test strip inside the cavity.

8. The integrated saliva collection and detection device according to claim 1, characterized in that, The funnel and the detection card are each housed in separate sealed packages.

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