A flip-top integrated anti-pollution colloidal gold kit

Abstract

The utility model relates to the technical field of in-vitro diagnosis discloses a flip type integrated anti -pollution colloidal gold reagent box, including small flip, big flip, transparent window, shell and detection component, wherein, the first accommodating groove and the second accommodating groove are set up on the shell, small flip and big flip are all hinged to the outside of shell, are used for respectively closing the first accommodating groove and the second accommodating groove, the transparent window is set up on big flip, the second accommodating groove is provided with the sample addition hole, the observation port and the water suction mouth that communicate with the inside of shell, when big flip closes the second accommodating groove, the transparent window is located the top of observation port, and the detection component sets up in the inside of shell, the utility model discloses through the integration flip design and shell optimization, solve the pollution risk and the complexity problem of operation of existing packaging, realize the whole process closed operation of sample addition, chromatography, interpretation, significantly improve the home applicability of colloidal gold reagent box.

Description

Technical Field

[0001] This utility model relates to the field of in vitro diagnostic technology, and in particular to a flip-top integrated anti-contamination colloidal gold reagent kit. Background Technology

[0002] Colloidal gold chromatography, due to its speed and convenience, has become an important tool in the field of in vitro diagnostics. However, the packaging design of existing colloidal gold reagent kits has significant flaws. The sample dispensing port and result display area are constantly exposed to the external environment, making them susceptible to contaminants, leading to sample contamination or test strip failure. Traditional packaging typically requires users to disassemble individual components multiple times, such as blood collection tubes and droppers, making the process cumbersome and increasing the complexity of home use. Furthermore, in existing technologies, the test strip is directly exposed to the air after sample dispensing, posing a risk of cross-contamination, especially in scenarios involving bodily fluid samples such as blood and saliva.

[0003] While existing technologies have attempted to reduce the risk of contamination by encapsulating the sample dispensing port with aluminum-plastic film, their designs are not optimized for the chromatographic characteristics of colloidal gold test strips. For example, the result display area lacks independent sealing protection, and the interpretation window may still be affected by environmental interference; the outer casing structure is complex and lacks a portable design suitable for home use. Utility Model Content

[0004] In view of the shortcomings of the prior art described above, the purpose of this utility model is to provide a flip-top integrated anti-contamination colloidal gold reagent kit. Through the integrated flip-top design and shell optimization, the contamination risk and operational complexity of existing packaging are solved, and the entire process of sample addition, chromatography and interpretation is closed, which significantly improves the home applicability of colloidal gold reagent kits.

[0005] The present invention adopts the following technical solution:

[0006] A flip-top integrated anti-contamination colloidal gold reagent kit includes a small flip-top, a large flip-top, a transparent window, a housing, and a detection component. The housing has a first and a second receiving slot. The small and large flip-tops are hinged to the outside of the housing to respectively close the first and second receiving slots. The large flip-top has the transparent window. The second receiving slot has a sample application port, an observation port, and a water absorption port communicating with the interior of the housing. When the large flip-top closes the second receiving slot, the transparent window is positioned above the observation port. The detection component is located inside the housing.

[0007] Preferably, in the above-mentioned flip-top integrated anti-contamination colloidal gold reagent kit, a rotating shaft is installed in the second receiving slot, the large flip-top is connected to the rotating shaft, a fastener is provided on the large flip-top, and a lock is provided on the housing. The large flip-top closes the second receiving slot by the cooperation of the fastener and the lock.

[0008] Preferably, the above-mentioned flip-top integrated anti-contamination colloidal gold reagent kit further includes an integrated needle, which is disposed inside the housing through a needle receiving hole provided on the housing.

[0009] Preferably, in the above-mentioned flip-top integrated anti-contamination colloidal gold reagent kit, the integrated needle includes a connected operating end and a needle tip.

[0010] Preferably, in the above-mentioned flip-top integrated anti-contamination colloidal gold reagent kit, a sterile cotton ball is provided in the first receiving slot.

[0011] Preferably, in the above-mentioned flip-top integrated anti-contamination colloidal gold reagent kit, a capillary tube is attached to the inner side of the small flip-top.

[0012] Preferably, in the above-mentioned flip-top integrated anti-contamination colloidal gold reagent kit, the detection component includes a PVC sheet, a sample pad, a colloidal gold binding pad, a chromatography membrane, a detection line T, a control line C, and an absorbent layer; wherein, the sample pad, the colloidal gold binding pad, the chromatography membrane, and the absorbent layer are all disposed on the PVC sheet, a portion of the colloidal gold binding pad is disposed at the lower end of the sample pad, a portion of the colloidal gold binding pad is disposed at the upper end of the chromatography membrane, the detection line T and the control line C are disposed on the chromatography membrane, a portion of the absorbent layer is disposed at the upper end of the chromatography membrane, the sample application port corresponds to the position of the sample pad, the observation port corresponds to the position of the detection line T and the control line C, and the absorbent layer corresponds to the position of the absorption port.

[0013] Preferably, in the above-mentioned flip-top integrated anti-fouling colloidal gold reagent kit, a flow guiding gap is provided between the absorbent layer and the chromatography membrane.

[0014] Preferably, in the above-mentioned flip-top integrated anti-contamination colloidal gold reagent kit, the width of the flow channel gap is 1.5 to 2.5 mm.

[0015] Preferably, in the above-mentioned flip-top integrated anti-fouling colloidal gold reagent kit, the absorbent layer is bonded to the end of the chromatography membrane by UV adhesive.

[0016] Compared with the prior art, the beneficial effects of this utility model are as follows:

[0017] This invention utilizes a physically isolated double-flip-top design: the smaller flip-top isolates the sample preparation contaminant source, while the larger flip-top isolates the core detection area. Combined with an integrated structure including a transparent observation window, sample dispensing port, observation port, and suction port, this significantly improves anti-contamination performance, effectively preventing cross-contamination of the detection area from sample preparation and contamination of the external environment and operator from the detection area. This ensures the accuracy of test results and the safety of operation. Simultaneously, the integrated design and flip-top-guided operation process make the reagent kit simple, fast, and user-friendly, making it ideal for point-of-care testing scenarios. Attached Figure Description

[0018] To more clearly illustrate the technical solutions in the embodiments of this utility model or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this utility model. For those skilled in the art, other drawings can be obtained based on the structures shown in these drawings without creative effort.

[0019] Figure 1 This is a structural diagram of a fully enclosed flip-top integrated anti-pollution colloidal gold reagent kit according to an embodiment of the present invention.

[0020] Figure 2 This is a structural diagram of the large flip-top open state of an integrated anti-pollution colloidal gold reagent kit according to an embodiment of the present invention.

[0021] Figure 3 This is a structural diagram of the small flip-top open state of a flip-top integrated anti-pollution colloidal gold reagent kit according to an embodiment of the present invention.

[0022] Figure 4 This is a schematic diagram of the inner side of the small flip cap of a flip-top integrated anti-pollution colloidal gold reagent kit according to an embodiment of the present invention;

[0023] Figure 5 This is a diagram of the integrated needle structure of a flip-top type integrated anti-pollution colloidal gold reagent kit according to an embodiment of the present invention.

[0024] Figure 6 This is a structural diagram of the detection component of a flip-top integrated anti-contamination colloidal gold reagent kit according to an embodiment of the present invention.

[0025] Explanation of reference numerals in the attached figures:

[0026] In the diagram, 1. Small flip cover; 2. Large flip cover; 3. Integrated needle; 4. Transparent window; 5. Shell; 6. Sample dispensing port; 7. Observation port; 8. Absorption port; 9. Button; 10. Lock; 11. Rotating shaft; 12. Sterile cotton ball; 13. First receiving tank; 14. Capillary tube; 15. Second receiving tank; 16. Needle tip; 17. Sample pad; 171. First sample pad body; 172. First sample pad body; 18. Colloidal gold binding pad; 19. Detection line T; 20. Quality control line C; 21. Chromatography membrane; 22. Absorbent material; 23. PVC sheet; 24. Flow guide gap; 25. Operating end. Detailed Implementation

[0027] The following specific examples illustrate the implementation of this utility model. Those skilled in the art can easily understand other advantages and effects of this utility model from the content disclosed in this specification. This utility model can also be implemented or applied through other different specific embodiments, and various details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of this utility model. It should be noted that, unless otherwise specified, the following embodiments and features described therein can be combined with each other.

[0028] In the description of this utility model, unless otherwise stated, "a plurality of" means two or more; the terms "upper," "lower," "left," "right," "inner," "outer," "front end," "rear end," "head," "tail," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this utility model and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this utility model. In addition, the terms "first," "second," "third," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0029] In the description of this utility model, it should be noted that, unless otherwise explicitly specified and limited, the terms "connected" and "linked" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium. Those skilled in the art can understand the specific meaning of the above terms in this utility model according to the specific circumstances.

[0030] The present invention will now be further described with reference to the accompanying drawings.

[0031] This utility model provides a flip-top integrated anti-contamination colloidal gold reagent kit, such as... Figures 1 to 3As shown, this flip-top integrated anti-contamination colloidal gold reagent kit includes a small flip-top 1, a large flip-top 2, a transparent window 4, a housing 5, and a detection component (located inside the housing 5 and therefore not shown in the image). Figures 1 to 3 (as shown in the figure); wherein, the housing 5 is provided with a first receiving groove 13 and a second receiving groove 15, the small flip cover 2 and the large flip cover 3 are both hinged to the outside of the housing 5, and are used to close the first receiving groove 13 and the second receiving groove 15 respectively. The large flip cover 3 is provided with a transparent window 4. The second receiving groove 15 is provided with a sample feeding hole 6, an observation port 7 and a water suction port 8 that communicate with the inside of the housing. When the large flip cover 3 closes the second receiving groove 15, the transparent window 4 is located above the observation port 7. The detection component is located inside the housing 5.

[0032] In use, the user first opens the small flip cover 1, revealing the first receiving slot 13. The first receiving slot 13 typically contains or is used to hold sample collection / processing tools. The user uses these tools to collect samples. The tools included are determined based on the sample to be collected for testing; for example, the sample may be blood, saliva, urine, etc. After sample collection, the user opens the large flip cover 3, revealing the second receiving slot 15. The sample application port 6 is visible in the second receiving slot 15. The user drips the prepared sample liquid through the sample application port 6, which is connected to the interior of the housing 5. The sample then enters the reagent kit and proceeds to the detection component for testing. Once inside the housing 5, the sample contacts the internal detection component. The sample is chromatographically deposited along the nitrocellulose membrane of the test strip by capillary action. The target analyte (antigen or antibody) in the sample binds to the pre-embedded colloidal gold label (such as gold-labeled antibody or gold-labeled antigen) on the test strip, forming a complex. This complex continues chromatographically, reaching the detection line (T line) and the control line (C line). At the test line, the target complex is captured by the immobilized trapping substance, aggregates, and develops a color, typically a red / purple line. Regardless of the presence of the target analyte in the sample, excess colloidal gold labeling or complexes continue to flow to the control line, where they are captured and developed by the immobilized substance, serving as a control for experimental validity. The absorbent port 8, located at the end of the chromatography line, absorbs excess liquid flowing through the entire test strip, maintaining capillary action. During the reaction or after the specified time, the user does not need to open the large flip-top 3. The user can directly observe the results through the transparent window 4 on the large flip-top 3. When the large flip-top 3 is closed, the transparent window 4 precisely covers the observation port 7 within the second receiving compartment 15. The observation port 7 communicates with the interior of the housing 5 and faces the reading area of ​​the detection component, i.e., the location of the T and C lines. Therefore, through the transparent window 4 and the observation port 7, the user can clearly see the color development of the test line T and the control line C on the test strip, thus interpreting the test results, which are typically positive, negative, or invalid.

[0033] This invention employs a dual-flip design with independent small flip-tops 1 and large flip-tops 3 to physically isolate the first receiving slot 13 (serving as the sample preparation area) and the second receiving slot 15 (serving as the sample addition / result reading area). The small flip-top 1 is only opened when handling raw samples or sample processing tools that may pose a risk of biological contamination, and is closed after the operation, thus sealing the source of contamination within the first receiving slot 13. The large flip-top 3 is only briefly opened during sample addition and is closed afterward. In its closed state, it covers the entire second receiving slot 15, effectively preventing external environmental contaminants from entering the core detection area and preventing the accidental escape of aerosols or liquids that may be generated during the detection reaction, thus preventing contamination of the environment or the user. The two flip-tops, when closed, form a reliable physical barrier, significantly reducing the possibility of contaminating the detection area during sample preparation or contaminating the environment from the detection area. This is crucial for ensuring the accuracy of test results (avoiding false positives / false negatives) and operator safety.

[0034] In some embodiments, such as Figures 1 to 3 As shown, both the small flip cover 1 and the large flip cover 2 can be hinged to the outside of the housing 5 using a pivot and a latch. The pivot is used to enable the small flip cover 1 or the large flip cover 2 to rotate relative to the housing 5, while the latch is used to fix the small flip cover 1 or the large flip cover 2 on the housing 5 so that it can close the first receiving groove 13 and the second receiving groove 15.

[0035] Taking the hinged installation achieved by the second receiving groove 15 as an example, such as Figure 2 As shown, a rotating shaft 11 is installed in the second receiving groove 15, and the large flip cover 3 is connected to the rotating shaft 11. A key 9 is provided on the large flip cover 3, and a lock 10 is provided on the housing 5. The large flip cover 3 closes the second receiving groove 15 by the cooperation of the key 9 and the lock 10.

[0036] In some embodiments, such as Figures 1 to 3 As shown, the flip-top integrated anti-contamination colloidal gold reagent kit also includes an attached needle 3, which is disposed within the housing 5 through a needle receiving hole. To facilitate the removal of the attached needle 3, its length can be greater than the depth of the needle receiving hole, so that when the attached needle 3 is disposed within the housing 5, a portion of the attached needle 3 protrudes outward relative to the surface of the housing 5. This allows the attached needle 3 to be removed for collecting test samples, such as collecting fingertip blood.

[0037] In some embodiments, such as Figure 5 As shown, the integrated needle 3 includes a connected operating end 25 and a needle tip 16.

[0038] In some embodiments, such as Figure 3 As shown, a sterile cotton ball 12 is placed in the first receiving tank 13.

[0039] In some embodiments, such as Figure 4As shown, a capillary tube 14 is attached to the inside of the small flip cover 1.

[0040] In use, open the small flip cover 1, remove the capillary tube 14, and then remove the attached needle 3. The user can use their right hand to take out the needle from the kit and prick the tip of their left finger. Place the fingertip close to the capillary tube attached to the inside of the small flip cover, and open the large flip cover 2. Guided by the capillary tube, allow blood to flow through the capillary tube into the sample well 6. After blood collection, close the large flip cover 2. The sterile cotton ball under the small flip cover 2 can be used to press on the left fingertip to stop bleeding. Wait for the detection component to react. After the appropriate time has elapsed, the final result can be viewed through the transparent window 4.

[0041] In some embodiments, such as Figure 6 As shown, the detection assembly includes a PVC sheet 23, a sample pad 17, a colloidal gold-binding pad 18, a chromatography membrane 21, a detection line T19, a control line C20, and an absorbent layer 22. The sample pad 17, colloidal gold-binding pad 18, chromatography membrane 21, and absorbent layer 22 are all mounted on the PVC sheet 23. A portion of the colloidal gold-binding pad 18 is located at the lower end of the sample pad 17, and another portion is located at the upper end of the chromatography membrane 21. The detection line T19 and control line C20 are mounted on the chromatography membrane 21. A portion of the absorbent layer 22 is located at the upper end of the chromatography membrane 21. The sample application port 6 corresponds to the position of the sample pad 17, the observation port 7 corresponds to the positions of the detection line T19 and control line C20, and the absorbent layer 22 corresponds to the position of the absorption port 8.

[0042] After the sample is added to sample pad 17, it is absorbed and large particles are filtered out. The sample liquid flows from sample pad 17 to the partially overlapping colloidal gold-binding pad 18 under capillary action. In the colloidal gold-binding pad 18, the target analyte in the sample specifically binds to the colloidal gold label pre-fixed on the pad, forming a "target analyte-colloidal gold label" complex. The complex and liquid continue to flow from colloidal gold-binding pad 18 to the partially overlapping chromatography membrane 21 under capillary action. On chromatography membrane 21, the liquid carries the complex forward. When it flows past detection line T19, if the sample contains the target analyte, the "target analyte-colloidal gold label" complex will be captured and aggregated by the trapping material fixed on detection line T19, forming a visible red / purple band. Regardless of whether the sample contains the target analyte, the liquid and excess colloidal gold labeling continue to flow through the control line C20. The substance immobilized on the control line C20 (usually an antibody against the gold-labeled antibody or other control) captures the colloidal gold labeling, forming another red / purple band, indicating that the chromatography process was completed normally and the reagent was effective. The liquid continues to flow to the absorbent layer 22, which partially overlaps with the chromatography membrane 21. The absorbent layer 22 is precisely positioned corresponding to the absorbent port 8. The absorbent layer 22 continuously absorbs the liquid flowing through the test strip, providing continuous power for capillary action and ensuring a complete reaction. The observation port 7 is precisely positioned corresponding to the area of ​​the detection line T19 and the control line C20 on the chromatography membrane 21. Therefore, the user can clearly see the color development of the detection line T19 and the control line C20 through the transparent window 4 and the observation port 7, and interpret the results accordingly (positive: both T and C lines are colored; negative: only C line is colored; invalid: C line is not colored).

[0043] In some embodiments, such as Figure 6 As shown, the sample pad 17 includes a first sample pad body 171 and a second sample pad body 172, which are joined together by a hot-pressing process. The first sample pad body is fixed to the front end of the PVC sheet 23, and the second sample pad body 172 is connected to the chromatography membrane 21 (such as nitrocellulose paper) through a colloidal gold-bonded pad 18. The sample pad 17 adopts a double-layer glass fiber structure, with a coarse fiber layer (pore size 20-40 μm) on top and a fine fiber layer (pore size 5-10 μm) on the bottom, which is used to absorb samples and filter impurities, thereby improving detection accuracy.

[0044] In some embodiments, a colloidal gold conjugate pad 18 is disposed at the rear end of the sample pad 17 and coated with colloidal gold labels with a particle size of 40 nm. The colloidal gold particles are prepared by sodium citrate reduction and their surface is modified with target-specific antibodies. The colloidal gold conjugate pad 18 is uniformly sprayed using a gold sprayer at a flow rate of 0.1 μL / mm, and after drying, a stable binding layer is formed, ensuring that the label binds efficiently to the target analyte during chromatography.

[0045] In some embodiments, the chromatography membrane 21 is fixed to the middle of a PVC sheet, with its front end bonded to the colloidal gold conjugate pad 18 using UV adhesive, and its rear end connected to the absorbent layer 22. Target-specific antibodies are sprayed onto the chromatography membrane 21 to form a detection line T19 and a control line C20. The spraying process employs a non-contact micro-spotting technique, with the line width controlled within 0.5 mm to ensure clear and easily readable color development.

[0046] In some embodiments, the absorbent layer 22 may be selected as a highly absorbent resin layer, which is bonded to the end of the chromatography membrane 21 with UV adhesive, leaving a flow guide gap 24 of 1.5 to 2.5 mm between them. This flow guide gap 24 is formed by precision molding, and the chromatography rate is controlled by capillary action to ensure that the sample flows through the detection line and the control line at a uniform speed, avoiding false positives or false negatives caused by uneven flow rates.

[0047] In some embodiments, the result display area of ​​the detection component corresponds to the detection line and control line of the nitrocellulose paper, and the result can be directly read through the transparent window 4: if both the detection line and the control line are colored, it indicates that the target analyte detection is positive; if only the control line is colored, it is negative; if no color is displayed, the detection is deemed invalid.

[0048] The above embodiments are only used to illustrate the technical solutions of this utility model, and are not intended to limit it. Although the utility model has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of this utility model, and they should all be covered within the scope of the claims and specification of this utility model.

Claims

1. A flip-top integrated colloidal gold kit for preventing contamination, characterized in that, The device includes a small flip cover, a large flip cover, a transparent window, a housing, and a detection component. The housing has a first and a second receiving groove. Both the small and large flip covers are hinged to the outside of the housing to respectively close the first and second receiving grooves. The large flip cover has the transparent window. The second receiving groove has a sample application hole, an observation port, and a water intake port communicating with the interior of the housing. When the large flip cover closes the second receiving groove, the transparent window is positioned above the observation port. The detection component is located inside the housing.

2. The integrated cover-type contamination-proof colloidal gold kit according to claim 1, characterized in that, A pivot is installed in the second receiving slot, and the large flip cover is connected to the pivot. A key is provided on the large flip cover, and a lock is provided on the housing. The large flip cover closes the second receiving slot by the cooperation of the key and the lock.

3. The integrated cover-type contamination-proof colloidal gold kit according to claim 1, characterized in that, It also includes an integrated needle, which is disposed inside the housing through a needle receiving hole provided on the housing.

4. The integrated cover-type contamination-proof colloidal gold kit according to claim 3, characterized in that, The integrated needle includes a connected operating end and a needle tip.

5. The integrated cover-type contamination-proof colloidal gold kit according to claim 1, characterized in that, The first receiving tank is provided with sterile cotton balls.

6. The integrated cover-type contamination-proof colloidal gold kit according to claim 1, characterized in that, A capillary tube is attached to the inside of the small flip cover.

7. The integrated lid-type contamination-proof colloidal gold kit according to any one of claims 1 to 6, characterized in that, The detection assembly includes a PVC sheet, a sample pad, a colloidal gold-binding pad, a chromatography membrane, a detection line T, a control line C, and an absorbent layer. The sample pad, colloidal gold-binding pad, chromatography membrane, and absorbent layer are all disposed on the PVC sheet. A portion of the colloidal gold-binding pad is disposed at the lower end of the sample pad, and a portion of the colloidal gold-binding pad is disposed at the upper end of the chromatography membrane. The detection line T and the control line C are disposed on the chromatography membrane. A portion of the absorbent layer is disposed at the upper end of the chromatography membrane. The sample application port corresponds to the position of the sample pad, the observation port corresponds to the position of the detection line T and the control line C, and the absorbent layer corresponds to the position of the absorption port.

8. The flip-top integrated anti-contamination colloidal gold reagent kit according to claim 7, characterized in that, A flow-guiding gap is provided between the water-absorbing layer and the chromatography membrane.

9. The integrated lid-type contamination-proof colloidal gold kit according to claim 8, characterized in that, The width of the flow guide gap is 1.5 to 2.5 mm.

10. The integrated cover-type contamination-proof colloidal gold kit according to claim 7, characterized in that, The absorbent layer is bonded to the end of the chromatography membrane with UV adhesive.

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