Hepatitis B virus five-item detection kit convenient to titrate

Abstract

The utility model relates to a convenient-to-titrate hepatitis B virus five-item detection kit, which solves the technical problem that the dropping position is easy to be inaccurate when the existing detection kit detects dropping buffer solution, and comprises a sample adding hole, slots arranged on the side wall of a detection card body are symmetrically arranged on two sides of the sample adding hole, and the slots are arranged on the side wall of the detection card body. The detection card body is provided with a plurality of slots, the slots are detachably matched with arched limiting plates in a sliding manner, the inner sides of the lower ends of the limiting plates are fixedly provided with inserting blocks matched with the slots, the limiting plates are provided with limiting holes corresponding to the sample adding holes, and integrated disposable buffer solution devices are inserted into the limiting holes. After the limiting plate is inserted into the detection card body, a limiting foundation for subsequently dropwise adding a buffer solution can be fixed, and after a buffer solution device is arranged, the accuracy of dropwise adding the buffer solution can be improved, the buffer solution can be accurately dropwise added, meanwhile, the waste of the buffer solution is avoided, the buffer solution is saved, and only a small amount of buffer solution needs to be prepared.

Description

Technical Field

[0001] This utility model relates to the field of hepatitis virus detection technology, specifically a convenient titration hepatitis B virus five-item detection kit. Background Technology

[0002] The Hepatitis B virus five-item test, also known as the Hepatitis B five-item test, mainly includes Hepatitis B surface antigen, Hepatitis B surface antibody, Hepatitis B e antigen, Hepatitis B e antibody, and Hepatitis B core antibody. It is primarily used to determine whether someone is infected with Hepatitis B. It employs the colloidal gold method, a commonly used immunochromatographic technique. The test kit is simple, rapid, and accurate, allowing for rapid testing in the clinical setting. It can be used as a screening tool for Hepatitis B virus infection, as well as for diagnostic and monitoring purposes. This test kit has significant clinical value for early screening and diagnosis of Hepatitis B virus infection, as well as for the treatment and intervention of Hepatitis B virus-infected individuals. Besides clinical applications, this test kit can also be used for patient self-testing, offering advantages such as ease of operation, convenience, speed, and affordability.

[0003] Existing test kits have limitations when adding buffer solution. The small sample wells on the test card make it difficult to accurately control the placement of the solution, and any deviation can affect the accuracy of the test. Furthermore, the test kits are disposable, and the provided buffer solution is often larger than the required amount. For patients, once the test is completed, the buffer solution becomes useless, resulting in waste.

[0004] Based on this, the present invention provides a convenient titration kit for detecting five hepatitis B virus markers. Utility Model Content

[0005] In view of the above situation and to overcome the defects of the prior art, this utility model provides a convenient titration hepatitis B virus five-item test kit. This utility model has a novel structure and ingenious design, and effectively solves the technical problem that the addition position of the buffer solution in existing test kits is easily inaccurate.

[0006] A convenient titration hepatitis B virus five-item test kit includes a test card body, which has an ID area, a category area, a display area, and a sample area. The sample area includes a sample application well. The kit is characterized by having slots symmetrically positioned on both sides of the sample application well and placed on the side wall of the test card body. An arched limiting plate is detachably slidably fitted to the slot. A matching insert block is fixed to the inner side of the lower end of the limiting plate. A limiting hole corresponding to the sample application well is formed on the limiting plate, and an integrated disposable buffer solution device is inserted into the limiting hole.

[0007] Preferably, the buffer solution device includes a film on which five buffer solution dropper bottles corresponding to the sample dispensing positions are fixed. The lower ends of the buffer solution dropper bottles are sequentially connected to an upper outlet tube, a squeeze tube, and a lower outlet tube. The diameter of the squeeze tube is larger than that of the upper and lower outlet tubes. A glass ball is inserted into the squeeze tube. The lower end of the lower outlet tube is connected to a titration port located below the limiting plate.

[0008] Preferably, the titration port is conical.

[0009] Preferably, a limiting ring is fixed to the titration port and placed at the lower end of the limiting plate.

[0010] Preferably, the substrate has a notch positioned at the limiting ring.

[0011] Preferably, the test kit further includes an inner box containing a sponge block with multiple placement slots.

[0012] Preferably, the test kit also includes a packaging box.

[0013] Preferably, the category area includes HBsAg, HBsAb, HBeAg, HBeAb, and HBcAb, and the display area includes positive and negative results.

[0014] This utility model has the following technical effects:

[0015] This invention adds a limiting plate at low cost without affecting the function of the test card itself. When the limiting plate is inserted into the test card, it can fix the limiting base for subsequent addition of buffer solution. After the buffer solution device is installed, the accuracy of buffer solution addition can be improved, ensuring that the buffer solution can be accurately added. At the same time, it avoids the waste of buffer solution and saves buffer solution, requiring only a small amount. Attached Figure Description

[0016] The accompanying drawings are provided to further illustrate the present invention and form part of the specification. They are used together with the embodiments of the present invention to explain the present invention, but do not constitute a limitation thereof. In the drawings:

[0017] Figure 1 This is a three-dimensional structural diagram of the present invention.

[0018] Figure 2 This is a schematic diagram of the main structure of this utility model.

[0019] Figure 3 This is a three-dimensional explosion diagram of the present invention.

[0020] Figure 4 This is a three-dimensional schematic diagram of the built-in box and sponge block of this utility model.

[0021] Figure 5 This is a three-dimensional schematic diagram of the packaging box of this utility model.

[0022] Figure label: Detailed Implementation

[0023] The foregoing and other technical contents, features and effects of this utility model are described in conjunction with the appendix below. Figures 1 to 5 The detailed description of the embodiments will make this clear. All references to the following embodiments are made with reference to the accompanying drawings.

[0024] Exemplary embodiments of the present invention will now be described with reference to the accompanying drawings.

[0025] This invention relates to a convenient titration hepatitis B virus five-item test kit, comprising a test card body 1, mainly used for the detection of five hepatitis B virus items, employing a colloidal gold method. It primarily detects hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), hepatitis B e antigen (HBeAg), hepatitis B e antibody (HBeAb), and hepatitis B core antibody (HBcAb) using immunochromatographic assay. The test card body 1 has an ID area 2 for identification information, a category area 3 for classifying the aforementioned antigens and antibodies, a display area 4 using C / T zones to indicate positive or negative results, a test strip for reaction, and a sample area 5 with a sample application well 6 for adding sampled blood and buffer solution. All of the above are existing technologies; this application does not improve the original functions of the test card body 1, but mainly improves the ease of adding buffer solution.

[0026] The structural description in this application is the structural position in the post-installation and use state. There are a total of five sample application holes 6. Slots 7 are symmetrically opened on both sides of the sample application holes 6 and placed on the two side walls of the test card body 1. The slots 7 are detachably and slidably fitted with arched limiting plates 8. The limiting plates 8 are made of medical-grade hard plates, such as medical metals, organic non-metals, ceramics, etc. The inner sides of both ends of the limiting plates 8 are fixed with insert blocks 9 that match the slots 7. The upper end of the limiting plates 8 has five limiting holes 10 that match the sample application holes 6. An integrated disposable buffer device 11 is detachably installed on the limiting holes 10.

[0027] The buffer device 11 includes a film 12 made of medical-grade PP or PE. Five buffer dropper bottles 13 made of PE or LDPE are fixed on the film 12. The two are fixedly connected. Each buffer dropper bottle 13 corresponds to the sample well 6. This is equivalent to having five fixing holes on the film 12. The buffer dropper bottle 13 is fixed through the fixing holes, so that one end of the buffer dropper bottle 13 is above the film 12 and the other end is below the film 12. To better describe the buffer dropper bottle 13, the various structures below the buffer dropper bottle 13 are named separately. From top to bottom, the buffer dropper bottle 13 has an integrated upper outlet tube 14, a squeeze tube 15, a lower outlet tube 16, and a titration port 18. The buffer dropper bottle 13, the upper outlet tube 14, the squeeze tube 15, and the lower outlet tube 16 are positioned above the film 12, and the titration port 18 is located below the film 12. The buffer dropper bottle 13 is a disposable item, containing buffer solution for the reaction. The amount of buffer solution is smaller than that of the original bottled buffer solution. Generally, only 1-2 drops need to be added during the reaction. Therefore, the buffer dropper bottle 13 is pre-filled with only 5-8 drops, approximately 200uL-320uL. The diameter of the squeeze tube 15 is larger than that of the upper outlet tube 14 at the top and the lower outlet tube 16 at the bottom. A glass bulb 17 is inserted into the squeeze tube 15 to limit the flow of the buffer dropper bottle 13.

[0028] To ensure that the buffer solution flows accurately into the sample well 6 after it flows out, the titration port 18 is conical.

[0029] To improve the stability of the film 12 after installation, a limiting ring 19 is fixed on the titration port 18 and placed at the lower end of the limiting plate 8. The diameter of the limiting ring 19 is slightly larger than that of the limiting hole 10, and a gap of the same thickness as the limiting plate 8 is reserved between the limiting ring 19 and the film 12.

[0030] To facilitate operation of the limiting ring 19, a notch 20 is provided on the film 12 above the limiting ring 19.

[0031] The test kit also includes an inner box 21, in which a sponge block 22 is placed. The sponge block 22 has multiple placement slots 23, which are used to place the test card body 1, the limiting plate 8, the buffer device 11, and the sterile blood collection kit. The sterile blood collection kit includes, but is not limited to, blood collection needles, alcohol swabs, bandages, disposable gloves, and blood collection droppers.

[0032] The test card body 1, the limiting plate 8, and the buffer device 11 are all packaged in disposable medical sterile packaging bags.

[0033] The buffer solution in the buffer dropper 13 is a solution containing 0.5% Na2HPO4, 0.5% Casein, 0.6% NaCl, and 0.1% NaM3.

[0034] All of the above accessories are also provided with a paper packaging box 24.

[0035] Operating steps:

[0036] 1. Open the packaging box 24, take out the inner box 21, and remove the test card body 1, the limiting plate 8, the buffer device 11, and the sterile packaging bag of the sterile blood collection kit.

[0037] 2. Disinfect the fingertip with an alcohol swab, and use a disposable sterile lancet to collect blood from the fingertip. Fresh blood should be used as much as possible for the blood sample.

[0038] 3. After collecting blood with the blood collection dropper, drip the blood sample into sample well 6, adding 2 drops of sample to each sample well 6, approximately 60uL.

[0039] 4. Lay the test card body 1 flat, and slide the limiting plate 8 from both sides of the test card body 1, with the insert block 9 and slot 7 engaging. When the limiting plate 8 slides to the bottom, it is positioned directly above the sample feeding hole 6, and the limiting hole 10 is aligned with the sample feeding hole 6.

[0040] 5. Observe whether there is buffer solution at the titration port 18. If so, squeeze the glass bulb 17 to return the buffer solution to the buffer solution dropper bottle 13. Cut open the end of the titration port 18 one by one with scissors and insert the titration port 18 into the limiting hole 10. Due to the blockage of the glass bulb 17, the liquid in the buffer solution will not flow out. Slightly squeeze the limiting ring 19 through the notch 20 to pass it through the limiting hole 10. At this time, the film 12 is placed on the upper end face of the limiting plate 8 and the limiting ring 19 is placed on the lower end face of the limiting plate 8 to fix the buffer solution device 11.

[0041] Alternatively, the buffer solution device 11 can be installed on the limiting plate 8 first, and then the limiting plate 8 can be slid into the detection card body 1.

[0042] 6. Gently press the glass bulb 17 in sequence to add 1-2 drops of buffer solution, approximately 40-80uL.

[0043] 7. Observe the display area of ​​the test results after standing for 20 minutes.

[0044] Precautions:

[0045] 1. This kit is for single-use in vitro testing only and the same kit must not be reused.

[0046] 2. This kit is suitable for testing human serum and plasma samples.

[0047] 3. The environment used should be sheltered from the wind, and experiments should not be conducted in environments with excessively high temperature, high humidity, or excessive dryness.

[0048] 4. When conducting experiments on a large number of samples, please label them carefully to avoid confusion.

[0049] 5. Experiments have shown that hepatitis A, hepatitis C, HIV, syphilis, hepatitis E, hepatitis G, and rheumatoid factor do not interfere with the results.

[0050] 6. Remember not to freeze or use after the expiration date.

[0051] This utility model has the following technical effects:

[0052] This invention adds a limiting plate at low cost without affecting the function of the test card itself. When the limiting plate is inserted into the test card, it can fix the limiting base for subsequent addition of buffer solution. After the buffer solution device is installed, the accuracy of buffer solution addition can be improved, ensuring that the buffer solution can be accurately added. At the same time, it avoids the waste of buffer solution and saves buffer solution, requiring only a small amount.

[0053] The precision in this application is not absolute precision, but rather improved accuracy compared to traditional methods.

[0054] Although the present invention has been described in detail through the above preferred embodiments, it should be understood that the above description should not be considered as a limitation of the present invention. Various modifications and substitutions to the present invention will be obvious to those skilled in the art after reading the above content. Therefore, the scope of protection of the present invention should be defined by the appended claims.

Claims

1. A convenient titration hepatitis B virus five-item test kit, comprising a test card body (1), wherein the test card body (1) is provided with an ID area (2), a category area (3), a display area (4), and a sample area (5), wherein the sample area (5) includes a sample application well (6), characterized in that, The sample application hole (6) is symmetrically provided with slots (7) placed on the side wall of the test card body (1). The slots (7) are detachably slidably fitted with an arched limiting plate (8). The inner side of the lower end of the limiting plate (8) is fixed with a plug (9) that matches the slot (7). The limiting plate (8) is provided with a limiting hole (10) corresponding to the sample application hole (6). An integrated disposable buffer device (11) is inserted into the limiting hole (10).

2. The convenient titration hepatitis B virus five-item detection kit according to claim 1, characterized in that, The buffer device (11) includes a substrate (12), on which five buffer dropper bottles (13) corresponding to the positions of the sample loading holes (6) are fixed. The lower end of the buffer dropper bottle (13) is connected to an upper outlet tube (14), a squeeze tube (15), and a lower outlet tube (16) in sequence. The diameter of the squeeze tube (15) is larger than that of the upper outlet tube (14) and the lower outlet tube (16). A glass ball (17) is inserted into the squeeze tube (15). The lower end of the lower outlet tube (16) is connected to a titration port (18) located below the limiting plate (8).

3. The convenient titration hepatitis B virus five-item detection kit according to claim 2, characterized in that, The titration port (18) is conical.

4. The convenient titration hepatitis B virus five-item detection kit according to claim 3, characterized in that, A limiting ring (19) is fixed on the titration port (18) and placed at the lower end of the limiting plate (8).

5. The convenient titration hepatitis B virus five-item detection kit according to claim 4, characterized in that, The substrate (12) has a notch (20) located at the limiting ring (19).

6. The convenient titration hepatitis B virus five-item detection kit according to claim 5, characterized in that, The test kit also includes an inner box (21), in which a sponge block (22) is placed, and multiple placement slots (23) are provided on the sponge block (22).

7. The convenient titration hepatitis B virus five-item detection kit according to claim 6, characterized in that, The test kit also includes a packaging box (24).

8. The convenient titration hepatitis B virus five-item detection kit according to claim 1, characterized in that, The category area (3) includes HBsAg, HBsAb, HBeAg, HBeAb, and HBcAb, and the display area (4) includes positive and negative results.

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