Mycoplasma pneumoniae IgM antibody colloidal gold immunochromatography detection kit

Abstract

The invention relates to the technical field of medical testing, and particularly discloses a mycoplasma pneumoniae IgM antibody colloidal gold immunochromatography detection kit which comprises a test box and detection test paper, the detection test paper is arranged in an inner cavity of the test box, a sample adding hole corresponding to the detection test paper is formed in the upper surface of the test box, and the sample adding hole corresponds to the detection test paper. A heating pad is installed at the bottom of the test box, the test box is repeatedly moved, the heating pad can generate heat through friction, the outer wall of the test box is sleeved with a heat preservation seat, an anti-infection mechanism and a temperature monitoring mechanism are transversely embedded in the front side and the rear side of the test box respectively, and the temperature of test paper is displayed through the temperature monitoring mechanism. And the anti-infection mechanism can sterilize and disinfect the tested test paper. The sensitivity is improved by changing the temperature of the test paper, so that the test accuracy is improved, serum on the test paper can be sterilized and disinfected, pneumovirus transmission is prevented, and the use safety is high.

Description

Technical Field

[0001] The invention relates to the technical field of medical testing, in particular to a Mycoplasma pneumoniae IgM antibody colloidal gold immunochromatography detection kit. Background Art

[0002] Mycoplasma pneumoniae is a cell wall-less prokaryotic cell microorganism belonging to the class Mollicutes. It is the main pathogen causing community-acquired pneumonia. Currently, the methods for diagnosing Mycoplasma pneumoniae include: isolation and culture, colloidal gold method, passive agglutination method, enzyme-linked immunosorbent assay, complement fixation test, fluorescent quantitative PCR, etc. The colloidal gold method can be easily tested at low cost. At the same time, the test results are intuitive and visible to the naked eye, and no special instruments or equipment are required.

[0003] During the test, open the test box and drop the blood sample and sample diluent onto the test paper in turn. The colloidal gold particles on the test paper can be adsorbed on the mouse anti-human IgM monoclonal antibody to form a strong bond. The T line on the nitrocellulose membrane is coated with recombinant Mycoplasma pneumoniae antigen. The immunological reaction between the mouse anti-human IgM monoclonal antibody, the human anti-Mycoplasma pneumoniae IgM antibody in the sample and the recombinant Mycoplasma pneumoniae antigen is used to detect whether the Mycoplasma pneumoniae IgM antibody in the sample is positive.

[0004] The test paper has high sensitivity. If the ambient temperature is low, the sensitivity of the test paper will be reduced, resulting in inaccurate test results. Moreover, after the test, the serum will be absorbed by the test paper. If the test paper cannot be sterilized, virus transmission is likely to occur. Therefore, a safe Mycoplasma pneumoniae IgM antibody colloidal gold immunochromatography detection kit is proposed. Summary of the invention

[0005] The object of the present invention is to provide a Mycoplasma pneumoniae IgM antibody colloidal gold immunochromatography detection kit to solve the problem that the test strips in the prior art cannot be used within the optimal temperature range and the test strips cannot be effectively disinfected.

[0006] To achieve the above-mentioned purpose, the present invention provides the following technical scheme: a Mycoplasma pneumoniae IgM antibody colloidal gold immunochromatography detection kit, comprising a test box and a test paper, wherein the test paper is arranged in the inner cavity of the test box, and a sample addition hole corresponding to the test paper is opened on the upper surface of the test box, a heating pad is installed at the bottom of the test box, and repeated movement of the test box can cause the heating pad to generate heat by friction, an insulation seat is sleeved on the outer wall of the test box, and an anti-infection mechanism and a temperature monitoring mechanism are respectively embedded in the front and rear sides of the test box, and the temperature of the test paper is displayed by the temperature monitoring mechanism, and the anti-infection mechanism can sterilize and disinfect the test paper after the test is completed.

[0007] Preferably, the temperature monitoring mechanism includes a support base embedded in the rear side of the test box, the inner cavity of the support base stores an expansion body, the support base is made of copper or nickel-chromium alloy, and the support base is used as a transition material to enable the expansion body to be consistent with the temperature of the test box, and a limit cylinder embedded in the test box is laterally installed on the top of the support base, and an observation window is provided in the middle of the upper surface of the limit cylinder, and a display rod and a spring are respectively inserted on the left and right sides of the inner cavity of the limit cylinder, and the display rod is pushed to the left under the action of the spring elastic force; the principle that the volume of the expansion body increases with the increase of temperature is utilized to allow the display rod to move left and right, and the color displayed on the display rod is judged by whether the test paper reaches the optimal use temperature.

[0008] Preferably, the heating pad is made of carbon fiber or graphite.

[0009] Preferably, the expansion body is used as a temperature measuring material, and its material is mercury or kerosene.

[0010] Preferably, the outer wall of the display rod is composed of three different colors from left to right.

[0011] Preferably, the anti-infection mechanism includes a liquid storage bag laterally embedded in the front side of the test box, a piston that can move left and right is inserted into the inner cavity of the liquid storage bag, the left and right sides of the inner cavity of the liquid storage bag are respectively filled with compressed gas and medical alcohol, and the compressed gas pressure can push the piston to move right to squeeze the medical alcohol, and a switch assembly is installed on the rear side of the liquid storage bag; by turning on the switch assembly, the compressed gas pressure is used to push the medical alcohol out to sterilize the test paper and avoid the risk of pneumonia virus transmission.

[0012] Preferably, the switch assembly includes a valve body installed laterally at the right end of the rear side of the liquid storage bag, a valve core that can slide left and right is inserted in the inner cavity of the valve body, and a through hole is provided on the valve core, a moving block that penetrates the inner wall of the liquid storage bag is inserted at the right end of the front side of the valve body, and the rear side of the moving block contacts the right side of the valve core, one end of a push rod is installed at the left end of the valve core, and the other end of the push rod extends out of the left side wall of the test box, liquid outlet holes are provided at both left and right ends of the rear side of the valve body, and a flow channel connected to the through hole is provided inside the valve core.

[0013] Preferably, the contact surface between the valve core and the moving block is an inclined surface.

[0014] Preferably, the test paper includes a rubber plate pasted on the bottom surface of the inner cavity of the test box, a sample pad is provided at one end of the upper surface of the rubber plate and is located below the sample loading hole, a blood filter membrane is provided at one end of the lower surface of the sample pad, and the lower surface of the blood filter membrane is in contact with the rubber plate, a gold label pad is provided at the bottom of the other end of the blood filter membrane, and the lower surface of the gold label pad is in contact with the rubber plate, a nitrocellulose membrane is provided at the bottom of the other end of the gold label pad, and the lower surface of the nitrocellulose membrane is in contact with the rubber plate, and an absorbent paper is provided on the upper surface of the other end of the nitrocellulose membrane, and the lower surface of the absorbent paper is in contact with the rubber plate.

[0015] The Mycoplasma pneumoniae IgM antibody colloidal gold immunochromatography detection kit proposed by the present invention has the following beneficial effects: 1. The present invention generates heat through friction of the heating pad to heat the test paper. Under the condition of heat conduction of the support base, the expansion body gradually heats up and increases in volume. The expansion body squeezes the display rod to the right. When the color of the middle part of the display rod is seen through the observation window, it means that the temperature of the test paper is in the optimal test temperature range. By changing the temperature of the test paper, the sensitivity is improved, thereby improving the test accuracy.

[0016] 2. The present invention moves the valve core to the right by pressing the push rod, and the inclined surface of the valve core squeezes the moving block forward. When the valve core contacts the right side of the inner cavity of the valve body, the medical alcohol pushes the moving block to move backward along the valve core through hole under the action of the compressed gas pressure until the moving block is stuck in the card slot. While the moving block positions the valve core, the flow channel is connected with the liquid storage bag. The medical alcohol flows into the test box along the through hole and the flow channel in turn. The test paper absorbs the medical alcohol to be sterilized and disinfected. Therefore, the serum on the test paper can be sterilized and disinfected to prevent the spread of pneumonia virus, and the use safety is high. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 It is a schematic diagram of the structure of the present invention; Figure 2 It is a schematic diagram of the structure of the temperature monitoring mechanism; Figure 3 It is the main cross-sectional view of the temperature monitoring mechanism; Figure 4 A schematic diagram of the display rod structure; Figure 5 A top-down cross-sectional view of an infection prevention mechanism; Figure 6 for Figure 5 Enlarged view of point A in the middle; Figure 7 It is a schematic diagram of the valve core structure; Figure 8 This is a schematic diagram of the test paper; Fig. 9 This is a diagram explaining the test results of the test paper.

[0018] In the figure: 1. test box; 2. test paper; 21. gold label pad; 22. sample pad; 23. blood filter membrane; 24. nitrocellulose membrane; 25. absorbent paper; 26. rubber plate; 3. heating pad; 4. insulation seat; 5. temperature monitoring mechanism; 6. anti-infection mechanism; 51. support seat; 52. expansion body; 53. limit cylinder; 54. observation window; 55. display rod; 56. spring; 61. liquid storage capsule; 62. piston; 63. compressed gas; 64. medical alcohol; 65. switch assembly; 651. valve body; 652. valve core; 653. moving block; 654. push rod; 655. liquid outlet; 656. slot; 657. flow channel; 7. sample adding hole. DETAILED DESCRIPTION

[0019] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0020] See also Figure 1-Figure 9 The present invention provides a technical solution: a Mycoplasma pneumoniae IgM antibody colloidal gold immunochromatography detection kit, comprising a test box 1 and a test paper 2, the test paper 2 is arranged in the inner cavity of the test box 1, serum and diluent are dripped onto the test paper 2 in sequence, the colloidal gold pad on the test paper 2 detects the serum, the upper surface of the test box 1 is provided with a sample addition hole 7 corresponding to the test paper 2, a heating pad 3 is installed at the bottom of the test box 1, and the test box 1 is repeatedly moved to generate heat by friction of the heating pad 3, the heating pad 3 is made of carbon fiber or graphite, which has excellent thermal conductivity and high thermal conversion efficiency, and can quickly heat up the test paper 2, the outer wall of the test box 1 is sleeved with a heat preservation seat 4, and the front and rear sides of the test box 1 are respectively transversely embedded with an anti-infection mechanism 6 and a temperature monitoring mechanism 5, the temperature of the test paper 2 is displayed by the temperature monitoring mechanism 5, and the anti-infection mechanism 6 can sterilize and disinfect the test paper 2 after the test is completed.

[0021] As a preferred solution, further, Figure 2 , Figure 3 and Figure 4As shown, the temperature monitoring mechanism 5 includes a support base 51 embedded in the rear side of the test box 1, and an expansion body 52 is stored in the inner cavity of the support base 51. The support base 51 is made of copper or nickel-chromium alloy with excellent thermal conductivity. The support base 51 is used as a transition material to enable the expansion body 52 to be consistent with the temperature of the test box 1. The expansion body 52 is used as a temperature measuring material, and its material is mercury or kerosene. They have a large thermal expansion coefficient and can be used as a medium for temperature measurement. A limiting cylinder 53 embedded in the test box 1 is horizontally installed on the top of the support base 51, and an observation window 54 is provided in the middle of the upper surface of the limiting cylinder 53. A display rod 55 and a spring 56 are respectively inserted on the left and right sides of the inner cavity of the limiting cylinder 53. Under the action of the elastic force of the spring 56, the display rod 55 is pushed to the left. The outer wall of the display rod 55 is composed of three different colors from left to right, and the three colors are used to identify the current temperature range of the test paper.

[0022] As a preferred solution, further, Figure 5 As shown, the anti-infection mechanism 6 includes a liquid storage capsule 61 which is laterally embedded in the front side of the test box 1. A piston 62 which can move left and right is inserted into the inner cavity of the liquid storage capsule 61. The left and right sides of the inner cavity of the liquid storage capsule 61 are respectively filled with compressed gas 63 and medical alcohol 64. The air pressure of the compressed gas 63 can push the piston 62 to move right to squeeze the medical alcohol 64. A switch assembly 65 is installed on the rear side of the liquid storage capsule 61.

[0023] As a preferred solution, further, Figure 6 and Figure 7 As shown, the switch assembly 65 includes a valve body 651 installed laterally at the right end of the rear side of the liquid storage capsule 61, a valve core 652 that can slide left and right is inserted into the inner cavity of the valve body 651, and a through hole is set on the valve core 652, a moving block 653 that penetrates the inner wall of the liquid storage capsule 61 is inserted into the right end of the front side of the valve body 651, and the rear side of the moving block 653 contacts the right side of the valve core 652, and the contact surface between the valve core 652 and the moving block 653 is an inclined surface. When the valve core 652 moves to the right, the moving block 653 can automatically move forward through the action of the inclined surface, one end of a push rod 654 is installed at the left end of the valve core 652, and the other end of the push rod 654 extends out of the left side wall of the test box 1, liquid outlet holes 655 are provided at both left and right ends of the rear side of the valve body 651, and a flow channel 657 connected to the through hole is provided inside the valve core 652.

[0024] As a preferred solution, further, Figure 8As shown, the test paper 2 includes a rubber sheet 26 pasted on the bottom surface of the inner cavity of the test box 1, a sample pad 22 is arranged at one end of the upper surface of the rubber sheet 26 and is located below the sample addition hole 7, a blood filter membrane 23 is arranged at one end of the lower surface of the sample pad 22, and the lower surface of the blood filter membrane 23 is in contact with the rubber sheet 26, a gold label pad 21 is arranged at the bottom end of the other end of the blood filter membrane 23, and the lower surface of the gold label pad 21 is in contact with the rubber sheet 26, a nitrocellulose membrane 24 is arranged at the bottom end of the other end of the gold label pad 21, and the lower surface of the nitrocellulose membrane 24 is in contact with the rubber sheet 26, and an absorbent paper 25 is arranged on the upper surface of the other end of the nitrocellulose membrane 24, and the lower surface of the absorbent paper 25 is in contact with the rubber sheet 26.

[0025] The detection line on the nitrocellulose membrane 24 is coated with recombinant Mycoplasma pneumoniae antigen, the quality control line is coated with goat anti-mouse IgG polyclonal antibody, and the gold label pad 21 is coated with colloidal gold-labeled mouse anti-human IgM monoclonal antibody; when a positive sample is detected, the Mycoplasma pneumoniae IgM antibody in the sample is combined with the colloidal gold-labeled mouse anti-human IgM monoclonal antibody to form an immune complex, and due to the chromatography, the complex flows forward inside the nitrocellulose membrane 24, and when passing through the detection line, it is combined with the coated recombinant Mycoplasma pneumoniae antigen to form "Au-mouse anti-human IgM monoclonal antibody-(MP-IgM)-recombinant Mycoplasma pneumoniae antigen" and agglutinates and develops color, and the remaining colloidal gold-labeled mouse anti-human IgM monoclonal antibody is combined with the goat anti-mouse IgG polyclonal antibody coated at the quality control line to agglutinate and develop color, and when a negative sample is detected, the sample does not contain Mycoplasma pneumoniae IgM antibody, so that the immune complex cannot be formed, and color can only be developed at the quality control line; Sample addition method: Take 10µL serum, plasma, or 20µL whole blood sample and add it directly to the sample well 7, then add 100µL (2-3 drops) sample diluent to the sample well 7; read the result within 5-20 minutes, and the test result will be invalid after 20 minutes; Interpretation and interpretation of results, such as Fig. 9 As shown: 1. Negative: Only a red band appears at the quality control line (C); 2. Positive: Two red stripes appear at the control line (C) and the test line (T); 3. Invalid: No red stripe appears at the quality control line (C); 4. In the early stage of infection, the lack of IgM production or very low titer will lead to negative results. Patients should be prompted to re-examine in 7 to 14 days. During the re-examination, the last collected specimen should be tested at the same time to determine whether there is a seroconversion or a significant increase in titer; 5. For patients with impaired immunity or receiving immunosuppressive therapy, the reference value of serological antibody testing is limited; 6. IgM antibody positivity is not only seen in primary infection, but also in secondary infection.

[0026] The detailed connection means are well-known in the art. The following mainly introduces the working principle and process. The specific work is as follows.

[0027] Step 1: Take 10µL of serum, plasma, or 20µL of whole blood sample and add it directly to the sample well 7, then add 100µL (2-3 drops) of sample diluent to the sample well 7 and drip it onto the test paper 2, and judge whether Mycoplasma pneumoniae is positive by the color position displayed on the test paper 2; Step 2: When the ambient temperature is low, the volume of the expansion body 52 decreases, and the elastic force of the spring 56 pushes the display stick 55 to the left. The color on the right side of the display stick 55 can be seen from the observation window 54, indicating that the test paper 2 has not reached the optimal temperature for use. Move the test box 1, and let the heating pad 3 rub back and forth on the desktop. The heating pad 3 generates heat by friction, which can heat the test paper 2. Under the heat conduction condition of the support seat 51, the expansion body 52 gradually heats up and increases in volume. The expansion body 52 pushes the display stick 55 to the right until the color of the middle part of the display stick 55 can be seen through the observation window 54, indicating that the temperature of the test paper 2 is at the optimal working temperature. The test box 1 is placed in the heat preservation seat 4 for insulation. At this time, the Mycoplasma pneumoniae test is performed to improve the test accuracy. Step three, when it is necessary to sterilize the test paper 2 that absorbs serum, press the push rod 654 to move the valve core 652 to the right, and the inclined surface of the valve core 652 squeezes the moving block 653 to move forward until the valve core 652 reaches the right side of the inner cavity of the valve body 651, and the medical alcohol 64 pushes the moving block 653 to move backward along the through hole of the valve core 652 under the action of the air pressure of the compressed gas 63 until the moving block 653 is stuck in the card groove 656, and the flow channel 657 is connected with the liquid storage capsule 61, and the medical alcohol 64 flows out from the two liquid outlets 655, and the medical alcohol 64 soaks the test paper 2. The test paper 2 is sterilized after absorbing the medical alcohol 64 to prevent the spread of pneumonia virus in the serum.

[0028] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A Mycoplasma pneumoniae IgM antibody colloidal gold immunochromatography detection kit, characterized in that: The invention comprises a test box (1) and a test strip (2), wherein the test strip (2) is arranged in the inner cavity of the test box (1), and a sample addition hole (7) corresponding to the test strip (2) is provided on the upper surface of the test box (1); a heating pad (3) is installed at the bottom of the test box (1); and the heating pad (3) can generate heat by friction by repeatedly moving the test box (1); a heat preservation seat (4) is sleeved on the outer wall of the test box (1); and an anti-infection mechanism (6) and a temperature monitoring mechanism (5) are respectively embedded in the front and rear sides of the test box (1) in a transverse manner, and the temperature of the test strip (2) is displayed by the temperature monitoring mechanism (5); and the anti-infection mechanism (6) can sterilize the test strip (2) after the test is completed; The temperature monitoring mechanism (5) comprises a support base (51) embedded in the rear side of the test box (1), the inner cavity of the support base (51) stores an expansion body (52), the support base (51) is made of copper or nickel-chromium alloy, and the support base (51) is used as a transition material to enable the expansion body (52) to have the same temperature as the test box (1), a limiting cylinder (53) embedded in the test box (1) is installed horizontally on the top of the support base (51), an observation window (54) is provided in the middle of the upper surface of the limiting cylinder (53), and a display rod (55) and a spring (56) are respectively inserted on the left and right sides of the inner cavity of the limiting cylinder (53), and the display rod (55) is pushed to move leftward under the elastic force of the spring (56).

2. A Mycoplasma pneumoniae IgM antibody colloidal gold immunochromatography detection kit according to claim 1, characterized in that: The heating pad (3) is made of carbon fiber or graphite.

3. A Mycoplasma pneumoniae IgM antibody colloidal gold immunochromatography detection kit according to claim 1, characterized in that: The expansion body (52) is used as a temperature measuring material and is made of mercury or kerosene.

4. The Mycoplasma pneumoniae IgM antibody colloidal gold immunochromatography detection kit according to claim 1, characterized in that: The outer wall of the display rod (55) is composed of three different colors from left to right.

5. The Mycoplasma pneumoniae IgM antibody colloidal gold immunochromatography detection kit according to claim 1, characterized in that: The anti-infection mechanism (6) comprises a liquid storage bag (61) which is laterally embedded in the front side of the test box (1); a piston (62) which can move left and right is inserted into the inner cavity of the liquid storage bag (61); the left and right sides of the inner cavity of the liquid storage bag (61) are respectively filled with compressed gas (63) and medical alcohol (64); the air pressure of the compressed gas (63) can push the piston (62) to move rightward to squeeze the medical alcohol (64); and a switch assembly (65) is installed on the rear side of the liquid storage bag (61).

6. A Mycoplasma pneumoniae IgM antibody colloidal gold immunochromatography detection kit according to claim 5, characterized in that: The switch assembly (65) comprises a valve body (651) installed transversely at the right end of the rear side of the liquid storage capsule (61); a valve core (652) capable of sliding left and right is inserted into the inner cavity of the valve body (651), and a through hole is provided on the valve core (652); a moving block (653) penetrating the inner wall of the liquid storage capsule (61) is inserted into the right end of the front side of the valve body (651), and the rear side of the moving block (653) contacts the right side of the valve core (652); one end of a push rod (654) is installed at the left end of the valve core (652), and the other end of the push rod (654) extends out of the left side wall of the test box (1); liquid outlet holes (655) are provided at both left and right ends of the rear side of the valve body (651), and a flow channel (657) communicating with the through hole is provided inside the valve core (652).

7. A Mycoplasma pneumoniae IgM antibody colloidal gold immunochromatography detection kit according to claim 6, characterized in that: The contact surface between the valve core (652) and the moving block (653) is an inclined surface.

8. The Mycoplasma pneumoniae IgM antibody colloidal gold immunochromatography detection kit according to claim 1, characterized in that: The test strip (2) comprises a rubber plate (26) adhered to the bottom surface of the inner cavity of the test box (1); a sample pad (22) is arranged at one end of the upper surface of the rubber plate (26) and is located below the sample loading hole (7); a blood filter membrane (23) is arranged at one end of the lower surface of the sample pad (22), and the lower surface of the blood filter membrane (23) is in contact with the rubber plate (26); a gold label pad (21) is arranged at the bottom end of the other end of the blood filter membrane (23), and the lower surface of the gold label pad (21) is in contact with the rubber plate (26); a nitrocellulose membrane (24) is arranged at the bottom end of the other end of the gold label pad (21), and the lower surface of the nitrocellulose membrane (24) is in contact with the rubber plate (26); an absorbent paper (25) is arranged on the upper surface of the other end of the nitrocellulose membrane (24), and the lower surface of the absorbent paper (25) is in contact with the rubber plate (26).

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