Respiratory tract 5-pathogen antigen combined detection kit

Abstract

The utility model provides a respiratory tract 5 item pathogen antigen combined detection kit relates to medical detection technical field, the combined detection kit includes casing and a plurality of reagent cards, casing surface is equipped with one sample adding opening and a plurality of observation ports, a plurality of reagent cards are located in the casing, each reagent card includes bottom plate and is equipped with sample pad, colloid gold combination pad, chromatography film and water absorption pad on bottom plate, a plurality of reagent cards are along the width direction interval of bottom plate setting, chromatography film has detection area, the part of chromatography film at detection area is coated with marked antibody, wherein, bottom plate includes recess, is equipped with a plurality of shunt parts in recess, and each reagent card's sample pad is installed in recess corresponding to shunt part, and is exposed to sample adding opening, and each chromatography film's detection area is exposed to corresponding observation port. This design makes a plurality of detection items can carry out simultaneously in the same kit, improves detection efficiency.

Description

Technical Field

[0001] This utility model relates to the field of medical testing technology, and in particular to a combined detection kit for five respiratory pathogen antigens. Background Technology

[0002] Streptococcus pneumoniae is a spherical bacterium that can cause a variety of infections, including pneumonia, otitis media, and meningitis. It is one of the most common pathogens causing pneumonia, especially prevalent in children and the elderly. Streptococcus pneumoniae is transmitted through airborne respiratory droplets.

[0003] Legionella pneumophila is a Gram-negative bacterium that can cause Legionnaires' disease (a severe form of pneumonia) and Pontiac fever (a milder form of influenza). This bacterium is primarily transmitted to humans through the inhalation of aerosolized droplets containing the bacteria. Legionnaires' disease typically presents with high fever, cough, shortness of breath, muscle aches, and headache, while Pontiac fever presents with fever and flu-like symptoms but without pneumonia.

[0004] Staphylococcus aureus is present in the nasal cavity of approximately 30% of healthy adults (usually transiently) and on the skin of approximately 20% of healthy adults. Staphylococcus aureus can be transmitted through direct contact or contact with contaminated objects (such as gym equipment, telephones, doorknobs, TV remotes, or elevator buttons), and rarely through inhaling droplets produced by an infected person's sneezing or coughing. Pneumonia caused by Staphylococcus aureus often leads to high fever, shortness of breath, cough, and bloody sputum, and can develop into lung abscesses.

[0005] Klebsiella pneumoniae is a group of Gram-negative bacteria widely found on the mucous membranes of animals or in the environment (such as water and soil). In humans, Klebsiella pneumoniae is concentrated in the gastrointestinal tract, with a small number concentrated in the nasopharynx. The bacteria can enter the bloodstream or other tissues through the gastrointestinal tract and then cause infection. Klebsiella pneumoniae is one of the main pathogens causing pneumonia in the human respiratory system. Klebsiella pneumoniae is a common cause of drug-resistant opportunistic infections in hospitalized patients, and in the past decade, Klebsiella pneumoniae has become a major clinical and public health threat.

[0006] Mycoplasma pneumoniae, commonly known as the walking pneumonia bacterium, is a unique microorganism lacking a cell wall, distinguishing it from bacteria or viruses. It is a common cause of pneumonia, especially in children and young adults, often resulting in mild to moderate respiratory infections. Mycoplasma pneumoniae is transmitted through airborne respiratory droplets.

[0007] Currently, traditional methods for detecting pathogens such as Streptococcus pneumoniae, Legionella pneumophila, Staphylococcus aureus, Klebsiella pneumoniae, and Mycoplasma pneumoniae suffer from low sensitivity, are labor-intensive, and time-consuming. With the continuous advancement of molecular biology and immunological detection technologies, methods such as fluorescent PCR, chemiluminescent immunoassay, and fluorescence immunoassay have gradually become the gold standard for etiological diagnosis due to their high sensitivity, high specificity, and rapid detection capabilities. However, these methods typically detect single pathogens and have complex procedures requiring specialized personnel, limiting their application in primary healthcare institutions. Utility Model Content

[0008] The purpose of this invention is to provide a combined detection kit for five respiratory pathogen antigens, aiming to solve the technical problem that existing pneumonia detection kits cannot simultaneously detect the content of Streptococcus pneumoniae, Legionella pneumophila, Staphylococcus aureus, Klebsiella pneumoniae, and Mycoplasma pneumoniae.

[0009] To achieve the above-mentioned objectives, this utility model provides a reagent kit, which includes:

[0010] The housing has a sample application port and multiple observation ports on its surface;

[0011] Multiple reagent cards are housed within a casing. Each reagent card includes a base plate and a sample pad, a colloidal gold binding pad, a chromatography membrane, and an absorbent pad disposed on the base plate. The multiple reagent cards are spaced apart along the width of the base plate. The chromatography membrane has a detection area, and the portion of the chromatography membrane in the detection area is coated with labeled antibodies. The base plate includes a groove, and multiple flow dividers are disposed within the groove for diverting the sample to be tested. The sample pad of each reagent card is installed in the groove corresponding to the flow dividers and is exposed at the sample dispensing port. The detection area of ​​each chromatography membrane is exposed at the corresponding observation port.

[0012] In one embodiment, the plurality of reagent cards include three reagent cards spaced apart along their length, each reagent card having a chromatographic membrane with multiple detection areas, each detection area corresponding to a different labeled antibody, and all multiple detection areas of each chromatographic membrane being exposed at the same observation port.

[0013] In one embodiment, the three reagent cards include a first reagent card, a second reagent card, and a third reagent card:

[0014] The first reagent card has two detection areas, which are spaced apart along the length of the reagent card. Each detection area is respectively coated with either Streptococcus pneumoniae or Legionella pneumophila; and / or,

[0015] The second reagent card has two detection areas, which are spaced apart along the length of the reagent card. The two detection areas are respectively coated with antibodies against Staphylococcus aureus and Klebsiella pneumoniae; and / or,

[0016] The third reagent card has a detection area, and the detection area is coated with Mycoplasma pneumoniae antibodies.

[0017] In one embodiment, the chromatography membrane further includes a quality control region, which is spaced apart from the detection region along its length.

[0018] The portion of the chromatographic membrane in the detection region is coated with labeled antibodies; and / or,

[0019] The portion of the chromatographic membrane in the quality control region is coated with goat anti-chicken IgY antibody; and / or...

[0020] The colloidal gold conjugate pad is coated with a colloidal gold-labeled monoclonal antibody against a specific antigen.

[0021] In one embodiment, the base plate is made of PVC; and / or,

[0022] The colloidal gold bonding pad is made of glass fiber membrane; and / or,

[0023] The chromatography membrane is a nitrocellulose membrane.

[0024] In one embodiment, the reagent card is 295–300 mm in length; and / or,

[0025] The reagent card has a width of 2.9–3.1 mm.

[0026] In one embodiment, a plurality of sample dispensing ports are arranged along the same straight line, a plurality of observation ports are arranged along the same straight line, and each sample dispensing port and the corresponding observation port are spaced apart along the length direction of the base plate.

[0027] In one embodiment, the chromatography membrane is disposed in the middle of the base plate, the colloidal gold binding pad partially overlaps one end face of the chromatography membrane, the absorbent pad partially overlaps the other end face of the chromatography membrane, and the sample pad partially overlaps the end of the colloidal gold binding pad away from the chromatography membrane.

[0028] In one embodiment, the reagent kit housing has a removable top cover and a bottom cover, with a plurality of reagents held between the top cover and the bottom cover.

[0029] In one embodiment, the peripheral edge of the housing is provided with multiple buckles, and the base plate of each reagent card is provided with multiple slots corresponding to the multiple buckles.

[0030] This invention proposes a multi-unit immunochromatographic assay kit, comprising a housing and multiple independent reagent cards. The housing has multiple sample dispensing ports and multiple observation ports, with the reagent cards housed within the housing. Each reagent card includes a sample pad, a colloidal gold conjugated pad, a chromatography membrane, and an absorbent pad. The chromatography membrane has detection areas, each coated with a specific antibody. Multiple reagent cards have multiple detection areas, each used to capture the corresponding antigen. When a sample is added to the sample dispensing port, it passes sequentially through the sample pad, colloidal gold conjugated pad, and chromatography membrane via capillary action, forming a purple band in the detection area to indicate the test result. The operator can visually read the test results through the observation ports. This design allows multiple tests to be performed simultaneously in the same kit, improving testing efficiency. Attached Figure Description

[0031] 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.

[0032] Figure 1 A schematic plan view of a test strip for an embodiment of a respiratory tract five pathogen antigen combined detection kit;

[0033] Figure 2 This is a plan view of an embodiment of the shunt section of the respiratory tract five pathogen antigen combined detection kit of this utility model;

[0034] Figure 3 This is a top view of the base plate of the respiratory tract five pathogen antigen combined detection kit of this utility model.

[0035] Explanation of icon numbers:

[0036] 100. Shell of the Respiratory Tract 5 Pathogen Antigen Combined Detection Kit; 1. Sample pad; 2. Colloidal gold conjugate pad; 3. Chromatographic membrane; 31. Quality control area; 32. Detection area; 32a. First detection area; 32b. Second detection area; 4. Absorbent pad; 5. Base plate; 51. First split section; 52. Second split section; 53. Third split section.

[0037] The realization of the purpose, functional features and advantages of this utility model will be further explained in conjunction with the embodiments and with reference to the accompanying drawings. Detailed Implementation

[0038] The technical solutions of the present utility model will be clearly and completely described below with reference to the accompanying drawings of the embodiments. Obviously, the described embodiments are only some embodiments of the present utility model, and not all embodiments. Based on the embodiments of the present utility model, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the protection scope of the present utility model.

[0039] It should be noted that, unless specific conditions are specified in the embodiments, conventional conditions or conditions recommended by the manufacturer shall apply. Reagents or instruments whose manufacturers are not specified are all commercially available products. Furthermore, the meaning of "and / or" throughout the text includes three parallel solutions; for example, "A and / or B" includes solution A, solution B, or a solution that simultaneously satisfies A and B. In addition, the technical solutions of the various embodiments can be combined with each other, but this must be based on the ability of those skilled in the art to implement them. If the combination of technical solutions is contradictory or impossible to implement, it should be considered that such a combination of technical solutions does not exist and is not within the scope of protection claimed by this utility model. Based on the embodiments of this utility model, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this utility model.

[0040] Currently, traditional methods for detecting pathogens such as Streptococcus pneumoniae, Legionella pneumophila, Staphylococcus aureus, Klebsiella pneumoniae, and Mycoplasma pneumoniae suffer from low sensitivity, are labor-intensive, and time-consuming. With the continuous advancement of molecular biology and immunological detection technologies, methods such as fluorescent PCR, chemiluminescent immunoassay, and fluorescence immunoassay have gradually become the gold standard for etiological diagnosis due to their high sensitivity, high specificity, and rapid detection capabilities. However, these methods typically detect single pathogens and have complex procedures requiring specialized personnel, limiting their application in primary healthcare institutions.

[0041] In view of the problems existing in the above-mentioned prior art, please refer to Figures 1 to 3 This utility model proposes a reagent kit, the reagent kit comprising:

[0042] The housing 100 has a sample application port and multiple observation ports on its surface;

[0043] Multiple reagent cards are disposed within a housing 100. Each reagent card includes a base plate 5 and a sample pad 1, a colloidal gold binding pad 2, a chromatography membrane 3, and an absorbent pad 4 disposed on the base plate 5. The multiple reagent cards are spaced apart along the width direction of the base plate 5. The chromatography membrane 3 has a detection area 32, and the portion of the chromatography membrane 3 in the detection area is coated with labeled antibodies. The base plate includes a groove, and multiple flow dividers are provided in the groove for diverting the sample to be tested. The sample pad of each reagent card is installed in the groove corresponding to the flow dividers and is exposed at the sample dispensing port. The detection area of ​​each chromatography membrane is exposed at the corresponding observation port.

[0044] This invention provides a reagent kit comprising a housing 100 and multiple independent reagent cards. The housing has a sample dispensing port and multiple observation ports, with the reagent cards housed within the housing. Each reagent card includes a sample pad 1, a colloidal gold conjugate pad 2, a chromatography membrane 3, and an absorbent pad 4. The chromatography membrane 3 has detection areas 32, each coated with a specific antibody. Multiple reagent cards have multiple detection areas 32, each used to capture the corresponding antigen. When a sample is added to the dispensing port, it is split through multiple streams via capillary action. The split sample sequentially passes through the sample pad 1, the colloidal gold conjugate pad 2, and the chromatography membrane 3, forming colored bands in the detection areas 32 to indicate the test results. The operator can visually read the test results through the observation ports. This design allows multiple tests to be performed simultaneously through a single dispensing port within the same reagent kit, improving testing efficiency.

[0045] In an embodiment of this utility model, the plurality of reagent cards include three reagent cards spaced apart along their length direction. The chromatography membrane 3 in each reagent card has a plurality of detection areas 32, which are respectively coated with different labeled antibodies, and the plurality of detection areas 32 of each chromatography membrane 3 are exposed in the same observation port.

[0046] Specifically, such as Figure 2 As shown, the multiple flow dividers are divided into three flow dividers, namely the first flow divider 51, the second flow divider 52 and the third flow divider 53. The groove and the flow dividers are all provided with gradients so that the sample to be tested added from the sample inlet can flow smoothly into each flow divider from the groove.

[0047] Understandably, having multiple detection areas exposed at the same observation port improves space utilization and simplifies the operation process. Users can simultaneously read the results of multiple detection areas 32 through a single observation port, reducing the complexity of the shell structure and making the detection more intuitive and efficient. Furthermore, the portion of the chromatography membrane 3 located in the detection area is coated with labeled antibodies. Different reagent cards, through the design of being coated with specific antibodies, can accurately detect corresponding pathogens, ensuring the specificity and sensitivity of the detection, while also improving sample utilization efficiency. For example, multiple detection areas can be represented by two detection areas, such as... Figure 3 As shown, they can be labeled "T1" and "T2" respectively, where T1 and T2 are coated with different specific antibodies, corresponding to... Figure 3 They are 32a and 32b respectively, both exposed through the same observation port, making it easy to observe whether the sample to be tested is infected with pathogens by displaying the reaction.

[0048] Specifically, the three reagent cards include a first reagent card, a second reagent card, and a third reagent card:

[0049] The first reagent card has two detection areas 32, which are spaced apart along the length of the reagent card. The two detection areas 32 are respectively coated with Streptococcus pneumoniae or Legionella pneumophila.

[0050] It is understood that the detection area 32 of the first reagent card can be provided in multiple ways. Here, two areas are provided respectively corresponding to Streptococcus pneumoniae or Legionella pneumophila. The two different Streptococcus pneumoniae and Legionella pneumophila can react with the corresponding pathogens in a colorimetric reaction, thereby enabling the detection of the two antigens mentioned above.

[0051] The second reagent card has two detection areas 32, including a first detection area 32a and a second detection area 32b. The two detection areas 32 are spaced apart along the length of the reagent card. The two detection areas 32 are respectively coated with Staphylococcus aureus and Klebsiella pneumoniae antibodies, which can react with the corresponding pathogens, thereby enabling the detection of the above two antigens.

[0052] In an embodiment of this utility model, the third reagent card is provided with a detection area 32, the detection area is coated with Mycoplasma pneumoniae antibody, and the third reagent card is used to detect Mycoplasma pneumoniae antibody.

[0053] The chromatographic membrane 3 for Mycoplasma pneumoniae antibody also includes a quality control region 31. The quality control region 31 and the detection region 32 of the chromatographic membrane 3 are spaced apart along their length. The quality control region 31 is marked with "C" as a control line to ensure the reliability of the detection. The quality control region 31 is used to verify whether the kit is operating normally, avoiding misjudgment due to kit failure or operational problems.

[0054] Furthermore, the portion of the chromatography membrane 3 located in the quality control region 31 is coated with goat anti-chicken IgY antibody. The goat anti-chicken IgY antibody coated in the quality control region 31 of the chromatography membrane 3 can bind to the colloidal gold-labeled antibody, thereby providing a quality control line so that the user can determine whether the kit is working properly.

[0055] The colloidal gold conjugate pad 2 is coated with a specific antigen monoclonal antibody labeled with colloidal gold.

[0056] In the embodiments of this utility model, the base plate 5 is made of PVC, the colloidal gold bonding pad 2 is made of glass cellulose membrane, and the chromatography membrane 3 is made of nitrocellulose membrane.

[0057] The PVC base plate 5 has good mechanical properties and chemical stability, ensuring the strength and durability of the reagent card; the colloidal gold binding pad 2 of the glass cellulose membrane provides good sample flow performance; the nitrocellulose membrane, as the chromatography membrane 3, has high binding capacity and clear color development, making it suitable for the fixation of labeled antibodies, improving the durability and detection effect of the kit, and enhancing the signal transmission efficiency during the detection process.

[0058] In an embodiment of this utility model, the length of the reagent card is 295-300mm and the width of the reagent card is 2.9-3.1mm. Within this size range, the length of the reagent card is sufficient to accommodate each functional area, and the width is optimized to fit the size of the shell.

[0059] In the embodiments of this utility model, multiple diversion sections are arranged along the same straight line, multiple observation ports are arranged along the same straight line, and each diversion section and the corresponding observation port are spaced apart along the length direction of the base plate 5. This improves the convenience of operation and avoids operational errors caused by misalignment of the ports.

[0060] It should be noted that the split section may also be equipped with a sample pad to facilitate rapid sample splitting to various detection areas.

[0061] In an embodiment of this invention, the chromatography membrane 3 is disposed in the middle of the base plate 5, the colloidal gold binding pad 2 partially overlaps one end face of the chromatography membrane 3, the absorbent pad 4 partially overlaps the other end face of the chromatography membrane 3, and the sample pad 1 partially overlaps the end of the colloidal gold binding pad 2 away from the chromatography membrane 3. By overlapping the multiple functional areas of the reagent card, the continuity of liquid flow is ensured, avoiding fluid blockage or leakage problems, thereby ensuring the smoothness of the detection process and improving the sensitivity and stability of the detection.

[0062] In an embodiment of this utility model, the reagent kit housing has a detachable upper cover and a bottom cover, and a plurality of reagent cards are disposed between the upper cover and the bottom cover. That is, the reagent kit includes an upper cover and a bottom cover, and the upper cover and the bottom cover are adapted to be connected between the upper cover and the bottom cover to form a receiving cavity, which can accommodate the plurality of reagent cards. At the same time, observation ports and sample dispensing ports are provided corresponding to the detection area 31 of the reagent card and the sample dispensing area of ​​the sample pad 1, which facilitates the addition of the test sample and the observation of the test sample results. The detachable design facilitates the replacement and maintenance of reagent cards, reduces the cost of use, increases the reusability of the reagent kit, and improves the flexibility of the reagent kit.

[0063] In an embodiment of this utility model, the periphery of the housing is provided with multiple buckles, and the bottom plate 5 of each reagent card is provided with multiple slots corresponding to the multiple buckles. That is, the periphery of the housing is provided with multiple buckles, and the bottom is provided with corresponding slots, so that the housing and the bottom plate 5 are connected and fixed by buckles, and multiple reagent cards are fixed on the bottom plate 5. At the same time, observation ports and sample dispensing ports are provided corresponding to the detection area 32 of the reagent card and the sample dispensing area of ​​the sample pad 1. The housing and multiple reagent cards are assembled to form a reagent kit. Through the design of buckles and slots, the position of the reagent cards is fixed during the detection process, thereby ensuring the accuracy and repeatability of the detection results.

[0064] In summary, this kit utilizes immunogold labeling technology and the principle of double-antibody sandwich immunochromatography. Specific antigen monoclonal antibodies and goat anti-chicken IgY are coated onto the detection and control lines of a nitrocellulose membrane, respectively. The colloidal gold-labeled specific antigen monoclonal antibodies are distributed within the glass fiber membrane. During detection, the sample is added to the well. If the sample contains specific antigens, they bind to the colloidal gold-labeled specific antigen monoclonal antibodies, forming antigen-antibody colloidal gold complexes. These complexes migrate via capillary action to the detection line area on the nitrocellulose membrane and are captured by the corresponding antibodies present there, forming the detection band. The remaining colloidal gold-labeled antibodies continue to migrate to the control line area and bind to goat anti-chicken IgY, forming the control band.

[0065] The technical solution of this utility model will be further described in detail below with reference to specific embodiments and accompanying drawings. It should be understood that the following embodiments are only used to explain this utility model and are not intended to limit this utility model.

[0066] Example 1: Preparation of colloidal gold binding pads

[0067] 1. Pretreatment of colloidal gold bonding pads:

[0068] Preparation of conjugate pad pretreatment solution: borate buffer;

[0069] The glass cellulose membrane was cut to a size of (6.8±0.1mm)×300.0mm and sprayed with a prepared bonding pad pretreatment solution. The process parameters of the gold spraying machine were: spray film concentration = 0.9μL / mm; speed = 50mm / s. After completion, it was transferred to an oven and dried at 37℃±2℃ for 24±2 hours.

[0070] 2. Colloidal Gold Labeling: Take a certain amount of colloidal gold solution in a beaker, adjust the pH to 9.5 using potassium carbonate solution, and wait 15 minutes. Add the corresponding antibody (Streptococcus pneumoniae / Legionella pneumophila antibody or Staphylococcus aureus antibody or Mycoplasma pneumoniae antibody) to make the final protein concentration 20 μg / mL, continue stirring for 20 minutes, add BSA solution, and continue stirring for 20 minutes. Centrifuge (20000 rpm, 10 minutes) to remove the supernatant. Resuspend the centrifuged precipitate in colloidal gold diluent to a suitable concentration and store at 2-8℃. Determine the OD value of the labeled substance using a spectrophotometer.

[0071] 3. Preparation of Colloidal Gold Pads: Dilute the colloidal gold markers with colloidal gold diluent. The Streptococcus pneumoniae antibody marker is diluted to 20% of the colloidal gold solution volume (as described in step 2 above), the Legionella pneumophila antibody marker is diluted to 20% of the colloidal gold volume (as described in step 2 above), the Staphylococcus aureus antibody marker is diluted to 20% of the colloidal gold volume (as described in step 2 above), and the Mycoplasma pneumoniae antibody marker is diluted to 20% of the colloidal gold volume (as described in step 2 above). Spray the diluted colloidal gold markers onto the treated glass fiber membrane using a gold spray gun, and then transfer them to a drying oven to dry (37℃±2℃, for 24±2 hours) to obtain the colloidal gold conjugate pads. After drying, the colloidal gold conjugate pads should be packaged in sealed bags, labeled, and sealed for storage at a temperature of 15-30℃ and a humidity ≤30%.

[0072] Note: Colloidal gold markers for Streptococcus pneumoniae and Legionella pneumophila need to be mixed in the specified proportions before being sprayed onto the treated glass cellulose membrane.

[0073] Example 2: Preparation of NC membrane

[0074] 1. Prepare the buffer solution for the test line and control line: 0.01M PBS;

[0075] 2. Concentration of coating solutions for test lines and control lines: 1.0 mg / mL for Streptococcus pneumoniae, Legionella pneumophila, Staphylococcus aureus, and Mycoplasma pneumoniae;

[0076] 3. Add the detection line antibody (Streptococcus pneumoniae / Legionella pneumophila antibody or Staphylococcus aureus antibody or Mycoplasma pneumoniae antibody) and the control line antibody (goat anti-chicken IgY antibody) to prepare a detection line and control line coating solution of appropriate concentration.

[0077] 4. Gently place the 25.0mm×300.0mm NC film in the center of the PVC base plate. Set the process parameters of the scribing machine: pump ① scribing concentration = 1.0μL / mm; pump ② scribing concentration = 1.0μL / mm; speed = 50mm / s; connect the coating solutions (detection line solution, control line solution) to the corresponding pipes of the scribing machine, adjust the position distance between the pipes, scrib the detection line and control line coating solutions onto the NC film, and place it in an oven to dry (37℃+2℃, 24±2 hours).

[0078] Example 3: Preparation of Sample Pad

[0079] The sample extraction solution formulation is PBS + surfactant. The sample extraction solution mainly consists of buffer solution and surfactant. The buffer solution provides a stable pH environment, while the surfactant is used to lyse bacteria, inactivating them and preventing the spread of pathogens. It also exposes nucleoproteins, facilitating detection.

[0080] The sample pad is a glass cellulose membrane treated with a sample pad treatment solution. The sample pad treatment solution is formulated as follows: Tris + surfactant. The sample pad treatment solution mainly consists of buffer solution and surfactant. The buffer solution provides a stable pH environment, and the surfactant is used to improve the hydrophilicity of the material, which is beneficial for chromatography.

[0081] Example 4: Assembly of Reagent Cards

[0082] Peel off the top edge of the PVC base plate and attach absorbent paper along the top edge, pressing it 2mm onto the NC membrane. Attach the bonding pad along the bottom edge of the N membrane, pressing it 2mm onto the NC membrane. Then attach the sample pad to the bottom edge of the PVC base plate, pressing it onto the bonding pad. After attaching, gently press to ensure the sample pad, bonding pad, absorbent paper, and NC membrane are firmly bonded. The assembled plate forms a large board, which is then cut into strips 3.0±0.1mm wide, forming... Figure 1 The reagent card shown.

[0083] During assembly, pay attention to the correspondence between the NC membrane and the conjugate pad. Take three reagent cards. The two detection areas of the first reagent card (Reagent Card I) correspond to the NC membrane coated with Streptococcus pneumoniae / Legionella pneumophila antibody and the conjugate pad labeled with Streptococcus pneumoniae / Legionella pneumophila antibody. The two detection areas of the second reagent card (Reagent Card II) correspond to the NC membrane coated with Staphylococcus aureus / Klebsiella pneumoniae antibody and the conjugate pad labeled with Staphylococcus aureus / Klebsiella pneumoniae antibody. The third reagent card (Reagent Card III) corresponds to the NC membrane coated with Mycoplasma pneumoniae antibody and the conjugate pad labeled with Mycoplasma pneumoniae antibody.

[0084] Example 5: Preparation of Reagent Cards

[0085] The three test reagent cards I, II, and III prepared in Examples 1, 2, and 3 are assembled in parallel into a single reagent card casing to form a reagent card. For example... Figure 3 As shown. Each reagent card has three sample application wells and three observation wells. The three sample application wells correspond to the sample pads of the three reagent cards, and the three observation wells correspond to the NC membranes of the three reagent cards. Reagent card I is used to detect Streptococcus pneumoniae / Legionella pneumophila, named Sp / Lp, and the corresponding observation wells are marked with "C" and "T". Reagent card II is used to detect Staphylococcus aureus / Klebsiella pneumoniae, named S. aureus / Kpn, and the corresponding observation wells are marked with "C" and "T". Reagent card III is used to detect Mycoplasma pneumoniae, named MP, and the corresponding observation wells are marked with "C" and "T". All three sample application wells are marked with "S".

[0086] The above are merely preferred embodiments of this utility model and do not limit the patent scope of this utility model. Various modifications and variations can be made to this utility model by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this utility model should be included within the patent protection scope of this utility model.

Claims

1. A combined detection kit for five respiratory pathogen antigens, characterized in that, The kit includes: The housing has a sample application port and multiple observation ports on its surface. Multiple reagent cards are housed within a casing. Each reagent card includes a base plate and a sample pad, a colloidal gold binding pad, a chromatography membrane, and an absorbent pad disposed on the base plate. The multiple reagent cards are spaced apart along the width of the base plate. The chromatography membrane has a detection area, and the portion of the chromatography membrane in the detection area is coated with labeled antibodies. The base plate includes a groove, and multiple flow dividers are disposed within the groove for diverting the sample to be tested. The sample pad of each reagent card is installed in the groove corresponding to the flow dividers and is exposed at the sample dispensing port. The detection area of ​​each chromatography membrane is exposed at the corresponding observation port.

2. The respiratory 5-pathogen antigen combination test kit as set forth in claim 1, wherein The plurality of reagent cards include three reagent cards spaced apart along their length, and the chromatographic membrane in each reagent card has multiple detection areas, each of which is coated with a different labeled antibody, and the multiple detection areas of each chromatographic membrane are exposed at the same observation port.

3. The respiratory tract five-pathogen antigen combined detection kit as described in claim 2, characterized in that, The three reagent cards include a first reagent card, a second reagent card, and a third reagent card: The first reagent card has two detection areas, which are spaced apart along the length of the reagent card. The two detection areas are respectively coated with Streptococcus pneumoniae or Legionella pneumophila. And / or, The second reagent card has two detection areas, which are spaced apart along the length of the reagent card. The two detection areas are respectively coated with antibodies against Staphylococcus aureus and Klebsiella pneumoniae; and / or, The third reagent card has a detection area, and the detection area is coated with Mycoplasma pneumoniae antibodies.

4. The kit of claim 1, wherein The chromatography membrane further includes a quality control region, which is spaced apart from the detection region along its length. The portion of the chromatographic membrane in the detection region is coated with labeled antibodies; and / or, The portion of the chromatographic membrane in the quality control region is coated with goat anti-chicken IgY antibody; and / or... The colloidal gold conjugate pad is coated with a colloidal gold-labeled monoclonal antibody against a specific antigen.

5. The respiratory 5-pathogen antigen combination test kit as set forth in claim 1, wherein The base plate is made of PVC; and / or, The colloidal gold bonding pad is made of glass fiber membrane; and / or, The chromatography membrane is a nitrocellulose membrane.

6. The respiratory 5-pathogen antigen combination test kit as set forth in claim 1, wherein The reagent card is 295–300 mm in length; and / or, The reagent card has a width of 2.9–3.1 mm.

7. The respiratory tract five-pathogen antigen combined detection kit as described in claim 1, characterized in that, Multiple flow dividers are arranged along the same straight line, multiple observation ports are arranged along the same straight line, and each flow divider and its corresponding observation port are spaced apart along the length of the base plate.

8. The respiratory 5-pathogen antigen combination test kit as set forth in claim 1, wherein The chromatography membrane is located in the middle of the base plate. The colloidal gold binding pad partially overlaps one end face of the chromatography membrane, the absorbent pad partially overlaps the other end face of the chromatography membrane, and the sample pad partially overlaps the end of the colloidal gold binding pad away from the chromatography membrane.

9. The respiratory tract five-pathogen antigen combined detection kit as described in claim 1, characterized in that, The reagent kit housing has a removable top cover and a bottom cover, with multiple reagents held between the top cover and the bottom cover.

10. The respiratory tract five-pathogen antigen combined detection kit as described in claim 1, characterized in that, The periphery of the housing is provided with multiple buckles, and the base plate of each reagent card is provided with multiple slots corresponding to the multiple buckles.

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