Immunochromatography reagent card for detecting Francisella tularensis antibody

By designing an immunochromatographic reagent card, the detection steps for Tula Francisella were simplified, enabling rapid and convenient detection that is suitable for use in primary healthcare institutions. This solves the problems of complex testing and high equipment dependence of existing reagent kits.

CN223940947UActive Publication Date: 2026-02-24SHENZHEN KINGFOCUS BIOMDICAL ENG CO LTD
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Patent Information

Application Number
CN202520463083.1
Authority / Receiving Office
CN · China
Patent Type
Utility models(China)
Current Assignee / Owner
Filing Date
2025-03-17
Publication Date
2026-02-24
Estimated Expiration
2035-03-17

AI Technical Summary

Technical Problem

Existing Tulafrancella detection kits have complex testing procedures and are highly dependent on equipment, making them difficult to popularize in primary healthcare institutions.

Method used

An immunochromatographic reagent card was designed, including a shell, a top cover, and a test strip. The test strip is set in a limiting groove and includes an absorbent pad, a strip-shaped fiber chromatography membrane, and a sample pad. It is equipped with a quality control line and a detection line for detecting Tula Francisella IgM/IgG antibodies and can detect both antibodies simultaneously.

Benefits of technology

It simplifies the testing process, improves testing efficiency, and can quickly produce results after one sample addition, making it suitable for use in primary healthcare institutions and reducing reliance on equipment.

✦ Generated by Eureka AI based on patent content.

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Abstract

The utility model discloses an immunochromatography reagent card for detecting a Francisella tularensis antibody, and relates to the technical field of biological detection. The reagent card comprises a shell, an upper cover and a first test strip, the upper cover and the shell are buckled and fixed, and the first test strip is arranged between the upper cover and the shell; the shell is provided with a limiting groove, the first test strip is arranged in the limiting groove, and a limiting pad is arranged between the first test strip and the limiting groove; the first test strip comprises a back plate, and a water absorption pad, a strip-shaped fiber chromatography membrane, a combination pad and a sample pad are sequentially adhered to the back plate in an end-to-end overlapping and connecting manner; at least one quality control line and at least one detection line are arranged on the strip-shaped fiber chromatography membrane so as to detect the Francisella tularensis IgM / IgG antibody; a sample adding hole is formed in the position, corresponding to the sample pad, of the upper cover, and an observation window is formed in the position, corresponding to the strip-shaped fiber chromatography membrane, of the upper cover. The reagent card provided by the utility model can be used for preventing the test strip from shifting, accommodating liquid and preventing the liquid from overflowing, and has the advantage of simple structure.
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Description

Technical Field

[0001] This utility model relates to the field of biological detection technology, and in particular to an immunochromatographic reagent card for detecting antibodies against Tula Francisella. Background Technology

[0002] Francisella tularensis, a Gram-negative cocci, presents as an asymptomatic carrier in 4%-19% of infections caused by its subspecies Tulare (type A) and the subspecies Holarctic (type B). Typical clinical symptoms include: rapid onset (fever >39°C for 3-5 days), multiple skin ulcers (occurring in 83% of cases on the extremities), and generalized pain. Without timely treatment, the fever period can be prolonged to 4-8 weeks. The incidence of sepsis in severe cases is as high as 22%, and the mortality rate can reach 5%-30% (according to data from *Clinical Infectious Diseases*, 2022; timely treatment can reduce this to <1%). Since this pathogen can be transmitted across species through animal contact (positive rate 17.3%) and vector bites (tick carrier rate 9.8%), establishing an early rapid diagnostic system is crucial for interrupting the transmission chain.

[0003] Immunological studies have shown that post-infection antibody dynamics exhibit a clear temporal pattern: IgM antibodies seroconvert on days 5-7 (sensitivity 92.3%, specificity 88.7%), serving as a core indicator for early diagnosis; IgG antibodies reach the detection threshold (titer ≥1:160) on days 14-21, and their levels are positively correlated with infection progression (r = 0.82, p < 0.01). Current guidelines for the diagnosis of zoonotic diseases explicitly recommend that combined detection of both antibodies can advance the clinical diagnostic window by approximately one week, significantly improving treatment efficacy (OR = 4.15, 95% CI 2.33-7.41). Therefore, detecting IgM / IgG antibodies in *Streptococcus tularensis* can assist clinicians in making accurate clinical diagnoses earlier and faster, understanding disease progression, and providing patients with more timely, accurate, and effective treatment methods.

[0004] Currently available commercially available diagnostic kits primarily employ PCR, which suffers from the following technical bottlenecks: ① long nucleic acid extraction time (including six steps such as centrifugation and purification); ② amplification and detection process taking ≥90 minutes; ③ equipment dependence leading to low adoption rates in primary healthcare institutions and limited options for clinicians. Therefore, developing a highly efficient, rapid, simple, and structurally stable *Tetrandrobium tularemia* diagnostic kit using immunochromatography would not only fill a market gap and meet practical clinical needs but also promote the advancement of healthcare. Utility Model Content

[0005] The technical problem to be solved by this utility model embodiment is that the existing detection kits for detecting Tula Francisella bacteria have complicated detection steps.

[0006] To address the above problems, the present invention proposes the following technical solutions:

[0007] An immunochromatographic reagent card for detecting antibodies against *Tetrandrine tularemia*, comprising a shell, a cap, and a first test strip;

[0008] The upper cover is fastened and fixed to the housing, and the first test strip is disposed between the upper cover and the housing;

[0009] The housing is provided with a limiting groove, the first test strip is disposed in the limiting groove, and a limiting pad is provided between the first test strip and the limiting groove;

[0010] The first test strip includes a back plate, on which an absorbent pad, a strip-shaped fiber chromatography membrane, a conjugate pad, and a sample pad are sequentially and sequentially pasted, overlapping end to end.

[0011] The strip-shaped fiber chromatography membrane is provided with at least one control line and at least one detection line to detect Tula Francisella IgM / IgG antibodies;

[0012] The top cover has a sample application hole at the position corresponding to the sample pad and an observation window at the position corresponding to the strip-shaped fiber chromatography membrane.

[0013] A further technical solution includes a second test strip, wherein the chromatography direction of the second test strip is opposite to that of the first test strip.

[0014] A further technical solution is that the second test strip is connected to the sample pad of the first test strip.

[0015] A further technical solution is that both the second test strip and the first test strip are disposed within the limiting groove.

[0016] A further technical solution is that there are two observation windows, which are respectively set on both sides of the sample application hole.

[0017] A further technical solution is that the first test strip and the second test strip have different detection items.

[0018] A further technical solution is that the strip-shaped fiber chromatography membrane is one of nitrocellulose membrane, nylon membrane, polyvinylidene fluoride membrane, polyamide membrane, or DEAE cellulose membrane.

[0019] A further technical solution is that the limiting pad is made of at least one of sponge, cotton, and silicone.

[0020] A further technical solution is that the shape of the sample feeding hole is one of the following: ellipse, circle, rectangle, square, or any combination of two shapes.

[0021] A further technical solution is that the shape of the observation window is one of the following: ellipse, circle, rectangle, square, or any combination of two shapes.

[0022] Compared with the prior art, the technical effects achieved by the embodiments of this utility model include:

[0023] This invention provides an immunochromatographic reagent card for detecting *Tetrandella tularensis* antibodies, comprising a shell, a top cover, and a first test strip. The top cover is fastened and fixed to the shell, and the first test strip is disposed between the top cover and the shell. The shell has a limiting groove, within which the first test strip is disposed, and a limiting pad is disposed between the first test strip and the limiting groove. The first test strip includes a back plate, on which an absorbent pad, a strip-shaped fiber chromatography membrane, a conjugate pad, and a sample pad are sequentially and overlappingly attached. The strip-shaped fiber chromatography membrane has at least one control line and at least one detection line for detecting *Tetrandella tularensis* IgM / IgG antibodies. The top cover has a sample application hole at the position corresponding to the sample pad and an observation window at the position corresponding to the strip-shaped fiber chromatography membrane. This immunochromatographic reagent card for detecting *Tetrandella tularensis* antibodies, with its limiting groove for mounting the test strip, prevents strip displacement and allows for liquid containment, preventing spillage, and has the advantage of simple structure. When using it, you only need to add the sample once to the sample well of the reagent card to quickly generate the test results.

[0024] Furthermore, the immunochromatographic reagent card for detecting *Tulafrancsis* antibodies provided by this invention also includes a second test strip. The second test strip has the same structure as the first test strip, but the chromatography direction is opposite. The two test strips detect different items respectively, and the results for two items can be obtained with a single sample addition, offering the advantage of high efficiency. Attached Figure Description

[0025] The accompanying drawings, which are incorporated in and form part of this specification, illustrate embodiments consistent with the present invention and, together with the description, serve to explain the principles of the present invention.

[0026] 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, for those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0027] One or more embodiments are illustrated by way of example with reference numerals in the accompanying drawings. These illustrations do not constitute a limitation on the embodiments. Elements with the same reference numerals in the drawings are denoted as similar elements. Unless otherwise stated, the figures in the drawings are not to be limited by scale.

[0028] Figure 1 A schematic diagram of the structure of the first test strip of the immunochromatographic reagent card for detecting antibodies against Tula Francisella provided by this utility model.

[0029] Figure 2 This is a schematic diagram of the top cover and shell of the immunochromatographic reagent card for detecting antibodies against Tula Francisella provided in Embodiment 1 of this utility model.

[0030] Figure 3 This is a schematic diagram of the top cover and shell of the immunochromatographic reagent card for detecting antibodies against Tula Francisella provided in Embodiment 2 of this utility model.

[0031] Figure 4 This is a schematic diagram showing the different configurations of the control line and the detection line of the first test strip for detecting antibodies against Tula Francisella provided in Embodiment 1 of this utility model.

[0032] Figure 5 This is a schematic diagram showing the different configurations of the control line and the detection line of the first and second test strips for detecting antibodies against Tula Francisella provided in Embodiment 2 of this utility model.

[0033] Figure Labels

[0034] 13. First test strip, 14. Second test strip, 1. Backing plate, 2. Absorbent pad, 3. Strip fiber chromatography membrane, 4. Binding pad, 5. Sample pad, 6. Control line, 7. Detection line.

[0035] 8. Top cover, 9. Shell, 10. Limiting pad, 11. Sample dispensing hole, 12. Observation window. Detailed Implementation

[0036] The technical solutions in the embodiments of this utility model will be clearly and completely described below with reference to the accompanying drawings. Similar component reference numerals in the drawings represent similar components. Obviously, the embodiments described below are only some embodiments of this utility model, and not all embodiments. All other embodiments obtained by those skilled in the art based on the embodiments of this utility model without creative effort are within the scope of protection of this utility model.

[0037] It should be understood that, when used in this specification and the appended claims, the terms "comprising" and "including" indicate the presence of the described features, integrals, steps, operations, elements and / or components, but do not exclude the presence or addition of one or more other features, integrals, steps, operations, elements, components and / or collections thereof.

[0038] It should also be understood that the terminology used in this specification of embodiments of the present invention is for the purpose of describing particular embodiments only and is not intended to limit the embodiments of the present invention. As used in this specification of embodiments of the present invention and the appended claims, the singular forms “a,” “an,” and “the” are intended to include the plural forms unless the context clearly indicates otherwise.

[0039] Example 1

[0040] See Figure 1 and Figure 2 This utility model provides an immunochromatographic reagent card for detecting antibodies against Tula Francisella, as shown in the figure, which includes a shell 9, a top cover 8 and a first test strip 13;

[0041] The upper cover 8 is fastened and fixed to the housing 9, and the first test strip 13 is disposed between the upper cover 8 and the housing 9;

[0042] The housing 9 is provided with a limiting groove, the first test strip 13 is disposed in the limiting groove, and a limiting pad 10 is provided between the first test strip 13 and the limiting groove;

[0043] The first test strip 13 includes a back plate 1, on which an absorbent pad 2, a strip-shaped fiber chromatography membrane 3, a conjugate pad 4, and a sample pad 5 are sequentially and sequentially pasted, overlapping each other.

[0044] The strip-shaped fiber chromatography membrane 3 is provided with at least one control line 6 and at least one detection line 7 to detect Tula Francisella IgM / IgG antibodies;

[0045] The upper cover 8 has a sample feeding hole 11 at the position corresponding to the sample pad 5 and an observation window 12 at the position corresponding to the strip fiber chromatography membrane 3.

[0046] It should be noted that the control line 6 on the strip-shaped fiber chromatography membrane 3 is coated with secondary antibody, and the detection line 7 is coated with antibody or antigen corresponding to the detection item. In some embodiments, one control line 6 and one detection line 7 can be set when detecting one item. In other embodiments, two control lines 6 and one detection line 7 can be set when detecting one item. In other embodiments, one control line 6 and two detection lines 7 can be set when detecting one item. In other embodiments, two control lines 6 and two detection lines 7 can be set when detecting one item. The number of detection lines 7 and control lines 6 depends on the detection item, detection principle, and specific requirements, and this utility model does not limit this.

[0047] In a specific embodiment, the strip-shaped fiber chromatography membrane 3 is one of nitrocellulose membrane, nylon membrane, polyvinylidene fluoride membrane, polyamide membrane, and DEAE cellulose membrane. In this embodiment, the strip-shaped fiber chromatography membrane 3 is a nitrocellulose membrane.

[0048] In a specific embodiment, the material sprayed onto the bonding pad 4 is one of the following: fluorescent particles, enzymes, chemiluminescent substances, nanomaterials (carbon nanoparticles, non-metallic nanoparticles, metallic nanoparticles, latex microspheres, quantum dots), magnetic microparticles, and rare earth ions. The fluorescent particles include, but are not limited to, anthocyanin-based fluorescent dyes, carboxyfluorescein, fluorescein isothiocyanate, 2-methoxyfluorescein, rhodamine, phycoerythrin, and lanthanide chelates. The enzymes include, but are not limited to, horseradish peroxidase, alkaline phosphatase, and luciferase. The chemiluminescent substances include, but are not limited to, acridine esters, isoluminol, and ruthenium tripyridine. The carbon nanoparticles include, but are not limited to, carbon nanotubes, carbon nanofibers, and carbon nanospheres. The non-metallic nanoparticles include, but are not limited to, colloidal selenium. The metallic nanoparticles include, but are not limited to, nano-gold particles, nano-silver particles, nano-nickel particles, and nano-palladium particles. The latex microspheres are polystyrene latex microspheres modified with chemical groups, wherein the chemical groups include, but are not limited to, carboxyl, amino, hydroxyl, thiol, and sulfate groups. The quantum dots include, but are not limited to, elemental semiconductor quantum dots, compound semiconductor quantum dots, alloy quantum dots, core-shell structure quantum dots, and doped quantum dots. The magnetic particles include, but are not limited to, magnetic metals / magnetic metal oxides (such as Fe, Co, Ni and their corresponding oxides and alloys) and composites formed with organic or inorganic materials through surface modification. The rare earth ions include, but are not limited to, scandium ions, yttrium ions, and cerium ions.

[0049] In this embodiment, the material sprayed on the bonding pad 4 is colloidal gold.

[0050] In other embodiments, the material sprayed onto the bonding pad 4 is quantum dots.

[0051] Understandably, in the first test strip 13, the sample pad 5 is used to receive the sample to be tested and to spread the sample evenly, and the absorbent pad 2 is used to assist the sample to flow directionally on the test strip and to control the sample flow rate.

[0052] In a specific embodiment, the limiting pad 10 is made of at least one of sponge, cotton, and silicone. In this embodiment, the limiting pad 10 is made of cotton.

[0053] In a specific embodiment, the sample feeding hole 11 is shaped as an ellipse, a circle, a rectangle, or a square, or a combination of any two shapes. In this embodiment, the sample feeding hole 11 is elliptical.

[0054] In a specific embodiment, the shape of the observation window 12 is one of an ellipse, a circle, a rectangle, or a square, or any combination of two shapes. In this embodiment, the shape of the observation window 12 is rectangular.

[0055] In this embodiment, the first test strip 13 is used to detect IgM antibodies and / or IgG antibodies against *Tetrandella tularensis*. The first test strip 13 is inserted into the limiting groove in the housing 9, placed above the limiting pad 10, and the top cover 8 is closed to form a reagent card capable of detecting IgM antibodies and / or IgG antibodies against *Tetrandella tularensis*.

[0056] See further Figure 4 The immunochromatographic reagent card for detecting *Tetrandella tularensis* antibodies provided in this embodiment uses an indirect method for detecting *Tetrandella tularensis* antibodies. The first test strip 13 has one or two detection lines 7 and one or two control lines 6, which are described below:

[0057] (a) Detection of Tulafrancsis IgM antibodies:

[0058] Figure 4 Figure (a) shows that the strip-shaped fiber chromatography membrane 3 of the first test strip 13 is coated with a detection line 7 and a control line 6, wherein the detection line 7 is used to detect Tula Francisella IgM antibody.

[0059] Figure 4 Figure (b) shows that the strip-shaped fiber chromatography membrane 3 of the first test strip 13 is coated with two detection lines 7 and two control lines 6. Both detection lines 7 are used to detect Tula Francisella IgM antibodies.

[0060] Figure 4 Figure (c) shows that a detection line 7 and two control lines 6 are sprayed onto the strip-shaped fiber chromatography membrane 3 of the first test strip 13. The detection line 7 is used to detect Tula Francisella IgM antibody.

[0061] Figure 4Figure (d) shows that the strip-shaped fiber chromatography membrane 3 of the first test strip 13 is coated with two detection lines 7 and one control line 6. Both detection lines 7 are used to detect Tula Francisella IgM antibodies.

[0062] (II) Detection of Tulafrancsis IgG antibody:

[0063] Figure 4 Figure (a) shows that the strip-shaped fiber chromatography membrane 3 of the first test strip 13 is coated with a detection line 7 and a control line 6, wherein the detection line 7 is used to detect Tula Francisella IgG antibodies.

[0064] Figure 4 Figure (b) shows that the strip-shaped fiber chromatography membrane 3 of the first test strip 13 is coated with two detection lines 7 and two control lines 6. Both detection lines 7 are used to detect Tula Francisella IgG antibodies.

[0065] Figure 4 Figure (c) shows that a detection line 7 and two control lines 6 are sprayed onto the strip-shaped fiber chromatography membrane 3 of the first test strip 13. The detection line 7 is used to detect Tula Francisella IgG antibodies.

[0066] Figure 4 Figure (d) shows that the strip-shaped fiber chromatography membrane 3 of the first test strip 13 is coated with two detection lines 7 and one control line 6. Both detection lines 7 are used to detect Tulafrancsis IgG antibodies.

[0067] (III) Simultaneous detection of Tulafrancsis IgM and IgG antibodies:

[0068] Figure 4 In Figure (a), the strip-shaped fiber chromatography membrane 3 of the first test strip 13 is coated with a detection line 7 and a control line 6. The detection line 7 is used to simultaneously detect Tulafrancsis IgM and IgG antibodies. Specifically, the left half of the detection line 7 can be set to detect Tulafrancsis IgM antibodies, and the right half can be set to detect Tulafrancsis IgG antibodies.

[0069] Figure 4 Figure (b) shows that the strip-shaped fiber chromatography membrane 3 of the first test strip 13 is coated with two detection lines 7 and two control lines 6. The two detection lines 7 are used to detect Tula Francisella IgM antibody and IgG antibody, respectively.

[0070] Figure 4In Figure (c), the strip-shaped fiber chromatography membrane 3 of the first test strip 13 is coated with a detection line 7 and two control lines 6. The detection line 7 is used to simultaneously detect Tulafrancsis IgM and IgG antibodies. Specifically, the left half of the detection line 7 can be set to detect Tulafrancsis IgM antibodies, and the right half can be set to detect Tulafrancsis IgG antibodies.

[0071] Figure 4 Figure (d) shows that the strip-shaped fiber chromatography membrane 3 of the first test strip 13 is coated with two detection lines 7 and one control line 6. The two detection lines 7 are used to detect Tula Francisella IgM antibody and IgG antibody, respectively.

[0072] Example 2

[0073] See further Figure 3 This embodiment, based on the above embodiment, further includes a second test strip 14, the second test strip 14 having the opposite chromatographic direction to the first test strip 13. Understandably, the second test strip 14 and the first test strip 13 have the same structure, and the sample pad 5 and absorbent pad 2 of the second test strip 14 and the first test strip 13 are arranged in opposite positions.

[0074] In a specific embodiment, the second test strip 14 is connected to the sample pad 5 of the first test strip 13. In other embodiments, the second test strip 14 and the first test strip 13 share the sample pad 5.

[0075] In a specific embodiment, both the second test strip 14 and the first test strip 13 are disposed in the limiting groove.

[0076] In a specific embodiment, there are two observation windows 12, which are respectively located on both sides of the sample application hole 11.

[0077] In specific embodiments, the first test strip 13 and the second test strip 14 detect different items. For example, the first test strip 13 is used to detect IgM antibodies against *François tularensis*, and the second test strip 14 is used to detect IgG antibodies against *François tularensis*. In other embodiments, the second test strip 14 is used to detect IgM antibodies against *François tularensis*, and the first test strip 13 is used to detect IgG antibodies against *François tularensis*.

[0078] First, assemble the first test strip 13 and the second test strip 14 in the preset structural order, put them together into the limiting groove in the housing 9, place them above the limiting pad 10, and cover them with the top cover 8 to form a reagent card that can simultaneously detect Tula Francisella IgM antibody and IgG antibody.

[0079] See further Figure 5The immunochromatographic reagent card for detecting *Tetrandella tularensis* antibodies provided in this embodiment uses an indirect method to detect *Tetrandella tularensis* antibodies. Based on the detection items of the first test strip 13 and the second test strip 14, for example, the first test strip 13 detects *Tetrandella tularensis* IgM antibodies, and the second test strip 14 detects *Tetrandella tularensis* IgG antibodies. The first test strip 13 has one or two test lines 7 and one or two control lines 6, and the second test strip 14 has one or two test lines 7 and one or two control lines 6. The different numbers of control lines 6 and test lines 7 in the first test strip 13 and the second test strip 14 are described below for the corresponding detection items:

[0080] Figure 5 Figure (a) shows that the first test strip 13 has a strip-shaped fiber chromatography membrane 3 coated with a detection line 7 and a control line 6, where the detection line 7 is used only to detect *Tetrandella tularensis* IgM antibodies; the second test strip 14 has two detection lines 7 and two control lines 6 coated with the strip-shaped fiber chromatography membrane 3, where the two detection lines 7 are used only to detect *Tetrandella tularensis* IgG antibodies. The resulting reagent card can simultaneously detect both *Tetrandella tularensis* IgM and IgG antibodies.

[0081] Figure 5 Figure (b) shows that the first test strip 13 has a strip-shaped fiber chromatography membrane 3 coated with a detection line 7 and a control line 6, where the detection line 7 is used only to detect *Tetrandella tularensis* IgM antibodies; the second test strip 14 has a strip-shaped fiber chromatography membrane 3 coated with a detection line 7 and two control lines 6, where the detection line 7 is used only to detect *Tetrandella tularensis* IgG antibodies. The resulting reagent card can simultaneously detect both *Tetrandella tularensis* IgM and IgG antibodies.

[0082] Figure 5 Figure (c) shows that the first test strip 13 has a strip-shaped fiber chromatography membrane 3 coated with a detection line 7 and a control line 6, where the detection line 7 is used only to detect *Tetrandella tularensis* IgM antibodies; the second test strip 14 has two detection lines 7 and a control line 6 coated with the strip-shaped fiber chromatography membrane 3, where the two detection lines 7 are used only to detect *Tetrandella tularensis* IgG antibodies. The resulting reagent card can simultaneously detect both *Tetrandella tularensis* IgM and IgG antibodies.

[0083] Figure 5Figure (d) shows that the first test strip 13 has two detection lines 7 and two control lines 6 sprayed onto its strip-shaped fiber chromatography membrane 3. The two detection lines 7 are used only to detect *Tetrandella tularensis* IgM antibodies. The second test strip 14 has one detection line 7 and two control lines 6 sprayed onto its strip-shaped fiber chromatography membrane 3. The detection line 7 is used only to detect *Tetrandella tularensis* IgG antibodies. The resulting reagent card can simultaneously detect both *Tetrandella tularensis* IgM and IgG antibodies.

[0084] Figure 5 Figure (e) shows that the first test strip 13 has two detection lines 7 and two control lines 6 sprayed onto its strip-shaped fiber chromatography membrane 3. The two detection lines 7 are used only to detect *Tetrandella tularensis* IgM antibodies. The second test strip 14 has two detection lines 7 and one control line 6 sprayed onto its strip-shaped fiber chromatography membrane 3. The two detection lines 7 are used only to detect *Tetrandella tularensis* IgG antibodies. The resulting reagent card can simultaneously detect both *Tetrandella tularensis* IgM and IgG antibodies.

[0085] Figure 5 Figure (f) shows that the first test strip 13 has a strip-shaped fiber chromatography membrane 3 coated with one detection line 7 and two control lines 6. The detection line 7 is used only to detect *Tetrandella tularensis* IgM antibodies. The second test strip 14 has two detection lines 7 and one control line 6 coated with the strip-shaped fiber chromatography membrane 3. The detection line 7 is used only to detect *Tetrandella tularensis* IgG antibodies. The resulting reagent card can simultaneously detect both *Tetrandella tularensis* IgM and IgG antibodies.

[0086] The immunochromatographic reagent card for detecting antibodies against *Tetrandella tularemia* provided by this invention features a limiting groove for mounting the test strip, preventing strip displacement while also accommodating liquid to prevent spillage. It boasts a simple structure. In use, only one drop of sample needs to be added to the sample well of the reagent card to quickly obtain the test result.

[0087] Furthermore, the immunochromatographic reagent card for detecting antibodies against *Tetrandella tularemia* provided by this invention also includes a second test strip, the second test strip having the opposite chromatographic direction to the first test strip. The two test strips detect different items respectively, and the results for two items can be obtained with a single sample addition, offering the advantage of high efficiency.

[0088] In the above embodiments, the descriptions of each embodiment have different focuses. For parts that are not described in detail in a certain embodiment, please refer to the relevant descriptions in other embodiments.

[0089] In the description of this utility model, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", etc., indicating the orientation or positional relationship are 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 are not intended to 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.

[0090] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of this utility model, "a plurality of" means two or more, unless otherwise explicitly specified.

[0091] In this utility model, unless otherwise explicitly specified and limited, the terms "installation," "connection," "joining," and "fixing," etc., should be interpreted broadly. For example, they can refer to a connection, a detachable connection, or an integral part; 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; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this utility model according to the specific circumstances.

[0092] In this invention, unless otherwise explicitly specified and limited, "above" or "below" the second feature can include direct contact between the first and second features, or contact between the first and second features through another feature between them. Furthermore, "above," "over," and "on top" of the second feature includes the first feature directly above or diagonally above the second feature, or simply indicates that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature includes the first feature directly below or diagonally below the second feature, or simply indicates that the first feature is at a lower horizontal level than the second feature.

[0093] In the description of this specification, the references to terms such as "one embodiment," "some embodiments," "example," "specific example," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of the present invention. The illustrative expressions of the above terms in this specification should not be construed as necessarily referring to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples. In addition, those skilled in the art can combine and integrate the different embodiments or examples described in this specification.

[0094] Obviously, those skilled in the art can make various modifications and variations to this utility model without departing from its spirit and scope. Since these modifications and variations fall within the scope of the claims of this utility model and their equivalents, this utility model also intends to include these modifications and variations.

[0095] The above description describes specific embodiments of this utility model, but the scope of protection of this utility model is not limited thereto. Any person skilled in the art can easily conceive of various equivalent modifications or substitutions within the technical scope disclosed in this utility model, and these modifications or substitutions should all be covered within the scope of protection of this utility model. Therefore, the scope of protection of this utility model should be determined by the scope of the claims.

Claims

1. An immunochromatographic reagent card for detecting antibodies against *Tulafrancsis*, characterized in that, Includes the casing, top cover, and first test strip; The upper cover is fastened and fixed to the housing, and the first test strip is disposed between the upper cover and the housing; The housing is provided with a limiting groove, the first test strip is disposed in the limiting groove, and a limiting pad is provided between the first test strip and the limiting groove; The first test strip includes a back plate, on which an absorbent pad, a strip-shaped fiber chromatography membrane, a conjugate pad, and a sample pad are sequentially and sequentially pasted, overlapping end to end. The strip-shaped fiber chromatography membrane is provided with at least one control line and at least one detection line to detect Tula Francisella IgM / IgG antibodies; The top cover has a sample application hole at the position corresponding to the sample pad and an observation window at the position corresponding to the strip-shaped fiber chromatography membrane.

2. The immunochromatographic reagent card for detecting antibodies against *Tulafrancsis* as described in claim 1, characterized in that, It also includes a second test strip, which has the opposite chromatographic direction to the first test strip.

3. The immunochromatographic reagent card for detecting antibodies against *Tulafrancsis* as described in claim 2, characterized in that, The second test strip is connected to the sample pad of the first test strip.

4. The immunochromatographic reagent card for detecting antibodies against *Tulafrancsis* as described in claim 2, characterized in that, Both the second test strip and the first test strip are placed in the limiting groove.

5. The immunochromatographic reagent card for detecting antibodies against *Tulafrancsis* as described in claim 4, characterized in that, There are two observation windows, one on each side of the sample application hole.

6. The immunochromatographic reagent card for detecting antibodies against *Tulafrancsis* as described in claim 2, characterized in that, The first test strip and the second test strip test different items.

7. The immunochromatographic reagent card for detecting antibodies against *Tulafrancsis* as described in claim 1, characterized in that, The strip-shaped fiber chromatography membrane is one of nitrocellulose membrane, nylon membrane, polyvinylidene fluoride membrane, polyamide membrane, or DEAE cellulose membrane.

8. The immunochromatographic reagent card for detecting antibodies against *Tulafrancsis* as described in claim 1, characterized in that, The limiting pad is made of at least one of sponge, cotton, and silicone.

9. The immunochromatographic reagent card for detecting antibodies against *Tulafrancsis* as described in claim 1, characterized in that, The shape of the sample application hole is one of the following: ellipse, circle, rectangle, square, or any combination of two shapes.

10. The immunochromatographic reagent card for detecting antibodies against *Tulafrancsis* as described in claim 5, characterized in that, The shape of the observation window is one of the following: ellipse, circle, rectangle, square, or any combination of two shapes.