Health monitoring test strip for hygienic products

Abstract

The utility model relates to the technical field of sample detection, and discloses a health monitoring test strip for hygienic products, which sequentially comprises a waterproof top layer, a composite layer and a waterproof bottom layer from top to bottom, the composite layer is I-shaped and consists of a sample collection pad, a colloidal gold combination pad, a color developing film and a sample absorption pad which are sequentially and partially overlapped, arranged and fixed on the waterproof bottom layer; the waterproof top layer does not cover the sample collection pad and completely covers the colloidal gold combination pad, the color developing film and the sample absorption pad. Compared with the traditional I-shaped test strip, the test strip disclosed by the utility model has the advantages that the sample collection pad and the sample absorption pad are extended by adopting the design of the I-shaped composite layer, so that the collection amount and the absorption amount of a sample are ensured, the collection area of the sample is enlarged, the collection rate of the test strip for liquid samples in hygienic products is improved, and the test strip is convenient to use. And the overall thickness of the test strip is also obviously reduced, so that the problems that a traditional I-shaped test strip is small in sampling area and strong in foreign body sensation when being used for hygienic products are solved.

Description

Technical Field

[0001] The utility model relates to the technical field of sample detection, in particular to a health monitoring test strip for sanitary products. Background Art

[0002] Colloidal gold test strips are widely used in daily life and experiments, and can quickly and easily perform semi-quantitative testing of biochemical indicators. Conventional colloidal gold test strips are mainly composed of five parts: a hard PET / PE base, absorbent paper, an NC membrane, a colloidal gold binding pad, and an absorption pad. In the design of the test strips, the sample collection area should be able to quickly absorb and transfer liquid samples, and have no effect on the components of the liquid sample to be tested; for the sample absorption part, it is required to have a strong ability to absorb and fix liquid samples. Since test strips are often used for rapid on-site testing such as clinical diagnosis, environmental monitoring, and food safety testing, in order to facilitate picking up or fixing, the bottom layer of the test strips is often made of relatively hard materials such as PVC. As for the shape of the test strips, considering simplicity and cost, the "I" shape is often used.

[0003] In recent years, with the advancement of medical technology and the improvement of health awareness, people have a growing demand for portable detection of physiological indicators, and more and more hygiene products with health monitoring functions have begun to appear. Among them, human chorionic gonadotropin (HCG), luteinizing hormone (LH), Streptococcus gonorrhea, Chlamydia trachomatis, Ureaplasma urealyticum, human papillomavirus, and herpes simplex virus in vaginal secretions or urine are common detection indicators. Prior art CN110013383A directly connects pregnancy test strips and ovulation test strips prepared by the colloidal gold method to female hygiene products for monitoring early pregnancy and ovulation; CN219289926U connects a pregnancy test strip set and a STD test strip set to a panty liner to obtain a product that can both test for pregnancy and detect STDs; WO2024084726A1 and WO2024085240A1 connect luteinizing hormone LH test strips (WO2024085239A1) to fabrics and absorbent articles for monitoring female ovulation. The test strips used in these products are still traditional long "I" shapes. When connected to daily wearable hygiene products, they face the problem of sample collection difficulties caused by the narrow sample collection area and the strong foreign body sensation caused by the excessive thickness of the sample collection pad and the sample absorption pad, which hinders the development of the health monitoring hygiene product market. Therefore, there is an urgent need for a test strip that is designed based on the demand for high wearing comfort of daily necessities and is overall lighter, thinner, more convenient to sample, and has high detection sensitivity. Utility Model Content

[0004] The purpose of the utility model is to provide an "I"-shaped health monitoring test strip for sanitary products, which solves the problems of small sample collection area and strong foreign body sensation faced when traditional "I"-shaped test strips are connected to daily sanitary products for biochemical index detection.

[0005] The utility model solves the above technical problems through the following technical means: a health monitoring test strip for sanitary products, which comprises, from top to bottom, a waterproof top layer, a composite layer and a waterproof bottom layer, the composite layer being designed in the shape of an "I", and consisting of a sample collection pad, a colloidal gold binding pad, a color developing film, and a sample absorption pad, which are arranged in sequence and partially overlapped and fixed on the waterproof bottom layer; above the composite layer is a waterproof top layer, which does not cover the sample collection pad but completely covers the colloidal gold binding pad, the color developing film, and the sample absorption pad; a detection line T line and a quality control line C line are provided on the color developing film; the composite layer is in the shape of an "I", with the sample absorption pad forming an upper horizontal part, the colloidal gold binding pad and the color developing film forming a middle vertical part, and the sample collection pad forming a lower horizontal part.

[0006] In a specific embodiment, the sample collection pad and the sample absorption pad are made of any absorbent material including cellulose, glass fiber, and polyester fiber; the waterproof top layer and the waterproof bottom layer are both made of PET with single-sided adhesive, with a thickness of 0.03-0.06 mm, and most preferably 0.03 mm.

[0007] In a specific embodiment, the sample collection pad and the sample absorption pad have the same width, which is 0.5-2.0 cm, and most preferably 1.5 cm; the sample collection pad is 0.3-0.9 cm long, preferably 0.6-0.8 cm, and has a thickness of <0.2 mm; the sample absorption pad is 1.0-1.5 cm long, and most preferably 1.3 cm, with a thickness of <0.2 mm and a gram weight of 20-80 g / m 2 .

[0008] In a specific embodiment, the colloidal gold binding pad and the color developing film have the same width, which is 0.2-0.4 cm, and most preferably 0.3 cm; the colloidal gold binding pad is 0.2-0.8 cm long and 0.1-0.5 mm thick, and most preferably 0.2 mm; the color developing film is 1.5-2.5 cm long and 0.1-0.5 mm thick.

[0009] In a specific embodiment, the colorimetric membrane is made of any porous material including polyester fiber and nitrocellulose that can uniformly adsorb proteins; a detection line T line is provided on the upper surface of the colorimetric membrane close to the colloidal gold binding pad, and a sheep anti-mouse IgG antibody quality control line C line is provided on the end away from the colloidal gold binding pad.

[0010] In a specific embodiment, depending on the type of disease being detected, the antibodies bound to the colloidal gold on the colloidal gold conjugate pad include one or more mouse monoclonal antibodies against β-HCG, LH, Streptococcus gonorrhoeae, Chlamydia trachomatis, Ureaplasma urealyticum, human papillomavirus, and herpes simplex virus; the color developing membrane can be coated with one or more rabbit polyclonal antibodies against β-HCG, LH, Streptococcus gonorrhoeae, Chlamydia trachomatis, Ureaplasma urealyticum, human papillomavirus, and herpes simplex virus.

[0011] In a specific embodiment, the colloidal gold used in the colloidal gold conjugate pad has a diameter of 10-200 nm.

[0012] In a specific embodiment, the test strip has an overall length of 3-8 cm and an overall thickness of 0.3-0.6 mm.

[0013] Beneficial effects

[0014] The health monitoring test strip for sanitary products described in the utility model makes the composite layer present an "I" shape by thinning and widening the sample collection pad and the sample absorption pad. Compared with the "I"-shaped test strip commonly used in the existing sample detection technology field, this design not only increases the sample collection area while ensuring the chromatography effect, improves the collection rate of the test strip for liquid samples in sanitary products, but also significantly reduces the overall thickness of the test strip, thereby solving the problem of the traditional "I"-shaped test strip having a small sampling area and a strong foreign body sensation when used in sanitary products. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] The present invention can be further described by way of non-limiting examples given in the accompanying drawings;

[0016] Figure 1 This is a schematic diagram of the appearance structure of the utility model;

[0017] Figure 2 It is a schematic diagram of the separation structure of the utility model;

[0018] Explanation of the numbers in the figure: 1. Waterproof top layer; 2. Composite layer; 21. Sample collection pad; 22. Colloidal gold binding pad; 23. Color development film; 231. Test line T line; 232. Quality control line C line; 24. Sample absorption pad; 3. Waterproof bottom layer. DETAILED DESCRIPTION

[0019] In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. The components of the embodiments of the present invention generally described and shown in the drawings here can be arranged and designed in various different configurations. Therefore, the following detailed description of the embodiments of the present invention provided in the drawings is not intended to limit the scope of the utility model for protection, but merely represents selected embodiments of the present invention. Based on the embodiments in the utility model, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention.

[0020] It should be noted that similar reference numerals and letters denote similar items in the following figures. Therefore, once an item is defined in one figure, it does not require further definition or explanation in subsequent figures. In the description of this utility model, it should be noted that the terms "upper" and "lower," etc., indicating orientations or positional relationships, are based on the orientations or positional relationships shown in the figures, or the orientations or positional relationships in which the utility model product is typically placed when in use. These terms are intended solely for ease of description and simplification of the utility model, and are not intended to indicate or imply that the devices or components referred to must have a specific orientation, be constructed, or operate in a specific orientation. Therefore, they should not be construed as limitations on the utility model. In the description of this utility model, it should also be noted that, unless otherwise expressly specified or limited, the term "connected" should be interpreted broadly, meaning, for example, fixed, removable, or integral; directly, indirectly through an intermediary, or internally connected between two components. Those skilled in the art will understand the specific meanings of these terms in this utility model based on the specific circumstances.

[0021] Example 1

[0022] like Figure 1-2 As shown, the present invention provides an early pregnancy test strip for use in sanitary products. The strip comprises, from top to bottom, a waterproof top layer, a composite layer, and a waterproof bottom layer. The composite layer comprises a sample collection pad, a colloidal gold binding pad, a chromogenic film, and a sample absorption pad, which are arranged and fixed to the waterproof bottom layer with an overlap of 1.5 mm. Above the composite layer is a waterproof top layer, which completely covers the colloidal gold binding pad, the chromogenic film, and the sample absorption pad, leaving the sample collection pad uncovered. The chromogenic film is provided with a test line (T) and a quality control line (C).

[0023] The sample collection pad is made of polyester fiber film with a thickness of 0.1mm; the waterproof top layer and waterproof bottom layer are both made of PET with a thickness of 0.03mm.

[0024] The sample collection pad and the sample absorption pad have the same width of 1.5 cm; the sample collection pad is 0.7 cm long, 0.1 mm thick, and has a water absorption capacity of 200 g / m 2 The sample absorption pad is 1.3 cm long, 0.1 mm thick, and weighs 40 g / m 2 , water absorption is 500g / m 2 .

[0025] The colloidal gold binding pad and the color developing film have the same width of 0.3 cm; the colloidal gold binding pad is 0.5 cm long and 0.2 mm thick; the color developing film is 2 cm long and 0.2 mm thick.

[0026] The colloidal gold binding pad contains a complex of colloidal gold and mouse anti-β-HCG monoclonal antibody, and the diameter of the colloidal gold used is 20 nm.

[0027] The colorimetric membrane is made of a nitrocellulose membrane with a length of 2 cm and a width of 0.3 cm. The upper surface of the colorimetric membrane is coated with a rabbit anti-β-HCG polyclonal antibody detection line T line and a goat anti-mouse IgG antibody quality control line C line. The upper surface of the colorimetric membrane is provided with a detection line T line at the 0.7 cm end close to the colloidal gold binding pad, and a quality control line C line at the 0.8 cm end close to the sample absorption pad.

[0028] The overall length of the test strip is 4 cm; the overall thickness of the test strip is 0.4 mm.

[0029] The specific usage and function of this embodiment are as follows: the test strip can be used alone or after being connected to a sanitary product. Female vaginal secretions or urine pass through the sample collection pad (21), and under the action of capillary siphon, move to the colloidal gold binding pad (22) and bind to the colloidal gold coated with mouse anti-β-HCG monoclonal antibody, and then move to the color developing film (23), and pass through the detection line (231) and the quality control line (232) in sequence. When the sample solution binds to the rabbit anti-β-HCG polyclonal antibody in the detection line (231), the detection line develops color; when the sample solution binds to the goat anti-mouse IgG antibody in the quality control line (232), the quality control line (232) develops color. By judging whether the detection line (231) and the quality control line (232) are highlighted, it can be identified whether the sample contains a high concentration of HCG. The use is very convenient and convenient for the general public to detect early pregnancy.

[0030] When used after being connected to sanitary products, the test strip has a sample collection pad and sample absorption pad with an enlarged but thinned area, which can improve the fit between the test strip and the sanitary product, and solve the problems of high hardness and strong foreign body sensation caused by the large thickness of the sample collection pad and sample absorption pad of the common "I"-shaped test strip; in addition, the enlarged area of ​​the sample collection pad improves the capture rate of the sample pad for liquid samples, which helps to reduce invalid and false-negative test results.

[0031] Example 2

[0032] The structures of various parts of this embodiment are the same as those of Example 1, except that the antibody bound to the colloidal gold on the colloidal gold binding pad is a mouse anti-LH monoclonal antibody; the antibody coated on the T line on the color developing membrane is a rabbit anti-LH polyclonal antibody, and the test strip is used to monitor the ovulation period.

[0033] The specific usage and function of this embodiment: The test strip can be used alone or after being connected to sanitary products. Female vaginal secretions or urine pass through the sample collection pad (21), and under the action of capillary siphon, move to the colloidal gold binding pad (22) and combine with the colloidal gold coated with antibodies, and then move to the color film (23), passing through the detection line (231) and the quality control line (232) in sequence. When the sample solution binds to the polyclonal antibody in the detection line (231), the detection line develops color; when the sample solution binds to the goat anti-mouse IgG antibody in the quality control line (232), the quality control line (232) develops color. The subject starts the test from the first day of menstruation, and selects a fixed time for measurement every day. When both the detection line (231) and the quality control line (232) show color, it is the ovulation period, which can be used to determine the best time for conception.

[0034] When used after being connected to sanitary products, the test strip has a sample collection pad and sample absorption pad with an enlarged but thinned area, which can improve the fit between the test strip and the sanitary product, and solve the problems of high hardness and strong foreign body sensation caused by the large thickness of the sample collection pad and sample absorption pad of the common "I"-shaped test strip; in addition, the enlarged area of ​​the sample collection pad improves the capture rate of the sample pad for liquid samples, which helps to reduce invalid and false-negative test results.

[0035] Example 3

[0036] The structure of this embodiment is similar to that of Example 1, except that the test strip is used for STD detection. Depending on the disease type, the antibody bound to the colloidal gold on the colloidal gold conjugate pad is one of the mouse monoclonal antibodies against Streptococcus gonorrhoeae, Chlamydia trachomatis, Ureaplasma urealyticum, human papillomavirus, or herpes simplex virus; correspondingly, the antibody coated on the T-line on the colorimetric membrane is one of the rabbit polyclonal antibodies against Streptococcus gonorrhoeae, Chlamydia trachomatis, Ureaplasma urealyticum, human papillomavirus, or herpes simplex virus.

[0037] The specific usage and function of this embodiment are as follows: the test strip can be used alone or after being connected to a sanitary product. Female vaginal secretions or urine pass through the sample collection pad (21), and are moved to the colloidal gold binding pad (22) under the action of capillary siphoning to bind with the colloidal gold coated with antibodies, and then move to the color developing film (23), and pass through the detection line (231) and the quality control line (232) in sequence. When the sample solution binds to the polyclonal antibody in the detection line (231), the detection line develops color; when the sample solution binds to the goat anti-mouse IgG antibody in the quality control line (232), the quality control line (232) develops color. By judging whether the detection line (231) and the quality control line (232) are highlighted, it is possible to identify whether the sample contains sexually transmitted disease pathogens. The use is very convenient and is convenient for the general public to conduct preliminary detection of sexually transmitted diseases.

[0038] The above embodiments are intended only to illustrate the technical solutions of the present invention and are not intended to limit the present invention. Although the present invention has been described in detail with reference to the preferred embodiments, those skilled in the art will appreciate that modifications or equivalent substitutions may be made to the technical solutions of the present invention without departing from the spirit and scope of the technical solutions of the present invention, and such modifications or equivalent substitutions shall be encompassed by the claims of the present invention. The techniques, shapes, and structural portions not described in detail in the present invention are well known.

Claims

1. A health monitoring test strip for sanitary products, characterized in that: The test strip comprises, from top to bottom, a waterproof top layer (1), a composite layer (2), and a waterproof bottom layer (3); the composite layer (2) is composed of a sample collection pad (21), a colloidal gold binding pad (22), a color developing film (23), and a sample absorption pad (24), which are partially overlapped and connected to the waterproof bottom layer (3); Above the composite layer (2) is a waterproof top layer (1), the waterproof top layer (1) does not cover the sample collection pad (21), and completely covers the colloidal gold binding pad (22), the color developing film (23), and the sample absorption pad (24); The composite layer (2) is in the shape of an "I" character, with the sample absorption pad (24) forming an upper horizontal portion, the colloidal gold binding pad (22) and the color developing film (23) forming a middle vertical portion, and the sample collection pad (21) forming a lower horizontal portion; In the composite layer (2), the sample collection pad (21) and the sample absorption pad (24) have the same width, and the colloidal gold binding pad (22) and the color developing film (23) have the same width: the width of the sample collection pad (21) and the sample absorption pad (24) is 2-6 times the width of the colloidal gold binding pad (22) and the color developing film (23).

2. The health monitoring test strip for sanitary products according to claim 1, characterized in that: The sample collection pad (21) is made of any absorbent material including cellulose, glass fiber, and polyester fiber.

3. The health monitoring test strip for sanitary products according to claim 1, characterized in that: The waterproof top layer (1) and the waterproof bottom layer (3) are both made of PET waterproof transparent material, and the thickness thereof is 0.03-0.06 mm.

4. The health monitoring test strip for sanitary products according to claim 1, characterized in that: The color developing membrane (23) is made of any porous material including polyester fiber and nitrocellulose that can uniformly adsorb proteins. A detection line (231) T line is provided on the upper surface of the membrane near the colloidal gold binding pad (22), and a quality control line (232) C line is provided on the upper surface away from the colloidal gold binding pad (22).

5. The health monitoring test strip for sanitary products according to claim 1, characterized in that: The sample absorption pad (24) is made of any absorbent material including cellulose, glass fiber, polyester fiber, and has a thickness of less than 1 mm.

6. The health monitoring test strip for sanitary products according to claim 1, characterized in that: The test strip has a length of 3-8 cm, a width of 0.5-2 cm, and an overall thickness of 0.2-1.2 mm.

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