CN219846638U

CN219846638U - Sampling and detecting integrated structure for saliva insulin detection

Info

Publication number: CN219846638U
Application number: CN202321310884.1U
Authority: CN
Inventors: 刘默文
Original assignee: Jiaxing Kangyuan Ketai Technology Development Co ltd
Current assignee: Jiaxing Kangyuan Ketai Technology Development Co ltd
Priority date: 2023-05-28
Filing date: 2023-05-28
Publication date: 2023-10-20
Anticipated expiration: 2033-05-28

Abstract

The utility model discloses a sampling and detecting integrated structure for saliva insulin detection, which comprises a saliva sampling head, a saliva detection reagent strip and a saliva detection shell, wherein the saliva detection reagent strip and the saliva detection shell are in a direct connection integrated structure, a first anti-insulin antibody marked by an indicator and a second non-marked anti-insulin antibody are coated on the saliva detection reagent strip, the saliva sampling head is of a sampling swab-like structure, the proximal end part of the saliva sampling head is exposed outside the saliva detection shell, the sampling head extends into the saliva detection shell through an opening of the sampling head, and the distal end part of the saliva sampling head is in direct contact connection with the saliva detection reagent strip through a sample pad of the saliva detection reagent strip, so that the saliva detection structure is suitable for detecting the insulin level of a saliva sample, and has the advantages of improving the detection efficiency, convenience and accuracy and important clinical significance.

Description

Sampling and detecting integrated structure for saliva insulin detection

Technical Field

The utility model relates to the technical field of medical instruments, in particular to a sampling and detecting integrated structure for saliva insulin detection.

Background

Insulin is an important protein hormone for human body, is secreted by islet beta cells, has the effects of promoting human anabolism and has important regulation effects on sugar, lipid and protein metabolism. Clinically, it has the effect of reducing blood sugar, and besides being used as endogenous hormone of human body, insulin is also widely used as a hypoglycemic drug. Therefore, measurement of insulin content in the human body is necessary for both disease diagnosis and drug use. At present, clinical detection of human insulin level is carried out by adopting a blood sample clinically, and the sampling and the detection result interpretation are carried out in a detection room of a medical institution or a detection room of the clinical detection institution by professional staff, wherein the adopted detection methods mainly comprise two main types, namely an immunoassay method and a non-immunoassay method, wherein the immunoassay method comprises a radioimmunoassay, an enzyme-linked immunoassay and a chemiluminescent immunoassay, and the non-immunoassay mainly comprises an isotope dilution method and a high performance liquid chromatography. The immunological detection method is carried out by utilizing the antigen-antibody reaction principle of protein, and is the most commonly used electrochemiluminescence immunoassay in clinic at present, and clinical typing of diabetes is assisted by measuring insulin secretion levels and curves of patients at various time points on an empty stomach and after meals to know the functions of islets of langerhans of the patients. None of these tests is suitable for widespread use in homes and medical institutions lacking the corresponding test conditions. There have been a great deal of reports on the study of insulin levels in saliva, and there are clear correlations with blood insulin levels, and changes in blood insulin regulation, such as fasting, food, drug, etc., affect blood concentration changes directly in saliva. A large number of researches prove that the insulin is a protein hormone and an important regulation marker which directly influence various metabolic related diseases and bad health states including diabetes, hypertension and coronary heart disease, is suitable for detecting various diseases and health states in and out of hospitals, therefore, the insulin can be developed for detecting and using medical institutions with home self-tests and lack of corresponding detection conditions, has a saliva insulin level rapid detection technology which is simple and convenient to operate, rapid to use and low in cost, is beneficial to improving medical quality and efficiency, and has important clinical significance and application value.

Disclosure of Invention

The utility model aims to provide a sampling and detecting integrated structure for saliva insulin detection, which has the advantages of convenient and rapid detection operation, low cost and the like compared with the prior art, and improves the detection quality.

In view of the above, the present utility model provides a sampling and detecting integrated structure for detecting saliva insulin, which is characterized in that: the integrated structure comprises a saliva sampling head, a saliva detection reagent strip and a saliva detection shell, and the saliva sampling head, the saliva detection reagent strip and the saliva detection shell are directly connected with each other; the saliva detection reagent strip comprises a sample pad, a marker binding pad, a nitrocellulose membrane and a water absorbing paper pad; the first anti-insulin antibody marked by the indicator is coated on the marker binding pad, and the non-marked second anti-insulin antibody is coated on the nitrocellulose membrane; the inside of the integrated structure is a strip-shaped structure which is directly connected with the saliva sampling head, the sample pad, the marker binding pad, the nitrocellulose membrane and the absorbent paper pad in sequence; the saliva detection shell is arranged on the outer side of the saliva detection reagent strip and comprises a detection shell upper cover and a detection shell lower cover, an observation window is formed in the saliva detection shell upper cover, and a sampling head opening is formed in the front end of the proximal end of the saliva detection shell; the saliva sampling head is of a sampling swab-like structure, the proximal end portion of the saliva sampling head is exposed to the outside of the saliva detection housing, the saliva sampling head extends into the inside of the saliva detection housing through the opening of the sampling head, and the distal end portion of the saliva sampling head is in direct contact connection with the saliva detection reagent strip through the sample pad.

In the integrated structure, the saliva sampling head is connected with the saliva detection reagent strip in a direct contact mode to select adhesion mode, the adhesion mode is that the saliva sampling head and the saliva detection reagent strip are adhered to the same support bottom sheet together, the adhesion mode is that the saliva sampling head, the sample pad, the marker binding pad, the nitrocellulose membrane and the absorbent paper pad are adhered to each other in sequence, wherein the distal end portion of the saliva sampling head is connected with the sample pad, the proximal end portion of the saliva sampling head extends from the support bottom sheet and is free from the support bottom sheet, the sampling head opening is located at the front end of the proximal end of the saliva detection shell, and the free portion of the proximal end of the saliva sampling head extends through the sampling head opening to form a sampling swab-like structure exposed outside the saliva detection shell.

In the integrated structure, the saliva sampling head is connected with the saliva detection reagent strip in a direct contact manner to select an insertion mode, the saliva detection reagent strip adopted in the insertion mode comprises a sample pad, a marker combination pad, a nitrocellulose membrane, a water absorption paper pad and a support bottom plate, the saliva detection reagent strip is placed in the saliva detection shell, a sampling head opening is formed in the front end of the proximal end of the saliva detection shell, an insertion channel with an inclined surface, which is gradually close to the upper and lower intervals of the sample pad, is arranged between the sampling head opening and the sample pad of the saliva detection reagent strip, the saliva sampling head is inserted through the sampling head opening, is connected with the sample pad in a direct contact manner through extrusion of the insertion channel, and the proximal end of the saliva sampling head forms a sampling swab structure exposed outside the saliva detection shell to directly sample.

In the above-mentioned integrated structure, saliva sampling head with direct contact between the saliva detect reagent strip is connected and is selected extrusion formula, the saliva detect reagent strip that extrusion formula adopted includes sample pad, marker combination pad, nitrocellulose membrane and absorbent paper pad and support film, set up in detect shell lower cover upside, the distal end portion of saliva sampling head sets up on the sample pad, proximal end portion is through sampling head opening sets up in saliva detects the outside of shell, detect the shell upper cover with withhold the form set up in saliva sampling head and saliva detect reagent strip's upside, form saliva sampling head's proximal end portion exposes in saliva detects the outside of shell, and its distal end portion and saliva detect reagent strip between connect and set up in through direct contact saliva detects the inside integrated structure of shell.

In the integrated structure, the saliva sampling head is of a rod-shaped structure with an inner core and a flexible water absorbing material wrapped on the outer side of the inner core. The flexible absorbent material is selected from the group of sponges, such as polyurethane sponges.

In the integrated structure, the saliva sampling head is of a sheet-shaped structure made of a hard water absorbing material. The hard water-absorbing material comprises a water-absorbing material which does not deform after absorbing water and a water-absorbing material which changes from hard to soft after absorbing water. The water absorbing material comprises natural and modified high molecular high water absorbing resin and artificial synthetic water absorbing resin. A water-absorbent material which does not deform after absorbing water, such as polyester fiber. The water absorbing material which is changed from hard to soft after absorbing water is selected from sponge products, polyvinyl alcohol products and the like. The polyvinyl alcohol (PVA) water-absorbing sponge not only has excellent chemical stability, water-absorbing function and high-quality physical properties, but also has the characteristics of high water-absorbing rate, high liquid absorption multiplying power, softness after water absorption and the like, and is widely used in the fields of daily cleaning, medical treatment and health and the like.

In the integrated structure, one side of the saliva sampling head at the proximal end of the saliva detection housing is provided with a cap-shaped protective sleeve.

In the integrated structure, the saliva detection reagent strip is at least one of a colloidal gold immunoassay reagent strip, a fluorescent immunoassay reagent strip and a color latex microsphere immunoassay reagent strip, and the indicator is at least one of colloidal gold particles, color latex microspheres and fluorescent microspheres.

In the integrated structure, the integrated structure is provided with a semi-quantitative color chart with the same color as the indicator, and 3 or more color strips with different color depths are printed on the color chart.

In the integrated structure, the integrated structure is provided with a portable quantitative detector, and the portable quantitative detector comprises at least one of a chromaticity quantitative analyzer and a fluorescence quantitative analyzer.

In the above integrated structure, the operation of the integrated structure includes the following steps:

1) Taking out the sampling and detecting integrated structure;

2) The saliva sampling head is placed into the oral cavity to collect saliva;

3) The saliva sample passes through the saliva sampling head and the sample pad of the saliva detection reagent strip and forwards flows through the marker binding pad, the nitrocellulose membrane and the water absorption pad;

4) And reading the detection result from the observation window to finish detection.

Due to the adoption of the technical scheme, the utility model has the following advantages:

1. the utility model relates to a sampling and detecting integrated structure for saliva insulin detection, which integrates a saliva sampling head, a saliva detection reagent strip and a saliva detection shell into a whole, wherein the saliva sampling head and the saliva detection reagent strip form a strip-shaped structure which is directly connected, the saliva sampling head is arranged in the saliva detection shell, and the saliva sampling head is arranged in an oral cavity and can directly sample, so that the detection of the human saliva insulin level can be performed, the one-step method is completed, the sampling is not needed, the detection is performed, the use is convenient, the user acceptance is high, the feasibility of clinical use can be obviously improved, and the detection effect is improved.

2. According to the saliva sampling head and the saliva detection reagent strip, the direct contact connection between the saliva sampling head and the saliva detection reagent strip adopts a pasting type structure, so that the saliva sampling head and the saliva detection reagent strip form an integrated structure in the preparation process, the preparation process is simplified, and the preparation efficiency can be effectively improved.

3. According to the saliva sampling head, the saliva detection reagent strip is connected with the saliva sampling head in a direct contact manner by adopting an insertion type structure, so that the preparation and assembly characteristics of the universal quick detection reagent kit in the market are reserved, and after the detection reagent kit is assembled, the saliva sampling head is additionally arranged in an insertion manner, so that the preparation operation process of the integrated structure is controllable and convenient, and the preparation efficiency is improved.

4. The saliva sampling head is of a rod-shaped structure with an inner core and an outer layer of flexible water absorbing material wrapped on the outer side of the inner core, the proximal end is a free end for sampling, and the distal end is in close contact connection with the saliva detection reagent strip. When the saliva sampling head is placed at the oral cavity part to collect saliva samples, the saliva samples can be quickly absorbed and soaked (soaked) by the outer layer of the water-absorbing material, and the saliva samples migrate and diffuse to the saliva detection reagent strip along the outer layer of the water-absorbing material to start detection reaction, so that the whole process of sampling and detection is completed in one step, and the convenience and the quick operability of technical products are realized.

5. The saliva sampling head is of a sheet structure of hard water absorbing material without an inner core, the near end is a free end for sampling, and the far end is in close contact connection with the saliva detection reagent strip. When the saliva sampling head is placed at the oral cavity part to collect saliva samples, the saliva sampling head with water absorption directly and rapidly absorbs the saliva samples and is soaked (soaked) and migrates and diffuses to the saliva detection reagent strip towards the far end, and the detection reaction is started, so that the whole process of sampling and detection is completed in one step, and the convenience and the rapid operability of technical products are realized.

6. The colorimetric card for semi-quantitatively detecting the color intensity of the detection strip is arranged, the semi-quantitatively judging of the detection result can be carried out through the comparison of the colorimetric card, the method is suitable for clinical application scenes without accurate quantification and only by observing the variation trend of the saliva insulin level, and the clinical application value is improved.

Drawings

FIG. 1 is a schematic diagram of the overall structure of the present utility model;

FIG. 2 is a schematic longitudinal section of the overall structure of the present utility model;

FIG. 3 is a schematic view of the structure of an externally wrapped flexible saliva sampling head of the present utility model;

FIG. 4 is a schematic diagram of a rigid sheet saliva sampling head according to the present utility model;

FIG. 5 is a schematic illustration of a bonded direct contact connection structure of the present utility model;

FIG. 6 is a schematic illustration of the construction of the present utility model with a bonded direct contact connection in a unitary structure;

FIG. 7 is a schematic illustration of a male direct contact connection structure of the present utility model;

FIG. 8 is a schematic illustration of the structure of the male direct contact connection of the present utility model in a unitary structure;

FIG. 9 is a schematic view of an extruded direct contact connection structure according to the present utility model;

FIG. 10 is a schematic illustration of the extruded direct contact connection of the present utility model in a unitary structure;

FIG. 11 is a schematic view of a saliva sampling head protective sleeve according to the present utility model;

FIG. 12 is a schematic view of the overall structure of the present utility model;

FIG. 13 is a schematic diagram of a semi-quantitative colorimetric structure of the present utility model.

The figures are labeled as follows:

a saliva sampling head 1; saliva detection reagent strip 2; a saliva detecting housing 3; a detection housing upper cover 4; a detection housing lower cover 5; a viewing window 6; a saliva sampling head proximal end 7; a saliva sampling head distal end 8; a sample pad 9; a label binding pad 10; a nitrocellulose membrane 11; a water absorbing pad 12; a support backsheet 13; a detection line 14; a quality control line 15; a sampling head opening 16; a wrapped sampling head proximal end 17; a wrapped distal sampling head end 18; a sampling head core 19; a rigid sampling head proximal end 20; a hard sampling head distal end 21; a stick-on detection housing upper cover 23; a lower cover 24 of the adhesive detection housing; a stick-on sampling head opening 25; a proximal adhesive saliva sampling head end 27; a stick-on saliva sampling head distal end 28; a plug-in detection housing upper cover 31; a plug-in test housing lower cover 32; a male sampling head opening 33; a male insertion face 34; an insert upper press ramp 36; a male insertion passage 38; a male saliva sampling head proximal end 39; an insertion saliva sampling head distal end 40; a squeeze saliva sampling head proximal end 50; a squeeze saliva sampling head distal end 51; squeeze-type sampling head opening 52; a squeeze-type detecting housing upper cover 54; a squeeze-type detection housing lower cover 55; a protective sheath 60; a protective sheath 61; a protective sleeve opening 62; a protective sheath lumen 63; semi-quantitative color chart 70.

Description of the embodiments

In order to further illustrate the technical means and effects adopted by the present utility model to achieve the preset purpose, the following embodiments are used for further illustrating the present utility model with reference to the accompanying drawings, but the present utility model is not limited to the following description.

As shown in fig. 1 and 2, the whole structure of the utility model is an integrated structure, and comprises a saliva sampling head 1, a saliva detecting reagent strip 2 and a saliva detecting housing 3. The saliva sampling head 1 is located the proximal end position of integrated structure and includes saliva sampling head proximal end 7 and saliva sampling head distal end 8, and the outside is saliva detection shell 3, including detecting shell upper cover 4 and detecting shell lower cover 5, detecting shell upper cover 4 is provided with observation window 6 of observation testing result, and detecting shell lower cover 5 is provided with saliva detection reagent strip 2, and detecting shell front end is equipped with sampling head opening 16. The saliva detection reagent strip 2 comprises a sample pad 9, a marker binding pad 10, a nitrocellulose membrane 11 and a water absorbing pad 12, which are sequentially arranged on a support bottom plate 13, wherein the marker binding pad 10 is coated with a first anti-insulin antibody marked by an indicator as a detection indicator, the indicator is usually colloidal gold particles, color latex microspheres and fluorescent microspheres, the nitrocellulose membrane 11 is coated with a second non-marked anti-insulin antibody as a detection line 14, and is also coated with a non-marked non-insulin specific binding antibody, such as goat anti-mouse IgG, as a quality control line 15. The saliva sampling head near end 7 is located outside the front end of the saliva detecting shell 3, the saliva sampling head far end 8 is located inside the front end of the saliva detecting shell 3 and is in overlapped contact connection with the sample pad 9, so that an integrated saliva detecting structure taking the saliva sampling head near end 7 as a saliva sampling swab head sample free structure is formed.

When the saliva sampling head is used, the saliva sampling head proximal end 7 of the saliva sampling head 1 is placed in an oral cavity, saliva samples pass through the saliva sampling head proximal end 7, the saliva sampling head distal end 8 and the sample pad 9, insulin in the samples is combined with a first insulin resistant antibody marked by an indicator through the marker combining pad 10 to form a first compound combined by the first insulin resistant antibody marked by the indicator and the insulin, the first compound is captured through the nitrocellulose membrane 11 by a non-marked second insulin resistant antibody coated on the nitrocellulose membrane 11 to form a second compound combined by the first insulin resistant antibody, the insulin and the second insulin resistant antibody marked by the indicator, and the second compound is fixedly gathered on the nitrocellulose membrane 11 and developed to form a developed or fluorescent developed detection line 14; the unbound first complex flows forward through the unlabeled goat anti-mouse IgG to capture, so that an indicator labeled first anti-insulin antibody and goat anti-mouse IgG conjugate is formed, the conjugate is fixedly accumulated on the nitrocellulose membrane 11 and developed, a developed or fluorescent developed quality control line 15 is formed, the detection result is observed through the observation window 6, and at the moment, the development depth of the detection line 14 is in direct proportion to the insulin content in the sample, so that saliva insulin level detection is completed.

As shown in fig. 3 and 4, the saliva sampling head in the integrated structure of the present utility model comprises a rod-shaped structure with an inner core and a sheet-shaped structure without an inner core, wherein the rod-shaped structure is provided with a flexible water absorbing material, and the sheet-shaped structure is completely made of a hard water absorbing material. The rod-like structure of the flexible absorbent material comprises a wrapped proximal sampling head end 17, a wrapped distal sampling head end 18 and a sampling head inner core 19. The sheet-like structure of the rigid absorbent material is comprised of a rigid sampling head proximal end 20 and a rigid sampling head distal end 21.

As shown in fig. 5 and 6, the connection structure between the saliva sampling head and the sample pad in the integrated structure of the present utility model is a paste structure (the name of the part is omitted from the paste), in which the saliva sampling head 1 and the sample pad 9, the label binding pad 10, the nitrocellulose membrane 11 and the absorbent pad 12 of the saliva test reagent strip 2 are all sequentially arranged and stuck on the support base 13, so as to prepare the test reagent strip integrated structure containing the saliva sampling head. The saliva detecting housing 3 includes a detecting housing upper cover 23 and a detecting housing lower cover 24, and a sampling head opening 25 is provided at the front end. During assembly, the saliva detection reagent strip integrated structure is integrally placed on the lower cover 24 of the detection shell, the upper cover 23 of the detection shell is covered, at the moment, the proximal end 27 of the saliva sampling head is positioned outside the front end of the saliva detection shell 3, the distal end 28 of the saliva sampling head is positioned inside the front end of the saliva detection shell 3 and is in overlapped contact connection with the sample pad 9, so that an integrated saliva detection structure taking the proximal end 27 of the saliva sampling head as a saliva sampling swab head-like free structure is formed. In use, the saliva detecting housing 3 is held by hand, the saliva sampling head proximal end 27 of the saliva sampling head 1 is placed into the oral cavity, and saliva samples flow through the sample pad 9 via the saliva sampling head proximal end 27 and the saliva sampling head distal end 28, so as to initiate a detecting reaction and complete a detecting process.

As shown in fig. 7 and 8, in the integrated structure of the present utility model, the connection structure of the saliva sampling head and the sample pad is an insertion structure (the name of the component is omitted below), wherein the saliva sampling head 1 and the saliva detecting housing 3 are mutually inserted, the saliva detecting reagent strip 2 adopted in the insertion structure comprises a sample pad 9, a marker binding pad 10, a nitrocellulose membrane 11 and a water absorbing pad 12, which are sequentially arranged and adhered on a support bottom sheet 13 and placed in the saliva detecting housing 3; the saliva sampling head 1 comprises a saliva sampling head proximal end 39 and a saliva sampling head distal end 40, the saliva detecting housing 3 comprises a detecting housing upper cover 31 and a detecting housing lower cover 32, and after the assembly is completed, the saliva sampling head distal end 40 is inserted through the sampling head opening 33 to be made into an integrated structure. The sampling head opening 33 is arranged at the front end of the proximal end of the saliva detection housing 3, an insertion channel 38 with an inclined surface, namely an insertion inclined surface 34, is arranged between the sampling head opening 33 and the sample pad 9 of the saliva detection reagent strip 2, the distance between the sampling head opening 33 and the sample pad 9 is gradually reduced, the distal end 40 of the saliva sampling head is inserted through the sampling head opening 33 and the insertion inclined surface 34, the free end of the saliva sampling head, namely the proximal end 39 of the saliva sampling head, is in direct contact connection with the sample pad 9 through the extrusion of the insertion channel 38, and a sampling swab-like structure exposed outside the saliva detection housing 3 is formed for direct sampling. In use, the saliva detecting housing 3 is held by hand, the saliva sampling head proximal end 39 of the saliva sampling head 1 is placed into the oral cavity, and saliva samples flow through the sample pad 9 via the saliva sampling head proximal end 39 and the saliva sampling head distal end 40, so as to initiate a detecting reaction and complete a detecting process.

As shown in fig. 9 and 10, the connection structure of the saliva sampling head and the sample pad in the integrated structure of the present utility model is a squeeze structure (the name of the component is omitted from squeezing below), wherein the saliva sampling head 1 comprises a proximal saliva sampling head end 50 and a distal saliva sampling head end 51, the sample pad 9, the label binding pad 10, the nitrocellulose membrane 11 and the absorbent pad 12 of the saliva test reagent strip 2 are sequentially arranged on the support bottom sheet 13, and then placed on the test housing upper cover 54 of the saliva test housing 3; the saliva sampling head 1 is arranged in a superposition direct contact way towards the sample pad 9 in the direction that the proximal end 50 of the saliva sampling head is arranged outside and the distal end 51 of the saliva sampling head is arranged inside, then a detection shell lower cover 55 is arranged, at the moment, the proximal end 50 of the saliva sampling head is positioned outside the front end of the saliva detection shell 3, the distal end 51 of the saliva sampling head is positioned inside the front end of the saliva detection shell 3 and is connected with the sample pad 9 in a superposition contact way, and an integrated saliva detection structure taking the proximal end 50 of the saliva sampling head as a saliva sampling swab head sample free structure is formed. In use, the saliva detecting housing 3 is held by hand, the saliva sampling head proximal end 50 of the saliva sampling head 1 is put into the oral cavity, and saliva samples flow through the sample pad 9 via the saliva sampling head proximal end 50 and the saliva sampling head distal end 51, so as to start a detecting reaction and complete a detecting process.

As shown in fig. 11, the protective sleeve structure of the integrated structure of the utility model has a sealed bottom and is in a cavity structure with one end open, and comprises a protective sleeve body 61, a protective sleeve opening 62 and a protective sleeve inner cavity 63, and is inserted and covered to one end of the saliva sampling head of the saliva detection shell to protect the saliva sampling head.

As shown in fig. 12, the overall structure of the integrated structure of the present utility model includes a protective sleeve 60, a saliva sampling head 1, a sampling head opening 16, a saliva detecting housing 3, an observation window 6, a saliva detecting reagent strip 2, a detecting housing upper cover 4 and a detecting housing lower cover 5, wherein the protective sleeve 60 can be covered or uncovered.

As shown in FIG. 13, the semi-quantitative color chart of the utility model is prepared by adopting saliva samples to prepare insulin solutions with different concentrations, directly dripping the insulin solutions with different concentrations into a sample adding window of a chromatographic detection structure, observing the color depth of a detection line, photographing, designing and printing the semi-quantitative color chart with corresponding concentrations according to photographing results, and taking the semi-quantitative color chart as a comparison basis for interpretation of the follow-up saliva sample semi-quantitative detection results. Examples are as follows: in use, 1, 5, 10, 15, 20, 25, 30 uIU/ml of insulin solution is prepared using fresh saliva. Taking insulin solutions with different concentrations, directly dripping the insulin solutions into a sample adding window of a chromatographic detection structure, standing, observing the color depth of a detection line, photographing, designing and printing a semi-quantitative color comparison card 70 according to photographing results, and taking the semi-quantitative color comparison card as a comparison basis for interpretation of the follow-up saliva sample semi-quantitative detection results.

In practical operation, when the integrated structure is a colloidal gold immune detection structure, the saliva detection reagent strip is prepared by a colloidal gold method, and a sample pad, a colloidal gold binding pad coated with a colloidal gold-labeled first anti-insulin antibody, a nitrocellulose membrane coated with a non-labeled second anti-insulin antibody and a water absorption pad are sequentially adhered on a support negative; when the integrated structure is a color latex microsphere immune detection structure, the saliva detection reagent strip is prepared by a color latex microsphere immune method, and a sample pad, a latex color microsphere combination pad coated with a color latex microsphere marker, a nitrocellulose membrane coated with a non-marked capture reagent and a water absorption pad are sequentially stuck on a support negative; when the integrated structure is a fluorescence immunoassay structure, the saliva detection reagent strip is prepared by using a fluorescence immunoassay method and using fluorescent microspheres or fluorescein as an indicator, and a sample pad, a fluorescent marker binding pad coated with a fluorescent marker, a nitrocellulose membrane coated with a non-marked capture reagent and a water absorption pad are sequentially adhered on a support negative plate.

The semi-quantitative detection specific operation comprises the following steps: 1) Taking out the sampling and detecting integrated structure; 2) The hand-held integrated structure is used for placing one side of the saliva sampling head into the oral cavity to collect saliva; 3) The saliva sample passes through the saliva sampling head and the sample pad of the saliva detection reagent strip and forwards flows through the marker binding pad, the nitrocellulose membrane and the water absorption pad; 4) And reading a detection result from the observation window, comparing the color depth of the detection line with the semi-quantitative color comparison card, and reading a semi-quantitative range value to finish detection.

The specific quantitative detection operation comprises the following steps: 1) Taking out the sampling and detecting integrated structure; 2) The saliva sampling head is placed into the oral cavity to collect saliva; 3) The saliva sample passes through the saliva sampling head and the sample pad of the saliva detection reagent strip and forwards flows through the marker binding pad, the nitrocellulose membrane and the water absorption pad; 4) And (3) placing the chromatographic detection structure in a quantitative detector, reading the detection result, and quantitatively calculating the measurement value to finish detection.

Experimental study of the utility model: the following experiments illustrate the detection method and the effect of the present utility model, but are not limiting of the present utility model. The experimental methods used in the following experiments are conventional methods unless otherwise specified. The materials, reagents and the like used, unless otherwise specified, are all commercially available.

Experiment one: immune colloidal gold method saliva insulin rapid detection experiment:

1. saliva detection reagent strip preparation:

the saliva detection reagent strip is prepared by adopting a double-antibody sandwich method by adopting a conventional immune colloidal gold detection technology, and an insulin detection experiment is carried out by adopting the detection kit prepared by adopting the integrated structure of the utility model, wherein the antibody of a colloidal gold marked indicator of a detection line T of the saliva detection reagent strip is a first anti-insulin monoclonal antibody of 10ug/ml, the particle size of colloidal gold particles of a colloidal gold solution is about 50nm, and the marked colloidal gold solution is coated on a glass cellulose membrane colloidal gold binding pad; the capture antibody of the detection line T of the saliva detection reagent strip is a paired non-labeled second anti-insulin monoclonal antibody, the coating concentration is 1.0mg/ml, and the coated cellulose nitrate film is coated; the capture antibody of the quality control line C of the saliva detection reagent strip is a goat anti-mouse IgG polyclonal antibody of 1.0mg/ml, and the goat anti-mouse IgG polyclonal antibody is coated on a nitrocellulose membrane and used for capturing a first anti-insulin monoclonal antibody which is not specifically captured and marked by colloidal gold. The two ends of the nitrocellulose membrane are respectively stuck with a water absorption pad and a colloidal gold mark bonding pad, and one side of the colloidal gold mark bonding pad is stuck with a sample pad. Placing the adhered detection sheet on a slitter, and cutting into saliva detection reagent strips with the thickness of 3.5 mm.

2. The preparation of the integrated structure comprises the following steps:

the upper cover and the base of the saliva detection shell are designed by Solidworks, a 3D printing sample is used, and a saliva insulin sampling detection integrated structure is prepared by adhesive connection and is used for experimental detection. Red color cards with different color depths are printed.

3. Experimental method and results:

during experiments, the saliva detection reagent strip and the saliva detection structure shell prepared by the method are assembled into an integrated structure, the assembled integrated structure is placed into an aluminum foil sealing bag with a drying agent, and the aluminum foil sealing bag is sealed on a sealing machine and labeled. 5, 10, 20, 40, 80 uIU/ml of Changxiu insulin glargine injection (100 IU/ml) was prepared with 10mM phosphate buffer salt solution. Taking 120ul of prepared long-xiu-shaped recombinant insulin glargine solution, directly placing saliva sampling heads with integrated structures into insulin solutions with different concentrations, standing for 15 minutes when a liquid phase appears in an observation window, checking the color depth of a detection line through the observation window, photographing, and printing purplish red color cards with 5 different color depths to obtain a semi-quantitative color card.

The prepared integrated structural samples are used for respectively detecting fasting saliva samples and postprandial saliva samples of 10 healthy donors, standing is carried out for 15 minutes, the color depth of the detection line is checked through an observation window, the color depth is compared with a semi-quantitative colorimetric card, the concentration range of a colorimetric result is judged, the fasting result is about 5-20uU/ml, the postprandial saliva sample is about 20-40uU/ml, and the detection range of normal people is met.

Experiment II: color latex microsphere immunochromatography insulin rapid detection experiment:

1. saliva detection reagent strip preparation:

the method comprises the steps of preparing saliva detection reagent strips by adopting a double-antibody sandwich method by adopting a conventional color latex microsphere immunochromatography technology, preparing a detection kit by adopting an integrated structure of the utility model, and carrying out an insulin detection experiment, wherein the color latex microspheres adopt biological 300nm red microspheres, latex microsphere marks of a detection line T of the saliva detection reagent strips indicate that an antibody is a first anti-insulin monoclonal antibody of 50ug/ml, and the marked latex microsphere marking liquid is coated on a glass cellulose membrane bonding pad; the capture antibody of the detection line T of the saliva detection reagent strip is a paired non-labeled second anti-insulin monoclonal antibody, and the coating concentration is 1.0mg/ml, and the coated cellulose nitrate film is coated; the capturing antibody of the quality control line C of the saliva detection reagent strip is a goat anti-mouse IgG polyclonal antibody of 1.0mg/ml, and the capturing antibody is coated on a nitrocellulose membrane and used for capturing the color latex microsphere marked anti-insulin monoclonal antibody which is not specifically captured. The two ends of the nitrocellulose membrane are respectively stuck with a water absorption pad and a latex microsphere marking combination pad, and the other side of the latex microsphere marking combination pad is stuck with a sample pad. Placing the adhered detection sheet on a slitter, and cutting into saliva detection reagent strips with the thickness of 3.5 mm.

2. The preparation of the integrated structure comprises the following steps:

prepared in the same experiment one and two.

3. Experimental method and results:

in the experiment, the saliva detection reagent strip and the saliva detection shell are assembled into an integrated detection structure, the assembled detection structure is placed into an aluminum foil sealing bag with a drying agent, and the aluminum foil sealing bag is sealed on a sealing machine and labeled. 5, 10, 20, 40, 80 uIU/ml of Changxiu insulin glargine injection (100 IU/ml) was prepared with 10mM phosphate buffer salt solution. Taking 120ul of prepared long-xiu insulin solution, directly placing saliva sampling heads with integrated structures into insulin solutions with different concentrations, standing for 15 minutes until a liquid phase appears in an observation window, checking the color depth of a detection line through the observation window, photographing, and printing 7 red color cards with different color depths to obtain a semi-quantitative color card.

The prepared integrated structural samples are used for respectively detecting fasting saliva samples and postprandial saliva samples of 10 healthy donors, standing is carried out for 15 minutes, the color depth of the detection line is checked through an observation window, the color depth is compared with a semi-quantitative colorimetric card, the concentration range of a colorimetric result is judged, the fasting result is about 5-20uU/ml, the postprandial saliva sample is about 10-80uU/ml, and the detection range of normal people is met.

Experiment III: immunofluorescence method insulin rapid detection experiment:

1. saliva detection reagent strip preparation:

the saliva detection reagent strip is prepared by adopting a double-antibody sandwich method by adopting a conventional immunofluorescence detection technology, and an insulin detection experiment is carried out by adopting the detection kit prepared by adopting the integrated structure, wherein a fluorescent microsphere marked antibody of the saliva detection reagent strip adopts a first anti-insulin monoclonal antibody with the particle size of 30ug/ml, fluorescent microspheres adopt fluorescent microspheres with the particle size of 300nm of the biological company, and fluorescent microsphere liquid of the marked antibody is coated on a glass cellulose membrane marked object binding pad; the capture antibody of the saliva detection reagent strip is 1.0mg/ml of paired non-labeled second anti-insulin monoclonal antibody, and the paired non-labeled second anti-insulin monoclonal antibody is coated on a nitrocellulose membrane; the capture antibody of the quality control line C of the saliva detection reagent strip is a goat anti-mouse IgG polyclonal antibody of 1.0mg/ml, and the goat anti-mouse IgG polyclonal antibody is coated on a nitrocellulose membrane and used for capturing fluorescent microsphere labeled first anti-insulin monoclonal antibodies which are not specifically captured. The two ends of the nitrocellulose membrane are respectively stuck with a water absorption paper membrane pad and a fluorescent microsphere marking combination membrane pad, and the other side of the combination membrane pad is stuck with a sample pad. Placing the stuck detection sheet on a strip cutting machine, and cutting into 3.5mm test strips.

2. The preparation of the integrated structure comprises the following steps:

prepared in the same experiment one and two.

3. Fluorescence detector: a commercially available Bos AFS-100 fluorescence detector was used.

4. Experimental method and results:

in the experiment, the saliva detection reagent strip and the saliva detection shell prepared by the method are assembled into an integrated detection reagent kit, the assembled detection reagent kit is placed into an aluminum-amber sealing bag with a drying agent, and the aluminum-amber sealing bag is sealed on a sealing machine and labeled. As before, 5, 10, 20, 40, 80 uIU/ml of Changxiu insulin glargine injection (100 IU/ml) was prepared with 10mM phosphate buffer solution, and a standard curve of Changxiu insulin glargine concentration and fluorescence reaction was established with the prepared detection kit and fluorescence quantitative analyzer. The prepared integrated detection kit is used for respectively detecting 1 hour of saliva samples of the empty stomach and the postprandial of 10 healthy donors, standing for 15 minutes, placing the saliva samples in a fluorescence quantitative analyzer for detecting fluorescence values and calculating the insulin concentration of the saliva samples through a standard curve, wherein the empty stomach is 12.67+/-3.19 uIU/ml, and the postprandial time is 38.22+/-7.83 uIU/ml, so that the detection range of normal people is met.

Claims

1. A sampling and detection integrated structure for saliva insulin detects, its characterized in that: the integrated structure comprises a saliva sampling head, a saliva detection reagent strip and a saliva detection shell, and the saliva sampling head, the saliva detection reagent strip and the saliva detection shell are directly connected with each other; the saliva detection reagent strip comprises a sample pad, a marker binding pad, a nitrocellulose membrane and a water absorbing paper pad; the first anti-insulin antibody marked by the indicator is coated on the marker binding pad, and the non-marked second anti-insulin antibody is coated on the nitrocellulose membrane; the inside of the integrated structure is a strip-shaped structure which is directly connected with the saliva sampling head, the sample pad, the marker binding pad, the nitrocellulose membrane and the absorbent paper pad in sequence; the saliva detection shell is arranged on the outer side of the saliva detection reagent strip and comprises a detection shell upper cover and a detection shell lower cover, an observation window is formed in the saliva detection shell upper cover, and a sampling head opening is formed in the front end of the proximal end of the saliva detection shell; the saliva sampling head is of a sampling swab-like structure, the proximal end portion of the saliva sampling head is exposed to the outside of the saliva detection housing, the saliva sampling head extends into the inside of the saliva detection housing through the opening of the sampling head, and the distal end portion of the saliva sampling head is in direct contact connection with the saliva detection reagent strip through the sample pad.

2. The integrated structure of claim 1, wherein the direct contact connection between the saliva sampling head and the saliva test reagent strip is selected from the adhesive type, the adhesive type is that the saliva sampling head and the saliva test reagent strip are adhered together on the same support bottom sheet, the adhesive type is that the saliva sampling head, the sample pad, the marker binding pad, the nitrocellulose membrane and the absorbent paper pad are adhered together in the same order, wherein the distal end part of the saliva sampling head is connected with the sample pad, the proximal end part of the saliva sampling head extends from the support bottom sheet and is free from the support bottom sheet, the sampling head opening is positioned at the front end of the proximal end of the saliva test housing, and the free part of the proximal end of the saliva sampling head extends through the sampling head opening to form a sampling swab-like structure exposed outside the saliva test housing.

3. The integrated structure of claim 1, wherein the saliva sampling head is selectively inserted into the saliva test reagent strip through direct contact connection, the saliva test reagent strip adopted by the insertion comprises a sample pad, a marker binding pad, a nitrocellulose membrane, a water absorbing paper pad and a support bottom sheet, the saliva test reagent strip is placed in the saliva test housing, the sampling head opening is arranged at the front end of the proximal end of the saliva test housing, an insertion channel with an inclined surface is arranged between the sampling head opening and the sample pad of the saliva test reagent strip, the insertion channel is gradually close to the sample pad in an up-down interval, the saliva sampling head is inserted through the sampling head opening, the insertion channel is pressed to form direct contact connection with the sample pad, and the proximal end of the saliva sampling head forms a sampling swab-like structure exposed outside the saliva test housing for direct sampling.

4. The integrated structure according to claim 1, wherein the saliva sampling head and the saliva test reagent strip are in direct contact connection selection extrusion type, the saliva test reagent strip adopted by the extrusion type comprises a sample pad, a marker binding pad, a nitrocellulose membrane, a water absorbing paper pad and a support bottom sheet, which are arranged on the upper side of the lower cover of the test housing, the distal end part of the saliva sampling head is arranged on the sample pad, the proximal end part is arranged on the outer side of the saliva test housing through the opening of the sampling head, the upper cover of the test housing is arranged on the upper sides of the saliva sampling head and the saliva test reagent strip in a buckling mode, the proximal end part of the saliva sampling head is exposed on the outer side of the saliva test housing, and the distal end part of the saliva sampling head and the saliva test reagent strip are connected through direct contact and are arranged in the integrated structure inside the saliva test housing.

5. The integrated structure of claim 1, wherein the saliva sampling head is a rod-like structure having an inner core wrapped around an outer side thereof with a flexible water absorbent material.

6. The integrated structure of claim 1, wherein the saliva sampling head is a sheet-like structure of a rigid, bibulous material.

7. The integrated structure of claim 1, wherein a cap-shaped protective sleeve is provided on a side of the saliva sampling head at the proximal end of the saliva detecting housing.

8. The integrated structure of claim 1, wherein the integrated structure is configured with a semi-quantitative color chart of the same color as the indicator, the color chart having 3 or more color depth strips printed thereon.