CN113721013B - Eye surface liquid collecting and detecting device - Google Patents
Eye surface liquid collecting and detecting device Download PDFInfo
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- CN113721013B CN113721013B CN202111285489.8A CN202111285489A CN113721013B CN 113721013 B CN113721013 B CN 113721013B CN 202111285489 A CN202111285489 A CN 202111285489A CN 113721013 B CN113721013 B CN 113721013B
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Images
Classifications
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/558—Immunoassay; Biospecific binding assay; Materials therefor using diffusion or migration of antigen or antibody
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/0045—Devices for taking samples of body liquids
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/5302—Apparatus specially adapted for immunological test procedures
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/0045—Devices for taking samples of body liquids
- A61B2010/0067—Tear or lachrymal fluid
Abstract
The invention provides an ocular surface liquid collecting and detecting device, and relates to the technical field of medical instruments. Meanwhile, the ocular surface liquid collected and flowed out from the outer eyelid can slide to the sample sucking hole under the action of gravity in the groove and then enter the matched immunochromatography detection card, so that the related protein factors and pathogenic microorganisms at the ocular surface part can be diagnosed rapidly and instantly, repeated freeze thawing influence of protein is avoided, and the method has the advantages of simple specific operation, short detection time and the like, can complete detection of related items of the ocular surface liquid within 15min, has accurate results, and really solves the problem of on-site diagnosis and treatment of related diseases of the ocular surface.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to an ocular surface liquid collecting and detecting device.
Background
The immunochromatography technology is that an antibody for marking tracer particles (colloidal gold, latex microspheres, fluorescent microspheres and the like) is combined with a substance to be detected in advance to form a compound, capillary action is utilized to carry out chromatography on a solid phase carrier such as a nitrocellulose membrane, and the antigen or the antibody coated on the membrane in advance is combined with the compound flowing through to develop color. The method can directly interpret the result by naked eyes, has simple and convenient operation, and is suitable for basic level diagnosis and large-area screening.
Quantitative studies of specific protein components in tears have been increasingly used to diagnose ocular surface diseases, determine their severity, and as an indication for the prevention or treatment of ocular surface diseases for clinical and scientific applications. In actual clinical diagnosis, it is difficult for a clinician to judge the eye diseases of a patient through the representation, so that some rapid detection technology is needed to assist judgment.
Contact collection is currently used for ocular surface fluids, such as stimulated tear fluid, capillary tear fluid and adsorption tear fluid, which all have varying degrees of discomfort to the person being collected. After collection, the samples are preserved by adopting freezing, and when the sample is used, the protein can be damaged by re-melting the samples, so that the detection result is influenced.
In view of the above, the present invention is particularly proposed.
Disclosure of Invention
The invention mainly aims to provide an ocular surface fluid collecting and detecting device, which is used for solving at least one technical problem in the prior art.
In order to achieve the above purpose of the present invention, the following technical solutions are adopted:
the invention provides an ocular surface liquid collecting and detecting device, which comprises a collecting part and a detecting piece, wherein the collecting part is arranged on the outer side of the collecting part;
the collecting part comprises a shell, a groove and a sample sucking hole, wherein the groove is formed in the outer surface of the shell and used for collecting ocular surface liquid, and the sample sucking hole is formed in the bottom of the groove;
the detection piece is arranged in the shell and comprises an immunochromatography detection card;
the sample suction holes are used for guiding the ocular surface fluid sample to be detected in the ocular surface fluid drainage groove to the immunochromatography detection card.
Furthermore, a groove is arranged at one end of the shell, and the groove and the edge of the shell form an opening;
preferably, the groove is also provided with a drainage groove, one end of the drainage groove is connected with the edge of the sample suction hole, and the other end of the drainage groove extends towards the opening of the groove;
preferably, the outermost edge of the groove is also provided with an anti-overflow strip.
Further, the shell comprises a card cover and a card bottom;
the inner surface of the card cover and the inner surface of the card bottom are both provided with a fixing piece, and the fixing pieces are used for connecting the card cover and the card bottom;
preferably, the fixing piece comprises a fixing column and a fixing hole, and the fixing column is inserted into the fixing hole;
preferably, the inner surface of the card cover is provided with a first fixing column and a first fixing hole, and the inner surface of the card bottom is provided with a second fixing hole and a second fixing column corresponding to the first fixing column and the first fixing hole.
Furthermore, the outer surface of the card cover is also provided with a result observation port for observing a detection result on the detection piece;
preferably, the outer surface of the clamping cover is sequentially provided with an ocular surface liquid drainage groove, a sample ID writing part, a result observation hole, an air hole and a frosted handle from one end to the other end.
Furthermore, a pressing part is arranged on the inner surface of the clamping cover and is positioned above the detection part and used for assisting in providing a siphon effect;
preferably, the inner surface of the card bottom is provided with a card slot for fixing the detection piece.
Furthermore, the inner surface of the card cover and/or the inner surface of the card bottom are/is also provided with an extrusion part for extruding the detection piece to be attached to the sample suction hole.
Further, along the flow direction of a sample to be detected, the immunochromatography detection card comprises a sample pad, a marking pad, a cellulose membrane and absorbent paper which are sequentially connected on a bottom plate;
the sample sucking hole is positioned above the sample pad.
Furthermore, at least two detection lines and one quality control line are arranged on the cellulose membrane;
the quality control line comprises one or more of a goat anti-mouse antibody, a goat anti-rabbit antibody, a goat anti-chicken antibody or a goat anti-human antibody;
the detection line comprises an antibody, a receptor protein, a polypeptide or a nucleic acid aptamer for resisting a factor to be detected.
Further, the marking pad comprises a glass fiber film, a nylon film or a polyester film;
the label pad comprises a conjugate of a tracer particle and an antibody, a receptor protein, a polypeptide or a nucleic acid aptamer for resisting a factor to be detected.
Further, the sample pad comprises a glass fiber film, a nylon film, or a polyester film;
the sample pad includes one or more of a protein protectant, a blocking agent, or a surfactant.
Compared with the prior art, the invention has the following beneficial effects:
according to the ocular surface liquid collecting and detecting device provided by the invention, the ocular surface liquid of a collected person can be collected at the external eyelid through the groove design on the shell, the ocular surface liquid is collected without directly contacting with the ocular surface of the patient, the ocular surface liquid is prevented from being reacted inappropriately, and the operation is simple and convenient. Meanwhile, the ocular surface liquid collected and flowed out from the outer eyelid can slide to the sample sucking hole under the action of gravity in the groove and then enter the matched immunochromatography detection card, so that the related protein factors and pathogenic microorganisms at the ocular surface part can be diagnosed rapidly and instantly, repeated freeze thawing influence of protein is avoided, and the method has the advantages of simple specific operation, short detection time and the like, can complete detection of related items of the ocular surface liquid within 15min, has accurate results, and really solves the problem of on-site diagnosis and treatment of related diseases of the ocular surface.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and other drawings can be obtained by those skilled in the art without creative efforts.
Fig. 1 is a top view of an ocular surface fluid collection and detection device provided by the present invention;
FIG. 2 is a diagram of the groove structure of the ocular surface fluid collection and detection device provided by the present invention;
FIG. 3 is a view showing the inner surface structure of the card cover of the ocular surface fluid collection and detection device provided by the present invention;
FIG. 4 is a view showing the inner surface structure of the card bottom of the device for collecting and detecting ocular surface fluid according to the present invention;
FIG. 5 (a) is a standard curve fit graph;
fig. 5 (b) is a graph showing the results of the linear regression equation and the coefficients.
Icon: 1-a groove; 2-sample sucking hole; 3-a drainage groove; 4-anti-overflow strip; 5-a first fixing column; 6-a first fixing hole; 7-a second fixing hole; 8-a second fixed column; 9-sample ID writing; 10-result viewing port; 11-air holes; 12-pressing the strip; 13-pressing point; 14-a card slot; 15-a first extrusion; 16-second extrusion.
Detailed Description
Unless defined otherwise herein, scientific and technical terms used in connection with the present invention shall have the meanings that are commonly understood by one of ordinary skill in the art. The meaning and scope of a term should be clear, however, in the event of any potential ambiguity, the definition provided herein takes precedence over any dictionary or extrinsic definition. In this application, unless otherwise indicated, the use of the term "including" and other forms is not limiting.
Generally, the nomenclature used, and the techniques thereof, in connection with the cell and tissue culture, molecular biology, immunology, microbiology, genetics and protein and nucleic acid chemistry and hybridization described herein are those well known and commonly employed in the art. Unless otherwise indicated, the methods and techniques of the present invention are generally performed according to conventional methods well known in the art and as described in various general and more specific references that are cited and discussed throughout the present specification. Enzymatic reactions and purification techniques are performed according to the manufacturer's instructions, as commonly practiced in the art, or as described herein. The nomenclature used in connection with the analytical chemistry, synthetic organic chemistry, and medical and pharmaceutical chemistry described herein, and the laboratory procedures and techniques thereof, are those well known and commonly employed in the art.
The technical solutions of the present invention will be described clearly and completely with reference to the following embodiments, and it should be understood that the described embodiments are some, but not all, embodiments of the present invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
According to one aspect of the invention, an ocular surface fluid collecting and detecting device is provided, which comprises a collecting part and a detecting piece;
the collecting part comprises a shell, a groove and a sample sucking hole, wherein the groove is formed in the outer surface of the shell and used for collecting ocular surface liquid, and the sample sucking hole is formed in the bottom of the groove;
the detection piece is arranged in the shell and comprises an immunochromatography detection card;
the sample suction holes are used for guiding the ocular surface fluid sample to be detected in the ocular surface fluid drainage groove to the immunochromatography detection card.
It can be understood that the groove can be a cambered surface structure or a planar structure, the invention is not limited to this, as long as the sample suction hole is positioned at the bottom convergence point of the groove, so that the medium flowing through the surface of the groove converges to the sample suction hole under the action of gravity, and therefore, even in the case of less ocular surface fluid samples to be detected, the medium can be transmitted to the immunochromatography detection card, and the situation of inaccurate or invalid detection cannot occur. And through the recess design on the casing, can collect by the person's of gathering ocular surface liquid in outer eyelid department, ocular surface liquid is collected and need not with patient's ocular surface direct contact, avoids the uncomfortable reaction of eye, and easy operation is convenient.
Meanwhile, the ocular surface liquid collected and flowed out from the outer eyelid can slide to the sample sucking hole under the action of gravity in the groove and then enter the matched immunochromatography detection card, so that the related protein factors and pathogenic microorganisms at the ocular surface part can be diagnosed rapidly and instantly, repeated freeze thawing influence of protein is avoided, and the method has the advantages of simple specific operation, short detection time and the like, can complete detection of related items of the ocular surface liquid within 15min, has accurate results, and really solves the problem of on-site diagnosis and treatment of related diseases of the ocular surface.
It should be noted that the tear analytes to be detected by the detection card of the present invention include, but are not limited to, proteins, peptides, metabolites, electrolytes, small molecules, lipids, saccharides, nucleic acids, etc. in ocular surface fluid.
When the device is used, normal saline is dripped at the inner eyelid of a person to be collected, the groove in the ocular surface fluid collection and detection device is placed at the outer eyelid of the person to be collected, after the person to be collected rotates the eyeball, the rinse solution containing the ocular surface fluid sample to be detected is collected and flows out of the outer eyelid, the fluid slides to the sample sucking hole and then enters the detection card for chromatographic reaction, and the result is read after 15 min.
In some preferred embodiments, the recess is provided at one end of the housing, and the recess forms an opening with an edge of the housing. The groove is formed in one end of the shell, so that the eye surface liquid collection and detection device can be used conveniently, and the collection efficiency of the eye surface liquid sample to be detected is improved.
Still be provided with the drainage groove on the recess, the one end of drainage groove is connected with the border of inhaling the appearance hole, and the other end extends to the opening part of recess. Because the drainage groove directly sets up in the recess surface, consequently can set up to the camber or linear type along with the recess, guarantee equally under the horizontal condition, with inhale the link at appearance hole border be less than to the opening part extension end of recess can.
In order to reduce unnecessary flow of the ocular surface fluid sample to be detected in the groove, and/or avoid overflow of the ocular surface fluid sample to be detected, and ensure that as much ocular surface fluid sample to be detected flows into the sample suction holes for detection, raised edges are preferably arranged on two sides of the drainage groove.
In addition, in order to avoid that the eye surface liquid sample to be measured adsorbed at the edge of the groove slides to the outer edge of the clamping shell due to surface tension, the outermost edge of the groove is also provided with an anti-overflow strip.
The shell can be integrally formed or assembled, and in order to facilitate installation and use of the detection piece, the shell preferably comprises a clamping cover and a clamping bottom.
The inner surface of the card cover and the inner surface of the card bottom are both provided with fixing pieces, and the fixing pieces are used for connecting the card cover and the card bottom. The specific choice of the fixing member is not limited, and any component that can play a fixing role is conventional in the art, and may be, for example, but not limited to, a snap, a slot, or a plug, etc.
Preferably, the fixing piece comprises a fixing column and a fixing hole, and the fixing column is inserted into the fixing hole;
the inner surface of the clamp cover is provided with a first fixing column and a first fixing hole, and the inner surface of the clamp bottom is provided with a second fixing hole and a second fixing column, wherein the second fixing hole and the second fixing column correspond to the first fixing column and the first fixing hole. The cross hole column design can ensure that the buckling of the card cover and the card bottom is tighter.
In order to enhance the convenience of using the device for collecting and detecting the ocular surface fluid, preferably, the outer surface of the card cover is further provided with a result observation port for observing a detection result on the detection piece.
The outer surface of the clamping cover is sequentially provided with a groove, a sample ID writing part, a result observation opening, an air hole and a frosted handle from one end to the other end.
In some preferred embodiments, the inner surface of the card cover is provided with a pressing part, and the pressing part is located above the detection piece and is used for assisting in providing a siphon action, so that the movement of the ocular surface fluid sample to be detected on the immunochromatography detection card is promoted, the detection speed is increased, and the detection efficiency is improved. The typical pressing part can be a bulge arranged on the inner surface of the card cover, when the outer surface of the card cover is pressed, the bulge is pressed downwards to the immunochromatography detection card due to stress, so as to provide a siphon effect; the pressing part can also be a bulge arranged on the outer surface of the card cover, when the bulge is pressed, the card cover is pressed downwards due to the stress, the inner surface of the card cover is pressed down to the immunochromatography detection card, and the siphon effect can be provided.
In some embodiments, the inner surface of the card cover and/or the inner surface of the card bottom are further provided with pressing portions for pressing the detection member to fit the sample absorbing hole.
The term "and/or" means that the pressing part can be arranged on the inner surface of the card cover alone, or the pressing part can be arranged on the inner surface of the card bottom alone, or the pressing parts can be arranged on the inner surfaces of the card cover and the card bottom. The typical extrusion part is a protruding structure arranged on the inner surface of the card cover and/or the inner surface of the card bottom, when the card cover and the card bottom are buckled, the protruding structure can contact the immunochromatography detection card arranged in the shell, so that the immunochromatography detection card is attached to the sample sucking hole to the maximum extent, and the sample of the ocular surface fluid to be detected is prevented from flowing away along with the gap after flowing into the shell from the sample sucking hole.
In some preferred embodiments, the immunochromatographic detection card comprises a sample pad, a label pad, a cellulose membrane and a water-absorbent paper which are connected to a base plate in sequence along the flow direction of a sample to be detected.
Wherein, the bottom plate is made of plastic for providing support, and the material can be PVC and the like.
The cellulose membrane comprises a cellulose acetate membrane or a cellulose nitrate membrane;
specifically, the cellulose membrane comprises a quality control line and at least two detection lines;
the term "at least two" means that two, three, or four or more detection lines can be set according to actual detection requirements, and are used for detecting a single pathogenic factor or a plurality of pathogenic factors.
Preferably, the quality control line comprises one or more of a goat anti-mouse antibody, a goat anti-rabbit antibody, a goat anti-chicken antibody, or a goat anti-human antibody;
the detection line comprises an antibody, a receptor protein, a polypeptide or a nucleic acid aptamer for resisting a factor to be detected.
In some alternative embodiments, the marking pad comprises a fiberglass film, a nylon film, or a polyester film;
the label pad comprises a conjugate of a tracer particle and an antibody, a receptor protein, a polypeptide or a nucleic acid aptamer for resisting a factor to be detected.
The tracer particles may be, for example, but not limited to, colloidal gold, colloidal selenium, colored latex microspheres, fluorescent microspheres, and the like.
The sample pad comprises a fiberglass film, a nylon film, or a polyester film;
the sample pad includes one or more of a protein protectant, a blocking agent, or a surfactant.
Wherein, the protein protective agent can be, but is not limited to, BSA or casein; the blocking agent may be, for example, but is not limited to, PEG20000, PEG6000 or PVP 10000; the surfactant can be, for example, but is not limited to, tween 20, tween 80, or the like.
The absorbent paper can be absorbent filter paper with strong water absorption capacity.
The invention is further illustrated by the following examples. The materials in the examples are prepared according to known methods or are directly commercially available, unless otherwise specified.
Example 1
The embodiment provides an ocular surface liquid collecting and detecting device, which comprises a collecting part and a detecting piece;
as shown in fig. 1 and 2, the collecting part comprises a shell, a groove 1 arranged on the outer surface of the shell and used for collecting ocular surface fluid, and a sample sucking hole 2 arranged at the bottom of the groove.
The groove 1 is arranged at one end of the shell, and the groove 1 and the edge of the shell form an opening.
Still be provided with drainage groove 3 on the recess 1, the one end of drainage groove 3 is connected with the border of inhaling appearance hole 2, and the other end extends to the opening part of recess 1.
And an anti-overflow strip 4 is also arranged at the outermost edge of the groove.
As shown in fig. 3 and 4, the housing includes a card cover and a card bottom:
the inner surface of the card cover and the inner surface of the card bottom are both provided with fixing pieces, and the fixing pieces are used for connecting the card cover and the card bottom.
Specifically, the internal surface of card lid is equipped with 4 first fixed columns 5 and 2 first fixed orificess 6, and the internal surface at the bottom of the card is equipped with 4 second fixed orificess 7 and 2 second fixed columns 8 that first fixed column and first fixed orificess correspond, and first fixed orifices 6 is located the card lid front portion, and first fixed column 5 is located card lid middle part and rear portion, the position corresponds at the bottom of the card.
The outer surface of the card cover is sequentially provided with a groove 1, a sample ID writing part 9, a result observation opening 10, an air hole 11 and a frosted handle from one end to the other end.
The inner surface of card lid is equipped with presses the splenium, it is located immunochromatography detection card top to press the splenium for the supplementary siphon effect that provides.
Specifically, the pressing part comprises a pressing strip 12 and a pressing point 13, wherein the pressing point 13 can effectively save the manufacturing cost, and the corresponding position of the pressing point is the junction of the absorbent paper and the nitrocellulose membrane; the pressing strip 12 can ensure that the ocular surface fluid sample to be detected is released uniformly and chromatographically uniformly, and the corresponding position is the junction of the sample pad and the nitrocellulose membrane.
And a clamping groove 14 for fixing the detection piece is formed in the inner surface of the clamping bottom.
The inner surface of the card cover and the inner surface of the card bottom are also provided with squeezing parts, wherein a first squeezing part 15 of the inner surface of the card cover is arranged around the result observation port, and a second squeezing part 16 of the inner surface of the card bottom is arranged between the clamping grooves 14. After the card cover and the card bottom are buckled, the first extrusion part 15 and the second extrusion part 16 are contacted with the immunochromatography detection card and are used for extruding the detection piece to be attached to the sample sucking hole 2.
The detection part is arranged inside the shell and comprises an immunochromatography detection card.
Along the sample flow direction that awaits measuring, immunochromatography detects the card including meeting in proper order in sample pad, mark pad, cellulose membrane and the paper that absorbs water on the bottom plate, inhale appearance hole 2 and be located sample pad top.
The connection mode with the bottom plate can be fixed connection, for example, the sample pad, the marking pad, the cellulose membrane and the absorbent paper are fixed on the bottom plate through adhesive substances. The adhesive substance is preferably a non-setting adhesive.
The sample pad, the marking pad, the cellulose membrane and the absorbent paper can be in butt joint in sequence and can also be in lap joint in sequence. When the sample pad, the marking pad, the cellulose membrane and the absorbent paper are sequentially lapped, the sample pad, the marking pad and the cellulose membrane are sequentially arranged from top to bottom along the flow direction of the sample, and the absorbent paper lapped on the cellulose membrane.
And the sample suction holes 2 are used for conducting the ocular surface fluid sample to be detected in the groove 1 to an immunochromatography detection card so as to realize rapid detection of the ocular surface fluid sample to be detected.
In this embodiment, when the device for collecting and detecting ocular surface fluid is used, the physiological saline is dripped on the inner eyelid, the device for collecting and detecting ocular surface fluid is placed on the outer eyelid of a patient, after the eyeball of the patient rotates, the wetting and washing fluid is collected and flowed out from the outer eyelid, the fluid slides to the sample sucking hole 2 and then enters the detection card for chromatographic reaction, and the result is read after 15 min.
The ocular surface fluid analyte to be detected in this embodiment includes, but is not limited to, proteins, peptides, metabolites, electrolytes, small molecules, lipids, sugars, nucleic acids, etc. in the ocular surface fluid. The analytes include a number of protein biomarkers including, but not limited to: immunoglobulins (immunoglobulin g (igg), immunoglobulin m (igm), immunoglobulin a (iga), immunoglobulin e (ige)), cytokines (tumor necrosis factor-a (TNF-a), transforming growth factor-beta (TGF- β), interleukins), proteins (lactoferrin, lipocalins, cathepsins, mucins, or other glycoproteins).
Example 2
This example provides a method for detecting specific IgE antibodies in an ocular surface fluid sample to be detected by a colloidal gold qualitative method as described in example 1:
1. principle of reaction
The immunochromatography detection card nitrocellulose membrane is fixed with an anti-IgE monoclonal antibody No. 1 (T line) and a goat anti-chicken polyclonal antibody (C line) in advance, and the gold mark pad is pre-coated with an anti-IgE monoclonal antibody No. 2 and chicken IgY marked by colloidal gold. After the collected ocular surface fluid sample to be detected enters the sample sucking hole 2, the ocular surface fluid sample to be detected flows through the sample pad, the gold-labeled pad and the nitrocellulose membrane according to the capillary action. When the sample contains IgE, a target object and the colloidal gold-labeled anti-IgE monoclonal antibody No. 2 form a reaction complex, a double-antibody sandwich complex is formed with the target object and the T line when the target object passes through the T line so as to develop color, and the colloidal gold-labeled chicken IgY antibody reacts with the C line so as to develop color; when no IgE is present in the sample, no double antibody sandwich formation is formed, so the T-line is not developed and the C-line is normally developed. Whether allergic conjunctivitis exists or not is judged by the existence of T lines.
2. Preparation of tracer antibody
1 mL of gold nanoparticle solution was added to 100. mu.L of borate buffer (pH = 8.5), and an appropriate amount of anti-IgE monoclonal antibody No. 2 was added to the solution, followed by shaking for 2 hours. 100 mu L of 10% BSA solution was slowly added dropwise to the colloidal gold solution, and shaken for 1 h. Centrifuging at 12000r/min for 15min, discarding supernatant, dissolving precipitate with 0.1 mL of preservation solution, and placing in a refrigerator at 4 deg.C for use.
3. T, C quilt for wrapping
The anti-IgE monoclonal antibody No. 1 and the goat anti-chicken polyclonal antibody are diluted by using a coating buffer solution, and the preferable concentration is as follows: the T line was 1.0mg/ml and the C line was 0.5 mg/ml. Drying at 37 deg.C for 24 hr, sealing and bagging.
4. Preparation of gold label pad
The colloidal gold labeled antibody is labeled on the polyester film at a certain film spraying speed, and the optimal film spraying speed is 3 muL/cm. Drying at 37 deg.C for 30min, sealing and packaging.
5. Sample pad preparation
Uniformly coating the sample pad with the sample pad treatment solution, drying at 37 ℃ for 2h, and cutting the sample pad into working specifications for later use by using a cutting machine.
6. Test strip assembly
The components are sequentially assembled on a PVC base plate in sequence, cut into 3.8mm immunochromatography detection cards by a slitter and then placed in card bottom clamping grooves 14 for standby.
7. Performance testing
(1) Positive rate of agreement
The test was performed on 10 positive patients, and the coincidence results were 100%.
(2) Negative rate of agreement
The test was performed on 10 positive patients, and the coincidence rate was 95%.
(3) Repeatability of
1 positive patient is repeatedly sampled for 10 times, the result is positive, and the color development is uniform.
Example 3
This example provides a method for detecting specific IgE antibodies in an ocular surface fluid sample to be detected by a fluorescence quantitative method as described in example 1:
1. principle of reaction
An anti-IgE monoclonal antibody No. 1 (T line) and a goat anti-chicken polyclonal antibody (C line) are fixed on the detection card nitrocellulose membrane in advance, and an anti-IgE monoclonal antibody No. 2 and chicken IgY marked by fluorescent microspheres are pre-coated on the fluorescent pad. After the collected ocular surface fluid sample to be detected enters the sample sucking hole, the ocular surface fluid sample to be detected flows through the sample pad, the fluorescent pad and the nitrocellulose membrane according to the capillary action. When a sample contains IgE, a target object and a fluorescence-labeled anti-IgE monoclonal antibody No. 2 form a reaction complex, a double-antibody sandwich complex is formed with the target object and the T line when the target object passes through the T line, so that a fluorescence band is formed, and a fluorescence-labeled chicken IgY antibody reacts with a C line to form a fluorescence band; when no IgE is present in the sample, no double antibody sandwich formation can be formed, so that the T-line has no fluorescent signal and the C-line is normal. The intensity of the signal of the fluorescent strip is positively correlated with the concentration of the target.
2. Preparation of tracer antibody
Diluting the fluorescent microspheres by 10 times with ultrapure water, and performing ultrasonic dispersion for 5min by using an ultrasonic cleaner. 50mg of N-hydroxysuccinimide (NHS) was dissolved in 0.1M MES to prepare a solution (solution A) having a concentration of 50mg/ml and 50mg of 1- (3-dimethylaminopropyl) -3-ethylcarbodiimide hydrochloride (EDC) was dissolved in 0.1M MES to prepare a solution (solution B) having a concentration of 50 mg/ml. Adding 0.4mL of solution A into the microsphere suspension, mixing, adding 0.4mL of solution B after 10min, and reacting at room temperature for 20 min. Centrifuging at 12000r/min for 30min, removing supernatant, adding 0.01M PBS, ultrasonic dispersing, and adding 0.1mg antibody. Stirring at 2-8 deg.C for 2 hr, and blocking with 0.5% BSA for 1 hr. Centrifuging at 12000r/min for 20min, removing supernatant, and resuspending with preservation solution.
3. T, C quilt for wrapping
The anti-IgE monoclonal antibody No. 1 and the goat anti-chicken polyclonal antibody are diluted by using a coating buffer solution, and the preferable concentration is as follows: the T line was 1.0mg/ml and the C line was 0.5 mg/ml. Drying at 37 deg.C for 24 hr, sealing and bagging.
4. Fluorescent pad preparation
The fluorescence labeling antibody is labeled on the polyester film at a certain film spraying speed, and the optimal film spraying speed is 2.4 muL/cm. Drying at 37 deg.C for 30min, sealing and packaging.
5. Sample pad preparation
Uniformly coating the sample pad with the sample pad treatment solution, drying at 37 ℃ for 2h, and cutting the sample pad into working specifications for later use by using a cutting machine.
6. Test strip assembly
The components are sequentially assembled on a PVC bottom plate in sequence, cut into detection cards with the thickness of 3.8mm by a slitter and then placed in a card bottom clamping groove 14 for standby.
7. Performance testing
(1) Standard curve establishment
IgE standards were diluted to working concentration using saline multiple ratio. And adding a certain amount of standard substance with working concentration into the sample sucking hole, waiting for reaction for 15min, and reading the ratio of the fluorescence intensity values of C, T lines by using a fluorescence reading instrument. Each concentration was replicated 3-fold, curve fitted and its linear regression equation and regression coefficients calculated (table 1 and figure 5).
TABLE 1 Standard Curve Signal values
(2) Detection limit test
And (5) taking the physiological saline to test a blank sample according to the sampling detection requirement, wherein the test times are 6 times. Calculating the 3-fold standard deviation value of the blank concentration value under a standard curve, wherein the formula is as follows: y =3 SD. The detection limit result is 0.041 mu g/kg.
(3) Measurement of precision
IgE standards were each diluted to working concentrations (0.5. mu.g/kg, 2. mu.g/kg, 10. mu.g/kg) using saline at a multiple ratio. Relative Standard Deviation (RSD) of the blank concentration values was calculated, taking 20 tests per concentration according to the detection method. The 3 concentration detection results are respectively as follows: 11.5%, 3.9% and 5.7%.
Finally, it should be noted that: the above embodiments are only used to illustrate the technical solution of the present invention, and not to limit the same; while the invention has been described in detail and with reference to the foregoing embodiments, it will be understood by those skilled in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some or all of the technical features may be equivalently replaced; and the modifications or the substitutions do not make the essence of the corresponding technical solutions depart from the scope of the technical solutions of the embodiments of the present invention.
Claims (9)
1. The device for collecting and detecting the ocular surface fluid is characterized by comprising a collecting part and a detecting piece;
the collecting part comprises a shell, a groove and a sample sucking hole, wherein the groove is formed in the outer surface of the shell and used for collecting ocular surface liquid, and the sample sucking hole is formed in the bottom of the groove;
the detection piece is arranged in the shell and comprises an immunochromatography detection card;
the sample sucking hole is used for conducting the ocular surface fluid sample to be detected in the groove to the immunochromatography detection card;
the groove is arranged at one end of the shell, and an opening is formed between the groove and the edge of the shell;
the groove is also provided with a drainage groove, one end of the drainage groove is connected with the edge of the sample suction hole, and the other end of the drainage groove extends to the opening of the groove;
two sides of the drainage groove are provided with raised edges;
an anti-overflow strip is further arranged at the outermost edge of the groove.
2. The ocular surface fluid collection and testing device of claim 1, wherein said housing comprises a card cover and a card bottom;
the inner surface of the card cover and the inner surface of the card bottom are both provided with a fixing piece, and the fixing pieces are used for connecting the card cover and the card bottom;
the fixing piece comprises a fixing column and a fixing hole, and the fixing column is inserted in the fixing hole;
the inner surface of the clamp cover is provided with a first fixing column and a first fixing hole, and the inner surface of the clamp bottom is provided with a second fixing hole and a second fixing column, wherein the second fixing hole and the second fixing column correspond to the first fixing column and the first fixing hole.
3. The ocular surface fluid collecting and detecting device according to claim 1, wherein the outer surface of the card cover is further provided with a result observation port for observing a detection result on the detection member;
the outer surface of the clamping cover is sequentially provided with a groove, a sample ID writing part, a result observation opening, an air hole and a frosted handle from one end to the other end.
4. The device for collecting and detecting the ocular surface fluid according to claim 1, wherein the inner surface of the card cover is provided with a pressing part which is positioned above the detecting member and is used for assisting in providing a siphon action;
and a clamping groove for fixing the detection piece is formed in the inner surface of the clamping bottom.
5. The ocular surface fluid collecting and detecting device according to any one of claims 1 to 4, wherein the inner surface of the card cover and/or the inner surface of the card bottom are further provided with pressing portions for pressing the detecting member to fit the sample sucking holes.
6. The ocular surface fluid collecting and detecting device of claim 1, wherein the immunochromatographic detection card comprises a sample pad, a marking pad, a cellulose membrane and absorbent paper which are connected to a bottom plate in sequence along the flow direction of a sample to be detected;
the sample sucking hole is positioned above the sample pad.
7. The ocular surface fluid collection and detection device of claim 6, wherein the cellulose membrane is provided with at least two detection lines and one quality control line;
the quality control line comprises one or more of a goat anti-mouse antibody, a goat anti-rabbit antibody, a goat anti-chicken antibody or a goat anti-human antibody;
the detection line comprises an antibody, a receptor protein, a polypeptide or a nucleic acid aptamer for resisting a factor to be detected.
8. The ocular surface fluid collection test device of claim 6, wherein said marker pad comprises a fiberglass, nylon, or polyester film;
the label pad comprises a conjugate of a tracer particle and an antibody, a receptor protein, a polypeptide or a nucleic acid aptamer for resisting a factor to be detected.
9. The ocular surface fluid collection test device of any one of claims 6-8, wherein the sample pad comprises a fiberglass, nylon, or polyester film;
the sample pad includes one or more of a protein protectant, a blocking agent, or a surfactant.
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