CN104820094A - Immune-chromatographic detection test paper and detection method - Google Patents
Immune-chromatographic detection test paper and detection method Download PDFInfo
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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
- G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
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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
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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
- G01N33/74—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving hormones or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors
- G01N33/76—Human chorionic gonadotropin including luteinising hormone, follicle stimulating hormone, thyroid stimulating hormone or their receptors
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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
- G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
- G01N33/54306—Solid-phase reaction mechanisms
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
- G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
- G01N2333/575—Hormones
- G01N2333/59—Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g. HCG; Luteinising hormone [LH]; Thyroid-stimulating hormone [TSH]
Abstract
The invention relates to an immune-chromatographic detection test paper and a detection method. The immune-chromatographic detection test paper includes a sample pad, a conjugate releasing pad, a reaction film, an absorption pad and a back lining. On the test paper, a to-be-detected sample liquid is moved along the reaction film due to the capillary effect, wherein the reaction film includes a detection zone and a quality control zone. The quality control zone is provided with quality control lines or quality control points. The detection zone is provided with 2-30 independent detection points at certain intervals. At least two detection points are arranged at a certain interval in a direction being vertical to the moving direction of the to-be-detected sample liquid. The detection points are coated with an antibody or an antigen. The detection test paper and the detection method are simple and quick in operation, can achieve qualitative, semi-quantitative or quantitative detection to different to-be-detected target substances in the to-be-detected sample, and can be widely used in the field of in-vitro diagnosis reagents.
Description
Technical field
The invention belongs to external diagnosis reagent field, in particular, relate to a kind of immunity chromatography detection test paper and detection method.
Background technology
Immunochromatographic method is a kind of quick diagnosis technology based on immune colloidal gold technique that the nineties is risen, Fig. 1 shows the structure of immunity chromatography detection test paper in prior art, as shown in Figure 1, comprise sample pad 4, bond release pad 5, reaction film 2, absorption pad 3, backing 1, reaction film 2 comprises detection zone T and quality control region C, its principle is first fixed on reaction film 2 by specific antibody, after the sample pad 4 of test paper immerses sample to be checked, due to capillarity, sample to be checked will move forward along this film, when moving to the region being fixed with antibody, in sample to be checked corresponding antigen namely with this antibody generation specific binding, if this region can be made to show certain color with immune colloid gold, thus realize specific immunodiagnosis.
Immunochromatography technique comprises double antibody sandwich method, indirect method, A competitive inhibition method substantially.
Double antibody sandwich method, belongs to non-competing combination and measures, be applicable to the polyvalent antigen in detection molecules with at least two antigenic determinants.Its basic functional principle is: the antibody that utilization is connected on reaction film 2 and labelled antibody are detected two antigenic determinants on antigen molecule respectively and are combined in sample to be checked, form labelled antibody-antigen-insolubilized antibody immune complex.
Indirect method, measures the method that antibody is the most frequently used, belongs to non-competing combination and measures.Its principle is by antigen immobilization in reaction film 2, and in sample to be checked, first test antibodies is combined with labeled molecule, form compound, then the antigen on reaction film 2 is combined, and forms labeled molecule-Antibody-antigen complex to be checked.
Competition law can be used for antigen and TPPA.To measure antigen, its ultimate principle is that the envelope antigen competition by inspection antigen and solid phase in sample to be checked is combined with labelled antibody, and when the amount by inspection antigen in sample to be checked is greater than the threshold value of reagent, labelled antibody then can not be combined with the envelope antigen of solid phase; If without being subject to inspection antigen in sample to be checked, labelled antibody is directly combined with the envelope antigen of solid phase.
Take colloid gold test paper as the various aspects that the immune chromatography test paper technology of main representative has now been widely used in immune detection, specific antibody or antigen are mainly fixed on reaction film 2 with ribbon by this technology, carry out qualitative analysis by the colour developing result of the banded detection line 8 of detection zone T mono-rule, the colour developing result of the banded detection line 8 of many rules is carried out sxemiquantitative and quantitatively detects.
Existing immunochromatography detection method and test paper, the every bar detection line 8 on test paper can only provide a kind of Detection Information, and in certain area, increase more detection line 8 quantity can cause information confusion even interpretation mistake to identification.
Application number be 201210200364.5 patent of invention disclose a kind of colloidal gold immunochromatographimethod quantitative testing test paper and detection method thereof, detection line on the T of detection zone has three at least, by quantitative combination and the detection of many detection lines and detected sample, realize the quantitative detection to detected sample.But the detection line that front and back are arranged side by side immune response each other can form interference, is unfavorable for accurate result of determination.
Summary of the invention
Technical matters to be solved by this invention is: provide a kind of immunity chromatography detection test paper and detection method, solves the interference in existing immunochromatographic assays between many detection lines, accurately cannot carry out the problem of result judgement.
The technical scheme that the present invention solves the problem is: provide a kind of immunity chromatography detection test paper, comprise sample pad, bond release pad, reaction film, absorption pad, backing, sample liquid to be checked moves along described reaction film due to capillarity, described reaction film comprises detection zone and quality control region, quality control region is provided with nature controlling line or Quality Control point, described detection zone is provided with 2 to 30 separate check points and keeps at a certain distance away between described check point, wherein, 2 check points are had at least to keep at a certain distance away in the vertical direction of sample liquid moving direction to be checked; Described check point is coated with antibody or antigen.
In immunity chromatography detection test paper provided by the invention, the shape of described check point is at least one in round dot, polygon, cartoon figure or several combinations.
In immunity chromatography detection test paper provided by the invention, determine the quantity of wrapping the antibody of quilt or the kind of antigen and content and described check point in described check point according to the object to be checked in sample to be checked.
In immunity chromatography detection test paper provided by the invention, the immunochromatography wrapped in object to be checked and described check point between the antibody of quilt or antigen reacts and comprises double antibody sandwich method, indirect method, A competitive inhibition method.
In immunity chromatography detection test paper provided by the invention, described bond release pad is provided with the specific marker thing relevant to object to be checked; Wherein, the labeling method of described specific marker thing comprises quantum dot-labeled method, Collaurum marking, colloidal selenium marked method, coloured or fluorescent latex labelling method, magnetic particle labels method.
The present invention also provides a kind of immunochromatography detection method, uses the immunity chromatography detection test paper described in aforementioned any one, treats sample and originally carries out qualitative, sxemiquantitative or quantitatively detect
In immunochromatography detection method provided by the invention, described sample to be checked comprises from the blood of clinical or non-clinical, body fluid, urine, saliva, genital discharge liquid or other liquid samples or thick sample.
In immunochromatography detection method provided by the invention, sample to be checked is added in described sample pad, after immunochromatography has reacted, first the object to be checked in sample to be checked is determined according to the colour developing situation of described check point, treat sample by the colour developing situation of check point separate in visual inspection detection zone again and originally carry out qualitative or half-quantitative detection, or, adopt the instrument with signal testing function to gather the characteristic signal of check point on test paper and carry out qualitative, sxemiquantitative or quantitatively detect.
Implement the present invention, there is following beneficial effect: simple to operate, quick, can realize treating qualitative, the sxemiquantitative of sample object to be checked different in this or quantitatively detect, external diagnosis reagent field can be widely used in.
Accompanying drawing explanation
In order to be illustrated more clearly in the embodiment of the present invention or technical scheme of the prior art, be briefly described to the accompanying drawing used required in embodiment or description of the prior art below, apparently, accompanying drawing in the following describes is only some embodiments of the present invention, for those of ordinary skill in the art, under the prerequisite not paying creative work, other accompanying drawing can also be obtained according to these accompanying drawings.
Fig. 1 is the structural representation of existing immunity chromatography detection test paper;
Fig. 2 is the structural representation of immunity chromatography detection test paper first of the present invention preferred embodiment;
Fig. 3 is the structural representation of immunity chromatography detection test paper second of the present invention preferred embodiment;
Fig. 4 is the structural representation of immunity chromatography detection test paper of the present invention 3rd preferred embodiment.
Embodiment
Below in conjunction with the accompanying drawing in the embodiment of the present invention, be clearly and completely described the technical scheme in the embodiment of the present invention, obviously, described embodiment is only the present invention's part embodiment, instead of whole embodiments.Based on the embodiment in the present invention, the every other embodiment that those of ordinary skill in the art obtain under the prerequisite not making creative work, all belongs to the scope of protection of the invention.
Existing immunity chromatography detection test paper arranges detection line in detection zone, usually a detection line is only had, when arranging many detection lines side by side, sample to be checked moves along reaction film due to capillarity, the movement of a small amount of immune substance will inevitably be driven, and detection line is vertical with the working direction of sample to be checked arranges, not to the mobile reserved passageway of sample to be checked, detection line interference is each other inevitable, in addition, in necessarily limited detection zone area, increase more detection line quantity and can cause information confusion even interpretation mistake to identification.Main innovate point of the present invention is, 2 to 30 separate check points are provided with in detection zone, each check point is spaced a distance, in addition, have at least 2 check points to keep at a certain distance away in the vertical direction of sample liquid moving direction to be checked, as the movable passageway of sample to be checked, reduce immune interference, check point is coated with antibody or antigen, for realizing treating qualitative, the sxemiquantitative of sample object to be checked different in this or quantitatively detecting.
Fig. 2 shows the structure of immunity chromatography detection test paper first of the present invention preferred embodiment, as shown in Figure 2, its agent structure is consistent with prior art, comprise sample pad 4, bond release pad 5, reaction film 2, absorption pad 3, backing 1, reaction film 2 comprises detection zone T and quality control region C, detection zone arranges 2 to 30 separate check points, and check point is coated with antibody or antigen.
When check point is coated with antibody or the antigen of identical type, the kind of object to be checked is a kind of, the antibody of the bag quilt then in check point or antigenic content difference, 6 check point T1 ~ T6 such as, are set in figure, wrap in each check point by same antibody, just in each check point, the content of antibody is different, and content increases progressively successively one by one.When detecting, only needing a check point display, can illustrate that having object to be checked exists, and completes qualitative detection accordingly; The check point quantity demonstrated is more, then illustrate that the amount of object to be checked is more, complete half-quantitative detection accordingly; If the content of antibody can accurately control in each check point, the quantity of check point display accurately can judge the amount of object to be checked, such as, the amount of a check point explicit declaration object to be checked is at 100 units, the amount of two check point explicit declaration objects to be checked is at 200 units, the amount of three check point explicit declaration objects to be checked is at 300 units ..., complete the quantitative detection of object to be checked accordingly.Certainly, in check point, envelope antigen is also suitable for aforementioned description completely, because the immunochromatography wrapped in object to be checked and check point in the application between the antibody of quilt or antigen reacts and comprises double antibody sandwich method, indirect method, A competitive inhibition method.Bond release pad is provided with the specific marker thing relevant to object to be checked; Wherein, the labeling method of specific marker thing comprises quantum dot-labeled method, Collaurum marking, colloidal selenium marked method, coloured or fluorescent latex labelling method, magnetic particle labels method.In order to better by each check point to show difference, the shape of check point is at least one in round dot, polygon, cartoon figure or several combinations.
The test paper that embodiment 1 uses colloidal gold immunity chromatography to detect human chorionic gonadotrophin
In the present embodiment, be coated with in the check point of identical type antibody or antigen at least partially, the content of antibody or antigen is different.Fig. 3 shows the structure of immunity chromatography detection test paper second of the present invention preferred embodiment, as shown in Figure 3, be specially a kind of test paper using colloidal gold immunity chromatography to detect human chorionic gonadotrophin, when check point is coated with antibody or the antigen of identical type, the kind of object to be checked is human chorionic gonadotrophin, in part check point, the content of antibody is different, such as check point T1 ~ T4, in part check point, the content of antibody is identical, such as 2 check point T1,2 check point T2.Concrete preparation method is as follows:
Material:
Biologically active raw material: α-HCG monoclonal antibody, β-HCG monoclonal antibody, IgG polyclonal antibody are all bought from market.
Reagent: bovine serum albumin(BSA) is bought from market.
Nitrocellulose filter is bought from market.
Test paper preparation procedure is as follows:
Step 1. reaction film 2 wraps quilt
Object determination coated antibody kind to be checked according in sample to be checked: α-HCG monoclonal antibody, IgG polyclonal antibody.
Content and the quantity of check point 10 and Quality Control point 11 is set: check point 10 arranges 6 points, 4 different contents according to the object to be checked in sample to be checked; Quality Control point 11 arranges 2 points, 1 content.
Be coated on nitrocellulose filter by the α-HCG monoclonal antibody of 15.42mg/ml, the IgG polyclonal antibody of 8.02mg/ml with the figure according to accompanying drawing 3, dry 24h, temperature is 37 DEG C, wet degree≤40%RH.
Prepared by step 2. bond release pad 5
Get the colloidal gold solution of 40nm, add the K of 0.2M in 1.2% ratio
2cO
3(sal tartari) regulates pH value, adds β-HCG monoclonal antibody, make label in 15 μ g/ml ratios, places room temperature 5min, adds BSA (bovine serum albumin(BSA)) stabilizing agent in 0.8% ratio.
The centrifugal 30min of 4500r, gets concentrating and precipitating thing; Supernatant is continued the centrifugal 45min of 6500r, get concentrating and precipitating thing; Supernatant is continued the centrifugal 60min of 9000r, get concentrating and precipitating thing; Three centrifugal concentrating sediments are mixed.
Diluted by centrifugal good concentrate, be laid on the nonwoven fabrics of 90cm × 30cm, liquid volume added 10-11ml/ opens, dry 24h, temperature 37 DEG C, Shi Du≤40%RH.
The preparation of step 3. sample pad 4
The glass fibre and nonwoven fabrics that cut into 83.5cm × 30cm are soaked with comprising 0.5%NaCl (potassium chloride), 0.5% sucrose, 0.1%BSA (bovine serum albumin(BSA)) and Tris-HCl damping fluid (trishydroxymethylaminomethane-hydrochloric acid) (pH7.4) working fluid.At 37 DEG C by dry for described pad 24h, obtain sample pad 4.
Step 4. assembles test paper
Backing 1 is lain on operator's console, sticks double faced adhesive tape.
Bag is attached on backing 1 by good reaction film 2.
Press the 2mm of reaction film 2 to stick absorption pad 3, the other end aligns with backing 1.
The 2mm place of reaction film 2 layer of non-woven fabric is pressed to stick.
Bond is discharged pad 5 to be pressed on together above nonwoven fabrics.
Glass fibre is pressed on bond release pad 5 half position, the other end aligns with backing 1.
Again layer of non-woven fabric one end and bond are discharged pad 5 upper end to align, the other end aligns with backing 1.
Step 5. Product checking
The sample urine to be checked of getting containing HCG is added drop-wise in sample pad 4, sentence read result during 5min, and T3 develops the color, and other T point, without colour developing, represents that containing HCG concentration in sample urine to be checked is 25-125mIU/ml; T2 and T3 develops the color, and other T, without colour developing, represents that containing HCG concentration in sample urine to be checked is 125-500mIU/ml; T1, T2, T3 develop the color, and T4, without colour developing, represents that containing HCG concentration in sample urine to be checked is 500-2500mIU/ml; T all develops the color, then represent in sample urine to be checked that containing HCG concentration is higher than 2500mIU/ml.
Embodiment 2 uses colloidal gold immunity chromatography to microdose urine protein, urinal beta2 microglobulin, presses down Guang element C tri-joint-detection test paper
In the present embodiment, when check point is coated with different types of antibody or antigen, the kind of object to be checked is multiple, and the kind quantity of object to be checked is consistent with the antibody or antigen type quantity wrapping quilt in check point.Fig. 4 shows the structure of immunity chromatography detection test paper of the present invention 3rd preferred embodiment, as shown in Figure 4, is specially one and uses colloidal gold immunity chromatography to microdose urine protein, urinal beta2 microglobulin, presses down Guang element C tri-joint-detection test paper.Concrete preparation method is as follows:
Material:
Biologically active raw material: human albumin monoclonal antibody, mouse-anti human albumin monoclonal antibody, Cys-C (pressing down Guang element C) monoclonal antibody, mouse-anti people Cys-C (pressing down Guang element C) antibody, β2-microglobulin monoclonal antibody, mouse-anti human β-2microglobulin antibody, IgG polyclonal antibody are all bought from market.
Reagent: bovine serum albumin(BSA) is bought from market.
Nitrocellulose filter is bought from market.
Test paper preparation procedure is as follows:
Step 1. reaction film 2 wraps quilt
Object determination coated antibody kind to be checked according in sample to be checked: human albumin monoclonal antibody, Cys-C (pressing down Guang element C) monoclonal antibody, β2-microglobulin monoclonal antibody, IgG polyclonal antibody.
Set antibody content and the quantity of check point 12 and Quality Control point 13 according to the object to be checked in sample to be checked: check point 12 arranges 3 points, each point is a kind of detection antibody; Quality Control point 13 arranges 2 points, 1 content.
By the IgG polyclonal antibody of the Cys-C of the β2-microglobulin monoclonal antibody of the human albumin monoclonal antibody of 2.5mg/ml, 2.26mg/ml, 2.42mg/ml (pressing down Guang element C) monoclonal antibody, 8.02mg/ml with reference to the accompanying drawings 4 figure be coated on nitrocellulose filter, dry 24h, temperature is 37 DEG C, Shi Du≤40%RH.
Prepared by step 2. bond release pad 5
The preparation of microdose urine protein gold mark bond release pad
Get the colloidal gold solution of 40nm, add the K of 0.2M in 1.2% ratio
2cO
3(sal tartari) regulates pH value, adds mouse-anti human albumin monoclonal antibody, make label in 12 μ g/ml ratios, places room temperature 5min, adds BSA (bovine serum albumin(BSA)) stabilizing agent in 0.8% ratio.
The centrifugal 30min of 4500r, gets concentrating and precipitating thing; Supernatant is continued the centrifugal 45min of 6500r, get concentrating and precipitating thing; Supernatant is continued the centrifugal 60min of 9000r, get concentrating and precipitating thing; Three centrifugal concentrating sediments are mixed.
Diluted by centrifugal good concentrate, be laid on the nonwoven fabrics of 90cm × 30cm, liquid volume added 10-11ml/ opens, dry 24h, temperature 37 DEG C, Shi Du≤40%RH.
The preparation of urinal beta2 microglobulin gold mark bond release pad
Get the colloidal gold solution of 40nm, add the K of 0.2M in 1.2% ratio
2cO
3(sal tartari) regulates pH value, adds mouse-anti human β-2microglobulin antibody, make label in 10 μ g/ml ratios, places room temperature 5min, adds BSA (bovine serum albumin(BSA)) stabilizing agent in 0.8% ratio.
The centrifugal 30min of 4500r, gets concentrating and precipitating thing; Supernatant is continued the centrifugal 45min of 6500r, get concentrating and precipitating thing; Supernatant is continued the centrifugal 60min of 9000r, get concentrating and precipitating thing; Three centrifugal concentrating sediments are mixed.
Diluted by normal concentration by centrifugal good concentrate, be laid on the nonwoven fabrics of 90cm × 30cm, liquid volume added 10-11ml/ opens, dry 24h, temperature 37 DEG C, Shi Du≤40%RH.
Press down the preparation of Guang element C gold mark bond release pad
Get the colloidal gold solution of 40nm, add the K of 0.2M in 1.2% ratio
2cO
3(sal tartari) regulates pH value, adds mouse-anti people Cys-C (pressing down Guang element C) antibody, make label, place room temperature 5min, add BSA (bovine serum albumin(BSA)) stabilizing agent in 0.8% ratio in 11 μ g/ml ratios.
The centrifugal 30min of 4500r, gets concentrating and precipitating thing; Supernatant is continued the centrifugal 45min of 6500r, get concentrating and precipitating thing; Supernatant is continued the centrifugal 60min of 9000r, get concentrating and precipitating thing; Three centrifugal concentrating sediments are mixed.
Diluted by normal concentration by centrifugal good concentrate, be laid on the nonwoven fabrics of 90cm × 30cm, liquid volume added 10-11ml/ opens, dry 24h, temperature 37 DEG C, Shi Du≤40%RH.
The preparation of step 3. sample pad 4
The glass fibre and nonwoven fabrics that cut into 83.5cm × 30cm are soaked with comprising 0.5%NaCl (potassium chloride), 0.5% sucrose, 0.1%BSA (bovine serum albumin(BSA)) and Tris-HCl damping fluid (trishydroxymethylaminomethane-hydrochloric acid) (pH7.4) working fluid.At 37 DEG C by dry for described pad 24h, obtain sample pad 4.
Step 4. assembles test paper
Backing 1 is placed on operator's console, sticks double faced adhesive tape.
Bag is attached on backing 1 by good reaction film 2.
Press the 2mm of reaction film 2 to stick absorption pad 3, the other end aligns with backing 1.
The 2mm place of reaction film 2 layer of non-woven fabric is pressed to stick.
By microdose urine protein bond release pad, urinal beta2 microglobulin bond release pad, press down Guang element C bond release pad and be pressed on together successively above nonwoven fabrics.
Glass fibre is pressed on bond release pad 5 half position, the other end aligns with backing 1.
Again layer of non-woven fabric one end and bond are discharged pad 5 upper end to align, the other end aligns with backing 1.
Step 5. Product checking
Get on sample urine specimen pad 4 to be checked, during 8min, sentence read result, T1 develops the color, and represents that in sample urine to be checked, microdose urine protein is for positive; T2 develops the color, and represents in sample urine to be checked and contains urinal beta2 microglobulin for positive; T3 develops the color, and represents in sample urine to be checked containing pressing down Guang element C for positive.
In addition, the present invention also provides a kind of immunochromatography detection method, use aforementioned a kind of immunochromatography detection method, sample to be checked comprises from the blood of clinical or non-clinical, body fluid, urine, saliva, genital discharge liquid or other liquid samples or thick sample.
Use procedure is as follows:
Sample to be checked is added in sample pad, after immunochromatography has reacted, treat sample by the colour developing situation of check point separate in visual inspection detection zone and originally carry out qualitative or half-quantitative detection, or, adopt the instrument with signal testing function to gather the characteristic signal of check point on test paper and carry out qualitative, sxemiquantitative or quantitatively detect.
Or, sample to be checked is added in sample pad, after immunochromatography has reacted, first the object to be checked in sample to be checked is determined according to the colour developing situation of check point, treat sample by the colour developing situation of check point separate in visual inspection detection zone again and originally carry out qualitative or half-quantitative detection, or, adopt the instrument with signal testing function to gather the characteristic signal of check point on test paper and carry out qualitative, sxemiquantitative or quantitatively detect.
The foregoing is only embodiments of the invention, do not limit the present invention, all on basis of the present invention, any amendment, improvement etc. done, all should be included within protection scope of the present invention.
Claims (8)
1. an immunity chromatography detection test paper, comprise sample pad, bond release pad, reaction film, absorption pad, backing, sample liquid to be checked moves along described reaction film due to capillarity, described reaction film comprises detection zone and quality control region, quality control region is provided with nature controlling line or Quality Control point, it is characterized in that, described detection zone is provided with 2 to 30 separate check points and keeps at a certain distance away between described check point, wherein, 2 check points are had at least to keep at a certain distance away in the vertical direction of sample liquid moving direction to be checked; Described check point is coated with antibody or antigen.
2. immunity chromatography detection test paper according to claim 1, is characterized in that, the shape of described check point is at least one in round dot, polygon, cartoon figure or several combinations.
3. immunity chromatography detection test paper according to claim 1, is characterized in that, determines the quantity of wrapping the antibody of quilt or the kind of antigen and content and described check point in described check point according to the object to be checked in sample to be checked.
4. immunity chromatography detection test paper according to claim 1, is characterized in that, the immunochromatography wrapped in object to be checked and described check point between the antibody of quilt or antigen reacts and comprises double antibody sandwich method, indirect method, A competitive inhibition method.
5. immunity chromatography detection test paper according to claim 1, is characterized in that, described bond release pad is provided with the specific marker thing relevant to object to be checked; Wherein, the labeling method of described specific marker thing comprises quantum dot-labeled method, Collaurum marking, colloidal selenium marked method, coloured or fluorescent latex labelling method, magnetic particle labels method.
6. an immunochromatography detection method, is characterized in that, uses the immunity chromatography detection test paper described in any one in claim 1 ~ 5, treats sample and originally carries out qualitative, sxemiquantitative or quantitatively detect.
7. immunochromatography detection method according to claim 6, is characterized in that, described sample to be checked comprises from the blood of clinical or non-clinical, body fluid, urine, saliva, genital discharge liquid or other liquid samples or thick sample.
8. immunochromatography detection method according to claim 6, it is characterized in that, sample to be checked is added in described sample pad, after immunochromatography has reacted, first the object to be checked in sample to be checked is determined according to the colour developing situation of described check point, treat sample by the colour developing situation of check point separate in visual inspection detection zone again and originally carry out qualitative or half-quantitative detection, or, adopt the instrument with signal testing function to gather the characteristic signal of check point on test paper and carry out qualitative, sxemiquantitative or quantitatively detect.
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| CN201510233043.9A CN104820094A (en) | 2014-05-14 | 2015-05-08 | Immune-chromatographic detection test paper and detection method |
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| CN201410202928 | 2014-05-14 | ||
| CN2014102029288 | 2014-05-14 | ||
| CN201510233043.9A CN104820094A (en) | 2014-05-14 | 2015-05-08 | Immune-chromatographic detection test paper and detection method |
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| CN201510233016.1A Pending CN104820104A (en) | 2014-05-14 | 2015-05-08 | Human chorionic gonadotropin immunochromatography detection test paper and preparation method thereof |
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| CN201410244152.6A Pending CN104764877A (en) | 2014-05-14 | 2014-06-04 | Immunity chromatography test method and test paper |
| CN201510233016.1A Pending CN104820104A (en) | 2014-05-14 | 2015-05-08 | Human chorionic gonadotropin immunochromatography detection test paper and preparation method thereof |
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| CN109444413A (en) * | 2018-09-26 | 2019-03-08 | 深圳市疾病预防控制中心（深圳市卫生检验中心、深圳市预防医学研究所） | A kind of detection device |
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| Publication number | Publication date |
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| WO2015172688A1 (en) | 2015-11-19 |
| CN104820104A (en) | 2015-08-05 |
| CN104764877A (en) | 2015-07-08 |
| WO2015172689A1 (en) | 2015-11-19 |
| WO2015184847A1 (en) | 2015-12-10 |
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