CN106950373A - A kind of half-quantitative detection kits of CA15 3 and preparation technology - Google Patents
A kind of half-quantitative detection kits of CA15 3 and preparation technology Download PDFInfo
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- CN106950373A CN106950373A CN201710194642.3A CN201710194642A CN106950373A CN 106950373 A CN106950373 A CN 106950373A CN 201710194642 A CN201710194642 A CN 201710194642A CN 106950373 A CN106950373 A CN 106950373A
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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
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- G01N33/574—Immunoassay; Biospecific binding assay; Materials therefor for cancer
- G01N33/57484—Immunoassay; Biospecific binding assay; Materials therefor for cancer involving compounds serving as markers for tumor, cancer, neoplasia, e.g. cellular determinants, receptors, heat shock/stress proteins, A-protein, oligosaccharides, metabolites
- G01N33/57492—Immunoassay; Biospecific binding assay; Materials therefor for cancer involving compounds serving as markers for tumor, cancer, neoplasia, e.g. cellular determinants, receptors, heat shock/stress proteins, A-protein, oligosaccharides, metabolites involving compounds localized on the membrane of tumor or cancer cells
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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
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- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
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- G01N33/6893—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids related to diseases not provided for elsewhere
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Abstract
The present invention relates to a kind of half-quantitative detection kits of CA15 3, sheep anti-mouse igg, goat anti-rabbit igg and the monoclonal antibodies 2 of CA15 3 are coated with its coated film, nature controlling line, line of reference and detection line are followed successively by from one end close to adsorptive pads to one end close to label pad, the monoclonal antibodies 1 of CA15 3, rabbit igg and mouse IgG are coated with its label pad；The invention further relates to mentioned reagent box preparation technology, using preparation, the preparation of label pad, the preparation of sample pad, the assembling of test strips and cutting, the preparation of buffer solution of double-antibody method immunochromatography diagnostic techniques, including coated film.Product cocoa half-quantitative detection of the present invention goes out the content of CA15 3 in whole blood, serum and blood plasma, and Sensitivity and Specificity is good, and testing result is reliable and stable, it is adaptable to which single part uses, and simple to operate, reaction is quick.
Description
Technical field
The invention belongs to field of medical examination, it is related to a kind of CA15-3 half-quantitative detections kit and preparation technology.
Background technology
Tumor associated antigen CA15-3 is a kind of larger mucin-like glycoprotein of the molecular weight being located on cell membrane, is MUC1
The product of gene, it is initially recognized by two kinds of monoclonal antibodies, is that glycoprotein MAM-6 is made on human milk fat ball film respectively
The antibody (DF-3) that antibody (115-DB) and hepatic metastases breast cancer cell membrane are made.Patient with breast cancer often has CA15-3 rises, just
Phase sensitiveness is relatively low, but CA15-3 has preferable Sensitivity and Specificity in terms of Metastasis in Breast Cancer is reflected.In addition,
The time of appearance of the CA15-3 detections than clinical symptoms and imageological examination (such as B ultrasound, x-ray or CT) detection recurrence and transfer will
The early several months.Therefore CA15-3 is used as Computer-aided Diagnosis of Breast Cancer index, is also to be used for Follow-up After, dynamic tracing, curative effect
Judge, detect tumor recurrence, the important indicator of transfer, referring generally to value scope<30IU/ml.
Clinical detection CA15-3 method has radiommunoassay (RIA), EIA enzyme immunoassay (ELISA), chemiluminescence to exempt from
Epidemic disease analyzes (CLIA) and Electrogenerated chemiluminescent immunoassay (ECLA) etc..Radioimmunoassay method is clinical the more commonly used side
Method, but exist cumbersome, time-consuming, and easily generation environment pollution, and the shortcomings of produce harm to operator, substantially
Withdraw from the market.At present using more for enzyme linked immunosorbent detection technology and chemiluminescence, both approaches principle is similar, and
Realize automation, high-volume, quantitative detection, but it is big to there is result difference between method, meanwhile, Aulomatizeted Detect is at present by state
Outer large manufacturer is monopolized, and instrument and equipment is expensive, and is not suitable for single part and small batch detection use, greatly limit it in base
Layer hospital, the application of clinic.
Immune colloidal gold technique is to be firstly appeared by Fa μ lk and Taylors phase early 1970s, is used primarily for immuno-electron microscope
Technology.Colloidal gold-labeled method is that, using collaurum as tracer label thing, the one kind reacted applied to antigen and antibody specific is new
Type immunolabelling technique, has been used successfully to the fields such as flow cytometer, Western blotting, the manufacture of in-vitro diagnosis preparation.At present
Golden labelling technique often coordinates with membrane carrier, forms specific immunoassay formats, immuno-chromatographic test paper strip is exactly that this technology is used for
One important development direction of external quick diagnosis, in recent years the technology quickly grow, in clinical diagnosis particularly bedside
It is widely applied in detection (POCT).
Immune colloidal gold technique is applied to clinical detection CA15-3, compared with traditional elisa technique, both remained
The Sensitivity and Specificity of elisa technique, in turn ensure that the reliability and stability of testing result, it is adaptable to which single part uses,
Quickly, without any instrument and equipment, result judge intuitive and reliable, economical and practical, suitable Site Detection with easy to operate, reaction
The advantages of.
The content of the invention
The technical problems to be solved by the invention are to provide a kind of application immune colloidal gold technique, double-antibody method principle
The CA15-3 half-quantitative detections kit and its preparation technology of preparation, Sensitivity and Specificity are good, and testing result is reliable and stable, fit
Used for single part, simple to operate, reaction is quick.
In order to solve the above technical problems, a kind of CA15-3 half-quantitative detections kit that the present invention is provided, including detection plate,
Three parts of buffer solution and suction pipe, the detection plate includes test strips and plastic mould, and the test strips are at plastic mould bottom
Plate is pasted coated film, adsorptive pads, label pad, sample pad and assembled successively, and sheep anti-mouse igg, sheep are coated with the coated film
Anti-rabbit IgG and CA15-3 monoclonal antibody 2, from close to adsorptive pads one end to close to label pad one end be followed successively by nature controlling line,
Line of reference and detection line；CA15-3 monoclonal antibodies 1, rabbit igg and mouse IgG are coated with the label pad.
The preparation technology of described CA15-3 half-quantitative detection kits, skill is diagnosed using double-antibody method immunochromatography
Art, comprises the following steps：
(1) preparation of coated film：0.015M is prepared, pH 7.4 ± 0.1 phosphate buffer is used as coating buffer solution；With
CA15-3 monoclonal antibodies 2 are diluted to 0.5mg/ml by coating buffer solution, and goat anti-rabbit igg is diluted to 0.1mg/ml, sheep anti-mouse igg
1.0mg/ml is diluted to, it is with 1.0 μ l/ml discharge rate that it is fine in nitric acid with the uniform spray printing in 5mm interval using continuity point film machine
On the plain film of dimension, dried and be placed in 37 DEG C of drying in oven, then added in drier, aluminium foil bag and seal standby up for safekeeping；
(2) preparation of label pad：The CA15-3 that particle diameter is 20~40nm is prepared respectively using reduction of sodium citrate gold chloride
The colloidal gold solution of monoclonal antibody 1, rabbit igg and mouse IgG, OD=30 is diluted to by the colloidal gold solution prepared, using draw
Film metal spraying mark machine with 2.0 μ l/ml discharge rate by its with the uniform spray printing in 8mm interval on polyester cellulose film, dried and be placed in
37 DEG C of drying in oven, then add drier aluminium foil bag and seal standby up for safekeeping；
(3) preparation of sample pad：Prepare and contain 1-1.5% trishydroxymethylaminomethanes, 0.05-1% polyvinylpyrrolidines
The pH of ketone, 0.05-1% surfactants S9,1-5% mouse anti-human RBC monoclonal antibody and 0.05-0.1% caseins is
8.0 ± 0.5 purification of aqueous solutions is used as sample pad treatment fluid；Sample treatment liquid is uniformly sprayed in sample pad, 37 after taking-up
DEG C drying in oven；
(4) assembling and cutting of test strips：By plastic bottom board, coated film, adsorptive pads, label pad and sample pad in order according to
After secondary stickup, test strips are cut into cutting machine, are fitted into mould；
(5) preparation of buffer solution：Prepare and contain 0.01-0.1M disodium hydrogen phosphates and 0.01-0.2M sodium chloride, pH is 7.4
± 0.1 purification of aqueous solutions.
Preferably, the size of the nitrocellulose filter in the step of preparation process (1) is 25mm × 310mm.
Preferably, the size of the polyester cellulose film in the step of preparation process (2) is 10mm × 310mm.
The present invention can half-quantitative detection go out the content of CA15-3 in whole blood, serum and blood plasma, suffer from for having made a definite diagnosis breast cancer
Person carries out disease dynamic detection, there is positive meaning with auxiliary judgment disease process or therapeutic effect.With traditional ELISA skills
Art is compared, and present invention operation is simpler, while the Sensitivity and Specificity of elisa technique is remained, the reliability of testing result
Property and stability.In addition, the present invention is easily grasped and spread by basic unit, can be widely used in hospital, clinic, be prevented
The high-volume such as epidemic disease station is used using unit or single part, with easy to operate, reaction it is quick, without any instrument and equipment, result
Judge it is intuitive and reliable, economical and practical, be adapted to Site Detection the advantages of.
Brief description of the drawings
The present invention is further detailed explanation with embodiment below in conjunction with the accompanying drawings.
Fig. 1 is the structural representation of CA15-3 half-quantitative detection kits.
Fig. 2 is the structural representation of the detection plate of CA15-3 half-quantitative detection kits.
Fig. 3 is sample-adding and testing result schematic diagram when CA15-3 half-quantitative detections kit is detected.
Embodiment
As shown in figure 1, CA15-3 half-quantitative detection kits, including detection plate 1,3 three parts of buffer solution 2 and suction pipe；
As shown in Fig. 2 the detection plate 1 includes test strips and plastic mould 4, the test strips are pasted successively in plastic mould base plate
Coated film 5, adsorptive pads 6, label pad 7, sample pad 8 assemble, and sheep anti-mouse igg, goat-anti rabbit are coated with the coated film 5
IgG and CA15-3 monoclonal antibodies 2, from close to adsorptive pads 6 one end to close to label pad one end be followed successively by nature controlling line (C) 9,
Line of reference (R) 10 and detection line (T) 11；CA15-3 monoclonal antibodies 1, rabbit igg and mouse IgG are coated with the label pad 7.
Embodiment 1
First, the step of preparation process of CA15-3 half-quantitative detections kit：
(1) preparation of coated film 5：0.015M is prepared, pH 7.3 phosphate buffer is used as coating buffer solution；With coating
CA15-3 monoclonal antibodies 2 are diluted to 0.5mg/ml by buffer solution, and goat anti-rabbit igg is diluted to 0.1mg/ml, sheep anti-mouse igg dilution
To 1.0mg/ml, using continuity point film machine with 1.0 μ l/ml discharge rate by its with the uniform spray printing in 5mm interval in nitrocellulose
On film (film size be 25mm × 310mm), dried and be placed in 37 DEG C of drying in oven 14 hours, then add drier, aluminium foil
Seal standby up for safekeeping in bag；
(2) preparation of label pad 7：The CA15-3 Dan Ke that particle diameter is 20nm are prepared respectively using reduction of sodium citrate gold chloride
The colloidal gold solution of grand antibody 1, rabbit igg and mouse IgG, OD=30 is diluted to by the colloidal gold solution prepared, is sprayed using film is drawn
Golden mark machine using 2.0 μ l/ml discharge rate by its using the uniform spray printing in 8mm interval on polyester cellulose film (film size as 25mm ×
310mm), dried and be placed in 37 DEG C of drying in oven 14 hours, then added drier aluminium foil bag and seal standby up for safekeeping；
(3) preparation of sample pad 8：Prepare containing 1% trishydroxymethylaminomethane, 0.05% polyvinylpyrrolidone,
0.05% surfactant S9,1% mouse anti-human RBC's monoclonal antibody and 0.05% casein pH are 7.5 purified water
Solution is used as sample pad treatment fluid；Sample treatment liquid is uniformly sprayed in the sample pad of 1.7cm width with syringe, after taking-up
Dried and be placed in 37 DEG C of drying in oven 8 hours；
(4) assembling and cutting of test strips：By plastic bottom board, coated film, adsorptive pads, label pad and sample pad in order according to
After secondary stickup, test strips are cut into cutting machine, are fitted into mould；Aforesaid operations are less than 40%, 12-26 DEG C of temperature in humidity
In the environment of carry out.
(5) preparation of buffer solution 2：Prepare and contain 0.01M disodium hydrogen phosphates and 0.01M sodium chloride, pH is 7.3 purified water
Solution.
2nd, kit sample loading alternative：
Detection reagent, sample are recovered to room temperature (20-30 DEG C) using preceding.Detection reagent is taken out from aluminium foil bag, will be examined
Test agent is placed in clean water flat surface.
Serum/plasma：1 is vertically instilled with suction pipe 3 and drips sample (about 40 μ l) in well (S), one is added dropwise and drips buffer solution
2, start simultaneously at timing.
Venous blood：2 are vertically instilled with suction pipe 3 and drips sample (about 80 μ l) in reagent pipetting volume hole (S), one is added dropwise and drips buffer solution
2, start simultaneously at timing.
Finger tip blood：2 are added dropwise with suction pipe 3 and drips finger tip blood (about 80 μ l) in reagent pipetting volume hole (S), are added dropwise one and are dripped buffer solution 2,
Start simultaneously at timing.
Aubergine band is waited to occur after dripping, test result should be read at 10-20 minutes, the knot read after 20 minutes
It is really invalid.
3rd, kit testing result judges
Positive (+)：Detection line position (T) has a band equal or close with reference line (R) intensity to occur, and shows sample
The concentration containing CA15-3 is about 30IU/ml in product.Detection line position (T) has band one stronger than reference line (R) to occur, table
The concentration containing CA15-3 is higher than 30IU/ml in bright sample.
Negative (-)：Quality control region (C) and reference area (R) have a purple band appearance.Detection zone (T) has one than ginseng
Examine the weak band of line (R) to occur, show that the concentration containing CA15-3 is between 5~30IU/ml in sample.Detection zone (T) does not have
Purple band occurs, and shows that the concentration containing CA15-3 is in below 5IU/ml in sample.
It is invalid：If quality control region (C) or reference area (R) have a region or two regions to occur without purple band, table
Bright incorrect operating process or reagent go bad to be damaged.
4th, kit sensitivity test
The solution of various concentrations is prepared using CA15-3 standard items, it is specific as follows：
The kit testing standard product that are prepared using embodiment 1 are dense to be measured, by paint color card interpretation concentration results, often
Individual concentration mensuration 3 times.As a result show, the sensitivity of kit prepared by embodiment 1 is 5IU/ml.5th, kit specificity examination
Test
Make cross reaction experiment, cross reacting rate ＜ 0.01% with its analog.
6th, kit precision test
(1) variation within batch：Take basic, normal, high three parts of quality controlled serum samples to carry out 10 parallel laboratory tests respectively, calculate in the phase batch
The coefficient of variation (CV%), draws crowd interior difference CV between 3.2-5.0.
(2) batch variation：Select the serum sample of 5 parts of various concentrations to carry out 3 replications to every part of serum, calculate it
Interassay coefficient of variation (CV%), draws batch variation CV between 8.95~10.
7th, stabilization of kit is tested
Influence in view of transporting and using process to kit, the present embodiment carries out adding within 35 days at 55 DEG C to kit
Speed experiment, test result indicate that the indices of kit comply fully with requirement.
The kit of above description of test the present embodiment can CA15-3 in half-quantitative detection whole blood, serum, blood plasma.
Embodiment 2
Step of preparation process be the same as Example 1, formula adjustment is as follows：
Step (1), prepares 0.015M, and pH 7.4 phosphate buffer is used as coating buffer solution；
Step (2), using reduction of sodium citrate gold chloride prepare respectively particle diameter be 30nm CA15-3 monoclonal antibodies 1,
The colloidal gold solution of rabbit igg and mouse IgG；
Step (3), prepares and is lived containing 1.2% trishydroxymethylaminomethane, 0.5% polyvinylpyrrolidone, 0.5% surface
Property agent S9,3% mouse anti-human RBC's monoclonal antibody and 0.07% casein pH be used as sample for 8.0 purification of aqueous solutions
Pad treatment fluid；
Step (5), prepares and contains 0.05M disodium hydrogen phosphates and 0.1M sodium chloride, and pH is 7.4 purification of aqueous solutions.
Kit sensitivity test, kit specific test, kit precision are carried out using the method for be the same as Example 1
Experiment, stabilization of kit experiment, the sensitivity for drawing the kit of the present embodiment is 5IU/ml, cross reacting rate ＜
0.01%, difference CV is 3.2-5.0 in batch, and batch variation CV is 8.95~10, and indices comply fully with requirement, can sxemiquantitative
Detect CA15-3 in whole blood, serum, blood plasma.
Embodiment 3
Step of preparation process be the same as Example 1, formula adjustment is as follows：
Step (1), prepares 0.015M, and pH 7.5 phosphate buffer is used as coating buffer solution；
Step (2), using reduction of sodium citrate gold chloride prepare respectively particle diameter be 40nm CA15-3 monoclonal antibodies 1,
The colloidal gold solution of rabbit igg and mouse IgG；
Step (3), prepares and contains 1.5% trishydroxymethylaminomethane, 1% polyvinylpyrrolidone, 1% surfactant
S9,5% mouse anti-human RBC's monoclonal antibody and 0.1% casein pH for 8.5 purification of aqueous solutions as sample pad at
Manage liquid；
Step (5), prepares and contains 0.1M disodium hydrogen phosphates and 0.2M sodium chloride, and pH is 7.5 purification of aqueous solutions.
Kit sensitivity test, kit specific test, kit precision are carried out using the method for be the same as Example 1
Experiment, stabilization of kit experiment, the sensitivity for drawing the kit of the present embodiment is 5IU/ml, cross reacting rate ＜
0.01%, difference CV is 3.2-5.0 in batch, and batch variation CV is 8.95~10, and indices comply fully with requirement, can sxemiquantitative
Detect CA15-3 in whole blood, serum, blood plasma.
Claims (4)
1. a kind of CA15-3 half-quantitative detections kit, including detection plate, three parts of buffer solution and suction pipe, the detection plate bag
Test strips and plastic mould are included, the test strips are to paste coated film, adsorptive pads, label pad, sample successively in plastic mould base plate
Product pad assembles, it is characterised in that sheep anti-mouse igg, goat anti-rabbit igg and CA15-3 monoclonals are coated with the coated film anti-
Body 2, nature controlling line, line of reference and detection line are followed successively by from one end close to adsorptive pads to one end close to label pad；The mark
CA15-3 monoclonal antibodies 1, rabbit igg and mouse IgG are coated with pad.
2. the preparation technology of the CA15-3 half-quantitative detection kits described in a kind of claim 1, it is characterised in that using dual anti-
Sandwich method immunochromatography diagnostic techniques, comprises the following steps：
(1) preparation of coated film：0.015M is prepared, pH 7.4 ± 0.1 phosphate buffer is used as coating buffer solution；With coating
CA15-3 monoclonal antibodies 2 are diluted to 0.5mg/ml by buffer solution, and goat anti-rabbit igg is diluted to 0.1mg/ml, sheep anti-mouse igg dilution
To 1.0mg/ml, using continuity point film machine with 1.0 μ l/ml discharge rate by its with the uniform spray printing in 5mm interval in nitrocellulose
On film, dried and be placed in 37 DEG C of drying in oven, then added in drier, aluminium foil bag and seal standby up for safekeeping；
(2) preparation of label pad：The CA15-3 Dan Ke that particle diameter is 20~40nm are prepared respectively using reduction of sodium citrate gold chloride
The colloidal gold solution of grand antibody 1, rabbit igg and mouse IgG, OD=30 is diluted to by the colloidal gold solution prepared, is sprayed using film is drawn
Golden mark machine with 2.0 μ l/ml discharge rate by its with the uniform spray printing in 8mm interval on polyester cellulose film, dried and be placed in 37 DEG C
Drying in oven, then adds drier aluminium foil bag and seals standby up for safekeeping；
(3) preparation of sample pad：Prepare containing 1-1.5% trishydroxymethylaminomethanes, 0.05-1% polyvinylpyrrolidones,
The pH of 0.05-1% surfactants S9,1-5% mouse anti-human RBC monoclonal antibody and 0.05-0.1% caseins is 8.0
± 0.5 purification of aqueous solutions is used as sample pad treatment fluid；Sample treatment liquid is uniformly sprayed in sample pad, 37 DEG C of bakings after taking-up
Dried in case；
(4) assembling and cutting of test strips：Plastic bottom board, coated film, adsorptive pads, label pad and sample pad are glued successively in order
After patch, test strips are cut into cutting machine, are fitted into mould；
(5) preparation of buffer solution：Prepare and contain 0.01-0.1M disodium hydrogen phosphates and 0.01-0.2M sodium chloride, pH is 7.4 ± 0.1
Purification of aqueous solutions.
3. the preparation technology of CA15-3 half-quantitative detections kit according to claim 2, it is characterised in that the preparation
The size of nitrocellulose filter in processing step (1) is 25mm × 310mm.
4. the preparation technology of CA15-3 half-quantitative detections kit according to claim 2, it is characterised in that the preparation
The size of polyester cellulose film in processing step (2) is 10mm × 310mm.
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Cited By (6)
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| CN108051591A (en) * | 2017-09-10 | 2018-05-18 | 华中农业大学 | A kind of bird flu H9 subtype virus antibody rapid quantitative detection reagent box and its application |
| CN108226466A (en) * | 2017-12-01 | 2018-06-29 | 郑乐民 | A kind of immuno-chromatographic test paper strip and immunochromatography detection method |
| CN108872611A (en) * | 2018-05-23 | 2018-11-23 | 浙江安吉赛安芙生物科技有限公司 | A kind of colloidal gold using the gold-marking immunity chromatograph test strip that the anti-label of mouse is indirectly connected with after label sheep anti mouse secondary antibody preparation method |
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| CN112763730A (en) * | 2020-12-29 | 2021-05-07 | 成都永安制药有限公司 | Colloidal gold immunochromatography trace whole blood detection test paper and detection method thereof |
| CN114720682A (en) * | 2022-04-15 | 2022-07-08 | 山东康华生物医疗科技股份有限公司 | Preparation method of sample pad for immunochromatography detection |
Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101256190A (en) * | 2008-03-27 | 2008-09-03 | 黑龙江美康汇融生物技术股份有限公司 | CA15-3, CEA, CA19-9, CA12-5, SF mammary cancer colloidal gold five joint inspection diagnostic reagent kit |
| CN204188623U (en) * | 2014-11-12 | 2015-03-04 | 正元盛邦(天津)生物科技有限公司 | A kind of NT-proBNP precursor immunochromatography half-quantitative detection test paper |
| CN204188618U (en) * | 2014-11-12 | 2015-03-04 | 正元盛邦(天津)生物科技有限公司 | A kind of DDi immunochromatography half-quantitative detection test paper |
| CN104849465A (en) * | 2015-05-29 | 2015-08-19 | 广州华弘生物科技有限公司 | Breast cancer triple diagnostic kit with tumor serum markers CA153, CEA and HCG and preparation method of breast cancer triple diagnostic kit |
| CN105467116A (en) * | 2015-11-28 | 2016-04-06 | 宁波美康生物科技股份有限公司 | Convenient procalcitonin detection kit |
| CN205374463U (en) * | 2015-12-18 | 2016-07-06 | 德康润生物科技（天津）有限公司 | Multinomial joint inspection device of supplementary general sieve of breast cancer |
| CN106442079A (en) * | 2016-08-31 | 2017-02-22 | 杭州博拓生物科技股份有限公司 | Hemofiltration sample pad and preparation method thereof |
-
2017
- 2017-03-29 CN CN201710194642.3A patent/CN106950373A/en active Pending
Patent Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101256190A (en) * | 2008-03-27 | 2008-09-03 | 黑龙江美康汇融生物技术股份有限公司 | CA15-3, CEA, CA19-9, CA12-5, SF mammary cancer colloidal gold five joint inspection diagnostic reagent kit |
| CN204188623U (en) * | 2014-11-12 | 2015-03-04 | 正元盛邦(天津)生物科技有限公司 | A kind of NT-proBNP precursor immunochromatography half-quantitative detection test paper |
| CN204188618U (en) * | 2014-11-12 | 2015-03-04 | 正元盛邦(天津)生物科技有限公司 | A kind of DDi immunochromatography half-quantitative detection test paper |
| CN104849465A (en) * | 2015-05-29 | 2015-08-19 | 广州华弘生物科技有限公司 | Breast cancer triple diagnostic kit with tumor serum markers CA153, CEA and HCG and preparation method of breast cancer triple diagnostic kit |
| CN105467116A (en) * | 2015-11-28 | 2016-04-06 | 宁波美康生物科技股份有限公司 | Convenient procalcitonin detection kit |
| CN205374463U (en) * | 2015-12-18 | 2016-07-06 | 德康润生物科技（天津）有限公司 | Multinomial joint inspection device of supplementary general sieve of breast cancer |
| CN106442079A (en) * | 2016-08-31 | 2017-02-22 | 杭州博拓生物科技股份有限公司 | Hemofiltration sample pad and preparation method thereof |
Cited By (6)
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|---|---|---|---|---|
| CN108051591A (en) * | 2017-09-10 | 2018-05-18 | 华中农业大学 | A kind of bird flu H9 subtype virus antibody rapid quantitative detection reagent box and its application |
| CN108226466A (en) * | 2017-12-01 | 2018-06-29 | 郑乐民 | A kind of immuno-chromatographic test paper strip and immunochromatography detection method |
| CN108872611A (en) * | 2018-05-23 | 2018-11-23 | 浙江安吉赛安芙生物科技有限公司 | A kind of colloidal gold using the gold-marking immunity chromatograph test strip that the anti-label of mouse is indirectly connected with after label sheep anti mouse secondary antibody preparation method |
| CN111517997A (en) * | 2020-04-17 | 2020-08-11 | 杭州博拓生物科技股份有限公司 | Ethyl sulfate artificial antigen, preparation method and application |
| CN112763730A (en) * | 2020-12-29 | 2021-05-07 | 成都永安制药有限公司 | Colloidal gold immunochromatography trace whole blood detection test paper and detection method thereof |
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Application publication date: 20170714 |