CN105929168A - Double-threshold detection test paper for breast cancer tumor marker CA153 - Google Patents
Double-threshold detection test paper for breast cancer tumor marker CA153 Download PDFInfo
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- CN105929168A CN105929168A CN201610542058.8A CN201610542058A CN105929168A CN 105929168 A CN105929168 A CN 105929168A CN 201610542058 A CN201610542058 A CN 201610542058A CN 105929168 A CN105929168 A CN 105929168A
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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
- G01N33/577—Immunoassay; Biospecific binding assay; Materials therefor involving monoclonal antibodies binding reaction mechanisms characterised by the use of monoclonal antibodies; monoclonal antibodies per se are classified with their corresponding antigens
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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
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/574—Immunoassay; Biospecific binding assay; Materials therefor for cancer
- G01N33/57407—Specifically defined cancers
- G01N33/57415—Specifically defined cancers of breast
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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
- G01N33/574—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
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Abstract
The invention provides double-threshold detection test paper for a breast cancer tumor marker CA153 and relates to breast cancer detection test paper. A user can utilize the detection test paper to detect by oneself and the detection test paper has the advantages of convenience, simplicity, rapidness, easiness of operation and accurate diagnosis result. The user of the test paper can determine the disease state at the early period of the disease and see the doctor to be treated in time; and meanwhile, the user can track and detect and randomly monitor the disease state for a long period after operation at any time. The detection test paper comprises a glass fiber membrane and a nitrocellulose membrane; the glass fiber membrane is coated with a colloidal gold solution for marking a CA153 antibody A; the nitrocellulose membrane is sequentially provided with a region T1, a region T2 and a quality control region from bottom to top; a CA153 antibody B is fixed on the region T1 of the nitrocellulose membrane; a CA153 antibody C is fixed on the region T2 of the nitrocellulose membrane; and rabbit polyclonal antibodies are fixed on the quality control region of the nitrocellulose membrane. The double-threshold detection test paper can be used for clinically detecting the breast cancer.
Description
Technical field
The present invention relates to a kind of breast cancer detection test paper.
Background technology
Breast cancer is one of normal malignant tumour sent out in women, and the early screening to breast cancer is the key improving survival.
CA153 is the related antigen of a kind of breast cancer, is present in breast cancer cell, and can be released into blood, CA153 in detection blood
Level can be used for detecting breast cancer.The reference value of general CA153 is less than 28U/ml, when CA153 is more than 100U/ml,
It is believed that there is metastatic pathology.Meanwhile, the change of CA153 content is closely related with result for the treatment of, is that patient with breast cancer diagnoses
With monitoring postoperative recurrence, the optimal parameter of observation curative effect.In long-term follow detection blood, CA153 content contributes to breast cancer trouble
Person's control to self state of an illness.But existing clinical testing procedure is frequently with chemiluminescence method, the method is the longest, need to join
The instrument of standby specialty and technical professional, poor operability, detects to the long-term follow of clinical patients and causes puzzlement.
Summary of the invention
The present invention provides the dual threshold Test paper of a kind of breast cancer tumour mark CA153, and user can detect voluntarily, tool
There are convenience, simple, quick, easily operated and diagnostic result advantage accurately.This test paper user can determine in early days in morbidity
The state of an illness, timely seeking medical attention；Long-term follow can also detect, monitor the state of an illness at any time after surgery simultaneously.
The dual threshold Test paper of breast cancer tumour mark CA153 of the present invention comprises glass fibre membrane and nitrocellulose filter；3
Plant different CA153 antibody, CA153 antibody A, CA153 antibody B and CA153 antibody C；
The colloidal gold solution of mark CA153 antibody A it is coated with on glass fibre membrane；
Nitrocellulose filter sets T1 district, T2 district and quality control region the most successively, and nitrocellulose filter T1 district is fixed with CA153
Antibody B, nitrocellulose filter T2 district is fixed with CA153 antibody C, and nitrocellulose filter quality control region is fixed with rabbit and resists more；
Wherein, in nitrocellulose filter T1 district, the concentration threshold of CA153 antibody B is 28U/ml；Nitrocellulose filter T2 district
The concentration threshold of interior CA153 antibody C is 100U/ml.
The present invention uses 3 kinds of CA153 antibody to prepare Test paper, obtains dual threshold testing result, reduce in one-time detection
The number of times of detection, saves the expense of user.And, the present invention avoids test paper bottom during dual threshold detects
Threshold test district, on the interference in threshold test district, top and impact, makes testing result the most accurately and reliably.
Using test paper of the present invention within 5 minutes, can go out testing result, detection speed is fast；User is without professional technique background and specialty
Instrument, convenient and simple for operation；Only need person's finger tip 1 to be tested to bleed, need blood volume few, and the pain of patient's blood drawing can be reduced；
With low cost, can test at any time and understand in time health and suffer from breast cancer risk, be suitable for the detection of postoperative long-term follow；Detection sensitivity
Height, high specificity.
The present invention has filled up tumor markers CA153 blank clinical quickly, that accurately detect.
Detailed description of the invention
Technical solution of the present invention is not limited to act detailed description of the invention set forth below, and also include between each detailed description of the invention is any
Combination.
Detailed description of the invention one: the dual threshold Test paper of present embodiment breast cancer tumour mark CA153 comprises glass fibers
Dimension film and nitrocellulose filter；
3 kinds of different CA153 antibody, CA153 antibody A, CA153 antibody B and CA153 antibody C；
The colloidal gold solution of mark CA153 antibody A it is coated with on glass fibre membrane；
Nitrocellulose filter sets T1 district, T2 district and quality control region the most successively, and nitrocellulose filter T1 district is fixed with CA153
Antibody B, nitrocellulose filter T2 district is fixed with CA153 antibody C, and nitrocellulose filter quality control region is fixed with rabbit and resists more；
Wherein, in nitrocellulose filter T1 district, the concentration threshold of CA153 antibody B is 28U/ml；Nitrocellulose filter T2 district
The concentration threshold of interior CA153 antibody C is 100U/ml.
The nitrocellulose filter T1 district of the dual threshold Test paper of present embodiment breast cancer tumour mark CA153, T2 district
It is horizontal banding with quality control region.
The dual threshold Test paper using method of breast cancer tumour mark CA153:
By person's droplet of blood to be tested under the nitrocellulose filter of the dual threshold Test paper of breast cancer tumour mark CA153
End, the most vertically stands 5 minutes, observes test paper T1 district, T2 district and quality control region colour developing situation, both can obtain testing result.
Test philosophy:
Present embodiment test paper utilizes capillary theory, and person's blood to be tested moves up along nitrocellulose filter, works as movement
To T1 district, T2 district and during quality control region, the antibody in region can occur specific binding by antigen corresponding with blood, if blood
Liquid demonstrates redness containing the Immuno gold in corresponding antigen then this region, if blood does not contains the antigen Ze Gai district of correspondence
Immuno gold in territory does not develops the color, thus realizes specific immune detection.
Testing result illustrates:
Test paper only has a band colour developing (quality control region colour developing is redness), and testing result is that in blood, CA153 concentration is less than 28U/ml.
Test paper has two band colour developings (T1 district and quality control region colour developing are redness), and testing result is that in blood, CA153 concentration is big
In 28U/ml and less than 100U/ml (28U/ml < CA153 < 100U/ml).
Test paper has three band colour developings (T1 district, T2 district and quality control region colour developing are redness), and testing result is that in blood, CA153 is dense
Degree is for more than or equal to 100U/ml.
Test strips develops the color without band, then explanation test paper lost efficacy.
Detailed description of the invention two: the present embodiment difference from detailed description of the invention one is: breast cancer tumour mark CA153
Dual threshold Test paper also include NC film and backing plate, glass fibre membrane, nitrocellulose filter, NC film are overlapping fixing successively
On backing plate.Other is identical with embodiment one.
Detailed description of the invention three: the present embodiment difference from detailed description of the invention one is: CA153 antibody A, CA153 are anti-
Body B and CA153 antibody C is 3 kinds of CA153 monoclonal antibodies.Other is identical with embodiment one.
Present embodiment CA153 antibody A, CA153 antibody B and CA153 antibody C are selected from Beijing hot scape limited public affairs of biotechnology
CA153 antibody " 8A6 " that department produces and the CA153 antibody " TM002 " that grand celebration Mai Baikang Bioisystech Co., Ltd buys
(pairing antibody).
Detailed description of the invention four: the present embodiment difference from detailed description of the invention one is: CA153 antibody A be coated
The colloidal gold solution of mark CA153 antibody A is made on colloid gold particle.Other is identical with embodiment one.
Detailed description of the invention five: the present embodiment difference from detailed description of the invention one is: nitrocellulose filter quality control region is also
It is fixed with glucose oxidase.Other is identical with embodiment one.
Under present embodiment test paper non-failure case, the grape in blood can be measured by electronics blood-sugar detecting instrument detection quality control region
Sugar content.Present embodiment has the multiple-effect detection of detection tumor markers and blood sugar concurrently.
Detailed description of the invention six: the present embodiment difference from detailed description of the invention one is: select grand celebration Mai Baikang biotechnology
A kind of monoclonal antibody in Co., Ltd's CA153 antibody " TM002 " is dense as CA153 antibody B, CA153 antibody B's
Degree is 35 μ g/mL；Select the CA153 antibody " 8A6 " that Beijing Hotgen Biotechnology Co., Ltd. produces as CA153 antibody C,
CA153 antibody C concentration is 10 μ g/mL.
Embodiment
Choose 100 women and use the dual threshold detection examination of the specific embodiment of the invention six breast cancer tumour mark CA153
Paper and chemiluminescence carry out contrast test.Wherein 25～random 30 of 60 years old popular women, make a definite diagnosis breast cancer pre-operative patients 30
Name, Postoperative Patient with Breast Cancer 40.
Test paper of the present invention is occurred to the crowd of 3 band colour developings carries out regular check, be all found to have metastatic pathology.Detection knot
Fruit proves that detection paper accuracy rate of the present invention is up to 100%, and becomes to do to Metastasis in Breast Cancer venereal disease and judge accurately.
Claims (4)
1. the dual threshold Test paper of breast cancer tumour mark CA153, it is characterised in that breast cancer tumour mark CA153
Dual threshold Test paper comprise glass fibre membrane and nitrocellulose filter；
3 kinds of different CA153 antibody, CA153 antibody A, CA153 antibody B and CA153 antibody C；
The colloidal gold solution of mark CA153 antibody A it is coated with on glass fibre membrane；
Nitrocellulose filter sets T1 district, T2 district and quality control region the most successively, and nitrocellulose filter T1 district is fixed with CA153
Antibody B, nitrocellulose filter T2 district is fixed with CA153 antibody C, and nitrocellulose filter quality control region is fixed with rabbit and resists more；
Wherein, in nitrocellulose filter T1 district, the concentration threshold of CA153 antibody B is 28U/ml；Nitrocellulose filter T2 district
The concentration threshold of interior CA153 antibody C is 100U/ml.
The dual threshold Test paper of breast cancer tumour mark CA153 the most according to claim 1, it is characterised in that 3
Planting CA153 antibody is 3 kinds of CA153 monoclonal antibodies.
The dual threshold Test paper of breast cancer tumour mark CA153 the most according to claim 1, it is characterised in that will
CA153 antibody A is coated on colloid gold particle the colloidal gold solution making mark CA153 antibody A.
The dual threshold Test paper of breast cancer tumour mark CA153 the most according to claim 1, it is characterised in that nitre
Acid cellulose film quality control region is further fixed on glucose oxidase.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610542058.8A CN105929168A (en) | 2016-07-11 | 2016-07-11 | Double-threshold detection test paper for breast cancer tumor marker CA153 |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610542058.8A CN105929168A (en) | 2016-07-11 | 2016-07-11 | Double-threshold detection test paper for breast cancer tumor marker CA153 |
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| CN105929168A true CN105929168A (en) | 2016-09-07 |
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| CN201610542058.8A Pending CN105929168A (en) | 2016-07-11 | 2016-07-11 | Double-threshold detection test paper for breast cancer tumor marker CA153 |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107121548A (en) * | 2016-02-25 | 2017-09-01 | 深圳市迈科龙生物技术有限公司 | Quantitatively detect test paper, preparation method and the detection method of tumor markers |
| CN109633158A (en) * | 2018-12-20 | 2019-04-16 | 黑龙江省科学院高技术研究院 | Breast cancer tumour marker CA153 dual threshold Rapid detection test strip and preparation method thereof |
| CN110818796A (en) * | 2018-08-09 | 2020-02-21 | 东莞市朋志生物科技有限公司 | Recombinant antibody of anti-human CA153 protein |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN201796036U (en) * | 2010-08-13 | 2011-04-13 | 中南大学 | Test strip for quantitative detection of tumor marker by colloidal gold immunochromatography |
| CN104569401A (en) * | 2014-12-10 | 2015-04-29 | 浙江工业大学 | CA15-3 detection kit and application thereof |
| 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 |
| CN105044339A (en) * | 2015-06-25 | 2015-11-11 | 天津大学 | Novel breast cancer quantum dot immunochromatographic test strip preparation method |
-
2016
- 2016-07-11 CN CN201610542058.8A patent/CN105929168A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN201796036U (en) * | 2010-08-13 | 2011-04-13 | 中南大学 | Test strip for quantitative detection of tumor marker by colloidal gold immunochromatography |
| CN104569401A (en) * | 2014-12-10 | 2015-04-29 | 浙江工业大学 | CA15-3 detection kit and application thereof |
| 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 |
| CN105044339A (en) * | 2015-06-25 | 2015-11-11 | 天津大学 | Novel breast cancer quantum dot immunochromatographic test strip preparation method |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107121548A (en) * | 2016-02-25 | 2017-09-01 | 深圳市迈科龙生物技术有限公司 | Quantitatively detect test paper, preparation method and the detection method of tumor markers |
| CN110818796A (en) * | 2018-08-09 | 2020-02-21 | 东莞市朋志生物科技有限公司 | Recombinant antibody of anti-human CA153 protein |
| CN109633158A (en) * | 2018-12-20 | 2019-04-16 | 黑龙江省科学院高技术研究院 | Breast cancer tumour marker CA153 dual threshold Rapid detection test strip and preparation method thereof |
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Application publication date: 20160907 |