CN205374463U - Multinomial joint inspection device of supplementary general sieve of breast cancer - Google Patents
Multinomial joint inspection device of supplementary general sieve of breast cancer Download PDFInfo
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- CN205374463U CN205374463U CN201521060508.7U CN201521060508U CN205374463U CN 205374463 U CN205374463 U CN 205374463U CN 201521060508 U CN201521060508 U CN 201521060508U CN 205374463 U CN205374463 U CN 205374463U
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Abstract
The utility model aims to design a develop a multinomial joint inspection device of supplementary general sieve of breast cancer. Can jointly detect the relevant antigen CA153 that marks of breast cancer simultaneously fast, CA199, CA125, CA549, CEA, HCG, TSGF, HER2 -ECD, this joint inspection device is by 2 test paper strips, the constitution that gets stuck, 1 couple of CA153 of test paper strip, CA199, CA125, CA549 detects, observe the interpretation in first detection window, 2 couples of CEA of test paper strip, HCG, TSGF, HER2 -ECD detects, interpretation in the second detects the window, it gets stuck to put into one with the test paper strip, there is an application of sample hole to carry out the application of sample on getting stuck, detect the mark of eight kinds of breast cancer simultaneously, has the high efficiency, save time, the operation is thus simple, sensitivity is high, characteristics such as the specificity is good.
Description
Technical field
This utility model relates to immunity lateral chromatography technical field in immunology, and a kind of utilization immunochromatography technique and colloidal gold-labeled method combine specifically, it is achieved the multinomial joint inspection of early diagnosing mammary cancer.
Background technology
Female mammary gland is made up of skin, fibrous tissue, corpus mamma and fat, and breast carcinoma is to occur at the malignant tumor of mammary gland glandular epithelium tissue.In breast carcinoma, 99% occurs in women, and current breast carcinoma has become the threat able-bodied kinds of tumor of women.But owing to the early symptom of breast carcinoma is less obvious, it is all arrived middle and advanced stage when often finding.But adhere to that the patient that mammary gland is made regular check on often can find in early days, win therapic opportunity.
Inspection project in current breast carcinoma hospital mainly have following some:
1. the photography of breast molybdenum target x line checks；
2. fiberoptic ductoscopy inspection；
The method diagnosis rate is high, painful little, but needs to check hbs antigen before inspection, also should detect HIV (human immunodeficiency virus) if desired, to prevent cross infection from occurring.
3.B is super to be checked；
The mastopathy such as the features such as the method has nontoxic, harmless, easy, can differentiate good, pernicious, capsule, reality, hypertrophy.But ultrasonic examination is it sometimes appear that false positive, and the lump less than 1 centimetre is made a definite diagnosis difficulty.
4. magnetic resonance examination；
To determining that there is certain values clinical stages.
5. pathological examination；
Histopathological examination not only can be qualitative, moreover it is possible to determines the type of tumor before surgery, provides reference for treatment.A new generation's tissue penetration equipment even can be inhaled (cutting) and avoid operation except early stage cancer.
6. mammary gland infrared inspection；
It utilizes normal structure with pathological tissues, infrared ray absorbing rate is different, and display transparent, the secretly different grayscale image such as bright, thus diagnosis of breast diseases.Although be not the specialty inspection of breast carcinoma, but can as the screening of breast lesion.
In hospital, the inspection method of these breast carcinoma needs the equipment of costliness mostly, and substantial amounts of rapidly healthy population cannot be carried out general sieve, is unfavorable for early discovery and Diagnosis of Breast tumor.Multiple marks of breast carcinoma can be tested by the general screen device of the multinomial joint inspection of breast carcinoma intending exploitation in this patent simultaneously, has quick, efficient, sensitive, advantage accurately.If coordinate electronic machine to use, it is possible to mark to be carried out automatic ration mensuration, solves the problem that detection project carries out in conventional checking process intricate operation and the wasting of resources one by one that cause, improve work efficiency, saved cost simultaneously.
Immune colloidal gold technique is to be firstly appeared by Faulk and Taylor the phase at the beginning of the seventies in last century, is used primarily for immunoelectronmicroscopy.Colloidal gold-labeled method is using gold colloidal as tracer label thing or developer, in a kind of Novel immune labelling technique of antigen antibody reaction, the field such as manufacture being successfully used for now Electronic Speculum, flow cytometer, immunoblotting, protein staining, external diagnosis reagent.Gold labelling technique often coordinates with membrane carrier at present, forms specific immunoassay formats, such as immunity percolation and immunochromatography etc..Lateral immune chromatography test paper is exactly this technology important development direction for external quick diagnosis, is the novel detection mode of one grown up on the basis of monoclonal antibody technique, colloidal gold immunochromatographimethod technology and new material technology development.This technical development in recent years is rapid, has detected in (POCT) at clinical diagnosis particularly bedside and has been widely applied, such as the detection of infectious disease, early pregnancy, tumor markers etc..
At present, there is a lot of company have developed and carried out, for single markers for breast cancer, the test kit that detects, as CA153 (CA153) quantitative determination reagent kit (colloidal gold method), CA199 (CA199) measure test kit (chemoluminescence method) etc. and be the test kit for single detection thing.This co-detection device is 8 kinds of marks that detection breast carcinoma is relevant simultaneously, it is achieved only take sample, detection once can obtain the purpose of multiple data, is effectively increased detection efficiency, decreases rate of missed diagnosis such that it is able to reach the purpose of general sieve.
Summary of the invention
The purpose of this utility model is the multinomial co-detection device of the general sieve of auxiliary breast carcinoma designing and developing out a kind of high sensitivity, high specific.Can simultaneously fast joint detection breast carcinoma correlating markings antigens c A153, CA199, CA125, CA549, CEA, HCG, TSGF, HER2-ECD, simplify detection process so that detection is simpler, save time, efficiently.
The multinomial co-detection device of this utility model is got stuck by one and 2 test strip form; wherein get stuck and be divided at the bottom of card and Ka Gai; card has covered result display window and well; covering with glass fibre element film below well, test strips is made up of PVC board, loading pad, colloidal gold pad, nitrocellulose filter, sample suction pad, protecting film.
The colloidal gold pad of test strips 1 is the monoclonal antibody with gold colloidal CA153, CA199, CA125, CA549 of labelling respectively, the colloidal gold pad of test strips 2 is the monoclonal antibody of gold colloidal labelling CEA, HCG, TSGF, HER2-ECD respectively, and then equal lyophilizing is made to different glass cellulose membrane.The monoclonal antibody being coated CA153, CA199, CA125, CA549 on test strips 1 nitrocellulose filter respectively detects line as 4, is coated sheep anti mouse as 1 nature controlling line.The monoclonal antibody being coated CEA, HCG, TSGF, HER2-ECD on test strips 2 nitrocellulose filter respectively detects line as other 4, is coated sheep anti mouse as other 1 nature controlling line.Loading pad is the glass fibre element film processed, and protecting film is 1cm width adhesive tape.Each get stuck in be respectively put into reagent paper 1 and test strips 2, detect CA153, CA199, CA125, CA549, CEA, HCG, TSGF, HER2-ECD by point sample in well simultaneously and realize this joint-detection of breast carcinoma Research of predicting markers in 8.
Using in order to convenient, multinomial co-detection device is furnished with dropper, facilitates user to draw and fast drop sample.
The beneficial effects of the utility model:
1. detection efficiency is high.Point sample can simultaneously complete the detection of 8 breast carcinoma Research of predicting markers；
2. the detection time is short.Compared with hospital conventional inspecting method, it is greatly shortened the detection time, and when needing to detect multiple serum sample, it is not necessary to sample process, can the multiple sample of continuous detecting, only need to directly click and enter well timing 20min and can go up instrument by detecting sample and carry out quantitative result judgement；
3. detection instrument is simple.Move liquid instrument without being equipped with other, use dropper directly to drip sample, it is not necessary to accurate measuring sample size；
Accompanying drawing explanation
Fig. 1 (1) and Fig. 1 (2) is the built-in test strips structural representation of this utility model co-detection device
Fig. 2 is this utility model co-detection device schematic diagram
Dropper schematic diagram is used in the detection of Fig. 3 this utility model co-detection device
Reference numeral illustrates:
1: loading pad；2: colloidal gold pad；3: nitrocellulose filter；4: sample suction pad 5: detection line T1；6: detection line T2；7: detection line T38: detection line T4；9: Quality Control (C) line；10: detection line T5；11: detection line T6；12: detection line T7；13, detection line T8；14:PVC plate；15, the first detection form；16, the second detection form；17, well；18, application of sample graduation mark；
Detailed description of the invention
One, the preparation of co-detection device
1. the preparation of colloidal gold pad
1.1. 0.025% chlorauric acid solution stirring is boiled by colloidal gold solution preparation, adds 2% trisodium citrate, makes trisodium citrate final concentration of 0.025%, and continuous heating stirs, and solution is gradually become claret by blueness, stops heating, and stirring is cooled to room temperature.
Prepared by 1.2 colloid gold label liquid
Take above-mentioned colloidal gold solution, use 0.02mol/LK2CO3PH value is adjusted to take out 3 parts to 8.0 ± 0.1,1mL/ part, adjust pH value to 7.5 ± 0.1, take out 2 parts, 1mL/ part；Adjust pH value to 7.0 ± 0.1, take out 2 parts,；Adjusting pH value to 8.5 ± 0.1, take out 1 part of 1mL/ part and add monoclonal antibody by table 1, mixing, vibrate 30min；Adding 10% casein of 20 μ L in every milliliter of colloidal gold solution, mixing, vibrate 30min；10000g is centrifuged 10min, abandons supernatant；The redissolution liquid adding 1/100 colloidal gold solution volume makes 100 times of concentrated solutions.
Table 1 labeling of monoclonal antibody amount
Prepared by 1.3 colloidal gold pad
Above-mentioned concentrated solution is surveyed the OD value at 540nm place, 8 kinds of concentrated solutions difference pH value redissolution liquid is diluted to 10-20OD, redissolution liquid as in figure 2 it is shown, then glass fibre element film spot sample, be placed in vacuum freeze drier, vacuum freeze-drying 3 hours, make colloidal gold pad.
The different traget antibody of table 2 liquid that redissolves used
The liquid 1 that redissolves configures: 0.5%BSA, 0.5%Tween-20,0.2% sucrose, 0.05mol/L borate buffer solution (pH8.0)；The liquid 2 that redissolves configures: 0.5%BSA, 0.5%Tween-20,0.5% sucrose, 0.1%trionX-100,0.05mol/L borate buffer solution (pH7.5).
2. nitrocellulose filter is coated
2.1 preparations being coated liquid
With 1*PBS(pH7.4) sheep anti mouse polyclonal antibody is diluted to 2mg/mL, another of CA153, CA199, CA125, CA549, CEA, HCG, TSGF, HER2-ECD is coated monoclonal antibody and is diluted according to table 3 corresponding concentration, make and be coated liquid；
Table 3 coated antibody concentration table
2.2 antibody are coated
Being coated on nitrocellulose filter by Film-cutting machine by above-mentioned antibody, respectively as C line (nature controlling line) and T line (detection line), being coated parameter is 0.12 μ L/mm.Wherein CA153, CA199, CA125, CA549 are coated T1, T2, T3, the T4 in test strips 1, and CEA, HCG, TSGF, HER2-ECD are coated T5, T6, T7, the T8 in test strips 2, nitrocellulose filter are placed in 37 DEG C dry 2 hours.
3, prepared by loading pad
The 0.05mol/L borate buffer solution (pH8.0) of preparation loading pad treatment fluid: 0.5%BSA, spreads glass fibre element film with loading pad treatment fluid, and 1mL spreads 20cm2, 37 DEG C dry 3 hours.
4, the assembling of colloidal gold strip
By the loading pad of test strips 1 and test strips 2, colloidal gold pad, nitrocellulose filter and sample suction pad by being pasted onto shown in Fig. 1 in PVC board; loading pad pressure colloidal gold pad 1mm; colloidal gold pad pressure nitrocellulose filter 1mm; sample suction pad pressure nitrocellulose filter 1mm; as shown in Figure 2; protecting film 9 is pressed in loading pad upper end and nitrocellulose filter lower end, covers colloidal gold pad.After being completed respectively, it is cut into the wide bar of 3mm with cutting cutter.
5, the assembling of co-detection device
By getting stuck shown in test strips 1 and test strips 2 load map 2.
Two, detection process
Drawing sample to dropper graduation mark 18 position with dropper shown in Fig. 3, be then added in Fig. 2 of co-detection device in well shown in 17 by sample drop, room temperature stands 20min, observed result.
Three, interpretation of result
When the lowest detection of its setting is prescribed a time limit by one or more the content in detection sample equal to or more than this co-detection device, antigen in sample will form complex with the corresponding monoclonal antibody of colloid gold label, the antibodies of T line corresponding in the process of lateral chromatography and aobvious line, if now C line also outlet, it was shown that this test positive；When the lowest detection of its setting is prescribed a time limit lower than this co-detection device by one or more the content in detection sample, aobvious line cannot be gone out at corresponding T line, and be negative；If the not aobvious line of C line, then prove that this detection is invalid.
Claims (6)
1. the multinomial co-detection device assisting the general sieve of breast carcinoma; it is characterized in that its composition includes the test strips of two tetrads, gets stuck and dropper; test strips is made up of PVC board, loading pad, colloidal gold pad, nitrocellulose filter, sample suction pad, protecting film; test strips is respectively put in the left and right draw-in groove got stuck; there is a well to carry out application of sample on getting stuck, eight kinds of breast carcinoma Research of predicting markers of CA153, CA199, CA125, CA549, CEA, HCG, TSGF, HER2-ECD can be detected simultaneously.
2. a kind of multinomial co-detection device assisting the general sieve of breast carcinoma according to claim 1, it is characterised in that colloidal gold pad has been to distinguish the solid phase glass fibre element film of CA153, CA199, CA125, CA549 and CEA, HCG, TSGF, HER2-ECD monoclonal antibody.
3. a kind of multinomial co-detection device assisting the general sieve of breast carcinoma according to claim 1, it is characterised in that the colloid gold particle used by traget antibody is sized to 40-80nm.
4. a kind of multinomial co-detection device assisting the general sieve of breast carcinoma according to claim 1, it is characterized in that the monoclonal antibody being coated CA153, CA199, CA125, CA549 on test strips 1 nitrocellulose filter respectively detects line as 4, it is coated sheep anti mouse as 1 nature controlling line, the monoclonal antibody being coated CEA, HCG, TSGF, HER2-ECD on test strips 2 nitrocellulose filter respectively detects line as other 4, is coated sheep anti mouse as other 1 nature controlling line.
5. a kind of multinomial co-detection device assisting the general sieve of breast carcinoma according to claim 1, get stuck described in it is characterized in that and be divided at the bottom of Ka Gai and card, card has covered two result display windows and a loading slot, detects, first, the position mark detection project name that the right side T line detecting form on the left of form with second is corresponding.
6. a kind of multinomial co-detection device assisting the general sieve of breast carcinoma according to claim 5, it is characterised in that described well is only one of which in a detection card, and lower section glass fibre element film covers.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106950373A (en) * | 2017-03-29 | 2017-07-14 | 杭州博拓生物科技股份有限公司 | A kind of half-quantitative detection kits of CA15 3 and preparation technology |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106950373A (en) * | 2017-03-29 | 2017-07-14 | 杭州博拓生物科技股份有限公司 | A kind of half-quantitative detection kits of CA15 3 and preparation technology |
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