CN101281198A - CA27.29, TPS, CYFRA21-1 breast cancer colloidal gold three-joint inspection diagnostic reagent kit and manufacture method thereof - Google Patents
CA27.29, TPS, CYFRA21-1 breast cancer colloidal gold three-joint inspection diagnostic reagent kit and manufacture method thereof Download PDFInfo
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- CN101281198A CN101281198A CNA2008100818522A CN200810081852A CN101281198A CN 101281198 A CN101281198 A CN 101281198A CN A2008100818522 A CNA2008100818522 A CN A2008100818522A CN 200810081852 A CN200810081852 A CN 200810081852A CN 101281198 A CN101281198 A CN 101281198A
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Abstract
The invention discloses a breast cancer diagnoses reagent kit and preparing method thereof. The inventive reagent kit includes a reaction card, a suction dropping tube, a blood serum adding sample cup and a disposable syringe, wherein, the reaction card is formed by in sequence connecting a sample mat, a colloidal gold marked combination mat, a pyroxylin film and a water absorption mat. The invention respectively fixes three monoclonal antibodies CA27.29, TPS and CYFRA21-1 on different positions of the pyroxylin film; meanwhile, gold granules with different sizes are used to mark the three monoclonal antibodies, the gold marked antibodies are mixed to produce a gold conjugating mat, and then the gold conjugating mat are combined with the sample mat and the water absorption mat to form a reaction card. The inventive reagent kit can quickly and exactly test the early or relapse breast cancer patients; has advantages of high sensitivity, strong specificity and the like, thereby only 3-20 minutes are required to complete the entire testing process.
Description
Technical field
The present invention relates to a kind of kit of diagnosing tumour, relate in particular to a kind of breast cancer colloidal gold three joint inspection diagnostic kits, the invention still further relates to the preparation method and the application of this kit in diagnosing mammary cancer of this kit, belong to biomedical sector.
Background technology
Breast cancer is modal in the world epithelial cell tumour, and human beings'health and existence are constituted significant threat, is one of most important social concern of facing of countries in the world.Even to this day, breast cancer accounts for the 7%-10% of whole body malignant tumour, and its incidence of disease is ascendant trend year by year, and is since nineteen eighty annual with 3% speed increment, particularly developed country such as North America, West Europe, performance particularly evident.The whole world has 1,200,000 women that breast cancer takes place every year approximately, wherein, has 500,000 women to die from breast cancer.2006 American Cancer Societies, international cancer association shows with the statistical data of the relevant breast cancer of international breast cancer association: in female population, per 8 just have 1 threat that will suffer breast cancer.Average per 2 minutes halfs just have 1 women to be diagnosed as the patient with breast cancer.In 2006, just there was 1 women to die from breast cancer in average per 13 minutes.Only in 2006, have 212,920 women to be subjected to the invasion and attack of breast cancer, nearly 40,970 patients will face death.
Under the present unclear situation of breast cancer pathogenesis, best approach is exactly early detection, early diagnosis and early treatment, and this is the key that improves the breast cancer curative effect.
Tumor markers is by the bioactivator of the unconventionality expression of tumor tissues and cell generation, can discern or diagnosing tumour according to its biochemistry or immunological characteristic.All can occur antibody in most patient with breast cancer's serum, and get the nod, so the tumor markers inspection all has great importance to the diagnosis and the therapeutic evaluation aspect of breast cancer with the correlativity of disease at some tumor markers.
CA27.29 is a kind of mucin antigen relevant with tumour, and its molecule is the compound sugar albumen that O-connects, and molecular weight is very big.At present, the known antigen relevant with breast cancer by human MUC-1 gene code has MAM6, milk mucin, CA27.29 and CA15-3 respectively.With the monoclonal antibody of these antigen preparation, II phase or III primary breast cancer women's cancer return situation is suffered from quantitative check to some extent.According to interrelated data, tumor associated antigen CA27.29 has higher specificity (reaching 99%) and accuracy rate (88%) to prediction II phase or III primary breast cancer patient recurrence situation.U.S. food and drug administration (FDA) approved in the recent period use RIA CA27.29.Clinically, use the upper limit of 40U/ml (RIA) usually as normal value.Patient to breast cancer and oophoroma transfer, the patient who particularly after treatment, does not have disease symptoms clinically, find when change of serum C A27.29 checks regularly carrying out, measured value greater than the patient of 40U/ml than measured value less than 40U/ml or equal the patient of 40U/ml, its survival rate is much lower.
Tissue polypeptides specific antigen (TPS) is the M3 antigenic determinant on the cytokeratin fragment 18, and the height of tissue polypeptides specific antigen content is a comparatively special index weighing tumour cell division and proliferation activity in the serum.Studies show that the tissue polypeptides specific antigen is having unique value aspect early diagnosis, predicting recurrence and the transfer of tumour, the evaluation prognosis.Different with traditional tumor markers such as alpha-fetoprotein, carcinomebryonic antigen etc. is, the tissue polypeptides specific antigen is " a tumor promotion dependent form ", the height of its content in serum is relevant with the number of the tumour cell that divides, breeds, and is promptly relevant with the activity of tumour; Alpha-fetoprotein, carcinomebryonic antigen etc. then are " tumour capacity dependent form ", are that the number of tumour cell is relevant with the knurl body of tumour load.Therefore, early stage in tumour, before the naked eyes recurrence occurring or shifting, because the tumour cell number is less, the serum levels of the mark of those reflection tumour capacity is very low often, and tumour cell division, propagation are enlivened at this moment, thereby tissue polypeptides specific antigen content can be very high, thereby help early detection, early diagnosis and control.
CYFRA21-1 is the english abbreviation of cytokeratin 19 fragment antigen 21-1 (cytokeratin 19 fragmentantigen 21-1), employing hybridoma technologies such as BODENMULER were prepared BM19.21 and KS19.1 two strain monoclonal antibodies in 1992, through being composed of method of immunity, fragment antigen that can specific recognizing cells keratin 19.Under normal circumstances cytokeratin 19 does not have expression or hangs down and express in peripheral blood, marrow, lymph node, and in pernicious epithelioma, the proteinase that activates has quickened the degraded of cell, makes the CYFRA21-1 of great amount of soluble be released, and causes CYFRA21-1 concentration rising in the blood.CYFRA21-1 is as a kind of tumor markers of new epithelial origin character, in the application of clinical tumor more and more widely in recent years, in many epithelial cancers such as lung cancer, nasopharyngeal carcinoma etc. in various degree recall rate arranged all; Bibliographical information patient with breast cancer change of serum C YFRA21-1 level is relevant with clinical stages, but its positive rate is not high, only be 21.2%, but conspicuousness arranged that the CYFRA21-1 positive rate is with clinical stages and have or not the degree increase of shifting or recurring to rise with benign tumour group difference.Because the tumour of relevant epithelium genesis all may be expressed CK19, so the detection of CYFRA21-1 also false positive can occur, and this need and be got rid of by tracing study in conjunction with clinical data.
Detect separately above-mentioned a certain tumor markers index, more information can not be provided, detection sensitivity and specificity are all lower, are difficult to detect early stage or recurrence breast cancer patient, occur mistaken diagnosis easily or fail to pinpoint a disease in diagnosis.
Summary of the invention
The object of the invention is to provide a kind of new breast cancer diagnosis kit, and than existing breast cancer diagnosis kit, breast cancer diagnosis kit of the present invention has higher highly sensitive and stronger high specificity.
At CA27.29 breast cancer diagnosis had the high characteristics of specificity, TPS is in the early diagnosis of tumour, predicting recurrence and transfer, estimate the prognosis aspect special advantages is arranged, CYFRA21-1 the breast cancer clinical stages about and distinguish characteristic aspect pernicious and the benign tumour, the present invention uses immunochromatographic method with above three kinds of antigen combined uses, thereby the sensitivity and the specificity of breast cancer clinical detection have been improved greatly, have highly sensitive and characteristics such as high specificity with respect to single check reagent, simultaneously, the colour developing color difference of every kind of tumor markers, the result judges more directly perceived.
Concrete, the present invention seeks to be achieved through the following technical solutions:
A kind of breast cancer colloidal gold three joint inspection diagnostic kits, comprise the reaction card, inhale dropper, serum sample adding cup and disposable syringe, wherein, be fixed in after described reaction card is linked together by pad, nitrocellulose filter and the adsorptive pads (edge separately) of sample pad, colloid gold label from bottom to top successively on the backing and form;
Wherein, the pad of described colloid gold label prepares in accordance with the following methods: after CA27.29 monoclonal antibody, TPS monoclonal antibody and CYFRA21-1 monoclonal antibody were used aurosol grain mark respectively, with its mixing, bag was by on glass fibre, promptly;
Preferred, the pad of described colloid gold label prepares in accordance with the following methods: be the aurosol grain mark of 24.5nm with CA27.29 monoclonal antibody particle diameter, TPS monoclonal antibody particle diameter is the aurosol grain mark of 41nm, CYFRA21-1CA12-5 monoclonal antibody particle diameter is the aurosol grain mark of 71nm, 3 kinds of monoclonal antibodies of aurosol grain mark are mixed back (being preferably equal proportion mixes), bag is by on glass fibre, promptly.
Contain on the described nitrocellulose filter by anti-CA27.29 monoclonal antibody, anti-TPS monoclonal antibody and anti-CYFRA21-1 monoclonal antibody and wrap 3 detection lines and 1 control line that is formed by the sheep anti-mouse igg bag that is formed respectively; Preferred, 3 detection lines on the described nitrocellulose filter and 1 control line are arranged in the following sequence and are formed: from being sheep anti-mouse igg control line, anti-CA27.29 monoclonal antibody detection line, anti-TPS monoclonal antibody detection line and anti-, CYFRA21-1 monoclonal antibody detection line near thieving paper one end to being followed successively by near collaurum pad one end.
Wherein, described nitrocellulose filter can be by replacements such as nylon membranes.
Described backing can be the holder of various hard, all can be used for the present invention as long as have the function that certain rigidity has appendix or support, for example can be plastic plate (PVC), cardboard etc., is preferably PVC.
The present invention at first prepares the monoclonal antibody (but described 3 kinds of disclosed methods of MONOCLONAL ANTIBODIES SPECIFIC FOR method reference example) of anti-CA27.29, TPS, CYFRA21-1; With the anti-CA27.29 of gold grain difference mark, TPS, the CYFRA21-1 monoclonal antibody of different sizes, mix by a certain percentage again, be prepared into golden bond pad; Find by test, anti-CA27.29, TPS, the different distributions of CYFRA21-1 monoclonal antibody on test strips are related to the accuracy and the specificity of testing result, the present invention is by a series of test, finally determined anti-CA27.29, TPS, the CYFRA21-1 monoclonal antibody optimal arrangement position on nitrocellulose filter, thereby significantly improved recall rate, sensitivity and specificity breast cancer diagnosis.
The using method of kit of the present invention and evaluating standard:
With inhaling dropper sample to be checked (serum) is collected in the serum sample adding cup, the lower end (thieving paper one end) of reaction card is immersed in the serum, waited about 1 minute, after sample was absorbed fully, the taking-up reaction sticked into row and identifies.Change color according to the species antibody of colloid gold label identifies that Absorb Water paper to sample pad is respectively the band that detects CA27.29, TPS, CYFRA21-1, and that corresponding color is respectively is orange red, redness and aubergine.
The present invention is at same the three kinds of tumor markerses such as the CA27.29 of breast cancer diagnosis, TPS, CYFRA21-1 that detected on the test paper joint-detection, utilize immunochromatography technique, with anti-CA27.29, the TPS of purifying, the automatic micro-specking equipment of monoclonal antibody utilization of CYFRA21-1, be fixed on the qualified nitrocellulose filter of pre-service; Simultaneously,, above-mentioned golden labeling antibody is mixed by a certain percentage, be prepared into golden bond pad with the anti-CA27.29 of gold grain mark, TPS, the CYFRA21-1 monoclonal antibody of different sizes; Be aided with sample pad again, be combined into the reaction card.
Kit of the present invention adopts the double antibody sandwich method principle, can fast detecting people whole blood or serum, CA27.29 in the blood plasma, TPS, CYFRA21-1 antigen, a lot of drawbacks of former separate detection method have been overcome, can detect three kinds of tumor markerses once bleeding, secondly, degree of correlation according to above-mentioned three kinds of tumor markerses and breast cancer diagnosis, the golden labeling antibody of determining these three kinds of tumor markerses is used the gold grain marks of different sizes respectively, make the colour developing color difference of every kind of tumor markers, the result judges more directly perceived, has also improved the sensitivity and the specificity of breast cancer detection simultaneously.
Clinical practice is the result show, collaurum three joint inspection diagnostic kits of the present invention can detect early stage or recurrence breast cancer patient accurately, sensitivity and specificity be all than higher, testing process very fast (all testing processes only need 3-20 minute), have easy, cheap, advantages such as the manual operation error is little, good stability.
Description of drawings
Reaction card synoptic diagram in Fig. 1 kit of the present invention; Be fixed on the backing after linking together by pad, nitrocellulose filter and the adsorptive pads of sample pad, colloid gold label successively from left to right, wherein, the colloid gold label antibody at nitrocellulose filter is followed successively by sheep anti-mouse igg, CA27.29 monoclonal antibody, TPS monoclonal antibody, CYFRA21-1 monoclonal antibody by the right side to a left side.
Embodiment
Further describe the present invention below in conjunction with specific embodiment, advantage of the present invention and characteristics will be more clear along with description.But these embodiment only are exemplary, scope of the present invention are not constituted any restriction.It will be understood by those skilled in the art that and down can make amendment or replace without departing from the spirit and scope of the present invention, but these modifications and replacing all fall within the scope of protection of the present invention the details of technical solution of the present invention and form.
The preparation of embodiment 1 collaurum three joint inspection diagnostic kits of the present invention
1, the monoclonal antibody for preparing anti-CA27.29, TPS, CYFRA21-1
Use CA27.29, TPS, CYFRA21-1 (CA27.29 and TPS available from CanAg DiagnosticsAB, CYFRA21-1 available from Medix Biochemica) to the immunity of BALB/c mouse inbred lines respectively, when mice serum produces corresponding antibody, can be with splenocyte and SP2/0 Fusion of Cells.Utilize HAT to select hybridoma, and McAb is detected with enzyme linked immunosorbent assay (ELISA).Use limiting dilution assay for the hybridoma that detects antibody positive and clone, preserve the positive cell strain simultaneously, utilize the BALB/c mouse inbred lines to prepare a large amount of monoclonal antibodies.
2, contain the preparation of the nitrocellulose filter of 3 detection lines and 1 control line
2.1 detection line and control line bag quilt
Three kinds of monoclonal antibody positions on nitrocellulose filter, the direction from sample pad to thieving paper is respectively CYFRA21-1 monoclonal antibody, anti-TPS monoclonal antibody and anti-CA27.29 monoclonal antibody.
Detection line line: will resist CYFRA21-1 monoclonal antibody, anti-TPS monoclonal antibody and anti-CA27.29 monoclonal antibody to pack into (albumen trace spray film system) in the BioDot Membrane jetter respectively, (the film specification is 25mm * 310mm) drawing by the amount of 0.1 μ l/mm on the nitrocellulose filter.
Control line line: the sheep anti-mouse antibody coating buffer is packed into (albumen trace spray film system) in the BioDot Membrane jetter, is drawing by the amount of 0.1 μ l/mm on the nitrocellulose filter.(the film specification is 25mm * 310mm)
The bag quilt: 37 ℃ of bags were by 2 hours;
Sealing: 37 ℃ were sealed 30 minutes;
Dry: the nitrocellulose filter that will wrap behind the quilt was put into the vacuum dryer inner drying 20 hours, vacuum tightness 0.1.
2.2 the pad of colloid gold label preparation
Colloid gold label: to CA27.29, TPS, CYFRA21-1 monoclonal antibody solution dialysis desalination (4 ℃ are spent the night), adjust protein concentration respectively to 1mg/ml; Under electromagnetic agitation, CA27.29 monoclonal antibody particle diameter is the aurosol grain mark of 24.5nm, TPS monoclonal antibody particle diameter is the aurosol grain mark of 41nm, CYFRA21-1CA12-5 monoclonal antibody particle diameter is the aurosol grain mark of 71nm, and the corresponding color of band that finally detects CA27.29, TPS, CYFRA21-1 is orange red, red, purplish red.Equal proportion is mixed 3 kinds of immunity gold then, obtains the mixed immunity gold;
The bag quilt: the collaurum diluted is to OD=6.0, and 10mm * 310mm glass fibre soaked in solution 5-10 minute;
Dry: glass fibre behind the mark was put into the vacuum dryer inner drying 20 hours, and it is stand-by to take out airtight preservation.
2.3 assembling
Get the raw materials ready: sample pad, pad, nitrocellulose filter, adsorptive pads and PVC backing etc. are cut into certain specification and size by manufacturing technique requirent.
Paste: each component is pasted on the white plastic plate by manufacturing technique requirent.
Cut: the reaction plate that assembles is cut into the wide reagent strip of 3mm with cutting cutter.
Pack: in the aluminium foil bag of packing into, add dryer damp-proofing.Machine seals.
The 1 kit clinical detection breast cancer test of the present invention of test example
Get 500 routine patient with breast cancers, be patient with breast cancer's (breast cancer group) that pathology is made a definite diagnosis, age 20-81 year, 47.5 years old mean age; Select 500 routine normal controls (control group) else.
Specimen collection: the person under inspection 3ml that all phlebotomizes on an empty stomach morning; Separation of serum is put one 20 ℃ of refrigerators and is preserved.Adopt kit of the present invention (embodiment 1 is prepared) to detect CA27.29, TPS, CYFRA21-1.The strict kit instructions of pressing is operated.
Critical value CA27.29 is decided to be 40U/ml, and TPS is 100U/L, and CYFRA21-1 is 45ng/ml, and the reaction that is higher than critical value is positive.Statistical method is used the SPSS11.5 statistical software and is carried out statistical study.Adopt one-way analysis of variance and q check; Rate relatively use x
2Check.
The colour developing result that three kinds of marks of table 1 detect 500 doubtful breast cancer serum
CA27.29 TPS CYFRA21-1
Positive 322 255 161
Negative 198 245 339
Table 2 change of serum C A27.29, TPS, CYFRA21-1 are to breast cancer recall rate (%)
Detect numerical value
The colour developing combination
Positive positive rate (%)
CA27.29 81 64.4
TPS 62 51
CYFRA21-1 22 32.2
CA27.29+TPS 118 80
CA27.29+CYFRA21-1 64 72
TPS+CYFRA21-1 16 68.2
CA27.29+TPS+CYFRA21-1 59 84.4
Do not develop the color 78
The colour developing result that three kinds of marks of table 3 detect 500 negative serums
CA27.29 TPS CYFRA21-1
Positive 8 34 21
Negative 492 467 479
The colour developing result that table 4 change of serum C A27.29, TPS, CYFRA21-1 detect 500 negative serums
The variable color combination develops the color
CA27.29 74 93
TPS 31 469
CYFRA21-1 19 481
CA27.29+TPS 1 499
CA27.29+CYFRA21-1 0 500
TPS+CYFRA21-1 2 498
CA27.29+TPS+CYFRA21-1 0 500
Test findings shows that collaurum three joint inspection diagnostic kits of the present invention can detect early stage or recurrence breast cancer patient accurately, highly sensitive, high specificity, and testing process very quick (all testing processes only need 3-20 minute).
Claims (7)
1, a kind of breast cancer diagnosis kit, comprise the reaction card, inhale dropper, serum sample adding cup and disposable syringe, it is characterized in that: be fixed in after described reaction card is linked together by pad, nitrocellulose filter and the adsorptive pads edge separately of sample pad, colloid gold label from bottom to top successively on the backing and form; Wherein, contain on the described nitrocellulose filter by anti-CA27.29 monoclonal antibody, anti-TPS monoclonal antibody, anti-CYFRA21-1 monoclonal antibody wrap 3 detection lines and 1 control line that is formed by the sheep anti-mouse igg bag that is formed respectively.
2, according to the described breast cancer diagnosis kit of claim 1, it is characterized in that: the pad of described colloid gold label prepares in accordance with the following methods: after will resisting CA27.29 monoclonal antibody, anti-TPS monoclonal antibody and anti-CYFRA21-1 monoclonal antibody to use aurosol grain mark respectively, with its mixing, bag is by on glass fibre, promptly.
3, according to the described breast cancer diagnosis kit of claim 2, it is characterized in that: the pad of described colloid gold label prepares in accordance with the following methods: anti-CA27.29 monoclonal anti body and function particle diameter is the aurosol grain mark of 24.5nm, anti-TPS monoclonal anti body and function particle diameter is the aurosol grain mark of 41nm, anti-CYFRA21-1CA12-5 monoclonal anti body and function particle diameter is the aurosol grain mark of 71nm, after 3 kinds of monoclonal antibodies mixing with aurosol grain mark, bag is by on glass fibre, promptly.
4, by the described breast cancer diagnosis kit of claim 3, it is characterized in that: 3 kinds of monoclonal antibodies of aurosol grain mark are wrapped by on glass fibre according to 1: 1: 1 part by weight mixing back.
5, according to the described breast cancer diagnosis kit of claim 1, it is characterized in that: 3 detection lines on the described nitrocellulose filter and 1 control line are arranged in the following sequence and are formed: from being followed successively by sheep anti-mouse igg control line, anti-CA27.29 monoclonal antibody detection line, anti-TPS monoclonal antibody detection line and anti-CYFRA21-1 monoclonal antibody detection line near thieving paper one end to close collaurum pad one end.
6, according to the described breast cancer diagnosis kit of claim 1, it is characterized in that: described nitrocellulose filter can be replaced by nylon membrane.
7, according to the described breast cancer diagnosis kit of claim 1, it is characterized in that: described backing is the holder of various hard.
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| CN2008100818522A CN101281198B (en) | 2008-05-08 | 2008-05-08 | CA27.29, TPS, CYFRA21-1 breast cancer colloidal gold three-joint inspection diagnostic reagent kit and manufacture method thereof |
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| CN2008100818522A CN101281198B (en) | 2008-05-08 | 2008-05-08 | CA27.29, TPS, CYFRA21-1 breast cancer colloidal gold three-joint inspection diagnostic reagent kit and manufacture method thereof |
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