CN102707050A - Colloidal gold test strip for fast detecting rheumatoid factors - Google Patents
Colloidal gold test strip for fast detecting rheumatoid factors Download PDFInfo
- Publication number
- CN102707050A CN102707050A CN2012101650402A CN201210165040A CN102707050A CN 102707050 A CN102707050 A CN 102707050A CN 2012101650402 A CN2012101650402 A CN 2012101650402A CN 201210165040 A CN201210165040 A CN 201210165040A CN 102707050 A CN102707050 A CN 102707050A
- Authority
- CN
- China
- Prior art keywords
- line
- people
- sex change
- igg
- gold
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Images
Landscapes
- Investigating Or Analysing Biological Materials (AREA)
Abstract
The invention discloses a colloidal gold test strip for fast detecting rheumatoid factors, belonging to medical test consumables. The colloidal gold test strip is characterized in that human denatured IgG with a colloidal gold label is enveloped on a gold label fiber pad; anti-mu chain IgM and human denatured IgG are enveloped on a T line, and the ratio of unit area envelop quantity of the human denatured IgG on the colloidal gold label, the anti-mu chain IgM and human denatured IgG on the T line on the gold label fiber pad is 0.133-0.889 to 5 to 1. The test strip uses an antibody capture method and a double antigen sandwich method principle during detection, has sensitivity and specificity, can fast detect the rheumatoid factors in human serum, plasma or whole blood by combining with an immune colloidal gold technique and has the advantages of simplicity, sensitivity and accuracy.
Description
Technical field,
The invention belongs to field of biological detection, relate to a kind of medical detection consumptive material, be specifically related to a kind of colloidal gold strip that is used for the fast detecting rheumatoid factor.
Background technology
Rheumatoid arthritis (rheumatoid arthritis; RA) be a kind of serve as main performance with chronic, symmetry, carrying out property panarthritis, the still fuzzy autoimmune disease of the cause of disease so far, preliminary investigation China should the disease morbidity rate be about 0.32%～0.36% (Tang Fulin. answer the Clinics and Practices of standard rheumatoid arthritis; Chinese Medical Journal; 2004,84 (12), 971-973).It is generally acknowledged that it is relevant in infection, heredity, endocrine metabolism, nutrition.Cold, humidity is the main inducing of its morbidity.RF finds in rheumatoid arthritis patients serum at first, is the autoantibody of a kind of antitypy IgG.Rheumatoid arthritis (RA) patient's positive rate is that 70%-80% is positive, and systemic loupus erythematosus (SLE) positive rate is 30%, and other connective tissues also; Like Sjogren syndrome, chorionitis, polymyositis; And chronic hepatitis; The elderly etc. also can detect certain positive rate (Wu Jianmin. practical medical test reference value and abnormal results analysis, People's Health Publisher, 184).
U.S. rheumatology association (ARA) rheumatoid arthritis criteria for classification in 1987: (1) morning is stiff: the joint and on every side stiff sense continue 1h at least.The course of disease >=6 weeks; The arthritis of (2) 3 or 3 above joint parts in zone: the doctor observes in following 14 zones (PIP on left side or right side, metacarpophalangeal joints, wrist, elbow, knee, ankle and articulationes metatarsophalangeae) and involves 3; And soft tissue swelling simultaneously or hydrops (not being simple bone protuberance), the course of disease >=6 weeks; (3) cheirarthritis: wrist, the palm refer to or the PIP inflammation in, have an arthroncus at least, the course of disease >=6 weeks; (4) symmetry arthritis: the joint, both sides get involved simultaneously (when bilateral PIP, metacarpophalangeal joints and articulationes metatarsophalangeae are got involved, absolute symmetry not necessarily.The course of disease >=6 weeks; (5) rheumatoid nodules: the doctor observes at the apophysis position, and subcutaneous nodule is arranged around extensor surface or the joint; (6) rheumatoid factor is positive: any detection method proof serum rheumatoid factor (SRF) content is unusual, and the positive rate of this method in normal population is less than 5%; (7) radiology changes: have typical rheumatoid arthritis radiology to change in the postero-anterior position of hand and wrist on mutually: must comprise bone erosion or the joint and be close to the position clear and definite sclerotin decalcification is arranged of getting involved.More than 7 satisfy more than 4 or 4, and get rid of other arthritis can the diagnostics classes rheumathritis (rheumatology branch of Chinese Medical Association. rheumatoid arthritis diagnosis and treatment guide, modern practical medical science 2004,16.).Wherein RF is as serological index unique in the RA criteria for classification, and therefore the diagnosis for RA plays important clinical diagnosis directive function.
Rheumatoid factor (rheumatoid factor; RF), the autoantibody of a kind of antitypy IgG is generally the IgM class, comes across rheumatoid arthritis patients serum, joint fluid or synovial membrane liquid more.Rheumatoid factor (rheumatoid factor; RF) can be divided into IgM, IgA, IgG, IgD, IgE five types; It is the one type of autoantibody that is directed against epitope on the IgG FC fragment in the rheumatoid arthritis serum; The rheumatoid factor positive patient is more with showing outside the joint, like subcutaneous nodule and vasculitis etc.All have the B cell clone that produces RF in patient RA and Yue 50% the healthy human body, under sex change IgG (or the IgG that combines with antigen) or Epstein-Barr virus directly act on, can synthesize RF in a large number.It is less that healthy subjects produces the cell clone of RF, and the soluble factor of monocyte secretion can suppress the generation of RF, so generally be difficult for measuring.Rheumatoid factor is because infectant (bacterium, virus etc.) causes that what produce in the body is a kind of antibody of antigen with sex change IgG (a kind of antibody), so claim antiantibody again.Common rheumatoid factor has IgM type, IgG type, IgA type and IgE type.Ubiquity rheumatoid factor in the human body, and plays certain physiological action.Understand the biological agent of IgM type rheumatoid factor is existing in recent years, these biological agents comprise: 1, immune response in the control agent; 2, activating complement accelerates to remove infected by microbes; 3, removing immune complex makes body avoid the damage of circulating complexe.Claim that rheumatoid factor is positive when having only the amount of rheumatoid factor to surpass certain titre.Because IgM type rheumatoid factor is the main type of rheumatoid factor, and has the characteristics of high aggegation, be easy to deposition, so mainly measure IgM type rheumatoid factor clinically, assay method is latex agglutination and enzyme linked immunosorbent assay.The rheumatoid factor positive also is found in virus infections such as flu, tumour, chronic infection such as pulmonary tuberculosis, subacute bacterial endocarditis and other autoimmune disease except that being shown in rheumatoid arthritis.
Most scholars think that the content of IgM class RF and the activity of RA do not have substantial connection; Symptom is closely related outside the content of IgG class RF and RA patient's synovitis, vasculitis and the joint.IgA class RF is shown in RA, chorionitis, Felty syndrome and SLE, is an index of RA clinical event.IgD class RF research is very few.RF is except that RA patient for the IgE class, also is shown in Felty syndrome and young type RA.RA patient, RF that height is tired exists and when limited, often points out prognosis mala with serious function of joint.In non-rheumatoid patient, the positive rate of RF increases with the increase at age, but that these people take place later on by RA person is few.Old rheumatoid arthritis is meant rheumatoid arthritis (RA) patient of age of onset >=60 years old; Account for 1/3 of RA; Along with social senilization; The incidence of disease in rising trend (Cheng Xiu peak Tan Kui unicorn Tan Jun. old patient with rheumatoid arthritis autoantibody detects and clinical meaning, the clinical department of internal medicine magazine, 545-546.).
Rheumatoid factor (RF) is the conventional project of clinical examination, and the detection for rheumatoid factor (RF) mainly is the RF in-vitro diagnosis at present, and RF in-vitro diagnosis major technique has; Latex agglutination, enzyme immunoassay and immunoturbidimetry (Chen Linjie, Li Zhijun, Fan Xiaoyun; Duan Jingming. anti-RA33 antibody is in rheumatoid arthritis significance in differential diagnosis and 1 year follow-up investigation, practical medical journal, 2005; 21 (11), 1141-1143; Li Jingyang, Zhou Lunxiang, Yi Qingsong, Cai Xiying, Luo Xiaowen, Dong Lixiang. APF ELISA, AKA and the meaning of rheumatoid factor joint-detection in rheumatoid arthritis, contemporary Chinese medical journal, 2006,16 (13), 1996-1999; Lei Xiaomei, what Baconic. AKA and rheumatoid factor be to the diagnostic value of rheumatoid arthritis, clinical department of internal medicine magazine, 2003,20 (12), 668.).Immunoturbidimetry adopts experimental apparatus to detect, and has guaranteed the sensitivity and the stability that detect, but it is superfluous all the time to keep in the reaction tube antibody protein in the testing process, and the waste sample is vulnerable to the influence of piarhemia simultaneously, and its complicated operation, and is consuming time.
At present; The method that the detection rheumatoid factor more generally adopts is the latex agglutination qualitative test, economical and practical and simple to operate being widely used because of it, but its sensitivity is low; Poor specificity; False positive rate is high, and it is tired plain more influenced by environment and individual difference etc., far can not satisfy the needs of clinical diagnosis, treatment and prognosis.RF latex agglutination slide detection method (Shanghai Yi Hua medical science and technology company limited).Because rheumatoid factor (RF) is a kind of anti-people's sex change lgG autoantibody that mainly betides in the patient with rheumatoid arthritis body, can combine and appear specific agglutination with the Fc section of lgG.This method detection sensitivity and accuracy are not high.
Application number is 200910194749.3 patent of invention, proposes a kind of half-quantitative detection rheumatoid factor method, this method complicated operation, and require the professional and technical personnel.
Application number is that 200910049923.5 patent of invention proposes a kind of lgG type rheumatoid factor enzyme immunity detection method; Application number is 200910222271.0 patent of invention; LgM antibody detection method in a kind of people's sex change IgG and rheumatoid factor absorption device and the relevant human serum is proposed; These two kinds of methods detect the forward and backward necessary apparatus of all need doing of rheumatoid factor and clean and maintenance work, and require the professional and technical personnel to operate.
Immune colloidal gold technique (Immunogold labelling techique) is the solid phase labelling immunoassay that after luciferin, radioactive isotope and enzyme three big labelling techniques, grows up the eighties in last century.This technology has mainly utilized gold grain to have the characteristic of high electron density, when these labels are assembled at corresponding part place in a large number, forms macroscopic redness or pink spot, thereby is used for qualitative or semiquantitative tachysynthesis detection method.Fast diagnose test paper bar is a novel vitro diagnostic techniques that on monoclonal antibody technique, colloidal gold immunochromatographimethod technology and novel chromatographic material basis, has grown up since the nineties in 20th century; Development in recent years is rapid, has particularly obtained widespread use in the medical test at biomedical sector.This technology mainly is that specific antigen or antibody are fixed on the nitrocellulose membrane with ribbon; Colloid gold label reagent is adsorbed on the pad; Be added on the sample pad of test strips one end when testing sample after, move forward, react to each other behind the colloid gold label reagent on the dissolving pad through capillary action; When moving to fixing antigen or antibody regions again; Specificity takes place with it and combines and be trapped in determinand gold marked reagent compound, and colloid gold label accumulates in to detect and is with, can be through the range estimation result that developed the color intuitively.Free label is then crossed and is detected band, thereby reaches and detect the purpose that thing separates automatically.At present colloidal gold technique and dual-antigen sandwich method, antibody capture method Combined application have been unusual proven technique, but are applied in the detection of rheumatoid factor (RF), have but occurred the low and narrow phenomenon of type of detection of sensitivity respectively; Use the immune colloidal gold technique of dual-antigen sandwich method separately; Its sensitivity is low, can not reach clinical common reference value, and uses the immune colloidal gold technique of antibody capture method separately; Its sensitivity is higher; Clinical reference value can be reached, but the IgM type that this method can only single detection target substance rheumatoid factor (RF), and other type of rheumatoid factor (RF) can not be detected.
A kind of technology of dual-antigen sandwich method (double antigen sandwich method) by enzyme immunity or radioimmunology detection antibody.Promptly encapsulate solid phase carrier, add the antigen of antibody to be measured and enzyme labeling in succession, thereby form sandwich appearance double antigens sandwich with known antigens.
Antibody capture method (also claiming reverse indirect method) ELISA is mainly used in the mensuration of certain antibody subtype composition in the serum.Its principle is that antigen is solidificated on the matrix, adds the hybridoma culture supernatant that contains antibody, the unconjugated antibody of flush away, and the antibody that is incorporated on the antigen can be by the anti-mouse immuning ball protein antibody recognition of the rabbit that is marked with luciferin, radioactive nuclide or some enzymes.
At present, can guarantee the sensitivity and the specificity that detect simultaneously, and easy to use, simple to operate, and the product that is used for the fast detecting rheumatoid factor of saving resource rarely has report.
Summary of the invention
Be demand and the blank that solves above-mentioned field; The present invention aims to provide a kind of colloidal gold strip that is used for the fast detecting rheumatoid factor; Test strips of the present invention is antibody capture method and dual-antigen sandwich method principle and usefulness when detecting; And the rheumatoid factor in binding immunoassay colloidal gold technique fast detecting human serum, blood plasma or the whole blood is used for the detection of patient with rheumatoid arthritis, has sensitivity and specificity concurrently; Simple to operate, easy to use, bring i.e. usefulness, do not need one of skill in the art; Can satisfy different levels personnel's needs, spread to hospital of grass-roots community easily, to the rheumatoid examination of the elderly's health check-up; With the symbol display result, broken away from specific (special) requirements to equipment, instrument, personnel and storage and transportation environment, can be widely used in the qualitative detection of rheumatoid factor (RF); And have quick, easy, sensitive, accurate, special characteristics, required sample is few simultaneously, saves resource.
A kind of colloidal gold strip that is used for the fast detecting rheumatoid factor comprises base plate supports layer, reaction reagent carrier absorption layer on short transverse, said reaction reagent carrier absorption layer is fixed on the said base plate supports layer; Be provided with the sample fiber pad from being stained with the liquid end successively to handheld terminal; Gold mark fiber mat; Cellulose medicine film, handheld terminal absorbent material pad is coated with protective film on said gold mark fiber mat and handle section absorbent material pad; On said cellulose medicine film, be printed with the detection line T line of strip and the control line C line of strip; Said detection line T line all is and the vertical strip of said colloidal gold strip length direction with said control line C line, it is characterized in that, on said gold mark fiber mat, is coated with people's sex change IgG of colloid gold label; On said T line, be coated with anti-μ chain IgM and people's sex change IgG, the unit area package amount ratio of people's sex change IgG, the anti-μ chain IgM on the T line and people's sex change IgG of the colloid gold label on the said gold mark fiber mat is 0.133～0.889:5:1.
The people's sex change IgG that encapsulates the colloid gold label on said gold mark fiber mat with encapsulate the anti-μ chain IgM on said T line, the unit area package amount ratio of people's sex change IgG is 1:15:3.
The people's sex change IgG that encapsulates the colloid gold label on said gold mark fiber mat with encapsulate the anti-μ chain IgM on said T line, the unit area package amount of people's sex change IgG is respectively 1600ng/cm
2, 24000ng/cm
2, 4800ng/cm
2
The said colloidal gold strip that is used for the fast detecting rheumatoid factor is characterized in that, protective film upper surface corresponding on the sample fiber pad indicates the visual MAX markings parallel with said detection line T.
Said sample fiber pad adopts glass fibre cotton, and said absorbent material pad adopts robust fibre thieving paper, and said gold mark fiber mat adopts the glass fibre cotton of ADSORPTION OF GOLD mark albumen.
Said protective film is an adhesive tape.
The plastic base of said base plate supports layer for not absorbing water.
Also comprise shell; Said shell has null; The shape size of the simple and easy colloidal gold strip that said null and said reaction reagent carrier absorption layer and said base plate supports layer form is complementary; Be used to load said reaction reagent carrier absorption layer, said upper surface of outer cover is respectively equipped with application of sample window and form corresponding to the position of sample fiber layer and cellulose medicine film.
A kind of kit that is used for the fast detecting rheumatoid factor is characterized in that: comprise above-mentioned arbitrary colloidal gold strip and diluted sample vessel.
Technique effect:
The difficulty that adopts antibody capture method and dual-antigen sandwich method to detect rheumatoid factor separately is that sensitivity and specificity can not be satisfactory to both parties; In order both to guarantee sensitivity; Improve specificity again; The present invention adopts the mode of antibody capture method and dual-antigen sandwich method principle and usefulness to prepare the test strips of the rheumatoid factor (RF) in fast detecting serum/whole blood sample; On the detection line of test strips, be coated with anti-μ chain IgM and people's sex change IgG mixed liquor; On the collaurum pad, encapsulate people's sex change IgG of colloid gold label, and the ratio of the unit area package amount of the people's sex change IgG through the colloid gold label on the adjustment gold mark fiber mat and the anti-μ chain IgM on the said T line, people's sex change IgG is in particular range, thereby guaranteed the detection sensitivity and the specificity of test strips.Test figure shows, sees table 1 and table 3, and in this ratio range, specificity and sensitivity all are higher than the test strips of single detection principle.
During detection: on nitrocellulose membrane, encapsulate anti-μ chain IgM, people's sex change IgG and anti-human IgG.When if RF content is higher than its detection threshold in the sample to be checked, people's sex change IgG of colloid gold label in the chromatography process with sample in RF combines, form " gold is marked people's sex change IgG-RF compound " and continue to creep; On detection line with people's sex change IgG effect of solid phase; Form " gold mark people sex change IgG-RF-people sex change IgG " antigen antibody complex deposition, a red stripes (detection line, T line) promptly occurs; Perhaps on detection line with the anti-μ chain IgM effect of solid phase; Form " the anti-μ chain of gold mark people sex change IgG-RF-IgM " antigen antibody complex deposition, a red stripes (detection line, T line) promptly occurs; No matter whether RF is present in the sample, and a red stripes all can appear in the check plot (C).The red stripes that is manifested in the check plot (C) is to judge whether enough samples are arranged, and whether the chromatography process normal standard, simultaneously also as the inner quality standard of reagent.
The invention solves the weak problem of poor specificity and sensitivity.The weak point of antibody capture method is a poor specificity, but it is highly sensitive; The weak point of dual-antigen sandwich method is a little less than the sensitivity, but its specificity is high.Both combinations have solved the problem of antibody capture method poor specificity, and the weak problem of dual-antigen sandwich method sensitivity, and its accuracy rate is higher than independent use antibody capture method and dual-antigen sandwich method.Simultaneously, compare with the test-strips of two kinds of methods of independent employing, the two unites two into one and has saved the starting material material, has reduced cost, has improved the efficient of using.
A kind of colloidal gold strip that is used for the fast detecting rheumatoid factor of the present invention, its unique distinction are, on said gold mark fiber mat, are coated with people's sex change IgG of colloid gold label; On said T line, be coated with anti-μ chain IgM and people's sex change IgG, the unit area package amount ratio of people's sex change IgG, the anti-μ chain IgM on the T line and people's sex change IgG of the colloid gold label on the said gold mark fiber mat is 0.133～0.889:5:1.According to table 1 data list, in the package amount ratio range of this unit area, colloidal gold strip all is qualified, and outside this scope, then is underproof.
The people's sex change IgG that encapsulates the colloid gold label on said gold mark fiber mat with encapsulate the anti-μ chain IgM on said T line, the unit area package amount ratio of people's sex change IgG is 1:15:3; Consider the error component in amplifying production run simultaneously; And cost factor, the package amount ratio of this unit area is preferable ratio.
The people's sex change IgG that encapsulates the colloid gold label on said gold mark fiber mat with encapsulate the anti-μ chain IgM on said T line, the unit area package amount of people's sex change IgG is respectively 1600ng/cm
2, 24000ng/cm
2, 4800ng/cm
2Consider the error component in amplifying production run simultaneously, and cost factor, the package amount of this unit area is best package amount.
The present invention, preferably corresponding protective film upper surface indicates the visual MAX markings parallel with said detection line T on the sample fiber pad.Be used to remind operating personnel, liquid to be measured does not surpass markings during operation, in order to avoid cause false positive.
The present invention, preferred said sample fiber pad adopts glass fibre cotton, and said absorbent material pad adopts robust fibre thieving paper, and said cellulose medicine film adopts nitrocellulose filter, and said gold mark fiber mat adopts the glass fibre cotton of ADSORPTION OF GOLD mark albumen.These material fit are used, its water absorptivity and capillarity no-float, the detection speed and the accuracy of assurance test strip of the present invention.
The present invention, preferred protective film is an adhesive tape, makes test strips avoid polluting, cost is low and effective.
The present invention, the plastic base of preferable substrate supporting layer for not absorbing water, the material that does not absorb water, thus avoid propping material to absorb the migration that liquid to be measured influences horizontal direction.
The present invention, the lower surface of the upper surface of preferred sample fiber pad and said gold mark fiber mat is established layer of non-woven fabric.Be used for an amount of imbitition, play certain buffer action.
The present invention; Preferably also comprise shell; Said shell has null; The shape size of the simple and easy colloidal gold strip that said null and said reaction reagent carrier absorption layer and said base plate supports layer form is complementary, and is used to load said reaction reagent carrier absorption layer, and said upper surface of outer cover is respectively equipped with application of sample window and form corresponding to the position of sample fiber pad and cellulose medicine film.Be easy to carry and preserve.
Test strips of the present invention adopts the principle of antibody capture method and dual-antigen sandwich method and usefulness, and the rheumatoid factor in binding immunoassay colloidal gold technique fast detecting human serum, blood plasma or the whole blood, is used for the detection of patient with rheumatoid arthritis; Test strips of the present invention is simple to operate, and is easy to use, brings i.e. usefulness, do not need one of skill in the art, can satisfy different levels personnel's needs, and guarantees sensitivity, accuracy and the high-level efficiency of detection.
Description of drawings:
The vertical view of Fig. 1 test strips of the present invention;
The longitudinal sectional drawing of Fig. 2 test strips of the present invention
Wherein: 1-handheld terminal, 2-control line C line, 3-detection line T line, 4-MAX markings; 5-is stained with the liquid end, 6-cellulose medicine film layer, 7-sample fiber layer, 8-handheld terminal absorbent material layer; 9-gold mark fibrage, the big nonwoven fabrics of 10-, the little nonwoven fabrics of 11-; 12-handheld terminal adhesive tape, 13-arrow adhesive tape, 14-base plate supports layer.
Embodiment:
It is in order further to understand the present invention better that following embodiment is provided; Be not limited to said preferred forms; Content of the present invention and protection domain are not constituted restriction; Anyone makes up with the characteristic of other prior aries and the identical or akin product of any and the present invention that draws under enlightenment of the present invention or with the present invention, all drops within protection scope of the present invention.
Principle according to the collaurum detection; The mucus end of colloidal gold strip of the present invention is immersed in the liquid to be measured; Perhaps the sample fiber layer at the mucus end drips liquid to be measured; Material in the liquid to be measured moves to handheld terminal from being stained with appearance end along test strips under the capillary action of fibrous sheet material, the target substance in the liquid to be measured during through gold mark fibrage with colloid gold label albumen adheres to each other and move to suction paper washer direction, during target substance process detection line in the liquid to be measured; The material that encapsulates on target substance and the detection line develops the color detection line because specificity combines to cause collaurum on detection line, to assemble.All the other colloid gold label albumen continuation migrations, during to control line, because the albumen that encapsulates on colloid gold label albumen that adopts and control line ability specific bond, therefore, collaurum is assembled on control line makes the control line colour developing.Be that detection line and control line all develop the color, show that liquid to be measured is positive; If do not have target substance in the liquid to be measured, so; When liquid to be measured migrates to detection line, in the liquid to be measured not with detection line on the material that the encapsulates composition that can combine, thereby cause collaurum can not be gathered in detection line; Therefore, detection line can not develop the color, but the control line place still develops the color.The control line colour developing is promptly only arranged, show that liquid to be measured is negative.
Test strips of the present invention comprises base plate supports layer 14, reaction reagent carrier absorption layer on short transverse, said reaction reagent carrier absorption layer is fixed on the said base plate supports layer 14; Said reaction reagent carrier absorption layer is followed successively by sample fiber pad 7 from being stained with liquid end 5 to handheld terminal 1, gold mark fiber mat 9, cellulose medicine film 6, handheld terminal absorbent material pad 8; On said gold mark fiber mat 9 and handheld terminal absorbent material pad 8, be coated with protective film.On said cellulose medicine film, be printed with the detection line T-3 of strip and the control line C-2 of strip, said detection line detection line T-3 all is and the vertical strip of said colloidal gold strip length direction with control line C-2.
It is characterized in that, on said gold mark fiber mat, be coated with people's sex change IgG of colloid gold label; On said T line, be coated with anti-μ chain IgM and people's sex change IgG, the unit area package amount ratio of people's sex change IgG, the anti-μ chain IgM on the T line and people's sex change IgG of the colloid gold label on the said gold mark fiber mat is 0.133～0.889:5:1.According to table 1 data list, in the package amount ratio range of this unit area, colloidal gold strip all is qualified, and outside this scope, then is underproof.
The people's sex change IgG that encapsulates the colloid gold label on said gold mark fiber mat with encapsulate the anti-μ chain IgM on said T line, the unit area package amount ratio of people's sex change IgG is 1:15:3; Consider the error component in amplifying production run simultaneously; And cost factor, the package amount ratio of this unit area is preferable ratio.
The people's sex change IgG that encapsulates the colloid gold label on said gold mark fiber mat with encapsulate the anti-μ chain IgM on said T line, the unit area package amount of people's sex change IgG is respectively 1600ng/cm
2, 24000ng/cm
2, 4800ng/cm
2Consider the error component in amplifying production run simultaneously, and cost factor, the package amount of this unit area is best package amount.
The present invention, preferably corresponding protective film upper surface indicates the visual MAX markings 4 parallel with said detection line T 3 on sample fiber pad 7.Be used to remind operating personnel, liquid to be measured does not surpass markings 4 during operation, in order to avoid cause false positive.
The present invention, preferred said sample fiber pad 7 adopts glass fibre cotton, and said absorbent material pad 8 adopts robust fibre thieving paper, and said cellulose medicine film 6 adopts nitrocellulose filter, and said gold mark fiber mat 9 adopts the glass fibre cotton of ADSORPTION OF GOLD mark albumen.These material fit are used, and its water absorptivity and capillarity no-float guarantee that test strip of the present invention is in detection speed and accuracy.
The present invention, preferred protective film is an adhesive tape, makes test strips avoid polluting, cost is low and effective.
The present invention, the plastic base of preferable substrate supporting layer 14 for not absorbing water, the material that does not absorb water, thus avoid propping material to absorb the migration that liquid to be measured influences horizontal direction.
The present invention, the lower surface of the upper surface of preferred sample fiber pad 7 and said gold mark fiber mat 9 is established layer of non-woven fabric 10,11.Be used for an amount of, quick imbitition, play certain buffer action.
The present invention; Preferably also comprise shell; Said shell has null; The shape size of the simple and easy colloidal gold strip that said null and said reaction reagent carrier absorption layer and said base plate supports layer form is complementary, and is used to load said reaction reagent carrier absorption layer, and said upper surface of outer cover is respectively equipped with application of sample window and form corresponding to the position of sample fiber pad and cellulose medicine film.Be easy to carry and preserve.
The difficulty of test strips of the present invention is that sensitivity and specificity can not be satisfactory to both parties; In order both to guarantee sensitivity; Improve specificity again, technical scheme of the present invention adopts the principle of antibody capture method and dual-antigen sandwich method and usefulness, has solved the weak problem of poor specificity and sensitivity.Simultaneously, compare with the test-strips of two kinds of methods of independent employing, the two unites two into one and has saved the starting material material, has reduced cost, has improved the efficient of using.
Test strips of the present invention adopts the principle of antibody capture method and dual-antigen sandwich method and usefulness, and the rheumatoid factor (RF) in the binding immunoassay colloidal gold technique fast detecting serum, blood plasma, whole blood sample.On nitrocellulose membrane, encapsulate people's sex change IgG and anti-μ IgM.Promptly when encapsulating the T line, be coated with anti-μ IgM and people's sex change IgG simultaneously; If the narrow false negative that occurs causing of type of detection will occur with the antibody capture method separately; The low value sample that separately will occur causing a little less than the sensitivity with dual-antigen sandwich method can not detect; Consider rheumatoid factor be a kind of be the autoantibody that target antigen produces with people's sex change IgG, antibody itself is mainly the IgM type again, so catch autoantibody RF simultaneously with anti-μ IgM antibody and people's sex change IgG; Realized the high accuracy of product, and sensitivity and specific combination.We adopt the method for 1000 times of dilutions on the quadrat method adding in addition, have overcome the phenomenon of product poor specificity and HOOK effect.
The processability checking of embodiment 2. test strips
The biologically active raw material: anti-μ chain IgM, people's sex change lgG, the purchase source of anti-human IgG is Canadian ArtronBioResearch Inc. import
Reagent: bovine serum albumin(BSA) (BSA), casein (casein) are available from Sigma.
Nitrocellulose filter: German Sai Duolisi (Sartorius) company
The preparation procedure of test strips is following
The anti-μ chain of step 1. IgM is following with mixing of people's sex change lgG:
Prepare the mixed liquor of anti-μ chain IgM and people's sex change lgG, dilute, make that to encapsulate concentration as shown in table 1 thereby be mixed with certain concentration with 20mM PBS antagonism μ chain IgM and people's sex change lgG.
The preparation of people's sex change lgG of step 2. colloid gold label
Get the colloidal gold solution of 40nm, press final concentration 16 μ l/ml and add 0.2M K
2CO
3Thereby, add people's sex change IgG and be prepared into certain concentration and make that to encapsulate concentration as shown in table 1, placed room temperature reaction 18 minutes, press the solution of final concentration 20 μ l/ml adding 20%BSA then, be used for saturated free collaurum.
Centrifugal 30 minutes of 10000rpm removes unconjugated protein in the supernatant.Redissolve the colloid gold label stoste of deposition with the 0.5M BAS (containing 1%Tween, 5% sucrose, 1% hydrolysis BSA, 1% caseinhydrolysate, 0.1%PVA) of 1/10 volume.Working solution adopts above-mentioned 0.5m BAS dilution, and concentration is 15% of stoste.
Encapsulating of step 3. reagent
Encapsulate the method for anti-μ chain IgM, people's sex change IgG and anti-human IgG on the nitrocellulose membrane:
Mixed liquor and the anti-human IgG of anti-μ chain IgM and people's sex change IgG are encapsulated respectively in T line and C line with the machine of encapsulating, and the spacing between C, the T line is 4.0mm, and C, T line width are 0.8mm, and the speed of encapsulating is 40mm/s.Be 6 hours drying time, and temperature is 30 ℃, humidity≤35%.
The fibrolaminar mark of gold mark:
People's sex change IgG solution of colloid gold label is laid on the 30*30cm fiberglass packing, and liquid volume added makes the people's sex change IgG on the fiberglass packing unit area as shown in table 1, and be 6 hours drying time, and temperature is 30 ℃, humidity≤35%.
Table 1 is the package amount of the unit area of the anti-μ chain of collaurum mark people sex change IgG/ IgM/ people sex change IgG, and its ratio is 0.133～0.889:5:1.
Table 1 is following
Interpretation of result:
1, from above result, the package amount of the unit area of collaurum mark people sex change IgG is controlled at 800-3200ng/cm
2The result be qualified, 800ng/cm
2Package amount be minimum package amount, consider the error component in amplifying production run, so package amount is increased to 1600ng/cm
2As best package amount, and 3200ng/cm
2Consider cost factor not as best package amount, and 400ng/cm
2Package amount false sun, directly rejecting have appearred.
2, from above result, for encapsulating anti-μ chain IgM on the T line, package amount is controlled at 18000-30000ng/cm
2Be qualified, 18000ng/cm
2Be minimum package amount, the same error component of considering in a large amount of production runes is so be decided to be 24000ng/cm with best package amount
2,, and 30000ng/cm
2Consider cost factor not as best package amount, and 12000ng/cm
2Package amount occurred a little less than the sensitivity, directly reject.
3, from above result, for encapsulating people's sex change IgG on the T line, package amount is controlled at 3600-6000ng/cm
2Be qualified, 3600ng/cm
2Be minimum package amount, the same error component of considering in a large amount of production runes is so be decided to be 4800ng/cm with best package amount
2,, and 6000ng/cm
2Consider cost factor not as best package amount, and 2400ng/cm
2Package amount occurred a little less than the sensitivity, directly reject.
The assembling of step 4. test strips:
1, plastic plate is lain on the operator's console, stick double sticky tape.
2, tear the double sticky tape lining paper, sticking the nitrocellulose filter that is coated with anti-μ chain IgM, people's sex change IgG and anti-human IgG apart from 30mm place, plastic plate upper end.
3, the robust fibre letterweight nitrocellulose filter upper end 2mm that absorbs water is sticked, even up on upper end and the plastic plate.
4, press 0.5mm place, nitrocellulose filter lower end to stick little nonwoven fabrics.
5, gold being marked fibrage evens up and is pressed on above the little nonwoven fabrics.
6, fiberglass packing is pressed on gold mark pad and goes up half thely approximately, stick at 2mm place, following end distance plastic plate lower end.
7, big nonwoven fabrics and gold mark pad upper end are evened up, lower end and plastic plate lower end are evened up and are sticked.
8, press nitrocellulose filter 1.5mm to stick on the arrow adhesive tape.
9, press robust fibre thieving paper to stick on the handheld terminal adhesive tape.
Definite experiment of the LDL of embodiment 3. products of the present invention.
RF does not have unified saying for defining of reference value at present as unique serodiagnosis standard of rheumatoid arthritis, generally all is located at＜20-30IU/ml.
1, clinical reference value or similar reagent critical value
(1) normal reference value of immunoturbidimetry is in " the practical medical test reference value and the abnormal results analysis " of People's Health Publisher's publication:＜30KU/L;
(2) contemporary Chinese medical journal; 2004; 14 (14), in " detect rheumatoid factor IgM-RF, Ig G-RF and the IgA-RF clinical meaning in rheumatoid arthritis " and the critical value of mentioning Beckman immunoturbidimetry reagent in the Beckman instructions be 20IU/mL;
(3) Jiangxi medical test magazine, 2002,20 (5), mention in " rheumatoid factor detect in latex agglutination test and turbidimetry comparative study " traditionally with 20IU/ml as normal reference value, but this paper advises being located at 50IU/ml.
(4) critical value of mentioning latex agglutination in the prompt gate technique in the Shanghai cooperative venture instructions is 20IU/mL.
2, product LDL of the present invention confirms
In conjunction with the performance of clinical reference value and actual product, the LDL of 25IU/mL for my company's rheumatoid factor detection reagent box (colloidal gold method) product confirmed in final checking.The following step of our processes:
(1) internal control is with reference to the preparation and the assignment of article
Get clinical rheumatoid factor positive serum; It is carried out serial dilution, after detecting through quantitative reagent, draw regression curve; Calculate the detected value of actual positive serum, and it is diluted obtain 0IU/mL, 6.25IU/mL, 12.5IU/mL, 25IU/mL, 50IU/mL internal control with reference to article.
(2) internal control LDL confirming with reference to article
Detect with the rheumatoid factor dilute serum of product of the present invention variable concentrations; Each detects 100 person-portions; Wherein 0IU/mL all detects negatively, and 6.25IU/mL wherein has 97% detection negative, and 12.5IU/mL has 53% detection negative; It all is the weak positive that 25IU/mL, 50IU/mL detect, so the last LDL of confirming 25IU/mL for my company's rheumatoid factor detection reagent box (colloidal gold method) product.
Say from the angle of medical diagnosis, when RF concentration reaches 20-30IU/mL in the serum, can be used as rheumatoid arthritis and be diagnosed as positive critical value.
Experimental example 4, method of application and methodology contrast experiment
The method of application of this product:
Test serum dilutes 1000 times, is added drop-wise on the sample fiber layer of horizontal test strips, or the mucus end MAX line of test strips is immersed about 5 seconds in the dilute sample with the lower part, takes out horizontal positioned and waits for colour developing.
Contrast 1: product contrast
Product of the present invention is compared with the product of prior art detection rheumatoid factor to have fast; Accurately; Characteristics easily, and clean and maintenance work detecting the forward and backward necessary apparatus of need not doing of rheumatoid factor, and do not require that one of skill in the art operates.
Reference product: No. 2400089 lot number of rheumatoid factor detection reagent box (colloidal gold method) Shandong food medicine prison tool (standard) word 2011 that Weifang Kanghua Biotech. Co., Ltd. produces: 110402
The result is following: a little less than the sensitivity of the Kang Hua of Weifang City, positive rate is low, and the result is difficult for interpretation.
Contrast 2: methodology contrast
Other products that detect rheumatoid factor are compared on the products and marketing of the present invention, and used sample is few, save resource, and guarantee the accuracy and the sensitivity of detection.
1) though Weifang Kang Hua also be colloidal gold method, what its adopted is percolation, is not immunochromatographic method, method on market utilization seldom, reason is that operation is more loaded down with trivial details, poor accuracy, perviousness is bad to cause that mortality is higher as a result.And the colloidal gold immunochromatographimethod technology is to have overcome above shortcoming and be widely used in the fast detecting field.
2) the prompt door in Shanghai is to adopt latex agglutination, and the method is to adopt the milky particle of visual inspection to come judged result, and its drawback is that milky white granules is easy to produce error for people's naked eyes, and collaurum be aubergine on naked eyes are judged clearly.
3) rheumatoid factor of Beckman adopts immunoturbidimetry, is that fully-automatic equipment is realized its detection through IMMAGE immunochemistry system; Its accuracy is higher, still all fail to popularize at basic hospital at present in view of apparatus expensive, and our product need not any instrument; It is quick; Accurately, convenient, inexpensive characteristics make it can spread to the examination that basic hospital is used for the rheumatoid arthritis patient fast.
Comparing result
Serum sample: sensitivity quality controlled serum, 100 parts of negative serums and 100 parts of positive sample
Adopt the 15 set products detection of the preparation of embodiment 2 to detect with a collection of serum sample, testing result such as table 2 data are following:
| The product group number | Sensitivity | Specificity |
| T1 | Qualified | Qualified |
| T2 | Qualified | Qualified |
| T3 | Qualified | Qualified |
| T4 | Qualified | Qualified |
| T5 | Qualified | Qualified |
| T6 | Qualified | Qualified |
| T7 | Qualified | Qualified |
| T8 | Qualified | Qualified |
| T9 | Qualified | Qualified |
| T10 | Qualified | False sun |
| T11 | Qualified | False sun |
| T12 | Qualified | False sun |
| T13 | A little less than the sensitivity | False sun |
| T14 | A little less than the sensitivity | Qualified |
| T15 | A little less than the sensitivity | Qualified |
The result shows, in the ratio that encapsulates of the anti-μ chain of collaurum mark people sex change IgG/ IgM/ people sex change IgG during at 0.133～0.889:5:1, can obtain good specificity and sensitivity simultaneously like the test strips of T1～T9,
And the test strips T10～T15 that adopts above-mentioned extraneous ratio to make demonstrates the defective on specificity or the sensitivity respectively.
The test strips of antibody capture principle is adopted in preparation separately, encapsulates on the collaurum pad on people's sex change IgG T line and encapsulates anti-μ chain IgM, encapsulates anti-human IgG on the C line.Encapsulate the ratio of T2 among the concentration embodiment 1.Get test strips C1
The test strips for preparing independent double antigens sandwich principle encapsulates on the collaurum pad on people's sex change IgG T line and encapsulates people's sex change IgG, encapsulates anti-human IgG on the C line.Encapsulate the ratio of T2 among the concentration embodiment 1.Get test strips C2
Sensitivity, 100 parts of negative serums and 100 parts of positive sample are detected contrast, sensitivity and positive and negative coincidence rate result such as following table 3.
| Test strips | Sensitivity | Negative match-rate | Positive coincidence rate |
| C1 | 25IU/ml | 100% | 95% |
| C2 | 50IU/ml | 100% | 97% |
| T2 | 25IU/ml | 100% | 99% |
Interpretation of result:
1, from above result, the sensitivity of C1 is higher, but its positive coincidence rate is lower, and can only to detect IgM type rheumatoid factor relevant with it for this.
2, from above result, the sensitivity of C2 is lower, is higher than C1 with its positive coincidence rate, but owing to a little less than its sensitivity, can not detect for the low value sample, its positive coincidence rate is also not too high.
3, from above result, in conjunction with two kinds of method principles, both improved its sensitivity, its positive coincidence rate is improved.
Can know according to last table correlation data, use the antibody capture method to detect the defective that there is poor specificity in rheumatoid factor separately, but it be highly sensitive; Use dual-antigen sandwich method to detect rheumatoid factor separately and have the weak defective of sensitivity.Solved the problem of antibody capture method poor specificity and use dual-antigen sandwich method and antibody capture method and dual-antigen sandwich method to combine, and the weak problem of dual-antigen sandwich method sensitivity, its accuracy rate is higher than independent use antibody capture method and dual-antigen sandwich method.
Also explanation simultaneously, even adopt the best to encapsulate ratio, the specificity of antibody capture method is still very poor, and the sensitivity of dual-antigen sandwich method is not good enough, when using two kinds of test strips test sample simultaneously, can not complementally solve the problem that exists separately.
Claims (9)
1. a colloidal gold strip that is used for the fast detecting rheumatoid factor comprises base plate supports layer, reaction reagent carrier absorption layer on short transverse, and said reaction reagent carrier absorption layer is fixed on the said base plate supports layer; Be provided with the sample fiber pad from being stained with the liquid end successively to handheld terminal; Gold mark fiber mat; Cellulose medicine film, handheld terminal absorbent material pad is coated with protective film on said gold mark fiber mat and handle section absorbent material pad; On said cellulose medicine film, be printed with the detection line T line of strip and the control line C line of strip; Said detection line T line all is and the vertical strip of said colloidal gold strip length direction with said control line C line, it is characterized in that, on said gold mark fiber mat, is coated with people's sex change IgG of colloid gold label; On said T line, be coated with anti-μ chain IgM and people's sex change IgG, the unit area package amount ratio of people's sex change IgG, the anti-μ chain IgM on the T line and people's sex change IgG of the colloid gold label on the said gold mark fiber mat is 0.133～0.889:5:1.
2. according to the said test strips of claim 1, it is characterized in that, the people's sex change IgG that encapsulates the colloid gold label on said gold mark fiber mat with encapsulate the anti-μ chain IgM on said T line, the unit area package amount ratio of people's sex change IgG is 1:15:3.
3. according to the said test strips of claim 1, it is characterized in that, the people's sex change IgG that encapsulates the colloid gold label on said gold mark fiber mat with encapsulate the anti-μ chain IgM on said T line, the unit area package amount of people's sex change IgG is respectively 1600ng/cm
2, 24000ng/cm
2, 4800ng/cm
2
4. according to the said test strips of claim 1, it is characterized in that protective film upper surface corresponding on the sample fiber pad indicates the visual MAX markings parallel with said detection line T.
5. according to the said test strips of claim 1, it is characterized in that said sample fiber pad adopts glass fibre cotton, said absorbent material pad adopts robust fibre thieving paper, and said gold mark fiber mat adopts the glass fibre cotton of ADSORPTION OF GOLD mark albumen.
6. according to the said test strips of claim 1, it is characterized in that said protective film is an adhesive tape.
7. according to the said test strips of claim 1, said base plate supports layer is the plastic base that does not absorb water.
8. the arbitrary said test strips of claim 1-7; Also comprise shell; Said shell has null; The shape size of the simple and easy colloidal gold strip that said null and said reaction reagent carrier absorption layer and said base plate supports layer form is complementary, and is used to load said reaction reagent carrier absorption layer, and said upper surface of outer cover is respectively equipped with application of sample window and form corresponding to the position of sample fiber pad and cellulose medicine film.
9. a kit that is used for the fast detecting rheumatoid factor is characterized in that: comprise arbitrary described colloidal gold strip of claim 1～6 and diluted sample vessel.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2012101650402A CN102707050A (en) | 2012-05-24 | 2012-05-24 | Colloidal gold test strip for fast detecting rheumatoid factors |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2012101650402A CN102707050A (en) | 2012-05-24 | 2012-05-24 | Colloidal gold test strip for fast detecting rheumatoid factors |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN102707050A true CN102707050A (en) | 2012-10-03 |
Family
ID=46899987
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2012101650402A Pending CN102707050A (en) | 2012-05-24 | 2012-05-24 | Colloidal gold test strip for fast detecting rheumatoid factors |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN102707050A (en) |
Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103412125A (en) * | 2013-08-25 | 2013-11-27 | 河南科技学院 | Gold-labeled test strip for rapid detection of chromium ions as well as preparation method and application thereof |
| CN103760370A (en) * | 2014-01-02 | 2014-04-30 | 北京健乃喜生物技术有限公司 | Detection kit for RF factor in human whole blood, serum and plasma |
| CN104360083A (en) * | 2014-12-05 | 2015-02-18 | 重庆乾德生物技术有限公司 | Detection kit for quantitatively detecting rheumatoid factors and antistreptolysin O and C reactive proteins |
| CN104374911A (en) * | 2014-12-05 | 2015-02-25 | 重庆乾德生物技术有限公司 | Detection kit for quantitative detection of rheumatoid factors and anti streptolysin O |
| CN104459140A (en) * | 2014-12-05 | 2015-03-25 | 重庆乾德生物技术有限公司 | Detection kit for quantitative detection of rheumatoid factor, antistreptolysin O, anti cyclic citrullinated peptide antibody and C reactive protein |
| CN105974111A (en) * | 2016-07-20 | 2016-09-28 | 国家纳米科学中心 | Joint detection method for rheumatoid factors (IgM type) and other antigen-specific IgM antibodies |
| CN109342743A (en) * | 2018-12-05 | 2019-02-15 | 菲鹏生物股份有限公司 | A kind of preparation method for the denaturation IgG that can be efficiently combined with rheumatoid factor |
| CN113063938A (en) * | 2021-03-13 | 2021-07-02 | 河南省农业科学院 | High-sensitivity gradient semi-quantitative immunochromatography detection test strip and detection method |
| CN115420899A (en) * | 2022-10-31 | 2022-12-02 | 迪亚莱博（张家港）生物科技有限公司 | Preparation method of fluorescence immunochromatographic kit for combined detection of RF-IgG/RF-IgM/RF-IgA |
Citations (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1338633A (en) * | 2001-09-29 | 2002-03-06 | 上海晶泰生物技术有限公司 | Protein chip for diagnosing autoimmune diseases |
| CN1963515A (en) * | 2005-11-10 | 2007-05-16 | 北京庄笛浩禾生物医学科技有限公司 | Test paper bar for testing colloidal gold of antibody of dengue fever virus |
| CN101021532A (en) * | 2007-03-28 | 2007-08-22 | 北京英诺特生物技术有限公司 | Colloidal gold chromatographic band for joint detecting specific IgM. IgG antibody and producing method thereof |
| CN101025418A (en) * | 2006-02-23 | 2007-08-29 | 上海富纯中南生物技术有限公司 | Concatenate antigen membrane detecting kit and its preparing method |
| CN101408545A (en) * | 2008-11-12 | 2009-04-15 | 河南省农业科学院 | Melamine fast detecting test paper bar and test paper card |
| CN101706503A (en) * | 2009-07-08 | 2010-05-12 | 无锡博慧斯生物医药科技有限公司 | Human IgG and rheumatoid factor absorption device and related detection method of IgM antibody in human serum |
| CN101788561A (en) * | 2010-03-26 | 2010-07-28 | 天津中新科炬生物制药有限公司 | Influenza A (H1N1) virus IgM and total antibody rapid detection test paper |
| CN101871938A (en) * | 2010-05-12 | 2010-10-27 | 蓝十字生物药业（北京）有限公司 | Rapid test strip with colloid gold label |
| CN101871940A (en) * | 2009-04-24 | 2010-10-27 | 上海市长宁区光华中西医结合医院 | IgG type rheumatoid factor enzyme immunity detection method |
| CN201637745U (en) * | 2010-03-26 | 2010-11-17 | 天津中新科炬生物制药有限公司 | Detecting test paper for influenza A H1N1 virus IgM and master antibody |
| CN102109523A (en) * | 2009-12-29 | 2011-06-29 | 北京库尔科技有限公司 | Hepatitis C virus IgG and IgM antibody joint detection kit and preparation method thereof |
| CN102109519A (en) * | 2009-12-29 | 2011-06-29 | 北京库尔科技有限公司 | Rubella virus IgG and IgM antibody joint inspection kit and preparation method thereof |
-
2012
- 2012-05-24 CN CN2012101650402A patent/CN102707050A/en active Pending
Patent Citations (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1338633A (en) * | 2001-09-29 | 2002-03-06 | 上海晶泰生物技术有限公司 | Protein chip for diagnosing autoimmune diseases |
| CN1963515A (en) * | 2005-11-10 | 2007-05-16 | 北京庄笛浩禾生物医学科技有限公司 | Test paper bar for testing colloidal gold of antibody of dengue fever virus |
| CN101025418A (en) * | 2006-02-23 | 2007-08-29 | 上海富纯中南生物技术有限公司 | Concatenate antigen membrane detecting kit and its preparing method |
| CN101021532A (en) * | 2007-03-28 | 2007-08-22 | 北京英诺特生物技术有限公司 | Colloidal gold chromatographic band for joint detecting specific IgM. IgG antibody and producing method thereof |
| CN101408545A (en) * | 2008-11-12 | 2009-04-15 | 河南省农业科学院 | Melamine fast detecting test paper bar and test paper card |
| CN101871940A (en) * | 2009-04-24 | 2010-10-27 | 上海市长宁区光华中西医结合医院 | IgG type rheumatoid factor enzyme immunity detection method |
| CN101706503A (en) * | 2009-07-08 | 2010-05-12 | 无锡博慧斯生物医药科技有限公司 | Human IgG and rheumatoid factor absorption device and related detection method of IgM antibody in human serum |
| CN102109523A (en) * | 2009-12-29 | 2011-06-29 | 北京库尔科技有限公司 | Hepatitis C virus IgG and IgM antibody joint detection kit and preparation method thereof |
| CN102109519A (en) * | 2009-12-29 | 2011-06-29 | 北京库尔科技有限公司 | Rubella virus IgG and IgM antibody joint inspection kit and preparation method thereof |
| CN101788561A (en) * | 2010-03-26 | 2010-07-28 | 天津中新科炬生物制药有限公司 | Influenza A (H1N1) virus IgM and total antibody rapid detection test paper |
| CN201637745U (en) * | 2010-03-26 | 2010-11-17 | 天津中新科炬生物制药有限公司 | Detecting test paper for influenza A H1N1 virus IgM and master antibody |
| CN101871938A (en) * | 2010-05-12 | 2010-10-27 | 蓝十字生物药业（北京）有限公司 | Rapid test strip with colloid gold label |
Cited By (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103412125B (en) * | 2013-08-25 | 2015-09-23 | 河南科技学院 | Chromium ion detects gold test strip and preparation method thereof and application fast |
| CN103412125A (en) * | 2013-08-25 | 2013-11-27 | 河南科技学院 | Gold-labeled test strip for rapid detection of chromium ions as well as preparation method and application thereof |
| CN103760370A (en) * | 2014-01-02 | 2014-04-30 | 北京健乃喜生物技术有限公司 | Detection kit for RF factor in human whole blood, serum and plasma |
| CN104360083B (en) * | 2014-12-05 | 2016-08-17 | 重庆乾德生物技术有限公司 | A kind of detection by quantitative rheumatoid factor, antistreptolysin O (ASO), the detection kit of c reactive protein |
| CN104459140A (en) * | 2014-12-05 | 2015-03-25 | 重庆乾德生物技术有限公司 | Detection kit for quantitative detection of rheumatoid factor, antistreptolysin O, anti cyclic citrullinated peptide antibody and C reactive protein |
| CN104374911A (en) * | 2014-12-05 | 2015-02-25 | 重庆乾德生物技术有限公司 | Detection kit for quantitative detection of rheumatoid factors and anti streptolysin O |
| CN104360083A (en) * | 2014-12-05 | 2015-02-18 | 重庆乾德生物技术有限公司 | Detection kit for quantitatively detecting rheumatoid factors and antistreptolysin O and C reactive proteins |
| CN105974111A (en) * | 2016-07-20 | 2016-09-28 | 国家纳米科学中心 | Joint detection method for rheumatoid factors (IgM type) and other antigen-specific IgM antibodies |
| CN109342743A (en) * | 2018-12-05 | 2019-02-15 | 菲鹏生物股份有限公司 | A kind of preparation method for the denaturation IgG that can be efficiently combined with rheumatoid factor |
| CN109342743B (en) * | 2018-12-05 | 2022-02-18 | 菲鹏生物股份有限公司 | Preparation method of denatured IgG capable of being efficiently combined with rheumatoid factor |
| CN113063938A (en) * | 2021-03-13 | 2021-07-02 | 河南省农业科学院 | High-sensitivity gradient semi-quantitative immunochromatography detection test strip and detection method |
| CN113063938B (en) * | 2021-03-13 | 2023-09-12 | 河南省农业科学院 | High-sensitivity gradient semi-quantitative immunochromatography detection test strip and detection method |
| CN115420899A (en) * | 2022-10-31 | 2022-12-02 | 迪亚莱博（张家港）生物科技有限公司 | Preparation method of fluorescence immunochromatographic kit for combined detection of RF-IgG/RF-IgM/RF-IgA |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN102707050A (en) | Colloidal gold test strip for fast detecting rheumatoid factors | |
| CN111060691A (en) | Fluorescence immunochromatography device for detecting COVID-19 and using method thereof | |
| CN105092861A (en) | Immunofluorescence chromatography test paper for CRP (C-reaction protein)/SAA (Serum amyloid A protein) quantitative combined detection and preparation method of immunofluorescence chromatography test paper | |
| CN111273003A (en) | 2019-nCoV novel coronavirus rapid detection immunochromatographic test strip | |
| CN205374467U (en) | Fluorescent quantitation of early inflammatory reaction jointly detects card | |
| CN102707067A (en) | Test strip for semi-quantitative detection of microalbuminuria | |
| CN101275954A (en) | Breast cancer early warning chip for easily rapid measuring human I type thymidine kinase gene protein | |
| CN111239400A (en) | Colloidal gold immunochromatographic device for detecting COVID-19 and use method thereof | |
| WO2018068582A1 (en) | Immunochromatography detection apparatus | |
| CN102680694A (en) | Colloidal gold test strip for rapid detection of Human enterovirus 71 (EV71) IgM (immunoglobulin m) | |
| CN104502591A (en) | Pepsinogen I and II combined detection method and kit thereof | |
| CN204964521U (en) | CRPSAA ration jointly detects immunofluorescence chromatography test paper | |
| CN111948389A (en) | Time-resolved fluorescence immunochromatographic test strip for detecting influenza A and B viruses and novel coronavirus antigens and preparation method thereof | |
| US10830779B2 (en) | Lateral flow immunoassays for the detection of antibodies against biological drugs | |
| CN109580933A (en) | A kind of test strips and preparation method detecting influenza virus | |
| CN106556703A (en) | A kind of chronic kidney disease mark suPAR detection kit and preparation method | |
| JP4976068B2 (en) | Simple immunoassay specimen suspension and assay method | |
| CN102608321A (en) | Echinococcus multilocularis circulating antigen dot immunogold filtration kit and preparation method | |
| CN103197063A (en) | Immunochromatography kit and detection method thereof | |
| CN202710567U (en) | Colloidal gold test paper strip and kit both capable of rapidly detecting lincomycin | |
| CN108061727A (en) | A kind of thyroglobulin quantitative testing test paper item and preparation method thereof | |
| CN106066401A (en) | Biomarker VWF and ADAMTS13 and the purposes in liver cirrhosis diagnosis reagent thereof | |
| CN1159580C (en) | Reagent for colloidal gold chromatographic analysis of SARS coronavirus antigen | |
| CN206038688U (en) | Immunity chromatography detection test strip's fluorescent quantitation spectral detection system | |
| CN105974111A (en) | Joint detection method for rheumatoid factors (IgM type) and other antigen-specific IgM antibodies |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Application publication date: 20121003 |