A kind of Novel Human C-reactive protein colloidal gold colloidal gold detection test paper strip
Technical field
The utility model belongs to the clinical diagnose field, is specifically related to a kind of Novel Human C-reactive protein colloidal gold colloidal gold detection test paper strip.
Background technology
C-reactive protein (C-reactive protein) is that the pod membrane C polysaccharide of a kind of ability and streptococcus pneumonia combines; The synthetic gamma Globulin of liver cell when body receives microbial ingress or tissue damage etc. and stimulates; Molecular weight is about 105KD, and trace is present in (about 580ng/ml) in the healthy subjects serum.In be inflamed disease or tissue damage 6~8 hours, serum or plasma C-reactive protein amount raises rapidly, and reaches the peak at 48~72 hours, but along with the state of an illness is improved or its content of institutional framework functional rehabilitation also recovers normal.Therefore the level of C-reactive protein in serum or the blood plasma can be used as and judges to have or not infection, disease whether to be in the index of active stage.
C-reactive protein detection method in the blood is a lot of at present, mainly contains: methods such as radiommunoassay (RIA), biochemical immunoassay, ELISA (ELISA), colloidal gold immunochromatographimethod.Colloidal gold immunity chromatography is because quick, easy in recent years, and visual result and being used widely has critical role in POCT (Point-Of-Care Testing) technology in modern times.One Chinese patent application CN101887063 A provides a kind of human C-reactive protein colloidal gold immunochromatographiassay assay quantitative test paper bar; Comprise successively and having sample pad, pad, nitrocellulose filter and the thieving paper that overlaps each other on the floor of bonding agent; Scribble the C-reaction protein antibody compound of colloid gold label on the pad, be combined with detection line and nature controlling line on the nitrocellulose filter.Though this method has solved the problem of collaurum detection by quantitative c reactive protein, it can only be used for serum detects, and can not be used for whole blood test.
China utility model patent CN201096787 relates to a kind of C-reactive protein colored particle diagnose test paper, utilizes the fast immune chromatographic method, the C-reactive protein in the qualitative detection clinical samples.This utility model is made up of base plate, water sucting plate, nitrocellulose filter, colored particle fixed bolster, sample liquid-adsorption layer, MAX line; The base plate middle part is a nitrocellulose filter; A C-reactive protein monoclonal antibody test wire and a sheep anti mouse polyclonal antibody control line are arranged on the nitrocellulose filter; In base plate one end termination is water sucting plate; Another termination is the sample liquid-adsorption layer, and the nitrocellulose filter two ends overlap each other with the color fixed bolster with water sucting plate respectively and are connected, and on the colored particle fixed bolster, are pressed with the sample liquid-adsorption layer.But said sample liquid-adsorption layer is made up of trilaminate material stack, and ground floor is that nonwoven layer, the second layer are that glass layer, the 3rd layer are nonwoven layer.The problem that three layers of sample pad brought is that to detect required sample liquid (whole blood/serum) amount bigger, and said sample pad material can not finely filter out the red blood cell in the blood, and this makes the result reliability of qualitative detection reduce.In addition, right-hand member and nitrocellulose filter that golden labeling antibody is positioned at the colored particle pad overlap on together, and the easy like this collaurum that occurs discharges the very slow problem uneven with opening up layer.
Summary of the invention
In order to solve the problem that above-mentioned prior art exists; The utility model provides the colloidal gold colloidal gold detection test paper strip of C-reactive protein in a kind of rapid sensitive, the qualitative detection clinical samples (whole blood/serum); This test strips is on the one hand through adopting two-layer sample pad; And having one in the two-layer sample pad material at least is the whole blood filter membrane; Change the colloid gold label antibody location on the other hand, make it can stop red blood cell effectively, antigen and colloid gold label antibody fully combine, open up layer more homogeneous, sensitivity is higher and the result is more reliable.
The technical scheme that the utility model topic is adopted is: the utility model provides a kind of Novel Human C-reactive protein colloidal gold colloidal gold detection test paper strip; Comprise end liner and thieving paper; Attached to what from left to right closely link to each other successively on the end liner is that the ground floor sample pad that is stacked together is marked film, nitrocellulose filter and thieving paper with the gold of second layer sample pad, coated with gold mark human C-reactive protein antibodies; The material that has a sample pad in said ground floor sample pad and the second layer sample pad at least is the whole blood filter membrane, and said gold mark human C-reactive protein antibodies is positioned at the left end or the centre of gold mark film.
The ground floor sample pad of said test strips covers on the second layer sample pad fully.
Said gold mark human C-reactive protein antibodies is the mouse-anti human C-reactive protein monoclonal antibody I of collaurum.
The material of said gold mark film is plain film of spun glass or nitrocellulose filter.
Said nitrocellulose filter middle part is parallel to be provided with a detection line and a control line that encapsulates rabbit anti-mouse igg antibody that encapsulates mouse-anti human C-reactive protein monoclonal antibody II.
Said mouse-anti human C-reactive protein monoclonal antibody I and II utilize the ELISA double antibody sandwich method from some strain of hybridoma, to screen.
The utlity model has following beneficial effect:
1. the utility model is through adopting two-layer sample pad; And the material that has a sample pad in the two-layer sample pad at least is the whole blood filter membrane; Solve prior art c reactive protein colloidal gold colloidal gold detection test paper strip and in the whole blood diagnostic procedure, can not effectively stop erythrocytic problem, improved the reliability of colloidal gold strip testing result;
2. the utility model makes antigen and colloid gold label antibody response time more abundant through adjustment colloid gold label antibody location, and the exhibition layer is homogeneous more, has improved the reliability of sensitivity and colloidal gold strip testing result.
Description of drawings
Fig. 1 is a Novel Human C-reactive protein colloidal gold colloidal gold detection test paper strip structural representation.
Fig. 2 is a gold mark human C-reactive protein antibodies position view on the gold mark film; A, golden labeling antibody are positioned at gold mark film left end; B, golden labeling antibody are positioned in the middle of the gold mark film.
Fig. 3 is Novel Human C-reactive protein colloidal gold colloidal gold detection test paper strip positive findings figure.
Fig. 4 is Novel Human C-reactive protein colloidal gold colloidal gold detection test paper strip negative findings figure.
Wherein, 1, end liner; 2, ground floor sample pad; 3, second layer sample pad; 4, gold mark film; 5, nitrocellulose filter; 6, thieving paper; 7, gold mark human C-reactive protein antibodies; 8, detection line; 9, control line.
Embodiment
Below in conjunction with accompanying drawing and embodiment the utility model is described further.
Shown in Fig. 1-4; A kind of Novel Human C-reactive protein colloidal gold colloidal gold detection test paper strip; Comprise end liner 1 and thieving paper 6; Attached to what from left to right closely link to each other successively on the end liner 1 is that the ground floor sample pad 2 that is stacked together is marked film 4, nitrocellulose filter 5 and thieving paper 6 with the gold of second layer sample pad 3, coated with gold mark human C-reactive protein antibodies 7; Having the material of a sample pad at least in said ground floor sample pad 2 and the second layer sample pad 3 is the whole blood filter membrane, and said gold mark human C-reactive protein antibodies 7 is positioned at the left end or the centre of gold mark film 4.
The ground floor sample pad 2 of said test strips covers on the second layer sample pad 3 fully.
Said gold mark human C-reactive protein antibodies 7 is the mouse-anti human C-reactive protein monoclonal antibody I of collaurum.
The material of said gold mark film 4 is plain film of spun glass or nitrocellulose filter.
Said nitrocellulose filter 5 middle parts are parallel to be provided with a detection line 8 and a control line 9 that encapsulates rabbit anti-mouse igg antibody that encapsulates mouse-anti human C-reactive protein monoclonal antibody II.
Said mouse-anti human C-reactive protein monoclonal antibody I and II utilize the ELISA double antibody sandwich method from some strain of hybridoma, to screen.
The making of the utility model human C-reactive protein-colloid gold test paper strip:
Adopt known technology ELISA double antibodies sandwich method from some strain of hybridoma, to filter out monoclonal antibody I and the II that combines the different epitopes of human C-reactive albumen.
From left to right paste the ground floor sample pad 2 and second layer sample pad 3, gold mark film 4, nitrocellulose filter 5 and thieving paper 6 that are stacked together above the end liner 1 successively; Gold mark human C-reactive protein antibodies 7 is positioned at the left end or the centre of gold mark film 4; Gold mark film 4 left ends are covered under the second layer sample pad 3 half territories; 1~2 mm zone, nitrocellulose filter 5 left sides is covered in the following of gold mark film 4, and its right side is covered in thieving paper 1/60th zone down, is cut into the test strips of specified width, which width at last with cutting machine.
Method of application:
Gather whole blood, serum or blood plasma and put into clean appearance cup, with sample spot at test strips sample pad place, observations in 8~14 minutes.Two red line in colour developing position, then testing result is positive; When only red zone appearred in the control zone, the result was negative; Red line does not appear in the control zone, shows that test paper is invalid.