CN2230037Y

CN2230037Y - Solid state colloidal gold immunoassay agent box

Info

Publication number: CN2230037Y
Application number: CN 95204963
Authority: CN
Inventors: 王继华
Original assignee: Individual
Current assignee: Individual
Priority date: 1995-04-06
Filing date: 1995-04-06
Publication date: 1996-06-26
Anticipated expiration: 2005-04-06

Abstract

The utility model relates to a solid state colloidal gold immunoassay agent box, comprising a filter and a detection plate which are inserted with each other. A piece of filter paper, fibrous materials fixed with antibody II-colloidal gold compound and a piece of filter paper are orderly overlapped and clamped between a central hole and a draining port of the filter. An upper cover with round holes and a lower cover are fastened and jointed to form the detection plate. A fiber membrane marked with an antibody I and a water adsorption material are overlapped orderly between the upper and the lower covers. The utility model has the advantages of simple structure, easy fabrication, low cost, convenience operation, safety and long service life.

Description

Solid colloid gold immunity detection reagent

The utility model is a solid colloid gold immunity detection reagent, belongs to medical vitro diagnostic techniques.

The kit of existing mensuration urine, serum and other body fluid of producing is collectively referred to as liquid-type colloid gold immune kit, what at present be applied to detect HCG in women's urine maturely is collaurum gestation detection kit, it is made up of check-out console, gold mark liquid and cleansing solution, wherein check-out console is formed by detecting box and filtrator again, detecting box has the loam cake in hole, garden, the tunica fibrosa that is marked with antibody I, absorbent material, lower cover to stack gradually and form by the centre, and filtrator is had the inner casing in hole, garden to form with the middle embedding filter paper mutually of shell by the centre.It detects behaviour: humoral specimen 1. to be measured passes tunica fibrosa subsequently and infiltrates absorbent material earlier by the insolubles in the filtrator filtering sample, and in wearing the infiltrate journey, the mark to be detected in the humoral specimen combines with the antibody I on the tunica fibrosa; 2. after removing filtrator, add golden mark liquid in hole, loam cake garden, allow it wear under the infiltrated fiber film, at this moment, red antibody I I-colloidal gold composite and mark to be measured knot are incorporated on the white tunica fibrosa and stay red vestige in the gold mark liquid; 3. add cleansing solution, so that remove the gold mark liquid that does not combine, so that red vestige is distincter clear, so that naked eyes clear view more with mark to be measured.Yet existing liquid-type colloid gold immune kit exists following shortcoming and problem: 1. its structure form complicated, detecting operation is cumbersome, makes the operator at two liquid addition sequences, quantitatively produce mistake easily, makes and detects error, causes accident; 2. Yin Qijin mark liquid---the antibody II in the liquid antibody I I-colloidal gold composite is a bioactivator, be higher than the inactivation that 20 ℃ the medium-term and long-term preservation of environment can cause antibody I I in temperature, thereby cause separating of antibody I I and collaurum, cause liquid-type colloid gold immune kit to lose efficacy.

The purpose of this utility model be exactly form complexity, detecting operation more complicated in order to overcome and solve structure that existing liquid-type colloid gold immune kit exists, easily make mistakes, easy shortcoming such as inefficacys, the golden immunity detection reagent of the solid colloid that a kind of structure of research and design is formed simply, detecting operation is easier, mass effect is stable, permanently effective under 20～35 ℃ of normal temperature, production cost is lower.

The utility model is realized by following technical proposals: solid colloid gold immunity detection reagent structure is formed the assembling synoptic diagram as shown in Figure 1, the shape and structure synoptic diagram of the filtrator in the solid colloid gold immunity detection reagent as shown in Figure 2, the shape and structure synoptic diagram of the check-out console loam cake in the detection kit as shown in Figure 3, the shape and structure synoptic diagram of the check-out console lower cover in the detection kit is as shown in Figure 4.It is formed by filtrator 5 and check-out console halved joint, wherein, the folded successively filter paper 1 that accompanies between the interval of the hole, central garden 4 of filtrator 5 and filtrator leak 6, be fixed with the fibrous material 2 and the filter paper 3 of antibody I I-colloidal gold composite, check-out console is formed by the check-out console loam cake 8 in band hole, garden 7 and check-out console lower cover 11 snapping that matches, folder is folded underlined tunica fibrosa 9 and the absorbent material 10 that antibody I is arranged successively between loam cake 8 and lower cover 11, its key is the folded fibrous material 2 that accompanies sessile antibody II-colloidal gold composite between filter paper 1 in the filtrator 5 and the filter paper 3, make specimen fluids earlier through colloidal gold composite again with check-out console in the reaction of antibody I tunica fibrosa.

The utility model compared with prior art has following advantage and beneficial effect: 1. the structure of this solid colloid gold immunity detection reagent is formed simpler, handling ease, can save material in the production, wrappage, processing charges reduces, production cost reduces the wide popularization and application of being more convenient for; 2. detecting operation uses more convenient.During with existing liquid-type kit detecting operation, after adding specimen fluids, also need add bottled gold mark liquid and cleansing solution respectively, and during with the utility model detecting operation, only need add specimen fluids can observations or add specimen fluids after only need add cleansing solution gets final product observations, thereby can avoid the detecting operation personnel when adding gold mark liquid and cleansing solution, the error that brings testing result at addition sequence, quantitative mistake; 3. use the utility model, detect steady quality, better, the unlikely error accident that causes of effect; 4. the mark of the gold in liquid-type kit liquid is antibody I I-colloidal gold composite solution, the medium-term and long-term preservation of normal temperature environment that is higher than 20 ℃ in temperature can cause antibody I I to lose efficacy with the gold mark liquid that separates, makes of collaurum, and then detection is slipped up, and this solid colloid gold reagent box, gold mark liquid has become the fibrous material that is fixed with antibody I I-colloidal gold composite, because compound is in dry solid state, having that active antibody I I preserves under 20～35 ℃ normal temperature also not can sex change, compound can not dissociate, and the term of validity of this kit is prolonged greatly.

Below Figure of description is further specified as follows: Fig. 1 forms the assembling synoptic diagram for the structure of solid colloid gold immunity detection reagent, Fig. 2 is the shape and structure synoptic diagram of solid colloid gold immunity detection reagent middle filtrator, and Fig. 3, Fig. 4 are respectively check-out console loam cake, the lower cover shape synoptic diagram in the solid colloid gold immunity detection reagent.Among each figure: 1,3 is that filter paper, 2 is that the fibrous material, 4 that is fixed with antibody I I-colloidal gold composite is that filtrator central circular hole, 5 is that filtrator, 6 is that filtrator leak, 7 is that check-out console loam cake central circular hole, 8 is that check-out console loam cake, 9 is that the tunica fibrosa, 10 that is marked with antibody I is that absorbent material, 11 is the check-out console lower cover.

Below in conjunction with accompanying drawing embodiment of the present utility model and embodiment are described as follows: existing complete, detailed explanation in the foregoing technical scheme of instructions is formed, is assemblied in to structure of the present utility model, as long as press Fig. 1～design shown in Figure 4, and adopt each parts such as common injection moulding process and machine-tooled method processing and manufacturing filtrator, loam cake, lower cover, then, assemble by the aforementioned techniques scheme, just can implement the utility model preferably.Its concrete Application Example is a lot, exemplifies two example explanations below.

Embodiment 1:HCG very early pregnancy detection kit.The fibrous material that is fixed with antibody I I-colloidal gold composite 2 in this box filtrator is compounds that freeze drying is fixed with anti-β-HCG monoclonal antibody thing or anti-α-HCG monoclonal antibody and aurosol particle on fibrous material, and the tunica fibrosa 9 that is marked with antibody I in check-out console is to be fixed with anti-α-HCG monoclonal antibody thing or anti-β-HCG monoclonal antibody thing in tunica fibrosa central authorities drying.When detecting operation, at first add 3～5 of urines in filtrator, treat that urine infiltrates filter paper and remove filtrator after down, if when containing chorionic gonadotrophin (pregnant mark HCG) in the urine, just on the white fiber film, have the punctation vestige, then show conceived; If there is not the punctation vestige, then showing does not have pregnancy.Whole detecting operation process was less than one minute, and gestation can accurately detect in 7 days.This kit measurement sensitivity is 50mIU/ml.

Embodiment 2: hepatitis B surface antibody (HBsAg) diagnostic kit.This box is folded being fixed with of pressing from both sides between filter paper 1 and filter paper 3 antibody I I---the fibrous material 2 of colloidal gold composite is that freeze drying is fixed with the monoclonal antibody thing of resistance of hepatitis B surface antigen determinant A or the compound of polyclonal antibody and aurosol particle on fibrous material, and the tunica fibrosa that is marked with antibody I 9 in check-out console is polyclonal antibody thing or the monoclonal antibody things that are fixed with the former determinant B of anti-HBsAb in tunica fibrosa central authorities drying.When detecting operation, at first add sample serum 200 μ l to be checked in filtrator, treat serum infiltrate filter paper down after, add cleansing solution again, treat cleansing solution infiltrate filter paper down after, remove filtrator, if there have punctation to occur on white fiber film 9 to be promptly positive, otherwise negative.The detecting operation process only needs 3 minutes, and this kit measurement sensitivity is 10mIU/ml.

Remove above-mentioned two application implementations exception, the utility model also can be used as the reagents series box of AFP alpha-fetoprotein, e antigen, e antibody, core antibody, c-hepatitis antibody etc.

Claims

1, a kind of solid colloid gold immunity detection reagent, it is characterized in that: it is formed by filtrator (5) and check-out console halved joint, wherein, the folded successively filter paper (1) that accompanies between the interval of hole, central garden (4) the filtrator leak (6) of filtrator (5), be fixed with the fibrous material (2) and the filter paper (3) of antibody I I-colloidal gold composite, check-out console is formed by check-out console loam cake (8) and the check-out console lower cover (11) in band hole, garden (7) snapping that matches, and folder is folded underlined tunica fibrosa (9) and the absorbent material (10) that antibody I is arranged successively between loam cake (8) and lower cover (11).

2, by the described solid colloid gold of claim 1 immunity detection reagent, it is characterized in that the described fibrous material (2) that has been fixed with antibody I I-colloidal gold composite is the compound that is fixed with anti-β-HCG monoclonal antibody thing or α-HCG monoclonal antibody and aurosol particle on fibrous material.

3, by the described solid colloid gold of claim 1 immunity detection reagent, its feature is that also the fibrous material (2) of the described II-colloidal gold composite of sessile antibody is to be fixed with the monoclonal antibody thing of resistance of hepatitis B surface antigen determinant A or the compound of polyclonal antibody and financial particle on fibrous material.

4, by the described solid colloid gold of claim 1 immunity detection reagent, it is characterized in that the described tunica fibrosa (9) that is marked with antibody I is to be fixed with anti-α-HCG monoclonal antibody thing or anti-β-HCG monoclonal antibody thing in tunica fibrosa central authorities.

5, by the described solid colloid gold of claim 1 immunity detection reagent, its feature is that also the described tunica fibrosa (9) that is marked with antibody I is polyclonal antibody thing or the monoclonal antibody thing that is fixed with the former determinant B of anti-HBsAb in tunica fibrosa central authorities.