The utility model content
The purpose of the utility model is to provide a kind of HBV antigen-antibody oral cavity fast detecting appearance; It is a kind of qualitative detection instrument; Have characteristics such as not having wound painless safer, simple to operate more easy-to-use and efficiently and accurately; Be not only applicable to medical institutions to demand personage's HBV antigen or antibody test are arranged, be applicable to that individual or family detect voluntarily yet.
For realizing above-mentioned purpose; The utility model provides a kind of HBV antigen-antibody oral cavity fast detecting appearance; Comprise: the plastics containment vessel, place HBV antigen or antibody immune chromatography reagent strip in the plastics containment vessel, and sample collecting device, this HBV antigen or antibody immune chromatography reagent strip comprise sample application zone, reaction zone and the suction zones that sets gradually; Sample collecting device has capillary micropore matrix structure, comprises the joint portion of shank, board and connection shank and board; The panel that the plastics containment vessel comprises base plate and is equipped with base plate, panel is provided with the watch window that is used for the interpretation testing result, the corresponding setting of reaction zone of watch window and HBV antigen or antibody immune chromatography reagent strip; The sample application zone top that the shank of sample collecting device is overlapped and is positioned over HBV antigen or antibody immune chromatography reagent strip, board stretches out outside the plastics containment vessel.
Also comprise developping agent, be used, make an addition on the sample collecting device that this developping agent splendid attire is in the transparent rigid plastic bottle of sealing with this HBV antigen-antibody oral cavity fast detecting appearance.
Said plastics containment vessel one end is made as the holding area, and the base plate of plastics containment vessel is provided with several air holes in an end of holding area, and its inboard is made as the sample collecting device assembly section away from an end of holding area, and the sample collecting device stationary installation is set on it; The middle part is made as HBV antigen or antibody immune chromatography reagent strip assembly section, and it is provided with the stationary installation that supplies to place HBV antigen or antibody immune chromatography reagent strip.
Said watch window top is bonded with an eyeglass, and the eyeglass marked has " T ", " C " or " Ts ", " Te ", " Tc " " C " to indicate line, respectively with the detection line and the corresponding setting of nature controlling line of HBV antigen or antibody immune chromatography reagent strip; Eyeglass is processed by transparent rigid plastic.
The base plate of plastics containment vessel and panel inboard are provided with coupling arrangement, are used for base plate is fixedly connected with panel.
Said HBV antigen or antibody immune chromatography reagent strip adopt colloid gold label, electroselenium mark, color latex particle mark or the preparation of fluorescent-substance markers technology, and it is HbsAg immunochromatography reagent bar, HBeAg immunochromatography reagent bar, HBsAb immunochromatography reagent bar, HBeAb immunochromatography reagent bar, HBcAb immunochromatography reagent bar, HbsAg-HBeAg immunochromatography reagent bar or HBsAb-HBeAb-HBcAb immunochromatography reagent bar.
Said sample collecting device is processed by hydrophilic fibre and hydrophobic material, and this hydrophilic fibre and hydrophobic material form capillary micropore matrix structure; The profile of this sample collecting device is table tennis plate or slurry shape.
Said sample collecting device is processed by hydrophobic material, and this hydrophobic material forms capillary micropore matrix structure; The profile of this sample collecting device is bar-shaped or tabular.
1), that operation the time does not have wound is painless safer the beneficial effect of the utility model:; The mouth cavity liquid sample collection is compared with the blood sample collection; Can not cause any harm to human body; There is not the risk that causes the tester to form scabies secondary infection yet, to implementing the medical personnel of Clinical detection, can effectively reduces the probability and the risk that infect blood source communicable disease (like AIDS, hepatitis B, hepatitis C, syphilis, malaria etc.) because of occupational exposure simultaneously.
2), simple to operate more easy-to-use; Whole uses of HBV antigen of the utility model or antibody oral cavity fast detecting appearance only have operation of mouth cavity liquid sample collection; Guide to specifications and just can realize; Other processes comprise that mouth cavity liquid sample process, HBV antigen or the antibody gathered separate and conveying operations, are all accomplished voluntarily by detector, in 10-20 minute, can with the naked eye directly read testing result from the testing result watch window.
3), the core component sample collecting device in the utility model is inner capillary micropore matrix structure; Not only can fully absorb the mouth cavity liquid sample; Also separate HBV antigen or antibody in the liquid sample of oral cavity voluntarily; And HBV antigen in the mouth cavity liquid sample or antibody is delivered to the HBV antigen or the antibody immune chromatography reagent strip of combining closely with sample collecting device voluntarily; Successfully broken through saliva sample or mouth cavity liquid sample application when Clinical detection content far below the bottleneck of blood sample; And evaded loaded down with trivial details saliva sample or mouth cavity liquid sample process process, be not only applicable to medical institutions, be applicable to that also individual or family detect voluntarily demand personage's HBV antigen or antibody test are arranged.
Embodiment
Shown in Fig. 1-5, the HBV antigen-antibody oral cavity fast detecting appearance of the utility model comprises: plastics containment vessel 2, place HBV antigen or antibody immune chromatography reagent strip 4 in the plastics containment vessel 2, and sample collecting device 6.
Wherein, HBV antigen or antibody immune chromatography reagent strip 4 comprise sample application zone 42, reaction zone 44 and the suction zones 46 that sets gradually, and reaction zone 44 is connected between sample application zone 42 and the suction zones 46, and reaction zone 44 is provided with detection line and nature controlling line; Plastics containment vessel 2 comprises base plate 22; The panel 24 that is equipped with base plate 22; Base plate 22 is fixedly connected through its inboard coupling arrangement 29 that is provided with panel 24, and fixing means can adopt the method for withholding, and also can adopt the ultrasonic plastic welder welding to be fixedly connected.Plastics containment vessel 2 one ends are made as holding area 23; Base plate 22 is provided with several air holes 21 in holding area 23; Base plate 22 inboards are made as sample collecting device assembly section 25 away from an end of holding area 23, and sample collecting device stationary installation 252 is set on it, are used to settle sample collecting device 6; The middle part is made as HBV antigen or antibody immune chromatography reagent strip assembly section 26, and reagent strip stationary installation 262 is set respectively on it, in order to place HBV antigen or antibody immune chromatography reagent strip 4.Panel 24 is provided with the watch window 27 that is used for the interpretation testing result, watch window 27 and reaction zone 25 corresponding settings; Above watch window 27, be bonded with an eyeglass 28; Eyeglass 28 marked have " T ", " C " or " Ts ", " Te ", " Tc " " C " to indicate line, respectively with, two or three detection lines and the corresponding setting of nature controlling line of HBV antigen or antibody immune chromatography reagent strip 4; Said eyeglass 28 is processed by transparent rigid plastic film.
Said sample collecting device 6 is used to have capillary micropore matrix structure; The joint portion 66 that comprises shank 62, board 64 and connection shank 62 and board 64; This sample collecting device is used to gather the oral cavity liquid sample, and separates voluntarily and carry HBV antigen or the antibody in the liquid sample of oral cavity; Sample application zone 42 tops that the shank 62 of sample collecting device 6 is overlapped and is positioned over HBV antigen or antibody immune chromatography reagent strip 4, board 64 stretches out outside the plastics containment vessel 2.The capillary action that sample collecting device 6 possesses itself need not extraneous mechanical compress or applied external force such as centrifugal or gravity, can separate and carry HBV antigen or the antibody in institute's collection liquid sample voluntarily.Mouth cavity liquid sample and HBV antigen wherein or antibody are absorbed, separate, are delivered to HBV antigen or antibody immune chromatography reagent strip 4 by sample collecting device 6 sample application zone 42; Utilize chromatographic theory to be delivered to reaction zone 44; And a series of immunological responses take place at reaction zone 44, demonstrate the directly result of interpretation (like red stripes) of the watch window 27 of naked eyes through panel.
Said HBV antigen or antibody immune chromatography reagent strip 4 adopt colloid gold label, electroselenium mark, color latex particle mark or the preparation of fluorescent-substance markers technology; So be not limited thereto; This HBV antigen or antibody immune chromatography reagent strip 4 can be HbsAg immunochromatography reagent bar, HBeAg immunochromatography reagent bar, HBsAb immunochromatography reagent bar, HBeAb immunochromatography reagent bar, HBcAb immunochromatography reagent bar, HbsAg-HBeAg immunochromatography reagent bar or HBsAb-HBeAb-HBcAb immunochromatography reagent bar; Adopt different immunochromatography reagent bars as required, to detect HBsAg, HBeAg, HBsAb, HBeAb, HBcAb, HBsAg-HBeAg or the HBsAb-HBeAb-HBcAb in the mouth cavity liquid sample.
Also comprise developping agent (not shown), be used, make an addition on the sample collecting device 6 that this developping agent splendid attire is in the transparent rigid plastic bottle of sealing with this HBV antigen-antibody oral cavity fast detecting appearance.Described developping agent is different from damping fluids such as laboratory PBS commonly used or Tris; It is the composite buffer system of a kind of pH value between 6.5~8.5; It act as the pH value of regulating the mouth cavity liquid sample; Make it to meet the potential of hydrogen needs of HBV antigen or antibody immune chromatography reagent strip 4 detection HBV antigens or antibody; Guarantee directivity and flow velocity that the mouth cavity liquid sample is carried; Fill up the space that after HBV antigen or the conveying of antibody immune chromatography reagent strip 4 directions, on sample collecting device, stays because of the mouth cavity liquid sample, can also adhere to the HBV antigen or the antibody on sample collecting device 6 capillary micropore matrix structures surface by wash-out, and it is flowed to HBV antigen or antibody immune chromatography reagent strip 4 directions with developping agent; Thereby make HBV antigen or antibody immune chromatography reagent strip 4 obtain enough mouth cavity liquid samples; And promote in the mouth cavity liquid sample HBV antigen or antibody to separate voluntarily and carries, effectively improve HBV antigen or the antibody front end concentration in solvent (comprising mouth cavity liquid sample and developping agent), guarantee the needs of detection HBV antigen or antibody.The component of every 1L developping agent is: potassium dihydrogen phosphate 0.2g, trishydroxymethylaminomethane 6.06g, sodium hydrogen phosphate 1.15g, sodium chloride 8.0g, potassium chloride 0.2g, Tween-20 0.5ml, thimerosal 0.1g, lauryl sodium sulfate 1.25g, ethylenediamine tetraacetic acid 1ml; Add de-ionate and be dissolved to 1L solution; Rigid plastic bottle splendid attire with transparent sealing; Every bottle of 0.8~3.0ml, room temperature preservation.
Said sample collecting device 6 is processed by hydrophilic fibre and hydrophobic material, and this hydrophilic fibre and hydrophobic material form capillary micropore matrix structure; It is 8%~80% that hydrophilic fibre accounts for sample collecting device general assembly (TW) ratio range, and hydrophilic fibre can be cotton fiber, filter paper, sponge, cloth; Hydrophobic material can be tygon, polypropylene, multi-styrene, high density polyethylene, ultra high molecular polyethylene, Polyvinylidene fluoride, teflon, polyester, nylon, polyethersulfone or other plastics, also can be glass, resin; The weight ratio scope of hydrophilic fibre and hydrophobic material is 1: 9 to 4: 1.These sample collecting device 6 profiles can be soldier's pang plate or oar shape, its parameter: total surface area is not less than 700 square millimeters, cumulative volume and is not less than 650 cubic millimeters, the surface area of sample collecting device board and is not less than 50% of sample collecting device total surface area; 20~500 microns of the average pore sizes of capillary micropore matrix structure, total void volume are no more than 500 cubic millimeters, total void rate and are no more than 80%, and the corresponding density of this sample collecting device is 0.21~0.86 gram/cubic centimetre.In this sample collecting device, preferred parameter be hydrophilic fibre to account for sample collecting device general assembly (TW) ratio range be 10%~58%, hydrophilic fibre is preferably cotton fiber, hydrophobic material is preferably polyester; Cotton fiber is preferably 1: 9 to 3: 2 with weight polyester than scope; The average pore size of capillary micropore matrix structure is preferably 20~200 microns, and the total void rate is preferably 40~45%, and the density of sample collecting device 6 is preferably 0.48~0.52 gram/cubic centimetre.
As another kind of selectivity embodiment, said sample collecting device 6 is processed by hydrophobic material, can be processed by one or more hydrophobic materials, and this hydrophobic material forms capillary micropore matrix structure.Hydrophobic material can be tygon, polypropylene, multi-styrene, high density polyethylene, ultra high molecular polyethylene, Polyvinylidene fluoride, teflon, polyester, nylon, polyethersulfone or other plastics, glass, resin etc.; This sample collecting device profile can be bar-shaped or tabular, its parameter: total surface area is not less than 700 square millimeters, cumulative volume and is not less than 650 cubic millimeters, the surface area of sample collecting device board and is not less than 50% of sample collecting device total surface area; 20~500 microns of the average pore sizes of capillary micropore matrix structure, total void volume are no more than 500 cubic millimeters, total void rate and are no more than 80%, and the corresponding density of sample collecting device is 0.49~0.92 gram/cubic centimetre.In this sample collecting device, preferred parameter is the hydrophobic material preferred polyester; The average pore size of capillary micropore matrix structure is preferably 20~200 microns, total void rate and is preferably 35~55%, and the density of sample collecting device is preferably 0.58~0.72 gram/cubic centimetre.This hydrophobic material also can pass through hydrophilic treated and process sample collecting device again, or the sample collecting device that will be processed by hydrophobic material is through hydrophilic treated, with the ability that improves the sample collecting device collection and carry liquid sample.
Said sample collecting device 6 is controlled at below 500 cubic millimeters through the amount of its capillary micropore matrix structure saturated absorption liquid sample; Time with immersion way saturated absorption liquid sample was controlled in 5 minutes; In preferred 1 minute, behind the sample collecting device saturated absorption moisture, its inner structure requires not take place significant change; Especially after passing through dried, tangible change does not take place in its rate of water absorption.Under the prerequisite that does not have extraneous mechanical compress or filtration, be adsorbed in liquid sample in the capillary micropore matrix structure runs to shank 62 edges from board 64 edges time to be controlled in 10 minutes, preferably in 2 minutes.
In the present embodiment, the base plate 22 of plastics containment vessel 2 adopts the ultrasonic plastic welder welding to be fixedly connected with panel 24.During installation; In the ultrasonic plastic welder mould, lay the base plate 22 of plastics containment vessel 2; Assemble HBV antigen or antibody immune chromatography reagent strip 4 and sample collecting device 6 successively in base plate 22 inboards; Make the shank 62 of sample collecting device 6 and the sample application zone 42 overlapping 1-3 millimeters of HBV antigen or antibody immune chromatography reagent strip 4; The panel 24 of plastics containment vessel 2 is installed then; Eyeglass 28 is installed in testing result watch window 27 positions at panel 24 middle parts, with ultrasonic plastic welder the base plate 22 of plastics containment vessel 2 is also fixed welding with the panel 24 of panel 24 and plastics containment vessel 2 with the sealing wire fusion of eyeglass 28, thereby forms the HBV antigen-antibody oral cavity fast detecting appearance of an integral body.
The HBV antigen-antibody oral cavity fast detecting appearance of the utility model combines sample collecting device and HBV antigen or antibody immune chromatography reagent strip; In order to detect HBV antigen or antibody in the mouth cavity liquid; Effectively HBsAg, HBeAg, HBsAb, HBeAb, HBcAb, HBsAg-HBeAg or HBsAb-HBeAb-HBcAb in the qualitative detection mouth cavity liquid sample; Be used for diagnostic detection person and whether infect hepatitis B; Judge perhaps whether the tester has immunity to hepatitis B, perhaps judge hepatitis B patient or the hepatitis carrier course of disease stage of living in, have the advantages that not have painless safer, simple to operate more easy-to-use and efficiently and accurately of wound; Be not only applicable to medical institutions to demand personage's HBV antigen or antibody test are arranged, be applicable to that individual or family detect voluntarily yet.
The above for the person of ordinary skill of the art, can make other various corresponding changes and distortion according to the technical scheme and the technical conceive of the utility model, and all these changes and distortion all should belong to the scope that the utility model is protected.