CN206583914U - A kind of chicken pox vaccine effect of inoculation Fast Evaluation kit - Google Patents

A kind of chicken pox vaccine effect of inoculation Fast Evaluation kit Download PDF

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Publication number
CN206583914U
CN206583914U CN201720081188.6U CN201720081188U CN206583914U CN 206583914 U CN206583914 U CN 206583914U CN 201720081188 U CN201720081188 U CN 201720081188U CN 206583914 U CN206583914 U CN 206583914U
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lid
antigen
accommodating chamber
test paper
box body
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王诺
吴边
丁建华
张薇
曾强
黄晶
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WUHAN LIFE TECHNOLOGY Co Ltd
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WUHAN LIFE TECHNOLOGY Co Ltd
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Abstract

The utility model is related to a kind of chicken pox vaccine effect of inoculation Fast Evaluation kit, including packing box, sample diluting liquid container containing and Test paper;Sample diluting liquid container containing and Test paper are separately positioned in box body, and corresponding are provided with a lid;Drier is also filled with box body;Test paper includes coated film, label pad, antigen pad;It is coated with varicella virus and antigen, is coated with label pad in mouse water resistant poxvirus and antigen monoclonal antibody in antigen pad, is coated with detection T lines on mouse anti-human IgG antibodies, Quality Control C lines and is coated with sheep anti-mouse igg antibody;The lowest detection line of Test paper is 5U/ml.The beneficial effects of the utility model are:Sample diluting liquid container containing and Test paper are provided separately, make the size of kit compacter, and when taking out sample diluting liquid, Test paper will not be interfered, drier is separately set up, extension reagent bottle stores the pot-life of reagent.

Description

A kind of chicken pox vaccine effect of inoculation Fast Evaluation kit
Technical field
The utility model is related to technical field of biological, and in particular to a kind of chicken pox vaccine effect of inoculation Fast Evaluation examination Agent box.
Background technology
Varicella is a kind of common acute, highly infective the respiratory infectious disease of children, and herpes zoster is to suffer from diving after varicella Caused by the reactivation for lying prostrate virus, its cause of disease is varicella virus (varicella-zoster virus, VZV), i.e., The type of nerpes vinrus hominis 3.Primary infection can cause most diseases after the typical disease of the different orders of severity, healthy children infection VZV Shape is slight, prognosis bona.But in some special populations, such as immunodeficiency and the children using immunosuppressant treatment, meeting Cause serious consequence, in addition it is dead.Symptom is also very serious after adult's infection VZV.
VZV belongs to herpetoviridae, is double-stranded DNA virus.Its form be concentric circles structure, a diameter of 150nm~ 200nm, nucleocapsid is in three dimensional symmetry, the symmetrical 20 face body that surface is made up of 162 shell particulates, and it is double-stranded DNA that it is interior, there is one outside Layer or multilayer coating, the glycoprotein produced by virus are constituted with the adipose membrane from cell.Only One serotype is currently known, people is Its unique natural reservoir (of bird flu viruses).Virus enters human body by pharynx nasalis mucous membrane, almost always susceptible individual is fallen ill.Incubation period is usually It is 10-21 days, average 14 days, cause varicella in children's primary infection, recover restrovirus and hide in vivo, a few patients are after adult Virus is sent out and causes herpes zoster again, therefore is referred to as varicella virus.
Varicella attenuation live vaccine in countries uses such as Japan, Germany, the U.S. for many years.Immunity inoculation was not suffering from for more than 1 years old The children and adult of varicella, the specific antibody of generation can be maintained 10 years as long as in vivo, and protective rate is higher.Some areas of China To more than 1 years old children also in kind of a chicken pox vaccine of trying.
It is exactly to detect the content of the specific antibody in inoculator's body in serum to evaluate the most reliable method of immune effect of vaccine. Using ELISA and fluorescent antibody to membrane antigen to test the method for detecting varicella virus neutralizing antibody on Vehicles Collected from Market more (FAMA), FAMA experiments are the goldstandards for detecting varicella virus antibody, but time-consuming for this method, complex operation, It can not be commercialized.Although ELISA sensitivity is high, result accurate, there is inconvenience, such as step in practical operation It is complicated, time-consuming longer, also need to use specific instrument and equipment;Kit needs 4 DEG C of preservations;To sample requirement venous blood collection etc., no Easily popularize and use in basic unit.
Immune colloid gold quick diagnosis technology be built upon EUSA, latex agglutination test, monoclonal resist On body technique and immuno-gold labeling technical foundation, using collaurum as label, amplified using special antigen-antibody reaction Reaction signal, by directly observing the new technology it is determined that result.The technology has simple, quick, accurate and pollution-free The advantages of, quickly examined in clinical medicine detection, animal medicine detection, hormone test, food safety detection, medicament residue and drugs Many diagnostic fields such as survey are developed rapidly.At present, the method for colloid gold label quick detection antibody is broadly divided into two kinds:One kind is By antigen standard gold, the antibody of test antibodies draws film;Another is that antigen is drawn into film, the antibody standard gold of test antibodies.Existing research Show:It is relatively stable to the colloid gold label of antibody protein because antibody protein property is relatively stable, the first above-mentioned side Then there is a lot of problem in the colloid gold label of the antigen described in method, because antigen is generally virus type, property is various, and some sizes are very It is extremely also bigger than colloid gold particle, and less stable, therefore it is difficult to directly by antigenic mark on colloid gold particle;Even if reluctantly Can be by antigenic mark, it is also desirable to which antigen reaches high purity, and be that a difficulty is larger, cost to the purifying of antigenic virus Higher engineering;Also someone finds the recombinant antigen of antigen to replace these native antigens, but many antigens are difficult to seek energy The recombinant antigen of replacement, even and if have, cost is also high, therefore the limitation of above-mentioned first method is higher.On The second method stated is to carry out antigen to draw film, and this method carries out golden mark using the antibody of test antibodies, can avoided The problem of antigen gold mark, but will be reacted on antigen stroke to film, it is necessary to which antigen has higher concentration and purity, this also increases The cost and difficulty of production are added;Antigen is drawn onto film in addition, because Antigen Stability is poor, it is difficult to protect for a long time Deposit, the term of validity of Test paper is extremely short.These are all the reason for limitation antibody quick detection class kit are fast-developing.
Utility model content
Technical problem to be solved in the utility model is to provide a kind of chicken pox vaccine effect of inoculation Fast Evaluation kit, The particle of antigen is big when solving to use colloid gold label, when purity requirement is high and draws film using antigen, due to Antigen Stability Difference, it is difficult to preserve for a long time, the problem of term of validity of Test paper is extremely short.
The technical scheme that the utility model solves above-mentioned technical problem is as follows:A kind of chicken pox vaccine effect of inoculation Fast Evaluation Kit, including packing box, sample diluting liquid container containing and Test paper;The packing box includes box body and lid, described The first dividing plate is provided with box body, the box body is divided into the first accommodating chamber and the second accommodating chamber, the detection by first dividing plate Test paper is in first accommodating chamber, and the sample diluting liquid container containing is in second accommodating chamber;The lid Including the first lid and the second lid, first lid is located at the top of first accommodating chamber, and second lid is located at The top of second accommodating chamber;Several second partitions, several described second partitions point are provided with first accommodating chamber Do not surrounded with the outer wall of the box body and drier is filled with the 3rd accommodating chamber, the 3rd accommodating chamber;On the second partition It is less than the air-vent of drier particle diameter provided with multiple diameters;Multiple chiasma type convex tendons are additionally provided with first accommodating chamber, it is described First lid is equipped with multiple raised lines on the position matched with each chiasma type convex tendon;The Test paper includes bag Envelope, label pad and antigen pad;It is coated with the antigen pad in varicella virus and antigen, the label pad On be coated with the mouse water resistant poxvirus of colloid gold label and antigen monoclonal antibody, be fixed with the coated film detection T lines With Quality Control C lines, it is coated with mouse anti-human IgG antibodies, the Quality Control C lines on the detection T lines and is coated with sheep anti-mouse igg antibody;Institute The lowest detection line for stating Test paper is 5U/ml.
The beneficial effects of the utility model are:The Test paper used, by introducing in varicella virus and antigen pad, together When antigen protection liquid is added in antigen pad, solve in varicella virus and antigen be not easy by gold mark due to stability difference The problem of;On the other hand, with antigen for crude antigen in the varicella virus used, during Test paper reaction chromatography, Crude antigen is screened and purified by double antibody sandwich method, it is ensured that the specificity of reagent reacting, therefore is not required to thick Antigen, which is further purified, can just reach reaction effect, and preparation cost is low, utilizes popularization and application.The chicken pox vaccine inoculation effect separately used Fruit Fast Evaluation kit by sample diluting liquid container containing and Test paper in packing box, user when in use, nothing Sample diluting liquid need to be prepared in addition, use more facilitates, and sample diluting liquid container containing and Test paper are respectively placed in reagent In two accommodating chambers of box, and one lid of corresponding setting, make the structure of kit compacter, another user is when in use Only the second lid, which need to be opened, can be taken off sample diluting liquid, and Test paper will not be interfered;Separately it is placed with packing box dry Drying prescription, can absorb moisture, oxygen in kit, and effectively extension reagent bottle stores the pot-life of diagnostic reagent;Separately by reagent The sensitivity of box is set to 5U/ml, and the rapid evaluation to chicken pox vaccine effect of inoculation can be achieved.
Further:The quantity of the second partition is two, and the second partition described in two, which is respectively arranged on described first, to be held Receive the front-end and back-end of chamber.
The beneficial effect of above-mentioned further scheme is:By setting two second partitions, two the are further provided with Drier is placed with three accommodating chambers, and each 3rd accommodating chamber, strengthens the absorption to moisture, oxygen.
Further:The positioner for fixing the Test paper is additionally provided with first accommodating chamber.
The beneficial effect of above-mentioned further scheme is:Test paper can be locked at by positioner by the first accommodating chamber In, prevent its double swerve.
Further:The positioner includes positioning component and movable component, the positioning component and the movable component It is respectively arranged on the left end and right-hand member of first accommodating chamber;The positioning component includes bottom plate and U-shaped locating piece, the bottom plate It is fixed on the box body;The U-shaped locating piece is fixed on the top of the bottom plate, and the openend court of the U-shaped locating piece To the movable component;The movable component includes fixed plate, portable plate and copper sheet, and the fixed plate is fixed on the box body On;One end of the copper sheet is embedded in the fixed plate, and the other end of the copper sheet is supported on the portable plate, the work Dynamic plate can be moved in the box body.
The beneficial effect of above-mentioned further scheme is:Positioning component is mainly used in determining the placement location of Test paper Position, movable component can be adjusted according to the specific size of Test paper, be that Test paper can be clamped in packing box, it is to avoid Its double swerve.
Further:The bottom of the portable plate is raised provided with several, the bottom of the box body provided with several with it is described The chute that projection matches.
The beneficial effect of above-mentioned further scheme is:The bottom of portable plate sets raised, and set on box body with it is described The chute that projection matches, can be oriented to mobile in box body of portable plate, prevent the skew of portable plate.
Further:The bottom of adding mouth on first lid is downwardly extending the 3rd cylinder.
The beneficial effect of above-mentioned further scheme is:3rd cylinder plays a part of water conservancy diversion, can prevent addition sample or add Plus during sample diluting liquid, liquid dissipates splash everywhere, and ensure that the sample diluting liquid of addition and the position consistency of sample, plays good Good diluting effect.
Further:It is connected through the hinge between first lid and second lid, and first lid and institute State between box body, connected between second lid and the box body by snap fit.
The beneficial effect of above-mentioned further scheme is:Ensure that the opening of the second lid does not interfere with the stabilization of Test paper Property.
Further:The second cylinder is provided with second accommodating chamber, second cylinder is used to place the sample dilution Liquid container containing.
The beneficial effect of above-mentioned further scheme is:Sample diluting liquid container containing is arranged in the second cylinder, makes sample The placement of product dilution container containing is more steady.
Further:The label pad is glass fibre.
Further:The antigen pad is glass fibre, non-woven fabrics or polyester film.
It is above-mentioned enter two step schemes beneficial effect be:Make after sample is added on Test paper, can by electrostatic interaction and The physical actions such as hydrophobic interaction are combined with protein and can deployed by capillarity.
Brief description of the drawings
Fig. 1 be the utility model chicken pox vaccine effect of inoculation Fast Evaluation kit in packing box explosive view;
Fig. 2 be the utility model in Test paper structural representation;
Structural representations of the Fig. 3 for the packing box in the utility model when opening the second lid;
Fig. 4 be the utility model in movable component structural representation.
Embodiment
Principle of the present utility model and feature are described below in conjunction with accompanying drawing, example is served only for explaining this practicality It is new, it is not intended to limit scope of the present utility model.
As shown in Figures 1 to 4, a kind of chicken pox vaccine effect of inoculation Fast Evaluation kit is dilute including packing box 1, sample Release liquid container containing and Test paper 3;The packing box 1 includes box body 12 and lid 13, in the box body 12 provided with first every 12 points of the box body is the first accommodating chamber 111 and the second accommodating chamber 112 by plate 11, the first dividing plate 11;The Test paper 3 is located at In first accommodating chamber 111, the sample diluting liquid container containing is in second accommodating chamber 112;The lid 13 Including the first lid 131 and the second lid 132, first lid 131 is located at the top of first accommodating chamber 111, described Second lid 132 is located at the top of second accommodating chamber 112;Several second partitions are provided with first accommodating chamber 111 1115, several described second partitions 1115 surround the 3rd accommodating chamber 1116, the described 3rd with the outer wall of the box body 12 respectively Drier is filled with accommodating chamber 1116;The second partition 1115 is less than the air-vent of drier particle diameter provided with multiple diameters 1117;The Test paper 3 includes coated film 32, label pad 33 and antigen pad 34;It is coated with the antigen pad 34 In varicella virus and antigen, it is coated with the label pad 33 in the mouse water resistant poxvirus of colloid gold label and antigen list It is fixed with clonal antibody, the coated film 32 on detection T lines 321 and Quality Control C lines 322, the detection T lines 321 and is coated with mouse Sheep anti-mouse igg antibody on anti-human IgG antibodies, the Quality Control C lines 322;The lowest detection line of the Test paper 3 is 5U/ml.Will Sample diluting liquid container containing and Test paper 3 are in packing box 1, and user is when in use, dilute without preparing sample in addition Liquid is released, use more facilitates, and sample diluting liquid container containing and Test paper 3 are respectively placed in two accommodating chambers of kit In, and one lid 13 of corresponding setting, make the size of kit compacter, another user need to only open second when in use Lid 132 can be taken off sample diluting liquid, and Test paper will not be interfered;Drier separately is placed with packing box 1, can be inhaled Moisture, the oxygen in kit are received, effectively extension reagent bottle stores the pot-life of diagnostic reagent;The another sensitivity by kit 5U/ml is set to, the rapid evaluation to chicken pox vaccine effect of inoculation can be achieved.
As shown in figure 1, being provided with multiple passages 1117 on second partition 1115, the moisture sorption effect of drier can be strengthened. The second partition 1115 is preferably two, and two second partitions 1115 are respectively arranged on before first accommodating chamber 111 Two ends afterwards, located at the front of the first accommodating chamber 111 the second partition 1115 two ends to before the first accommodating chamber 111 Side wall extends to form the 3rd accommodating chamber 1116, located at the two ends of the second partition 1115 at the rear of the first accommodating chamber 111 Extend to form another 3rd accommodating chamber 1116 to the rear wall of the first accommodating chamber 111.
The positioner for fixing the Test paper 3 is additionally provided with first accommodating chamber 111.Pass through positioner Test paper 3 can be locked in the first accommodating chamber 111, prevent its double swerve.
As shown in figure 1, the positioner includes positioning component 1112 and movable component 1113, the positioning component 1112 The left end and right-hand member of first accommodating chamber 111 are respectively arranged on the movable component 1113;The positioning component 1112 includes Bottom plate 11121 and U-shaped locating piece 11122, the bottom plate 11121 are fixed on the box body 12;The U-shaped locating piece 11122 Be fixed on the top of the bottom plate 11121, and the U-shaped locating piece 11122 openend towards the movable component 1113; The movable component 1113 includes fixed plate 11131, portable plate 11133 and copper sheet 11132, and the fixed plate 11131 is fixed on On the box body 12;One end of the copper sheet 11132 is embedded in the fixed plate 11131, the copper sheet 11132 it is another End is tilted, and the copper sheet 11132 of tilting is supported on the portable plate 11133, and the portable plate 11133 can be in the box body Moved in 12.Positioning component 1112 is mainly used in positioning the placement location of Test paper 3, and movable component 1113 can basis The specific size of Test paper 3 is adjusted, and Test paper 3 is clamped in packing box 1, it is to avoid its double swerve.
As shown in Figure 1 and Figure 4, the bottom of the portable plate 11133 is provided with several projections 11134, the box body 12 Bottom is provided with several and described raised 11134 chutes 1118 matched.The setting of projection 11134 and chute 1118 can be right Mobile in box body 12 of portable plate is oriented to, and prevents the skew of portable plate 11133.
As shown in figure 1, multiple chiasma type convex tendons 1114 are additionally provided with first accommodating chamber 111, multiple chiasma types Convex tendon 1114 be located between the positioning component 1112 and the movable component 1113, first lid 131 with it is each Multiple raised lines 1312 are equipped with the position that the chiasma type convex tendon 1114 matches.By set chiasma type convex tendon 1114 and with Multiple raised lines 1312 that chiasma type convex tendon 1114 matches, can play a part of good support and fixation to Test paper 3.
As shown in figure 1, first lid 131 is provided with adding mouth, the adding mouth is located at the top of sample pad 35 First lid 131 on, the bottom of the adding mouth is downwardly extending the 3rd cylinder 1313.3rd cylinder 1313 is played The effect of water conservancy diversion, when can prevent addition sample or add sample diluting liquid, liquid dissipates splash everywhere, and ensure that the sample of addition The position consistency of dilution and sample, plays good diluting effect.
Dust plug is additionally provided with first lid 131, the dust plug matches with the adding mouth.Sample-adding can be prevented Gather dust, impurity at mouthful, influence the accuracy of the testing result of Test paper 3.Observation window is additionally provided with first lid 131 1314, the observation window 1314 is on first lid 131 of the top of coated film 32.It is easy to user's observation detection As a result.
As shown in figures 1 and 3, connected between first lid 131 and second lid 132 by hinge 133, and By the side of engaging between first lid 131 and the box body 12, between second lid 132 and the box body 12 Formula is connected.Specifically, being provided with multiple first cylinders 1111 in first accommodating chamber 111, first lid 131 is provided with more Individual the first projection 1311 matched with first cylinder 1111.Described first can be passed through between box body 12 and lid 13 The projection of cylinder 1111 and first 1311 is connected together, and is also had using the first cylinder 1111 and the cooperation of the first projection 1311 There is good locating effect.Second lid 132 is provided with neck 1321, and the neck 1321 is located at second lid On the inwall of 132 sides away from first lid 131, the box body 12 is provided with the be engaged with the neck 1321 Two projections 121.Directly it is connected between second lid 132 and box body 12 using neck 1321 with the second projection 121, It is convenient to open.
As shown in figure 1, being provided with the second cylinder 1121 in second accommodating chamber 112, second cylinder 1121 is used to put Put the sample diluting liquid container containing.Sample diluting liquid container containing is arranged in the second cylinder 1121, sample is diluted The placement of liquid container containing is more steady.The sample diluting liquid container containing is chosen as bottle or packaging bag, and the bottle of bottle Taper is set at mouth or the opening of packaging bag, is easy to pouring out for sample diluting liquid.
The assemble method of the utility model chicken pox vaccine effect of inoculation Fast Evaluation kit is:Movable component is stirred first Portable plate 11133 in 1113, the bottom plate 31 of Test paper 3 is placed on chiasma type convex tendon 1114 and Test paper 3 is leaned on One end of nearly sample pad 35 is arranged in positioning component 1112, is unclamped portable plate 11133 and is pushed against Test paper 3;Then by sample Product dilution container containing is arranged in the second cylinder 1121, and box body 12 and lid 13 then are passed through into the first cylinder 1111 and One projection 1311 is connected together, and the second projection 121 is fastened in neck 1321.In use, user need to only open Two lids 132, and sample diluting liquid taking-up is dropped at adding mouth, it is simple to operate.
As shown in Fig. 2 the Test paper 3 also includes bottom plate 31 and absorption pad 36, the coated film 32 is located at the bottom On plate 31;The label pad 33, the antigen pad 34 and the sample pad 35 are overlapped on the coated film 32 successively One end, the absorption pad 36 is overlapped on the other end of the coated film 32.The antigen pad 34 be glass fibre, non-woven fabrics or Polyester film.The label pad 33 and sample pad 35 are glass fibre, and the absorption pad 36 is blotting paper.
Described sample diluting liquid is:Phosphoric acid disodium hydrogen, sodium dihydrogen phosphate, the mixed aqueous solution of sodium chloride.Following reality Apply in example, the component of sample diluting liquid is:Disodium hydrogen phosphate 5.72g, sodium dihydrogen phosphate 0.624g, sodium chloride 8g, ultra-pure water is fixed Hold to 1L.
Below by varicella virus and IgG antibody Test paper 3 preparation, assembling, Cleaning Principle and Detection results It is described in detail:
1st, main material
Antigen:The U.S. ADS Biosystems, Inc. are come from antigen in varicella virus, is by gene engineering expression Related antigen fragment, it is thick pure, without biohazard, for preparing antigen pad.
Mouse anti-human igg monoclonal antibody, purchased from Xiamen Bo Sheng Bioisystech Co., Ltd, for nitrocellulose filter T lines Coating.
In mouse water resistant poxvirus and antigen monoclonal antibody, purchased from Wuhan YiL bio tech ltd, for marking Collaurum.
Sheep anti-mouse igg antibody, purchased from Hangzhou Long Ji Bioisystech Co., Ltd, for nitrocellulose filter Quality Control C lines Coating.
Gold chloride:Sigma Products.
Nitrocellulose filter:Millipore Products.
Bovine serum albumin(BSA) (BSA), casein:Sigma Products.
Remaining chemical reagent is AR.
Clinical trial is completed in company's research and development laboratory, cloudy with 220 parts of IgG antibody positive sample wherein in varicella virus 144 parts of sample of property.
2nd, the preparation of label pad 33
Gold chloride-trisodium citrate reduction method prepares a diameter of 40nm colloidal gold solution, after the completion of preparation, takes 100ml Colloidal gold solution is placed on magnetic stirring apparatus and is slowly stirred, and pH to 8.0 is adjusted, then by every 100ml colloidal gold solutions 0.8mg Antibody is added in mouse water resistant poxvirus and antigen monoclonal antibody 0.8mg, is continued to stir 30min, is added final concentration of 0.5% BSA closed, continue stir 30min.After mark terminates, marking fluid is centrifuged with 9000r/min, supernatant is abandoned, so Precipitation is redissolved to original volume with solution is redissolved afterwards, the formula of the redissolution solution is:Tris:1.965g, Casein- Na:2.5g, trisodium citrate:2.5g, Tween-20:0.50ml, sucrose:10.0g, 1L is settled to ultra-pure water.It will redissolve Golden label solution press the paving 18cm per 1ml solution2Ratio uniform paving on the glass fibers, be placed in 37 DEG C, relative humidity is less than In 20% environment, dry 12-18 hours, label pad 33 is made.
3rd, the preparation of antigen pad 34
It will be diluted using antigen protection liquid to 20 times with antigen in varicella virus and obtain antigen liquid, it is anti-by what is diluted Stoste is pressed per 1ml solution paving 18cm2Ratio uniform be layered on glass fibre, non-woven fabrics or polyester film, be placed in 37 DEG C, it is relatively wet In environment of the degree less than 25%, dry 4 hours, antigen pad 34 is made.The formula of antigen protection liquid is:Na2HPO4: 5.72g, NaH2PO4:0.624g, trisodium citrate:8.5g, sucrose:10g, water is settled to 1L;In the varicella virus and antigen For crude antigen, the wherein content of antigen is 40wt% to 45wt%.
4th, the preparation of coated film 32
Using 0.02M, mouse anti-human igg monoclonal antibody is diluted to 2.0mg/ by pH respectively for 7.2 phosphate buffer Ml (T lines solution), sheep anti-mouse igg antibody is diluted to 400IU/ml (C lines solution).Then using draw film instrument will detect T lines 321 with The solution of Quality Control C lines 322 is equably coated on NC films (nitrocellulose filter) by 1.9ul/cm liquid outlet quantity, and NC films are sticked in advance It is affixed on plastic bottom board, after the completion of coating, NC films is placed in 37 DEG C, environment of the relative humidity less than 40%, 3 to 4 are dried small When, coated film 32 is made.
5th, in varicella virus and IgG antibody Test paper 3 assembling
In dry environments (coated film 32 is placed in clean environment by 20 to 25 DEG C of temperature, relative humidity less than 30%), Label the pad 33, (label of label pad 33 are closely crimped in one end of the detection T lines 321 close to coated film 32 Prior cutting is wide into 6mm for pad 33) the close length being crimped on coated film 32 is 2mm or so the, (antigen pad of antigen pad 34 Prior cutting is wide into 10mm) the close other end for being crimped on label pad 33, (antigen pad 34 is prior for antigen pad 34 Cutting is wide into 10mm) the close length for being crimped on label pad 33 is 2mm or so, the close crimping antigen pad of sample pad 35 34 other end, length of the sample pad 35 closely in crimping antigen pad 34 is 4 to 5mm, finally with cutting machine by the bottom plate posted 31 are cut into the wide Test papers 3 of about 4mm.
6th, in varicella virus and IgG antibody Test paper 3 application method
Serum to be checked or blood plasma or whole blood (measuring samples) balance are put into room temperature, and by the Test paper 3 prepared In packing box 1, by adding mouth to addition 5ul measuring samples at sample pad 35,2 to 3 drop sample diluting liquids are added, if sample In contain varicella virus in and IgG antibody, its by with the varicella virus in antigen pad 34 and antigen formation varicella virus neutralize With IgG antibody compound in antigen-varicella virus, the compound is moved forward, in the varicella virus in compound with antigen again With being combined in the mouse water resistant poxvirus of the colloid gold label in label pad 33 with antigen monoclonal antibody, chickenpox is formed Poison is neutralized in IgG antibody-varicella virus and is immunized with antigen monoclonal antibody in the mouse water resistant poxvirus of antigen-colloid gold label Compound, the compound is moved forward due to chromatography effect along paper slip, into the varicella virus detected in T lines 321, compound With IgG antibody and coated mouse anti-human igg monoclonal antibody reactive formation mouse anti-human igg monoclonal antibody on detection T lines 321- In varicella virus and IgG antibody-varicella virus in and antigen-colloid gold label mouse water resistant poxvirus in and antigen monoclonal Antibody immune complex, the compound can be gathered in detection zone, when the compound of aggregation reaches certain quantity, then form one The macroscopic band of bar (T lines), judged result is the positive;If not containing or being neutralized containing minimal amount of varicella virus in sample IgG antibody, then can not form immune complex, i.e., can not form macroscopic band, and judged result is feminine gender;Quality Control C lines 322 as reagent quality control standard, positive and negative detection sample can produce band.Specifically, can be direct in 20 minutes Detect by an unaided eye and detect the colour developing situation of T lines 321 and Quality Control C lines 322:Quality Control C lines 322 do not develop the color, and illustrate this test failure; Quality Control C lines 322 develop the color, and detection T lines 321, which do not develop the color, illustrates that chicken pox vaccine inoculation is unsuccessful;Quality Control C lines 322 and detection T lines 321 Colour developing explanation chicken pox vaccine is inoculated with successfully.
7th, according to " 6 weeks gpELISA titres >=5U/ml then about there is protection to make for the individual by kind of person after vaccine inoculation With ", then in varicella virus and the minimal protection titre of IgG antibody is 5U/ml, when in varicella virus and IgG antibody concentration >=5U/ Ml illustrates that human body has repellence to varicella virus, when in varicella virus and IgG antibody concentration < 5U/ml illustrate human body to varicella Virus does not produce repellence also or body drag is weaker, thus this Test paper by detect in varicella virus and IgG antibody inspection Survey critical value and be set to 5U/ml, the aobvious line of T lines shows concentration >=5U/ml in varicella virus with IgG antibody, chicken pox vaccine inoculation Success, the not aobvious line of T lines shows the concentration < 5U/ml in varicella virus with IgG antibody, and chicken pox vaccine inoculation is unsuccessful.Therefore, originally Kit described in utility model can realize the effect of inoculation of Fast Evaluation chicken pox vaccine.
8th, clinical sample testing result is compareed
The clinical serum sample collected to company is entered simultaneously using the application Test paper and fluorescent antibody to membrane antigen experiment Row detection, then testing result is compareed.
Using fluorescent antibody to membrane antigen experiment as control, to being detected in varicella virus with IgG antibody, 220 parts are detected With IgG positive samples in varicella virus, with IgG negative samples in 144 parts of varicella viruses, and this Test paper detects 227 parts With IgG positive samples in varicella virus, with IgG negative samples in 137 parts of varicella viruses, overall coincidence rate is 95.88%.It is clinical Testing result shows that the performance of this kit, without significant difference, illustrates the utility model compared with fluorescent antibody to membrane antigen is tested It is suitable for clinical examination, with practical value.
Preferred embodiment of the present utility model is the foregoing is only, it is all in this practicality not to limit the utility model Within new spirit and principle, any modification, equivalent substitution and improvements made etc. should be included in guarantor of the present utility model Within the scope of shield.

Claims (10)

1. a kind of chicken pox vaccine effect of inoculation Fast Evaluation kit, it is characterised in that:Including packing box (1), sample diluting liquid Container containing and Test paper (3);The packing box (1) includes being provided with box body (12) and lid (13), the box body (12) The box body (12) is divided into the first accommodating chamber (111) and the second accommodating chamber by the first dividing plate (11), first dividing plate (11) (112), the Test paper (3) is in first accommodating chamber (111), and the sample diluting liquid container containing is located at described In second accommodating chamber (112);The lid (13) includes the first lid (131) and the second lid (132), first lid (131) top of first accommodating chamber (111) is located at, second lid (132) is located at second accommodating chamber (112) Top;Several second partitions (1115), several described second partitions (1115) point are provided with first accommodating chamber (111) Do not surrounded with the outer wall of the box body (12) and drying is filled with the 3rd accommodating chamber (1116), the 3rd accommodating chamber (1116) Agent;The second partition (1115) is less than the air-vent (1117) of drier particle diameter provided with multiple diameters;Described first accommodates Be additionally provided with multiple chiasma type convex tendons (1114) in chamber (111), first lid (131) with each chiasma type convex tendon (1114) multiple raised lines (1312) are equipped with the position matched;The Test paper (3) includes coated film (32), label Pad (33) and antigen pad (34);It is coated with the antigen pad (34) in varicella virus and antigen, the label is combined It is coated with pad (33) in the mouse water resistant poxvirus of colloid gold label and antigen monoclonal antibody, it is fixed on the coated film (32) Have and be coated with mouse anti-human IgG antibodies, the Quality Control C on detection T lines (321) and Quality Control C lines (322), the detection T lines (321) Line is coated with sheep anti-mouse igg antibody on (322);The lowest detection line of the Test paper (3) is 5U/ml.
2. a kind of chicken pox vaccine effect of inoculation Fast Evaluation kit according to claim 1, it is characterised in that:Described second The quantity of dividing plate (1115) is two, and the second partition (1115) described in two is respectively arranged on first accommodating chamber (111) Front-end and back-end.
3. a kind of chicken pox vaccine effect of inoculation Fast Evaluation kit according to claim 1, it is characterised in that:Described first The positioner for fixing the Test paper (3) is additionally provided with accommodating chamber (111).
4. a kind of chicken pox vaccine effect of inoculation Fast Evaluation kit according to claim 3, it is characterised in that:The positioning Device includes positioning component (1112) and movable component (1113), the positioning component (1112) and the movable component (1113) It is respectively arranged on the left end and right-hand member of first accommodating chamber (111);The positioning component (1112) includes bottom plate (11121) and U Type locating piece (11122), the bottom plate (11121) is fixed on the box body (12);The U-shaped locating piece (11122) is fixed Top in the bottom plate (11121), and the U-shaped locating piece (11122) openend towards the movable component (1113); The movable component (1113) includes fixed plate (11131), portable plate (11133) and copper sheet (11132), the fixed plate (11131) it is fixed on the box body (12);One end of the copper sheet (11132) is embedded in the fixed plate (11131), institute The other end for stating copper sheet (11132) is supported on the portable plate (11133), and the portable plate (11133) can be in the box body (12) moved in.
5. a kind of chicken pox vaccine effect of inoculation Fast Evaluation kit according to claim 4, it is characterised in that:The activity The bottom of plate (11133) is provided with several and the projection provided with several raised (11134), the bottom of the box body (12) (11134) chute (1118) matched.
6. a kind of chicken pox vaccine effect of inoculation Fast Evaluation kit according to claim 1, it is characterised in that:Described first The bottom of adding mouth on lid (131) is downwardly extending the 3rd cylinder (1313).
7. a kind of chicken pox vaccine effect of inoculation Fast Evaluation kit according to claim 1, it is characterised in that:Described first It is connected between lid (131) and second lid (132) by hinge (133), and first lid (131) and the box It is connected between body (12), between second lid (132) and the box body (12) by snap fit.
8. a kind of chicken pox vaccine effect of inoculation Fast Evaluation kit according to claim 1, it is characterised in that:Described second The second cylinder (1121) is provided with accommodating chamber (112), second cylinder (1121) is used to place the sample diluting liquid splendid attire Container.
9. according to any a kind of chicken pox vaccine effect of inoculation Fast Evaluation kit in claim 1 to 8, its feature exists In:The label pad (33) is glass fibre.
10. according to any a kind of chicken pox vaccine effect of inoculation Fast Evaluation kit in claim 1 to 8, its feature exists In:The antigen pad (34) is glass fibre, non-woven fabrics or polyester film.
CN201720081188.6U 2017-01-20 2017-01-20 A kind of chicken pox vaccine effect of inoculation Fast Evaluation kit Active CN206583914U (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109991416A (en) * 2019-03-12 2019-07-09 江苏伯纳德生物科技发展有限公司 A kind of immunochromatographyassay assay reagent box and preparation method thereof

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109991416A (en) * 2019-03-12 2019-07-09 江苏伯纳德生物科技发展有限公司 A kind of immunochromatographyassay assay reagent box and preparation method thereof

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