CN206583915U - A kind of hepatitis B vaccination effect Fast Evaluation kit - Google Patents

Abstract

The utility model is related to a kind of hepatitis B vaccination effect 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 are correspondingly arranged a lid；Drier is also filled with box body；Test paper includes coated film, label pad, antigen pad；It is coated with antigen pad on hepatitis B virus surface antigen, label pad and is coated with mouse anti-hepatitis B virus surface antigen monoclonal antibody, 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 10mIU/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 hepatitis B vaccination effect Fast Evaluation kit

Technical field

The utility model is related to technical field of biological, and in particular to a kind of hepatitis B vaccination effect Fast Evaluation examination Agent box.

Background technology

Hepatitis type B virus is a kind of a diameter of 42nm, belongs to Hepadnaviridae, is a kind of double-strand, tunicary virus. HBsAg is a kind of lipoprotein on peplos, can be circulated in blood, in spherical and tubular particle, a diameter of 22nm. HBsAg contains neutralizing epitope, i.e. α antigenic determinants.

After the mankind are unique host of hepatitis type B virus, hepatitis b virus infected human body, can produce one it is extensive Spectrum of disease, including symptomless infection, acute hepatitis B and chronic hepatitis B.Formed after people's hepatitis b virus infection Chronic infection, can be further developed into as chronic hepatitis, eventually result in hepatic sclerosis and liver cancer.Acute hepatitis b sees about 1% Perinatal period HBV infection, 10% brephic (1~5 years old) HBV infection and 30% other age bracket (＞ 5 years old) HBV infections.It is quick-fried Hair style infection sees 0.1%~0.6% acute hepatitis cases, and its case fatality rate is about 70%.The generation of chronic HBV infection with The infection age is negatively correlated, accounts for the 80%~90% of perinatal period HBV infection person, accounts for infancy (＜ 6 years old) HBV infection person's 30%, account for the ＜ 5% of adult the infected of no other diseases.

The clinical manifestation of acute hepatitis B is difficult to distinguish with other virus hepatitis, and it, which is made a definite diagnosis, needs according to serological test Result.It is 90 days (scopes from the average latency occurred exposed to the infection sources to jaundice：60~150 days)；From leaking cruelly in biography Dye source to the abnormal average latency of serum alanine aminotransferase (ALT) be 60 days (scopes：40~90 days).Acute The performance for infecting prodromal stage is various, and its feature shows as discomfort, apocleisis, Nausea and vomiting, low-heat, myalgia and fatiguability etc. Symptom.In prodromal stage.5%~10% patient may occur in which arthralgia or arthritis, fash and angioedema.With jaundice Hepatitis cases, jaundice symptom is typically occurred in 1~2 week after morbidity；Dark brown urine, clay color stool occur to go out in jaundice symptom In 1~5 day before existing.In stage of icterus, due to the silght enlargement of liver, its premonitory symptom is usually expressed as becoming thin and right upper quadrant of the abdomen Pain.10%~30% acute hepatitis B case myalgia can occur in the case of no jaundice and other clinical manifestations Or arthralgia, 1/3 disease may occur in which maculopapule.The clinical symptoms of acute hepatitis B generally disappeared in 1~3 month.

Patients with Chronic HBV Infection has 15%~25% may be because suffering from the related hepatic sclerosis of HBV and HCC and premature death. Clinically can not possibly by hepatitis B with the hepatitis caused by other virokines distinguish Lai.Therefore, it is necessary to pass through laboratory Detect to confirm diagnosis.From serological angle, acute HBV infection is characterized in the presence of the anti-core of HBsAg and IgM types Heart antigen-antibody (IgM types Anti-HBc Serum).In initial infection, viral massive duplication also can be in hepatitis B virus e antigen in patients serum (HBeAg) it is positive.AntiHBsAg antibody (Anti-HBsAg antibody) can be used as the mark of immunity in appearance after several weeks, usual IgG types Anti-HBsAg antibody Thing, therewith HbsAg be eliminated.Chronic infection is characterized in that HbsAg (while can with or without HBeAg) continues the presence of (＞ 6 months).HBsAg lasting presence is that occur chronic liver disease and progress to the main danger mark of hepatocellular carcinoma in later life Will.The infectiousness that HBV carrier has height for blood and body fluid is then pointed out in HBeAg presence.

Current hepatitis B is also without clearly effective treatment method, and it is inoculation second to prevent hepatitis B infected most efficient method Liver surface antigen vaccine, the protectiveness effect that hepatitis B vaccination is formed is related to the induction of Anti-HBsAg antibody, but is directed to memory T The induction of cell.1~3 month after fundamental immunity last pin injection, antibody titer >=10mIU/ml is such as measured, then can be considered collection Body possesses defensive ability/resistance ability to HBV infection.Complete after 3 pin fundamental immunities, can in 95% baby, children and Young Adults Induce the antibody level for reaching protectiveness.In the adult after 40 years old, antibody response rate is gradually reduced.For 3 pins basis Antibody response can be almost induced after immunological unresponsiveness person (i.e. Anti-HBsAg antibody titre is not up to >=10mIU/ml), the pin of multiple cropping 3.WHO Advise carrying out some people at highest risk immunity after inoculation in position paper on " hepatitis B vaccine " to detect.Detection should be It has been inoculated with last pin hepatitis B vaccine to carry out after 1~2 month, using can determine that Anti-HBsAg antibody protectiveness titre (>=10mIU/ml) Method.European hepatitis B immune common recognition group suggestion, immunologic hypofunction person should receive one-time detection every year, assess Anti-HBsAg antibody titre. , should multiple cropping such as by Anti-HBsAg antibody titre ＜ 10mIU/ml in kind of person's body after whole fundamental immunity terminates.The pin of multiple cropping meter 3, is connecing Finish the 3rd pin and anti-HBS antibody is detected after 1~2 month.

The Immune Programming work is all one of emphasis of Chinese government's work all the time, and the epidemic prevention of children concerns one Raw health, vaccine inoculation, prevention from suffering from the diseases are even more important more than the treatment of epidemic disease.Difference, vaccine due to individual immunity level Quality, the specification of vaccine program whether and antibody level such as is gradually reduced at the reason, after vaccine inoculation, big portion over time Divide crowd to obtain immunoprotection, but still there is part population to cause antibody level low due to above reason, it is impossible to resist correlation The invasion and attack of infectious disease.Carry out antibody test, not enough crowd is targetedly reseeded to antibody level, is exempted to being effectively formed Epidemic disease barrier, the generation kept off infection, the health of protection correlated crowd have highly important meaning.China is by exerting for many years Power, planned immunization has obtained suitable achievement, but is immunized after vaccine inoculation after related corresponding antibody level detection, vaccine inoculation The work such as the evaluation of effect relatively lag behind, and country has strengthened the job placement deployment of this respect at present.

To adapt to the demand that market, clinical hospitals at different levels and Center for Disease Control at different levels carry out antibody test, through great efforts, We have developed the anti-HBs diagnostic kit (collaurum for being suitable for whole blood, serum, plasma sample Method), stabilization of kit, its lowest detection is limited to 10mIU/ml, and the term of validity reaches a year and a half, every time detection only need 5 microlitres of whole bloods, Serum/plasma.

This kit is applied to the examination of Hepatitis B surface antibody, and screening results can be applied to be inoculated with hepatitis type B virus After vaccine crowd produce hepatitis B virus antibody positive rate detection, hepatitis B relevant epidemiologic investigation, individual it is B-mode The judgement of hepatitis viruse neurological susceptibility.

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. ELISA and chemoluminescence method being used the commercial kit that Hepatitis B surface antibody is detected on Vehicles Collected from Market more, these Although method sensitivity is high, result accurate, chemical illuminating reagent can also be quantified to antibody, exist in practical operation Inconvenience, such as step are complicated, time-consuming longer, also need to use specific instrument and equipment；Kit needs 4 DEG C of preservations；Will to sample Venous blood collection etc. is sought, is difficult to popularize in basic unit and uses.

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 hepatitis B vaccination effect 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 hepatitis B vaccination effect 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 first cylinders, described first are provided with first accommodating chamber Lid is provided with multiple the first projections matched with first cylinder；The Test paper includes coated film, label knot Close pad and antigen pad；It is coated with the antigen pad on hepatitis B virus surface antigen, the label pad and is coated with colloid Detection T lines and Quality Control C lines, institute are fixed with the mouse anti-hepatitis B virus surface antigen monoclonal antibody of gold mark, the coated film State to be coated with mouse anti-human IgG antibodies, the Quality Control C lines on detection T lines and be coated with sheep anti-mouse igg antibody；The Test paper Lowest detection line is 10mIU/ml.

The beneficial effects of the utility model are：The Test paper used, by introducing hepatitis B virus surface antigen pad, together When in antigen pad add antigen protection liquid, solve hepatitis B virus surface antigen due to stability difference and be not easy by gold mark The problem of；On the other hand, the hepatitis B virus surface antigen used is crude antigen, 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 hepatitis B vaccination 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 10mIU/ml, and the rapid evaluation to hepatitis B vaccination effect 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：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 hepatitis B vaccination effect 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 hepatitis B vaccination effect Fast Evaluation kit includes packing box 1, sample dilution Liquid container containing and Test paper 3；The packing box 1 includes being provided with the first dividing plate in box body 12 and lid 13, the box body 12 11,12 points of the box body is the first accommodating chamber 111 and the second accommodating chamber 112 by the first dividing plate 11；The Test paper 3 is located at institute State in the first accommodating chamber 111, the sample diluting liquid container containing is in second accommodating chamber 112；The lid 13 is wrapped Include the first lid 131 and the second lid 132, first lid 131 is located at the top of first accommodating chamber 111, described the Two lids 132 are 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 The mouse anti-hepatitis B virus surface antigen list of colloid gold label is coated with hepatitis B virus surface antigen, the label pad 33 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 is coated with anti-human IgG antibodies, the Quality Control C lines 322；The lowest detection line of the Test paper 3 is 10mIU/ml.By sample diluting liquid container containing and Test paper 3 in the packing box 1, user when in use, without in addition Prepare sample diluting liquid, use more facilitates, and sample diluting liquid container containing and Test paper 3 are respectively placed in the two of kit In individual accommodating chamber, and one lid 13 of corresponding setting, make the size of kit compacter, another user only needs when in use Open the second lid 132 and can be taken off sample diluting liquid, Test paper 3 will not be interfered；Separately it is placed with packing box 1 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 10mIU/ml, and the rapid evaluation to hepatitis B vaccination effect 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 hepatitis B vaccination effect 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 preparation, assembling, Cleaning Principle and the Detection results of Hepatitis B Surface IgG antibody Test paper 3 It is described in detail：

1st, main material

Antigen：Hepatitis B virus surface antigen is bought purchased from Xiamen Bo Sheng Bioisystech Co., Ltd, and it is thick pure, is not had 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.

Mouse anti-hepatitis B virus surface antigen monoclonal antibody, purchased from Wuhan Saixin Biological Technology Co., 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 by company in Wuhan City's institution of clinical trial above the provincial level, and wherein Hepatitis B Surface IgG resists 217 parts of body positive sample, 147 parts of negative sample.

Anti-HBs detection kit (colloidal gold method)：It is limited purchased from the biological high-tech stock part of Sichuan mikey Company, is the commercial product for having State Bureau's registration certificate.

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 1.0mg Antibody adds mouse anti-hepatitis B virus surface antigen monoclonal antibody 1.0mg, continues to stir 30min, adds final concentration of 1% BSA is closed, and continues to stir 30min.After mark terminates, marking fluid is centrifuged with 10000r/min, supernatant is abandoned, then Precipitation is redissolved to original volume with solution is redissolved, 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.By the gold redissolved Label solution is pressed per 1ml solution paving 18cm²Ratio uniform paving on the glass fibers, be placed in 37 DEG C, relative humidity is less than 20% Environment in, dry 12-18 hours, label pad 33 is made.

3rd, the preparation of antigen pad 34

Hepatitis B virus surface antigen is diluted to 20 times using antigen protection liquid and obtains 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 40%, 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；The hepatitis B virus surface antigen For crude antigen, the wherein content of antigen is 45wt% to 50wt%.

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 110IU/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 1.3ul/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, the assembling of Hepatitis B Surface IgG antibody Test paper 3

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, the application method of Hepatitis B Surface IgG antibody Test paper 3

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 Hepatitis B Surface IgG antibody, its will with antigen pad 34 hepatitis B virus surface antigen formation Hepatitis B Surface Antigen-Hepatitis B Surface IgG antibody compound, the compound is moved forward, and the hepatitis B virus surface antigen in compound is again Combined with the mouse anti-hepatitis B virus surface antigen monoclonal antibody of the colloid gold label in label pad 33, form B-type hepatitis The mouse anti-hepatitis virus surface monoclonal antibodies of malicious surface IgG antibody-hepatitis B virus surface antigen-colloid gold label are immune compound Thing, the compound is moved forward due to chromatography effect along paper slip, to the Hepatitis B Surface IgG detected in T lines 321, compound Antibody and coated mouse anti-human igg monoclonal antibody reactive formation mouse anti-human igg monoclonal antibody-hepatitis B on detection T lines 321 The mouse anti-hepatitis B virus surface antigen monoclonal antibody of virus surface IgG antibody-hepatitis B virus surface antigen-colloid gold label is exempted from Epidemic disease compound, the compound can be gathered in detection zone, when the compound of aggregation reaches certain quantity, then form a naked eyes Visible band (T lines), judged result is the positive；If not contained in sample or containing minimal amount of Hepatitis B Surface IgG antibody, Immune complex can not be then formed, i.e., can not form macroscopic band, judged result is feminine gender；Quality Control C lines 322 are used as examination The quality control standard of agent, positive and negative detection sample can produce band.Specifically, can directly be detected by an unaided eye in 20 minutes 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 Colour developing, detection T lines 321, which do not develop the color, illustrates that hepatitis B vaccination is unsuccessful；Quality Control C lines 322 and detection T lines 321 colour developing explanation Hepatitis B vaccination success.

7th, the complete protection titre of Hepatitis B Surface IgG antibody according to as defined in the World Health Organization is 10mIU/ml, When Hepatitis B Surface IgG antibody concentration >=10mIU/ml illustrates that human body has repellence to Hepatitis B Surface, work as B-type hepatitis Malicious surface IgG antibody concentration ＜ 10mIU/ml illustrate that human body does not produce repellence or only part also to Hepatitis B Surface Protection, therefore the detection critical value for detecting Hepatitis B Surface IgG antibody is set to 10mIU/ml by this Test paper, T lines show Line shows concentration >=10mIU/ml of Hepatitis B Surface IgG antibody, hepatitis B vaccination success, and T lines do not show line and show hepatitis B The concentration ＜ 10mIU/ml of virus surface IgG antibody, hepatitis B vaccination is unsuccessful.Therefore, reagent described in the utility model Box can realize the effect of inoculation of Fast Evaluation Hepatitis B Surface.

8th, clinical sample testing result is compareed

The application Test paper and commercial gold-immunochromatographyreagent reagent for assay box are used the clinical serum sample that company collects simultaneously Detected, then testing result is compareed.

" anti-HBs detection kit (the collaurum of Sichuan Maker Biological Science and Technology Co., Ltd. Method) " it is the product for obtaining State Bureau's registration certificate, use it as the contrast agents box of our company's colloidal gold strip.

Using colloidal gold kit as control, Hepatitis B Surface IgG antibody is detected, 217 parts of B-type hepatitis are detected Malicious surface IgG positive samples, 147 parts of Hepatitis B Surface IgG negative samples, and this Test paper detects 217 parts of B-type hepatitis Malicious surface IgG positive samples, 147 parts of Hepatitis B Surface IgG negative samples, overall coincidence rate is 99.45%.Clinical detection As a result show, the performance of this kit, without significant difference, illustrates that the utility model is fitted compared with granted colloidal gold kit Share in 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 (9)

1. a kind of hepatitis B vaccination effect 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 Multiple first cylinders (1111) are provided with chamber (111), first lid (131) is provided with multiple and first cylinder (1111) first raised (1311) matched；The Test paper (3) include coated film (32), label pad (33) and Antigen pad (34)；It is coated with hepatitis B virus surface antigen, the label pad (33) and is coated with the antigen pad (34) Have and detection T lines are fixed with the mouse anti-hepatitis B virus surface antigen monoclonal antibody of colloid gold label, the coated film (32) (321) and Quality Control C lines (322), it is coated with the detection T lines (321) on mouse anti-human IgG antibodies, the Quality Control C lines (322) It is coated with sheep anti-mouse igg antibody；The lowest detection line of the Test paper (3) is 10mI U/ml.

2. a kind of hepatitis B vaccination effect 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 hepatitis B vaccination effect 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 hepatitis B vaccination effect 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 hepatitis B vaccination effect 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 hepatitis B vaccination effect 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 hepatitis B vaccination effect 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.

8. according to any a kind of hepatitis B vaccination effect Fast Evaluation kit in claim 1 to 7, its feature exists In：The label pad (33) is glass fibre.

9. according to any a kind of hepatitis B vaccination effect Fast Evaluation kit in claim 1 to 7, its feature exists In：The antigen pad (34) is glass fibre, non-woven fabrics or polyester film.