CN108226511A - A kind of novel saliva CRP Test papers and preparation method thereof - Google Patents
A kind of novel saliva CRP Test papers and preparation method thereof Download PDFInfo
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- CN108226511A CN108226511A CN201611154088.8A CN201611154088A CN108226511A CN 108226511 A CN108226511 A CN 108226511A CN 201611154088 A CN201611154088 A CN 201611154088A CN 108226511 A CN108226511 A CN 108226511A
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/558—Immunoassay; Biospecific binding assay; Materials therefor using diffusion or migration of antigen or antibody
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/577—Immunoassay; Biospecific binding assay; Materials therefor involving monoclonal antibodies binding reaction mechanisms characterised by the use of monoclonal antibodies; monoclonal antibodies per se are classified with their corresponding antigens
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Abstract
The present invention relates to a kind of novel saliva CRP Test papers and preparation method thereof, including Test paper, spittle collector and detection device, wherein, the Test paper includes sample pad, gold conjugation pad, NC nitrocellulose filters, water sucting plate and PVC board, and the sample pad, gold conjugation pad, NC nitrocellulose filters, water sucting plate are pasted on the PVC board surface；The water sucting plate of the NC nitrocellulose filters of the sample pad and the gold conjugation pad of its underpart, the gold conjugation pad and its underpart, the NC nitrocellulose filters and upper part, partly overlap handing-over respectively.Advantageous effect of the present invention：The qualitative colloidal gold tests of CRP, principle is identical, and only samples sources are different, is using whole blood or serum and blood plasma as detection sample, it is impossible to carry out sxemiquantitative and quantitatively be detected.
Description
Technical field
The present invention relates to medical Test paper field more particularly to a kind of novel saliva CRP Test papers and its making sides
Method.
Background technology
((C-reactive protein, CRP) is a kind of to be formed with streptococcus pneumonia C polysaccharide precursor reactants to c reactive protein
The Acute reaction protein of compound, 19 hours half-life period；Serum CA125 is synthesized by liver, interleukin 1 b, 6 and swollen
Tumor necrosis factor is the most important regulatory factor of its synthesis；The molecular weight of CRP be 105 500, by contain there are five it is identical not
Glycosylated polypeptide sub-units composition, each subunit contain 187 amino acid, are linked between these subunits by non-covalent bond
Pentamer circlewise, and there are one interchain disulfide bonds.CRP can cause the immuno-recuperative function and phagocytosis work to invading cell
With, and show inflammatory reaction.An extremely sensitive indexs of the CRP as acute-phase response, CRP concentration is in the acute heart in blood plasma
Significantly increase rapidly when flesh infarct, wound, infection, inflammation, surgical operation, cancer infiltration, up to 2000 times of normal level.
With reference to clinical medical history, contribute to the follow-up course of disease.Especially in inflammatory process, follow-up rheumatism, systemic loupus erythematosus, leukaemia
Deng.
The method and instrument quickly detected to c reactive protein at present is more, mainly has colloidal gold immunity chromatography, fluorescence to exempt from
The detection methods such as epidemic disease chromatography, immunoturbidimetry, chemoluminescence method, enzyme-linked immunization, detection sample be mostly human serum, blood plasma or
Whole blood.Health care professional is needed to acquire blood sample, result interpretation relies on the reasons such as professional detecting instrument.Patient can not complete family
It tests oneself.At home and abroad there is no the c reactive protein saliva Test papers developed and produced using human saliva as detection sample at present
Item.
There are following shortcomings during its use for existing blood testing strips item：Sample collection can bring certain pain
Bitterly, it is difficult to receive for many sample collection persons；And the medical staff of profession is needed when acquiring blood sample, and can be made during acquisition blood sample
Into wound, potential danger is generated, it is very inconvenient, it is not suitable for patient home and tests oneself；Blood sample can only be detected, including whole blood,
Blood plasma, serum；Prior art products do not carry out half-quantitative detection；There is no dedicated mating smart mobile phone APP to carry out quantitative inspection
It surveys, realizes that individual tests oneself and retains and detect CRP results.
In view of drawbacks described above, creator of the present invention obtains this creation finally by prolonged research and practice.
Invention content
Present invention aims at a kind of novel saliva CRP Test papers and preparation method thereof are provided, to overcome above-mentioned skill
Art defect.
To achieve the above object, present invention employs following technical solutions：A kind of novel saliva CRP Test papers, including
Test paper, spittle collector and detection device, wherein,
The Test paper includes sample pad, gold conjugation pad, NC nitrocellulose filters, water sucting plate and PVC board, institute
The sample pad stated, gold conjugation pad, NC nitrocellulose filters, water sucting plate are pasted on the PVC board surface；
The NC nitric acid of the sample pad and the gold conjugation pad of its underpart, the gold conjugation pad and its underpart
The water sucting plate of cellulose membrane, the NC nitrocellulose filters and upper part, partly overlap handing-over respectively；
The gold conjugation pad is sprayed with the CRP- alpha monoclonal antibodies of colloid gold label；
Two parallel antibody capture lines are drawn on the NC nitrocellulose membranes respectively, close to the one of gold conjugation pad
CRP- β monoclonal antibody monoclonal antibodies, as detection line, another contains the sheep anti-mouse igg antibody through concentration is determined, as
Normal concentration colour developing nature controlling line.
Further, the spittle collector is wound packages spittle collector, including acquisition handle frame, container cartridge, is adopted
Market-head and cylinder cap, the acquisition handle frame are arranged on the top of collection head, and the two is connected as a single entity；Acquire handle frame and collection head
It is arranged on inside container cartridge.
Further, the detection device is the first CRP Test paper cards.
Further, the detection device is the 2nd CRP Test paper cards.
Further, the detection device is mating color chart, is provided with T lines color and corresponding concentration value, can
Carry out CRP concentration half-quantitative detections.
Further, the detection device is APP softwares, is stored with corresponding detectable concentration value, can carry out CRP
Concentration quantitative or half-quantitative detection.
The present invention also provides a kind of production method of novel saliva CRP Test papers, which is：
1) preparation of sample pad：Glass fibre element film is cut into 25*30cm, is impregnated on 30 minutes with sample pad treatment fluid,
Drying is taken out, the 2.5*30cm sample filler strips for being cut into respective width are spare；
2) preparation of gold conjugation pad：Colloidal gold liquid, which is prepared, with gold chloride-trisodium citrate reduction method cools down spare, tune
Whole pH value adds in the CRP- alpha monoclonal antibodies of required amount, stirs 30 minutes, add in suitable BSA, stir 10 points to appropriate value
Supernatant is removed in clock, centrifugation, adds in suitable redissolution liquid and redissolves to appropriate volume, shaken well is sprayed on polyester film, 37 DEG C of dryings
4 hours or more, the direction of liquid is redissolved along metal spraying, in the case that ensure every it is golden complete, be cut into 1*30cm colloidal gold knots
It is spare to close pad；
3) preparation of coated film：It dilutes CRP- β monoclonal antibodies respectively with antibody diluent and sheep anti mouse resists to certain more
Concentration, cross respectively on NC films, be respectively formed T and C lines, such as the position of the said goods figure, 37 DEG C of dryings 4 hours or more,
Then it is spare to be cut into 30cm long；
4) preparation of water-absorbent material：It is spare that water sucting plate is cut into 3.3*30cm bar shapeds；
5) golden film combines：By the sequence of coated film, water-absorbent material, gold conjugation pad, sample pad according to upper figure and stacking
It is sticked in PVC board, forms profiled sheeting；
6) it cuts：Above-mentioned profiled sheeting is cut into 3mm or requires the item of width；
7) stripe shape product：Pack and sealing：Above-mentioned item is respectively charged into aluminum foil bag one by one, sealed；It is spare；
7) board products：Pack and sealing：6) item that step produces is respectively charged into corresponding card, is respectively charged into aluminium
It moors in bag, sealing；It is spare.
Further,
The production technology of above-mentioned wound packages collector is：
1) handle frame, collection head, container cartridge, cylinder cap are acquired to be cleaned three times with purified water, scatters be laid in clothes hanger respectively；
2) above-mentioned clothes hanger is pushed into drying chamber and be dried, is respectively charged into for use in clean bag；
3) collection head is soaked in specific solution, is placed on clothes hanger within 30 minutes, scatters and be laid on clothes hanger, then
It is sent into dry in drying chamber；
4) collection head for taking drying has been crossed acquisition handle frame and immersion treatment dried, by collection head in ultrasonic wave
The connecting pin of acquisition handle frame is welded on bonding machine；Quality inspection；
5) collector welded of quality inspection qualification is packed into each container cartridge one by one, takes a cap；
More than process is produced in 100,000 grades of clean rooms；
7) above-mentioned assembling is finished after collector sterilized, and quality inspection qualification storage is for use.
Further,
Above-mentioned color chart production technology is：
1) CRP quality-control products concentration (mg/L) is respectively configured：0.5、1、5、10、20、50、80、100、120、150；
2) it detects the quality-control product of above-mentioned concentration respectively with qualified CRP Test papers, obtains the developed band of detection line respectively；
3) developed band with camera is taken pictures, passed on computer, concentration and developed band are corresponded, do color chart
Template original；
4) color chart original is printed factory is printed；
5) quality inspection qualification enters for use.
Compared with prior art, the present invention is detected using saliva sample, is exempted from reference to colloidal gold more mature at present
Epidemic disease chromatographic technique, can it is easy, quick, completion CRP of the patient without any injury is detected, it can be used for the quick of medical institutions
Detection, it more difficult to can it is valuable be that consumer can be allowed to test oneself.
In addition it can 1) be compared by color chart matching used with this project, CRP concentration sxemiquantitative inspection can be carried out
It surveys.2) it is combined by intelligence APP mobile phones matching used together with this project, CRP concentration can be carried out and carry out quantitative detection.Disappear
Expense person also oneself can carry out the medication that holds water according to mobile phone prompting suggestion, prevent abuse of antibiotics.3) this product is used continuously,
Therapeutic effect can be evaluated.
Advantageous effect of the present invention：
1) the qualitative colloidal gold tests of CRP, principle is identical, and only samples sources are different, are with whole blood or blood
Cleer and peaceful blood plasma is detection sample, it is impossible to carry out sxemiquantitative and quantitatively be detected.
2) CRP quantifies colloidal gold test, and principle is identical, and sample is whole blood or serum and blood plasma, but it is by colloid
Golden test paper and the gold mark readout instrument of profession combine and carry out quantitative detection, are now widely used for medical institutions.
Description of the drawings
Fig. 1 is the structure diagram of the wound packages spittle collector of the present invention；
Fig. 2 is the structure diagram of the first CRP Test paper cards of the present invention；
Fig. 3 is the structure diagram of the 2nd CRP Test paper cards of the present invention；
Fig. 4 is the structure diagram of the color chart of the present invention；
Fig. 5 is the structure diagram of the Test paper of the present invention；
Fig. 6 is the flow chart of the processing technology of the novel saliva CRP Test papers of the present invention.
Specific embodiment
Below in conjunction with the attached drawing in the embodiment of the present invention, the technical solution in the embodiment of the present invention is carried out clear, complete
Site preparation describes, it is clear that described embodiment is only part of the embodiment of the present invention, instead of all the embodiments.
Embodiment one
The saliva CRP Test papers of the present embodiment include Test paper, spittle collector and the first CRP Test paper cards,
Wherein, the spittle collector is wound packages spittle collector.
The first CRP Test papers card includes card bottom, test strips and Ka Gai compositions.Wherein, have in the card bottom
Card slot, test strips are placed in card slot, and sample pad end corresponds to sample-adding end, and water sucting plate corresponds to handheld terminal.Card is stamped liquid collecting well 21
With display window 22, after card bottom installs test strips, Ka Gai is covered, is fastened.The liquid collecting well of Ka Gai corresponds to sample pad end, display
Window corresponds to NC nitrocellulose filters；Ka Gai and card bottom are positioned and are installed by column 23.
Reaction principle is：
The liquid collecting well of test card is inserted into collection head one end that single collector of saliva will be collected, and slightly firmly squeezes,
Saliva sample is the sample end for being added to test strips, and sample starts lateral chromatography movement, is detected, the same test strips of principle,
When containing a certain amount of CRP antigens in sample, display window shows two parallel lines (C and T), when not having CRP to resist in sample
Hereinafter, display window only shows a C line when former or less than detection range of linearity lower concentration values.
The wound packages collector cylinder cap for being collected saliva is backed out, the middle part of collection cylinder is pinched, saliva sample is squeezed into test card
Liquid collecting well, saliva sample are the sample end for being added to test strips, and sample starts lateral chromatography movement, is detected, former
Same test strips are managed, when containing a certain amount of CRP antigens in sample, display window shows two parallel lines (C and T), when in sample
Do not have during CRP antigens or less than detection range of linearity lower concentration values hereinafter, display window only shows a C line.
Refering to Figure 1, the wound packages spittle collector includes acquisition handle frame 11, container cartridge 12, collection head 13
With cylinder cap 14, the acquisition handle frame 11 is arranged on the top of collection head 13, and the two is connected as a single entity；It acquires handle frame 11 and adopts
Market-head 13 is arranged on inside container cartridge 12.
It please refers to shown in Fig. 5, the Test paper of the present embodiment includes sample pad 1, gold conjugation pad 2, NC cellulose nitrates
Plain film 3, water sucting plate 4 and PVC board 5, the sample pad 1, gold conjugation pad 2, NC nitrocellulose filters 3, water sucting plate 4 are pasted
In 5 surface of PVC board, and its is of same size；
The sample pad 1 and the gold conjugation pad 2 of its underpart, the gold conjugation pad 2 and the NC of its underpart
Nitrocellulose filter 3, the NC nitrocellulose filters 3 and the water sucting plate 4 of upper part, partly overlap handing-over respectively, and overlapping is wide
Degree is respectively 1-4mm.
The gold conjugation pad 2 is sprayed with the CRP- alpha monoclonal antibodies of colloid gold label；
Two parallel antibody capture lines are drawn on the NC nitrocellulose membranes 3 respectively, close to gold conjugation pad 2
One CRP- β monoclonal antibody monoclonal antibody, as detection line 6, i.e. T lines, another contains the sheep anti-mouse igg through concentration is determined
Antibody, as normal concentration colour developing nature controlling line 7, i.e. C lines.
Embodiment two
The saliva CRP Test papers of the present embodiment include Test paper, spittle collector and the 2nd CRP Test paper cards,
Wherein, the spittle collector is the wound packages spittle collector of embodiment one；Test paper is the Test paper of embodiment one；
The difference is that use the 2nd CRP Test paper cards.
It please refers to shown in Fig. 3, the 2nd CRP Test papers card includes card bottom, test strips and Ka Gai, has card slot in card bottom, tries
Paper slip is placed in card slot, and sample pad end corresponds to sample-adding end, and water sucting plate corresponds to handheld terminal.Card is stamped well 31 and display window 32,
After card bottom installs test strips, Ka Gai is covered, is fastened.The liquid collecting well of Ka Gai corresponds to sample pad end, and display window corresponds to NC nitre
Acid cellulose film.Card bottom and Ka Gai are positioned and are installed by column 33.
The wound packages collector cylinder cap for being collected saliva is backed out, the middle part of collection cylinder is pinched, saliva sample is squeezed into test card
Liquid collecting well, saliva sample are the sample end for being added to test strips, and sample starts lateral chromatography movement, is detected, former
Same test strips are managed, when containing a certain amount of CRP antigens in sample, display window shows two parallel lines (C and T), works as sample
In do not have during CRP antigens or less than detection range of linearity lower concentration values hereinafter, display window only shows a C line.
Embodiment three
The present embodiment uses sxemiquantitative saliva CRP Test papers, including Test paper, spittle collector device and with chromatography
Mark card；
Wherein, the Test paper is identical with the Test paper of embodiment one, and the spittle collector device is real
Apply the wound packages spittle collector of example one；Using the first CRP Test paper cards.
Wherein, T lines color and corresponding concentration value are provided on the mating color chart.It can carry out CRP concentration semidefinites
Amount detection.
Example IV
The present embodiment uses sxemiquantitative saliva CRP Test papers, including Test paper, spittle collector device and with chromatography
Mark card；
Wherein, the Test paper is identical with the Test paper of embodiment one, and the spittle collector device is real
Apply the wound packages spittle collector of example one；The difference is that the 2nd CRP Test paper cards using embodiment two.It can carry out CRP concentration
Half-quantitative detection.
Embodiment five
The present embodiment is using quantitative saliva CRP Test papers, including Test paper, spittle collector device and equipped with mating
APP software smart mobile phones；
Wherein, the Test paper is identical with the Test paper of embodiment one, using the first CRP Test paper cards；
Wherein, the APP software memories contain corresponding detectable concentration value.It can carry out CRP concentration quantitatives or semidefinite
Amount detection.
The present invention reaction mechanism be：
Sample acquires saliva by the spittle collector that this product carries, and the principle of product development is by c reactive protein list
Clonal antibody and sheep anti-mouse igg are coated on cellulose nitrate film respectively, are the specific pole of colloid gold label on polyester film
Strong c reactive protein monoclonal antibody.When detecting, as there is no c reactive protein presence, the specificity of colloid gold label in sample
Antibody forms two red lines (detection line a T, a nature controlling line C) with the antigen binding of film area, shows testing result for feminine gender；
When reaching 10mg/L such as the concentration there are c reactive protein and c reactive protein in sample, c reactive protein molecule just with
The c reactive protein antibody of colloid gold label combines, and when sample is sprung up forward, the C that can be coated on nitrocellulose filter reacts
Protein monoclonal antibody captures, and forms macroscopic (purple) red detection line, and the coated sheep anti-mouse igg of nature controlling line can also be caught
The c reactive protein monoclonal antibody of colloid gold label is obtained, so as to form one (purple) red nature controlling line, shows testing result for sun
Property.In certain concentration range, the colour developing color of detection line is deeper to illustrate that concentration is higher, otherwise concentration is lower.It in addition, can
Carrying out sxemiquantitative 1) mating gradient colour developing card is that the reaction color of the standard quality-control product detection line for detecting various concentration makes phase
The gradient answered, in use, the detection line in testing result and colour atla are compared, you can know the about concentration of CRP in sample.
Quantitative detection is carried out 2) with the detection of matching used smart mobile phone APP scanning test paper if can be also used in combination with cell phone application
Line and nature controlling line, mobile phone can detect the concentration of sample with direct quantitative.
In current CRP detection techniques and application, be using whole blood or serum and blood plasma to detect sample, not with
Saliva is as sample object.
It please refers to shown in Fig. 6, a kind of novel saliva CRP Test papers provided by the invention, including
A kind of production method of novel saliva CRP Test papers provided by the invention is as follows：
1) preparation of sample pad：Glass fibre element film is cut into 25*30cm, is impregnated on 30 minutes with sample pad treatment fluid,
Drying is taken out, the 2.5*30cm sample filler strips for being cut into respective width are spare；
2) preparation of gold conjugation pad：Colloidal gold liquid, which is prepared, with gold chloride-trisodium citrate reduction method cools down spare, tune
Whole pH value adds in the CRP- alpha monoclonal antibodies of required amount, stirs 30 minutes, add in suitable BSA, stir 10 points to appropriate value
Supernatant is removed in clock, centrifugation, adds in suitable redissolution liquid and redissolves to appropriate volume, shaken well is sprayed on polyester film, 37 DEG C of dryings
4 hours or more, the direction of liquid is redissolved along metal spraying, in the case that ensure every it is golden complete, be cut into 1*30cm colloidal gold knots
It is spare to close pad；
3) preparation of coated film：It dilutes CRP- β monoclonal antibodies respectively with antibody diluent and sheep anti mouse resists to certain more
Concentration, cross respectively on NC films, be respectively formed T and C lines, such as the position of the said goods figure, 37 DEG C of dryings 4 hours or more,
Then it is spare to be cut into 30cm long；
4) preparation of water-absorbent material：It is spare that water sucting plate is cut into 3.3*30cm bar shapeds；
5) golden film combines：By the sequence of coated film, water-absorbent material, gold conjugation pad, sample pad according to upper figure and stacking
It is sticked in PVC board, forms profiled sheeting；
6) it cuts：Above-mentioned profiled sheeting is cut into 3mm or requires the item of width；
7) stripe shape product：Pack and sealing：Above-mentioned item is respectively charged into aluminum foil bag one by one, sealed；It is spare；
7) board products：Pack and sealing：6) item that step produces is respectively charged into corresponding card, is respectively charged into aluminium
It moors in bag, sealing；It is spare.
Wherein, the production technology of above-mentioned wound packages collector is：
1) handle frame, collection head, container cartridge, cylinder cap are acquired to be cleaned three times with purified water, scatters be laid in clothes hanger respectively；
2) above-mentioned clothes hanger is pushed into drying chamber and be dried, is respectively charged into for use in clean bag；
3) collection head is soaked in specific solution, is placed on clothes hanger within 30 minutes, scatters and be laid on clothes hanger, then
It is sent into dry in drying chamber；
4) collection head for taking drying has been crossed acquisition handle frame and immersion treatment dried, by collection head in ultrasonic wave
The connecting pin of acquisition handle frame is welded on bonding machine；Quality inspection；
5) collector welded of quality inspection qualification is packed into each container cartridge one by one, takes a cap；
More than process is produced in 100,000 grades of clean rooms；
7) above-mentioned assembling is finished after collector sterilized, and quality inspection qualification storage is for use.
Wherein, above-mentioned color chart production technology is：
1) CRP quality-control products concentration (mg/L) is respectively configured：0.5、1、5、10、20、50、80、100、120、150；
2) it detects the quality-control product of above-mentioned concentration respectively with qualified CRP Test papers, obtains the aobvious of detection line (T lines) respectively
Colour band；
3) developed band with camera is taken pictures, passed on computer, concentration and developed band are corresponded, do color chart
Template original；
4) color chart original is printed factory is printed；
5) quality inspection qualification enters for use.
More than specific embodiment is merely illustrative of the technical solution of the present invention and unrestricted, although with reference to preferred embodiment
The present invention is described in detail, it will be understood by those of ordinary skill in the art that, can to technical scheme of the present invention into
Row modification or equivalent replacement without departing from the spirit and scope of technical solution of the present invention, should all cover the power in the present invention
In sharp claimed range.
Claims (9)
1. a kind of novel saliva CRP Test papers, which is characterized in that using saliva as detection sample, including Test paper, saliva
Collector and detection device, wherein,
The Test paper includes sample pad, gold conjugation pad, NC nitrocellulose filters, water sucting plate and PVC board, described
Sample pad, gold conjugation pad, NC nitrocellulose filters, water sucting plate are pasted on the PVC board surface；
The NC cellulose nitrates of the sample pad and the gold conjugation pad of its underpart, the gold conjugation pad and its underpart
The water sucting plate of plain film, the NC nitrocellulose filters and upper part, partly overlap handing-over respectively；
The gold conjugation pad is sprayed with the CRP- alpha monoclonal antibodies of colloid gold label；
Two parallel antibody capture lines are drawn on the NC nitrocellulose membranes respectively, close to one of gold conjugation pad
CRP- β monoclonal antibody monoclonal antibodies, as detection line, another contains the sheep anti-mouse igg antibody through concentration is determined, as mark
Quasi- concentration colour developing nature controlling line.
2. novel saliva CRP Test papers according to claim 1, which is characterized in that the spittle collector is cylinder
Spittle collector is filled, acquisition is arranged on including acquisition handle frame, container cartridge, collection head and cylinder cap, the acquisition handle frame
The top of head, the two are connected as a single entity；Acquisition handle frame and collection head are arranged on inside container cartridge.
3. novel saliva CRP Test papers according to claim 1, which is characterized in that the detection device is first
CRP Test paper cards.
4. novel saliva CRP Test papers according to claim 1, which is characterized in that the detection device is second
CRP Test paper cards.
5. novel saliva CRP Test papers according to claim 1, which is characterized in that the detection device is mating
Color chart is provided with T lines color and corresponding concentration value, can carry out CRP concentration half-quantitative detections.
6. novel saliva CRP Test papers according to claim 1, which is characterized in that the detection device is soft for APP
Part is stored with corresponding detectable concentration value, can carry out CRP concentration quantitatives or half-quantitative detection.
7. a kind of production method of novel saliva CRP Test papers, which is characterized in that the preparation method is：
1）The preparation of sample pad：Glass fibre element film is cut into 25*30cm, is impregnated on 30 minutes with sample pad treatment fluid, is taken out
Drying, the 2.5*30cm sample filler strips for being cut into respective width are spare；
2）The preparation of gold conjugation pad：Colloidal gold liquid, which is prepared, with gold chloride-trisodium citrate reduction method cools down spare, adjustment PH
It is worth to appropriate value, adds in the CRP- alpha monoclonal antibodies of required amount, stir 30 minutes, add in suitable BSA, stirs 10 minutes, from
The heart removes supernatant, adds in suitable redissolution liquid and redissolves to appropriate volume, and shaken well is sprayed on polyester film, 37 DEG C of dryings 4 hours
More than, the direction of liquid is redissolved along metal spraying, in the case that ensure every it is golden complete, it is standby to be cut into 1*30cm gold conjugation pads
With；
3）The preparation of coated film：CRP- β monoclonal antibodies and sheep anti mouse is diluted respectively with antibody diluent to resist to certain dense more
Degree, crosses on NC films, is respectively formed T and C lines respectively, such as the position of the said goods figure, 37 DEG C of dryings 4 hours or more, then
It is spare to be cut into 30cm long；
4）The preparation of water-absorbent material：It is spare that water sucting plate is cut into 3.3*30cm bar shapeds；
5）Golden film combines：Coated film, water-absorbent material, gold conjugation pad, sample pad are sticked to according to the sequence and stacking of upper figure
In PVC board, profiled sheeting is formed；
6）Cutting：Above-mentioned profiled sheeting is cut into 3mm or requires the item of width；
7）Stripe shape product：Pack and sealing：Above-mentioned item is respectively charged into aluminum foil bag one by one, sealed；It is spare；
7）Board products：Pack and sealing：By 6）The item of step production is respectively charged into corresponding card, is respectively charged into aluminum foil bag
In, sealing；It is spare.
8. the production method of novel saliva CRP Test papers according to claim 7, which is characterized in that
The production technology of above-mentioned wound packages collector is：
1）Acquisition handle frame, collection head, container cartridge, cylinder cap are cleaned three times with purified water, scatter be laid in clothes hanger respectively；
2）Above-mentioned clothes hanger is pushed into drying chamber and is dried, is respectively charged into for use in clean bag；
3）Collection head is soaked in specific solution, is placed on clothes hanger within 30 minutes, is scattered and be laid on clothes hanger, be then fed into
It is dry in drying chamber；
4）The collection head for taking drying has been crossed acquisition handle frame and immersion treatment dried, by collection head in ultrasonic bonding
The connecting pin of acquisition handle frame is welded on machine；Quality inspection；
5）The collector welded of quality inspection qualification is packed into each container cartridge one by one, takes a cap；
More than process is produced in 100,000 grades of clean rooms；
6）Above-mentioned assembling is finished after collector sterilized, and quality inspection qualification storage is for use.
9. the production method of novel saliva CRP Test papers according to claim 7, which is characterized in that
Above-mentioned color chart production technology is：
1）CRP quality-control product concentration is respectively configured（mg/L)：0.5、1、5、10、20、50、80、100、120、150；
2）It detects the quality-control product of above-mentioned concentration respectively with qualified CRP Test papers, obtains the developed band of detection line respectively；
3）Developed band with camera is taken pictures, is passed on computer, concentration and developed band are corresponded, does the template of color chart
Original；
4）Color chart original is printed factory is printed；
5）Quality inspection qualification enters for use.
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