CN102236022A - Detection device - Google Patents

Detection device Download PDF

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Publication number
CN102236022A
CN102236022A CN2010101567815A CN201010156781A CN102236022A CN 102236022 A CN102236022 A CN 102236022A CN 2010101567815 A CN2010101567815 A CN 2010101567815A CN 201010156781 A CN201010156781 A CN 201010156781A CN 102236022 A CN102236022 A CN 102236022A
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CN
China
Prior art keywords
surveyed area
liquid
sample
downstream
label
Prior art date
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Granted
Application number
CN2010101567815A
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Chinese (zh)
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CN102236022B (en
Inventor
胡伯里
赵福铨
刘杰
吴银飞
高飞
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ABON Biopharm Hangzhou Co Ltd
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ABON Biopharm Hangzhou Co Ltd
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Publication date
Application filed by ABON Biopharm Hangzhou Co Ltd filed Critical ABON Biopharm Hangzhou Co Ltd
Priority to CN201010156781.5A priority Critical patent/CN102236022B/en
Priority to CN201510103101.6A priority patent/CN104777298B/en
Publication of CN102236022A publication Critical patent/CN102236022A/en
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Publication of CN102236022B publication Critical patent/CN102236022B/en
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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/558Immunoassay; Biospecific binding assay; Materials therefor using diffusion or migration of antigen or antibody

Abstract

The invention relates to a detection device for detecting whether a sample contains a target analyte. The detection device comprises a carrier which supports the flowing of a liquid sample, wherein the carrier comprises a detection area, which contains specific molecules that bind to the target analyte and is characterized in that the downstream of the detection area contains a structure that slows down the liquid flow speed. The device provided by the invention can be used to improve the detection sensitivity.

Description

A kind of pick-up unit
Technical field
The invention belongs to medical diagnosis class article, whether contain a kind of pick-up unit of target analytes in specifically exactly can the fast detecting sample.
Background technology
In any one check, surveyed area all is very important ingredient.In immunological test, the reaction on these surveyed areas is finished in conjunction with forming by immunity principle usually, and the result on the surveyed area can be shown as the coloured lines on the test bar.Except these basic requirements, the sensitivity that improve to detect is one of target of updating of product.
Summary of the invention
Proving installation provided by the invention, the sensitivity that can well improve pick-up unit.On the one hand, the invention provides a kind of immunoassay device, comprise the carrier of supporting liquid flow, on carrier, comprise surveyed area, comprise the structure of slowing down liquid flow in the downstream of surveyed area.This effect that slows down the structure of liquid flow is exactly to allow more liquid rest on surveyed area or allow liquid rest on for a long time on the surveyed area, allows the material in the liquid fully react the sensitivity that improves detection with the reagent on the surveyed area.
In a mode, surveyed area is positioned on the film, comprises the structure of slowing down liquid flow on the film in surveyed area downstream.When sample solution arrived detection zone, solution temporarily rested on the detection zone, made that the reagent on sample and the surveyed area fully reacts for a long time.Through after the brief stay, liquid is finally finished whole detection because the capillary pulling power effect of film self allows liquid continue to flow to the downstream.In a word, this effect that slows down the structure of liquid flow is that solution can be reacted by the reagent on surveyed area more fully.In a preferred mode, the width of film of making way for the surveyed area downstream is less than the width of surveyed area, when liquid flows to surveyed area, because such structure, allow the flow velocity of liquid slow down or the flow to the surveyed area downstream reduces, allow liquid phase through surveyed area more like this resting on the surveyed area.Along with flowing of liquid, liquid is finally by the diffluence downstream of narrow part.
In another preferred mode, on the subregion in the downstream of surveyed area, handle hydrophobic agents, allow the hydrophobic ability essence of surveyed area downstream part greater than the hydrophobic ability of surveyed area itself.Like this, when liquid flows to surveyed area, because the surveyed area downstream hydrophobic ability different with surveyed area, the liquid that is positioned on the surveyed area is stopped by the hydrophobic part in downstream, flow velocity slows down, allow like this liquid phase to rest on the surveyed area more with surveyed area on reagent contact a little times more, react more abundant, thereby improved the sensitivity that detects.The hydrophobic agents of processing in the surveyed area downstream can be the hydrophobic agents of using always, and be special, can be used for the hydrophobic agents on the nitrocellulose filter.
On the other hand, provide the pick-up unit that includes the immunodiagnosis test strips, be used for the target analytes of test sample.In some embodiments, analyte is an antibody, as resisting HIV (HIV) antibody or anti-hepatitis c virus (HCV) antibody.In the other embodiment, analyte is an antigen, as human chorionic gonadotrophin (hCG).
This diagnosis test paper preferably includes and contains detection zone, detection zone comprise can specificity combining target analyte fixing bond.For example, if target analytes is an antibody, then the positive detection district preferably includes fixing antigen.If target analytes is an antigen, then the positive detection district preferably includes fixing antibody.Comprise the structure of slowing down liquid flow in the downstream of detection zone.
Preferably, test strips comprises that label comes source region, label comprise can the combining target analyte first binding constituents and second show composition.Design is used for the label source district of label of combining target analyte and is positioned at the upstream of surveyed area; Being positioned at label comes upstream, source region and design to be used for receiving the sample application zone of fluid sample.
The sample that uses in the test can be any liquid.Preferably sample comprises, for example, and blood, serum, blood plasma, saliva and urine.Sample is added to sample application zone, then comes the source region to flow out from label.Label flows and passes film, and contact has been attached to all analytes in positive detection district, produces visible signal.
In a preferred embodiment, test strips comprises having fixing IIIV detection of antigens district, is used to detect anti-HIV antibody.In this embodiment, this test can be used for diagnosing patient's HIV to infect.In a further preferred embodiment, test strips comprises having fixing HCV detection of antigens district, is used for the HCV antigen/antibody combination of test sample.In this embodiment, this test can be used for diagnosing patient's HCV to infect.In another embodiment, test strips comprises having fixing anti-hCG detection of antibodies district.In this embodiment, this test can be used for determining whether individuality is conceived.
Label comes the source region to preferably include dry label.For example, it can be labeling pad that label comes the source region, and label is dry thereon.Labeling pad preferably is communicated with membrane fluid.In some embodiments, behind the sample application zone application of sample, labeling pad moves to membrane fluid and is communicated with.In another embodiment, it is the part of film that label comes the source region, and label is dry thereon.
In another embodiment, label is suspended in the damping fluid.Adding to label by the damping fluid that will contain label to make on the source region label to flow to detection zone.
In another embodiment, test strips also comprises the check plot that is positioned at detection zone downstream on the film.The check plot preferably include can binding label the contrast bond.The structure of slowing down liquid flow is between surveyed area and check plot.
Test strips can comprise one or more other assemblies.The buffering fluid cushion can come the source region fluid to be communicated with label, applies lavation buffer solution like this and can make label come the source region to flow out from label on the buffering fluid cushion, passes film, touches detection zone.Water sucting belt and adsorptive pads can be positioned at the downstream of film, when damping fluid is used for absorbing excessive damping fluid during by film.Drying agent chip also can be used for absorbing excessive liquid and moisture near film.
Test strips can randomly be placed on shell for example in the plastic casing.Shell preferably includes window that is positioned at detection zone and top, check plot and the sample window that is positioned at the detection zone upstream.
The method of the analyte in the tracer liquid sample also is provided, has comprised sample is added to sample window or sample application zone, sample flows through label successively and comes a kind of label on the source region, and this label can the combining target analyte and produced the visible signal of indication combination.
Beneficial effect
Use device of the present invention can improve the sensitivity of detection.
Description of drawings
Figure 1A is the test strips perspective view in embodiment of the present invention, the top plan view that Figure 1B assembles for test strips that Figure 1A illustrated.
Fig. 2 is the perspective view of the detection film of the test strips in another embodiment of the present invention.
Fig. 3 is the perspective view of the detection film of the test strips in another embodiment of the present invention.
Fig. 4 is the tangent plane structural representation of the detection film of the test strips in another embodiment of the present invention.
Description of reference numerals
Application of sample pad 18; Label pad 12; Detect film 15; Surveyed area 11; Control zone 10; Flow rate of liquid slows down regional 13 103; Outer object 114.
Definition
Unless otherwise defined, all scientific and technical terminologies here all have the identical connotation known to usually with those skilled in the art in the invention.Can use in the implementation of the present invention and similar or suitable all methods, device and material described herein.
Term " label " is meant and designs the composition that is used for the combining target analyte and produces detectable signal.Label generally comprises the binding constituents with the label mark.This binding constituents makes the label can the combining target analyte, randomly in conjunction with control compound.Label produces detectable signal, preferred visible signal.In one embodiment, only when combining with analyte, label just produces visible signal.In a preferred embodiment, target analytes be antibody and label comprise can binding antibody binding constituents.For example, first binding constituents can be an albumin A, although also can use the molecule that other can binding antibody.In another embodiment, target analytes be the binding constituents of antigen and label comprise can conjugated antigen antibody.Antibody is monoclonal antibody preferably.
Label is can adhere to binding constituents or mark and can produce any molecule or the compound of detectable signal.A kind of preferred label is a collaurum.Perhaps, label can also be black or other compositions well known in the art of latex particle, collargol or other colloidal metals, colloid that for example dye.Preferably, the particle diameter of label can not disturb the ability of binding constituents combining target analyte.For example, when binding constituents was albumin A, the particle diameter of label was preferably about 5 nanometers to about 120 nanometers, and more preferably from about 20 nanometers are to about 80 nanometers.
Preferably preparation in can stablizing and preserve " the mark damping fluid " of this label of label.In one embodiment, as hereinafter describing in detail, behind the preparation label, label can be gone up dry in " labeling pad " in the mark damping fluid.Label dry in substrate is considered to " but diffusion-bonded ".If can cause diffusion or mobile, for example it is contacted with damping fluid, then label is " but diffusion-bonded ".For example, but diffusion-bonded comes the label on the source region to dissolve with damping fluid to label by drying, thereby makes its membrane flow along test strips.
" contrasting marking thing " is a kind of like this label, and wherein binding constituents is specific for control compound.When may all labels all combining and can't preferably use the contrasting marking thing when comparing with analyte on the detection line.Control compound generally is known in the sample of being analyzed, and can in conjunction with contrast with on the contrast bond.Randomly, the binding constituents of contrasting marking thing may be specific for the compound that exists in the check plot of detecting film.
Label preferably is present in " label comes the source region ".But label comes the source region to generally comprise the label of diffusion-bonded with it, as the label of drying.Perhaps, label comes the source region to comprise to be suspended in the label in damping fluid such as lavation buffer solution or the label damping fluid.In one embodiment, it is labeling pad that label comes the source region, comprises dry label, is communicated with the detection membrane fluid.In the another one embodiment, it is a part that detects film that label comes the source region, and label is dry thereon.In the another one embodiment, it is the buffering fluid cushion that label comes the source region, can apply the damping fluid that comprises label upward, and it is communicated with the detection membrane fluid.Label comes the source region generally to be positioned to detect the upstream of the detection zone of film, thereby but comprises behind the solution of label in adding or after the label dissolving of diffusion-bonded, label flows and passes the detection film, contacts with detection zone.
Label is preferably used " lavation buffer solution " As described in detail below dissolving.Briefly, lavation buffer solution is the buffer solution that preferably contains " sealer ".Sealer is well known in the art, comprises any molecule or the compound that reduce non-specific interaction such as non-specific antibody combination.Preferred sealer is a protein, as casein and bovine serum albumin(BSA) (BSA).Other available sealers can be bought, and those skilled in the art should know.
" detection film " is a kind of solid support, comprises detection zone and optional check plot.Detecting film can be any solid support, and analyte binding agent and contrast bond can be attached to top.Detect preferably cellulose nitrate of film.
Detect film and provide side stream passages for liquid.If liquid such as fluid sample or damping fluid can flow to another assembly from an assembly, claim that then other assemblies of detection film and test strips are " fluid connections ".If the assembly of test strips contacts with each other, then they are that fluid is communicated with.But, it will be appreciated by those skilled in the art that the fluid connection does not need two specific components directly to contact.
" detection zone ", " detecting band " and " detection line " can exchange use, all are meant and detect the accompanying zone of analyte binding agent on the film.
" analyte binding agent ", " specific binding ligand " or " binding constituents " are that design is used for any molecule or the compound of specificity combining target analyte.For example, but be not limited to, analyte binding agent can comprise that antigen, antibody, acceptor, other polypeptide, peptide, haptens, agglutinin, nucleic acid comprise oligonucleotides or micromolecule.In one embodiment, analyte binding agent is a kind of antigen, and it is specific for the antibody to be measured in the sample.In the another one embodiment, the analyte binding compounds is the specific antibody of target antigen.
" check plot ", " contrast band " and " control line " can exchange use, all are meant the accompanying zone of contrast bond on the film.
" contrast bond " is can the specificity binding label or any molecule or the compound of contrasting marking thing.
" test strips " is meant and can be used for whether containing in the test sample intact device of analyte.Test strips preferably comprises the detection film with detection zone at least.As mentioned below, test strips can be placed in shell such as the plastic casing.Perhaps, test strips can not have shell yet.If be placed in the shell, test strips and shell can be called as " test card " together.
" test card window " and " sample window " are meant the hole on the test card shell, can application of sample by it.The test card window is preferably located in the top of detection zone and check plot.The test card window also preferably allows the viewing test result.
" sample application zone " is the position that applies sample on pick-up unit or the test strips.Sample application zone is preferably located in the upstream that label comes the source region.Sample can be applied directly to sample application zone, for example by transfer pipet, perhaps applies indirectly.
The term " antibody " that uses is its wideest connotation, comprises such as but not limited to complete antibody and single-chain antibody, antibody fragment and chimeric antibody, as long as they keep the binding specificity that needs.
Describe in detail
In the following detailed description, the subsidiary reference word of legend is a part here, and it illustrates to illustrate the mode that the present invention can actable specific concrete scheme.We do not get rid of the present invention and can also carry out other concrete scheme and changing structure of the present invention under the situation of usable range of the present invention.
Carrier
Support the carrier of liquid flow to be meant that liquid can flow to another district from a district on carrier.In a concrete mode, liquid can come source region to flow to surveyed area from label.
On the one hand, flowing of this liquid can be the difference of the own material of carrier and allow liquid being moved initiatively.In a concrete scheme, device comprises a kind of absorbent material, and the carrier material of supporting liquid flow is provided." carrier material " is meant a kind of material of supporting liquid flow and transportation.In a concrete scheme, carrier material is a kind of absorbent material.Flow of liquid is crossed this device and is realized by means of the capillary motion effect.Can comprise that on carrier surveyed area and label come source region.Certainly can also comprise sample area and suction zone.In different concrete schemes, carrier material can be the bar that homogenous material constitutes, also can be by the multiple test strips that interactional absorbent material is formed in liquid, Fig. 1 for example, carrier can comprise sample application pad 18, the label pad 12 that glass fibre is formed, the detecting pad 15 of nitrocellulose membrane composition and the adsorptive pads 17 that filter paper is formed that glass fibre or filter paper are formed, and they connect successively can allow liquid flow on the adsorptive pads from sample pad.On label pad, handle the material that is labeled is arranged; 15 comprise surveyed area 11 on detecting pad, perhaps preferably comprise control zone 10, comprise the structure 13 of slowing down liquid flow in the downstream of surveyed area." suction " material is meant the material that those can stably absorb moisture and moisture is transported by the capillary motion effect therein.The example of absorbent material comprises nitrocellulose, filter paper, glass fibre, polyester and other suitable material.Simultaneously, this carrier material also comprises only provides one or several independent carrier capillaceous, and liquid moves by these independent capillarities.
In a preferred mode, the reagent of handling on carrier exists with the state of doing, and when liquid was applied on carrier, carrier was moistening by liquid.
Slow down the structure of flow rate of liquid
Liquid always flows on carrier and to carry out with certain speed, is called for short flow velocity.Different carrier materials has different flow rate of liquid, and when carrier material was homogenous material, liquid was also constant relatively in the last speed that flows, but can be by allowing the flow velocity of liquid on carrier be in non-constant state in that some structures are set on the carrier.
For example, shown in Figure 4, carriers are oppressed with hard foreign object 114 in 13 position on the carrier material of even material, allowing carrier produce at 13 position shrinks, when liquid from 152 when flowing to 111, owing to make the quality of carrier no longer even, liquid flow velocity when flowing through 13 slows down, but still having partially liq to pass through 13 positions flows to 111 parts, allow more liquid rest on 152 parts like this, but along with the prolongation of time, the liquid that finally is positioned on 152 positions flows to 111 positions by 13.In addition, hard foreign object can be the part on the test card shell, and hard foreign object can be plastics or metal.
Except above physical method, can also on zone 13, handle some organic solvents, allow the structure of film change, some organic solvents for example, alcohol for example can destroy the structure of some carriers, cellulose nitrate for example, the place depression of the carrier of handling with alcohol, liquid is when flowing through the place of depression, and flow rate of liquid is slowed down.In addition, also can come joint detection zone 11 and control zone 13 (optionally having) in the place in zone 13 with the carrier of some other materials, liquid is less than the flow velocity of liquid on surveyed area 11 carriers at the flow velocity on the carrier 13, so also can obtain same effect.
The surveyed area of traditional immunoassay device usually is positioned on the single carrier of material, for example on the nitrocellulose filter, the speed that liquid flows on carrier is also constant relatively, and the present invention comprises on the carrier of surveyed area that some slow down the structure of flow rate of liquid containing, allow liquid phase to rest on the surveyed area more with its on reagent contact a little times more, react more abundant, thereby improve the sensitivity that detects.
Preferably, these structures of slowing down flow rate of liquid are positioned at the downstream of surveyed area.In a concrete mode, as Fig. 1, test strips comprises application of sample zone 18, label comes source region 12 and detects film 15, detect on the film and comprise surveyed area 11 and control zone 10, comprise the hydrophobic region of handling with hydrophobic agents 13 in the downstream of surveyed area, and the suction zone 17 that connects with the detection symphysis, these zone head and the tail connect, and allow liquid and detect film 15 from the regional 18 process marked regions 12 of application of sample and flow on the suction zone 17.When in use, when liquid flows to surveyed area, because the existence of hydrophobic region 13, allow flow rate of liquid slow down at the hydrophobic region place, allow reagent or longer time of contact detection zone on the more liquid contact detection zone, can allow reaction more abundant, improve the sensitivity that detects.Liquid flows to the control zone in downstream slowly by hydrophobic region then.
Some commercial detection film itself is hydrophilic, can allow it become water repellent region with the hydrophobic agents processing in the surveyed area downstream like this, and some commercial detection film itself is hydrophobic, can be processed into surveyed area hydrophilic, and do not handle the zone in surveyed area downstream, allow it keep the hydrophobic property of self.
Those any reagent that can change the carrier hydrophobic performance can apply to the present invention.Especially, some hydrophobic agents are handled the reagent that changes hydrophobic performance on nitrocellulose filter.The method of processing on film can be to be coated with, to draw or spray with the bulk spreading truck device, and these methods are that those skilled in the art realize easily.The hydrophobic agents here can be the sulfydryl polysiloxane emulsion, emulsifying wax wax emulsion, butadiene-styrene latex etc.
In another concrete mode, the detection film that also can make way for the surveyed area downstream is narrower relatively, so also can allow the flow velocity of liquid slow down.As shown in Figure 2, along the direction of the liquid flow shown in the arrow, allow the relative surveyed area of detection film want narrower, narrow part 103 joint detection zone and control zone 11 in the downstream of surveyed area 11.For example, the width in surveyed area downstream is the 1/2-1/10 of surveyed area width, or 1/4-1/8; Or 1/5.When liquid flows to surveyed area, because unexpected narrow in downstream, because the flow velocity of narrow 103 certain (when the material of the carrier of the material of narrow and surveyed area is the same or material changeless time), but carry the ability drop of liquid, can not be transported to liquid on the control zone 11 timely from surveyed area, allow more liquid rest on the surveyed area like this, allow more material in the fluid sample, for example analyte substance of interest and/or mark substance, the compound substance that target analytes and mark substance form, has the reagent on the contact detection zone, more time ground 11, for example Gu Ding antibody or antigen have improved the sensitivity that detects.Certainly, in a selectable mode, as Fig. 3, stenosis is narrow gradually in the downstream of surveyed area 11 also can play similar effects.In the concrete mode shown in Fig. 2 and 3, preferred, the material that constitutes the carrier of narrow 103 is different from the material that constitutes surveyed area 11 carriers, select like this, allow liquid be less than liquid by the flow velocity on the surveyed area by the flow velocity of narrow, so more can make more liquid rest on surveyed area, thereby allow reagent react more fully, improve the sensitivity that detects.
Certainly, also can constitute the zone in surveyed area and surveyed area downstream separately with the carrier of support liquid flow with different liquids flow velocity.For example can constitute surveyed area with the fast carrier of flow rate of liquid separately, constitute the zone in surveyed area downstream than the little carrier of surveyed area carrier flow velocity, allow liquid can flow to the downstream of surveyed area from surveyed area with flow rate of liquid.When in use, when flowing to the zone in surveyed area downstream from the liquid of surveyed area, flow rate of liquid slows down; Allow this time the liquid can the more time or the resting on the surveyed area of more relatively volume; Allow some materials in the liquid like this, for example analyte or mark substance can be more in quantity or the time go up secure bond molecule on the contact detection zone, obtain higher sensitivity.
More than these methods can adopt separately, also can be used in combination.In addition, more than control zone in these embodiments as optional mode, in other mode, can omit control zone.
The type of target analytes
Can analyze any analyte substance of interest with the present invention.The example of the target analytes of the enough stable detection of the present invention of energy comprises (but not only comprising) human chorionic gonadotrophin (hCG), lutropin (LH), ovarian stimulation element (FSH), hepatitis C virus (HCV), hepatitis B (HBV), hepatitis B surface antigen, the medicine of AIDS virus and any abuse.Analyte can detect in any liquid or liquefied sample, urine for example, saliva, saliva, blood, blood plasma, perhaps serum.The example of other target analytes also has the acid of flesh ammonia acid anhydride, cholerythrin, nitrite, protein (nonspecific), blood, leucocyte, blood sugar, heavy metal and toxin, the bacterium composition is (for example, special protein and the sugar of the bacterium of particular type, colon bacillus 0157: H7 for example, staphylococcus aureus, salmonella, C.perfringens, campylobacter, listeria monocytogenes, enteritis vibrios, perhaps cured shape bacillus).Any other analyte of suitable lateral flow assay form can detect with this device.
The type of sample
The sample of any kind can both be tested with device of the present invention, comprises body fluid (for example, urine and other body fluid, and clinical sample).Fluid sample may be derived from sample solid or semisolid, comprises excrement, biological tissue and foodstuff samples.These solids can be transformed into fluid sample by any suitable method with semisolid sample, for example in a kind of suitable liquid, mix, stamp broken, macerate, hatch, dissolving or enzymolysis solid sample are (for example, water, phosphate buffer or other damping fluid)." biological sample " comprises the sample that is derived from animal alive, plant and food, also comprise urine, saliva, blood and blood constituent, cerebrospinal fluid, vaginal swab, the culture of seminal fluid, ight soil, sweat, secretion, tissue, organ, tumour, tissue and organ, condition medium cell culture and there is no matter be the people's or animal.Foodstuff samples comprises finished composition of food and last product, meat, cheese, wine, milk and potable water.Plant sample comprises the sample of the condition medium that is derived from any plant, plant tissue, plant cell cultures and there." environmental sample " is those samples that are derived from environment (for example, the sample of lake water sample or other water body, sewage sample, pedotheque, underground water sample, seawater sample, the samples of runoff water).Sewage also can be included in the environmental sample with relevant refuse.
Experiment
1. experiment material:
Gold mark: antihuman hemoglobin mark gold mark; T line: antihuman hemoglobin;
Sample pad solution: Tris:6mg/ml; Casein:5mg/ml; PVP:5mg/ml;
Sample: positive sample is confirmed as positive FOB sample with PBS buffer extraction process; Negative mark
This confirms as negative FOB sample for the process of PBS buffer extraction
Hydrophobing agent: sulfydryl polysiloxane emulsion BD-307;
The NC film, polyester film and glass:
Material Model Lot number
Detect film 15 Millipore?HF135?20mm R9PN67501
Label pad 12: polyester film The polyester film EP09020052
Application of sample pad 18: glass The CMA-435 glass EG09120050-T2
2. experimental technique:
The processing of gold mark pad 12:
Gold solution is processed into OD60, and is sprayed on the polyester film with the discharge rate of 2.0ul/cm.37 ℃ of oven for drying are spent the night.
The Treatment Solution of NC film T line 11: antihuman hemoglobin becomes 1mg/ml with the PBS solution dilution, and is sprayed on the NC film with the discharge rate of 1ul/cm, spends the night in 37 ℃ of oven for drying.
The processing of sample pad 18: be sprayed on the wide glass of 18cm with sample pad solution, 37 ℃ of oven for drying are spent the night.
Handle 1:
The NC film that baking is good is sprayed onto on the NC film with the discharge rate of sulfydryl polysiloxane emulsion with 1.0ul/cm at about 0.2cm place above the T line, forms hydrophobic region 13.And put into 37 ℃ of oven for drying once more and spend the night.(Figure 1A)
Handle 2:
Be sprayed onto on the NC film with the discharge rate of PBS solution with the 0.2cm place at about 0.5cm place above the T line with 1.0ul/cm.And put into 37 ℃ of oven for drying once more and spend the night.
Handle 3:
About 0.2cm place above the T of film line cuts off each osculum that about 0.2cm is wide to the film both sides with scissors, and the bridge of about 0.5cm is stayed in the centre, and solution can be passed through from the bridge 103 of centre.(Fig. 2)
Contrast:
Other modes are identical with processing 1-3, but the downstream of detection line 11 is left intact.
The assembling of reagent strip
According to above method, application of sample pad 18, label pad 12 is connected according to the method for Fig. 1 is the first with adsorptive pads 17 with detecting pad 15, obtains reagent strip corresponding and processing 1-3 and contrast.On the application of sample pad 18 of 12 reagent strips of each processing, drip 2 positive FOB solution then, and then drip negative sample and handle to each on remaining 10 reagent strips, read testing result at 3 minutes inner reference standard colorimetric cards then, each is handled and repeats 3 times.See Table 3.
3. experimental result:
Positive sample Negative sample 1 Negative sample 2 Negative sample 3
Contrast +4 ?- - -
Handle 1 +8 ?- - -
Handle 2 +4 ?- - -
Handle 3 +8 ?- - -
4. sum up:
After having handled hydrophobing agent on the film, form a strong hydrophobic surface, when the solution in sample and Jinsui River arrives this local the time, solution temporarily rests on this place, makes sample and T line fully react.Through after the brief stay, liquid perhaps passes through from the bottom and the both sides of film because the pulling force effect can be crossed this layer hydrophobic surface, finally finishes the race plate.In a word, the effect of this layer hydrophobic surface is that biased sample solution can fully be reacted in the capture antigen of T line, and reaches the effect that final T line fully reacts.
In like manner, after making sample arrive the T line, make sample and T line that the sufficient reaction time can be arranged, used narrow bridge method, promptly allow the width that is less than T line place at the width of the part in T line downstream, this method has also reached same effect.

Claims (11)

1. whether one kind in order to contain the pick-up unit of target analytes in the test sample, comprising: support the carrier that fluid sample flows, comprise surveyed area on this carrier; Described surveyed area comprises specific binding molecule, it is characterized in that, comprises the structure that allows flow rate of liquid slow down in described surveyed area downstream.
2. device as claimed in claim 1, wherein, the structure of the described flow rate of liquid that slows down is the width that the width in the downstream of surveyed area is less than surveyed area.
3. device as claimed in claim 1, wherein, the structure of the described flow rate of liquid that slows down is for comprising the part of depression on the carrier in surveyed area downstream.
4. device as claimed in claim 3, wherein, the structure of the described flow rate of liquid that slows down is for to comprise hydrophobic parts in the surveyed area downstream, wherein, the hydrophobic ability of this downstream hydrophobic parts is greater than the hydrophobic ability of surveyed area.
5. device as claimed in claim 4, wherein, described hydrophobic parts was handled by hydrophobic agents.
6. device as claimed in claim 5, wherein, described hydrophobic agents is the sulfydryl polysiloxane emulsion.
7. as the described device of one of claim 1-6, wherein, described surveyed area is positioned on the nitrocellulose filter.
8. whether one kind in order to contain the pick-up unit of analyte in the test sample, comprising: support the carrier that fluid sample flows, comprise surveyed area on this carrier; Described surveyed area comprises specific binding molecule, it is characterized in that, and is littler than the width of surveyed area at the width in described surveyed area downstream.
9. device as claimed in claim 8, wherein, liquid is greater than the flow velocity of liquid at surveyed area at the flow velocity that detects the little part of downstream width.
10. device as claimed in claim 8, wherein, the width in surveyed area downstream is the 1/2-1/10 of surveyed area width.
11. device as claimed in claim 10, wherein, the width in surveyed area downstream is 1/5 of a surveyed area width.
CN201010156781.5A 2010-04-26 2010-04-26 Detection device Expired - Fee Related CN102236022B (en)

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CN201010156781.5A CN102236022B (en) 2010-04-26 2010-04-26 Detection device
CN201510103101.6A CN104777298B (en) 2010-04-26 2010-04-26 A kind of detection means

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CN102768275A (en) * 2012-07-10 2012-11-07 北京陆桥技术有限责任公司 Staphylococcal enterotoxin assay kit, method for preparing same and application
CN103163304A (en) * 2011-12-19 2013-06-19 天津中新科炬生物制药有限公司 Method for rapidly detecting follicle stimulating hormone (FSH) in urine sample in a quantitative mode
CN104515848A (en) * 2013-09-26 2015-04-15 艾博生物医药(杭州)有限公司 Immunity detection reagent strip
CN104777194A (en) * 2015-04-21 2015-07-15 苏州市玮琪生物科技有限公司 Anti-interference sensing electrode and microfluidics test paper runner flow velocity control method
CN104515848B (en) * 2013-09-26 2016-11-30 艾博生物医药(杭州)有限公司 A kind of immunologic function test reagent bar
CN106525838A (en) * 2016-12-07 2017-03-22 百奥森(江苏)食品安全科技有限公司 Prednisolone determination method and prednisolone determination card
CN106796226A (en) * 2014-10-02 2017-05-31 索尼公司 Target substance determines kit, target substance measurement system, immune chromatograph and determines kit and immune chromatograph measurement system
CN108535472A (en) * 2018-02-27 2018-09-14 上海艾瑞德生物科技有限公司 A kind of detection strip significantly improving lateral flow immunochromatography

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CN103163304A (en) * 2011-12-19 2013-06-19 天津中新科炬生物制药有限公司 Method for rapidly detecting follicle stimulating hormone (FSH) in urine sample in a quantitative mode
CN102768275A (en) * 2012-07-10 2012-11-07 北京陆桥技术有限责任公司 Staphylococcal enterotoxin assay kit, method for preparing same and application
CN104515848A (en) * 2013-09-26 2015-04-15 艾博生物医药(杭州)有限公司 Immunity detection reagent strip
CN104515848B (en) * 2013-09-26 2016-11-30 艾博生物医药(杭州)有限公司 A kind of immunologic function test reagent bar
CN106796226A (en) * 2014-10-02 2017-05-31 索尼公司 Target substance determines kit, target substance measurement system, immune chromatograph and determines kit and immune chromatograph measurement system
CN104777194A (en) * 2015-04-21 2015-07-15 苏州市玮琪生物科技有限公司 Anti-interference sensing electrode and microfluidics test paper runner flow velocity control method
CN104777194B (en) * 2015-04-21 2017-10-27 苏州市玮琪生物科技有限公司 Anti-interference sensing electrode and micro-fluidic test paper runner flow rate control method
CN106525838A (en) * 2016-12-07 2017-03-22 百奥森(江苏)食品安全科技有限公司 Prednisolone determination method and prednisolone determination card
CN108535472A (en) * 2018-02-27 2018-09-14 上海艾瑞德生物科技有限公司 A kind of detection strip significantly improving lateral flow immunochromatography
CN108535472B (en) * 2018-02-27 2021-09-24 上海艾瑞德生物科技有限公司 Detection test strip capable of remarkably improving lateral flow immunochromatography

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