CN101341407A - Apparatus and method for immune detection - Google Patents

Apparatus and method for immune detection Download PDF

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Publication number
CN101341407A
CN101341407A CNA2006800484094A CN200680048409A CN101341407A CN 101341407 A CN101341407 A CN 101341407A CN A2006800484094 A CNA2006800484094 A CN A2006800484094A CN 200680048409 A CN200680048409 A CN 200680048409A CN 101341407 A CN101341407 A CN 101341407A
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China
Prior art keywords
analyte
positive control
control area
binding domain
pick
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Inventor
高飞
吴淑江
陈惠康
熊登峰
林继南
詹目斯·麦克米那梅
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Alere Switzerland GmbH
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Inverness Medical Switzerland GmbH
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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
    • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54366—Apparatus specially adapted for solid-phase testing
    • 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
    • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54366—Apparatus specially adapted for solid-phase testing
    • G01N33/54386—Analytical elements
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/575—Hormones
    • G01N2333/59—Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g. HCG; Luteinising hormone [LH]; Thyroid-stimulating hormone [TSH]

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  • Immunology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • Chemical & Material Sciences (AREA)
  • Hematology (AREA)
  • Urology & Nephrology (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Cell Biology (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
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  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Investigating Or Analysing Materials By The Use Of Chemical Reactions (AREA)

Abstract

The present invention provides devices, methods and kits for detecting the presence of an analyte in a liquid sample. The invention provides devices having a positive control area covered with an opaque, movable material, such as an ink, dye, or other material, that is moved on the device by the flow of liquid sample, thereby exposing the positive control area underneath. Using the interaction of colored signals from the positive control area and the analyte binding area, a recognizable symbol is revealed on the device that correlates with the test results, and appears as the test is conducted.

Description

The apparatus and method of immune detection
Technical field
The present invention directly belongs to a kind of pick-up unit that detects analyte, and it shows the result who detects with a discernible symbol.
Background of invention
Following background of invention is used to help reader understanding the present invention, and can not be considered to prior art.
Include positive control and negative control and realize that certain detection or chemical examination are vitals of analytical test device.In a lot of chemical examination test format, there are a lot of methods to be applied in the control test and go.For example, in the immune detection form, control test is utilized an analyte to be incorporated on the control line that contrasts on the control area and is realized.Like this, the control material that is labeled is incorporated on the control line, and color lines will appear on the control area.The function that control test this or other form is used for confirming chemically examining pick-up unit is normal.But they also can increase simultaneously the manufacturing cost and use cost of this pick-up unit, especially, when some specific bond molecules be applied in the control test the time, produce and use cost higher.In addition, control test allows some not be subjected to professional training people from ground sometimes to feel fascination in this wise, thereby causes normally explaining testing result.Like this, just need a kind of better more effectively pick-up unit and method to detect sample.
Summary of the invention
The invention provides the existence of analyte in a kind of test fluid sample, and have the symbol that to discern and show the analyzed device that whether exists, method and kit to the user.In one embodiment, the invention provides a kind of sample region of acceptance that has, the reagent strip of reagent areas and surveyed area.On surveyed area, comprise positive control area, negative control area and analyte calmodulin binding domain CaM.This positive control area is described by a colored symbol, is negative sign in this embodiment.The analyte calmodulin binding domain CaM is near positive control area and interaction with it.The analyte calmodulin binding domain CaM comprises bound substances, the analyte that this bound substances can the underlined material of capture zone.In a mode, positive control area or part surveyed area, or whole surveyed area are covered for example a kind of dyestuff or ink by a kind of opaque movably material.When beginning to detect, before fluid sample arrived surveyed area, positive control area was covered by material opaque and that can be moved and invisible.When fluid sample flows through surveyed area, thus this opaque and movably material washed away and allow positive control area become can to see.If there is not analyte to exist in the fluid sample, relevant positive control area shows a negative sign, and the analyte calmodulin binding domain CaM does not have color negative result to occur being expressed as simultaneously.On the contrary, if analyte is present in the sample, the analyte that has mark substance just is incorporated on the calmodulin binding domain CaM.Positive control area and analyte calmodulin binding domain CaM make up mutually to the user and form a visible positive sign.The present invention also provides the method for using this pick-up unit and the kit that has this pick-up unit.
On the one hand, the invention provides the device that whether has analyte in a kind of test fluid sample.This device comprise one can support fluid in the last matrix that flows, comprise the sample region of acceptance of accepting sample on the matrix, have the surveyed area of symbol.This surveyed area (meeting with this) to small part is covered by a kind of opaque and material that can be moved and can not see.One or more reagent areas of finishing the required reagent of reaction that comprise are present on the matrix.Utilize the present invention can detect a lot of middle analytes, human chorionic gonadotrophin (hCG) for example, lutropin (LH), ovarian stimulation element (FSH), differential protein or non-differential protein, blood or blood constituent, antibody, drugs or drug abuse material, urea, nitrite or glutaraldehyde.
In a concrete embodiment, surveyed area comprises an analyte calmodulin binding domain CaM and a positive control area.Matrix can be porosint, and opaque transportable material is a kind of aqueous ink.For example, matrix is the nitrocellulose filter reagent strip, and positive control area is positioned on the longitudinal axis of reagent strip with the form of negative sign (-).In close examples of implementation, the analyte calmodulin binding domain CaM is made up of the part of the both sides that lays respectively at positive control area, the molecule that on the analyte calmodulin binding domain CaM, comprises a specific bond analyte, or a kind of another kind of molecule that is combined on the analyte of specific bond.When having analyte in the sample, this positive control area and analyte are formed the symbol that can intuitively discern in conjunction with common the interaction.In a lot of concrete embodiments, this symbol that can intuitively discern can be a positive sign (+), negative sign (-), X number or other symbols known in the prior art or represent the symbol of certain certain sense.In a concrete embodiment, this is opaque, and transportable material is a kind of water-based ink, and this ink covers positive control area.This specific bond molecule is a kind of antibody or antibody fragment.In a concrete embodiment, analyte behaviour chorionic gonadotropin (HCG).
In some relevant embodiments, the positive control area on the matrix can be one or morely to have the zone of color but do not comprise that a specific bond molecule is right.Analyte can be labeled a mark substance that has the detected signal of energy, and this mark substance can be to have colored particle or latex particle.The analyte calmodulin binding domain CaM can also be parts that are positioned on the reagent strip transversal line, can comprise that also the molecule of a specific bond analyte or one of specific bond are combined in by the molecule on the material.
In another embodiment, mark substance has identical color with positive control area.Such device can also comprise the sample receiving pad that is positioned at device one end, and surveyed area is positioned at the centre of reagent strip, and label pad is between sample receiving pad and surveyed area.
On the other hand, the present invention also provides the method that whether has analyte in this device test fluid sample of utilizing.This method comprises that the sample region of acceptance on the device that the present invention describes adds fluid sample, allow fluid sample flow through matrix and pass through one or more reagent areas simultaneously, when having analyte in the fluid sample, allow reagent on the reagent areas and fluid sample react to form one can be detected product, allow fluid flow through surveyed area, this surveyed area to small part by a kind of opaque, transportable material covers, fluid will rinse out this opaque material and comes out by positive control area like this, simultaneously, exist the analyte in the sample just to be caught by the analyte calmodulin binding domain CaM, the surveyed area on the finder judges whether there is analyte in the fluid sample.
In a concrete embodiment, in the time of fluid sample process surveyed area, the stream sample rinses out water-based ink, so just allows positive control area come out.In another embodiment, positive control area is made up of the two parts that are positioned at analyte calmodulin binding domain CaM both sides, and positive control area and analyte calmodulin binding domain CaM are formed a kind of symbol that can discern.
On the other hand, the invention provides a kind of kit, this kit comprises pick-up unit provided by the invention and how to use the operation instructions of this device.In a kind of kit, this operational manual is to be used for whether having analyte in the test fluid sample for making of this device.
The present invention also comprises other any utilizable form, and these all can have detailed description.These characteristic feature of an inventions or mode can realize with becoming to assign to by production technology described in the invention.Content with reference to disclosed is easy to recognize that other is similar to other disclosed form and can produces in conjunction with the embodiment that the present invention explained.In addition, other any form and embodiment all have detailed description in the present invention.
Introduction of the present invention described above is also not exhaustive, and other features and advantages of the present invention will can elaborate in following description and statement.
Description of drawings
Fig. 1 is the schematic top plan view of an embodiment of pick-up unit of the present invention, and this pick-up unit comprises a reagent strip 10, sample region of acceptance 15, reagent areas 17, surveyed area 12, negative control area 19, positive control area 11 and analyte surveyed area 13.Arrow is represented the direction that sample flows.
Fig. 2 is the synoptic diagram of a pick-up unit in the embodiment before being used, when whole surveyed area by a kind of opaque, after transportable material 20 covered, positive control area 11 was positioned at this opaque, under the transportable material 20.
Fig. 3 is the synoptic diagram of pick-up unit before being used in another embodiment, when only having only the part surveyed area by a kind of opaque, after transportable material 20 covers, positive control area 11 is positioned at this opaque, under the transportable material 20, the part of shade is represented positive control area 11.
Fig. 4 represents that after sample flow to the other end of reagent strip from the sample region of acceptance on the pick-up unit shown in Figure 3, if there is not analyte in sample, in this embodiment, positive control area occurred with the form of negative sign (-).
Fig. 5 represents, after sample flows to the other end of reagent strip from the sample on the pick-up unit shown in Figure 1 from the sample region of acceptance, if there is analyte in sample, in this embodiment, the common positive sign (+) of forming of positive control area and analyte calmodulin binding domain CaM.
In the examples of implementation shown in Figure 6, positive sign is to be combined by analyte calmodulin binding domain CaM 13 and positive control area 11, and this positive control area is positioned under the analyte calmodulin binding domain CaM and overlaps.
In the examples of implementation shown in Figure 7, positive sign is to be combined by positive control area 11 and analyte calmodulin binding domain CaM 13, and this positive control area is positioned on the analyte calmodulin binding domain CaM and overlaps.
In another examples of implementation shown in Figure 8, positive control area partly is made up of the positive control area of a plurality of arrangements, and this positive control part is adjacent with the analyte calmodulin binding domain CaM and combine a positive sign.
In another examples of implementation shown in Figure 9, analyte calmodulin binding domain CaM 13 is made up of the analyte bound fraction of a plurality of arrangements, and this analyte bound fraction and positive control area 11 are adjacent and be combined into a positive sign.
In another embodiment shown in Figure 10, analyte calmodulin binding domain CaM 13 and positive control area 11 are in conjunction with forming big " X " symbol, and the direction of analyte calmodulin binding domain CaM and positive control area and liquid flow is certain included angle.
Figure 11 is the synoptic diagram in another concrete embodiment, and in this embodiment, analyte calmodulin binding domain CaM and positive control area form capitalization " Y " type symbol.
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
Pick-up unit
Pick-up unit described in the invention can utilize reagent strip to come the existence of analyte in the test fluid sample.Such pick-up unit uses positive control area and analyte calmodulin binding domain CaM to form colored signal, provides the symbol that can discern to show testing result.Fig. 1-3 is the synoptic diagram of a specific embodiment of the present invention.A reagent strip 10 comprises that one can be supported fluid in the last matrix that flows.This device comprises the sample region of acceptance 15 of accepting fluid sample, reagent areas 17 and a surveyed area 12.Reagent areas 17 comprises that some are used for finishing analysis or chemically examine necessary reagent, based on the special requirement of some detections, can a more than reagent areas exist on the pick-up unit.Surveyed area comprises 11, one analyte calmodulin binding domain CaMs 13 of positive control area (or a test zone) and a negative control area 19.The direction of direction shown in the figure arrow that fluid flows.The sample region of acceptance can comprise that buffer reagent melts sample, perhaps only is that a part on the matrix is used for accepting sample, and it also can be to comprise that other reagent participates in detecting.The sample region of acceptance can also be exactly a reagent areas.Sample is except the form as liquid state is applied on the pick-up unit, and sample can also be to be maintained on the reagent strip with the form of doing, and then by applying water, buffering liquid or other reagent dissolve sample to be made it to become liquid state and detect.Certainly, sample itself is exactly a liquid form also, or the sample of the liquid form of solid-state form that can be dissolved or its treated with same.Reagent on reagent areas can be moved.Some reagent can be labeled and can be in conjunction with the analyte in the sample, thereby form an analyte that is labeled.The sample region of acceptance and, or reagent areas can also comprise that a buffer reagent dissolves the pH value of sample or conditioned reaction, perhaps other reagent that needs because special detection requires.Usually, reagent strip is to support fluid sample to flow last by porous materials as matrix." matrix " is meant that those can support the material that fluid flows.In a concrete embodiment, host material is a porosint.Fluid flowing in pick-up unit can be to flow because of the capillary suction-operated.In a mode, the reagent strip that matrix can be made up of same material, in another different mode, the reagent strip that matrix can be made up of different porosints, each different porosint is in the liquid communication state mutually." suction " material is meant that those can stably absorb moisture and make the moisture material by capillary motion effect transportation therein.The example of absorbent material comprises nitrocellulose, filter paper, glass fibre, polyester and other suitable material.
Symbol
But distinguished symbol is to be interacted by positive control area in the device and analyte land to form.Positive control area can is-symbol a part, this part and analyte calmodulin binding domain CaM are in conjunction with forming symbol, perhaps this part also forms positive control area with fixing form.The part of this symbol or symbol can fix the formation positive control area by the method for prior art, method as shown in the figure, promptly print or be coated in matrix and form positive control area, perhaps coloured particulate protein adheres to above the matrix, following or middle this symbol of formation (the perhaps part of symbol) by being stained with.
In various concrete schemes, " but distinguished symbol " can be plus sige, minus sign, and dash, a long strip shape object, " X " is on the perhaps another kind of professional technique or can pass on the symbol of the Special Significance of test findings in word.Any significant symbol can use, the letter of Roman alphabet for example, numeral, the operational symbol of mathematics, scientific symbol, the letter of perhaps another kind of language or alphabet system, Chinese character for example, Japanese letter, perhaps Arabic alphabet.For example, negative findings be convenient to represent in minus sign, because it is the symbol of a significant and easy identification, simultaneously also easily and analyte calmodulin binding domain CaM formation positive sign.Other symbol, for example " X ", " O ", zero, " Y ", " N ", " Z ", perhaps arrow also can use.These symbols can be read and be understood by deconditioned user easily.When mark substance that can be detected and positive control area were all used with a kind of color, when obtaining a positive findings, but positive control area and analyte land interacted and have just formed distinguished symbol.When symbol was a minus sign, its edge can be the right angle, also can be circular.
Positive control area
This Device Testing zone comprises positive control area, negative control area and analyte land.Negative control area is positioned at detection zone, but can promptly not be part of positive control area, a part that neither the analyte land.Have the mark substance that detects model if in negative control area, can be detected, illustrate because produced wrong negative control, thereby this testing result is invalid.In some concrete schemes, detection zone is rectangle or the square region on the absorbent substrate, surrounds positive control area and analyte land, distributes along longitude (vertically) direction of test bar, is further surrounded by the test bar edge.
Positive control area can be depicted as one or more the colored zone on the device, and in some concrete schemes, it can not comprise that a kind of specific bond molecule is right.In the concrete scheme as shown in Figure 4, positive control area adopts the color mark form to adhere on the detection zone, and like this, "-" negative sign is just along vertical arrangement of reagent strip." vertically " represent the direction parallel, usually along the matrix length direction with the sample flow direction.Dyestuff or ink adhere on the matrix of positive control area or adhere on the structure that is positioned at below the matrix.For example, use in the concrete scheme of holders at those, dyestuff, ink or other materials of describing positive control area adhere to the top of holder or below.Positive control area generally places on the structure of following pick-up unit of test film, for example, and between host material and pick-up unit housing.This structure can be that plastics or other have the material of mark.Positive control area can be marked on the framework of device case, also can not mark.The dyestuff or the ink that are suitable for that are used for describing positive control area include, but not limited to 3132 fast red 2R, and 4230 is peacock blue, connect the colored latex particle of BSA, the IgG of golden mark.Certainly many other are not included in dyestuff in such example, and ink or colored materials can be used for dyeing.
Transparent, material movably
In these embodiments, these opaque but movably material only cover positive control area (as Fig. 3), but in the other embodiment, these opaque but movably material can cover whole surveyed area (as Fig. 2), perhaps cover a part of surveyed area, or cover whole positive control area and a part of surveyed area, or cover the outer part zone of non-surveyed area.A kind of " opaque movably material " is a kind of like this material, and under common indoor situation, they can not be penetrated by certain light and can see and cover following meeting, but the liquid solution that it can be flow through or pass matrix moves.Like this, when flow of liquid is crossed or pass matrix, be coated over that symbol under the opaque movably material just shows and as seen.In some embodiments, these symbols are covered fully, and in the other embodiment, some other light can pass these opaque materials and call sign below can be indistinctly visible, but can not influence this pick-up unit must make this usefulness.Like this, in these embodiments, these symbols can not be seen easily, in any case but can not clearly be recognized.
In the accompanying drawings, positive control area occurs with ghost form, but in the actual detection device, positive control area is covered by opaque but transportable material and can not see, perhaps see through these opaque positive control area of material movably, positive control area is unclear or seem very fuzzy.In a concrete embodiment, movably material can be dissolved in the aqueous solution.Can " dissolve " meaning and being meant that aqueous liquid sample can allow the symbol that is covered by opaque movably material reveal showing by surveyed area, movably material is washed away or is moved from symbol.Like this, this symbol is just high-visible under indoor light by naked eyes.
When can dissolved dyestuff being used as opaque movably material, any those dyestuffs opaque but can be dissolved can be used.A lot of colored mobile dyestuffs also can be used.Ponceau 4R and viridine green (Chinese Shanghai dyestuff research institute), from Chinese Shanghai Marine printing material company ground rose-red (lot number is 020811) and), the effect that water-soluble pigment composition and some food colorings also can the numbers of having.In an embodiment, this opaque, movably material can show white dyestuff.A kind of food of white adheres to reagent two sunization titaniums (TiO2) and can be used.When this dyestuff covers positive control area, before detection, can allow the user see without any symbol on the surveyed area on the pick-up unit, and the solid colour at other position on this color and the matrix.Certainly, the opaque movably material of other color is because some special considerations also can be used in the pick-up unit.Opaque movably material can be sprayed, and smears or prints or be applied on the positive control area by other machinery and equipment.In other embodiments, this opaque movably material can show such class material, for example latex particle or other similar substance, as long as these materials can by the fluid that flows from positive control area move open just passable.
In a concrete embodiment, the color of these opaque movably materials can with positive control area on color different, like this after these materials are moved away from positive control area, a symbol that is different from previous color shows, this symbol can with the color combination on the analyzed calmodulin binding domain CaM.
The analyte calmodulin binding domain CaM
The analyte land be positioned on the matrix and can with the positive control area combination, therefore when containing the target analyte in the fluid sample when, but it can with the positive control area distinguished symbol of generation that interacts.Mark substance on the reagent area can be in conjunction with (directly or indirectly) target analyte, thereby when sample flow was crossed matrix, analyte just had been labeled and can have detected the ground mark material.The analyte land also comprises can be in conjunction with the reagent of analyte related locus.This site material may be analyte self or in conjunction with the epitope on a kind of immunology of a kind of reagent of analyte (for example, a kind of reagent can combine with analyte during by reagent area at analyte).In various concrete schemes, with the reagent of analyte combination can be a kind of antibody, a kind of segment of antibody or part, a kind of and be attached to the derivant (perhaps segment wherein) of the different types of antibody of antibody of analyte land, perhaps specificity is in conjunction with another right composition, for example, and avidin, streptomycete avidin, the perhaps biotin that can combine with halfbody in conjunction with analyte.
In another concrete scheme, the analyte land is a bar that distributes along the latitude direction of the test bar longitudinal axis, wherein comprises a kind of specific binding molecules of analyte, or in conjunction with the molecular complex of analyte.The analyte land can be made up of the position of the both sides that are positioned at positive control area, and therefore when containing analyte in the sample, the analyte that has mark substance just has been retained in the analyte land.The color of analyte land and positive control area interacts and has formed discernible symbol.In some concrete schemes, mark is a kind of coloured particle, may be dextran bead, and the particle that aurosol or other are labeled, these marks can provide any suitable mark of detectable signal.
Reagent areas
The mark of combining target analyte provide produced the analyte land can observed detection signal, but it and positive control area interact and form distinguished symbol when containing analyte in the sample.The specific binding molecules of analyte carries the mark of reagent area.When specific binding molecule catch analyte and also the analyte that has been labeled when the analyte land is combined, because label gathers this district here and just can observe." specific binding molecule " be meant combine with analyte and can not with the binding molecule of other any molecule strong bonded in the sample.The specific binding molecule of analyte also can combine with existence that shows analyte in sample or the molecule that is associated with the existence of analyte.Strong bonded is meant in conjunction with reaching and changes test findings or make the unconspicuous degree of test findings.In some concrete schemes, specific binding molecule may be a kind of antibody or a kind of antibody fragment (for example, a kind of Fab district of antibody), a kind of antigen, a kind of acceptor of binding partner or the fragment of acceptor, perhaps biotin-streptomycete avidin in conjunction with a right composition or other type in conjunction with right.
Reagent area just can provide mark like this, and when sample flow was crossed reagent area, analyte combined the mark that can produce detectable signal." label pad " is meant the position of the material that contains the analyte that may exist in the underlined sample on the matrix.Therefore a reagent area is exactly a label pad." mark " can be any suitable mark that produces detectable signal.For example, mark can be a sol particle, fluorescent grain, and chemiluminescent molecule, metal or alloy (for example, collaurum), perhaps capsule particularly comprises the liposome of visible dyes.Hydrophobic sol also is that useful, hydrophobic organic dyestuff or pigment are soluble or have only very limited sub-fraction solvable in water.Mark can also be a polymer particles, for example coloured granules of polystyrene (for example, spherical).Other useful granular mark comprises ferritin, phycoerythrin, phycobilin-albumen, metal precipitation or solubility or alloy, fungi, marine alga, perhaps pigment of bacterium or derivant, for example chlorophyll of bacterium or other plant material.In some concrete scheme, mark is a coloured particle, for example dextran bead.In other concrete scheme, as the mark color identical of positive control, the interaction when producing single tangible symbol on matrix or in the matrix to strengthen two kinds of signals with dye selection
In other concrete scheme, mark may be the specific binding molecules (for example, a kind of antibody) that analyte a kind of has been labeled.For example, in a concrete scheme, the target analyte is human chorionic gonadotrophin (hCG), is the anti-hCG antibody of aurosol mark in conjunction with the mark of hCG.When sample arrived reagent area (perhaps label pad), the hCG in the sample was by the anti-hCG antibodies of aurosol mark.Labelled antibody does not disturb the capture molecules of analyte land and the hCG of mark to combine.For example, mark can be in conjunction with a part of analyte, and capture molecules can be in conjunction with another part or the incorporation of markings of analyte.HCG-is anti--and hCG antibody-gold compound moves to the downstream of matrix.When compound arrives the analyte land and capture molecules combine form gold-anti--hCG anti--hCG-is anti--hCG antibody.Capture molecules may be the another kind of specific binding molecules of hCG, or in conjunction with the specific binding molecules of the halfbody of hCG analyte.When gold-anti--hCG specific binding molecules-hCG-anti--when hCG specific binding molecules compound was attached to the analyte land, as seen the analyte land became naked eyes by the golden marker coloring on the compound and at analyte land gold mark.In a concrete scheme, specific binding molecule is antibody or antibody fragment.Mark with catch binding molecule can be in conjunction with epitopes different on the analyte, in a concrete scheme, the specific binding molecules of mark combines β-hCG, combines α-hCG and catch binding molecule.
" antibody " is meant immunoglobulin (Ig), no matter is natural or some or all of synthetic.This term also comprises the derivant of the antibody that wherein keeps binding ability, also comprise any contain with the binding domain homologue of immunoglobulin (Ig) or the protein that combines the territory of homology to a great extent.These protein may be to be derived from natural materials, also may be some or all of synthetic.A kind of antibody may be monoclonal or polyclonal.A kind of antibody may be a member in any immunoglobulin class, comprises any mankind's immunoglobulin class: IgG, IgM, IgA, IgD, IgG and IgE." antibody fragment " is a part less than total length of the derivant or the antibody of antibody.Antibody fragment can remain to the remarkable site of the binding ability of a few full length antibody.The example of antibody fragment comprises Fab, Fab ', F (ab ') 2, scFv, Fv, dsFv dimer and Fd fragment, but not only comprise above these.
Antibody fragment can be generated by any way.For example, antibody fragment can generate by enzymolysis or complete antibody of chemical cracking, perhaps also can be by the genetic recombination from the coded portion antibody sequence.In other words, the antibody fragment generation of can recombinating partially or entirely.Antibody fragment can be a single chain antibody fragments arbitrarily.In other words, antibody fragment can comprise many peptide chains that interconnect, and for example, passes through disulfide linkages.Antibody fragment also can be a kind of arbitrarily polymolecular compound.One has the antibody fragment of function to comprise about at least 50 amino acid usually, and more antibody fragment comprises about at least 200 amino acid usually.
Strand Fvs (scFvs) is the antibody fragment of reorganization, and it is only by variable light chain (V L) and variable heavy chain (V H) mutually with the polypeptied chain covalent bond.V LAnd V HIn a side have the amido end regions.Polypeptied chain length and to form be variable, its length can make two mutual bridgings of variable domain and the arrangement of atom not had a strong impact on.Polypeptied chain mainly is made of glycocoll and serine residue extension usually, wherein has some glutamic acid and lysine residue to be dispersed in distribution to increase its solubleness." dimer " is meant the dipolymer of strand Fvs.The peptide chain that dimeric monomer comprises is usually than the weak point of most of strand Fvs, and they demonstrate the tendency that forms dipolymer.
" Fv " fragment is by a V HWith a V LThe territory is with the non-covalent composition that interconnects.Term " dsFv " here is meant and comprises a stable V H-V LThe Fv of right intermolecular disulfide bond." F (ab ') 2" fragment is a fragment of antibody, in essence with identical with the pepsin fragment that digestion immunoglobulin (Ig) (normally IgG) obtains when the pH 4.0-4.5.This fragment also can be re-combined into." Fab ' " fragment is a kind of antibody fragment, in essence with by reducing F (ab ') 2The fragment that two interconnective cystine linkages of heavy chain on the fragment obtain is identical.Fab ' fragment also can be re-combined into." Fab " and fragment be a kind of in essence with the identical antibody fragment of fragment that obtains with papain digestion immunoglobulin (Ig) (usually IgG).The Fab fragment also can be re-combined into.Heavy chain fragment on the Fab fragment is the Fd fragment.
The symbol that can be identified is combined by positive control area analyte calmodulin binding domain CaM.This combination can be finished by a lot of modes, shown in Fig. 6-11.These be not have a mind to remove to limit these examples, the symbol of other form, for example circular or square, also be fine.
Before not using pick-up unit, the analyte calmodulin binding domain CaM shows sightless to the user.In such embodiment, based on whether there being analyte in the sample, testing result can be positive sign or negative sign.The testing result of Fig. 4 in analyte is not present in by sample the time.Because the opaque movably material that covers on the positive control area is washed off and demonstrates by the flowing liquid sample, thereby demonstrates negative sign.Fig. 5 represents the testing result when having analyte in the sample.Analyte and mark substance reaction are located at the material combination on the analyte calmodulin binding domain CaM then.The transversal line of analyte calmodulin binding domain CaM and reagent strip is unified direction.The mode of " passing through transversal line " is represented vertical with the liquid flow direction that flows through pick-up unit, and perhaps the length direction with reagent strip is vertical.Positive control area and analyte calmodulin binding domain CaM are designed on the reagent strip, and they are combined to form the symbol that can be identified mutually like this.In this embodiment, symbol is a positive sign.In another embodiment, the analyte calmodulin binding domain CaM can be combined to form other symbol with positive calmodulin binding domain CaM.
Fig. 6 is the synoptic diagram of another embodiment, and positive sign is that analyzed calmodulin binding domain CaM is staggered to form on positive control area.In this embodiment, allow earlier positive control area be positioned at reagent strip under, then the analyte calmodulin binding domain CaM is positioned at positive control area just above.In another mode, these zones can interlock or be not staggered.The color of handling ink on the positive control area or dyestuff can be the same with the color of the mark substance of mark analyte, when they in conjunction with the time, positive control area and analyte calmodulin binding domain CaM will form the symbol of solid color.In this embodiment, positive test symbol is a positive sign, and negative result is a negative sign.
Fig. 7 is the synoptic diagram of another embodiment, and positive sign is formed by positive control area and analyte calmodulin binding domain CaM, and positive control area can be positioned on the analyte calmodulin binding domain CaM or not and concern downwards.This embodiment and embodiment shown in Figure 6 now with, except the analyte calmodulin binding domain CaM is processed on the reagent strip prior to positive control area.Similar with last embodiment, positive test result is a positive sign, and negative result is a negative sign.
In another embodiment, positive control area can be post-treated on reagent strip, and the analyte calmodulin binding domain CaM is along the lateral processes of reagent strip.Like this, positive test symbol is position one positive sign still, and negative result is a negative sign.
Fig. 8 and 9 allows positive control area and analyte calmodulin binding domain CaM be combined into the method for positive sign for another kind of.As shown in Figure 8, positive control area is the zone (rather than a zone) of a plurality of arrangements, and these areal distribution form positive sign in the both sides of analyte calmodulin binding domain CaM with the analyte calmodulin binding domain CaM.In another mode kind, analyzed calmodulin binding domain CaM is that the zone of a plurality of arrangements is formed, and these areal distribution form positive sign in the both sides and the positive control area of positive control area.
Figure 10 is the synoptic diagram of another embodiment, and analyte calmodulin binding domain CaM and positive control area form " X " shape greatly.The liquid flow direction of positive control area and analyte calmodulin binding domain CaM and reagent strip is certain included angle and arranges.Figure 11 is the synoptic diagram of another embodiment, and positive control area and analyte calmodulin binding domain CaM form " Y " shape.
The type of analyte
The example of the analyte 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 analyte 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.
Using method
This invention provides uses this pick-up unit to come test fluid sample kind whether to have the method for analyte.This method comprises the step that the sample region of acceptance that fluid sample is applied to pick-up unit allows fluid flow along reagent strip.Fluid sample can be applied on the sample region of acceptance by some modes commonly used, for example uses dropper.
With reference to the accompanying drawings 1, after fluid or fluid sample were applied on the sample region of acceptance 15, sample flow through reagent strip along matrix flow.When this sample enters on the reagent areas 17, handle reagent on reagent areas or mark substance and sample that can the mark analyte and react, wherein, the antibody of an analyte has gold mark colloidal solid mark substance.Certainly mark substance can the time other any type of mark substance, for example gold colloid particles, enzyme or latex particle.When beginning to detect, surveyed area 12 has at least a part to be covered by opaque movably material, and wherein opaque movably material covers positive control area 11.When sample flow was crossed surveyed area, the moving of fluid sample can rinse out and cover the opaque removable material on the positive control area and allow positive control area reveal.Simultaneously, by the antibodies of another analyte on the analyte calmodulin binding domain CaM, this antibody is molecule of molecule centering of specific bond analyte to the analyte in the sample (being had the mark substance institute mark of detection signal this moment).
Positive control area 11 can be identical color with mark substance that can be detected, the analyte that has mark substance like this by analyte calmodulin binding domain CaM 13 in conjunction with after, positive control area and analyte calmodulin binding domain CaM be in conjunction with forming the symbol that can discern, for example "+" number.
If there is not analyte to exist in the sample, after detection was finished, the previous formed negative sign of positive control area just formed a negative sign and represents negative testing result on surveyed area.
Kit
The present invention also provides a kit, comprises one or more pick-up units of the present invention and the operational manual that how to use these pick-up units to detect.Requirement according to different consumers can be packaged into different forms.
In one embodiment, kit comprises reagent rod or pen shaped arrangement and operational manual that is used for detecting HCG in the urine that a detection is whether conceived.How this instructions explanation detects and the interpretation testing result.For example, a women is drenched urine on the absorption pad of pick-up unit, and it can be transferred to her urine on the reagent strip.Through after a few minutes, opaque movably material is washed away.If testing result is negative, show that this women does not have pregnancy, a negative sign is just shown because of opaque material washes away.If testing result is positive, represent that this women may be conceived, a positive sign is just shown because of opaque material washes away, and the HCG that has mark substance simultaneously is by the combination of analyte calmodulin binding domain CaM, thereby a negative sign that can be identified is provided.
In another concrete embodiment, this kit comprises 6,7,8,9,10,11 or 12, and perhaps greater than 3, greater than 4 or greater than 5 ovulation tests devices or 1,2,3, or more early pregnancy pick-up unit and operational manual.The LH level that these devices can detect in the menstrual period.In this embodiment, instructions is used for illustrating how to use these pick-up units to test.In another embodiment, instructions can illustrate women's hormone and the menstrual cycle and how determine the onset of ovulation.
In another embodiment, whether reagent strip of the present invention can be detected conceived by specialized laboratory.This kit comprises some pick-up units and operational manual.Kit can comprise 15 or more than 20 reagent strip.This class reagent strip can be provided more quantity and be used in clinical detection.
Test one detects pick-up unit and the assembling of early pregnancy HCG
This example is used for illustrating structure and the purposes that detects the hCG device.This example utilizes a kind of green food additive to cover positive control area as opaque coloring matter.This example illustrates the existence of the detection target analytes (hCG) that this device can be correct, and provides cheer and bright symbol that the positive or negative testing result is described.
Except the place that additionally marks, can make hCG detectable bar by the described method of prior art.At first by the microsyringe of microprocessor control sheep anti-mouse igg (1.3mg/ml, as the testing result control line) handle on the nitrocellulose filter, and then the IgG of mouse-anti α-hCG (concentration is 4.0mg/ml) handled nitrocellulose filter as detection line, as the analyte calmodulin binding domain CaM.When containing hCG in the sample, form positive positive sign perpendicular line.Discharge rate all is 1.1 μ l/cm.After finishing, nitrocellulose filter fixes antibody reagent in 45 ℃ of dryings (2 hours) immediately.
Apple green dyestuff (final concentration 1%, Shanghai Dye Inst. Co., Ltd., Chinese Shanghai, lot 99031923) and gold mark sheep anti-mouse igg (final 0D 520=121) be dissolved in Na 2HPO 4Damping fluid (final concentration is 50mM) is made a kind of solution, and this solution is attached on the positive control area on the nitrocellulose filter, becomes the identifiable marker the earliest (a kind of "-" mark) that detects the territory.Occur this mark after the detection and represent negative result.This solution is that 0.8 μ l/cm uses at discharge rate, and the length of processing is 10 millimeters.Also can be to handle 22-32mm length, be cut into reagent strip then.Immediately film is placed on 55 ℃ of dried overnight after handling well.
After the nitrocellulose filter drying, reagent areas and sample region of acceptance can be adhered on the film.Thieving paper in the device is used for promoting the mobile device that passes of liquid.The big card that assembles can the wide independent reagent strip of the about 60mm length * 7.2mm of cropped formation.Independently test bar is installed in the pick-up unit and is gone, and a suction sheet also can be installed in this device.Device package has two windows, and one is used for showing testing result, and one is used for showing the testing result control line.Detection window contains the negative sign mark of a green before using, and the control window is blank.
With containing 0mIU/ml respectively, the urine sample 1ml of 25mIU/ml and 100mIU/ml hCG is applied in the pick-up unit of 3 class different models, and every class device is total up to 27 pick-up units with 3.Respectively at 3min, 7min, and 10min observes testing result.When fluid sample flow through matrix, green dyestuff rinsed out from detection window, exposed negative (-) mark of following redness as positive control area.In the detection to the hCG sample of 0mIU/ml, each device all ownly shows that red (-) mark of bearing is promptly as negative findings three time periods.
When those sample flow that contain 25mIU/ml or 100mIU/ml of hCG are crossed the matrix of device, hCG by a kind of by golden target antibody labeling.Analyzing in conjunction with the territory when the hCG of mark arrives, also is must be when the zone, and the hCG of mark concentrates on analysis in conjunction with the territory, causes analyzing in conjunction with the territory showing redness.After chemical examination finishes, the detection zone of finder.
Contain 25mIU/ml hCG sample and begin within the 10min from detection, all devices all have red positive control area and red analyzed calmodulin binding domain CaM.Positive control area and red analysis present plus sige "+" mark at detection zone together in conjunction with the territory.
When device detected and to contain 100mIU/ml of hCG sample, all types of devices all showed plus sige "+" beginning to detect in the 3min, illustrate that having hCG is positive findings.
Apparatus and method of the present invention can be used in many aspects.For example specialized laboratory be used for clinical test pregnant,
Or accurately judge ovulation period by understanding the LH hormone.This pick-up unit also can be for the equipment of same purpose as family's detection.Whether this device can be used to detect conceived, can also be used to detect any analyte in other fluid sample certainly.Kit can be assembled for above different purpose.
The invention that this paper describes for example just can be used under the situation that each part all possesses, and being limited in here of it just do not specified.It is not unique constant being used for the term and the expression way of tracing device herein, and the expression way of the structure that we use these terms and expression way to get rid of to describe this device without any intention or any same meaning of feature, the various expression way of our approvals in the scope that the present invention states.Therefore, although we think the present invention in this article with various concrete schemes and arbitrarily feature description clearly display, but the expression way that changes the design that discloses herein also will be sought help from those experienced professional technique personages, and these changes are consistent with the statement that the present invention attaches.
Article, patent, patent application and the content of all other documents and the useful digitized information of mentioning herein and quote as proof combine, must come reference as a complete content, delivering wherein, any one part all will specialize this point.The applicant has and these any and whole articles, patent, patent is used or the information of other document and material are integrated with the right of the part that this application book discloses as patent specification.

Claims (30)

1. whether one kind detected and exist the pick-up unit of analyte to comprise in the sample: a kind of fluid sample of can supporting is in the last matrix that flows, on this matrix, comprise a sample region of acceptance, the surveyed area that has symbol, one or more reagent areas that detect required reagent that comprise, wherein, at least a portion of described surveyed area is covered by a kind of opaque movably material.
2. pick-up unit as claimed in claim 1 is characterized in that: described surveyed area comprises a positive control area and analyte calmodulin binding domain CaM.
3. pick-up unit as claimed in claim 1 is characterized in that: described opaque removable material is an aqueous ink.
4. pick-up unit as claimed in claim 2 is characterized in that: described matrix is the nitrocellulose filter reagent strip, simultaneously described positive control area with the shape of negative sign by vertical setting along reagent strip.
5. pick-up unit as claimed in claim 4, it is characterized in that: the analyte calmodulin binding domain CaM comprises two zones that are positioned at the positive control area both sides, this analyte calmodulin binding domain CaM comprises a kind of specific bond molecule simultaneously, and this molecule can be in conjunction with analyte or in conjunction with the another kind of molecule that is combined on the analyte.
6. pick-up unit as claimed in claim 2 is characterized in that: when having analyte in the sample, described positive control area and analyte calmodulin binding domain CaM can form a symbol that can be identified.
7. pick-up unit as claimed in claim 6 is characterized in that: described symbol is a positive sign.
8. pick-up unit as claimed in claim 5 is characterized in that: described opaque movably material is an aqueous ink, and this ink covers positive control area.
9. pick-up unit as claimed in claim 5 is characterized in that: described specific bond molecule is antibody or antibody fragment, and described opaque movably material is an aqueous ink.
10. pick-up unit as claimed in claim 9 is characterized in that: described analyte is a human chorionic gonadotrophin.
11. pick-up unit as claimed in claim 5 is characterized in that: described positive control area is made up of one or more zones that have color on the porosint, and this positive control area does not comprise any one molecule of specific bond molecule centering.
12. pick-up unit as claimed in claim 5 is characterized in that: described analyte calmodulin binding domain CaM also comprise one can the described analyte of specific bond molecule and the mark substance that detection signal is provided.
13. pick-up unit as claimed in claim 12 is characterized in that: described mark substance is the particle that has color.
14. pick-up unit as claimed in claim 13 is characterized in that: the described particle that has color is a dextran bead.
15. pick-up unit as claimed in claim 2, it is characterized in that: described analyte calmodulin binding domain CaM comprises parts that are provided with along the reagent strip lateral shaft, also comprise a kind of specific bond molecule simultaneously, this molecule can be in conjunction with analyte or in conjunction with the another kind of molecule that is combined on the analyte.
16. pick-up unit as claimed in claim 15 is characterized in that: described analyte calmodulin binding domain CaM and positive control area are formed the symbol that can discern.
17. pick-up unit as claimed in claim 15, it is characterized in that: described positive control area is made up of two zones that are separately positioned on analyte calmodulin binding domain CaM both sides, and this positive control area and analyte calmodulin binding domain CaM are formed the symbol that can be identified.
18. whether have the method for analyte in the test fluid sample, comprising:
Fluid sample is applied in the pick-up unit, this pick-up unit comprises the matrix that can support that fluid sample flows, on this matrix, comprise a sample region of acceptance of accepting fluid sample, the surveyed area that has symbol, one or more reagent areas that detect required reagent that comprise, wherein, at least a portion of described surveyed area is covered by a kind of opaque movably material;
Allow fluid flow through this matrix, when having analyte in the sample, exist the reagent on the reagent areas to react the reaction product that one of generation can be detected with sample also by described one or more reagent areas;
Allow fluid flow through surveyed area, the part of this surveyed area is covered by a kind of opaque movably material, like this, thereby fluid washes away this opaque movably material exposes positive control area, wherein, when sample flow was crossed surveyed area, the analyte in the sample was caught by the analyte calmodulin binding domain CaM;
Observe the surveyed area of pick-up unit and judge whether there is analyte in the fluid sample.
19. method as claimed in claim 18 is characterized in that: described surveyed area comprises an analyte calmodulin binding domain CaM, this zone comprise a kind of can be in conjunction with the specific bond molecule of analyte.
20. method as claimed in claim 19 is characterized in that: described specific bond molecule is antibody or antibody fragment, and described opaque movably material is an aqueous ink.
21. method as claimed in claim 20 is characterized in that: when fluid sample flows through surveyed area, expose positive control area thereby this fluid washes away described aqueous ink.
22. method as claimed in claim 18 is characterized in that: described matrix is the reagent strip that comprises porosint; Positive control area is with the longitudinal axis setting along reagent strip of the shape of a negative sign; Described analyte calmodulin binding domain CaM comprises two zones that are positioned at the positive control area both sides; Positive control area and analyte calmodulin binding domain CaM group are formed the symbol that can discern.
23. method as claimed in claim 22, it is characterized in that: described analyte calmodulin binding domain CaM comprises parts that are provided with along the reagent strip horizontal direction, this analyte calmodulin binding domain CaM comprises a specific bond molecule simultaneously, the analyte that this molecule can the underlined material of combined belt.
24. method as claimed in claim 23 is characterized in that: described positive control area comprises two parts that lay respectively at analyte calmodulin binding domain CaM both sides, and this positive control area and analyte calmodulin binding domain CaM are formed the symbol that can be identified.
25. a kit comprises:
The pick-up unit that whether has analyte in a kind of test fluid sample, this device comprise that one can be supported fluid sample in the last matrix that flows, and comprise a sample region of acceptance of accepting fluid sample on this matrix,
Surveyed area and one or more reagent areas that detects required reagent that comprises that has symbol, wherein the part of positive control area is covered by a kind of opaque movably material; With
Use the instructions of this device.
26. kit as claimed in claim 25, it is characterized in that: described surveyed area comprises analyte calmodulin binding domain CaM and positive control area, this positive control area is with the longitudinal direction setting along reagent strip of the shape of negative sign, and described opaque movably material is an aqueous ink.
27. kit as claimed in claim 26, it is characterized in that: described analyte calmodulin binding domain CaM comprises two zones that lay respectively at the positive control area both sides, this analyte calmodulin binding domain CaM comprises a specific bond molecule simultaneously, and this molecule can be in conjunction with analyte or in conjunction with another molecule on the analyte; When having analyte in the sample, described positive control area and analyte calmodulin binding domain CaM form a distinguished symbol.
28. kit as claimed in claim 27 is characterized in that: described symbol is a positive sign.
29. kit as claimed in claim 26 is characterized in that: the specific bond molecule is antibody or antibody fragment, and opaque movably material is for saying the dissolubility ink.
30. kit as claimed in claim 27 is characterized in that: described analyte is selected from human chorionic gonadotrophin (hCG) or lutropin (LH).
CNA2006800484094A 2006-01-10 2006-01-10 Apparatus and method for immune detection Pending CN101341407A (en)

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