CN2886555Y - Apparatus for collecting and detecting sample - Google Patents
Apparatus for collecting and detecting sample Download PDFInfo
- Publication number
- CN2886555Y CN2886555Y CN 200520131943 CN200520131943U CN2886555Y CN 2886555 Y CN2886555 Y CN 2886555Y CN 200520131943 CN200520131943 CN 200520131943 CN 200520131943 U CN200520131943 U CN 200520131943U CN 2886555 Y CN2886555 Y CN 2886555Y
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- sample
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- liquid
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- pick
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Images
Abstract
The utility model provides a device for collecting specimens and detecting analyzed substance and a reagent box including the device. The detecting device provided in the utility model comprises a detecting element, a result reading window, and a dock area for receiving and engaging specimen collector, wherein a liquor charging hole comprising a conduction structure is included on the dock area. In a specific operation manner, the device in the utility model can be used to detect the hemoglobin in human stool, which is occult blood examination.
Description
Technical field
The utility model belongs to medicine equipment, collects sample and detects the apparatus and method that whether contain material to be checked in the sample about a kind of specifically.
Background technology
The Preliminary detection of intestinal cancer is determined by the occult blood examination in the ight soil.The method of protoheme often causes a large amount of false positive results in traditional detection ight soil, and for example based on the chemical detection of guaiac resin, but this method can be subjected to the interference of food (meat product) and produce false positive.In order to overcome the deficiency of above method, immunological method has high specific and is used, because the antibody of special antihuman hemoglobin can not be subjected to the influence of other non-human haemoglobin.
The utility model provides a kind of new collection and has detected the device of analyte in the sample, and it is easy to use this device to have, and sanitation and hygiene can make the operator avoid sample contamination, and these advantages are that the pick-up unit of prior art does not have.
The utility model content
The utility model provides a kind of device of collecting and detecting sample, the method that detects that contains the kit of this device and use this device.In a kind of embodiment, the biological specimen of detection is the stool sample, and analyte is the haemoglobin in the stool.Can be used to collect stool sample to be checked with the sample collection sheet that pick-up unit is used in addition.The sample collection sheet that has the sample of defecating is placed to detect on the pick-up unit that contains detecting element (for example reagent strip) whether contain analyte in this sample.Wherein contain the docking zone of accepting the sample collection sheet on the pick-up unit, on this docking zone, contain the sample receiving orifice, in the sample receiving orifice, contain one or more liquid that allow and flow to flow guiding structure on the reagent strip fast, for example be across crossbeam of sample receiving orifice or the like from the sample collection sheet.
On the one hand, this utility model provides a pick-up unit to detect analyte in the sample.This pick-up unit contains detecting element (for example reagent strip), accepts and mesh the docking zone and the results window that reads testing result of sample collection sheet.The sample receiving orifice is contained in this docking zone, contains one or more liquid that allow and flow to flow guiding structure on the reagent strip fast from the sample collection sheet on the sample receiving orifice.
In one embodiment, to connect the hole be a well shape hole to the sample on the docking zone.In another embodiment, flow guiding structure can be a crossbeam, and this crossbeam can be positioned at same plane with well shape hole, also can be positioned at the inside in well shape hole, can also be higher than the empty plane of well shape.The crossbeam of this flow guiding structure and the sample collection sheet that is engaged on the pick-up unit can carry out liquid communication.
In another embodiment, also contain the structure of some similar engagements on the docking zone on the pick-up unit, this structure can allow the collection sheet be in fixing position on pick-up unit.This similar engaging structure can be the Elastic buckle structure.In another embodiment, this docking zone can be pick-up unit self to lower recess, this depression have the enclosure wall shape structure of projection to the small part periphery.
In another embodiment, this reagent strip is made up of water-absorbing material, and it comprises the sample region of acceptance, finishes necessary reagent areas of reaction and surveyed area.The sample region of acceptance of reagent strip and flow guiding structure can carry out liquid flow.On surveyed area, be fixed with the molecule of specific bond analyte, can directly judge the existence that in sample, whether contains analyte by having or not change color on this surveyed area.In one embodiment, the molecule of this specific bond analyte can antibody, and in another embodiment, the molecule of this specific bond analyte is the antibody of antihuman hemoglobin.In another embodiment, reagent areas comprises the molecule of the specific bond analyte that has mark substance.
On the other hand, the utility model provides the method that detects analyte in the sample.This method comprises the collection sheet that has a sample is put on the docking zone on the pick-up unit detect in the sample whether contain analyte.In one embodiment, this sample collection sheet comprises that the first hydrophobic upward card and the hinge that have liquid filling hole block, and are also containing a flow of liquid through hole on the card down under second hydrophobicity on last the card.This collection sheet can have the open and close two states, when this collection sheet is under the closure state, has a sample to accept carrying tablet between the liquid flow through hole of last card and following card.This method also comprises dripping on liquid through-hole extracts buffering liquid, makes this buffering liquid by the reagent strip in the sample carrying tablet arrival pick-up unit, reads testing result by result window.
In one embodiment, this reagent strip is made up of water-absorbing material, and it comprises the sample region of acceptance, finishes necessary reagent areas of reaction and surveyed area.This sample region of acceptance and flow guiding structure can carry out liquid flow, are fixed with the molecule of specific bond analyte on this surveyed area, can directly judge the existence that whether contains analyte in sample by having or not change color on this surveyed area.In one embodiment, the molecule of this specific bond analyte can antibody, and in another embodiment, the molecule of this specific bond analyte is the antibody of antihuman hemoglobin.In another embodiment, reagent areas comprises the molecule of the specific bond analyte that has mark substance.In another embodiment, the surveyed area on this reagent strip contains chemical substance and finishes chemical detection.
On the other hand, the utility model also provides a kind of kit to collect and detect analyte in the sample.This kit comprises pick-up unit, collects sheet and sampler.This kit can also comprise one bottle or many bottles of buffering liquids.
Described here utility model content is not only limited in above the limited embodiment of enumerating, and puts down in writing in detailed description that some other better implement scheme can be below and the claim.
The beneficial effects of the utility model are: 1) collect the structure that sheet has packing ring and groove and complements each other to form sealing, when this sample collection sheet is in closure state, unnecessary sample can be extruded to the outer also sealed structure of carrying tablet to be separated, reach quantitative effect, make testing result more accurate.2) have one to accept and mesh the docking zone of collecting sheet on the pick-up unit, this docking zone cooperates with the collection sheet, collection sheet and pick-up unit are combined, to collect the dockland of going into that sheet is inserted into pick-up unit when detecting detects, the collection of sample can be finished in different periods and space with detecting, made things convenient for patient and medical worker.3) flow guiding structure in docking zone makes the sample carrying tablet of pick-up unit on can more close collection sheet, thereby reaches better drainage effect, makes to detect fast and accurately.
Description of drawings
Fig. 1 is the three-dimensional exploded view of an embodiment.
Fig. 2 is the more detailed decomposing schematic representation of Fig. 1.
Fig. 3 A-3C is to the process synoptic diagram of collecting on the sheet sample collection.Fig. 3 A shows the open mode of collecting sheet; Fig. 3 B demonstration is applied on the collection card after having collected sample with sampler; Fig. 3 C shows this collection sheet closed condition.
Fig. 4 collects sheet to be engaged to synoptic diagram on the docking zone on the pick-up unit.
Fig. 5 drips the synoptic diagram of buffering liquid to the liquid through-hole of collecting on the sheet.
Fig. 6 is the collection sheet of working good and the cross-sectional view of test card.
Fig. 6 A is the enlarged drawing of frame of broken lines part among Fig. 6.
Description of reference numerals: sample collection sheet 110, the first hydrophobicity cards 114, the second hydrophobicity cards 112, the second hydrophobicity card liquid through-hole 116, upper plate 122, reading window 128 as a result, docking zone 126, lower plate 124, crossbeam 132, pick-up unit sample receiving orifice 226, well 130, sampler 134, emulsion sheet 218, packing ring 220, sample carrying tablet 216, groove 212, rib 214, the first hydrophobicity card liquid through-holes 210, reagent strip 222, reagent strip downstream area 234, the upstream region 232 of reagent strip, lower plate jack 228, lower plate inside surface 230, hinge 224, the second hydrophobicity card pin 316, the first hydrophobicity card jack 318, spatula 312, handle 314, Elastic buckle structure 412, buffering liquid 512, surge flask 510, raised structures 410.
Embodiment
In the following detailed description, the subsidiary reference word of legend is a part here, and it illustrates to illustrate the mode that the utility model can actable specific concrete scheme.We do not get rid of the utility model and can also carry out other concrete scheme and changing structure of the present utility model under the situation of usable range of the present utility model.
The sample collection sheet
The utility model provides a kind of sample collection sheet.This sample can be some biological specimens, for example fecal sample.The utility model also provides and detects the pick-up unit that whether contains analyte in the sample and use the method for collecting sheet.This pick-up unit can be used with sample collection sheet 110.
Shown in Fig. 1-5, this sample collection sheet 110 comprises the first hydrophobicity card 114 and the second hydrophobicity card 112.This first and second hydrophobicitys card can be made by a lot of materials, some hydrophobic materials for example, and as plastics, some fluid-tight metals or glass material or the like.In a concrete scheme, the first hydrophobicity card 114 can be in the same place by hinge with the second hydrophobicity card 112, for example links together (as shown in Figure 2) by hinge 224.Be meant that by " hinge connection " end of two cards is joined together respectively and the other end of two cards all is in free state respectively.The structure of much similar " hinge " can be applied to this collection sheet and come up.For example, in process of production, this hinge arrangement can be touched the plastic hinge that the tool cast forms by plastics, and this plastic hinge two card connection of collecting sheet together.Certainly can also be have respectively on two cards of this collection sheet cooperatively interact " " the shape structure makes a buckle receive on another card to button like this.The second hydrophobicity card liquid through-hole 116 of one buffering liquid or solvent circulation is arranged on the second hydrophobicity card 112, and the buffer solution 512 in the reagent bottle 510 can be added drop-wise on the sample collection sheet by this through hole 116.
As illustrated in fig. 1 and 2, this sample collection sheet can be in and close and open two states.As shown in Figure 2, have on the first hydrophobicity card to have on one first hydrophobicity card liquid through-hole, 210, the second hydrophobicity cards one second hydrophobicity card liquid through-hole 116 is also arranged.Be in when closing when collecting sheet, two liquid through-holes are corresponding and roughly overlapping mutually.Can allow and be added drop-wise to the flow of liquid of collecting on the sheet by the second hydrophobicity card liquid through-hole 116 and cross sample carrying tablet 216 and arrive the corresponding first hydrophobicity card liquid through-hole 210 just passable as long as said here two liquid through-holes are roughly overlapping.
As shown in Figure 2, an emulsion sheet 218 covers the inside surface of the second hydrophobicity card 112, and covers on the second hydrophobicity card liquid through-hole 116.This emulsion sheet and sample collection carrying tablet can be made by a lot of suitable materials, these materials have can be allowed flow of liquid cross and carry aneroid character, these materials all are that persons skilled in the art can be expected easily based on this patent, for example the paper of some polyester films, cellulose membrane, filter paper, nylon membrane, synthetic cellulose, nitrocellulose filter, glass fibre, processing, thieving paper or the material made based on cellulose.In an example, this emulsion sheet 218 is fixed on the inside surface of the second hydrophobicity card by the packing ring 220 of an annular.
One first hydrophobicity card liquid through-hole 210 is arranged on the first hydrophobicity card, and this through hole is covered by sample carrying tablet 216.The material of making this sample carrying tablet 216 also has much as previously mentioned.This carrying tablet 216 can be surrounded by the rib 214 of the groove 212 of one or more ring-types and projection.In some embodiments, the material that this carrying tablet 216 and emulsion sheet 218 are adopted can be the same, preferable material has good absorbability and the property held for this slide glass, also has simultaneously certain physical toughness, so promptly can absorb and hold abundant sample and can also avoid collecting and be coated with the mechanical damage of sample process sampler, perhaps avoid this material to be damaged easily by after moistening to it.
Usually, the patient collects the stool sample makes collection excessive easily, may cause some adverse effects to testing result like this.But the collection sample what the sample collection sheet that is to use the utility model to provide can directly limit simply, and do not need other complicated unnecessary method to eliminate unnecessary sample.When this sample collection sheet is in closure state, limit because the area of sample carrying tablet is looped around this regional hermetically-sealed construction (for example packing ring and groove fit), thereby the amount of sample also has been subjected to qualification.Detailed saying is exactly that when closing the collection sheet, for example the groove 212 of the packing ring 220 of the second hydrophobicity card and the first hydrophobicity card cooperates the hermetically-sealed construction that forms to separate the sample on unnecessary sample and the sample carrying tablet.Simultaneously, because closure function, it is outer and sealed structure is separated that the unnecessary sample on the carrying tablet also can be extruded to carrying tablet.The sealing structure can also be other structures except packing ring and groove fit form, and for example can be to be sticked together or around the wax (for example paraffin) around carrying tablet or the emulsion sheet by pressure.When the collection sheet is in closure, just passable as long as this structure can seal the zone of this carrying sample.Here said " sealing " is not to seal state of isolation, only when the collection sheet is closed, plays the sample that stops outside the carrying tablet and enters on the carrying tablet.Those of ordinary skill in the art can expect easily that by description of the present utility model other similar structures realizes the function of this " hermetically-sealed construction ".
Can handle the flowing property that some reagent increase liquid on this emulsion sheet and/or the sample carrying tablet.These handle the ability that also can improve buffer solution extraction/dissolving analyte from the sample of event attitude drying simultaneously.For example, these materials can be handled by some surface-active agents, can prevent that like this albumen in the sample from attaching to the stability that can also increase albumen on the carrying tablet.Preferred reagent is that some contain the capable surface-active agents of electronegative nonionic.Some kations or zwitter-ion surface-active agents also can be used for handling, and for example, are not limited in this, some polymerized fatty ethers, and as lauryl alcohol, 16 (alkane) alcohol, octadecanol, oleyl alcohol (BRIJ
(ICI US, Inc); Some other surface-active agents, for example derivant of oxirane or oxirane (soil temperature class); Own oxo-compound (the Rohm of coal acids of band octyl group; Haas, PhiladelphiaPA).In conjunction with the utility model, some gyp surface-active agents commonly used can be used the utility model, for example examination of the surfactivity of Pragmatics company or similarly agent box.These kits provide simple and practical method to select suitable surface-active agents to improve the dissolving of albumen and the ability of liquid flow.
In some specific embodiment, these materials also can be handled to improve the stability of analyte by some buffer solution.Simultaneously, buffer solution can also provide molecule (antibody, antibody fragment etc.) optimum reaction condition, for example the pH value of conditioned reaction of analyte and specific bond analyte.These buffer solution comprise that this is cited when not only being confined to, carbonic acid, phosphoric acid, boric acid, tartrate or phthalic acid or the like.
Emulsion sheet and sample carrying tablet can also be handled the stability that improves analyte and be dissolved into the ability of going in the eluting liquid (buffering liquid of dropping) by some high polymer matter.The polymkeric substance of some purifying proteins of using always also can be used the utility model.Some PVP (polyvinylpyrrolidone), PEO (poly (methylvinylether-co-maleic anhydride, polyethylen eoxide), PEG (polyelthylene glycol), PVA (polyvinylalcohol), HPC (hydroxypropylcellulose), CMC (sodium carboxymethylcelluose), HEC (hydroxyethylcellulose) or the like for example.These polymeric materials all are can be available easily on market, for example pass through (Pragmatics, Inc., Elkhart, Indiana) company's order or the like to Pragmatics.
For analyte solution is extracted from sample, these materials (the sample carrying tablet is or/and emulsion sheet) not some Profilin are handled.Any albumen can, for example bovine serum albumin (BSA), albumin, casein (casein) or the like.These albumen not only are confined to listed above.
Emulsion sheet and sample carrying tablet can also be increased between the storage of sample collection sheet by some anticorrosion agent treated.Said anticorrosion reagent comprises that some compound systems nature or synthetic suppress microbial growth or kill microorganisms.Any anticorrosion reagent can use and interference detection results not, and for example Sodium azide, benzoic acid are received (ProClin
300 (Supelco, Inc., Bellefonte, limited to, PA).These reagent not only are confined to listed above, also comprise other anticorrosion reagent that persons skilled in the art are expected easily in conjunction with the utility model.
Collecting on the sheet, some mechanisms are being set on the card therein can make two cards better be in closure state.For example, some short and small pins 316 are set at the inside surface of the second hydrophobicity card 112, and some are set on the corresponding first hydrophobicity card can be for the jack 318 of projection insertion.When the collection sheet was closed, the pin 316 of last card will be inserted into down in the jack 318 of card with pressure, collects sheet like this and is just well closed and be not easy arbitrarily to be opened.In addition also have other similar method to make the collection sheet be in the mode that is not easy arbitrarily to open, for example clamp two cards of collecting sheet with the reversion pin.One of ordinary skill in the art all expects adopting suitable means to make the collection sheet better be in closing state easily in a word.
Sampler
As shown in Figure 1, the utility model also provides sampler 134.Shown in Fig. 3 B, this sampler has one handle 314 and collects the spatula 312 of sample.In one embodiment, some holes are arranged on this spatula, when collecting sample, can reduce the content of liquid like this, also can avoid collecting unnecessary sample.Hole on this spatula can be 2,3,4,5,6,7,8,9,10,11,12 or more hole.Spatula on the gatherer is normally more flat, can certainly be the structure of other similar spoon shape or groove shape.This gatherer can be made by a lot of materials, as plastics.In one embodiment, the spatula of this gatherer is made by flexible plastic, and handle is made by duroplasts.Be easy to like this sample of collecting is coated onto on the sample carrying tablet.
Collection method
Another feature of this utility model has just provided the method for collecting sample.In one embodiment, this sample is the stool sample.The Collection and analysis of sample examples of implementation shown in Fig. 3 A-3C.The patient at first opens the collection sheet allows the zone of carrying sample come out (Fig. 3 A), then a certain amount of stool sample is coated onto (Fig. 3 B) on the sample carrying tablet 216, closes at last and collects sheet (Fig. 3 C).
This collection sheet can be got rid of unnecessary sample, and only makes the sample on the carrying sample areas participate in detection.When the collection sheet was pent, a kind of structure on a kind of structure on the first hydrophobicity card and the second hydrophobicity card complemented each other to form and is surrounded on carrying sample fence structure on every side.In one embodiment, the formation of this fence structure is by the and groove and rib on the card upper gasket and the first hydrophobicity card form.After the collection sheet is closed, two liquid through-holes on the first and second hydrophobicity cards, the sample bearing area is in a straight line.Like this, after buffer solution is added dropwise in the liquid through-hole on the second hydrophobicity card, its in turn stream flow out by the liquid through-hole on the first hydrophobicity card then and collect sheet through emulsion sheet and sample carrying tablet, arrive on the pick-up unit.When flow of liquid was crossed on the sample carrying tablet, owing to be Packed fence structure around the carrying tablet, liquid only may dissolve the analyte in the sample and get in the zone that can not flow to beyond the carrying tablet in the carrying tablet scope so.On pick-up unit, this liquid is by finishing detection on the detecting element (for example reagent strip) in the flow guiding structure arrival pick-up unit.Simultaneously, the analyte of this buffering liquid in can diluted sample makes and arrives The optimum reaction conditions on the reagent strip.
People's haemoglobin is very easy to degraded under the situation of humidity.In order to overcome this problem, this method also comprises dry this sample.This method can be to allow collect sheet air dry or be placed in the temperature environment that is higher than 45 ℃ dryly in air, can also be that this collections sheet is placed on drying in the sealing bag that contains dried reagent.After the drying, these are collected sheet and can be detected by doctor or tester.Sanitation and hygiene more when detecting sample are not almost polluted environment like this.
Pick-up unit
As illustrated in fig. 1 and 2, this pick-up unit comprises that upper plate 122 and lower plate 124 cooperates or tightly lock together formation.The material that forms this pick-up unit can be the known material of prior art, as plastics, strengthens cardboard, metal, pottery, some polymeric materials or other material.Being connected of upper plate and lower plate also is to utilize traditional method to connect, as shown in Figure 2, the pin (not showing) of a lot of projections is arranged on upper plate, and the jack 228 that this pin can be inserted on the lower plate inside surface 230 gets on, and upper and lower plates has just well been coupled together like this.
On pick-up unit, have one to accept and mesh the docking zone 126 of collecting sheet.May contain the biological specimen that to analyze on this collection sheet.This docking zone can be the structure of Any shape, as long as these structures can cooperatively interact with the collection sheet, it is just passable to allow both be in the liquid communication state.In one embodiment, external collection sheet can be accepted and mesh in this docking zone.After having collected sample and before detecting, this collection sheet can be to be independent of pick-up unit and to exist.The meaning of " accept and engagement " is meant and makes them after this collections sheet and pick-up unit cooperate both are in state to be detected that what is called state to be detected is meant that the crossbeam 132 on sample collection sheet 110 and the pick-up unit 120 is in the state of liquid communication.
It is a reversible process that sheet can be accepted to collect in the docking zone, and the meaning is to collect on the sheet when buffering liquid is added to, and after sample was washed down, this collection sheet can also be removed from pick-up unit.As shown in Figure 4, by collecting the hinge area of sheet, collect sheet can be directly with the upper surface that is approximately perpendicular to the docking zone from withholding on the docking zone.One or more Elastic buckle structures 412 are arranged on the docking zone, and this Elastic buckle structure can allow the collection sheet be in fixing position.In another embodiment, collecting sheet can be inserted in the docking zone of pick-up unit with the upper surface that is roughly parallel to the docking zone, make a docking zone part cooperate the collection sheet and make the collection sheet be in stable position, for example docking zone upper process structure 410 can be withheld an end of collecting the sheet card tightly.This moment, the Elastic buckle structure can change to the slide rail of being inverted the L type.After sample collection sheet and pick-up unit are placed, can carry out liquid flow between sample carrying tablet and the flow guiding structure.Like this, after buffer solution is added dropwise in the liquid through-hole on the second hydrophobicity card, its in turn stream flow out by the liquid through-hole on the first hydrophobicity card at last and collect sheet and reach on the pick-up unit outward through emulsion sheet and sample carrying tablet.On pick-up unit, this liquid is by finishing detection on the detecting element (for example reagent strip) in the flow guiding structure arrival pick-up unit.
Simultaneously, in one embodiment, the sample collection sheet is accepted in the inside that this docking zone can be positioned at pick-up unit, makes between sample carrying tablet and the flow guiding structure and can carry out liquid flow.For example collect in the opening that sheet can be inserted into pick-up unit and go, like this, the sample carrying tablet is placed on the position that can carry out liquid flow with flow guiding structure.In another embodiment, the sample receiving orifice 226 on the pick-up unit only is to be used for accepting sample or to analyze liquid, and the mixed platform liquid of sample and analysis liquid flows to the pick-up unit the inside by flow guiding structure together like this.Here said " analysis liquid " is meant that buffering liquid or other are used for participating in the material of response analysis.Here, the sample receiving orifice 226 on pick-up unit only is the through hole as liquid communication, and dissolved sample and analysis liquid enter sample receiving orifice 226 by flow guiding structure together.
As shown in Figure 1, in another concrete embodiment, this docking zone comprises a well 130, and this well forms the structure in sunk area or well shape hole, and one or more liquid flow guiding structures are arranged in their inside.This flow guiding structure can be any form to outer process, can better contact like this or near the sample carrying tablet surface of collecting in the sheet, thereby reach better drainage.For example, flow guiding structure can be by the surface of sunk area or the well shape pore structure one or more dentalations to outer lug, or some stretch to and near raised structures or the crossbeam of collecting sample carrying tablet in the sheet.Any amount of raised structures can, as 1,2,4,6,8,10,12,2-6,2-8,2-10,2-12 or 4-8.
In the embodiment as shown in Figure 2, this flow guiding structure is the part of pick-up unit self to outer lug.This flow guiding structure one end can be present within the sample receiving orifice 226 of pick-up unit, and the other end can be to be positioned under the docking area planar and the docking area planar maintains an equal level or is positioned on the docking area planar.This flow guiding structure can be to any suitable height of outer process, for example 1 millimeter, 2 millimeters, 3 millimeters, 5 millimeters or the like.The plane in said here docking zone is meant surface level vertical with the sample receiving orifice and above solid space.
In one embodiment, the liquid flow guiding structure can be the crossbeam that is across on the sample receiving orifice.Like this, can two crossbeams being parallel to each other or intersecting be across on the sample receiving orifice, and this intersection can be at right angles, acute angle, or be " X " type, honeycomb type or triangular form.In the other embodiment, beam structure can link to each other with the one or more raised structures of vertical extension that make progress around sample receiving orifice surface.In another embodiment, be centered around sample receiving orifice raised structures or some ends on every side and be positioned at sample receiving orifice the inside, the outward extending son of leaning on of the other end also can serve as flow guiding structure.In a word, as long as a lot of structures that can transfer liquid can apply to this utility model.
This flow guiding structure is exactly that the liquid of collecting on the sheet is transferred on the reagent strip of pick-up unit.In one embodiment, after the collection sheet is withheld the docking zone of pick-up unit, collect the flow guiding structure all roughly overlapping (Fig. 6) on two liquid through-holes, emulsion sheet, sample carrying tablet and the pick-up unit on the sheet.In the present embodiment, this flow guiding structure is to docking area planar outer process, sample carrying tablet surface in the collection sheet and the flow guiding structure on the pick-up unit well connect together like this, keep good liquid communication state thereby can make the sample receiving orifice of pick-up unit and collect sheet.So-called " liquid communication " meaning is meant that the liquid that flows through the sample carrying tablet can continue to flow forward by drainage system.Flow guiding structure and to collect sheet can be directly or it is logical in succession to ask is as long as can keep liquid communication just passable.
" combination " on the physical significance is meant because the effect of molecular link makes a hydrone connect another hydrone." absorption affinity " and " combination " is similar, but it comprises that also a hydrone is adsorbed on the in addition individual non-hydrone.The flow guiding structure here provides a passage for fluid molecule flows exactly, can allow the liquid that flows through the carrying sample chips better flow in the pick-up unit like this and go.This flow guiding structure is the infiltrating material of aqueous solution preferably, and the strong more then drainage effect of its water wettability is good more.The principle of this flow guiding structure provides a surface for hydrone flows exactly, by this surface hydrone is flowed freely by absorption.When flow guiding structure with after liquid links to each other, this liquid just by the surface flow of flow guiding structure, so just can conveniently arrive on the reagent strip in the pick-up unit.After liquid flow on the reagent strip, this liquid continued to flow forward to finish detection reaction by the capillary absorption affinity.After enough buffering liquids are added dropwise to liquid through-hole, this buffering liquid can dissolve, the analyte in the eluted sample, this solution flows out to be collected sheet and flows to the sample region of acceptance of an end on the reagent strip by flow guiding structure, and surveyed area arrives the other end of reagent strip at last.The flow guiding structure butt can obtain the drainage effect of the best when collecting sample carrying tablet in the sheet, even but flow guiding structure has tiny gap (being no more than 3.0 millimeters) with the sample carrying tablet of collecting in the sheet, because liquid can permeate and pass carrying tablet and surface by self gravitation effect and flow guiding structure links to each other and reaches the effect of dredging liquid.Therefore, the sample carrying tablet in said flow guiding structure of the utility model and the collection sheet is in the liquid communication state and had both comprised flow guiding structure and the mutual butt of collecting in the sheet of sample carrying tablet, also comprises having tiny gap between the two.
Shown in Fig. 2 to 6, detectable bar 222 is positioned in the pick-up unit.Certainly reagent strip can be put in the pick-up unit before detection or in the testing process and go, and before detection, reagent strip just has been placed in the pick-up unit and has gone here.As shown in Figure 6, this flow guiding structure links to each other with reagent strip one end.In one embodiment, this reagent strip is the horizontal effluent detector bar of water absorptivity.A lot of similar agents bars can apply to this pick-up unit, for example common nitrocellulose filter reagent strip.The sample region of acceptance is arranged, marked region, surveyed area or the like on this reagent strip.The sample region of acceptance links to each other with flow guiding structure, can allow liquid flow freely, and finishes the necessary reagent of reaction and may reside in the sample region of acceptance, also can separately exist between sample region of acceptance and the surveyed area, for example some labels.These react necessary reagent a lot of purposes, and for example the molecule for analyte and specific bond provides top condition, or increases stability of analyte or the like.So-called optimum reaction condition comprises the pH value of conditioned reaction, perhaps reducing those influences the interference of analyte in conjunction with other quasi-molecule of special molecular, as add some can deactivation or a kind of deactivation reagent of the analyte enzyme that suppresses to degrade or suppress reagent
The sample region of acceptance can be positioned at the upstream region 232 of reagent strip, and some reaction reagent zones can be positioned at the downstream area 234 of reagent strip, are surveyed areas in the downstream in reaction reagent zone.Some reagent and the mark substance that comprise conditioned reaction on reagent areas, this mark substance can the specific bond analytes or the similar substance of analyte.In some concrete embodiments, this mark substance comprise can the specific bond analyte a class special molecular, for example antibody or antibody fragment or the like, and be present on the reagent strip with the form of doing.When flow of liquid was crossed this zone, liquid can dissolve these mark substances of doing and flow forward with liquid.In a concrete embodiment, analyte is human hemoglobin (IIb), mark substance comprise can the specific bond haemoglobin antibody. the antibody of this specific bond haemoglobin can adopt any way mark, metallic colloid for example, latex colloid or some water-soluble polymeric fuel marks etc.The method of mark and the material of mark all are that prior art is known.
The specific bond molecule is meant just insufficient molecule in conjunction with other non-analyte in conjunction with the molecule (haemoglobin) of analyte in the sample.When combining in the sample behind the analyte, just can detect whether there is analyte in this sample directly or indirectly.So-called insufficient combination is meant between specific bond molecule and the non-analyte more or less all combination might take place, but these nonspecific combinations can not change the combination between specific bond molecule and the analyte.The specific bond molecule can be some antibody, antibody fragment, antigen or other pairing, as antibody of biotin and antibiotin or the like.
Surveyed area is to detect the zone that whether has analyte in the sample.In a concrete embodiment, whether this surveyed area macroscopic detection lines occur and represents having or not of amalyzing substances, and the detection lines are a kind of form wherein, the lines of all right other shape.On surveyed area, be fixed with another special molecular of specific bond analyte.For example, when analyte is human hemoglobin, be fixed with the antibody of antihuman hemoglobin on the surveyed area, another antibody of antihuman hemoglobin is arranged on mark substance.Be fixed on antibody on the surveyed area like this and be the human hemoglobin in the specific bond sample and not in conjunction with the molecule of non-human hemoglobin, based on this, immunity is in conjunction with detecting the false positive that greatly reduces testing result, make detection more accurately and reliable.
Detection method
Another aspect of the present utility model has just provided the method for using this sample collection and pick-up unit.This method comprises: a pick-up unit is provided, and pick-up unit comprises: the docking zone of detecting element, the reading window that reads testing result, acceptance and engagement sample collection sheet also comprises the sample receiving orifice simultaneously on the docking zone; In the sample receiving orifice, also comprise one or more flow guiding structures; A sample collection sheet is provided, the collection sheet comprises: the first hydrophobicity card and the second hydrophobicity card that has another liquid through-hole that have a liquid through-hole, the first hydrophobicity card and the second hydrophobicity cartoon are crossed hinge and are linked together, this collection sheet can be in the opening and closing state simultaneously, when this sheet is in closed condition, between the first hydrophobicity card liquid through-hole and the second hydrophobicity card liquid through-hole, a sample carrying tablet is arranged; Earlier the collection sheet that has sample is put into the docking zone of pick-up unit, makes sample carrying tablet and flow guiding structure be in the liquid communication state; Drip to a liquid through-hole collecting sheet then and extract buffering liquid, this liquid flows on the detecting element in the pick-up unit by sample carrying tablet and another liquid through-hole; The window that reads by testing result reads testing result.
In a concrete embodiment, after the collection sheet that has sample being put into the docking zone of pick-up unit, liquid through-hole on the second hydrophobicity card of collecting sheet drips buffering liquid 512, and this liquid flows through emulsion sheet successively, the liquid through-hole on the sample carrying tablet and the first hydrophobicity card.If there is analyte in the sample, this buffering liquid will wash-out and the dissolving sample in analyte and flow to buffering liquid on the flow guiding structure surface of pick-up unit.
In another embodiment, the sample of collecting on the sheet is done, buffering liquid wash-out and the dissolving dry sample analyte in this, and the liquid through-hole that this eluting liquid and unnecessary buffering liquid flow through the first hydrophobicity card arrives the docking region surface.Surface in the docking zone, these liquid parts are flowed in the sample receiving orifice that enters together on the pick-up unit and flow on the sample region of acceptance of reagent strip by well shape hole/sunk area, another part directly flows on the sample region of acceptance on the reagent strip by flow guiding structure.
Also pass through reagent areas when the sample region of acceptance that these liquid flow on the reagent strip, these liquid will dissolve the material of anticipating on reagent strip.In the concrete embodiment, when the form of analyzing the employing sandwich detects analyte, just comprise a kind of molecule of specific bond analyte in this reagent, for example antibody or antibody fragment.In this embodiment, the coloured mark substance of mark on this antibody or the antibody fragment, these reagent materials are to be present on the reagent strip with the form of doing in advance.Specifically, for example, in detecting stool, whether contain human hemoglobin in, this reagent is exactly antihuman hemoglobin antibody or the antibody fragment that has the gold grain colloid, fixing another antibody of antihuman hemoglobin on surveyed area.If in the stool sample, have human hemoglobin, the antihuman hemoglobin antibodies that this haemoglobin will be had the gold grain colloid forms compound substance, when this compound substance flows on the surveyed area with liquid, another antihuman hemoglobin that is fixed on the surveyed area will specially be caught this compound substance, thereby on surveyed area, just form and detect lines, just can know the result of detection by reading window 128 as a result.
In another embodiment, adopt competition law to carry out immunoassay.Marked region on reagent strip or reagent areas comprise and the similar thing of analyte, have label on this material, as have the human hemoglobin similar substance of gold mark particle.If there is not analyte to be present in the sample, the analyte similar substance of this mark will with the antibodies on the surveyed area, so positive findings shows not have analyte to exist in the sample.If there is analyte in the sample, this material will be attached on the surveyed area with the similar substance competition of mark.When the amount of analyte many more, just few more being attached on the surveyed area of the similar substance of this mark, so just appearance on surveyed area, do not occur or occur more shallow color lines show analyte how much.
On reagent strip, can also comprise the control area, no matter whether there is analyte in the sample, lines all can appear on this control area, if do not control the existence of lines then illustrate that the testing result on the surveyed area is invalid.
In another embodiment, the liquid that wash-out comes out on collecting sheet can also detect analyte the sample with chemical method.For example utilize guaiacol to detect haemoglobin.
The type of sample and analyte
The sample of any kind can both be tested with device of the present utility model, 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, mince, 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 refuse water).Sewage also can be included in the environmental sample with relevant refuse.
Utilize collection sheet of the present utility model and pick-up unit can detect a lot of analytes.These amalyzing substances comprise, but be not limited only to this, composition in haemoglobin or other blood, creatinine, cholerythrin, pressure nitrate, albumin, some hormone (HCG, LH etc.), the composition of white blood cell, carbohydrate, heavy metal ion, toxin, microorganism (as, the specific antigen of albumen, blood sugar, specific antigen, for example Escherichia coli O 157, salmonella or the like other microorganism) to a certain microorganism, the proportion of parasite and urine, other interested material in the urine.
Detection kit
Of the present utility model also providing comprises one or more collection sheets of the present utility model and pick-up unit and operational manual.This kit can be to satisfy any type of packing that the user requires.In a concrete embodiment, in kit, comprise operational manual, the user can collect and detect according to operating guidance.In another specific embodiment, kit comprises three dry sack and the instructionss collecting sheet, three pick-up units, three sampler and have annular seal space.This kit can be any suitable containers, as chest, box, sack or a wrapping paper the simple packing of this several sections is linked together or the like.In another embodiment, one or more collection sheets and pick-up unit are sub-divided in separately respectively in two thin aluminum bags, and buffer solution and instructions are placed in another sack.In the place of detecting, may once there be many collection sheets to need to detect, it also is feasible that the pick-up unit of a plurality of independent packings and big bottle buffering liquid and a operational manual are provided this time.In another embodiment, a kit is divided into two parts, and a part aims at the gatherer and provides, and the part that provides for the gatherer comprises collection sheet and collection process operational manual; For the tester provides another part, this part comprises pick-up unit and the instructions that cushions liquid and how to detect.
Experiment 1 usefulness collects sheet and pick-up unit detects haemoglobin in the people stool
As shown in drawings, all collecting the someone on the carrying tablet of six collection sheets defecates; By the time after these have the collection sheet drying of people stool, each is collected sheet and is placed on the docking zone of pick-up unit and is fixed under the bayonet socket in docking zone, make the liquid through-hole collected on the sheet and the sample receiving orifice of sample carrying tablet and pick-up unit keep the liquid communication state, the while flow guiding structure links to each other the sample carrying tablet with pick-up unit.The buffer solution of about 3 (about 200 microlitres) flow into by the liquid through-hole on the second hydrophobicity card and collects on the sheet.In all experiments, approximately spent 7-16 second, buffer solution flows in the sample receiving orifice on the pick-up unit by collecting sheet; In 50 seconds, this buffer solution flows through the relics bar, article one, line appears on the control area, is fixed with the antibody of specific bond human hemoglobin on the surveyed area on this reagent strip, handles another antibody that the antihuman hemoglobin that has mark substance is arranged on reagent areas.
The utility model 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 utility model is stated.Therefore, although we think in this article the utility model 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 utility model 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 these any and whole articles, patent, patent application or the information of other document and the right that material is integrated with this application book.
Claims (9)
1. device of collecting and detecting sample, comprise: detecting element (222), the reading window as a result (128) that reads testing result, docking zone (126), on the docking zone, also comprise simultaneously sample receiving orifice (226), it is characterized in that, also comprise one or more flow guiding structures in the described sample receiving orifice.
2. the device of collection as claimed in claim 1 and detection sample is characterized in that described sample receiving orifice comprises funnelform well (130).
3. the device of collection as claimed in claim 1 and detection sample is characterized in that described flow guiding structure comprises crossbeam (132), and this crossbeam is to upper process and be not less than the docking area planar.
4. the device of collection as claimed in claim 3 and detection sample is characterized in that described crossbeam and the sample collection sheet liquid communication that is engaged on the pick-up unit.
5. collection as claimed in claim 1 and detect the device of sample is characterized in that described docking zone comprises that one makes the sample collection sheet be in raised structures (410) on the sample receiving orifice.
6. the device of collection as claimed in claim 5 and detection sample is characterized in that described docking zone comprises one or more buckle structures (412).
7. the device of collection as claimed in claim 1 and detection sample is characterized in that described docking zone is to be formed by pick-up unit surface depression, at least bossed enclosure wall around the part sunk area.
8. the device of collection as claimed in claim 1 and detection sample, it is characterized in that described detecting element comprises contains sample region of acceptance, reagent areas and surveyed area, can carry out liquid communication between wherein said sample region of acceptance and the flow guiding structure, surveyed area comprises that shows detection lines that whether contain analyte in the sample.
9. the device of collection as claimed in claim 1 and detection sample, it is characterized in that described device also comprises sample collection sheet (110), the sample collection sheet combines with the docking zone of pick-up unit, this collection sheet comprises: the first hydrophobicity card (114) with a liquid through-hole (210) and inside surface, the second hydrophobicity card (112) with another liquid through-hole (116) and inside surface, first card and second cartoon are crossed hinge (224) and are linked together; Also have the sample carrying tablet (216) that has the sample bearing area between two liquid through-holes, sample carrying tablet and flow guiding structure communicate.
Priority Applications (9)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200520131943 CN2886555Y (en) | 2005-10-25 | 2005-10-25 | Apparatus for collecting and detecting sample |
| CA002624954A CA2624954A1 (en) | 2005-10-25 | 2006-10-20 | Method and a kit for detecting an analyte in a sample |
| PCT/GB2006/003909 WO2007049009A1 (en) | 2005-10-25 | 2006-10-20 | Method and a kit for detecting an analyte in a sample |
| DE212006000062U DE212006000062U1 (en) | 2005-10-25 | 2006-10-20 | Device for detecting an analyte in a sample |
| AU2006307725A AU2006307725A1 (en) | 2005-10-25 | 2006-10-20 | Method and a kit for detecting an analyte in a sample |
| US12/091,354 US20090226928A1 (en) | 2005-10-25 | 2006-10-20 | Method and kit for detecting an analyte in a sample |
| JP2008537176A JP2009513966A (en) | 2005-10-25 | 2006-10-20 | Method and kit for detecting an analyte in a sample |
| EP06794847A EP1941253A1 (en) | 2005-10-25 | 2006-10-20 | Method and a kit for detecting an analyte in a sample |
| IL191053A IL191053A0 (en) | 2005-10-25 | 2008-04-27 | Devices and methods for sample collection and analysis |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200520131943 CN2886555Y (en) | 2005-10-25 | 2005-10-25 | Apparatus for collecting and detecting sample |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN2886555Y true CN2886555Y (en) | 2007-04-04 |
Family
ID=37961644
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200520131943 Expired - Lifetime CN2886555Y (en) | 2005-10-25 | 2005-10-25 | Apparatus for collecting and detecting sample |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN2886555Y (en) |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107796945A (en) * | 2016-09-05 | 2018-03-13 | 深圳市普方吉生物医药有限公司 | Fecal specimens processing, fecal occult blood test method and kit |
| CN108510845A (en) * | 2018-03-17 | 2018-09-07 | 长江大学 | A kind of geologic sedimentation mutually learns to use auxiliary tool |
| CN109943473A (en) * | 2019-04-02 | 2019-06-28 | 邦睿生技股份有限公司 | Inspection test piece device |
| CN115089043A (en) * | 2019-07-26 | 2022-09-23 | 重庆德方信息技术有限公司 | Sampling and detecting device, intelligent toilet lid and sampling and detecting method thereof |
-
2005
- 2005-10-25 CN CN 200520131943 patent/CN2886555Y/en not_active Expired - Lifetime
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107796945A (en) * | 2016-09-05 | 2018-03-13 | 深圳市普方吉生物医药有限公司 | Fecal specimens processing, fecal occult blood test method and kit |
| CN108510845A (en) * | 2018-03-17 | 2018-09-07 | 长江大学 | A kind of geologic sedimentation mutually learns to use auxiliary tool |
| CN109943473A (en) * | 2019-04-02 | 2019-06-28 | 邦睿生技股份有限公司 | Inspection test piece device |
| CN109943473B (en) * | 2019-04-02 | 2022-04-05 | 邦睿生技股份有限公司 | Test strip device |
| CN115089043A (en) * | 2019-07-26 | 2022-09-23 | 重庆德方信息技术有限公司 | Sampling and detecting device, intelligent toilet lid and sampling and detecting method thereof |
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