CN101498717A - Sample collecting device used for collecting solid or semi-solid sample - Google Patents
Sample collecting device used for collecting solid or semi-solid sample Download PDFInfo
- Publication number
- CN101498717A CN101498717A CNA2009101264487A CN200910126448A CN101498717A CN 101498717 A CN101498717 A CN 101498717A CN A2009101264487 A CNA2009101264487 A CN A2009101264487A CN 200910126448 A CN200910126448 A CN 200910126448A CN 101498717 A CN101498717 A CN 101498717A
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- sample collection
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- collection device
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Abstract
The invention provides a sample collecting device for collecting solid or semisolid samples, comprising a first board and a second board, wherein the first board is provided with a first opening and a cover plate for covering the first opening; the second board is provided with a second opening and a sample collecting plate for covering the second opening; and the cover plate and the sample collecting plate are made of material which prevents solid or semisolid samples from passing through but allows solution to pass through. The sample collecting device is provided with an opening position and a closed position, when the sample collecting device is at the closed position, the first opening is opposite to the second opening, and a sample collecting zone is formed between a zone where the cover plate covers the first opening and a zone where the sample collecting plate covers the second opening.
Description
Present patent application is dividing an application of Chinese patent application 200510070353.X number
Technical field
The present invention relates to a kind of medical appliance, especially a kind of sample collection device that is used to collect solid or semi-solid samples.
The invention still further relates to a kind of detection method of using above-mentioned collection and pick-up unit assembly that the stool sample is detected.
Background technology
Detecting the occult blood test in the stool sample is the first one step process that detects colon cancer.The method of the haemoglobin in the existing detection stool sample, be the reaction substrate (chemical method of Guaiac-based) for example based on guaiacol, owing to can't differentiate the haemoglobin that derives from the diet (as come from the diet meat) or mankind itself's haemoglobin, so cause the generation of a large amount of false positive test findings.In order to overcome this shortcoming, the specific immune analysis method of human body hemoglobin (hHb) is used.The haemoglobin that the antibody that uses in this immune analysis method can come from human body in the future makes a distinction from the haemoglobin that derives from other animal.The existing device that is used for the Collection and analysis occult blood brings a lot of inconvenience for patient and operator's use, and is longer as detection time; In the detecting operation process, to expose sample as the operator, cause environmental pollution easily like this, also might cause infection to the operator simultaneously, and also exist operating process loaded down with trivial details.Therefore, be necessary to develop and a kind ofly can reduce being in contact with one another between patient and test operation person and the sample, and detect the device of the human body hemoglobin (hHb) in the sample simultaneously quickly and accurately.
Summary of the invention
The invention provides a kind of sample testing apparatus, it has the absorption material for transfer, can promote to detect flowing of liquid, thereby shorten detection time.
The invention provides a kind of sample testing method, it is easy and simple to handle, and can avoid contacting between operator and sample, and then guarantees the safe and reliable of detecting operation.
The invention provides a kind of sample collection device that is used to collect solid or semi-solid samples.This sample can be a biological specimen, as the sample etc. of defecating.
The invention provides the assembly of a kind of sample collection and pick-up unit, it is easy and simple to handle, can shorten detection time, and can reduce contacting between operator and sample, and then guarantees the safe and reliable of detecting operation.
The present invention is as follows for the technical scheme that solves its technical matters and adopt: a kind of sample testing apparatus that is used for detecting the analyte of sample, and it comprises body, fixedly is housed in intrinsic detecting element and absorption material for transfer; Wherein body be provided be used to accommodate the external samples gathering-device and be mated go into the dockland, be used for application of sample mouth that passes through for sample liquid and the display window as a result that is used for the observation test result; Above-mentioned absorption material for transfer be positioned at described application of sample mouth and with detecting element fluid connection mutually.
As a further improvement on the present invention, described absorption material for transfer is selected from following material: ultrahigh molecular weight polyethylene, tygon, polyurethane, nylon, polyester, polypropylene, teflon and cellulose sample material.
As a further improvement on the present invention, described absorption material for transfer includes surfactant.
As a further improvement on the present invention; described absorption material for transfer includes reagent; this reagent is selected from following material: tygon (23) 12 (alkane) basic ethers; lauryl alcohol; poly-(oxygen ethene-copolymerization oxygen third is rare) blocking-up multipolymer; p-different Nonylphenoxy-poly-(epoxy prapanol); the monostearate sorbitol anhydride; dimethyl silicone polymer methyl ethoxy thing; polyethoxy (20) oleyl alcohol; polyethoxy (35) castor oil; polyoxyethylene (20) mono laurate sorbierite; polyoxyethylene (20) mono laurate sorbierite; octyl phenol ethoxylate (1.2); octylphenoxypoly octyl group benzene oxygen polyethoxy (5) ethanol; octyl group benzene oxygen polyethoxy (9-10) ethanol; octyl group benzene oxygen polyethoxy (30) ethanol; C14-C16 alkene sulfonic acid sodium; polyoxyethylene sodium (1) sulfuric acid lauryl alcohol; toluene alkane ammonium chloride; ethylenediamine alkoxy blocking-up multipolymer; 2; 4; 7; 9-tetramethyl-5-decine-4; 7-diol ethoxylate (10); 2; 4; 7; 9-tetramethyl-5-good wet agent decine-4; 7-diol ethoxylate (30); the benzene sulfonamide acid amide; poly-(oxygen ethylene copolymer oxygen third is rare) blocking-up multipolymer; telomer B monoether; dioctyl sulfonic acid-sodium succinate; poly-(ethene methyl ether/maleic anhydride) multipolymer; N-oleyl-N-methyl sodium aurate; sodium dodecylsulphonate; natrium taurocholicum; sodium taurocholate; N-ring trimethyl-tryptophane amine chloride; N, N-dimethyl lauryl amine sodium sulfonate N-oxide; 3-[3-(chloramines third is rare) dimethyl amine]-1-propane; ethylene glycol ethoxy base thing; n-octyl group sucrose; n-dodecyl sucrose; n-Lauryl.beta.-maltoside; octyl glucoside; the octyl group giucosinolate; n-ethyl cyclophosphadenosine glycoside; n-dodecyl glucoside; tris (methylol) aminomethane buffer solution; phosphate buffer; borate buffer solution; tartrate buffer; the phthalic acid salt buffer; the polyvinylpyrrolidone homopolymer; poly-(vinyl methylether/maleic anhydride); polyethylene oxide; polyethylene glycol; polyvinyl alcohol; 1-ethene-2-pyrrolidone; the bony fiss gel; crosslinked acrylic acid polymer; the hydroxypropyl alkoxy cellulose; sodium carboxymethyl cellulose; kayexalate; sodium carrageen; acrylic emulsion; hydroxyethyl cellulose; bovine serum albumin(BSA); ovalbumin; casein; 5-chlorine-2-methyl-isothiazoline-3-ketone and sodium azide.
A kind of detection method that whether contains analyte in the sample that detects, it comprises the steps:
The external samples gathering-device is cooperated with sample testing apparatus;
Wherein sample collection device comprises: first plate, second plate with the hinge joint of first plate, wherein first plate has the eluent mouth, second plate has the lysate mouth, this gathering-device has open position and make-position, when it is positioned at make-position, between eluent mouth and lysate mouth, be formed with the sample collection district;
Sample testing apparatus comprises: body, fixedly be housed in intrinsic detecting element and absorb material for transfer; Wherein body be provided be used to accommodate the external samples gathering-device and be mated go into the dockland, be used for application of sample mouth that passes through for sample liquid and the display window as a result that is used for the observation test result; Above-mentioned absorption material for transfer be positioned at described application of sample mouth and with detecting element fluid connection mutually;
Buffer solution is added drop-wise in the lysate mouth of sample collection device;
Allow that damping fluid passes through sample, absorbs behind the material for transfer to detecting element;
From observing testing result the display window as a result.
A kind ofly be used for collecting sample and detect sample whether contain the sample collection of analyte and the assembly of pick-up unit, it comprises sample collection device and sample testing apparatus; Wherein sample collection device comprises: first plate, second plate with the hinge joint of first plate, wherein first plate has the eluent mouth, second plate has the lysate mouth, this gathering-device has open position and make-position, when it is positioned at make-position, between eluent mouth and lysate mouth, be formed with the sample collection district; Sample testing apparatus comprises: body, fixedly be housed in intrinsic detecting element and absorb material for transfer; Wherein body be provided be used to accommodate the external samples gathering-device and be mated go into the dockland, be used for application of sample mouth that passes through for sample liquid and the display window as a result that is used for the observation test result; Above-mentioned absorption material for transfer be positioned at described application of sample mouth and with detecting element fluid connection mutually.
The invention has the beneficial effects as follows: in conjunction with experiment 1 and experiment 3, sample testing apparatus of the present invention has adopted the suction material for transfer, and its surfactant that is used to promote analyte to transfer to the test-strips of pick-up unit from sample collection device was handled, thereby promoted to detect flowing of liquid, shortened detection time, simultaneously can interference detection results; Gathering-device of the present invention in addition and pick-up unit branch are arranged, and can finish easily and collect and testing, and the operator need not open gathering-device when detecting, thereby avoid contacting between operator and sample, and then guarantee the safe and reliable of detecting operation.
Description of drawings
Fig. 1 is the stereographic map of Sample Collected With Checkout Gear Assembly of the present invention;
Fig. 2 is the three-dimensional exploded view of Sample Collected With Checkout Gear Assembly of the present invention;
Fig. 3 A is the stereographic map of gathering-device of the present invention under open mode;
Fig. 3 B is the stereographic map of gathering-device of the present invention when collecting sample;
Fig. 3 C is the stereographic map of gathering-device of the present invention under closure state;
Fig. 4 is the three-dimensional assembly diagram of Sample Collected With Checkout Gear Assembly of the present invention;
Fig. 5 drips the stereographic map of damping fluid when detecting for Sample Collected With Checkout Gear Assembly of the present invention;
Fig. 6 is the side direction cut-away illustration after Sample Collected With Checkout Gear Assembly of the present invention cooperates.
Embodiment
The invention will be further described below in conjunction with accompanying drawing:
Sample collection device
The invention provides a kind of sample collection device that is used to collect solid or semi-solid samples.This sample can be a biological specimen, as the sample etc. of defecating.
Shown in Fig. 1-5, sample collection device 110 comprises first plate 114 and second plate 112.First and second plates can be made by any suitable material.For example, can be to make, as plastics, cated cardboard, metal or glass etc. by resilient, anti-water or impermeable material.First and second plate links mutually, for example connects by hinge 224 (joining shown in Figure 2)." hinge joint " is meant that first and second plate interconnects at their end respectively, free end separately then can around hinge towards mutually away from the direction motion.There are many hinge joint modes to adopt.In the present embodiment as shown in Figure 2, by first and second plate the 114, the 112nd of injection mo(u)lding, hinge joint by an activity together.In other embodiment, hinge also can be one or more folding thin slice, two boards is bonded together and a plate is folded on another piece plate.In addition, first and second plate also can be separated from each other, but can be fixed together, for example the effect by latching device.Second plate contains a damping fluid mouth or lysate mouth 116, can for damping fluid 510,512 by and be added drop-wise on the collected sample (ginseng Fig. 1 and shown in Figure 5).
Sample collection device has an open position and a make-position (more illustrated in figures 1 and 2).As shown in Figure 2, have on first plate on eluent mouth 210, the second plates lysate mouth 116 is arranged.When sample collection device was positioned at make-position, two mouths alignd mutually.Can make and to put on second the liquid of the lysate mouth of (perhaps) plate when the amount that applies is enough, to flow through the sample collection district mutually by two mouths " alignment " and by the eluent mouth.
Please refer to shown in Figure 2ly, gathering-device comprises a cover plate 218, and it is positioned at the inside surface of second plate 112 and covers lysate mouth 116.Gathering-device comprises sample collection sheet 216, and it is positioned on first plate 114 and covers eluent mouth 210.Cover plate and sample collection sheet can be to be made by any material that is fit to of can retain sample and flow of liquid being crossed.This material is as the polyester nethike embrane, stringiness or water-absorbing material, paper or paper material, synthon, nethike embrane and woolen knitwear, cated or paper, polyester, nylon membrane, nitrocellulose, glass wool, refining paper, thieving paper or the cellulose sample material of bottom arranged.Certainly those of ordinary skill in the art can expect easily that cover plate and/or sample collection sheet also can adopt other material that is fit to make.
In the present embodiment, cover plate 218 is on every side round packing ring 220.The all sides of sample collection sheet are surrounded by a convex ridge 214 and a groove 212, can certainly be surrounded by some convex ridges and groove.Above carried, cover plate and sample collection sheet can be made by any suitable material of can retain sample and liquid being passed through.In addition, this material also will have enough elasticity, can bear the pressure when adding sample, and the wetted back of this material is difficult for decomposing or being torn.
In the difficulty that runs into often of stool sample collection is often application of sample repeatedly on sample collection device of patient, thereby disturbs the result of immune detection.Sample size when sample collection device of the present invention can limit application of sample is not simultaneously needing the relevant speciality personnel can directly operate under instructing.When sample collection device was positioned at make-position, cover plate and sample collection sheet were closed structure and surround (for example, by packing ring and groove fit), so sample size is limited in the sample collection district on the sample collection sheet.When sample collection device was in make-position, the interaction of enclosed construction (for example, the interaction of packing ring and convex ridge and groove being arranged) was trapped among sample packages in the sample collection district, thereby itself and the sample separation that is applied to outside the sample collection district are come.After sample is added to collecting region on the sample collection sheet, the position of pinning will be closed and remain on to sample collection device, and first and second plate coarctate the time unnecessary sample be extruded, the sample in the collecting region is extruded simultaneously, thereby has limited the sample size that is retained in the sample collection district.Enclosed construction also can be the structure that is different from packing ring, convex ridge and groove.For example, this structure can be to be easy to the bonding agent of compressive deformation or sample collection sheet and/or above the cover plate or wax stone on every side (perhaps some wax stones), the sample collection district can be closed when first and second plate closing and coarctate the time.Among the present invention, " sealing " might not need airtight completely live, and just can stop sample to flow into sample collection district or outflow sample collection district when sample collection device is positioned at closed position basically.For the ordinary skill in the art, its can expect easily many other can be used in structure in other the embodiment of the present invention.
Cover plate and/or sample collection sheet can be contained the agent treated that promotes liquid flow and be crossed to improve the ability of liquid by cover plate or sample collection sheet.In addition, also can promote the target analyte in the dryness sample in sample collection district to be come out by such processing by elution.In the present embodiment, cover plate and/or sample collection sheet contain surfactant, thereby it can Profilin matter adhere to the dissolving that promotes protein on cover plate and/or the sample collection sheet.The surfactant of various normally used negative ion and non-polar multiple variable concentrations can use effectively.Some surfactants cationic and both sexes also can be with in the present invention.The example that can be used for handling the surfactant of cover plate and/or sample collection sheet comprises, but comprises that not only the polyoxyethylene aliphatic ether, cetyl alcohol, octadecanol and the oleyl alcohol that extract in the lauryl alcohol are (for example,
(ICI US, Inc.) series of surfactants).Other useful surfactant comprises octyl phenol alcohol ethoxylate surfactant (for example, polyethylene glycol list-p-different-octyl phenyl ether and other
(Rohm ﹠amp; Haas, Philadelphia, PA) series of surfactants), the polyoxyethylene deriv of sorbitan ester (for example,
(ICI Americas, Inc.) series of surfactants) and by oxirane and epoxypropane form with HO (C2H4O) a (C3H6O) b (C2H4O) aH (.e.g., the
(BASF) Xi Lie surfactant) be the blocking-up multipolymer of representative.About what disclosed among the present invention, surfactant can select technology to select easily by known surfactant, such as surfactant instrument cases by buying on the market, for example, reagent developer's (Reagent Developer) surfactant instrument cases (Pragmatics, Inc., Elkhart, Indiana), perhaps similar instrument cases.The simple and easy method that these instrument cases can provide detection that the surfactant of special efficacy is arranged in a large number reaches optimum efficiency thereby make the extraction of protein and flow through.
In some embodiments, cover plate and/or sample collection sheet can also be handled with the damping fluid that contains the composition that improves analyte stability.Damping fluid can also be regulated the sample state and promote best combination (for example, antibody or antibody fragment) between analyte and the specificity combinating reagent, and this point can be used in detection.For example, reach this point by the pH value of regulating analyte.Damping fluid with above-mentioned these useful qualitys comprises, but not only comprises Tris (methylol) aminomethane buffer solution, phosphate buffer, borate buffer solution, tartrate buffer and phthalic acid salt buffer.
" specific binding molecules " be meant combining target analyte (as human body hemoglobin) and can not with the well-bound molecule of any other molecule in the sample.In some embodiments, the molecule combination that specific binding molecules also can be relevant with target analyte in the sample or the indicating target analyte exists.Fully in conjunction with being meant the degree that influence testing result that the specificity binding analysis produces in conjunction with reaching, the result who promptly obtains the best or accurate result is weaker.The issuable a small amount of non-specific binding that does not influence testing result is not considered to abundant combination.In some embodiments, specific binding molecules can 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 and the acceptor that part combines or the fragment of acceptor, perhaps biotin-streptavidin to or other type in conjunction with a right member.
Cover plate and/or sample collection sheet also can have the condensate processing of the character of improving analyte stability and promoting wash-out with one or more.Sometimes the condensate that is applied to protein purification can be used for this purpose.These condensates comprise, but not only comprise, polyvinylpyrrolidone (PVP), poly-ethylene methacrylic ether copolymerization maleic anhydride, polyethylene oxide (PEO), polyethylene glycol (PEG), the multipolymer of ethylene methacrylic ether (for example, poly (ethylene methacrylic ether copolymerization maleic anhydride), polyvinyl alcohol (PVA) (PVA), vinylpyrrolidone/vinyl acetate, bony fiss gel (from the fish of bony fishes, obtaining), crosslinked polyacrylic acid condensate (HPC), sodium carboxymethyl cellulose (CMC), kayexalate, sodium carrageen, acrylic emulsion and hydroxyethyl cellulose (HEC)).These condensates can buy from the market (for example, Pragmatics Inc, Elkhart Indiana), and can be designed to a polymeric tool box easily.Therefore they can systematically be used for determining the specific polymeric benefit in application-specific.
In order to promote the extracting of analyte, cover plate and/or sample collection sheet also can be handled with a kind of nonspecific proteins matter with blocking agent function.Any can comprising as the protein of this purpose, but not only comprise bovine serum albumin, ovalbumin, and casein.
Cover plate and sample collection sheet also can be handled with a kind of antiseptic that can increase the pot-life of sample collection device." antiseptic " can be a kind of natural or synthetic chemical substance, can suppress growth of microorganism or unnecessary chemical reaction after the interpolation.Any antiseptic can be used for anticorrosion, and can the interference test result.This examples of preservatives comprises, but comprises that not only 5-chlorine-2-methyl-isothiazoline-3-ketone (for example,
300 (Supelco, Inc., Bellefonte, PA) and sodium azide.Certainly, those of ordinary skill in the art also can expect easily many other can be used for antiseptic of the present invention.
Cover plate and sample collection sheet form the upper wall and the lower wall in sample collection district respectively, and can discharge the unnecessary sample in sample collection district.Above-mentioned packing ring, the convex ridge that is positioned on first and second plate, perhaps groove, they also can be positioned on the relative plate.
In the present embodiment, first and second plates of sample collection device are provided with and can make both be fixed on the fastening structure of make-position reliably.Shown in Fig. 3 B, on the inside surface of second plate 112, be provided with projection 316, the first relative button hole that plate 114 is provided with and this projection is complementary 318.When sample collection device was closed, projection can insert in the button hole and have enough resistances can make sample collection device be fixedly located in the position of make-position or " pinning ".In the present embodiment, fasten first and second plate and can send the sound of smacking one's lips at an easy rate, remind patient's sample collection device closed.Certainly first and second plate also can adopt other manner.For example, can adopt the outside with two boards to clamp so that its clip that is fixed together, perhaps those of ordinary skill in the art can expect other the structure that sample collection device can be remained on make-position easily.
Sample collecting device
Sample Collected With Checkout Gear Assembly as shown in fig. 1, it also comprises a sample collector.Cooperate shown in Figure 3ly, this sample collecting device has a handle 314 and a spreader portion 312 of gathering and smearing sample.In the present embodiment, offer a plurality of through holes on the spreader portion, be used for reducing the amount of liquid in the sample and when smearing sample, extrude the unnecessary sample that is applied on the sample collection sheet.In other embodiments, can offer 4,5,6,7,8,9,10,11,12 or more a plurality of hole on the spreader portion of this sample collecting device.The spreader portion of gatherer is the plane normally, also can be (being similar to spoon) of curve form.This sample collecting device can be made of any suitable material, for example plastics.In the present embodiment, spreader portion adopts soft plastic to make, and handle then is to adopt relative harder plastics to make.Can make the spreader portion can be crooked when sample being coated on the sample collection sheet by this structure.Through hole on the spreader portion also can help sample is coated on the sample collection sheet flatly equably.
Collection method
The invention provides a kind of method of collecting sample.In the present embodiment, the sample of required collection is a stool.Fig. 3 A-3C has disclosed the method for operating of collecting sample.
In the present embodiment as Fig. 3 A announcement, the patient opens sample collection device, exposes the inside surface of first and second plates.The sample of will defecating on a small quantity is applied to sample collection sheet 216.Then closed sample collection device (shown in Fig. 3 C).When sample collection device was closed, the hermetically-sealed construction that is arranged on first and second plates can form an enclosure wall in all sides in sample collection district.In the present embodiment, the hermetically-sealed construction on second plate is a packing ring, and the hermetically-sealed construction structure on the first relative plate is groove and convex ridge.When sample collection device is positioned at make-position, all in the vertical direction alignment of lysate mouth, sample collection district and eluent mouth.At this moment, when damping fluid flowed into the lysate mouth, it can flow through cover plate and enter the sample collection district, flowed out the eluent mouth by the sample collection sheet then, thus eluted sample, the target analyte in the dissolving sample.In addition, damping fluid diluted sample and regulate the sample state, make analyte can with the specificity junction mixture matter combination best on the test-strips.After damping fluid flow through the eluent mouth, lysed sample entered the absorption material for transfer in the pick-up unit.
As everyone knows, human body hemoglobin can very fast degraded in liquid sample.In order to prevent the analyte degraded, in detection method, can add the step of dry sample.This step comprises that collector cards is exposed in the air a period of time perhaps dries sample with air-dry sample in 45 ℃ baking box.This step can also comprise puts into a container that drying agent is housed with the sample collection device of closure.This container can be can capping sack (for example, mailbag).After the sample drying (perhaps sample collection device is put into one adorning drying agent can the sack of capping in), sample collection device just can be used as a medical apparatus and has been used for check and analysis.
Sample testing apparatus
Sample testing apparatus of the present invention as depicted in figs. 1 and 2, it is used to detect whether have the target analyte on the sample of collecting in the sample collection device.In the present embodiment, pick-up unit is one and forms the body that can snap together by a loam cake 122 and a lower cover 124.This body can be made with any suitable material, for example, and plastics, the cardboard of compacting, metal, pottery, condensate (for example, polycarbonate, polypropylene, cyclenes) and other material.In the present embodiment shown in the figure, body is injection mo(u)lding.Loam cake and lower cover can be bonded together by any method easily, for example fastening, viscose glue, welding and other method.In present embodiment shown in Figure 2, loam cake is provided with some projection (not shown)s at inside surface, it can buckle in the corresponding hollow posts 228 on the inside surface 230 that is arranged on lower cover securely, thereby the loam cake and the lower cover of pick-up unit can be retained on together reliably.
Sample testing apparatus be provided with accommodate and engage sample collection device go into dockland 126." loading " has for the sample that detects on the sample collection device.Going into the dockland can have a lot of shapes, only need guarantee its can with the sample collection zone of sample collection device be complementary.In the present embodiment, go into the dockland and can accommodate and engage the external samples gathering-device." external samples gathering-device " is meant that sample collection device can break away from sample testing apparatus and collect sample, rather than needs to be connected with sample testing apparatus in advance when collecting sample." accommodate and engage " and be meant that sample collection device and sample testing apparatus are in one " detection position ".Should " detection position " be meant the sample collection sheet and absorb the state that material for transfer is in the liquid phase connection.
Go into the dockland and also can accept sample collection device, that is to say that sample collection device can remove from device behind the sample that adds on damping fluid and the eluted sample gathering-device in reversible mode.As shown in Figure 4, in the present embodiment, sample collection device buckles into into the dockland then by projection 410 belows that its hinge edge abuts to into dockland one end setting.The both sides of going into the dockland at sample collection device are provided with button column 412, and it can be fixed on sample collection device in the dockland reliably.In other embodiment, go into the dockland and also can flatly slip into pick-up unit.In the present embodiment, go into the dockland and have and can match with the part of fixed position with sample collection device, this part is overcast in the upper surface of body loam cake, and its all sidepieces subregion is besieged.When this position, sample collection sheet and absorption material for transfer are in the state that liquid phase is communicated with.The lysate mouth is exposed to the outside accepting damping fluid, and the damping fluid sample collection sheet of flowing through then flows into and absorbs material for transfer.In the present embodiment, go into the dockland and be designed to accept sample collection device, so that sample collection district and absorption material for transfer can be in the state that liquid phase is communicated with the outside surface of sample testing apparatus.In other embodiment, go into the inside that the dockland can be arranged on sample testing apparatus.The dockland of going at sample testing apparatus is provided with application of sample mouth 226, is used for passing through for sample liquid or detection liquid." detection liquid " is meant damping fluid or other reagent that uses in detection.In the present embodiment, the application of sample mouth be for detect liquid by and enter unique inlet of pick-up unit.
As shown in Figure 1, in the present embodiment, the surface of going into the dockland has been recessed to form a depressed part 130 in application of sample mouth 226 all sides, contains one in it and absorbs material for transfer 132.This absorption material for transfer can have multiple shape, and for example, ball-point pen type, cube, cylindricality, ellipse or other shape etc. only need its shape to be fit to be positioned at the inboard of depressed part 130.As shown in Figure 2, absorb material for transfer and stretch out depressed part 130, pass application of sample mouth 226 and flush or protrude from a little basically surface into the dockland.In the present embodiment, absorbing material for transfer is that pearl is shifted in a suction.Cooperation is consulted shown in Figure 6, and after sample collection device buckled into the dockland, all in the vertical direction alignment of pearl were shifted in lysate mouth, cover plate, sample collection sheet, eluent mouth and suction.In the present embodiment, suction is shifted pearl and is protruded from surface into the dockland a little, so that the state that pearl can be communicated with in liquid phase by the eluent mouth and the outer surface of sample collection sheet is shifted in suction." liquid phase connection " is meant and detects that liquid can flow through sample collection district and sample collection sheet and enter the absorption material for transfer.The sample collection sheet can be directly to contact with absorbing material for transfer, also can be to have certain clearance between the two, but still the state that can keep liquid phase to be communicated with.
Absorbing material for transfer can be made of multiple different absorbent material.This material allows that detecting liquid can flow on the detecting element of sample testing apparatus from sample collection device easily, and can interference detection results.The example of this absorption material for transfer comprises, but not only comprises filtration membrane or other papery membrane material, nylon wire filtration membrane stream, cellulose membrane (the perhaps filtration membrane of being made by cellulose sample material), dacron and glass wool fiber.In other embodiment, suction transfer pearl is tygon (UHMWPE), tygon, polyurethane, nylon, polyester, polypropylene, the perhaps teflon by ultrahigh molecular weight.In preferred implementation, this absorption material for transfer can be the filtration membrane made from the polyethylene film of ultrahigh molecular weight.
In the present embodiment, absorbing material for transfer is that the agent treated that is used to promote analyte to transfer to the test-strips of pick-up unit from sample collection device is crossed.Above-mentionedly be used to handle the cover plate of sample collection device and the reagent of sample collection sheet, also can be used for handling and absorb material for transfer.These handle cover plate; the example of the reagent of sample collection sheet and absorption material for transfer comprises; but not only comprise; polyoxyethylene (23) lauryl ether; polyoxyethylene (9) lauryl alcohol; polyoxyethylene copolymerization oxygen third rare blocking-up multipolymer; p-different Nonylphenoxy-poly-(epoxy ethanol); sorbierite acid anhydrides Monostearate; dimethyl silicone polymer methyl ethoxy thing; polyethoxylate (20) oleyl alcohol; polyethoxylate (35) castor oil; polyoxyethylene (20) mono laurate sorbitan; polyoxyethylene (20) mono laurate sorbitan; octyl phenol ethoxylate (1.2); Octylphenoxy polyethoxy (5) ethanol; Octylphenoxy polyethoxy (10) ethanol; Octylphenoxy polyethoxy (30) ethanol; C14-C16 alkene sulfonic acid sodium; polyoxyethylene sodium (1) sulfuric acid lauryl alcohol; toluene alkane ammonium chloride; ethylenediamine alkoxy blocking-up multipolymer; 2; 4; 7; 9-tetramethyl-5-decine-4; 7-diol ethoxylate (10); 2; 4; 7; 9-tetramethyl-5-good wet agent decine-4; 7-diol ethoxylate (30); the benzene sulfonamide acid amide; poly-(oxygen ethylene copolymer oxygen third is rare) blocking-up multipolymer; telomer B monoether; dioctyl sulfonic acid-sodium succinate; poly-(ethene methyl ether/maleic anhydride) multipolymer; N-oleyl-N-methyl sodium aurate; sodium dodecylsulphonate; natrium taurocholicum; sodium taurocholate; N-ring trimethyl-tryptophane amine chloride; N, N-dimethyl lauryl amine sodium sulfonate N-oxide; 3-[3-(chloramines third is rare) dimethyl amine]-1-propane; ethylene glycol ethoxy base thing; n-octyl group sucrose; n-dodecyl sucrose; n-Lauryl.beta.-maltoside; octyl glucoside; the octyl group giucosinolate; n-ethyl cyclophosphadenosine glycoside; n-dodecyl glucoside; tris (methylol) aminomethane buffer solution; phosphate buffer; borate buffer solution; tartrate buffer; the phthalic acid salt buffer; the polyvinylpyrrolidone homopolymer; poly-(vinyl methylether/maleic anhydride); polyethylene oxide; polyethylene glycol; polyvinyl alcohol; 1-ethene-2-pyrrolidone; the bony fiss gel; crosslinked acrylic acid polymer; the hydroxypropyl alkoxy cellulose; sodium carboxymethyl cellulose; kayexalate; sodium carrageen; acrylic emulsion; hydroxyethyl cellulose; bovine serum albumin(BSA); ovalbumin; casein; 5-chlorine-2-methyl-isothiazoline-3-ketone and sodium azide.
Shown in Fig. 2 and 6, contain detecting element 234 in the body.This detecting element can be fixed in body interior enduringly, this means in testing process and can not move or insert, and is a complete part of pick-up unit.As shown in Figure 6, suction transfer pearl and detecting element are in the state that liquid phase is communicated with.In the present embodiment, detecting element is a test-strips of being made and be applicable to the chemical examination of lateral flow (lateral flow) by absorbent material.Various test-strips all is applicable to this pick-up unit.In the present embodiment, test-strips comprises the absorptive matrix of one deck, for example nitrocellulose filter, and/or other material that is fit to.This matrix membrane (test-strips) has a sample application zone, a reagent area and a detection zone.
For the ordinary skill in the art, it can expect being applicable to various test-strips of the present invention easily.In some embodiments, the sample application zone end that is positioned at test-strips is applied on the test-strips for sample.Sample application zone is a part that is communicated with absorption material for transfer liquid phase on the test-strips.Also be useful on the reagent that detects and regulate the sample state on the sample application zone, perhaps they also can independently exist or also can be positioned at reagent area.These reagent have multiple different effect, for example, regulate the sample state it is combined best with specific binding molecules, perhaps improve the stability of target analyte." adjusting " sample state is meant the state characteristic of regulating sample, carries out thereby promotion or improvement detect the reaction of analyte.For example, the damping fluid of adding can be regulated the pH value of sample.If contain the material that in detection, combines in the sample with the specific binding molecules competition, can add second blocking antibody with in conjunction with this material, if contain the enzyme of the specific binding molecules of degrading in the sample, can add the inhibitor of one or more enzymes at reagent area.
Sample application zone is positioned at the upstream extremity 232 of test-strips, is reagent area 222 successively along downstream direction, and detection zone.Reagent area comprises the reactant (for example, the specific binding molecules in the sandwiching immunity detection method) of regulating sample state and mark analyte or the analog (for example, when being at war with immunodetection) of the analyte that indicated.In some embodiments, the specific binding molecules that reagent area contains underlined, can binding matrix in the analyte of dryness, the analyte of dryness can be dissolved when sample liquid flows through matrix.In the present embodiment, specific binding molecules is a kind of antibody or antibody fragment.In the present embodiment, analyte is human body hemoglobin (hHb), and mark specific binding molecules be a kind of can be in conjunction with the antibody of hHb.This antibody can be with any suitable method mark, for example, and metallic solution, colored rubber pearl and dyestuff.In other embodiments, sample application zone and reagent area are overlapping.In other embodiments, a series of reagent area is arranged on the test-strips.
Detection zone is the zone of detecting analyte on the test-strips.In some embodiments, detection zone comprises the detection line whether visual detection target analyte exists.Detection line can be any type of, can be not only a line.Detection line contains the specific binding molecules that is useful on the detection analyte.When the target analyte was human body hemoglobin, the specific binding molecules on the detection line can be in conjunction with human body hemoglobin.In the present embodiment, specific binding molecules not in conjunction with the haemoglobin that may exist in the diet, thereby avoids occurring false positive results in conjunction with people's human body hemoglobin.
Sample testing method
Sample testing method of the present invention is used for detecting in the contained sample of sample collection device whether have the target analyte.As shown in Figure 4, in the present embodiment, the gathering-device that contains sample is placed into the dockland of going into of pick-up unit.Extraction buffer 512 is joined the lysate mouth of sample collection device.If there is analyte, extraction buffer will elute it.Damping fluid in the lysate mouth flows through cover plate and enters the sample collection district of containing the dryness sample.The dryness sample is dissolved, and a part of sample is flowed out sample collection device by wash-out, by the eluent mouth.In the present embodiment, damping fluid is transferred to the absorption material for transfer by capillary pumped motion from the sample collection sheet.The unnecessary damping fluid of wash-out is collected in and surrounds the depressed part that absorbs material for transfer from the sample collection device.Eluent in the absorption material for transfer flows into the downstream end of test-strips then by the sample application zone of capillary moving inflow test-strips.When eluent flowed into test-strips from absorbing material for transfer, the unnecessary eluent of depressed part can be absorbed material for transfer and absorb and transfer to test-strips and can not run off.
When eluent flow through the sample application zone of test-strips and reagent area, it had dissolved the reactant that is used to detect at sample application zone or reagent area.In the present embodiment, the reactant on these test-strips is a dryness.As mentioned above, also can contain the reactant that adjusting eluent state makes testing result the best in the reactant.For example, if carry out sandwiching immunity detection method, can contain specific mark in the reagent the binding molecule of detection analyte, for example a kind of antibody or antibody fragment.If analyte is arranged in the sample, mark specific binding molecules will catch analyte, and form a kind of mark the compound of solubility, can be detected at detection zone.Eluent continues to flow through the detection zone of test-strips, and there is the detection line of the specific binding molecules that contains analyte the there.For example, specific binding molecules may be a kind of antibody of unlabelled analyte, and it can be in conjunction with analyte on another epi-position of the epi-position that is different from the incorporation of markings reactant.If carry out sandwich assay, the specific binding molecules capture of labels on the detection line antibody-analyte compound, form macroscopic detection line and indicate and contain analyte in the sample.Therefore testing result just shows at the display window as a result 128 of body loam cake.
Adopted a kind of competition immunodetection in another embodiment.In this embodiment, the reactant mark zone of test-strips contain a kind of mark the analog of detection analyte, a kind of hHb analog of gold-mark for example.If there is not analyte in the sample, mark the analyte analog can be on detection line binding antibody.Therefore on detection line, show positive findings, show and do not contain analyte in the sample.When containing analyte in the sample, it and mark the competition of analyte analog in conjunction with the antibody on the detection line.When the analyte concentration in the sample raises, just reduced with the analyte analog of antibodies on the detection line.Therefore, lighter line or show without line and to contain analyte in the sample.
Detection zone can comprise the contrast part on a kind of program.Contrast on this program part can be a line, i.e. no matter whether control line contain analyte in the sample, and it all can show.Program contrast part does not demonstrate and just shows invalid detection.
In other embodiment, eluent can detect with the method that is different from immune detection.For example, the eluent that contains analyte can detect with a kind of chemical method, and for example Guaiac detects or other chemical method.
The type of analyte and sample
" sample " is meant and is used for detecting a kind of existence of analyte, do not exist or the material of quantity.In some embodiments, sample is a kind of biological specimen, the sample of for example defecating.As long as can be dissolved and flow through the analyte that gathering-device enters pick-up unit but contain, the sample of any kind can detect with the present invention.Sample can have many kinds of forms, solid for example, semisolid or high viscosity material, for example stool, soil, tissue, blood, body fluid or macerate organ.Sample also can be buccal swab or vaginal swab.
Multiple different analyte can detect with this device.The example of the analyte that can be used for detecting comprises, but not only comprise, haemoglobin or other blood constituent, creatine, cholerythrin, nitrite, protein (non-specific), hormone (for example, human chorionic gonadotrophin, lutropin, follicular stimulating hormone etc.), leucocyte, carbohydrate, heavy metal or toxin, the bacterium composition (for example, protein, the specific antigen of carbohydrate or particular type bacterium, colon bacillus 0157: H7 for example, staphylococcus aureus, salmonella, salmonella typhi, the perfringens shigella boydii, the difficulty clostridium perfringens enterotoxin, campylobacter, helicobacter pylori, listeria monocytogenes, the enteritis vibrios, comma bacillus or Bacillus cereus), ovum and parasite, with the physical property of urine specimen, for example pH value and specific gravity.As long as detection method is reliable, any analyte can detect.Certainly, with reference to the present invention, those of ordinary skills can expect easily with the multiple different antigenic substance that is applicable to that multiple detection method of the present invention detects.
The suction transfer pearl of experiment 1-handled with surfactant is for the effect of damping fluid flowing velocity
This experimental verification when the operation detection device, use surfactant
X-100, i.e. octyl phenol ethyl oxide, tygon, octyl group diphenyl ether) handle the benefit that absorbs material for transfer.
The absorption material for transfer of pearl is with containing 0,1,2,3,4 or 5%
Tris-casein of X-100-PVP damping fluid is handled.Pearl is shifted in saturated then suction dries when 55 ° of C fully, then every pearl is embedded in the well of the pick-up unit that is assembled with test-strips.The sample collection device that does not embed pearl has the 0.06ug of using
The sample collection sheet that X-100 handled, it engages with pick-up unit, adds 200-240 μ l damping fluids in each lysate mouth.Measure the time that on the control line of display window as a result, to observe display result then.In all examples, damping fluid flows through empty sample collection device needs 5 seconds.Shift pearl when suction and do not contain (0%)
X-100 o'clock, display result needed 68 seconds on the control line of test-strips.But concentration is 1-5%
X-100 can shorten this time to 19-26 seconds.Therefore concentration is 1-5%
X-100 has obviously reduced the time span that sample flow is crossed.
The surfactant concentration of experiment 2-sample collection device cover plate is for the effect of damping fluid flowing velocity
This experimental verification handle the cover plate of sample collection device to obtain the effect of damping fluid flowing velocity faster with surfactant.
All pick-up units all contain useful 1.2 μ g's
Pearl is shifted in the suction that X-100 handled.The sample collection sheet of sample collection device was not then handled.Cover plate is with 0,0.31 of 20 μ l, and 0.63,1.25,2.5 or 5%
X-100 handled.Be bonded with each other in empty sample collection device and the pick-up unit, add the damping fluid of 200 μ l in each lysate mouth, make it carry out the chemical examination of lateral flow (lateral flow).When cover plate surfactant of no use (0%
X-100) processing is out-of-date, and damping fluid can not flow into sample collection device.When
When the concentration of X-100 increased, the flowing velocity of damping fluid had also increased.When cover plate with 0.31%
It is out-of-date that X-100 handles, and control line can show in the time of 20 seconds.When
X-100 concentration is 0.63%, 1.25%, 2.5% and 5% o'clock, and control line can show in the time of 15 and 12 seconds respectively 17,16.Yet, at surfactant concentration higher (1.25% and 5%
X-100) time, damping fluid can overflow outside the sample area of sample collection device.
The influence of pearl to detection sensitivity shifted in experiment 3-sample collection sheet and suction
This experimental verification cover plate and sample collection sheet have the ability that allows haemoglobin to pass through, therefore can not influence the susceptibility of detection.
Be ready to contain 0,50,100 and the hHb solution of 200ng/ml.Have with 0.53% of 20 μ l
The sample collection device of the cover plate that X-100 handled with have with 1.2 μ g's
The dockland of going into that the pick-up unit of pearl is shifted in the suction that X-100 handled engages.The hHb solution that in the lysate mouth of sample collection device, adds 200 μ l, the intensity of mensuration detection line after hatching 5 minutes then.The hHb solution of the direct 140 μ l of adding in contrast on the test-strips of the pick-up unit that does not contain suction transfer pearl.The intensity of the detection line of control experiment also is to detect in the time of 5 minutes.
Testing result is to detect sample can produce identical result with check sample.When hHb concentration is 0ng/ml, detects sample and check sample and all produce negative findings.When hHb concentration is 50ng/ml, contains pick-up unit and the comparison device that the cover plate handled, sample collection sheet/suction shift pearl and all produce low positive signal.When hHb concentration was 100ng/ml, two devices all produced the moderate positive signal.When hHb concentration is 200ng/ml, contains pick-up unit and the comparison device that the cover plate handled, sample collection sheet/suction shift pearl and all produce the moderate positive signal.Therefore cover plate and suction transfer pearl can not keep hHb, for not obviously influence of the susceptibility that detects.
The use of the pick-up unit of hBh in experiment 4-sample collection device and the detection stool
Be that a patient has prepared 3 sample collection devices of the present invention in this experiment.Each gathering-device is all put into the dockland of going into of pick-up unit of the present invention.By sample collection device is put into into the dockland, the hinged face of gathering-device is inserted into plush copper 410 belows, after being depressed, pick-up unit snaps into, so that be in the state that liquid phase is communicated with between the absorption material for transfer of the eluent mouth of sample collection device and pick-up unit into the dockland.
In the lysate mouth of sample collection device, add 3 (about 200 μ l) extraction buffers.In of short duration incubation period (for example, 5 minutes), damping fluid flows through sample collection device, and by absorbing material for transfer, the test-strips that enters pick-up unit is carried out the detection reaction of analyte (hHb).Test-strips on detection line, have hHb specific binding molecules and reagent area combine mark hHb antibody.After process was hatched, the detection zone of pick-up unit demonstrated the positive findings (red line bar) on control line and the p-wire, showed in the stool sample to contain hHb.
Claims (10)
1, a kind of sample collection device that is used to collect solid or semi-solid samples, it is characterized in that: comprise first plate and second plate, wherein first plate has the cover plate of first opening and covering first opening, second plate has second opening and covers the sample collection sheet of second opening, cover plate and sample collection sheet by stop solid or semi-solid samples by but the material that allows solution to pass through make, this sample collection device has open position and make-position, when it is in the close position, first opening is relative with second opening, and cover plate is formed with the sample collection district in zone that covers first opening and sample collection sheet between the zone of covering second opening.
2, sample collection device according to claim 1 is characterized in that: include the surfactant that promotes liquid flow at least on one of cover plate and sample collection sheet.
3, sample collection device according to claim 2 is characterized in that: described surfactant is selected from anionic surfactant, nonpolarity surfactant, cationic surfactant and amphoteric surfactant or their combination.
4, sample collection device according to claim 1 is characterized in that: described cover plate and sample collection sheet lay respectively at first plate when sample collection device is in the close position and the inside surface of second plate.
5, sample collection device according to claim 1 is characterized in that: be provided with the enclosed construction that is used for fixing the sample collection amount in the sample collection district.
6, sample collection device according to claim 5 is characterized in that: the described enclosed construction that is used for fixing the sample collection amount comprises the packing ring that is fixed between cover plate and the sample collection sheet.
7, sample collection device according to claim 1 is characterized in that: sample collection device is provided with and makes first plate and second plate remain on the buckle structure of make-position.
8, sample collection device according to claim 1 is characterized in that: one of cover plate and sample collection sheet also contain the composition that can improve analyte stability in solid or the semi-solid samples at least.
9, sample collection device according to claim 1 is characterized in that: one of cover plate and sample collection sheet also contain the eluted condensate of analyte in promotion solid or the semi-solid samples at least.
10, sample collection device according to claim 1 is characterized in that: one of cover plate and sample collection sheet also contain the antiseptic of the pot-life that can increase sample collection device at least.
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN106932262A (en) * | 2017-02-23 | 2017-07-07 | 北京神雾环境能源科技集团股份有限公司 | The test solution preparation method of iron content in a kind of pyrrolidones of measure N methyl 2 |
| 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 |
| CN108463726A (en) * | 2016-01-15 | 2018-08-28 | 帝斯曼知识产权资产管理有限公司 | The method for testing and analyzing object |
| CN110836889A (en) * | 2018-08-16 | 2020-02-25 | 吴智良 | Fecal occult blood detection device and method |
| CN113260847A (en) * | 2018-08-23 | 2021-08-13 | Essenlix 公司 | Assay plate, separation sheet, filter, and sample deposition label |
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| WO2000000288A1 (en) * | 1998-06-30 | 2000-01-06 | Vedalab | Device for determining an analyte in a liquid sample |
| CN1384769A (en) * | 1999-06-10 | 2002-12-11 | 普罗瓦利斯诊断有限公司 | Mixing apparatus and method of mixing |
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| CN108463726A (en) * | 2016-01-15 | 2018-08-28 | 帝斯曼知识产权资产管理有限公司 | The method for testing and analyzing object |
| 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 |
| CN106932262A (en) * | 2017-02-23 | 2017-07-07 | 北京神雾环境能源科技集团股份有限公司 | The test solution preparation method of iron content in a kind of pyrrolidones of measure N methyl 2 |
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| CN113260847A (en) * | 2018-08-23 | 2021-08-13 | Essenlix 公司 | Assay plate, separation sheet, filter, and sample deposition label |
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| CN101498717B (en) | 2013-08-28 |
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