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CN101419228B - Sample detection device and detection method - Google Patents

Sample detection device and detection method Download PDF

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Publication number
CN101419228B
CN101419228B CN 200810175463 CN200810175463A CN101419228B CN 101419228 B CN101419228 B CN 101419228B CN 200810175463 CN200810175463 CN 200810175463 CN 200810175463 A CN200810175463 A CN 200810175463A CN 101419228 B CN101419228 B CN 101419228B
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China
Prior art keywords
card
sample
hole
upper plate
test
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CN 200810175463
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CN101419228A (en
Inventor
孙少民
戴节林
王中平
胡海鹏
向庆宁
沈宏波
朱伟
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Abbott Rapid Diagnostics International ULC
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Alere Switzerland GmbH
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Abstract

The invention relates to a sample testing apparatus and a testing method. The sample testing apparatus comprises a testing card and a collecting card, wherein the testing card comprises an upper plate and a lower plate which are connected together; a testing strip is arranged between the upper plate and the lower plate; the upper plate is provided with a reading window and provided with a through hole corresponding to the testing strip; the collecting card comprises an upper card and a lower card; a film carrier for carrying samples is arranged between the upper card and the lower card; and the testing card and the collecting card are provided with a socket device and a plug-in device which are mutually matched respectively. The testing method comprises the following steps: collecting samples to the film carrier of the collecting card; inserting the collecting card into the testing card; dripping a testing liquid and making the liquid flow to the testing strip through the film carrier in the collecting card; and reading testing results and so on.

Description

A kind of sample testing apparatus and detection method
The application is dividing an application of patented claim 200410067068.8.
Technical field
The present invention relates to a kind of medical class article, especially a kind of sample testing apparatus and detection method for the fecal occult blood detection.
Background technology
It is one of important means of prevention intestines problem that fecal occult blood detects, detect the immunological method employing double antibodies sandwich method that fecal occult blood adopts at present, this method may further comprise the steps: patient oneself collects the stool sample and gives the doctor, and the doctor is carrying out immune fast detecting to the sample of handing over.Specifically, mainly contain following several method.First kind be patient be in the stool sample collection be equipped with in the plastic containers of aqueous solution one, give the doctor then, the doctor drips the aqueous solution that contains sample to be detected and is being equipped with on the proving installation of reagent strip, whether the observing response window has change color to determine in the patient stool whether occult blood is arranged then, as United States Patent (USP) 5514341,5543115,5880942 announcements.Second method is exactly the gathering-device of making of paper card, the product of Beckman Coulter Inc company for example, this detection method is that patient is evenly coated in the stool sample on the collector cards, allow the card drying that contains sample, give the doctor then, the doctor tears a little test-strips that contains sample from collector cards, the sample that is placed on test card is then prepared the zone, drip buffering liquid, detect and whether contain haemoglobin in the sample, as United States Patent (USP) 6168956,6548309,5846838 methods that disclose.The third method be exactly patient feces collection on test card, give doctor or check laboratory then, the doctor is inserted into test-strips in the test card and drips buffering liquid, the method that discloses as United States Patent (USP) 6271046,6221678.
Wherein, the shortcoming of first method is that patient carries and transmit sample trouble, and the sample storage time is restricted, will allow haemoglobin be degraded to cause omission thereby storage time is long.The shortcoming of second method mainly is will expose sample in doctor's operating process, causes environmental pollution easily like this, also might cause infection etc. to the operator simultaneously, also exists operating process loaded down with trivial details simultaneously.The third method though it is loaded down with trivial details not have significantly operation, needs specialized laboratories to detect operation, and this makes detection time long, inconvenience.
Summary of the invention
The present invention will solve the defective of above-mentioned prior art, and a kind of sample collection, pick-up unit and detection method of handled easily is provided.
The present invention solves the technical scheme that its technical matters adopts.This sample collection, pick-up unit, comprise test card and collector cards, this test card comprises upper plate and the lower plate that links together, establish a test-strips between the upper and lower plates, have on the described upper plate be used to the reading window that reads the result, and be provided with one for the through hole that drips test fluid with the test-strips corresponding section; Collector cards include upper blocking hole on block and have the following card of lower blocking hole, last card and be useful on the film carrier of carrying sample down between the card is respectively equipped with the docking apparatus of working in coordination and inserts device on test card and the collector cards.
The docking apparatus of described test card is to be made of slideway, and upper panel surface is provided with the location lock, and this location lock one end is connected with upper plate, and the other end is suspended from the through hole top, and leaves the gap of socket joint collector cards between this location lock and the upper panel surface; Link between upper plate and the location lock is formed for limiting the barricade of collector cards insertion depth.
Described upper plate upper surface can be a surface level, is raised up and horizontal-extending forms location lock by the upper plate upper surface, and protruding link was formed for limiting the barricade of collector cards insertion depth between upper plate was locked with the location.Described upper plate also can be by the plane at reading window place and the liquid through-hole plane is stepped constitutes, one end on reading window plane stretches out being positioned at the liquid filling hole plane, form a location lock, and leave the gap of socket joint collector cards between the surface at the through hole place of this location lock and upper plate.The recessed rail that is preferably the lower surface of locking in this location and has in addition two protruding rails and collector cards cooperatively interacts to limit the position, the left and right sides of collector cards, perhaps has liquid filling hole at the location lock with the through hole corresponding section.
The docking apparatus of described test card can also be, the upper plate upper surface is made of two stair-stepping upper and lower two planes, and the junction between two planes is formed for limiting the barricade of collector cards insertion depth.Two sides that are preferably at the upper plate upper surface also are provided with the lateral retaining wall that cooperates with collector cards, limit the position, the left and right sides of collector cards, or planar horizontal extends to form the location lock on the upper plate, and leave the gap of socket joint collector cards between the surface at the through hole place of this location lock and upper plate, two sides of upper plate upper surface also are provided with the lateral retaining wall that cooperates with collector cards, limit the position, the left and right sides of collector cards.The location lock with lower plane on the through hole corresponding section have liquid filling hole.
The location bridge that one projection can also be arranged between the upper plate of described test card and the lower plate.The location bridge of this projection can be positioned at the below of test-strips one end, raised an end of test-strips, this end is preferable over the sample region of acceptance of test-strips, after collector cards and test card cooperatively interact, the location bridge of this projection makes test-strips one end close to film carrier, makes the liquid that comes from the carrier film be more prone to flow on the test-strips.The location bridge of this projection also can be positioned at test-strips one end top, this end is preferable over the sample region of acceptance of test-strips, after collector cards and test card cooperatively interact, collector cards one end of this projection leans near film carrier, the other end connects test-strips, the location bridge of this projection plays a liquid drainage, makes the liquid that comes from the carrier film be more prone to flow on the test-strips by the location bridge of this projection.This raised structures can be made of non-water absorptivity and dank material in the prior art, also can be that non-water-absorbing material constitutes, filter paper for example, glass dimension, polyester film, plastics etc.
Described test-strips is test-strips of the prior art, this test-strips comprises calmodulin binding domain CaM and conversion zone at least, markd antigen or antibody on the calmodulin binding domain CaM fixedly have on the conversion zone and can be labeled the composition react that the detection material in material and the sample forms with the material that is labeled on the calmodulin binding domain CaM or this.This test-strips is preferably strip of the prior art, and this test-strips comprises the sample region of acceptance, sample calmodulin binding domain CaM, sample conversion zone and suction zone.Utilizing the detection thing in this test-strips test sample book can be double antibodies sandwich method or the competition law of prior art, also can be additive method.
The insertion device of described collector cards can be, last card, is stuck in the film carrier corresponding position and is respectively equipped with upper blocking hole, the lower blocking hole that matches with test card down, and upper blocking hole and lower blocking hole communicate and be connected as a single entity; Last card and down the card hinge is together the time, upper blocking hole and lower blocking hole form the insertion device that cooperates with test card respectively in the both sides of film carrier.It is preferable between card and film carrier and also is provided with a diaphragm; or also be provided with one at the carrier film upper surface and be coated with model; this be coated with model have communicate with film carrier be coated with the model through hole; or blocking and planting to also have in one between the film and block; should have the through hole that communicates with last card by interior card; and the internal diameter than upper blocking hole is little, forms the recessed rail that cooperates with test card together by this through hole and upper blocking hole, or upper blocking hole and lower blocking hole is connected as a single entity and by easily tearing the sheet capping.So most preferably between card and film carrier, be provided with a diaphragm, and between diaphragm and carrier film, be provided with one and be coated with model, this be coated with model have communicate with film carrier be coated with the model through hole.
The insertion device of described collector cards can also be, last card, be stuck in the film carrier corresponding position and be respectively equipped with upper blocking hole and lower blocking hole down, last card has the card breach respectively and blocks breach down with following card connection place, when last card and following card hinge together the time, upper blocking hole and lower blocking hole be respectively in the both sides of film carrier, on block breach and down the card breach form the insertion device that matches with test card.It is preferable over; can also between card and film carrier, be provided with a diaphragm; or be provided with one at the carrier film upper surface and be coated with model; this be coated with model have communicate with film carrier be coated with the model through hole; or blocking and planting to also have in one between the film and block; should have the through hole that communicates with last card by interior card, and littler than the internal diameter of upper blocking hole, formed the recessed rail that cooperates with test card together by this through hole and upper blocking hole.So most preferably between card and film carrier, be provided with a diaphragm, and between diaphragm and carrier film, be provided with one and be coated with model, this be coated with model have communicate with film carrier be coated with the model through hole.
Described collector cards go up card and down card be to utilize the art post paperboard material of prior art to make or other non-water-absorbing materials are made.Described carrier film can be to be made of some water-absorbing materials, filter paper for example, glass dimension, polyester film etc.
Described detection sample can be people or mammiferous biofluid or secretion, also can be other samples, and they can detect whether there is the analyte that will detect by collecting.People or mammiferous biofluid or secretion comprise saliva, blood, and serum, blood plasma, stool, urine etc., other samples can be microorganisms, plant, food etc.
The collection of sample of the present invention detects the method for material in the sample, and this method comprises: collect on the film carrier of the carrying sample of sample in the described collector cards; Described collector cards is inserted on the described test card; Drip test fluid, the film carrier of liquid by the carrying sample in the collector cards flows on the test-strips in the collector cards; Read the result.
This collection detection method is further improved: the sample that sample is applied to sampling rod on the following card of collector cards is coated with the sample hole, then the model that is coated with on the sample collection card is taken off, covers the card of going up of collector cards; The sheet that easily tears of collector cards is torn along easy-torn line, expose diaphragm and the film carrier of collector cards, and be inserted in the test card along last slide rail, glidepath, drip test fluid to liquid filling hole; Test fluid is mixed the back and is flowed into the sample region of acceptance with sample on the film carrier, be drawn to reaction zone again; Can be observed the result of reaction zone from the reading window.
The effect that the present invention is useful is:
The method that is used for collection and detection fecal occult blood is having detailed description in a lot of United States Patent (USP)s, for example United States Patent (USP) 3996006,4225557, and 4789629,5064766,5100619,5106582,5171528,5171529,5591645,5622871 and 5182191.The present invention compares with the described method of prior art, and its useful effect is:
1, collector cards and test card separately are convenient to multiple check.
When collecting sample, when particularly collection stool sample detects occult blood, owing to stomach is hemorrhage uncontinuity is arranged, usually to collect the sample of defecating several times continuously, in case the leak-stopping inspection.So a plurality of gathering-devices are connected together, be convenient to the patient and collect.Having collected repeatedly sample simultaneously, can also detect at different testing goals, whether stool in have occult blood and whether also have harmful microorganism, as E.Coli if for example can detect simultaneously.
2, the sample after the collection is easy to carry, and is convenient to transmit.
Because it is an amount of that sample is applied to collector cards sample inboard and that be collected, the sample that is collected is dry easily, also indeformable seepage.Under external pressure with the concussion situation under can not occur as above-mentioned plastic containers and sampling jar carry and take place to transmit as, meet accident in the process of mailing.
3, can accomplish to satisfy the quantitative sampling of measuring.
Because tested sample has in various degree quantitative requirement, the present invention adopts by taking off and is coated with the method that model discards unnecessary sample and solves this quantitative problem.For the second method of collecting sample, what quantivative approach adopted is to take out quantitative part from the sample of collecting.The shortcoming of this method is that existing sample to be tested has unnecessary sample again in the sample of collecting before measuring, and can make the use of restriction collector cards like this.As take a sample too much, may cause pollution; As do the generaI investigation experiment, then a large amount of samples concentrate in together the working environment that destroys detection.And have the sampling jar of extract, can't finish the quantitative collection of sample.Being used for the model that is coated with that quantitative band is coated with the model through hole simultaneously on the one hand can be quantitative, should measure and require to adjust the next quantitative sample of the size that is coated with model through-hole aperture area, link to each other with adhesive sticker with the following card of collector cards on the other hand, after taking this off and being coated with model, the adhesive sticker under it can also serve as in conjunction with card, the effect of card down on the collector cards.
4, the sample of Shou Jiing is not easy degraded, has improved the accuracy that detects.
The present invention can make sample dry easily, suppresses microbial growth, thereby plays the target protein protective effect in the sample.And in above-mentioned first during the sampling of the described employing plastic containers of method, when environment temperature is high, as 30 ℃, microorganism will grow, destroy the detected material that detects in the sample, particularly when detecting fecal occult blood, detected haemoglobin is easy to Institute of Micro-biology's degraded of being grown in the sample and causes omission, be on the other hand, the testing protein that is present in liquid state is stable not as solid-state protein.Our experiment shows: for example, the haemoglobin normal saline solution of 50ng/ml, room temperature was placed after 1 hour in plastic bottle, and haemoglobin wherein just can not surveyed.And the haemoglobin of 50 μ g/ml is positioned over solid support surface, as glass fibre, after the drying; Use physiological saline solution again, then the 50ng/ml haemoglobin aqueous solution still can measure.
5, the doctor is simple to operate, improves the security of operation and the reliability of experimental result
For above-mentioned the third method, the doctor wants the engaged test bar, as immunity test strip, though this is convenient, requires the doctor to operate and has suitable professional standards.Can not pollute test strips on the one hand, and guarantee test strips on the other hand again when inserting the sample collection card, guarantee not damaged by artificial mechanical force, otherwise will the breaking test result.
Mention second method for the front, the doctor will take off sample from collector cards, and will record patient's information.So on the one hand sample is exposed in face of the doctor, has increased the danger of operation, on the other hand easy mispairing patient information and experimental result.This invention has then overcome the difficulty of this two aspect, incites somebody to action not direct control sample when the doctor detects, and directly gathering-device is inserted on the docking apparatus of pick-up unit, drips liquid, and reads the result of detection, and is easy and simple to handle like this, efficient; Need not fill in simultaneously patient's information again, reduce the mistake in the experiment.
Obviously also there are as above two problems for first kind of pattern, because oozing dew and can causing the injury to a certain degree to the doctor of excess liquid causes experimental result and patient's mispairing simultaneously easily.
Description of drawings
Fig. 1 is test card embodiment 1 external structure synoptic diagram of the present invention;
Fig. 2 is test card embodiment 1 assembly structure synoptic diagram of the present invention;
Fig. 3 is test card embodiment 1 upper plate bottom surface structural representation of the present invention;
Fig. 4 is the plan structure synoptic diagram of test card embodiment 1 of the present invention;
Fig. 5 be among Fig. 4 A-A to the sectional structure synoptic diagram;
Fig. 6 is collector cards structural representation of the present invention;
Fig. 7 is the structural representation in card on the collector cards of the present invention, following engaging jail;
Fig. 8 be among Fig. 7 A-A to the sectional structure synoptic diagram;
Fig. 9 is collector cards, test card fit structure synoptic diagram;
Figure 10 be among Fig. 9 A-A to the sectional structure synoptic diagram;
Structural representation when Figure 11 is collector cards insertion test card;
Figure 12 be among Figure 11 A-A to the sectional structure synoptic diagram;
Figure 13 is the local structure for amplifying synoptic diagram of the A part among Figure 12;
Figure 14 be among Figure 11 B-B to the sectional structure synoptic diagram;
Figure 15 is the local structure for amplifying synoptic diagram of the A part among Figure 14.
Figure 16 is the upper panel surface structural representation of the embodiment of the invention 2 pick-up units;
Figure 17 is the upper plate bottom surface structural representation of the embodiment of the invention 2 pick-up units;
Figure 18 is the upper panel surface structural representation of the embodiment of the invention 3 pick-up units;
Figure 19 is the structural representation of the collector cards of the embodiment of the invention 3 when inserting test card;
Figure 20 is the collector cards structural representation of the embodiment of the invention 4;
Figure 21 is the collector cards deployed configuration synoptic diagram of the embodiment of the invention 4;
Figure 22 is the upper panel surface structural representation of the embodiment of the invention 4 pick-up units;
Figure 23 is the structural representation of the collector cards of the embodiment of the invention 4 when inserting test card;
Figure 24 is collector cards, the test card fit structure synoptic diagram of the embodiment of the invention 4;
Figure 25 is the collector cards structural representation of the embodiment of the invention 5;
Figure 26 is the collector cards layer structure synoptic diagram of the embodiment of the invention 5;
Figure 27 is the collector cards deployed configuration synoptic diagram of the embodiment of the invention 5;
Figure 28 is the structural representation of the collector cards of the embodiment of the invention 5 when being coated with model and taking off;
Figure 29 is card on the collector cards of the embodiment of the invention 5, the structural representation during the engaging jail down;
Figure 30 is the perspective view of the collector cards of the embodiment of the invention 5 when easily tearing sheet and tearing;
Figure 31 is the plan structure synoptic diagram of the collector cards of the embodiment of the invention 5 when easily tearing sheet and tearing;
Figure 32 be among Figure 31 A-A to the sectional structure synoptic diagram;
Figure 33 is the test card structural representation of the embodiment of the invention 5;
Figure 34 is the interior card down of the test card of the embodiment of the invention 5 deployed configuration synoptic diagram;
Figure 35 is the test card half deployed configuration synoptic diagram of the embodiment of the invention 5;
Figure 36 is the complete deployed configuration synoptic diagram of the test card of the embodiment of the invention 5;
Figure 37 is the test card upper plate of the embodiment of the invention 5, the structural representation when lower plate is closed the jail;
Figure 38 is that Figure 37 C-C is to the sectional structure synoptic diagram;
Figure 39 is that Figure 37 A-A is to the sectional structure synoptic diagram;
Figure 40 is the right TV structure synoptic diagram of Figure 37;
Figure 41 is the test card upper plate of the embodiment of the invention 5, the perspective view when lower plate is closed the jail;
Figure 42 is the local structure for amplifying synoptic diagram of the B part among Figure 41;
Figure 43 is the structural representation of the collector cards of the embodiment of the invention 5 when inserting test card;
Figure 44 is that D-D among Figure 43 is to the sectional structure synoptic diagram;
Figure 45 is that B-B among Figure 43 is to the sectional structure synoptic diagram.
Description of reference numerals: test card 1, lower plate 2, test-strips 3, suction zones 3-1, reaction zone 3-2, land 3-3, sample region of acceptance 3-4, upper plate 4, through hole 4-1, reading window 5, location lock 6, liquid filling hole 7, positioning strip 8, rail bar 9, barricade 10, bridge floor 11, reference column 12, pilot hole 13, upper plate crossbeam 14, hurdle 15, location, locating slot 16, lower plate crossbeam 17, location bridge 18, bridge railing 19, lateral retaining wall 20, drainage strip 21; Collector cards 100, interior card 101, on block 102, following card 103, be coated with model 104, be coated with sample hole 105, be coated with model through hole 106, film carrier 107, lower blocking opening 108, easy-torn line 109, upper blocking opening 110, the first hinges 111, second hinge 112, breach 113, diaphragm 114, the anti-line 115 that tears, adhesive area 116, card sealing 117, last slide rail 118 opens tear tape 119, easily tear sheet 120, easily tear sheet last slice 120-1, easily tear sheet 120-2 under the sheet, glidepath 121; Interior upper plate 201, upper blocking hole 202, lower blocking hole 203, interior lower plate 204,206, the second liquid feedings, half hole 207, outer lower plate 205, the first liquid feedings, half hole, interior upper plate form hole 208, upper plate form hole 209, the three hinges 210, the 5th hinge 211, the six hinges 212, test-strips groove 213, outer lower plate form hole 214, on block breach 215, the four hinges 216, under block breach 217, collector cards limiting section 218, slide rail 219.
Embodiment
The invention will be described further below in conjunction with drawings and Examples:
Embodiment 1: as shown in the figure, this sample collection, pick-up unit comprise collector cards 100 and test card 1, and this test card 1 is made of plastics, and comprise the upper plate 4 and the lower plate 2 that link together; Upper plate 4 bottoms are provided with reference column 12, and lower plate 2 is provided with the pilot hole 13 that is complementary with this reference column 12, and upper plate 4, lower plate 2 cooperate together by reference column 12, pilot hole 13.Such connection is firm, and is convenient to assembling.Described lower plate 2 is provided with protruding location bridge 18 with through hole 4-1 corresponding position, and this location bridge 18 has the bridge floor 11 of arch, and bridge floor 11 both sides are provided with bridge railing 19; The width of the width of bridge floor 11 and test-strips 3 is complementary.Lower plate 2 is provided with test-strips 3, and test-strips 3 comprises sample region of acceptance 3-4, land 3-3, reaction zone 3-2 and suction zones 3-1, and the position of liquid filling hole 7 and through hole 4-1 is corresponding with sample region of acceptance 3-4, and the position of reading window 5 is corresponding with reaction zone 3-2.The sample region of acceptance 3-4 of test-strips 3 is stuck on the bridge 18 of location, and like this, sample region of acceptance 3-4 is convenient to accept mixed liquor more near through hole 4-1; After sample region of acceptance 3-4 raises, be convenient to mixed liquor and flow to reaction zone 3-2.Described lower plate 2 one ends are provided with hurdle 15, location, and this hurdle, location 15 is provided with the draw-in groove 15-1 that is complementary with test-strips 3 width, are convenient to test-strips 3 location.Upper plate 4 is provided with and locatees hurdle 15 and be the positioning strip 8 that clamping cooperates; Have the locating slot 16 that is complementary with test-strips 3 width on lower plate 2 other ends; Hurdle 15, location, bridge floor 11 are being on the identical axis with locating slot 16.Upper plate 4 is provided with the through hole 4-1 that drips test fluid in the sample region of acceptance 3-4 corresponding position with test-strips 3, upper plate 4 is provided with the reading window 5 that reads the result in the reaction zone 3-2 corresponding position with test-strips 3; Upper plate 4 surfaces are provided with location lock 6, and these location lock 6 one ends are connected with upper plate 4, and the other end is suspended from through hole 4-1 top, and location lock 6 has liquid filling hole 7 with through hole 4-1 corresponding section, and leave the gap of socket joint collector cards 100 between this location lock 6 and upper plate 4 surfaces.Upper plate 4 upper surfaces are a surface level, are raised up and horizontal-extending forms location lock 6 by upper plate 4 upper surfaces, and upper plate 4 is locked the barricade 10 that link protruding between 6 is formed for limiting collector cards 100 insertion depths with the location.Upper plate 4 and lower plate 2 are respectively equipped with upper plate crossbeam 14, lower plate crossbeam 17, and upper plate crossbeam 14, lower plate crossbeam 17 cooperate can be with test-strips 3 chuckings.Upper plate 4 is provided with positioning strip 8 with 15 corresponding positions, hurdle, location, and positioning strip 8 can will be positioned at test-strips 3 chuckings of draw-in groove 15-1.This test card is firm, stable, handled easily.
Collector cards 100 comprises by hinged the going up card 102, block 103 down of first hinge 111, on block 102, block 103 down and be made of paper, and be connected as a single entity, the folding line place between the two is first hinge 111.Under block 103 and be provided with film carrier 107, film carrier 107 is seepage materials, is used for the carrying sample.Last card 102, under block 103 and be respectively equipped with upper blocking hole 202 with film carrier 107 corresponding positions, lower blocking hole 203, upper blocking hole 202, lower blocking hole 203 communicates and forms upper blocking opening 110 and lower blocking opening 108, about in the of 107 both sides to be positioned at film carrier after two openings fold by first hinge 111, this two opening 108,110 are connected as a single entity and by easily tearing sheet 120 cappings, easily tear easily tearing sheet last slice 120-1 and easily tearing under the sheet sheet 120-2 by easy-torn line 109 and last card 102 of sheet 120, under block 103 and link to each other, easily tearing sheet 120 can easily tear, after tearing, film carrier 107 namely is exposed to the outside, the convenient detection.Easy-torn line 109 outsides are provided with prevents tearing line 115, prevents from tearing when opening card 102 excessive.Film carrier 107 upper surfaces are stained with the removable model 104 that is coated with, this be coated with model 104 have communicate with film carrier 107 be coated with model through hole 106.Be coated with model 104 usefulness adhesive stickers and stick on the film carrier 107, can easily take off.Be coated with model 104 and be folding two-layer cardboard together, what the upper strata cardboard had a rectangle is coated with sample hole 105, is coated with model through hole 106 and opens on layer paperboard down.When being coated with sample, evenly be coated with sample being coated with sample hole 105, sample penetrates into film carrier 107 from being coated with model through hole 106.After being coated with sample, will being coated with model 104 and taking off, like this, unnecessary sample can be thrown away.The upper paper panel edges is connected with and opens tear tape 119, is convenient to take off being coated with model 104.Last card 102 inboard and film carrier 107 corresponding position coated with protective film 114.Card 101 in last card 102 inboards are hinged with by second hinge 112, interior card 101 also is made of paper.Last card 102, interior card 101 folding line between the two is second hinge 112.Described diaphragm 114 is affixed on and blocks on 101 in this; In card 101 have breach 113, the width of this breach 113 is littler than the width of upper blocking opening 110, after interior card 101 and last card 102 are folding by hinge 112, forms stepped track.Block 103 down and be provided with the adhesive area 116 that last card 102 is cemented, also be provided with and go up the card sealing 117 in card 102 card jails.After being coated with sample, will going up card 102 and close the jail with following card 103, sample is not exposed to the outside, is easy to carry, and can not pollute environment.During detection, will easily tear sheet 120 again and tear, sample is by upper blocking opening 110, and lower blocking opening 108 is exposed to the outside, detects.Described opening 110 both sides of going up card form slide rail 118, and lower blocking opening 108 both sides form glidepath 121; Width and last slide rail 118 that the bottom of location lock 6 and the both sides of liquid filling hole 7 respectively are provided with between 9, two rail bars 9 of a rail bar adapt; Upper plate 4 face widths and the lower blocking opening 108 of test card 1 adapt, and glidepath 121 matches with upper plate 4 both sides.
During detection, tear easily tearing sheet 120, upper blocking opening 110, the lower blocking opening 108 of collector cards 100 are aimed at rail bar 9, upper plate 4 surfaces respectively, then collector cards 100 is pushed into the space of location lock 6 and upper panel surface, at this moment, on blocking 101 in rail bar 9 is pressed in, the following rail bar 121 that last slide rail 118 and lower blocking opening 108 form defines the position, the left and right sides that collector cards inserts together, barricade 10 on the proving installation 1 limits the degree of depth that gathering-devices 100 insert, and makes film carrier 107 on the truck 100 so just between liquid filling hole 7 and through hole 4-1.Liquid filling hole 7 on location lock 6 drips test fluid, and test fluid is mixed the sample region of acceptance 3-4 that through hole 4-1 inflow test-strips 3 is passed through in the back with sample on the film carrier 107, is drawn to reaction zone 3-2 again.Can be observed the result of reaction zone 3-2 from reading window 5.
The experimental result explanation: detect haemoglobin in the stool with collector cards and plastics test card
Haemoglobin aqueous solution 3mg/ml injects negative stool, and mixing to final concentration is that 50 μ g/g defecate.The sample that sample is applied to sampling rod on the following card 103 of collector cards 100 is coated with sample hole 105, and to take the sample surplus off be 0.7cm with the scale 104 that is coated with on the sample collection card 100 then 2, cover and block 102 on the collector cards; Collect several samples according to the method.After having collected at that time with 24 hours, detect respectively.The sheet 120 that easily tears of collector cards is torn along easy-torn line 109, expose diaphragm 114 and the film carrier 107 of collector cards, and be inserted in the test card 1 along last slide rail 118, glidepath 121, drip the about 120 μ l of test fluid to liquid filling hole 7.Observations in 5 to 10 minutes, simultaneously according to the product description trade mark of SmithKline company: the stool sample of the same hemoglobin concentration of Hemoccult operational testing, two test macro results are as follows:
The assay of table 1 50 μ g haemoglobins/g stool
Test macro of the present invention The test macro of SmithKline
Detect immediately after having collected + -
Collected detection in back 24 hours + -
+ expression is positive, and-expression is negative
As can be seen from the above table, collector cards of the present invention and test card are higher than the sensitivity of the product brand of SmithKline company: Hemoccult, illustrate that also this test macro can better detect the haemoglobin in the stool simultaneously, thereby detect occult blood.
Embodiment 2: as Figure 16 and shown in Figure 17, difference from Example 1 is: described upper plate 4 upper surfaces are made of two stair-stepping upper and lower two planes, junction open form between two planes becomes to be used for limiting the barricade 10 of collector cards 100 insertion depths, last planar horizontal extends to form location lock 6, and the through hole 4-1 corresponding section on the lock plane, 6 up and down 6, location has liquid filling hole 7.Like this, location lock 6 is suspended from through hole 4-1 top, and leaves the gap of socket joint collector cards 100 between this location lock 6 and upper plate 4 surfaces.
Embodiment 3: as Figure 18 and shown in Figure 19, difference from Example 2 is: two sides of upper plate 4 upper surfaces are provided with the lateral retaining wall 20 that cooperates with collector cards 100, described lower plate 2 is provided with drainage strip 21 with through hole 4-1 corresponding position, and 3-4 is corresponding with through hole 4-1, sample region of acceptance respectively for drainage strip 21.
Embodiment 4: as Figure 20-shown in Figure 24, difference from Example 2 is: be not provided with location lock 6 on the test card 1, just two sides at upper plate 4 upper surfaces are provided with the lateral retaining wall 20 that cooperates with collector cards 100, lower plate 2 is provided with drainage strip 21 with through hole 4-1 corresponding position, and 3-4 is corresponding with through hole 4-1, sample region of acceptance respectively for drainage strip 21.Block 102 on the collector cards, block 103 down and be respectively equipped with upper blocking hole 202 and lower blocking hole 203 with film carrier 107 corresponding positions, last card 102 and card 103 junctions down have card breach 215 and card breach 217 down, on block 102 and go up card breach 215 with card 103 folding backs down and the following breach 217 formation slide rails 219 that block match with barricade 10 and lateral retaining wall 20 on the test card 1.Lower blocking hole 203 is provided with the film carrier 107 for the carrying sample, and upper blocking hole 202 is provided with diaphragm 114, and described film carrier 107 upper surfaces are provided with and are coated with model 104, this be coated with model 104 have communicate with film carrier 107 be coated with sample hole 105.During use, be coated with and get the sample that will detect by the sample hole 105 that is coated with that is coated with on the model 104, this sample is evenly coated on the film carrier 107, close and go up card 102.
During detection, collector cards 100 is inserted in the test card 1, owing to have breach 215,217 go up card and cooperating of the barricade 10 on the slide rail 121 that forms of card and the pick-up unit and lateral retaining wall 20 down, the front and back of collector cards 100 have been limited, position, the left and right sides, make the upper blocking hole 202 of collector cards corresponding with the through hole 4-1 of the upper plate 4 of proving installation 1, upper blocking hole 202 to gathering-device drips test fluid, test fluid is with after sample on the film carrier 107 mixes, sample region of acceptance 3-4 by on the upper plate through hole 4-1 inflow test-strips of the lower blocking hole 203 on the gathering-device and proving installation is drawn to reaction zone 3-2 again.Can be observed the result of reaction zone 3-2 from upper plate form hole 209.
Embodiment 5: this sample collection pick-up unit of the present invention, comprise collector cards 100, test card 1, this collector cards 100 comprises by 111 hinged the going up card 102 and block 103 down of first hinge, last card 102 and following card 103 are made of paper, and be connected as a single entity, the folding line place between the two is first hinge 111.Under block 103 and be provided with film carrier 107, film carrier 107 is seepage materials, is used for the carrying sample.Last card 102, block 103 down and be respectively equipped with upper blocking hole 202, lower blocking hole 203 with film carrier 107 corresponding positions, upper blocking hole 202 communicates with lower blocking hole 203 and forms upper blocking opening 110 and lower blocking opening 108, this opening is by easily tearing sheet 120 cappings, easily tear sheet 120 easily tear sheet last slice 120-1 with easily tear under the sheet sheet 120-2 by easy-torn line 109 with last card 102, block 103 down and link to each other, easily tearing sheet 120 can easily tear, after tearing, film carrier 107 namely is exposed to the outside, the convenient detection.Easy-torn line 109 outsides are provided with prevents tearing line 115, tears excessive when preventing from opening card 102.Film carrier 107 upper surfaces are stained with the removable model 104 that is coated with, this be coated with model 104 have communicate with film carrier 107 be coated with model through hole 106.Be coated with model 104 usefulness adhesive stickers and stick on the film carrier 107, can easily take off.Be coated with model 104 and be folding two-layer cardboard together, what the upper strata cardboard had a rectangle is coated with sample hole 105, is coated with model through hole 106 and opens on layer paperboard down.When being coated with sample, evenly be coated with sample being coated with sample hole 105, sample penetrates into film carrier 107 from being coated with model through hole 106.After being coated with sample, will being coated with model 104 and taking off, like this, unnecessary sample can be thrown away.The upper paper panel edges is connected with and opens tear tape 119, is convenient to take off being coated with model 104.Last card 102 inboard and film carrier 107 corresponding position coated with protective film 114.Card 101 in last card 102 inboards are hinged with by second hinge 112, interior card 101 also is made of paper.Last card 102, interior card 101 folding line between the two is second hinge 112.Described diaphragm 114 is affixed on and blocks on 101 in this; Interior card 101 has breach 113 with the sheet last slice 120-1 corresponding position of easily tearing of easily tearing sheet 120, and these breach 113 shapes and upper blocking hole 110 adapt.Block 103 down and be provided with the adhesive area 116 that last card 102 is cemented, also be provided with and go up the card sealing 117 in card 102 card jails.After being coated with sample, will going up card 102 and close the jail with following card 103, sample is not exposed to the outside, is easy to carry, and can not pollute environment.During detection, will easily tear sheet 120 again and tear, sample is by upper blocking hole 110, and lower blocking hole 108 is exposed to the outside, detects.
Test card 1 comprises that upper plate 4 and lower plate 2 are made of paper by the 3rd hinge 210 hinged upper plate 4 and lower plate 2, and the folding line between the two is the 3rd hinge 210.Lower plate 2 is provided with test-strips 3, and upper plate 4 has upper plate form hole 209 with these test-strips 3 corresponding positions.Test-strips 3 is respectively sample region of acceptance 3-4, land 3-3, reaction zone 3-2, suction zones 3-1 by the outer end to the inner, upper plate form hole 209 is corresponding with reaction zone 3-2.Mixed solution is seeped into sample region of acceptance 3-4, and suction zones 3-1 is drawn onto reaction zone with mixed solution, after reaction zone 3-2 reaction, can observe out the result from upper plate form hole 209.
Upper plate 4 inboards are provided with and the upper blocking opening 110 corresponding slide rails 118 of going up, and upper blocking hole 110 both sides form and get on the right track, and last slide rail both sides form the slide rail bar.Lower plate 2 is provided with and lower blocking opening 108 corresponding glidepaths 121, and lower blocking opening 108 both sides form lower railway, and the glidepath both sides form the downslide rail bar.Also be provided with collector cards limiting section 218 on the test card 1.Upper plate 201 in upper plate 4 inboards are connected with by the 4th hinge 216, interior upper plate 201 also is made of paper, the folding line between interior upper plate 201 and the upper plate 4 is the 4th hinge 216.Width and the upper blocking opening 110 of interior upper plate 201 outer ends are complementary, and slide rail 118 in the formation; Interior upper plate 201 inner width play position-limiting action greater than the outer end width.Interior upper plate 201 has interior upper plate form hole 208, is complementary with upper plate form hole 209.Lower plate 204 in lower plate 2 inboards are connected with by the 5th hinge 211, interior lower plate 204 also is made of paper, the folding line between interior lower plate 204 and the lower plate 2 is the 5th hinge 211.The width of interior lower plate 204 and lower blocking hole 108 are complementary, and form glidepath 121; Interior lower plate 204 inner width play position-limiting action greater than the outer end width.Interior lower plate 204 has the test-strips groove 213 that is complementary with test-strips 3.Interior lower plate 204 outsides are connected with outer lower plate 205 by the 6th hinge 212, and outer lower plate 205 also is made of paper, and the folding line between interior lower plate 204 and the outer lower plate 205 is the 6th hinge 212.The outer ledge that is somebody's turn to do outer lower plate 205 forms collector cards limiting section 218.When collector cards 100 pushed test card 1, the inner of collector cards 100 peaked at collector cards limiting section 218, and collector cards limiting section 218 plays position-limiting action.Outer lower plate 205 has outer lower plate form hole 214, aligns with upper plate form hole 209, interior upper plate form hole 208 test-strips grooves 213.
Upper plate 4 outer ends are provided with first liquid feeding, half hole 206, on block 102 and be provided with second liquid feeding, half hole 207 that is complementary with this first liquid feeding half hole 206.When upper plate 2 closed the jail with lower plate 4, liquid filling hole 7 was formed in first liquid feeding, half hole 206, second liquid feeding, half hole 207.Breach 113 on the last card 102 forms less than the semicircular edge of upper blocking hole 110, the second liquid feedings half hole 207 by breach 113.
During use, upper plate 4 and lower plate 2 are got togather.Tear easily tearing sheet 120 again, upper blocking opening 110, the lower blocking opening 108 of collector cards 100 are aimed at slide rail 118, glidepath 121 respectively, then collector cards 100 is pushed, spacing by collector cards limiting section 218.At this moment, first liquid feeding, half hole 206 on the upper plate 4 and second liquid feeding, half hole 207 on the last card 102 just form liquid filling hole 7, and liquid filling hole 7 is aimed at sample region of acceptance 3-4, is separated with diaphragm 114, film carrier 107 successively between liquid filling hole 7 and sample region of acceptance 3-4.Drip test fluid to liquid filling hole 7, test fluid is with after sample on the film carrier mixes, and the sample region of acceptance 3-4 by lower blocking opening 108 inflow test-strips 3 is drawn to reaction zone 3-2 again.Can be observed the result of reaction zone 3-2 from upper plate form hole 209.

Claims (7)

1. sample testing apparatus, comprising: upper plate and lower plate are provided with test-strips between upper plate and the lower plate; Have read test result's reading window on the described upper plate, and be provided with the through hole of test fluid with the test-strips corresponding section, it is characterized in that, be provided with the docking apparatus that matches for collector cards at described pick-up unit, cooperate with insertion device on the collector cards by this docking apparatus, wherein, described docking apparatus is to be made of slideway, cooperates by the slide rail on the collector cards of this slideway and collection sample.
2. pick-up unit according to claim 1, it is characterized in that described slideway is to be made of the surface that lock the location that upper panel surface is provided with, this location lock one end is connected with upper plate, the other end is suspended from the through hole top, and leaves the gap of accepting collector cards between this location lock and the upper panel surface.
3. pick-up unit according to claim 2, it is characterized in that, described location lock is that the upper surface of the upper plate of a surface level raises up and horizontal-extending forms by the surface, and protruding link was formed for limiting the barricade of collector cards insertion depth between upper plate was locked with the location.
4. pick-up unit according to claim 2, it is characterized in that, described upper plate upper surface is made of two stair-stepping upper and lower two planes, described location lock is extended to form calmly in the lower plane upper horizontal by the last plane of upper plate, and the junction between described two planes is formed for limiting the barricade of collector cards insertion depth.
5. pick-up unit according to claim 4 is characterized in that, the upper surface horizontal-extending of described upper plate forms the location lock, and this location lock is suspended from the lower surface top that has through hole.
6. pick-up unit according to claim 2 is characterized in that, described location lock with upper plate on the through hole corresponding position have liquid filling hole.
7. sample testing apparatus as claimed in claim 1, described sample is the stool sample.
CN 200810175463 2004-10-12 2004-10-12 Sample detection device and detection method Expired - Fee Related CN101419228B (en)

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WO2014176753A1 (en) * 2013-04-30 2014-11-06 成都领御生物技术有限公司 Quantum-dot immunochromatographic test strip detection system and use thereof
CN104297509B (en) * 2014-11-03 2016-05-18 深圳市亚辉龙生物科技股份有限公司 A kind of for device for analyzing samples transmission sample and to the pinpoint system of sample
CN114624216A (en) * 2014-12-10 2022-06-14 丰能医药科技(上海)有限责任公司 Device for detecting occult blood of excrement
CN105866400B (en) * 2015-01-21 2019-04-09 艾博生物医药(杭州)有限公司 The quickly device and its application method of detection and preservation sample

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