CN204462145U - The device of quick detection and preservation sample - Google Patents

Abstract

The utility model provides a kind of pick-up unit, comprising: test chamber, test chamber entrance, and collection well wherein, comprises at least one testing element, it is characterized in that in test chamber: the complete essence of tested chamber, sample collection region entrance of testing element exposes.Utilize such device to detect sample, effectively overcome the defect of broken string.

Description

The device of quick detection and preservation sample

Technical field

The utility model relates to a kind of for collecting the device existed with analyte in quick tracer liquid sample.

Background technology

Background technology below for helping reader understanding's the utility model, and can not be considered to prior art.

In our society, illicit drug use has become one and has generally acknowledged and the social concern increasingly worsened.2003, U.S. Department of Health and Human Service investigation found about have 1,950 ten thousand Americans or the crowd of 8.2% age more than 12 years old to suck illicit drugs." use illicit drugs recently " and refer to carry out investigating in the previous moon at U.S. Department of Health and Human Service and use a kind of illicit drugs.Hemp is found to be the most frequently used illicit drugs, accounts for 6.2% (1,460 ten thousand).Estimate that 2,300,000 people (1.0%) use cocaine, 604 now, 000 people employs crack, and have 1,000,000 people to use psychedelic, and estimate 119,000 people uses heroin.

In order to hit drug abuse and this social concern of monitoring, drug test is for example employed in every profession and trade, educate, physical culture, law enforcement etc. become standard test procedure.In order to promote this effort, drug test industry is formed.This industry provides various drug test product.The A urine sample collection device cup can analyzed sample is the test products of a classics.These devices may be complicated, difficulties or dirty concerning user, or for concealing the situation using illicit drugs recently, may cause the problem that sample is adulterated.In addition, urine sample cannot be collected in some occasion, such as in roadside or public arena.

In the testing process of carrying out drugs, time particularly for immunoassay, due to many reasons, usually cause lines on the test strip uneven, deep mixed, or even the appearance of only some lines, the namely phenomenon of usually said " broken string ".A kind of apparatus and method solving broken string are described in Chinese utility model patent ZL200810120955.5.Because broken string reason more complicated, be usually many reasons comprehensively.Obtain the test-strips of broken string, not only affect the judged result of naked eyes, in time carrying out the number of degrees with machine, also cause a lot of difficulty, false positive and false-negative result can be caused.Also be just necessary to provide the device of other solution broken string, need better method and apparatus collect sample and detect.

Utility model content

One side of the present utility model, provides a kind of pick-up unit, comprising: test chamber, test chamber entrance, collection well, wherein, comprise at least one testing element in test chamber, it is characterized in that: the complete essence of tested chamber, sample collection region entrance of testing element exposes.

In some preferred modes, it is characterized in that: test chamber entrance is for oval, and the sample collection region of testing element is vertical with oval major axis essence.Preferably, test chamber entrance is oval or rectangle.

The discovery that end user of the present utility model is surprised, when test chamber entrance is become large, after allowing the sample reception region of test-strips almost expose completely, test-strips fully can absorb sample, evenly runs plate, almost eliminates broken string completely.

Preferably, the utility model provides the proving installation existed for analyte in tracer liquid sample.This device also comprises reservoir compartment, test chamber, and for receiving the Plug Division of collection well.This device also comprises and is positioned Plug Division and rotating collection well, and applicator can insert this collecting chamber.Stripper plate extruding gatherer also makes sample be extruded, and enters this pick-up unit.Utilizing the test chamber outlet on collecting chamber and reservoir outlet, by rotating collection well, directly causing the flowing of sample in device.This device also comprises the detecting element of the existence detecting analyte.What rotation collection well caused device to export opening and/or closing, and operator directly can shunt the sample of collection in a device.The utility model also provides the method using this device and the detection kit including this device.

Preferably, the utility model provides the pick-up unit that a tracer liquid analyte in sample exists on the one hand.This device contains a housing, comprises reservoir compartment, test chamber and the Plug Division for collection well grafting.This device also comprises can rotating collection well matching used with Plug Division.In various embodiments, collection well at least comprises a upper cavity, stripper plate, lower chamber, test chamber outlet and reservoir outlet.Test chamber at least comprises a testing element.In various embodiments, one or more element is included in housing.Collection well includes primary importance and the second place, when being in this primary importance, liquid sample is transmitted between collection well and reservoir compartment by reservoir outlet, when being in the second place, liquid sample is transmitted between collection well and testing element by test chamber outlet, and now reservoir outlet is closed.In one embodiment, when collection well is in primary importance, test chamber outlet is closed, and when collection well is in the second place, reservoir outlet is closed.Collection well is rotated between two positions.

" reservoir compartment " is the sealing area of finger device, and liquid sample is saved wherein and prevents liquid evaporate to dryness or be subject to extraneous pollution.The liquid sample be stored in reservoir compartment can be used for later exact p-value." liquid transfer " refers to a kind of ability making liquid flow in two regions and transmit.Therefore, when liquid flow into reservoir compartment by reservoir outlet from collecting chamber, collecting chamber and reservoir compartment are in liquid transfer state." Plug Division " is a part for device or housing, and collection well can be connected with housing by Plug Division, and makes, between test chamber and reservoir compartment, liquid transfer occurs by rotating collection well.Collection well can as independent partial insertion Plug Division, and collection well also can manufacture one with housing.Collection well self can be manufactured into parts, or is formed by multiple assembling parts.

" test chamber outlet " is the hole being positioned at collection well, when " test chamber outlet " is in open mode, between collection well and test chamber, liquid transfer occurs." reservoir outlet " is the hole be positioned in collection well, when " reservoir outlet " is in open mode, between collection well and reservoir compartment, liquid transfer occurs.Test chamber outlet and reservoir outlet are all positioned in collection well.In one embodiment, test chamber outlet and reservoir outlet are positioned at lower chamber." rotatably " refers to the function that collection well can be rotated in Plug Division.Rotation collection well causes test chamber to export and reservoir outlet is opened or close.

In one embodiment, when collection well is in primary importance, pass through reservoir outlet, liquid transfer process is there is between reservoir compartment and collection well lower chamber, when collection well is in the second place, exported by test chamber, between testing element and collection well lower chamber, produce liquid transfer.Lower chamber refers to the region bottom rotating collection well and between compressive plane.Test chamber outlet and reservoir outlet are positioned at bottom collection well.Collection well also comprises seal, and when collection well is in the second place, reservoir compartment seals by seal.Can by rotate collection well realize test chamber outlet with reservoir outlet between sealing, its close reservoir outlet time, make test chamber export open.

In one embodiment, lower chamber is the region between stripper plate and rotatable collection well.Further in embodiment, test chamber outlet and reservoir outlet are positioned at bottom collecting chamber.In addition, in certain embodiments, when rotating collection well is in the second place, the seal on collecting chamber makes reservoir compartment be in sealing state.Further in embodiment, there is a chute Plug Division, and rotating collection well has a register pin given prominence to from its outside surface, and may be stuck in chute mobile, thus guides collection well from primary importance to the second place.Chute and detecting element radial parallel." chute " is a groove in housing or hatch frame, chute can make register pin or other insert wherein from the teat that collection well is outstanding.When register pin inserts chute, collection well can rotate the open and close causing reservoir outlet and test chamber outlet in Plug Division.

" stripper plate " is a plane, and the gatherer containing liquid sample is extruded thereon, and sample is wherein separated.The opening in sample collection chamber stripper plate having the sample allowing to extrude flow through or hole.Stripper plate can be arranged in collection well, also can be arranged on and can make liquid sample from gatherer, be extruded other positions flowing into collecting chamber.In one embodiment, stripper plate is positioned at collection well, and is divided into upper cavity and lower chamber, also comprises at least one opening as passage or aperture, and liquid-like instinct is entered in collection well from sampler.When sampler pressing stripper plate, sample flows into lower chamber by the through hole of stripper plate.

In another embodiment, this device or housing comprise the window for observation test element and observation test result.Device of the present utility model or housing also comprise can by the reservoir compartment through hole sealed, and liquid sample takes out in reservoir compartment by this through hole.Therefore, sample can be shifted in reservoir compartment by this reservoir compartment through hole easily, does not need to take this device apart.Reservoir compartment through hole can be positioned on housing, and accessible, so do not need to rotate collection cups, also passes collection cups close to the sample be kept in reservoir compartment without any need for the utensil inserted.

" testing element " is any element performing test.In one embodiment, testing element is test-strips.This test-strips can comprise thereon for the material pair with specific binding of immunoassay.Test-strips can be a kind of change by color upon completion of the assays or the test chemical bar of other signal intensity judged results.Be suitable for the sample that the utility model carries out detecting and include but not limited to body fluid, the sample be separated from biological tissue or body fluid.Such as, sample can be saliva, blood, serum, blood plasma, urine, excreta, spinal fluid, vaginal secretion, mucus and tissue.

" the sample reception district of testing element " testing element comprises sample reception region, this region is for receiving sample, or for sample contact, sample reception region can process some reagent, these reagent may be used for regulating the pH value of sample or carrying out pre-service in advance to sample, and these reagent are existing technology.Form the material of sample can be filter paper the material such as glass fibre, this is also prior art.But, in the conventional technology, sample reception region is corresponding with test chamber entrance, but be generally all the size that test chamber entrance is less than sample reception region, sample essence can be allowed so all to contact with sample reception region, but the area due to entrance is less than the area in sample reception region, the region receiving sample has obvious boundary with the region not receiving sample, liquid flow will be produced between region wet like this and dry region, this flowing may cause the essence unevenness of flowing, thus causes the structure of broken string.And the utility model allows the sample reception region essence of a test-strips or multiple test-strips be exposed under test chamber entrance completely, in time having liquid to flow to sample reception region from test chamber entrance, the area in all sample reception regions removes liquid sample all simultaneously, thus eliminate dry and wet boundary, thus can allow liquid flowing at the uniform velocity on testing element, thus eliminate the phenomenon of broken string.Special in those analytes, they itself are easily adsorbed by the material in sample reception region, and the effect of such structural design is more obvious, such as COC etc.

When test chamber entrance correspondence is the sample reception region of many testing elements time, be exposed under test chamber entrance to allow the complete essence in sample reception region of testing element, this in time, the width of test chamber entrance needs wider than the width of two sample areas or essence is wide.In some preferred modes, test chamber entrance is oval, oval major axis is vertical with the direction that test-strips arranges or essence is vertical, under oval long axis direction is exposed to test chamber entrance completely by the sample reception region of test-strips, simultaneously in order to avoid mighty torrent phenomenon that too much liquid produces, make oval minor axis parallel with test-strips orientation, decrease mighty torrent so to greatest extent, solve the technical barrier of broken string simultaneously to greatest extent.

The utility model can detect multiple analyte.Analyte can be infectious substance or its indicant of infected person.Analyte can be medicine (as drug abuse), hormone, albumen, nucleic acid molecules pathogen and specificity junction mixture.Drug abuse (DOA) refers to that non-medical destination uses medicine (usually playing paralysis neural).Abusing these medicines can cause body & mind to suffer damage, and produces dependence, addicted and/or dead.The example of drug abuse comprises cocaine; Amphetamine (such as, black beauty, white amphetamine tablet, dextroamphetamine, dexie, Beans); Crystal methamphetamine (crank, meth, crystal, speed); Barbiturate (as roche Pharmaceuticals, Nutley, New Jersey); Sedative (paramedicines of namely sleeping); Lysergic acid diethylamide (LSD); Inhibitor (downers, goofballs, barbs, blue devils, yellow jackets, methaqualone); The anti-antidepressant of tricyclic antidepressants (TCA, i.e. imipramine, amitriptyline and doxepin); Hog (PCP); Tetrahydrocannabinol (THC, pot, dope, hash, weed etc.); Opiate (i.e. morphine, opium, codeine, heroin, hydroxyl dihydrocodeinone).In order to the object of medical treatment, the medicine of Law Control can be taken, but it is excessive to be easy to that use occurs, and just can detect by these test strip.Such as three rings resist strongly fragrant dose (imipramine and its analog) and the OTC product containing acetaminophen.

On the other hand, the utility model additionally provides the method that in tracer liquid sample, analyte exists.The method comprises has the sample of analyte to be added in applicator suspection, applicator is put into collection well and extrudes, sample is contacted with detecting element, judging whether there is analyte in liquid sample.

In one embodiment, mouth applicator being put into tester carries out sample collection, makes gatherer be full of saliva.By extruding on stripper plate and pressing gatherer, make liquid sample enter pick-up unit, take out gatherer in the mode reversed simultaneously, liquid sample is flow in collection well.In one embodiment, sample flows into the lower chamber of collecting chamber.After having filled saliva in reservoir compartment, collection well has turned to the second place from primary importance, starts to detect.

On the other hand, the utility model additionally provides a kind of detection kit existed for analyte in analytic liquid sample body.This detection kit comprises the pick-up unit and applicator that so describe.Applicator comprises the absorption piece made with sponge or polyfoam.Applicator can soaked containing stimulating in the salivary solution of tester in advance.Thus make more easily to collect saliva when tester's mouth put into by gatherer.This kit also comprises this device of use, utilizes gatherer collect sample and detect the operation instructions whether having analyte method in saliva.

Above-mentioned utility model summary is nonrestrictive, and other feature and advantage of the present utility model become obvious by from detailed description below and claims.

Accompanying drawing explanation

Fig. 1 is the skeleton view of the utility model device 100 1 embodiments.

Fig. 2 is the exploded view of Fig. 1 device.

Fig. 3 is another exploded view of Fig. 1 device.

Fig. 4 is six views of Fig. 1 device.

Fig. 5 is external view and the sectional view of Fig. 1 device, shows the state before device use.

Fig. 6 is external view and the sectional view of Fig. 1 device, shows the unit state that sample 610 extrudes from absorber element 112.

Fig. 7 is external view and the sectional view of Fig. 1 device, shows the unit state that the sample 610 squeezed out enters test chamber.

Fig. 8 is external view and the sectional view of Fig. 1 device, illustrates that device is covered the state of lid.

Fig. 9 is the structural representation in this utility model embodiment, and the shape of wherein test chamber import is oval.

Figure 10 be in collection well test chamber outlet formation, also corresponding with the shape of test chamber import and be ellipse.

Embodiment

The utility model compared with prior art has many advantages.

Device of the present utility model and its using method can analytes easily in tracer liquid sample.This device can preserve a certain amount of sample relatively easily, utilize the time that different Cleaning Principle enters afterwards, because the utility model allows user that sample is full of reservoir compartment by collection well, but until when user rotates collection well and opens test chamber outlet, just start to carry out analysis and detect.

Fig. 1-10 in order to illustrate the utility model for some embodiments, but to be not limited thereto, also to comprise other embodiments that those of ordinary skill in the art expect by reference to the utility model.

With reference to the utility model accompanying drawing, the utility model embodiment comprises housing 120 and collection well 130.Also provide containing firm handle 114, the applicator 110 of wheel limit 116 and absorber element 112.Shown in Fig. 5, this housing has two regions, and one is test chamber 510, and one is reservoir compartment 310.Shown in Fig. 3, these two regions by injection moulding top 260,274 compositions bottom bottom 265 and reservoir compartment.Different piece of the present utility model can manufacture easily and then combine.Shown in Fig. 3, detecting element 290 is positioned at test chamber.The in store a part of sample of reservoir compartment 310 can be used for validation test.

With reference to accompanying drawing 2 and 3, in the present embodiment, collection well 130 comprises sleeve pipe 220, is embedded in the annular squeezer 210 in sleeve pipe and the collar 240.Collection well 130 is positioned at housing upper plate Plug Division 276.The collar 240 and housing upper plate are connected as a single entity, and have a chute 250 parallel with collar coboundary within it.Sleeve pipe 220 has one also to pass cover circular slide way 250 from the register pin 320 that its outside surface 222 is outstanding.Chute 250 and register pin 320 respectively containing two or more on the collar and sleeve pipe.Cooperatively interact between the collar and sleeve pipe, sleeve pipe can rotate in the collar.Because the movement of register pin can not exceed the scope of chute 250, by the cooperation between chute 250 and register pin, the rotation of sleeve pipe is limited in the collar.

With reference to accompanying drawing 5, test chamber import 540 and reservoir compartment import 530 are positioned on the upper plate 260 of housing.Test chamber import 540 enters the passage of test chamber from collection well as liquid.Test chamber is not bubble-tight, and gas can be got rid of from the gap between upper plate and lower plate.Reservoir compartment import 530 flows into the passage of reservoir compartment as liquid.This reservoir compartment is bubble-tight, therefore has exhausr port (not shown) to make gas can discharge reservoir compartment import 530.In one embodiment, at least one exhausr port adjacent with reservoir compartment import 530 (such as, aperture is positioned at reservoir compartment import both sides).Therefore, when gas overflows from exhausr port, liquid can flow in reservoir compartment.

Bottom collection well, 336 have test chamber outlet 330 and a reservoir outlet 332, flow into the passage of test chamber and reservoir compartment respectively as sample from collection well.In certain embodiments, sleeve pipe has the first and second positions.Reservoir outlet 332 and test chamber outlet 330 are positioned at bottom collection well, and when sleeve pipe is positioned at primary importance, reservoir outlet is opened, and therefore reservoir compartment can carry out fluid exchange with the lower chamber of collection well 130.When collection well is positioned at primary importance, liquid squeezes out and flows through stripper plate from the absorber element 112 of gatherer 110, enters storage chamber 310 by reservoir outlet 332.When collection well is positioned at primary importance, liquid can not flow into test chamber, because can not carry out fluid exchange between test chamber outlet and stripper plate.

Collection well 130 can forward the second place (see accompanying drawing 5-7) to.When collection well is positioned at the second place, test chamber outlet 330 is alignd with test chamber import 540, and test chamber can carry out fluid exchange with collection well.Once collection well is positioned at the second place, the liquid extruded from absorber element 112 flows through stripper plate, is entered test chamber by test chamber outlet 330 and test chamber import 540 and is arrived test-strips.

Bottom collecting chamber, 336 can also have reservoir compartment seal 334, when its size and position can make collection well be positioned at the second place, the seal 334 just in time seals up reservoir compartment import 530 and the exhausr port adjacent with reservoir compartment import (when liquid sample enters reservoir compartment, this exhausr port can get rid of the gas in chamber).In a certain embodiment, O shape ring 230 is placed in test chamber outlet, on reservoir outlet and seal 334 (see accompanying drawing 3).

applicator

The utility model also provides applicator.In one embodiment, applicator has an absorber element and is affectedly bashful portion.Other sponge of medical grade that absorber element is commonly used by this area usually or plastic foam material are made.But many other materials also can be made into absorber element, such as cotton or paper, or other any materials with water absorbing properties.Be affectedly bashful portion's normally rigidity, be conducive to the operation to absorber element.The material that the portion of being affectedly bashful can be commonly used by this area is made, such as plastics, timber, metal or cardboard.In an embodiment, the portion of being affectedly bashful has wheel limit 116 (see accompanying drawing 1), and absorber element is pasted thereon.

test-strips (290)

Multiple detected components can Combination application in the utility model.Analytical test strip can have various ways, such as, adopt immunity or test chemical form, for detecting the analyte in sample, and the such as correlative metabolites of drugs or instruction health.In some form, test-strips has sample application zone, the water-absorbing material of reagent area and test results zone.Sample is added to sample application zone, utilizes capillarity to flow into reagent area.In reagent area, sample solubilising reagent also mixes with it and can be used for detecting analyte (if there is analyte in sample).Sample now with reagent continues to flow to test results zone.Other reagent is fixed on test results zone.These are fixed on reagent and the analyte (if existence) of detection zone or carry out reacting and combining with the first reagent of reagent area.In noncompetitive test format, if there is analyte in sample signal will be produced, if analyte does not exist, then do not produce signal.In competition test format, if there is not analyte in sample, produce signal, if there is analyte, do not produce signal.The utility model is applicable to various analytical form.

When the test element is a test strip, it can be made with water suction or unwetted material, and a test-strips can use multiple material, for the transmission of liquid.A kind of material of test-strips can be superimposed upon on another kind of test-strips material, and such as, filter paper overlaid on nitrocellulose.Or, after a region at least containing a kind of material in test-strips is positioned at the another kind of region at least containing a kind of different materials.In this case, between each region, liquid is circulation, can mutually superpose or not superpose between them.On the holder that material in test-strips can be fixed on such as plastics liner or hard surface, power can be held to strengthen test-strips.

In the embodiment that some detected materials are detected by signal generation system (as at least one enzyme and detected material generation specific reaction), the material of at least one generation signal can be attracted to the analyte detection zone of test-strips, just the same on the material being adsorbed on test-strips specifically described above.In addition, be present in the sample application zone 2901 of test-strips, reagent area, analyte detection zone, or pre-service can be shifted to an earlier date on one or more materials of test-strips throughout the material of the generation signal of whole test-strips.Can by the surface or be immersed in signal solutions by one or more material of test-strips producing the substance solution of signal and be added to application area be realized.Test-strips is dried after adding signal solutions or soaking in the solution by test-strips.In addition, above method is present in the sample application zone of test-strips, reagent area, analyte detection zone, or can shift to an earlier date pre-service on one or more materials of test-strips throughout the material of the generation signal of whole test-strips.In addition, be present in test-strips sample application zone, reagent area, or the semiochemicals of detection zone can be added to one or more surfaces of test-strips material as labelled reagent.

The each region of test-strips can by following arrangement: sample application zone, at least one reagent area, at least one test results zone, at least one control zone, at least one detection of adulterations district and liquid absorption area.If detection zone comprises a control zone, after preferred control zone is positioned at the analyte detection zone of test results zone.All these districts or its combination can containing in a kind of single test strips of material.In addition, these districts are made from a variety of materials, and link together by the direction of liquid transfer.Such as, zones of different directly or indirectly can carry out liquid transfer.In the present example, different districts can be connected along the direction end of liquid transfer with end, or mutually superposes along liquid transfer direction, or is connected by other materials, such as connecting media material (preferred water-absorbing material such as filter paper, glass fibre or cellulose nitrate).When using connecting material, the material of end with joining distal ends that connecting material can make to comprise each region, comprise each region end with joining distal ends but the material that do not circulate of liquid or comprise each region overlapped (such as but not limited to overlapping from the beginning to the end) but the material that do not circulate of liquid, form liquid communication.

If test-strips contains detection of adulterations control zone, before or after this district can be placed on result detection zone.When result judges that control zone is contained in district, before adulterated control zone is preferably placed on control zone, may not be such situation.An embodiment of the present utility model, test-strips is the control test-strips judging for adulteration analyte and/or control, before or after adulterated control zone can be positioned at control zone, before being preferably placed at control zone.

Biofluid (such as casing fluids or clinical sample) is comprised with the sample that pick-up unit of the present utility model can detect.Liquid sample can derive from solid-state or semi-solid sample, comprises excreta, biological tissue and food samples.Utilize any suitable method solid-state or semi-solid sample can be changed into liquid sample, such as mix, smash to pieces, macerate, hatch, dissolve or (such as water, phosphate solution or other buffer solution) utilizes enzymolysis digestion of solid sample in a suitable solution." biological specimen " comprises and derives from animal, plant and food samples, such as, comprise the urine deriving from human or animal, saliva, blood and composition thereof, spinal fluid, vaginal fluid, sperm, ight soil, sweat, secretion, tissue, organ, knurl, culture, cell culture and the medium of tissue and organ.Preferred biological sample is urine.Food samples comprises the material of food processing, final products, meat, cheese, wine, milk and quote water.Plant sample comprises and comes from any plant, plant tissue, plant cell cultures and medium." environmental samples " derives from environment (such as, coming from the liquid sample of lake or other water bodys, sewage sample, soil property sample, underground water, seawater and waste liquid sample).Environmental samples also can comprise sewage or other waste water.

Utilize the utility model and suitable detecting element, any analyte can be detected.Preferably utilize the drugs in the utility model detection saliva.

Such as, include but not limited to the analyte that the utility model detects, creatinine, cholerythrin, nitrite, albumen (non-specific), hormone (such as, human chorionic promotes sex hormone, luteinizing hormone, follicular stimulating hormone etc.), blood, white blood cell, sugar, heavy metal or toxin, bacterial components is (as the albumen of specific bacterial or glucide, as such as colon bacillus 0157: H7, staphylococcus, salmonella, fusobacterium, Campylobacter, L.monocytogenes, vibrio, or cactus bacillus) with material relevant to physiological characteristic in urine sample, as pH and proportion.Other any Clinical Urinary chemical analyses all can utilize lateral flow test format to coordinate the utility model device to detect.

using method

The utility model additionally provides and utilizes the method that in this device tracer liquid sample, analyte exists.Accompanying drawing 5-8 depicts some detecting step of these methods.As Fig. 5 illustrates, the absorber element of gatherer has put into tester's mouth, and fully absorbs sample.As shown in the figure, gatherer is inserted collection well 130.From its external view, applicator is positioned at primary importance, and register pin is positioned at the side (namely 1 of chute ^stposition).Visible by its sectional view, when applicator is positioned at primary importance, together with reservoir outlet is arranged above and below with reservoir compartment import, make to form a passage between collection well lower chamber 520 and reservoir compartment.In addition, be close between the import of test chamber and test chamber.

As Fig. 6 illustrates, applicator have been inserted in sample chamber and has been pressed stripper plate.Applicator presses stripper plate 340 downwards, makes absorber element distortion pressurized, impels the liquid in absorber element to be extruded and enters in collecting chamber.As shown by arrows, liquid passes through stripper plate.The liquid be extruded is as shown in gray shade.Stripper plate can have two or more vertical tendon 570, and under the effect of muscle, gatherer can be twisted, and absorber element is extruded fully.The liquid be extruded is entered bottom collecting chamber by the hole on stripper plate.As previously mentioned, when applicator is positioned at primary importance, reservoir outlet and reservoir compartment import consistency from top to bottom.In the present embodiment, when collection well is positioned at primary importance, test chamber outlet is closed.Therefore, the liquid bottom collection well flows through the export and import of reservoir compartment.By aperture adjacent with reservoir outlet on collecting chamber base plate, by the liquid that enters gas in the reservoir compartment that replaces be excluded and enter bottom collection well.

As shown in Figure 7, collection well turns to the second place.As shown in external view, the chute other end that register pin moves to, as 2 ^ndindicated by.When register pin is positioned at the second place, reservoir outlet is closed, and reservoir compartment import is sealed (Fig. 3) by the seal element 334 of reservoir compartment.Test chamber outlet 330 and test chamber import 540 consistency from top to bottom, make the lower chamber of testing element 290 and collecting chamber to carry out liquid transfer.Therefore the liquid being kept at lower chamber flows in test chamber and touches test-strips.Once liquid comes into contact is to test-strips, liquid just tested bar absorbs, and namely analysis design mothod starts.Depend on the density of sample and the use of testing element analysis time.

Accompanying drawing 8 discloses and uses another step of the utility model device---adds a cover on device.As shown in Figure 8, collection well removes from the second place.Lid 280 is placed on the top of collection well.Reservoir compartment is still sealed.Device now can be transported to other places and carry out confirmation experiment.When carrying out confirmation experiment, can remove or stave the seal 272 of sample tap, being taken out the part sample in reservoir compartment by sample tap 270.

Test kit of the present utility model also comprises applicator.In certain embodiments, additionally provide in kit and how to use this device to saliva or saliva, or in the liquid solution of other types, whether there are the operation instructions of analyte.Pack according to client need adopt various shape.Such as, carry out a large amount of entering trade-before drug abuse examination, preferably adopt one containing a instructions, the packaging of 20 vacuum-packed pick-up units and applicator.Other form can be preferably include a proving installation, an applicator and a instructions.

In another embodiment, such as Fig. 9-10, the test chamber entrance 540 of this gathering-device is oval, the sample reception region of two corresponding testing elements is positioned at below ellipse, under the sample reception region 2091 laying respectively at test-strips is exposed to oval entrance completely, on the so-called completely exposed Width referring to the part sample application zone of test-strips, tested chamber entrance comes out, but the longitudinal direction of sample application zone not having tested chamber entrance exposes completely; That is, on the Width being positioned at the part sample reception region 2091 in test-strips not by the entrance of ellipse overlap or hide, because the part sample reception region in test-strips is long in the vertical, generally do not need by the entrance of ellipse institute overlapping or hide (see accompanying drawing 9).In some preferred modes, collecting chamber outlet 330 is also the same with test chamber entrance 540 be all oval, facilitates fluid sample to flow into from collecting chamber outlet the detection that analyte is carried out in sample reception region that test chamber entrance 540 also contacts the test-strips be positioned at test chamber entrance 540 like this.

embodiment

embodiment 1---detection sensitivity is tested

The present embodiment is in order to illustrate the detection sensitivity of the utility model device and using method.Each sample solution ten devices detect, totally 300 tests.These device saliva samples detect, and the test-strips used have the antigen of detected drugs.Test-strips uses competition law, and there is the antibody of colloid gold label mark zone, and p-wire has antigen.

This device is simultaneously again with containing 0 times, 0.5 times, 1.5 times and 3 times of cocaines to detectability (COC), methamphetamine (MAMP), Hog (PCP), tetrahydrocannabinol (THC), morphine (MOP) or amphetamine (AMP) PBS solution detect.Such as, in saliva, the detectability of THC is 4ng/ml.Therefore the PBS solution containing THC being 0ng/ml, 2ng/ml, 6ng/ml and 8ng/ml is detected.Following table is the consumption of detected drugs.

When detecting, above-mentioned negative saliva, PBS, or the PBS of spike is absorbed by the absorption sponge of applicator, then extrudes and enters collection well.Then, collection well is transferred to the second place.When collection well is positioned at the second place, test-strips touches sample, and liquid utilizes capillarity to pass through test-strips.Logging test results after 10 minutes also shows in the following table.

Result shows, and the utility model has good sensitivity and desirable cutoff scope.

embodiment 2---sample amount ranges changeability is tested

This example is in order to interpret sample consumption is on the impact using the utility model device.Same drugs sample in example 1 uses 0 times, 0.5 times respectively, concentration (utilizing PBS to prepare as mentioned above) pick-up unit duplicate detection 5 times of 3 times.Sample size is 100ul, 150ul, 200ul and 250ul respectively and accurately adds proving installation with suction pipe respectively, replaces applicator directly to put into sample.After application of sample 10 minutes, record positive findings or negative findings.Except 0.5 times of THC (having four results consistent in five tests) of 250ul, the result that all the other every detections repeat for five times is consistent.Therefore consider the consumption of sample, the utility model can provide correct result.

embodiment 3---enter trade-before drug abuse examination

The utility model also can detect other test items, such as, enter the drug abuse examination experiment of trade-before.Applicator is put into mouth by tester, collects saliva sample, and makes gatherer in mouth, retain about 5 minutes.An embodiment, includes in pick-up unit and detects multiple common drugs test-strips.Such as cocaine, Hog, tetrahydrocannabinol, morphine or amphetamine.These test-strips adopt competitive immunoassay method, contain the specific binding molecules (as antibody) of often kind of labeled tested drugs in the mark zone of test-strips.P-wire contains detected antigen.If containing analyte in sample, it can the molecule that be labeled of specific binding be combined with mark zone, stops the antigen of the antibody of this mark on p-wire to be combined.Therefore, when an analyte is present, p-wire do not have signal.On the contrary, when no antigen is present in the saliva, the antigen of the antibody be labeled on p-wire is combined, and produces signal.

After gatherer fully collects sample, laboratory technician is inserted into collecting chamber.Laboratory technician presses gatherer and rotates gatherer simultaneously, and the muscle of collecting chamber pins the edge of gatherer.Saliva is extruded and is entered the lower chamber of collecting chamber by the aperture of stripper plate.When collecting chamber is in primary importance, sample flows through reservoir outlet and enters reservoir compartment.When all samples are collected, and when reservoir compartment saves abundant sample, collection well forwards the second place to from primary importance, reservoir compartment is sealed and opens test chamber outlet.Sample flows into test-strips.After a few minutes, demonstrate control line, show that test completes.When p-wire display, show there are not these drugs in saliva.If result is positive, pick-up unit can be sent to validation test laboratory, and in further detection reservoir compartment, sample is to confirm testing result.

embodiment 4---to the improvement of broken string

From the sub-1-3 of above specific embodiment, we also find, although can well testing result be obtained, but its broken string phenomenon exists more serious, especially at the product of some gradient difference, phenomenon is more obvious, especially in positive sample, increases false-negative risk, increase the difficulty of debugging, qualification rate obviously strengthens simultaneously.Therefore, we improve the structure of this device, for the new lower sample hole after improvement, (shape of test chamber entrance changes, alteration of form is in the past present ellipse, allow the horizontal of the sample reception district of test-strips almost expose completely, surprised discovery obviously can have the advantage improving broken string).

Because the broken string at saliva COC product is the most serious and obviously, so for COC saliva, this hypothesis at following the results show.

Sensitivity experiment is analyzed

As can be seen from the above data, conclusion: above two kinds of moulds all can produce the product meeting QC standard.

Broken string improves comparative experiments:

COC situation

Result:

After more than broken string improves, outage is reduced to 5.86% after improvement, successful by original 70%, reduces debugging difficulty.This improves, and broken string improves reduced rate and do not reduce 10-60% not etc.Limitation: after adopting this structure-improved to want, perforate is comparatively large, and exposed sample becomes greatly, easily causes the risk of FLOODING " mighty torrent ", therefore notes.

When lack herein concrete disclosed any element, restriction, utility model shown and described herein can be realized.The term adopted and representation be used as illustrate term and unrestricted, and do not wish shown in getting rid of in the use of these terms and representation and any equivalent of described feature or its part, and should be realized that various remodeling is all feasible in scope of the present utility model.Therefore should be appreciated that, although specifically disclose the utility model by various embodiment and optional feature, but the amendment of concept as herein described and modification can adopt by those of ordinary skill in the art, and think that these amendments and modification fall within the scope of the present utility model of appended claims restriction.

Herein described or record article, patent, patented claim and every other document and electronically available information content be included in this with for referencial use in full to a certain extent, just as each independent publication by specifically with point out separately with for referencial use the same.Applicant retains the right being incorporated into from any and all material of any this article, patent, patented claim or other documents and information in the application.

Claims (14)

1. a pick-up unit, comprising: test chamber, test chamber entrance, and collection well wherein, comprises at least one testing element, it is characterized in that in test chamber: the complete essence of tested chamber, sample collection region entrance of testing element exposes.

2. pick-up unit as claimed in claim 1, is characterized in that: test chamber entrance is for oval, and the sample collection region of testing element is vertical with oval major axis essence.

3. pick-up unit as claimed in claim 1, is characterized in that: test chamber entrance is oval or rectangle.

4. pick-up unit as claimed in claim 1, is characterized in that: collection well comprises test chamber outlet and reservoir outlet, and this pick-up unit also comprises reservoir compartment, and this reservoir compartment is for preserving the liquid sample needing to confirm testing result further; Collection well has primary importance and the second place, when collection well is positioned at primary importance, liquid sample is transmitted between collection well and reservoir compartment by reservoir outlet, when collection well is positioned at the second place, liquid sample is transmitted between collection well and testing element by test chamber outlet.

5. pick-up unit as claimed in claim 4, is characterized in that, when collection well is positioned at primary importance, and test chamber port closing.

6. pick-up unit as claimed in claim 4, is characterized in that, when collection well is positioned at the second place, reservoir outlet is closed.

7. pick-up unit as claimed in claim 6, it is characterized in that, collection well also comprises lower chamber and stripper plate, and lower chamber comprises the region bottom rotating collection well and between stripper plate.

8. pick-up unit as claimed in claim 6, is characterized in that, test chamber outlet and reservoir outlet are positioned at the bottom of collection well.

9. pick-up unit as claimed in claim 6, it is characterized in that, collection well also comprises a seal, the salable reservoir compartment when collection well is positioned at the second place.

10. pick-up unit as claimed in claim 7, it is characterized in that, stripper plate comprises opening, and liquid sample flows into lower chamber by this opening from upper cavity.

11. pick-up units as claimed in claim 4, it is characterized in that, this pick-up unit has a housing, and this housing also comprises the window of an observation detecting element.

12. pick-up units as claimed in claim 4, it is characterized in that, this pick-up unit has a housing, and this housing also comprises a sealable reservoir compartment through hole, is extracted in reservoir compartment by this reservoir compartment through hole liquid.

13. pick-up units as claimed in claim 4, it is characterized in that, testing element is test-strips.

14. pick-up units as claimed in claim 13, is characterized in that, this test-strips comprises fixing specific binding molecules on the test strip.