CN105866400A - Device for rapidly detecting and preserving samples and usage method thereof - Google Patents
Device for rapidly detecting and preserving samples and usage method thereof Download PDFInfo
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- CN105866400A CN105866400A CN201510030328.2A CN201510030328A CN105866400A CN 105866400 A CN105866400 A CN 105866400A CN 201510030328 A CN201510030328 A CN 201510030328A CN 105866400 A CN105866400 A CN 105866400A
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Abstract
The invention provides a device for rapidly detecting and preserving samples and a usage method thereof. The detection device comprises a testing cavity, a testing cavity inlet and a sample collecting cavity, wherein at least one testing element is arranged in the testing cavity. The detection device is characterized in that a sample collecting area of the testing element is completely and substantially exposed by the testing cavity inlet. When the detection device is used for detecting a sample, the line breaking defect can be effectively overcome.
Description
Technical field
The present invention relates to a kind of for collecting and quickly detecting the device that in liquid sample, analyte exists.
Background technology
Following background technology is adapted to assist in the reader understanding present invention, and is not construed as prior art.
In our society, illicit drug use has had become as a social concern generally acknowledged and increasingly deteriorate.2003, beautiful
State's health and Human Services investigate discovery and there are about 19,500,000 Americans or 8.2% age crowd more than 12 years old sucks
Illicit drugs." use illicit drugs recently " and refer to use one in U.S. Department of Health and Human Service carries out investigating the previous moon
Plant illicit drugs.Hemp is found to be the most frequently used illicit drugs, accounts for 6.2% (14,600,000).Estimate that 2,300,000 people (1.0%) are existing
Being currently in use cocaine, 604,000 people employ crack, have 1,000,000 people to use psychedelic, and estimate 119, and 000 people is just
Using heroin.
In order to hit drug abuse and monitor this social concern, drug test is such as employed in every profession and trade, is educated, physical culture,
Law enforcement etc. has had become as standard test procedure.In order to promote this effort, drug test industry has been formed.This industry carries
For various drug test product.The A urine sample collection device cup can being analyzed sample is the test product of a classics.These dresses
Put for user, be probably complexity, difficult or dirty, or for concealing the situation using illicit drugs recently, may make
Become the problem that sample is adulterated.It addition, urine sample cannot be collected in some occasion, such as in roadside or public arena.
During the detection carrying out drugs, the when of especially for immunoassay, due to many reasons, often result in and surveying
Lines in strip are uneven, deep mixed, even only the appearance of some lines, namely the most described " broken string "
Phenomenon.A kind of apparatus and method solving broken string are described in Chinese invention patent ZL200810120955.5.Because broken string
Reason more complicated, may often be such that many reasons is comprehensively.Obtain the test-strips of broken string, not only affect the judgement of naked eyes
As a result, when carrying out the number of degrees with machine when, also result in a lot of difficulty, false positive and false-negative result can be caused.The most just have
The necessary device providing other solution to break, needs better method and device are collected sample and detect.
Summary of the invention
An aspect of of the present present invention, it is provided that a kind of detection device, including: test chamber, test chamber entrance, collection well, wherein,
At least one testing element is comprised in test chamber, it is characterised in that: tested chamber, the sample collection region entrance of testing element is complete
Essence exposes.
In some preferred modes, it is characterised in that: test chamber entrance is oval, the sample collection region of testing element with
Oval major axis essence is vertical.Preferably, test chamber entrance is oval or rectangle.
The present inventor has surprisingly found that, when test chamber entrance is become big, makes the sample reception region of test-strips the most complete
After exposure, test-strips can fully absorb sample, uniformly runs plate, broken string is almost completely eliminated.
Preferably, present invention provide for detecting the test device that in liquid sample, analyte exists.This device also includes storage
Sap cavity, test chamber, and for receiving the Plug Division of collection well.This device also includes being positioned Plug Division rotating sample
This collecting chamber, applicator can be inserted into this collecting chamber.Stripper plate extruding collector also makes sample be extruded, and enters this detection dress
Put.Utilize the test chamber outlet on collecting chamber and reservoir outlet, by rotating collection well, directly result in sample at dress
Put interior flowing.This device also includes the detecting element detecting presence of analyte.Rotating collection well causes device to go out
Mouthful open and/or close, operator can the most directly shunt the sample of collection.The present invention also provides for using the method for this device
With the detection kit including this device.
Preferably, the detection device that during one aspect of the present invention provides a detection fluid sample, analyte exists.This device contains
There is a housing, including reservoir compartment, test chamber and the Plug Division for collection well grafting.This device also includes can be with Plug Division
Matching used rotating collection well.In various embodiments, collection well at least includes a upper cavity, squeezes
Pressing plate, lower chamber, test chamber outlet and reservoir outlet.Test chamber includes at least a testing element.In different embodiments
In, one or more element is included in housing.Collection well includes primary importance and the second place, is in this
During 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 Guan Bi.?
In one embodiment, when collection well is in primary importance, test chamber outlet is Guan Bi, when collection well is in the
During two positions, reservoir outlet is Guan Bi.Collection well rotates between two positions.
" reservoir compartment " refers to the sealing area of device, and liquid sample is saved wherein and prevents liquid to be evaporated or by the external world
Pollution.The liquid sample being stored in reservoir compartment can be used for later exact p-value." liquid transfer " refers to that one makes liquid
The ability flowed in two regions and transmit.Therefore, when liquid is flowed 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 passed through
Plug Division is connected with housing, and makes to occur between test chamber and reservoir compartment liquid transfer by rotating collection well.Sample collection
Chamber can be as single partial insertion Plug Division, and collection well can also be manufactured into one with housing.Collection well self
Parts can be manufactured into, or assembled by multiple parts.
" test chamber outlet " is in the hole of collection well, when " test chamber outlet " is in open mode, and sample collection
Liquid transfer is there is between chamber and test chamber." reservoir outlet " is in the hole in collection well, when " reservoir outlet "
When being in open mode, between collection well and reservoir compartment, there is liquid transfer.Test chamber outlet and reservoir outlet are all located at
In collection well.In one embodiment, test chamber outlet and reservoir outlet are positioned at lower chamber." rotatably " refers to that sample is received
The function that collection chamber can rotate in Plug Division.Rotating collection well causes test chamber outlet and reservoir outlet to open or close.
In one embodiment, when collection well is in primary importance, by reservoir outlet, reservoir compartment and sample collection
There is liquid transfer process between the lower chamber of chamber, when collection well is in the second place, exported by test chamber, test unit
Liquid transfer is produced between part and collection well lower chamber.Lower chamber refer to bottom rotating collection well with compressive plane it
Between region.Test chamber outlet and reservoir outlet are positioned at bottom collection well.Collection well also includes seal, works as sample
When this collecting chamber is in the second place, reservoir compartment is sealed by seal.Can by rotate collection well realize test chamber outlet and
Sealing between reservoir outlet, when it closes reservoir outlet, makes test chamber outlet open.
In one embodiment, lower chamber is in the region between stripper plate and rotatable collection well.The most real
Executing in example, test chamber outlet and reservoir outlet are positioned at bottom collecting chamber.It addition, in certain embodiments, when rotating sample
When this collecting chamber is in the second place, the seal on collecting chamber makes reservoir compartment be in sealing state.In further embodiment,
Plug Division has a chute, rotating collection well to have one from the prominent alignment pin of its outer surface, and moves in may be stuck in chute,
Thus guide collection well from primary importance to the second place.Chute is radial parallel with detecting element." chute " is in housing
A groove or hatch frame, chute can make alignment pin or other be inserted from the teat that collection well is prominent.Work as location
When pin inserts chute, collection well can rotate in Plug Division and cause reservoir outlet and the open and close of test chamber outlet.
" stripper plate " is a plane, and the collector containing liquid sample is extruded thereon so that it is in sample be separated
Come.Opening or the hole in the sample collection chamber allowing the sample extruded to flow through is had on stripper plate.Stripper plate can be arranged on sample and receive
In collection chamber, it is also possible to be arranged on and liquid sample can be made to be extruded other positions flowing into collecting chamber from collector.An enforcement
In example, stripper plate is positioned at collection well, and is classified as upper cavity and lower chamber, also includes that at least one is as passage
Opening or aperture, make liquid-like instinct enter in collection well from sampler.When sampler pressing stripper plate, sample passes through
The through hole of stripper plate flows into lower chamber.
In another embodiment, this device or housing include for observing testing element and observing the window of test result.The present invention
Device or housing also include the reservoir compartment through hole that can be sealed, liquid sample can be taken out in reservoir compartment by this through hole.Therefore,
Sample can be shifted in reservoir compartment by this reservoir compartment through hole easily, is not required to take this device apart.Reservoir compartment through hole can position
On housing and accessible, so need not rotate collection cups, it is not required that the utensil of any insertion is close through collection cups
The sample being saved in reservoir compartment.
" testing element " is any element performing test.In one embodiment, testing element is test-strips.This test
Bar may be included on it has specific binding material pair for immunoassay.Test-strips can be one upon completion of the assays
Changed by color or the test chemical bar of other signal intensity judged results.Be suitable for the sample that the present invention carries out detecting include but
It is not limited to body fluid, the sample 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 includes sample reception region, and this region is used for receiving sample, or uses
In with sample contact, sample reception region can process some reagent, these reagent may be used for regulate sample pH value
Or sample is carried out pretreatment in advance, and these reagent are existing technology.Constitute sample material can be filter paper glass
The materials such as fiber, this is also prior art.But, in the conventional technology, sample reception region is corresponding with test chamber entrance,
But typically all test chamber entrance is less than the size in sample reception region, so can allow sample essence all with sample reception district
Territory contacts, but owing to the area of entrance is less than the area in sample reception region, receives the region of sample and do not receive sample
Region has obvious boundary, will produce liquid flowing between the wettest region and dry region, and this flowing is likely to result in
The essence inhomogeneities of flowing, thus cause the structure of broken string.And the present invention allows the sample of a test-strips or multiple test-strips connect
Receive region essence and be completely exposed under test chamber entrance, when there being liquid to flow to sample reception region from test chamber entrance
Waiting, the area in all of sample reception region releases liquid sample the most simultaneously, thus eliminates the boundary of dry and wet, such that it is able to
Allow liquid flowing on testing element at the uniform velocity, thus eliminate the phenomenon of broken string.Especially for those analytes, they
Itself is easily adsorbed by the material in sample reception region, and the effect of such structure design becomes apparent from, such as COC etc..
When the sample reception region that test chamber entrance correspondence is a plurality of testing element when, in order to allow the sample reception of testing element
The complete essence in region is exposed under test chamber entrance, this in time, the width of test chamber entrance needs than two sample areas
Width wants wide or essence is wide.In some preferred modes, test chamber entrance is oval, oval major axis and test
The direction of bar arrangement is vertical or essence vertical, and oval long axis direction is fully exposed to test by the sample reception region of test-strips
Under the entrance of chamber, the mighty torrent phenomenon simultaneously produced in order to avoid too much liquid, make oval short axle parallel with test-strips orientation,
Decrease mighty torrent the most to greatest extent, solve the technical barrier of broken string simultaneously to greatest extent.
The present invention can detect multiple analyte.Analyte can be infectious substance or its indicant of infected person.Quilt
Analyte can be medicine (such as drug abuse), hormone, albumen, nucleic acid molecules pathogen and specificity junction mixture.Drug abuse
(DOA) refer to that non-medical destination uses medicine (generally playing the effect that paralysis is neural).Abuse these medicines can cause health and
Spirit suffers damage, and produces dependence, addicted and/or dead.The example of drug abuse includes cocaine；Amphetamine (example
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 i.e. 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).For the purpose of medical treatment,
The medicine of Law Control can be taken, but is easy to occur to use excess, it is possible to carries out by these test strip
Detection.Such as three rings resist strongly fragrant dose (imipramine and its analog) and the OTC product containing acetaminophen.
On the other hand, present invention also offers the method that in detection liquid sample, analyte exists.The method includes suspection being had
The sample of analyte is added in applicator, applicator is put in collection well and extrudes, and makes sample and detection
Element contacts, it is judged that whether there is analyte in liquid sample.
In one embodiment, applicator is put into the mouth of tester carries out sample collection, make collector be full of saliva.
By extruding on stripper plate and pressing collector, make liquid sample enter detection device, in the way of torsion, take out collection simultaneously
Device, makes liquid sample flow in collection well.In one embodiment, sample flows into the lower chamber of collecting chamber.Work as reservoir compartment
In become loaded with saliva after, collection well turns to the second place from primary importance, start detection.
On the other hand, present invention also offers a kind of for analyzing the detection kit that analyte in liquid sample exists.This inspection
Test agent box includes detection device and the applicator so described.Applicator includes making with sponge or foamed plastics
Absorption piece.Applicator can soaked containing stimulating in the salivary solution of tester in advance.So that when receiving
It is easier to when storage is put in tester's mouth collect saliva.This kit also includes using this device, utilizing collector to collect sample
With the operation instructions whether having analyte method in detection saliva.
Foregoing invention summary is nonrestrictive, and other features and advantages of the present invention will be from detailed description below and claim
Book become obvious.
Accompanying drawing explanation
Fig. 1 is the perspective view of 100 1 embodiments of apparatus of the present invention.
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, it is shown that the state before device use.
Fig. 6 is external view and the sectional view of Fig. 1 device, it is shown that the unit state that sample 610 extrudes from absorber element 112.
Fig. 7 is external view and the sectional view of Fig. 1 device, it is shown that the sample 610 squeezed out enters the unit state of test chamber.
Fig. 8 is external view and the sectional view of Fig. 1 device, it is shown that device is covered the state of lid.
Fig. 9 is the structural representation in one detailed description of the invention of this present invention, wherein test chamber import be shaped as ellipse.
Figure 10 be in collection well test chamber outlet formation, also corresponding with the shape of test chamber import and be ellipse.
Detailed description of the invention
The present invention compared with prior art has many advantages.
Assembly of the invention and its using method can detect the analyte in liquid sample easily.This device can relatively hold
Change places and preserve a certain amount of sample, utilize the time that different Cleaning Principle enters afterwards, because the present invention allows user by sample
By collection well full reservoir compartment, but during until user rotates collection well and opens test chamber outlet, just start
It is analyzed detection.
Fig. 1-10 in order to illustrate the present invention for some embodiments, but be not limited thereto, also include those of ordinary skill in the art
By other embodiments expected with reference to the present invention.
With reference to accompanying drawing of the present invention, one embodiment of the invention includes housing 120 and collection well 130.Also provide for containing firm
Handle 114, wheel limit 116 and the applicator 110 of absorber element 112.Shown in Fig. 5, this housing has two regions, one
Being test chamber 510, one is reservoir compartment 310.Shown in Fig. 3, these two regions by being molded top 260, bottom 265 and reservoir
274 composition bottom chamber.The different piece of the present invention can manufacture easily and then combine.Shown in Fig. 3, detection unit
Part 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 includes sleeve pipe 220, the annular squeezing being embedded in sleeve pipe
Device 210 and the collar 240.Collection well 130 is positioned at housing upper plate Plug Division 276.The collar 240 is linked as with housing upper plate
Integrally, and within it there is a chute 250 parallel with collar top edge.Sleeve pipe 220 has one from its prominent determining of outer surface 222
Position pin 320 also passes set circular slide way 250.Two or more chute 250 and alignment pin 320 is contained respectively on the collar and sleeve pipe.
Cooperating between the collar and sleeve pipe, sleeve pipe can rotate in the collar.Because the movement of alignment pin is without departing from chute 250
Scope, by the cooperation between chute 250 and alignment pin, makes the rotation of sleeve pipe be 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
Enter the passage of test chamber from collection well as liquid.Test chamber is not bubble-tight, and gas can be from upper plate and lower plate
Between gap in get rid of.Reservoir compartment import 530 flows into the passage of reservoir compartment as liquid.This reservoir compartment is bubble-tight, because of
This has exhaust outlet (not shown) to make gas can discharge reservoir compartment import 530.In one embodiment, at least one exhaust outlet with
Reservoir compartment import 530 adjacent (such as, aperture is positioned at reservoir compartment import both sides).Therefore, when gas overflows from exhaust outlet,
Liquid can flow in reservoir compartment.
Bottom collection well, 336 have test chamber outlet 330 and a reservoir outlet 332, respectively as sample from sample collection
Chamber flows into test chamber and the passage of reservoir compartment.In certain embodiments, sleeve pipe has the first and second positions.Reservoir outlet 332
Being positioned at bottom collection well with test chamber outlet 330, when sleeve pipe is positioned at primary importance, reservoir outlet is opened, because of
This reservoir compartment can carry out fluid exchange with the lower chamber of collection well 130.When collection well is positioned at primary importance, liquid
Body squeezes out from the absorber element 112 of collector 110 and flows through stripper plate, enters storage chamber 310 by reservoir outlet 332.
When collection well is positioned at primary importance, liquid cannot flow into test chamber, because can not enter between test chamber outlet and stripper plate
Row fluid exchange.
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 sample collection
Chamber is positioned at the second place, and from absorber element 112, the liquid of extrusion flows through stripper plate, by test chamber outlet 330 and test chamber
Import 540 enters test chamber and arrives test-strips.
Bottom collecting chamber, 336 can also have reservoir compartment seal 334, and its size and position can make collection well be positioned at second
During position, this seal 334 just seals up reservoir compartment import 530 and the exhaust outlet adjacent with reservoir compartment import (at liquid
When sample enters reservoir compartment, this exhaust outlet can get rid of the gas in chamber).In a certain embodiment, O 230 is placed in
Test chamber exports, (see accompanying drawing 3) on reservoir outlet and seal 334.
Applicator
The present invention also provides for applicator.In one embodiment, applicator has an absorber element and is affectedly bashful portion.Absorb
Element is generally made up of the other sponge of medical grade commonly used in the art or plastic foam material.But many other materials may be made as
Absorber element, such as cotton or paper, or other any materials with water absorbing properties.The portion of being affectedly bashful is typically rigidity, has
It is beneficial to the operation to absorber element.The portion of being affectedly bashful can be made up of material commonly used in the art, such as plastics, timber, metal or paper
Plate.In one 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 be with in combination application to the present invention.Analytical test strip can have various ways, for example with immunity or
Person's test chemical form, for detecting the analyte in sample, such as drugs or the correlative metabolites of instruction health.?
In some form, test-strips is to have sample application zone, reagent area and the water-absorbing material of test results zone.Sample is added to sample application zone,
Capillarity is utilized to flow into reagent area.In reagent area, sample solubilising reagent and mixed can be used for detect analyte (as
Really there is analyte in sample).Now the sample with reagent continues to flow to test results zone.Other reagent is fixed on
Test results zone.These are fixed on the reagent of detection zone and analyte (if present) or the first examination with reagent area
Agent is reacted and combines.In noncompetitive test format, if sample existing analyte will produce signal, if
Analyte does not exists, and does not the most produce signal.In competition test format, if sample does not exist analyte, produce letter
Number, signal is not the most produced if there is analyte.The present invention 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 many
Plant material, for the transmission of liquid.A kind of material of test-strips can be superimposed upon on another kind of test-strips material, such as, and filter paper
Superposition is on nitrocellulose.Or, test-strips at least contains a region of a kind of material and is positioned at another kind and at least contains one
After the region of different materials.In this case, between each region liquid be circulation, can be overlapped mutually between them or
Person's not superposition.Material in test-strips can be fixed on the holder of such as plastics liner or hard surface, to strengthen test
Bar can holding force.
(as at least one enzyme occurs with detected material in the embodiment that some detected materials are detected by signal generation system
Specific reaction), at least one material producing signal can be attracted to the analyte detection zone of test-strips, the most as mentioned above
As specifically adsorbing on the material of test-strips.Additionally, there are the sample application zone 2901 in test-strips, reagent area, analyzed
Analyte detection district, or throughout whole test-strips produce signal material can pre-process the one or more materials in test-strips in advance
On material.By the substance solution producing signal being added to the surface of application area or one or more material of test-strips can be soaked
Signal solutions realizes.After test-strips adds signal solutions or soaks in the solution, test-strips is dried.It addition,
Above method is present in the sample application zone of test-strips, reagent area, analyte detection zone, or the generation throughout whole test-strips
The material of signal can pre-process in advance on one or more materials of test-strips.Additionally, there are in test-strips sample application zone, reagent
District, 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 be arranged as follows: sample application zone, at least one reagent area, at least one test results zone, and at least one
Individual control zone, at least one detection of adulterations district and liquid absorption area.If detection zone includes a control zone, preferably control position
After the analyte detection zone of test results zone.All these districts or a combination thereof can be at the single test paper containing a kind of material
On bar.It addition, these districts are made from a variety of materials, and link together by the direction of liquid transfer.Such as, zones of different
Can directly or indirectly carry out liquid transfer.In the present example, different districts can be along the direction end of liquid transfer and end
It is connected, or is overlapped mutually along liquid transfer direction, or be connected by other materials, such as, connect dielectric material and (preferably inhale
Water-based material such as filter paper, glass fibre or celluloid).When using connecting material, connecting material can make to comprise each region
Material that the material of end and joining distal ends, the end comprising each region do not circulate with joining distal ends but liquid or comprise each region
The material that overlapped (such as but not limited to overlapping from the beginning to the end) but liquid do not circulate, forms 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
Control zone is contained in district, before adulterated control zone is preferably positioned at control zone, it is also possible to be not such situation.One of the present invention
Embodiment, test-strips be for adulteration analyte judge and/or control control test-strips, adulterated control zone may be located at control zone it
Before or afterwards, before being preferably placed at control zone.
The sample that can detect with the detection device of the present invention includes biofluid (such as casing fluids or clinical sample).Liquid
Sample can derive from solid-state or semi-solid sample, including excreta, biological tissue and food samples.Utilize any suitably
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 cushioning liquid) utilizes enzymolysis digestion of solid sample in a suitable solution." biological
Sample " include deriving from animal, plant and food samples, such as include the urine deriving from human or animal, saliva, blood and one-tenth thereof
Point, spinal fluid, vaginal fluid, sperm, ight soil, sweat, secretion, tissue, organ, knurl, tissue and the training of organ
Support thing, cell culture and medium.Preferred biological sample is urine.Food samples includes the material of food processing, final products,
Meat, cheese, wine, milk and quote water.Plant sample includes coming from any plant, plant tissue, plant cell cultures and
Medium." environmental samples " derives from environment and (such as, comes from the liquid sample of lake or other water bodys, sewage sample, soil property
Sample, underground water, seawater and waste liquid sample).Environmental samples may also include sewage or other waste water.
Utilize the present invention and suitable detecting element, any analyte can be detected.Detect in saliva preferably by the present invention
Drugs.
Such as, including but not limited to the analyte of present invention detection, creatinine, bilirubin, nitrite, albumen are (non-
Specifically), 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 (as the albumen of specific bacterial or glucide, such as such as colon bacillus 0157:
H7, staphylococcus, salmonella, fusobacterium, Campylobacter, L.monocytogenes, vibrio or cactus bacillus)
The material relevant to physiological characteristic with in urine sample, such as pH and proportion.Other any Clinical Urinary chemical analyses all may utilize lateral flow
Test format coordinates apparatus of the present invention to detect.
Using method
Present invention also offers and utilize the method that in this device detection liquid sample, analyte exists.Accompanying drawing 5-8 depicts these
Some detecting step of method.As Fig. 5 illustrates, the absorber element of collector has been put in tester's mouth, and fully absorbs sample.
As it can be seen, collector to be inserted collection well 130.From its external view, applicator is positioned at primary importance, fixed
Position pins position is in the side (i.e. 1 of chutestPosition).Visible by its sectional view, when applicator is positioned at primary importance, storage
Together with sap cavity outlet is arranged above and below with reservoir compartment import, makes between collection well lower chamber 520 and reservoir compartment, to form one and lead to
Road.It addition, be to close between the import of test chamber and test chamber.
As Fig. 6 illustrates, applicator is already inserted in sample chamber and press stripper plate.Applicator presses down on stripper plate
340, make absorber element distort pressurized, promote the liquid in absorber element to be extruded in entrance collecting chamber.As shown by arrows, liquid
Pass through stripper plate.The liquid being extruded is as shown in gray shade.Stripper plate can have two or more vertical tendon 570, at the work of muscle
Under with, collector can be twisted, and makes absorber element extrude fully.The liquid being extruded is entered by the hole on stripper plate and receives
Bottom collection chamber.As it was previously stated, 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 to close.Therefore, at the bottom of collection well
The liquid in portion flows through the export and import of reservoir compartment.By aperture adjacent with reservoir outlet on collecting chamber base plate, it is entered
Liquid gas in substituted reservoir compartment be excluded and enter bottom collection well.
As it is shown in fig. 7, collection well turns to the second place.As shown in external view, the chute other end that alignment pin moves to,
Such as 2ndIndicated.When alignment pin is positioned at the second place, reservoir outlet is closed, and close by reservoir compartment of reservoir compartment import
Envelope element 334 seals (Fig. 3).Test chamber outlet 330 and test chamber import 540 consistency from top to bottom so that testing element 290 He
The lower chamber of collecting chamber can carry out liquid transfer.Therefore test-strips is touched in being saved in the liquid inflow test chamber of lower chamber.One
Denier liquid touches test-strips, and liquid absorbs with regard to tested strip, analyzes experiment and i.e. starts.Depend on the density of sample analysis time
Use with testing element.
Accompanying drawing 8 discloses and uses another step of apparatus of the present invention to add a cover on device.As shown in Figure 8, sample collection
Chamber 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 carry out elsewhere confirming experiment.When carrying out confirming experiment, can remove or stave the seal 272 of sample tap,
The part sample in reservoir compartment is taken out by sample tap 270.
The test kit of the present invention also includes applicator.In certain embodiments, additionally provide in kit and how to use
This device operation instructions to whether there is analyte in saliva or saliva, or other kinds of liquid solution.Packaging basis
The needing of client uses variously-shaped.Such as, carry out substantial amounts of enter trade-before drug abuse examination, it is preferred to use one containing a explanation
Book, 20 vacuum-packed detection devices and the packaging of applicator.Other form can be to preferably include a test dress
Put, an applicator and a specification.
In another embodiment, such as Fig. 9-10, the test chamber entrance 540 of this collection device is oval, corresponding two
The sample reception region of individual testing element is positioned at below ellipse, and the sample reception region 2091 laying respectively at test-strips is completely exposed
Under oval entrance, tested chamber on the width of the most exposed so-called part sample application zone referring to test-strips
Entrance comes out, but in the longitudinal direction of sample application zone, tested chamber entrance is not completely exposed；It is to say, be positioned at
Not by oval entrance institute's overlap or covering on the width in the part sample reception region 2091 in test-strips, owing to testing
Part sample reception region on bar is the most long, typically need not by oval institute of entrance institute overlap or covering (see
Accompanying drawing 9).In some preferred modes, collecting chamber outlet 330 is also all oval as test chamber entrance 540, this
Sample prescription just fluid sample is flowed into test chamber entrance 540 from collecting chamber outlet and contact is positioned at the test-strips test chamber entrance 540
Sample reception region on carry out the detection of analyte.
Embodiment
Embodiment 1 detection sensitivity is tested
The present embodiment is in order to illustrate the detection sensitivity of apparatus of the present invention and using method.Each sample solution enters with ten devices
Row detection, totally 300 tests.These devices saliva sample detects, and the test-strips used has 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 the most again with containing 0 times, and 0.5 times, 1.5 times and 3 times are detected the cocaines (COC) limited, methyl An Feita
Life (MAMP), Hog (PCP), THC (THC), morphine (MOP) or amphetamine (AMP) PBS
Solution detects.Such as in saliva, the detection limit of THC is 4ng/ml.Therefore to being 0ng/ml containing THC, 2ng/ml, 6ng/ml
Detect with the PBS solution of 8ng/ml.Following table is the consumption of detected drugs.
When detecting, above-mentioned negative saliva, PBS, or the PBS of spike absorbed by the absorption sponge of applicator, then squeezes
Go out to enter collection well.Then, collection well is transferred to the second place.When collection well is positioned at the second place, survey
Strip touches sample, and liquid is by capillary action through test-strips.Record test result after 10 minutes and show in the following table.
Result shows, the present invention has good sensitivity and preferable cutoff scope.
Embodiment 2 sample amount ranges changeability is tested
This example is in order to illustrate the amount of samples impact on using apparatus of the present invention.Same drugs sample in example 1 respectively with 0 times,
0.5 times, the concentration (utilizing as discussed above PBS to prepare) of 3 times is with detecting device duplicate detection 5 times.Sample size is 100ul respectively,
150ul, 200ul and 250ul also accurately add test device respectively with suction pipe, replace applicator to be directly placed in sample.
It is loaded latter 10 minutes, record positive findings or negative findings.Except 0.5 times of THC of 250ul (has four knots in five tests
Fruit is consistent), the result that remaining every detection repeats for five times is consistent.Therefore considering the consumption of sample, the present invention can provide correct knot
Really.
Embodiment 3 enters trade-before drug abuse examination
The present invention also can detect other detection projects, such as, enter the drug abuse examination experiment of trade-before.Applicator is put into by tester
In Kou, collect saliva sample, and make collector retain about 5 minutes in mouth.One embodiment, includes inspection in detection device
Survey multiple common drugs test-strips.Such as cocaine, Hog, THC, morphine or amphetamine.These
Test-strips uses competitive immunoassay method, contains specific binding point of the tested drugs of labeled every kind in the mark zone of test-strips
Son (such as antibody).P-wire contains detected antigen.If containing analyte in sample, it can specifically be tied with mark zone
The labeled molecule closed combines, and stops the antibody of this mark antigen on p-wire to be combined.Therefore, when an analyte is present,
Signal is not had on p-wire.On the contrary, when no antigen is present in the saliva, labeled antibody antigen on p-wire is combined, and produces
Raw signal.
After collector fully collects sample, laboratory technician is inserted into collecting chamber.Laboratory technician presses collector and rotates collection simultaneously
Device, the muscle of collecting chamber pins the edge of collector.Saliva be extruded and pass through stripper plate aperture enter collecting chamber lower chamber.
When collecting chamber is in primary importance, sample flows through reservoir outlet and enters reservoir compartment.When all of sample is collected, and reservoir
When chamber saves abundant sample, collection well forwards the second place to from primary importance, makes reservoir compartment seal and opens test
Chamber exports.Sample flows into test-strips.After a few minutes, demonstrate control line, show that test is complete.When p-wire display letter
Number time, show saliva does not exist these drugs.If result is positive, detection device can be sent to validation test laboratory,
In further detection reservoir compartment, sample is to confirm testing result.
The embodiment 4 improvement to broken string
From the sub-1-3 of embodiments above it has been found that, although can well obtain testing result, but its broken string phenomenon
There is ratio more serious, especially at the product of some gradient difference, phenomenon becomes apparent from, and especially in positive sample, increases vacation
Negative risk, increases the difficulty of debugging simultaneously, and qualification rate substantially strengthens.Therefore, the structure of this device is carried out by we
Improving, for the new lower sample hole after improving, (shape of test chamber entrance changes, and former alteration of form is present
Ellipse, allows the horizontal of sample reception district of test-strips almost be completely exposed, has surprisingly found that can substantially have improvement broken string
Advantage).
Owing to the broken string at saliva COC product is the most serious and obvious, then as a example by COC saliva, at following the results show
This hypothesis.
Sensitivity experiment is analyzed
As can be seen from the above data, conclusion: both the above mould all can produce the product meeting QC standard.
Broken string improvement comparative experiments:
COC situation
Result:
After more than broken string improves, outage by original 70% be reduced to after improving 5.86%, effect is obvious, reduces debugging
Difficulty.This improves, and broken string improves reduced rate and reduces 10-60%.Limitation: after using this structure-improved to want, perforate is relatively
Greatly, exposed sample becomes significantly, easily causes the risk of FLOODING " mighty torrent ", therefore noted that.
In the case of lacking any element specifically disclosed herein, limiting, it is possible to achieve invention shown and described herein.
The term used and representation are used as the term of explanation and unrestricted, and are not intended to the use at these terms and representation
With described feature or any equivalent of its part shown in middle eliminating, and should be realized that various remodeling is in the scope of the present invention
It is the most all feasible.Although it is therefore to be understood that specifically disclose the present invention by various embodiments and optional feature, but
The amendment of concept as herein described and modification can be used by those of ordinary skill in the art, and think that these are revised and modification
Within falling into the scope of the present invention that appended claims limits.
Specifically described herein or record article, patent, patent application and every other document and the most available information
Content be in full included in this by reference to a certain extent, just as each single publication specifically and individually pointed out with
Make with reference to equally.Applicant retains any and all material from any this article, patent, patent application or other documents
The right that material and information are incorporated in the application.
Claims (20)
1. a detection device, including: test chamber, test chamber entrance, collection well, wherein, in test chamber, comprise at least one
Individual testing element, it is characterised in that: tested chamber, the sample collection region complete essence of entrance of testing element exposes.
Detect device the most as claimed in claim 1, it is characterised in that: test chamber entrance is oval, and the sample of testing element is received
Collection region is vertical with oval major axis essence.
Detect device the most as claimed in claim 1, it is characterised in that: test chamber entrance is oval or rectangle.
Detect device the most as claimed in claim 1, it is characterised in that: collection well includes test chamber outlet and reservoir outlet,
This detection device also includes reservoir compartment, and this reservoir compartment is for preserving the liquid sample that need to further confirm that testing result；Sample collection
Chamber has primary importance and the second place, and when collection well is positioned at primary importance, liquid sample passes through reservoir outlet at sample
Transmitting between this collecting chamber and reservoir compartment, when collection well is positioned at the second place, liquid sample is exported at sample by test chamber
Transmit between this collecting chamber and testing element.
Detecting device the most as claimed in claim 4, it is characterized in that, when collection well is positioned at primary importance, test chamber exports
Close.
Detect device the most as claimed in claim 4, it is characterized in that, when collection well is positioned at the second place, reservoir outlet
Close.
Detecting device the most as claimed in claim 6, it is characterized in that, collection well also includes lower chamber and stripper plate, lower chamber
Including the region bottom rotating collection well and between stripper plate.
Detecting device the most as claimed in claim 6, it is characterized in that, test chamber outlet and reservoir outlet are positioned at collection well
Bottom.
Detecting device the most as claimed in claim 6, it is characterized in that, collection well also includes a seal, works as collection well
It is positioned at salable reservoir compartment during the second place.
Detecting device the most as claimed in claim 7, it is characterized in that, stripper plate includes opening, liquid sample by this opening from upper
Cavity flows into lower chamber.
11. detect device as claimed in claim 4, it is characterized in that, this detection device has a housing, and this housing also includes a sight
Examine the window of detecting element.
12. detect device as claimed in claim 4, it is characterized in that, this detection device has a housing, and this housing also includes that one can
The reservoir compartment through hole sealed, is extracted in reservoir compartment by this reservoir compartment through hole liquid.
13. detect device as claimed in claim 4, it is characterized in that, testing element is test-strips.
14. detect device as claimed in claim 13, it is characterized in that, this test-strips includes fixing on the test strip specific binding
Molecule.
15. detect device as claimed in claim 13, it is characterized in that, test-strips includes chemical detection.
16. detect device as claimed in claim 4, it is characterized in that, liquid sample is body fluid or derives from tissue or body fluid.
17. detect device as claimed in claim 4, it is characterized in that, liquid sample is selected from: saliva, blood, serum, blood plasma,
Urine, ight soil, spinal fluid, vaginal swabs, mucus and tissue.
18. detect device as claimed in claim 17, it is characterized in that, liquid sample is saliva.
19. detect device as claimed in claim 18, it is characterized in that, collection well is made up of two or more parts, and first
Individual parts include upper cavity and stripper plate, and second component includes lower chamber.
The 20. detection devices as described in one of claim 1-19, is characterized in that, collection well is rotating.
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Cited By (1)
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