CN105866400B - The quickly device and its application method of detection and preservation sample - Google Patents
The quickly device and its application method of detection and preservation sample Download PDFInfo
- Publication number
- CN105866400B CN105866400B CN201510030328.2A CN201510030328A CN105866400B CN 105866400 B CN105866400 B CN 105866400B CN 201510030328 A CN201510030328 A CN 201510030328A CN 105866400 B CN105866400 B CN 105866400B
- Authority
- CN
- China
- Prior art keywords
- sample
- test
- detection device
- collection well
- chamber
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
Landscapes
- Investigating Or Analysing Biological Materials (AREA)
Abstract
The quickly device and its application method of detection and preservation sample.The present invention provides a kind of detection device, comprising: test chamber, test chamber entrance, collection well, wherein includes at least one testing element in test chamber, it is characterised in that: the sample collection region of testing element is tested chamber entrance and substantially exposes completely.Sample, the defect of effective customer service broken string are detected using such device.
Description
Technical field
The present invention relates to one kind for collecting and device existing for analyte in quickly detection liquid sample.
Background technique
Following background technique is used to help reader and understands the present invention, and is not construed as the prior art.
In our society, illicit drug use has become the social concern generally acknowledged and deteriorated increasingly.2003
Year, U.S. Department of Health and Human Service investigation discovery there are about 19,500,000 Americans or 8.2% age 12 years old or more crowd just
Sucking illicit drugs." using illicit drugs recently ", which refers to, investigate in the previous moon in U.S. Department of Health and Human Service
Used a kind of illicit drugs.Hemp is found to be most common illicit drugs, accounts for 6.2% (14,600,000).Estimate 2,300,000 people
(1.0%) cocaine is used now, 604,000 people have used crack, and there are 1,000,000 people using psychedelic, and estimate 119,
Heroin is used in 000 people.
In order to hit drug abuse and monitor this social concern, drug test for example employs in every profession and trade, educates, body
It educates, enforce the law etc. and having become standard test procedure.In order to push this effort, drug test industry has been formed.This production
Industry provides various drug test product.It can be the test product of a classics to the A urine sample collection device cup that sample is analyzed.
These devices may be complicated, difficult or dirty for user, or to conceal the case where using illicit drugs recently, can
The adulterated problem of sample can be will cause.In addition, urine sample can not be collected in certain occasions, for example in roadside or public arena.
In the detection process for carrying out drugs, when especially for immunoassay, due to many reasons, often result in
Lines on the test strip are uneven, deep mixed, even the only appearance of some lines, that is, usually described
The phenomenon that " broken string ".A kind of device and method for solving broken string are described in Chinese invention patent ZL200810120955.5.
Because the reason of broken string is more complicated, made of often many reasons are comprehensive.The test-strips for obtaining broken string, not only influence meat
The judging result of eye also results in many difficulties when carrying out degree with machine, will cause the knot of false positive and false negative
Fruit.Also it is necessary to provide the device of other solution broken string, better method and device is needed to be collected and examine sample
It surveys.
Summary of the invention
An aspect of of the present present invention provides a kind of detection device, comprising: test chamber, test chamber entrance, collection well,
In, it include at least one testing element in test chamber, it is characterised in that: the sample collection region of testing element is tested chamber entrance
Essence exposure completely.
In some preferred modes, it is characterised in that: test chamber entrance is ellipse, the sample collection area of testing element
Domain and the long axis of ellipse are substantially vertical.Preferably, test chamber entrance is ellipse or rectangle.
The present inventor has surprisingly found that, becomes larger when test chamber entrance, makes the sample reception region of test-strips several
After being completely exposed, test-strips can fully absorb sample, uniformly run plate, almost eliminate broken string.
Preferably, the present invention provides for detecting test device existing for analyte in liquid sample.The device is also
Including reservoir compartment, test chamber, and the plug division for receiving collection well.The device further includes being positioned at plug division and can turning
Dynamic collection well, applicator can be inserted into the collecting chamber.Stripper plate squeezes collector and is extruded sample, into this
Detection device.Using on collecting chamber test chamber outlet and reservoir outlet, by rotate collection well, directly result in sample
Originally flowing in the device.The device further includes the detecting element to detect presence of analyte.Rotation collection well is led
Opening and/or closing for device outlet is caused, operator can directly shunt the sample of collection in a device.The present invention also provides use this
The method of device and the detection kit for including the device.
Preferably, one aspect of the present invention provides detection device existing for analyte in a detection fluid sample.It should
Device contains a shell, including reservoir compartment, test chamber and the plug division for collection well grafting.The device further includes can be with
The matching used rotatable collection well in plug division.In various embodiments, collection well includes at least on one
Cavity, stripper plate, lower chamber, test chamber outlet and reservoir outlet.Test chamber contains at least one testing element.Different
In embodiment, one or more constituent element is included in shell.Collection well includes first position and the second position,
When in the first position, liquid sample is transmitted between collection well and reservoir compartment by reservoir outlet, is in second
When position, liquid sample is exported by test chamber and is transmitted between collection well and testing element, and reservoir outlet is at this time
Closure.In one embodiment, when collection well is in first position, test chamber outlet is closure, when sample is received
When collection chamber is in the second position, reservoir outlet is closure.Collection well rotates between two positions.
" reservoir compartment " refers to the sealing area of device, liquid sample be saved wherein and prevent liquid be evaporated or by
Extraneous pollution.The liquid sample being saved in reservoir compartment can be used for later exact p-value." liquid transmitting " refers to one kind
The ability for making liquid flow and transmit in two regions.Therefore, when liquid is flowed into storage from collecting chamber by reservoir outlet
When sap cavity, collecting chamber and reservoir compartment are in liquid transmitting state." plug division " is a part of device or shell, collection well
It can be connect by plug division with shell, and by rotating collection well make that liquid biography occurs between test chamber and reservoir compartment
It passs.Collection well can be used as individual partial insertion plug division, and collection well can also manufacture integral with shell.Sample
This collecting chamber itself can be manufactured into a component, or be assembled by multiple components.
" test chamber outlet " is the hole positioned at collection well, when " test chamber outlet " in the open state, sample receipts
Collect and liquid transmitting occurs between chamber and test chamber." reservoir outlet " is the hole in collection well, when " reservoir compartment goes out
Mouthful " liquid transmitting occurs in the open state, between collection well and reservoir compartment.Test chamber outlet and reservoir outlet are all
In collection well.In one embodiment, test chamber outlet and reservoir outlet are located at lower chamber." rotatable " refers to sample
The function that this collecting chamber can rotate in plug division.Rotation collection well cause test chamber outlet and reservoir outlet open or
Closure.
In one embodiment, when collection well is in first position, by reservoir outlet, reservoir compartment and sample
Liquid transmittance process occurs between collecting chamber lower chamber to export when collection well is in the second position by test chamber, surveys
It tries to generate liquid transmitting between element and collection well lower chamber.Lower chamber refers to rotatable collection well bottom and squeezes
Region between pressure surface.Test chamber outlet and reservoir outlet are located at collection well bottom.Collection well further includes sealing
Part, when collection well is in the second position, sealing element seals reservoir compartment.It can be realized and be surveyed by rotation collection well
The sealing between chamber outlet and reservoir outlet is tried, when closing reservoir outlet, opens test chamber outlet.
In one embodiment, lower chamber is positioned at stripper plate and to can be rotated the region between collection well.More into one
In the embodiment of step, test chamber outlet and reservoir outlet are located at collecting chamber bottom.In addition, in certain embodiments, when can turn
When dynamic collection well is in the second position, the sealing element on collecting chamber makes reservoir compartment be in sealing state.Further
In embodiment, there is a sliding slot in plug division, and rotatable collection well has one from its outer surface positioning pin outstanding, and may be stuck in
It is moved in sliding slot, to guide collection well from first position to the second position.Sliding slot and detecting element it is radial parallel.
" sliding slot " is a slot or hatch frame in shell, sliding slot can make positioning pin or other from collection well protrusion outstanding
It is inserted.When positioning pin is inserted into sliding slot, collection well can rotate in plug division leads to reservoir outlet and test
The open and close of chamber outlet.
" stripper plate " is a plane, and the collector containing liquid sample is extruded on it, divides sample therein
It separates out and.There are the opening or hole of the sample collection chamber for allowing the sample squeezed out to flow through on stripper plate.Stripper plate can be set
Sample collection is intracavitary, also can be set in the other positions that liquid sample can be made to be extruded inflow collecting chamber from collector.?
In one embodiment, it is intracavitary that stripper plate is located at sample collection, and is classified as upper cavity and lower chamber, further includes at least one work
For the opening or aperture in channel, liquid sample is set from sampler to enter sample collection intracavitary.When sampler presses stripper plate,
Sample flows into lower chamber by the through-hole of stripper plate.
In another embodiment, the device or shell include for observing testing element and observing the window of test result.
The device of the invention or shell further include the reservoir compartment through-hole that can be sealed, and liquid sample can be taken out of reservoir compartment by the through-hole
Out.Therefore, what sample can be convenient is shifted out of reservoir compartment by the reservoir compartment through-hole, does not need to dismantle the device.Reservoir
Chamber through-hole can be located on shell, and accessible, so not needing rotation collection cups, the utensil for also not needing any insertion is passed through
The close sample being stored in reservoir compartment of collection cups.
" testing element " is the element of any executable test.In one embodiment, testing element is test-strips.The survey
Strip may include having the substance pair specifically bound for immunoassay on it.Test-strips can be a kind of detecting
At the rear test chemical item by color change or other signal intensity judging results.It is applicable in the sample that the present invention is detected
Including but not limited to body fluid, the sample separated from biological tissue or body fluid.For example, sample can be saliva, and blood, serum,
Blood plasma, urine, excreta, spinal fluid, vaginal secretion, mucus and tissue.
" the sample reception area of testing element " testing element includes sample reception region, which is used to receive sample, or
Person is used for and sample contact, can handle some reagents on sample reception region, these reagents can be used for adjusting sample
PH value carries out pretreatment in advance to sample, these reagents are existing technology.Constitute sample material can be filter paper
The materials such as glass fibre, this is also the prior art.But in the conventional technology, sample reception region and test chamber entrance pair
It answers, but typically test chamber entrance is less than the size in sample reception region, can allow sample essence whole and sample in this way
Receiving area contact, but since the area of entrance is less than the area in sample reception region, receives the region of sample and do not connect
The region for receiving sample has apparent boundary, and liquid flowing, this stream will be generated between region wet in this way and dry region
The dynamic substantive inhomogeneities that may cause flowing, to cause the structure of broken string.And the present invention allows a test-strips or multiple surveys
The sample reception region of strip is substantially completely exposed under test chamber entrance, when there is liquid to flow to sample from test chamber entrance
When on receiving area, the area in all sample reception regions all releases liquid sample simultaneously, to eliminate dry and wet
Boundary, so as to allow the flowing of liquid on testing element at the uniform velocity, thus the phenomenon that eliminating broken string.Especially for those
Analyte, they itself are easy to be adsorbed by the material in sample reception region, and the effect of such structure design becomes apparent,
Such as COC etc..
When test chamber entrance correspondence is the sample reception region of a plurality of testing element, in order to allow the sample of testing element
This receiving area is substantially exposed under test chamber entrance completely, this in time, the width of test chamber entrance needs than two samples
The width of one's respective area wants wide or essence is wide.In some preferred modes, test chamber entrance is ellipse, oval length
Axis is vertical with the direction that test-strips arrange or essence is vertical, and oval long axis direction is complete by the sample reception region of test-strips
Be exposed under test chamber entrance, at the same in order to avoid excessive liquid generate mighty torrent phenomenon, allow ellipse short axle and test-strips
Orientation is parallel, reduces mighty torrent to greatest extent in this way, while solving the technical problem of broken string to greatest extent.
The present invention can detecte a variety of analytes.Analyte can be infectious substance or its instruction of infected person
Object.Analyte can be drug (such as drug abuse), hormone, albumen, nucleic acid molecules pathogen and specificity junction mixture.Drug
Abuse (DOA) refers to that non-medical destination uses drug (usually playing paralysis nerve).Abusing these drugs will lead to body
Body and spirit are damaged, and generate dependence, addicted and/or dead.The example of drug abuse includes cocaine；An Feita
Bright (for example, black beauty, white amphetamine tablet, dextroamphetamine, dexie, Beans)；Methylbenzene third
Amine (crank, meth, crystal, speed)；Barbiturate is (such as, Roche
Pharmaceuticals, Nutley, New Jersey)；Sedative (i.e. sleep paramedicines)；Lysergic acid diethylamide
(LSD)；Inhibitor (downers, goofballs, barbs, blue devils, yellow jackets, methaqualone)；Tricyclic
The anti-antidepressant of class (TCA, i.e. imipramine, amitriptyline and doxepin)；Phencyclidine (PCP)；Tetrahydrocannabinol (THC,
Pot, dope, hash, weed etc.)；Opiate (i.e. morphine, opium, codeine, heroin, hydroxyl dihydrocodeinone).In order to
The purpose of medical treatment, the drug of Law Control can be taken, but be easy to occur using excessive, so that it may be examined with these
Test paper slip is detected.Such as tricyclic resists strongly fragrant dose (imipramine and its analog) and the OTC product containing acetaminophen.
On the other hand, the present invention also provides methods existing for analyte in detection liquid sample.This method includes will
Suspection has the sample of analyte to be added in applicator, and applicator is put into collection well and is squeezed, makes sample
This is contacted with detecting element, is judged in liquid sample with the presence or absence of analyte.
In one embodiment, applicator is put into the mouth of tester and carries out sample collection, be full of collector
Saliva.By the way that collector is squeezed and pressed on stripper plate, liquid sample is set to enter detection device, while taking in a manner of torsion
Collector out flows into liquid sample in collection well.In one embodiment, sample flows into the lower chamber of collecting chamber.When
After being loaded with saliva in reservoir compartment, collection well turns to the second position from first position, starts to detect.
On the other hand, the present invention also provides one kind for analyzing detection reagent existing for analyte in liquid sample
Box.The detection kit includes the detection device and applicator so described.Applicator includes with sponge or bubble
Absorption piece made of foam plastics.Applicator can impregnated containing can stimulate in the salivary solution of tester in advance.
So that being easier to collect saliva when collector is put into tester mouthful.The kit further includes using the device, utilizes
Collector collects sample and detects the operation instructions for whether having analyte method in saliva.
Foregoing invention summary is non-limiting, and other features and advantages of the present invention will be from following detailed description and power
Become obvious in sharp claim.
Detailed description of the invention
Fig. 1 is the perspective view of 100 one embodiment 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 face views of Fig. 1 device.
Fig. 5 is the external view and sectional view of Fig. 1 device, the state before showing device use.
Fig. 6 is the external view and sectional view of Fig. 1 device, shows the device shape that sample 610 is extruded from absorber element 112
State.
Fig. 7 is the external view and sectional view of Fig. 1 device, shows the device shape that the sample 610 squeezed out enters test chamber
State.
Fig. 8 is the external view and sectional view of Fig. 1 device, shows the state that device is covered lid.
Fig. 9 is the structural schematic diagram in one specific embodiment of this present invention, and wherein the shape of test chamber import is ellipse
It is round.
Figure 10 be collection well on test chamber outlet formation, it is also corresponding with the shape of test chamber import and be ellipse
Shape.
Specific embodiment
The present invention has many advantages compared with prior art.
The device of the invention and its application method can easily detect the analyte in liquid sample.The device can
Relatively easily to save a certain amount of sample, afterwards using different testing principles into time because the present invention allow using
Sample is passed through collection well and is full of reservoir compartment by person, but until user rotates collection well and opens test chamber outlet
When, just start to carry out analysis detection.
Fig. 1-10 in order to illustrate the present invention for some embodiments, however, it is not limited to this, further includes the common skill in this field
The other embodiments that art personnel are expected by reference to the present invention.
With reference to attached drawing of the present invention, one embodiment of the invention includes shell 120 and collection well 130.Also it provides and contains
Firm handle 114 takes turns the applicator 110 on side 116 and absorber element 112.Shown in Fig. 5, the shell is there are two region, and one
It is test chamber 510, one is reservoir compartment 310.Shown in Fig. 3, two regions are by being molded top 260, lower part 265 and reservoir compartment bottom
Portion 274 forms.Different piece of the invention easily can be manufactured and then be combined.Shown in Fig. 3, detecting element 290
In test chamber.The in store a part of sample of reservoir compartment 310 can be used for validation test.
With reference to attached drawing 2 and 3, in the present embodiment, collection well 130 includes casing 220, the annular pressure in casing
Squeeze device 210 and lantern ring 240.Collection well 130 is located in shell upper plate plug division 276.Lantern ring 240 and shell upper plate are linked as one
Body, and have a sliding slot 250 parallel with lantern ring top edge in it.Casing 220 has one from its positioning pin outstanding of outer surface 222
320 and pass through set circular slide way 250.Respectively containing the sliding slot of two or more 250 and positioning pin 320 on lantern ring and casing.Set
It cooperates between ring and casing, casing can rotate in lantern ring.Because the movement of positioning pin is without departing from the model of sliding slot 250
It encloses, by the cooperation between sliding slot 250 and positioning pin, is limited at the rotation of casing in lantern ring.
With reference to attached drawing 5, test chamber import 540 and reservoir compartment import 530 are located on the upper plate 260 of shell.Test chamber import
540 enter the channel of test chamber as liquid from collection well.Test chamber is not air-tightness, gas can from upper plate and
It is excluded in gap between lower plate.Reservoir compartment import 530 flows into the channel of reservoir compartment as liquid.The reservoir compartment is air-tightness
, therefore there is exhaust outlet (not shown) to make gas that reservoir compartment import 530 can be discharged.In one embodiment, at least one is vented
Mouth (for example, aperture is located at reservoir compartment import two sides) adjacent with reservoir compartment import 530.Therefore, when gas is overflowed from exhaust outlet
When, liquid can flow into reservoir compartment.
One test chamber outlet 330 and reservoir outlet 332 is arranged at collection well bottom 336, respectively as sample from sample
The channel of collecting chamber inflow test chamber and reservoir compartment.In certain embodiments, casing has the first and second positions.Reservoir outlet
332 and test chamber outlet 330 be located at collection well bottom, when casing is located at first position, reservoir outlet is open,
Therefore reservoir compartment can carry out fluid exchange with the lower chamber of collection well 130.When collection well is located at first position,
Liquid squeezes out and flows through stripper plate from the absorber element 112 of collector 110, enters storage chamber by reservoir outlet 332
310.When collection well is located at first position, liquid cannot flow into test chamber, because between test chamber outlet and stripper plate
It not can be carried out fluid exchange.
Collection well 130 can go to the second position (see attached drawing 5-7).When collection well is located at the second position,
Test chamber outlet 330 is aligned with test chamber import 540, and test chamber can carry out fluid exchange with collection well.Once sample
Collecting chamber is located at the second position, and the liquid squeezed out from absorber element 112 flows through stripper plate, by test chamber outlet 330 and surveys
Examination chamber import 540 enters test chamber and reaches test-strips.
Reservoir compartment sealing element 334 can also be arranged at collecting chamber bottom 336, and size and position can be such that collection well is located at
When the second position, the sealing element 334 just seal up reservoir compartment import 530 and the exhaust outlet adjacent with reservoir compartment import (
When liquid sample enters reservoir compartment, which can exclude intracavitary gas).In a certain embodiment, O-ring 230 is pacified
It is placed on test chamber to export, (see attached drawing 3) on reservoir outlet and sealing element 334.
Applicator
The present invention also provides applicators.In one embodiment, applicator has an absorber element and is affectedly bashful portion.
Absorber element is usually made of the other sponge of medical grade commonly used in the art or plastic foam material.But many other materials
It can be made into absorber element, such as cotton perhaps paper or other any materials with water absorbing properties.Being affectedly bashful portion is usually rigidity
, be conducive to the operation to absorber element.The portion of being affectedly bashful can be made of material commonly used in the art, such as plastics, timber, metal
Or cardboard.In one embodiment, the portion of being affectedly bashful has wheel side 116 (see attached drawing 1), and absorber element is pasted on it.
Test-strips (290)
A variety of detected components can be with combined application into the present invention.Analytical test strip can there are many form, for example, by using
Immune or test chemical form, for the analyte in test sample, such as drugs or the related generation for indicating physical condition
Thank to object.In some forms, test-strips are with sample application zone, the water-absorbing material of reagent area and test results zone.Sample is added
To sample application zone, reagent area is flowed into using capillarity.In reagent area, sample solubilising reagent simultaneously mixed can be used for detecting quilt
Analyte (if there are analytes in sample).The sample with reagent continues to flow to test results zone at this time.In addition
Reagent is fixed on test results zone.These are fixed on the reagent and analyte (if present) or and reagent of detection zone
The first reagent in area is reacted and is combined.It, will if there are analytes in sample in noncompetitive test format
It generates signal and does not generate signal if analyte is not present.In competition test format, if quilt is not present in sample
Analyte then generates signal, does not generate signal then if there is analyte.The present invention is suitable for various analytical forms.
When the test element is a test strip, it can be made of water suction or unwetted property material, and test-strips can be with
Transmitting using multiple material, for liquid.A kind of material of test-strips can be superimposed upon on another test strip material, example
Such as, filter paper overlaid is on nitrocellulose.Alternatively, at least a region containing a kind of material is located at another kind at least in test-strips
After a kind of region containing different materials.In this case, liquid is circulation between each region, can phase between them
It is mutually superimposed or is not superimposed.Material in test-strips can be fixed on such as support of plastics liner or hard surface,
It can holding force to reinforce test-strips.
It (such as at least one enzyme and is detected in the embodiment that some detected materials are detected by signal generation system
Specific reaction occurs for object), at least one substance for generating signal can be attracted to the analyte detection zone of test-strips, just
It is specifically adsorbed on the material of test-strips as described above the same.Additionally, there are in the sample application zone of test-strips 2901, reagent
Area, analyte detection zone, or the substance of the generation signal throughout entire test-strips can pre-process in advance in test-strips
On one or more materials.It can be by the way that the substance solution for generating signal to be added to the surface of application area or by the one of test-strips
Or multiple materials are immersed in signal solutions and realize.After test-strips joined signal solutions or impregnate in the solution, it will survey
Strip drying.In addition, above method is present in the sample application zone, reagent area, analyte detection zone of test-strips, or throughout whole
The substance of the generation signal of a test-strips can be pre-processed in advance on one or more materials of test-strips.Additionally, there are in survey
The semiochemicals of strip sample application zone, reagent area or detection zone as labelled reagent can be added to test one of strip material or
Multiple surfaces.
Each region of test-strips can be arranged as follows: sample application zone, at least one reagent area, at least one test results zone, until
A few control zone, at least one detection of adulterations area and liquid absorption area.If detection zone includes a control zone, preferably control
Area is located at after the analyte detection zone of test results zone.It all these areas or combinations thereof can be in the list for containing a kind of material
In one test strips.In addition, these areas are made from a variety of materials, and link together by the direction that liquid transmits.For example, different
Region can directly or indirectly carry out liquid transmitting.In the present example, different areas can be along the direction end that liquid transmits
It is connected with end, or is overlapped mutually along liquid direction of transfer, or be connected by other materials, such as connection dielectric material
(preferably water-absorbing material such as filter paper, glass fibre or nitrocellulose).When with connecting material, connecting material can make include
Material that the material of the end in each region and joining distal ends, the end comprising each region and joining distal ends but liquid do not circulate or
Comprising each region overlapped (such as, but not limited to from the beginning to the end be overlapped) but material that liquid does not circulate, liquid communication is formed.
If test-strips contain detection of adulterations control zone, which can be placed on before or after result detection zone.Work as knot
Fruit determines that control zone is contained in area, and adulterated control zone is preferably positioned at before control zone, may not be such situation.The present invention
One embodiment, test-strips be for adulteration analyte judge and/or control control test-strips, adulterated control zone can be located at
Before or after control zone, it is preferably placed at before control zone.
It include biofluid (such as casing fluids or clinical sample with the sample that detection device of the invention can detecte
This).Liquid sample can be from the sample of solid-state or semisolid, including excreta, biological tissue and food samples.It utilizes
The sample of solid-state or semisolid can be converted to liquid sample by any method appropriate, such as mix, smash to pieces, macerating, being incubated for,
Dissolution or in a suitable solution (such as water, phosphate solution or other buffer solutions) utilize enzymolysis digestion of solid sample
This." biological sample " includes deriving from animal, plant and food samples, for example including the urine for deriving from human or animal, saliva, blood
And its ingredient, spinal fluid, vaginal fluid, sperm, excrement, sweat, secretion, tissue, organ, tumor, the training of tissue and organ
Support object, cell culture and medium.Preferred biological sample is urine.Food samples include the substance of food processing, final products,
Meat, cheese, wine, milk and reference water.Plant sample includes being derived from any plant, plant tissue, plant cell cultures and Jie
Matter." environmental samples " from environment (for example, from lake or the liquid sample of other water bodys, sewage sample, soil property sample
Product, underground water, seawater and waste liquid sample).Environmental samples may also include sewage or other waste water.
Using the present invention and suitable detecting element, any analyte can detecte.Saliva is detected preferably by the present invention
Drugs in liquid.
For example, including but is not limited to creatinine, bilirubin, nitrite, albumen with the analyte that the present invention detects
(non-specificity), hormone (for example, human chorionic promotes sex hormone, luteinizing hormone, follicular stimulating hormone etc.), blood, white blood cell,
Sugar, heavy metal or toxin, bacterial components (albumen or glucide as being directed to specific bacterial, such as such as colon bacillus 0157:
H7, staphylococcus, salmonella, fusobacterium, Campylobacter, L.monocytogenes, vibrio or cactus bacillus) and urine
Substance relevant to physiological characteristic in sample, such as pH and specific gravity.Other any Clinical Urinary chemical analyses are all examined using lateral flow
Survey form cooperates apparatus of the present invention to be detected.
Application method
The present invention also provides utilize method existing for analyte in device detection liquid sample.Attached drawing 5-8 describes
Certain detecting steps of these methods.If Fig. 5 illustrates, the absorber element of collector has been put into tester mouthful, and is sufficiently inhaled
Receive sample.As shown, collector is inserted into collection well 130.From its external view as it can be seen that applicator is located at first
It sets, positioning pin is located at the side (i.e. 1 of sliding slotstPosition).By its sectional view as it can be seen that when applicator is located at first position
When, together with reservoir outlet is arranged above and below with reservoir compartment import, make to be formed between collection well lower chamber 520 and reservoir compartment
One channel.In addition, being to close between the import and test chamber of test chamber.
If Fig. 6 illustrates, applicator is already inserted into sample chamber and presses stripper plate.Applicator, which presses down on, squeezes
Pressing plate 340 makes absorber element distortion be pressurized, the liquid in absorber element is promoted to be extruded into collecting chamber.As shown by arrows,
Liquid passes through stripper plate.The liquid being extruded is as shown in gray shade.Stripper plate can there are two or multiple vertical tendons 570, in muscle
Under the action of, collector can be twisted, and squeeze absorber element fully.The liquid being extruded by the hole on stripper plate into
Enter collecting chamber bottom.As previously mentioned, when applicator is located at first position, it is right above and below reservoir outlet and reservoir compartment import
Together.In the present embodiment, when collection well is located at first position, test chamber outlet is to close.Therefore, collection well
The liquid of bottom flows through the export and import of reservoir compartment.By aperture adjacent with reservoir outlet on collecting chamber bottom plate, by into
Gas in reservoir compartment replaced the liquid entered is excluded and enters collection well bottom.
As shown in fig. 7, collection well turns to the second position.As shown in external view, the sliding slot that positioning pin is moved to is another
One end, such as 2ndIt is indicated.When positioning pin is located at the second position, reservoir outlet is closed, and reservoir compartment import is by reservoir
The sealing element 334 of chamber seals (Fig. 3).Test chamber outlet 330 and 540 consistency from top to bottom of test chamber import, so that testing element 290
Liquid transmitting can be carried out with the lower chamber of collecting chamber.Therefore the liquid for being stored in lower chamber, which flows into test chamber, touches test
Item.Once liquid touches test-strips, liquid is just tested strip and absorbs, and analysis experiment starts.Analysis time depends on sample
Density and testing element use.
Attached drawing 8 discloses another step using apparatus of the present invention --- it is covered on device.As shown in Fig. 8, sample
Collecting chamber is removed from the second position.Lid 280 is placed on the top of collection well.Reservoir compartment is still sealed.At this time
Device can be transported to carries out confirmation experiment elsewhere.When carrying out confirmation experiment, the close of sample tap can be removed or staved
Sealing 272 takes out the part sample in reservoir compartment by sample tap 270.
Test kit of the invention further includes applicator.In certain embodiments, additionally provided in kit as
What is using the present apparatus to the operation instructions that whether there is analyte in saliva or saliva or other kinds of liquid solution.
Packaging is needed according to client's using various shape.For example, carrying out largely entering trade-before drug abuse screening, it is preferred to use one contains
A specification, the packaging of 20 vacuum-packed detection devices and applicator.Other form, which can be, to be preferably included
One test device, an applicator and a specification.
In another embodiment, such as Fig. 9-10, the test chamber entrance 540 of the collection device are ellipse, are corresponded to
Two testing elements sample reception region be located at ellipse in the following, the sample reception region 2091 for being located at test-strips is complete
It is exposed under the entrance of ellipse entirely, in the so-called width direction of the exposed part sample application zone for referring to test-strips completely
Tested chamber entrance is exposed, but there is no tested chamber entrances to be completely exposed on the longitudinal direction of sample application zone；Also
It is to say, is not overlapped or is hidden by the entrance of ellipse in the width direction in the part sample reception region 2091 in test-strips
Lid does not need generally since the part sample reception region in test-strips is long in the longitudinal direction by the institute, entrance institute of ellipse
Overlapping covers (see attached drawing 9).In some preferred modes, collecting chamber outlet 330 is also all as test chamber entrance 540
Ellipse is located at test chamber entrance 540 so that it is convenient to which fluid sample is flowed into test chamber entrance 540 and contacts from collecting chamber outlet
Under test-strips sample reception region on carry out analyte detection.
Embodiment
Embodiment 1 --- detection sensitivity experiment
The present embodiment in order to illustrate apparatus of the present invention and application method detection sensitivity.Each sample solution is with ten
Device is detected, totally 300 tests.These devices are detected with saliva sample, there is detected drugs in used test-strips
Antigen.Test-strips use competition law, and there is the antibody of colloid gold label in mark zone, has antigen on p-wire.
For the device simultaneously again with 0 times, 0.5 times, the 1.5 times and 3 times cocaine (COC) for detecting limit is contained, methyl peace is non-
He orders (MAMP), phencyclidine (PCP), tetrahydrocannabinol (THC), morphine (MOP) or amphetamine (AMP) PBS solution
It is detected.Such as the detection limit of THC is 4ng/ml in saliva.Therefore to containing THC be 0ng/ml, 2ng/ml, 6ng/ml and
The PBS solution of 8ng/ml is detected.Following table is to be detected the dosage of drugs.
When being detected, above-mentioned feminine gender saliva, the PBS of PBS or spike is absorbed by the absorption sponge of applicator, so
After extrude into collection well.Then, collection well is transferred to the second position.When collection well is located at the second position
When, test-strips touch sample, and liquid is by capillary action through test-strips.Test result is recorded after ten minutes and is shown in
In following table.
The results show that the present invention has good sensitivity and ideal cutoff range.
Embodiment 2 --- sample amount ranges changeability experiment
Influence of this example in order to illustrate amount of samples to apparatus of the present invention are used.Same drugs sample difference in example 1
With 0 times, 0.5 times, 3 times of concentration (being prepared as described above using PBS) repeats detection 5 times with detection device.Sample size is respectively
Simultaneously test device is accurately added with suction pipe respectively in 100ul, 150ul, 200ul and 250ul, is directly placed into sample instead of applicator
In this.10 minutes after sample-adding, positive findings or negative findings are recorded.In addition to 0.5 times of THC of 250ul is (there are four in five tests
As a result consistent), remaining five duplicate result of items detection is consistent.Therefore consider the dosage of sample, the present invention can provide correct
Result.
Embodiment 3 --- enter trade-before drug abuse screening
The present invention also can detect other detection projects, such as enter the drug abuse screening experiment of trade-before.Tester is by sample collection
Device is put into mouth, collects saliva sample, and retain collector in mouth about 5 minutes.One embodiment includes in detection device
There are the multiple common drugs test-strips of detection.Such as cocaine, phencyclidine, tetrahydrocannabinol, morphine or amphetamine.This
A little test-strips use competitive immunoassay method, contain the specificity knot of the tested drugs of labeled every kind in the mark zone of test-strips
It closes molecule (such as antibody).P-wire contains detected antigen.It, can be special with mark zone if containing analyte in sample
Property combine labeled molecule combine, prevent the antigen binding on the antibody and p-wire of the label.Therefore, when analyte is deposited
When, there is no signal on p-wire.On the contrary, when no antigen is present in the saliva, the antigen knot on labeled antibody and p-wire
It closes, generates signal.
After collector sufficiently collects sample, laboratory technician is inserted into collecting chamber.Laboratory technician presses collector and turns simultaneously
Dynamic collector, the muscle of collecting chamber lock the edge of collector.Saliva, which is extruded and passes through the aperture of stripper plate, enters collecting chamber
Lower chamber.When collecting chamber is at first position, sample flows through reservoir outlet and enters reservoir compartment.When all samples are collected,
And when reservoir compartment saves enough samples, collection well goes to the second position from first position, seals reservoir compartment
And open test chamber outlet.Sample flows into test-strips.After a few minutes, control line is shown, show that test has been completed.Work as test
When line shows signal, show that there is no the drugs in saliva.If detection device can be sent to validation test the result is that positive
Laboratory, further detect reservoir compartment in sample to confirm testing result.
Embodiment 4 --- the improvement to broken string
Although it breaks from the sub- 1-3 of embodiments above it has been found that can be very good to obtain testing result
Phenomenon exists than more serious, especially in certain gradient differences product, and phenomenon is more obvious, especially in positive sample, increases
The risk of false negative, while the difficulty of debugging is increased, qualification rate obviously increases.Therefore, we carry out the structure of the device
It improves, for improved newly lower sample hole, (shape of test chamber entrance changes, and pervious shape is changed into present ellipse
Circle allows the transverse direction in the sample reception area of test-strips almost to expose, and has surprisingly found that obviously to have and improves broken string
Advantage).
Due to the broken string most serious in saliva COC product and obviously, then by taking COC saliva as an example, in following experimental result
Demonstrate this hypothesis.
Sensitivity experiment analysis
As can be seen from the above data, conclusion: both the above mold can produce the product for meeting QC standard.
Broken string improves comparative experiments:
COC situation
As a result:
After the above broken string improves, breakage ratio is reduced to improved 5.86% by original 70%, and effect is obvious, reduces
Debugging difficulty.This is improved, and broken string improves reduced rate reduction 10-60% and differs.Limitation: will rear aperture using the structure-improved
Larger, exposed sample becomes larger greatly, easily causes the risk of FLOODING " mighty torrent ", therefore noted that.
In the case where lacking any element specifically disclosed herein, limitation, may be implemented illustrated and described herein
Invention.Used terms and expressions method is used as the term of explanation rather than limits, and is not intended in these terms and table
Up to any equivalent for excluding shown and described feature or part thereof in the use of method, and it should be realized that various remodeling exist
It is all feasible in the scope of the present invention.It is therefore to be understood that although specifically being disclosed by various embodiments and optional feature
The present invention, but the modifications and variations of concept as described herein can be used by those of ordinary skill in the art, and recognize
It is fallen into for these modifications and variations within the scope of the present invention of the appended claims restriction.
It is described herein or record article, patent, patent application and every other document and can electronically obtain
The content of information to a certain extent in full include herein by reference, just as each individual publication by specific and single
Solely point out by reference.Applicant retains from any of any this article, patent, patent application or other documents
And all material and information are incorporated into the right in the application.
Claims (17)
1. a kind of detection device, comprising: test chamber, test chamber entrance, collection well, wherein include at least one in test chamber
A testing element, it is characterised in that: the sample collection region of testing element is tested chamber entrance and substantially exposes completely；Test chamber enters
Mouth is ellipse, and the sample collection region of testing element and the long axis of ellipse are substantially vertical；Collection well includes test chamber
Outlet and reservoir outlet, the detection device further include reservoir compartment, which need to further confirm that testing result for saving
Liquid sample；Collection well has first position and the second position, when collection well is located at first position, liquid-like
This is transmitted between collection well and reservoir compartment by reservoir outlet, when collection well is located at the second position, liquid
Sample is exported by test chamber and is transmitted between collection well and testing element；The test chamber outlet of the collection well is
Ellipse.
2. detection device as described in claim 1, characterized in that when collection well is located at first position, test chamber goes out
Mouth is closed.
3. detection device as described in claim 1, characterized in that when collection well is located at the second position, reservoir compartment goes out
Mouth is closed.
4. detection device as claimed in claim 3, characterized in that collection well further includes upper cavity, lower chamber and extruding
Plate, lower chamber include the region between rotatable collection well bottom and stripper plate.
5. detection device as claimed in claim 3, characterized in that test chamber outlet and reservoir outlet are located at collection well
Bottom.
6. detection device as claimed in claim 3, characterized in that collection well further includes a sealing element, works as sample collection
Chamber is located at salable reservoir compartment when the second position.
7. detection device as claimed in claim 4, characterized in that stripper plate include opening, liquid sample by the opening from
Upper cavity flows into lower chamber.
8. detection device as described in claim 1, characterized in that the detection device has a shell, which further includes one
Observe the window of testing element.
9. detection device as described in claim 1, characterized in that the detection device has a shell, which further includes one
Sealable reservoir compartment through-hole is extracted out of reservoir compartment by the reservoir compartment through-hole liquid.
10. detection device as described in claim 1, characterized in that testing element is test-strips.
11. detection device as claimed in claim 10, characterized in that the test-strips include fixed specificity on the test strip
Binding molecule.
12. detection device as claimed in claim 10, characterized in that test-strips are used for chemical detection.
13. detection device as described in claim 1, characterized in that liquid sample is body fluid or derives from tissue or body fluid.
14. detection device as described in claim 1, characterized in that liquid sample is selected from: saliva, blood, serum, blood plasma,
Urine, excrement, spinal fluid, vaginal swabs, mucus and tissue.
15. detection device as claimed in claim 14, characterized in that liquid sample is saliva.
16. detection device as claimed in claim 15, characterized in that collection well is made of two or more components,
First component includes upper cavity and stripper plate, and second component includes lower chamber.
17. the detection device as described in one of claim 1-16, characterized in that collection well is rotatable.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510030328.2A CN105866400B (en) | 2015-01-21 | 2015-01-21 | The quickly device and its application method of detection and preservation sample |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510030328.2A CN105866400B (en) | 2015-01-21 | 2015-01-21 | The quickly device and its application method of detection and preservation sample |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN105866400A CN105866400A (en) | 2016-08-17 |
| CN105866400B true CN105866400B (en) | 2019-04-09 |
Family
ID=56623088
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201510030328.2A Active CN105866400B (en) | 2015-01-21 | 2015-01-21 | The quickly device and its application method of detection and preservation sample |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN105866400B (en) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108620142A (en) * | 2017-03-22 | 2018-10-09 | 杭州博拓生物科技股份有限公司 | The detection device and method of analyte in a kind of detection fluid sample |
| CN212514605U (en) * | 2019-01-10 | 2021-02-09 | 浙江东方基因生物制品股份有限公司 | Detection device |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1882836A (en) * | 2003-11-14 | 2006-12-20 | 香港澳维有限公司 | Rapid sample analysis and storage devices and methods of use |
| CN101419228A (en) * | 2004-10-12 | 2009-04-29 | 艾康生物技术(杭州)有限公司 | Sample detection device and detection method |
| CN101876661A (en) * | 2009-05-08 | 2010-11-03 | 艾博生物医药(杭州)有限公司 | Device for analyzing analyte in liquid sample |
| CN103969433A (en) * | 2013-01-29 | 2014-08-06 | 艾博生物医药(杭州)有限公司 | Sample detection apparatus |
| CN204462145U (en) * | 2015-01-21 | 2015-07-08 | 艾博生物医药(杭州)有限公司 | The device of quick detection and preservation sample |
-
2015
- 2015-01-21 CN CN201510030328.2A patent/CN105866400B/en active Active
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1882836A (en) * | 2003-11-14 | 2006-12-20 | 香港澳维有限公司 | Rapid sample analysis and storage devices and methods of use |
| CN101419228A (en) * | 2004-10-12 | 2009-04-29 | 艾康生物技术(杭州)有限公司 | Sample detection device and detection method |
| CN101876661A (en) * | 2009-05-08 | 2010-11-03 | 艾博生物医药(杭州)有限公司 | Device for analyzing analyte in liquid sample |
| CN103969433A (en) * | 2013-01-29 | 2014-08-06 | 艾博生物医药(杭州)有限公司 | Sample detection apparatus |
| CN204462145U (en) * | 2015-01-21 | 2015-07-08 | 艾博生物医药(杭州)有限公司 | The device of quick detection and preservation sample |
Also Published As
| Publication number | Publication date |
|---|---|
| CN105866400A (en) | 2016-08-17 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN101876657B (en) | Rapid sample detection and storage devices and methods of use | |
| CN208860630U (en) | A kind of fluid specimen collection device | |
| TW201215365A (en) | Fecal occult blood testing device | |
| CN107782575A (en) | A kind of system and method collected and detect analyte in sample | |
| CN105866400B (en) | The quickly device and its application method of detection and preservation sample | |
| CN110161269A (en) | A kind of sample collection device, collection method and detection method | |
| CN108620142A (en) | The detection device and method of analyte in a kind of detection fluid sample | |
| CN204462145U (en) | The device of quick detection and preservation sample | |
| CN206945339U (en) | A kind of sample collection device | |
| CN110161272A (en) | A kind of collecting chamber | |
| WO2017084540A1 (en) | Collection and detection device for fluid samples | |
| CN209269717U (en) | The detection device of analyte in sample | |
| CN207591888U (en) | The detection device of analyte in a kind of detection fluid sample | |
| CN108968982A (en) | The detection device of analyte in sample | |
| CN108627635A (en) | The device and method of analyte in a kind of detection fluid sample | |
| CN110161271A (en) | A kind of lid |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| GR01 | Patent grant | ||
| GR01 | Patent grant |