CN107782906A - A kind of detection means and detection method - Google Patents

A kind of detection means and detection method Download PDF

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Publication number
CN107782906A
CN107782906A CN201610717441.2A CN201610717441A CN107782906A CN 107782906 A CN107782906 A CN 107782906A CN 201610717441 A CN201610717441 A CN 201610717441A CN 107782906 A CN107782906 A CN 107782906A
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China
Prior art keywords
test chamber
chamber
gas
detection means
sample
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CN201610717441.2A
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Chinese (zh)
Inventor
高飞
范·佳斯菲
陆维克
王海剑
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Hangzhou Aotai Biotechnology Ltd By Share Ltd
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Hangzhou Aotai Biotechnology Ltd By Share Ltd
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Priority to CN201610717441.2A priority Critical patent/CN107782906A/en
Publication of CN107782906A publication Critical patent/CN107782906A/en
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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/10Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices
    • G01N35/1095Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices for supplying the samples to flow-through analysers
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00Sampling; Preparing specimens for investigation
    • G01N1/02Devices for withdrawing samples
    • G01N1/10Devices for withdrawing samples in the liquid or fluent state
    • G01N1/18Devices for withdrawing samples in the liquid or fluent state with provision for splitting samples into portions

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  • Life Sciences & Earth Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Hydrology & Water Resources (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

The present invention provides a kind of detection means, the detection means includes one the test chamber containing test chamber, gas regulation material is set between the test chamber and extraneous swap-in air, when gas regulation material is dry when, test chamber carries out gas circulation with ambient atmosphere by the gas regulation material, when gas regulation material moistens, test chamber can not carry out gas circulation with ambient atmosphere by the gas regulation material.Using said structure, there is the characteristics of simple and reasonable, use lower cost for material, function admirable;Gas regulation material (such as, sponge core), with the function of preventing leakage, the air pressure of pattern detection intracavitary also can be effectively adjusted simultaneously, it is allowed to keep constant pattern detection liquid level, the stabilization of testing result can be ensured, is individually provided with sample storage chamber (collecting chamber) in addition, ensure that unnecessary sample by reagent contamination, is not easy to secondary detection.

Description

A kind of detection means and detection method
Technical field
The present invention relates to divided in a kind of detection means, the especially collection in quick diagnosis field and detection fluid sample Analyse the device of material, such as urine detection and collection device.
Background technology
Be presently used for detect sample in whether the detection means containing analyte, be largely used to hospital or family In, these detection means for being applied to quick diagnosis include one or more detection reagent bars, such as early pregnancy detection, drug abuse Detection etc..The detection means of this quick diagnosis is very convenient, can be at one minute, or at most ten minutes or so are detecting Testing result is obtained on reagent strip.
Illicit drugs inspection is widely used, be usually used in prohibition of drug department, public security bureau, narcotic house, medical center, country conscription physical examination at Etc. mechanism.Illicit drugs inspection wide variety, number is frequent, can be automatically separated the illicit drugs inspection urine cup of remaining sample and detected sample With the huge market demand, for illicit drugs inspection urine cup in the market after detection is completed, sample in urine cup will be by It can not continue on for second of confirmation detection to the pollution of detection reagent, such as the description of United States Patent (USP) 7300633.
Although detected sample in the conventional technology, can be allowed to be isolated with the sample collected, cost Height, and do not allow easy to operate.Such as United States Patent (USP), the piston urine cup that the patent No. 7300633 describes, when the mistake for promoting piston-advance Cheng Zhong, the fluid sample allowed in collecting chamber, such as urine, are transferred to test chamber from collecting chamber, there is detection sample in test chamber The testing element of middle analyte, and the fluid sample of collecting chamber is kept apart by piston, so as to two local samples not It can obscure, so as to for later confirmation detection.Although the sample that can so keep apart the sample of detection and collect, It is the urine cup cost height of this piston, and operation is not easy, and promotes piston to need bigger strength after all, because living Plug needs reach transfer sample, are necessarily required to play the effect of hydraulic seal with the wall of piston, the effect needs for reaching sealing allow Piston and piston closely combine by force.
For some above-mentioned technical problems, therefore need to make improvements, there is provided approach in addition is solved can be with The deficiency of existing conventional art, separated so as to reach detection liquid and collect liquid, reach secondary detection purpose.
The content of the invention
For the above situation, the defects of to overcome prior art, it is an object of the invention to provide one kind to be automatically separated The detection means of remaining sample and detected sample, the urine cup is after sample has been collected, while spiral cover, a certain amount of sample Originally in the test chamber from interior cup (collecting chamber) by (test chamber) in small sircle hole (through hole) inflow outer cup, it is automatically performed detection Process, and unnecessary sample is stored in interior cup (collecting chamber), the pollution from being detected reagent strip, can be used for second Detection.
On the one hand, the present invention provides a kind of detection means, and the detection means includes a test chamber, the test chamber bag Include with a passage outside test chamber, for the passage when not having liquid, test chamber carries out gas circulation with extraneous, when there is liquid When body, gas circulation is not carried out with the external world.
A kind of detection means, the detection means include one the test chamber containing test chamber, changed in the test chamber with the external world Enter and gas regulation material is set between air, when gas regulation material is dry when, test chamber and ambient atmosphere pass through the gas Body regulation material carries out gas circulation, and when gas regulation material moistens, test chamber can not pass through the gas with ambient atmosphere Body regulation material carries out gas circulation.Preferably, gas regulation material can be arranged on test chamber with extraneous in the position of circulation Between putting, such as test chamber and external world are and other any structures progress gas circulations with passage, hole, hole in advance, at these Gas regulation material is set in structure, so as to allow regulation material to carry out test chamber and the regulation of extraneous gas circulation.
The present invention provides a kind of detection means, and the detection means includes a test chamber, and allows the detection of test chamber Chamber and extraneous passage be connected, the passage is not when having liquid, test chamber and extraneous progress gas circulation, when there is liquid When body, test chamber can not carry out gas circulation with the external world.Preferably, gas regulation material is set in the passage.
In some embodiments, test chamber is the cavity body structure of relative closure.Preferably, test chamber includes detection Chamber, when thering is fluid sample to enter test chamber, it can be contacted with the testing element (if there is) in test chamber, It whether there is or existing quantity so as to obtain analyte in fluid sample.
In some embodiments, a collecting chamber is also included in test chamber, collecting chamber passes through a through hole and detection Chamber is in fluid communication.When collection has fluid sample in collecting chamber, fluid sample is entered in test chamber by the through hole. In some embodiments, when collecting chamber is located in test chamber, the wall of collecting chamber and the wall of test chamber and bottom form this The test chamber of invention.In some embodiments, the channel design being in communication with the outside is located at the bottom of test chamber.
Or in some embodiments, the detection means also includes a collection device, the collection device and test chamber It is in fluid communication, so as to which the fluid in collecting chamber is entered in test chamber.The structure of fluid communication can include through hole, even Lead to, jack and latch, irrigation canals and ditches, the mode such as channel carries out fluid communication therebetween.When collecting chamber or collection device and inspection When surveying chamber contact, the liquid positioned at collecting chamber is flowed into test chamber.
In some preferable modes, there are a small slot structure or sunk structure in the bottom of test chamber, for collecting Fluid sample in test chamber.Preferably, testing element is included in test chamber, the sample of testing element applies end and sulculus knot Fluid sample contact in structure or sunk structure.
In some preferable modes, connecting detection chamber and extraneous passage are (when having passage, if without also may be used With) include gas regulation material, such as sponge core material, or other similar materials.Gas regulation material is in relatively dry When either gas regulation material does not contact with liquid or do not absorb liquid under dry environment, the material can allow Passage has gas circulation, i.e., the gas in test chamber can be entered in ambient atmosphere by the material, or, the external world is big certainly Air in gas can be entered in test chamber by the material.But under environment very moist at the gas regulation material When either gas regulation material contacts or drawn absorption liquid with liquid, the material can not allow passage to have gas stream Logical, i.e., the gas in test chamber can not be entered in ambient atmosphere by the material, certainly or, the air in ambient atmosphere It cannot be entered by the material in test chamber.
In some preferable modes, when collecting chamber is located in test chamber, the bottom of collecting chamber includes a through hole, Should be by allowing test chamber to be in fluid communication with collecting chamber.In some preferable modes, include in test chamber bottom one it is raised Structure, raised structure include groove either channel structure or as structure be referred to as flow guiding structure, allow by through hole stream Liquid the place contacted in test chamber with testing element is entered by flow guiding structure, so as to allow fluid sample and testing element Contact.
In some preferable modes, multiple necks for being used to accommodate testing element are provided with the outer wall of collecting chamber.Or Person, the structures such as the test card of testing element, prod are included in test chamber.
In some preferable modes, collecting chamber includes being used for the opening for collecting fluid sample.Preferably, collecting chamber includes Lid for sealed opening.Preferably, collecting chamber is located in test chamber, and the outer of collecting chamber opening seals opening for test chamber Mouthful, so as to separate the space of a sealing in test chamber.Preferably, the test chamber of sealing passes through the passage with the external world and the external world Atmosphere.
In some specific embodiments, detection means includes outer cup (8) and interior cup (10), edge in the outer cup (2) lower end with interior cup screw thread adapter (5) is formed with airtight connection;Interior cup (10) upper end and spiral cup lid (9) shape It is sealed into sealing;Interior cup (10) outer surface is formed with neck (6);Interior cup (10) bottom is formed with small sircle hole (7);The cup Body bottom is formed with pattern detection chamber (3);The pattern detection chamber (3) is provided with the hollow of the inner and outer boundary's air of UNICOM's cup test chamber Post (11);The hollow posts bottom is provided with the sponge core (4) of sealing hollow posts.
As a preferred embodiment of the present invention, the interior cup cup and outer cup are welded into one by ultrasonic bonding art Body, the pattern detection intracavitary that sample is flowed into outer cup by the bottom through-hole of interior cup.
As a preferred embodiment of the present invention, upright place can be automatic after spiral cover is only needed after the urine cup collection sample Testing result, reading after certain time, the sample liquid level constant of pattern detection intracavitary, the steady of testing result can be ensured It is fixed.As a preferred embodiment of the present invention, the urine cup body is plastic material.
On the other hand, the present invention provides a method for being used to collecting or detecting the analyte in liquid sample, should Method includes providing foregoing arbitrary collection device or detection means, so as to allow fluid to be flowed into inspection by through hole from collecting chamber Survey intracavitary, you contact and detected the liquid part being flowed into test chamber with the test original cost in test chamber, another and Gas regulation material in connecting detection chamber and ambient atmosphere passage, so as to allow test chamber not carry out gas with the external world Circulation.
Preferably, after test chamber does not carry out gas circulation with the external world, test chamber forms a closed space, including one Point gas in test chamber, entered back into so as to limit fluid sample from collecting chamber into test chamber, so as to realize collect and Detect the separation of sample.
Beneficial effect
Using said structure, there is the characteristics of simple and reasonable, use lower cost for material, function admirable;Gas is adjusted Material (for example, sponge core) is saved, there is the function of preventing leakage, while also can effectively adjust the air pressure of pattern detection intracavitary, It is allowed to keep constant pattern detection liquid level,The stabilization of testing result can be ensured, be individually provided with sample storage chamber (collecting chamber) in addition, Ensure that unnecessary sample by reagent contamination, is not easy to secondary detection.
Brief description of the drawings
Figure 1A is the principle schematic of the present invention.
Figure 1B is that the specific work process schematic diagram of the principle schematic of the invention shown in Figure 1A (is collected, separated, detect Process).
Fig. 2A is the structural representation of another specific embodiment of the invention.
Fig. 2 B are that the specific work process schematic diagram of the principle schematic of the invention shown in Fig. 2A (is collected, separated, detect Process).
Fig. 3 is the structural representation of the test chamber in an embodiment of the invention;
Fig. 4 is the bottom overlooking the structure diagram of the test chamber in an embodiment of the invention;
Fig. 5 is the bottom overlooking the structure diagram of the test chamber in an embodiment of the invention;
Fig. 6 is the structural representation of the collecting chamber in an embodiment of the invention
Fig. 7 is structural representation (collecting chamber and the test chamber group of the detection means in an embodiment of the invention The structural representation of conjunction).
Embodiment
Structure of the present invention or these used technical terms are described further below.
Detection
Detection represents to chemically examine or test a kind of material or material whether there is, such as, but this is not limited to, chemical substance, The generation of organic compound, inorganic compound, metabolism product, medicine or drug metabolite, organic organization or organic organization Thank thing, nucleic acid, protein or polymer.In addition, detection represents test substances or the quantity of material.Furtherly, table is gone back in chemical examination Show immune detection, chemical detection, enzyme detection etc..
Sample
Signified sample of the invention refers to those and can be used for detecting, chemically examine or diagnosing whether there is analyte interested The material of matter, or the sample of pure broken meaning.Sample can be, for example, fluid sample, it is liquid sample that fluid sample, which can be, Liquid sample can include urine, blood, blood plasma, serum, urine, saliva and various juices, can also include solid sample The liquid solution formed with semi-solid samples after anticipating.Liquid sample can be the liquid sample without processing, Treated liquid solution sample etc. can also be included.Collect the sample come and can be used for immune detection, chemical detection, enzyme The methods of detection, detects whether analyte be present.
Testing element
Testing element can select the test strip of lateral flow, and it can detect a variety of analytes.Certainly, other are closed Suitable testing element can also be used in the present invention.
Various testing elements can be grouped together and apply in the present invention.A kind of form is Test paper.For dividing The Test paper of analyte (such as drugs or show the metabolin of health) in analysis sample can be various forms, such as exempt from Epidemic disease determines or the form of chemical analysis.Test paper can use the analytical model of non-competing method or competition law.Test paper bag Containing an absorbent material with sample application zone, reagent area and test section.Sample-adding passes through capillarity originally to sample application zone Flow to reagent area.In reagent area, if there is analyte, sample is combined with reagent.Then sample continues to flow to detection zone. Other reagents, such as molecule with the Non-specific combination of analyte are fixed on detection zone.These reagents and being divided in sample Analysis thing (if present) is reacted and analyte is incorporated in into the area, or is combined with some reagent of reagent area.For showing Show that the label of detection signal is present and reagent area or the mark zone separated.
Typical non-competing method analytical model is that signal will produce if containing analyte in sample, if do not wrapped Containing analyte, signal is not just produced.In competition law, if analyte is not present in sample, signal produces, if deposited In analyte, then signal is not produced.
Testing element is Test paper, can select water suction or the material not absorbed water.Test paper may include multiple material For liquid sample transmission.The material of one of which Test paper can cover on another material, as filter paper is covered in nitric acid On cellulose membrane.One area of Test paper can select one or more materials, and another area selects other different one kind Or multiple material.Test paper can be attached on certain holder or hard surface is used for raising and is affectedly bashful the strong of Test paper Degree.
Analyte is detected by signal generating system, such as utilizes one with this analyte generation specific reaction Kind or a variety of enzymes, using such as foregoing method being fixed on specific combinating substance on Test paper, one or more signals are sent out The composition of raw system is fixed on the analyte detection zone of Test paper.Produce signal material can in sample application zone, reagent area, Or on detection zone, or whole Test paper, the material can be full of on one or more materials of Test paper.Signal will be contained The solution of thing is added to the surface of test paper or one or more materials of test paper is immersed in the solution of the thing containing signal.Contain addition The test paper of signal thing solution is dried.
Each area of Test paper can arrange in the following manner:Sample application zone, reagent area, detection zone, control zone, determine sample This whether adulterated area, liquid sample uptake zone.Control zone is located at after detection zone.All areas can be arranged at only with a kind of On one test paper of material.It may also be not same district and use different materials.Each area directly can contact with liquid sample, or not Direction arrangement of the same area according to liquid sample flowing, the end in each area is connected and overlapped with the front end in another area.Used Material can be the preferable material of water imbibition such as filter paper, glass or nitrocellulose filter etc..Test paper can also use it His form.
Typically conventional reagent strip is nitrocellulose assay strip, i.e. detection zone includes nitrocellulose filter, in nitre Specific binding molecule is fixed on acid cellulose film to show the result of detection;It can also be cellulose acetate film or nylon membrane etc. Deng.Such as reagent strip or the device containing reagent strip of the following patent description:US 4857453;US 5073484;US 5119831;US 5185127;US 5275785;US 5416000;US 5504013;US 5602040;US 5622871;US 5654162;US 5656503;US 5686315;US 5766961;US 5770460;US 5916815;US 5976895;US 6248598;US 6140136;US 6187269;US 6187598;US 6228660;US 6235241;US 6306642;US 6352862;US 6372515;US 6379620;With US 6403383.Test-strips disclosed in patent documents above and carry The similar device of test-strips, which can be applied in testing element of the invention or detection means, carries out analyte Detection, for example, in sample by point about material detection.
Apply to the horizontal effluent reagent strip that the detection reagent bar of the present invention can be known as, these detection reagent bars Concrete structure and Cleaning Principle be technology known to persons skilled in the art in the prior art.Common detection reagent Bar, including sample collecting zone, marked region, detection zone and suction zone, sample collecting zone include sample receiving pad, mark Note region includes label pad, and suction zone can include adsorptive pads, including that can detect whether containing being divided wherein in detection zone Analyse the necessary chemical substance of material, such as immunoreagent or enzymology reagent.Typically conventional detection reagent bar is fine for nitric acid Plain membrane reagent bar is tieed up, i.e. detection zone includes nitrocellulose filter, and specific binding molecule is fixed on nitrocellulose filter to show Show the result of detection;Cellulose acetate film or nylon membrane etc. are can also be, certainly, can also be included in the downstream of detection zone Testing result control area, generally, occur on control area and detection zone in the form of horizontal line, be detection line or control Line.Such detection reagent bar is traditional reagent strip, certainly or other other classes for being detected using capillarity The reagent strip of type.In addition, dry chemistry reagent composition is carried on general detection reagent bar, such as fixed antibody or other examinations Agent, after liquid is run into, liquid flows along reagent strip with capillarity, with flowing, allows dry agent formulations to be dissolved in Liquid, so as to which the dry reagent to next regional processing in the area reacts, so as to carry out necessary detection.Liquid flowing master To be carried out by capillarity.These testing elements are shown in the description and record of following file:Li Fu is firm《Nitrocellulose filter Regeneration treatment and its adhesion protein ability research》;Ma Hongyan, Li Qiang's etc.《Membrane material is chromatographed in colloidal gold diagnosis kit Expect the analysis of performance》;Wang Yong, Wang Luhai's etc.《A kind of Novel colloidal gold immunity-chromatography test strip》.It can be transported herein In the detection means for using the present invention, either it is arranged in test chamber and is contacted with liquid sample or for detecting into inspection Analyte whether there is or existing quantity in the liquid sample surveyed in chamber.
Analyte
Some haptens materials can be included with the example for the analyte being related in the present invention, these haptens include poison Product (such as drug abuse)." drug abuse " (DOA) refers to that non-medical destination uses medicine (generally playing paralysis nerve). Abusing these medicines can cause body & mind to suffer damage, and produce dependence, addicted and/or dead.Drug abuse Example includes ***e;Amphetamine AMP is (for example, black beauty, white amphetamine tablet, dextroamphetamine, dextrorotation benzene are different Propylamine tablet, Beans);Crystal methamphetamine MET (crank, meth, crystal, speed);Barbiturate BAR (such as Valium, Roche Pharmaceuticals, Nutley, New Jersey);Sedative (paramedicines of sleeping);Wheat Angle acid acyl diethylamine (LSD);Inhibitor (downers, goofballs, barbs, blue devils, yellow jackets, Methaqualone);The anti-antidepressant of tricyclic antidepressants (TCA, i.e. imipramine, amitriptyline and doxepin);Diformazan methylenedioxymethamphetamine aniline MDMA;Hog (PCP);Tetrahydrocannabinol (THC, pot, dope, hash, weed, etc..);Opiate (i.e. morphine MOP or, opium, ***e COC;, heroin, hydroxyl dihydrocodeinone);Anxiolytic and hypnotic sedative agent, anxiolytic It is that one kind is mainly used in anxiety reduction, anxiety, fear, sets the mind at rest, has the medicine of hypnosis sedation, including Benzodiazepine concurrently Class BZO (benzodiazepines), atypia BZ classes, fusion phenodiazine NB23C classes, benzene nitrogen Zhuo class, the part class of BZ acceptors, open Ring BZ classes, diphenylmethane derivatives, piperazine carboxylic acid salt, piperidine carboxylic acid salt, Kui oxazoline ketone, thiazine and thiazole, Other heterocyclics, imidazole type calmness/anodyne (such as hydroxyl dihydrocodeinone OXY, methadone MTD), propanediol derivative-ammonia Formate ester, aliphatic compound, anthracene derivative etc..Detection, which is can be used for, using the detection means of the present invention belongs to medical science The detection of purposes but easy overdose, such as tricyclic antidepressant (imipramine or the like) and Paracetamol.This A little medicines can resolve into different small-molecule substances after being absorbed by the body, and these small-molecule substances are present in blood, urine, saliva In the body fluid such as liquid, sweat or there is above-mentioned small-molecule substance in part body fluid.
Detection means or collection device
Detection means refer to for detect in sample whether the device containing analyte.Collection device refers to carry out liquid The collection and storage of body sample.Detection means can include collection device, and collection device can also include detection means, Huo Zheshou Acquisition means separate with detection means, when detection, collection device and detection means are combined, so as to complete to examine Survey.Can also be the device that collection device and detection means are structure as a whole, after liquid sample is collected, it is possible at once Detected, obtain test result, while detect sample with collecting the separation of sample, so as to carry out secondary detection (if desired).
In some embodiments in the present invention, as seen in figs. 1 a-1b, detection means includes the He of collection chamber 20 Test chamber 30, collection chamber are surrounded by opening 21 and side wall and bottom, and test chamber also includes opening and side wall and bottom Surround, herein, the opening of test chamber is collected the sealing of chamber, and collection chamber is located in test chamber in addition, such as Figure 1A, So as to which, collection chamber is in itself divided into test chamber by its side wall the cavity 60 of one sealing, the cavity of the sealing can be with Referred to as test chamber 60.Collection chamber is used for collecting liquid sample, such as urine.Collection chamber is located in test chamber, wherein, The bottom of collection chamber includes a through hole 22, the through hole 22 be through hole, so as to, allow test chamber 60 with collection chamber Collecting chamber 28, which is in, to be in fluid communication.Certainly, in optional mode.The through hole may not be what is be through at the very start, and Be when detection is needed, by puncturing or other mechanisms allow through hole to open, so as to allow test chamber 60 with collection chamber Collecting chamber 28 be in be in fluid communication.There is a certain distance between the bottom 27 of collecting chamber and the bottom 36 of test chamber.At some In preferable mode, connecting the through hole 22 of collecting chamber and test chamber can be located at Anywhere, as long as the liquid of collecting chamber can be allowed Body sample is flowed into test chamber by the through hole 22, and this flowing can be Action of Gravity Field (such as Fig. 1 collection because liquid The position relationship of chamber and test chamber) or non-gravity factor, such as other pressure or compressing, or gravity work With the common results acted on other pressure.Preferably, be based on liquid caused by gravity factor from high to lower Flowing.In some modes, one end pipeline 29 is additionally provided with the through hole 22 of collecting chamber bottom, pipeline one end connection through hole 22, the other end is located in collecting chamber, so as to play a kind of purpose for protecting through hole.When this can reduce collection sample, by Entered by through hole in test chamber in the irregular flowing of liquid sample is a small amount of, can so allow collecting chamber to be collected into one When quantitative liquid, liquid is smoothly flow in test chamber by pipeline 29 and by through hole 22.In some modes, Such as Figure 1A, the bottom of test chamber 60 includes a bulge-structure, and one is formed between the bulge-structure and the side wall of test chamber Groove structure 31, groove structure, which can play, collects liquid sample, so as to allow a small amount of liquid sample just can be in the trench It reach a certain height.Meanwhile also including gas regulation material at groove, the material, which is worked as, not to be contacted with liquid or does not inhale When receiving liquid, allow test chamber to carry out gas circulation or gas exchanges with ambient atmosphere, work as when the material and contacted with liquid Or absorb when have liquid, allow test chamber to be circulated with ambient atmosphere without gas or without gas exchanges.Certainly, Can first either the bottom of test chamber is provided with a hole or passage at groove, in the channel place gas regulation material, from And play above-mentioned effect.Certainly, the position of gas regulation material can also arbitrarily be set as needed, as long as can touch Liquid sample can, this contact can be liquid it is passive flow on gas regulation material or natural stream Onto gas regulation material, so as to allow the material to carry out mutual effect with liquid sample, this effect is probably physical action, Can also be chemical action, or physics and the common effect of chemistry, so as to change the physics of material or chemical property, from And play gas regulation effect.Or with gas regulation material, so as to moisten the material, so as to allow gas regulation material have Having can allow test chamber to carry out the circulation of gas (either air) with the external world or exchange when doing, when moistening, The circulation of gas (either air) can not be carried out with the external world or is exchanged for test chamber.
Principle demonstration process schematic as shown in Figure 1B.For example, when detection is needed, liquid sample is injected first Into collecting chamber 28, injection can be the injection of existing sample, or subject it is directly that liquid sample (such as urine) is direct Urinate in collecting chamber.Once have urine in collecting chamber, urine is just flowed into test chamber due to Action of Gravity Field, this When individual, because gas regulation material is in dry state, because test chamber 60 is the cavity of sealing, with entering for liquid sample Enter, existing air or gas in test chamber certainly will be discharged, so, gas or air are just smoothly adjusted by gas Section material is discharged in ambient atmosphere environment.As liquid sample further increases, collected in the bottom of test chamber, this Sample, a part of sample may be contacted with being arranged on the testing element of test chamber in advance, so as to detect the quilt in liquid sample Material is analyzed, another can flow to the contact that gas regulation material is in, and so as to moisten gas regulation material, the material is general It is wet, the property of gas regulation material changes, such as automatic expansion, expands can breathe freely when so as to allow dry Bore closure, so as to which test chamber and the gas in the external world can not be allowed to swap, so as to allow test chamber to go completely into the state of sealing.By Sealing being completely in test chamber, if liquid is continuously introduced to test chamber, then the gas pressure of test chamber just increases, with The pressure gradually increased, the spontaneous gravity of liquid can be overcome, so as to which the liquid sample in collecting chamber is not just continuing to flow into Into test chamber, so as to reach a kind of balance.So, the liquid positioned at test chamber positioned at remaining liquid in collecting chamber with being in Separation physically, the two is not in contact with, and if necessary to further detection, can directly take part to be located at the liquid of collecting chamber Carry out two measurements or confirm measurement.
In this mode or in the latter's other modes, the size positioned at the through hole of collecting chamber can be designed arbitrarily, example Can be such as 1-10 millimeters, 1-5 millimeters, 0.1-3 millimeters, 0.5-2 millimeters are all feasible.When through hole is bigger, liquid Can because of Action of Gravity Field and under flow in test chamber, if through hole is smaller, due to the work of capillary and surface tension With, flowed under the more difficult nature of liquid in test chamber, can collecting chamber liquid surface apply pressure, force liquid sample to enter Enter into test chamber, for the liquid of entrance as described above, a part contacts with testing element, another part can be subsequently or concurrently With gas regulation material, gas regulation material is allowed to be changed into moistening from dry, so as to not allow test chamber and ambient atmosphere environment Carry out the exchange or circulation of gas.
Applying stressed mode has a lot, and a preferable mode is exactly to cover lid 9, because lid once covers collection The opening that the opening of chamber just seals, with the rotation of lid, the gas volume that lid is just made way on the liquid level of collecting chamber reduces, So as to increase the pressure for acting on liquid surface, it is flowed into so as to force liquid through through hole 22 in test chamber.Certainly, press Pressure is a preferable mode, it is not absolutely required to complete.
In other modes, the easier flowing of liquid due to being flowed into test chamber by through hole 22, in test chamber Inside also include drainage element, for example, either structure can be any absorbent material or not practise absorbent material composition flow guiding structure, So as to guide the fluid from collecting chamber than more smoothly flowing to the place of test chamber preventing and treating testing element or flowing to gas Adjust at material, so as to change the property of gas regulation material, such as be changed into the state of moistening from dry state, so as to change gas Body adjusts the ventilatory conditions of material, for example, it is dry when ventilate, stuffiness when moistening.
In other embodiment, such as Fig. 2A, it is to separate to collect body 200 with detection body 300, and collection chamber includes The opening 201 and collecting chamber 203 of side wall and bottom, include in side wall one can either on or off passage 202, detect body bag Include side wall, the test chamber 303 that bottom surrounds, include gas regulation material in the bottom of test chamber, its allow test chamber simply by The material carries out gas exchanges with ambient atmosphere.In the side wall of test chamber also include one can either on or off passage 301.Inspection Testing element can be included by surveying in chamber.Before being detected, collect body 200 and be used for collecting liquid sample, now can either on or off Passage 202 be close, so liquid will not flow.When detection is needed (such as Fig. 2 B), allow and collect body and detection body Contact or coordinate, so as to collect on body can either on or off passage 202 with detection body on can either on or off passage 301 Coordinate, so as to allow liquid sample 50 flow into test chamber 303, because at the beginning, gas regulation material is not in contact with liquid Sample is dry state, is discharged into the liquid of test chamber and the air or gas that extrude by gas regulation material outer In boundary's atmospheric environment, with the increase of liquid, a part contacts with testing element, and another portion, which is flow to, sets gas regulation material Place and the material, so as to moisten the material, change the physical property of the material, allow gas regulation material from ventilative State is changed into impermeable gaseity.With the formation of impermeable gaseity, test chamber forms a cavity being fully sealed, according to foregoing Principle (Figure 1A -1B) description, with continuing into for liquid, the increase of test chamber internal pressure, consequently reach balance, collecting chamber Liquid sample be just no longer flowed into by passage 202 and 301 in test chamber.So as to allow the liquid of test chamber to keep fixed body Product.When feeling to need secondary chemical examination or confirmation chemical examination, collecting chamber is directly removed from test chamber 300, is now led to Road 202 is closed, and then covers lid sealed opening 201, is routed directly to laboratory and is carried out secondary chemical examination or confirmation detection.
It can be readily apparent that, the various embodiments of test chamber in figure ia can be applied to the inspection in Fig. 2A Survey device in come carry out improve fluid circulation either collect fluid contacted to a specific position with testing element or and With gas regulation material, so as to change the state of gas regulation material, so as to allow detection means to be changed into completely sealing.
In some preferable modes, position of the gas regulation material in test chamber is to pass through passage away from collecting chamber 202 or through hole 22, after so liquid sample being allowed to reach certain volume, with increasing, then flow to gas regulation material The position of material, so as to allow test chamber to be fully sealed.Or, it is envisaged that obtain, in a preferable mode, in test chamber The position of the gas regulation material of setting can allow the position that liquid sample naturally flows to, and so conveniently moisten dry gas and adjust Material is saved, so as to complete the isolation of gas, so as to allow test chamber to be in the state of air seal.Certain gas regulation material can be with Be arranged on hole, hole, groove, irrigation canals and ditches, in passage, this some holes, hole, groove, irrigation canals and ditches, passage when no gas regulation material, Allow test chamber freely to be connected with atmosphere, when gas regulation material is set in these structures, allow gas Circulated by gas regulation material between test chamber and the environment of ambient atmosphere and either exchange or do not flow or not Exchange.This unlatching circulation or immobilising process are one naturally, automatic process.
For setting the quantity of gas regulation material to be one or more, can be based on also without specific limitation Actual conditions are voluntarily selected.
Gas regulation material can have many selections, such as select to breathe freely when those dryings, and when moisten Air-locked material can.This so-called " drying " and " moistening " are a relative concepts, and drying can refer to the material Material can be with the change of gas permeability caused by the change of humidity, such as swap-in more moistens or humidity, the material are more impermeable Gas.Certainly opposite state can also, such as environment is drier, and the material is more airtight.Such material can be cork Plug, rubber stopper or sponge core.
Sponge core can material selection main component be polyvinyl alcohol, for the tasteless solid of white, shape is mostly cylinder, certainly Various suitable surname Zhu shapes can be processed into, for example, it is circular, and figure of tablet is square, or other suitable shapes.Density is 0.8-1.6g/cm3.Sponge core can be used alone or is used in mixed way with other gas regulation materials.Typically, sponge core Interior to have viscoplasticity, be deformed because of temperature and pressure containing warming particle, the sponge core ventilative and hygroscopicity can be splendid, memory Deformation being capable of sufficiently sealed space.When drying, the permeability is good, and test chamber can be allowed big by the material and the external world Gas phase is same, after moistening (such as after liquid sample moistens the material or material absorption liquid sample), material deformation, Can sufficiently sealed space, so as to allow the exchanging of test chamber and external environment air progress gas or air, avoid urinating Cup gas leak phenomenon.Optional sponge core is purchased in Hangzhou Bei Chi Science and Technology Ltd.s.The analog of other identical functions can also be used Matter or material.
In other specific embodiments, the present invention provides a kind of specific detection means, knot as in Figure 3-5 Structure.The detection means includes detection body 8 and collection body 10, wherein collection body is internal positioned at detection, so as to be formed in vivo detecting Test chamber.Wherein, the bottom of collecting chamber includes through hole 7, and the through hole 7 allows test chamber to carry out fluid with collecting chamber or liquid connects It is logical, include the hollow posts 11 of a connecting detection chamber and ambient atmosphere environment in the bottom of test chamber, gas is set in hollow posts Body adjusts material, such as sponge core material, so as to adjust the gas that test chamber and ambient atmosphere are changed between part in different situations Body exchanges.
More specifically say, as shown in figure 3, detection body 8 includes side wall and bottom and opened, 37 cavitys surrounded 30, have one along 2 in opening.And the structure for forming collection body 10 is opening 21, side wall 23 and bottom, through hole is provided with bottom 7.Opening has the edge for collecting body opening, and along screw thread is above provided with, the screw thread of screw thread and lid 9 coordinates, so as to form sealing.In spiral shell There is a raised loop configuration 5 under line, the loop configuration is tightly connected with detection body along 2, so as to the opening of sealing detection body 37.Sample combination here is formed detection means as shown in Figure 5.Here be sealed into hermetic seal with loop configuration 5 along 2, The mode of sealing can pass through ultra-sonic welded, bonding reagent bonding etc..Preferably, it is provided with the outer surface for the side wall for collecting body Neck 6, the neck are used for bearing test element.When body and detection body assembling is collected, testing element is located in neck 6, Sample applying zone is located at the bottom of neck simultaneously, and at annular groove 35, and contacted with annular groove bottom.
In some preferable modes, in the loop configuration body 70 that detection body bottom includes raising up, the loop configuration Raised to form annular groove 35 with partial sidewall, when having liquid to enter test chamber, a small amount of liquid is collected in annular groove, So as to ensure the height of certain liquid, the convenient sample application port position for moistening testing element.Preferably, loop configuration projection 70 is wrapped Funnelform depression 71 is included, the depression corresponds to the through hole 7 of collecting chamber bottom.In other embodiments, connected with depression 71 One groove 3, groove one end connection depression 71, one end connects the bottom of annular groove 35.When the liquid-like flowed down by through hole 7 Originally when collecting in recess, liquid sample enters the bottom of annular groove along groove 3, and gradual in the bottom of annular groove Collect, and the gradual height of liquid level.In preferred mode, in order to allow the liquid for entering annular groove 35 under small size, liquid Face can be divided into annular groove separation structure 72 each independent several parts, such as groove positioned at a pair of separations with more higher Between structure 72, and this is divided into annular groove 2 independent parts to separation structure 72.When liquid enters annular from groove 3 When groove 35, the liquid sample of such less volume can allow liquid level to reach certain height in annular.It is to be appreciated that ring Liquid in shape groove reaches under certain height, and the sample of testing element applies end or applying zone only has a small amount of liquid just Liquid can be allowed to be flowed on the test strip by capillarity, so as to complete the detection of analyte in sample.Example again Such as, as shown in figure 4, between a pair of separation structures 72 be annular groove 37 place, set hollow posts 11, set in hollow posts 11 Put gas regulation material 4, after the liquid sample from collecting chamber enters annular groove 35, on the one hand with the survey in annular groove Try first pole and like that you contact, when the opposing party can flow to the place of circular column 11 to contact gas regulation material 4, gas regulation material The state of material changes, such as is changed into moistening or dampness from dry state, so as to which test chamber can be entered with the external world Row gas exchanges (such as dry state) can not carry out gas exchanges (such as moistening dampness) to test chamber with the external world, from And close exchanging for test chamber and ambient atmos.Test chamber is so allowed to turn into complete hermetic seal state.As before, by It is complete gaseous state sealing state in test chamber, by the liquid sample of through hole due to the increase of test chamber internal pressure, reaches After balance, more liquid samples are not had and are flowed into test chamber, so as to the liquid sample and testing element allowed in test chamber Contact, without polluting the liquid sample being located in collecting chamber, so as to play a part of separation.In addition, the effect of gas pressure Under, make the volume of the liquid sample flowed into test chamber constant in each different test chamber, can quantify to detect The volume of sample.So, can be directly in collecting chamber when needing to carry out secondary detection or further confirm that chemical examination Part sample is taken out, and the sample is sample contamination that is independent, not contacted with testing element.
In with upper type, the position of hollow posts 11 can also be arranged on the opposite side of separation structure 72, not positioned at ring In shape groove 37, and in annular groove 38, as shown in Figure 5.So, a part of liquid from collecting chamber is entered by groove 3 Into annular groove 35, contacted with the testing element in annular groove 35.Another liquid from collecting chamber passes through groove 03 Enter in annular groove 38, flow on gas regulation material 4 and pay contact in advance, so as to moisten the material 4.
In a preferable mode, lid 9 is used for sealing the opening of collecting chamber.In other modes, lid 9 can be with Apply pressure to the liquid in collecting chamber while closed collecting chamber opening.Specially when lid covers collecting chamber opening Wait, hermetically closed collecting chamber opening, closed one section of gas, rotates, gas when with lid between liquid surface and opening Volume-diminished, so as to apply certain pressure in the liquid surface of collecting chamber, such pressure can accelerate the liquid of collecting chamber Body is flowed into test chamber by through hole.Equally, when gas regulation materials behavior changes, for example, from allowing test chamber With extraneous progress gas exchanges to after allowing test chamber to carry out the state of gas with the external world, in fact, test chamber also turns into gas Body sealing state, collecting chamber also turns into air seal state, but test chamber is liquid communication shape by through hole 22 with collecting chamber State, so, after collecting chamber reaches balance with test chamber, liquid will not flow to test chamber, enter so as to complete quantitative liquid To test chamber, while the separation of collecting chamber and test chamber liquid is also completed, do not disturbed mutually.
When needing to carry out secondary detection, simply need to open the lid of collecting chamber, when lid is taken away, though Gas pressure (if there is) in right collecting chamber recovers consistent with extraneous, but because test chamber is still within air-tight state, even The liquid of individual chamber is also appointed will not so be flowed again.So as to directly take out segment fluid flow from collecting chamber and carry out secondary chemical examination (progress The secondary detection same with testing element) or the chemical examination of progress secondary-confirmation (progress and the different secondary detection of testing element, Such as testing element is detected using immunity principle, secondary-confirmation chemical examination can be used and examined different from immune detection principle Survey, such as gas-chromatography, liquid chromatogram etc.).
All patents and publication mentioned in description of the invention all represent that these are the public technologies of this area, this hair It is bright to use.All patents referred to herein and publication are all equally listed in bibliography, with each publication It is specific to be individually referenced equally.The present invention described here can lack any element or multiple element, and one Realized in the case of kind limitation or a variety of limitations, this limitation here is not particularly illustrated.Such as art in each example here Language "comprising", " essence by ... form " and " by ... form " can be replaced with remaining 2 term of one of both.Here adopt Describing mode carried out by term and expression way, and be not limited except as, also indicate that this book describes without any intention here These terms and explain and eliminate any equivalent feature, but it is recognised that can be in the model of the present invention and claim Do in enclosing and any be suitably altered or modified.Preferably implement it is appreciated that examples of implementation described in the invention are all some Example and feature, any those of ordinary skill in the art can be changed and become according to some are done under the marrow of the invention that describe Change, these are changed and change is recognized as belonging to the scope of the present invention and independent claims and appended claims are limited In the range of.

Claims (13)

1. a kind of detection means, the detection means includes one the test chamber containing test chamber, in the test chamber and extraneous swap-in Gas regulation material is set between air, and when gas regulation material is dry when, test chamber and ambient atmosphere pass through the gas Adjust material and carry out gas circulation, when gas regulation material moistens, test chamber can not pass through the gas with ambient atmosphere Adjust material and carry out gas circulation.
2. detection means according to claim 1, testing element is set, when there is fluid sample entrance in described test chamber When test chamber, it can be contacted with the testing element in test chamber, so as to obtain analyte in fluid sample Matter whether there is or existing quantity.
3. according to the detection means described in one of claim 1-2, described gas regulation material is moistened by liquid sample.
4. according to the detection means described in one of claim 1-3, the detection means also includes a collecting chamber, and collecting chamber passes through Through hole is in fluid communication with test chamber.
5. according to the detection means described in one of claim 1-4, when collection has fluid sample in collecting chamber, fluid-like This is entered in test chamber by the through hole.
6. according to the detection means described in one of claim 1-5, collecting chamber is located in described test chamber, the wall of collecting chamber with Test chamber described in the wall and bottom shape of test chamber.
7. according to the detection means described in one of claim 1-6, described test chamber connects logical by one with ambient atmosphere Road, hole, hole or groove are connected, and described gas regulation material is located in described passage, hole, hole or groove.
8. according to the detection means described in one of claim 1-7, when liquid sample enters test chamber or after, During or, test chamber only carries out gas exchanges or without gas by described gas regulation material and ambient atmosphere Exchange.
9. according to the detection means described in one of claim 1-8, after liquid sample enters test chamber, a part of liquid Sample participates in chemical examination or detection, another liquid sample are changed into moisture state by gas regulation material from dry state.
10. according to the detection means described in one of claim 1-9, wherein, described gas regulation material is sponge core material.
11. the method for collecting or detecting the analyte in liquid sample, this method include:
A kind of detection means is provided, the detection means includes one the test chamber containing test chamber, is changed in the test chamber with the external world Enter and gas regulation material is set between air, when gas regulation material is dry when, test chamber and ambient atmosphere pass through the gas Body regulation material carries out gas circulation, and when gas regulation material moistens, test chamber can not pass through the gas with ambient atmosphere Body regulation material carries out gas circulation;
Fluid sample is allowed to be flowed into test chamber, the liquid part being flowed into test chamber connects with the testing element in test chamber Touch and detected, another with the gas regulation material in the connecting detection chamber and ambient atmosphere passage, examined so as to allow Survey chamber and do not carry out gas circulation with the external world.
12. according to the method for claim 11, wherein, described detection means also includes a collecting chamber, and collecting chamber leads to Through hole is crossed with test chamber to be in fluid communication;Fluid sample is allowed to be flowed into by described through hole in test chamber.
13. according to the method described in one of claim 11-12, wherein, after test chamber does not carry out gas circulation with the external world, allow Test chamber formed a closed space, including a part gas in test chamber, so as to limit fluid sample from collection Chamber is entered back into test chamber.
CN201610717441.2A 2016-08-24 2016-08-24 A kind of detection means and detection method Pending CN107782906A (en)

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CN111397965A (en) * 2020-03-11 2020-07-10 杭州奥泰生物技术股份有限公司 One-step fluid detection cup
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