CN107643391A - The device of analyte in a kind of detection sample - Google Patents

Abstract

The present invention provides a kind of detection means, including：One collecting chamber, the collecting chamber include an opening for being used for collecting liquid sample；One testing element for being used for analyte in test liquid samples；With a lid for being used for covering the opening of collecting chamber；Also include the suggestion device whether a prompting lid covers specified location wherein on device.Detected using the present apparatus, it is simple to operate.

Description

The device of analyte in a kind of detection sample

Technical field

It is used to detect in liquid sample with the presence or absence of the detection means of analyte the present invention relates to a kind of.

Background technology

In medical health field, detection body fluid is a universal behavior.Factory, government organs, team and other groups Knit more and more the safety in maintenance work place and is ensured in accordance with law, regulation and article using diagnostic test.

Liquid sample, such as urine are collected using detection means, and judges whether specific analyte (such as drugs And/or its metabolin, or the mark related to disease) turn into a kind of very universal method.The device so tested is general It is required that sample is collected in sample container, person skilled inserts a test strip and floods a part for test strips In the sample, test strips are then taken out and reads result.Technical staff may touch sample, and possible entail dangers to is healthy or makes sample This is contaminated.For avoid this risk, it is necessary on sample collection container add closure body after operated.At present, deposited There are many obturators, such as United States Patent (USP) US 4,976,923, US 5,429,804, and US 6, the dress disclosed in 726,879 Put.These devices are that test strip is fixed on the lid of detection means.In use, container, which is overturn or tilted, makes sample This infiltration test strip is detected.U.S. Patent Application Publication US2003/0027359A1 is disclosed within 2 6th, 2003 One kind detection urine cup.The detection urine cup still needs to be promoted pillar piston movement with push rod and made stream after the opening of lid lid to cup Body sample flows out from cup cavity and moistens detecting element.Patent application 200510113977.5 discloses one kind disclosed in China Detect urine cup.Detection urine cup start liquid after the opening of lid lid to cup flows to test chamber from collecting chamber, so as to start The beginning of detection.In patent application disclosed in another China's application, 200480033286.8 also reveal that a kind of detection urine Cup.Detection urine cup starts the beginning of detection after the opening of lid lid to cup.

Recently, this detection means is used by average family or amateur mechanism more and more.Due to these inspections Test and appraisal, which are estimated, to be aimed at designed by layman, so these detection means need to make operating process simple, and can guarantee that inspection Survey the accuracy of result.

Therefore, accurately and reliably detection means is that present society is required to simple to operate and testing result.The present invention is just It is to provide a kind of detection means for meeting this demand.

The content of the invention

The present invention provides a kind of detection means simple to operate.Concretely, there is provided a kind of detection urine cup simple to operate. After the opening of the lid lid of urine cup to cup, a suggestion device is also included on detection urine cup, the device prompts lid Whether specified location is covered.On the one hand, when lid being covered all in the opening of cup, due to different operators, it is particularly Those laymans, lid can be caused to cover the tightness difference of cup opening, this this may result in some lids not The opening of cup can be sealed well, and some detection urine cups have the possibility of leakage.The present invention sets one on detection means and carried Showing device, (position may be considered that lid is enough to seal collecting chamber when lid covers specified location on collecting chamber Opening), suggestion device prompting lid has sealed the opening of collecting chamber, and operator no longer needs to cover lid.So The problem of being totally sealed off the opening of each device and not having to worry leakage.On the other hand, in some devices, lid After in the opening for cover collecting chamber, the liquid sample in collecting chamber is detected son with regard to engaged test element.In tradition Detection urine cup in, be now typically necessary and start the clock, wait until after certain time detection zone on read test element On test result.When different operating person is operated, from neither one one of specifically when starting the clock Cause and unified standard, same device may cause different testing results for different operators.The present invention provides A kind of detection means, when lid covers specified location on collecting chamber, suggestion device sends a prompt message, such as A kind of sound, the information tell operator can start calculate read test element on test result needs wait when Between.

On the one hand, the present invention provides a kind of device for detecting and whether there is analyte in sample, including：Collecting chamber, should Collecting chamber includes being used for the opening for collecting liquid sample；For the testing element of analyte in test liquid samples；With for Cover the lid of collecting chamber opening；Also include the suggestion device whether prompting lid covers specified location wherein on device.

In some preferable modes, when lid covers specified location, suggestion device prompting lid is close The opening of collecting chamber is sealed；Or when lid covers specified location, suggestion device prompting starts to calculate read test Testing result on element needs the time waited.

In some preferable modes, suggestion device is prompted by sending sound.In some specific modes, Suggestion device includes some elements, and these elements can be by the way that mutually collision sends sound after elastic deformation.Specifically, prompting dress Put including two elements, resilience is mutually collided again respectively or after one of generation elastic deformation after two elements contact with each other Sound is sent to be prompted.In a specific mode, suggestion device includes a flexible member and a non-resilient member Part, when flexible member passes through non-elastic member, flexible member is oppressed to become by non-elastic member occurs elastic deformation, when being oppressed Power disappear after, resilience sends sound to flexible member again.The present invention is mentioned here " flexible member " and " non-elastic member " be One relative concept.In setting, in general, the elastic feel quantity of flexible member is less than the elastic feel quantity of non-elastic member. For example, from plastics as flexible member, from metal, such as iron, the material of steel or lead as non-elastic member, such plastics Under the power effect mutual with non-elastic member, the elastic feel quantity of flexible member is smaller than the elastic feel quantity of non-elastic member, Mutually under similar circumstances, relatively the change of shape easily occurs power for flexible member, when the power received is in pop-off for both Afterwards, flexible member is needed to restore to the original state, and sound is sent so as to beat or vibrate.Here occur suffered by elastically-deformable element Power generally requires the elastic limit intrinsic less than the element, and so they can voluntarily recover former after being disappeared when external force Shape.Optionally, flexible member and non-elastic member are all plastic material.

It is furthermore preferred that flexible member can be located on the outer surface of cover rim；Non-elastic member can also be located at the outer of rim of a cup On wall surface.More specifically in embodiment, non-elastic member includes a planing surface gradually increased, is opened relatively in lid During mouth rotatory sealing rim of a cup, flexible member is gradually moved into a high position for planing surface from the low level of planing surface.Wherein, bullet is worked as Property element when passing through non-elastic member, flexible member is by resilience beats cup and sends sound again after protruding member compressing deformation.

In another specific mode, on a substrate, elastic deformation can occur non-elastic member for substrate.Allow Substrate, which is easier elastically-deformable mode occurs, many kinds.In a specific embodiment, the both ends of substrate and cover rim Connection, wherein, the width of the one end being connected with cover rim is more than the width that the other end is connected with cover rim.In addition, flexible member and receipts Collection chamber can be moved synchronously counterclockwise relative to lid；Non-elastic member and lid relatively can also be synchronously clockwise with collecting chamber It is mobile.In an optional mode, wherein, substrate is rectangle, includes a rectangular breach in the side of long side. In one optional scheme, under the non-elastic member interaction force on flexible member and substrate, flexible member and substrate are simultaneously Generation elastic deformation, after interaction force disappears, flexible member and substrate mutually collide the sound of prompting.

In the specific mode of other, non-elastic member is made up of ABS material；Flexible member is made up of PP materials. Optionally, flexible member is by non-elastic member and after beaing cup, and flexible member is prevented with can not phase by non-elastic member Make for cup mobile clockwise.In another optional mode, flexible member by non-elastic member and after beaing cup, Flexible member can move clockwise relative to lid.Selectable, the mode that lid covers collecting chamber opening passes through for lid The mode of rotation seals the opening of collecting chamber, opening includes the external screw thread that coordinates with lid, and lid includes and opening coordinates Internal thread.

On the other hand, the present invention provides a kind of method for detecting analyte in sample, including, there is provided one kind detection dress Put, including：One collecting chamber, the collecting chamber include an opening for being used for collecting liquid sample, and one is used for test liquid sample The testing element of analyte in this, and a lid for being used for covering collecting chamber opening；Lid is covered opening for collecting chamber On mouth, whether the suggestion device prompting lid allowed in detection means covers specified location.In a mode, dress is prompted Put by sending sound to be prompted.In another mode, once hearing that suggestion device sends prompting, stopping continues to cover Lid is in the opening of collecting chamber.In a specific mode, lid seals the opening of collecting chamber by way of rotation, Once hearing that suggestion device sends prompting, stop the rotation lid.In addition, in a mode, once hear that suggestion device is sent Prompting, start to calculate the time waited required for testing result on read test element.In another mode, carried once hearing Showing device sends prompting, starts to calculate the time waited required for testing result on read test element, while the lid that stops the rotation Body.

The present invention provides a kind of method for detecting analyte in sample, including：A kind of detection means is provided, the device Including one the collecting chamber containing opening；One testing element；Rotated against with one with collecting chamber to seal collecting chamber opening Lid, wherein also including whether a prompting lid rotates to the suggestion device of specified location on device；It is straight to rotate lid Prompting is sent to suggestion device.

In some preferable modes, after suggestion device sends prompting, stop the rotation.Optionally, when suggestion device is sent out After going out prompting, starting to calculate needs the testing result on read test element to need the time waited.In a specific mode In, suggestion device is prompted by sending sound.It is furthermore preferred that suggestion device includes one from collecting chamber outer surface projection Non-elastic member and a flexible member from cover rim outer surface projection, during lid is rotated, allow flexible member to oppress Then beaing cup sends sound after non-elastic member deformation.Most preferably, non-elastic member include one gradually increase one Individual slipsurface, flexible member is allowed to slide into a high position from the low level of slipsurface, moment moves on cover rim and beaten from a high position Cover rim sends sound.

Beneficial effect

Apparatus and method of the present invention makes the operation of detection means simpler, is adapted to layman to use, provides simultaneously Testing result it is more accurate.

Brief description of the drawings

Fig. 1 is the dimensional structure diagram of collecting chamber in a specific embodiment of the invention, and the part of suggestion device is tied Structure is located on the outer surface of collecting chamber, and is located at close to rim of a cup, flexible member on lid, and non-elastic member is located on cup, bullet Property element is located at the end place position of non-elastic member.

Fig. 2 is the part-structure schematic diagram of the suggestion device in Fig. 1, and flexible member is located on lid, non-elastic member position In on cup, flexible member starts to be forced to raise with non-elastic member effect.

Fig. 3 is the part-structure schematic diagram of the suggestion device in Fig. 2, and flexible member is located on lid, non-elastic member position In on cup, flexible member starts to be forced to be lifted to extreme higher position with non-elastic member effect.

Fig. 4 is the part-structure schematic diagram of the suggestion device in Fig. 3, and flexible member is located on lid, non-elastic member position In on cup, flexible member starts to be forced after being lifted to extreme higher position with non-elastic member effect, pats cup and sends sound.

Fig. 5 is the part-structure schematic diagram of the suggestion device in Fig. 1, and flexible member is located on lid, non-elastic member position In the mplifying structure schematic diagram on cup.

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..

Detection means

In a specific example, detection means includes a collecting chamber for being used for collecting and storing liquid sample, collects Chamber is surrounded by side wall and a bottom, and is open including one for importing liquid sample.The specification of the present invention, including summary At least one is construed as with "one" described in claim, or includes one in quantity, it is impossible to is only understood Into " unique " or the meaning of " only there was only one ".For example, detection means includes a suggestion device, it is clear that in detection means It should also be dropped into including the suggestion devices of 2 or more than 2 in the range of the claim of this hair and outside not being excluded. A test chamber 207 can also be included in detection means, include testing element in test chamber, the liquid sample in collecting chamber can be with Controllably contact freely or with the testing element in test chamber；Chemical reagent can be with test liquid samples on testing element In whether there is analyte or existing quantity.A lid 100 can also be included on detection means, the lid is used for covering Close the opening of collecting chamber.In a specific mode, detection means includes a suggestion device, and the suggestion device can prompt Whether lid covers specified location, in more detail, prompts whether lid covers the specified location on collecting chamber.On the one hand, When lid covers the specified location on collecting chamber, suggestion device can prompting lid has sealed opening for collecting chamber Mouthful.On the other hand, when lid covers the specified location on collecting chamber, suggestion device can prompt to start to calculate read test The time waited required for test result on element.The mode that lid is covered on collecting chamber has many kinds, such as with screw thread Form cover.For example, the opening of collecting chamber includes external screw thread, lid includes the internal thread coordinated with external screw thread；Work as lid After body is covered on collecting chamber, by rotating against come sealed opening.In addition it is also possible to it is the lid insertion in the form of piston Carry out sealed opening into opening.

The suggestion device of the present invention can also be applied in other detection means, especially, lid can be contained with those Body is simultaneously sealed in the device of the opening of collecting chamber with lid；So other similar devices are special in the disclosed U.S. Profit, US 7,270,959；US 7,300,633；US 7,560,272；US 7,438,852, US 4,976,923, US 5,429, There is specific description in 804, and the grades of US 6,726,879, it is special that disclosed suggestion device may be incorporated into the above One of concrete mode in the concrete mode of each detection means disclosed in profit as the present invention.

Suggestion device

In a concrete mode, suggestion device can be located in detection means, and suggestion device is entered by sending sound Row prompting.This sound can be " ", " bang ", " rub-a-dub ", " stining purine ", " pipa " or other any suitable sounds.

In other modes, lid rotates against with collecting chamber carrys out sealed opening, and a part for suggestion device is positioned at lid On body, another part of suggestion device is located on the wall of collecting chamber, when lid rotatory sealing opening, on lid Under the interaction of power elastic deformation occurs for part suggestion device and the part suggestion device on collecting chamber, when power disappears Afterwards, elastically-deformable part occur mutually collide to send sound and prompted.In more detail, suggestion device includes an elasticity Element and non-elastic member.Such as detection urine cup as Figure 1-5, including lid 100 and collecting chamber 200.Lid includes lid Edge, includes an element 101 on the outer surface of cover rim, and the element can be substantive flexible member.Simultaneously in the outer of collecting chamber Wall, also include an element 201 close to the place of rim of a cup, the element can be substantive non-elastic member, and non-elastic member 201 is perpendicular It is vertical and parallel with the outer wall 202 of collecting chamber, and maintained a certain distance with outer wall；Flexible member has alien invasion and corresponding Interior facade, and there is certain thickness, can be 1-5 millimeters.When lid is covered in opening, interior facade 209 can be light The outer surface of cup is first contacted micro-ly.After flexible member 101 is by perpendicular to the power of interior facade and remote covered body wall, elasticity Element outwards carries out bending or distorting away from collection chamber wall, if normal to the power of interior facade is in pop-off, flexible member by Effect to itself stress needs to be returned to original state, during case of bending promptly returns to original state, The interior vertical surface of flexible member beats cup surface 202 and sends sound, specific such as Fig. 1-5 process.

Detection method

The present invention provides a kind of method for detecting analyte in sample, including, there is provided a kind of detection means, including： One collecting chamber, the collecting chamber include an opening for being used for collecting liquid sample, and one is used for being divided in test liquid samples Analyse the testing element of thing, and a lid for being used for covering collecting chamber opening；Lid is covered in the opening of collecting chamber, allows inspection Whether the suggestion device prompting lid surveyed on device covers specified location.In a mode, suggestion device passes through hair Go out sound to be prompted.In another mode, once hearing that suggestion device sends prompting, stopping covers lid to collecting chamber Opening on.In a specific mode, lid seals the opening of collecting chamber by way of rotation, once hear prompting Device sends prompting, and stop the rotation lid.In addition, in a mode, once hearing that suggestion device sends prompting, start to calculate The time waited on read test element required for testing result.In another mode, carried once hearing that suggestion device is sent Show, start to calculate the time waited required for testing result on read test element, while the lid that stops the rotation.

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 Area.Other reagents, such as molecule with the Non-specific combination of analyte are fixed on detection zone.These reagents and the quilt in sample Analyte (if present) is reacted and analyte is incorporated in into the area, or is combined with some reagent of reagent area.For 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.

The type of sample

Any kind of sample can be tested with the device of the present invention, including body fluid is (for example, urine and other bodies Liquid, and clinical sample).Liquid sample may originate from solid or semisolid sample, including excrement, biological tissue and food Sample.These solids and semisolid sample can be transformed into liquid sample by any suitable method, such as in one kind Mixed in appropriate liquid, stamp broken, macerated, be incubated, dissolving or enzymolysis solid sample (for example, water, phosphate buffer or Other buffer solutions)." biological specimen " includes the sample from animal living, plant and food, also including urine, saliva, blood With blood constituent, cerebrospinal fluid, vaginal swab, seminal fluid, excrement, sweat, secretion, tissue, organ, tumour, tissue and organ It is the conditioned media of culture, cell culture and there, either people or animal.Food sample includes finished food Thing composition and last product, meat, cheese, wine, milk and drinking water.Plant sample include from any plant, plant tissue, The sample of the conditioned media of plant cell cultures and there." environmental samples " are that those are derived from the sample of environment (for example, lake water The sample of sample or other water bodys, sewage sample, soil sample, underground water sample, Seawater Samples, the sample of runoff water). Sewage and related waste can also be included in environmental samples.

The type of analyte

Any analyte can be analyzed with the present invention.The example bag of the analyte of stable detection of the present invention can be used Include (but not only including) human chorionic gonadotrophin (hCG), lutropin (LH), ovarian stimulation element (FSH), hepatitis The medicine of viral (HCV), hepatitis B (HBV), hepatitis B surface antigen, AIDS virus and any abuse.Analyte can Detected in any liquid or liquefaction sample, such as urine, saliva, saliva, blood, blood plasma, or serum.It is other The example of analyte also has flesh ammonia acid anhydride acid, bilirubin, nitrite, protein (nonspecific), blood, leucocyte, blood Sugar, heavy metal and toxin, bacterial component (for example, the special protein and sugar of certain types of bacterium, such as Escherichia coli 0157:H7, staphylococcus aureus, salmonella, C.perfringens, campylobacter, listeria monocytogenes, enteritis arc Bacterium, or wax bacillus).The analyte of any other suitable lateral flow test format can be detected with the present apparatus. Analyte, which can also be, to be infectious material or can prompt the material of infection period.Analyte can be medicine (such as drug abuse Thing), hormone, albumen, nucleic acid molecules, pathogen." drug abuse " (DOA) refers to that non-medical destination (is generally risen using medicine Benumb the effect of nerve).Abusing these medicines can cause body ＆ mind to suffer damage, produce dependence, it is addicted and/or It is dead.The example of drug abuse includes cocaine；Amphetamine (for example, black beauty, white amphetamine tablet, dextrorotation peace it is non- He is life, dexie, Beans)；Crystal methamphetamine (crank, meth, crystal, speed)；Bar ratio Appropriate hydrochlorate is (such asRoche Pharmaceuticals, Nutley, New Jersey)；Sedative (adjuvant of sleeping Product)；Lysergic acid diethylamide (LSD)；Inhibitor (downers, goofballs, barbs, blue devils, yellow Jackets, methaqualone)；The anti-antidepressant of tricyclic antidepressants (TCA, i.e. imipramine, amitriptyline and doxepin)；Hog (PCP)；Tetrahydrocannabinol (THC, pot, dope, hash, weed, etc..)；Opiate (i.e. morphine, opium, codeine, Hai Luo Cause, hydroxyl dihydrocodeinone).Can be used for belonging to medical usage using the test strip but the easily inspection of overdose Survey, such as tricyclic antidepressant (imipramine or the like) and Paracetamol.

Claims (10)

1. a kind of device for detecting analyte in sample, including：The collecting chamber of liquid sample is received, the collecting chamber is opened including one Mouthful；For the testing element of analyte in test liquid samples；With for covering the lid of collecting chamber opening；Wherein in device On also include whether a prompting lid covers the suggestion device of specified location on collecting chamber.

2. device as claimed in claim 1, wherein, when lid covers specified location, suggestion device prompting lid The opening of collecting chamber is sealed.

3. device as claimed in claim 1, wherein, when lid covers specified location, suggestion device prompting starts Calculate the time that the testing result on read test element needs to wait.

4. device as claimed in claim 1 or 2, wherein, the suggestion device is prompted by sending sound.

5. device as claimed in claim 4, wherein, described suggestion device is by the way that mutually collision sends sound after elastic deformation Sound.

6. device as claimed in claim 5, wherein, the suggestion device includes a flexible member and non-elastic member, bullet Property element by non-elastic member oppress produce elastic deformation after again resilience send sound.

7. device as claimed in claim 6, wherein, when flexible member passes through non-elastic member, flexible member is by projection member Resilience beats lid and sends sound again after part compressing deformation.

8. device as claimed in claim 7, wherein, non-elastic member is located on the outer surface of collecting chamber；Flexible member is located at On the outer surface of lid.

9. device as claimed in claim 8, wherein, the relative shifting counterclockwise synchronous with lid of the non-elastic member and collecting chamber It is dynamic；Flexible member and lid are relative to synchronous with collecting chamber mobile clockwise.

10. device as claimed in claim 6, wherein, described non-elastic member is copolymerized by acrylonitrile-butadiene-styrene (ABS) Thing forms；Flexible member is made up of polypropylene.