Summary of the invention
The invention provides and be used for the check and analysis thing in the existence of fluid sample or the apparatus and method of quantity.In one embodiment, fluid sample is a saliva, and analyte is ethanol (alcohol) or drug abuse.This device can comprise sample divider and receive cup.Sample divider can comprise absorbing material, and the composition of this absorbing material makes sample divider be convenient to be placed in person under inspection's the mouth.After absorbing material was filled saliva, sample divider was inserted in the reception cup of this device, and was placed on latched position (for example realizing through sample divider being screwed into receive in the cup).This makes absorbing material be compressed, and sample is extracted and moves on on the testing element, this testing element detect the existence or the quantity of interested analyte.
Therefore, in first aspect, the invention provides a kind of check and analysis thing that is used at the existence of fluid sample or the device of quantity.This device has sample divider, and this sample divider comprises the compressible absorption piece that is used to collect fluid sample.This device also comprises the reception cup, is used for receiving cup reception and maintenance sample divider.Sample divider has the primary importance and second latched position in receiving cup, absorption piece is not compressed in primary importance, and is compressed and remains in the cup in second latched position.Sample divider or reception cup also comprise at least one testing element, have on this testing element to be used for the check and analysis thing at the existence of fluid sample or the reagent of quantity.When sample divider was positioned at second latched position, testing element and absorption piece kept the fluid connected state.
In one embodiment, sample divider comprises dress and is receiving the testing element retainer of testing element.Testing element can be in fluid with absorption piece through the passage in the sample divider that connects absorption piece and testing element and be communicated with.In one embodiment, absorption pad is positioned between passage and the testing element.Sample divider can have circumferential screw-in screw thread, can have circumferential reception screw thread and receive cup.In one embodiment, when sample divider is in second latched position, screws in screw thread and receive engage threads.
In one embodiment, when sample divider is positioned at second latched position, receives cup and sealed in order to avoid be communicated with extraneous fluid.In another embodiment, when sample divider was positioned at second latched position, sample divider coupled together through being clasped with the reception cup.Absorption piece can be to be suitable for being placed on the sponge in person under inspection's mouth, and fluid sample can be a saliva.
In one embodiment, sample divider has flat handle so that with holding sample divider in hand, and receives cup and comprise testing element.When sample divider was positioned at second latched position, absorption piece can be communicated with the testing element fluid through receiving the passage in the cup.
On the other hand, the invention provides a kind of check and analysis thing that is used at the existence of fluid sample or the device of quantity.This device comprises sample divider, and this sample divider has the compressible absorption piece that screws in screw thread and be used to collect fluid sample.This device also has and receives cup, is used for receiving and keeping sample divider receiving cup, and receives cup and comprise the reception screw thread.Sample divider has primary importance and second latched position that screws in screw thread and the reception cup that receives engage threads in receiving cup.Absorption piece is not compressed in primary importance, and is compressed and remains in the cup in second latched position.Receive cup and be directly connected in the testing element retainer that comprises at least one testing element, this testing element has and is used for the check and analysis thing at the existence of fluid sample or the reagent of quantity.When sample divider was positioned at second latched position, testing element was communicated with the absorption piece fluid.
On the other hand, the invention provides and be used for the check and analysis thing in the existence of fluid sample or the method for quantity.These methods comprise uses device disclosed herein.Method step comprises: a certain amount of fluid sample is placed in the absorption piece, sample divider inserted in the reception cup and with sample divider move to second latched position, and existence or the quantity of definite analyte in fluid sample.
In one embodiment, fluid sample is a saliva, and through sample divider being placed in person under inspection's mouth and saliva is absorbed in the absorption piece.
When sample divider was in second latched position in the reception cup, sample divider was sealed with the reception cup, and remained in the reception cup.The fluid sample that squeezes out from absorption piece will flow into testing element automatically and detect.Because such structural design; The operator only needs open compact when detecting, the absorption piece of sample divider is put into person's to be checked oral cavity or liquid sample to be checked; Make absorption piece absorb the liquid sample of q.s; Insert to receive absorption piece in the cup then and make sample divider in receiving cup, be in second latched position,, just can check testing result through behind the preset time.Therefore, device operation steps of the present invention is very simple, even ordinary consumer when first the use, just can oneself use this device to detect according to the instructions in the packing box.So; Device of the present invention is fit to family very much to be used, and can be used as the standing oneself of family and detects medical treatment device, just can understand the health of oneself thereby the tester needn't obtain professional's assistance; Greatly facilitate people's life, reduced the expense that detects simultaneously.Whether in addition, device of the present invention also is suitable for some special places very much,, be used to detect the driver and drive when intoxicated when on duty such as the traffic police, and whether perhaps also can detect tested personnel has the forbidden drug of sucking or drugs etc.Therefore, the invention has the beneficial effects as follows: 1) operation steps is very simple, and everybody can use; 2) be convenient for carrying and can know testing result fast, be fit to very much special place and use; 3) detect finish after, sample divider still remains on and receives in the cup, can avoid sample divider and receive cup and be scattered and contaminated environment.
The foregoing invention summary is nonrestrictive, and other features and advantages of the present invention will become obvious from following detailed description and claims.
Embodiment
Referring to Fig. 1, be shown at the compact device 100 of the existence of fluid sample or quantity and be in its confined state according to the check and analysis thing that is used for of the first embodiment of the present invention.Among the embodiment shown in the figure, this device comprises the flat grip 201 that is used to catch device, comprise the sample collection part 104 of the compressible absorption piece that is used to collect fluid sample.Handle can be taked any form easily or shape.Also show the reception cup 106 that is used to receive and keep sample divider.Embodiment among Fig. 1 is shown as confined state, and wherein sample divider is fixed on the latched position that receives in the cup.The member of this device is processed by molded plastic parts easily, but also can use any suitable material." compressible " refers to the shape of material and can be out of shape so that when material keeps fluid, from this material, extrude the material behavior of fluid through mechanical pressure.
In Fig. 2, sample divider 102 has been shown in exploded view.Also show the reception cup 106 that is used for receiving therein and keeping sample divider 102.Sample divider 102 has lower case 203 and upper body 205.In this embodiment, testing element 207 is positioned at sample divider 102 inside easily.In upper body 205, can comprise view window 223 so that the observation test result.In an illustrated embodiment, absorbent material 225 (for example filter paper) is between the outlet and testing element 207 of passage 503.Absorbent material 225 absorbs by the fluid of absorption piece 213 releases and with it and is transported to testing element 207, therefore provides the fluid between passage and the testing element to be communicated with.This device is designed to make that absorbent material 225 can not absorb and carry the fluid more than the amount that can load on the testing element, thereby can not cause the overflow on the testing element.Arrive of the outlet of the unnecessary fluid of absorbent material 225, and be prevented from flowing to testing element 207 so that prevent the overflow on the testing element 207 through passage 503.The structure of " fluid connection " is meant that the fluid from a structure will lead to another structure that is communicated with its fluid.Therefore, when passage was communicated with the testing element fluid, the fluid through passage was again through absorbent material and arrive in the testing element.Passage, absorbent material and testing element can direct physical contact, but perhaps can be communicated with by gapped maintenance fluid between them.Absorption piece can be by absorbing and keeping any material of fluid to process.In one embodiment, absorption piece is a sponge, but it can be absorption paper, nylon in other embodiments, perhaps any other can absorb and keep the material of fluid to cotton." absorbent material " is absorption fluids and the material that can pass through the capillary action conveyance fluid.Its example includes but not limited to that the absorption paper of filter paper or other types, specific nylon, nitrocellulose and other have the material of said characteristic.With reference to disclosure text, it will be recognized by those of ordinary skills the other material that is suitable for forming these structures.
In an illustrated embodiment, sample divider 102 forms through linking together upper body 205 and lower case 203, and testing element 207 is housed within the housing with absorbent material 225.In other embodiment, sample divider can form single independently unit, is perhaps formed by other parts except that part described herein.In an illustrated embodiment, snap tabs 219 is arranged on the sample collector base 209, and this snap tabs cooperates with receiver hole 221 on being arranged on testing element retainer 102, fixing in this embodiment thus these two parts.When assembling sample divider 102, openend and snap tabs 219 that the near-end of sample divider 102 inserts sample collector base 209 engage with corresponding receiver hole 221.In other embodiments, snap tabs and receiver hole can be replaced or change by other usability methods of connecting elements, for example are threaded, are snapped into the position with the complementary parts that is fixedly connected, or bonding, or any suitable method.In this embodiment, upper body 205 and the lower case flat handle of 203 assembled formation are so that with holding sample divider 102 in hand.And the various parts of this device can be combined together through any method easily.In various embodiments, through using snap tabs or snug fit other parts together, perhaps, each part is cooperated through bonding, heat seal or any other suitable method.
" testing element " can be any test unit that detectable result is provided.In certain embodiments, testing element is test-strips (a for example lateral flow test strip).Test-strips can have the special binding molecule and the reagent that is used to carry out immunoassays on the test-strips of being fixed on.But in various other embodiment, this testing element also can be contain test agent based on chemical reaction,, based on biological test agent (for example enzyme or ELISA test), or based on fluorometric investigation reagent etc.。In addition, in some other embodiment, as long as have some other reagent on the testing element, it is just passable that this reagent can be used for detecting the quantity that whether has analyte or analyte in the sample.。In one embodiment, testing element comprises the reagent of the existence that is used to detect drug abuse.Yet in other embodiments, testing element can provide any element of test findings indication.For example, can use some chemistry or biological indicators.
When testing element was test-strips, it can comprise suction matrix (for example nitrocellulose) and/or other materials that is suitable for.Matrix can have sample loading area, reagent or marked region and surveyed area.The test-strips of these types is being known in the art, and with reference to disclosure text, it will be recognized by those of ordinary skills the various test-strips that can be used among the present invention.In certain embodiments, the sample loading area be positioned at test-strips an end so that sample is added on the test-strips.The reagent that is used to make an experiment or regulates sample also can be positioned at the sample loading area, and perhaps they can be positioned at independent reagent areas or the marked region on the test-strips.These reagent can be used for various purposes, and for example preparation is used for the sample of realizing ideal and combining with concrete binding molecule, perhaps improvement the stability of interested analyte.
The sample that comprises the analyte that is detected by this device can be any fluid sample.Be suitable for utilizing the instance of the fluid sample that the present invention tests to comprise mouth cavity fluid, saliva, whole blood, serum, blood plasma, urine, spinal fluid, biological extraction liquid, mucus and tissue." saliva " refers to the secretion of salivary gland." mouth cavity fluid " is any fluid that is present in the oral cavity.
Its existence or quantity analyte to be detected can be any analyte, and testing element can be this analyte and processes.In one embodiment, analyte is a drug abuse.Other instance of interested analyte comprise that hormone, albumen, peptide, nucleic acid molecules, morbidity reagent and concrete combination are to parts." drug abuse " is a kind of medicine that is used for non-medical purpose (being generally used for hazy and illusionary effect) (DOA).The abuse potential of this medicine causes body & mind injury and (in some cases) dependence, habituation even death.The instance of DOA comprises cocaine, amphetamine (for example black beauties, white bennies, amphetamine tablet, dexamphetamine amine medicine, dexies, beans), methamphetamine class (crank, methyl An Feita life, crystal, speed), barbiturates (stable
![Figure BSA00000367900200061](https://patentimages.storage.googleapis.com/3d/2b/5b/ba0fd7961c760f/BSA00000367900200061.png)
Roche Pharmaceuticals; Nutley; New Jersey), sedative class (being hypnotic), lysergic acid diethylamide (LSD), sedative (downers, goofballs, barbs, blue devils, yellow jackets, ludes), tricyclic antidepressant (TCA; For example imipramine, amitriptyline and doxepin), Hog (PCP), THC (THC; Pot; Dope; Hash, weed etc.) and opiate (for example morphine, opium, codeine, heroin, oxycodone).
Among the embodiment shown in the figure, sample divider 102 also comprises sample collector base 209.In this embodiment, sample collector base 209 has screw-in screw thread 227 so that sample divider 102 is fixed on the latched position in the reception cup 106.In this embodiment, sample divider 102 also has and is used for absorption piece 213 is fixed to the stopper head 217 on the sample divider 102, and is used for the absorption piece installation in position to make it easy to the comfortable extension 215 that remains on mouth by the person under inspection.Absorption piece 213 can be processed by absorbing material, for example sponge or spongy material, perhaps other materials that have absorption and keep the ability of fluid sample.When absorbing material was sponge, it can be derived from natural or synthetic.In an illustrated embodiment, absorption piece 213 is to be suitable for being placed in person under inspection's mouth to collect the cylindrical sponge material of saliva.But in other embodiments, absorption piece can be any being suitable for and shape easily.In certain embodiments, absorption piece 213 was handled to promote salivary secretion by chemical constitution (for example citrate or other chemicalss).Absorption piece 213 can be fixed to the far-end of extension 215 through any adequate measures, for example bonding, epoxy resin, thermal, or realize strong bonded or otherwise fixedly absorption piece to any other mode of the far-end of extension.Extension 215 can also have stopper head 217, and absorption piece 213 is combined on the stopper head 217.
In an illustrated embodiment, sample collector base 209 is cylinder or columniform basically, and at the near-end of its distal openings with acceptance test element retainer 102.The part of the testing element retainer 102 of sample collector base 209 is designed to complementary easily, and is combined together through any suitable mode, for example through being fastened togather, perhaps realizes through bonding or any other method that is suitable for.
In an illustrated embodiment, receive cup 106 and be essentially cylindrical shape, it has bottom 501 and open circumferential side wall 502.Shown in Fig. 5-7, bottom 501 is suitable for receiving absorption piece 213, and sidewall 502 is suitable for receiving sample collector base 209.In this embodiment, receive screw thread 505 and be arranged in the openend of sidewall 502, and match with screw-in screw thread 227 on the pedestal 209 of sample divider 102.Therefore, in one embodiment, through screw-in screw thread that makes sample collector base and the reception engage threads that receives cup, sample divider 102 is threaded in the reception cup 106 and is placed in latched position.
In the embodiment that uses " screw-in screw thread " and " reception screw thread ", screw in screw thread and can insert the reception screw thread so that two members are tightened together in latched position.Another kind of scheme is receive cup and can have the screw-in screw thread, and sample divider can have the reception screw thread.But in other embodiment, can use other method that sample divider and reception cup are fastened on latched position.For example, can use be clasped connection or other structures that sample divider and reception cup placed latched position.In other embodiments, receive cup can snug fit on sample collector base, thereby form a sealing, fluid sample can not leak from device through sealing.Used for example O type ring of hermetically-sealed construction in certain embodiments, even can not be through the sealing of wherein leaking but do not use such structure also can form fluid sample.In certain embodiments, sample divider with receive cup can be oppositely fastening, make this device can be placed into latched position and be movable to unlocked position subsequently.But in other embodiments, fastening needing not be can be reverse, is used for confirming test as long as sample can take out from device easily.
An embodiment of the latched position of this device is shown among Fig. 6.When being in latched position, the openend that receives cup 106 is covered or blocks by sample collector base 209.The enclosure space 601 that is used for storing fluid is present in and receives cup, and is defined in one embodiment between the inside surface 605 of inside surface 603 and sample collector base 209 of stopper head 217.In one embodiment, receive cup through the packoff sealing in order to avoid is communicated with the extraneous fluid of device, the sealing device for example is arranged on the circumferential exterior surface of sample collector base 209 and receives the O type ring 607 between the inside surface of glasss 106 sidewall 502.But in other embodiments; The mechanism that is used to seal this device can be snug fit other parts together; Fluid motion through holdout device between inside and outside realizes the other materials (for example plastics, elastomeric material) that seals; Perhaps be arranged at other positions, for example at the circumferential exterior surface of stopper head and the O type ring between reception cup 106 inside surface of side wall.
" locking " position is meant sample divider and receives that cup is secured together to become single unit system so that fluid sample can not leak from device, and this device can be safely and transport easily to be used for confirming test.In one embodiment, sample divider has and screws in screw thread and receive cup and have the reception screw thread, and these two kinds of screw threads are joined together to connect sample divider and the fluid sample that receives in cup and the packoff.In another embodiment, sample divider can have the reception screw thread, can have the screw-in screw thread and receive cup.In other embodiment, latched position can realize through other structures.For example be fastened togather to connect the contact pin of two members, perhaps snug fit and other parts that two members are kept together.In one embodiment, when sample divider was in latched position, the absorption piece of device was compressed.
Referring to Fig. 5, the sample divider that shows assembling inserts and receives in the cup 106.In this embodiment, Fig. 5 also show extension 215 entreat therein the zone be hollow so that passage 503 to be provided, make fluid arrive testing element from absorption piece (through absorbent material).Passage 503 has the inlet 507 that is used for receiving fluids from absorption piece 213 and is used for the outlet 509 of exhaust fluid to testing element.In other embodiment, can use other structures to make sample get into testing element.For example, absorbent material can extend the sample that arrives in the device, perhaps can use other paths that sample fluid is transported to testing element.
In one embodiment, thief hole 229 is present in the sidewall that receives cup and in the process of specimen and conveying arrangement, can is covered and sealed by stopper 231.When on the clinical trial facility, receiving this device, can take off stopper 231, and the operator can take out sample to be used for confirming test.In one embodiment, when stopper is opened, use suction pipe or other samplers to take out sample easily by the operator.This device remains on latched position easily, but still allows to take out sample fluid.In one embodiment, a plurality of ribs 233 are formed on around the sidewall so that reinforced sidewall, and make the reception cup part of catching device easily.
Describe the operating position of the embodiments of the invention shown in Fig. 1-7 now, the absorption piece 213 of sample divider 102 is placed in person under inspection's mouth and through use stopper head 217 and easily is supported in the mouth.Absorption piece has been full of saliva thus.Then, as shown in Figure 5, sample divider 102 is inserted into and receives cup and be positioned at a primary importance that receives in the cup, and in this primary importance, absorption piece is not compressed and has been full of saliva sample.Its near-end 301 can or can not recline and receive the bottom 511 of cup.Sample divider 102 moved axially receive in the cup and rotate to the second latched position (see figure 6).In this embodiment, when device was positioned at latched position, absorption piece was compressed and the screw-in screw thread 227 of sample collector base 209 engages with the reception screw thread 505 that receives cup 106.In latched position, sample divider is fastened to and receives in the cup, and fluid can not leak from device.When sample divider is positioned at latched position, extrude the fluid sample of collecting in the absorption piece through the mechanical pressure of compression absorption piece.This makes a part of fluid sample flow through passage 503 and arrives on the absorbent material 225 of testing element 207.After accomplishing required a period of time of test, confirmed existence or the quantity of analyte in fluid sample.When absorbing material 213 was compressed, the fluid sample of another part was pressed against in the enclosure space 601 so that subsequently, for example on the clinical trial facility, confirmed test.For confirming test, remove stopper 235, and use suction pipe 401 can easily regain institute's stored fluid sample through thief hole 229.
In Fig. 8 and 9, show an alternative embodiment of the invention.In this embodiment, the testing element retainer is directly connected in and receives on the cup 106, and is not attached on the sample divider.Referring to Fig. 9, device 100 comprises sample divider 102 and receives cup 106 that testing element retainer 801 extends from receiving cup.Sample divider 102 comprises absorption piece 213.In one embodiment, be convenient to place on the testing element retainer with the handle 803 of holding sample divider 102 in hand.In this embodiment, the extension is not a hollow, and fluid can not arrive testing element through the passage in the extension.On the contrary, fluid sample is through the path 807 in the bottom 501 that receives cup 106.Two structures that " directly connect " are meant and between at least some parts of two structures, have contact.
In various embodiment, test element handle 805 also may reside on the testing element retainer 801.In the sectional view of Fig. 9, there is a path 807 to be arranged in the bottom 501 that receives cup 106.In one embodiment, be positioned at the socket 809 that receives on the cup and be arranged on the bottom 501, be suitable for connecting testing element retainer 801 and be held in place in receiving glass.Referring to Fig. 9, when the use test element, retainer 801 inserts socket 809 and fix in position, makes absorbing material 213 be communicated with absorbent material 225 fluids, therefore also is communicated with at least one testing element 207 fluid through path 807.The operating process of this embodiment and last embodiment are roughly the same.
Instance 1
Be full of saliva through sample divider is placed in person under inspection's mouth up to it, use sample divider as herein described to collect 130 saliva samples from 130 persons under inspection.After being mounted with sample, sample divider is placed in the reception cup of device, compress absorption piece and extrude sample.30 samples are mixed with the potpourri of drug abuse, comprise amphetamine, cocaine, crystal methamphetamine, opiate, THC and Hog.Sample divider has and screws in screw thread and receive cup and have the reception screw thread.This device is placed in latched position then so that sample is remained in the device, and test begins to carry out automatically.After 10 minutes, the result is positive or negative for record.Each device body plan has two test-strips, three kinds of drug abuse of each test-strips test.Between two test-strips, following six kinds of drug abuse have been tested: amphetamine (AMP), cocaine (COC), methamphetamine class (MET), opiate (OPI), tetra-hydrocannabinol (THC) and Hog (PCP).
100 samples of the drug abuse of not mixing are all tested negative.For in six kinds of medicines each, it is to have only 28 tests for THC positive in 30 samples that 30 samples that have been mixed with medicinal mixture all provide positive findings.
Then in the affirmation test of the enterprising enforcement of these samples with the program of accepting extensively.In confirming test, for all six kinds of medicines, all 30 sample tests are positive.
In lacking this paper under the situation of concrete disclosed any element, restriction, can realize shown in this paper and described invention.Term that is adopted and representation are used as the term of explanation and are unrestricted; And with any equivalent of described characteristic or its part, and not should be realized that various remodeling all are feasible within the scope of the invention shown in not hoping in the use of these terms and representation to get rid of.Therefore should be appreciated that; Although specifically disclose the present invention through various embodiment and optional characteristic; But the modification of notion as herein described and modification can be adopted by those of ordinary skills, and think that these are revised and modification falls within the scope of the present invention of appended claims qualification.
Described in this paper or the content of article, patent, patented claim and the every other document of record and the information that can get with the electronics mode be included in this with for referencial use in full to a certain extent, just as each independent publication quilt specifically with point out separately with for referencial use the same.The applicant keeps any and all material and information from any this article, patent, patented claim or other documents and is incorporated into the right among the application.