DEVICE FOR DETECTING AN ANALTE IN A LIQUID SAMPLE
20230296598 · 2023-09-21
Inventors
Cpc classification
B01L9/52
PERFORMING OPERATIONS; TRANSPORTING
B01L9/00
PERFORMING OPERATIONS; TRANSPORTING
B01L3/5023
PERFORMING OPERATIONS; TRANSPORTING
International classification
G01N33/543
PHYSICS
B01L3/00
PERFORMING OPERATIONS; TRANSPORTING
Abstract
The present invention provides a device for detecting an analyte in a sample, including a chamber for receiving a testing element, where the testing element has a first position and a second position in the chamber; the testing element is not in contact with a fluid sample when the testing element is located in the first position, and the testing element is in contact with a fluid sample when the testing element is located in the second position.
Claims
1. A device for detecting an analyte in a sample comprising: a chamber for receiving a testing element, wherein the testing element has a first position and a second position in the chamber; the testing element is not in contact with a fluid sample when the testing element is located in the first position; and the testing element is in contact with a fluid sample when the testing element is located in the second position.
2. The device according to claim 1, wherein the chamber is further connected with a fluid sample collector, and the fluid sample collector is disposed on one end of the chamber.
3. The device according to claim 1, wherein the testing element and the chamber are in a locking state when the testing element is located in the first position.
4. The device according to claim 1, wherein a portion of the testing element stretches out of the chamber when the testing element is located in the second position.
5. The device according to claim 1, wherein the chamber further comprises a carrier used for bearing the testing element; the carrier has a first position and a second position in the chamber; and the carrier drives the testing element to change or move between the first position and the second position, or the carrier drives the testing element to move from the first position to the second position.
6. The device according to claim 5, wherein the carrier is connected to the chamber by a locking structure; the carrier dose not move with respect to the chamber when the carrier is in a locking first position, or, the carrier is capable of moving to the second position from the first position relative to the chamber when the locking structure is unlocked.
7. The device according to claim 6, wherein when the carrier is located in the first position, the whole carrier is completely located in the chamber; when the carrier is located in the second position, a portion of the carrier stretches out of the chamber, thus contacting the liquid sample.
8. The device according to claim 5, wherein the device further comprises a movable element; the movable element is connected with the carrier; and the movable element is capable enabling the carrier to move from the first position to the second position.
9. The device according to claim 8, wherein the movable element comprises a first sliding rail and a second sliding rail; the carrier is fixedly connected with a second sliding rail.
10. The device according to claim 9, wherein the chamber comprises a first sliding groove matched with the first sliding rail of the movable element and a second sliding groove matched with the second sliding rail of the movable element; the second sliding groove penetrates through a side wall of the chamber, and the first sliding groove is located on an outer surface of the chamber.
11. The device according to claim 9, wherein the movable element comprises a portion of the locking structure, and the chamber comprises another portion of the locking structure; the movable element is fixed on the chamber via the locking structure.
12. The device according to claim 9, wherein the carrier comprises a suspending structure, and the carrier is fixedly connected on the second sliding rail via the suspending structure.
13. The device according to claim 11, wherein the locking structure comprises a bulge structure and a notched structure; the movable element comprises the bulge structure; and an outer wall of the chamber comprises a notched structure.
14. The device according to claim 13, wherein the notched structure is located at a sheet structure on a side wall of the chamber; the sheet structure is a portion of the side wall of the chamber; meanwhile, the sheet structure is elastic.
15. The device according to claim 8, wherein the movable element is sleeved on an outer surface of the chamber, and the carrier and the second sliding rail are located in the chamber for receiving the testing element; the first sliding rail is located on the outer surface of the chamber and matched with the first sliding groove on the surface of the chamber.
16. The device according to claim 15, wherein the chamber comprises a limiting structure; the limiting structure comprises an edge; the carrier is a curved surface structure; a concave surface of the carrier is in contact with the edge of the limiting structure, wherein the carrier comprises a backbone structure.
17. The device according to claim 16, wherein the chamber for receiving the testing element comprises a first chamber side wall and a second chamber side wall, wherein the first chamber side wall faces the concave surface of the carrier, and the second chamber side wall faces the backbone structure.
18. The device according to claim 2, wherein the device further comprises an accommodating device; the accommodating device is used for accommodating the collector and a portion of the testing element.
19. The device according to claim 18, wherein the portion of the testing element comprises a portion of a sample application area.
20. The device according to claim 1, wherein the sample is one of saliva, sputum, urine and nasal secretion; and the analyte comprises corona virus.
Description
BRIEF DESCRIPTION OF DRAWINGS
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DETAILED DESCRIPTION OF EMBODIMENTS
[0056] The structures or technical terms used in the present invention are further described in the following. Unless otherwise indicated, they are understood or interpreted according to ordinary terms and definitions in the art.
Detection
[0057] Detection denotes assaying or testing whether a substance or material exists, for example, but not limited to, chemicals, organic compounds, inorganic compounds, metabolites, drugs or drug metabolites, organic tissues or metabolites of organic tissues, nucleic acid, proteins or polymers. Moreover, detection denotes testing the number of a substance or material. Further, assay also denotes immunoassay, chemical detection, enzyme detection and the like.
Samples
[0058] The samples that can be detected by the detecting device or collected by the collector of the present invention include biological liquid (e.g. case liquid or clinical samples). Liquid samples or fluid specimens may be derived from solid or semi-solid samples, including excreta, biological tissues and food samples. Solid or semi-solid samples are transformed into liquid samples by any proper method, for example, mixed, mashed, macerated,incubated, dissolved into a proper solution (for example, water, phosphate solution or other buffer solutions), and solid samples are digested by zymolysis. “Biological samples” include samples from animals, plants and food, for example, including urine, saliva, blood and components thereof, spinal fluid, vaginal secretion, semen, faeces, sweat, secreta, tissues, organs, tumors, cultures of tissues and organs, cell culture and medium from human or animals. The preferred biological sample is urine, preferably, the biological sample is saliva, sputum, nasal secretion, and the like. Food samples include substances processed from food, final products, meat, cheese, wine, milk and drinking water. Plant samples are derived from any plants, plant tissues, plant cell cultures and media. “Environmental samples” are derived from the environment (for example, liquid samples, wastewater samples, soil texture samples, underground water, seawater and effluent samples from lakes and other water bodies). Environmental samples may further include sewage or other waste water.
[0059] Any analyte can be detected using the appropriate detecting element or testing element of the present invention. Preferably, the present invention is used to detect small drug molecules in saliva and urines. Preferably, the present invention is used to detect virus, bacteria and other small molecules in saliva, throat or nasal cavity fluid. Any form of samples above, either initially solid or liquid, can be collected by the collector 201 in the present invention, as long as the liquid or liquid samples can be absorbed by the absorbing element; and the absorbing element 2022 is generally located on the collector. The absorbing element 2022 here is generally prepared from a water absorbent material and is initially dry. It can absorb liquid or fluid samples by capillary or other characteristics of the absorbing element material, so as to keep the fluid samples in the absorbing element. The absorbent material can be any liquid absorbing material such as sponge, filter paper, polyester fiber, gel, non-woven fabric, cotton, polyester film, yarn, flocking, etc. When a flocking swab is taken, the flocking swab described in the following patents may be used to collect the fluid samples as a part of the present invention: US8,114,027, US 8,317,728, US 8,979,784, US 9,011,358, US 9,173,779, US 10,327,741, AU2004226798, JP4579902 and ZL200610099310.9. In some embodiments, the absorbing element is hard when it is dry, for example, a sponge becomes soft when it is wet, and can be compressed after softening to release liquid. Of course, when it is a relatively sparse sponge, for example, a sponge swab, liquid samples can be still absorbed in a little amount, for example, 5-100 .Math.L; for example, a sponge swab described in a US provisional application 63/300,811 with application number: Jan. 19, 2022 may be also used in this present invention as a detailed example of the collector.
[0060] Of course, the absorbing element is not necessarily prepared by an absorbent material but may be prepared by a non-water absorbent material. But the absorbing element has pores, threads, and cavities, and samples may be collected on these structures. These samples are generally solid or semi-solid samples, and are filled between threads, or in cavities or holes, thus collecting the samples. Of course, optionally, the absorbing element may consist of some non-water absorbent fibers and hairs; these materials are used to scratch solid, semi-solid or liquid samples such that these samples are maintained on the absorbing element.
Downstream and Upstream
[0061] Downstream or upstream is divided according to a flow direction of a liquid, generally, a liquid or fluid flows to a downstream area from an upstream area. The downstream area receives the liquid from the upstream area, and a liquid also may flow to a downstream area along an upstream area. Here, downstream or upstream is generally divided according to a flow direction of a liquid, for example, on some materials where capillary force is utilized to promote the flow of a liquid, a liquid may overcome gravity to flow towards an opposite direction to the gravity; and at this time, downstream or upstream is divided according to a flow direction of the liquid. For example, as shown in
[0062] Of course, the upstream and the upstream here may be also a motion trail or direction of an object instead of a circulation direction of a liquid. For example, in the operating process, after the chamber 14 containing a treatment agent is inserted by an absorber, the chamber is bonded with the chamber with a testing element at this time, as shown in
Gas Flow or Liquid Flow
[0063] Gas flow or liquid flow means that liquid or gas can flow from one place to another place. The flow process may pass through some physical structures, to play a guiding role. The “passing through some physical structures” here means that liquid passes through the surface of these physical structures or their internal space and flows to another place passively or actively, where passivity is usually caused by external forces, such as the flow of the capillary action and air pressure action. The flow here may also be a flow due to self-action (gravity or pressure) of the liquid or gas, and also may be a passive flow. The fluid under the action of air pressure may be a forward flow, or also a reverse flow; or a fluid is urged to flow to another position from a position under the action of air pressure. Here, the flow does not mean that a liquid or a gas is necessarily present, but indicates a relationship or state between two objects under some circumstances. In case of presence of liquid, it can flow from one object to another. Here it means the state in which two objects are connected. In contrast, if there exists no gas flow or liquid flow state between two objects, and liquid exists in or above one object but cannot flow into or on another object, it is a non-flow, non-liquid or non-gas flow state.
Detachable Combination
[0064] A detachable combination means that the connection relationship of two parts is in several different states or locations, for example, when two physical parts are separated initially, they can connect or combine together at an appropriate first condition; and at an appropriate second condition, the two parts can be separated, and the separation is a separation of physical space, without contact. Or, the two parts are combined together initially, and when appropriate, the two parts can be separated physically, or two objects are separated initially, and when required, they combine together to complete some functions, and then separate, or combine again for some purposes subsequently. In a word, the combination or separation of two parts is easy, and such combination or separation can be repeated for many times, of course, it can be one-time combination or separation. In addition, the combination may be a detachable combination between two parts, or a mutually detachable combination between three or more parts, for example, with three parts, the first part is detachably combined with the second part, and the second part can also be detachably combined with the third part, and the first part can also be detachably combined with or separated from the third part. Moreover, the combination between them can be achieved by two detachable objects or indirectly through another object. Here, the absorbing element 201 can be detachably combined with the chamber 13 for accommodating the testing element 18. The detachable combination can be in a direct or an indirect way, as described in details below. The carrier 16 with a testing element is also detachably combined with the chamber 13 of a holding element 18, such that they are combined to form a detecting device, but after disassembly, they may each have their own purposes. In the present invention, after the absorbing element 201 is separated from the testing element, the absorbing element can be separately sterilized, such as sterilization by high temperature, X-ray, radiation, etc. After the sterilization, the absorbing element is combined with the testing element. By this way, the absorbing element can be brought into fluidic communication with the testing element such that the liquid from the absorbing element can flow from the absorbing element to the testing element. In some embodiments, the absorbing element 201 is fixedly disposed on the chamber 13 that accommodates the testing element, for example, on an end (as shown in
Testing Element
[0065] The “testing element” used herein refers to an element that can be used to detect whether a sample or a sample contains an interested analyte. Such testing can be based on any technical principles, such as immunology, chemistry, electricity, optics, molecular science, nucleic acids, physics, etc. The testing element can be a lateral flow test strip that can detect a variety of analytes. Of course, other suitable testing elements can also be used in the present invention.
[0066] Various testing elements can be combined for use in the present invention. One form of the testing elements is test paper or transverse-flow test paper. The test papers used for analyzing the analyte (such as drugs or metabolites that show physical conditions) in samples can be of various forms such as immunoassay or chemical analysis. The analysis mode of non-competition law or competition law can be adopted for test papers. A test paper generally contains a water absorbent material that has a sample application area, a reagent area and a testing area. Fluid or liquid samples are added to the sample application area and flow to the reagent area through capillary action. If analyte exists in the reagent area, samples will bind to the reagent. Then, samples continue to flow to the testing area. Other reagents such as molecules that specifically bind to analyte are fixed in the testing area. These reagents react with the analyte (if any) in the sample and bind to the analyte in this area, or bind to a reagent in the reagent area. Marker used to display the detection signal exists in the reagent area or the detached mark area.
[0067] Typical non-competition law analysis mode: if a sample contains analyte, a signal will be generated; and if not, no signal will be generated. Competition law: if no analyte exists in the sample, a signal will be generated; and if analyte exists, no signal will be generated.
[0068] The testing element can be a test paper, which can be water absorbent or non-absorbing materials. The test paper can contain several materials used for delivery of liquid samples. One material can cover the other material.For example, the filter paper covers the nitrocellulose membrane. One area of the test paper can be of one or more materials, and the other area uses one or more other different materials. The test paper can stick to a certain support or on a hard surface for improving the strength of holding the test paper.
[0069] Analyte is detected through the signal generating system. For example, one or more enzymes that specifically react with this analyte is or are used, and the above method of fixing the specifically bound substance on the test paper is used to fix the combination of one or more signal generating systems in the analyte testing area of the test paper. The substance that generates a signal can be in the sample application area, the reagent area or the testing area, or on the whole test paper, and one or more materials of the test paper can be filled with this substance. The solution containing a signifier is added onto the surface of the test paper, or one or more materials of the test paper is or are immersed in a signifier-containing solution;and the test paper containing the signifier solution is made dry.
[0070] Each area of the test paper can be arranged in the following way: sample application area, reagent area, testing area, control area, area determining whether the sample is adulterated, and liquid sample absorbing area. The control area is located behind the testing area. All areas can be arranged on a test paper that is only made of one material. Also, different areas may be made of different materials. Each area can directly contact the liquid sample, or different areas are arranged according to the flow direction of liquid sample; and a tail end of each area is connected and overlapped with the front end of the other area. Materials used can be those with good water absorption such as filter papers, glass fibers or nitrocellulose membranes. The test paper can also be in the other forms.
[0071] The nitrocellulose membrane test strip is commonly used, that is, the testing area includes a nitrocellulose membrane (NC) on which a specific binding molecule is fixed to display the detecting result; and other test strips such as cellulose acetate membrane or nylon membrane test strips can also be used. For example, the test strips and similar apparatuses with test strips disclosed in the following patents can be applied to the testing elements or detecting devices in this invention for analyte detection, such as the detection of the analyte in the samples: 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, and US 6403383. The test strips and similar device provided with a test strip disclosed in the above patent literatures may be applied in the testing element or detecting apparatus of the present invention for the detection of an analyte, for example, the detection of an analyte in a sample.
[0072] The test strips used in the present invention may be those what we commonly called lateral flow test strip, whose specific structure and detection principle are well known by those with ordinary skill in the art. Common test strip 18 (
[0073] In addition to the foregoing test strip or lateral flow test strip which is used to contact with the liquid to test whether the liquid samples contain analytes, the testing element of the present invention may be used as a detecting device by itself to detect an analyte in a sample. Therefore, the detecting device here is equal to a testing element. For example, after being mixed with the treatment solution, the fluid sample is detected with a testing element directly. when the receiving device is described to treat a fluid sample, the testing element may be used for detection alone.
Analyte
[0074] Examples that can use the analyte related to this invention include small-molecule substance, including drugs (such as drug abuse). ″Drug of Abuse″(DOA) refers to using a drug (playing a role of paralyzing the nerves usually) not directed to a medical purpose. Abuse of these drugs will lead to physical and mental damage, produce dependency, addiction and/or death. Examples of DOA include cocaine, amphetamine AMP (for example, Black Beauty, white amphetamine table, dextroamphetamine, dextroamphetamine tablet, and Beans); methylamphetamine MET (crank, methamphetamine, crystal, speed); barbiturate BAR (e.g., Valium, Roche Pharmaceuticals, Nutley, and New Jersey); sedative (namely, sleep adjuvants); lysergic acid diethylamide (LSD); depressor (downers, goofballs, barbs, blue devils, yellow jackets, methaqualone), tricyclic antidepressants (TCA, namely, imipramine, Amitryptyline and Doxepin); methylene dioxymetham-phetamine (MDMA); phencyclidine (PCP); tetrahydrocannabinol (THC, pot, dope, hash, weed, and the like). Opiates (namely, morphine MOP or, opium, cocaine COC; heroin, oxycodone hydrochloride); antianxietics and sedative hypnotics, antianxietics are drugs for alleviating anxiety, tension, fear, stabilizing emotion and having hypnosis and sedation, including benzodiazepines (BZO), non-typical BZs, fusion dinitrogen NB23Cs, benzoazepines, ligands of a BZ receptor, open-loop BZs, diphenylmethane derivatives, piperazine carboxylates, piperidine carboxylates, quinazoline ketones, thiazine and thiazole derivatives, other heterocyclic, imidazole sedatives/analgesics (e.g., oxycodone hydrochloride OXY, metadon MTD), propylene glycol derivatives, mephenesin carbamates, aliphatic compounds, anthracene derivatives, and the like. The detecting device of the present invention may be also used for detecting drugs which belong to medical use but is easy to be taken excessively, such as tricyclic antidepressants (Imipramine or analogues), acetaminophen and the like. These medicines will be resolved into micromolecular substances after being absorbed by human body, and these micromolecular substances will exist in blood, urine, saliva, sweat and other body fluids or in some of the body fluids.
[0075] For example, the analyte detected by the present invention includes but not limited to creatinine, bilirubin, nitrite, proteins (nonspecific), hormones (for example, human chorionic gonadotropin, progesterone, follicle-stimulating hormone, etc.), blood, leucocyte, sugar, heavy metals or toxins, bacterial substances (such as, proteins or carbohydrates against specific bacteria, for example, Escherichia coli. 0157:H7, Staphylococcus, Salmonella, Fusiformis genus, Camyplobacter genus, L. monocytogenes, Vibrio, or Bacillus cereus) and substances associated with physiological features in a urine sample, such as, pH and specific gravity. The chemical analysis of any other clinical urine may be conducted by means of a lateral cross-flow detection way and in combination with the device of the present invention. In some embodiments, the treatment solution contained in the receiving device is free of an analyte.
Detecting Device
[0076] The detecting device refers to an apparatus for detecting the presence or absence of an analyte. The collection device refers to a part that receives a part of the detecting device or a part that the detecting device inserted into the receiving device to mix or process the samples, elute the absorbing element 201 and treat the liquid or liquid samples. The receiving device is not present especially for receiving the detecting device, and may be present alone, and independently has the function of treating a fluid sample. The detecting device may include a testing element having a test function, for example, a carrier with a testing element, or may also include an accommodating element of a carrier, for example, a chamber 13 for accommodating the testing element. The detecting device may include an absorbing element 201 for collecting a sample, or include an absorbing element (a collector) with a connecting rod. The absorbing element 2022 with collected samples may be also called a collection device or a collector. The collection device may also include a detecting device; or the collector may be detachably combined with the detecting device. The collection device is assembled with the collection device in detection to complete the test. The detecting device may also include a collecting device. It is also possible that the collection device and the detecting device are an integrated structure, and once liquid samples are collected, the detection can be performed immediately to obtain the test result. Here, the connotation of the detecting device or testing element is interchangeable.
[0077] The “receiving device” here is merely for the convenience of description. In a detailed embodiment, the receiving device 14 receives a portion of the collector, for example, receives an absorbing element 2022, or receives a portion of the detecting device with an absorbing element. When the receiving device is not for the purpose of receiving, it may be called a sample treatment/sample mixing device. In the process of treating a sample, the detecting device may be not received, but the absorbing element may be only received to achieve independent completion (detailed description is as follows). To sum up, the “receive” here neither defines the scope of the device, nor play the defining role of claims of any Patent Law, but is merely a way of expression for the convenience of description.
[0078] In some detailed embodiments, the detecting device of the present invention includes a chamber 13 for accommodating the testing element; the testing element 18 has a first position and a second position in the chamber. When the testing element is located in the first position, the testing element is locked on or in the chamber 13. In some preferred embodiments, the detecting device includes a sliding element 11; the sliding element has a first position and a second position in the chamber 13, capable of moving to the second position from the first position. In some embodiments, when the sliding element is located in the first position, the sliding element is located in the locking position or locking state with the chamber 13; when or after being unlocked, the sliding element may move to the second position from the first position. In some embodiments, the testing element 11 may drive the testing element to move from the first position to the second position.
[0079] In some embodiments, the chamber for receiving the testing element has a three-dimensional structure as shown in
[0080] It is understood that the testing element 18 or the carrier 16 bearing the testing element is located in two states or two position states in the chamber 13. In some embodiments, the chamber 13 is cylindrical; one end 103 is opened and another end 1032 is also opened; another end thereof has a structure which may be detachably assembled with the collector 201. The structure 156 may be an insertion hole 191; one end 2023 of the collector 201 may be inserted into the insertion hole 191, or fixed with the chamber 13 in threaded manner, thus being assembled into a collector. The collector has a rod-like body 2024 and an absorbing element 2022. In some embodiments, the locking state of the testing element or carrier or sliding element with the chamber is fixed on the chamber via a locking mechanism. The locking structure has locking and unlocking states; in case of being in the locking state, the position fixed on the chamber 13 may be fixed or not easy to move; in case of being in the unlocking state, the element fixed on the chamber may move or slide on the chamber. In some embodiments, the chamber includes a portion of locking structure, used for locking the testing element 18 or carrier 16 such that the testing element or carrier is in a locking state relative to the chamber 13. A portion of locking structure is shown in
[0081] For example, on the sectional diagram of the sliding element as shown in
[0082] Moreover, the notch 151 on the outer surface of the chamber is formed by upper and lower protruding strips 149,150. When the protruding strips are higher than the outer surface of the chamber 13, there is a certain width of gap between the inner surface of the sliding element 11 and the outer surface of the chamber 13, and the two protruding strips 149,150 will not substantively contact the inner surface of the movable element 11, thus reducing the resistance of the movable element sleeved on the outer surface of the chamber 11. When the movable element 11 slides to the position of the notch 151, the protruding strip 118 located in the movable element 11 is easy to be meshed and clamped by the notch 151. Certainly, what is described above is merely an embodiment of the locking structure. In some embodiments, one protruding strip 149 may be disposed on the sheet structure 135 on the outer surface of the chamber 13 only without a notch 151 and other protruding strip 150, thus achieving the locking between the sliding element and the chamber. The protruding strip 118 in the groove 116 nearby the sliding rail 111 of the sliding element is still constant. When the sliding element 11 is sleeved on the outer surface of the chamber 13, the protruding strip 118 of the movable element 11 is touched by the protruding strip 149 of the sheet structure 135 on the outer surface of the chamber 13 to block the further sliding of the movable element, which also achieves the locking state between the movable element 11 and the chamber 13. The locking here means that the movable element 11 is fixed in the position of the chamber 13 under different states. The movable element 11 may not continue to move up and down on the chamber 13, but be located in a fixed position here. Therefore, in some embodiments, the sliding element is locked in a certain fixed position on the chamber 13 for accommodating the testing element, which may be called a first position or a first initial position here. The sliding element 11 is very light by itself. After being provided with the testing element or a carrier for bearing the testing element, it is still lighter in some embodiments. Therefore, the notch 151 and the protruding rib strip 118 may be designed simply as long as buckling can be achieved. In some embodiments, the sheet notched structure is located nearby the sliding groove 140 with a bottom surface of the chamber and close to the upper end of the chamber. Certainly, there are other possible locking structures except the above locking structure, for example, a bolt, a jack, clamping and the like. In terms of simple design, the locking structure described in detail herein can be achieved most easily and conveniently.
[0083] In some embodiments, the chamber for accommodating the testing element is divided into two parts 103,104 by symmetrical sliding grooves 132,131. The length of the sliding grooves limits the sliding distance of the sliding element 11 on the chamber 13. Moreover, the sliding distance of the sliding element is also limited by the sliding groove 140 with a bottom surface of the chamber 13. For example, as shown in
Carrier Element
[0084] In some detailed embodiments, the testing element may be also disposed on some carrier elements; then the carrier elements contain the testing element to complete the detection and assay of the analytes in fluid samples. Therefore, in some embodiments, the detecting device includes a carrier 16, and the carrier is provided with a testing element 18. In some embodiments, the carrier is located in the chamber 13 for accommodating the testing element, and the carrier has a first locking position and a second position in the chamber; and the second position is not a locking state. As shown in
[0085] In some detailed embodiments, the carrier 16 includes two parts, and one of them is a groove structure 161; the groove structure is used for holding a testing element; generally, the groove structure is used for holding the testing area or labeled area of the testing element such that the testing area or the labeled area is located in a relatively fixed and safe position. Such a design may ensure the accuracy and reliability of the test results. The carrier further includes an area connected to the sliding element 11. The structure of the area is designed in fixed fit with the sliding element. In some embodiments, when the chamber for accommodating the testing element is round, the carrier is designed in a curved surface. Therefore, the groove for accommodating the testing element on the carrier is distributed according to a curved surface. Specifically, the carrier shows a regular curved surface on the whole. The middle part of the curved surface has a backbone 1691; the carrier is divided into two parts by the backbone 1691; each part is provided with a groove for accommodating a reagent strip; the testing element is located in the groove 161. The backbone is provided with horizontal extension areas 1612,1611; the extension areas are distributed above the groove on the backbone. In this way, when the testing element 18 is disposed in the groove, the extension areas may protect the test stripe from being damaged. The major reason is that the carrier is driven to move in the chamber 13; during the moving process, it needs to ensure the testing element free of damage, and also needs to ensure a fixed position of the testing element in the groove. Otherwise, the location change of the testing element will also affect the accuracy of the final test result. For example, household operation has high arbitrariness because the operator does not possess enough professional knowledge, which demands for the fixed position of each component and for the convenience of the operation.
[0086] Moreover, to keep the position of the testing element in the groove still and not separated from the groove, a tail end of the carrier is provided with a blocking piece 1692 (
[0087] In some embodiments, a structure fixed with the movable element 11 is disposed on another end of the carrier, namely, one end close to the water absorbing area 184 of the testing element. The carrier is connected with the movable element by the structure. In this way, the movable element moves to drive the carrier to move. The carrier may not only drive the testing element to move, but also protect the testing element from being damaged. In some embodiments, the sliding element 11 is also a hollow structure having an internal space 1120. Side wall of the inner part of the hollow structure has a second sliding rail 112 and a fourth sliding rail 115. The first function of the sliding rail is to set in the sliding grooves 132,131 of the chamber 11, thus driving the carrier to slide in the chamber. Another function is to connect the carrier with the sliding element. The sliding rail 112 and fourth sliding rail 115 are distributed symmetrically protruding from the hollow side wall to the central position has a certain width (
[0088] When the sliding element with a carrier element is assembled on the chamber 13, for example, as shown in
[0089] \For example,
[0090] \During assembly, the bulge structure located nearby the first sliding rail is matched with the notched structure on the chamber such that the sliding element is located on the chamber 13. At this time, the carrier and the testing element on the carrier are indirectly locked on the relatively fixed position of the chamber. At this time, the whole carrier and the test stripe on the carrier are surrounded by the chamber 13. Only a collector is exposed outside the detecting device such that the operator spontaneously envisages collecting a sample with the collector upon seeing such a structure. After collecting the sample, the collector is inserted into the chamber of the accommodating device 14. At this time, the accommodating device vertically stands on the table. Inner wall of the opening of the accommodating device is matched with the outer edge 109 at another end of the chamber 13 such that the outer edge 109 is inserted into the opening of the accommodating chamber; on the one hand, the opening is sealed to avoid the leakage of the liquid sample during operation. For example, the collecting element 2022 of a collector is used to absorb saliva, urine, sputum or nasal secretion, and then inserted into an accommodating device 14. At this time, the opening is sealed by the outer edge 109. At this time, the movable element is located in the first locking position, and the testing element 18 of the carrier is located in the chamber 13. When test needs to be done, the movable element is located in the unlocking state, and then the movable element moves to the second position from the first position. Such a motion is specifically as follows: the carrier is driven by the motion of the sliding rail on the movable element and the sliding groove on the chamber 13 to move such that a portion of the carrier stretches out of the chamber 13. The stretched portion also enters to the chamber of the accommodating device 14. In this way, a portion of the sample application area of the testing element contacts the liquid sample. The liquid sample flows from the upstream of the testing element to the downstream labeled area relying on the capillary action generated by the water absorption of the testing element. Accordingly, the testing area completes the detection or assay of the analyte in the sample. At this time, due to the movement of the position, the testing area of the testing element is located below the window 143 for reading the test result on the chamber 13, which may read the test result on the testing area. After reading the test result, the whole detecting device may be discarded directly. The accommodating device 14 includes an accommodating chamber 141 which accommodates a collector and a portion of carrier. Moreover, there are two supporting walls 143,142 such that the accommodating device stands on the table firmly.
Cover Body Structure
[0091] As shown in
[0092] The following specific technical solutions are a portion of the present invention.
[0093] 1. A device for detecting an analyte in a sample, comprising a chamber for receiving a testing element, wherein the testing element has a first position and a second position in the chamber; the testing element is not in contact with a fluid sample when the testing element is located in the first position, and the testing element is in contact with a fluid sample when the testing element is located in the second position.
[0094] 2. The device according to clause 1, wherein the chamber is further connected with a fluid sample collector, and the fluid sample collector is disposed on one end of the chamber.
[0095] 3. The device according to any one of clauses 1-2, wherein the testing element and the chamber are in a locking state when the testing element is located in the second position.
[0096] 4. The device according to any one of clauses 1-3, wherein a portion of the testing element stretches out of the chamber when the testing element is located in the second position.
[0097] 5. The device according to any one of clauses 1-4, wherein the chamber further comprises a carrier used for bearing the testing element; the carrier has a first position and a second position in the chamber; and the carrier drives the testing element to change or move between the first position and the second position, alternatively, the carrier drives the testing element to move from the first position to the second position.
[0098] 6. The device according to any one of clauses 1-5, wherein the carrier is connected to the chamber by a locking structure; the carrier dose not move with respect to the chamber when the carrier is in a locking first position, alternatively, the carrier is capable of moving to the second position from the first position relative to the chamber when the locking structure is unlocked.
[0099] 7. The device according to any one of clauses 1-6, wherein when the carrier is located in the first position, the whole carrier is completely located in the chamber; when the carrier is located in the second position, a portion of the carrier stretches out of the chamber, thus contacting the liquid sample.
[0100] 8. The device according to any one of clauses 1-7, wherein the device further comprises a movable element; the movable element is connected with the carrier; and the movable element is capable of moving the carrier from the first position to the second position.
[0101] 9. The device according to any one of clauses 1-8, wherein the movable element comprises a first sliding rail and a second sliding rail; the carrier is fixedly connected with a second sliding rail.
[0102] 10. The device according to any one of clauses 1-9, wherein the chamber comprises a first sliding groove coupled to the first sliding rail of the movable element and a second sliding groove coupled to the second sliding rail of the movable element; the second sliding groove is throughout a side wall of the chamber, and the first sliding groove is located on an outer surface of the chamber.
[0103] 11. The device according to any one of clauses 1-10, wherein the movable element comprises a portion of the locking structure, and the chamber comprises another portion of the locking structure; the movable element is fixed on the chamber via the locking structure.
[0104] 12. The device according to any one of clauses 1-11, wherein the carrier comprises a suspending structure, and the carrier is fixedly connected on the second sliding rail via the suspending structure.
[0105] 13. The device according to any one of clauses 1-12, wherein the locking structure comprises a bulge structure and a notched structure; the movable element comprises the bulge structure; and an outer wall of the chamber comprises a notched structure.
[0106] 14. The device according to any one of v 1-13, wherein the notched structure is located at a sheet structure on a side wall of the chamber; the sheet structure is a portion of the side wall of the chamber; meanwhile, the sheet structure is elastic.
[0107] 15. The device according to any one of clauses 1-14, wherein the movable element is sleeved on an outer surface of the chamber, and the carrier and the second sliding rail are located in the chamber of the testing element; the first sliding rail is located on the outer surface of the chamber and coupled to the first sliding groove on the surface of the chamber.
[0108] 16. The device according to any one of clauses 1-15, wherein the chamber comprises a limiting structure; the limiting structure comprises an edge; the concave surface of the carrier is in contact with the edge of the limiting structure, wherein the carrier comprises a backbone structure.
[0109] 17. The device according to any one of clauses 1-16, wherein the chamber for receiving the testing element comprises a first chamber side wall and a second chamber side wall, wherein the first chamber side wall is in front of the concave surface of the carrier, and the second chamber side wall is in front of the backbone structure.
[0110] 18. The device according to any one of clauses 1-17, wherein the device further comprises an accommodating device; the accommodating device is used for holding the collector and a portion of the testing element.
[0111] 19. The device according to any one of clauses 1-18, wherein the portion of the testing element comprises a partial sample application area.
[0112] 20. The device according to any one of claims 1-19, wherein the sample is one of saliva, sputum, urine and nasal secretion; and the analyte comprises corona virus.
[0113] 21. A method for detecting an analyte in a sample, wherein the method comprises steps of: providing a detecting device; and the device comprises a carrier for accommodating a testing element; the carrier is located in a chamber; the carrier is fixedly connected with a movable element on the chamber such that the movable element has a locked first position and a second position.
[0114] 22. The method according to clause 21, wherein the movable element is fixed on the chamber via a locking structure.
[0115] 23. The method according to clause 21, wherein the movable element is allowed to be unlocked, and then the movable element moves to the second position from the first position, thus driving the carrier to move from the first position to the second position.
[0116] 24. The method according to clause 21, wherein the carrier is located in the chamber and not exposed when the movable element is located in the first position; the carrier is exposed outside the chamber and in contact with a liquid sample when the movable element is located in the second position.
[0117] 25. The method according to clause 24, wherein providing an accommodating device, wherein the accommodating device is used for holding the collector; the collector is first inserted into the accommodating device, and then the movable element moves to the second position from the first position.
[0118] 26. The method according to clause 24, wherein the collector is configured on the detecting device; a portion of the detecting device is allowed to get into an accommodating chamber and seal the accommodating while the collector is inserted into the accommodating device.
[0119] 27. The method according to clause 23, wherein the movable element is coupled to a sliding rail via a sliding groove to move from the first position to the second position.
[0120] 28. The method according to clause 27, wherein the sliding rail is configured on the chamber of the movable element; and the sliding groove is disposed on an outer wall of the chamber for holding the carrier.
[0121] 29. The method according to clause 22, wherein the locking structure comprises a bulge structure located at the movable element and a notched structure located on the chamber and used for receiving a bulge.
[0122] 30. The method according to clause 29, wherein when the movable element is located in a locking position, the bulge structure is located in the notched structure; when the movable element is located in an unlocking state, the bulge structure is separated from the notched structure.
[0123] All patents and publications mentioned in the description of the present invention are disclosures of the prior art and they may be used in the present invention. All patents and publications referred to herein are incorporated in the references as if each individual publication is specifically referred to separately. The invention described herein may be practiced in the absence of any one or more of the elements, any one limitation or more limitations that are not specifically recited herein. For example, the terms “comprising”, “consisting of ...substantively” and “consisting of ...” in each example herein may be replaced by the rest 2 terms. The so-called “a/an” herein merely means “one”, but does not exclude including 2 or more instead of including only one. The terms and expressions which have been employed herein are descriptive rather than restrictive, and there is no intention to suggest that these terms and expressions in this description exclude any equivalents, but it is to be understood that any appropriate changes or modifications can be made within the scope of the present invention and appended claims. It should be understood that, the embodiments described in the present invention are some preferred embodiments and features, and any person skilled in the art may make some changes and variations based on the essence of the description of the present invention, and these changes and variations are also considered to fall into the scope of the present invention and the independent claims and the appended claims.