The present application claims priority to a Chinese prior application No. CN2022105647065 and filed on May 23, 2022, a Chinese prior application No. CN2022106085309 and filed on May 23, 2022, as well as a U.S. prior provisional application No. 63/352,036 and filed on Jun. 14, 2022, and a UK prior application No. GB2208268.9 and filed on Monday, Jun. 6, 2022; the entire contents of the above application, including the description, claims, abstract and abstract drawings of which are incorporated herein as a portion of the present invention.
The present invention relates to a device for collecting and detecting a liquid sample, in particular, a device for collecting and detecting an analyte in a liquid sample in the field of rapid diagnosis, such as a urine and saliva collection and testing device.
The following description is merely an introduction to the background art and not to limit the present invention.
At present, the test device for detecting the presence or absence of an analyte in sample is widely used in hospitals or homes, and such test device for rapid diagnosis comprises one or more test strips, such as early pregnancy detection, drug abuse detection, etc. The test device for rapid diagnosis is very convenient, and the test result can be obtained from the test strip after one minute or no more than ten minutes.
The drug detection is widely used by drug control department, Public Security Bureau, drug rehabilitation centers, physical examination centers, the national conscription offices, etc. The drug detection is diverse and frequent. Some detections need to collect samples and then samples are detected in professional testing agency or testing laboratories, and some detections needs to be completed in the site in time, for example, roadsides, for example, persons who drive after drug use need to be tested on the spot (referred to as “Drug Driving”), to obtain the results in time.
For example, the detection of saliva samples is gradually accepted and favored by testing agencies or testing personnel due to convenient collection. In some literatures, various sample collection and test devices for clinical and domestic uses have been obtained and described. For example, the U.S. Pat. No. 5,376,337 discloses a saliva sampling device in which a piece of filter paper is used to collect saliva from the mouth of a subject and deliver saliva to an indicator reagent. The U.S. Pat. Nos. 5,576,009 and 5,352,410 have disclosed a syringe-type fluid sampling device.
For another example, a US patent application with the application number of Ser. No. 14/893,461 and publication number of US2016/0121322A1 discloses a test device for a sample; the patent only discloses some basic detection schemes and principles, and appears more difficult in the actual implementation of a specific product. For example, how to compress the pipet tip for absorbing saliva and how to move it if the cover body combination is matched with the detection combination, as well as how to mix with liquid effectively, the practical effects are undesirable.
Moreover, a large number of plastics are used as the package or carriers of a testing element of these test devices above, which brings huge challenge for the subsequent environmental treatment, causes high cost in production and processing. Furthermore, practical detection operation is tedious, and it is complex for some personnels of non-professional institutes. If it is easy for a person without any medical background to operate the device, the device is more universal and popular to the control of diseases.
In view of the above technical problems in some conventional products, it is necessary to improve them and provide an alternative approach to solve the drawbacks of the prior art.
Directed to the above situation, to overcome the shortcomings in the prior art, the objective of
the present invention is to provide a device for detecting an analyte in a fluid sample; paper is used as a test carrier of the device, and a testing element is disposed in the carrier, and the paper carrier is capable of achieving changes in shape arbitrarily, which is convenient for detection and easy to be stored and treated after the detection is finished.
In one aspect, the present invention provides a test device, including a housing accommodating a testing element, where the housing is formed by folding.
In some embodiments, the housing is made of a paper material, and formed by folding the paper material to form the housing to contain the test element therein.
In some embodiments, the folded housing may be opened for test when in need of detection.
In some embodiments, when the housing is opened partially, the sample application area of the testing element is exposed such that the sample application area can receive a liquid sample or contact a liquid sample. In some embodiments, the opened carrier may be closed once the sample is received such that a receiving area of the testing element is located in the housing to be protected, expectedly, protected by the closed part of the housing.
In some embodiments, the foldable housing may be kept standing by relying on the opened structure of the housing when opened, and the testing element is kept standing within the housing as well. In some embodiments, when the housing is standing, the sample application area of the testing element may be allowed to be in the liquid sample. In some embodiments, the liquid sample is contained in a container; the sample application area of the testing element is standing in the container, and the opened structure is standing at both sides of the container.
In some embodiments, the housing or the carrier includes the testing element therein, and the testing element includes a test area for testing an analyte in a liquid sample and a sample application area for contacting the liquid sample, and the test area is in fluidic communication with the sample application area.
In some embodiments, the housing or the carrier includes a window for reading the test area of the testing element.
In some embodiments, the housing or the carrier includes a space for accommodating the testing element therein, and the space is occupied by the testing element or the space is used for bearing the testing element thereon.
In some embodiments, the folding refers to multi-folding of an integral paper sheet. In some embodiments, the folding is performed on the basis of fold lines. In some embodiments, the sheet is a rectangle, and the sheet includes fold lines and is folded along fold lines to form the housing or carrier.
In some embodiments, the folding of the fold lines renders the housing to be in different states, thus achieving the contact between the testing element and the liquid sample and obtaining a test result, or reading a test result.
In some embodiments, the housing has different states, in case of being in different states, the housing is capable of achieving the contact between the testing element and the liquid sample and obtaining the test result, or reading the test result.
In some embodiments, the states refer to a first closed state and a second open state; in case of being in the first state, the testing element is fully covered by the housing; in case of being in the second state, a portion of the sample application area of the testing element is exposed to contact the fluid sample, and then the housing may change into the initial state from the open state.
In some embodiments, the housing includes one or two elements capable of being in closed and open states; the elements are in the closed or open state such that the housing is in the different closed or open state.
In some embodiments, the closed or opened elements are covered on or around the sample application area of the testing element. When the two elements are opened, a part of the sample application area is exposed, or completely exposed; when the two elements are in the closed state, the sample application area is located between the two elements, thus being protected or covered by the two elements, or deposited in the sample that formed by the closed two elements.
In some embodiments, when the elements are in the open state, the two elements allow the housing or carrier to be in a standing state or the whole house can be standing status depending on the two elements.
In some embodiments, when the elements are in the closed state, the two elements are closed via a closing structure or a closing device, or a locking structure.
In some embodiments, the elements are closed by the closing structure including a buckle, a splice, a lock catch, a snap fastener and a magnet.
In some embodiments, the magnet renders the elements to be closed via attraction of positive and negative electrodes, or the elements are closed via a magnetic magnet and a metal with attraction.
In some embodiments, when the fluid sample is contained by the container, the two elements to be opened are standing at both sides of the container such that the carrier is in a standing state, and the sample application area of the testing element is inserted into the container to contact the fluid sample. In some embodiments, the sample application area of the testing element is drawn from the container once contact such that the two elements are closed. A test result of the test area is then read, or a test result on the test area is read through a window after the sample application area of the testing element contacts the fluid sample. The reading here may be implemented via naked eyes, photographing and other ways.
In the other aspect, the present invention provides a test device; the device is formed by folding a card; the card includes a folding area with a slot, a window area with a window, a supporting area with a side for supporting the testing element, and movable areas connected with the window area and the supporting area; after being folded, the folding area, the window area and the supporting area are bonded with each other as to protect the test area being moved ; and the movable areas are located at both sides of the testing element. The movable areas may be in a closed or open state.
In some embodiments, the present invention provides a test device; the device is formed by folding a card; the card includes an area with a slot, a window area with a window, a supporting area with a side for supporting the testing element, and movable areas connected with the window area and the supporting area; after being folded, the slot area is bound on the supporting area; the window area is bound on the slot area; and the movable areas are located at both sides of the testing element, being in a state capable of being closed or unfolded.
In some embodiments, two movable areas are provided with a structure which renders the movables areas to be closed or expanded or opened. Elements may be closed by the closing structure, in some embodiments, via buckling, splicing, locking, pressing and a magnet. When elements need to be expanded, the buckling, splicing, locking, or pressing structure is removed, or the magnet is separated to remove the closing. In some embodiments, the unfolded state includes separation; and movable elements serve as a supporting structure to make the test device standing by itself. In some embodiments, the expanding of the movable areas includes that the movable areas overturn to cover on the window area or the supporting area.
In some other embodiments, the card is made of a paper material.
In some other embodiments, the present invention provides a test device, including a window area and a supporting area; the window area is hinged to the supporting area. In some other embodiments, a bonding area for bearing the testing element is disposed on the supporting area, and the testing element is bound on the bonding area. In some embodiments, the test area of the testing element is bound on the supporting element. In some embodiments, a drying agent is stick on the bonding area of the supporting area; the drying agent has double-sided pasting functions; the test area of the testing element is stick on the drying agent. In some embodiments, there are two movable areas connected to the window area and the supporting area; the movable areas are in a closed or an expanded state; in case of being the closed state, the sample application area of the testing element is covered or protected by the closed area; in case of being in the expanded state, the expansion of the movable areas forms a certain included angle to play the supporting role, for example, the way as shown in
In the other aspect, a method for detecting an analyte in a fluid sample is provided; the method includes:
The area for bearing the sample application area is in the open state to expose the sample application area such that the sample application area of the testing element is in contact with the liquid sample.
In some embodiments, the area for bearing the sample application area is in the open state to expose the sample application area such that the sample application area of the testing element is inserted into the container containing the liquid sample.
In some embodiments, the area includes one or more elements capable of being opened; the sample application area of the testing element is wrapped or covered by the element; when the element is opened, the sample application area of the testing element is inserted into the container containing the liquid sample and the opened element is located around the container to make the housing standing vertically such that the testing element is inserted into the container in a vertical way.
In some embodiments, the testing element, or the sample application area of the testing element is drawn out of the container. In some embodiments, the drawing way refers that the sample application area is driven by the housing to leave the container containing the liquid sample.
In some embodiments, the opened element is closed after the sample application area leaves the container containing the liquid sample such that the sample application area of the testing element is wrapped by the element again or covered on a space formed by closing the element.
In some embodiments, there are two elements which may be opened or closed after being opened; the two elements are located at both sides of the sample application area, separately when opened.
In some embodiments, bonding elements are disposed at tail ends of the two elements such that the two elements may be opened easily and bound together easily when assembled. In some embodiments, the bonding element includes a buckle, magnetic adsorption, a magnet and the like.
Beneficial Effects
The use of the above structure may reduce the cost of rapid diagnosis. If a paper material is used as a buckle bearing a sample and the sample is not applied with a water dropper, but the carrier is opened directly, and the area of the testing element contacts liquid to achieve detection. Therefore, the present invention is more suitable for household detection and omits tedious steps, thus achieving simpler and more convenient operation.
present invention.
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
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
The samples that can be detected by the test device 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. 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.
The suitable test device of the present invention may be used to detect any analyte. Preferably, the present invention is utilized to detect small molecules of drugs in saliva and urine. Of course, any form of samples, either initially solid or liquid, can be detected by the test device in the present invention, as long as these liquid or liquid samples can be absorbed by the sample application area of the testing element. The sample application area here is generally prepared from a water absorbent material. It can absorb liquid or fluid specimens by capillary or other characteristics of the absorbing element material such that liquid samples flow in the sample application area. The material of the sample application area of liquid samples can be any liquid absorbing material such as sponge, filter paper, polyester fiber, gel, non-woven fabric, cotton, polyester film, yarn, etc. Of course, the sample application area of fluid samples 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 sample application area of liquid samples 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 sample application area of liquid samples. In need of detection, a buffer solution is added to the sample application area to dissolve the sample such that the dissolved sample flows on the testing element or detecting element.
In some embodiments, the fluid sample is not manually applied onto the sample application area of the testing element in the present invention, but the sample application area may be directly inserted into the fluid sample; the sample application area may be directly taken out or removed after being inserted, and also may be kept in the fluid sample until the completion of the test. During the process, the sample application area is kept upright by means of own structure without manual help. It will be further described in detail with reference to detailed examples below.
Downstream and Upstream
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, in the test device 10 of the present invention, after the testing element 20 absorbs fluid samples or liquid samples, the fluid can flow from the sample application area 202 of the testing element to the test area 201 of the testing element 20. At this time, the liquid flow from the sample application area 202 to the test area 201 is flow from the upstream to the downstream. During the flow, the test area 201 has a detecting area 905 and a detecting result control area 906. The test area may be a polyester fiber film and the sample application area may be a glass fiber. At this time, the sample application area or absorbing area 202 is located at the upstream of the test area of the testing element. The specific structure of the testing element is shown in
Gas Communication or Liquid Communication
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.
Testing Element
The “testing element” used herein refers to an element that can be used to detect whether a fluid specimen or a fluid sample (a liquid specimen or a liquid 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.
Various testing elements can be combined for use in the present invention. One form of the testing elements is 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 test 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 test area. Other reagents such as molecules that specifically bind to analyte are fixed in the test 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. A marker used to display the detection signal exists in the reagent area or the detached labeled area.
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.
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.
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.
Each area of the test paper can be arranged in the following way: sample application area 202, reagent area, test area 201, control area, area determining whether the sample is adulterated, and liquid sample absorbing area. The control area or control line 906 is located behind the test area or the test line 905. 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.
The nitrocellulose membrane test strip is commonly used, that is, the test 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 test devices in this invention for analyte detection, such as the detection of the analyte in the samples: U.S. Pat. Nos. 4,857,453; 5,073,484; 5,119,831; 5,185,127; 5,275,785; 5,416,000; 5,504,013; 5,602,040; 5,622,871; 5,654,162; 5,656,503; 5,686,315; 5,766,961; 5,770,460; 5,916,815; 5,976,895; 6,2485,98; 6,140,136; 6,187,269; 6,187,598; 6,228,660; 6,235,241; 6,306,642; 6,352,862; 6,372,515; 6,379,620, and 6,403,383. 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 test device of the present invention for the detection of an analyte, for example, the detection of an analyte in a sample.
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 (
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 test device by itself to detect an analyte in a sample. Therefore, the test 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, specifically described as follows: when the receiving device is described to treat a fluid sample, the testing element may be used for detection alone.
Analyte
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 test 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.
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.
Carrier Element
In some detailed embodiments, the testing element may be also disposed on some carrier elements; then the carrier elements contain the testing element therein to complete the detection and assay of the analytes in fluid samples. Therefore, in some embodiments, the test device includes a carrier, and the carrier is provided with a testing element. In some embodiments, the carrier of the present invention is a housing used for bearing or accommodating the testing element terein; the carrier element does not participate in the detection directly by itself, but serves as a carrier or a housing used for bearing or accommodating the testing element. In some embodiments, the housing or carrier of the present invention includes a trough structure, and the structure is used for limiting the position of the testing element on the carrier. One or more trough structures here may be available. Each trough body is provided with a testing element, and the testing element may be used for testing the number or presence of analytes in a sample.
In some embodiments, as shown in
In some embodiments, the test tube has a standing structure by itself. As shown in
In some embodiments, the device has a packaging box 60; the packaging box has an insertion hole 70 such that the test tube is inserted. At this time, the application area 202 of the testing element in the test device is directly inserted into the test tube; the opened elements 104 and 108 allow the test device to stand on the box body. The box body of the present invention may be further a packaging box in UK and European applications, as described in UK application number 6191823 and European application number 008867121. The packaging box described herein may be used for storing the test device 10 or 200 of the present invention.
In some embodiments, the housing of the test device of the present invention is not just like a traditional plastic housing; all the traditional plastic housings include upper and lower face plates; the face plates have trough structures such that the testing element is located in the housing, for example, as described in European patent application EP2120048A1, US patent application US20070287198A1 and PCT patent application WO2013096804A2, the test device includes upper and lower face plates, and is formed by mold injection molding, and then the testing element is placed into the two face plates, thus being integrated into the housing. The housing of the present invention is formed by folding a card. Firstly, the folding process is very simple and requires no a mold for injection molding. The folding of a paper or paper card omits the injection molding process, which not only reduces the production cost, but also greatly reduces the adverse impacts of plastic degradation and disposal on the environment. Moreover, when a card made of a paper material is folded to form the housing, the weight is also greatly reduced to save the transportation cost. When the paper is biodegradable, compared with plastic, the paper device greatly decreases environmental pollution.
Therefore, in some embodiments, the housing of the test device of the present invention is formed by folding an integral paper card.
In some embodiments, the folded slot 101 is mainly used for accommodating the test area 201 of the testing element or an water absorbing area 903 downstream of the test area; of course, if the folded slot 101 is long enough, a labeled area 904 may be accommodated. Antibodies, antigen reagents, and the like necessary to the detection are treated on the test area and the labeled area in the whole testing element, and these components are preferably kept in a fixed position and protected. In such a folding way, the portion with a window 102 covers on the test area 201 to expose the test area 201. The folded slot 101 is divided into two overlapped slot structures 1013 and 1014. After being folded, the slot area 101 is located on the surface 103. In this way, the surface 103 and slot opening 101 form an integrated slot structure for fixing the testing element therein. The surface 103 may be called a supporting face used for binding with the slot to support the testing element. In some embodiments, the length of the slot opening 101 in the slot area after being folded is generally greater than the test area of the testing element, for example, when the testing element also has an absorbing area, the test area 201 and the absorbing area of the testing element are located in the slot. For example, the length of 1014 may accommodate the test area 201 and the absorbing area of the testing element 20 or the labeled area. The length of the window 102 covering on the trough body only shows the test area 201, thus exposing the window area (as shown in
The movables area 108 or 104 is provided with a functional structure which allows the two movables areas to be bound. The structure may render the movables areas to be closed, and such a closed function may be removed. The movables area 108 or 104 is allowed to be closed or unfolded according to the requirements such that the sample application area of the testing element is exposed to be in contact with fluid samples. For example, as shown in
To make the test device being in an intact assembly state, glue may be coated on the window area 107, the slot areas 1012 and 1011 and the supporting area 103 such that faces of the areas contact and are bonded with each other, but the movables areas are not glued. Of course, to fix the testing element better, the supporting face may be glued such that the testing element is fixed on the supporting face. The portion of the testing element located at the movable areas is not glued such that the movable areas are closed or expanded, thus exposing the sample application area 202 of the testing element.
In some other embodiments, a paper card is provided, and the card is provided with a plurality of openings or windows which are folded to form a test card or a test device containing a testing element therein. For example,
In case of being in the open state, the movable areas 203,205 are folded reversely such that the movable areas cover on the window area 202; and the window 2031 on the movable area 203 is overlapped with the window 2021 on the window area 202. Another movable area 205 is also folded reversely to be back to back with the supporting area 204; and the movable area 205 covers on the supporting area 204 to form a structure as shown in
The closed or expanded state between the movable areas 203,205 may be achieved without any extra structure such that the movable areas are in a free closed or expanded or open state. However, to protect the testing element therein better, the movable areas are allowed to be in a closed or expanded state via an extra structure. The structure here which allows the movable areas to be in a closed or expanded state may be any structure capable of making two surfaces bonded with each other. The structure is operated to achieve the expanding state of the movable areas when necessary.
Such a structure which allows the movable areas to be in a closed or expanded state may be any achievable structure, for example, a clamping mode, the movable area 108 has openings, and some similar bolts are cut on another movable area 104. In this way, in need of being closed, the bolts are inserted into the openings to form a closed state, and the bolts are formed by cutting on the movable area 104 and located in the same position with the plane of the movable area 104 when not used and hidden in the plane 104. The bolts are exposed when necessary, for example, the cut bolts are kept vertical to achieve the coordination between the bolts and holes, thus achieving the closed state. Of course, a similar snap button may be also arranged on the movable area, and the snap button has a hole, and another movable face 104 is provided with a bolt. In need of being closed, the bolt is directly inserted into the hole to achieve the closed state; in need of being expanded, the bolt is removed from the insertion hole such that the movable area is expanded. In some embodiments, a magnetic piece 106 is pasted on the movable area 108; one paster or one magnetic piece is pasted on another movable area 105. When the movable areas need to be closed, two sides are made close with each other directly to achieve the closed state due to magnetic attraction, in need of being expanded, two movables areas 108 and 104 are allowed to be expanded. In some embodiments, the movable area 205 is allowed to cover on the supporting face 204, and the movable area 203 with a window area 2031 is allowed to cover on the window area 202. In this way, the two movable areas with magnetic attraction 2051,2039 are made close with each other such that two faces are close together with attraction, and each face covered is not easy to get back into shape at least, as shown in
In some embodiments, the movable area 108 and another movable face 104 are pasted with N paster, and the N paster may also achieve free closed or expanded state.
In another detailed embodiment, for example, as shown in
In some other embodiments, for example, as shown in
Test Device
The test device refers to a device for detecting the presence or absence of an analyte in a sample, including a testing element; the testing element is an element used for testing an analyte in a liquid sample. In some embodiments, the test device of the present invention may also include a container accommodating a fluid sample, and the container allows the sample application area of the testing element in the test device to be directly inserted, thus being in contact with the fluid sample. In some embodiments, the container accommodating a fluid sample may be a test tube; the test tube may be kept in a test tube stand (as shown in
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 present 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.
Number | Date | Country | Kind |
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2022105647065 | May 2022 | CN | national |
2022106085309 | May 2022 | CN | national |
2208268.9 | Jun 2022 | GB | national |
Number | Date | Country | |
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63352036 | Jun 2022 | US |