A device for detecting an analyte in a liquid sample

Abstract

The invention provides a device for detecting an analyte in a sample, comprising: a cavity for receiving a test element, the test element having a first position and a second position within the cavity, when in the first position the test element does not contact a fluid sample, when in the second position the test element contacts a fluid sample.

Description

[0001] Cross-references

[0002] This application claims priority to the prior Chinese applications, No. 2022103771424, filed April 11, 2022; and No. 2022102544334, filed March 15, 2022; and the prior U.S. provisional applications, Nos. 63 / 333,299, filed April 21, 2022; and 63 / 327,048, filed April 4, 2022. All contents of the foregoing applications, including the specification, drawings, and claims, are part of this invention. Technical Field

[0003] This invention relates to an apparatus for collecting and detecting liquid samples, particularly an apparatus for collecting and detecting analysible substances in liquid samples, such as urine and saliva collection and detection apparatus, in the field of rapid diagnostics. Background Technology

[0004] The following background information is merely a general overview and does not constitute any limitation on the present invention.

[0005] Currently, testing devices used to detect the presence of analytes in samples are widely used in hospitals and homes. These devices, applied to rapid diagnosis, contain one or more test strips, such as for early pregnancy testing and drug abuse testing. These rapid diagnostic devices are very convenient, providing results on the test strip in one minute, or at most ten minutes.

[0006] Some tests require sample collection and then professional testing institutions or laboratories for analysis. Others require on-site testing, such as at the roadside, to ensure timely results. For example, saliva sample testing has become increasingly accepted and welcomed by testing institutions and personnel due to its ease of collection. Various sample collection and testing devices for clinical or home use are already available and described in the literature. For instance, US Patent 5,376,337 discloses a saliva sampling device in which a filter paper is used to collect saliva from the subject's mouth and transfer the saliva to an indicator reagent. US Patents 5,576,009 and 5,352,410 each disclose a syringe-type fluid sampling device.

[0007] Furthermore, with the prevalence of infectious diseases in recent years, home testing has become a mainstream product. For home testing, sampling is convenient and the operation is user-friendly, while also preventing environmental contamination and potential transmission. This places higher demands on home testing products.

[0008] In view of the technical problems of some of the traditional products mentioned above, it is necessary to improve them and provide alternative ways to solve the shortcomings of existing traditional technologies, so as to meet the growing demand for in vitro diagnostics, especially the demand of the home self-testing market. Summary of the Invention

[0009] In view of the above, and to overcome the shortcomings of the prior art, the present invention aims to provide an apparatus for detecting the analyte in a fluid sample, and a receiving device for receiving the detection apparatus in conjunction with the detection apparatus. The receiving device includes a cavity containing a liquid chamber for containing liquid and an insertion chamber for receiving inserted test elements. The term "receiving" in the receiving device does not limit its specific application; it can be referred to as a liquid handling or mixing device, or a liquid sample transfer or transport device; therefore, it can be simply called an apparatus.

[0010] According to a first aspect of the present invention, an apparatus for detecting an analyte in a sample includes: a cavity for receiving a test element, the test element having a first position and a second position within the cavity, wherein when in the first position the test element does not contact the fluid sample, and when in the second position the test element contacts the fluid sample.

[0011] In some specific embodiments, the receiving test element cavity is further provided with a fluid sample collector, which is disposed at one end of the cavity. In some embodiments, the sample collector is detachably combined with the cavity. In some embodiments, the sample collector is a sponge swab or a flocked swab for collecting fluid samples. In some embodiments, the sample collected by the collector cannot or will not flow directly onto the test element. In some embodiments, the collector is treated, mixed, or eluted by a solution located in the cavity, and then a portion of the test element is allowed to enter the receiving device to contact the solution to complete the detection. In some embodiments, the portion of the test element includes a sample receiving area or a sample application pad for the test element.

[0012] In some embodiments, the cavity for receiving the test element further includes a carrier for carrying the test element, the carrier having a first position and a second position within the cavity, the carrier driving the test element to change position or move between the first and second positions.

[0013] In some embodiments, the device further includes a sliding element connected to the cavity of the receiving test element via a locking structure. Here, "connection" refers to a connection at a relatively fixed position. When locked, the sliding element is fixed to a relatively fixed position on the cavity; when unlocked, the sliding element can move or slide on the cavity. The sliding method allows it to slide from a first position to a second position. In some embodiments, the sliding element is connected to a carrier; when the sliding element is in the locked position, the carrier does not move relative to the cavity of the receiving test element. In other embodiments, when the locking structure is unlocked, the sliding element can move relative to the cavity of the receiving test element, thereby driving the movement of the carrier. In some embodiments, when the carrier is in the first position, it is fixed to or within the cavity of the receiving test element via the locking structure; when unlocked, the carrier moves from the first position to the second position by moving the locking structure. In some embodiments, when the carrier is in the first position, the sliding element is fixed to or within the cavity of the receiving test element via the locking structure; when unlocked, the carrier moves from the first position to the second position by moving the sliding element.

[0014] In some methods, the carrier is in a first position where the test element on the carrier does not contact the fluid sample. When the carrier is in a second position, the carrier contacts the fluid sample, thereby allowing the test element to contact the fluid sample. In this way, the flow of the fluid sample on the test element allows the test result to be read in the detection area of ​​the test element.

[0015] In some embodiments, the locking structure includes one or more pin structures, and the cavity receiving the test element includes one or more recessed structures for receiving the pins. When in the locked state, the pins are inserted into the recesses, thereby being fixed or locked. In some embodiments, the sliding element has a pin with a locking structure, and the cavity receiving the test element has a recessed structure for receiving the pins. The sliding element is fixed in a first position relative to the cavity by the locking structure, and after unlocking, the sliding element can slide relative to the cavity.

[0016] In some embodiments, the sliding element includes a connector integrally formed with the carrier and a partial locking structure. In some embodiments, the sliding element can slide along a sliding groove in the cavity. In some embodiments, the sliding can drive the carrier to slide or move from a first position to a second position.

[0017] The so-called "locked structure" includes at least two functions: locking and unlocking. Locking fixes the carrier directly or indirectly relative to the cavity of the receiving test element. Unlocking allows the carrier to move freely relative to the cavity, either directly or indirectly. When a sliding element is included, it incorporates a partial locking structure, while the cavity of the receiving test element includes another locking structure. These two structures work together to achieve either a locked or unlocked state.

[0018] In some embodiments, the sliding element includes a protruding structure, while the cavity receiving the test element has a recessed structure for receiving the protrusion. The cooperation between the protruding structure and the recessed structure functions as a locking structure. In some embodiments, the recessed structure is elastic, while the protruding structure is relatively inelastic. The recessed structure and the protruding structure constitute the locking structure in a specific embodiment of the present invention. When the protruding structure is received by the recessed structure, or when the protruding structure meshes or engages with the recessed structure, the sliding element and the cavity receiving the test element are in a locked state. When the protruding structure disengages from the recessed structure, it is in an unlocked state. In some embodiments, the cavity receiving the test element includes a sidewall, and the recessed structure is located on the cavity and is part of the cavity sidewall. In some embodiments, one end of the recessed structure is connected to the sidewall of the cavity receiving the test element, while the other three sides are not connected to the sidewall of the cavity receiving the test element, thereby giving the recessed structure a certain degree of elasticity. The term "elasticity" here is a relative concept. Relative to the protruding structure, when the protruding structure slides along the recessed structure, it presses against the recessed structure, causing elastic deformation. When the protruding structure enters the recessed structure, the elasticity locks the sliding element onto the cavity. Conversely, when the sliding element needs to move, the protruding structure disengages from the recessed structure, releasing the sliding element from its unlocked state.

[0019] In some embodiments, the device also includes a limiting structure, allowing the sliding element to slide a fixed distance on the cavity receiving the test element. That is, the distance the sliding element travels from the first locked state to the second position is fixed. In some embodiments, the limiting structure is a groove structure on the cavity receiving the test element. In some embodiments, the groove is located on the cavity receiving the test element, and the sliding element is provided with a slide rail. The slide rail slides within the groove. In some embodiments, the groove structure includes a slide rail with a bottom surface, or a groove without a bottom surface that opens through the side wall of the cavity. Here, "receive" indicates the function of the cavity; it can mean that the cavity contains a test element or that it does not contain a test element, indicating the specific purpose of the cavity.

[0020] In some embodiments, the cavity receiving the test element includes a limiting structure protruding inward from the sidewall, which ensures that the carrier can only be inserted into the cavity in a single orientation. The cavity receiving the test element is cylindrical, and the carrier is curved or arc-shaped, having a first surface for supporting the test element and a second surface that contacts the limiting structure. In some embodiments, the arc-shaped carrier has a groove for accommodating the test element, and also includes a protective structure for protecting the test element, located on the sidewall of the groove.

[0021] In some embodiments, the sidewalls of the cavity pass through the interior of the sliding element. In some embodiments, the sliding element includes a cavity structure, or a cavity for sliding, with a first slide rail and a second slide rail disposed on the sidewalls inside the sliding cavity. The first slide rail slides in a groove having a bottom surface, and the second slide rail slides in a groove penetrating the sidewall of the cavity receiving the test element. In other embodiments, the second slide rail is used to connect to a carrier. Thus, when the sliding element slides, it slides on the cavity via the slide rails, thereby allowing the carrier to move within the cavity. In some embodiments, a through-opening groove divides the cavity receiving the test element into a first part of the cavity sidewall and a second part of the cavity sidewall, with the first part of the cavity sidewall and the second part of the cavity sidewall for receiving the test element distributed on both sides of the second slide rail, thereby passing through the interior of the cavity of the sliding element. In this way, the sliding element can slide outside the cavity receiving the test element, causing the carrier inside the cavity to move within the cavity. Thus, the cavity for receiving the test element actually passes through the sliding element and moves relative to it. In some embodiments, the movable element includes a first and a third slide rail, as well as a second and a fourth slide rail, symmetrically distributed. The first and third slide rails move in grooves with bottom surfaces, while the second and fourth slide rails move in open grooves within the receiving cavity.

[0022] In some embodiments, the test element on the curved carrier includes a detection area and a sample application area that contacts the sample. In some embodiments, the detection area is located near one end of the cavity or near a sliding element, while the sample application area is located near the other end of the cavity. In some embodiments, the other end of the cavity receiving the test element is used to mate with or be inserted into a receiving cavity. Thus, when the carrier is moved from a first position to a second position by the sliding element, one end of the carrier is inserted into or enters the receiving cavity, and the sample application area of ​​the test element on the carrier comes into contact with the liquid in the receiving cavity, such as a liquid sample, a mixture of liquid and liquid samples, or a fluid sample. The liquid then flows from the sample application area to the detection area via capillary action of the test element, thereby detecting whether the sample contains the analyte.

[0023] In some methods, the receiving chamber includes a solution reagent for processing the sample. In other methods, the sample collector is first introduced into the receiving chamber, followed by a portion of the carrier.

[0024] In some embodiments, the device further includes a receiving cavity for receiving the collector insertion, the receiving cavity being separate from the cavity housing the test element. In some embodiments, the cavity for receiving the collector may also be used to receive a portion of the test element. In some embodiments, the cavity for receiving the collection cavity may also be used to receive the sample application area of ​​the test element. In some embodiments, the receiving cavity includes a reagent for processing the fluid sample. In some embodiments, when the test element is in the second position, the test element is inserted or enters, or is already located in the receiving cavity. In some embodiments, the receiving cavity is pre-sealed with a solution reagent. In some embodiments, the sample application area of ​​the test element is located on a carrier, and when the carrier is in the second position, the sample application area located on the carrier enters the receiving cavity and comes into contact with the fluid sample.

[0025] In some methods, after being positioned in the second position, the carrier can return to the first position and remain fixed there. Upon returning to the first position, the test results on the test element can be read. Alternatively, when the test element or carrier is in the second position, the test results of the detection area can be read. In another method, the cavity receiving the test element includes a window for reading test results; when the test element moves from the first position to the second position, the test area is below the window.

[0026] In some methods, the sample is saliva, nasal mucus, or throat mucus. In other methods, the analyte is a virus, bacteria, or small drug molecules.

[0027] On the other hand, the present invention provides a method for detecting an analyte in a sample, the method comprising:

[0028] A cavity is provided for accommodating a test element, the test element having a locked first position and an unlocked second position in the cavity, the test element being movable from the first position to the second position;

[0029] Specifically, when the test element is in the first position, it does not come into contact with the fluid sample, and when the test element is in the second position, it comes into contact with the fluid sample.

[0030] In some embodiments, the cavity housing the test element also includes a collector for collecting fluid samples.

[0031] In some embodiments, a receiving cavity is provided for engagement or connection with a cavity housing a test element, thereby allowing a collector to be inserted into the receiving cavity. In other embodiments, the collector is first inserted into the receiving cavity, and then the test element is moved from a first position to a second position, allowing a portion of the test element to be inserted into or enter the receiving cavity, or allowing a sample application area to enter or be inserted into the receiving cavity. Upon entering the receiving cavity and contacting the sample, the detection or testing of the analyte begins.

[0032] In some methods, a collector is inserted into a containment chamber, allowing the processing liquid in the containment chamber to come into contact with the collector, thereby dissolving, lysing, and washing the sample on the collector, and mixing the sample with the processing liquid.

[0033] In some methods, the containment cavity is sealed with a processing fluid before the collector is inserted into it. In other methods, the collector is used to collect fluid samples, such as saliva, sweat, blood, urine, sputum, or nasal secretions, before insertion into the containment cavity.

[0034] In some methods, the test element is locked in a first position and unlocked in a second position, allowing the test element to move from the second position to the initial first position and be locked.

[0035] In some embodiments, the device further includes a sliding element that moves the test element from a first locked position to a second position. In some embodiments, the test element is disposed on a carrier, and the sliding element moves the carrier from the first position to the second position. The sliding element and the cavity housing the test element are positioned in a first locked position and a second position, respectively. In some embodiments, the second position may or may not be a locked position.

[0036] In some embodiments, the movement of the sliding element from the first position to the second position is fixed. In some embodiments, the sliding element is fitted outside a cavity that houses the test element, and the test element or carrier is located inside the cavity that houses the test element.

[0037] In some embodiments, the sliding element includes a locking bolt that locks to a cavity housing the test element, and a slide rail that slides on the cavity housing the test element, wherein the locking bolt and the cavity or test chamber may be in a locked state.

[0038] Beneficial effects

[0039] Using the above structure, home self-testing can be achieved. It is easy to operate and less prone to errors, while reducing environmental pollution and harm to the operator. Attached Figure Description

[0040] Figure 1 This is a three-dimensional structural diagram of the assembly structure (assembly of the detection device and the housing device) in a specific embodiment of the present invention.

[0041] Figure 2 This is an exploded structural diagram of a testing device in a specific embodiment of the present invention (the detection device and the housing device are separated).

[0042] Figure 3 This is a three-dimensional exploded view of the detection device in a specific embodiment of the present invention.

[0043] Figure 4 This is an exploded structural diagram of a housing cavity and collector for housing test elements according to a specific embodiment of the present invention.

[0044] Figure 5 This is a schematic diagram of the cover body in a specific embodiment of the present invention.

[0045] Figure 6 This is a three-dimensional structural diagram of a cavity for containing a carrier in a specific embodiment.

[0046] Figure 7 This is an enlarged structural diagram of the cavity of a housing carrier, labeled A, in a specific embodiment.

[0047] Figure 8 This is a partial cross-sectional structural diagram of the cavity of a housing carrier according to a specific embodiment.

[0048] Figure 9 This is a schematic diagram of the carrier structure in a specific implementation.

[0049] Figure 10 This is a schematic diagram of a carrier structure in a specific implementation.

[0050] Figure 11 This is a schematic diagram of a carrier structure in a specific implementation.

[0051] Figure 12 This is a three-dimensional structural diagram of the sliding element.

[0052] Figure 13 This is a schematic diagram of the cross-sectional structure of the sliding element.

[0053] Figure 14 This is a schematic diagram of the connection between the sliding element and the carrier.

[0054] Figure 15 It is a schematic diagram of the sliding element, the carrier, and the cylindrical cavity structure.

[0055] Figure 16 This is a schematic diagram of a sliding element in the first locking position according to one embodiment.

[0056] Figure 17 This is a schematic diagram of the structure in one embodiment where the sliding element is located in the second position.

[0057] Figure 18 This is a cross-sectional structural diagram of the cover covering the cavity opening in another embodiment. Detailed description

[0058] The structures involved in this invention or the technical terms used therein will be further described below. Unless otherwise specified, they shall be understood and interpreted in accordance with general terms commonly used in the art.

[0059] Detection

[0060] A test indicates the presence or absence of a substance or material, such as, but not limited to, chemical substances, organic compounds, inorganic compounds, metabolites, drugs or drug metabolites, organic tissues or their metabolites, nucleic acids, proteins, or polymers. Additionally, a test indicates the quantity of the substance or material being tested. Furthermore, tests also include immunoassays, chemical assays, enzyme assays, etc.

[0061] sample

[0062] The detection device of the present invention can detect samples or the collector can collect samples or specimens including biological fluids (e.g., case fluids or clinical samples). Liquid samples or fluid samples can be derived from solid or semi-solid samples, including excrement, biological tissues, and food samples. Solid or semi-solid samples can be converted into liquid samples using any suitable method, such as mixing, crushing, softening, incubating, dissolving, or digesting solid samples by enzymatic action in a suitable solution (e.g., water, phosphate solution, or other buffer solution). "Biological samples" include samples derived from animals, plants, and food, such as urine, saliva, blood and its components, cerebrospinal fluid, vaginal secretions, sperm, feces, sweat, secretions, tissues, organs, tumors, cultures of tissues and organs, cell cultures, and media derived from humans or animals. Preferred biological samples are urine; more preferably, biological samples are saliva, sputum, nasal secretions, etc. Food samples include food processing substances, final products, meat, cheese, wine, milk, and drinking water. Plant samples include those derived from any plant, plant tissues, plant cell cultures, and media. "Environmental samples" originate from the environment (e.g., liquid samples from lakes or other water bodies, sewage samples, soil samples, groundwater, seawater, and wastewater samples). Environmental samples may also include sewage or other wastewater.

[0063] Using suitable detection or testing elements of this invention, any analyte can be detected. Preferably, this invention is used to detect small drug molecules in saliva and urine. More preferably, it can detect small molecules such as viruses and bacteria in saliva, throat, or nasal fluid. The collector 201 of this invention can collect samples of any form, whether initially solid or liquid, as long as these liquids or liquid samples can be absorbed by the absorption element 2022, which is generally located on the collector. The absorption element 2022 is generally made of absorbent material and is initially dry. Through the capillary or other properties of the absorption element material, it can absorb liquid or fluid samples, keeping the fluid sample within the absorption element. The absorbent material can be any material capable of absorbing liquids, such as sponge, filter paper, polyester fiber, gel, non-woven fabric, cotton, polyester film, yarn, flocking, etc. When using flocked swabs, the flocked swabs described in the following patents can be used to collect fluid samples as part of this invention: US8,114,027, US8,317,728, US8,979,784, US9,011,358, US9,173,779, US10,327,741, AU2004226798, JP4579902, ZL200610099310.9. In some embodiments, the absorbent element 2022 is rigid when dry, such as a sponge, and softens when wet. After softening, it can be compressed to release liquid. Of course, when it is a relatively sparse sponge, such as a sponge-like material, it can also absorb liquid samples in small amounts, such as 5-100 microliters. For example, the sponge swab described in U.S. Provisional Patent Application No. 63 / 300,811, filed on January 19, 2022, is also a specific embodiment of the present invention as a collector.

[0064] Of course, the absorbent element does not necessarily have to be made of a water-absorbing material; it can be made of a non-water-absorbing material. However, the absorbent element has holes, threads, or cavities to collect samples. These samples are generally solid or semi-solid, and they are filled between the threads, holes, or cavities to collect the samples. Alternatively, the absorbent element can be composed of non-water-absorbing fibers or hair, which are used to scrape a solid, semi-solid, or liquid sample, allowing the sample to be retained on the absorbent element.

[0065] Downstream and upstream

[0066] Downstream or upstream is a classification based on the direction of liquid flow. Generally, liquids or fluids flow from upstream to downstream. A downstream region receives liquid from an upstream region, and liquid can also flow upstream to downstream. This classification is generally based on the direction of liquid flow. For example, in some materials where capillary force drives liquid flow, the liquid can overcome gravity and flow in the opposite direction. In this case, upstream and downstream are still classified according to the direction of liquid flow. For example... Figure 10 As shown, the test element 18 mentioned in this invention has a sample application area 183, a marking area 182, a test area 181, and an absorption area 184. The sample application area 183 is upstream of the marking area 182, the test area 181 is downstream of the marking area, and the absorption area is downstream of the test area. Generally, the fluid flows from upstream to downstream along the direction of the test element. In a specific embodiment of this invention, when the test device is vertical, for example... Figure 1 As shown, once the fluid sample comes into contact with the sample application area 183, it overcomes gravity and flows upward due to capillary force, that is, from upstream to downstream. In this way, the liquid sample flows through the marking area 182, then to the detection area 181, and finally to the water absorption area.

[0067] Of course, upstream and downstream here can also refer to the trajectory or direction of an object's movement, not necessarily the direction of liquid flow. For example, during operation, after the absorber inserts the chamber 14 containing the treatment reagent, this chamber is combined with the chamber containing the test element, such as... Figure 1 As shown, once the processing solution inside the container comes into contact with the sampling element 201 of the collector, the sample is processed, such as by dissolving, lysing, or eluting. At this time, the test element located inside the cavity is in its initial position. When testing is required, the container is unlocked, allowing the test element 18 or the carrier 16 supporting the test element to slide within the cavity, thereby moving from the first position to the second position. In the second position, the test element extends from one end of the container cavity 13 (e.g., ...). Figure 17 For example, a sample-applying cavity extends out and directly enters a cavity containing 101 kinds of liquid or liquid sample mixtures to complete the test or detection.

[0068] Gas connection or liquid connection

[0069] Gas or liquid connectivity refers to the ability of a liquid or gas to flow from one place to another, possibly guided by physical structures. These physical structures generally refer to the liquid flowing passively or actively through their surfaces or internal spaces. Passive flow is typically caused by external forces, such as capillary action or pressure. The flow can also be due to the liquid or gas's own forces (gravity or pressure) or be passive. Pressure-driven fluids can flow in the direction of gravity, in the opposite direction, or be propelled by pressure from one location to another. Connectivity does not necessarily require the presence of a liquid or gas; it merely indicates a connection or state between two objects where liquid can flow from one to another. Conversely, if there is no gas or liquid connectivity between two objects, and liquid cannot flow from one object to the other, this state is called non-connectivity, a state where there is no gas or liquid connectivity.

[0070] Detachable combination

[0071] Detachable assembly refers to the connection between two components existing in several different states or positions. For example, when there are two physically distinct components, they can initially be separate, connected or combined under suitable first conditions, and then separated under suitable second conditions—this separation is a physical spatial separation without contact. Alternatively, the two components can initially be combined, and then physically separated under suitable conditions. Or, two objects can initially be separate, combined to perform a certain function when needed, then separated again, or later combined again for a certain purpose. In short, the combination or separation of two entities can be easily performed and can be repeated multiple times; of course, it can also be a one-time combination and separation. Furthermore, it can be a detachable combination between two components, or a detachable combination of three or more components in pairs. For example, with first, second, and third components, the first and second components can be detachably combined, the second and third components can also be detachably combined, and the first and third components can also be detachably combined or separated. Additionally, the combination method can be that the two objects themselves are detachable, or that they can be indirectly combined through other objects. Here, the absorber element 201 can be detachably combined with the cavity 13 for accommodating the test element 18. This detachable combination can be direct or indirect, as will be described in detail below. The carrier 16 carrying the test element and the cavity 13 accommodating the test element 18 are also a detachable combination. Thus, their combination forms a detection device, but when separated, each can have its own purpose. In this invention, after the absorber element 201 is separated from the test element, the absorber element can be sterilized separately, for example, by high temperature, X-ray, radiation sterilization, etc. After sterilization, it is then combined with the test element. This allows fluid communication between the absorber element and the test element, so that liquid from the absorber element can flow from the absorber element to the test element. In some embodiments, the absorber element 201 is fixedly mounted on the cavity 13 accommodating the test element, for example, on one end (e.g., Figure 4 At this point, no test element is assembled on the cavity 13. After sterilization is completed, the test element 18 or the carrier 16 with the test element is inserted into the cavity 13 and fixed on the cavity 13 by the locking structure.

[0072] Test element

[0073] The term "test element" as used here refers to any element that can detect whether a sample contains the analyte of interest. This detection can be based on any technical principle, including immunology, chemistry, electricity, optics, molecular biology, nucleic acid science, physics, etc. A transversely flowing test strip can be used as the test element, capable of detecting multiple analytes. Of course, other suitable test elements can also be used in this invention.

[0074] Various testing elements can be combined and used in this invention. One form is a test strip or a transversely flowing test strip. Test strips used to analyze analytes (such as drugs or metabolites indicating physical condition) in samples can be in various forms, such as immunoassays or chemical analyses. Test strips can employ non-competitive or competitive analytical methods. Test strips generally contain an absorbent material with a sample loading area, a reagent area, and a test area. A fluid or liquid sample is added to the sample loading area and flows to the reagent area via capillary action. In the reagent area, if the analyte is present, the sample binds to the reagent. The sample then continues to flow to the test area. Other reagents, such as molecules that specifically bind to the analyte, are immobilized in the test area. These reagents react with the analyte in the sample (if present) and bind the analyte in that area, or bind to a reagent in the reagent area. A marker for displaying the detection signal is present in or separate from the reagent area.

[0075] In a typical non-competitive analysis model, a signal is generated if the analyte is present in the sample, and no signal is generated if the analyte is not present. In a competitive method, a signal is generated if the analyte is not present in the sample, and no signal is generated if the analyte is present.

[0076] The test element can be a test strip, made of absorbent or non-absorbent material. The test strip can include various materials for liquid sample transfer. One material of the test strip can be overlaid on another, such as filter paper over a nitrocellulose membrane. One area of ​​the test strip can be made of one or more materials, while another area can be made of a different material or one more. The test strip can be adhered to a support or rigid surface to improve its grip strength.

[0077] The analyte is detected by a signal generation system, such as using one or more enzymes that specifically react with the analyte, or by immobilizing a specific binding substance on a test strip as described above, to fix a composition of one or more signal generation systems onto the analyte detection area of ​​the test strip. The signal-generating substance may be in the sample application area, reagent area, detection area, or the entire test strip, and may fill one or more materials of the test strip. A solution containing the signal substance is added to the surface of the test strip or one or more materials of the test strip are immersed in a solution containing the signal substance. The test strip containing the signal substance solution is then dried.

[0078] The test strip's zones can be arranged as follows: sample application zone, reagent zone, detection zone, control zone, sample adulteration detection zone, and liquid sample absorption zone. The control zone follows the detection zone. All zones can be arranged on a single strip using only one material, or different zones can use different materials. Zones can be in direct contact with the liquid sample, or different zones can be arranged according to the direction of liquid sample flow, with the ends of each zone connected to the front of another zone and overlapping. The material used can be highly absorbent, such as filter paper, glass fiber, or nitrocellulose membrane. Other forms of test strips are also possible.

[0079] The most commonly used reagent strips are nitrocellulose membrane reagent strips, where the detection area includes a nitrocellulose membrane (NC). Specific binding molecules are immobilized on the nitrocellulose membrane to display the detection results. Other options include cellulose acetate membranes or nylon membranes, etc. For example, the following patents describe reagent strips or devices containing reagent strips: US 4857453; US 5073484; US5119831; US ​​5185127; US 5275785; US 5416000; US 5504013; US 5602040; US 5622871; US5654162; US 5656503; US 5686315; US 5766961; US ​​5770460; US 5916815; US 5976895; US6248598; US 6140136; US 6187269; US 6187598; US 6228660; US 6235241; US US 6306642; US 6352862; US 6372515; US 6379620; and US 6403383. The test strips disclosed in the above patent documents and similar devices with test strips can be used in the test elements or detection devices of the present invention to detect analytes, such as the detection of analytes in samples.

[0080] The test strips used in this invention can be what are commonly referred to as lateral flow test strips. The specific structure and detection principle of these test strips are well-known to those skilled in the art. Ordinary test strip 18 ( Figure 9 This test strip includes a sample collection area or sample application area 183, a labeling area 182, a detection area 181, and an absorbent area 184. The sample collection area includes a sample receiving pad, the labeling area includes a labeling pad, and the absorbent area may include an absorbent pad. The detection area includes the necessary chemical substances to detect the presence of the analyte, such as immunoassay reagents or enzyme reagents. Commonly used test strips are nitrocellulose membrane strips, where the detection area 181 includes a nitrocellulose membrane, on which specific binding molecules are immobilized to display the detection result area 1811. Other options include cellulose acetate membranes or nylon membranes. Downstream of the detection area, there may be a control area 1812, typically represented by horizontal lines on both the control and detection areas, serving as detection or control lines. Such test strips are traditional; however, other types of test strips utilizing capillary action for detection are also possible. In addition, typical test strips contain dry chemical reagents, such as fixed antibodies or other reagents. When these reagents come into contact with liquid, the liquid flows along the strip via capillary action. As the strip flows, the dry reagents dissolve in the liquid, allowing them to proceed to the next area where they react and trigger the necessary detection. The liquid flow is primarily achieved through capillary action. These principles can be applied to the detection device of this invention, either by placing it in the detection chamber to contact the liquid sample or by detecting the presence or quantity of the analyte in the liquid sample entering the detection chamber.

[0081] Besides the aforementioned test strips or transverse flow test strips being used to contact liquid samples to test whether the liquid sample contains the analyte, the test element of this invention can itself serve as a detection device to detect the analyte in the sample. Therefore, the detection device itself is equivalent to the test element. For example, after the fluid sample is mixed with the processing liquid, it can be directly detected using the test element. A detailed description follows; when describing the receiving device for processing fluid samples, the test element can be used independently for detection.

[0082] Analyzed material

[0083] Examples of analytes applicable to this invention include small molecules, including narcotics (such as drugs of abuse). “Drug of abuse” (DOA) refers to the use of drugs for non-medical purposes (typically for numbing or paralyzing effects). Abuse of these drugs can lead to physical and psychological harm, dependence, addiction, and / or death. Examples of drug abuse include cocaine; amphetamines (AMPs) (e.g., Black Beauty, White Amphetamine Tablets, Dextroamphetamine, Dextroamphetamine Tablets, Beans); methamphetamine (METs) (crank, crystal speed); barbiturates (BARs) (e.g., Valium, Roche Pharmaceuticals, Nutley, New Jersey); sedatives (i.e., sleep aids); lysergic acid diethylamide (LSD); and depressants (downers, goofballs, barbs, blue devils, yellow). Jackets (methaqualone); tricyclic antidepressants (TCAs, i.e., imipramine, amitratriptyline, and doxepin); dimethicone (MDMA); phencyclohexylpiperidine (PCP); tetrahydrocannabinol (THC, pot, dope, hash, weed, etc.); opioid preparations (i.e., morphine (MOP), opium, cocaine (COC), heroin, hydroxydihydrocodeine); anti-anxiety drugs and sedative-hypnotics. Anti-anxiety drugs are a class of drugs mainly used to reduce anxiety, tension, and fear, stabilize mood, and also have hypnotic and sedative effects, including benzodiazepines (BZO). Benzodiazepines, atypical benzodiazepines, fused diazepines (NB23C), benzodiazepines, ligands of benzodiazepine receptors, open-ring benzodiazepines, diphenylmethane derivatives, piperazine carboxylates, piperidine carboxylates, quinazolinones, thiazides and thiazole derivatives, other heterocyclic compounds, imidazole-type sedatives / analgesics (such as hydroxydihydrocodeine oxy, methadone MTD), propylene glycol derivatives—carbamates, aliphatic compounds, anthracene derivatives, etc. The detection device of this invention can also be used to detect drugs intended for medical use but prone to overdose, such as tricyclic antidepressants (imipramine or analogues) and acetaminophen. These drugs are metabolized into small molecules after absorption by the body, and these small molecules exist in bodily fluids such as blood, urine, saliva, and sweat, or are present in some bodily fluids.

[0084] For example, analytes detected using this invention include, but are not limited to, creatine anhydride, bilirubin, nitrite, proteins (non-specific), hormones (e.g., human chorionic gonadotropin, progesterone, follicle-stimulating hormone, etc.), blood, white blood cells, sugars, heavy metals or toxins, bacterial substances (such as proteins or sugars specific to certain bacteria, such as Escherichia coli O157:H7, Staphylococcus, Salmonella, Clostridium, Campylobacter, L. monocytogenes, Vibrio, or Cactobacillus), and physiologically relevant substances in urine samples, such as pH and specific gravity. Any other clinical urinalysis can be performed using a lateral flow detection method in conjunction with the device of this invention. In some embodiments, the processing solution contained in the receiving device does not contain the analyte.

[0085] Detection device

[0086] A detection device is a device used to detect whether a sample contains the analyte. A receiving device is a device that receives a portion of the detection device or allows a portion of the detection device to be inserted into the receiving device for sample mixing or processing, elution of the absorption element 201, and processing of liquid or liquid samples. The receiving device is not specifically designed to receive the detection device; it can exist independently and have the function of processing fluid samples. The detection device may include a test element with testing functions, or a carrier with a test element, or a housing element for the carrier, such as a cavity 13 housing the test element. The detection device may include an absorption element 201 for collecting samples, or an absorption element (collector) with a connecting rod. An absorption element 2022 for collecting samples can also be called a collecting device or a collector, so the collecting device may also include the detection device, or the collector and detection device may be detachably combined. During detection, the collecting device and the detection device are combined to complete the detection. The detection device may also include the collecting device. Alternatively, the collecting device and the detection device may be an integrated structure, allowing immediate detection after collecting the liquid sample to obtain test results. The terms "detection device" and "test element" are interchangeable here.

[0087] The term "receiving device" here is merely for illustrative purposes. In one specific embodiment, the receiving device 14 receives a partial collector, such as receiving an absorption element 2022, or a detection device with an absorption element. When the receiving device is not for receiving functions, it can also be called a sample processing or sample mixing device. During sample processing, a receiving detection device may not be necessary; receiving the absorption element alone may suffice (more details below). In short, the term "receiving" here does not limit the scope of the device, nor does it serve any limiting function in the sense of patent law claims; it is merely a term used for descriptive convenience.

[0088] In some specific embodiments, the detection device of the present invention includes a cavity 13 for housing a test element 18, the test element 18 having a first position and a second position within the cavity. When the test element is in the first position, it is locked onto or within the cavity 13. In some embodiments, the detection device includes a sliding element 11 having a first position and a second position on the cavity 13, and capable of moving from the first position to the second position. In some embodiments, when the sliding element is in the first position, it is locked to the cavity 13, and when or after unlocking, the sliding element can move from the first position to the second position. In some embodiments, the sliding element 11 can move the test element from the first position to the second position.

[0089] In some embodiments, the three-dimensional structure of the cavity of the receiving test element is as follows: Figure 4 As shown in Figure 6-8, the cavity is used to receive a test element or a carrier holding the test element. The carrier and the cavity are locked in a first position, and when unlocked, the cavity can move from the first position to a second position. In some embodiments, when in the second position, part of the test element comes into contact with the liquid sample, thereby initiating the detection. In some embodiments, when in the first position, the test element is located within the cavity and not exposed; when in the second position, the test element or part of the test element extends out of the cavity. Figure 17 The portion of the test element extending outside cavity 13 contacts the liquid sample. In some embodiments, the liquid sample is located in a liquid sample processing cavity (processing cavity 14), for example... Figure 1 As shown, the processing chamber 14 contains a liquid sample. After the chamber 13 containing the test sample is inserted into the processing chamber 14, the test element or the carrier carrying the test element is unlocked from the locked state of the first position, thereby moving from the first position to the second position. Part of the test element extends into the processing chamber 14 and contacts the liquid sample, thereby completing the adsorption of the liquid sample.

[0090] It is understood that the test element 18 or the carrier 16 carrying the test element can be in two states or two positions within the cavity 13. In some embodiments, the cavity 13 is cylindrical, with one end 103 open and the other end 1032 also open, and has a structure 156 that can be detachably assembled with the collector 201. This structure can be an insertion hole 191 into which one end 2023 of the collector 201 can be inserted, or it can be fixed to the cavity 13 by threads, thereby assembling a collector. The collector has a rod-shaped body 2024 and an absorption element 2022. In some embodiments, the locking state of the test element, carrier, or sliding element with the cavity is fixed to the cavity by a locking mechanism. This locking structure has two states: locked and unlocked. When locked, the element fixed to the cavity 13 cannot or is not easily moved. When unlocked, the element fixed to the cavity can move or slide within the cavity. In some embodiments, the cavity includes a partial locking structure for locking the test element 18 or the carrier 16, ensuring that the test element or carrier is in a locked, fixed state relative to the cavity 13. The partial locking structure includes, for example... Figure 6 As shown in Figure 7, the partial locking structure includes a sheet-like mechanism 135, which is part of the sidewall of the cavity. This sheet-like structure has a notch 151, which includes two protrusions, an upper and lower notch, and two similar protrusions formed between two plastic strips 149 and 150. Externally, the notch is positioned at the same level as the outer wall of the cavity, while the two plastic strips 149 and 150 slightly protrude from the outer wall of the cavity. In some embodiments, the sheet-like structure is elastic. To make the structure with the notch elastic, two perforations 147 and 152 are provided on the sidewall of the cavity, allowing the sheet-like structure to appear suspended from the sidewall, generally maintaining a plane with the sidewall. In some embodiments, only one end is connected to the wall of the cavity 13; the other three sides of the sheet-like structure 135 are not connected to the cavity and have a perforated structure. Thus, when the protruding structure 118 of the sliding element 11 passes the plate-like structure, the protruding structure is received, engaged, meshed, or snapped together by the recessed structure, locking the sliding element onto the cavity 13. When the protruding structure on the sliding element encounters the plate-like structure, before entering the recessed structure, the movement forces the plate-like structure to slightly bend and deform into the cavity. When the protruding structure 18 slides into the recess, the elasticity disappears or rebounds, causing the protruding structure to mesh with the recessed structure, thus achieving the locked state. In some embodiments, the sliding element 11 also has a cavity 1120 ( Figure 12-13The inner wall of the cavity has a raised structure 118, which resembles a plastic rib protruding from the inner wall of the sliding element. In some embodiments, a groove 116 is formed in the inner wall of the sliding element, and the groove has the raised structure 118. Generally, the raised structure is parallel to the transverse direction of the sliding element, and the notch on the outer wall of the cavity 13 is also transverse, thus achieving a locking state between the sliding element 11 and the cavity as the sliding element moves from top to bottom. In some embodiments, the depth of the groove 116 is the same as the height of the raised structure 118, meaning that in the groove, only the raised structure 118 is the highest relative to the rest of the groove.

[0091] For example, Figure 12-13 The cross-sectional view of the sliding element is shown. The protruding plastic rib 118 is located next to or near the first slide rail 111 and the third slide rail 114 of the sliding element. This design, when the slide rails slide, firstly restricts the consistency of the sliding element's top-to-bottom path, and secondly restricts the sliding element's rotational performance, essentially preventing rotation and allowing only up-and-down sliding. In this non-rotational state, the protrusion on the side wall of the sliding element can engage with the recessed element on the cavity 13, thereby achieving a locking effect. Furthermore, the height of the first slide rail and / or the second slide rail protruding from the inner wall of the sliding element 11 is greater than that of the adjacent protruding structure 118. The first and third slide rails inside the sliding element 11 directly contact the grooves 140 and / or 1400 on the outer wall of the cavity 13. Therefore, in some configurations, the depth of the grooves on the outside of the cavity 13 is less than the height of the slide rails on the inner wall of the sliding element 11. This way, when the sliding element 11 is fitted onto the cavity 13, there is a gap of approximately 1-3 mm between the outer wall of the cavity 13 and the inner wall of the sliding element 11, preventing large-area contact between the outer wall of the cavity and the inner wall of the sliding element. This allows the sliding element to slide on the outer wall of the cavity 13 primarily through the sliding of the slide rails on the grooves, reducing friction and facilitating sliding. Here, to achieve the height difference between the groove 140 on the outer surface of the cavity and the slide rail 111 inside the movable element, one of the best methods is to have a bottom surface in the groove, thereby achieving the height difference and reducing friction. This is substantially different from the other slide rails 131 and 132 of the cavity, which will be described in detail below.

[0092] Furthermore, since the notch 151 on the outer surface of the cavity is formed between two protruding strips 149 and 150, when the protruding strips are higher than the outer surface of the cavity 13, due to the gap of a certain width between the inner surface of the sliding element 11 and the outer surface of the cavity 13, the two protruding strips 149 and 150 will not actually contact the inner surface of the movable element 11, reducing the resistance of the movable element on the outer surface of the cavity 11. When the movable element 11 slides to the position of the notch 151, the protruding strip 118 located on the movable element 11 is easily engaged and locked together by the notch 151. Of course, the above is only one specific method of locking structure. In some methods, the sheet-like structure 135 on the outer surface of the cavity 13 can be provided with only one protruding strip 149, without the notch 151 or other protruding strips 150, and the fixed locking of the sliding element and the cavity can also be achieved. The raised strip 118 in the groove 116 next to the slide rail 111 of the sliding element remains unchanged. When the sliding element 11 is sleeved on the outer surface of the cavity 13, the raised strip 118 of the movable element 11 is contacted by the raised strip 149 on the sheet-like structure 135 on the outer surface of the cavity 13, preventing the movable element from sliding further, and thus achieving a fixed and locked state between the movable element 11 and the cavity 13. One meaning of locking here is to fix the movable element 11 in different positions within the cavity 13. Here, it could mean preventing the movable element 11 from continuing to move downwards on the cavity 13 and keeping it in a fixed position. Therefore, in some methods, the sliding element is locked in a fixed position on the cavity 13 that houses the test element; this can be called the first position or the first initial position. The sliding element 11 itself is very lightweight, and even when carrying the test element or the carrier supporting the test element in some methods, it is relatively portable. Therefore, the notch 151 and the raised rib 118 can be simply designed to snap together. In some embodiments, the notched sheet structure is located next to the groove 140 with a bottom surface on the cavity and near the upper end of the cavity. Of course, in addition to the above-mentioned locking structure, there are other possible locking structures, such as pins, holes, snap-fits, etc., but in terms of relative design simplicity, the locking structure described in detail in this invention is the most convenient and easy to implement.

[0093] In some embodiments, the cavity for accommodating the test element is divided into two parts 103 and 104 by symmetrical grooves 132 and 131. The length of these grooves limits the distance the sliding element 11 slides on the cavity 13. Additionally, a groove 140 with a bottom surface on the cavity 13 also limits the sliding distance of the sliding element. For example... Figure 8The sliding grooves 132 and 131 that penetrate the sidewalls serve two purposes: firstly, to guide the sliding trajectory and distance of the sliding rails 112 and 115 of the sliding element 11; and secondly, to clearly identify the state of the carrier element within the cavity when the carrier element 16 is present and the sliding element 11 moves along with it. Furthermore, when the sliding element is in the first position, part of the carrier is within the cavity 13, filling the gaps in the sliding grooves 132 and 131, yet still appears as a single unit. In some configurations, the carrier and the sliding element are fixedly connected; the specific connection method will be described in detail below. Therefore, the additional sliding rails 112 and 115 of the movable element 11 serve two purposes: firstly, they allow sliding on the cavity; and secondly, they connect the carrier to the movable element, so that when the movable element 11 slides, it moves the carrier 16 from the first position to the second position. Furthermore, the two sliding rails 131 and 132 penetrating the sidewall of the cavity 13 also reduce contact with the carrier, thereby reducing the friction between the inner wall of the cavity 13 and the carrier. This facilitates the free sliding or movement of the carrier 16 within the cavity, reducing frictional resistance. This is another advantage or function of the sliding rails 131 and 132 penetrating the sidewall of the cavity 13. Although the internal diameter of the cavity 13 can be large, to achieve a compact testing device and ease of operation, the lateral dimensions of the carrier 16 should maintain optimal compatibility with the dimensions of the cavity 13. If the overall size of the testing device is large, it will be inconvenient to operate. For a compact design, it is necessary to solve some inherent problems of compact structures, such as friction, the need for a locking function, and the desire for easy movement with reduced resistance when moving inside. Therefore, the above design can solve these functional needs.

[0094] carrier element

[0095] In some specific embodiments, the test element can also be mounted on a carrier element, such that the carrier element contains the test element, enabling the detection and analysis of the analyte in the fluid sample. Therefore, in some embodiments, the detection device includes a carrier 16 on which the test element 18 is mounted. In some embodiments, the carrier is located within a cavity 13 for housing the test element, and the carrier has a first locked position and a second position within the cavity, the second position being non-locked. Figure 9-11As shown, for example, on some carriers 16, the carrier generally has one or more grooves 1617, and the test element 18 is located in the groove 161. The carrier generally has a front and a back 164, and the test element 18 is located on the front of the carrier, or in the groove 161 on the front. The number of grooves is not limited. Generally, one test element is located in one groove. Usually, one test element can detect one analyte in the sample. Of course, one test element can detect one or more analytes simultaneously.

[0096] In some embodiments, the carrier 16 comprises two parts, including a groove structure 161 for accommodating the test element. This groove structure typically accommodates the detection or marking area of ​​the test element, placing the detection or marking area in a relatively fixed and secure position. This design ensures the accuracy and reliability of the test results. The carrier also includes an area connected to the sliding element 11, the structure of which is designed to be fixedly fitted with the sliding element. In some embodiments, when the cavity housing the test element is circular, the carrier itself is also designed as a curved surface, so the grooves accommodating the test element on the carrier are also distributed on the curved surface. Specifically, the carrier as a whole has a regular curved surface with a ridge 1691 in the middle, dividing the carrier into two parts. The ridge 1691 divides the carrier into two regions, each region having a groove for accommodating a reagent strip, in which the test element is located. A laterally extending region 1612, 1611 is provided on the spine, and this extending region is distributed above the groove on the spine. This extends the region to protect the test strip from damage when the test element 18 is placed in the groove. This is primarily because the carrier is moved within the cavity 13, and during this movement, it is necessary to ensure that the test element is not damaged, and that its position within the groove remains constant. Otherwise, movement of the test element itself will affect the accuracy of the final test result. For example, when operating at home, the operator may not have much professional knowledge, leading to greater arbitrariness in operation. Therefore, it is necessary to ensure that the positions of all components remain fixed while also ensuring ease of operation.

[0097] In addition, to keep the test element fixed in the groove and prevent it from detaching from the groove, a stop block 1692 is provided at the end of the carrier. Figure 9 The blocking block has a plane 1561 ( Figure 10The carrier contacts the end of the test element (not shown) to prevent the test strip from falling out of the groove. This is because during subsequent movement, the carrier needs to extend from inside the cavity 13, and the extended portion needs to be immersed in the liquid; therefore, it is undesirable for the test element to slip out of the groove. Simultaneously, a ring 1698 at the end of the carrier partially encloses the end of the test strip, primarily to protect the end of the test strip. When the carrier 16 pulls the test strip 18 out from one end of the cavity, the extended portion is inserted into the cavity 104 of the receiving cavity 14 and comes into contact with the liquid sample. At this time, a collector is located in the cavity 104 within the receiving cavity, preventing damage to the test element and always protecting the end of the test strip. In other embodiments, perforations 1693, 1694, and 1695 are provided in the groove, distributed at different locations within the groove. It should be noted that one of the perforations is located on the plane 1561 of the stop block 1692 and communicates with the plane. When the end of the test element contacts the surface 1561 of the blocking block, a portion of the test element is exposed through the perforation 1695, particularly the sample application area. Thus, when the carrier extends from the cavity 13 and enters the cavity of the collection device, directly contacting the liquid sample in the collection device cavity, the sample passes through the perforation 1695 and contacts the sample area of ​​the test element. Another perforation 1694 is located approximately in the middle of the groove to prevent the liquid sample from prematurely wetting the test strip through the capillary gap formed between the back of the test element and the bottom of the groove, thereby affecting the normal reaction; this perforation acts as a barrier. Typically, the speed at which liquid flows due to the capillary force of the test strip itself is much slower than the speed of liquid flowing through the capillary gap. Therefore, if other areas of the test element, such as the detection area, are prematurely wetted, the test cannot be completed when the sample liquid carrying the analyte flows to the detection area, because the prematurely arrived liquid wets the test area, eliminating the capillary force in that area and affecting the flow of the liquid sample.

[0098] In some embodiments, the other end of the carrier, near the water absorption area 184 of the test element, is provided with a structure fixed to the movable element 11. This structure secures it to the movable element, so that the movement of the movable element drives the movement of the carrier. The carrier not only drives the movement of the test element but also protects the test element from damage. In some embodiments, the sliding element 11 is also a hollow structure with an internal space 1120. A second slide rail 112 and a fourth slide rail 115 are located on the inner sidewall of the hollow space. The first function of these slide rails is to be positioned within the grooves 132 and 131 of the cavity 11, allowing the carrier to slide within the cavity. Another function is to fix the carrier to the sliding element. The second slide rail 112 and the fourth slide rail 115 are symmetrically distributed, and are sheet-like structures protruding from the hollow sidewall towards the center, having a certain thickness (e.g., ...). Figure 10 A suspension structure is provided on the carrier 16. This suspension structure is connected to the slide rails of the moving elements. Specifically, the suspension structure includes three staggered strip structures 167, 166, and 1671 (e.g., ...). Figure 11 ,9), wherein the first strip 166 and the second strip 167 are distributed at the ends of the carrier, with a gap 800 or a set distance between them. The width of the gap matches the width of the fourth slide rail 115 of the sliding element, allowing the fourth slide rail 115 to be inserted into the gap. The third strip 1671 is located below the first and second strips, is L-shaped, and has a flat surface. During assembly, the suspension structure of the carrier moves upward from the internal space of the sliding element, allowing the fourth slide rail 115 to be inserted into the suspension structure through the gap 800. The L-shaped third strip 1671 limits the insertion depth of the second slide rail in the gap 800. Similar suspension structures are respectively arranged on both sides of the carrier. Specifically, the suspension structure includes three staggered strip structures 162, 1600, 1621 (e.g. Figure 11 ,9), wherein the first strip 162 and the second strip 1600 are distributed at the ends of the carrier, with a gap 900 between them, the width of which matches the width of the second slide rail 112 of the sliding element. A third strip 1621, located below the first and second strips, is L-shaped and has a plane 1606 that limits the insertion depth of the second slide rail 112. During assembly, the suspension structure of the carrier moves upward from the internal space of the sliding element, allowing the second slide rail 112 to be inserted into the suspension structure through the gap 900. The third strip 1671, having an L-shape, limits the insertion depth of the second slide rail in the gap 900. The structure of the sliding element and carrier after assembly is as follows. Figure 15 As shown, at this time, the spine structure 1691 of the carrier basically faces the third slide rail 111, while the concave surface 164 faces the first slide rail 114 that the third slide rail faces. At this time, there is still a certain distance between the third slide rail 111 and the spine mechanism 1691. Figure 14 As shown by the curved double arrow 202), the concave surface 164 of the curved carrier is also set at a distance from the first slide rail 114. Figure 14(As shown by the curved double arrow 201). The carrier is suspended at the center of the hollow sliding element 11, and is only connected to the sliding element through the slide rails, the second slide rail, and the fourth slide rail. It does not contact the inner wall of the hollow sliding element. These distances are set so that the sidewall of the cavity 13 needs to pass through these predetermined distances to engage with the sliding element, allowing the movable element 11 to drive the carrier element to move within the cavity 13. Since the carrier and the movable element 11 are connected through slide rails 112 and 115, the grooves on the cavity 13 that connect to slide rails 115 and 112 are through-type (131, 132), and cannot be designed like the other groove 140 in the cavity; otherwise, the carrier cannot move within the cavity 13. At this time, the sliding element is set on the outer wall of the cavity 13, and moves by cooperating with different types of sliding grooves on the cavity 13 through two different types of slide rails. The carrier is connected to the sliding element 11 and is set in the cavity 13. The carrier moves within the cavity 13 by relying on the movement of the movable element 11 driven by the outside. It should be noted that the above specific embodiment is provided with two pairs of slide rails on the movable element. It can be understood that either pair of slide rails can be omitted, and the movable element 11 can still drive the test element 18 or the carrier element 16 to move from the locked first position to the second position in the cavity 13.

[0099] When the sliding element with the carrier element is assembled onto the cavity 13, for example... Figure 15As shown, the cavity 13 has open grooves 132 and 131 that divide the cavity into two parts 103 and 104. A limiting structure is provided in one part of the cavity, ensuring that the carrier can only enter the cavity 13 from a single direction. Specifically, the limiting structure resembles two symmetrically arranged wing-like structures 138 and 137. The two wing-like structures are close together at their edges 1381 and 1371, forming an overall "eight" shape, and extend from the inner wall of the cavity 13 towards its center. When the product needs to be assembled, the interactive element with the carrier is inserted into the cavity 13 from one end, with the concave surface of the carrier contacting the limiting structures 137 and 137 and then sliding into the cavity 13 upon contact with the edges 1371 and 1381. Here, the limiting structure functions in two ways: firstly, it restricts the direction of the carrier's entry, allowing the concave surface of the carrier to enter the cavity 13 only through the edge of the limiting structure; secondly, the contact between the edge of the limiting structure and the surface of the concave surface also guides the movement of the carrier. At this time, when the second slide rail 112 and the fourth slide rail 115 enter the grooves 131 and 132 of the cavity respectively, the edges 1371 and 1381 of the wing-shaped structures 138 and 137 contact the concave surface of the curved carrier. Part of the sidewall 131 of the cavity 13 passes between the concave surface 164 of the curved surface and the sidewall of the cavity of the sliding element 11, while part of the sidewall 104 of the cavity 13 passes through the gap between the third slide rail 111 of the sliding element and the ridge structure 1691 of the curved carrier. Thus, the third slide rail 111 and the first slide rail 114 of the sliding element are engaged with the grooves 140 and 1400 on the outer wall surface of the cavity 11. When the movable element 11 moves on the outer surface of the cavity 13, the slide rail of the movable element 11, the slide groove of the cavity 13, and the edge of the limiting structure ensure that the carrier's sliding position in the cavity 13 is always consistent in the longitudinal direction and the directional path is stable without deviation or offset. In this way, a portion of the sidewall 103 of the cavity 13 that houses the carrier is located between the concave surface 164 of the carrier 16 and the sidewall of the sliding element (as shown by the double arrows), while another portion of the sidewall 104 of the cavity 13 that houses the carrier is located between the spine structure 1691 of the carrier 16 and another portion of the sidewall of the sliding element.

[0100] For example, Figure 15 This is a three-dimensional structural diagram showing the sliding element installed at one end of the cavity 11 in the locked position. From... Figure 15 It can be seen that if the concave surface 164 of the curved surface does not contact the edges of the wing-like structures 138 and 137, but instead changes direction so that the spine structure 1691 of the curved surface carrier resembles a wing structure, the carrier 16 cannot correctly enter the cavity 13. This is for ease of assembly and to avoid errors. This results in a more compact structure, generally ensuring that the movement of the carrier within the cavity 13 is not disturbed or obstructed.

[0101] During assembly, the protruding structure next to the first slide rail engages with the recessed structure on the cavity, locking the sliding element onto the cavity 13. At this point, the carrier and the test element on it are indirectly locked in a relatively fixed position within the cavity. Also at this point, the entire carrier and the test strip on it are surrounded by the cavity 13, with only the collector exposed outside the detection device. This structure naturally leads the operator to assume that the collector is used to collect samples. After collecting the sample, the collector is inserted into the cavity of the receiving device 14. The receiving device stands vertically on the table, and the inner wall of the opening of the receiving device engages with the outer edge 109 at the other end of the cavity 13, allowing the outer edge 109 to be inserted into the opening of the receiving cavity. This seals the opening and prevents leakage of liquid samples during operation. For example, when the collecting element 2022 of the collector absorbs saliva, urine, sputum, or nasal secretions, the collection is complete, and then it is inserted into the receiving device 14. At this time, the outer edge 109 seals the opening, and the movable element is in the locked first position, with the test element 18 or the carrier inside the cavity 13. When testing is required, the movable element is unlocked. After unlocking, it moves from the locked first position to the second position. This movement is achieved through the movement of the movable element's slide rail and the slide groove on the cavity 13, causing the carrier to move. This allows part of the carrier to extend out of the cavity 13, and the extended part also enters the cavity of the receiving device 14. In this way, part of the sample application area of ​​the test element comes into contact with the liquid sample. The liquid sample flows from upstream to downstream of the test element through capillary action due to the water absorption of the test element, thus completing the detection or analysis of the analyte in the sample. At this time, due to the positional change, the detection area of ​​the test element is located below the window 143 on the cavity 13 for reading the test results, allowing the test results on the test area to be read. After the test results are read, the entire testing device can be discarded. The containment device 14 includes a containment collector and a containment cavity 141 for part of the carrier. In addition, there are two support walls 143 and 142 to make the containment device stand stably on the table.

[0102] Cover structure

[0103] like Figure 5As shown in Figure 18, in some embodiments, the detection device of the present invention further includes a cover element 12, which engages with one end opening of the cavity 13. This one end opening is for the movable element 11 to be inserted. The cover includes a cover body 124 and a cover extension 125. Symmetrically arranged slide rails are provided within the cover, engaging with the slide grooves 131 and 132 of the cavity, and located within the cavity 13. This allows the cover to be stably inserted into one end of the opening of the cavity 13, thus keeping one end of the opening closed. The slide rail of the cover has a hollow tube cavity 121 and wing-shaped elastic clamping plates 122 and 123 distributed on both sides. When the cover is inserted into the opening of the cavity 13, the elastic clamping plates contact the inner wall of the cavity 13, preventing the cover from easily falling off. To more firmly fix the cover to the cavity 13, one or more suspension structures are provided at one end of the opening of the cavity 13. These suspension structures resemble hooks, such as… Figure 7 Therefore, the suspension structure 133 includes a hook body 154 and a hook handle 153. This structure can be designed in pairs, for example... Figure 7 The structures 133 and 134 are essentially part of the cavity sidewalls, while the cover has hook structures that cooperate with the suspension hooks, such as... Figure 18 The portion of the cover edge 108 and platform structure 128 shown are such that when the cover 12 is closed onto the cavity 13, the internal slide rail is inserted into the slide groove, and the hook on the outer surface of the cavity 13 matches the corresponding structure of the cover, thereby making the cover more firmly fixed on the opening end of the cavity 13.

[0104] The following specific solutions are also part of this invention.

[0105] An apparatus for detecting an analyte in a sample includes: a cavity for receiving a test element, wherein the test element has a first position and a second position within the cavity, wherein when in the first position the test element does not contact the fluid sample, and when in the second position the test element contacts the fluid sample.

[0106] According to the device described above, a fluid sample collector is also connected to the cavity, and the collector is disposed at one end of the cavity.

[0107] According to the device described above, when the test element is in the first position, the test element and the cavity are locked together.

[0108] According to the device described above, when the test element is in the second position, a portion of the test element extends outside the cavity.

[0109] According to the device described above, the cavity further includes a carrier for carrying the test element. The carrier has a first position and a second position in the cavity. The carrier drives the test element to change or move between the first position and the second position, or the carrier drives the test element to move from the first position to the second position.

[0110] According to the device described above, the carrier is connected to the cavity via a locking structure. When in the locked first position, the carrier does not move relative to the cavity, or when the locking structure is unlocked, the carrier can move relative to the cavity from the first position to the second position.

[0111] According to the device described above, when the carrier is in the first position, the entire carrier is located in the cavity, and when the carrier is in the second position, a portion of the carrier extends out of the cavity to contact the liquid sample.

[0112] According to the aforementioned device, the device further includes a movable element connected to a carrier, the movable element enabling the carrier to move from a first position to a second position.

[0113] According to the device described above, the movable element includes a first slide rail and a second slide rail, and the carrier is fixedly connected to the second slide rail.

[0114] According to the device described above, the cavity includes a first slide groove that cooperates with a first slide rail of the movable element and a second slide groove that cooperates with a second slide rail of the movable element. The second slide groove penetrates the side wall of the cavity, and the first slide groove is located on the outer surface of the cavity.

[0115] According to the device described above, the movable element includes a partial locking structure, and the cavity includes another partial locking structure, wherein the movable element is fixed to the cavity by the locking structure.

[0116] According to the device described above, the carrier includes a suspension structure, and the carrier is fixedly connected to the second slide rail through the suspension structure.

[0117] According to the device described above, the locking structure includes a protruding structure and a recessed structure, the movable element includes the protruding structure, and the outer wall of the cavity includes the recessed structure.

[0118] According to the device described above, the notch structure is located on the sheet-like structure of the sidewall of the cavity, the sheet-like structure is part of the sidewall of the cavity, and the sheet-like structure is elastic.

[0119] According to the device described above, the movable element is sleeved on the outer surface of the cavity, the carrier and the second slide rail are located in the cavity for receiving the test element, and the first slide rail is located on the outer surface of the cavity and cooperates with the first slide groove on the surface of the cavity.

[0120] According to the device described above, the cavity includes a limiting structure, the limiting structure includes an edge, the carrier is a curved structure, the concave surface of the carrier contacts the edge of the limiting structure, and the carrier includes a spine structure.

[0121] According to the device described above, the cavity for receiving the test element includes a first cavity sidewall and a second cavity sidewall, wherein the first cavity sidewall faces the concave surface of the carrier, and the second cavity sidewall faces the ridge structure of the carrier.

[0122] According to the aforementioned apparatus, the apparatus further includes a containment device for containing the collector and some test elements.

[0123] According to the apparatus described above, the portion of the test element includes a portion of the sample application area.

[0124] According to the device described above, the sample is one of saliva, sputum, urine, or nasal secretions, and the substance being analyzed includes coronaviruses.

[0125] A method for detecting an analyte in a sample, the method comprising: providing a detection apparatus including a carrier housing a test element, the carrier being located in a cavity, the carrier being fixedly connected to a movable element on the cavity; and having the movable element having locked first and second positions on the cavity.

[0126] According to the method described above, the movable element is fixed to the cavity by a locking structure.

[0127] According to the method described above, the movable element is unlocked from the first position, and after unlocking, the movable element is moved from the first position to the second position, thereby driving the carrier to move from the first position to the second position.

[0128] According to the method described above, when the active element is in the first position, the carrier is located in the cavity and not exposed; when the active element is in the second position, the carrier is exposed outside the cavity and in contact with the liquid sample.

[0129] According to the method described above, a containment device is provided for containing a collector, wherein the collector is first inserted into a containment container, and then a movable element is moved from a first position to a second position.

[0130] According to the method described above, the collector is placed on the detection device, and while the collector is inserted into the receiving container, a portion of the detection device is allowed to enter the receiving cavity and the receiving cavity is sealed.

[0131] According to the method described above, the movable element is moved from the first position to the second position through the cooperation of the slide groove and the slide rail.

[0132] According to the method described above, a slide rail is provided inside the cavity of the movable element, and a slide groove is provided on the outer wall of the cavity containing the carrier.

[0133] According to the method described above, the locking structure includes a protrusion located on the movable element and a recessed structure located on the cavity for receiving the protrusion.

[0134] According to the method described above, when the movable element is in the locked position, the protruding structure is located in the recessed structure, and when the movable element is in the unlocked state, the protruding structure disengages from the recessed structure.

[0135] All patents and publications mentioned in this specification represent publicly available technology that can be used by this invention. All patents and publications cited herein are also listed in the references as individually referenced. The invention described herein can be implemented in the absence of any one or more elements, or one or more limitations, which are not specifically stated herein. For example, the terms “comprising,” “substantially consisting of,” and “consisting of” in each instance herein can be replaced by the other two terms. The term “an” herein simply means “one” and does not exclude the inclusion of only one, but may also indicate the inclusion of two or more. The terminology and expressions used herein are descriptive and not limiting, and there is no intention to suggest that the terms and interpretations described herein exclude any equivalent features; however, it is understood that any suitable changes or modifications can be made within the scope of this invention and the claims. It is understood that the embodiments described herein are preferred embodiments and features, and any modifications and variations can be made by those skilled in the art based on the spirit of the description, and such modifications and variations are also considered to fall within the scope of this invention and the limitations of the independent and appended claims.

Claims

1. An apparatus for detecting an analyte in a sample, comprising: A cavity for receiving a test element, wherein the test element has a first position and a second position within the cavity; when in the first position, the test element does not contact the fluid sample, and when in the second position, the test element contacts the fluid sample. A carrier for carrying a test element, the carrier having a first position and a second position in a cavity, the carrier causing the test element to change or move between the first and second positions, or the carrier causing the test element to move from the first position to the second position; A sliding element is provided, which is connected to a cavity receiving a test element via a locking structure. When locked, the sliding element is fixed at a relatively fixed position on the cavity, thus placing the carrier in a locked first position. When unlocked, the sliding element can move or slide on the cavity, thereby moving the carrier from the first position to a second position. The sliding element includes a partial locking structure, and the cavity includes another locking structure. The sliding element includes a first slide rail and a second slide rail, and the carrier is fixedly connected to the second slide rail.

2. The apparatus according to claim 1, wherein, A fluid sample collector is also connected to the cavity, and the collector is located at one end of the cavity.

3. The apparatus according to claim 1, wherein, When the test element is in the second position, part of the test element extends out of the cavity.

4. The apparatus according to claim 1, wherein, The carrier is connected to the cavity via a locking structure. When it is in the locked first position, the carrier does not move relative to the cavity. Alternatively, when the locking structure is unlocked, the carrier can move relative to the cavity from the first position to the second position.

5. The apparatus according to claim 4, wherein, When the carrier is in the first position, the entire carrier is located inside the cavity. When the carrier is in the second position, part of the carrier extends out of the cavity and comes into contact with the liquid sample.

6. The apparatus according to claim 1, wherein, The cavity includes a first slide groove that mates with a first slide rail of the sliding element and a second slide groove that mates with a second slide rail of the sliding element. The second slide groove penetrates the side wall of the cavity, and the first slide groove is located on the outer surface of the cavity.

7. The apparatus according to claim 6, wherein, The carrier includes a suspension structure, and the carrier is fixedly connected to the second slide rail through the suspension structure.

8. The apparatus according to claim 7, wherein, The locking structure includes a protruding structure and a recessed structure, the sliding element includes the protruding structure, and the outer wall of the cavity includes the recessed structure.

9. The apparatus according to claim 8, wherein, The notch structure is located on the sheet-like structure on the side wall of the cavity. The sheet-like structure is part of the side wall of the cavity and is elastic.

10. The apparatus according to claim 9, wherein, The sliding element is sleeved on the outer surface of the cavity, the carrier and the second slide rail are located in the cavity of the receiving test element, and the first slide rail is located on the outer surface of the cavity and cooperates with the first slide groove on the surface of the cavity.

11. The apparatus according to claim 1, wherein, The cavity includes a limiting structure, the limiting structure includes an edge, the carrier is a curved structure, the concave surface of the carrier contacts the edge of the limiting structure, and the carrier includes a spine structure.

12. The apparatus according to claim 11, wherein, The cavity for receiving the test element includes a first cavity sidewall and a second cavity sidewall, wherein the first cavity sidewall faces the concave surface of the carrier, and the second cavity sidewall faces the ridge structure of the carrier.

13. The apparatus according to claim 1, wherein, The device also includes a containment device for containing the collector and some of the test elements.

14. The apparatus according to claim 13, wherein, The aforementioned test element includes a portion of the sample application area.

15. The apparatus of claim 1, wherein the sample is one of saliva, sputum, urine, or nasal secretions, and the substance being analyzed includes coronaviruses.

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