A device for detecting analytes in a sample

Abstract

The present invention provides an apparatus 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, 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.

Description

[0001] Cross-references

[0002] This application claims priority to the earlier Chinese applications, application numbers 2022103771424 and 2022102544334, filed on April 11, 2022; and the earlier U.S. provisional applications, application numbers 63 / 333,299 and 63 / 327,048, filed on 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] Drug testing has a wide range of applications. Drug tests are diverse and frequent. For example, saliva sample testing has gradually been 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 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 spread of infectious diseases in recent years, home testing has become a mainstream product. For home testing, sampling is convenient and 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. In some embodiments, the partial locking structure is located on the sliding groove of the cavity.

[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 partial locking structure on the cavity is located on a groove on the cavity. In some embodiments, the partial locking structure on the groove includes opposing recesses. In some embodiments, the partial locking structure is located on a sliding element, and the locking structure on the sliding element includes two pins that are received by the two recesses when the sliding element is in the locked position; when the sliding element is unlocked, the two pins are disengaged from the recesses, thereby allowing the sliding element to move from a locked first position to a second position.

[0019] In some embodiments, the sliding element includes a slide rail that moves within the groove, thereby moving the carrier.

[0020] In some embodiments, the sliding element is a sheet-like structure including a first surface and a second surface. The slide rail is located on the first surface and connected to a positioning element. The positioning element is connected to the slide rail, and the slide rail drives the positioning element to move within the cavity. In some embodiments, the positioning element is located within the cavity, and the slide rail connects to the sheet-like sliding element, which is located on the outer surface of the cavity. In some embodiments, a groove on the cavity is located between the positioning element and the sheet-like sliding element, and the slide rail passes through the groove.

[0021] In some embodiments, the groove is formed by an opening in the sidewall of the cavity and has a set distance, which is the distance the sliding element travels from a first position to a second position.

[0022] In some embodiments, an insert is connected to the positioning element, which is used to insert into the receiving port of the carrier, thereby achieving a fixed connection between the carrier and the active element.

[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 exploded view of the assembly structure in a specific embodiment of the present invention.

[0041] Figure 2 This is a partial enlarged structural schematic diagram of one specific embodiment of the present invention.

[0042] Figure 3 This is an enlarged schematic diagram of a sliding element in a specific embodiment of the present invention.

[0043] Figure 4 This is an exploded structural diagram of a portion of the structure in a specific embodiment of the present invention.

[0044] Figure 5A This is a schematic diagram of the structure of a receiving container or receiving device according to a specific embodiment of the present invention. Figure 5B This is a bottom view of the containment device. Figure 5C It is the left view. Figure 5D This is a top view of the containment device.

[0045] Figure 6 This is an enlarged schematic diagram of a partial locking structure in a specific implementation.

[0046] Figure 7 This is an enlarged structural schematic diagram of a sliding element in a specific implementation.

[0047] Figure 8 This is an exploded structural diagram of a test device according to a specific implementation.

[0048] Figure 9 This is an exploded structural diagram of a test device in a specific implementation.

[0049] Figure 10 This is a schematic diagram of the three-dimensional structure of the test device assembly in another specific embodiment.

[0050] Figure 11 This is a schematic diagram of the three-dimensional structure of the sliding element and the carrier assembly.

[0051] Figure 12 This is a schematic diagram of the three-dimensional structure of the carrier.

[0052] Figure 13 This is a three-dimensional structural diagram of the sliding element.

[0053] Figure 14 This is a three-dimensional structural diagram of the cavity and carrier assembly.

[0054] Figure 15 It is a three-dimensional structural diagram of the cavity, carrier, and sliding element assembly.

[0055] Figure 16A three-dimensional structural diagram of the cavity.

[0056] Figure 17 This is an enlarged schematic diagram of the upper part of the cavity, structure A. Detailed description

[0057] 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.

[0058] Detection

[0059] 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.

[0060] sample

[0061] 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.

[0062] 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 absorbent 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.

[0063] 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.

[0064] Downstream and upstream

[0065] 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 1 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.

[0066] 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. When the treatment solution in the container comes into contact with the sampling element 201 of the collector, the sample is processed, such as dissolved, lysed, or eluted. At this time, the test element located in the chamber is in its initial position. When testing is required, the chamber is unlocked, allowing the test element 18 or the carrier 16 supporting the test element to slide within the chamber, thus moving from the first position to the second position. In the second position, the test element extends from one end of the container chamber 13, for example, from the chamber with the sample application area, and directly enters the chamber 101 containing the treatment reagent to contact the liquid or the mixture of liquid samples, thereby completing the test or detection.

[0067] Gas connection or liquid connection

[0068] 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.

[0069] Detachable combination

[0070] 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 9 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.

[0071] Test element

[0072] 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.

[0073] 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.

[0074] 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.

[0075] 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.

[0076] 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.

[0077] 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.

[0078] 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.

[0079] 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 1 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.

[0080] 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.

[0081] Analyzed material

[0082] 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 a drug 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... Drugs with hypnotic and sedative effects include benzodiazepines (BZO), atypical BZ classes, fused diazonium nitrates (NB23C), benzodiazepines, ligands of BZ receptors, open-ring BZ classes, 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. After being absorbed by the body, these drugs are metabolized into small molecules, which are present in bodily fluids such as blood, urine, saliva, and sweat, or in some bodily fluids.

[0083] 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.

[0084] Detection device

[0085] 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.

[0086] 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.

[0087] 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.

[0088] In some embodiments, the three-dimensional structure of the cavity of the receiving test element is as follows: Figure 1-9 As shown, 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, a portion of the test element contacts the liquid sample, thereby initiating 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 a portion of the test element extends out of the cavity, and the portion of the test element extending out of the cavity 13 contacts the liquid sample. In some embodiments, the liquid sample is located in a liquid sample processing cavity (processing cavity 15), for example... Figure 5A As shown in -D, the processing chamber 15 contains a liquid sample. After the chamber 13 containing the test sample is inserted into the processing chamber 151, 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 15 and contacts the liquid sample, thereby completing the adsorption of the liquid sample.

[0089] It is understood that the test element 18 or the carrier 16 supporting the test element can be in two states or two positional states within the cavity 13. In some embodiments, the cavity 13 is cylindrical, or as... Figure 1The illustrated cuboid has an opening at one end 103 and another end 1032. The other end 1032 has a structure detachably assembled with the collector 201. This structure 156 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, thus assembling into 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 or carrier, or sliding element, to the cavity is achieved 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 carrier 16, keeping the test element or carrier in a locked, fixed state relative to the cavity 13.

[0090] Partial locking structure such as Figure 2 And as shown in 3; or Figure 6-7 The partial locking structure includes grooves 133 and 134 set on the cavity slide groove, which cooperate with the pins or cylinders 111 and 112 on the sliding element 11. When the sliding element cooperates with the groove, a locked state is formed, and the slide rail 113 on the sliding element is located in the slide groove of the cavity 13. The groove structure protrudes slightly from the edge of the slide groove, which allows the sliding element to be in a more stable position in the slide groove, making the lock more secure. Of course, there is also a channel 135 and 136 on both sides of the groove on the slide groove to allow the pin to easily enter the groove and to disengage the pin from the groove. In this way, the pin can easily enter the groove to be in the locked state and can also easily disengage from the groove to be in the unlocked state. The sliding element is a sheet-like structure that covers the surface of the slide groove. The sheet-like structure has two sides, one side 118 facing the slide groove and the other side 119 facing the operator. The pins 111 and 113 are set on the side facing the slide groove, and the slide groove 113 is also set there. The cavity 13 has an opening 103 at one end and two surfaces. A groove 131 is provided on one of the surfaces, typically positioned in the middle of one surface. This groove divides the cavity surface into two parts. A positioning element is provided on the slide rail of the sliding element. This positioning element, connected to the groove, is shaped like a "T," and the positioning elements on both sides of the slide rail 113 match the opening 103 at one end of the cavity opening. In some embodiments, such as... Figure 4 As shown, an insert 115 is connected to the positioning member, and this insert is connected to the receiving port 162 of the carrier (e.g., Figure 4The sliding element 11 is matched to the carrier 16 to connect and fix them together. For a more stable connection, a pin 116 is also provided on the insert 115, which cooperates with the insertion hole 163 on the carrier to connect the carrier and the sliding element. During assembly, the carrier is inserted into the cavity 13 through the opening 103 at one end of the cavity, the two ends of the positioning element 114 contact the inner walls 140, 141 of the cavity, and the slide rail 113 is located in the slide groove on the cavity 13. At this time, the two pins on the sliding element are received by the notches on the slide groove and engage together, in a fixed or locked state.

[0091] When unlocking is required, push the sliding element down again to disengage the pins 111, 112 from the notches 133, 134 on the slide groove. At this time, the two sides of the positioning element 114 are still in contact with the inner walls 140, 141 of the cavity. This contact prevents the sliding element from changing position, while the slide rail 113 slides in the slide groove 131, thereby driving the carrier 16 to move in the cavity 13, allowing part of the carrier to extend out of the wall from its previous first position where it was completely in the cavity.

[0092] In some ways, for example Figure 6-9 In another specific embodiment shown, the testing device includes a cavity 23 for receiving a carrier. The cavity has an opening at one end with a groove 231 and a structure 235 for fixing a collector at the other end. The cavity is relatively flat. There are inner walls 233 and 234 on both sides of the groove 231. The interior cooperates with the transverse positioning member 214 on the sliding element. The slide rail 213 on the sliding element is transversely inserted into the groove. Similarly, the sliding element has an insert 215 for inserting into the receiving port 263 of the carrier. In this way, the carrier and the sliding element are connected as one unit. The carrier has a testing element. The water absorption area of ​​the testing element is located at one end of the receiving port 263, and the sample application area of ​​the testing element is located at the opposite end of the carrier.

[0093] Similarly, Figure 6-7 The locking structure is located on the upper part of the slide, such as... Figure 6 As shown, there are two opposing structures with protrusions in the slide groove. The protrusions have notches, and the distance between the two protrusions is less than the width of the slide groove. When the two pins 212 and 211 on the sliding element are received by the notches, the sliding element is in a locked position by mechanical interaction. When the pins are disengaged from the notches, the sliding element is in a movable and sliding state. Thus, the sliding element moves from the first position to the second position by the operator's sliding. The distance of the slide groove limits the maximum distance traveled by the sliding element.

[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 16 has a first locked position and a second position within the cavity, the second position being non-locked. Figure 9-11 As shown, for example, on some carriers 16, the carrier generally has one or more grooves 161, 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, and 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, one of which is a groove structure 161 for accommodating the test element. Generally, the groove structure is used to accommodate the detection area or marking area of ​​the test element, thus placing the detection area or marking in a relatively fixed and safe position. This design can ensure 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 matched with the sliding element.

[0097] The connection area is located at one end of the carrier, such as Figure 1As shown, one end of the carrier 16 has an insertion port 162, which is used to receive the insertion of the insert 115 on the sliding element 11, thereby realizing the connection between the sliding element and the carrier. Of course, this connection method can also be any other method, such as a latch, a pin, or a socket. In order to make the connection between the carrier 16 and the sliding element 11 more stable, a pin 116 is provided on the insert 115 on the sliding element 11. The pin extends from the insert towards the back surface 117, and an insertion hole 163 is provided on the insertion port 162 of the carrier. In this way, when the insert 115 on the sliding element is inserted into the insertion port 162 of the carrier, the pin 116 on the insert 115 is inserted into the insertion hole 163 on the carrier, thereby realizing the fixed connection between the carrier and the sliding element. Understandably, after the pin 116 is inserted into the insertion hole 163 on the carrier, there is still a certain distance between the front side of the carrier (the side with the test strip) and the back side 117 of the sliding element. This distance is limited by the length of the slide rail 113. Thus, when the carrier 16 is inserted into the cavity from one end 103, the slide rail 113 is located in the slide groove 131, and the sliding element covers the outer surface of the cavity 13. The carrier is located in the cavity 13, and the transverse members 114 on the sliding element 11, distributed on both sides of the slide rail 113, cover the opening at one end of the cavity 13. From the outside, the carrier is enclosed in the cavity. According to the above description, the carrier is allowed to enter the cavity and is in the locked position. When it needs to move downward, it is unlocked, thereby enabling movement from the locked first position to the second position. When the sliding element moves on the slide groove, the lateral positioning member 114 slides from the first position to the second position by relying on the inner walls 140, 141 on both sides of the slide groove 131 of the cavity 13.

[0098] In some methods, a sample, such as a fluid sample like saliva, sputum, urine, or nasal analyte, is first collected using a collector 201. This collector 201 is fixedly connected to the other end 1032 of the cavity 13 of the testing device. After collection, the collector is inserted into a receiving device 15, which is pre-filled with a processing liquid. The collector is inserted into the cavity 152 of the receiving device 15, contacting the processing liquid, thus dissolving the sample in the liquid. If it is a virus, the processing liquid lyses the sample; otherwise, it elutes or dissolves it. At this point, the carrier, initially fully contained within the cavity, is moved from a first locked position to a second position by a sliding element. A portion of the carrier extends out of the cavity 13 and enters the cavity of the receiving device 15, contacting the liquid. The testing element on the carrier then comes into contact with the liquid. Through capillary action, the liquid flows from the sample application area of ​​the testing element to the marking area, detection area, and absorption area, thus completing the analysis of the analyte in the sample.

[0099] In some embodiments, the receiving device includes two spaced-apart cavities. One cavity 153 is used to insert a collector, and the other cavity 153 is used to insert a portion of the carrier. In this arrangement, a partition separates the two cavities, while the bottom remains fluidly connected, similar to the principle of communicating vessels. The main consideration for this design is that when the collector is inserted into cavity 153, it is desirable that the sidewalls of a portion of the cavity be flexible, allowing for manual pressing of the cavity sidewalls to compress the collector and accelerate sample dissolution or lysis. When the carrier needs to be inserted into cavity 153, it is undesirable for the collector to interfere with the carrier insertion, nor is it desirable for the collector to directly contact the test element. Generally, the test element is flexible, and it is desirable for its position on the carrier to be fixed. If the position of the test element changes during operation, it will affect the test results. Therefore, a partition separates the cavity 152 where the carrier is inserted from the cavity 152 where the collector is inserted, preventing mutual interference. For example... Figure 9 The shown containment device 24 includes two cavities of different shapes. One is a cavity 241, which is similar in shape to the collection cavity and is generally cylindrical, while the other cavity 242 is a regular cube, similar in structure and shape to the carrier. This avoids the collector and the test elements on the carrier from interfering with each other during operation, even without a partition.

[0100] In some ways, for example Figure 10-15 In other embodiments shown, when the cavity 33 housing the test element is circular, the carrier 36 itself is also designed as a curved surface, so the slots on the carrier that accommodate the test element are also distributed on the curved surface. Specifically, the carrier is generally a regular curved surface with a ridge 3691 in the middle of the curved surface, dividing the carrier into two parts. The ridge 3691 divides the carrier into two regions, each region having a groove for accommodating a test strip, in which the test element is located. A laterally extending region 3612 is provided on the ridge, penetrating the entire groove of the carrier. This extending region is distributed on the ridge above the groove, so that when the test element 18 is placed in the groove, this extending region can protect the test strip from damage. This is mainly because the carrier 36 is moved within the cavity 33, and during this movement, it is necessary to ensure that the test element is not damaged, and also to ensure that the position of the test element in the groove does not change and remains fixed. Otherwise, the 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, and the operation may be quite arbitrary. Therefore, it is necessary to ensure that the positions of each component remain unchanged while also ensuring ease of operation.

[0101] In addition, to keep the test element fixed in the groove and prevent it from detaching from the groove, a stop block 3692 is provided at the end of the carrier. Figure 12The blocking block has a flat surface that contacts the end of the test element (not shown), thus preventing the test strip from falling out of the groove. This is because, during subsequent movement, the carrier needs to extend from inside cavity 33, and the extended portion needs to be immersed in the liquid; it is undesirable for the test element to slip out of the groove. In other embodiments, perforations are formed in the groove at different locations. It should be noted that one of the perforations is located on the flat surface of the blocking block and communicates with the surface. When the end of the test element contacts the surface of the blocking block, a portion of the test element is exposed through the perforation, particularly the sample application area. Thus, when the carrier extends from cavity 33 and enters the cavity of the collection device, it directly contacts the liquid sample in the collection device cavity, and the sample passes through the perforation to contact the sample area of ​​the test element. Another perforation 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 surface of the groove, thereby affecting the normal reaction; this perforation acts as a barrier. Typically, the speed at which liquid flows through the capillary force of the test strip itself is much slower than the speed at which liquid flows through the capillary slits. Therefore, if other areas of the test element, such as the detection area, are pre-wetted, the test cannot be completed when the sample liquid carrying the analyte flows to the detection area. This is because the pre-wetted liquid has eliminated the capillary force in the test area, thus affecting the flow of the liquid sample.

[0102] 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 sliding element 31. This structure, fixed to the sliding element, allows the sliding element to move, thus moving the carrier and protecting it from damage. The fixing structure consists of fixing blocks 364 on slide rails 363 on both sides of the carrier. The sides 3631 and 3632 of the slide rails 363 engage with the sides of the grooves 331 penetrating the sidewall of the receiving cavity 33. The friction between the surfaces of the slide rails 363 and the grooves ensures the carrier maintains a fixed position within the cavity.

[0103] The fixing block 364 located on the slide rail cooperates with the opening 311 on the sliding element to fix the carrier and the sliding element together. The thickness and length of the fixing block 364 correspond to the opening 311 on the sliding element 31. In this way, the sliding element with the carrier and the cavity 33 are assembled to form a testing device. Specifically, as shown... Figure 15As shown, the sliding element 31 is like a cavity, with slide rails 313 and 314 distributed symmetrically on its inner wall. Openings 311 and 312 are provided near the slide rails 313 and 314, respectively, which are combined with the fixing blocks 364 and 366 on the carrier. The slide rail 314 on the inner sidewall of the movable cavity 31 engages with the groove 332 on the surface of the cavity 33, and the slide rail 313 engages with the groove 335 on another cavity 31. The slide rail on the outer surface of the cavity does not penetrate the sidewall but has a depth and a bottom groove. Two grooves 331 and 334 penetrating the sidewall are provided on the cavity. The slide rail 363 of the carrier is set on the groove 331. Because the surface of the groove contacts the side of the slide rail 363 on the carrier, friction is generated, allowing the carrier to rely on gravity and not slide down. Figure 14 As shown. Specifically, the groove on the cavity 33 also has a certain length, and some protrusions, 3341 and 3342, are provided on one end of the groove. These protrusions are relatively raised on the side wall of the groove. When the slide rail 363 on the carrier is located on the groove, the protrusions are located above the slide rail 363, preventing the carrier from falling out of the groove. When the carrier is inserted into the cavity, although the slide rail 363 will pass through the protrusions on the groove 331, due to the elasticity of the plastic material, it can be inserted into the correct position. Once in the correct position (e.g. Figure 14 As shown, the slide rails 363 and 366 on the carrier are respectively engaged with the slide grooves 331 and 334. They remain in a fixed first position due to friction. This friction only needs to overcome the weight of the carrier, including the weight of the sliding element. In actual products, the weight of the carrier plus the test strip and the sliding element is approximately 20-50 grams. As long as the friction provides such resistance, it is sufficient. During operation, when it is necessary to move the carrier, simply push the sliding element 31 downwards slightly to move the carrier 36 within the cavity 33, allowing part of the carrier to extend into the receiving device 34, allowing the test element to contact the liquid. The following specific solution is also part of this invention.

[0104] 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.

[0105] According to the above-described device, a fluid sample collector is also connected to the cavity, and the collector is located at one end of the cavity.

[0106] According to the above-described apparatus, when the test element is in the first position, the test element and the cavity are locked together.

[0107] According to the above-described apparatus, when the test element is in the second position, a portion of the test element extends outside the cavity.

[0108] According to the above-described device, 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 and second positions, or the carrier drives the test element to move from the first position to the second position.

[0109] According to the above-described device, 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.

[0110] According to the above-described device, when the carrier is in the first position, the entire carrier is located inside 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.

[0111] According to the above-described device, the device further includes a sliding element connected to the carrier, the sliding element enabling the carrier to move from a first position to a second position.

[0112] According to the above-described device, the sliding element includes a first slide rail and a second slide rail, and the carrier is fixedly connected to the second slide rail.

[0113] According to the above-described device, the cavity includes a first slide groove that cooperates with a first slide rail of the sliding element and a second slide groove that cooperates 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.

[0114] According to the above-described device, the sliding element includes a partial locking structure, and the cavity includes another partial locking structure, wherein the sliding element is fixed to the cavity by the locking structure.

[0115] According to the above-described device, the carrier includes a suspension structure, and the carrier is fixedly connected to the second slide rail via the suspension structure.

[0116] According to the above-described device, 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.

[0117] According to the above-described device, the notch structure is located on the sheet-like structure of the sidewall of the cavity, the sheet-like structure being part of the sidewall of the cavity, and the sheet-like structure being elastic.

[0118] According to the above-described device, the sliding 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.

[0119] According to the above-described device, 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.

[0120] According to the above-described device, 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.

[0121] According to the above-described apparatus, the apparatus further includes a containment device for containing the collector and some test elements.

[0122] According to the above-described apparatus, the portion of the test element includes a portion of the sample application area.

[0123] According to the aforementioned apparatus, the sample is one of saliva, sputum, urine, or nasal secretions, and the substance being analyzed includes coronaviruses.

[0124] 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 sliding element on the cavity; and having the sliding element having a locked first position and a second position on the cavity.

[0125] According to the method described above, the sliding element is fixed to the cavity by a locking structure.

[0126] According to the above method, the sliding element is unlocked from the first position. After unlocking, the sliding 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.

[0127] According to the method described above, when the sliding element is in the first position, the carrier is located inside the cavity and not exposed; when the sliding element is in the second position, the carrier is exposed outside the cavity and in contact with the liquid sample. According to the method described above, a receiving device is provided for receiving a collector, wherein the collector is first inserted into a receiving container, and then the sliding element is moved from the first position to the second position.

[0128] According to the above method, the collector is placed on the detection device, the collector is inserted into the receiving container, and at the same time, part of the detection device enters the receiving cavity and seals the receiving cavity.

[0129] Using the method described above, the sliding element moves from a first position to a second position through the cooperation of the sliding groove and the sliding rail. Using the method described above, a sliding rail is provided inside the cavity of the sliding element, and a sliding groove is provided on the outer wall of the cavity containing the carrier.

[0130] According to the above method, the locking structure includes a protrusion located on the sliding element and a recessed structure on the cavity for receiving the protrusion.

[0131] According to the above method, when the sliding element is in the locked position, the protruding structure is located in the recessed structure, and when the sliding element is in the unlocked state, the protruding structure disengages from the recessed structure.

[0132] An apparatus for detecting an analyte in a sample includes: a cavity for receiving a carrier element, wherein a test element is located on the carrier element, the carrier 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.

[0133] According to the above-described device, the cavity has a groove and includes a slide rail that can slide on the groove, wherein the carrier is positioned in a first position by means of the friction between the groove and the slide rail.

[0134] According to the above-described device, the device further includes a sliding element capable of moving the carrier from a first position to a second position. The sliding element is located on the outer surface of the cavity. The sliding element includes an opening, and a fixing block is provided on the slide rail on the carrier. The fixing block is located in the opening, thereby connecting the carrier and the sliding element together.

[0135] According to the above-described device, the sliding element is provided with a slide rail, which can slide in a groove on the outer wall of the cavity.

[0136] According to the above-described device, the carrier can be moved from the first position to the second position by pushing the carrier to overcome friction.

[0137] 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 test components; A carrier located in a cavity, the carrier being used to carry the test element; A sliding element is connected to a carrier. The sliding element has a first locking position and a second position on the cavity. When the sliding element is in the first position, the test element on the carrier does not contact the fluid sample. When it is in the second position, the test element contacts the fluid sample. When the sliding element is unlocked, it can move from the first locking position to the second position, thereby moving the carrier from the first position to the second position. The sliding element is connected to the cavity via a locking structure. Part of the locking structure is located on a groove in the cavity, and part of the locking structure is located on the sliding element. The cavity includes a groove, and the sliding element includes a slide rail. The sliding element can move from the first position to the second position via the slide rail in the groove of the cavity. The partial locking structure on the groove includes opposing notches, and the partial locking structure on the sliding element includes two pins.

2. The apparatus according to claim 1, wherein, When the pin is received by the notch, the sliding element is locked in the first position. When the pin is disengaged from the notch, the active element can move from the first position to the second position.

3. The apparatus according to claim 2, wherein, The carrier includes a receiving port, and the sliding element includes an insert. The insert is inserted into the receiving port, thereby connecting the carrier and the sliding element.

4. The apparatus according to claim 3, wherein, The slide rail on the sliding element is connected to the insert.

5. The apparatus according to claim 4, wherein, The slide rail on the sliding element is connected to the positioning component, which is located inside the cavity and is driven by the slide rail to slide on the slide groove.

6. The apparatus according to claim 5, wherein, The sliding element is a sheet-like structure. A slide rail and a positioning member connected to the slide rail are provided at the top of the sheet-like structure. An insert is connected below the positioning member, and the pin is located at the other end of the sheet-like structure.

7. The apparatus according to claim 6, 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.

8. The apparatus according to claim 7, wherein, The device also includes a test element located on the carrier.

9. The apparatus according to claim 8, wherein, The device further includes a containment element and a sample collector, the containment element including a processing fluid for processing the sample, and the collector being fixedly connected to a cavity for receiving test elements.

10. The apparatus of claim 9, wherein when the carrier is in the second position, the portion of the carrier extending from the cavity enters the cavity of the receiving element and contacts the liquid sample in the receiving cavity.

11. The apparatus according to claim 10, wherein, The liquid sample mentioned is a sample that has been dissolved or lysed by the liquid sample processing solution collected by the collector.

12. The apparatus according to claim 11, wherein, The collector collects liquid samples including saliva, sputum, urine, and nasal secretions.

13. The apparatus according to claim 12, wherein, The substances being analyzed include small drug molecules, viral antigen fragments, or antibodies.

14. The apparatus according to claim 13, wherein, The substances being analyzed include coronaviruses.

15. The apparatus of claim 1, wherein the cavity has a groove, and a slide rail is included on the cavity, which is slidable on the groove, wherein... The carrier is positioned in the first position by relying on the friction between the slide and the slide rail.

16. The apparatus of claim 15, further comprising a sliding element capable of moving a carrier from a first position to a second position, the sliding element being located on the outer surface of the cavity, wherein, The sliding element includes an opening, and a fixing block is provided on the slide rail on the carrier. The fixing block is located in the opening, thereby connecting the carrier and the sliding element together.

17. The device according to claim 16, wherein the sliding element is provided with a slide rail, the slide rail being able to slide in a groove on the outer wall of the cavity.

18. The apparatus of claim 17, wherein the carrier can be moved from the first position to the second position by pushing the carrier to overcome friction.

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