A device for detecting an analyte in a sample

Abstract

The present invention provides a device for detecting an analyte in a liquid sample, the device comprising a channel with an opening at one end and a closed end, wherein the channel is used to set a test reagent strip, wherein the channel comprises a flood flow prevention structure, and the structure makes the cross-sectional area of ​​the channel smaller at the flood flow prevention structure. Through the device, the flooding phenomenon of the test reagent strip can be prevented, and the error rate can be reduced.

Description

Technical Field

[0001] The invention relates to a carrier for accommodating a detection reagent strip, in particular to a accommodating device for the detection reagent strip in the field of rapid diagnosis. Background Art

[0002] At present, detection devices for detecting whether a sample contains an analyte are widely used in hospitals or homes. These detection devices for rapid diagnosis include one or more test strips, such as early pregnancy tests, drug tests, etc. This rapid diagnosis detection device is very convenient and can obtain test results on the test strip in one minute, or at most ten minutes.

[0003] In these detection devices, the test strip is generally located on a certain carrier. The carrier can be a plate-shaped mold or a plug plate, etc. The carrier is generally composed of a slot or a channel, and a slot or a channel can accommodate a test strip, so that the carrier with the test strip can be used alone or in conjunction with a container. When such a carrier is used to accommodate the test strip, it can be directly used to detect whether the sample contains a substance of interest. At this time, the sample can be a liquid sample, such as urine. When the carrier with the test strip is inserted into the sample, or the liquid sample is allowed to flow into the container with the carrier, since the flow of the liquid into the carrier is not a smooth flow, but a disorderly flow, it often flows into the slot or channel in a short time, or into the cavity that accommodates the test strip, which will cause the phenomenon commonly known as "flooding", thereby affecting the normal operation and normal reaction of the test strip.

[0004] This makes it necessary to improve the traditional carrier for carrying the detection reagent strip to avoid phenomena such as flooding, thereby improving the accuracy and effectiveness of the detection reagent strip. Summary of the invention

[0005] In order to solve the problems existing in the prior art, the present invention provides a carrier, which includes a channel for accommodating a detection reagent strip, the channel is closed at one end and has an opening at the other end, and the detected fluid sample can enter the channel through the opening, wherein the channel includes a flood control flow structure. Alternatively, the present invention provides a channel, the channel is closed at one end and has an opening at the other end, and the detected fluid sample can enter the channel through the opening, wherein the channel includes a flood control flow structure. Preferably, the liquid entering the channel contacts the detection reagent strip, preferably, contacts the sample receiving area of ​​the detection reagent strip, or only contacts the sample receiving area of ​​the detection reagent strip.

[0006] In some preferred embodiments, the flood flow prevention structure is located near the opening of the channel.

[0007] In some preferred embodiments, the flood flow prevention structure is located below the labeled area of ​​the test reagent strip or away from the labeled area of ​​the test reagent strip. In some preferred embodiments, the flood flow prevention structure is located near the fluid application area of ​​the test reagent strip or is not at the same horizontal position as the labeled area of ​​the test reagent strip. Preferably, the flood flow prevention structure is located near the water level of the test strip, and more preferably, the flood flow prevention structure is located above the water level of the test strip and below the labeled area.

[0008] In some preferred embodiments, the flood flow prevention structure includes a protruding element in the channel, and the protruding element reduces the cross-sectional area of ​​a portion of the channel. In some preferred embodiments, the protruding elements are respectively located on the two side walls of the cavity and protrude into the channel. Preferably, the flood flow prevention structure reduces the cross-sectional area of ​​a portion of the channel, or narrows a portion of the channel.

[0009] In some preferred embodiments, the cross-sectional area of ​​the opening of the channel is larger than the cross-sectional area of ​​the channel at the location containing the flood flow prevention structure. In some preferred embodiments, the width of the opening of the channel is larger than the width of the interior of the channel.

[0010] In some preferred embodiments, the flood control flow structure divides the channel into two parts, one part is the first section of the channel from the flood control flow structure to the channel opening, and the other part is the second section of the channel from the flood control flow structure to one end of the closed channel, wherein the cross-sectional area of ​​the first section of the channel is greater than the cross-sectional area of ​​the second section of the channel; or, the cross-sectional area of ​​part of the first section of the channel is greater than the cross-sectional area of ​​part of the second section of the channel; or, the cross-sectional area of ​​each part of the first section of the channel is greater than the cross-sectional area of ​​each part of the second section of the channel. The junction of the first section of the channel and the second end channel forms the flood control flow structure of the present invention, or the junction of the first section of the channel and the second end channel makes the channel narrower. Preferably, the junction of the first section of the channel and the second end channel is a gradually narrowing area, which makes the channel narrower. To form the flood control flow structure of the present invention, when the channel is cylindrical, the cross-sectional area of ​​the channel can be used to measure the size of the channel. When the channel is rectangular or cuboid, with the same height, the wider the channel is, the larger the overall cross-sectional area is. Therefore, the width of the first section of the channel may be greater than the width of the second section of the channel, wherein the heights of the first channel and the second channel are the same.

[0011] Preferably, the width of the opening of the channel is greater than the width of the narrow part of the channel, but the height of the opening of the channel is also greater than the height of the narrow part of the channel.

[0012] In some preferred embodiments, the channel includes a bottom plate and a slot structure, wherein the bottom plate and the slot structure form a channel with an opening at one end and a sealing at the other end, wherein the opening is located near the sample application area of ​​the test strip. Preferably, the slot includes a narrow structure, which divides the slot into two parts, wherein the width of the narrow structure is smaller than the width of other parts of the slot. Preferably, the top of the slot includes an elongated small groove, which runs through the entire channel, or runs through the entire top of the slot.

[0013] In some preferred ways, the cavity channel may also include a test strip, the sample application area of ​​the test strip being located near the channel opening, and the sample absorption area being located at one end or near the channel closure. In some preferred ways, the marking area on the test strip is located near the flood control structure in the channel.

[0014] In all the above-mentioned specific embodiments, the channel on the carrier for accommodating the detection reagent strip includes a transparent flat plate structure and a slot structure, wherein the slot structure and the flat plate structure form the channel. Preferably, the slot structure is non-transparent. In some preferred embodiments, the detection area of ​​the detection reagent strip can be seen through the flat plate structure, or the detection area of ​​the detection reagent strip is facing the transparent flat plate structure or is arranged facing the transparent flat plate structure.

[0015] On the other hand, the present invention provides a detection device, wherein the device includes the aforementioned carrier or channel, the carrier includes a channel for accommodating a detection reagent strip, the channel is closed at one end, and has an opening at the other end, and the fluid sample to be detected can enter the channel through the opening, wherein the channel includes a flood-proof flow structure. In some preferred embodiments, the device also includes a detection reagent strip, wherein the reagent strip is located in the channel. All of the aforementioned flood-proof flow structure modes can be included in the detection device of the present invention. Preferably, the flood-proof flow structure is located below the marking area on the detection reagent strip, or the flood-proof flow structure is located between the marking area and the sample area on the detection reagent strip; or the marking area on the reagent strip is located above the flood-proof flow structure.

[0016] In a preferred embodiment, the device further comprises a cavity for accommodating a liquid sample, wherein the carrier is located in the cavity, wherein the sample application area of ​​the inspection reagent strip is close to the bottom of the cavity, so that the liquid sample in the cavity can enter the channel through the opening of the channel and contact the sample application area of ​​the reagent strip in the channel, so that the liquid passes through the marking area, the detection area, the detection control area (if any) in sequence along with the reagent strip from the sample application area, and finally reaches the water absorption area (if any).

[0017] The present invention provides a method for detecting an analyte in a fluid sample, the method comprising: providing a detection device, the detection device comprising a carrier, the carrier comprising a channel for accommodating a detection reagent strip, the channel having one end closed and the other end having an opening, the detected fluid sample can enter the channel through the opening, wherein the channel comprises a flood flow prevention structure, wherein the channel comprises a detection reagent strip, wherein the flood flow prevention structure is located between a marking area of ​​the detection reagent strip and the channel opening; allowing the fluid sample to enter the channel through the channel opening, allowing the sample application area of ​​the detection reagent strip to contact the fluid sample in the channel, thereby detecting the analyte in the fluid sample. Alternatively, the flood flow prevention structure is located below the marking area of ​​the detection reagent strip and above the channel opening.

[0018] In some preferred embodiments, the flood flow prevention structure is located near the opening of the channel.

[0019] In some preferred embodiments, the flood flow prevention structure is located below the labeled area of ​​the test reagent strip or away from the labeled area of ​​the test reagent strip. In some preferred embodiments, the flood flow prevention structure is located near the fluid application area of ​​the test reagent strip or is not at the same horizontal position as the labeled area of ​​the test reagent strip.

[0020] In some preferred embodiments, the flood flow prevention structure includes a protruding element in the channel, which reduces the cross-sectional area of ​​the channel. In some preferred embodiments, the protruding elements are respectively located on the two side walls of the cavity and protrude into the channel.

[0021] In some preferred embodiments, the cross-sectional area of ​​the opening of the channel is larger than the cross-sectional area of ​​the channel at the location containing the flood flow prevention structure. In some preferred embodiments, the width of the opening of the channel is larger than the width of the interior of the channel.

[0022] In some preferred embodiments, the flood control structure divides the channel into two parts, one part is the first section of the channel from the flood control structure to the channel opening, and the other part is the second section of the channel from the flood control structure to one end of the closed channel, wherein the cross-sectional area of ​​the first section of the channel is greater than the cross-sectional area of ​​the second section of the channel. When the channel is cylindrical, the cross-sectional area of ​​the channel can be used to measure the size of the channel. When the channel is rectangular or cuboid, when the height is consistent, the greater the width of the channel, the greater the overall cross-sectional area, so the width of the first section of the channel can also be greater than the width of the second section of the channel, wherein the height of the first channel and the second channel are the same.

[0023] In some preferred ways, the cavity channel may also include a test strip, the sample application area of ​​the test strip being located near the channel opening, and the sample absorption area being located at one end or near the channel closure. In some preferred ways, the marking area on the test strip is located near the flood control structure in the channel. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 The schematic diagram of the principle of the present invention and the structural comparison diagram with the traditional channel. Figure 1 A and Figure 1 D is a schematic diagram of the principle of the vector of the present invention, Figure 1 B is a schematic diagram of the structure of a traditional test reagent strip. Figure 1 C is a schematic diagram of the structure of the detection reagent strip; Figure 1 E is a schematic diagram of the combined structure of the carrier structure and the reagent strip in one embodiment of the present invention.

[0025] Figure 2 It is a schematic diagram of a three-dimensional structure in which a plurality of channels are arranged on a carrier according to an embodiment of the present invention, and a detection reagent strip can be accommodated in the channels.

[0026] Figure 3 yes Figure 2 An enlarged three-dimensional structural diagram of a channel structure in;

[0027] Figure 4 is a three-dimensional schematic diagram of the card slot structure without the transparent flat plate structure;

[0028] Figure 5 It is a schematic diagram of the local enlarged structure of a channel;

[0029] Figure 6 is a longitudinal section of the channel and a schematic diagram of the reagent strip. Figure 6 A is a longitudinal sectional view of a channel of another embodiment of the present invention, Figure 6 B is a schematic diagram of the assembly position of the reagent strip;

[0030] Figure 7 Schematic diagram of the principle of flooding caused by the flow of liquid containing a reagent strip in a traditional channel.

[0031] Figure 8 It is a schematic diagram of the assembly structure of a urine cup containing the channel of the present invention in a specific embodiment of the present invention. DETAILED DESCRIPTION

[0032] The structures involved in the present invention or the technical terms used are further explained below.

[0033] Detection

[0034] Detection means to test or examine a substance or material for the presence or absence of a substance or material, such as, but not limited to, a chemical substance, an organic compound, an inorganic compound, a metabolite, a drug or a drug metabolite, an organic tissue or a metabolite of an organic tissue, a nucleic acid, a protein, or a polymer. In addition, detection means to test the amount of a substance or material. Furthermore, assay also means immunoassay, chemical assay, enzyme assay, etc.

[0035] sample

[0036] The samples referred to in the present invention refer to those substances that can be used to detect, test or diagnose the presence of an analyte of interest. The sample can be, for example, a fluid sample, which can be a liquid sample, which can include blood, plasma, serum, urine, saliva and various secretions, and can also include a liquid solution formed by pre-treatment of solid samples and semi-solid samples. The collected samples can be used for immunoassays, chemical assays, enzyme assays and other methods to detect the presence of an analyte.

[0037] Test strips

[0038] The test strip applied to the present invention can be the so-called lateral flow test strip 500, and the specific structure and detection principle of these test strips are well-known technologies for those skilled in the art in the prior art. Common test strip 500 includes sample collection area 503, labeling area 502, test area 504 and water absorption area 501, the sample collection area includes a sample receiving pad, the labeling area 502 includes a labeling pad, and the water absorption area 501 may include a water absorption pad, wherein the test area 504 includes necessary chemical substances that can detect whether the analyzed substance is contained, such as immunoreagents or enzyme chemical reagents. The commonly used test strip is a nitrocellulose membrane test strip, that is, the test area 504 includes a nitrocellulose membrane, and specific binding molecules are fixed on the nitrocellulose membrane to display the result of the test; it can also be a cellulose acetate membrane or a nylon membrane, etc., of course, the downstream of the test area can also include a test result control area 505, usually, the control area and the test area appear in the form of horizontal lines, which are test lines or control lines. Such a test strip is a traditional test strip, of course, it can also be other types of test strips that utilize capillary action to detect. In addition, the test strips generally carry dry chemical reagent components, such as fixed antibodies or other reagents. When they encounter liquid, the liquid flows along the strips due to capillary action. As it flows, the dry reagent components are dissolved in the liquid, and then processed in the next area to react with the dry reagent in that area, so as to perform the necessary test. Liquid flow is mainly carried out by capillary action.

[0039] Analyte

[0040] Examples of analytes that can be used in the present invention include some haptens, which include drugs. The detection device of the present invention can also be used to detect drugs. After being absorbed by the human body, these drugs will be decomposed into different small molecules. These small molecules exist in body fluids such as blood, urine, saliva, sweat, etc., or some body fluids contain the above-mentioned small molecules.

[0041] Detection device

[0042] The detection device refers to a device used to detect whether a sample contains an analyte. In the present invention, the detection device particularly refers to a detection device used in the field of rapid diagnosis, such as a detection reagent strip 500, a detection card or insert structure 100, a detection stick, a detection cup ( Figure 8 Here, the reagent strip is inserted into the test card 100 ( Figure 2 ) in a channel 300, wherein the sample application area of ​​the test strip is exposed from the opening 305 (e.g. Figure 5 Neutralization Figure 7 ), thus forming a test card, which can complete the test independently. Figure 1 A. Using one of the channels to illustrate the principle of detection, when in use, insert the detection card into the liquid sample. Since one end 12 of the channel of the detection card is closed and the other end 11 is open, a part of the liquid sample flows into the channel. However, since one end of the channel is closed, the inflow of liquid forms a closed gas inside the channel. Therefore, under the internal and external pressures, the liquid can only maintain a certain horizontal height in the channel after entering the channel. As the liquid enters the channel and maintains a fixed horizontal height, the liquid submerges the sample application area of ​​the reagent strip. Due to the capillary action of the reagent strip, the liquid flows upward along the reagent strip, thereby completing the detection. If lines or no lines appear in the detection area of ​​the reagent strip, it indicates whether the analyzed substance exists in the sample. Figure 1 B is a traditional assembly diagram of a channel and a reagent strip for detection using this principle.

[0043] No matter like Figure 1 B, a single reagent strip for the detection of one or several analytes in liquid samples, or Figure 2 In this way, multiple detection test strips are arranged in multiple different channels 300 (the structure of each channel is basically the same), and each detection reagent strip corresponds to a substance to be analyzed. In this way, the detection card 100 is directly inserted into the liquid sample, and multiple different analytes can be detected at one time, for example, 3, 10, 15 different analytes. Of course, it is also possible to Figure 8 That is, a channel containing a reagent strip or Figure 2Multiple reagent strips are arranged in a card with multiple channels arranged in a Figure 8 In a container (such as a commonly described urine cup), one end of the channel opening is located at the bottom 92 of the urine cup, and the closed end 312 of the channel is located near the mouth 91 of the urine cup. In this way, when the urine cup collects urine, as the urine enters the cavity 90 of the urine cup, as the working principle of the single channel described above, each channel has a certain height of liquid in each channel (when the internal and external air pressures are balanced) due to the effect of the enclosed gas, thereby completing the reaction of each reagent strip.

[0044] The detection device may include a detection card 20 and components used in conjunction with the detection card 20, such as Figure 8 As shown, the urine cup 2 can be used as a form of detection device.

[0045] In current detection, this card-type or cup-type detection device needs to support the detection reagent strip 500 with a carrier 100 to play the detection function. In this way, the carrier may include multiple channels 300, each channel 300 may include a reagent strip 500, and each reagent strip corresponds to one or more analyzed substances. Or, at least one channel is required, and a reagent strip is arranged in the channel. However, in the existing traditional field, when detecting under the channel principle (enclosed gas and internal and external pressures), because the reagent strip is located in the channel, because of the coordination or physical position between the reagent strip and the channel, many defects of the reagent strip are often caused. One defect is, for example, a patent, which overcomes the phenomenon of broken wires. This is because the detection reagent strip is often closely connected to the wall of the channel, thereby generating capillary action, thereby causing broken wires. The solution is to try not to let the detection reagent strip contact or large-area contact with the wall of the channel, that is, for example, like Figure 1 B or Figure 7 In this way, the channel and the test strip have a certain distance, such as 1-4 mm or more, or a few mm. Although this can effectively solve the problem of disconnection, the accompanying problem, and the biggest problem, is the "flooding" problem. Because whether a test strip in a single channel is directly inserted into a liquid sample for detection, or a detection device (such as a urine cup) includes multiple channels to detect the analyte in the liquid sample, there will be a flooding phenomenon.

[0046] The so-called flood phenomenon, combined with Figure 7To further explain, within a short period of time, a large amount of liquid sample 701 flows into the reagent strip, so that the reagent strip 500 does not have time to absorb the sample by capillary action for normal flow (the liquid in 561 is the trace of flow through normal capillary action). Instead, more sample flows onto the test strip or the surface (the liquid indicated by 560), and flows forward rapidly through the surface of the test strip. Since the flow of most liquid samples is not the flow of capillary action, but the rapid flow directly on the surface, the dry chemical reagent on the reagent strip is difficult to quickly and completely dissolve and release into the liquid sample in a short time. This results in no lines appearing in the detection area or the detection control area. Because the liquid on the surface does not pass through or flows less with the help of capillary action and flows faster, it wets the other parts of the reagent strip in advance. Therefore, the reagent strip loses its main capillary action in advance, thus making it almost impossible for the reagent carrying or dissolved in the dry treatment on the reagent strip to flow forward. In this way, although the test strip appears to be moistened, no substantial reaction occurs, and thus no reaction occurs in the test area or the control area, resulting in inaccurate test results, and sometimes no test results appear.

[0047] like Figure 7In that way, in the traditional device, the reagent strip 500 is generally not in direct contact with the channel 300 (at most the channel has a support frame), once the reagent strip and the channel are inserted into the liquid sample 700, due to the different operators of different pairs, the depth of insertion, the speed of insertion, and the state 701 of the liquid sample are different (static or whether flowing, or the splashing liquid flower 701), when the channel containing the test strip enters the liquid sample, due to the influence of the short-term microenvironment, a large amount of liquids can be caused to pour into the channel in a very short time, under the microenvironment, the liquid pours into the channel through the channel opening 305, due to the sealing of one end 312 of the channel 300, the liquid entering and the end have just sealed a section of gas, thereby producing pressure on the liquid level of the liquid, thereby limiting more liquid to enter the channel, finally reaching balance, allowing the liquid to be at a certain height in the channel. Although the time to reach balance is very short, in this process, the liquid is in a mess, and under the microscopic state, the reagent strip is produced in many different directions, very large impact force, thereby causing the so-called flood phenomenon. Similarly, the channel or card 100 containing the reagent strip is statically set in the urine cup. When a liquid sample, such as urine, is injected into the urine cup, the liquid flows rapidly in a short time and then enters the channel. Although the process of achieving internal and external balance is short, the liquid flow in the microenvironment is still intense, so that part of the liquid flows directly from the surface of the reagent strip, thereby causing a flood phenomenon, which makes the test result invalid or inaccurate. Of course, there are also differences in the direction, angle, and speed of pouring the liquid sample into the urine cup; and, in particular, when the test is performed, the subject directly injects urine into the urine cup through the genitals. The urine cup usually contains a reagent strip with a channel. In this case, because different subjects do not have professional operating capabilities, the angle, size, and amount of urine entering the urine cup are also different. In particular, the entrance of the channel is in a relatively complex environment. In short, the test is placed under a very complex condition, which is more likely to cause a flood phenomenon, thereby affecting the final test result.

[0048] In order to overcome this defect, the present invention adopts such a carrier 100 or channel 300, which can limit the arbitrary flow of liquid samples in the channel, thereby reducing the occurrence of floods. Furthermore, the structure of the anti-flood structure can quickly put the liquid in a calm state, or quickly reach an internal and external balance, or, can reduce the phenomenon that the liquid does not flow through the capillary action of the test strip. As analyzed above, the main function of the reagent strip to make the liquid flow is capillary action, and the flood caused is to make the liquid flow on the reagent strip almost without or very little through capillary action.

[0049] Carrier or channel

[0050] The carrier 100 or the channel 300 refers to a component or element for accommodating the detection reagent strip 500. Figure 1 A and Figure 7 As shown, the detection reagent strip 500 can be arranged in the channel 300 on the carrier, one end of the channel is closed 312, and the other end is open 305. The external liquid enters the channel through the opening. When the carrier 100 is placed upright or horizontally, the detection reagent strip 500 generally will not fall out of the carrier 100. Specifically, the reagent strip will not fall off from the channel 300 on the carrier. Here, the carrier itself is the channel, or the channel itself is a form of the carrier, and the detection reagent strip is contained in the channel. In this sense, the present invention provides a channel, one end of the channel is closed, the other end is open, and the detection reagent strip is arranged in the channel. Preferably, the sample application area 503 of the detection reagent strip is close to the opening of the channel, and the detection control area is located near the closed end of the channel. The element constituting the carrier 100 can be in the form of a card slot, or in the form of a channel 300, or the card slot is assembled with a flat plate structure to form the channel 300 of the present invention. The number of card slots or channels 300 can be 1, 2, 3, 4 or even more. Generally speaking, a slot or channel 300 can accommodate a test reagent strip 500. Generally, at one end of the channel, such as a closed end, the channel 300 or the slot includes a clamping structure, such a structure can clamp the test reagent strip. Of course, the clamping structure is not a necessary structure, it is just a preferred technical solution.

[0051] In some preferred embodiments, the flood flow prevention structure is located in the channel, and the structure divides the channel into two different parts, for example, a first channel and a second channel. The first channel is located from the opening of the channel to the flood flow prevention structure, and the second channel is from the location of the flood flow prevention structure to the closed end of the channel. The intersection of the first channel and the second channel is the flood flow prevention structure. The structure that restricts the fluid reduces the cross-sectional area of ​​the channel or allows the restricting fluid structure to form a local narrow space in the channel. In some specific embodiments, for example Figure 1 A, the confining fluid structure 309 is close to the end of the opening 11 of the channel and away from the closed end 12 of the channel 300. Preferably, the confining fluid structure is located below the marked area of ​​the reagent strip. In some preferred embodiments, the confining fluid structure divides the channel into two different parts, near the opening, for example Figure 1 A, the structure that restricts the flow narrows a certain position of the channel, and at the same time, the wall of the channel extends outward along the narrow place, so that the extension is gradual, and thus, as the extension is extended, the cross-sectional area of ​​the channel gradually increases, so that the cross-sectional area of ​​a section of the extended section is larger than the cross-sectional area of ​​the second channel. Or, Figure 1 D and Figure 1E, that way, the structure 309 that confines the fluid divides the channel into two different parts, near the opening, e.g. Figure 1 D. The structure for limiting the fluid narrows a certain position of the channel, and then extends along the narrow position toward the opening 11. As it extends, the cross-sectional area of ​​the channel does not gradually increase, but remains unchanged, so that the cross-sectional area of ​​the first channel is always smaller than the cross-sectional area of ​​the second channel. Figure 1 B is a schematic diagram of a channel in a conventional existing detection device, wherein the entire channel is substantially the same cross section, or the distance between the walls of the channel is substantially the same, and the channel is in a smooth or parallel wall. Through the experiments of the present invention, it is unexpectedly found that the embodiments of the present invention (e.g. Figure 1 A, Figure 1 D's solution, or similar solutions) can significantly reduce the flood phenomenon, and can reduce the probability of flooding by 20-30%, greatly improving the defects of existing products or existing technologies, and improving the traditional (such as Figure 1 B) A channel including a reagent strip is used to detect the performance of the analyte in the sample.

[0052] In some preferred embodiments, the plurality of channel structures of the present invention (e.g. Figure 1 A, Figure 1 D that a single channel) can be integrated on a plastic plate, for example Figure 2 As shown, such a plastic plate includes a plurality of channels 300, and such a carrier 100 includes a base plate 200, on which a plurality of slot structures 30 are arranged, and the slots and the base plate are bonded to form a complete channel 300. The base plate 200 can be a transparent plastic base plate, and the slot structure can be made of a transparent or opaque material. Generally, the base plate is a flat transparent plate, and is assembled with the slots to form a complete channel structure. In some preferred embodiments, one end of the channel 300 is closed 312, and the other end is open 305. The transparent base plate has an end extension surface 201 at the channel opening, and the sample application pad on the sample application area 503 of the reagent strip can be clearly seen through the transparent material on the extension surface. As shown in FIG. Figure 2 As shown, multiple channels are integrated on the transparent bottom plate 200 to form a fan-shaped card. Since the card is flexible, it can be easily folded or formed into a certain shape and inserted into the urine cup (detailed description is provided later), thereby forming a complete detection device. Optionally, such an insert can also be used alone and directly inserted into a liquid sample for detection.

[0053] The following is a detailed description of such a plug structure in conjunction with specific figures. Figure 3-5 for Figure 2 The schematic diagram of the structure of a channel in the insert structure shown in FIG. Figure 3 As shown, the bottom plate 200 includes a slot structure 30 ( Figure 4), the transparent bottom plate and the card slot are combined to form a complete channel 300, one end of the channel is closed 312, and the other end is an opening 305, through which the external liquid enters the channel. Such a channel can be formed in the form of a roughly rectangular parallelepiped, and the shape of the rectangular parallelepiped is not a regular rectangular parallelepiped, with narrow ends and a wide middle, and the open end is wider than the rest of the channel. The height of the rectangular parallelepiped is substantially the same, and in fact, different structural units with different cross-sectional areas are formed. This is because the height is the same, and the difference in width forms the difference in cross-sectional areas. Figure 4 The stereoscopic schematic diagram of the slot structure of the channel (excluding the bottom film 200), with symmetrical feather pieces 325, 326 structures on both sides of the approximately rectangular channel, the feather pieces have smooth surfaces 321, 322, and outer edges 328, 327 on the smooth surfaces, each edge having a certain width plane, such as 1 mm or 2 mm, and the edge surface is smooth and flat, and is used to bond with the bottom film 200 to form an airtight seal, so that the bottom film seals the slot, thereby forming a complete channel 300. Figure 4 It can be seen that the slot structure 30 contains a slot cavity 329 for arranging the test reagent strip. The slot cavity 329 has a certain depth, which can be expressed as the height of the channel (in this specific embodiment). At the same time, the slot has different widths. Near the opening 305, the width between the two depth walls 332 and 333 of the slot (first width A) is greater than the width between the two walls 334 and 335 of the slot (second width B). However, the width between the walls 331 and 330 that form the depth of the slot (third width C) is smaller than the second width. In this way, the intersection of different widths forms the flood control structure of the present invention. Optionally, as Figure 4 As shown, in fact, at the third width C, the wall of the slot extends outward (opening 305), gradually extending outward, and as it extends outward, the width between the two walls gradually increases, forming a small "trumpet" shape. Here, the "trumpet" shape is not necessary for the present invention, but is a preferred solution. Figure 6 As shown, such a channel does not have a "trumpet" mouth, but there is a narrowing 309 on the channel, and the channel is concave inward at the narrowing point, so that the inner diameter of the channel at this point becomes smaller. In fact, other places in the channel have not actually changed, and the narrowing 309 also forms the flood control structure of the present invention. This inward concave structure can be a sudden concave, or it can be a gradual concave, and then gradually extend out. In this embodiment ( Figure 4In the embodiment of the present invention, the third width C is formed by the protrusion of the slot wall. Of course, in order to make the slot have different widths, in addition to the slot wall protruding inward, there can be other ways, such as setting square protrusions, or circular protrusions, or protrusions of any other form on the slot wall, so that the slot has different widths. In addition, when the slot is cylindrical or semicircular, according to the same principle, different protrusions can also be set between the slot walls to form channels of different widths.

[0054] In some preferred embodiments, the bottom of the card slot ( Figure 4 ) is formed with a small groove 312, which runs through the bottom of the entire card slot (such as Figure 3 In this way, when liquid flows into the opening of the channel, the fine groove 312 can expel gas in time, and the air pressure inside and outside can be balanced more quickly in the sealed channel, which can improve the time to reach equilibrium, allow the liquid to return to a calm state faster, and reduce the impact of the flood.

[0055] Further, after combining Figure 5 , Figure 6 As shown, the length of the entire card slot or channel is 57.5 mm, and the length of the test strip is 60 mm, so a portion of the test strip is not in the card slot but exposed. The second width B of the card slot is 4.25 mm. The third width C is 3.25 mm. When there is a flared mouth (it cannot have, for example, Figure 6 As shown), the first width A is 5.4 mm ( Figure 5 ), the depth of the card slots is the same or different parts have different depths. Figure 5 It can be clearly seen that the width from the position of the third width C to the position of the first width A is gradually increasing. This gradual increase can be a gentle increase or a relatively drastic increase, which is included in the essence of the present invention. In a preferred embodiment, the width of the opening is gradually increased, and the height of the channel is also gradually increased, for example Figure 5 In the middle, the narrow place 309 is sunken and then gradually increases in width. At the position 308, the height of the slot also gradually increases with the extension of the wall, forming a lip structure 311, so that a relatively open area 310 is formed at the opening 305, and then a narrow area is formed in the channel. This may be able to reduce the flooding phenomenon and reduce the impact of local liquid on the reagent strip.

[0056] In another way, for example, Figure 6As shown (without a trumpet mouth structure), the third width C is 3.25 cm, which is smaller than the second width B (4.25 cm). There is a section of the structure in the concave part that is always smaller than the second width of the slot 4.25 cm, and then gradually reaches the second width structure, which does not have a trumpet mouth structure (such as Figure 5 ). However, the width of the reagent strip is 3.20 or 3.1 mm. In this way, when the reagent strip is arranged in the slot, part of the reagent strip is at the narrow part 309. Although the reagent strip does not contact the wall of the slot, the narrow part divides the reagent strip into two parts relative to the channel, the part close to the opening and the part away from the narrow part (for example, B). When the channel containing the reagent strip is inserted into the liquid sample in various ways (vertical, tilted at different angles) or a detection device (for example, a urine cup) with a channel receives the liquid sample (urine), no matter at what angle, speed and amount the urine enters the urine cup, the flood phenomenon can be significantly reduced.

[0057] In some preferred embodiments, the structure of the flood flow prevention structure is located below the marked area of ​​the reagent strip. Generally, there is a water level line below the marked area of ​​the reagent strip, indicating the maximum insertion or immersion of the reagent strip, or the position line where the sample submerges the reagent strip (e.g. Figure 1 E 509), then the flood control structure (e.g. Figure 6 309 of them, Figure 4 The structures at 331 and 330 in , or Figure 1 900 in A) are all located near the water level, for example, level with the water level, or above the water level, but are all below the marked area.

[0058] The following is a detailed description of the embodiments of the present invention in conjunction with the specific drawings. These specific embodiments are only limited examples without violating the spirit of the present invention, and do not exclude other specific implementation schemes produced by ordinary technicians in this field by combining the prior art with the present invention.

[0059] The present invention selects a series of DOA products for different tests, mainly including AMP (amphetamine), BAR (barbital), BZO (benzodiazepine), COC (cocaine), MET (methamphetamine), MDMA (dimethyldioxymethylaniline), MOP (morphine), OP1 (morphine), OXY (hydroxydihydrocodone), MTD (methadone), PCP (phencyclidine), PPX (propoxyphene), TCA (tricyclic antidepressants), THC (tetrahydrocannabinol), COT (nicotine), BUP (buprenorphine), ACE (acetaminophen), KET (ketamine), MQL (methamphetamine), EDDP (2-acetal-1,5-dimethyl-3,3-diphenylpyrrolidine).

[0060] Example 1: Comparative experiment on flooding phenomenon under different card slot structures

[0061] The first channel: This embodiment relates to a detection card. Figure 2 The detection card 100 includes a carrier 200 and a detection reagent strip 500. The carrier 100 includes a plurality of slot structures 30 that form a channel together with the plane carrier. The slots 30 are rectangular in shape and have different widths. Figure 6 A and Figure 5 In the schematic diagram shown, the third width C (3.25 mm) of the slot is smaller than the second width B (4.25 mm), but the second width B is smaller than the maximum width of the first width A (5.4 mm), wherein the first width A is below the marking area of ​​the reagent strip and close to the opening 305, wherein the second width B of the slot is larger than the width of the reagent strip, and the first width A is equivalent to or substantially equal to the width of the reagent strip (the width of the reagent strip is 3.2 mm), and the other end of the channel is sealed. The test strip 500 in the test card is used to detect whether a sample contains drug substances, such as marijuana, cocaine, etc. At this time, the height or depth of the slot is the same.

[0062] The second channel (comparison, traditional card slot structure): Similarly, compared with the first channel, the difference is: we use the same width of the card slot (the distance between the corresponding walls in the card slot is 4.25 mm wide), the width of the reagent strip is still 3.20 mm, and the position of the reagent strip in the card slot is the same as in the first card slot.

[0063] The third channel: Compared with the first channel, the other parts are the same, except that the card slot is rectangular in shape and has different widths, such as Figure 6 A and Figure 5 In the schematic diagram shown, the third width C (3.25 mm) of the card slot is smaller than the second width B (4.25 mm), but the second width B is equal to the first width A (4.25 mm), that is, the card slot has a concave portion (309) instead of a bell-shaped structure. Other portions are the same as the first card slot, including the reagent strip, which has the same width.

[0064] Operation method: When the test is in progress, insert the test card 100 (a test card directly containing the above three channel structures) directly into a mixed solution containing a variety of small molecule drugs. Keep it in the liquid sample for 1 minute to ensure that there is enough sample for testing. At this time, the liquid sample will follow the sample receiving area 503 of the test reagent strip 500, reach the marking area 502, and be fully mixed with the marking substance on the marking area, and then reach the detection area 504, forming a detection symbol in the detection result area of ​​the detection area 504, such as a detection line, which is used to determine whether the liquid sample contains the substance to be analyzed. The following table is a statistical table of the number of torrents, as shown in the following table:

[0065]

[0066] As can be seen from the above table, when the structure with anti-flood flow structure appears in the slot or channel, in all the tested slots, the first slot has no flood phenomenon, and the control line occurrence rate is 100%, while in the same slot or channel without restricting fluid structure, the flood occurrence rate is 15%, and only 86.5% of the test strips have control lines, indicating that there are still 13.5% of the test strips without control lines, which represent invalid results regardless of the test line. Relatively speaking, the probability of flooding in the third channel is much smaller than that of the test strips in the traditional existing channel structure.

[0067] Example 2: Comparative experiment of flooding phenomenon under different slot structures (in urine cup) - laboratory

[0068] The first card slot: This embodiment relates to a detection card. Figure 2 The detection card 100 includes a carrier 200 and a detection reagent strip 500. The carrier 100 includes a plurality of card slot structures 30 that form a channel together with the carrier. The card slots are rectangular in shape and have different widths. For example, Figure 6 A and Figure 5 As shown in the schematic diagram, the third width C (3.25 mm) of the slot is smaller than the second width B (4.25 mm), but the second width B is smaller than the first width A (5.4 mm) (the maximum width of the horn), wherein the third width C is below the marking area 502 of the reagent strip and close to the opening 305, wherein the second width B of the slot is larger than the width of the reagent strip, and the third width C is equivalent to or substantially equal to the width of the reagent strip (the width of the reagent strip is 3.2 mm), and the other end of the channel is sealed. The test strip 500 in the test card is used to detect whether a sample contains narcotic substances, such as marijuana, cocaine, etc.

[0069] The second slot (comparison): Similarly, compared with the first slot, the difference is: we use the same width of the slot (the distance between the corresponding walls in the slot is 4.25 mm wide), the width of the reagent strip is still 3.20 mm, and the position of the reagent strip in the slot is the same as in the first slot.

[0070] The third card slot: Compared with the first card slot, the other parts are the same, except that the card slot is rectangular in shape and has different widths, such as Figure 6 A and Figure 5As shown in the schematic diagram, the third width C (3.25 mm) of the card slot is smaller than the second width B (4.25 mm), but the second width B is equal to the first width A (4.25 mm), that is, the card slot has a recessed portion (309) instead of a trumpet-shaped structure, and the rest is the same as the first card slot, including the reagent strip, which has the same width.

[0071] Operation method: When testing, first put the cards of three different channels (first card slot, second card slot, third card slot) (such as Figure 2 As shown) is bent and inserted into the cup body of the urine cup, wherein the opening of the channel is located at the bottom of the urine cup ( Figure 8 ), and then quickly pour urine into the urine cup (the height of the cup body is 75 mm, the length of the entire channel is 57.5 cm, and the length of the reagent strip is 60 mm), the volume of the urine cup is 50 ml (it takes almost 2 seconds to fill the entire urine cup with liquid sample). Once the urine cup is full of urine, at this time, the liquid sample will enter the channel through the opening of the channel, along the sample receiving area 503 of the detection reagent strip 500, reach the marking area 502, and fully mix with the marking substance on the marking area, and then reach the detection area 504, forming a detection symbol in the detection result area of ​​the detection area 504, such as a detection line, which is used to determine whether the liquid sample contains the substance to be analyzed. The following table is a statistical table of the number of torrents, as shown in the following table:

[0072]

[0073] As can be seen from the above table, when the structure with anti-flooding structure appears in the slot, in all the urine cups tested, the first slot has no flooding phenomenon, and the control line occurrence rate is 100%, while in the same slot or channel without restricting fluid structure, the flooding rate is 17%, and only 83% of the test strips have control lines, indicating that there are still 17% of the test strips that do not have control lines, which represent invalid results regardless of the test line. Relatively speaking, the probability of flooding in the third channel is much smaller than that of the test strips in the traditional existing channel structure.

[0074] Example 3: Comparative experiment on flooding phenomenon under different slot structures (in urine cup) - clinical

[0075] The first card slot: This embodiment relates to a detection card. Figure 2 The detection card 100 includes a carrier 200 and a detection reagent strip 500. The carrier 100 includes a plurality of card slot structures 30 that form a channel together with the carrier. The card slots are rectangular in shape and have different widths. For example, Figure 6 A and Figure 5As shown in the schematic diagram, the third width C (3.25 mm) of the slot is smaller than the second width B (4.25 mm), but the second width B is smaller than the first width A (5.4 mm) (the maximum width of the horn), wherein the third width C is below the marking area 502 of the reagent strip and close to the opening 305, wherein the second width B of the slot is larger than the width of the reagent strip, and the third width C is equivalent to or substantially equal to the width of the reagent strip (the width of the reagent strip is 3.2 mm), and the other end of the channel is sealed. The test strip 500 in the test card is used to detect whether a sample contains narcotic substances, such as marijuana, cocaine, etc.

[0076] The second slot (comparison): Similarly, compared with the first slot, the difference is: we use the same width of the slot (the distance between the corresponding walls in the slot is 4.25 mm wide), the width of the reagent strip is still 3.20 mm, and the position of the reagent strip in the slot is the same as in the first slot.

[0077] The third card slot: Compared with the first card slot, the other parts are the same, except that the card slot is rectangular in shape and has different widths, such as Figure 6 A and Figure 5 As shown in the schematic diagram, the third width C (3.25 mm) of the card slot is smaller than the second width B (4.25 mm), but the second width B is equal to the first width A (4.25 mm), that is, the card slot has a recessed portion (309) instead of a trumpet-shaped structure, and the rest is the same as the first card slot, including the reagent strip, which has the same width.

[0078] Operation method: Before the test, first put the cards of three different channels (first card slot, second card slot, third card slot) (such as Figure 2 As shown) bend and insert into the cup body of the urine cup (as shown Figure 8 ), where the opening of the channel is located at the bottom of the urine cup, and then different people are conducted to conduct clinical experiments, that is, people without professional operation collect urine, usually directly let the genitals urinate into the urine cup, so as to observe the probability of flooding phenomenon. The results are as follows:

[0079]

[0080] As can be seen from the above table, when the structure with anti-flooding structure appears in the slot, in all the urine cups tested, the first slot has no flooding phenomenon, and the control line occurrence rate is 100%, while in the same slot or channel without restricting fluid structure, the flooding rate is 20%, and only 80% of the test strips have control lines, indicating that there are still 20% of the test strips that do not have control lines, which represents invalid results regardless of the test line. Relatively speaking, the probability of flooding in the third channel is much smaller than that of the test strips in the traditional existing channel structure.

[0081] Example 4: Experiment on flooding phenomenon under extreme conditions

[0082] The first card slot: This embodiment relates to a detection card. Figure 2 The detection card 100 includes a carrier 200 and a detection reagent strip 500. The carrier 100 includes a plurality of card slot structures 30 that form a channel together with the carrier. The card slots are rectangular in shape and have different widths. For example, Figure 6 A and Figure 5 As shown in the schematic diagram, the third width C (3.25 mm) of the slot is smaller than the second width B (4.25 mm), but the second width B is smaller than the first width A (5.4 mm) (the maximum width of the horn), wherein the third width C is below the marking area 502 of the reagent strip and close to the opening 305, wherein the second width B of the slot is larger than the width of the reagent strip, and the third width C is equivalent to or substantially equal to the width of the reagent strip (the width of the reagent strip is 3.2 mm), and the other end of the channel is sealed. The test strip 500 in the test card is used to detect whether a sample contains narcotic substances, such as marijuana, cocaine, etc.

[0083] The second slot (comparison): Similarly, compared with the first slot, the difference is that we use the same width slot (the distance between the corresponding walls in the slot is 4.25 mm wide), the width of the reagent strip is still 3.20 mm, and the position of the reagent strip in the slot is the same as in the first slot.

[0084] ]The third card slot: Compared with the first card slot, the other parts are the same, except that the card slot is rectangular in shape and has different width settings on the card slot, such as Figure 6 A and Figure 5 As shown in the schematic diagram, the third width C (3.25 mm) of the card slot is smaller than the second width B (4.25 mm), but the second width B is equal to the first width A (4.25 mm), that is, the card slot has a recessed portion (309) instead of a trumpet-shaped structure, and the rest is the same as the first card slot, including the reagent strip, which has the same width.

[0085] In the urine cup Figure 8) is filled with a certain amount of urine. Once the urine reaches the designated mark, it is placed in a shaker for vigorous shaking (frequency is hz per second) for about 5 minutes. The shaker is then removed to see the results of the experiment. The results are as follows:

[0086]

[0087] Under extremely severe conditions, only one of the first slot or channel structure has a flood phenomenon, but the control line still appears. On the contrary, the traditional channel structure, because there is no anti-flood structure, only 86.7% of the test strips have control lines, and some do not appear, indicating that the test is invalid due to the influence of the flood. At the same time, the third one is also superior to the traditional one.

Claims

1. A device for detecting an analyte in a liquid sample, characterized in that: The device includes a channel with an open end and a closed end, wherein the channel is used to set a detection reagent strip, and the opening is located near the sample application area of ​​the detection reagent strip; wherein the channel includes a flood flow prevention structure, which divides the channel into two different parts, a first channel and a second channel, the first channel is located from the opening of the channel to the flood flow prevention structure, and the second channel is from the position of the flood flow prevention structure to the closed end of the channel, and the junction of the first channel and the second channel is the flood flow prevention structure, which is close to the opening end of the channel and away from the closed end of the channel; the marking area on the detection reagent strip is located above the flood flow prevention structure in the channel; the device also includes a cavity for accommodating a liquid sample, wherein the channel is located in the cavity, and wherein the opening of the channel is located in the cavity. near the bottom; the channel includes a bottom plate and a slot structure; the slot includes a rectangular slot, which is divided into two parts, a first part with a slot opening and a second part with a closed end, and the slot has different widths, wherein a first width is formed at the slot opening, a second width is formed with a closed end, the first width is greater than the second width, and a third width is formed at the interface between the first part and the second part, the third width is less than the second width; the slot wall of the third width at the opening gradually extends outward, the width between the two walls gradually increases to form a trumpet structure, and the height of the slot also gradually increases with the extension of the wall to form a lip structure; wherein the slot also includes a groove running through the bottom of the slot.

2. The device according to claim 1, wherein: The bottom plate and the slot structure form a channel with one end open and the other end sealed.

3. The device according to claim 1, wherein: The bottom plate is transparent and flat, and the card slot structure is non-transparent.

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