A carrier for preventing the flood of detection reagent strips

Abstract

The present invention provides a carrier, which includes a channel for accommodating a test strip. One end of the channel is closed and the other end has an opening, and the fluid sample to be detected can enter the channel through the opening. Wherein, a flood prevention structure is included in the channel. By changing the channel in the carrier structure, the flood phenomenon of the test strip can be prevented and the error rate can be reduced.

Description

Technical Field

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

[0002] Currently, test devices for detecting whether an analyte is contained in a sample are widely used in hospitals or at home. These test devices for rapid diagnosis include one or more test strips, such as early pregnancy tests, drug abuse tests, and so on. Such rapid diagnostic test devices are very convenient and can obtain test results on the test strip in about one minute or at most about ten minutes.

[0003] In these test devices, the test strip is generally located on a certain carrier. The carrier can be a plate-shaped mold or an insertion board, etc. The carrier is generally composed of a card slot or a channel. One card slot or channel can accommodate one test strip. In this way, the carrier with the test strip can be used alone or in cooperation with a container. When such a carrier is used to accommodate the test strip, it can be directly used to detect whether a substance of interest is contained in the sample. 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 steady flow but chaotic, it often floods into the card slot or channel or the cavity for accommodating the test strip in a very short time. In this way, it will cause the so-called "flooding" phenomenon, thus affecting the normal operation and normal reaction of the test strip.

[0004] Therefore, it is necessary to improve the traditional carrier for carrying the test strip to avoid phenomena such as flooding, thereby improving the accuracy and effectiveness of the test strip. Summary of the Invention

[0005] To solve the problems existing in the prior art, the present invention provides such a carrier. The carrier includes a channel for accommodating a test strip. One end of the channel is closed and the other end has an opening. The fluid sample to be detected can enter the channel through the opening. Among them, a flood prevention structure is included in the channel. Alternatively, the present invention provides a channel. One end of the channel is closed and the other end has an opening. The fluid sample to be detected can enter the channel through the opening. Among them, a flood prevention structure is included in the channel. Preferably, the liquid entering the channel contacts the test strip, preferably, contacts the sample receiving area of the test strip, or only contacts the sample receiving area of the test strip.

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

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

[0008] In some preferred embodiments, the flood prevention flow structure includes a raised element in the channel, and this raised element reduces the cross-sectional area of part of the channel. In some preferred embodiments, the raised elements are respectively located on both side walls of the cavity and protrude into the channel. Preferably, the flood prevention flow structure reduces the cross-sectional area of part of the channel or makes part of the channel narrower.

[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 where the flood prevention flow structure is provided. In some preferred embodiments, the width of the opening of the channel is greater than the width inside the channel.

[0010] In some preferred embodiments, the flood prevention flow structure divides the channel into two parts. One part is the first section of the channel from the flood prevention flow structure to the opening of the channel, and the other part is the second section of the channel from the flood prevention flow structure to one end of the closed channel. Among them, the cross-sectional area of the first section of the channel is larger than that of the second section of the channel; or, the cross-sectional area of part of the first section of the channel is larger than that 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 larger than that of each part of the second section of the channel. The junction of the first section of the channel and the second section of the channel forms the flood prevention flow structure of the present invention, or the junction of the first section of the channel and the second section of the channel makes the channel narrower. Preferably, the junction of the first section of the channel and the second section of the channel is a gradually narrowing area, and the channel becomes narrower at this area. When the channel is cylindrical, the size of the channel can be measured by the cross-sectional area of the channel. When the channel is rectangular or cuboid, when the height is the same, the larger the width of the channel, the larger the overall cross-sectional area. Therefore, it can also be that the width of the first section of the channel is greater than the width of the second section of the channel, where 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 at 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 one end open and one end sealed, and the opening is located near the sample application area of the test strip. Preferably, the slot includes a narrow structure that divides the slot into two parts, and the width at the narrow structure is smaller than the width of other parts of the slot. Preferably, a slender groove is included at the top of the slot, and the groove runs through the entire channel or through the top of the entire slot.

[0013] In some preferred embodiments, the cavity channel may further include a detection reagent strip, and the sample application area of the reagent strip is located near the opening of the channel, and the sample absorption area is located at or near the closed end of the channel. In some preferred embodiments, the labeled area on the reagent strip is located near the anti-flood flow structure in the channel.

[0014] In all of the foregoing 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 faces the transparent flat plate structure or is arranged opposite to the transparent flat plate structure.

[0015] On the other hand, the present invention provides a detection device, which includes the foregoing carrier or channel. The carrier includes a channel for accommodating a detection reagent strip. One end of the channel is closed and the other end has an opening. The fluid sample to be detected can enter the channel through the opening. The channel includes an anti-flood flow structure. In some preferred embodiments, the device further includes a detection reagent strip, and the reagent strip is located in the channel. All of the foregoing embodiments of the anti-flood flow structure can be included in the detection device of the present invention. Preferably, the anti-flood flow structure is located below the labeled area on the detection reagent strip, or the anti-flood flow structure is located between the labeled area and the sample area on the detection reagent strip; or the labeled area on the reagent strip is located above the anti-flood flow structure.

[0016] In a preferred embodiment, the device further includes a cavity for accommodating a liquid sample. The carrier is located in the cavity. The sample application area of the inspection reagent strip is close to the bottom of the cavity. In this way, 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. Then the liquid sequentially passes through the labeled area, the detection area, the detection control area (if any), and finally reaches the water absorption area (if any) along with the reagent strip from the sample application area.

[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 test strip, one end of the channel being closed and the other end having an opening through which the fluid sample to be detected can enter the channel, wherein, a flood prevention flow structure is included in the channel, wherein, a test strip is included in the channel, and the flood prevention flow structure is located between the marked area of the test strip and the opening of the channel; allowing the fluid sample to enter the channel through the opening of the channel, and allowing the sample application area of the test strip to contact the fluid sample in the channel, so as to detect the analyte in the fluid sample. Alternatively, the flood prevention flow structure is located below the marked area of the test strip and above the channel opening.

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

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

[0020] In some preferred embodiments, the flood prevention flow structure includes a raised element in the channel, and the raised element reduces the cross-sectional area of the channel. In some preferred embodiments, the raised elements are respectively located on both 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 where the flood prevention flow structure is located. In some preferred embodiments, the width of the opening of the channel is larger than the width inside the channel.

[0022] In some preferred embodiments, the flood prevention flow structure divides the channel into two parts, one part is the first section of the channel from the flood prevention flow structure to the opening of the channel, and the other part is the second section of the channel from the flood prevention flow structure to the closed end of the channel, wherein, the cross-sectional area of the first section of the channel is larger than the cross-sectional area of the second section of the channel. When the channel is cylindrical, the size of the channel can be measured by the cross-sectional area of the channel. When the channel is rectangular or cuboid, in the case of the same height, the larger the width of the channel, the larger the overall cross-sectional area. Therefore, it can also be that the width of the first section of the channel is larger than the width of the second section of the channel, wherein, the heights of the first channel and the second channel are the same.

[0023] In some preferred embodiments, the cavity channel may further include a test strip, the sample application area of the test strip is located near the opening of the channel, and the sample absorption area is located at or near the closed end of the channel. In some preferred embodiments, the marked area on the test strip is located near the flood prevention flow structure in the channel. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] FIG. 1 is a schematic diagram of the principle of the present invention and a structural comparison diagram with a traditional channel. Among them, FIGS. 1A and 1D are schematic diagrams of the principle of the carrier of the present invention, FIG. 1B is a schematic diagram of the structure of a traditional test strip carrier, FIG. 1C is a schematic diagram of the structure of the test strip; FIG. 1E is a schematic diagram of the combined structure of the carrier structure and the test strip in one embodiment of the present invention.

[0025] Figure 2 is a three-dimensional structure diagram of a carrier in one embodiment of the present invention, on which a plurality of channels are arranged, and a test strip can be accommodated in the channels.

[0026] Figure 3 is Figure 2 an enlarged three-dimensional structure diagram of one of the channel structures in

[0027] Figure 4 is a three-dimensional schematic diagram of the card slot structure with the transparent flat plate structure removed;

[0028] Figure 5 is a partial enlarged structure diagram of one channel;

[0029] FIG. 6A is a longitudinal sectional view of one channel in another embodiment of the present invention, and FIG. 6B is a schematic diagram of the assembly position of the test strip;

[0030] Figure 7 is a schematic diagram of the principle of the flood phenomenon caused by the liquid flow containing the test strip in the traditional channel.

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

[0032] The following further describes the structures involved in the present invention or the technical terms used therein.

[0033] Detection

[0034] Detection means assaying or testing whether a substance or material is present, such as, but not limited to, chemical substances, organic compounds, inorganic compounds, metabolites, drugs or drug metabolites, organic tissues or metabolites of organic tissues, nucleic acids, proteins or polymers. Additionally, detection means testing the quantity of a substance or material. Further, assay also means immunoassay, chemical assay, enzyme assay, etc.

[0035] Sample

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

[0037] Test strip

[0038] The test strip applied to the present invention can be the commonly referred to lateral flow test strip 500. The specific structure and detection principle of these test strips are well-known to those of ordinary skill in the art in the prior art. A common test strip 500 includes a sample collection area 503, a labeling area 502, a detection area 504 and an absorption area 501. The sample collection area includes a sample receiving pad. The labeling area 502 includes a labeling pad. The absorption area 501 can include an absorption pad. Among them, the detection area 504 includes the necessary chemical substances for detecting whether the analyte is contained, such as immunoassay reagents or enzyme chemical reagents. The commonly used test strip is a nitrocellulose membrane test strip, that is, the detection area 504 includes a nitrocellulose membrane, and specific binding molecules are fixed on the nitrocellulose membrane to display the detection result. It can also be a cellulose acetate membrane or a nylon membrane, etc. Of course, a test result control area 505 can also be included downstream of the detection area. Usually, the control area and the detection area appear in the form of a horizontal line, as a test line or a control line. Such a test strip is a traditional test strip. Of course, it can also be other types of test strips that utilize capillary action for detection. In addition, generally, the test strip has dry chemical reagent components, such as immobilized antibodies or other reagents. When encountering a liquid, the liquid flows along the test strip by capillary action. As it flows, the dry reagent components dissolve in the liquid, so as to reach the next area to react with the dry reagent in this area, thereby performing the necessary detection. The liquid flow is mainly carried out by capillary action.

[0039] Analyte

[0040] Examples of analytes involved in the present invention include some hapten substances, and these haptens include drugs (such as abused drugs). "Drug of abuse" (DOA) refers to the non-medical use of drugs (usually acting as nerve paralytics). The abuse of these drugs can cause physical and mental damage, dependence, addiction and / or death. Examples of drug abuse include cocaine; amphetamine AMP (e.g., black beauties, white amphetamine tablets, dextroamphetamine, dextroamphetamine tablets, Beans); methamphetamine MET (crank, meth, crystal, speed); barbiturates BAR (such as Valium, Roche Pharmaceuticals, Nutley, New Jersey); sedatives (i.e., sleep aids); lysergic acid diethylamide (LSD); depressants (downers, goofballs, barbs, blue devils, yellow jackets, methaqualone); tricyclic antidepressants (TCA, i.e., imipramine, amitriptyline, and doxepin); 3,4-methylenedioxymethamphetamine (MDMA); phencyclidine (PCP); tetrahydrocannabinol (THC, pot, dope, hash, weed, etc.); opiates (i.e., morphine MOP or opium, cocaine COC, heroin, hydrocodone); anxiolytics and sedative-hypnotics. Anxiolytics are a class of drugs mainly used to relieve anxiety, tension, fear, stabilize emotions, and have hypnotic and sedative effects, including benzodiazepines BZO (benzodiazepines), atypical BZ classes, fused diazepines NB23C classes, benzazepines, ligands of BZ receptors, open-ring BZ classes, diphenylmethane derivatives, piperazine carboxylates, piperidine carboxylates, quinazolinones, thiazine and thiazole derivatives, other heterocyclic classes, imidazole-type sedative / painkillers (such as hydrocodone OXY, methadone MTD); propylene glycol derivatives - carbamates, aliphatic compounds, anthracene derivatives, etc. The detection device of the present invention can also be used for the detection of drugs that are for medical use but are prone to overdose, such as tricyclic antidepressants (imipramine or analogs) and acetaminophen, etc. After being absorbed by the human body, these drugs will be decomposed into different small molecule substances, and these small molecule substances exist in body fluids such as blood, urine, saliva, sweat, etc. or some of the body fluids contain the above small molecule substances.

[0041] Detection device

[0042] A detection device refers to a device used to detect whether an analyte is contained in a sample. In the present invention, the detection device especially refers to a detection device in the field of rapid diagnosis, such as a test strip 500, a test card or an insert structure 100, a test rod, a test cup ( Figure 8Detection devices in various forms such as those shown). Here, the reagent strip is inserted into the channel 300 of the test card 100( Figure 2 ), and the sample application area of the test strip is exposed from the opening 305 (as Figure 5 neutralization Figure 7 ), thus forming a test card, and the test card itself can complete the detection independently. For example, in Figure 1A, taking one of the channels to illustrate the detection principle, when in use, the test card is inserted into the liquid sample. Since one end 12 of the channel of the test card is closed and the other end is open 11, a part of the liquid sample flows into the channel. However, due to the closed end of the channel, the inflow of the liquid forms a sealed gas inside the channel. Thus, under the internal and external pressures, the liquid can only maintain a certain level height in the channel after entering the channel. During the process of the liquid entering the channel and maintaining at a fixed level 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 appear or do not appear in the detection area of the reagent strip, it indicates whether the analyte exists in the sample. Figure 1B is an assembly diagram of a channel and a reagent strip for traditional detection using this principle.

[0043] Whether detecting the analyte in one or several liquid samples using a single reagent strip as in Figure 1B, or like Figure 2 wherein, multiple 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 one analyte. In this way, by directly inserting the test card 100 into the liquid sample, multiple different analytes can be detected at one time, such as 3, 10, 15 different analytes. Of course, it can also be like Figure 8 wherein, a channel containing a reagent strip or like Figure 2 a card with multiple reagent strips arranged in multiple channels is arranged in a container such as Figure 8 (such as a commonly used urine cup). Let one end of the channel opening be located at the bottom 92 of the urine cup, and the closed end 312 of the channel be located near the urine cup mouth 91. In this way, when the urine cup collects urine, as the urine enters the cavity 90 of the urine cup, similar to the working principle of a single channel introduced above, due to the action of the sealed gas, there is still a certain height of liquid in each channel (when the internal and external air pressures are balanced), thereby completing the reaction of each reagent strip.

[0044] The detection device may include a test card 20 and components used in conjunction with the test card 20, such as Figure 8 shown, the urine cup 2 can be used as a form of the 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 (confined 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 such as 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, as shown in Figure 1B 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 7 To 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 the traditional device, the reagent strip 500 and the channel 300 generally do not come into direct contact (at most, the channel has a support frame). Once the reagent strip and the channel are inserted into the liquid sample 700, due to different operators, the insertion depth, insertion speed, and the state of the liquid sample 701 are different (static or flowing, or splashing liquid droplets 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 liquid will rush into the channel in a very short time. In the microenvironment, the liquid rushes into the channel through the channel opening 305. Since one end 312 of the channel 300 is sealed, the entering liquid seals a section of gas at this end, thereby generating pressure on the liquid level, which restricts more liquid from entering the channel and finally reaches equilibrium, making the liquid reach a certain height in the channel. Although the time to reach equilibrium is very short, during this process, the liquid is in a chaotic state, and at the microscopic level, it generates a lot of large impact forces on the reagent strip in different directions, resulting in the so-called flood phenomenon. Similarly, when the channel or card 100 containing the reagent strip is statically placed in a urine cup and a liquid sample, such as urine, is poured into the urine cup, although the process of reaching internal and external equilibrium is short due to the rapid flow of the liquid in a short time and then entering the channel, the liquid flow in the microenvironment is still intense, and some liquid directly flows from the surface of the reagent strip, resulting in the flood phenomenon and making the test result invalid or inaccurate. Of course, there are also factors such as the direction, angle, and speed of pouring the liquid sample into the urine cup; in particular, when performing the test, the subject directly urinates into the urine cup through the genitals, and the urine cup usually contains a reagent strip with a channel. In such a case, since different subjects do not have professional operating capabilities, the angle, size, and amount of urine urinated into the urine cup are also different. In particular, the channel entrance is in a relatively complex environment. In short, the test is under very complex conditions, making it easier to cause the flood phenomenon and thus affecting the final test result.

[0048] To overcome this defect, the present invention adopts such a carrier 100 or channel 300 that can restrict the arbitrary flow of the liquid sample in the channel, thereby reducing the occurrence of floods. Further, the structure of this flood prevention structure can quickly calm the liquid or quickly reach internal and external equilibrium, or can reduce the phenomenon of liquid flowing without passing through the capillary action of the test strip. As analyzed above, the main role of the reagent strip in making the liquid flow is capillary action, and the flood is caused by the liquid flowing on the reagent strip with little or no capillary action.

[0049] Carrier or channel

[0050] The carrier 100 or the channel 300 refers to a component or element for accommodating the test strip 500. As shown in FIGS. 1A and Figure 7 As shown, the test 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 test strip 500 generally will not fall out of the carrier 100. Specifically, the test strip will not fall out of 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 test strip is accommodated in the channel. In this sense, the present invention provides a channel with one end closed and the other end open, and the test strip is arranged in the channel. Preferably, the sample application area 503 of the test strip is close to the opening of the channel, and the test control area is located close to 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 more. Generally, one card slot or channel 300 can accommodate one test strip 500. Generally, at one end of the channel, for example, the closed end, the channel 300 or the card slot includes a clamping structure, and such a structure can clamp the test strip. Of course, the clamping structure is not an essential structure, and it is only a preferred technical solution.

[0051] In some preferred embodiments, the flood control flow structure is located within the channel, which divides the channel into two different parts, such as being divided into a first channel and a second channel. The first channel extends from the opening of the channel to the flood control flow structure, and the second channel extends from the position of the flood control flow structure to the closed end of the channel. The junction of the first channel and the second channel is the flood control flow structure. This structure that restricts the fluid reduces the cross-sectional area of the channel or forms a locally narrow space within the channel. In some specific embodiments, such as in FIG. 1A, this fluid-restricting structure 309 is near one end of the opening 11 of the channel and far from the closed end 12 of the channel 300. Preferably, the fluid-restricting structure is located below the marked area of the reagent strip. In some preferred embodiments, the fluid-restricting structure divides the channel into two different parts. Near the opening, as shown in FIG. 1A for example, the fluid-restricting structure narrows a certain position of the channel. At the same time, the walls of the channel extend outward along the narrow area, and this extension is a gradual one. Thus, as the extension progresses, the cross-sectional area of the channel gradually increases, such that the cross-sectional area of a section of the extended channel is larger than that of the second channel. Alternatively, as shown in FIGS. 1D and 1E, the fluid-restricting structure 309 divides the channel into two different parts. Near the opening, as shown in FIG. 1D for example, the fluid-restricting structure narrows a certain position of the channel, and then extends towards the opening 11 along the narrow area. As the extension progresses, the cross-sectional area of the channel does not gradually increase but remains unchanged, such that the cross-sectional area of the first channel is always smaller than that of the second channel. FIG. 1B is a schematic diagram of the channel in a traditional existing detection device. The entire channel has a substantially identical cross-section, or the distance between the walls of the channel is substantially the same, and the channel has smooth or parallel walls. Through the experiments of the present invention, it was surprisingly found that by adopting the embodiments of the present invention (such as the schemes in FIGS. 1A and 1D, or similar schemes), the phenomenon of flooding can be significantly reduced, and the probability of flooding can be reduced by 20 - 30%. This greatly improves the defects of existing products or prior art, and enhances the performance of traditional devices (such as those in FIG. 1B) that use reagent strips in the channel to detect the analyte in the sample.

[0052] In some preferred embodiments, multiple channel structures of the present invention (such as a single channel like those in FIGS. 1A and 1D) can be integrally arranged on a plastic plate, for example Figure 2As 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. Figures 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 4It can be seen that in the formation of the card slot structure 30, there is a card slot cavity 329 for arranging a detection reagent strip. The card 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 card slot has different widths. Near the opening 305, the width (the first width A) between the two depth walls 332 and 333 of the card slot is greater than the width (the second width B) between the two walls 334 and 335 of the card slot. However, the width (the third width C) between the walls 331 and 330 forming the depth of the card slot is smaller than the second width. Thus, the junction of different widths forms the flood prevention flow structure of the present invention. Optionally, as Figure 4 shown, actually, at the place of the third width C, the walls of the card slot extend outward (towards the opening 305), and they gradually extend outward. As they extend, the width between the two walls also gradually increases, forming a small "flared" shape. Here, the formed "flared" shape is not essential for the present invention, but it is a preferred solution. As shown in Figure 6, such a channel does not have the form of a "flared" shape, but on the channel, there is a narrow part 309. The narrow part of the channel is recessed inward, so that the inner diameter of the channel becomes smaller at this place. In fact, other parts of the channel have not actually changed, and the narrow part 309 also forms the flood prevention flow structure of the present invention. This inward recessed structure can be a sudden recess or a gradual recess, and then gradually extend out. In this embodiment ( Figure 4 in), the formation of the third width C is in the form of a protrusion of the card slot wall. Of course, in order to make the card slot have different widths, in addition to the inward protrusion of the card slot wall, there can be other ways, such as setting square protrusions, or circular protrusions, or any other form of protrusions on the wall of the card slot, so that the card slot has different widths. In addition, when the shape of the card slot is a cylinder or a semi-circle, according to the same principle, different protrusions can also be set between the walls of the card slot to form channels with different widths.

[0054] In some preferred ways, small grooves 312 are formed on the bottom ( Figure 4 ) of the card slot, and the grooves penetrate the entire bottom of the card slot (as Figure 3 is the top of the channel). In this way, when liquid surges into the opening of the channel, the small grooves 312 can timely discharge gas, and it can make the internal and external pressures reach equilibrium more quickly in the sealed channel, which can improve the time to reach equilibrium, make the liquid return to a calm state faster, and can also reduce the impact of the flood.

[0055] Furthermore, after combination Figure 5, as shown in Figure 6, the length of the entire card slot or channel is 57.5 mm, and the length of the test strip is 60 mm. Therefore, a part 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 opening (it may not have it, for example, as shown in Figure 6), the first width A is 5.4 mm ( Figure 5 ), and the depth of the card slot is the same depth or has different depths at different parts. From 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 gradually increases. This gradual increase can be a gentle increase or a relatively sharp increase, which is all included in the essence of the present invention. In a preferred manner, the width at the opening gradually increases, or the height of the channel also gradually increases. For example, Figure 5 in it, the narrow part 309 is recessed, and then the width gradually increases. At the position of 308, the height of the card slot also gradually increases as the wall extends, forming a structure like a flared lip 311. In this way, a relatively open area 310 is formed at the opening 305, and then towards the inside of the channel, a narrow area is formed. This may be more capable of reducing the flood phenomenon and reducing the impact of local liquid on the test strip.

[0056] In another example, in another way, for example, as shown in Figure 6 (without a flared opening structure), the third width C is 3.25 cm, which is less than the second width B (4.25 cm). There is a section of the structure in the recess that is always less than the second width of the card slot, 4.25 cm, and then gradually reaches the second width structure, without a flared opening structure (such as Figure 5 ). However, the width of the test strip is 3.20 or 3.1 mm. In this way, when the test strip is set in the card slot, part of the test strip is at the narrow part 309. Although the test strip does not contact the wall of the card slot, relative to the channel, the narrow part divides the test strip into two parts, the part close to the opening and the part far from the narrow part (such as at B). When the channel containing the test strip is inserted into the liquid sample in various ways (vertically, at different angles of inclination) or the detection device with a channel (such as a urine cup) is used to receive 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 ways, the flood-preventing structure is below the marked area of the test strip. Generally, there is a water level line below the marked area of the test strip, indicating the maximum insertion or immersion of the test strip, or the position line where the sample submerges the test strip (such as 509 in Figure 1E). Then the flood-preventing structure (such as 309 in Figure 6, Figure 4The structures at 331 and 330 in [it], or at 900 in Figure 1A) are all near the water level line, for example, level with the water level line or above the water level line, but all in places below the marked area.

[0058] The following will specifically describe the embodiments of the present invention with reference to the accompanying drawings. These specific embodiments are only limited enumerations without violating the spirit of the present invention, and do not exclude other specific implementation schemes generated by those of ordinary skill in the art by combining the prior art and the present invention.

[0059] A series of DOA products are selected in the present invention for different detections, mainly including AMP (amphetamine), BAR (barbiturate), BZO (benzodiazepine), COC (cocaine), MET (methamphetamine), MDMA (3,4-methylenedioxymethamphetamine), MOP (morphine), OPI (morphine), OXY (oxycodone), MTD (methadone), PCP (phencyclidine), PPX (propoxyphene), TCA (tricyclic antidepressant), THC (tetrahydrocannabinol), COT (nicotine), BUP (buprenorphine), ACE (acetaminophen), KET (ketamine), MQL (methaqualone), EDDP (2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine).

[0060] Comparative experiment on the flood phenomenon under different card slot structures in Example 1

[0061] The first channel: This embodiment relates to a test card. As Figure 2 , the test card 100 is composed of a carrier 200 and a test reagent strip 500. The carrier 100 includes a plurality of card slot structures 30 which form a channel together with the planar carrier. The card slot 30 is rectangular in shape, and there are different width settings on the card slot. For example, as shown in the schematic diagrams of Figure 6A and Figure 5 , the third width C (3.25 mm) of the card slot is less than the second width B (4.25 mm), but the second width B is less than the maximum width A (5.4 mm) of the first width. Among them, the first width A is below the marked area of the reagent strip and near the opening 305. Among them, the second width B of the card slot is greater 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). The other end of the channel is sealed. The test reagent strip 500 in the test card is used to detect whether there are drug substances in the sample, such as substances like marijuana, cocaine, etc. At this time, the height or depth of the card slot is the same.

[0062] The second channel (for comparison, traditional card slot structure): Similarly, compared with the first channel, the differences are as follows: We use card slots with the same width (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 that in the first card slot.

[0063] The third channel: Compared with the first channel, everything else is the same. The difference is that the card slot is rectangular in shape and has different width settings on the card slot. For example, in the schematic diagrams shown in Figure 6A and Figure 5 As shown, the third width C (3.25 mm) of the card slot is less than the second width B (4.25 mm), but the second width B is equal to the first width C (4.25 mm). That is, there is a recessed part (309) on the test slot and no flared structure. Other parts are the same as the first card slot, including the reagent strip with the same width.

[0064] Operation method: During the detection, insert the detection card 100 (directly containing the above three channel structures) directly into a mixed solution of multiple small molecule drugs. Keep it in the liquid sample for 1 minute to ensure sufficient sample for detection. At this time, the liquid sample will flow along the sample receiving area 503 of the detection 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, where a detection symbol, such as a test line, is formed in the detection result area of the detection area 504 to determine whether the liquid sample contains the analyte. The following table is the statistical table of the number of flood flows, as follows:

[0065]

[0066] As can be seen from the above table, when the structure with a flood prevention flow structure appears in the card slot or the channel, in all the tested card slots, there is no flood phenomenon in the first card slot, and the appearance rate of the control line is 100%. Without a restricted fluid structure in the same card slot or channel, the incidence of flood is 15%, and only 86.5% of the test strips show the control line, indicating that 13.5% of the test strips do not show the control line. Regardless of the test line, it represents an invalid result. Relatively speaking, the probability of flood in the third channel is much smaller compared to the test strips in the traditional existing channel structure.

[0067] Comparative experiment on the flood phenomenon under different card slot structures in Example 2 (in urine cup) - Laboratory

[0068] The first card slot: This embodiment relates to a detection card. As Figure 2, the test card 100 is composed of a carrier 200 and a test reagent strip 500. The carrier 100 includes a plurality of card slot structures 30 which form a channel together with the carrier. The card slots are rectangular in shape and have different width settings on the card slots. For example, in FIGS. 6A and Figure 5 as shown in the schematic diagram, the third width C (3.25 mm) of the card slot is less than the second width B (4.25 mm), but the second width B is less than the first width A (5.4 mm) (the maximum width of the flared opening). Among them, the third width C is below the marking area 502 of the reagent strip and close to the opening 305. Among them, the second width B of the card slot is greater than the width of the reagent strip, and the third width C is equal 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 reagent strip 500 in the test card is used to detect whether there are drug substances in the sample, such as marijuana, cocaine and other substances.

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

[0070] The third type of card slot: Compared with the first type of card slot, everything else is the same. The difference is that the card slot is rectangular in shape and has different width settings on the card slot. For example, in FIGS. 6A and Figure 5 as shown in the schematic diagram, the third width C (3.25 mm) of the card slot is less than the second width B (4.25 mm), but the second width B is equal to the first width C (4.25 mm), that is, there is a recessed part (309) on the test slot and there is no flared opening structure. Everything else is the same as the first card slot, including the reagent strip with the same width.

[0071] Operation method: When the test is in progress, first bend the cards with three different channel structures (the first type of card slot, the second type of card slot, the third type of test slot) (such as Figure 2 as shown) and insert them into the cup body of the urine cup. Among them, make the opening of the channel 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 the 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, follow the sample receiving area 503 of the test reagent strip 500, reach the marking area 502, and be fully mixed and homogenized with the marking substance on the marking area, and then reach the detection area 504, and a detection symbol, such as a detection line, will be formed in the detection result area of the detection area 504 to determine whether the analyzed substance is contained in the liquid sample. The following table is the statistical table of the number of flood flows, as follows:

[0072]

[0073] It can be seen from the above table that when the structure with the flood prevention flow structure appears in the card slot, in all the tested urine cups, there is no flood phenomenon in the first card slot, and the occurrence rate of the control line is 100%. Without restricting the fluid structure in the same card slot or channel, the occurrence rate of flood is 17%, and only 83% of the test strips show the control line, indicating that 17% of the test strips do not show the control line. Regardless of the detection line, it represents an invalid result. Relatively speaking, the probability of flood in the third channel is much smaller compared to the test strips in the traditional existing channel structure.

[0074] Comparative experiment on the flood phenomenon under different card slot structures in Example 3 (in urine cup) - Clinical

[0075] The first card slot: This embodiment relates to a detection card. As 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 slot is rectangular in shape, and there are different width settings on the card slot. For example, in the schematic diagrams shown in FIGS. 6A and Figure 5 , the third width C (3.25 mm) of the card slot is less than the second width B (4.25 mm), but the second width B is less than the first width A (5.4 mm) (the maximum width of the flared opening). Among them, the third width C is below the marking area 502 of the reagent strip and close to the opening 305. Among them, the second width B of the card slot is greater 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 detection reagent strip 500 in the detection card is used to detect whether drug substances, such as marijuana, cocaine, etc., are contained in the sample.

[0076] The second card slot (comparison): Similarly, compared with the first card slot, the differences are as follows: We use a card slot with the same width (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 that in the first card slot.

[0077] The third card slot: Compared with the first card slot, everything else is the same. The difference is that the card slot is rectangular in shape and has different width settings on the card slot. For example, in the schematic diagrams shown in Figure 6A and Figure 5 as shown, the third width C (3.25 mm) of the card slot is less than the second width B (4.25 mm), but the second width B is equal to the first width C (4.25 mm). That is, there is a recessed part (309) on the test slot and no flared structure. Everything else is the same as the first card slot, including the reagent strip having the same width.

[0078] Operation method: Before the detection, first bend the cards with three different structural channels (the first card slot, the second card slot, and the third test slot) (as Figure 2 shown) and insert them into the cup body of the urine cup (as Figure 8 )), where the opening of the channel is located at the bottom of the urine cup. Then, different people conduct clinical experiments, that is, people without professional operation collect urine. Usually, they directly urinate into the urine cup from the genitals to observe the probability of the flood phenomenon occurring. The results are as follows in the table:

[0079]

[0080] As can be seen from the above table, when the structure with a flood prevention structure appears in the card slot, in all the urine cups tested, there is no flood phenomenon in the first card slot, and the appearance rate of the control line is 100%. Without a restricted fluid structure in the same card slot or channel, the incidence of the flood is 20%, and only 80% of the test strips show the control line, indicating that 20% of the test strips do not show the control line. Regardless of the test line, it represents an invalid result. Relatively speaking, the probability of the flood occurring in the third channel is much smaller compared to the test strips in the traditional existing channel structure.

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

[0082] The first card slot: This embodiment relates to a detection card. As Figure 2 , the detection card 100 is composed of 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 slot is rectangular in shape and has different width settings on the card slot. For example, in the schematic diagrams shown in Figure 6A and Figure 5In the schematic diagram shown, the third width C (3.25 mm) of the card slot is less than the second width B (4.25 mm), but the second width B is less than the first width A (5.4 mm) (the maximum width of the flared opening). The third width C is below the marking area 502 of the reagent strip and close to the opening 305. The second width B of the card slot is greater than the width of the reagent strip, and the third width C is equal to or substantially equal to the width of the reagent strip (the width of the reagent strip is 3.2 mm). The other end of the channel is sealed. The test reagent strip 500 in this test card is used to detect whether there are drug substances in the sample, such as marijuana, cocaine and other substances.

[0083] The second card slot (for comparison): Similarly, compared with the first card slot, the difference is that we use a card slot with the same width (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 that in the first card slot.

[0084] The third card slot: Compared with the first card slot, everything else is the same. The difference is that the card slot is rectangular in shape and has different width settings on the card slot. For example, in Figure 6A and Figure 5 In the schematic diagram shown, the third width C (3.25 mm) of the card slot is less than the second width B (4.25 mm), but the second width B is equal to the first width C (4.25 mm), that is, there is a recessed part (309) on the test slot and no flared opening structure. Everything else is the same as the first card slot, including the reagent strip with the same width.

[0085] Pour a certain amount of urine into the cavity 90 in the urine cup ( Figure 8 ). Once it is poured to the specified scale, then place it in a shaker and shake it violently (the frequency is hz per second). The shaking time is about 5 minutes. Then take it off and check the experimental results. The results are as follows:

[0086]

[0087] Under extremely severe conditions, only one of the first card slot or the channel structure has a flooding phenomenon, but the control line still appears. On the contrary, for the traditional channel structure, because there is no flood prevention structure, only 86.7% of the reagent strips show the control line, and some do not appear, indicating that it is an invalid detection due to the influence of the flood. At the same time, the third one is also superior to the traditional one.

Claims

1. A carrier, characterized in that, the carrier includes a channel for accommodating a test strip, the channel includes a bottom plate and a card slot structure, wherein the bottom plate and the card slot structure form a channel with one end open and one end sealed; the fluid sample to be detected can enter the channel through the opening, wherein, a flood prevention flow structure is included in the channel; the flood prevention flow structure divides the channel into two parts, one part is the first section of the channel from the flood prevention flow structure to the channel opening, and the other part is the second section of the channel from the flood prevention flow structure to the closed end of the channel, wherein, the cross-sectional area of the first section of the channel is larger than that of the second section of the channel; the junction of the first section of the channel and the second section of the channel is the flood prevention flow structure; the flood prevention flow structure is located above the water level line of the test strip and below the marking area; the card slot has different widths, near the opening, the width between the two depth walls of the card slot is larger than the second width between the two walls of the card slot, and the third width between the walls forming the depth of the card slot is smaller than the second width, and the junction of the different widths forms the flood prevention flow structure; the flood prevention flow structure is located near the opening of the channel; at the place of the third width, the walls of the card slot gradually extend outwards, and the width between the two walls also gradually increases, forming a flared shape; the height of the card slot also gradually increases with the extension of the walls, forming a structure with a raised lip; the card slot also includes a groove penetrating through the entire bottom of the card slot.

2. The carrier according to claim 1, wherein, the flood prevention flow structure is located near the fluid application area of the test strip or is not at the same horizontal position as the marking area of the test strip.

3. The carrier according to claim 1 or 2, wherein, the flood prevention flow structure includes a raised element in the channel, and the raised element reduces the cross-sectional area of the channel.

4. The carrier according to claim 3, wherein, the cross-sectional area of the opening of the channel is larger than the cross-sectional area of the channel at the place where the flood prevention flow structure is located.

5. The use of a carrier for preparing a test card for detecting an analyte in a liquid sample, characterized in that, The detection card includes a carrier and a detection reagent strip; the carrier includes a channel for accommodating the detection reagent strip, and the channel includes a bottom plate and a slot structure, wherein the bottom plate and the slot structure form a channel with one end open and one end sealed; the fluid sample to be detected can enter the channel through the opening, and a flood prevention flow structure is included in the channel; the flood prevention flow structure divides the channel into two parts, one part is the first section of the channel from the flood prevention flow structure to the channel opening, and the other part is the second section of the channel from the flood prevention flow structure to the closed end of the channel, wherein the cross-sectional area of the first section of the channel is larger than that of the second section of the channel; the junction of the first section of the channel and the second section of the channel is the flood prevention flow structure; the flood prevention flow structure is located above the water level line of the reagent strip and below the marking area; the slot has different widths. Near the opening, the width between the two depth walls of the slot is greater than the second width between the two walls of the slot, and the third width between the walls forming the depth of the slot is less than the second width, and the junction of the different widths forms the flood prevention flow structure; the flood prevention flow structure is located near the channel opening; at the place of the third width, the walls of the slot gradually extend outwards, and the width between the two walls also gradually increases, forming a flared shape; the height of the slot also gradually increases with the extension of the walls, forming a structure like a raised lip; the slot also includes a groove penetrating the entire bottom of the slot.

Images