WO2018006865A1

WO2018006865A1 - Test strip kit used for storing test strip and testing device

Info

Publication number: WO2018006865A1
Application number: PCT/CN2017/092205
Authority: WO
Inventors: 费凤琴; 商涛
Original assignee: 利多(香港)有限公司
Priority date: 2016-07-08
Filing date: 2017-07-07
Publication date: 2018-01-11
Also published as: CN113466443A; CN106198950A

Abstract

A test strip kit use for storing a test strip and a testing device. The test strip kit comprises a first cover plate (2) and a second cover plate (3). When in use, the first cover plate (2) and the second cover plate (3) are assembled together, and a test strip (100) is mounted therein. A volume-controlled sample adding channel (5) is provided on the first cover plate (2). The volume-controlled sample adding channel (5) comprises a section of capillary channel in proximity to a sample adding opening. By utilizing the capillary principle, the volume-controlled sample adding channel (5) automatically draws therein a liquid sample (102) in contact with the sample adding opening (4). The test strip kit used for storing the test strip and the testing device not only implement automatic collection of the liquid sample, but also allow effective control of the volume of a liquid being added and prompting of whether same satisfies the minimum amount for testing, are applicable in multiple testing fields such as physiological index testing and environment testing.

Description

Test tray and detection device for storing test strips

Technical field

The invention relates to a detecting device for measuring clinical physiological indexes, in particular to a detecting device for rapidly measuring biochemical indicators.

Background technique

The analysis of the sample can generally be divided into two types of technologies, namely dry chemical analysis technology and wet chemical analysis technology. Dry chemical analysis technology is relative to wet chemical technology, which means that the liquid test sample is directly added to the dry test strip (dry test strip), and the specific sample is caused by the moisture of the sample as a solvent. , thereby performing a chemical analysis method. Test strips for dry chemical analysis techniques are typically tested using a lateral-flow or vertical-flow method. The structure of the dry test strip using the lateral cross flow method generally comprises a bottom plate of a hard impervious material, and a sample pad, a bonding pad, a test pad and an absorption are sequentially adhered from left to right (or from right to left) on the bottom plate. pad. The structure of the dry test strip using the vertical flow method generally includes a sample pad, a filter mat, and a test pad from top to bottom. The use of dry test strips to detect samples basically involves two steps of loading and reading the results. Dry test strips can be used independently for sample analysis, or dry test strips can be assembled into the test tray for sample analysis. The test tray includes a sample port corresponding to the test strip and a result observation window. Whether the test strip is used independently or in combination with the test strip, it is necessary to take a certain amount of sample in advance by using a separate sampling device, and then drop it on the sample pad of the test strip by the sampling device. The amount of sample to be sampled is controlled by the operator to control the amount of sample to be sampled. Therefore, the existing detection device can not realize the automatic sampling function, and it is impossible to control whether the sample loading amount is sufficient to meet the detection requirements, and it is entirely judged by the operator.

For example, the detecting device shown in Chinese Patent No. 201220201209.0 includes an upper cover, a bottom plate combined with the upper cover, and a test paper between the upper cover and the bottom plate. The upper cover includes an upper surface and a lower surface, and a sample loading through the upper and lower surfaces. The lower surface of the upper cover is opposite to the test paper. The diameter of the sample port is relatively large, and the distance between the sample port and the test strip is very short. The sample port designed in this way allows the added sample to quickly touch the test paper, allowing the sample to smoothly enter the test paper and complete the test. However, the disadvantage of this design is that when the amount of sample added does not reach the amount required for testing, the sample will still come into contact with the test strip and enter the test strip, and the inspector will also get a result. Due to the insufficient amount of sample loading, the test results are not accurate. Because this type of test paper does not give enough load The prompt is therefore not known to the inspector. This not only wastes the test strips, but it can also lead to erroneous diagnostic conclusions.

Summary of the invention

One of the objectives of the present invention is to provide a test paper cassette for storing test strips, comprising a first cover plate and a second cover plate, the first cover plate comprising a controlled sample loading channel, the controlled sample loading channel The loading port and the sampling port are arranged on the upper side, and the controlled sample loading channel includes a capillary channel at least near the loading port.

Further, the shape of the wall of the controlled sample loading channel is selected from a cylinder having a substantially equal channel diameter or an approximately cylindrical body, a shape in which the diameter of the channel is gradually increased from the loading port to the outlet, and the tapered cone is cut off. One of a body, a horn or a step, or a combination of the above shapes.

Preferably, the upper surface of the first cover plate further comprises at least one flow guiding groove communicating with the sample inlet.

Preferably, the flow guiding groove is provided with a blocking block at an end away from the loading port.

Preferably, the first cover plate further includes a sample loading platform protruding from the upper surface of the first cover plate, wherein the controlled sample loading channel and the sample loading port are located in the sample loading station.

The upper surface of the first cover plate includes a curved concave shape of a pan bottom shape at least in a region surrounding the loading port.

Further, the diameter of the capillary channel of the controlled sample loading channel is greater than or equal to 0.2 mm and less than or equal to 2 mm.

Further, the capillary channel has a diameter of 1 mm.

Further, the inner wall of the controlled sample loading channel is subjected to a hydrophilic treatment to form an infiltration relationship between the inner wall surface and the liquid sample to be added, thereby promoting the flow of the liquid sample in the controlled sample loading channel.

A second object of the present invention is to provide a detecting device comprising a test paper box and a test strip placed in the test paper box, the kit comprising a first cover plate and a second cover plate, the first cover plate including the control The sample loading channel is provided with a sample port and a sample port on the control sample loading channel, and the control sample loading channel includes a capillary channel at least near the sample port.

Preferably, the first cover plate further includes a sample loading table protruding from the upper surface of the first cover plate, and the control sample is applied Both the track and the sample port are located in the loading station.

The beneficial effects of the invention are:

A capillary channel is arranged in the controlled sample loading channel. By using the capillary principle, the liquid sample in contact with the sample filling port is automatically sucked into the sample loading channel by the controlled sample loading channel, thereby automatically completing the sample loading process. Compared with the product in which the fingertip blood is transferred to the test strip by an additional straw or capillary, the invention can add the blood sample to the test strip in one step after the fingertip blood is pricked, and the operation procedure is simple. .

The volume of the metering channel is designed to be at least the minimum amount of liquid required for testing. Since the controlled sample loading channel has capillary action, when the amount of liquid inhaled does not reach the minimum amount of detection, the inhaled liquid will be kept in the controlled sample loading channel and cannot continue to flow and come into contact with the test strip, without successful loading. The test strip will not initiate the test reaction. After waiting for a certain period of time, no result appears, the tester will get a hint that the amount of liquid sample added cannot meet the minimum amount of detection. At this point, the tester only needs to add some blood to meet the test dosage, avoiding the inaccurate test result and wasting the test strip due to insufficient sample loading.

The shape of the wall of the controlled sample loading channel is a cylinder with a channel diameter substantially equal or an approximate cylinder, and the diameter-adding sample channel is convenient for processing, and the manufacturing process is simple. The shape of the sample loading channel is a shape in which the diameter of the channel is gradually increased from the sample port to the sample port, and the size of the sample port is larger than the sample port, and the contact area of the sample port with the test paper is increased, which is beneficial for inhalation. The sample spreads more quickly and evenly onto the test paper; at the same time, the design is also beneficial to ensure the capillary adsorption of the liquid sample at the loading port, and effectively increase the volume of the liquid sample contained in the controlled sample loading channel. For example, the shape of the controlled sample loading channel is cut by a top cone or a horn, and a capillary action is formed at the upper end of the channel to quickly suck the liquid sample into the channel, and the enlarged sample port increases the liquid sample and The contact area of the test strip accelerates the speed at which the liquid sample enters the test strip. And the dosing channel of the flared or chipped cone has a larger capacity than the cylindrical dosing channel, and can accommodate more liquid in the same length of channel. Therefore, the length of the top-loaded cone or flared dosing channel is not required to be long enough to meet the minimum requirements for testing. Under normal circumstances, the shorter the distance of the quantitative sample channel, the less time the liquid sample reaches the test strip from the sample port, which shortens the detection time and improves the detection efficiency. Sometimes, you need to control the timing of the sample accurately. There are two main methods for controlling the loading time: controlling the flow rate of the liquid sample in the controlled sample loading channel and controlling the flow of the liquid sample in the controlled loading channel. The journey. Controlling the flow rate of the liquid sample within the controlled loading channel can be accomplished by treating the inner surface of the controlled loading channel wall or by improving the fluidity of the liquid sample. Controlling the flow path of the liquid sample in the controlled sample loading channel can be extended by controlling the length of the controlled sample loading channel, or effectively extending the liquid sample under the condition of not extending the length of the controlled sample loading channel The length of the path of the flow on the channel wall. The control sample loading channel designs the shape of the wall of the controlled sample loading channel to be stepped, thereby effectively extending the distance that the liquid sample flows in the controlled sample loading channel without increasing the length of the controlled sample loading channel. The time during which the liquid sample flows within the controlled loading channel is appropriately controlled. When the shape in the controlled sample loading channel is designed to be a combination of two or more of a cylinder or an approximately cylindrical body, a stepped shape, a sharpened cone or a horn shape, The advantages of the shape, in order to achieve more desirable benefits.

The guiding groove is provided with a blocking block to effectively prevent the liquid sample from flowing out of the loading table from the guiding groove, thereby avoiding contamination of the surrounding environment.

The sample table that protrudes from the first cover allows the fingertip blood to quickly find the position of the sample, and simply places the finger on the sample table to allow the blood to pass accurately through the sample station. The sample port at the center position enters the control sample loading channel.

When the shape of the upper surface of the first cover and the area around the loading port is a curved concave shape of the bottom of the pot, the outer surface of the detecting device can be kept in a relatively flat state, which is more conducive to packaging, and the plurality of individually packaged detecting devices can be neatly arranged. Stacked in a large box to increase the utilization of the box and facilitate transportation.

DRAWINGS

Figure 1 is a detection device in which a first cover and a second cover are fastened together.

Figure 2 is an exploded view of Figure 1.

Figure 3 is a cross-sectional view taken along the line A-A of Figure 1;

Figure 4 is a structural view of the first cover of the test paper cassette.

Figure 5 is a cross-sectional view taken along the line B-B of Figure 4;

Figure 6 is a first cover with a flow guiding structure.

Figure 7 is a schematic illustration of a finger with fingertip blood ready for top loading.

Figure 8 is a schematic illustration of the sample filling the controlled loading channel when there are enough blood samples.

Figure 9 is a schematic diagram of the sample not filling the controlled sample loading channel when the amount of blood sample does not reach the required amount of detection.

Figure 10 is a schematic illustration of a finger with fingertip blood ready for underloading.

Figure 11 is a schematic illustration of the loading of the sample below and the filling of the sample loading channel.

Figure 12 is a schematic view showing a detecting device in which a lateral cross flow detecting test paper is mounted in a test paper cassette.

Figure 13 is a first cover having a nip and a drainage zone.

Figure 14 is a bottom plan view of the cover plate of Figure 13;

Figure 15 is a cross-sectional view taken along line C-C of Figure 13;

Figure 16 is a schematic illustration of a first cover plate having another form of controlled charge application channel.

Figure 17 is a schematic view of the first cover plate without the sample loading station.

Figure 18 is a schematic view showing the structure of the arc-shaped concave surface detecting device including the bottom shape of the upper surface of the first cover plate at least in the area surrounding the loading port.

Figure 19 is a schematic view of a first cover plate having a lower surface without a flow guiding structure and a liquid passage.

Figure 20 is a schematic view showing the structure of the test paper tray from which the controlled loading channel extends from the upper surface of the first cover to the second cover.

detailed description

As shown in FIGS. 1 to 17, the test paper cassette for storing the sample test strip includes a first cover 2 and a second cover 3. In use, the first cover and the second cover are assembled with each other to detect the test strip 100. Installed in it. The first cover plate 2 is provided with a control sample loading channel 5, and the sample loading channel is provided with a sample port 4 and a sample port 6.

The controlled sample loading channel 5 includes a capillary channel at least near the loading port 4. By using the capillary principle, the controlled sample loading channel 5 can automatically inhale the liquid sample in contact with the loading port 4, and the inhaled liquid sample The controlled amount of sample loading channel 5 flows out of the sample outlet 6 and contacts the test strip, and the sample reacts with the reagent on the test strip to obtain a test result. As shown in Figures 7 to 9, or in the loading embodiment shown in Figures 10 and 11, the inspector does not need to inhale the fingertip blood into the blood collection device in advance, but directly places the finger with fingertip blood on the loading port 4. The capillary channel in the control sample channel 5 draws blood into it, thereby achieving the process of automatic sample addition. In a specific embodiment, after the first cover plate and the second cover plate are assembled with each other, the distance between the sample outlet 6 and the test strip is such that the liquid sample entering the controlled sample loading channel 5 can be at the sample outlet 6 Touch the test strip. For example, the liquid sample at the outlet 6 will form a convex curved surface, and the bottom end of the liquid curved surface will be in contact with the test strip, and once the liquid contacts the test strip with strong liquid adsorption performance, the inside of the sample loading channel is controlled. The liquid is quickly sucked onto the test strip by the test strip.

In the embodiment shown in Fig. 10, the shape of the wall of the controlled sample loading channel 5 is a cylinder having a substantially equal channel diameter or an approximately cylindrical body. In another embodiment, the control sample loading channel wall may also be a shape in which the diameter of the channel is gradually increased from the loading port to the outlet port, for example, cutting off the top cone (as shown in FIG. 5) or a horn. Shape (as shown in Figure 3) and other shapes. In the embodiment shown in FIG. 16, the shape of the wall of the sample loading channel is stepped, that is, the diameter of the upper channel 17 near the sample port 4 is smaller than that of the lower channel 16, and the diameter of the entire upper channel is the same. The diameter of the entire lower passage is approximately the same, and the steps may have two or more. The cross-sectional shape of the control sample channel wall can also be a polygon or other irregular pattern, or a combination of shapes. For example, in the embodiment shown in FIG. 17, the upper channel 17 and the lower channel 16 are connected in combination with the cylindrical channel 18 by a tapered tapered channel 18. The size setting of the sample inlet is in accordance with the capillary principle, and a capillary channel is arranged below the sample port, and the liquid sample is sucked into the controlled sample loading channel from the sample port by capillary action. The size of the sample port can be greater than, less than or equal to the size of the sample port. In a preferred embodiment, the sample port is in contact with the test strip, the size of the sample port is larger than the sample port, and the area of the sample port contacting the test paper is increased, which facilitates the faster and more uniform diffusion of the sample to the test paper. The shape-measuring sample channel 5 shown in FIG. 3 has a flare shape, and at least a capillary action is formed at the upper end of the channel to quickly suck the liquid sample into the channel, and the sample port of the sample port and the test strip are increased. The increased contact area further accelerates the speed at which liquid samples enter the test strip.

In the case where the sample port and the channel length are the same, the dosing channel of the flare (Fig. 3) or the tipped cone (Fig. 5) has a more quantitative loading channel than the cylindrical (Fig. 10) dosing channel. Large capacity to hold more liquid. Therefore, the cutting-out cone or flared dosing channel does not require a long length, and the channel capacity can meet the minimum amount of detection required. The shorter the channel distance, the less time the liquid sample reaches the test strip from the sample port, which shortens the detection time and the detection efficiency is high. Any other loading channel structure that utilizes a capillary channel for automated loading is within the scope of the present invention.

In one design, the volume of the metering channel 5 is at least the minimum amount of liquid required for detection, that is, the amount of liquid stored between the inlet and the outlet can meet the minimum amount of detection. When the amount of liquid inhaled does not reach the minimum amount of detection, since the controlled sample loading channel has capillary action, the inhaled liquid is kept in the controlled sample loading channel and is not in contact with the test strip, and cannot be absorbed by the test strip. At least when the sample size is insufficient, after the sample is added, the liquid sample does not quickly come into contact with the test strip, so that the tester notices that the amount of the sample added does not meet the test dosage requirement, and the sample needs to be reloaded or replenished. When the amount of liquid inhaled reaches the minimum amount of detection, the sample of the inhaled liquid is filled with the sample channel between the sample port and the sample port, so that the liquid at the sample port The body sample can be in contact with the test strip, and the attraction of the test strip to the liquid is detected so that the sample in the channel is quickly drawn into the sample pad. In this design, the controlled sample loading channel not only realizes automatic collection of liquid samples, but also effectively controls and indicates whether the amount of liquid added can meet the minimum amount of detection. In addition, by pre-designing the volume of the controlled sample loading channel 5 of the present invention, the amount of liquid sample added can be accurately controlled to achieve the purpose of quantitative loading. In some embodiments, by performing a hydrophilic treatment on the inner wall of the controlled sample loading channel 5, the inner wall surface is infiltrated with the liquid sample to be added, which facilitates promoting the liquid sample along the controlled sample loading channel 5. The flow velocity of the inner wall shortens the loading time and improves the efficiency of detection.

In the loading example shown in FIGS. 7 to 9, after the subject places a finger with fingertip blood on the loading port 4, the controlled loading channel 5 uses capillary action to suck the fingertip blood into the channel. . When the blood volume of the fingertip blood of the subject does not reach the blood volume for detection as shown in Fig. 9, the lower surface 103 of the blood 102 sucked into the sample channel 5 cannot reach the sample port 6 end of the sample channel. Due to the surface tension, the inhaled liquid is retained in the controlled loading channel 5, and the test strip is not touched. The test paper that has not been exposed to the liquid sample will not have a detection reaction, and the test paper will remain unchanged as before the sample is applied. The tester will therefore know that the amount of blood added is insufficient and the sample needs to be continued. As shown in Fig. 8, the blood volume of the fingertip of the subject is sufficient, and when the blood volume requirement for detection has been reached, the lower surface of the blood 102 sucked into the sample channel 5 reaches the sample port 6 end of the sample channel and contacts To test the test paper, the suction of the test paper is sucked into the test paper by the blood in the sample channel, and the reagent on the test paper reacts with the blood sample to obtain the test result.

There is a certain distance between the sample port and the sample port to prevent the finger placed on the sample port from coming into contact with the test strip. The capillary port has a capillary action, and because the opening is relatively small, the finger can be prevented from coming into contact with the test paper.

In the embodiment shown in Figures 1 to 5, the first cover 2 further includes a loading station 7 projecting from the upper surface thereof for supporting the blood collection site of the examinee. A finger with fingertip blood can be placed on the loading station. The sample port 4 connected to the controlled sample loading channel 5 is located at the center of the sample loading station 7. In one mode, the upper surface of the loading table is inclined from the outer circumference toward the center position. In another embodiment, the sample loading station includes a flow guiding groove radiated from the loading port to the periphery, and the guiding groove collects the liquid sample drainage on the loading table to the loading port. In one embodiment, the bottom surface 9 of the flow guiding groove 8 is gradually lowered from the periphery to the center loading port, which is more advantageous for the liquid sample to flow to the loading port. In another embodiment, the periphery of the flow guiding trough 8 is provided with a blocking block 10 that prevents liquid samples from flowing out of the loading station from the diversion trough to contaminate the surrounding environment.

In the embodiment shown in Fig. 17, the thickness of the cover of the first cover 2 is the same as the length of the passage of the controlled loading channel 5. The upper surface of the loading table 7 is flush with the upper surface of the first cover 2.

In the embodiment shown in Fig. 18, the upper surface of the first cover 2 includes an arcuate concave surface having a pan bottom shape at least in a region surrounding the loading port.

A flow guiding structure 11 is disposed at a lower surface of the first cover plate 2 as shown in FIG. 6, and a liquid passage 14 is formed between the sample opening 6 and the flow guiding structure. The flow guiding structure defines the liquid in the liquid passage, and the sample flowing out of the outlet flows to the side along the flow guiding structure to transfer the liquid sample to the corresponding area of the test paper. In the embodiment shown in Figures 13 to 15, the outlet 6 comprises a squeezing zone 12 and a drainage zone 13 between the two squeezing zones. The pressing zone is in communication with the flow guiding structure and is in the same plane as the guiding structure. The bottom surface of the pressing zone is further away from the bottom surface of the first cover than the bottom surface of the drainage zone. The sample flowing from the outlet exits the drainage zone and enters the liquid channel 14, which further ensures that the sample flows in a defined path.

In the embodiment shown in Fig. 19, the structure in which the lower surface of the first cover 2 is associated with the flow of the sample includes only the sample opening 6. The sample flowing out of the sample port 6 flows directly onto the test strip.

The test paper cassette further includes a detection result observation window corresponding to the detection area of the test paper. As shown in Figures 2 and 3, the viewing window 15 is located on the second cover 3. As shown in Figure 12, the viewing window 15 is located on the first cover.

The test paper cassette shown in FIG. 20 includes a first cover plate 2 and a second cover plate 3. The first cover plate 2 is provided with a controlled sample loading channel 5, and the sample loading channel is provided with a sample filling port. 4 and the outlet 6, the sample port is located on the upper surface of the first cover, and the sample loading channel 5 extends from the upper surface of the first cover toward the second cover. The test strip 100 is also mounted in the detecting device of the test paper cassette according to the embodiment. The controlled sample loading channel 5 includes a capillary channel at least near the loading port 4. By using the capillary principle, the controlled sample loading channel 5 can automatically inhale the liquid sample in contact with the loading port 4, and the inhaled liquid sample The controlled amount of sample loading channel 5 flows out of the sample outlet 6 and contacts the test strip, and the sample reacts with the reagent on the test strip to obtain a test result.

The detection device of the invention can be used for detecting a series of physiological and biochemical indicators such as glucose, cholesterol, high density fatty acid, low density fatty acid, triglyceride, uric acid, bilirubin, total protein, hemoglobin and ketone body. The results can be observed and analyzed by the human eye, and the results can be read and analyzed by the instrument.

Claims

a test paper tray for storing test strips, comprising a first cover plate and a second cover plate, wherein the first cover plate comprises a controlled sample loading channel, and the control sample loading channel is provided with a sample loading port And the sample port, the control sample channel includes a capillary channel at least near the sample port.
The test paper cell according to claim 1, wherein the shape of the wall of the controlled sample loading channel is selected from a cylinder having a channel diameter substantially equal to or approximately a cylinder, and a channel extending from the loading port to the outlet port. A shape with a gradually increasing diameter, one of a sharpened cone, a flared or stepped shape, or a combination of the above shapes.
The test strip according to claim 1, wherein the upper surface of the first cover further comprises at least one flow guiding groove in communication with the loading port.
The test paper cassette according to claim 3, wherein the flow guiding groove is provided with a blocking block at an end away from the filling port.
The test strip according to claim 1, wherein the first cover further comprises a loading station protruding from the upper surface of the first cover, wherein the controlled loading channel and the loading port are located in the loading tray. Inside the sample.
The test strip according to claim 1, wherein the upper surface of the first cover comprises an arc-shaped concave surface having a pan-bottom shape at least in a region surrounding the loading port.
A test paper cassette according to any one of claims 1 to 6, characterized in that the diameter of the capillary channel of the controlled sample loading channel is 0.2 mm or more and 2 mm or less.
The test paper cassette according to claim 7, wherein the capillary passage has a diameter of 1 mm.
The test paper cassette according to any one of claims 1 to 6, wherein the inner wall of the controlled sample loading channel is subjected to a hydrophilic treatment, so that the inner wall surface forms an infiltration relationship with the liquid sample to be added, and the liquid sample is promoted. Flow in the controlled loading channel.
A detecting device comprises a test paper box and a test strip placed in the test paper box, the kit comprising a first cover plate and a second cover plate, wherein the first cover plate comprises a controlled sample loading channel, The sample loading channel is provided with a sample port and a sample port, and the sample loading channel includes a capillary channel at least near the sample port.
The detecting device according to claim 10, wherein the shape of the wall of the controlled loading channel is selected from a cylinder having a channel diameter substantially equal to or approximately a cylinder, and a diameter of the channel from the loading port to the outlet. A progressively larger shape, one of a sharpened cone, a flared or stepped shape, or a different combination of the above shapes.
The detecting device according to claim 10, wherein the upper surface of the first cover further comprises at least one flow guiding groove communicating with the loading port.
The detecting device according to claim 10, wherein the first cover further comprises a loading station protruding from the upper surface of the first cover, wherein the controlled loading channel and the loading port are located in the loading Inside the platform.
The detecting device according to claim 11, wherein the upper surface of the first cover plate includes a curved concave shape of a pan bottom shape at least in a region surrounding the loading port.
The detecting device according to any one of claims 10 to 14, wherein the diameter of the capillary channel of the controlled sample loading channel is 0.2 mm or more and 2 mm or less.