In vitro diagnostic strips

Abstract

An in vitro diagnostic strip according to one embodiment of the present invention may include a strip body into which a sample is introduced, a main development channel formed on the strip body and through which the sample introduced into the strip body is developed, and a plurality of sub-development channels branching and extending from one side of the main development channel and through which the sample is developed.

Description

[Technical Field]

[0001] The present invention relates to in vitro diagnostic strips, and more particularly to in vitro diagnostic strips for collecting specimens for in vitro diagnosis. [Background technology]

[0002] Recently, a variety of simple test reagents, diagnostic reagents and diagnostic devices have been developed to diagnose whether or not a person is infected with a pathogen such as a virus or bacteria, whether or not a person is pregnant, whether or not a person has developed cancer, and whether or not a person has harmful substances such as pesticide residues in specific raw materials such as food.

[0003] In particular, in vitro diagnostic technology is a technology that uses substances derived from the human body, such as blood, feces, urine, body fluids, and saliva, to quickly diagnose diseases outside the body, and it plays an important role in clinical decision-making, becoming an essential and specialized element in patient treatment.

[0004] In vitro diagnostic devices using this technology are medical devices containing reagents used in tests using tissue, blood, urine, and other specimens collected from the human body for purposes such as diagnosing disease, determining prognosis, assessing health, determining the effectiveness of treatment for disease, and preventing disease. These devices are less physically demanding than medical devices that are inserted into the human body and perform diagnosis outside the body.

[0005] At this time, it is necessary to develop an in vitro diagnostic strip that can obtain various test results from a single sample. Summary of the Invention [Problem to be solved by the invention]

[0006] One embodiment of the present invention provides an in vitro diagnostic strip that can perform various types of diagnoses using a single sample by determining the state of each sample developed through a sub-development channel.

[0007] Another embodiment of the present invention provides an in vitro diagnostic strip in which the widths of the main development channel, sub-development channel, and vent channel are different, so that the sample is drawn into the channel with the smaller width through capillary action, allowing the sample to flow more smoothly into the sub-development channel and vent channel.

[0008] Another embodiment of the present invention provides an in vitro diagnostic strip that has a label in the form of a barcode, QR code, or the like on one side of the strip body, and that can implement automatic scanning and diagnostic item measurement protocols after recognizing the label when the strip is inserted into an in vitro diagnostic device.

[0009] The problems to be solved by the present invention are not limited to those mentioned above, and other problems not mentioned here will be clearly understood by those skilled in the art from the following description. [Means for solving the problem]

[0010] An in vitro diagnostic strip according to one embodiment of the present invention may include a strip body into which a sample is introduced; a main development channel formed on the strip body and through which the sample introduced into the strip body is developed; and a plurality of sub-development channels branching and extending from one side of the main development channel, through which the sample is developed.

[0011] The sub-deployment channels may extend in a vertical direction on both sides of the main deployment channel.

[0012] The sub-deployment channel may have an inspection hole formed therein through which light can pass.

[0013] A first vent hole communicating with the outside air may be formed at an end of the main deployment channel.

[0014] The width of the main deployment channel may be greater than the width of the sub deployment channel.

[0015] A vent channel is formed between the end of the main deployment channel and the first vent hole, and the vent channel may be formed to be smaller in width than the sub-deployment channel.

[0016] A second vent hole communicating with the outside air may be formed at the end of each of the sub-deployment channels.

[0017] The strip body may include a gripping portion in which a sample insertion hole into which the sample is inserted is formed; and a film-shaped channel portion coupled to one side of the gripping portion and in which the main expansion channel and the sub-expansion channel are formed.

[0018] The channel part may include a channel film in which the main expansion channel and the sub-expansion channel are formed; and a first cover film and a second cover film attached to an upper surface and a lower surface of the channel film, respectively.

[0019] The sub-deployment channel may have a light-transmitting inspection hole formed therein, and the first cover film and the second cover film may have a first cover inspection hole and a second cover inspection hole formed therein, the first cover film and the second cover film communicating with the inspection hole.

[0020] A first vent hole communicating with external air is formed at an end of the main deployment channel, and a second vent hole communicating with external air is formed at an end of the sub deployment channel, and a first cover vent hole and a second cover vent hole communicating with the first vent hole and the second vent hole may be formed in either the first cover film or the second cover film.

[0021] The first cover film and the second cover film may have a hydrophilic coating layer formed on portions corresponding to the main deployment channel and the sub deployment channel.

[0022] A label on which information about a diagnostic item is entered may be provided on one side of the strip body. [Effects of the Invention]

[0023] According to one embodiment of the present invention, the state of the sample developed through the sub-development channels can be determined and diagnosed, so that various types of diagnoses can be made from a single sample.

[0024] In addition, according to one embodiment of the present invention, the widths of the main development channel, the sub-development channel, and the vent channel are formed to be different, so that the sample is drawn into the channel with the smaller width through capillary action, allowing the sample to flow more smoothly into the sub-development channel and the vent channel.

[0025] According to one embodiment of the present invention, a label in the form of a barcode, QR code, or the like is provided on one side of the strip body, and when the strip is inserted into an in-vitro diagnostic device, the label is recognized and an automatic scan and diagnostic item measurement protocol can be implemented. [Brief explanation of the drawings]

[0026] [Figure 1] 1 is a perspective view illustrating an in vitro diagnostic strip according to an embodiment of the present invention.

[0027] [Figure 2] 1 is an exploded perspective view illustrating a channel portion of an in-vitro diagnostic strip according to an embodiment of the present invention.

[0028] [Figure 3] 1 is a plan view illustrating an in vitro diagnostic strip according to an embodiment of the present invention with a first cover removed.

[0029] [Figure 4] 1 is a bottom view illustrating an in vitro diagnostic strip according to one embodiment of the present invention.

[0030] [Figure 5] FIG. 10 is a perspective view illustrating an in vitro diagnostic strip according to another embodiment of the present invention.

[0031] [Figure 6] 10 is an exploded perspective view illustrating a channel portion of an in-vitro diagnostic strip according to another embodiment of the present invention. FIG. DETAILED DESCRIPTION OF THE INVENTION

[0032] Since the present invention can be modified in various ways and has various embodiments, specific embodiments will be illustrated in the drawings and described in detail. However, this is not intended to limit the present invention to the specific embodiments, and it should be understood that the present invention includes all modifications, equivalents, and alternatives that fall within the spirit and technical scope of the present invention. In describing the present invention, if it is determined that detailed descriptions of related publicly known technologies may obscure the gist of the present invention, such detailed descriptions will be omitted.

[0033] Terms such as "first," "second," etc. may be used to describe various components, but the components should not be limited by these terms. These terms are used only to distinguish one component from another.

[0034] The terms used in this application are merely used to describe specific embodiments and are not intended to limit the present invention. The singular expressions include the plural expressions unless the context clearly dictates otherwise. In this application, the terms "comprise" or "have" are intended to specify the presence of features, numbers, steps, operations, components, parts, or combinations thereof described in the specification, and should be understood not to preclude the possibility of the presence or addition of one or more other features, numbers, steps, operations, components, parts, or combinations thereof.

[0035] Furthermore, throughout the specification, when the term "connected" is used, it does not only mean that two or more components are directly connected, but also that two or more components are indirectly connected through other components, that they are not only physically connected but also electrically connected, or that they are designated by different names depending on their position or function but are actually one unit.

[0036] Furthermore, when something is described as being formed or disposed "above or below" a component, "above" or "below" includes not only the case where two components are in direct contact with each other, but also the case where one or more other components are formed or disposed between the two components. Furthermore, when something is expressed as "above" or "below," it can mean not only the upper direction but also the lower direction based on one component.

[0037] Hereinafter, one embodiment of the in vitro diagnostic strip according to the present invention will be described in detail with reference to the accompanying drawings. In the description with reference to the accompanying drawings, the same or corresponding components will be given the same drawing numbers, and duplicate descriptions thereof will be omitted.

[0038] FIG. 1 is a perspective view of an in vitro diagnostic strip according to one embodiment of the present invention, FIG. 2 is an exploded perspective view of the strip body of the in vitro diagnostic strip according to one embodiment of the present invention, FIG. 3 is a plan view of the in vitro diagnostic strip according to one embodiment of the present invention with the first cover removed, and FIG. 4 is a bottom view of the in vitro diagnostic strip according to one embodiment of the present invention.

[0039] As shown in the above figures, the in vitro diagnostic strip according to one embodiment of the present invention may include a strip body 10, a main development channel 212 formed on the strip body 10 and through which a sample introduced into the strip body 10 is developed, and a plurality of sub-development channels 216 branching and extending from one side of the main development channel 212 and through which the sample is developed.

[0040] The strip body 10 forms the overall appearance of the in vitro diagnostic strip and may be formed in the shape of a flat plate. The strip body 10 includes a gripping portion 100 in which a sample insertion hole 110 into which a sample is inserted is formed, and a film-type channel portion 200 coupled to one side of the gripping portion 100 in which the main expanding channel 212 and the sub-expanding channel 216 are formed.

[0041] That is, the strip body 10 includes a handle 100 that an operator holds to insert the strip into an in-vitro diagnostic device, and a channel 200 that is coupled to one end of the handle 100. The handle 100 may be made of a plastic material, and the channel 200 may be made of a film.

[0042] The gripper 100 is formed with a sample input hole 110, which is in communication with a channel input hole 214, a first input hole 234, and a second input hole 244, respectively, formed in the channel portion 200. The sample input into the sample input hole 110 can be developed along a main development channel 212 and a sub-development channel 216 formed in the channel portion 200.

[0043] 2, the channel unit 200 may include a channel film 210 in which the main deployment channel 212 and the sub-deployment channel 216 are formed, and cover films 230 and 240 attached to the upper and lower surfaces of the channel film 210, respectively. The cover films 230 and 240 may include a first cover film 230 attached to the upper surface of the channel film 210 and a second cover film 240 attached to the lower surface of the channel film 210. The first cover film 230 and the second cover film 240 may be attached to the upper and lower surfaces of the channel film 210 using double-sided tape. By configuring the channel unit 200 by attaching the cover films 230 and 240 to the channel film 210 in this manner, it is easy to form the main deployment channel 212 and the sub-deployment channel 216 and a constant contact angle can be maintained.

[0044] Here, the main deployment channel 212 and the sub-deployment channel 216 may be formed by opening at the top and bottom on the channel film 210 that essentially constitutes the channel part 200. Then, cover films 230 and 240 are attached to the top and bottom surfaces of the channel film 210, respectively, to form the main deployment channel 212 and the sub-deployment channel 216.

[0045] The main development channel 212 is a portion where a sample introduced into the strip body 10 is first developed, and may be formed long along the longitudinal direction of the channel portion 200. A plurality of sub-development channels 216 extend in a perpendicular direction on both sides of the main development channel 212, through which the sample may be developed. Of course, the sub-development channels 216 do not have to extend in a perpendicular direction on both sides of the main development channel 212, but may extend in an inclined direction.

[0046] A plurality of sub-development channels 216 may be formed at regular intervals along both sides of the main development channel 212, and the sub-development channels 216 arranged on one side and the other side may be arranged to intersect with each other. That is, the sub-development channels 216 arranged on one side may be arranged to intersect with the sub-development channels 216 arranged on the other side. When the sub-development channels 216 are arranged on both sides to intersect with each other in this manner, the sample can smoothly flow into each sub-development channel 216.

[0047] The sub-deployment channel 216 may have an inspection hole 218 formed therein through which light from the in-vitro diagnostic device is irradiated. The inspection hole 218 is a portion through which light passes in an optical module attached to the in-vitro diagnostic device, and the state of a sample can be determined and diagnosed through the light transmission. Because the inspection holes 218 are formed in the sub-deployment channel 216, an operator can make various types of diagnoses based on the sample detected through each inspection hole 218. That is, in this embodiment, since multiple inspection holes 218 are formed, a single in-vitro diagnostic device can be used to detect various targets equal to the number of inspection holes 218, and each inspection hole 218 can be used to detect the same target or different targets.

[0048] First cover inspection holes 236 and second cover inspection holes 246 are formed in the first cover film 230 and the second cover film 240, respectively, in an opening shape corresponding to the plurality of inspection holes 218, allowing light to pass through. An operator can easily check whether the reagent has been spread over the entire channel portion 200 by checking from the inspection hole 218 formed closest to the first vent hole 220.

[0049] Meanwhile, a first vent hole 220 communicating with the outside air is formed at the end of the main development channel 212. The first vent hole 220 is formed at the end of the main development channel 212 to facilitate the flow of the sample in the main development channel 212 and the sub-development channel 216 by capillary action. In addition, a second vent hole 222 communicating with the outside air is formed at the end of the sub-development channel 216. Like the first vent hole 220, the second vent hole 222 also facilitates the flow of the sample by capillary action.

[0050] The first vent hole 220 and the second vent hole 222 may be formed to communicate with the first cover vent hole 237 and the second cover vent hole 238, respectively, formed in the first cover film 230. In this embodiment, the first cover vent hole 237 and the second cover vent hole 238 may be formed only in the first cover film 230, and the first cover vent hole 237 and the second cover vent hole 238 may be formed long in the form of a slit, thereby communicating with the first vent hole 220 and the second vent hole 222 disposed inside.

[0051] A vent channel 224 having a narrow flow path may be formed between the end of the main expansion channel 212 and the first vent hole 220. In this embodiment, the vent channel 224 is formed to be narrower than the width of the main expansion channel 212, allowing for good capillary action.

[0052] More specifically, in this embodiment, the main development channel 212 is formed to be wider than the sub-development channel 216 and the vent channel 224, and the sub-development channel 216 is formed to be wider than the vent channel 224. That is, the widths of the channels may be formed to be wider in the order of the main development channel 212, the sub-development channel 216, and the vent channel 224. When the channels are formed with different widths in this manner, the channel with the smaller width absorbs the sample through capillary action, allowing the sample introduced into the main development channel 212 to flow more smoothly into the sub-development channel 216 and the vent channel 224.

[0053] According to one embodiment of the present invention, 16 sub-deployment channels 216 may be formed in the main deployment channel 212, and accordingly, 16 inspection holes 218 may also be formed. According to one embodiment of the present invention, eight inspection holes 218 and sub-deployment channels 216 connecting the inspection holes 218 and the main deployment channel 212 may be formed on one side of the main deployment channel 212. Furthermore, eight inspection holes 218 and sub-deployment channels 216 may be formed on the other side of the main deployment channel 212. However, this is merely one embodiment of the present invention, and other numbers of sub-deployment channels 216 and inspection holes 218 may also be formed.

[0054] According to one embodiment of the present invention, an enzyme for conducting a test may be contained or applied in the first cover test hole 236 and the second cover test hole 246. An example of the enzyme may be, but is not limited to, bilirubin oxidase. The test may proceed by reacting the enzyme with the introduced sample.

[0055] Meanwhile, a hydrophilic coating layer may be formed on the cover films 230, 240 in the areas where the main development channel 212 and the sub-development channel 216 are formed, thereby realizing a capillary function. Here, it is not necessary to form a hydrophilic coating layer on the cover films 230, 240; the cover films 230, 240 may be made of a hydrophilic material, or the relevant areas may be hydrophilically treated (coated with a chemical reagent). If the cover films 230, 240 are not hydrophilically treated, the capillary function may be reduced, slowing down the sample injection speed and making it impossible to properly develop and measure the sample.

[0056] 4, a label 250 on which information about a diagnostic item is input may be provided on one side of the strip body 10. The label 250 may be provided in the form of a barcode, QR code, etc. on the underside of the strip body 10, i.e., the underside of the channel portion 200. When the label 250 is provided in this manner, when the strip is inserted into an in-vitro diagnostic device, the label 250 can be recognized and an automatic scan and diagnostic item measurement protocol can be implemented.

[0057] FIG. 5 is a perspective view illustrating an in vitro diagnostic strip according to another embodiment of the present invention, and FIG. 6 is an exploded perspective view illustrating a channel portion of the in vitro diagnostic strip according to another embodiment of the present invention.

[0058] Referring to this, in this embodiment, a configuration may be added to the first cover film 230 of the cover films 230 and 240 constituting the channel unit 200. A first input hole 234 communicating with the channel input hole 214 is formed in the first cover film 230. A sample input into the first input hole 234 may be developed along the first main development channel 232 and the first sub-development channel 235. The first main development channel 232 and the first sub-development channel 235 may be formed to correspond to the main development channel 212 and the sub-development channel 216.

[0059] The first main development channel 232 is a portion where a sample introduced into the strip body 10 is first developed, and may be formed long along the longitudinal direction of the channel portion 200. A plurality of sub-development channels 235 extend perpendicularly on both sides of the first main development channel 232, through which the sample may be developed.

[0060] Although the present invention has been described above with reference to specific embodiments, it will be understood by those skilled in the art that various modifications and variations of the present invention may be made without departing from the spirit and scope of the present invention as set forth in the following claims. [Explanation of symbols]

[0061] 10: Strip body 100: Grip part 110: Sample input hall 200: Channel section 210: Channel film 212: Main development channel 214: Channel input hole 216: Sub-expansion channel 218: Inspection Hall 220: First vent hole 222: Second vent hole 224: Vent channel 230: First cover film 232: First main channel 234: First hole 235: 1st sub-channel 236: First cover inspection hall 237: First cover vent hole 238: Second cover vent hole 240: Second cover film 244: Second hole 246: Second cover inspection hole 250: Label

Claims

1. the strip body into which the sample is applied; a main development channel formed on the strip body, through which a sample introduced into the strip body is developed; and The in-vitro diagnostic strip includes a plurality of branched sub-development channels extending from one side of the main development channel, in which the sample is developed.

2. The in-vitro diagnostic strip of claim 1 , wherein the sub-developing channels extend perpendicularly to both sides of the main developing channel.

3. 2. The in-vitro diagnostic strip of claim 1, wherein a plurality of the sub-expansion channels extend on both sides of the main expansion channel, and the sub-expansion channels arranged on one side of the main expansion channel and the sub-expansion channels arranged on the other side of the main expansion channel are arranged to intersect each other.

4. The in-vitro diagnostic strip of claim 1 , wherein the sub-expansion channel has an inspection hole formed therein through which light passes.

5. The in-vitro diagnostic strip according to claim 1 , wherein a first vent hole communicating with the outside air is formed at an end of the main development channel.

6. The in-vitro diagnostic strip of claim 1 , wherein the width of the main deployment channel is greater than the width of the sub-deployment channel.

7. The in-vitro diagnostic strip according to claim 5 , wherein a vent channel is formed between the end of the main deployment channel and the first vent hole, and the vent channel is formed to be smaller in width than the sub-deployment channel.

8. The in-vitro diagnostic strip according to claim 6 , wherein a second vent hole communicating with the outside air is formed at each end of the sub-expansion channel.

9. The strip body includes: a gripping portion having a specimen insertion hole formed therein into which the specimen is inserted; and The in-vitro diagnostic strip according to claim 1 , further comprising a film-shaped channel portion coupled to one side of the grip portion, in which the main developing channel and the sub-developing channel are formed.

10. The channel portion is a channel film in which the main deployment channel and the sub-deployment channels are formed; and The in vitro diagnostic strip of claim 9 , further comprising a first cover film and a second cover film attached to the upper and lower surfaces of the channel film, respectively.

11. The sub-deployment channel has an inspection hole through which light passes; The in-vitro diagnostic strip of claim 10 , wherein the first cover film and the second cover film are formed with a first cover test hole and a second cover test hole communicating with the test hole.

12. a first vent hole communicating with external air is formed at an end of the main deployment channel, and a second vent hole communicating with external air is formed at an end of the sub-deployment channel, The in-vitro diagnostic strip of claim 10 , wherein one of the first cover film and the second cover film has a first cover vent hole and a second cover vent hole communicating with the first vent hole and the second vent hole.

13. The in-vitro diagnostic strip according to claim 10 , wherein the first cover film and the second cover film have a hydrophilic coating layer formed on portions corresponding to the main development channel and the sub-development channel.

14. The in-vitro diagnostic strip of claim 1 , wherein a label on which information about a diagnostic item is input is provided on one side of the strip body.

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