Laminate-type nucleic acid amplification microfluidic diagnosis module and nucleic acid amplification microfluidic point-of-care testing device comprising same

Abstract

The present invention relates to a laminate-type nucleic acid amplification microfluidic diagnosis module and a nucleic acid amplification microfluidic point-of-care testing device comprising same. The laminate-type nucleic acid amplification microfluidic diagnosis module according to the present invention comprises: a frame formed of a pair of films partially fused to each other; and a membrane which is provided inside the frame between the pair of films and forms a flow path through which a sample moves. The frame may include: an amplification unit disposed at the front end of the membrane and corresponding to a position corresponding to an amplification module for nucleic acid amplification of the introduced sample; and a diagnosis unit which extends from the amplification unit and is disposed toward the rear end of the membrane, and in which the nucleic acid-amplified sample generates a detectable signal by reacting with a biometric material while moving to the rear end of the membrane.

Description

Laminated-type nucleic acid amplification microfluidic diagnostic module and nucleic acid amplification microfluidic point-of-care testing device including the same

[0001] The present invention relates to a laminated nucleic acid amplification microfluidic diagnostic module and a nucleic acid amplification microfluidic field inspection device including the same. More specifically, the invention relates to a laminated nucleic acid amplification microfluidic diagnostic module and a nucleic acid amplification microfluidic field inspection device including the same, which is used to rapidly and conveniently amplify nucleic acids from a sample at the site and to inspect it using a microfluidic diagnostic method.

[0002] In modern fields of infectious disease diagnosis, food safety management, environmental monitoring, and emergency and disaster medical care, the importance of Point-of-Care Testing (POCT) technology, which enables results to be obtained immediately at the site—outside the laboratory—is rapidly increasing. Consequently, there is a growing demand for technologies that can achieve the accuracy level of molecular diagnostics while maintaining speed and convenience.

[0003] For example, conventional technologies include membrane-based microfluidic diagnostic technologies such as LFA (Lateral Flow Assay). These technologies allow for the simple reading of colorimetric signals resulting from the binding of antibodies, antigens, or target molecules while moving the sample naturally through capillary action. While they are suitable for point-of-care diagnosis as they can be used without power and are intuitive to use, they have the problem of being difficult to achieve sufficient sensitivity at low virus or bacterial concentrations or in the early stages of infection.

[0004] Therefore, inevitably, a method is used in which target nucleic acids in a sample are selectively amplified using nucleic acid amplification techniques such as PCR (Polymerase Chain Reaction) to secure very high sensitivity and specificity, and then membrane-based microfluidic diagnostic technology is applied.

[0005] However, a certain level of heat is essential for the selective amplification of nucleic acids, but this heat can damage the diagnostic modules used in microfluidic diagnostic technology, which prevents the continuous use of the aforementioned technologies.

[0006] Of course, there are isothermal nucleic acid amplification methods that do not require heat, such as RPA (Recombinase Polymerase Amplification) or HDA (Helicase-Dependent Amplification); however, relying solely on these methods has limitations in selectively amplifying nucleic acids without excluding heat-cycling-based nucleic acid amplification methods like PCR (Polymerase Chain Reaction).

[0007] In other words, when using a thermal cycling-based nucleic acid amplification method to selectively amplify nucleic acids, problems inevitably arise in the diagnostic module used in microfluidic diagnostic technology where the thermal expansion coefficients between the layers surrounding the membrane are inconsistent, leading to delamination or deformation, or where the edges lift up as the adhesion partially softens due to uneven thermal conductivity.

[0008] To address these issues, one could consider changing the entire material of the diagnostic module used in microfluidic diagnostic technology to a highly heat-resistant material and increasing interlayer bonding strength; however, such a material change presents difficulties in forming a structure that controls sample flow in response to the degree of nucleic acid amplification.

[0009] In other words, due to the heat required to selectively amplify nucleic acids, there are limitations to the continuous use of microfluidic diagnostic technology after nucleic acid amplification technology has been applied. Consequently, there are significant difficulties in ensuring the accuracy of molecular diagnostics while maintaining speed and convenience in the field.

[0010] The present invention is designed to solve the problems of the aforementioned prior art and aims to provide a laminated nucleic acid amplification microfluidic diagnostic module used to rapidly and conveniently amplify nucleic acids from a sample at the site and to test it using a microfluidic diagnostic method, as well as a nucleic acid amplification microfluidic field inspection device including the same.

[0011] The problems of the present invention are not limited to those mentioned above, and other unmentioned problems will be clearly understood by those skilled in the art from the description below.

[0012] A laminated nucleic acid amplification microfluidic diagnostic module according to the present invention for achieving the aforementioned purpose may be configured to include a frame formed by a pair of films that are partially fused together, and a membrane provided inside the frame between the pair of films to form a flow path through which a sample moves.

[0013] Here, the frame may be configured to include: an amplification unit positioned at the front end of the membrane and corresponding to a position corresponding to an amplification module that amplifies the nucleic acid of the incoming sample; and a diagnostic unit extending from the amplification unit and positioned toward the rear end of the membrane, which generates a detectable signal by reacting with a biometric material as the nucleic acid-amplified sample moves toward the rear end of the membrane.

[0014] In addition, the frame may be configured to further include a control unit that extends from the diagnostic unit and is positioned at the rear end of the membrane, and controls the movement of the sample.

[0015] At this time, the control unit may be configured to control the movement of the sample by opening the rear end of the membrane to the outside by releasing the fusion of at least one of the pair of films constituting the frame.

[0016] Meanwhile, the pair of films forming the frame may be composed of a base film located on the lower surface of the membrane; and a cover film located on the lower surface of the membrane; and the control unit may be configured to release the fusion as the cover film is folded at a predetermined angle from the base film, thereby opening the rear end of the membrane to the outside.

[0017] At this time, the predetermined angle at which the cover film is folded may be determined according to at least one of the type or state of the sample, the degree of nucleic acid amplification of the sample, the type or state of the membrane, and the state of movement of the sample on the membrane.

[0018] In addition, the cover film may be configured to include a control hole communicating with the outside in the diagnostic part so as to additionally control the movement of the sample.

[0019] In addition, the cover film may further comprise an inlet hole communicating with the outside of the amplification unit so that the sample can flow into the membrane, and an additional hole communicating with the outside of the amplification unit or the diagnostic unit so that the sample can be additionally flowed into the membrane.

[0020] Meanwhile, the above frame may be configured such that the bonding force between a pair of fused films constituting the amplification unit is greater than the bonding force between a pair of fused films constituting the diagnosis unit.

[0021] At this time, the frame may further include a compression part that additionally compresses the fused pair of films constituting the amplification part so that the bonding force between the fused pair of films constituting the amplification part can be greater than the bonding force between the fused pair of films constituting the diagnostic part.

[0022] Meanwhile, the above membrane may be provided in multiple numbers within a range where the movement of the sample does not overlap.

[0023] Additionally, the membrane may include a first membrane into which the sample is introduced; and a second membrane connected to the first membrane through which the sample moves continuously, wherein the second membrane may be configured to have at least one or more.

[0024] Meanwhile, a nucleic acid amplification microfluidic field inspection device according to the present invention for achieving the aforementioned purpose may be configured to include: a laminated-type nucleic acid amplification microfluidic diagnostic module as described above; an amplification module disposed at a position corresponding to the amplification part of the frame included in the diagnostic module to amplify the nucleic acid of the sample; and a reading module that reads the sample from a signal generated from the diagnostic part of the frame included in the diagnostic module.

[0025] According to the laminated nucleic acid amplification microfluidic diagnostic module and the nucleic acid amplification microfluidic point-of-care testing device including the same, since microfluidic diagnostic technology can be used continuously after nucleic acid amplification technology is applied, it is possible to perform point-of-care testing that ensures accuracy at the level of molecular diagnostics while maintaining speed and convenience.

[0026] The effects of the present invention are not limited to those mentioned above, and other unmentioned effects will be clearly understood by those skilled in the art from the description in the claims.

[0027] FIG. 1 is a perspective view illustrating one embodiment of a laminated nucleic acid amplification microfluidic diagnostic module according to the present invention.

[0028] FIG. 2 is an exploded perspective view of one embodiment shown in FIG. 1.

[0029] FIG. 3 is an operating state diagram for one embodiment shown in FIG. 1.

[0030] FIG. 4 is an operational state diagram illustrating another embodiment of a laminated nucleic acid amplification microfluidic diagnostic module according to the present invention.

[0031] FIG. 5 is a perspective view illustrating a variation of another embodiment shown in FIG. 4.

[0032] FIG. 6 is a perspective view illustrating another embodiment of a laminated nucleic acid amplification microfluidic diagnostic module according to the present invention.

[0033] FIG. 7 is a cross-sectional view illustrating one embodiment of a nucleic acid amplification microfluidic field inspection device according to the present invention.

[0034] Various embodiments in which the objectives of the present invention can be specifically realized will be described below with reference to the attached drawings.

[0035] Prior to this, terms and words used in this specification and claims must be interpreted in a meaning and concept consistent with the technical spirit of the invention, based on the principle that the inventor can appropriately define the concept of the terms to best describe his invention.

[0036] Furthermore, the terms and words used in this specification and claims are used merely to describe specific embodiments and are not intended to limit the invention.

[0037] For example, a singular expression includes a plural expression unless the context clearly indicates otherwise. Furthermore, terms such as "include," "equip," or "have" are intended to specify the existence of the features, numbers, steps, actions, components, parts, or combinations thereof described in the specification, and should be understood as not precluding the existence or addition of one or more other features, numbers, steps, actions, components, parts, or combinations thereof.

[0038] Furthermore, when a part such as a layer, membrane, region, or plate is said to be "above" another part, this includes not only the case where it is "directly above" the other part, but also the case where there is another part in between. Conversely, when a part such as a layer, membrane, region, or plate is said to be "below" another part, this includes not only the case where it is "directly below" the other part, but also the case where there is another part in between.

[0039] In addition, terms including ordinal numbers, such as "first," "second," etc., used in this specification may be used to describe various components, but said components are not limited by said terms, and said terms are used solely for the purpose of distinguishing one component from another.

[0040] As illustrated in FIGS. 1 to 3, one embodiment of a laminated nucleic acid amplification microfluidic diagnostic module according to the present invention comprises a frame (100) formed by a pair of films (100-1, 100-2) that are partially fused, and a membrane (200) provided inside the frame (100) between the pair of films (100-1, 100-2) to form a flow path through which a sample (S) moves.

[0041] Here, FIG. 1 is a perspective view illustrating an embodiment of a laminated nucleic acid amplification microfluidic diagnostic module according to the present invention, FIG. 2 is an exploded perspective view of the embodiment illustrated in FIG. 1, and FIG. 3 is an operating state diagram of the embodiment illustrated in FIG. 1.

[0042] First, the frame (100) is configured to wrap the membrane (200) through a pair of films (100-1, 100-2).

[0043] At this time, the film of a pair of films (100-1, 100-2) may be composed of a base film (100-1) located on the lower surface of the membrane (200) and a cover film (100-2) located on the lower surface of the membrane (200), and if there is difficulty in fusing the film of a pair of films (100-1, 100-2) due to the thickness of the membrane (200), a support film (100-3) may be additionally included.

[0044] These pairs of films (100-1, 100-2) can be made of various materials and can be fused in various ways according to the composition, and it is obvious that the scope of rights is not limited by this.

[0045] However, for further detailed explanation, for example, a pair of films (100-1, 100-2) may be composed of PET (Polyethylene Terephthalate), which has high transparency, good mechanical strength, and is easy to process; may be composed of Polypropylene (PP) or Polyethylene (PE), which is inexpensive and easy to process in various ways; or may be composed of Nylon or PA (Polyamide), which has excellent strength and is mainly used in composite structures.

[0046] In addition, as for the method of fusing a pair of films (100-1, 100-2) made of such materials, both dry and wet lamination methods may be possible, and it may be an environmentally friendly method with a low risk of solvent residue, such as solvent-free lamination, or a method suitable for mass production and advantageous for realizing a composite structure, such as extrusion lamination.

[0047] The frame (100) configured in this way may be configured to include an amplification unit (120), a diagnostic unit (140), and a control unit (160) depending on the relative position with respect to the membrane (200).

[0048] At this time, the amplification section (120) is a part positioned at the front end of the membrane (200) and is located in correspondence with the amplification module (20) that amplifies the nucleic acid of the incoming sample (S).

[0049] Additionally, the diagnostic section (140) is a portion that extends from the amplification section (120) and is positioned toward the rear end of the membrane (200), so that as the nucleic acid amplified sample (S) moves toward the rear end of the membrane (200), it reacts with a biometric material to generate a detectable signal.

[0050] Meanwhile, the control unit (160) is a part that extends from the diagnostic unit (140) and is positioned at the rear end of the membrane (200), and controls the movement of the sample (S).

[0051] The amplification unit (120), diagnosis unit (140), and control unit (160) constituting the frame (100) may be arranged in a line as shown in the drawing, but it is obvious that they fall within the scope of the present invention even if they are arranged in a different form as long as they satisfy the relative position condition with respect to the membrane (200).

[0052] In addition, in the case of the amplification unit (120), the bonding strength of a pair of films (100-1, 100-2) constituting the amplification unit (120) may be weakened due to heat generated in the amplification module (20), so it is advantageous to have a bonding strength greater than that of a pair of films (100-1, 100-2) constituting the diagnosis unit (140).

[0053] At this time, a compression unit may be further included to additionally compress the fused pair of films (100-1, 100-2) constituting the amplification unit (120) so that the bonding force of the fused pair of films (100-1, 100-2) constituting the amplification unit (120) can be greater than the bonding force of the fused pair of films (100-1, 100-2) constituting the diagnosis unit (140).

[0054] These compression parts will be described in more detail in another embodiment of the present invention.

[0055] Meanwhile, the control unit (160) may apply various methods to control the movement of the sample (S), but in one embodiment of the present invention illustrated in the drawing, a method of controlling the movement of the sample (S) by releasing the fusion of at least one of the pair of films (100-1, 100-2) constituting the frame (100) to open the rear end of the membrane (200) to the outside may be applied.

[0056] For example, when the cover film (100-2) is folded at a predetermined angle (a) along the fold line (cl) from the base film (100-1), the fusion between the base film (100-1) and the cover film (100-2) is released, and accordingly, the rear end of the membrane (200) is opened to the outside.

[0057] When the rear end of the membrane (200) is opened to the outside in this way, when the sample (S) flows toward the rear end of the membrane (200), the air contained in the membrane (200) flows to the open outside, thereby reducing the resistance received when the sample (S) flows inside the membrane (200).

[0058] That is, when the rear end of the membrane (200) is opened to the outside to a large degree, the resistance received when the sample (S) flows within the membrane (200) is reduced, so the sample (S) moves faster on the membrane (200), and the control unit (160) uses this to control the movement of the sample (S).

[0059] In other words, the control unit (160) controls the degree to which the rear end of the membrane (200) is opened to the outside by controlling the predetermined angle (a) at which the cover film (100-2) is folded along the fold line (cl) from the base film (100-1), thereby controlling the speed at which the sample (S) moves.

[0060] At this time, the predetermined angle (a) at which the cover film (100-2) is folded by the control unit (160) can be determined by considering at least one of the type or state of the sample (S), the degree of nucleic acid amplification of the sample (S), the type or state of the membrane (200), and the movement state of the sample (S) on the membrane (200).

[0061] For example, in the case of a sample (S) that does not move well on the membrane (200), the predetermined angle (a) is increased so that the rear end of the membrane (200) is opened to the outside to a greater degree, and accordingly, the resistance received when the sample (S) flows within the membrane (200) can be reduced.

[0062] Of course, increasing the predetermined angle (a) alone does not change the area of ​​the rear end of the membrane (200) that comes into contact with the outside, but it will be sufficiently understood by those skilled in the art that increasing the predetermined angle (a) increases the degree of opening of the rear end of the membrane (200) to the outside, in that it can reduce the extent to which the cover film (100-2) obstructs the discharge of air inside the membrane (200) to the outside when the sample (S) moves.

[0063] In addition, as an example of the opposite case, when nucleic acid amplification of the sample (S) proceeds slowly, moving the sample (S) slowly to the rear end of the membrane (200) is advantageous for properly adjusting the amount of sample (S) that reacts with the biorecognition material in the diagnostic unit (140). Therefore, in this case as well, it is advantageous to make the predetermined angle (a) small so that the degree of opening of the rear end of the membrane (200) to the outside is small, thereby allowing the sample (S) to move slowly on the membrane (200).

[0064] That is, when the sample (S) needs to move quickly or slowly on the membrane (200), the control unit (160) determines this by considering the type or condition of the sample (S), the degree of nucleic acid amplification of the sample (S), the type or condition of the membrane (200), and the movement state of the sample (S) on the membrane (200), and adjusts the predetermined angle (a) at which the cover film (100-2) is folded.

[0065] One embodiment of the laminated nucleic acid amplification microfluidic diagnostic module according to the present invention, described in detail above, may be modified and implemented as another embodiment or yet another embodiment as shown in FIGS. 4 to 6.

[0066] First, with reference to FIGS. 4 and 5, another embodiment of the laminated nucleic acid amplification microfluidic diagnostic module according to the present invention will be described in detail below, focusing on the parts that differ from the previously described embodiment.

[0067] Here, FIG. 4 is an operational state diagram illustrating another embodiment of a laminated nucleic acid amplification microfluidic diagnostic module according to the present invention, and FIG. 5 is a perspective view illustrating a modified example of another embodiment shown in FIG. 4.

[0068] As illustrated in FIGS. 4 and 5, another embodiment of the laminated nucleic acid amplification microfluidic diagnostic module according to the present invention may have a plurality of membranes (200) provided within a range where the movement of the sample (S) does not overlap.

[0069] That is, another embodiment of the present invention is an extension of the one produced by placing one membrane (200) inside a pair of films (100-1, 100-2) and fusing them, wherein a plurality of membranes (200) are placed inside a pair of films (100-1, 100-2) and fusing them.

[0070] In this way, when multiple membranes (200) are included inside the frame (100), multiple detectable signals can be generated by reacting with various biometric materials for a single sample (S).

[0071] If multiple detectable signals are generated by reacting with various biometric materials in this way, there will be an advantage in being able to examine various aspects of a single sample (S).

[0072] However, when a plurality of membranes (200) are included inside the frame (100), the compressed portion is relatively smaller than the uncompressed portion, so there may be a disadvantage that the bonding strength of a pair of films (100-1, 100-2) forming the frame (100) may be reduced, and this disadvantage may be more pronounced in the amplification unit (120), but this can be resolved through the aforementioned compression unit.

[0073] That is, as described above, a compression unit may be further included to additionally compress a pair of films (100-1, 100-2) between a pair of fused films (100-1, 100-2) constituting an amplification unit (120), and further, although not illustrated, between a pair of fused films (100-1, 100-2) constituting a diagnosis unit (140).

[0074] At this time, if the compression part (100-4) can further increase the bonding strength of a pair of fused films (100-1, 100-2) constituting the amplification part (120), there are no limitations on the means or methods thereof.

[0075] That is, the compression part (100-4) can be configured in various ways, such as by adding a chemical adhesive or by attaching a fixing member that physically fixes the base film (100-1) and the cover film (100-2), and it is obvious that the scope of rights is not limited by this.

[0076] In addition, when multiple membranes (200) are included inside the frame (100), a detectable signal can be generated for each of the multiple samples (S) by reacting with a biometric material for each of the multiple samples (S).

[0077] At this time, the movement speed on the membrane (200) may differ for each sample (S), and since there may be limitations to controlling them collectively through the control unit (160), the configuration for additionally controlling the movement of the sample (S) may be further included.

[0078] For example, a control hole (186) that communicates the diagnostic unit (140) and the outside is added to the cover film (100-2) so that the degree of air discharged within the membrane (200) as the sample (S) moves can be increased, thereby further controlling the movement of the sample (S) on the membrane (200).

[0079] In addition, in addition to the inlet hole (184) communicating with the outside near the amplification unit (120) so that the sample (S) can be initially introduced into the membrane (200), an additional hole (182) communicating with the outside and the diagnostic unit (140) can be added so that the sample (S) can be additionally introduced into the membrane (200), thereby increasing the amount of sample (S) moving on the membrane (200) and additionally controlling the movement of the sample (S) on the membrane (200).

[0080] Of course, as explained above, the additional configuration for controlling the movement of the sample (S) together with the control unit (160) is not applicable only to another embodiment of the present invention, but is applicable to both the aforementioned embodiment of the present invention and another embodiment of the present invention to be described later, and thus the scope of rights is not limited.

[0081] Next, with reference to FIG. 6, another embodiment of the laminated nucleic acid amplification microfluidic diagnostic module according to the present invention will be described in detail below, focusing on the parts that differ from the previously described embodiment or other embodiment.

[0082] Here, FIG. 6 is a perspective view illustrating another embodiment of a laminated nucleic acid amplification microfluidic diagnostic module according to the present invention.

[0083] As illustrated in FIG. 6, another embodiment of the laminated nucleic acid amplification microfluidic diagnostic module according to the present invention may be configured such that a plurality of membranes (200) are provided in the longitudinal direction.

[0084] That is, in another embodiment of the laminated nucleic acid amplification microfluidic diagnostic module according to the present invention, the membrane (200) may be configured to include a first membrane (200-1) into which a sample (S) is introduced, and a second membrane (200-2) connected to the first membrane (200-1) through which the sample (S) moves continuously.

[0085] At this time, since there is at least one second membrane (200-2), it is obvious that the scope of the present invention is included even if the membrane (200) is provided with three or more in the longitudinal direction.

[0086] In this way, if the membrane (200) is configured to be provided in multiple lengthwise directions, it will be possible to continuously reflect multiple biometric materials to one sample (S) and generate detectable signals for each of the multiple samples (S).

[0087] Including various embodiments of the laminated nucleic acid amplification microfluidic diagnostic module according to the present invention as described above, the present invention may be configured as a nucleic acid amplification microfluidic field inspection device, which will be described in detail below with reference to FIG. 7.

[0088] Here, FIG. 7 is a cross-sectional view illustrating one embodiment of a nucleic acid amplification microfluidic field inspection device according to the present invention.

[0089] As illustrated in FIG. 7, one embodiment of the nucleic acid amplification microfluidic field inspection device according to the present invention may be configured to include an amplification module (20) and a reading module (30) together with a diagnostic module (10) as described above.

[0090] At this time, the amplification module (20) is positioned at a location corresponding to the amplification section (120) of the frame (100) and configured to amplify the sample (S) into nucleic acid, and any structure or shape is acceptable as long as it can amplify the sample (S) into nucleic acid.

[0091] That is, the amplification module (20) is configured to amplify the nucleic acid of a sample (S), such as a polymerase chain reaction (PCR) device. Any structure or form is acceptable as long as it is configured to supply heat to perform nucleic acid amplification, which involves replicating or increasing nucleic acid molecules such as DNA or RNA in large quantities through an artificial biochemical reaction. However, for an embodiment of the nucleic acid amplification microfluidic field inspection device according to the present invention to be used in the field, it is advantageous to have a small weight or volume.

[0092] Meanwhile, the reading module (30) is configured to read the sample (S) from a signal generated in the diagnostic unit (120) of the frame (100), and it may have any structure or form as long as it can read the sample from a signal generated when the sample (S) reacts with a biometric material in the diagnostic unit (120).

[0093] That is, the reading module (30) is configured to read all of the various signals generated when a sample (S) reacts with a biorecognition material on the membrane (200), such as visible signals and electrical signals converted through antigen-antibody reactions, nucleic acid hybridization, enzyme reactions, etc., and can be configured in various ways depending on the type of signal.

[0094] For example, in the case where a visible signal is generated in a colorimetric manner in which metal nanoparticles aggregate / fixation according to antigen-antibody binding to cause a color change, it may be an LFA (Lateral Flow Assay) platform and an image acquisition device associated with said platform; and in the case where an electrical signal is generated in an electrochemical manner in which charge moves on an electrode or changes in current or potential are detected and converted into an electrical signal according to sample concentration, it may be a microelectrode-based LoC (Lab-on-a-Chip) platform and an electrical measurement device associated with said platform.

[0095] Meanwhile, one embodiment of the nucleic acid amplification microfluidic field inspection device according to the present invention may further expand its functions by including other components in addition to the diagnostic module (10), amplification module (20), and reading module (30), and it is obvious that the scope of the present invention is not limited even if such other components are included.

[0096] As described above, preferred embodiments according to the present invention have been examined. It is obvious to those skilled in the art that, in addition to the embodiments described above, the present invention may be embodied in other specific forms without departing from its spirit or scope. Therefore, the embodiments described above should be regarded as illustrative rather than restrictive, and accordingly, the present invention is not limited to the description above but may be modified within the scope of the appended claims and their equivalents.

[0097]

[0098] *[Explanation of symbols]

[0099] 1: Nucleic acid amplification microfluidic field inspection device according to the present invention

[0100]

[0101] 10: Laminated nucleic acid amplification microfluidic diagnostic module according to the present invention

[0102] 20: Amplification Module

[0103] 30: Reading module

[0104]

[0105] 100: Frame

[0106] 100-1: Base film 100-2: Cover film

[0107] 100-3: Support film

[0108] 120: Amplification section 140: Diagnostic section

[0109] 160: Control unit

[0110] 182: Control hole 184: Inlet hole

[0111] 186: Additional hole

[0112] 200: Membrane

[0113] 200-1: 1st membrane 200-2: 2nd membrane

[0114]

[0115] S: Sample

[0116] a: A predetermined angle

[0117] cl: fold line

Claims

1. A frame formed by a pair of films that are partially fused, and a membrane provided inside the frame between the pair of films to form a channel through which a sample moves, wherein The above frame is, An amplification unit positioned at the front end of the above membrane and corresponding to a position corresponding to an amplification module that amplifies the nucleic acid of the incoming sample; and A laminated nucleic acid amplification microfluidic diagnostic module characterized by including: a diagnostic unit extending from the amplification unit and positioned toward the rear end of the membrane, wherein the nucleic acid-amplified sample moves toward the rear end of the membrane and reacts with a biorecognition material to generate a detectable signal.

2. In Paragraph 1, The above frame is, A laminated nucleic acid amplification microfluidic diagnostic module characterized by further including a control unit that extends from the diagnostic unit and is disposed at the rear end of the membrane, and controls the movement of the sample.

3. In Paragraph 2, The above control unit is, A laminated nucleic acid amplification microfluidic diagnostic module characterized by controlling the movement of the sample by opening the rear end of the membrane to the outside by releasing the fusion of at least one of the pair of films constituting the frame.

4. In Paragraph 3, The pair of films forming the above frame, It is composed of a base film located on the lower surface of the membrane; and a cover film located on the lower surface of the membrane. The above control unit is, A laminated nucleic acid amplification microfluidic diagnostic module characterized by the fact that the cover film is folded at a predetermined angle from the base film and the fusion is released, thereby opening the rear end of the membrane to the outside.

5. In Paragraph 4, The predetermined angle at which the above cover film is folded is, A laminated nucleic acid amplification microfluidic diagnostic module characterized by being determined according to at least one of the type or state of the sample, the degree of nucleic acid amplification of the sample, the type or state of the membrane, and the state of movement of the sample on the membrane.

6. In Paragraph 4, The above cover film is, A laminated nucleic acid amplification microfluidic diagnostic module characterized by including a control hole in the diagnostic part that communicates with the outside to additionally control the movement of the sample.

7. In Paragraph 4, The above cover film is, A laminated nucleic acid amplification microfluidic diagnostic module characterized by further including an inlet hole communicating with the outside in the amplification part so that the sample can be introduced into the membrane, and an additional hole communicating with the outside in the amplification part or the diagnostic part so that the sample can be additionally introduced into the membrane.

8. In Paragraph 1, The above frame is, A laminated nucleic acid amplification microfluidic diagnostic module characterized in that the bonding force between a pair of fused films constituting the amplification section is greater than the bonding force between a pair of fused films constituting the diagnostic section.

9. In Paragraph 8, The above frame is, A laminated nucleic acid amplification microfluidic diagnostic module further comprising a compression unit that additionally compresses the fused pair of films constituting the amplification unit so as to make the bonding force between the fused pair of films constituting the amplification unit greater than the bonding force between the fused pair of films constituting the diagnostic unit.

10. In Paragraph 1, The above membrane is, A laminated nucleic acid amplification microfluidic diagnostic module characterized by having multiple samples provided within a range where the movement of the above samples does not overlap.

11. In Paragraph 1, The above membrane is, A first membrane into which the sample is introduced; and a second membrane connected to the first membrane through which the sample moves continuously; comprising, A laminated nucleic acid amplification microfluidic diagnostic module characterized in that the second membrane is at least one or more.

12. A diagnostic module of any one of paragraphs 1 to 11; An amplification module disposed at a position corresponding to the amplification part of the frame included in the diagnostic module above, for amplifying the sample into nucleic acids; and A nucleic acid amplification microfluidic point-of-care testing device comprising: a reading module that reads the sample from a signal generated in the diagnostic unit of the frame included in the diagnostic module.

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