Isothermal amplification diagnostic apparatus

Abstract

This isothermal amplification diagnostic apparatus comprises: a body including a power control unit; an isothermal amplification unit that is provided in the body, includes an insertion port into which nucleic acids may be inserted and a heating member provided inside the insertion port, and isothermally amplifies the inserted nucleic acids; a display unit provided on the body to display the time for which the isothermal amplification unit isothermally amplifies the nucleic acids; a power supply unit provided on the body and formed as a charging terminal compatible with a standard smartphone cable; and a detection cartridge including a sample tube accommodating a bio-sample collected from a test subject and having a fluid channel for lateral flow assay provided therein, wherein the bio-sample flows into the fluid channel through a first end portion having a pen nib form insertable into the sample tube.

Description

Isothermal amplification diagnostic device

[0001] The following description relates to an isothermal amplification diagnostic device.

[0002] Isothermal amplification is a method that exponentially amplifies DNA using DNA polymerase at a constant temperature. Compared to conventional PCR (Polymerase Chain Reaction), isothermal amplification does not require temperature changes, allowing for the simple and rapid amplification of target genes. A representative example of isothermal amplification is Loop-mediated Isothermal Amplification (LAMP). Recently, isothermal amplification has garnered attention as a fast and convenient method for gene amplification, and miniaturized devices are being released through various research and development efforts. It is being utilized in various fields, including medical diagnostics, agriculture, and food safety, with particularly high potential for application in point-of-care testing. By enabling rapid diagnosis through fast and efficient gene amplification, isothermal amplification can significantly reduce the complex equipment and time required by conventional PCR, playing a crucial role in environments with limited resources and time. Furthermore, when combined with various detection methods, it can contribute to real-time monitoring and early diagnosis. For example, fluorescence detection is a method that detects DNA amplified through a fluorescently labeled probe, requiring equipment capable of detecting fluorescence; lateral flow analysis is a technique that moves amplified DNA through a strip and induces a color change through binding with antibodies or probes immobilized on the strip. Colorimetric detection is a method that detects results from nucleic acid amplification using pH indicators or gold nanoparticles. However, isothermal amplification technology has limited portability because it requires heating mechanisms and fluorescence detection equipment. The existing RAPID immunodiagnostic method offers excellent portability but has a disadvantage in sensitivity due to a low limit of detection, while the existing PCR method offers high sensitivity but is impossible to carry due to the need for expensive precision equipment.Therefore, there is a need for a nucleic acid detection technology that possesses excellent sensitivity and portability despite the application of isothermal amplification technology. The aforementioned background technology is one that the inventor possessed or acquired in the process of deriving the content of the disclosure of this application, and it cannot be considered as prior art disclosed to the general public prior to this application.

[0003] The objective of the embodiments is to provide an isothermal amplification diagnostic device with excellent sensitivity and portability. The problems to be solved by the embodiments 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.

[0004] An isothermal amplification diagnostic device according to an embodiment is described. The isothermal amplification diagnostic device comprises a body equipped with a power control unit, an insertion port provided in the body in which nucleic acid can be inserted, and a heating element provided inside the insertion port, and an isothermal amplification unit that isothermally amplifies the inserted nucleic acid, a display unit provided in the body for indicating the time during which the isothermal amplification unit isothermally amplifies the nucleic acid, a power supply unit provided in the body and formed in the shape of a charging terminal compatible with a standard smartphone cable, a sample tube for receiving a bio sample collected from a subject, a first end portion formed in the shape of a pen nib that can be inserted into the sample tube, and a detection cartridge having a fluid channel for lateral flow analysis provided inside through which the bio sample flows into the interior through the first end portion.

[0005] According to one embodiment, the isothermal amplifier can maintain the temperature of the heating element at a constant level for 15 to 20 minutes.

[0006] According to one embodiment, the detection cartridge may have a side facing the detection result display area of ​​the fluid channel open so that the area where the detection result is displayed in the fluid channel is exposed to the outside.

[0007] According to one embodiment, the detection cartridge may be formed such that the distance between the open surface and the first end is greater than the depth of the insertion opening.

[0008] According to one embodiment, the fluid channel may sequentially contain biotin and FITC detection probes, metal particle antibodies, streptavidin, and rabbit antibodies.

[0009] According to the embodiments, the isothermal amplification diagnostic device is a detection system composed of an isothermal amplification unit and a detection cartridge, and can have excellent sensitivity and portability even though isothermal amplification technology is applied.

[0010] The effects of the isothermal amplification diagnostic device according to the embodiments are not limited to those mentioned above, and other unmentioned effects will be clearly understood by a person skilled in the art from the description below.

[0011] FIG. 1 is a perspective view of an isothermal amplification diagnostic device according to one embodiment.

[0012] FIG. 2 is a perspective view of an isothermal amplification diagnostic device connected to a smartphone according to one embodiment.

[0013] FIG. 3 is a perspective view of a detection cartridge according to one embodiment.

[0014] FIG. 4 is a schematic diagram of a fluid channel according to one embodiment.

[0015] FIG. 5 is a schematic diagram showing the detection process through an isothermal amplification diagnostic device according to one embodiment.

[0016] Hereinafter, embodiments are described in detail with reference to the attached drawings. However, various modifications may be made to the embodiments, and thus the scope of the patent application is not limited or restricted by these embodiments. It should be understood that all modifications, equivalents, and substitutions to the embodiments are included within the scope of the rights.

[0017] The terms used in the embodiments are for illustrative purposes only and should not be interpreted as intended to be limiting. Singular expressions include plural expressions unless the context clearly indicates otherwise. In this specification, terms such as “comprising” or “having” are intended to specify the presence 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. Unless otherwise defined, all terms used herein, including technical or scientific terms, have the same meaning as generally understood by those skilled in the art to which the embodiments pertain. Terms such as those defined in commonly used dictionaries should be interpreted as having a meaning consistent with their meaning in the context of the relevant technology, and should not be interpreted in an ideal or overly formal sense unless explicitly defined in this application.

[0018] In addition, when describing with reference to the attached drawings, identical components are assigned the same reference numeral regardless of drawing symbols, and redundant descriptions thereof are omitted. In describing the embodiments, if it is determined that a detailed description of related prior art could unnecessarily obscure the essence of the embodiments, such detailed description is omitted.

[0019] Additionally, terms such as first, second, A, B, (a), (b), etc., may be used when describing the components of the embodiments. These terms are intended merely to distinguish the components from other components, and the nature, order, or sequence of the components is not limited by these terms. Where it is stated that a component is "connected," "combined," or "joined" to another component, it should be understood that the component may be directly connected or joined to the other component, but that another component may also be "connected," "combined," or "joined" between each component.

[0020] Components included in any one embodiment and components having common functions shall be described using the same names in other embodiments. Unless otherwise stated, the descriptions given in any one embodiment may also apply to other embodiments, and specific descriptions shall be omitted to the extent of overlap.

[0021] FIG. 1 is a perspective view of an isothermal amplification diagnostic device (10) according to one embodiment, FIG. 2 is a perspective view of an isothermal amplification diagnostic device (10) connected to a smartphone (11) according to one embodiment, FIG. 3 is a perspective view of a detection cartridge (10) according to one embodiment, FIG. 4 is a schematic diagram of a fluid channel (143) according to one embodiment, and FIG. 5 is a schematic diagram showing a detection process through an isothermal amplification diagnostic device (10) according to one embodiment.

[0022] The body (100) forms the overall shape of the isothermal amplification diagnostic device (10) and can be formed from a material having high strength and heat resistance. For example, the body (100) is made of polycarbonate material to prevent damage to the isothermal amplification diagnostic device (10) which is frequently subjected to collisions with external factors during portable use.

[0023] Additionally, the body (100) is provided with a power control unit (101). The power control unit (101) is formed in the form of a switch so that the isothermal amplification diagnostic device (10) can be turned on and off according to user input. At this time, the power control unit (101) can indicate whether the isothermal amplification diagnostic device (10) is on or off using a visual element, for example, by providing an LED indicator so that the LED indicator emits light when the signal is on.

[0024] The isothermal amplification unit (110) is provided in the body (100) and consists of an insertion port (111) into which nucleic acid can be inserted and a heating element (113) provided inside the insertion port (111), and isothermally amplifies the inserted nucleic acid. For example, the isothermal amplification unit (110) has a body protruding from the upper part of the body (100), and the depth of the insertion port (111) can be formed to the extent that the body protrudes. At this time, the insertion port (111) is intended for inserting a sample tube containing a nucleic acid sample, and has a shape corresponding to the sample tube so as not to wear out the sample tube.

[0025] The heating element (113) serves to heat the inserted sample tube and can maintain a preset temperature at a constant level. To this end, the isothermal amplifier (110) further includes a temperature sensor to monitor the temperature of the heating element (113) and the sample tube in real time, and when a temperature change is detected, the heating element (113) can be adjusted to a temperature for isothermal conditions.

[0026] At this time, the isothermal amplifier (110) maintains the temperature of the heating element (113) at a constant level for 15 to 20 minutes.

[0027] Additionally, the isothermal amplifier (110) may be provided with a cover (112) that opens and closes the insertion port (111), so that foreign substances are not introduced into the insertion port (111) when not in use.

[0028] A display unit (120) is provided on the body (100) to display the time during which the isothermal amplification unit (110) isothermally amplifies the nucleic acid. For example, the display unit (120) is formed as an LCD or OLED display panel and is positioned on the upper part of the body (100) to enable intuitive time monitoring.

[0029] The power supply unit (130) is provided in the body (100) and is formed in the shape of a charging terminal compatible with a standard smartphone cable. For example, the power supply unit is formed as a standard USB Type C or 8-pin charging terminal, so that power charging through a power outlet and charging through a smartphone (11) may be possible.

[0030] The sample tube (142) receives a bio sample taken from the subject.

[0031] The detection cartridge (140) has a first end portion (141) formed in the shape of a pen nib that can be inserted into the sample tube (142). For example, the circumference of the detection cartridge (140) corresponds to the inner circumference of the insertion opening (111) to facilitate insertion.

[0032] The detection cartridge (140) allows the bio sample in the sample tube (142) to flow into the interior through the first end (141). At this time, the detection cartridge (140) is formed such that the length of the first end (141) is smaller than the depth of the insertion port (111), so that the entire body of the sample tube (142) can be accommodated within the insertion port (111).

[0033] Additionally, the detection cartridge (140) may be provided with a fastening means to secure the sample tube (142) to the first end (141). For example, the detection cartridge (140) may have a groove formed in the first end (141) into which a portion of the body of the sample tube (142) can be seated, so that a portion of the body of the sample tube (142) can be fitted into the first end (141).

[0034] The detection cartridge (140) is equipped with a fluid channel (143) for lateral flow analysis inside. Biotin and FITC detection probes, metal particle antibodies, streptavidin, and rabbit antibodies are sequentially arranged in the fluid channel (143). The fluid channel (143) forms a microchannel inside the detection cartridge (140), thereby providing a path for the sample in the sample tube (142) to flow through. Through this, the fluid channel (143) forms multiple reaction zones, and the sample can cause sequential chemical reactions as it moves through each reaction zone. In this configuration, the detection cartridge (140) has an open side surface facing it so that the area where the detection result is displayed in the fluid channel (143) is exposed to the outside. This allows the results of the chemical reaction to be visually confirmed even though the fluid channel (143) is embedded in the detection cartridge (140). The area of ​​the fluid channel (143) exposed through the open surface of the detection cartridge (140) includes a test area equipped with streptavidin and a control area equipped with rabbit antibodies. At this time, detection can be determined by whether a chemical reaction occurs in the test area, and whether the function of the fluid channel (143) is normal can be confirmed by whether a chemical reaction occurs in the control area, and this can be indicated by fluorescent particles. The detection cartridge (140) is formed such that the distance between the open surface and the end in the direction of the first end (141) is greater than the depth of the insertion port (111). In this configuration, when the detection cartridge (140) is inserted into the insertion port (111), the test area and the control area of ​​the fluid channel (143) are not inserted into the insertion port (111), thereby allowing the chemical reaction to be checked in real time. Meanwhile, the detection cartridge (140) may not necessarily be equipped with a single fluid channel (143), but may be equipped with multiple fluid channels (143) and multiple open surfaces corresponding to the test and control areas of each fluid channel (143) may be formed.Additionally, the detection cartridge (140) may be formed in a modular form. For example, the detection cartridge (140) may have a first end (141) that is detachably coupled to the body, and thus may have a structure in which the fluid channel (143) can be replaced. Through this, the user can perform detection while replacing the fluid channel (143) which is composed of antibodies suitable for the purpose and environment of the experiment. In this embodiment, the isothermal amplification diagnostic device (10) is a detection system composed of an isothermal amplification unit (110) and a detection cartridge (140), and although isothermal amplification technology is applied, both sensitivity and portability may be excellent. Although the embodiments have been described above with reference to limited drawings, those skilled in the art can apply various technical modifications and variations based on the above. For example, suitable results may be achieved even if the described techniques are performed in a different order than described, and / or the components of the described system, structure, device, circuit, etc. are combined or assembled in a form different from described, or are replaced or substituted by other components or equivalents. Therefore, other implementations, other embodiments, and equivalents to the claims are also included within the scope of the claims set forth below.

Claims

1. A body equipped with a power control unit; An isothermal amplification unit comprising an insertion port provided in the above body and capable of inserting a nucleic acid, and a heating element provided inside the insertion port, for isothermally amplifying the inserted nucleic acid; A display unit provided in the above body to indicate the time during which the isothermal amplification unit isothermally amplifies nucleic acid; A power supply unit provided in the above body and formed in the shape of a charging terminal compatible with a standard smartphone cable; and A sample tube for receiving a bio-sample collected from a test subject; A detection cartridge having a first end portion formed in the shape of a pen nib that can be inserted into the sample tube, and having a fluid channel for lateral flow analysis provided inside through which the bio sample flows into the interior through the first end portion; An isothermal amplification diagnostic device including 2. In Paragraph 1, The above isothermal amplification unit is an isothermal amplification diagnostic device that maintains the temperature of the heating element at a constant level for 15 to 20 minutes.

3. In Paragraph 1, The above detection cartridge is an isothermal amplification diagnostic device in which a side facing the detection result display area of ​​the fluid channel is open so that the area where the detection result is displayed in the fluid channel is exposed to the outside.

4. In Paragraph 3, The above detection cartridge is an isothermal amplification diagnostic device formed such that the distance between the open surface and the first end is greater than the depth of the insertion port.

5. In Paragraph 1, The above fluid channel is an isothermal amplification diagnostic device in which biotin and FITC detection probes, metal particle antibodies, streptavidin, and rabbit antibodies are sequentially arranged.

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