KR102104965B1 - Test Device for in vitro diagnostics having self-heating function integrated therein - Google Patents

Abstract

Disclosed herein is an in vitro diagnostic test apparatus equipped with a self-heating function which does not require the use of a separate thermostat set to a specific temperature for an apparatus containing a strip for antigen antibody response and development during lateral flow analysis for in vitro diagnostics. Analysis using the apparatus according to the invention does not require the use of the separate thermostat set to the specific temperature for the apparatus containing the strip, thereby maximizing user convenience and cost savings.

Description

In vitro diagnostic test device with built-in self-heating function {Test Device for in vitro diagnostics having self-heating function integrated therein}

The present application relates to a device having a self-heating function used for an in vitro diagnosis.

In general, in accordance with advances in medicine and various related technologies, in vitro diagnostic tests of substances such as blood cells, nucleic acids, proteins and antigens, antibodies and drugs contained in a predetermined biological sample such as saliva, blood, urine, and the like are made. After collecting the sample as described above, by analyzing and observing the change occurring after reacting the collected sample with a predetermined reagent, inspection of the presence or absence, proportion, and quantity of various substances contained in the sample can be performed. Therefore, it is possible to obtain information on the presence or absence of a disease and the condition of the disease for in vitro diagnosis.

Various experimental methods and devices for this are used for the detection of a specific component contained in a sample during such an inspection process. For example, one of these is the detection of a specific component in an analyte by an antigen-antibody reaction in a lateral flow manner. To this end, a device is used in which the loading of the sample, the conduct and development of the antigen-antibody reaction occur. Including this, many biological reactions require performance at specific temperatures.

Therefore, for this purpose, a temperature control device has been developed to allow such a reaction to occur at a specific temperature. For example, inside a large biochemical equipment such as i-chamber (Boditech Med, Korea) or Roche or Abbott used for in situ immunoassay, a temperature control device for controlling the reaction temperature is included.

However, since they have to use a separate constant temperature device in addition to the inspection device, they cause additional cost and inconvenience to the user. It is necessary to develop a device with a built-in heat or endothermic function in the inspection device.

Republic of Korea Utility Model Application No. 20-2012-0006935 (released on October 10, 2012)

The present application is to provide a device for lateral flow analysis with built-in self-heating function.

In one aspect, the present application provides a device for lateral flow analysis with built-in self-heating function.

In one embodiment, the device includes a cover member having a measuring window and a sample inlet line formed in a line along a length; A base member fastened with the cover member to cover its lower surface along the length of the cover member, and formed with a heating member accommodating part on a surface facing the cover member when fastening; A heat generating member including a supersaturated solution, a metal plate receiving portion formed at one end, and a metal plate positioned on the metal plate receiving portion, all or a part of which is located in the heat receiving member receiving portion of the base member; And a chromatographic strip used for the lateral flow located on the heating member so that its lower surface is in contact.

In one embodiment, all of the heat generating members are located in the heat receiving member receiving portion, and the heat generating members may be located in a space created by fastening the base member and the cover member when the base member and the cover member are fastened.

In another embodiment, a part of the heating member is located in the heating member accommodating part, that is, the heating pack is located in the heating member accommodating part, in this case, the heating member accommodating part is a fixing protrusion for fixing the heating pack In addition, the metal plate and the metal plate receiving portion of the heating member are arranged to be exposed to the outside when the base member and the cover member are fastened.

In another embodiment, the cover member further includes a pressing plate configured to be moved downward by physical force and pressed against the lower one, and the pressing plate is configured to move upward and return to its original position when the force is removed. In addition, the heating member is positioned on the base member so that the force is transmitted to the metal plate by the force applied to the pressing plate, so that the metal plate receiving portion for receiving the metal plate is below the pressing plate.

In another embodiment, the device according to the present application further includes a heat conduction plate, the heat conduction plate is positioned to come between the strip and the heating member, and a guide for mounting the strip can be formed.

In another embodiment, instead of the strip on the heating member so that its lower surface is in contact with the heating pack, the circumference of the strip contacts the heating pack, in which case the metal plate accommodating part is provided in the heating pack. A device for lateral flow analysis having a built-in heating function, in which a strip-shaped strip accommodating portion for accommodating the strip is formed in a portion not formed.

In another embodiment, the heating pack includes sodium acetate or sodium sulfate supersaturated solution.

In another embodiment, the supersaturation degree of the supersaturation solution is 700% to 150%, and has a heating function of about 56 ° C to about 29 ° C depending on the supersaturation degree.

The device according to the present invention does not require the use of a separate thermostat set to a specific temperature for a device containing a strip for antigen antibody response and deployment during lateral flow analysis for in vitro diagnostics, thus reducing user convenience and cost. Is maximized.

1 is an exploded perspective view (left side) of a device according to an embodiment of the present application, and a perspective view showing a state in which a configuration of a device excluding a cover member is fastened (right side). The entire lower surface of the strip contacts the heating pack of the heating member of the present application, and the metal plate accommodating part and the metal plate of the heating member represent an embodiment exposed to the outside when the cover member and the base member are fastened.
2 is an exploded perspective view of the device according to another embodiment of the present application (left) and a perspective view showing a state in which the configuration of the device except the cover member is fastened (right). The entire lower surface of the strip is in contact with the heating pack of the heating member of the present application, the cover member includes a pressing plate, and the entire heating member including the metal plate accommodating part and the metal plate of the heating member is fastened by the fastening when the cover member and the base member are fastened. It is accommodated in the formed space, the metal plate represents an embodiment positioned to come under the pressing plate.
3 is an exploded perspective view of the device according to another embodiment of the present application (left) and a perspective view showing a state in which the configuration of the device except the cover member is fastened (right). The side surface of the strip contacts the heating pack of the heating member, and the metal plate accommodating part and the metal plate of the heating member represent an embodiment exposed to the outside when the cover member and the base member are fastened.
Figure 4 is an exploded perspective view of the device according to another embodiment of the present application (left) and a perspective view showing a state in which the cover member and the base member are fastened (on the right), and a lower right side of the device in a state where the cover member and the base member are fastened It is a sectional view along the length of the center. The side surface of the strip is in contact with the heat generating pack, the cover member includes a pressing plate, and the entire heat generating member including the metal plate of the heat generating member and the receiving portion accommodating the metal plate is in a space formed by the fastening when the cover member and the base member are fastened. It is accommodated and represents an embodiment in which the metal plate is positioned to be below the pressing plate.

Hereinafter, various embodiments of the present invention will be described with reference to the accompanying drawings. However, this is not intended to limit the present invention to specific embodiments, and it should be understood that it includes various modifications, equivalents, and / or alternatives of the embodiments of the present invention.

Here, in the whole drawings for describing the embodiments of the present application, those having the same function are given the same reference numerals, and detailed description thereof will be omitted.

Hereinafter, a device for lateral flow analysis with a built-in self-heating function of the present invention will be described with reference to the drawings.

1 to 4 disclose a device for lateral flow analysis with a built-in self-heating function according to various embodiments of the present disclosure.

In the present application, the lateral flow assay quantitatively or qualitatively measures a target analyte included in a sample, for example, a biological sample, such as blood, saliva, or other mucus, for example, a specific nucleic acid or protein. As a method, for example, by using a oligonucleotide hybridizing to a nucleic acid of a certain sequence or a nitrocellulose membrane (a medium for development, or aka strip) in which a specific antibody and / or antigen is bound to a specific position, by chromatography It is a method to detect specific nucleic acids or proteins in a sample through sequence-specific hybridization reaction or antigen-antibody reaction by moving an analyte. The device according to the present application is used in one embodiment especially for qualitative analysis.

In general, for such lateral flow analysis, a strip used in chromatography for conducting and developing an antigen and antibody reaction, including a membrane made of a material such as nitrocellulose, and such a strip are accommodated, and loading of the sample into the strip, There is a need for a case comprising a cover member and a base member having a structure necessary for reaction detection. Many biological reactions, including binding of antigens and antibodies for lateral flow analysis, or sequence-specific hybridization reactions, or signal release to detect whether such binding and reactions are required to be performed at specific temperatures.

To this end, the device according to the present application has a self-heating function. The self-heating employed herein is in one embodiment using sodium acetate or sodium sulfate supersaturated solution. The supersaturated solution refers to a solution in which a larger amount of solute is dissolved than can be dissolved in a solvent at a specific temperature. This supersaturated solution is very unstable, and crystals are formed when the supersaturation state is easily broken even with a small impact, and heat energy is released in the process of changing from liquid to solid.

Self-heating using the supersaturated solution according to the present application may generate heat at a specific temperature according to the degree of supersaturation of the solution. In one embodiment, the degree of supersaturation of the supersaturated solution is about 700% to 150%, and exotherm of about 56 ° C to 29 ° C is possible depending on the degree of supersaturation.

1 is a view showing a lateral flow analysis device having a self-heating function according to an embodiment of the present application, the entire lower surface of the strip is in contact with the heating pack of the heating member, the metal plate of the heating member and a receiving portion for receiving the metal plate It shows an embodiment exposed to the outside when the cover member and the base member are fastened.

Referring to FIG. 1, a measurement window 111 and a sample inlet 112 are formed in the cover member 10. The sample inlet is a portion in which a sample for lateral flow analysis is loaded into the strip 40 accommodated therein, and a measurement window enables to measure whether an antigen-antibody binding reaction occurs as the loaded sample unfolds in the strip.

The base member 20 is formed with a heating member accommodating portion 210. The heating member accommodating part 210 is accommodated in the heating member 30 required for self-heating according to the present application as described above.

In one embodiment, a projection is formed on the cover member 10 on the base member 20. As a result of the fastening, the projections 16 are engaged and interlocked with each other at their interface. A space for accommodating the strip and the heating member is formed by fastening.

The heating member 30 includes a supersaturated solution included in the heating pack 330, a metal plate 310 for applying a stimulus to the supersaturated solution, and a metal plate receiving portion 320 in which the metal plate is accommodated.

The metal plate 310 is made of a thickness and size and material sufficient to transmit a stimulus sufficient to crystallize in a supersaturated solution with a thickness sufficient to bend by a physical force sufficient to be applied by the force of a finger. do. The metal plate accommodating part 320 is a portion where the metal plate is located and is formed at one end of the heat generating member 30. The strip 40 is located on the heating member accommodated in the heating member accommodating portion 210 of the base member 20 so that the whole is in contact with the heating member 30, and as a result, lateral flow analysis at a specific temperature is possible. Do.

1 and 3, in one embodiment, only the heating pack 330 contacting the strip of the heating member 30 is a space created for fastening the cover member and the base member as described above The remaining metal plate receiving portion and the metal plate are positioned to be exposed to the outside. In this case, in one embodiment, the base member may further include a heating pack fixing protrusion 211 for fixing the heating pack 330. At this time, the heating pack 330 may include a means for fastening the fixing protrusion 211, for example, a groove.

1 and 3, when the metal plate and the metal plate receiving portion are exposed to the outside, the physical force is directly applied to the metal plate exposed to the outside.

2 and 4, in one embodiment, the cover member 10 may further include a pressing plate 113. The pressing plate 113 is for applying a physical force to the metal plate, and has a structure that can move downward as a physical force is applied. When a force is applied, the metal plate is pressed, and the pressed metal plate excites the supersaturated solution of the heating pack to generate heat. Will induce The pressing plate 113 is formed to return to the original position once the force is removed.

2 and 4, when the pressing plate 113 is included, a physical force is applied through the pressing plate. The space formed by the fastening when the cover member and the base member are fastened, the entire heat generating member including a metal plate of the heat generating member and a portion formed with a receiving portion accommodating the metal plate so that the force applied to the pressing plate is transmitted to the metal plate 310. It is accommodated in, and the metal plate is positioned to be below the pressing plate.

1 and 2, the device according to the present application may further include a heat conduction plate 50. The heat conduction plate is for more effectively transferring heat generated from the heat generating member to the strip, and is made of various materials capable of conducting heat, for example, a metal material. 1 and 2, the heat conduction plate 50 is positioned between the strip and the heat generating member, and the lower surface of the strip is in contact with the heat conduction plate. The heat conduction plate 50 may be manufactured in a size and shape to cover all or part of the rest of the heat generating member excluding the metal plate accommodating portion along the length of the heat generating member.

In one embodiment, a plurality of guides 510 may be formed on the thermal conductive plate 50 so as to accommodate the strips and be fixed.

3 and 4, the heating member according to the present application may contact the heating member 30 in a manner of contact along four sides of the strip. In this case, the heat generating member 30 may be formed in a space for accommodating the strip 40, that is, the strip receiving portion 340 is formed in the heat generating pack 330 of the heat generating member. When the heating member is in contact with the strip in the manner shown in FIGS. 3 and 4, the heat conduction plate 50 is not included, and the strip accommodating portion 340 may be formed in the heating pack 330. The strip receiving portion 340 is configured to fit the size and shape of the strip so that the four sides of the strip can be in close contact with the heating element.

The lateral flow analysis device of the present application may be made of a chemically stable synthetic resin and a combination thereof. For example, but not limited to, polyethylene, polypropylene, polystyrene, polyethylen terephthalide, polyamide, polyester, polyvinyl chloride, polyurethane, polycarbonate, polyvinylidene chloride, polytetrafluoromethylline, polyether It can be manufactured using a known molding method using various plastics of thermosetting and thermoplastics such as mid and combinations thereof. However, the present invention is not necessarily limited thereto, and any material suitable for the purpose of the present device may be used.

In addition, the apparatus of the present application may be manufactured using injection, rotation, extrusion and / or calendering methods according to various kinds of known molding methods, for example, but not limited to. In one embodiment of the present application, the device of the present application is manufactured by injection molding the cover member and the base member with ABS resin (Acrylonitrile, Butadiene, Styrene) and acrylic when a transparent material is required. Those skilled in the art will be able to select materials and molding methods suitable for the purposes of the present application from various known materials and molding methods in order to manufacture the device. In addition to the synthetic resin, various additives for producing a device suitable for the purpose of the present application, for example, fillers, plasticizers, stabilizers, colorants, antistatic agents, etc., may be used as needed.

On the other hand, the present invention is not limited only to the above-described embodiments, but can be modified and modified without departing from the gist of the present invention, and the technical idea to which such modifications and modifications have been applied also belongs to the following claims. Must see.

Hereinafter, experimental results using the apparatus of the present invention will be described.

Experimental Example 1

It was tested whether there is a difference in exothermic temperature according to the degree of supersaturation of the sodium acetate solution filled in the exothermic member of the present invention. Specifically, sodium acetate trihydrate (Sigma) was added to distilled water to 6 concentrations (150% to 700%), heated and melted, and then each solution was placed in a plastic wrapper (9 x 1.5 cm) in a circular metal plate (diameter 1.2 cm). ) And sealed. Subsequently, after completely cooling the vinyl acetate-filled plastic wrapper, the inner metal plate was bent back and forth to apply an impact to break the supersaturation state so that the entire solution was turned into a solid. In addition, the maximum temperature reached by supersaturation was recorded by attaching a thermometer probe to each plastic wrapper. As a result of the experiment, it was confirmed that there was a difference in the maximum heating temperature according to the degree of supersaturation as shown in Table 1.

[Table 1] Maximum heating temperature according to sodium acetate supersaturation

Experimental Example 2

The heating element of the device (FIG. 3) of the present invention was filled with a saturated sodium acetate 150% solution to prepare a heating temperature of 26.4 ° C (measurement error ± 1 ° C). Cortisol quantitative reagent (MiriChek ^TM salivary cortisol) was tested using the device of the present invention and a commercial temperature control device (i-chamber, Boditech Med, Korea). To this end, cortisol standards (Cerilliant, USA) were prepared in three concentrations. The prepared sample After applying 75uL each to the test cartridge according to the Cortisol Quantitative Reagent Instruction Manual, it was allowed to stand for 10 minutes in the device of the present invention or a commercial temperature control device (i-chamber). Each test cartridge was then measured for cortisol concentration in the specimen using a medical immunofluorescence measuring device (s-chrmoma ^TM II, Ministry of Food and Drug Safety No. 19-330). The difference in results between the two devices at the three concentrations was 0.55-7.8% (Table 2). This confirmed that the device of the present invention can be used to control the reaction temperature of the test reagent with a value that comes within 15%, which is the standard of the tolerance value of our test reagent.

[Table 2] Experimental results using the device of the present invention and a commercial constant temperature device

1, 1 ': device according to the present application
10: cover member
20: base member
30: heating member
40: chromatographic strip
50: heat conduction plate
111: Measurement window
112: sample inlet
113: pressing plate
210: heating pack receiving unit
211: fixed projection of the heating pack
310: metal plate
320: metal plate receiving portion
330: fever pack
340: strip receiving portion
510: strip guide

Claims (9)

A device for lateral flow analysis with built-in self-heating function.
A cover member having a measuring window and a sample inlet line formed in a line along the length;
A base member fastened with the cover member to cover its lower surface along the length of the cover member, and formed with a heating member accommodating part on a surface facing the cover member when fastening;
A heat generating member including a supersaturated solution, a metal plate receiving portion formed at one end, and a metal plate positioned on the metal plate receiving portion, all or a part of which is located in the heat receiving member receiving portion of the base member;
A chromatography strip used for the lateral flow positioned on the heating member so that its lower surface is in contact; And
Located between the strip and the heating member, including a heat conduction plate is formed with a guide for mounting the strip, side flow analysis device with a built-in heating function.
According to claim 1,
All of the heat generating members are located in the heat receiving member receiving portion, and the heat generating members are located in a space created by the fastening of the base member and the cover member when the base member and the cover member are fastened. Device for lateral flow analysis.
According to claim 1,
The heating pack of the heating member is located in the heating member accommodating part, in this case, the heating member accommodating part further includes a fixing protrusion for fixing the heating pack, and the metal plate and the metal plate accommodating part of the heating member are the base A device for lateral flow analysis with a built-in heating function, which is exposed to the outside when the member and the cover member are fastened.
The method of claim 1 or 2,
The cover member further includes a pressing plate configured to move downward by physical force,
The heating member is located in the base member so that the force is transmitted to the metal plate by the force applied to the pressing plate, and the metal plate accommodating portion accommodating the metal plate is below the pressing plate. Analytical devices.
delete delete According to claim 1,
The strip is located on the heating member so that its lower surface is in contact with the heating pack, and the circumference of the strip is in contact with the heating pack, in which case the heating plate is placed in a region where the metal plate accommodating portion is not formed. A device for lateral flow analysis with a built-in heating function, in which a strip-shaped strip accommodating portion for receiving a strip is formed.
The method according to any one of claims 1 to 3,
The exothermic pack comprises sodium acetate or sodium sulfate supersaturated solution, lateral flow analysis device with a built-in exothermic function.
The method of claim 8,
The supersaturation degree of the supersaturated solution is 150% to 700%, and has a heating function of 29 ° C to 56 ° C according to the supersaturation degree, a lateral flow analysis device having a built-in heating function.

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