KR20240056094A - Device for point of care testing - Google Patents

Abstract

A point-of-care diagnostic testing device according to an embodiment is disclosed. A point-of-care diagnostic testing device includes a sample reservoir configured to store a sample, a buffer reservoir configured to store a buffer, a first penetrating body configured to penetrate the sample reservoir, a second penetrating body configured to penetrate the buffer reservoir, and the first penetrating body configured to penetrate the buffer reservoir. 1 may include a strip holder containing a test strip disposed on the penetrating body.

Description

On-site diagnostic testing device {DEVICE FOR POINT OF CARE TESTING}

The present disclosure relates generally to point-of-care diagnostic testing devices, for example, to devices for molecular diagnosis using nucleic acid lateral flow assay.

Nucleic acid lateral flow analysis is a method of detecting nucleic acid amplification products using an antibody reaction against a primer tag. The nucleic acid lateral flow assay is easy to use and has the advantage of visually confirming the product at the test line even when the amplification reaction is weak. However, after nucleic acid amplification, the process of mixing the nucleic acid amplification product sample and buffer and transferring the mixture to the test strip is cumbersome, and contamination from external exposure may occur in the process, resulting in non-specific reactions. For example, US Patent Application Publication US 2022/0196639 A1 discloses reducing optical interference in fluidic devices. The above-mentioned background technology is possessed or acquired in the process of deriving this disclosure and cannot necessarily be said to be known technology disclosed to the general public before the application of this disclosure.

One aspect of the present disclosure is to provide a point-of-care diagnostic test device that prevents samples from being exposed to the outside during nucleic acid amplification and/or diagnosis.

According to one embodiment, a point-of-care testing device includes a sample reservoir configured to store a sample, a buffer reservoir configured to store a buffer, a first penetrating body configured to penetrate the sample reservoir, and a second penetrating body configured to penetrate the buffer reservoir. It may include a strip holder including a penetrating body and a test strip disposed on the first penetrating body.

In one embodiment, the sample reservoir may include a sample vessel, a lid configured to cover the sample vessel, the lid comprising a frangible region, and a first seal configured to seal the lid. .

In one embodiment, the buffer storage may include a buffer container and a plurality of second seals configured to seal one side and an opposite side of the buffer container, respectively.

In one embodiment, the buffer reservoir may include a recess configured to at least partially receive the first penetrating body.

In one embodiment, the sample storage and the buffer storage may be arranged in series.

In one embodiment, the first penetrating body includes a first extension having a first length, and a width disposed at an end of the first extension and decreasing in a direction along the first length of the first extension. It may include a first tapered portion.

In one embodiment, the first penetrating body includes a first extension having a first length, and a first extension extending from the first extension in a direction intersecting the first longitudinal direction of the first extension and engaging the buffer reservoir. It may include a protrusion configured to lie.

In one embodiment, the first penetrating body may include a groove configured to receive the test strip.

In one embodiment, the first penetrating body includes a first extension, and the test strip may extend beyond the first extension.

In one embodiment, the second penetrating body includes a second extension having a second length, and a second penetrating body disposed at an end of the second extension and having a width that decreases in a direction along the second length of the second extension. 2 May include a tapered portion.

In one embodiment, the first penetrating body includes a first extension having a first length, and the second penetrating body includes a second extending portion having a second length, the first length being the second length. It can be bigger than

In one embodiment, the strip holder may further include a connection body connecting the first penetrating body and the second penetrating body.

In one embodiment, the point-of-care diagnostic testing device may further include a guide configured to guide the movement of the first penetrating body and the second penetrating body.

In one embodiment, the guide may include a guide container surrounding the sample reservoir, the buffer reservoir, the first penetrating body, the second penetrating body, and the test strip.

In one embodiment, the guide may further include a guide cap connected to the strip holder and configured to cover the guide container.

According to one embodiment, an isothermal nucleic acid amplification method may be applied to a point-of-care diagnostic testing device, and a simple and miniaturized heat block may be used.

According to one embodiment, external exposure of the sample can be reduced or prevented during the nucleic acid amplification and detection process, and the false positive rate due to contamination can be reduced.

According to one embodiment, the point-of-care diagnostic testing device does not require specialized testing equipment and can therefore be easily used by non-experts.

According to one embodiment, infection with pathogens can be quickly diagnosed in the field.

The effects of the on-site diagnostic test device according to an embodiment are not limited to those mentioned above, and other effects not mentioned will be clearly understood by those skilled in the art from the description below.

The above and other aspects, features and advantages of specific embodiments of the present disclosure will become apparent from the following detailed description with reference to the accompanying drawings.
1 is a perspective view of a field diagnostic test device according to an embodiment.
Figure 2 is an exploded perspective view of a point-of-care diagnostic test device according to an embodiment.
Figure 3 is a perspective view of a sample reservoir according to one embodiment.
Figure 4 is a cross-sectional view along line 4-4 of the sample reservoir of Figure 3 according to one embodiment.
Figure 5 is a perspective view of a buffer storage according to one embodiment.
Figure 6 is a cross-sectional view of the buffer storage of Figure 5 according to one embodiment.
Figure 7 is a perspective view of a strip holder according to one embodiment.
Figure 8 is a front view of a strip holder according to one embodiment.
Figure 9 is a side view of a strip holder according to one embodiment.
Figure 10 is a rear view of a strip holder according to one embodiment.
Figure 11 is a perspective view of a guide according to one embodiment.
FIG. 12 is a cross-sectional view taken along line 12-12 of the guide of FIG. 11 according to an embodiment.
13 is a flowchart of an exemplary manufacturing method of a point-of-care diagnostic testing device according to an embodiment.
14 to 17 are diagrams showing an exemplary method of using a point-of-care diagnostic test device according to an embodiment;
Figure 14 is a diagram showing the operation of injecting a sample into a sample reservoir according to an embodiment;
Figure 15 is a diagram showing an operation of performing gene amplification (e.g., loop-mediated isothermal amplification (LAMP)) on a sample stored in a sample storage according to an embodiment;
Figure 16 is a diagram showing a state in which the sample storage, buffer storage, and strip holder are placed on a guide (e.g., undeployed state) according to an embodiment;
FIG. 17 is a diagram showing a state in which a strip holder is deployed toward a sample storage and a buffer storage (eg, deployed state) according to an embodiment.

Hereinafter, embodiments will be described in detail with reference to the attached drawings. However, since various changes may be made to the embodiments, the scope of the patent application is not limited or limited by these embodiments. It should be understood that all changes, equivalents, or substitutes for the embodiments are included in the scope of rights.

The terms used in the examples are for descriptive purposes only and should not be construed as limiting. Singular expressions include plural expressions unless the context clearly dictates otherwise. In this specification, terms such as “comprise” or “have” are intended to designate the presence of features, numbers, steps, operations, components, parts, or combinations thereof described in the specification, but are not intended to indicate the presence of one or more other features. It should be understood that it does not exclude in advance the possibility of the existence or addition of elements, numbers, steps, operations, 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 a person of ordinary skill in the technical field to which the embodiments belong. Terms defined in commonly used dictionaries should be interpreted as having a meaning consistent with the meaning in the context of the related technology, and unless explicitly defined in the present application, should not be interpreted in an ideal or excessively formal sense. No.

In addition, when describing with reference to the accompanying drawings, identical components will be assigned the same reference numerals regardless of the reference numerals, and overlapping descriptions thereof will be omitted. When describing an embodiment, if it is determined that a detailed description of related known technology may unnecessarily obscure the gist of the embodiment, the detailed description will be omitted.

Additionally, in describing the components of the embodiment, terms such as first, second, A, B, (a), and (b) may be used. These terms are only used to distinguish the component from other components, and the nature, sequence, or order of the component is not limited by the term. When a component is described as being “connected,” “coupled,” or “connected” to another component, that component may be directly connected or connected to that other component, but there is no need for another component between each component. It should be understood that may be “connected,” “combined,” or “connected.”

Components included in one embodiment and components including common functions will be described using the same names in other embodiments. Unless stated to the contrary, the description given in one embodiment may be applied to other embodiments, and detailed description will be omitted to the extent of overlap.

1 is a perspective view of a field diagnostic test device according to an embodiment.

Referring to FIGS. 1 and 2 , the point-of-care testing device 100 may be configured to detect nucleic acids from a sample. For example, the point-of-care test device 100 is used in the biopharmaceutical field, medical field, clinical diagnostic reagents, medical devices, monitoring and predictive medical systems, high-speed screening, and biological weapon detection in addition to point of care test (POCT). It can be applied to various fields, environmental screening, or lab-on-a-chip. Unlike the method of performing nucleic acid amplification on a sample in a separate container to use the nucleic acid lateral flow method and then transferring the sample to a test strip to perform the test, the point-of-care diagnostic test device 100 is a sample storage device 110 where the sample is stored. ) may be configured to deploy at least a portion of the test strip 131 into the sample reservoir 110 without substantially opening it to the outside. External exposure of the sample reservoir 110 while the test strip 131 is deployed may be substantially reduced, and contamination of the sample may be reduced.

Figure 2 is an exploded perspective view of a point-of-care diagnostic test device according to an embodiment.

Referring to FIG. 2 , the point-of-care testing device 100 may include a sample reservoir 110 . Sample storage 110 may be configured to store samples. For example, a sample may include at least one type of biological material obtained from a living organism (e.g., a human or animal). Biological material may include nucleic acids (e.g. DNA or RNA).

In one embodiment, the point-of-care testing device 100 may include a buffer storage 120. Buffer storage 120 may be configured to store buffers. The buffer reservoir 120 contains, in addition to phosphate-buffered saline (PBS) buffer, at least one reagent selected from the group consisting of sodium dodecyl sulfate (SDS), bovine serum albumin (BSA), and Triton (detergent) or a combination thereof, and/or at least one reagent of Tween-20, glycine, or glycerol, or a combination thereof. For example, the buffer storage 120 may store a PBS buffer containing 1% SDS reagent and 2% glycerol reagent.

In one embodiment, buffer storage 120 may be arranged in line with sample storage 110. For example, buffer storage 120 may be placed on or over sample storage 110.

In one embodiment, the point-of-care testing device 100 may include a strip holder 130. Strip holder 130 may be configured to hold the test strip 131. The test strip 131 may be configured to at least partially accommodate a mixture of sample and buffer by transfer of the buffer. Strip holder 130 may be configured to deploy test strip 131 into sample reservoir 110 and buffer reservoir 120 . After test strip 131 is deployed into sample reservoir 110 and buffer reservoir 120, the buffer may transfer the sample to test strip 131.

In one embodiment, the point-of-care testing device 100 may include a guide 140. Guide 140 may be configured to align strip holder 130 with sample reservoir 110 and buffer reservoir 120. In one embodiment, the guide 140 may include a guide container 141. The guide container 141 can accommodate a sample reservoir 110, a buffer reservoir 120, and a strip holder 130. The sample reservoir 110, buffer reservoir 120, and strip holder 130 may be aligned in a line inside the guide container 141. In one embodiment, guide 140 may include guide cap 142. The guide cap 142 may be configured to be coupled to the strip holder 130. Guide cap 142 may be configured to center strip holder 130 in guide container 141 .

Figure 3 is a perspective view of a sample storage unit according to one embodiment. Figure 4 is a cross-sectional view along line 4-4 of the sample reservoir of Figure 3 according to one embodiment.

Referring to FIGS. 3 and 4 , sample storage 110 may include a sample container 111 . Sample container 111 may be configured to store sample M1. The sample container 111 has a first container top surface 111A (e.g., substantially in the +Z direction), and a first container bottom surface 111B opposite the first container top surface 111A (e.g., substantially in the -Z direction). surface), a first outer side container surface (111C) between the first container upper surface (111A) and the first container lower surface (111B), and opposite to the first outer side container surface (111C) and a first container upper surface (111A) ) and a first inner side container surface (111D) between the first container lower surface (111B).

In one embodiment, the first container top surface 111A may include an at least partially open surface. The first container lower surface 111B may include a closed surface.

In one embodiment, the sample vessel 111 may include a solid (eg, cylinder) having a substantially circular or oval ring-shaped cross-section.

In one embodiment, the sample container 111 may include a convex portion 112. The convex portion 112 may be formed at least partially on the first container lower surface 111B.

In one embodiment, sample vessel 111 may include a first thread 113. The first screw thread 113 may be disposed on the first outer side container surface 111C. For example, the first screw thread 113 may be disposed in an area adjacent to the first container top surface 111A of the first outer side container surface 111C. The first screw thread 113 may be disposed in a recessed area in the first outer side container surface 111C toward the first inner side container surface 111D.

In one embodiment, the sample container 111 may include a plastic material.

In one embodiment, sample reservoir 110 may include a lid 114 (lid). Lid 114 may be configured to cover the sample container 111. The lead 114 has a first lead surface 114A (e.g., substantially a +Z direction surface) and a second lead surface 114B opposite the first lead surface 114A (e.g., a substantially -Z direction surface). ), an outer side lead surface 114C between the first lead surface 114A and the second rib surface 114B, and opposite to the outer side lid surface 114C and opposite to the first lead surface 114A and the second rib. It may include an inner side lid surface 114D between surfaces 114B.

In one embodiment, the first lid surface 114A may include a closed surface. The second lead surface 114B may include an at least partially open surface.

In one embodiment, lid 114 may include a recessed surface 114E. The recess surface 114E may be formed on the second lead surface 114B in a direction toward the first lead surface 114A. The distance between the first lead surface 114A and the recess surface 114E may be smaller than the distance between the second lead surface 114B and the recess surface 114E.

In one embodiment, the lead 114 may include a substantially circular or oval cross-sectional shape between the first lead surface 114A and the recess surface 114E. In one embodiment, the lead 114 may include a substantially circular or oval ring-shaped cross-section between the recess surface 114E and the second lead surface 114B.

In one embodiment, the recess surface 114E may face the first container top surface 111A. The inner side lid surface 114D may face at least a portion of the first outer side container surface 111C (eg, an area where the first screw thread 113 is disposed).

In one embodiment, the lead 114 may include a fragile area 115. The brittle region 115 may have a lower strength than other regions of the lead 114 . For example, the brittle area 115 may include perforations 116 that may be formed by a sharp instrument.

In one embodiment, lead 114 may include a second thread 117. The second screw thread 117 may be configured to engage with the first screw thread 113. The second thread 117 may be disposed in at least a portion of the inner side lid surface 114D.

In one embodiment, sample reservoir 110 may include a first seal 118 . The first seal 118 may be configured to seal the lid 114.

In one embodiment, the first seal 118 may be configured to be at least partially torn. For example, at least a portion of the first seal 118 may be torn by a sharp instrument (eg, a penetrating body of the strip holder 130).

In one embodiment, the first seal 118 may include a layer shape. For example, the first seal 118 may include tape.

In one embodiment, the first seal 118 may be disposed on the first lead surface 114A. The first seal 118 may also be disposed on at least a portion of the outer side lid surface 114C. The first seal 118 may be configured to seal the brittle area 115 . For example, while nucleic acid amplification (e.g., loop-mediated isothermal amplification (LAMP)) is performed on the sample M1 contained in the sample container 111, the first seal 118 is used to store the sample M1. Evaporation of (M1) can be reduced or prevented.

In one embodiment, the first seal 118 may include a metal material. For example, the first seal 118 may include aluminum.

Figure 5 is a perspective view of a buffer storage according to one embodiment. Figure 6 is a cross-sectional view of the buffer storage of Figure 5 according to one embodiment.

Referring to FIGS. 5 and 6 , the buffer storage 120 may include a buffer container 121 . The buffer container 121 may be configured to store the buffer M2. The buffer container 121 has a second container upper surface 121A (e.g., substantially in the +Z direction), and a second container lower surface 121B opposite the second container upper surface 121A (e.g., substantially in the -Z direction). surface), a second outer side container surface (121C) between the second container upper surface (121A) and the second container lower surface (121B), and opposite to the second outer side container surface (121C) and the second container upper surface (121A) ) and a second inner side container surface (121D) between the second container lower surface (121B). In one embodiment, the second container top surface 121A may include an at least partially open surface. In one embodiment, the second container lower surface 121B may include an at least partially open surface.

In one embodiment, the buffer container 121 may include a substantially circular or oval cross-sectional shape.

In one embodiment, the buffer container 121 may include a partial area (PA). The partial area PA of the buffer container 121 may be an area including the buffer M2. The area of the buffer container 121 excluding the partial area PA may be an area that does not include the buffer M2. For example, the partial area PA may include a substantially semicircular cross-sectional shape.

In one embodiment, buffer container 121 may include a recess 122 . The recess 122 may be formed in the second inner side container surface 121D. The recess 122 may extend between the second container upper surface 121A and the second container lower surface 121B. The recess 122 may be open at each of the second container upper surface 121A and the second container lower surface 121B. In one embodiment, recess 122 may include a polygonal (eg, rectangular or square) cross-sectional shape.

In one embodiment, the buffer storage 120 may include a plurality of second seals 124 and 125. For example, the upper seal 124 may be configured to seal the upper surface 121A of the second container, and the lower seal 125 may be configured to seal the lower surface 121B of the second container.

In one embodiment, the upper seal 124 and lower seal 125 may be configured to be at least partially torn. For example, at least a portion of the upper seal 124 and at least a portion of the lower seal 125 may be torn by a sharp instrument (eg, a penetrating body of the strip holder 130).

In one embodiment, the upper seal 124 and lower seal 125 may include a layer shape. For example, the upper seal 124 and lower seal 125 may include tape.

In one embodiment, the upper seal 124 and lower seal 125 may include a metal material. For example, the upper seal 124 and lower seal 125 may include aluminum.

Figure 7 is a perspective view of a strip holder according to one embodiment. Figure 8 is a front view of a strip holder according to one embodiment. Figure 9 is a side view of a strip holder according to one embodiment. Figure 10 is a rear view of a strip holder according to one embodiment.

Referring to FIGS. 7 to 10 , the strip holder 130 may include a first penetrating body 132 . The first penetrating body 132 may be configured to penetrate the sample reservoir 110 of FIGS. 1 to 4 . For example, the first penetrating body 132 may penetrate the first seal 118 and the brittle region 115 and be deployed into the sample container 111 holding the sample M1.

In one embodiment, the first penetrating body 132 may include a first extension portion 1321. The first extension 1321 includes a first body upper end surface 1321A (e.g., +Z direction end surface) and a first body lower end surface 1321B (e.g., a +Z direction end surface) opposite to the first body upper end surface 1321A. e.g. -Z direction end face), first body front surface 1321C (e.g. +Y direction face) between first body upper end face 1321A and first body lower end face 1321B, first body A first body rear surface 1321D (e.g., -Y direction surface) opposite to the front surface 1321C and between the first body upper end surface 1321A and the first body lower end surface 1321B, and a first body upper surface. A plurality of first body side surfaces 1321E (e.g., + /-X direction plane) may be included.

In one embodiment, the first extension 1321 may include a first length (eg, +/-Z direction dimension). The first length may be defined as the distance between the first body upper end surface 1321A and the first body lower end surface 1321B. The first extension 1321 may include a first width (eg, +/-X direction dimension). The first width may be defined as the distance between the plurality of first body side surfaces 1321E. The first extension 1321 may include a first thickness (eg, +/-Y direction dimension). The first thickness may be defined as the distance between the front side of the first body (1321C) and the back side of the first body (1321D).

In one embodiment, the first extension 1321 may include a first width that is substantially constant along the first length. The first extension 1321 may include a first thickness that is substantially constant along the first length.

In one embodiment, the first extension 1321 may include a polygonal (eg, rectangular or square) cross-section.

In one embodiment, first extension 1321 may be at least partially received in recess 122 of buffer storage 120 of FIGS. 5 and 6 . For example, at least a portion of the first extension 1321 (eg, the rear surface of the first body 1321D) may contact the wall surface (eg, the +Y direction surface) of the recess 122.

In one embodiment, the first penetrating body 132 may include a first tapered portion 1322. The first tapered portion 1322 includes a first tapered portion upper end surface 1322A (e.g., +Z direction end surface), a first tapered portion lower end surface opposite to the first tapered portion upper end surface 1322A ( 1322B) (e.g., -Z direction face), first tapered portion front surface 1322C (e.g., substantially +Y) between first tapered portion upper end face 1322A and first tapered portion lower end face 1322B. direction surface), a first tapered portion rear surface 1322D opposite the first tapered portion front surface 1322C and between the first tapered portion upper end surface 1322A and the first tapered portion lower end surface 1322B (e.g., -Y direction surface), and between the first tapered portion upper end surface 1322A and the first tapered portion lower end surface 1322B and between the first tapered portion front surface 1322C and the first tapered portion rear surface 1322D. It may include a plurality of first tapered portion side surfaces 1322E (eg, +/-X direction surfaces).

In one embodiment, first tapered portion upper end surface 1322A may face first body lower end surface 1321B. The first tapered portion upper end surface 1322A may contact the first body lower end surface 1321B. The first tapered portion upper end surface 1322A may be integrally and seamlessly connected to the first body lower end surface 1321B.

In one embodiment, first tapered portion lower end surface 1322B can include a substantially flat surface. In one embodiment, the first tapered portion lower end surface 1322B may include at least a partially sharp portion.

In one embodiment, first tapered portion front surface 1322C can be inclined at a non-zero angle relative to first tapered portion upper end surface 1322A and first tapered portion lower end surface 1322B. First tapered portion rear surface 1322D can be substantially perpendicular to first tapered portion upper end surface 1322A and first tapered portion lower end surface 1322B. The plurality of first tapered portion side surfaces 1322E may be inclined at a non-zero angle with respect to the first tapered portion upper end surface 1322A and the first tapered portion lower end surface 1322B.

In one embodiment, the first tapered portion 1322 may include a second length (e.g., a +/-Z dimension). The second length may be defined as the distance between first tapered portion upper end surface 1322A and first tapered portion lower end surface 1322B. The first tapered portion 1322 may include a second width (e.g., +/-X dimension). The second width may be defined as the distance between the plurality of first tapered portion side surfaces 1322E. The first tapered portion 1322 may include a second thickness (e.g., +/-Y dimension). The second thickness may be defined as the distance between the first tapered portion front surface 1322C and the first tapered portion rear surface 1322D.

In one embodiment, first tapered portion 1322 can include a second width that varies along a second length. For example, the second width may decrease from first tapered portion upper end face 1322A to first tapered portion lower end face 1322B.

In one embodiment, first tapered portion 1322 can include a second thickness that varies along a second length. For example, the second thickness may decrease from first tapered portion upper end face 1322A to first tapered portion lower end face 1322B.

In one embodiment, first tapered portion 1322 may include a polygonal (eg, trapezoidal) cross-section. In one embodiment, first tapered portion 1322 may include a substantially circular or oval cross-section.

In one embodiment, the first penetrating body 132 may include a first groove 1323. The first groove 1323 may accommodate at least a portion of the test strip 131 of FIGS. 1 and 2 . The first groove 1323 may include a groove shape (eg, a substantially flat bottom surface) corresponding to the shape of the test strip 131. The first groove 1323 may be disposed in a partial area of the front surface of the first body 1321C. The first groove 1323 may extend beyond the first body upper end surface 1321A.

In one embodiment, the first penetrating body 132 may include a second groove 1324. The second groove 1324 may accommodate at least a portion of the test strip 131 of FIGS. 1 and 2 . The second groove 1324 may include a groove shape (eg, a substantially flat bottom surface) corresponding to the shape of the test strip 131. The second groove 1324 may be disposed on a partial area of the first body front surface 1321C and the first tapered portion front surface 1322C. Second groove 1324 may extend beyond first body lower end surface 1321B to first tapered portion lower end surface 1322B.

In one embodiment, the first groove 1323 and the second groove 1324 may be connected to each other.

In one embodiment, the width (eg, dimension in +/-X direction) of the first groove 1323 may be larger than the width (eg, dimension in +/-X direction) of the second groove 1324.

In one embodiment, the first penetrating body 132 may include a protrusion 1325. Protrusion 1325 may be configured to engage buffer storage 120 of FIGS. 1, 2, 5, and 6. For example, the protrusion 1325 may be disposed on or above the second container lower surface 121B. The protrusion 1325 may contact the lower seal 125. The protrusion 1325 may protrude from the rear surface of the first body 1321D in one direction (eg, -Y direction).

In one embodiment, the strip holder 130 may include a second penetrating body 133. The second penetrating body 133 may be configured to penetrate the buffer storage 120 of FIGS. 1, 2, 5, and 6. For example, the second penetrating body 133 may penetrate the upper seal 124, be deployed into the buffer container 121 holding the buffer M2, and penetrate the lower seal 125. The second penetrating body 133 may be configured to penetrate the sample reservoir 110 of FIGS. 1 to 4 . For example, the second penetrating body 133 may penetrate the first seal 118 and the brittle region 115 and be deployed into the sample container 111 holding the sample M1.

In one embodiment, the second penetrating body 133 may include a second extension portion 1331. The second extension portion 1331 has a second body upper end surface 1331A (e.g., +Z direction end surface) and a second body lower end surface 1331B (e.g., a +Z direction end surface) opposite to the second body upper end surface 1331A. Example: -Z direction end surface), a second body upper end surface 1331A, and a second body side surface 1331C between the second body lower end surface 1331B.

In one embodiment, the second body upper end surface 1331A may be substantially on the same plane as the first body upper end surface 1321A. At least a portion of the second body side surface 1331C may face the first body rear surface 1321D. The second body side surface 1331C forms a gap with the first body rear surface 1321D and may be spaced apart from the first body rear surface 1321D.

In one embodiment, the second extension 1331 may include a third length (eg, +/-Z direction dimension). The third length may be defined as the distance between the second body upper end surface 1331A and the second body lower end surface 1331B. In one embodiment, the third length may be smaller than the first length. The second extension 1331 may include a third width or a third thickness. The third width or third thickness may be defined as the diameter or width of the second body side surface 1331C.

In one embodiment, the second extension 1331 may include a third width or a third thickness that is substantially constant along the third length. The gap between the second body side surface 1331C and the first body rear surface 1321D may be substantially constant along the third length.

In one embodiment, the second extension 1331 may include a substantially circular or oval cross-section. In an embodiment not shown, the second extension 1331 may include a polygonal (eg, rectangular or square) cross-section.

In one embodiment, the second penetrating body 133 may include a second tapered portion 1332. The second tapered portion 1332 includes a second tapered portion upper end surface 1332A (e.g., +Z direction end surface), a second tapered portion lower end surface opposite to the second tapered portion upper end surface 1332A ( 1332B) (e.g., -Z direction face), second tapered portion front surface 1332C between second tapered portion upper end face 1332A and second tapered portion lower end face 1332B (e.g., substantially +Y direction surface), a second tapered portion rear surface 1332D opposite the second tapered portion front surface 1332C and between the second tapered portion upper end surface 1332A and the second tapered portion lower end surface 1332B (e.g., -Y direction surface), and between the second tapered portion upper end surface 1332A and the second tapered portion lower end surface 1332B and between the second tapered portion front surface 1332C and the second tapered portion rear surface 1332D. It may include a plurality of second tapered portion side surfaces 1332E (eg, +/-X direction surfaces).

In one embodiment, second tapered portion upper end surface 1332A may face second body lower end surface 1331B. The second tapered portion upper end surface 1332A may contact the second body lower end surface 1331B. The second tapered portion upper end surface 1332A may be integrally and seamlessly connected to the second body lower end surface 1331B.

In one embodiment, second tapered portion lower end surface 1332B may include a sharp portion. In one embodiment, the second tapered portion lower end surface 1332B can at least partially include a substantially flat surface.

In one embodiment, the second tapered portion front surface 1332C may face the first body rear surface 1321D. The second tapered portion front surface 1332C may not face the first tapered portion rear surface 1322D.

In one embodiment, second tapered portion front surface 1332C can be substantially perpendicular to second tapered portion upper end surface 1332A and second tapered portion lower end surface 1332B. The second tapered portion rear surface 1332D may be inclined at a non-zero angle relative to the second tapered portion upper end surface 1332A and the second tapered portion lower end surface 1332B. The plurality of second tapered portion side surfaces 1332E may be inclined at a non-zero angle with respect to the second tapered portion upper end surface 1332A and the second tapered portion lower end surface 1332B.

In one embodiment, the second tapered portion 1332 may include a fourth length (e.g., a +/-Z dimension). The fourth length may be defined as the distance between the second tapered portion upper end surface 1332A and the second tapered portion lower end surface 1332B. The second tapered portion 1332 may include a fourth width (e.g., +/-X dimension). The fourth width may be defined as the distance between the plurality of second tapered portion side surfaces 1332E. The second tapered portion 1332 may include a fourth thickness (e.g., +/-Y direction dimension). The fourth thickness may be defined as the distance between the second tapered portion front surface 1332C and the second tapered portion rear surface 1332D.

In one embodiment, second tapered portion 1332 can include a fourth width that varies along a fourth length. For example, the fourth width can decrease from second tapered portion upper end face 1332A to second tapered portion lower end face 1332B.

In one embodiment, second tapered portion 1332 can include a fourth thickness that varies along a fourth length. For example, the fourth thickness may decrease from second tapered portion upper end face 1332A to second tapered portion lower end face 1332B.

In one embodiment, the sum of the third length and the fourth length may be less than the first length.

In one embodiment, the second tapered portion 1332 may include a polygonal (eg, trapezoidal) cross-section. In one embodiment, the second tapered portion 1332 may include a substantially circular or oval cross-section.

In one embodiment, the strip holder 130 may include a connecting body 134. The connection body 134 may be configured to connect the first penetrating body 132 and the second penetrating body 133.

In one embodiment, the connection body 134 may include a third extension portion 1341. The third extension portion 1341 has a third body upper end surface 1341A (e.g., +Z direction surface) and a third body lower end surface 1341B (e.g., opposite to the third body upper end surface 1341A). : -Z direction end surface), the third body front surface 1341C (e.g. +Y direction surface) between the third body upper end surface 1341A and the third body lower end surface 1341B, and the third body comprising third body side surfaces 1341E (e.g., a radial surface perpendicular to the Z axis) between the upper end surface 1341A and the third body lower end surface 1341B and connected to the third body front surface 1341C. can do.

In one embodiment, the third body lower end surface 1341B may face the first body upper end surface 1321A and the second body upper end surface 1331A. The third body lower end surface 1341B may contact the first body upper end surface 1321A and the second body upper end surface 1331A. The third body lower end surface 1341B may be integrally and seamlessly connected to the first body upper end surface 1321A and the second body upper end surface 1331A.

In one embodiment, the third body front surface 1341C may be substantially on the same plane as the first body front surface 1321C. The third body front surface 1341C may be integrally and seamlessly connected to the first body front surface 1321C.

In one embodiment, the connection body 134 may include a first groove 1323. The first groove 1323 may be disposed on the front surface of the third body 1341C. The first groove 1323 may extend beyond the first body upper end surface 1321A to the third body upper end surface 1341A.

In one embodiment, the connection body 134 may include a coupling portion 1342. The coupling portion 1342 may be configured to couple with the guide cap 142 of FIGS. 2, 11, and 12. The coupling portion 1342 may be disposed on the third body upper end surface 1321A. The coupling portion 1342 may be integrally and seamlessly connected to the first extension portion 1341. At least a portion of the coupling portion 1342 may protrude convexly in one direction (eg, +X direction) from the third body front surface 1341C. One surface of the coupling portion 1342 may be integrally and seamlessly connected to the third body side surface 1341E.

Figure 11 is a perspective view of a guide according to one embodiment. FIG. 12 is a cross-sectional view taken along line 12-12 of the guide of FIG. 11 according to an embodiment.

Referring to FIGS. 11 and 12 , the guide 140 may include a guide container 141. The guide container 141 may be configured to sequentially accommodate the sample storage 110, buffer storage 120, and strip holder 130 of FIG. 2. The guide container 141 includes a third container upper surface 141A (e.g., +Z direction surface), a third container lower surface 141B (e.g., -Z direction surface) opposite to the third container upper surface 141A, and a third container upper surface 141A (e.g., +Z direction surface). A third outer side container surface 141C between the third container upper surface 141A and the third container lower surface 141B, and opposite to the third outer side container surface 141C and between the third container upper surface 141A and the third container lower surface 141A. It may include a third inner side container surface (141D) between the container lower surface (141B).

In one embodiment, the third container top surface 141A may include an at least partially open surface. The third container lower surface (141B) may include a closed surface.

In one embodiment, the guide container 141 may include a solid (eg, cylinder) having a substantially circular or oval ring-shaped cross-section.

In one embodiment, guide 140 may include guide cap 142. The guide cap 142 has a first cap surface 142A (eg, +Z direction surface), a second cap surface 142B (eg, -Z direction surface) opposite to the first cap surface 142A, and a second cap surface 142B (eg, -Z direction surface). an outer side cap side 142C between first cap side 142A and second cap side 142B, and opposite to outer side cap side 142C and between first cap side 142A and second cap side 142B. ) may include an inner side cap surface (142D) between them.

In one embodiment, the first cap surface 142A may include a closed surface. The second cap surface 142B may include an at least partially open surface.

In one embodiment, guide cap 142 may include a recessed cap surface 142E. The recess cap surface 142E may be formed on the second cap surface 142B in a direction (eg, +Z direction) toward the first cap surface 142A. The distance between the first cap surface 142A and the recess cap surface 142E may be smaller than the distance between the second cap surface 142A and the recess cap surface 142E.

In one embodiment, the guide cap 142 may include a substantially circular or oval cross-sectional shape between the first cap surface 142A and the recess cap surface 142E. In one embodiment, the guide cap 142 may include a substantially circular or oval ring-shaped cross-section between the recess cap surface 142E and the second cap surface 142A.

In one embodiment, the recess cap surface 142E may face the third container top surface 141A. The coupling portion 1342 of FIGS. 7 to 10 may be connected to the recess cap surface 142E. For example, a bonding layer (eg, adhesive tape) may be disposed between bonding portion 1342 and recess cap surface 142E.

In one embodiment, the inner side cap surface 142D may face the third outer side container surface 141C. The inner side cap surface 142D may be in contact with the third outer side container surface 141C. The guide container 141 and the guide cap 142 may be fitted and coupled to each other.

13 is a flowchart of an exemplary manufacturing method of a point-of-care diagnostic testing device according to an embodiment.

1 to 13, the manufacturing method may include an operation 1110 of preparing the buffer storage 120. For example, the buffer is stored inside the buffer container 121, and then the second container upper surface 121A and the second container lower surface 121B are sealed by the upper seal 124 and lower seal 125, respectively. You can.

The manufacturing method may include an operation 1120 of preparing the sample reservoir 110 . For example, a perforation 116 may be formed in the brittle region 115 of the lead 114, and the sample M1 may be stored inside the sample container 111 through the perforation 116. The perforation 116 may be sealed by a first seal 118 .

The manufacturing method may include an operation 1130 of preparing the strip holder 130. For example, the test strip 131 may be attached to the first groove 1323 and the second groove 1324 by a bonding layer (eg, adhesive tape). Test strip 131 may be arranged to extend beyond first tapered portion lower end 1322B.

The manufacturing method may include an operation 1140 of coupling the buffer reservoir 120 to the strip holder 130. For example, the first extension 1321 may be disposed in the recess 122, and the protrusion 1325 may be disposed on the second container lower surface 121B and contact the lower seal 125. The first tapered portion 1322 may be disposed beyond the second container lower surface 121B. The second extension 1331 and the second tapered portion 1332 may be disposed on the partial area PA of the buffer container 121.

The manufacturing method may include an operation 1150 of coupling the strip holder 130 to the guide cap 142. For example, bonding portion 1342 may be attached to recess cap surface 142E by a bonding layer (eg, adhesive tape).

The manufacturing method may include an operation 1160 of placing the sample reservoir 110, the buffer reservoir 120, and the strip holder 130 into the guide container 141. For example, the sample reservoir 110 and the buffer reservoir 120 are sequentially placed on the third container lower surface 141B in the direction from the third container lower surface 141B of the guide container 141 toward the third container upper surface 141A. ) and strip holder 130 can be placed.

Meanwhile, the order of the manufacturing method described here is not limited to this and may be performed in a different order, and at least one operation among the described operations may be omitted, or additional operations may be included before and after any described operation. For example, the operation 1110 of preparing the buffer storage 120 may be performed after the operation 1120 of preparing the sample storage 110. As an example, the test strip 131 may be attached to the strip holder 130 before the operations 1110 and 1120.

FIGS. 14 to 17 are diagrams showing an exemplary method of using a point-of-care diagnostic test device according to an embodiment. FIG. 14 is a diagram showing an operation of injecting a sample into a sample reservoir according to an embodiment, and FIG. 15 is a diagram showing an operation of injecting a sample into a sample reservoir according to an embodiment. A diagram illustrating an operation of performing gene amplification (e.g., loop-mediated isothermal amplification (LAMP)) on a sample stored in a sample storage according to an embodiment, and FIG. 16 is a diagram illustrating a sample storage according to an embodiment. , It is a diagram showing a state in which the buffer storage and the strip holder are placed on the guide (e.g., non-deployed state), and FIG. 17 shows a state in which the strip holder according to one embodiment is deployed toward the sample storage and buffer storage (e.g., deployed state). ) is a drawing showing.

Referring to FIG. 14 , the method of use may include injecting a sample into the sample storage 110. Referring to Figure 15, the method of use may include performing gene amplification (e.g., loop-mediated isothermal amplification (LAMP)) on a sample stored in the sample storage 110. Figure 16 Referring to FIG. 17 , the operation of sequentially placing the sample reservoir 110, the buffer reservoir 120, and the strip holder 130 in the guide container 141 may include the guide cap 142. The test strip 131 can be expanded toward the sample reservoir 110 and the buffer reservoir 120 by pushing in the downward direction. The mixture of buffers moving from the sample reservoir 110 may be transferred to the test strip 131 .

Meanwhile, the order of the usage method described here is not limited to this and may be performed in a different order, and at least one operation among the described operations may be omitted, or additional operations may be included before and after any described operation.

As described above, although the embodiments have been described with limited drawings, those skilled in the art can apply various technical modifications and variations based on the above. For example, the described techniques are performed in a different order than the described method, and/or components of the described system, structure, device, circuit, etc. are combined or combined in a different form than the described method, or other components are used. Alternatively, appropriate results may be achieved even if substituted or substituted by an equivalent.

Therefore, other implementations, other embodiments, and equivalents of the claims also fall within the scope of the following claims.

Claims (15)

a sample repository configured to store samples;
a buffer store configured to store a buffer, and
A strip holder comprising a first piercing body configured to penetrate the sample reservoir, a second piercing body configured to penetrate the buffer reservoir, and a test strip disposed in the first piercing body.
A point-of-care diagnostic testing device comprising: According to claim 1,
The sample repository is,
sample container,
a lead configured to cover the sample vessel, the lead comprising a brittle region, and
a first seal configured to seal the lid;
A point-of-care diagnostic testing device comprising: According to claim 1,
The buffer storage is,
a buffer vessel, and
A plurality of second seals configured to seal one side and the opposite side of the buffer container, respectively.
A point-of-care diagnostic testing device comprising: According to claim 1,
The point-of-care testing device of claim 1, wherein the buffer reservoir includes a recess configured to at least partially receive the first penetrating body. According to claim 1,
A point-of-care diagnostic testing device wherein the sample reservoir and the buffer reservoir are arranged in a row. According to claim 1,
The first penetrating body is,
a first extension having a first length, and
A first tapered portion disposed at an end of the first extension and having a decreasing width in a direction along the first length of the first extension.
A point-of-care diagnostic testing device comprising: According to claim 1,
The first penetrating body is,
a first extension having a first length, and
A protrusion protruding from the first extension in a direction intersecting the first longitudinal direction of the first extension and configured to engage with the buffer storage.
A point-of-care diagnostic testing device comprising: According to claim 1,
The point-of-care testing device of claim 1, wherein the first penetrating body includes a groove configured to receive the test strip. According to claim 1,
The first penetrating body includes a first extension portion,
The point-of-care testing device of claim 1, wherein the test strip extends beyond the first extension. According to claim 1,
The second penetrating body,
a second extension having a second length, and
a second tapered portion disposed at an end of the second extension and having a decreasing width in a direction along the second length of the second extension.
A point-of-care diagnostic testing device comprising: According to claim 1,
The first penetrating body includes a first extension having a first length,
The second penetrating body includes a second extension having a second length,
A point-of-care diagnostic test device wherein the first length is greater than the second length. According to claim 1,
The strip holder further includes a connection body connecting the first penetrating body and the second penetrating body. According to claim 1,
A field diagnostic test device further comprising a guide configured to guide the movement of the first penetrating body and the movement of the second penetrating body. According to claim 13,
The guide includes a guide container surrounding the sample reservoir, the buffer reservoir, the first penetrating body, the second penetrating body, and the test strip. According to claim 14,
The guide further includes a guide cap connected to the strip holder and configured to cover the guide container.

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