KR20210084719A - A cassette for point-of-care testing - Google Patents

Abstract

The present invention relates to a cassette for point-of-care testing, which is capable of improving reliability of results of a sample test. According to an embodiment of the present application, the cassette for point-of-care testing comprises: a container including a first reservoir containing a first solution and a second reservoir containing a second solution; and a body including a first region capable of accommodating the first reservoir, a second region capable of accommodating the second reservoir, a third region capable of receiving a light source from the outside of the cassette, and a sample loader capable of receiving a sample, and positioned in the first region. The first solution contains a substance which specifically reacts with a target of the sample. The container is movably fixed to the body such that the container is movable between a first position and a second position. When the container is positioned in the first position, at least a portion of the sample loader is exposed to the outside, and the sample loader is not inserted into the first reservoir. When the container is positioned in the second position, at least the portion of the sample loader is inserted into the first reservoir received by the first region such that the substance reacts specifically with the target of the sample.

Description

CASSETTE FOR POINT-OF-CARE TESTING

The present invention relates to a cassette for on-site inspection, and more specifically, on-site display in which a container in which a sample processing solution is accommodated is movably coupled to the body of the cassette, so that the user's manual is minimized and the reliability of the test result for the specimen is improved It is related to the test cassette.

Recently, in the field of in vitro diagnostics, point-of-care testing for detecting a target of a biological sample has been widely used. The on-site inspection method has advantages in that the cost is low and the diagnosis result can be quickly confirmed, compared to the diagnosis method using a general clinical pathology protocol performed in hospitals and bio-laboratories.

However, the on-site examination method is a diagnostic method performed according to a manual emphasizing user convenience without the clinical judgment of a medical professional, and has a disadvantage in that it has low reliability compared to the conventional diagnostic method. Accordingly, there is an increasing demand for a technology for an on-site inspection method with improved reliability of diagnostic results.

One object of the present invention is that the mixing process for pre-treatment and/or post-treatment of the sample is performed in the container without leakage from the container in which the sample treatment solution is accommodated, so that the test reliability for the target of the sample is improved It is to provide a cassette for on-site visual inspection.

Another object of the present invention is to provide a cassette for on-site inspection in which a container for accommodating a sample processing solution is movably coupled to a cassette body, so that user intervention for performing on-site inspection is minimized.

The problem to be solved by the present invention is not limited to the above-mentioned problems, and the problems not mentioned will be clearly understood by those of ordinary skill in the art to which the present invention belongs from the present specification and the accompanying drawings. .

According to an aspect of the present application, there is provided a cassette for point-of-care testing, comprising: a container including a first reservoir including a first solution and a second reservoir including a second solution; and a first region capable of accommodating the first reservoir, a second region accommodating the second reservoir, a third region capable of receiving a light source from the outside of the cassette, and a sample capable of receiving the second region a body including a specimen loader located in area 1; wherein the first solution contains a material that specifically reacts with the target of the specimen, and the container is movably fixed to the body so that the container can move between a first position and a second position. (movably fixed), when the container is positioned in the first position, at least a part of the specimen loader is exposed to the outside, the specimen loader is not inserted into the first reservoir, and the container is moved to the second position A cassette may be provided wherein at least a portion of the specimen loader is inserted into the first reservoir accommodated by the first region so that the substance reacts specifically with the target of the specimen when positioned in the .

Solutions of the present invention are not limited to the above-described solutions, and solutions not mentioned will be clearly understood by those of ordinary skill in the art to which the present invention belongs from the present specification and the accompanying drawings. will be able

According to the present invention, since the mixing process for the pretreatment and/or reaction of the sample is performed in the container containing the sample treatment solution, the residual ratio that is not mixed with the sample with respect to the sample treatment solution or the material contained in the sample treatment solution is reduced can be minimized.

In addition, according to the present invention, the container for accommodating the sample treatment solution is movably coupled to the cassette body and provided as a kit, and a user manual including the operation of coupling the container for accommodating the sample treatment solution to the cassette body As this is minimized, the convenience of diagnosis can be increased, and the reliability of the sample test result can be improved.

The effects of the present invention are not limited to the above-described effects, and the effects not mentioned will be clearly understood by those of ordinary skill in the art to which the present invention belongs from the present specification and accompanying drawings.

1 is a flowchart illustrating an example of a general diagnostic protocol.
2 is a configuration diagram showing a cassette for on-site inspection according to an embodiment of the present specification.
3 is a view showing a container of a cassette for on-site inspection according to an embodiment of the present specification.
4 is a view showing the cassette body of the cassette for on-site inspection according to an embodiment of the present specification.
5 and 6 are views showing a cassette for on-site inspection according to an embodiment of the present specification, and is a view showing a cassette for on-site inspection when the container is located in the first position.
7 and 8 are views showing a cassette for on-site inspection according to an embodiment of the present specification, and is a view showing a cassette for on-site inspection when the container is located in the second position.
9 is a flowchart illustrating a preferred method of use for a cassette for on-site inspection according to an embodiment of the present specification.
10 to 12 are diagrams illustrating an example of a rotation process of a cassette for on-site inspection according to an embodiment of the present specification.

The embodiments described in this specification are for clearly explaining the spirit of the present invention to those of ordinary skill in the art to which the present invention pertains, so the present invention is not limited by the embodiments described herein, and the present invention It should be construed as including modifications or variations that do not depart from the spirit of the present invention.

The terms used in the present specification are selected as widely used general terms as possible in consideration of the functions in the present invention, but they may vary depending on the intention, custom, or emergence of new technology of those of ordinary skill in the art to which the present invention belongs. can However, if a specific term is defined and used with an arbitrary meaning, the meaning of the term will be separately described. Therefore, the terms used in this specification should be interpreted based on the actual meaning of the terms and the contents of the entire specification, rather than the names of simple terms.

The drawings attached to this specification are for easy explanation of the present invention, and the shapes shown in the drawings may be exaggerated as necessary to help understand the present invention, so the present invention is not limited by the drawings.

In the present specification, when it is determined that a detailed description of a known configuration or function related to the present invention may obscure the gist of the present invention, a detailed description thereof will be omitted if necessary.

According to an aspect of the present application, there is provided a cassette for point-of-care testing, comprising: a container including a first reservoir including a first solution and a second reservoir including a second solution; and a first region capable of accommodating the first reservoir, a second region accommodating the second reservoir, a third region capable of receiving a light source from the outside of the cassette, and a sample capable of receiving the second region a body including a specimen loader located in area 1; wherein the first solution contains a material that specifically reacts with the target of the specimen, and the container is movably fixed to the body so that the container can move between a first position and a second position. (movably fixed), when the container is positioned in the first position, at least a part of the specimen loader is exposed to the outside, the specimen loader is not inserted into the first reservoir, and the container is moved to the second position A cassette may be provided in which at least a portion of the specimen loader is inserted into the first reservoir accommodated by the first region so that the substance reacts specifically with the target of the specimen.

When the container is positioned in the second position, the second reservoir and the third region are fluidly connected to each other so that the second solution can be moved to the third region, and the first reservoir and the third region A cassette may be provided in which the three regions are fluidly connected to each other so that the first solution can be moved to the third region.

When the container is positioned at the second position, a cassette may be provided in which the first solution and the sample can be mixed without moving the first solution out of the first reservoir.

The cassette further includes an absorbent pad including pores having a predetermined size, wherein the absorbent pad is connected to the third region to absorb the solution contained in the third region, A cassette may be provided in which the solution contained in the first region or the second region is not connected to the first region or the second region without moving to the third region.

The material comprises beads having a size at least greater than the predetermined size such that the material does not migrate to the absorbent pad when the first solution and/or the second solution is absorbed into the absorbent pad from the third region. A linked, cassette may be provided.

The sample loader has a through hole through which the sample can be held, and when the sample is provided to the sample loader, the sample is provided in the through hole by capillary action. A cassette may be provided. have.

A cassette may be provided in which a groove is formed in an outer cover area of the cassette body corresponding to the position of the specimen loader.

When the container is moved from the first position to the second position, the sample loader is configured such that the point at which the sample loader is inserted into the first reservoir and the point at which the sample is mixed with the first solution are substantially the same. A cassette for cutting the first reservoir may be provided.

A space in the body corresponding to the third region may be provided with a cassette in contact with one side of the body.

The cassette includes a first flow path fluidly connecting the first region and the third region and a second flow path fluidly connecting the fourth region and the third region, the thickness of the cassette body The first flow path and the second flow path are narrower toward the third flow path so that the height of the third region is smaller than the height of the first region and the fourth region in the direction. may be provided.

The material included in the first solution includes at least a bead to which boronic acid is connected, and the second solution is a buffer solution, a cassette may be provided.

The bead may be provided with a cassette including at least a bead made of polymethyl methacrylate (PMMA).

Hereinafter, a cassette for on-site inspection according to an embodiment of the present specification will be described.

The present invention relates to a cassette for on-site inspection, and more particularly, the container in which the specimen processing solution is accommodated is movably coupled to the body of the cassette, so that the user's manual is minimized and the reliability of the inspection result for the specimen is improved. It relates to a cassette for visual inspection.

1. Overview of the diagnostic process

1-1 General Diagnostic Process

The diagnostic process refers to a series of protocols for acquiring information on a specific biotarget included in a biological sample to be diagnosed. Although the specific procedure of the diagnosis process is different depending on the characteristics of a specific biotarget to be diagnosed, the general diagnosis process is performed through pre-processing and post-processing for detecting a specific bio-target to finally obtain a diagnosis result. .

As the above-described diagnostic process, the Enzyme-Linked ImmunoSorbent Assay protocol (ELISA protocol), which is one of the most representative methods used in hospitals or research institutes, takes a long time for pre-processing and post-processing, so it takes a long time to derive diagnostic results. was required in many cases, and for this reason, there was a need in the market for in vitro diagnostics to obtain biometric information conveniently by immediately deriving diagnostic results. According to the needs in this market, a field test method implemented based on a protocol that has a short processing time and a relatively simple implementation during the diagnostic process for a target biotarget is widely used.

1-2 on-site visual inspection

1-2-1 Definition

Point-of-care testing (POCT) is one of the types of diagnostic methods in the field of in vitro diagnostics. It refers to a diagnostic technology that can quickly provide diagnostic results. All kinds of samples that can be collected from a subject to be tested (eg, human, animal, etc.) may be used as the biological sample that is the subject of on-site visual inspection, and it is determined whether the type of sample is determined as the target sample is determined by the test. A sample containing more of the target type (eg, a specific protein, a specific lipid, a specific DNA, etc.) may be selected.

In addition, for on-site inspection, there is a kit in which a diagnostic protocol for measuring the presence or amount of a specific disease or specific target (eg, specific protein, specific lipid, specific DNA, etc.) is implemented. need.

Meanwhile, during a diagnostic protocol, a reagent that specifically binds to a specific protein is used so that the specific protein can bind to the reagent, and then the amount of the protein specifically bound to the reagent is measured more accurately. For this purpose, there may be a diagnostic protocol that uses a method of 'removing' everything except the protein specifically bound to the reagent from the reaction products of the sample and the reagent.

In this case, when manufacturing a diagnostic kit for on-site inspection of the above-mentioned diagnostic protocol, it should be designed so that the reaction products of the reagent and the sample can be separated into proteins specifically bound to the reagent and the rest. , one of these design methods is to bind the reagent to beads of a certain size or larger to react with the sample, and then use a filter or absorbent pad having a specific pore size for the reaction products with the sample and reagent Therefore, there are cases where a diagnostic kit is configured so that a filtering method using a physical size can be applied.

The kit disclosed by the present invention relates to a diagnostic kit for point-of-care testing according to the diagnostic protocol described above.

For example, the protocol according to an example implemented in the on-site inspection method may include linking a specific binder to a biotarget included in a sample, and then physically separating the biotarget to which the specific binder is linked. can In the case of the protocol including the step of physically separating, an additional reaction procedure performed to measure information about the bio-target may be omitted, and thus the time required to output a diagnostic result may be reduced. Accordingly, a protocol including the step of physically separating is implemented in many cassettes for on-site inspection in recent years.

Hereinafter, a diagnostic protocol related to the on-site inspection method including the physically separating will be described later.

Referring to FIG. 1 , the diagnostic protocol including the physically separating step includes the steps of preparing a sample (S1200), pre-processing the prepared sample (S1400), and post-processing the pre-treated sample (S1600) , physically separating the biotarget included in the specimen (S1800) and obtaining information about the biotarget (S1900).

In the step of preparing the sample ( S1200 ), the sample including the bio-target may be provided. The sample may be different depending on the type of the biotarget to be measured. For example, the sample may be blood, urine, body fluid, or the like. Once a specific target is determined, it may be determined which sample is more suitable for detecting that target. In addition, the target may be very diverse depending on the disease to be diagnosed or the type of the target to be diagnosed, in particular, the target may be a protein in blood cells or a protein in blood including glycated hemoglobin, glycated albumin, etc., When the target is a protein in blood or a protein in blood cells, such as glycated hemoglobin or glycated albumin, the target sample may be blood.

When the specimen is prepared, the step of pre-processing the prepared specimen ( S1400 ) may be performed. In this step, “pre-treatment” means preliminarily treating the prepared sample with chemical and/or physical action so that information on the bio-target, which is the measurement target, can be measured externally. This may mean making the biotarget in a state in which it can specifically bind to a specific binder described below. For example, glycated hemoglobin means that sugar is bound to hemoglobin present in red blood cells. Since glycated hemoglobin is present in blood cells (red blood cells), the specific binding body and the glycated hemoglobin 'react with each other' In order to do this (more specifically, the functional group related to the sugar of the glycated hemoglobin reacts with a specific binder), it is necessary to destroy (remove) the cell membrane of the red blood cells. In this case, a lysis solution for removing the cell membrane is reacted with the sample, through which the glycated hemoglobin is provided to the outside of the red blood cells, so that it can be physically contacted with an external substance. This process will also be included in the 'pre-processing' process.

When the pre-processing step is performed, a post-processing step (S1600) of the pre-treated specimen may be performed. In this step, the specific binder and/or a solution including at least a specific identifier linked to or separate from the specific binder may be provided to the pretreated sample. Accordingly, the sample and the solution may be mixed.

The specific binding body is a substance that specifically binds to the biotarget for the purpose of identifying or discriminating the biotarget to obtain information about the biotarget. If the bio-target is glycated hemoglobin, the specific binder may be boronic acid.

It has been described above that the protocol for the on-site inspection method according to an example may include the step of physically separating the bio-target. That is, after the post-processing is performed, the step (S1800) of physically separating the bio-target included in the specimen may be performed. The separating may be distinguished from other materials based on physical properties related to the specific binder linked to the bio-target in the post-processing.

For example, when the specific binding body is linked to a bead having a predetermined size and the specific binding body is bound to the biotarget, the bound biotarget is interpreted as having at least the same size as the bead. When the absorbent pad having pores having a smaller size than the bead is located below the solution containing the biotarget, based on the direction of gravity, the bound biotarget due to gravity is absorbed by the biotarget. Other materials that do not move to the pad but have a size smaller than the size of the pores may move (or absorb) to the absorbent pad, and eventually the biotarget and the other material may be physically separated.

At this time, according to an example, the bead may have a predetermined size. Specifically, the diameter of the beads may be 50 micrometers to 150 micrometers.

After the separation step, a step (S1900) of obtaining information about the biotarget may be performed. In this case, the information about the biotarget may mean the presence of the biotarget or the amount of the biotarget.

The information on the bio-target may be obtained in various ways. Among the methods for obtaining information about the biotarget, there may be a method based on the absorbance of the biotarget for light in a specific wavelength band.

For example, when a light source of a wavelength band specifically absorbed by the hemoglobin is irradiated with respect to a solution containing hemoglobin and the intensity of the reflected light is measured at this time, the solution contained in the solution moved to the irradiated area with the light source is irradiated. Information on the amount of hemoglobin can be obtained. In this case, the wavelength band of the light specifically absorbed by the hemoglobin may be 415 nanometers or a wavelength band in a numerical range including at least 415 nanometers.

Hereinafter, in relation to the protocol for the above-described on-site visual inspection method, the disadvantages of the conventional on-site visual inspection cassette will be described.

1-2-2 Cassette for conventional field inspection

Conventional on-site visual inspection cassettes have the following disadvantages.

First, in the conventional cassette for on-site inspection: in the pre-treatment and/or post-treatment step, the mixing process between the prepared sample and the solution for pre-treatment and/or post-treatment is not sufficiently performed, so binding of a specific binder to a bio-target This may not be done sufficiently, and eventually, the reliability of the diagnosis result may be lowered.

For example, it is designed so that the sample treatment solution leaks from the container so that the pre-treatment and post-treatment steps are performed and the sample is provided to a part of the body of the cassette loaded with the sample. That is, for pre-treatment and post-treatment, that is, when the solution leaks into the body of the cassette, the separately loaded sample and the solution are mixed in "a region separate from the container".

Specifically, in order to perform the pre-treatment and post-treatment steps, the specimen and the pre-treatment material and/or the post-treatment material must be in physical contact. In actual implementation, individual materials are generally provided in the form of a solution rather than as separate particles, and eventually the pre-treatment and post-treatment described above with reference to FIG. 1 at the time the sample treatment solution is mixed with the sample. Steps may be performed. To this end, in the embodiment of the conventional on-site inspection cassette, the sample processing solution is poured into an area for mixing with the sample in a container having a higher potential energy based on the direction of gravity, and the container In the "leakage and pouring process" of the sample treatment solution, at least a portion of the specific binder contained in the sample treatment solution remains. That is, a phenomenon occurs that all specific binders that must react with the biotarget cannot move to the 'separate region', and this phenomenon acts as a cause of inaccurate diagnosis results.

For example, when the mixing process of the sample and the sample treatment solution for the pre-treatment and post-treatment steps is performed outside the container accommodating the sample treatment solution, at least a part of the specific binding body does not leak, so the bio contained in the sample A portion of the target may not form a binding with a specific binder. As a result, an error different from the actual information is generated in the bio-target information, leading to a measurement result, and a measurement error inevitably occurring in the conventional on-site inspection cassette causes a decrease in the reliability of the inspection result.

In order to solve the essential problem existing in some conventional cassettes for on-site inspection, users shake the container sufficiently so that the specific binders contained in the sample processing solution can leak to the outside, and then react with the sample. However, if the additional operation is performed by a user rather than a medical professional, the reliability of the diagnosis result may be reduced due to the operation itself, and a separate additional operation is forced on the user, thereby impairing the convenience of diagnosis. do.

Hereinafter, some embodiments of the configuration of a diagnostic kit for a biotarget disclosed by the present application will be described. In the description of the embodiments below, in order to more specifically and more clearly describe the configuration and operation of a diagnostic kit for a biotarget, a kit for measuring 'glycated hemoglobin' or a kit for measuring 'glycated albumin' Although described as an example, the diagnostic kit for a biotarget disclosed by the present application should not be interpreted as being limited to a kit for measuring 'glycated hemoglobin' or 'glycated albumin'.

2. Cassette for measuring blood glucose information - glycated hemoglobin, glycated albumin

The new type of on-site visual inspection disclosed in the present application is intended to solve the above-mentioned conventional problems, and hereinafter, with reference to FIGS. 2 to 12, a cassette according to an embodiment of the present invention will be described later.

2-1 Structure and Features of Cassette

A cassette for on-site inspection according to an embodiment of the present specification is a diagnostic kit for acquiring blood glucose information. In this case, the blood glucose information may be obtained by measuring information on glycated hemoglobin or glycated albumin. Glycated hemoglobin is one of the types of hemoglobin, has a state in which some functional groups of sugar are bound to hemoglobin, and may be referred to as HbA1c. Glycated albumin is a protein contained in red blood cells in blood, and refers to albumin to which glucose is bound.

In this case, in general, the blood glucose information may refer to information about a glycated ratio, not an absolute amount of a substance to which glucose is bound (glycated hemoglobin or glycated albumin in the present embodiment). Accordingly, in the present embodiment, the amount to be measured to obtain blood glucose information may be the amount of glycated hemoglobin relative to the total amount of hemoglobin (or the amount of glycated hemoglobin relative to the amount of total albumin).

Hereinafter, glycosylated albumin or glycosylated albumin, which is a specific diagnostic target, is referred to as a biotarget.

Hereinafter, the structure and characteristics of the cassette will be described later with reference to FIGS. 3 to 8 .

Referring to FIG. 3 , the cassette 1000 for on-site inspection according to an embodiment of the present specification may include a cassette body 1200 and a container 1400 .

2-1-1 Combination relationship between container and cassette body

The container 1400 may be connected to the cassette body 1200 . In particular, the container may be fixed in a first position relative to the cassette body. Alternatively, the container may be fixed to be in the second position relative to the cassette body. That is, the container 1400 may be fixed to be moved from the first position to the second position with respect to the cassette body 1200 .

When the container is fixed to be in the first position with respect to the cassette body, a portion of the container may be largely exposed to the outside of the cassette body (refer to FIG. 6 ).

When the container is fixed to be in the second position with respect to the cassette body, most of the container may be inserted into the cassette body (see FIG. 7 ).

2-1-2 Container configuration and shape

3 is a view showing a container of a cassette for on-site inspection according to an embodiment of the present specification. Referring to FIG. 3 , a container 1400 may include a first reservoir 1420 containing a first solution and a second reservoir 1440 containing a second solution.

The first reservoir 1420 may contain a solution containing a material having a function for pre-processing the sample and a material capable of specifically binding to a biotarget included in the sample. (In this case, in the connection relationship between the specifically binding material and the biotarget, the portion where the bond is formed may be a functional group representing the sugar of the biotarget. That is, when the biotarget is glycated hemoglobin The portion forming a binding relationship with the specifically binding material is a functional group representing a sugar in the glycated hemoglobin, and when the biotarget is glycated albumin, the portion forming a binding relationship with the specifically binding material may be a functional group representing a sugar in glycated albumin)

For example, the sample may be a blood sample, and the material serving for the pretreatment may be a material for hemolysis of blood cells of the blood sample. According to an example, the material functioning for the pretreatment is a surfactant, and may be implemented as a Hepes buffer solution (N-2-Hydroxyethylpiperazine-N'-2-ethanesulfonic Acid HEPES; pH 8.1).

In addition, the material capable of specifically binding may be a specific binding body to the biotarget. The material capable of specifically binding to the bio-target (glycated hemoglobin or glycated albumin) may typically be boronic acid, but is not necessarily limited thereto.

According to an embodiment, the specific binding body may be provided in combination with a bead. According to an example, the bead is a polysaccharide support such as polymethyl methacrylate (PMMA), agarose, cellulose or sepharose, or glass beads, latex. It can be implemented with beads.

Hereinafter, it is possible to specifically bind to a substance having a function for pre-processing the sample and a biotarget included in the sample (that is, a functional group representing sugar in glycated hemoglobin or a functional group representing sugar in glycated albumin). The solution containing the substance present is called the first solution.

The first solution may be basically implemented in the form of a mixed solution in which a material having a function for pre-processing the sample and a material capable of specifically binding to the bio-target are mixed in water.

On the other hand, the first solution may include a bead in which a material capable of specifically binding to the biotarget is connected to the bead in addition to water and a material having a function for pre-processing the sample. Specifically, the first solution may include beads having a size (50 micrometers to 150 micrometers) coated with the boronic acid.

As described above, the second reservoir may contain a solution containing a material for facilitating the movement of materials other than the bio-target among the reaction products of the sample and the first solution to an absorbent pad to be described later. have. According to an example, the material for accelerating may be a buffer solution.

Hereinafter, the solution included in the second reservoir is referred to as a washing solution.

Referring to FIG. 3 , the first reservoir 1420 and the second reservoir 1440 may be partitioned by a separation groove 1460 .

In this case, the separation groove 1460 may have a predetermined length and a predetermined width, and may separate the first reservoir 1420 and the second reservoir 1440 from each other. As a result, the container 1400 is provided with the separation groove 1460, so that the first solution and the second solution can be separately separated.

Referring to FIG. 3 , the container 1400 may include a third coupling member 1422 , a fourth coupling member 1442 , a fifth coupling member 1424 , and a sixth coupling member 1444 .

In this case, the third coupling member 1422 may be provided at a position further apart from the fifth coupling member 1424 in the positive direction of the x-axis defined with reference to FIG. 4 . In addition, the fourth coupling member 1442 may be provided at a position further apart from the sixth coupling member 1444 in the positive direction of the x-axis defined with reference to FIG. 4 . The third to sixth coupling members 1422 , 1442 , 1424 , and 1444 are formed in the cassette body 1200 provided with a coupling member capable of complementary coupling to each coupling member, and the container 1400 . may be held at a predetermined position of the cassette body 1200 . Details on this will be described later.

2-1-3 Cassette body

4 is a view showing the cassette body of the cassette for on-site inspection according to an embodiment of the present specification. The cassette body 1200 includes first to fourth regions 1220 , 1240 , 1260 , 1280 , an absorbent pad 1250 , a sample loader 1222 , a first cutter 1224 , and a second cutter 1244 . can do.

In the first region 1220 and the third region 1260 , the solution contained in the first region 1220 moves to the third region 1260 or the solution contained in the third region 1260 . They may be fluidically connected to each other so that they can be moved to the first region 1220 . Accordingly, as will be described later, the first solution included in the first reservoir 1420 can freely move from the first region 1220 to the third region 1260 under specific conditions.

In the second region 1240 and the fourth region 1280 , the solution contained in the second region 1240 is moved to the fourth region 1280 or the solution contained in the fourth region 1280 is moved to the second region 1240 and the fourth region 1280 . They may be fluidly connected to each other so that they can be moved to the second region 1240 . Accordingly, as will be described later, the second solution included in the second reservoir 1440 can freely move from the second region 1240 to the fourth region 1280 under specific conditions.

The first region 1220 and the second region 1240 may be partitioned by a first partition wall 1226 . By the first partition wall 1226 , the first region 1220 and the second region 1240 are not directly and fluidly connected, but the first region 1220 and the second region ( 1240 may be fluidly connected to each other through the third region 1260 and the fourth region 1280 .

The third region 1260 and the fourth region 1280 of the cassette for on-site visual inspection according to the embodiment of the present specification may be partitioned by the second partition wall 1266 .

An area on the x-y plane of the fourth region 1280 defined by the second partition wall 1266 may be larger than an area on the x-y plane of the second region 1240 . As a result, a volume in the fourth region 1280 may be greater than a volume of the second solution. This will be described later with reference to FIG. 11 .

The cassette body 1200 may include a first coupling member 1228 and a second coupling member 1248 . As described above with reference to FIG. 4, the first coupling member 1228 and the second coupling member 1248 may be complementarily coupled to the coupling member provided in the container 1400, respectively, and the container ( 1400 may be held at a predetermined position of the cassette body 1200 . Details on this will be described later.

The cassette body 1200 may include a sample loader 1222 that can receive a sample.

The specimen loader 1222 is located in the first region 1220 and may receive a specimen as described above. Referring to FIG. 4 , the sample loader 1222 is located in the first area 1220 , and is located on a portion of the outer cover portion of the cassette body 1200 corresponding to the first area 1220 . A groove may be formed. According to an example, in the cassette body 1200 , a half-moon-shaped groove may be formed in an outer cover portion of the first region 1220 . Specifically, as will be described later, when the container 1400 is positioned at the first position, at least a portion of the sample loader 1222 may be exposed to the outside to receive the sample.

In this case, the sample loader 1222 may have a through hole capable of holding the liquid sample by capillary action when the liquid sample is provided.

For example, when a blood sample is provided, the sample loader 1222 may hold the blood sample in the through hole of the sample loader 1222 . In addition, an end of the sample loader 1222 may protrude so as to crush an external cover structure. Although specifically described later, with this feature, the sample loader 1222 can crush a part of the first reservoir 1420 of the container 1400, and in the process of crushing, the sample loader 1222 is provided Contamination or loss of the blood sample can be prevented.

Referring to FIG. 4 , the cassette body 1200 may include a first cutter 1224 positioned in the first region 1220 and a second cutter 1244 positioned in the second region 1240 . .

The end of the first cutter 1224 may be sharply implemented to break the separately provided external cover structure. The end of the second cutter 1244 may be sharply implemented so as to crush an externally provided cover structure, similarly to the first cutter 1224 .

As will be described in detail later, the first cutter 1224 and the second cutter 1244 perform a function of crushing (or cutting) a portion of the first reservoir 1420 and the second reservoir 1440, respectively. .

Referring to FIG. 4 , the cassette body 1200 may further include an absorbent pad 1250 . It is connected to the third region 1260 so as to absorb the solution included in the third region 1260 , and the solution included in the first region 1220 or the second region 1240 is the third region 1260 . It may not be connected to the first area 1220 or the second area 1240 without moving to the area 1260 .

For example, when the first solution is included in the third region 1260 , the first solution may be absorbed from the third region 1260 to the absorbent pad 1250 . Also, since the first region 1220 is not directly connected to the absorbent pad 1250 , when the first solution is included in the first region 1220 , the first solution is transferred to the third region ( If it does not pass through 1260 , it cannot move to the absorbent pad 1250 . Also, since the second region 1240 is not directly connected to the absorbent pad 1250 , when the second region 1240 contains the second solution, the second solution is transferred to the third region ( If it does not pass through 1260 , it cannot move to the absorbent pad 1250 .

As described above, the absorbent pad 1250 may include pores having a predetermined size. That is, the absorbent pad 1250 allows particles having a size smaller than the predetermined size to pass through, but does not allow particles having a size larger than the predetermined size to pass therethrough.

That is, the boronic acid-linked beads included in the first solution may have a size that is at least larger than the predetermined size, so that the boronic acid-linked beads and/or the boronic acid-linked beads are bound biotarget (glycated hemoglobin or glycated albumin). ) may not be absorbed by the absorbent pad 1250 . As a result, when the second solution moves from the fourth region 1280 to the absorbent pad 1250 through the third region 1260 , the particle size is larger than the predetermined size among the particles located in the third region 1260 . Materials having a small size are transferred with the second solution to the absorbent pad 1250 . That is, even though the second solution is moved to the absorbent pad 1250, the biotarget (glycated hemoglobin or glycated albumin) to which the boronic acid is connected is not moved to the absorbent pad 1250 due to the size of the bead. may not be

That is, the absorbent pad 1250 and the first region 1220 and the second region 1240 are connected to each other when the first solution and the second solution do not pass through the third region 1260 . doesn't happen That is, as the pose of the cassette body 1200 is changed, the first solution and the second solution may move to the absorbent pad 1250 through the third region 1260 due to gravity.

The third region 1260 may receive a light source from the outside of the cassette for on-site visual inspection.

In this case, when the third region 1260 is based on the z-axis direction (the z-axis direction may mean the thickness direction of the cassette body), the first region 1220 and the second region It may have a smaller height than that of 1240 and the fourth region 1280 .

The above-described characteristic regarding the height of the third region 1260 is the z-axis with respect to the third region 1260 when a light source is irradiated to the solution included in the third region and the reflected light is measured. This may be to minimize light loss that may occur during the passage of the light source in the direction.

However, the height in the z-axis direction of the third region may be for forming a layer that is not excessively stacked when the beads included in the first solution described above with reference to FIG. 3 are accommodated in the third region. . In this regard, it will be described later with reference to FIG. 9 .

At this time, at least one surface of the cassette body 1200 corresponding to the third region 1260 may be made of a material through which the light source can pass. According to an example, a material of at least one surface of the cassette body corresponding to the third region 1260 may include polycarbonate (PC).

The above-described space for the third region may be adjacent to the at least one surface in order to minimize loss of reflected light with respect to the irradiated light source.

Hereinafter, the structural features of the cassette for on-site inspection according to an embodiment of the present specification that are specifically distinguished from the conventional cassette for on-site inspection will be described in more detail.

2-1-3 positional relationship

5 to 8 are views showing the positional relationship of the container with respect to the cassette body in the cassette for on-site inspection according to the embodiment of the present specification.

As described above, the cassette body 1200 and the container 1400 may be connected to one another to be movable. In other words, the container may be movably fixed to the cassette body.

5 and 8 , the container 1400 may be located at a first position or a second position with respect to the cassette body 1200 . 5 and 6 are diagrams illustrating a cassette for in-situ display when the container 1400 is positioned in the first position, and FIGS. 7 and 8 are views for in-situ display when the container 1400 is positioned in the second position. A drawing showing a cassette.

The cassette body 1200 and the container 1400 may not be spaced apart more than a predetermined range.

For example, referring to FIGS. 5 and 6 , when the container 1400 is spaced apart so that the overlapping area is the smallest based on the movable range with respect to the cassette body 1200, the container 1400 is fixed to the cassette body 1200 and may not be released.

As described above with reference to FIGS. 3 and 4 , the cassette body 1200 may be provided with a first coupling member 1228 and a second coupling member 1248 , and the container 1400 includes the third to Sixth coupling members 1422 , 1442 , 1424 , and 1444 may be provided.

In this case, the third coupling member 1422 may be complementary to the first coupling member 1228 . The fourth coupling member 1442 may be complementary to the second coupling member 1248 .

In addition, the fifth coupling member 1424 may be complementary to the first coupling member 1228 . The sixth coupling member 1444 may be complementary to the second coupling member 1248 .

The above-described complementary coupling member may be implemented as a hook and a groove corresponding to the hook, respectively, or may be implemented as a hook capable of complementary coupling, respectively, but the complementary coupling member When an external force is applied in physically different directions, a method of engaging with each other to form a coupling relationship will suffice, and it will not be limited to the example described above.

Due to the coupling relationship between the different coupling members described above, when the container 1400 is positioned in the first position, even when an external force is applied from the second position to the first position, the first coupling Disengagement may be prevented due to the coupling relationship between the member 1228 and the third coupling member 1422 , and the second coupling member 1248 and the fourth coupling member 1442 .

In addition, when the container 1400 is positioned at the second position, even when an external force in a direction from the second position to the first position is applied, the first coupling member 1228 and the fifth coupling Disengagement may be prevented due to the member 1424 and the coupling relationship between the second coupling member 1248 and the sixth coupling member 1444 .

The container 1400 may be moved by sliding along a predetermined path to the cassette body 1200 . Alternatively, the cassette body 1200 may be moved by sliding along a predetermined path to the container 1400, or both the cassette body 1200 and the container 1400 may slide and the positional relationship between each other may be changed. have.

When the container 1400 is positioned at the second position, the first area 1220 may accommodate the first reservoir 1420 . Alternatively, the first region 1220 may be connected to the first reservoir 1420 . That is, when the container 1400 is inserted into the cassette body 1200 and moved, the first reservoir 1420 may be located in the first area 1220 .

Also, when the container 1400 is positioned at the second position, the second area 1240 may accommodate the second reservoir 1440 . Alternatively, the second area 1240 may be connected to the second reservoir 1440 . That is, when the container 1400 is inserted into the cassette body 1200 and moved, the first reservoir 1420 may be located in the first area 1220 .

As described above, the first reservoir 1420 and the second reservoir 1440 partitioned from each other are provided in the first region 1220 and the second region 1240, respectively, so that the container 1400 At a point in time when is introduced into the cassette body 1200 and moved, the first solution and the second solution may be separately provided to the cassette body 1200 without mixing.

The first cutter 1224 allows the first solution to be discharged to the outside of the first reservoir 1220 when the container 1400 is moved from the first position to the second position. At least a portion of the reservoir 1420 (according to an example, a cover member of the first reservoir 1420) may be cut.

As described above, the first reservoir 1420 may be cut by the sample loader 1222 . That is, when the container 1400 moves from the first position to the second position after the specimen is provided to the specimen loader 1222, the specimen loader 1222 cuts the first reservoir 1420 and , the reaction may proceed by mixing with the first solution contained in the first reservoir 1420 immediately after cutting.

The first reservoir 1420 may be cut by the first cutter 1224 and the sample loader 1222 .

According to one embodiment, based on the side of the cassette body 1200 corresponding to the side into which the container 1400 is introduced, the first cutter 1224 will be further spaced apart than the sample loader 1222. can In this case, when the container 1400 is drawn into the cassette body 1200 and moved, the sample loader 1222 cuts the first reservoir 1420 at a first time point, and a time point later than the first time point. At a second point in time, the first cutter 1224 may additionally cut the first reservoir 1420 .

Like the first cutter 1224 , the second cutter 1244 transfers the second solution to the second reservoir 1440 when the container 1400 is moved from the first position to the second position. At least a portion of the second reservoir 1440 may be cut to be discharged to the outside of the .

When the container 1400 is located at the second position, the area where the container 1400 is located is: the first area without overlapping with the third area 1260 and the fourth area 1280 . At least a portion of 1220 and the second region 1240 may overlap.

When the container 1400 is positioned at the first position, at least a portion of the sample loader 1222 is exposed to the outside. In this case, the sample loader 1222 may receive a sample for diagnosing a target target.

Also, when the container 1400 is positioned at the second position, the sample loader 1222 may cut at least a portion of the first reservoir 1420 to be inserted into the first reservoir 1420 .

When the container 1400 is positioned at the second position and the sample loader 1222 is inserted into the first reservoir 1420, the blood sample provided to the sample loader 1222 may be mixed with the first solution. have. That is, even when the first solution is not discharged to the outside of the first reservoir 1420 , the first solution may be mixed with the blood sample inside the first reservoir 1420 .

As described above, when the blood sample and the first solution are mixed, the biotarget of the blood sample may bind to a material capable of specifically binding to the biotarget. That is, when the blood sample and the first solution are mixed for a sufficient time, the mixed solution contains glycated hemoglobin (or glycated albumin) to which boronic acid is linked beads and hemoglobin (or albumin) to which boronic acid is not linked beads can

The cassette for in-situ measurement according to the embodiment of the present specification has improved advantages compared to the conventional cassette for in-situ measurement in two aspects.

However, in comparison with this, according to an embodiment of the present specification, a cassette for on-site inspection in which the above-described problems are improved can be provided.

First, mixing and reaction between the diagnostic target sample and the first solution proceeds inside the first reservoir. That is, the container containing the first solution is movably coupled to the cassette body, the container is moved from the first position to the second position, and the sample loader provided with the sample is inserted into the first reservoir. From the time point, mixing with the first solution may proceed. That is, the mixing of the sample and the first solution may be performed even when the first solution is not discharged from the container (the first reservoir). After all, unlike the conventional cassette for on-site inspection, since the mixing and reaction of the sample proceeds inside the first reservoir, the reaction and mixing can be performed while minimizing the residue. Furthermore, unlike the conventional on-site inspection cassette for glycated hemoglobin (or glycated albumin), it is an operation by the “user” and does not require an operation for discharging the sample treatment solution to the outside of the container. This means that, in the end, there is no action by the “user” on the glycated hemoglobin (or glycated albumin) measurement protocol, which means that the reliability of the diagnostic results for the glycated hemoglobin (or glycated albumin) measurement has been improved.

Hereinafter, a preferred method of using the cassette for on-site inspection according to an embodiment of the present specification will be described later.

2-2 How to use

With reference to FIG. 9 , a method for measuring blood glucose information using a cassette for on-site inspection according to an embodiment of the present specification will be described. The method for measuring blood glucose information described below may be a preferred operation example for the cassette for on-the-spot inspection according to an embodiment of the present specification. In relation to the content to be described below, the content overlapping with the content described above will be omitted.

Hereinafter, however, the method for measuring blood glucose information will be described based on the glycated hemoglobin among the blood glucose information.

10 to 12 are views showing an example of the rotation process of the cassette for on-site inspection according to an embodiment of the present specification.

Referring to FIG. 8 , the method for measuring glycated hemoglobin using a cassette for on-site inspection according to an embodiment of the present specification includes loading a blood sample into a specimen loader (S3200), and placing a container in a second position. Step S3400, performing the first operation (S3600), obtaining information on the amount of hemoglobin in the blood sample (S3700), performing the second operation (S3800), and measuring the glycated hemoglobin in the blood sample It may include a step of obtaining information about the amount (S3900).

A container, a cassette body, and each detailed configuration to be described below have been described above with reference to FIGS. 3 to 5 , and overlapping contents will be omitted.

Loading the blood sample into the specimen loader ( S3200 ) may be performed when the container is in the first position. In this step, a blood sample to be diagnosed is provided to a sample loader capable of receiving a sample (ie, at least partially exposed to the outside). At this time, the amount of the blood sample provided may be 2 microliters or more, or 5 microliters or more. Alternatively, the amount of blood sample provided may be 20 microliters or less.

In the step of positioning the container at the second position ( S3400 ), as described above, the container may move from the first position to the second position. An external force in the positive direction of the x-axis shown in FIG. 10 may be applied to the container so that the position of the container can be moved. Alternatively, an external force in the negative direction of the x-axis shown in FIG. 10 may be provided to the cassette body. Preferably, after the cassette for on-site visual inspection according to an embodiment of the present specification is inserted into a separate measurement device, the external force may be provided. At this time, the external force may be applied by the user, or may be provided by the separate measuring device.

At this time, according to a preferred embodiment, the step of positioning the container at the second position in a state where the container is located below the cassette body with respect to the direction of gravity may be performed. That is, when the container is moved from the first position to the second position, the moving direction of the container may be opposite to the direction of gravity. Alternatively, when the cassette body is moved, the moving direction of the cassette body may be the same as the direction of gravity. In this case, when a separate operation is not provided to the cassette body after the blood sample is provided to the first reservoir, the first solution contained in the first reservoir and the blood sample provided to the first reservoir are transferred to the outside. Mixing can proceed without leakage.

When the loading step is performed, the blood sample is provided to the specimen loader, the blood sample enters through the through hole provided by the specimen loader by capillary action, and the entered blood sample enters the through hole held within.

After the loading step, a step (S3400) of positioning the container in a second position may be performed.

The loading step may be performed, and the blood sample may be provided to the specimen loader. Thereafter, the step of positioning the container in the second position is performed, whereby the specimen loader is inserted into the first reservoir, and the blood sample provided to the specimen loader is physically combined with the first solution contained in the first reservoir. can be contacted.

According to a preferred embodiment, the container is located in the negative direction of the x-axis with respect to the cassette body, so that the sample loader can be inserted from the top to the bottom.

As described above, the first solution and the blood sample may be mixed in physical contact. Eventually, the lysate solution included in the first solution destroys blood cells of the blood sample, and a substance that specifically binds to a biotarget in the blood sample included in the first solution - Here, the specifically binds The material is provided in connection with the bead- is specifically bound to the bio-target.

In the step of placing the container at the second position (S3400), after the container is positioned at the second position, the blood sample and the first solution are sufficiently mixed, and the glycated hemoglobin of the blood sample and the first solution The method may further include applying a shaking motion to the cassette body so that the beads to which the boronic acid of the boronic acid is linked can react better.

After the blood sample and the first solution are sufficiently mixed, the step of performing the first operation ( S3600 ) may be performed.

The first operation may be implemented by performing an operation in the first rotational direction with respect to the cassette body. In this case, the first rotation direction may refer to a clockwise direction based on a gaze direction viewed from the positive direction of the z-axis when referring to FIG. 10 . According to a preferred embodiment, the first operation may be rotating in the first rotation direction, but applying the rotation operation so that the third region is located below the first region. The pose of the cassette for on-site visual inspection according to the embodiment of the present specification before the first operation is performed is shown in FIG. 10 .

When the step of performing the first operation is performed, the pose of the cassette for on-site visual inspection according to the embodiment of the present invention shown in FIG. 11 may be changed.

When the first operation is performed, the first solution included in the first reservoir may be moved to the third region due to gravity.

Referring to FIG. 11 , in this step, the first solution located in the first reservoir may be discharged to the third area, and the second solution located in the second reservoir may be discharged to the fourth area. That is, the first solution moves to the third region, and the second solution moves to the fourth region. At this time, as described above with reference to FIG. 4 , the volume in the fourth region is larger than the volume of the second solution, so that the on-site visual inspection cassette according to an embodiment of the present specification poses according to FIG. 11 . Even when , the second solution may not move to the third region.

At this time, as described above with reference to FIG. 4 , the third region and the fourth region may be partitioned by a second partition wall, whereby the mixture of the first solution and the blood sample is transferred to the third region. At the time of movement, the second solution may not be moved to the third region.

In step S3700 of obtaining information on the amount of hemoglobin in the blood sample, a light source having a wavelength band specifically absorbed by hemoglobin may be irradiated. Information on the amount of hemoglobin moved to the third region may be obtained through the intensity of the light source that is measured by irradiating a specific light source and reflected thereon.

According to an example, the wavelength band specifically absorbed by the hemoglobin may be a wavelength band including 415 nanometers. However, when the biotarget to be measured is albumin, the specific light source to be irradiated must include a wavelength band specifically absorbed by albumin. According to an example, the wavelength band specifically absorbed by the albumin may be a wavelength band including 595 nanometers.

For example, the light source may be a light source provided in the aforementioned separate measurement device, and the information on the amount of hemoglobin may be calculated according to the amount of the light source sensed by the light receiving unit provided in the separate measurement device. have.

Referring to FIG. 11 , when the step of performing the first operation is performed, the third region may be in a state in which a solution including a biotarget is included. In this step, a light source of a wavelength band specifically absorbed by the hemoglobin is irradiated to a surface adjacent to the solution in the third region, and the light receiving unit acquires the reflected light source and measures the intensity of the reflected light source can do. The intensity of the reflected light source may include information on the amount of the hemoglobin.

In this case, it may be preferable that the step of acquiring information on the amount of hemoglobin is performed quickly.

The second operation may be performed (S3800). The second operation may be implemented by performing an operation in the second rotational direction with respect to the on-site visual inspection cassette according to the embodiment of the present specification. The second operation may be implemented by performing an operation in a second rotational direction with respect to the cassette body, wherein the second rotational direction is a gaze direction viewed from the positive direction of the z-axis when referring to Fig. 11 . According to a preferred embodiment, the second operation rotates in the first rotation direction, and the rotation operation is applied so that the third region is located below the fourth region. The pose of the on-site visual inspection cassette according to the embodiment of the present specification before the second operation is performed is shown in FIG.

After this step is performed, the pose of the cassette for on-site visual inspection according to an embodiment of the present specification is shown in FIG. 12 .

When this step is performed, the second solution is washed with the mixture located in the third region, the mixture is a mixture between the first solution and the blood sample, and the hemoglobin is transferred to the absorbent pad together. . However, the glycated hemoglobin is bound to the boronic acid-linked bead and cannot enter the absorbent pad having pores smaller than the size of the bead. As a result, the glycated hemoglobin does not move to the absorption pad despite the washing of the third region of the second solution. That is, after this step S3800 is performed, unglycated hemoglobin is not located or only a very small amount is located in the third region, and only a very small amount of glycated hemoglobin is lost or not lost due to washing of the second solution. located in area 3.

Further, according to a preferred embodiment, the region where the blood sample and the first solution are mixed (corresponding to the first reservoir according to a preferred embodiment) is preliminarily provided before the second solution is moved to the third region. It may be different from an area accommodated as a (a fourth area according to a preferred embodiment). In the end, when an additional external force other than the second operation is not applied to the cassette for on-site inspection (after all, according to the preferred method of use for the cassette for on-site inspection according to an embodiment of the present invention), the second The solution does not migrate into the mixing area. That is, even if a portion of the glycated hemoglobin and/or the non-glycated hemoglobin remains in the mixed region in the mixed region, both substances remain in the mixed region, resulting in finally obtained blood glucose information, that is, the total The effect on the diagnostic result on the ratio of glycated hemoglobin to hemoglobin may be negligible.

In the step of acquiring information on the amount of glycated hemoglobin in the blood sample (S3900), as in the previously performed step of acquiring information on the amount of total hemoglobin (S3700), a light source having a wavelength band specifically absorbed by the hemoglobin is selected. can be investigated When the intensity of the reflected and measured light is measured compared to the intensity of the irradiated light source, information on the amount of hemoglobin located in the third region may be obtained in this step. As described above, when this step is performed, the hemoglobin moved to the third region is the glycated hemoglobin bound to the boronic acid-linked beads, and thus information on the glycated hemoglobin can be obtained by measuring the reflected light.

As described above, a loss of light intensity may occur while the reflected light is transmitted and reflected in the third region. To prevent this, the value of the height in the thickness direction of the third region may be included in a predetermined numerical range. According to an example, the thickness of the first region, the thickness of the second region, and the thickness of the fourth region are 10 mm, and the height of the third region in the thickness direction may be 3 nm, and a value of 2 nm to 5 nm may be included in the scope.

As a result, according to the method for measuring information on glycated hemoglobin described with reference to FIG. 9 , information on the amount of total hemoglobin and information on the amount of glycated hemoglobin can be obtained, and accordingly, the amount of total glycated hemoglobin compared to the amount of total hemoglobin It is possible to confirm the glycated ratio for the sample showing .

3. Other Examples - Biochemical markers, etc.

The cassette for on-site inspection according to other modified embodiments of the present specification may be a kit for on-site inspection for obtaining information on biochemical markers.

According to an example, the biomarker is micro-albumin, creatine, total cholesterol (TC), triglyceride (TG), high density lipoprotein cholesterol (HDL), Aspartate aminotransferase (Aspartate Aminotransferase; AST), alanine aminotransferase (alanine transaminase; ALT), it may be at least one.

In the biochemical marker, the biotarget is contained in the protein, and the outer membrane of the protein must be destroyed for pretreatment, and an enzymatic reaction is performed for detection. That is, the first solution described above with reference to FIG. 2 may include a protinase and a surfactant so as to destroy the protein structure in order to detect the target of the biochemical marker, and the second solution contains the target biochemical An enzyme capable of reacting specifically with the marker and a dyeing material for externally measuring the result of the enzyme reaction may be included. According to an example, the dyeing material may be peroxidase (POD) and/or nanozyme.

In this embodiment, there is a difference in the diagnosis protocol when compared with the first and second embodiments, but the technical configuration described above with reference to the first and second embodiments and the technical features improved compared to the prior art are It could also be applied to examples.

The methods according to the embodiments of the present invention described above may be used alone or in combination with each other. Each of the steps described in the method according to the embodiment of the present invention is not essential, so it is possible for each method to be performed including all of the steps as well as only some of the steps. In addition, since the order in which each step is described is only for convenience of description, each step in the method described in the present invention does not necessarily have to be performed in the described order.

The above description is merely illustrative of the technical spirit of the present invention, and various modifications and variations will be possible without departing from the essential characteristics of the present invention by those skilled in the art to which the present invention pertains. Accordingly, the embodiments of the present invention described above may be implemented separately or in combination with each other.

Therefore, the embodiments disclosed in the present invention are not intended to limit the technical spirit of the present invention, but to explain, and the scope of the technical spirit of the present invention is not limited by these embodiments. The protection scope of the present invention should be construed by the following claims, and all technical ideas within the equivalent range should be construed as being included in the scope of the present invention.

Claims (12)

A cassette for point-of-care testing, comprising:
a container including a first reservoir containing a first solution and a second reservoir containing a second solution; and
A first region that can accommodate the first reservoir, a second region that can accommodate the second reservoir, a third region that can receive a light source from the outside of the cassette, and a first region that can receive a sample a body comprising a specimen loader positioned in the area; including,
The first solution contains a material that specifically reacts with the target of the sample,
the container is movably fixed to the body such that the container is movable between a first position and a second position;
When the container is positioned in the first position, at least a portion of the sample loader is exposed to the outside, and the sample loader is not inserted into the first reservoir,
when the container is positioned in the second position, at least a portion of the specimen loader is inserted into the first reservoir received by the first region such that the substance reacts specifically with the target of the specimen;
cassette.
According to claim 1,
When the container is positioned in the second position,
The second reservoir and the third region are fluidly connected to each other so that the second solution can be moved to the third region, and the first reservoir and the third region include the first solution in the third region. fluidly connected to each other so that they can be moved to
cassette.
3. The method of claim 2,
When the container is positioned in the second position, the first solution and the sample can be mixed without moving the first solution out of the first reservoir,
cassette.
According to claim 1,
The cassette further comprises an absorbent pad comprising pores having a predetermined size,
The absorbent pad,
It is connected to the third region so as to absorb the solution contained in the third region, and the solution contained in the first region or the second region does not move to the first region or the second region without moving to the third region. 2 not connected to the realm
cassette.
5. The method of claim 4,
The material comprises beads having a size at least greater than the predetermined size such that the material does not migrate to the absorbent pad when the first solution and/or the second solution is absorbed into the absorbent pad from the third region. connected,
cassette.
According to claim 1,
The sample loader has a through hole through which the sample can be held,
When the sample is provided to the sample loader, the sample is provided in the through hole by capillary action,
cassette.
According to claim 1,
A groove is formed in the outer cover area of the cassette body corresponding to the position of the sample loader,
cassette.
According to claim 1,
When the container is moved from the first position to the second position,
wherein the sample loader cuts the first reservoir so that a time point at which the sample loader is inserted into the first reservoir and a time point at which the sample is mixed with the first solution are the same;
cassette.
According to claim 1,
A space in the body corresponding to the third region is in contact with one side of the body,
cassette.
10. The method of claim 9,
The cassette includes a first flow path fluidly connecting the first region and the third region and a second flow path fluidly connecting the fourth region and the third region,
In the thickness direction of the cassette body, the height of the third region is smaller than the height of the first region and the height of the fourth region, so that the first flow path and the second flow path are directed toward the third region. narrower,
cassette.
According to claim 1,
The material includes at least a bead to which boronic acid is linked,
The second solution is a buffer solution,
cassette.
According to claim 1,
The bead comprises at least a bead made of polymethyl methacrylate (PMMA),
cassette.

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