KR102654052B1 - Diagnosis kit for qualitative test, and automated apparatus for comprising the kit - Google Patents

Abstract

The diagnostic kit of the embodiment includes a collection means that accommodates a sample and a sample preservation solution, a means configured to be partially insertable into one surface of the collection means, and an analysis strip having a reaction area formed of a detection material capable of reacting with the sample. It includes built-in diagnostic tools.
The proposed diagnostic kit of the present invention can improve the existing qualitative testing method that relies on operators, and has the advantage of confirming and storing and managing the diagnostic results of a large number of analysis strips.

Description

Diagnosis kit for qualitative test, and automated apparatus for comprising the kit}

The present invention relates to an automated device capable of qualitative testing, and includes a tray capable of storing a large number of kits and an automated device capable of reading, storing, and managing patient information and diagnostic results from each kit stored in the tray. It's about.

Various diagnostic and analysis methods using analytical strips are easy to test, and if necessary, multiple ligands can be immobilized on one strip to obtain many analysis results in a single experiment. Rapid testing is a method that can qualitatively and quantitatively analyze trace amounts of target substances (analytes) in a short period of time, including diagnosis or testing of various diseases, medicine, agriculture, livestock industry, food, military, environment, etc. It is used in various fields.

The most widely used immunochromatography method among rapid testing methods is an assay strip containing a reactive substance that can react with the target substance to be detected using an antigen-antibody reaction to show a change, or the assay strip is made of plastic. Analytical devices in the form of devices mounted on a case are commonly used.

Figure 1 is a cross-sectional view of an analysis strip used in conventional immunochromatographic analysis.

As shown in Figure 1, a typical analysis strip includes a sample pad for receiving a liquid sample; A conjugate pad containing a conjugate in which a label (eg, gold particle) that generates a signal that can be detected by the naked eye or a sensor is conjugated to a ligand such as an antigen or antibody; A detection pad on which a test line immobilized with a binding agent (antibody or antigen) that specifically binds to the target substance and/or the conjugate in the sample and a control line capable of confirming the development of the sample are formed; and a moisture absorption pad that ultimately accommodates the liquid sample. These functional pads are connected in a partially overlapping form in the order listed above and are attached to a solid support and arranged continuously.

When the analysis strip is used mounted inside a plastic case, there is a sample inlet at the top of the case for dropping the sample at the location of the sample pad, and a result confirmation window at the location where the binder of the detection pad is fixed to check the test results. is formed

As such, in the immunochromatographic analysis method using an analysis strip, when a liquid sample is dropped onto a sample pad, the liquid sample moves through the conjugate pad and the detection pad by capillary action and is finally received in the moisture absorption pad. For example, an antibody that can bind to the antigen to be measured is immobilized in a line on a membrane pad (test line), and another antibody is bound to a labeling material such as gold particles, and the sample is developed. .

As the developed sample passes through the conjugate pad, a portion of it is developed to form an antigen-gold particle antibody complex, and the antigen-gold particle antibody is captured by the fixed test line, which is called 'test line fixed antibody-antigen-gold particle'. Antibodies are formed. As a result, the inspection line appears red due to the gold particles.

In this way, the conjugate contained in the conjugate pad also moves along with the liquid sample, and if a substance to be analyzed is present in the sample, the conjugate binds to the binder fixed to the detection pad through the target substance (commonly referred to as "sandwich"). (referred to as a “sandwich reaction”). Alternatively, the conjugate and the target material may bind to the binding agent competitively (commonly referred to as a “competition reaction”). Using an analysis strip based on the above principle, the presence or absence of a target substance in a sample can be detected with the naked eye or using a sensor.

The rapid test described above, that is, the immunochromatographic analysis method using a rapid test kit, is mainly made by drawing several horizontal lines of specific substances in the form of lines on a long membrane and cutting them vertically to form strips. Therefore, the production process is simple and mass production is possible. In addition, compared to ELISA, there is no need for a separate washing process or secondary reaction, and the reaction time is about 10 minutes, which is excellent for simplicity. However, disadvantages include the relatively low detection limit and the lack of quantification since it is generally judged with the naked eye. For this reason, the conventional immunochromatographic analysis method is mainly used for qualitative analysis, and has many limitations in quantitative analysis.

In the case of qualitative testing in the above manner, it is very cumbersome if the number of samples is large, and the results may be distorted depending on the status of the discriminator during the visual discrimination process. The process of compiling the results is not only cumbersome, but there is also a possibility of errors or mistakes. .

In order to improve the existing qualitative testing method and enable quantitative analysis through automation, the present invention includes a tray that can store a large amount of kits and reads patient information and diagnostic results from each kit stored in the tray. We would like to propose an automated device that can store and manage data.

The diagnostic kit of the embodiment includes a collection means that accommodates a sample and a sample preservation solution, a means configured to be partially insertable into one surface of the collection means, and an analysis strip having a reaction area formed of a detection material capable of reacting with the sample. It includes built-in diagnostic tools.

In addition, the automated qualitative test device of the embodiment includes a collection means that accommodates the sample and the sample preservation solution, and a reaction area formed of a detection material capable of reacting with the sample as a means configured to be partially inserted into one surface of the collection means. An apparatus for performing a qualitative test using a diagnostic kit consisting of a diagnostic means with an analysis strip embedded therein, comprising: a first tray in which a plurality of the collection means is stored, a second tray in which the plurality of the diagnostic means is stored, and the diagnostic means. It includes a sensor for photographing diagnostic results displayed through an analysis strip within the sensor, and a rail member configured to support and sequentially move the sensor.

The proposed diagnostic kit and automated device of the present invention can improve the existing qualitative testing method that relies on operators, and have the advantage of confirming and storing and managing the diagnostic results of a large number of analysis strips.

Figure 1 is a cross-sectional view of an analysis strip used in conventional immunochromatographic analysis.
Figures 2 and 3 are diagrams showing the configuration of a diagnostic kit according to an embodiment of the present invention.
Figure 4 is a diagram showing in detail the structure of the collection means that constitutes the diagnostic kit of this embodiment.
Figures 5 and 6 are diagrams showing in detail the configuration of diagnostic means constituting the diagnostic kit of this embodiment.
Figure 7 is a diagram showing a plurality of diagnostic kits each stored in a tray according to an embodiment of the present invention.
Figure 8 is a diagram showing an automated device that can check and store diagnostic results for each patient for each diagnostic kit stored in a tray according to an embodiment of the present invention.
Figure 9 is a diagram showing an example of a table storing patient information and examination results detected through an automated examination device according to an embodiment of the present invention.

Hereinafter, this embodiment will be examined in detail with reference to the accompanying drawings. However, the scope of the invention of this embodiment can be determined from the matters disclosed by this embodiment, and the spirit of the invention of this embodiment can be defined by adding, deleting, or changing components with respect to the proposed embodiment. It will be said to include transformation.

The diagnostic kit of the present invention is designed to be used in an automated qualitative testing device, and can be used to easily check the test results through an analysis strip after preserving the sample, while also allowing a large amount of diagnostic kits to be used in a device that can quickly organize the test results for each patient. Let’s explain this in detail.

Figures 2 and 3 are diagrams showing the configuration of a diagnostic kit according to an embodiment of the present invention.

Referring to Figures 2 and 3, the diagnostic kit of this embodiment includes a collection means 10 in which a sample is received/preserved, and a thin film portion 113 constituting one side of the collection means 10, which penetrates the collection means. It includes a diagnostic means (20) that allows qualitative testing of the specimen within (10).

An internal space (A) in which the sample preservation solution is accommodated is formed within the collection means (10), and the sample collected together with the sample preservation solution is accommodated in the internal space (A).

In addition, a thin film portion 113 that can be opened when pressed by an external member such as aluminum foil is formed on one side of the sampling means 10, and the thin film portion 113 is formed on one side of the diagnostic means 20. An insertion portion 231 configured to be pierced and inserted into the extraction means 10 is formed.

In addition, an analysis strip 210 is disposed within the diagnostic means 20, and the analysis strip 210 is formed to extend from the inside of the main body of the diagnostic means 20 to the insertion portion 231. The analysis strip may be made of a porous membrane pad including at least one reaction area formed of a detection material capable of reacting with the analyte in the liquid sample, and may form a reactive material or a detection material for qualitative testing of the liquid sample. Any result can be used as long as it can be displayed as a mark that can be checked from the outside.

Through the above-described configuration, the insertion portion 231 of the diagnostic means 20 penetrates the thin film portion 113 and is partially inserted into the sampling means 10. The specimen comes into contact with the analysis strip 210, and the specimen can be diagnosed by the analysis strip 210, that is, as positive or negative. As will be described later, a portion of the diagnostic means 20 is opened so that the diagnostic results displayed by the analysis strip 210 can be observed from the outside.

The configuration of the collection means 10 constituting the diagnostic kit of this embodiment will be described in more detail.

Figure 4 is a diagram showing in detail the structure of the collection means that constitutes the diagnostic kit of this embodiment.

Referring to FIG. 4, the collection means 10 of the embodiment includes a collection body 110 containing a sample preservation solution, and a sample collection unit 120 configured to be coupled to one side of the collection body 110. Includes.

The collection body 110 accommodates the sample preservation solution in the internal space, has a coupling protrusion 111 protruding with a predetermined thickness on one side, and has an insertion portion 231 of the diagnostic means 20 on the other side so that the insertion portion 231 of the diagnostic means 20 can be inserted. A thin film portion 113 made of a thin film is formed.

The coupling protrusion 111 has a cylindrical shape, and at least one locking confirmation protrusion 112 of a predetermined height is formed on the outer peripheral surface. The locking confirmation protrusion 112 is intended to confirm the state of close coupling with the sample collection unit 120, and the collection handle 121 of the sample collection unit 120 is connected to the locking confirmation protrusion 112. The user is guided to engage/rotate the sample collection unit 120 until rotation is not achieved.

The sample collection unit 120 allows the user to collect a sample to be accommodated in the collection body 110, and includes a collection handle 121 in a rectangular shape for easy manipulation, and the collection handle ( 121) and includes a locking neck 122 made of a cylinder with a predetermined thickness, and a sampling bar 123 extending from the locking neck 122.

A sample collection groove 124 consisting of at least one groove is formed on the end side of the collection bar 123, and the user holds the collection handle 121 to place the sample to be collected into the sample collection groove 124. Ensure that it is collected and stored.

After the sample is stored in the sample collection groove 124, the collection bar 123 of the sample collection unit 120 is inserted into the collection body 110, and the locking neck 122 is connected to the coupling. The sample collection unit 120 and the collection body 110 are coupled to each other by inserting and engaging the inner peripheral surface of the protrusion 111.

At this time, in order to prevent the sample and sample preservation solution in the collection body 110 from leaking to the outside, a flow prevention thread 122a consisting of a plurality of threads is formed on the outer peripheral surface of the locked neck 122, and the flow prevention thread 122a is formed. The prevention thread 122a is in close contact/contact with the inner peripheral surface of the coupling protrusion 111, so that leakage of the sample and sample preservation solution can be prevented even if the collection means 10 shown in FIG. 3 is stored in an automated device in an upside-down state. there is.

That is, in the drawing of FIG. 4, the thin film portion 113 is formed at the lower part of the harvesting body portion 110, but when the diagnostic means 20 is coupled with the thin film portion 113 facing upward. The flow prevention thread 122a prevents the sample inside the collection body 110 from leaking.

Figures 5 and 6 are diagrams showing in detail the configuration of diagnostic means constituting the diagnostic kit of this embodiment.

Referring to FIGS. 5 and 6, the diagnostic means 20 for diagnosing the sample accommodated in the collection means 10 and displaying the results through the analysis strip 210 includes a lower body in which the analysis strip 210 is stored ( 201) and an upper body 202 coupled to the lower body 210 and having a diagnostic confirmation opening 220 so that the results of the sample diagnosis on the analysis strip 210 can be confirmed from the outside.

In addition, it includes a first insertion part 231 that is formed to protrude from one side of the lower body 210 and has a shape whose width gradually narrows so that it can be easily inserted into the thin film part 113. In addition, the second insertion part 232, which has a shape corresponding to that of the first insertion part 231, is formed to protrude from one side of the upper body 202.

When the lower body 201 and the upper body 202 are coupled, a predetermined gap is formed between the first insertion part 231 and the second insertion part 232, so that the first insertion part 201 is connected to the upper body 202. The analysis strip 210, which is partially disposed between 231 and the second insertion portion 232, can easily come into contact with the sample stored inside the collection means 10.

Figure 7 is a diagram showing a plurality of diagnostic kits each stored in a tray according to an embodiment of the present invention, and Figure 8 is a diagram showing the diagnosis results for each patient for each diagnostic kit stored in a tray according to an embodiment of the present invention. This is a drawing showing an automated device that can check and save.

The diagnostic kit according to this embodiment consists of a collection means 10 in which the sample is stored, and a diagnostic means 20 in which an insertion part is inserted into the collection means 10 and then the diagnosis result of the sample is displayed through an analysis stream. , Since these collection means 10 and diagnostic means 20 can be stored/moved separately before performing the diagnosis, the first tray 300 for storing the collection means 10 and the diagnostic means 20 are provided. The second tray 400 may be configured separately.

That is, when performing a diagnostic test, the first tray 300 contains the respective collection means containing the specimens to be tested, and the second tray 400 is placed so that the diagnostic means are coupled to the collection means at each position. /Insert allows you to check the diagnostic results for multiple collection methods at the same time.

The second tray 400 accommodates diagnostic means 20, and each diagnostic means 20 is positioned on one side (thin film portion) of the collection means 10 stored in the first tray 300. The size and storage location of the trays are determined.

The second tray 400 has an open area so that the diagnostic confirmation openings 220 of each diagnostic means 20 can be checked from the outside, and this configuration facilitates automatic recognition through the color sensor of the automation device. It becomes.

The automated diagnostic device shown in FIG. 8 is configured to fix the first tray 300 and the second tray 400, and is configured to recognize a barcode attached to the collection means stored in the first tray 300. It includes a barcode reader 510 and a color sensor 520 that can check the color or number of result bands in which the diagnostic result of the specimen is displayed by the diagnostic means stored in the second tray 400.

For this purpose, the barcode attached to each of the collection means contains information about the patient from whom the sample was collected, and the barcode reader 510 and the color sensor 520 sequentially read the results diagnosed by the barcode and the diagnosis means. Rail-type members are further configured to detect and move. However, in order to support and sequentially move the barcode reader 510 and the color sensor 520, various configurations other than the rail-type members shown may be combined. Figure 9 illustrates the case where patient information is recognized through the barcode reader 510 of this embodiment and the test result information confirmed by the test line (and variable control line, etc.) indicating the diagnosis result using the color sensor 520 is converted into a database. It is done.

However, in an embodiment of the present invention, when collecting a sample, the user attaches a barcode recording data on patient information to the collection means and stores it in a first tray, and the first tray containing these collection means is installed in an automated device. After mounting, the second tray containing the diagnostic means stored thereon is mounted on the automated device, and the second tray is moved toward the first tray. When each diagnostic means is partially inserted into each collection means, diagnosis is performed. Can be performed simultaneously. And, for the diagnosis performed in this way, it is possible to sequentially collect diagnosis results for each patient through the barcode reader 510 and color sensor 520 of the automated device.

In addition, the information collected through the barcode reader 510 and color sensor 520 can store diagnosis results for each patient, and users (administrators) can check/manage each qualitative test in bulk. .

Claims (5)

A collection means that accommodates the sample and sample preservation solution,
A means configured to be partially insertable into one surface of the collection means, comprising a diagnostic means having a built-in analysis strip having a reaction area formed of a detection material capable of reacting with the sample,
An insertion part protruding at a predetermined height is formed on one side of the diagnostic means,
One surface of the extraction means is formed with a thin film portion that may be torn when the insertion portion is pressed,
A diagnostic kit for qualitative testing, wherein the analysis strip has a shape extending from the inside of the diagnostic means to the inside of the insertion part. delete According to claim 1,
The diagnostic means includes a lower body in which the analysis strip is stored, and an upper body coupled to the lower body and having a diagnostic confirmation opening formed on the analysis strip to externally check the results of sample diagnosis,
The insertion portion includes a first insertion portion extending from one side of the lower body and a second insertion portion extending from one side of the upper body,
A diagnostic kit for qualitative testing, wherein the first insertion portion and the second insertion portion configured to face each other are spaced apart by a predetermined distance. It consists of a collection means that accommodates the sample and the sample preservation solution, and a diagnostic means that has a built-in analysis strip having a reaction area formed of a detection material capable of reacting with the sample as a means configured to be partially insertable into one side of the collection means. A device for performing qualitative testing using a diagnostic kit,
a first tray storing a plurality of said collection means;
a second tray storing a plurality of the diagnostic means;
a sensor for photographing diagnostic results displayed through an analysis strip within the diagnostic means;
It includes a rail member configured to support and sequentially move the sensor,
An insertion part protruding at a predetermined height is formed on one side of the diagnostic means, one side of the collection means is formed with a thin film portion that can be torn when the insertion part is pressed, and the analysis strip is inside the diagnostic means and inside the insertion part. An automated qualitative inspection device characterized in that it has a shape that extends to. According to claim 4,
A barcode containing patient information of the received sample is attached to each of the collection means,
Further comprising a barcode reader for recognizing the barcode,
An automated qualitative examination device characterized in that the patient information read through the barcode reader and the diagnostic results of each analysis strip detected by the sensor are matched, stored, and managed.

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