KR20100104394A - Diagnostic kit and diagnostic method thereby - Google Patents

Abstract

PURPOSE: A housing structure of an immunodiagnosis kit is provided to minimize distance between a strip and diagnosis device and to improve diagnosis sensitivity. CONSTITUTION: A housing structure of an immunodiagnosis kit comprises a detection distance control unit. The detection distance control unit comprises: a protruded control main body(300) which is able to pressurize a diagnosis strip(200) in upward or downward. The detection distance control unit is formed corresponding to a detection region(101) which is opened to a housing(100a,100b) and membrane region. The detection distance control unit further contains a height control device which is able to control up and down height and a height fixing unit.

Description

Immunodiagnostic kit and diagnostic method using the same

The present invention relates to a structure of a housing of an immunodiagnostic kit, and in particular, by providing a detection distance control unit capable of locating a diagnostic strip of an immunodiagnostic kit at the top of the housing, thereby minimizing the distance between the strip and the diagnostic apparatus. It is not only easy to visually check, but also relates to a structure and a diagnostic method using the same to increase the diagnostic sensitivity for measurement by a quantitative diagnostic device.

A diagnostic kit is a device that tests or examines the presence of a single or multiple substances in a liquid sample, such as a urine or blood sample. Specifically, the modern diagnostic business is being integrated into one point-of-care testing (POCT). POCT is a test that takes place outside the centralized test room and can be used by the general public without expertise. Currently, the diagnosis area is expanding from the hospital to the field and the individual.

For example, in a hospital, a patient may need to receive a large amount of antibiotics to fight infection, and then collect a small amount of blood to determine whether there is an adequate amount of antibiotics in the blood or a cognitive function. In the case of this overdose of injured patients or infants unable to communicate, examples of application include rapid investigation of the types of ingested drugs in the human body to ensure proper therapeutic administration.

In particular, rapid diagnostic tests, represented by immunochromatographic analysis, are used to identify diseases or identify changes in health care, and qualitatively and quantitatively examine trace analytes in various fields such as food, biological process, and environment. Is developed in an easy way. The field of health care is also expanding its application to pregnancy, ovulation, infectious diseases, drug abuse, acute myocardial infarction and cancer.

In conventional immunochromatographic assay systems, labeled and polymerized detection antibodies are accumulated on a conjugation pad in a dry state, and when a sample is added, the conjugate dissolves and reacts with the analyte in the liquid phase. This reaction occurs when the sample solution moves along the fluid flow that occurs in capillary phenomena, and sandwich bonds form an immune conjugate between the conjugate and the analyte (antigen).

The immunoconjugate is captured by immobilized antibodies that move up the membrane and react specifically with the analyte, generating a signal proportional to the analyte concentration.

The present invention relates to a cassette (housing) comprising such a membrane to allow the immunoconjugate to be migrated and to facilitate measurement.

Conventionally, there is a window in which a sample is inserted and a window for checking a diagnosis result in a basic form used as an immunodiagnostic kit, and has a structure in which a disease can be confirmed through a test line on a membrane. For example, FIG. 1 illustrates a chromatographic binding assay device 1 as disclosed in Korean Patent Publication No. 1989-0005513 in the form of a basic cassette used for immunochromatography analysis. There is a hole (2) and the window (3) to confirm the diagnosis result. Such cassettes are for optical measurement purposes only and are limited in performing quantitative analysis.

Of course, in recent years, Japanese Patent Application No. 2002-581996 has proposed a structure of a housing that can accommodate a plurality of diagnostic strips so that a plurality of tests can be performed inside the kit housing. However, this has disadvantages such as the complexity of manufacturing facilities, the concern of interference between the diagnostic strips inside, the problem of not being able to narrow the measurement distance with the strips of the diagnostic apparatus. In other words, such a housing structure uses a diagnostic kit as a qualitative diagnostic method, so it only needs to maintain capillary phenomena sufficiently, but in a recent quantitative diagnosis method, the detecting device must also perform a role of easily accessing the kit. In the existing housing structure, it is difficult to perform this role.

To this end, as shown in Korean Patent Publication No. 2005-7001045 to facilitate a particular diagnostic detection method, an easy-to-access assay test strip is proposed. In other words, the U-shaped outer housing is mounted on the part where the diagnostic strip is located and the removable strip is attached to the magnetic strip device so that the magnetic device can be accessed. The practicality is poor to apply, and in particular, there is a disadvantage in view of the manufacturing cost.

As described above, the housing which is currently used universally has a low sensitivity because the distance between the detector and the strip that can be measured is low, and the strip and the detector are not easily accessible.

In this case, it is difficult to precisely adjust the distance and takes a long time for measurement. Therefore, in order to quantitatively diagnose POCT requiring rapid diagnosis, a diagnostic kit including a membrane strip should be designed to easily access a detector such as a sensor. In addition, there is a need to apply a slight deformation structure to improve the convenience of the manufacturing method.

The present invention has been made to solve the above-mentioned problems, an object of the present invention is to provide a detection distance control unit for positioning the diagnostic strip of the immunodiagnostic kit at the top of the housing, thereby minimizing the distance between the strip and the diagnostic device In addition, the present invention provides a housing structure of a diagnostic kit that not only makes it easy to check the diagnosis result but also improves the sensitivity of the measurement by measuring a quantitative diagnosis device.

As a specific configuration for solving the above problems, the present invention is to provide a housing structure of the immunodiagnostic kit, characterized in that it comprises a detection distance adjusting unit for adjoining the detection target of the immunodiagnostic kit to the diagnostic device.

In particular, the detection distance adjusting portion formed in the above-mentioned housing is characterized in that it comprises a protruding control body capable of pressing the diagnostic strip of the immunodiagnostic kit in the upward or downward direction.

In addition, the position of the adjusting body of the detection distance adjusting unit is characterized in that formed in a position corresponding to the detection area that is open to the membrane region and the housing of the diagnostic strip.

The control body is an embodiment preliminarily formed on the lower housing, the control body formed on the lower housing surface due to the control body formed on the upper housing of the diagnostic strip (opened part) of the membrane of the diagnostic strip The area rises by a predetermined portion, thereby minimizing the distance between the diagnostic device and the object to be detected (membrane area). This improves the sensitivity of the diagnosis, but utilizes the conventional diagnostic kit housing as it is, but with a small process change. Advantages of easy manufacturing can be realized.

Of course, the above-described detection distance adjusting unit can be modified in various ways.

In one embodiment of the present invention, the detection distance adjusting unit is formed on the lower surface of the housing, the housing structure of the immunodiagnostic kit, characterized in that it further comprises a height adjusting means capable of adjusting the vertical height can be presented. Make sure

That is, the height adjusting means is formed in a structure capable of vertically moving through the lower surface of the control body, the height fixing hole formed on any one side of the protruding structure and the height fixing hole in the lower surface of the housing Providing a housing structure of the immunodiagnostic kit, characterized in that it has a fixing lead to secure the corresponding, by presenting a housing structure that can be adjusted in height as needed can be applicable to a variety of situations and devices.

In this case, the fixing lead fixing the adjusting body to be adjusted in height may be formed in a structure that is fixed to the fixing hole by driving elastically.

In addition, in addition to the method of adjusting the height by moving the control body itself up and down, it is possible to propose a method for adjusting the desired height by using a height correction unit that can adjust the height of the projecting structure of the detection distance adjusting unit.

In this case, the height correction unit may be formed into a structure that can be coupled to the upper portion of the protruding structure.

In any of the embodiments described above, the gist of the present invention lies in the housing structure of an immunodiagnostic kit, wherein the membrane region is formed higher than the upper surface of the housing by the detection distance adjusting unit.

By using the structure of the housing, in the present invention, in the method for detecting a detection object using the immunodiagnostic kit, the detection strip is opened on the upper surface of the upper housing by using a height adjusting portion protruding in the immunodiagnostic kit. It is possible to provide a method for detecting an immunodiagnostic kit, which is formed to be higher than the upper surface of the region, so as to minimize and measure the distance from the diagnostic device.

According to the present invention, by providing a detection distance control unit for positioning the diagnostic strip of the immunodiagnostic kit at the top of the housing, it is possible to minimize the distance between the strip and the diagnostic device, and to easily confirm the diagnosis result. The measurement has the effect of increasing the diagnostic sensitivity.

In particular, the immunodiagnostic kit according to the present invention minimizes the distance between the detection target and the diagnostic device, and improves the diagnostic sensitivity due to the small space constraints around the bar. In addition, there is an advantage that can be utilized in the method of reading the change of the magnetic component.

Hereinafter, with reference to the accompanying drawings will be described a specific configuration and operation according to the present invention.

Summary of the Invention As described above, in the detector of a detection object using an immunodiagnostic kit, a detection region having a height adjusting portion protruding inside the immunodiagnostic kit, and having a diagnostic strip open on an upper surface of the upper housing, is provided. Formed to be higher than the upper surface of the, by minimizing the distance to the diagnostic device to measure, to improve the diagnostic sensitivity and to provide a housing structure of the diagnostic kit that can reduce the manufacturing cost.

An embodiment of an immunodiagnostic kit according to the present invention will be described with reference to FIG. 2.

The structure of the immunodiagnostic kit according to the present invention basically includes a detection distance control unit for adjoining a detection target of the immunodiagnostic kit to a diagnostic device. In other words, the outer shape of the housing may be deformed into any shape, and in particular, the membrane area, which is a detection target portion of the diagnostic strip, may be moved to the outside of the housing to minimize the distance from the diagnostic device. It is characterized by.

For example, as illustrated in FIG. 2, housings 100a and 100b separated into upper and lower portions are provided, and a diagnostic strip 200 for diagnosis is disposed inside the housing.

The upper housing 100a is preferably provided with a detection area 101 having an upper surface penetrated therethrough and an administration hole 102 through which the detection sample is administered.

The diagnostic strip 200 is divided into a sample pad region 210, a membrane region 220, and an absorbent pad region 230. The sample pad region 210 is a region into which a liquid sample is injected, and in some cases, a conjugation pad formed by conjugating particles generating a signal that can be measured by the naked eye or using a sensor with a ligand such as a primary antibody. It may further include.

In addition, the membrane region 220 is preferably formed of a porous membrane pad in which a detection antibody specifically binding to an antigen to be analyzed and a secondary antibody for secondary detection of particles are fixed.

The absorbent pad region 230 is formed of a structure that finally receives a liquid sample.

In the above diagnostic strip, when a liquid sample such as halal fluid or urine is introduced through the sample pad, the liquid sample may be reacted with the analyte (antigen) in the liquid sample while the liquid sample is transferred through the membrane region connected to the sample pad. Coupling (conjugation) is performed with the above non-flow detection material. (In this case, a test line, which is a reaction region formed of an antibody capable of reacting with an antigen to be analyzed in a liquid sample, and a control line formed of an antibody capable of directly binding to a primary antibody not bound to an antigen, if necessary, are uniform with each other. It is generally provided spaced apart.)

In general, particles that generate measurable signals are re-dissolved when the sample pad is wetted by the liquid sample, and expands in the direction of the absorbent pad in the strip through capillary action (X-> X 'direction).

Preferably, the lower housing 100b includes a detection distance control unit 300 to allow the membrane region of the diagnostic strip to be bent. As shown, the detection distance adjusting unit 300 forms an adjusting body which is formed to protrude on the surface of the lower housing so that the membrane region 220 of the entire diagnostic strip 200 rises upward and is upward in the vertical upward direction. It is preferable to form so as to be exposed to the outside through the detection area 101 formed on the housing surface. The shape or structure of the assembly body described above is not limited in form, and as long as the membrane region 220 can protrude above the detection region, any shape may be used.

Another modified embodiment of the detection distance adjusting unit according to the present invention will be described with reference to FIGS. 3A to 3B.

Referring to Figure 3a, the adjustment body 300 formed in the lower housing (100b) is formed in a structure that can be moved up and down through a hole through the lower housing. In particular, the fixing hole 310 is formed on the side of the adjusting body 300 to be fixed from the left and right by the fixing lead 320 formed on the lower housing 100b. In this case, the fixing lead 320 is preferably formed to have a structure in which the opposite side of the fixing portion of the main body is elastically driven through an elastic body (spring, etc.) formed in the lower housing. Such a structure may be formed as a structure having a fixing lead having elastic force coupled to the fixing hole in one direction or left and right directions of the control body 300 as shown in FIG. 3B. That is, by adjusting the height of the adjustment body it is possible to reduce the inconvenience of having to manufacture a separate housing separately according to the measurement environment of the various diagnostic devices. Of course, the part of fixing the height can change the shape or shape. In this example, the coupling method using the fixing hole and the fixing lead has been described, but various types of height adjustment may be applied.

3c may be applied to the adjusting body 300 in such a manner that the auxiliary height adjusting means is provided instead of the fixing hole or the fixing lead method. That is, the auxiliary height adjusting units 340a and 340b which are inserted into the upper surface of the adjusting body of FIG. 3A may be combined and separated as necessary to be applied in various inspection environments without additional manufacturing.

4 illustrates a method of detecting an immunodiagnostic kit using a structure capable of moving a membrane region of a detection object, which is the subject of the present invention, to an upper portion of a housing. That is, to minimize the distance between the detection unit 410 of the diagnostic device 400 and the membrane region 300 present on the housing 100, the membrane may be positioned at the top of the housing to improve diagnostic sensitivity. It is possible to provide a method of measurement that allows it.

This measurement method is not only to apply the housing structure of the immunodiagnostic kit according to the present invention, it is also possible to use the existing housing.

That is, referring to FIG. 5, in the above-described embodiment, a structure in which the membrane region protrudes from the upper surface of the upper housing does not need to be integrally formed with the housing. This can be applied to a structure in which the membrane region is minimized the distance from the diagnostic device through the protrusion structure, which is commonly referred to as the control body to form any structure.

For example, the internal design of the existing housing can be used as it is, an embodiment thereof will be described with reference to FIG. 5. First, (a) to form a predetermined slit (S) on the lower surface of the existing housing (100). (This figure is a plan view from the top of the housing.)

(b) and then the housing having a membrane area on the housing feeder (F) (tester object fixing device) and proceeds the immunological response for diagnosis like the existing immunodiagnostic kit. (This figure is a side cross-sectional view of the housing from the side.)

(c) Thereafter, the membrane region 200 may protrude from the upper surface of the housing by inserting a structure (adjusting body) 300 protruding through the slit of the lower surface of the housing 100. That is, it is possible to ascend by the height A of the assembly main body into the hole through the slit of the lower surface of the housing so as to rise slightly higher than the housing. (This figure is a side cross-sectional view of the housing and the housing feeder unit viewed from the side.)

(d) After the diagnostic device (D) for quantified diagnosis, for example, by using a photodiode, a magnetic sensor, etc., the height of the diagnostic device and the detection object is minimized.

According to the housing structure of the immunodiagnostic kit and the measuring method using the same according to the present invention, any detection method (photodiode, magnetic sensor, etc.) in which the quantitative diagnostic device is linked can minimize the distance between the detection target and the diagnostic device. The diagnostic sensitivity can be increased, and the space constraint that can minimize the collision with a mechanical device driven inside the device can be provided to minimize the configuration.

In the foregoing detailed description of the present invention, specific examples have been described. However, various modifications are possible within the scope of the present invention. The technical idea of the present invention should not be limited to the embodiments of the present invention but should be determined by the equivalents of the claims and the claims.

1 is a conceptual diagram showing the form of a basic cassette used in the conventional immunochromatography analysis.

Figure 2 illustrates one embodiment of an immunodiagnostic kit according to the present invention.

3a to 3c show another embodiment of the regulatory body of the immunodiagnostic kit according to the present invention.

4 is a conceptual diagram illustrating an operation example according to the present invention.

5 is a conceptual view illustrating another embodiment according to the present invention.

Claims (10)

A housing structure of an immunodiagnostic kit comprising a detection distance adjusting unit for adjoining a detection target of the immunodiagnostic kit to a diagnostic device. The method according to claim 1, The detection distance control unit is a housing structure of the immunodiagnostic kit, characterized in that formed as a protruding control body capable of pressing the diagnostic strip of the immunodiagnostic kit up or down. The method according to claim 2, The detection distance adjusting unit, The housing structure of the immunodiagnostic kit, characterized in that formed in a position corresponding to the membrane region of the diagnostic strip and the detection region open to the housing. The method according to claim 3, The detection distance adjusting unit is formed on the lower surface of the housing, The housing structure of the immunodiagnostic kit, characterized in that it further comprises a height adjusting means capable of adjusting the vertical height. The method according to claim 4, The height adjusting means is formed in a structure capable of moving up and down through the lower surface of the control body, A housing structure of an immunodiagnostic kit, comprising: a height fixing hole formed at one side of the protruding structure and a fixing lead corresponding to the height fixing hole at a lower surface of the housing. The method according to claim 4, The fixing lead is elastically driven housing structure of the diagnostic kit, characterized in that fixed to the fixing hole. The method according to claim 3, The detection distance control unit housing structure of the immunodiagnostic kit further comprises a height correction unit that can adjust the height of the projecting structure. The method of claim 7, The height correction unit is a housing structure of the immunodiagnostic kit, characterized in that formed into a structure that can be coupled to the upper portion of the protruding structure. The method according to any one of claims 1 to 8, The membrane structure is characterized in that the membrane area is formed higher than the upper surface of the housing by the detection distance adjusting unit. In the detection method of the detection object using the immunodiagnostic kit, By using the height adjusting part protruded in the immunodiagnostic kit, The diagnostic strip is formed to be higher than the upper surface of the detection area open to the upper surface of the upper housing, A method for detecting an immunodiagnostic kit, characterized in that the measurement by minimizing the distance to the diagnostic device.

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