KR200394358Y1 - Immunoassay device capable of performing several immunoassays - Google Patents

Abstract

In an immunoassay for diagnosing a disease or the like using an immunochromatography method, an immunoassay apparatus capable of simultaneously performing a plurality of immunoassays is disclosed. The immunoassay device is a liquid sample is injected, one or more sample pads disposed so that one end is adjacent to each other; Two or more immunoassay pads, each connected to another non-contiguous end of the sample pad to perform an immunoassay; A lower case for supporting a lower portion of the sample pad and an immunoassay pad; And a sample inlet is formed to correspond to an area where the two or more sample pads are adjacent to each other, and includes an upper case covering an upper portion of the sample pad and an immunoassay pad.

Description

Immunoassay device capable of performing several immunoassays

The present invention relates to an immunoassay device, and more particularly, to an immunoassay device capable of simultaneously performing a plurality of immunoassays in an immunoassay for diagnosing a disease using an immunochromatography method.

Immunochromatography is a method for qualitative and quantitative testing of trace analytes in a short time using antigen-antibody reactions, including the testing of various diseases, medicine, agriculture, animal husbandry, food, and military It is widely used in various fields such as environment and environment. For such immunochromatographic analysis, an assay strip or an assay device in which the assay strip is mounted inside a plastic case is generally used. 1 and 2 are exploded perspective and longitudinal cross-sectional views of a conventional immunoassay device used for immunochromatographic analysis, respectively. As shown in Figures 1 and 2, the conventional immunoassay device is the upper case 20 and the lower case 30 to be engaged with each other and the analysis strip mounted between the upper and lower cases (20, 30) ( 10). The assay strip 10 includes a sample pad 12, a conjugate pad 14, a porous membrane pad 16, and a moisture absorbing pad 18, in which connection portions overlap each other, which are formed by a plastic support 19. Supported. In the upper case 20, a sample inlet 22 is formed at a position corresponding to the sample pad 12, and a result confirmation window is positioned at a position corresponding to the binder 16a fixed to the porous membrane pad 16. 24 may be formed, and a vent hole 26 may be formed at a position corresponding to the moisture absorption pad 18. In addition, a plurality of guides 32, protrusions, etc. may be formed in the upper or lower cases 20 and 30 to appropriately arrange and fix or compress the analysis strip 10. The cases 20 and 30 may be coupled by conventional means such as coupling grooves, coupling protrusions, or in some cases, may be integrally formed.

Referring to the operation of the immunoassay device as follows. When a liquid sample, such as blood or diluted saliva, is injected into the sample pad 12 through the sample inlet 22 of the upper case 20, the liquid sample is a conjugate pad 14 and a porous membrane pad by capillary action. It moves through 16 and is finally received in the moisture absorption pad 18. The conjugate pad 14 contains a conjugate in which a label that generates a signal that can be detected using the naked eye or a sensor is conjugated to a ligand such as an antigen or an antibody, and the conjugate is dissolved in the liquid sample. , Move with the liquid sample. The analyte in the sample and / or a binder (16a, antibody or antigen) that binds specifically to the conjugate is immobilized on the porous membrane pad 16, so that if analyte is present in the sample, The bound analyte binds to the binder 16a (commonly referred to as a "sandwich" reaction), or the analyte and binder competitively binds to the binder 16a (commonly referred to as a "competition" reaction). . Therefore, by checking the amount of the binder bound to the binder 16a through the result confirmation window 24, it is possible to check the presence of an analyte in the sample. The ventilation hole 26 formed on the upper side of the moisture absorbing pad 18 facilitates the ventilation of the moisture absorbing pad 18 to prevent the liquid sample and the conjugate from flowing back toward the result confirming window 24, thereby reducing the To facilitate reading.

However, such a conventional immunoassay device can perform only one immunoassay using one liquid sample. Therefore, if multiple analyzes or tests are required for one sample, the liquid sample is divided into as many as necessary. However, there is a disadvantage in that liquid samples must be separately analyzed using a plurality of immunoassays. For example, when a hepatitis test is performed with a specific blood, both the hepatitis antigen and the hepatitis antibodies should be analyzed. In this case, the blood samples are usually divided into two parts, and each blood is analyzed using an immunoassay device for detecting hepatitis antibodies and an immunoassay device for detecting hepatitis antigens. Not only is it cumbersome, it also has the disadvantage of being costly and time consuming for immunoassays.

Accordingly, it is an object of the present invention to provide an immunoassay device that can reduce the cost and time required for an immunoassay. Another object of the present invention is to provide an immunoassay device capable of simultaneously performing a plurality of immunoassays.

In order to achieve the above object, the present invention is a liquid sample is injected, one or more sample pads disposed so that one end is adjacent to each other; Two or more immunoassay pads, each connected to another non-contiguous end of the sample pad to perform an immunoassay; A lower case for supporting a lower portion of the sample pad and an immunoassay pad; And a sample inlet is formed so as to correspond to a region in which the two or more sample pads are adjacent to each other, and an upper case covering an upper portion of the sample pad and the immunoassay pad.

Hereinafter, with reference to the accompanying drawings will be described the present invention in more detail.

Figure 3 is a longitudinal cross-sectional view of the immunoassay device according to an embodiment of the present invention. As shown in FIG. 3, an immunoassay device according to an embodiment of the present invention includes two or more sample pads 52 and 62; Two or more immunoassay pads 54, 64; Lower case 70; And an upper case 80. As the two or more sample pads 52 and 62, a conventional sample pad into which a liquid sample is injected can be used without limitation, and in the present invention, the two or more sample pads 52 and 62 are disposed such that one end thereof is adjacent to each other. . The two or more immunoassay pads 54 and 64 are connected to the other non-contiguous ends of the sample pads 52 and 62, respectively, to perform an immunoassay, and may include conventional pads for performing an immunoassay. Include. For example, the immunoassay pads 54 and 64 may include a conjugate pad 14 containing a conjugate in which a label for generating a signal that can be detected using the naked eye or a sensor is conjugated to a ligand such as an antigen or an antibody. It may be composed of a porous membrane pad 16 to which an analyte in a sample and / or a binder 16a specifically binding to the conjugate is fixed, and a moisture absorbing pad 18 to finally receive a liquid sample. Since the two or more immunoassay pads 54 and 64 may be used in different kinds of immunoassays, the conjugates used in the immunoassay pads 54 and 64, according to the type of test or analysis desired, The kind of binder etc. can be selected suitably. In addition, the immunoassay pads 54 and 64 may not include the conjugate pad 14, the moisture absorption pad 18, or the like, or other auxiliary pads including a separate reagent for immunoassay, depending on the type of the immunoassay. Various modifications applied to the conventional immunoassay device are possible, including further. 3, the sample pads 52 and 62 and the immunoassay pads 54 and 64 are preferably supported by plastic supports 56 and 66, respectively. 52 and 62 and the lower portion of the immunoassay pads 54 and 64 may be fully or partially supported by the lower case 70.

4 is a plan view of an immunoassay device according to an embodiment of the present invention. As shown in FIGS. 3 and 4, the upper portions of the sample pads 52 and 62 and the immunoassay pads 54 and 64 are entirely or partially covered by the upper case 80. In the upper case 80, a sample inlet 82 is formed to correspond to an area where one end of the two or more sample pads 52 and 62 is adjacent to each other, and the porosity of the immunoassay pads 54 and 64 is increased. Result confirmation windows 84 are respectively formed at positions corresponding to the respective binders 16a fixed to the membrane pads 16, and vent holes 86 are formed at positions corresponding to the moisture absorption pads 18, respectively. There may be. Ventilation port 86 formed on the upper portion of the moisture absorbing pad 18 is to facilitate the ventilation of the moisture absorbing pad 18, to prevent the backflow of the liquid sample and the conjugate toward the result confirmation window 84, In the upper or lower cases 80 and 70, a plurality of guides, protrusions, etc. may be formed to properly arrange and fix or compress the sample pads 52 and 62 and the immunoassay pads 54 and 64. The upper or lower cases 80 and 70 may be coupled by conventional means such as coupling grooves or coupling protrusions, or may be integrally formed in some cases.

3 and 4, the operation of the immunoassay device according to the present invention will be described. When the liquid sample is injected through the sample inlet 82 formed in the upper case 80, the liquid sample is dropped into an area where the sample pads 52 and 62 are adjacent to each other, so that each of the sample pads 52 and 62 is used. Immunohistochemistry is performed by dividing into two parts and moving to the respective immunoassay pads 54 and 64 by capillary action. In this case, each of the immunoassay pads 54 and 64 is configured to perform different kinds of immunoassays, for example, to perform hepatitis antigen analysis and hepatitis antibody analysis, respectively, and thus formed in the upper case 80. By confirming the test result through each result check window 84, different types of immunoassays can be performed at the same time. In the present invention, adjacent portions of the two or more sample pads 52 and 62 are adjacent to each other so that the sample can be injected into both of the two or more sample pads 52 and 62 by one sample input.

FIG. 5 is a longitudinal cross-sectional view of an immunoassay device according to another embodiment of the present invention, wherein the immunoassay device shown in FIG. 5 is injected such that a liquid sample is separately injected into respective sample pads 52 and 62. The sample impermeable pad separating plate 90 separating the adjacent ends of the above-described sample pads 52 and 62 has the same configuration as that of the immunoassay device shown in FIG. 3. Thus, when the liquid samples are separated and injected into the respective sample pads 52 and 62, the samples used for the respective immunoassays can be prevented from being mixed with each other. The pad separating plate 90 may protrude from the lower case 70, and may be inserted and fixed between the two or more sample pads 52 and 62. 6 is a plan view (A) and a partial cross-sectional view (B) of the sample inlet 82 formed in the immunoassay device according to another embodiment of the present invention, the immunoassay device shown in FIG. 3, except that a plate-shaped inlet separating plate 92 for separating the sample inlet 82 is further formed in the sample inlet 82 so as to be separately injected into the sample pads 52 and 62. It has the same configuration as the immunoassay device. The inlet separating plate 92 extends a predetermined distance in the direction of the lower case 70, and is inserted between the two or more sample pads 52 and 62. In the immunoassay device according to the present invention, the sample pads 52 and 62 and the immunoassay pads 54 and 64 are not only two, but the liquid sample is divided into a plurality of sample pads by one sample input. As long as it can be injected, the number of sample pads and immunoassay pads can be increased to allow multiple immunoassays to be performed simultaneously. For example, as shown in FIG. 3, when the sample pad and the immunoassay pad are two, the sample pad and the immunoassay pad may be disposed at an angle of 180 degrees so that one end of the sample pad is adjacent to each other. In the case of individuals, they may be placed at an angle of 120 degrees such that one end of the three sample pads are adjacent to each other, and in the case of four sample pads and an immunoassay pad, they may be placed 90 degrees such that one end of the four sample pads is adjacent to each other Can be placed at an angle.

As described above, the immunoassay device according to the present invention has the advantage of reducing the cost and time required for immunoassay by simultaneously performing a plurality of immunoassays.

1 is an exploded perspective view of a conventional immunoassay device.

2 is a longitudinal cross-sectional view of a conventional immunoassay device.

Figure 3 is a longitudinal cross-sectional view of the immunoassay device according to an embodiment of the present invention.

4 is a plan view of the immunoassay device shown in FIG.

Figure 5 is a longitudinal cross-sectional view of the immunoassay device according to another embodiment of the present invention.

Figure 6 is a plan view (A) and a partial cross-sectional view (B) of the sample inlet formed in the immunoassay device according to another embodiment of the present invention.

Claims (5)

Two or more sample pads in which liquid samples are injected and one end is disposed to be adjacent to each other; Two or more immunoassay pads, each connected to another non-contiguous end of the sample pad to perform an immunoassay; A lower case for supporting a lower portion of the sample pad and an immunoassay pad; And A sample inlet is formed to correspond to a region where the two or more sample pads are adjacent to each other, and an immunoassay device including an upper case covering an upper portion of the sample pad and an immunoassay pad. The immunoassay device of claim 1, wherein the two or more immunoassay pads are configured to perform different kinds of immunoassays. According to claim 1, wherein the pad separation plate for separating the adjacent ends of the two or more sample pads is further formed, the two or more sample pads can be injected into both of the two or more sample pads in one sample input To be adjacent to the immunoassay device. The immunoassay device according to claim 3, wherein the pad separating plate protrudes from the lower case. The immunoassay device according to claim 1, wherein a plate-type inlet separator is further formed in the sample inlet so that a liquid sample is separately injected into each sample pad.