KR20110019843A - Diagnostic system of using diagnostic kit - Google Patents

Abstract

PURPOSE: A detection system of immunoassay kit is provided to control reaction of immunoconjugates and to maximize formation rate. CONSTITUTION: A detection system of immunoassay kit comprises: a diagnosis kit(200) having a test sample(100); a mounting part(300) for mounting the diagnosis kit; a binding induction unit(400) for controlling movement of magnetic particles of the test sample; and a detection sensor unit(500) for detecting magnetic ingredient of the test sample. The mounting part comprises: a fixation stage, and a transfer unit which is able to move to the lower part of the detection sensor unit by mounting the diagnosis kit.

Description

Detection system for immunodiagnostic kits {Diagnostic system of using Diagnostic Kit}

The present invention relates to an immunochromatography quantitative analysis system for detecting a sample containing magnetic particles.

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 examine whether there is an adequate amount of antibiotics in the blood, 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 a variety of fields, including food and bioprocessing and the 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 immune conjugates 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.

However, in the case of membrane chromatography using a conventional labeling substance and an antibody conjugate, there is a problem in that the binding efficiency of the antigen antibody is reduced by diffusion in a laminar flow state generated through minute pores of the membrane. This is due to the short response time or the inability to control it.

In particular, in order to improve the reactivity between the analyte and the antibody-conjugate of the conventional immunochromatography, after binding a specific protein to the conjugate of the label and the antibody and immobilized it on the membrane of the diagnostic kit, the analyte (antigen) and The reaction forms a primary immune conjugate. This is done to ensure a sufficient reaction time for forming the primary immune conjugate, which is intended to further secure the reaction time by restricting mobility because the primary immune conjugate is formed in a fixed state.

Then, the primary immune conjugate was desorbed using a strong acid or a strong base, and the deactivated primary immunoconjugate was combined with a secondary antibody to implement a method of increasing the efficiency of the reaction. However, in order to increase the reaction efficiency with the analyte (antigen), the formation of the primary immune conjugate and the strong acid and strong base used in the desorption process have a negative effect on the secondary immune response. This difficult problem arises.

The present invention has been made to solve the above-described problems, an object of the present invention is to control the mobility of the magnetic particles in the measurement system of the immunodiagnostic kit for diagnosing a specimen that can fix the magnetic particles that can be fixed to the magnetic force The present invention provides an analysis system having high sensitivity analysis ability by maximizing the formation rate by adjusting the reaction time of the immunoconjugate by providing a binding induction unit for applying magnetic force.

The present invention is a configuration for solving the above problems, a diagnostic kit for receiving a sample containing magnetic particles; A diagnostic kit mounting unit for mounting the diagnostic kit; A coupling induction unit formed on the diagnostic kit mounting unit to control movement of the magnetic particles of the specimen; A detection sensor unit for detecting magnetic components of the specimen; To provide a detection system of an immunodiagnostic kit comprising a.

In particular, the diagnostic kit mounting unit described above includes a transfer unit having a structure capable of moving below the detection sensor unit by mounting a diagnostic kit on the fixed stage and the fixed stage; It may be formed to include.

In addition, the binding induction unit that can control the reaction time of the immunoconjugate may be formed of a magnetic field applying module formed of any one or a plurality of solenoid coils, Helmholtz coils, electromagnet yokes, permanent magnets. This is to increase the reaction time of the immunoconjugate by applying the magnetic field to control the mobility of the magnetic particles, it is preferable that the binding induction unit is formed under the conjugation pad of the diagnostic kit.

In addition, the detection sensor unit in the detection system of the present invention further comprises a time-control unit for controlling the application time of the magnetic force.

In addition, the detection sensor unit in the present invention, the magnetic resistance (MR) sensor for detecting the magnetic component of the sample to which the magnetic particles are coupled; A first application unit for applying a magnetic field to the magnetoresistive sensor in a horizontal direction (Y axis); A second application unit for applying a magnetic field to the magnetoresistive sensor in a vertical direction (Z axis); It can be made to include, so as to maximize the detection efficiency, such a magnetoresistive sensor can be used a giant magnetoresistive sensor (GMR).

According to the present invention, an immunodiagnostic kit measuring system for diagnosing a specimen capable of fixing magnetic particles that can be immobilized to a magnetic force is provided with a binding induction unit for applying a magnetic force that can control the mobility of the magnetic particles. By controlling the reaction time of the conjugate to maximize the formation rate is effective to provide an analysis system with high sensitivity analysis capability.

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

Referring to FIG. 1, FIG. 1 is a block diagram showing the configuration of a detection system according to the present invention.

The detection system according to the present invention includes a diagnostic kit that accepts a sample containing magnetic particles, the received sample forms an immunoconjugate on a conjugate pad, and allows analysis through the magnetic response of the magnetic particles of the immunoconjugate ( 200).

In particular, for this purpose it is provided with a diagnostic kit mounting unit 300 for mounting the diagnostic kit in the measuring device, in particular the coupling kit unit formed in the diagnostic kit mounting unit 300 to control the movement of the magnetic particles of the sample ( More preferably 400). In addition, it further comprises a detection sensor unit 500 for detecting the magnetic component of the sample.

Referring to Figure 2 will be described the specific configuration and operation of the detection system according to the present invention.

Diagnostic kit according to the invention can be applied to the kit of various structures used for the application of immunochromatography. Looking at the configuration diagram of the general diagnostic kit shown, the sample pad 210, which is a portion to drop the sample containing the analyte, and the sample dropped on the sample pad 210, the conjugation pad 220 by capillary action Will be moved to). The conjugation pad 220 is a portion in which a detection antibody capable of specifically binding to magnetic particles and analyte is fixed. In this portion, the analyte has a specific conjugate to which the detection antibody and magnetic particle are coupled. Reacts to form an immunoconjugate. Sufficient reaction time is required between the analyte and the conjugate for the formation of the immunoconjugate. If this reaction time is not secured, the analyte that has not reacted passes through the area of the moving pad 230 of the diagnostic kit due to capillary action. Since the movement to the detection pad 240 is made, precise analysis cannot be made. Therefore, in the present invention, in the conjugation pad 220 region, the reaction time of the conjugate of the conjugate in which the analyte, the detection antibody, and the magnetic particles are combined (hereinafter referred to as 'sample') is sufficiently secured or the desired reaction time is controlled. The gist of the present invention is to provide a coupling induction unit 400 to the measurement equipment.

The detection system according to the present invention includes a diagnostic kit mounting unit 300 inside the measuring equipment P so that the diagnostic kit 200 can be mounted, and the diagnostic kit mounting unit 300 includes the above-described coupling induction unit ( Preferably 400).

The diagnostic kit mounting unit 300 is a structure that can be moved to the lower side of the detection sensor unit 500 by mounting a diagnostic stage 200 and the diagnostic kit 200 on the fixed stage to mount the diagnostic kit as shown, It may be formed of the transfer unit 320. (Of course, it is also possible to form a fixed stage and the conveying unit integrally.) The conveying unit is preferably to be moved to the lower portion of the detection sensor unit 500 in a sliding manner. In this structure, the coupling guide unit is preferably formed on the fixed stage. In addition, the coupling induction unit 400 is more preferably to be formed in the lower portion of the above-described conjugation pad 220 when the diagnostic kit is mounted for analysis. This is to control the time to bind the analyte, the detection antibody and the magnetic particles. That is, the binding induction unit 400 is to apply the magnetic force to the magnetic particles to control the mobility of the analyte coupled to the magnetic particles.

Therefore, the coupling induction unit 400 may utilize various magnetic field applying modules capable of applying magnetic force. For example, the coupling induction unit 400 may be formed of any one or more selected from solenoid coils, Helmholtz coils, electromagnet yokes, and permanent magnets. Magnetic field applied module can be formed.

The control of the reaction time of the coupling induction unit 400, if the permanent magnet is used, after setting the desired reaction time, the diagnostic kit through the transfer unit 320 of the above-described diagnostic kit mounting unit 300 detection sensor unit ( If you move to the bottom of 500, it will automatically be released from the magnetic force it is possible to adjust the reaction time.

If a unit generating magnetic force by applying an external current, such as a solenoid coil or a Helmholtz coil, may be used, the method may be used to adjust the reaction time through the transfer unit 320 as in the case of using a permanent magnet. By blocking, the reaction time can be easily adjusted.

With reference to Figures 2 and 3 will be described schematically the operating state according to the present invention.

The diagnostic kit mounting unit 300 may be formed inside the measuring device P, and the long-term diagnostic kit mounting unit may be formed in a structure capable of being pulled out of the measuring device. In addition, when the diagnostic kit 200 is mounted on the transfer unit 320 of the diagnostic kit mounting unit 300, the sample (S) containing the analyte is dropped on the sample pad 210, and then the analyte is capillary phenomenon. By the magnetic particles, the immune antibody and the conjugation pad 220 is combined to react with the specimen (immunoconjugate) is formed. This coupling reaction time is to control the reaction time by limiting the mobility of the magnetic particles through the coupling induction unit 400 for applying a magnetic force. After sufficient reaction time, the magnetic force is removed by moving the moving part 320 toward the detection sensor unit 500 as described above, or when the coupling induction unit is formed to generate the magnetic force through the current, the current is cut off. Allows you to control the reaction time.

When the magnetic force by the binding induction unit 400 is removed, the sample (immunorecontainer including magnetic particles) is moved to the detection pad 240 via the moving pad 230, and formed on the detection pad 240 A secondary immunoconjugate is formed by binding to a substance such as a capture antibody that captures an existing sample (immunoconjugate) and is fixed to the detection pad. Thereafter, the detection sensor unit 500 detects a change in the magnetic force of the magnetic particles or detects the color of the magnetic particles to detect a color signal (which emits a color signal in proportion to the concentration of the analyte). Figure out. In the case of performing quantitative analysis when performing detection, it is preferable to keep the reaction time the same for accurate measurement. For this purpose, the coupling induction unit 400 of the present system further includes a time-control unit for controlling the application time of magnetic force. It can be configured to include. The time-control unit may adjust the magnetic force application time by controlling the time for removing the magnetic force of the coupling induction unit from the diagnostic kit or the time for removing the supply of current by moving the transfer unit.

In addition, as described above, the detection sensor unit 500 according to the present invention may use a sensor that detects a color signal of the magnetic particles using the magnetic particles as the labeling material, and furthermore, the magnetic resistance (MR) sensor Sensors can also be used.

In particular, the method using the magnetoresistive sensor is a method of sensing the magnetic force change of the magnetic particles of the sample by applying a magnetic force to the sample from the outside, further comprising an external magnetic field applying device for applying a magnetic field to the magnetoresistive sensor from the outside. Can be.

In this case, the magnetoresistance (MR) sensor for detecting the magnetic component of the sample in which the magnetic particles are coupled is a first application unit for applying a magnetic field in the horizontal direction (Y axis) to the magnetoresistance sensor and a perpendicular direction to the magnetoresistance sensor ( Z-axis) and the second application unit for applying a magnetic field can be formed to maximize the detection sensitivity by ensuring a stronger magnetic force due to the magnetic field applied in the two axis (vertical, horizontal) direction. In particular, the magnetoresistance sensor used in this case is a normal magnetoresistance (OMR) sensor, anisotropic magnetoresistance (AMR) sensor, a giant magnetoresistance (GMR) sensor, a colossal magnetoresistance , CMR) sensor, Tunneling Magnetoresistance (TMR) sensor, MJT (Magnetic Tunneling Junction) sensor, Planar Hall Resistance (Planar Hall Resistance) sensor is preferably used any one selected from. Particularly preferably, a giant magnetoresistance (GMR) sensor may be used.

4a and 4b, this shows a comparative experiment data when and when the reaction time is secured by applying a magnetic force using the coupling induction unit according to the present invention. As shown in the data shown, it can be seen that the detection sensitivity according to the concentration of the analyte increases rapidly when the magnetic force is applied (2 minutes).

In the detailed description of the present invention as described above, specific embodiments 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 block diagram of a system for detecting an immunodiagnostic kit according to the present invention.

2 is an exploded perspective view showing a schematic configuration of a detection system of an immunodiagnostic kit according to the present invention.

3 shows an operational state diagram of a detection system according to the present invention.

4A and 4B show results showing differences in detection sensitivity in the case of applying magnetic force or not.

Claims (7)

A diagnostic kit containing a sample containing magnetic particles; A diagnostic kit mounting unit for mounting the diagnostic kit; A coupling induction unit formed on the diagnostic kit mounting unit to control movement of the magnetic particles of the specimen; A detection sensor unit for detecting magnetic components of the specimen; Detection system for immunodiagnostic kit comprising a. The method according to claim 1, The diagnostic kit mounting portion fixed stage; Wow A transfer unit having a structure in which a diagnostic kit is mounted on an upper portion of the fixed stage, and which is movable under the detection sensor unit; Detection system of immunodiagnostic kit comprising a. The method according to claim 1, The coupling induction unit, A detection system for an immunodiagnostic kit, characterized in that it is formed of a magnetic field applying module formed of any one or a plurality of solenoid coils, helmotz coils, electromagnet yokes, and permanent magnets. The method according to claim 2 or 3, The binding induction unit is a detection system of an immunodiagnostic kit, characterized in that formed in the lower conjugation pad of the diagnostic kit. The method according to claim 4, The detection sensor unit further comprises a time-control unit for controlling the application time of the magnetic force detection system of the immunodiagnostic kit. The method according to claim 4, The detection sensor unit, A magnetoresistance (MR) sensor for detecting magnetic components of a sample to which magnetic particles are bound; A first application unit for applying a magnetic field to the magnetoresistive sensor in a horizontal direction (Y axis); A second application unit for applying a magnetic field to the magnetoresistive sensor in a vertical direction (Z axis); Immune diagnostic kit detection system comprising a. The method according to claim 6, The magnetoresistive sensor is a detection system for an immunodiagnostic kit, characterized in that the giant magnetoresistance sensor (GMR).

Images