KR101181898B1 - Precision device for detecting bio-materials using the lateral flow immunochromatography test - Google Patents

Abstract

The present invention relates to an apparatus for precise analysis of biomaterials using parallel transfer immunochromatography.
Parallel transfer immunochromatography has been widely used in hospitals, laboratories, and industrial sites because of its simplicity. However, since the test process is performed by hand, the accuracy of the test results is low, a large amount of samples are required, and the processing speed is slow.
The present invention is a device that precisely controls the entire process of the parallel immunochromatography test by using precise signal control system for precise operation control of various test instruments and materials, micro flow control of test sample or solution, and test result. The aim is to speed up, high precision and standardize parallel immunoassay tests.

Description

Precision device for detecting bio-materials using the lateral flow immunochromatography test}

The present invention uses a parallel immunochromatography for precise quantification of sample processing, product supply, and test procedure, which have been conventionally performed by hand in the parallel immunochromatography test, which is used for diagnosis of disease or examination of other samples. It relates to a precise analysis device of a biological material.

Chromatography is used for the purpose of material analysis or pure water separation. As one kind of chromatography, the liquid sample is moved in one direction by capillary action of the porous membrane using a very thin porous membrane in the form of a dry solid rather than a liquid. Lateral Flow Porous Membrane Chromatography (LCD) is used to detect analytes contained in the stomach.

In such a parallel immunochromatography, an antibody or antigen is attached to a porous membrane in a predetermined shape, and another antibody or antigen is conjugated to a report (reporter) material such as gold, fluorescent material, or luminescent material. After capturing the analyte contained by an immunological action, the immunoconjugate bound to the analyte flows horizontally along the membrane due to capillary action and meets the antibody or antigen already attached to the membrane. The complex is formed.

In the case of the conventional parallel immunoassay test, as described in US Pat. No. 5,528,71, the examiner checks whether the analyte is present in the sample using the naked eye.

Document 1 US Patent 5622871 (May, Keith) 1997. 04. 22.

However, in the conventional test using the parallel immunochromatography principle, the inspection process is not only carried out by the investigator's manual work, but also by the visual confirmation and determination of the test result, and thus cannot be precisely quantified and highly reproducible. Has been raised.

In addition, since visual inspection by manual examination has a lot of subjective opinions of the investigator, different diagnosis decisions may be made depending on the inspector or the examination time or environment for the examination of the same subject at the medical diagnosis site. Problems have arisen and problems of insufficient quantitative judgment have not been provided to provide sufficient information for the clinical field.

Although various problems have been raised in such a conventional method using parallel mobile immunochromatography, a chromatographic reading device that can replace the naked eye of the examiner as a means for excluding only the subjective test result judgment of the examiner among these various problems. Is disclosed in Publication 10-2006-0015456.

The immunochromatographic reading apparatus disclosed in the above-mentioned Patent Publication No. 10-2006-0015456 is limited to immunochromatography using a gold colloid conjugate. In this case, the captured image is analyzed and calculated to quantitatively quantify the user. I'm suggesting how to provide.

[Patent 2] Publication 10-2006-0015456 (Kazunori Yamauchi) 2005.06.28.

However, the process of testing for the presence of analytes such as bacteria, virus, and other diseases by using parallel immunochromatography, first, collects the sample to be tested, treats it in an appropriate buffer, and pipettes it into the test specimen. If necessary, separate buffer solution is processed, and then waits for a certain time until the reaction occurs, and when the result is visually determined, the accuracy of each test step is directly related to the determination of the test result. In order to precisely determine the final test result, the amount of sample to be sampled, the amount of solution added, and the uniformity of the measured time are guaranteed. It is essential to ensure total quantitative precision Is required.

Nevertheless, the above-mentioned disclosure of the prior art Patent Publication No. 10-2006-0015456 is only to partially improve the final result measurement part which is visually determined by the inspection worker, and the whole inspection process is still made by the direct processing and judgment of the operator. As a result, there is still a fundamental problem in that the quantitative reliability required for each step of the inspection cannot be obtained, which causes the entire test result to be inaccurate.

Precise analysis of the biological material using the parallel transfer immunochromatography of the present invention to solve the problems of the prior art as described above, as described above in the prior art the presence or absence of the analyte using the chromatography In the case of inspection of each inspection step, every step of inspection is performed to provide reliable and reproducible measurement data by solving the inaccuracy of the inspection result value caused by the work error caused by manual operation by the operator. It aims to obtain precise inspection results and to significantly shorten the time required for inspection by automating and stabilizing the values obtained at each step.

Precise quantitative analysis apparatus for biological material using the parallel immunochromatography of the present invention is a straight specimen holder in which the specimen of the parallel immunochromatography is located, a specimen holder disk for rotating the specimen holder, the lower portion of the specimen holder disk A specimen supply module including a specimen holder driving motor to be mounted; A nozzle for sucking or ejecting a sample or solution, a sampling arm at which the nozzle is located at one end, a sampling arm support at the other end of the sampling arm, and a lower portion of the sampling arm support for supporting the sampling arm A sampling arm drive motor, a multiport valve, a pump connected to one port of the multiport valve, a test solution container connected to another port of the multiport valve, and a support for supporting the multiport valve and the pump. A sample processing module; A result measurement module positioned on top of the specimen and in communication with the control module, the result measuring module including an image sensor of any one of CMOS, CCD, CIS and photodiode; A control module for controlling according to a signal input from the specimen supply module, the sample processing module, and the result measuring module; and outputting data generated by the result measuring module according to the signal from the control module. Result display module; characterized in that consisting of.

The present invention having the above-mentioned problem solving means automates all the processes performed by the tester manually in the parallel immunochromatography test by means of the mechanisms, built-in algorithms and control algorithms illustrated in the drawings, and thus the occurrence of work errors according to the tester's manual work. It fundamentally blocks the room, increases the number of tests per unit time, and enables the micronization of samples, which improves the reproducibility and reliability of the parallel immunoassay test, and the test through the quantitative and precise analysis of the immune response. It is possible to achieve the effect of reducing the inspection cost, and the inspection result has the effect of obtaining a more precise result than by the manual work, the effect of reducing the inspection manpower and inspection cost is generated and inspection 5 times from startup to acquisition of test results Within accomplish is the effect of a significant reduction in the test time and exercise,

The device of the invention can be miniaturized to a size and weight that is portable, and consumes low power to operate using a small battery, so that the medical infrastructure can be used in field treatments in remote and remote areas where the medical infrastructure is poor. The effect is exerted.

Figure 1 is a block diagram of a precise analysis device of a biological material using a parallel transfer immunochromatography of the present invention
Figure 2 is a view showing a specific embodiment of a precise analysis device of a biological material using a parallel transfer immunochromatography of the present invention
Figure 3 is a view showing a specimen used in the precise analysis device of a biological material using a parallel immunoassay of the present invention
Figure 4 is a rotary type specific embodiment of a precise analysis device of a biological material using a parallel transfer immunochromatography of the present invention
Figure 5 is a specific embodiment of the linear type of the precise analysis device of a biological material using a parallel immunoassay of the present invention
Figure 6 is another specific embodiment of the multi-port valve of the precise analysis device of the biological material using the parallel transfer immunochromatography of the present invention
Figure 7 is a specific embodiment of the linear type sampling module of the precise analysis device of the biological material using the parallel immunochromatography of the present invention.

Hereinafter, with reference to the accompanying drawings will be described in detail the configuration of a precise analysis device of a biological material using a parallel transfer immunochromatography of the present invention.

First, the precise analysis device of a biological material using the parallel immunochromatography of the present invention is a specimen supply module (1) for supplying a parallel immunochromatography specimen (see Figure 2) as shown in Figure 1; A sample processing module (2) for collecting a sample and supplying a test solution for a test; A result measurement module (3) for measuring the test results by the specimen and the specimen with an optical sensor or an image sensor; And a control module (4) for controlling according to the signals input from the specimen supply module (1), the specimen processing module (2), and the result measurement module (3). And a result display module 5 for outputting data generated by the result measuring module 3 according to the signal from the control module 4.

The configuration of each module constituting the precise analysis device of the biological material using the parallel transfer immunochromatography of the present invention as described above will be described in more detail with reference to the drawings below.

As shown in FIG. 2, the specimen supply module 1 includes a specimen holder 210 in which a specimen 202 is located, a specimen holder disk 213 for rotating the specimen holder 210, and the specimen holder disk ( It consists of a drive motor 214 mounted to the bottom of 213.

In addition, the sample processing module 2 includes a nozzle 203 for sucking or ejecting a sample or solution as shown in FIG. 2, a sampling arm 204 at which the nozzle 203 is located below one end, and the sampling. A sampling arm support 211 positioned at the other end of the arm 204 and supporting the sampling arm 204, a drive motor 212 positioned below the sampling arm support, a multiport valve 205, and A pump 206 connected to one port of the multiport valve 205, a test solution container 207 connected to the other port of the multiport valve, and the multiport valve 205 and the pump 206 are supported. It is composed of a support 216.

In addition, the result measuring module 3 is composed of an image sensor 208 located on the upper portion of the specimen 202 and in communication with the control module (4).

In addition, the result display module 5 is composed of a liquid crystal display for displaying the result value in accordance with the signal transmitted from the control module (4).

Referring to the operation of the precise analysis device of the biological material using the parallel transfer immunochromatography of the present invention as described above are as follows.

The test specimen used in the present invention uses the principle of parallel immunochromatography, and may be used in various forms such as a strip form as shown in FIG. 3A or a form in which an external plastic cover protects the chromatography strip as shown in FIG. Parallel transfer immunochromatography is a method that utilizes the force that moves through capillary action when the liquid comes into contact with a drier porous solid and the mutual coupling property by various forces between the analyte and the detection material. It has the advantage of being able to be analyzed.

Figure 2 shows a specific embodiment of a precise analysis device of a biological material using a parallel transfer immunochromatography of the present invention.

Samples to be tested are contained in a container such as 201 of FIG. 2 and sucked through the sampling nozzle 203. In this case, when the test target sample is human blood, blood may be directly collected from the fingertip of the target subject. When the sampling nozzle 203 is used, the shape of the container or the sampling method is not limited. The sampling nozzle 203, which has finished the suction of the sample, rotates at a predetermined angle and discharges the sample sucked into the sample inlet 321 of the parallel immunochromatographic specimen 202 mounted on the specimen holder 210. At this time, the suction and discharge are made by the action of the multi-port valve 205 and the pump 206 connected to the sampling nozzle 203. If necessary, another solution can be added to the product in a separate suction discharge operation.

Sampling nozzle 203 finished the sample and the solution required for the test can be used to wash through the waste water treatment funnel 215 as necessary to prevent cross-contamination or infection, or to replace when using a disposable nozzle. The operation of the sampling nozzle 203 is not necessarily limited to the rotational movement, and as shown in FIG. 7, which shows a specific embodiment of the linear type sampling module of the precise analysis device of the biological material using the parallel moving immunochromatography of the present invention. The linear guide 725 and the actuator 726 may be used as a combination of linear motions.

When the sampling nozzle 203 is operated or the product is supplied by a combination of rotational movements, the movement may be generated by directly connecting the specimen holder driving motor 214 to the module or through a motor connected to the module through a belt. have. After the specimen and the required solution is added to the specimen 202, the test result is measured by the image sensor 208 after a predetermined time.

The measured test results are converted into final results through the control module 4 of FIG. 1 and then provided to the tester. Samples should be aspirated for the test purpose. At this time, the amount of sample to be collected should be precise, and for this purpose, a pump system capable of precisely transferring the fluid, such as a syringe-type pump, a peristaltic pump, or a diaphragm pump, may be used.

On the other hand, Figure 4 is a view showing a rotary type specific embodiment of a precise analysis device of a biological material using a parallel transfer immunochromatography of the present invention circular supply device 409 in which the specimen and the specimen 202 is a rotary motion The specific examples provided in the test are shown.

In this case, a large number of specimens and products can be sequentially put into the inspection at an optimized timing, thereby enabling high-speed processing of the test.

On the other hand, Figure 5 is a diagram showing a specific embodiment of the linear type of the precise analysis device of the biological material using the parallel immuno-chromatography of the present invention mounted on a supply device 509 in which a large number of samples and products are linear movement It is an embodiment that enables high-speed processing of the test by being provided to the test.

As such, the sampling nozzle 203 and the supply of specimens and specimens 202 enable efficient and accurate automated immunochromatography testing by the proper combination of rotary and linear motion.

On the other hand, Figure 6 is a multi-port valve of a precise analysis device of a biological material using a parallel immuno-chromatography of the present invention showing another specific embodiment as a multi-port for controlling the transport direction of various liquids used in the sample or test The valve 205 is illustrated.

Control of fluid flow may be achieved by a rotary type valve, such as the multiport valve 205 of FIG. 2, which may be opened and closed at one time, or a combination of unit valves in which one valve may control one fluid movement. The unit valves 622 may be attached to the circular manifold 623 or the straight manifold 623-1 to constitute a valve module. In addition, additional valves and pumps can be used to speed up the overall throughput when multiple solutions are used or when a large amount of sample needs to be tested.

The motor used in the present invention may be mainly used as a stepper, servo, brushless DC motor for precise operation, but is not necessarily limited to the kind. Encoder is attached to the motor as needed to ensure more precise position control. At each particular position or point, the movement of the mechanism is controlled by using sensors such as limit switches or photocouplers.

When the sample and other necessary solution is added, the specimen 202 is positioned to be in a predetermined position, and after waiting for mutual reaction between the sample and the reactant for a predetermined time for each test purpose, the result measurement module (3 Measure the test results.

The measurement of the test result is performed by the image sensor 208 of FIG. 2, and various measuring means may be used according to the characteristics of the reporter (reporter) material used in the parallel immunochromatography specimen 202. If the report material is a material that can be visually observed in the visible region, such as gold colloids and synthetic resin particles, test results are measured using image sensors such as CMOS, CCD, CIS, and photodiodes.

On the other hand, when measuring a trace amount of analyte, such as molecular bonds of millions or less, the analyte is quantitatively analyzed using a device such as an optical sensor or an optical amplifier. In the case of measuring test results using a magnetic material, the test results can be quantified using a magnetic sensor.

As such, measurement and analysis of test results may be performed using image analysis, photon analysis, and magnetometry, but are not limited to these methods.

The result measurement module 3 may transmit the measured test results to the control module 4 in the form of primitive data in analog or digital manner, and in some cases, perform the calculation for the quantitative analysis in the result measurement module 3 itself. The calculated result may be transmitted to the control module 4.

Each module can be controlled by a program embedded in the control module 4 or by a remote computer. The control module 4 is composed of a microcontroller and an integrated circuit capable of high-speed data processing, and finely controls the movement of various sensors and motors, and transmits and receives test result data.

1: specimen supply module 2: sample processing module
3: result measurement module 4: control module
5: Result Display Module 202: Specimen
203: nozzle 204: sampling arm
205: multi-port valve 206: pump
207: test solution container 208: image sensor
210: specimen holder 211: sampling arm support
212: sampling arm drive motor 213: specimen holder disc
214: drive motor 215: funnel for wastewater treatment
216: support 321: sample inlet
409: circular feeder 509: feeder
622: unit valve 623: circular manifold
623-1: Straight Manifold 725: Straight Guide
726: Actuator

Claims (1)

A specimen supply module including a straight specimen holder in which a specimen of parallel moving immunochromatography is located, a specimen holder disk for rotating the specimen holder, and a specimen holder driving motor mounted to the lower portion of the specimen holder disk;
A nozzle for sucking or ejecting a sample or solution, a sampling arm at which the nozzle is located at one end, a sampling arm support at the other end of the sampling arm, and a lower portion of the sampling arm support for supporting the sampling arm A sampling arm drive motor, a multiport valve, a pump connected to one port of the multiport valve, a test solution container connected to another port of the multiport valve, and a support for supporting the multiport valve and the pump. A sample processing module;
A result measurement module positioned on top of the specimen and in communication with the control module, the result measuring module including an image sensor of any one of CMOS, CCD, CIS, and photodiode;
A control module for controlling according to a signal input from the specimen supply module, the specimen processing module, and the result measurement module; and
A result display module for outputting data generated by the result measurement module according to a signal from the control module; Precision analysis device of a biological material using a parallel immunochromatography, characterized in that consisting of.

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