KR20120043788A - Diagnosis apparatus and method used in-vitrodiagnostics - Google Patents

Abstract

PURPOSE: An optical external body diagnosis device and a diagnosis method using the same are provided to enhance measurement sensitivity by using color information of a color image and enhance measuring efficiency. CONSTITUTION: A high efficiency optical external body diagnosis device comprises an image input part(100) which inputs a color image of a detection object. The image input part is formed into an image pickup module inputting the color image of the detection object. The high efficiency optical external body diagnosis device comprises an image control part(200) which analyzes pixel intensity of the color image inputted in the image input part and forms target concentration of the detection object. The high efficiency optical external body diagnosis device comprises a display part(300) which displays a result value of the transformed target concentration.

Description

Optical in vitro diagnostic device and diagnostic method using same {Diagnosis apparatus and method used in-vitrodiagnostics}

The present invention relates to an optical in vitro diagnostic device capable of improving the measurement efficiency.

In general, an in vitro diagnostic device is a medical device that diagnoses through analysis of assays in an environment created for a specific purpose in vitro. Usually, blood sugars, liver enzymes, calcium, salts, potassium, and drugs are measured.

Figure 1 shows the structure of the strip used in immunochromatography commonly used in in vitro diagnostic apparatus. As shown in FIG. 1, a typical immunochromatography strip 10 used for immunochromatographic analysis is an elongated rectangular support 11 made of an adhesive plastic material, and from one side to the other on the support. It includes a sample pad 21, a conjugate pad 22, a signal detection pad 23, and an absorption pad 24, which are disposed substantially sequentially. The sample pad 21 absorbs a liquid sample (or analyte) to be analyzed and ensures a uniform flow of the liquid sample. The conjugate pad 22, which is disposed to partially overlap with the other end of the sample pad, includes a flowable conjugate that specifically binds to the analyte contained in the liquid sample, and thus through the sample pad 21. As the introduced liquid sample passes through the conjugate pad 22, specific binding between the analyte and the flowable conjugate occurs. The signal detection pad 23 disposed at a position next to the sample pad 21 and the conjugate pad 22 is usually a detection zone 23a and a control zone which are spaced apart from each other by a certain distance. zone) 23b. In this case, the detection area 23a is an area for checking whether an analyte is present in the liquid sample, and the control area 23b is an area for checking whether the liquid sample has normally passed through the detection area 23a. . The absorption pad 24 is disposed at a position next to the signal detection pad 23, that is, at a position adjacent to the other end of the support 11. The absorbent pad 24 absorbs the liquid sample that has passed through the signal detection pad 23 and assists in capillary flow of the liquid sample onto the immunochromatography strip 10.

In particular, the measurement factor bound to the labeling particle in the detection region (23a) is bound to the antibody, in the case of a colormetric in vitro diagnostic device, the concentration of the target to be measured by the labeling particle (for example, Au particles) It is proportional to the color density of the detection area. The detection of color concentration in the detection area uses image sensors such as CCD and CMOS, and in particular, in the case of the optical in vitro diagnostic device using the same, most of the monochrome devices are used.

To date, it is difficult to apply a color image sensor to a diagnostic apparatus that performs quantitative analysis, which intentionally captures information about wavelengths coming from a subject in order to simulate the eyes of a person who is more sensitive to green than other color components. Because it functions to distort. In fact, Bayer filters used in most color CCD and CMOS have a 1: 2: 1 ratio of pixel numbers to R, G, and B.

However, in the case of a diagnostic device using a monochrome CCD or CMOS, color information cannot be obtained, and thus it is impossible to satisfy the sensitivity of the measurement that can be realized through color discrimination. Furthermore, performance improvement such as expansion of a linear section can be realized. Unavoidable problems arise.

Furthermore. In the case of using a black and white image sensor in a small in vitro diagnostic medical device, in order to extract only a signal of a specific wavelength band and improve its performance, a physical optical filter is inevitably used, resulting in cost and manufacturing inefficiencies. .

The present invention has been made to solve the above-described problems, an object of the present invention is to analyze the color image of the target to be detected for each pixel, and to measure by selecting a color channel that implements a high density of pixels, By using the color information of the image to obtain an image of a specific wavelength band that can increase the measurement sensitivity, to provide an in vitro diagnostic apparatus and method that can increase the efficiency of the measurement.

As a means for solving the above problems, the present invention provides an image input unit for inputting a color image of a target to be detected; An image controller which analyzes pixel intensity of an image input from the image input unit and forms a target concentration of a detection target; It is possible to provide a high-efficiency optical in vitro diagnostic apparatus comprising a display unit for displaying the result of the converted target concentration.

In particular, the image control unit in the above-described device, the image separation unit for separating the input color image into R (red), G (Green), B (Blue) channel; And an image processor converting an average intensity of one of the separated channels into a target concentration of a detection target.

In addition, the image input unit may be configured as an imaging module using an image sensor composed of a color CCD or a color CMOS.

In addition, the image processing unit in the above-described device, the color pixel analysis unit for analyzing the distribution of the number of pixels for each (intensity) of the separated channel; And a concentration converter configured to convert an average intensity of at least one or more channels into a target concentration of a target to be detected based on the distribution of pixels analyzed by the color pixel analyzer.

In addition, the in vitro diagnostic apparatus according to the invention, the receiving module for receiving a target fixing unit for receiving the target to be detected; An illumination module disposed on the accommodation module to irradiate a predetermined amount of light; The lens module may be disposed on the lighting module and adjust the magnification of the image to transmit the image to the image input unit.

By using the in vitro diagnostic apparatus according to the present invention described above it is possible to measure the detection object in the following method.

Specifically, step 1 of applying light to a detection area in which a target to be detected exists, and inputs a color image of the detection area; Separating the color image into R (red), G (Green), and B (Blue) channels; Three steps of converting the average intensity (intensity) of any one of the separated channels to the target concentration of the detection target; can be implemented by a process comprising a.

In addition, the step 1 may be implemented by inputting a color image through the image pickup module using an image sensor configured of a color CCD or a color CMOS.

In addition, in the third step, by analyzing the distribution of the number of pixels by the intensity (intensity) of the separated channel, the target density using the inverse relationship with the detection object to the average intensity (intensity) of the channel with the highest distribution of pixels Or converting the average intensity to a target concentration of the detection target by combining one or more channels.

According to the present invention, a color image of a target to be detected is analyzed for each pixel and a measurement is performed by selecting a color channel that implements a pixel having a high density, thereby measuring a sensitivity using color information of a color image. Since the image of the wavelength band can be obtained, there is an effect that can increase the efficiency of the measurement.

In addition, the conventional black and white detection equipment can remove the configuration of the optical filter to obtain an image of a specific wavelength band has the effect of simplifying the structure and high sensitivity of the detection performance.

Figure 1 shows the structure of the strip used in immunochromatography commonly used in in vitro diagnostic apparatus.
Figure 2 is a schematic diagram showing the configuration of a high-efficiency optical in vitro diagnostic device (hereinafter referred to as "the device") according to the present invention.
3A and 3B illustrate an embodiment in which the apparatus described above is actually implemented.
FIG. 4 is a flowchart of image analysis showing an exaggeration of converting a color image obtained in the above-described step into a final target concentration.
Figure 5 shows the result of comparing the measurement method according to the present invention with the conventional black and white image analysis method.

Hereinafter, with reference to the accompanying drawings will be described in detail the configuration and operation according to the present invention. In the description with reference to the accompanying drawings, the same components are given the same reference numerals regardless of the reference numerals, and duplicate description thereof will be omitted. The terms first, second, etc. may be used to describe various components, but the components should not be limited by the terms. The terms are used only for the purpose of distinguishing one component from another.

In the present invention, by separating the R, G, B image from the color image of the assay obtained from the color imager, and using only a specific channel having the highest sensitivity for the diagnostic measurement, a diagnostic that realizes significant sensitivity and performance improvement compared to the use of the monochrome device It is a summary of the provision of measurement equipment.

Figure 2 is a schematic diagram showing the configuration of a high-efficiency optical in vitro diagnostic device (hereinafter referred to as "the device") according to the present invention.

Referring to the drawings, the apparatus according to the present invention analyzes the pixel intensity (intensity) of the image input unit 100 for inputting the color image of the target to be detected, the image input from the image input unit target concentration of the detection target The image controller 200 may be configured to include a display unit 300 that displays a result value of the converted target concentration.

In particular, the image input unit 100 is preferably implemented as an imaging module that can input a color image of the target to be detected, and in particular, a preferred example according to the present invention uses an image sensor composed of a color CCD or color CMOS It may be configured as an imaging module.

The image control unit 200 analyzes the image input from the image input unit 100 to analyze the intensity of the pixel to select a specific channel that can implement the highest sensitivity to determine the average intensity of the channel. To convert the concentration to the concentration of the target to be measured. Specifically, the image controller 200 may divide the input color image into an R (red), G (Green), and B (Blue) channel, and an image separation unit 210 and any one channel of the separated channel. It may be configured to include an image processor 220 for converting the average intensity (intensity) of the target concentration of the detection target, in particular, the image processor 220 is a distribution of the number of pixels by the intensity (intensity) of the separated channel Including a color pixel analysis unit 221 for analyzing the concentration conversion unit 222 for converting the average intensity (intensity) of the channel having the highest distribution of the pixel analyzed by the color pixel analysis unit to the target concentration of the detection target; Can be configured.

3A and 3B illustrate an embodiment in which the apparatus described above is actually implemented.

Referring to Figure 3a, the device may be provided with a receiving module 400 for receiving a target fixing unit for receiving a target to be detected. The target fixing unit refers to an assay for repairing a structure in which a detection target is fixed to a predetermined support. Examples of the diagnostic kit include an immunochromatography strip or a diagnostic kit including the same.

In addition, the device is disposed on the receiving module 400, the illumination module 500 for irradiating a constant amount of light, and is disposed on the upper portion of the lighting module to adjust the magnification of the image to be transmitted to the image input unit 100. A lens module 600 may be further provided.

In addition, the upper part of the lens module 600 may be provided with an image input unit 100 consisting of the above-described imaging module, the color image photographed by the imaging module is an image separation unit and an image implemented in software therein Image processing is performed in the image control unit configured as a processing unit so that analysis can be performed. The analyzed result may be displayed on the display unit 300, and the display unit 300 may be implemented to control the operation of the entire equipment through the GUI. In addition, the outside of the device may be implemented with a housing (H) as shown in Figure 3b.

The method of measuring a detection object using the above-described apparatus may be performed by the following process.

Specifically, the step of applying light to a detection area in which a target to be detected is present and inputting a color image of the detection area through an imaging module using an image sensor composed of a color CCD or a color CMOS may be performed. Can be.

Thereafter, a step of separating the color image into R (red), G (Green), and B (Blue) channels may be performed, and the average intensity of any one of the separated channels may be determined as a target to be detected. Conversion to concentration may be performed. Specifically, by analyzing the distribution of the number of pixels by the intensity of the separated channel, it is possible to convert the average intensity of the channel with the highest pixel distribution to the target density using the inverse relationship with the detection object. have.

Of course, it is also possible to mix a plurality of channels by mixing one or more channels instead of one channel to convert them to a target concentration, if necessary. Here, one or more channels can be analyzed by equally or differently weighting each channel. For example, by using a combination of a G channel of 0.7 weights and a B channel of 0.3 weights, the pixel intensity used for analysis is 0.7 x G + 0.3 x Processed as B, it is used to analyze the detection range of wavelength band that can maximize sensitivity by combining two channels.

After that, the measurement result can be displayed based on the target concentration.

FIG. 4 is a flowchart of image analysis showing an exaggeration of converting a color image obtained in the above-described step into a final target concentration.

As shown in the image, first, the detection target is a lateral flow assay (Lateral flow assay), and the color image of the lateral flow assay (Lateral flow assay) obtained through the imaging module as shown in Figure 4 R (Red), Separate into G (Green) and B (Blue) channels (S 1).

The region of interest (ROI) shown shows a portion (test line portion) of the entire image obtained where the actual image analysis is performed. The histogram of the color channel intensity of the ROI part shows the distribution of the number of pixels (S2 to S4) by the intensity of each color, and obtains the average intensity to determine the target to be measured. Convert to concentration.

In the case of the particle color used in the present example, the measurement sensitivity according to the target concentration in the B channel was the best. Therefore, the average intensity (intensity) of the B channel was obtained and converted to the concentration of the target (target) to be used for the measurement.

However, as described above in the configuration of the apparatus, the selection of the color channel having excellent sensitivity may be differently taken depending on the color of the particle, and in some cases, may be a mixture of a plurality of color channels.

Figure 5 shows the result of comparing the measurement method according to the present invention with the conventional black and white image analysis method.

The configuration of the measurement using the conventional monochrome monochrome module (Monochrome CCD) was applied to the same device configuration by placing the conventional monochrome imaging module in the image input unit according to the present invention for accurate comparison results, performance according to the camera specifications To exclude the difference, color (with Bayer mask) and monochrome (without Bayer mask) cameras of the same CCD type were compared. In addition, the same ROI as the color analysis was used to process the black and white image. That is, the average pixel intensity in the obtained ROI is obtained through a monochrome histogram. In the figure, the x-axis represents the concentration of the indicator (particle), which can be regarded as the concentration of the target material, and the y-axis is standardized based on the intensity (I (0)) value when no particles exist. Intensity when normalized. As shown in the figure, it can be seen that the measurement sensitivity when using the color CCD according to the present invention and analyzed using the B (blue) channel of the obtained image is better than when using a monochrome CCD.

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.

100: video input unit
200: image control unit
210: image separator
220: image processing unit
221: color pixel analysis unit
222: concentration conversion unit
300: display unit
400: receiving module
500: lighting module
600: lens module

Claims (8)

An image input unit which inputs a color image of a target to be detected;
An image controller which analyzes pixel intensity of an image input from the image input unit and forms a target concentration of a detection target;
A display unit displaying a result value of the converted target concentration;
High efficiency optical in vitro diagnostic device comprising a.
The method according to claim 1,
The image control unit,
An image separator for separating the input color image into R (red), G (Green), and B (Blue) channels;
An image processor converting an average intensity of any one of the separated channels into a target concentration using an inverse relationship with a detection object;
High efficiency optical in vitro diagnostic device configured to include.

The method according to claim 1,
The image input unit,
High efficiency optical in vitro diagnostic device composed of imaging module using image sensor composed of color CCD or color CMOS.
The method according to claim 2,
Wherein the image processing unit comprises:
A color pixel analyzer for analyzing a distribution of the number of pixels for each intensity of the separated channel;
A density converter converting an average intensity of at least one or more channels into a target concentration of a target to be detected based on the target concentration distribution of the pixels analyzed by the color pixel analyzer;
High efficiency optical in vitro diagnostic device configured to include.
The method according to claim 2,
The in vitro diagnostic device,
Receiving module for receiving a target fixing unit for receiving the target to be detected;
An illumination module disposed on the accommodation module to irradiate a predetermined amount of light;
A lens module disposed on the lighting module and controlling the magnification of the image and transmitting the magnification of the image to the image input unit;
High efficiency optical in vitro diagnostic device further comprises a.
Applying light to a detection area in which a target to be detected exists and inputting a color image of the detection area;
Separating the color image into R (red), G (Green), and B (Blue) channels;
Converting an average intensity of any one of the separated channels into a target concentration;
High efficiency optical in vitro diagnostic method comprising a.

The method of claim 6,
The first step,
And a color image is inputted through the image pickup module using the image sensor configured as a color CCD or a color CMOS.
The method according to claim 7,
The third step,
The relationship between the distribution of the number of pixels by intensity and the target concentration of the separated channel is analyzed, and the average intensity of the channel having the highest sensitivity (change) of pixel change is inversely related to the detection object. To the target concentration,
A method for converting an average intensity to a target concentration of a detection target by combining one or more channels with the same or different weights.

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