KR102005621B1 - Immunochromatography rapid diagnostic kit and method of detection using the same - Google Patents

Abstract

A test pad which is connected to a sample pad, a connection pad, a membrane, and an absorbent pad which are sequentially passed through the sample, and is connected to the membrane in a sequential manner, Disclosed is an diagnostic kit using an immunochromatographic technique in which at least one reflective baseline is spaced a predetermined distance from a test line and a membrane surface adjacent to the test line, and an inspection method using the same. When using the test kit for the diagnostic kit using the immunochromatography technique, the test line position can be precisely determined by using the reflection type reference line installed adjacent to the test line, and the focus position for the test line can be precisely adjusted So that an accurate and rapid inspection can be performed.

Description

FIELD OF THE INVENTION [0001] The present invention relates to an immunochromatographic rapid diagnostic kit,

The present invention relates to a rapid diagnostic kit (hereinafter simply abbreviated as a diagnostic kit) using an immunochromatographic technique or a lateral flow test technique, more specifically, The present invention relates to a quick diagnostic kit and a diagnosis method using the same.

A rapid diagnosis kit using lateral flow test or immunochromatography technique has been developed and used.

The immunochromatography technique uses insoluble carrier particles having a ligand that characteristically recognizes the substance to be detected. The carrier particles capture the substance to be detected, and a test piece (membrane) having a fiber structure is subjected to capillary phenomenon (Test line) of the test specimen, and the aggregated insoluble carrier particles are accumulated at a predetermined position in the test piece by binding with a capturing substance that specifically binds to the detected substance that is fixed to a predetermined position (test line) in the test piece. It is one of the immunological techniques for detecting the presence or absence of insoluble carrier particles by the inspection device and analyzing the presence or absence of the substance to be detected.

This immunochromatographic technique is widely used as an in vitro diagnostic drug for POCT (Point Of Care Test) for on-site diagnosis which is not easy for a laboratory due to its simplicity.

Insoluble carrier particles such as gold colloid, platinum-gold colloid, and colored polystyrene particles are used as target particles for identifying a ligand that specifically recognizes a substance to be detected, and visual inspection or inspection The presence or absence of particle accumulation was often detected by a device.

Further, in order to facilitate detection, a method of improving the sensitivity with a sieve utilizing simplicity by immunological coagulation reaction by using fine particles emitting fluorescence has been used. In this case, a dedicated device for detecting fluorescence has been essentially used.

On the other hand, a rapid diagnostic kit using immunochromatography has a sample pad, a conjugate pad, a membrane (detection pad), and an absorbent pad sequentially connected from one side to a substrate (plastic support) It mainly uses the form.

In this kit, when a sample (sample) containing a test substance or a substance to be detected (for example, an antigen) is put into a sample pad, insoluble carrier particles having a ligand having specificity for the antigen are present in the binding pad connected to the sample pad The membrane moves through the porous fiber membrane by capillary phenomenon in the state of being bound to the antigen, and a trapping substance that specifically binds to the antigen, for example, a test line is fixedly attached to the membrane, and the ligand or insoluble carrier particle Are integrated in the trapping material band to exhibit the color or reflectivity of the form that is easy to detect in the naked eye or in the detection device.

In addition to the test line, a membrane (control line) is formed on the membrane to allow the sample to be identified as an appropriate and meaningful object, for example, a saliva, blood, or urine of a human body. At this time, the membrane is a material in which lateral flow can be easily performed, and usually porous nitrocellulose material is used.

By the way, the change of the test line caused by the antigen in the practical sense by the sample passing through the test line may be easily detectable, but there are many cases where it is necessary to check carefully.

These variations may be due to nonuniformities in the components of the rapid diagnostic kit, the amount of antigen in the sample, the properties of the material that makes up the test line, and the amount of material that makes up each component or test line. It may be because you can not secure quality.

On the other hand, in order to make such confirmation work more precise, there are many cases where the manual operation by the operator's eyes is changed to the automatic operation by the automatic apparatus having the optical means.

The diagnostic result of the kit by the automatic operation can be obtained by scanning an area of the membrane and acquiring an optical signal containing an image of the diagnostic result in the installed test line or an electrical signal converted by the diagnostic result and analyzing the signal.

However, in the case of reading and diagnosing test results by such an automatic operation, it is necessary to obtain clear and clean images or electrical signals for more clear detection. For example, when a blurred image that does not focus is obtained, the position of the test line itself becomes unclear, so that the distinction between the peripheral area and the test line area becomes unclear and the change state of the test line can not be clearly determined, ≪ / RTI >

In addition, if the image signal is not more visible than the ambient light in the process of converting an optical image signal to an electrical signal, slight contamination around the test line or difference between the external side or electrical noise and the changed test line may not be easily distinguished.

Particularly, if the membrane is made of a hard material such as a metal plate and has a small shape change due to an external factor, the surface can be leveled constantly and the position of the test line installed on the membrane can be accurately and stably secured. However, It is not easy to focus on the diagnostic optical measuring device and it is not easy to check the position accurately because the risk of deformation such as bending or stretching of the length by internal and external factors is high and surface level is not constant and variation is easy to occur there is a problem.

One way to overcome this problem is to increase the sensitivity of the optical pick-up device to slow down the scan rate and acquire the signal. However, it is time-consuming to test all membrane areas in this way, There is a problem in that the cost of the apparatus for scanning can be increased.

Therefore, it is necessary to perform a precise inspection only in the test line area. If the position of the test line is not known accurately, this selective inspection becomes difficult.

In addition, if the rapid diagnostic kit is for simple numerical diagnosis using automatic measurement and not for easy identification, it is necessary to make a more accurate diagnosis in the measuring device for accurate identification of the numerical value, and a simple line in one direction of the lateral flow When a signal is detected while a plurality of detection material regions exist in a test line so as to be coupled to a lateral flow direction and scan in a direction perpendicular to the lateral flow direction, instead of obtaining an optical signal while acquiring an optical signal while crossing the test line, The need to perform close-up inspections only in the test line area is increased, and the need to accurately grasp the test line area becomes even greater.

Therefore, in order to obtain the diagnosis result accurately and inexpensively and economically, it is necessary to accurately know the position of the test line so as to obtain a clear result when performing the automatic diagnosis, and to accurately check the level of the membrane on which the test line is installed It is necessary to adjust the focus properly.

An optical measuring apparatus having an autofocus function may be used as a method for adjusting the focus properly. However, in an environment where it is not easy to accurately detect the test line itself due to a weak signal provided by the test line, it is not easy to set the auto focus, There is a problem that it is not easy to detect whether or not it is.

The present invention relates to a rapid diagnosis kit using an existing immunochromatography technique, which can accurately detect a position of a test line when performing an automatic test using an inspection device, Kit and an inspection method using the same.

In one aspect, the present invention provides an apparatus and method for accurately detecting an external signal represented by a test line when performing an automatic test using an inspection device for a rapid diagnostic kit using an existing immunochromatographic technique, And a diagnostic method using the quick diagnostic kit.

In order to accomplish the above object, the present invention provides a diagnostic kit comprising: a sample pad, a connection pad, a membrane, and an absorbent pad successively connected to a specimen; Wherein at least one reflective baseline is provided on a surface of the membrane adjacent to the test line installed on the membrane and spaced apart from the test line by a predetermined distance.

In one embodiment, the reflective baseline can be provided with a spacing of greater than 100 microns, e.g., within 1 mm of the test line, and can be made of a metal film having excellent reflectivity.

In one embodiment, the reflective baseline can be installed before or after the test line, or both before and after the test line, and if there are a plurality of test lines, a reflective baseline can be provided adjacent to each test line.

According to another aspect of the present invention, there is provided an inspection method comprising: an illumination device; an optical pickup device that receives an optical signal and converts the optical signal into an electrical signal; An optical pickup module including an optical system for receiving an optical signal and sending the optical signal to an optical pickup device; A diagnostic kit module to which the quick diagnostic kit is mounted; A movement module capable of relatively moving the rapid diagnosis kit to an arbitrary position on one plane with respect to the optical pickup module; And a processor module including a control unit for adjusting a focal position of the optical system and controlling driving of the moving module, and an analyzing unit for receiving and analyzing an electric signal of the optical pickup device, Wherein the optical pickup module is moved in a lateral flow direction with respect to the membrane and is scanned in the primary scanning direction while using reflected light from the reflection type reference line, Identifying the position and identifying the level of the membrane surface for focus position adjustment; Identifying a position of the test line using a predefined positional relationship between the reflective reference line and the test line and moving the optical pickup module to a position of the test line; Moving the optical pick-up module to a position of the test line and moving the optical pick-up module with respect to the membrane through a secondary scan in a state in which the focus position of the optical system is adjusted to be formed on the surface of the membrane, Obtaining an optical signal; And converting the optical signal for the test line into an electrical signal and analyzing the electrical signal in the analyzer to derive the inspection result.

In the method of the present invention, in order to adjust the focus position of the optical system to be formed on the surface of the membrane, the analysis unit analyzes the electrical signal in a state in which the optical pick- The distance between the optical pickup module and the quick diagnostic kit is adjusted so that the control unit can place the reflective type reference line surface at the focus position of the optical system, Can be used.

In one embodiment, the optical pickup device is usually provided with a photodiode integrated circuit (PDIC).

In one embodiment, the primary scan and the secondary scan may be performed by a scan or scan method such as scanning direction or speed, sensitivity setting of the optical pickup device, characteristics of the illumination light to be used, or an actual or signal processing technique May vary.

According to the present invention, when an automatic test is carried out using an inspection device for a diagnostic kit using immunochromatography technology, the position of the test line can be accurately known by using the reflective type reference line provided adjacent to the test line, Accurate and rapid inspections can be made by precisely aligning the positions.

INDUSTRIAL APPLICABILITY According to the present invention, it is possible to improve the accuracy of the diagnosis result and the precision in the numerical measurement when the automatic test is performed on the rapid diagnosis kit using the immunochromatographic technique using the test apparatus.

1 is a schematic perspective view showing a configuration of a diagnostic kit of the present invention,
Fig. 2 is a structural conceptual view showing a schematic configuration of the inspection apparatus of the present invention,
FIG. 3 is a graph showing the relationship between the membrane (a) of the diagnostic kit of the present invention in which a reflective type reference line is provided before and after the test line and the control line, the distribution (b) of the signal appearing through the analysis unit when the first scan is performed on the membrane, (C) showing the distribution of the immunoreaction result signal,
Figure 4 is an exemplary view of the dimensions of a diagnostic kit of the present invention,
5 to 8 are views showing a specific configuration of the inspection apparatus of the present invention,
Fig. 9 is an enlarged view of main components of the inspection apparatus of the present invention,
10 is a view for explaining a diagnosis result by the diagnostic kit and the inspection equipment of the present invention,
11 is a graph for explaining a detection signal change according to the fluorescence dilution concentration in the diagnostic kit of the present invention.

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

FIG. 1 is a schematic perspective view showing an embodiment of the rapid diagnosis kit of the present invention, and FIG. 2 is a conceptual diagram showing a conceptually showing an embodiment of a testing apparatus used in the method of the present invention.

1, the diagnostic kit includes a sample pad 13, a connection pad 15, a membrane 17 (see FIG. 1) And an absorbing pad 19 are provided so as to overlap one after another. This configuration is the same as that of a conventional diagnostic kit, and the functions thereof are the same.

The liquid sample is put into the sample pad 13 through the hole formed in the case 20 as indicated by a thick arrow A and moved sideways in the direction of the absorbent pad 19 through the entire pad along the arrow direction.

The test line 171 and the control line 173 are formed in the membrane 17 in the direction of the absorbent pad 19 in the sample pad 13 and the test line 171 and the control line 173 Reflection type reference lines 175 and 177, respectively, are provided.

These reflective baselines 175 and 177 are formed by forming a thin metal film on the surface of the membrane 17 with a narrow width. The reason why the material is made of a metal film is to stably reflect the illumination light at a high rate by its own metallic luster and to allow the optical pickup device to clearly detect the reflected light. When the thickness of the metal film is thin, the surface of the membrane 17 on which the metal film is to be provided is not substantially different from the surface of the metal film, In order to have a focus effect. The reason why the width of the metal film is narrow is that the position in the lateral flow direction of the metal film is accurately defined close to one point within a range in which the metal film is clearly detected by the optical pickup device and the analysis section, This is to prevent such a problem because there is a limitation in the area of the test lines and the like.

The reflection type reference lines 175 may be provided at positions spaced a predetermined distance forward or backward from the test line 171 or may be installed one on the front side and the other on the front side and the rear side. It is assumed that there is a test line 171 before or after the certain distance and the optical pick-up module is moved by a certain distance to the diagnostic kit module and the optical signal obtained by the second scan of the test line is inputted to the test line 171) can be used for analysis.

If one of them is installed on the front and back sides, if the distance of the half of the distance between the two reference lines identified in the first scan is shifted from the first reference line, the optical signal obtained by performing the second scan at this position is regarded as the position of the test line 171, It can be analyzed as a signal.

If the normal test line 171 has a simple one line shape, the secondary scan can be made by traversing the test line 171 in the same lateral flow direction as the primary scan. However, when a plurality of capturing material regions exist in a matrix form in the test line region, in order to obtain an optical signal while passing through each of the matrix regions, the scan moves in the primary scanning direction (B) Scanning the wafer in a vertical direction as well as scanning each dye area on the wafer in a zigzag manner or a step and repeat method.

Even if the test line 171 linearly applies the detection substance on the membrane 17 in a simple line, the direction C of the secondary scan is made perpendicular to the lateral flow direction A in order to improve the accuracy of the inspection . In this case, since the distribution of the detection substance or the porosity of the membrane on the same line may vary depending on the position on the line, and the resultant form of the immune response may vary, the signal is collected over the entire test line and the signal is averaged or the strongest signal value So as to be analyzed by the analysis unit.

On the other hand, in the first scan, the test line position determination in the above-mentioned manner determines the overall absolute reference position for the position of the test line 171 in the conventional method because the membrane 17 of the diagnostic kit has flexibility and stretch deformation possibility It is difficult. On the other hand, when the reflection type reference line 175 is provided around the test line as in the present invention, when the reference line is formed only on one side of the test line, the test line and the reflection type reference line are adjacent to each other Therefore, the distance between them is not largely changed, and the position of the test line 171 can be known accurately within the error range by accurately finding only the position of the reflective reference line.

In addition, in the present invention, when the reflection type baseline 175 is provided on both sides of the test line 171 and the test line intervals are equal to the respective reference lines, even if a change in length is caused by the overall expansion and contraction of the membrane 17, It can be seen that the test line is located at the intermediate position of the test line.

Of course, the premise here is that the expansion and contraction of the membrane is made at an evenly proportionate rate, and even though it is not even, the difference is not really large, so all of this is reasonable.

On the other hand, in order to simplify the configuration and operation of the inspection apparatus, it is preferable to set the conditions such as the illumination light used for the primary scan and the secondary scan to be the same. However, in the present invention, the characteristics of the reflective baseline and the characteristics The illumination light used to detect the reflective baseline by the primary scan and the illumination light used to acquire the optical signal through the test line by the secondary scan It is also possible to use a different technique such as an actual filter for detecting an optical signal or a filter technique using an electronic processing method.

Similarly, in order to make the detection accuracy of the primary scan and the secondary scan different, the speed of the scan, the sensitivity setting of the optical pickup device, and the amplification may be different.

If the distances between the baseline and the test line are such that the distances between the baseline and the test line are not adversely affected by the mutual interference in the signal graph finally obtained by the analysis section and the distinction between the mechanical movement and the optical aspect can be reliably made, , And when a large distance of 1 mm or more occurs, the distance between the reference line and the test line increases in proportion to the expansion and contraction of the membrane. Therefore, even when the position of the test line is determined by the first scan, There is a possibility to set the wrong position.

Although the above description is based on the test line, the control line 173 may be described in the same manner. However, if the result detection of the control line 173 can be obtained clearly compared to the detection of the result of the test line, it is not necessary to further provide the reflective type reference line 177 around the control line.

FIG. 2 is a configuration diagram showing a schematic configuration of a testing apparatus for inspecting an object to be inspected using a diagnostic kit according to the present invention. FIG.

The inspection apparatus mainly includes a diagnostic kit module 200 for mounting the optical pickup module 100 and the diagnostic kit, and a moving module for performing relative movement in the plane between the optical pickup module 100 and the diagnostic kit module 200. [ (300) and a processor module (400) as components, and most of them have a configuration that is common with a known configuration.

The optical pickup module 100 is further subdivided into an illumination device 110, an optical pickup device 130, and an optical system 120 as components. As the illumination device 110, a focused single wavelength light, such as a laser diode, is often used. The optical system 120 is composed of optical elements such as a beam splitter 121, a mirror, and a lens assembly 123 to guide the light of the illumination device to the membrane region to be inspected by the diagnostic kit, And transmits the optical signal including the video data to the optical pickup device. The lens assembly 123 constituting the optical system is controlled by the control unit 420 so that the relative position between the lenses can be adjusted so that the focal length can be adjusted. The optical pickup device 130 receives an optical signal and generates an electric signal corresponding to the optical signal, and is widely used in a reproducing apparatus such as a compact disc.

The diagnostic kit module 200 has a cartridge type in which the diagnostic kit can be detachably mounted to insert and withdraw in a manner similar to mounting a memory chip in a computer slot. The surface of the membrane is installed to look at the illumination light of the optical pickup module 100 based on the inspection apparatus for the reflection type diagnostic kit.

The optical pick-up module 100 and the diagnostic kit module 200 are arranged such that the illumination light can scan the required area in the membrane of the diagnostic kit as a whole and can appropriately acquire the optical signal included in the reflected light along the area irradiated with the illumination light. The relative movement is performed in a plane substantially parallel to the scan plane. This movement is performed by the rotation of each step motor 310 responsible for the X and Y axis movement on the plane and the combination of the linear movement devices 320. The frame structure and the stepping motor 310, The linear movement device 320 can be viewed as a movement module 300.

The relative movement between the optical pick-up module and the diagnostic kit module may be a simple reciprocating manner in the lateral flow direction when the configuration of the diagnostic kit is such that it has a simple baseline and a simple test line and control line in the membrane.

The processor module 400 can be viewed as a computer device embedded in the testing apparatus. The processor module 400 includes an analyzing unit 410 configured to receive a signal and process the processed signal in accordance with a built-in program to express a result, The control unit 420 that controls the optical system to adjust the focus position by the manual operation signal and instructs the relative movement between the optical pickup module 100 and the diagnostic kit module 200 through the movement module 300, It is often included as one.

3 is a schematic view showing a membrane 17 provided with a reflection type reference line 175 and 177 before and after the test line 171 and the control line 173 and an analysis unit A b showing the distribution of the reflected light signal (signal intensity according to the scan progress distance) and a c showing the signal distribution of the immunoreaction result appearing through the analysis unit when the second scan is performed are compared with each other.

Referring to FIG. 3, a method of performing a test using the test apparatus of this configuration and performing the test using the test kit of the present invention will be described. First, a sample is supplied to a sample pad. In the diagnostic kit module of FIG. The optical pickup module moves to the initial position or maintains the initial position by the control unit. The controller drives the moving module to move the optical pick-up module horizontally and parallel to the lateral flow direction of the diagnostic kit and horizontally to the table plane on which the inspection apparatus is placed to perform the first scan by moving the entire module on the membrane. In the first scanning process, for example, laser light having a wavelength of 650 nanometers is used as illumination light. Optical signals of reflected light are detected through an optical system in a 690 nm wavelength band and processed through an optical pickup device and an analyzing unit. It can be seen that all four peaks are shown.

 In the processor module, the position of the center of the two adjacent peaks is set as the position of the test line and the control line through the processing result of the analyzing section, the position information is sent to the control section, and the moving module is driven through the control section, (C) of FIG. 3 is obtained by processing the optical signal through the optical pick-up device and the analyzing part, Can be obtained. The graph shows signals with strong intensities exactly at the test line and control line positions, thus confirming that the test line has detected an immune response to the test object or the corresponding antigen. The degree of detection of the object to be inspected can be expressed as a numerical value according to the magnitude of the signal intensity as necessary.

On the other hand, in addition to confirming the position of the reflective baseline, the analyzing unit confirms the level of the reflective baseline by the first scan, calculates the average level of the adjacent first and second baseline, Position, the relative position of the lens forming the optical system is adjusted so that the focus of the optical system is formed at the level. Similarly, when the second scan is performed by calculating the average level of the adjacent third and fourth reference lines, the relative position of the lens forming the optical system is adjusted so that the focus of the optical system is formed at the average level at the control line position, .

In this embodiment, the controller can be operated on the basis of the position and the level of the reflection type reference line obtained in the primary scan to obtain accurate test results without confusion in the test line and the control line.

4 is an exemplary view of the dimensions of a diagnostic kit of the present invention.

The diagnostic kit according to the present embodiment may have dimensions as shown in FIG. The lower drawing of Fig. 4 shows the installation positions of the test line (T line) and the control line (C line) on the membrane.

FIGS. 5 to 8 are views showing a specific configuration of the inspection apparatus of the present invention, and FIG. 9 is an enlarged view of main components of the inspection apparatus of the present invention.

5 to 8, an inspection apparatus 500 according to the present embodiment includes a cartridge mounting portion (corresponding to a diagnostic kit module) on which a cartridge or a diagnostic kit is mounted, an optical pickup module 100, an SLED motor Step motor), and the like.

FIG. 10 is a graph for explaining the diagnostic result of the diagnostic kit and the test equipment of the present invention, and FIG. 11 is a graph for explaining a change in the detection signal according to the fluorescence dilution concentration in the diagnostic kit of the present invention.

10 and 11, even when the detection signal changes due to the fluorescence intensity, fluorescence dilution concentration, focusing error, or the like, the diagnostic kit according to the present embodiment and / The accuracy in numerical measurement can be increased.

The specific embodiments of the present invention have been described above. It is to be understood, however, that the spirit and scope of the invention are not limited to these specific embodiments, but that various changes and modifications may be made without departing from the spirit of the invention, If you are a person, you will understand.

Therefore, it should be understood that the above-described embodiments are provided so that those skilled in the art can fully understand the scope of the present invention. Therefore, it should be understood that the embodiments are to be considered in all respects as illustrative and not restrictive, The invention is only defined by the scope of the claims.

11: Plate 13: Sample pad
15: connection pad 17: membrane
19: absorptive pad 20: case
100: optical pickup module 110: illumination device
120: optical system 130: optical pickup device
171: Test line 173: Control line
175, 177: Reflective baseline 200: Diagnostic kit module
300: Moving module 310: Step motor
320: Linear motion device 400: Processor module
410: Analyzing section 420: Control section

Claims (6)

1. An immunochromatographic rapid diagnostic kit comprising a sample pad, a connection pad, a membrane, and an absorbent pad, which are sequentially passed through a sample, and which are sequentially stacked one over the other and react with an object to be tested,
A test line and a control line are spaced apart from the sample pad in the direction of the absorbent pad by a predetermined distance on the membrane, a reflective baseline is provided at an adjacent position of the test line and the control line,
Wherein the reflective baseline is a metal film and is disposed at a position spaced by 100 占 퐉 or more within 1 mm from the test line,
Wherein the reflection type reference line is installed in front of and behind the test line and the control line in the lateral flow direction, respectively. delete delete And an optical system configured to irradiate the illumination light of the illumination device to the rapid diagnosis kit, receive the optical signal reflected from the rapid diagnosis kit, and send the optical signal to the optical pickup device An optical pickup module; A diagnostic kit module to which the quick diagnostic kit is mounted; A movement module capable of relatively moving the rapid diagnosis kit to an arbitrary position on one plane with respect to the optical pickup module; And a processor module including a control unit that adjusts a focal position by adjusting a position of an element forming the optical system and adjusts driving of the moving module, and an analyzing unit that receives and analyzes an electric signal of the optical pick- 1. A test method for a diagnostic kit to be performed,
The test kit includes a sample pad, a connection pad, a membrane, and an absorbent pad, which are sequentially passed through the specimen, and are connected one after another to form a test line and a control line on the membrane in the direction of the absorbent pad , A reflective type reference line is provided at an adjacent position of the test line and the control line, the optical pick-up module is moved in a lateral flow direction with respect to the membrane, Identifying the position of the reflective baseline and identifying the level of the membrane surface for focus position adjustment;
Identifying a position of the test line using a predefined positional relationship between the reflective reference line and the test line and moving the optical pickup module to a position of the test line;
Moving the optical pick-up module to a position of the test line and moving the optical pick-up module with respect to the membrane through a secondary scan in a state in which the focus position of the optical system is adjusted to be formed on the surface of the membrane, Obtaining an optical signal; And
Converting an optical signal for the test line into an electrical signal, and analyzing the electrical signal in the analysis unit to derive a test result. 5. The method of claim 4,
The analysis unit analyzes the electrical signal in a state in which the optical pickup apparatus converts the optical signal at the reflective reference line into an electrical signal through the optical system so as to adjust the focus position of the optical system to be formed on the surface of the membrane Wherein the controller is configured to determine an accurate focus position of the optical system and a current position of the reflective reference line and to set the mutual distance between the optical pickup module and the quick diagnosis kit such that the reflective type reference line surface is located at the focus position of the optical system Or adjusting the mutual position between the elements constituting the optical system. 5. The method of claim 4,
The primary scanning and the secondary scanning may be performed by adjusting the focus position of the optical system, adjusting the scanning direction, the speed, the sensitivity setting of the optical pickup device, the characteristics of the used illumination light, Wherein at least one of the filter selections is made differently.

Images