JP3518940B2 - Method for managing performance of immunoreaction test apparatus and performance control plate for immunoreaction test apparatus - Google Patents

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a performance control method for an immune reaction test apparatus used for testing an immune reaction of an antibody or the like.

[0002]

2. Description of the Related Art As a means for detecting infectious diseases related to viruses such as HBs and bacteria such as syphilis, blood groups (ABO, HLA, etc.), an immune reaction test apparatus utilizing an antigen-antibody reaction has been conventionally known. . This type of inspection device is for inspecting the presence or absence of an antibody or an antigen by using fine particles such as blood cells and latex particles, and an agglutination image (sedimentation pattern) of fine particles formed on a test plate such as a well plate is CCD. After the image is picked up by an image pickup means such as a camera, the image signal is subjected to signal processing to determine whether the serum as a sample dispensed into the wells of the well plate is positive or negative, and the determination result is used as CRT or It is configured to display on a display device such as a printer (Japanese Patent Laid-Open No. 58-105).
No. 065, Japanese Examined Patent Publication No. 6-76963, JP-A-63-58
237, JP-A-63-256839, JP-A-3-5
6843, JP-A-3-191848, and JP-A-4-7.
2547, JP-A-4-120442, US Pat.
096,835, U.S. Pat. No. 5,388,164, etc.).

[0003]

When a failure or abnormality occurs in such an immune reaction testing device, a serviceman repairs or adjusts the failed part, and further a performance confirmation test of the immune reaction testing device. However, the user could not confirm the performance (test accuracy) of the immune reaction test device. This is because the reference agglomeration image pattern could not exist.

The present invention has been made in view of the above-mentioned circumstances, and an object thereof is to enable a user to easily confirm whether or not the test accuracy of an immune reaction test device is normal, and to ensure accurate immunity. (EN) A method for controlling the performance of an immune reaction test device capable of performing a reaction test and a performance management plate for the immune reaction test device.

[0005]

In order to solve the above-mentioned problems, the invention according to claim 1 is provided with an image pickup means for picking up an agglutination image of fine particles formed on a well plate in an immunoreaction test of an antibody or the like. A method for controlling the performance of a reaction inspection device, wherein the reference pattern of the agglutination image is printed in advance.
Using a standard plate formed Ri comprising the step of confirming the performance of the immune response test apparatus, the standard plate numerical values when imaging the reference pattern to which the step is formed in the standard plate by the imaging device It is characterized in that the content of the comparison is displayed on the display device by comparing with the reference value attached to.

According to a second aspect of the present invention, there is provided a method for managing the performance of an immune reaction test apparatus equipped with an image pickup means for picking up an agglutination image of fine particles formed on a well plate in an immune reaction test of an antibody or the like. advance reference pattern agglutination image
The method is characterized by including the step of calibrating the imaging means based on the measured values of the standard plate formed by printing .

According to a third aspect of the present invention, in order to control the performance of the immune reaction testing device equipped with an image pickup means for picking up an agglutination image of fine particles formed by an immune reaction, the agglutination image is formed on the focal point of the image pickup means. It is characterized in that it is provided by printing the reference pattern.

[0008]

BEST MODE FOR CARRYING OUT THE INVENTION An embodiment of the present invention will be described below with reference to the drawings. FIG. 1 is a schematic configuration diagram of an immune reaction test apparatus, in which P indicates a well plate as a test plate. The well plate P is made of a transparent resin such as acrylic, and a plurality of wells W (see FIG. 2) are provided in a matrix on the upper surface thereof.

Further, in FIG. 1, reference numeral 1 denotes a C aggregation image (sedimentation pattern) of fine particles formed in each well W of the well plate P.
The image pickup section 2 set to a specific focus position for picking up an image by the CD camera 1a, 2 is a plate transfer section for transferring the well plate P to the image pickup position of the image pickup section 1, and 3 is a plate transfer section 2
The plate supply section 4 for supplying the well plate P to the plate storage section 4 for recovering the well plate P from the plate transfer section 2 includes the imaging section 1, the plate transfer section 2, the plate supply section 3 and the plate storage section. Part 4,
It is controlled by a signal sent from the CPU 5 as a control unit.

In the figure, 6 is an input unit including a keyboard for inputting various commands to the CPU 5, and 7 is an input unit 6.
The storage unit 8 stores information input to the CPU 5 from the image capturing unit 1 and the result of processing by the CPU 5 that is input from the image capturing unit 1. Reference numeral 8 denotes the sharpness of the aggregate image captured by the image capturing unit 1 ( The CRT display part which displays (differential value) etc. is shown. The input unit 6 also has a built-in bar code reader for reading the type of the well plate P based on the bar code attached to the well plate P.

FIGS. 3 and 4 show a first embodiment of a performance management plate for an immunological reaction test apparatus according to the present invention. This performance management plate (hereinafter referred to as "standard plate") 60 is shown. , A transparent film 61 made of polyester or the like, and two transparent plates 6 attached to the focal position of the image pickup unit 1 with the transparent film 61 interposed therebetween.
2, 63, and the transparent film 61,
A plurality of reference patterns 64a, 64b, 64c (see FIG. 5) simulating the agglomeration image (sedimentation pattern) of the fine particles are formed by printing or the like. Where the lower plate 63
It is preferable that the upper surface of is aligned with the focus position of the imaging unit 1 in the transport unit 2.

It should be noted that the transparent film 61 or the transparent plates 62, 63 shows the sharpness when the reference patterns 64a, 64b, 64c formed on the transparent film 61 are imaged by the image pickup section 1 of the immunological reaction test apparatus. The reference value is attached with the barcode (not shown).

The standard plate 60 is formed to have substantially the same size as the well plate P, and the reference patterns 64a, 64b and 64c are formed on the transparent film 61 at the same pitch as the wells W provided on the well plate P. Has been done.

When the performance of the immune reaction tester is controlled by using the standard plate 60, the standard plate 60 is set in the plate supply section 3 of the immune reaction tester and then the input section of the immune reaction tester is set. An inspection start command is input to the CPU 5 via 6. Then, the plate supply unit 3 operates and the standard plate 60 set in the plate supply unit 3 is supplied to the plate transport unit 2.

When the standard plate 60 is supplied to the plate transport unit 2 in this manner, the plate transport unit 2 is activated by a signal from the CPU 5, whereby the standard plate 6 is operated.
0 is conveyed to a position below the image pickup unit 1. Then, when the standard plate 60 is conveyed to a position below the image pickup unit 1, CP
The image pickup unit 1 is activated by the signal from U5, and the reference patterns 64a, 64 of the agglomerated image formed on the standard plate 60 are displayed.
b and 64c are imaged by the CCD camera 1a.

Here, reference patterns 64a, 64b, 64c of the standard plate 60 imaged by the CCD camera 1a.
Is supplied to the CPU 5, and the reference pattern 6 is
The sharpness of 4a, 64b, 64c (differential value near the boundary of the agglomerated image) is calculated. The sharpness of the reference patterns 64a, 64b, 64c calculated by the CPU 5 is displayed on the CRT display unit 8 and is printed out from the printer unit (not shown). The user can easily confirm the performance of the immunological reaction test device by comparing the numerical value with the reference value attached to the standard plate 60 in advance.

That is, according to the above-described performance management method of the embodiment of the present invention, it is possible to easily confirm whether or not the test accuracy of the immune reaction test device is normal, and thus the immune reaction test is performed. Can always be done accurately.

Further, by using the standard plate 60 shown in FIGS. 3 and 4, the reference pattern of the transparent film 61 provided at the focal position of the image pickup unit 1 is used as the transparent plate 6.
Since it can be protected by 2, 63, a stable photometric value can be obtained over a long period of time.

The standard plate 60 shown in FIGS. 3 and 4 has a transparent film 61 on which a reference pattern is formed.
Since it is formed by sandwiching the transparent plates 62 and 63 in a side-itch shape, it has the advantage that it is strong and can be formed relatively easily, and that displacement is unlikely to occur.

Further, the reference pattern reference pattern 64
Since a, 64b, and 64c are formed by printing, they have good reproducibility and are easy to create. FIG. 6 is a flow chart showing a procedure for calibrating the measurement data of the immune reaction test apparatus using the standard plate 60 shown in FIG. 3. As shown in FIG. 6, the measurement data of the immune reaction test apparatus is calibrated. In this case, the user or the operator first switches the immune reaction test device to the calibration mode and sets the standard plate 60 on the immune reaction test device (step S).
1, S2). Next, the immunoreaction test device is operated, and the reference pattern 64a of the agglutination image formed on the standard plate 60,
The CCD camera 1a images 64b and 64c (step S3).

At this time, the CPU 5 of the immune reaction tester calculates the sharpness of the reference patterns 64a, 64b, 64c based on the image signal from the CCD camera 1a, and displays the calculation result on the CRT display section 8 (step). S4).

Here, at the time of shipment of the immune reaction test device,
An operator operates the input unit 6 to preliminarily serve as a master immune reaction test apparatus (hereinafter referred to as “master machine”) or a user side immune reaction test apparatus at shipping (hereinafter referred to as “user machine”). .), And the numerical value X of the sharpness of the standard plate 60 displayed on the display unit 8 is input to the user machine (step S5). At this time, the CPU 5 of the user machine stores the numerical value X from the input unit 8 in the storage unit 7.

It should be noted that the standard plate 60 is attached with a label in which the numerical value X of the sharpness required by the master machine or the user machine before shipment is bar-coded in advance.
Alternatively, the numerical value X of the sharpness required by the master machine or the user machine before shipment is printed or printed.

When calibrating the measurement data of the user machine, the user switches the user machine to the input mode, and then inputs the numerical value Y of the sharpness displayed on the display section 8 from the input section 6 to the CPU 5 ( Steps S6 and S7). At this time, the CPU 5 stores the numerical value Y from the input unit 6 in the storage unit 7. When the numerical value Y is stored in the storage unit 7, CP
U5 obtains the ratio between the numerical value X and the numerical value Y stored in the storage unit 7, and stores this in the storage unit 7 as the coefficient value Z (= X / Y) of the measurement data (step S8). The coefficient value at the time of shipment is set to Z = X / X = 1.

In this way, the coefficient value Z of the measurement data is set to Z
After changing from = X / X to Z = X / Y, when the user machine is switched from the calibration mode to the measurement mode, the value obtained by multiplying the measurement data by the coefficient value Z (= X / Y) is aggregated on the display unit 8. Since it will be displayed as the definition of the image (step S
9) The correction of the measurement data can be performed easily and surely, and the variation in the measurement performance between the devices can be eliminated.

In the flow chart shown in FIG.
Although the user operates the input unit 6 to input the numerical value Y of the sharpness displayed on the display unit 8, the CPU 5 automatically inputs the numerical value Y as in step S7 of the flowchart shown in FIG. It may be done. In this case, the input unit 6
When the bar code reader incorporated in the CPU detects the bar code attached to the standard plate 60, the CPU 5 controls so as to automatically switch to the calibration mode.

Standard plate 60 used under the above conditions
Is for the purpose of stabilizing the data regardless of damage, etc.
It is necessary to update to a new standard plate 60 (hereinafter, referred to as "second standard plate") at regular intervals.

When the second standard plate 60 is replaced, a sharpness value X'previously obtained by the master machine is added in consideration of the possibility that the accuracy at the time of shipment is not maintained. The second standard plate 60 is supplied to the user. Then, a second standard plate 60 with a numerical value X '
For the value X ′ of the sharpness of the image, the user reads the displayed value with the bar code reader or the displayed value is input by the user.
And stores it in the storage unit 7 of the CPU 5. Less than,
The operation is performed in accordance with each step of the flowchart shown in FIG. 6 or 7.

At this time, since the numerical value Y'of the sharpness by the second standard plate 60 is newly input, the ratio of the numerical value X'and the numerical value Y'stored in the storage unit 7 is obtained below, and this is calculated. Is stored in the storage unit 7 as a coefficient value Z (= X '/ Y') of the measurement data, and a value obtained by multiplying the measurement data by the coefficient value Z (= X '/ Y') is used as the sharpness of the agglomerated image. It is displayed on the CRT display unit 8.

Next, a case where a failure occurs in the user machine will be described below. First, the operator confirms that the numerical value Y of the calculation result of the reference pattern 60 displayed by the user machine is not in doubt by the operator.

When it is confirmed that the value is suspicious,
The operator replaces the standard plate 60 as described above,
Input the numerical value X'from the master machine to the user machine and
Alternatively, the operation according to each step of the flowchart shown in FIG. 7 is executed.

If the numerical value Y'of the calculation result at that time is not a doubtful numerical value, the numerical value abnormality can be regarded as the abnormality of the standard plate 60. Also, if the numerical value Y ′ of the calculation result still appears to be a suspicious numerical value, the cause of the numerical value abnormality is determined as follows.
It is possible to narrow down to the point where the focal position of is shifted.

In the above-described embodiment of the present invention, the standard plate 60 is formed by interposing the transparent film 61 on which the reference pattern is formed between the transparent plate 62 and the transparent plate 63, but it is melted, for example. After the transparent film 61 is attached to the transparent plate 62 (or 63) under the condition that the plastic does not deform, the transparent plate 62 (or 6) to which the transparent film 61 is adhered
3) It is preferable that the transparent resin is injection-molded on the plate to form the transparent plate 63 (or 62) because the airtightness with the film is improved and the measurement data becomes stable.

Further, as in the second embodiment shown in FIG. 8, a concave portion 66 is provided on the surface of the transparent plate 65, and the concave portion 6 is formed.
It is preferable that a plurality of transparent films 61a, 61b, 61c, 61d having a reference pattern printed on the bottom surface of 6 are attached with an adhesive to form the standard plate 60 because the manufacturing cost can be reduced.

Further, as in the third embodiment shown in FIG. 9, a small metal sphere 69 is interposed between a transparent plate 67 and a transparent plate 68 which are bonded together with an adhesive or the like to form a standard plate 60. Alternatively, as in the fourth embodiment shown in FIG. 10, a metal small sphere 69 is adhered and fixed to the bottom of the well W formed in the well plate P to form the standard plate 60. You may do it. According to the fourth embodiment shown in FIG. 10, the standard plate 60 can be easily formed.

[0036]

As described above, according to the inventions of claims 1 and 3, the user can easily confirm whether or not the test accuracy of the immune reaction test device is normal.
An accurate immune reaction test can always be performed.

According to the invention of claim 2, in addition to the effect of the invention of claim 1, it is possible to easily and surely correct the measurement data of the immunological reaction test apparatus, and to eliminate the variation in the measurement performance between the apparatuses. It can be resolved.

[Brief description of drawings]

FIG. 1 is a schematic configuration diagram of an immune reaction test apparatus.

FIG. 2 is a perspective view of a well plate.

FIG. 3 is a plan view of a performance management plate for an immune reaction test device according to the first embodiment of the present invention.

4 is a cross-sectional view taken along the line EE of FIG.

5 is a plan view of the transparent film shown in FIG.

FIG. 6 is a flowchart showing a procedure for calibrating the immune reaction test device.

FIG. 7 is a flowchart showing another procedure for calibrating the immune reaction testing device.

FIG. 8 is a side view of a performance management plate for an immune reaction test device according to a second embodiment of the present invention.

FIG. 9 is an exploded perspective view of a performance management plate for an immune reaction test device according to a third embodiment of the present invention.

FIG. 10 is a side view of a performance management plate for an immune reaction testing device according to a fourth embodiment of the present invention.

[Explanation of symbols]

P ... Well plate W ... Well 1 ... Imaging unit 2 ... Plate transport section 3 ... Plate supply unit 4 ... Plate storage 5 ... CPU 6 ... Input section 7 ... Storage 8 ... Display 60 ... Standard plate 61 ... Transparent film 62, 63 ... Transparent plate 64a, 64b, 64c ... Reference pattern

─────────────────────────────────────────────────── ─── Continuation of the front page (56) Reference JP-A-3-75563 (JP, A) JP-A-53-79025 (JP, A) JP-A-63-256839 (JP, A) (58) Field (Int.Cl. ⁷ , DB name) G01N 33/543 581 G01N 21/17

Claims (3)

(57) [Claims] 1. A method for managing the performance of an immune reaction test apparatus comprising an image pickup means for picking up an agglutination image of fine particles formed on a well plate in an immunoreaction test of an antibody or the like, wherein the reference pattern of the agglutination image is provided. Includes a step of confirming the performance of the immunological reaction test device using a standard plate formed by printing in advance , and the step of displaying a numerical value when the reference pattern formed on the standard plate is imaged by the imaging means. A performance management method for an immune reaction testing device, comprising: comparing with a reference value attached to the standard plate and displaying the content of the comparison on a display device. 2. A method for managing the performance of an immune reaction test apparatus equipped with an image pickup means for picking up an agglutination image of fine particles formed on a well plate in an immunoreaction test of an antibody or the like, the reference pattern of said agglutination image. 2. The method of managing the performance of an immune reaction testing device according to claim 1, further comprising the step of calibrating the imaging means based on the measured values of a standard plate formed by printing in advance . 3. A reference pattern of an agglutination image is printed on a focal position of the imaging means in order to perform performance management of an immune reaction inspection device equipped with an imaging means for taking an agglutination image of fine particles formed by an immune reaction. A performance control plate for an immunological reaction test device, which is characterized by being provided.