JPH0395461A - Testing tool - Google Patents

Abstract

PURPOSE:To expose a part where a test specimen is uniformly adhered thereby to achieve correct measurement by a measuring means by making an opening area of a second opening smaller than that of a first opening for collecting said test specimen. CONSTITUTION:A circular first opening 4a is formed in a lid 4 of a testing instrument 1. A second opening 2a with approximately half the diameter of the first opening 4a is formed in the main body 2. The center line C.L of the opening 4a of the lid 4 is made common to the second opening 2a. A part of a lower surface of a light passing layer 6 made of transparent resinous material is exposed outside from the opening 2a, and a reagent layer 8 is provided on the upper surface of the layer 6 for color reaction with a test specimen. Moreover, a liquid developing layer 10 is provided above the layer 8. Therefore, the test specimen penetrates the reagent layer 8 after it is developed in the liquid developing layer 10 through the opening 4a, showing the color reaction. The reaction is measured by an optical measuring means to obtain a measuring value.

Description

DETAILED DESCRIPTION OF THE INVENTION [Industrial Application Field] The present invention relates to a test device, and more particularly to a test device that automatically measures the color reaction of a specimen applied to the test device using a measuring device.

[Prior Art] Conventionally, a multilayer analysis sheet for liquid sample analysis, which facilitates the quantitative determination of specific components in a sample, has been published in Japanese Patent Publication No. 61-61347.
However, this multilayer analysis sheet 1 for liquid sample analysis had the disadvantage of a long reaction time due to its structure.

Therefore, in view of this drawback, the applicant of the present application
34198, in particular, proposes a test device with a shortened reaction time, which consists of a reagent layer on one side of a permeable support, in order to analyze components in a specimen. A developing layer for uniformly developing the specimen is fixed integrally by the holding member with the developing layer facing outward.

According to this applicant's proposal, the specimen reaches the reagent layer,
It shortens the time until penetration and improves the permeability of gases such as oxygen necessary for color reaction, speeding up the color reaction while inserting the test device into the insertion opening of the measuring device. It was intended to be used in a measuring device designed to measure the elapsed time of a color reaction.

FIG. 7 is a first view of the test device proposed by the applicant, and is a sectional view taken along a plane passing through the center of the circular opening of the test device. In this figure, an opening 200a with a diameter of d2 is formed in the main body 200 of the test device l○0, while a lid 40
0 is provided integrally with the main body 200 by gluing or the like as shown in the figure, and the main body 20 is attached to the lid 400.
0 centerline of the opening 200a C. If L is a common central axis, then the opening 40 has a diameter d that is approximately the same as d2.
0a is drilled.

In addition, a part of the lower surface of the light-transmitting layer section 6 made of a transparent resin material is exposed to the outside through the opening 200a, while a reagent layer section on the upper surface of the light-transmitting layer section 6 undergoes a color reaction with the specimen. 8 is provided. A liquid developing layer section 10 is laid on the layer of this reagent layer section 8, and a part of the upper surface of this liquid developing layer section 10 is exposed to the outside through the above-mentioned opening 400a. The lower surface of the layer section 10 is brought into contact with the reagent layer section 8.

Therefore, after the sample is developed in the liquid developing layer section 10 through the opening 400a, it permeates into the reagent layer section 8 and causes a color reaction, and this color reaction is measured by an optical measuring means. I try to obtain measured values using For this measurement, the opening 200a of the main body 200 is irradiated with light from a light emitting element, and a light receiving element detects the amount of reflected light that changes approximately in proportion to the color reaction. Blood sugar levels are measured by measuring changes in blood sugar levels.

[Problems to be Solved by the Invention] However, in the above test device of the present applicant, the circular diameters of the opening 200a of the transparent light-transmitting layer 6 and the opening 400a of the liquid spreading layer 10 are set as described above. As a result, by uniformly spreading the sample over the range of the opening 400a of the liquid developing layer section 10, the sample that has reacted with the reagent layer is spread over the entire range of the opening 200a of the light-transmitting layer section 6. However, there is a problem in that it is extremely difficult to uniformly distribute the specimen over a wide range.

Therefore, the test device of the present invention has been developed in view of the above-mentioned problems, and its purpose is to uniformly distribute the sample over a wide range, but not to distribute the sample uniformly over a wide range. The object of the present invention is to provide a test device in which a specimen is distributed uniformly.

[Means for Solving the Problems] and [Operations] In order to solve the above-mentioned problems and achieve the objectives, the test device of the present invention has the following features:
A test device in which a specimen is measured by a measuring device, a first opening for accessing the specimen, and a second opening that is placed in a front-back position relationship with respect to the first opening and is measured by the measuring means. A test device comprising: an opening area of the second opening is set smaller than an opening area of the first opening, so that a uniformly attached portion of the specimen is exposed to the second opening. It thus serves to measure the second opening.

[Embodiments] Hereinafter, embodiments of the present invention will be described in detail with reference to the accompanying drawings. FIG. 1 shows an external perspective view of a measuring device used for measuring the test device of the first embodiment, and the measuring device is provided with an insertion hole 24, which is an insertion opening into which the test device 1 shown by the two-dot chain line is inserted. 50 shows an example in which the measuring device 50 is configured for measuring blood sugar levels. In this figure, the measuring device 50 has a cover 38 formed on its outer peripheral surface, and the left half of the upper surface of the cover 38 is formed on the outer peripheral surface of the measuring device 50. is provided with a display section 51 made of liquid crystal or the like, while this display section 5
In front of 1 is a power switch 5 that turns the power on/off.
2, and a memory recall button 53 for recalling the date and time of past measurement and the blood glucose level at that date and time in the order of new measurement and displaying them on the display section 51. A total of three operation switches 54 are provided on the right side of the measuring instrument 50, and are used to set and change the date and time of measurement, to store measurement results, and the like.

Next, on the front part of the upper surface of the right half of the measuring instrument 50, there is provided a detachable sub-cover unit 22 that makes it easier to insert the test device 1 by forming a tapered part T starting from the edge of the insertion hole 24. An opening 40 to be attached to is formed up to a portion spanning the front surface.

There are two reasons why the sub cover unit 22 is detachably attached to the cover unit 38 in this way.
The second purpose is to allow the insertion hole 24 to be removed and washed with water if the insertion hole 24 becomes dirty with blood or dirt, and the second purpose is to attach the transparent body 3 to be described later.
Translucent body 32 to clean the surface of 2 using a cotton swab etc.
This is to make it accessible.

On the other hand, the test device 1 is inserted from above into the insertion hole 24 with the opening 4a in front as shown in the figure.
If this test device 1 is inserted with the front and back sides reversed, measurement cannot be performed, so a means for preventing reverse insertion, which will be described later, is provided.

FIG. 2 is a perspective view of the external appearance of the measuring section of the measuring device shown in FIG. 1, and the upper and lower parts of the cover 38 are cut away as shown in the figure to make it easier to see the measuring section into which the test tool I is inserted. At the same time, the secondary cover unit 22 is inserted into the opening 40 of the cover unit 38.
The sub cover unit 22 is shown removed from the cover unit 38.
The insertion hole 24 when the device is installed is shown in broken lines.

Further, the spring body 26 whose one end is fixedly supported by a stud 22b formed on the bottom surface of the sub cover unit 22 is also shown by a solid line and a broken line. When mounted as shown in the figure and the spring body 26 is placed in the position shown by the broken line, the outer surface 4 of the test device 1
As a result, when the test device 1 is inserted from above and placed at a predetermined measurement position, it does not move from the measurement position due to the elastic biasing force of the spring body 26. It will be done like this.

In this way, the auxiliary cover unit 22, which can be attached to and detached from the cover unit 38, must withstand a predetermined external force after being set. On the other hand, a part of the sub-cover unit 22 is formed with a male hooking portion 22a that is hooked on the hooking portion 40a as shown in the figure.

Next, a notch 24 a is formed in a part of the inner peripheral surface of the insertion hole 24 , and this notch 24 is formed in the outer surface 4 of the test device 1 .
The protrusion 4b formed on the lower right edge of C is shaped and positioned in a male-male relationship, so that the test device 1 can only be inserted when the opening 4a is facing forward as shown in the figure. hole 2
4 so that it can be inserted from above, thereby preventing reverse insertion of the front and back sides.

The detection body 28 is a molded member made of a light-blocking material that is integrally provided on a substrate on which electronic components are mounted, and has a cross-sectional shape of a "U" shape into which the test device 1 can be inserted from above, as shown in the figure. A letter-shaped groove portion is formed, and both side portions 28b and a contact portion 28a are formed in this groove portion. A microswitch 36 equipped with an actuator 36a is provided in the lower half of one of the both sides 28b as shown in the figure, and by turning on the actuator 36a when the test device 1 is inserted, the measurement can be started with the automatic star 1. I'm trying to make it possible.

Next, among the electronic components provided inside the detection main body 28, the light emitting element 30a and the light receiving element 30b emit and receive light of a predetermined wavelength along the optical path L shown by the broken line in the figure. The light emitted from the light-emitting element 30a is illuminated by a light-transmitting layer section (described later) provided in the opening 2a of the test device 1, and the amount of light reflected by the reagent layer section laid on the back side of the light-transmitting layer section is received. The basic principle of its operation is to detect using the element 30b. A transparent body 32 made of glass or the like is provided at a predetermined position of the detection body 28 facing the opening 2a of the test device 1.

FIG. 3 is a cross-sectional view of the measuring section in FIG. 2, and shows how the light output from the light emitting element 30a described above travels along the optical path L and is finally reflected by the light receiving element 30b. .

11 D2 In this figure, the test device 1 has its side portions 2C and outer surface portion 2f in contact with the both side portions 28b and the contact portion 28a that constitute the groove portion of the detection main body 28, respectively, as shown in the figure, and A pair of arcuate contact portions 26 formed on the above spring body 26
a to press the outer surface part 4C and hold it in the state shown in the figure,
The optical path L is such that the light reflected on the reagent layer section 8 passes through the transparent body 32.
The path through which light is emitted and received is shown.

In order to allow the optical path L to reach the reagent layer 8, the edge of the opening 2a of the test device 1 is chamfered in a circular shape at a predetermined angle (for example, 45 degrees) as shown in the figure. The light receiving element 30 of the light emitting element 30a is
It is possible to set a large allowable range of the mounting angle with respect to b.

Here, the edge of the opening 2a is not limited to an angle of 45 degrees as shown in the figure, and there is no need to chamfer the entire circumference.
What is necessary is to form a chamfered portion on a part of the edge.

Next, FIG. 4 is a partially cutaway front view of the test device of the example. In FIG. 4, the test device 1 has a base body 2 made of a resin material that can be injection molded and can be stably mass-produced, and has two gripping protrusions that the test subject can grip with his/her fingers. The upper half of the main body 2 is formed as shown in the figure, and the lower half of the main body 2 has a rectangular shape centered around the opening 2a shown in broken lines with the chamfered edges formed on the edges. A joint portion 2d is formed, and the main body 2
A box portion B is formed in the lower half of the box.

In this box part B, in order from the bottom, there is a light-transmitting layer part 6 whose one side is exposed through the opening 2a, and a light-transmitting layer part 6 coated on the light-transmitting layer part 6 to react with the sample, such as blood. a reagent layer section 8 for uniformly applying the test object onto the reagent layer section 8; A liquid absorbing layer section 12 for absorbing liquid is set as shown in the figure.

This liquid absorbing layer portion 12 is provided with an opening l2a having a larger opening diameter than the opening diameter of the opening 4a of the lid 4, and the radius up to the opening 4a of the lid 4 is Approximately 2.
The liquid absorbing layer portion 12 can be disposed inside the radius portion R of 8 mm as shown in the figure.

After this, the lid 4 with the opening 4a located approximately at the center is inserted into the guide hole 2e drilled on the joint 2d of the main body 2, as shown by the broken line provided in the lid 4. After the stud 4e is guided and aligned, the joint 2d of the main body 2 and the joint 4d of the lid body 4, which will be described later, are welded by ultrasonic welding, adhesive bonding, etc. to obtain a finished product of the test device 1. I have to.

Next, FIG. 5 is a cross-sectional view taken along a plane passing through the center of the opening of the test device.
A circular opening 4a with a diameter D2, which is a first opening, is formed in the main body 2, while a center line C. of the opening 4a of the lid 4 is formed in the main body 2. An opening 2a, which is a second opening, is formed with a common central axis L and a circular diameter D2 that is approximately half the diameter D1.

In addition, a part of the lower surface of the light-transmitting layer section 6 made of a transparent resin material is exposed to the outside through the opening 2a, while a reagent layer section on the upper surface of the light-transmitting layer section 6 undergoes a color reaction with the specimen. 8 is provided. A liquid developing layer 10 is laid on the layers 15 16 of the reagent layer 8, and a part of the upper surface of the liquid developing layer 10 is exposed to the outside through the opening 4a. The lower surface of the liquid developing layer section 10 is connected to the reagent layer section 8.
I try to make contact with.

Therefore, the specimen passes through the opening 4a to the liquid developing layer section 10.
After the reagent is developed, it permeates into the reagent layer portion 8 and causes a coloring reaction, so this coloring reaction is measured by an optical measuring means to obtain a measured value. For this measurement, the light from the light emitting element is directed against the opening 2a of the main body 2, and the amount of reflected light, which changes approximately in proportion to the color reaction, is detected by the light receiving element. Blood sugar levels are measured by measuring changes in blood sugar levels.

FIG. 6 is a cross-sectional view showing how the specimen is attached.
In this figure, a sample K of blood from a fingertip or the like permeates into the liquid spreading layer part 10 through the opening 4-a, and then into the reagent layer part 8. When taking the sample K, even if the opening 4a has an unattached area X where no sample K is attached as shown in the figure, the opening 2a is made smaller than the opening 4a, so that As shown in the figure, the unattached part X is the opening 2.
It is not exposed to a. That is, by attaching the sample K using the vicinity of the center of the opening 4a as a guide, the opening 2a where the measurement is performed will surely show a portion to which the sample K is evenly attached.

The operation of the test device configured as described above, that is, how to use it, is to turn on the power switch 52 in advance, and turn on the display section 5.
When the start of measurement is displayed at 1, the test device 1 with the specimen attached is inserted into the insertion hole 24. Next, the microswitch 3 attached to the detection main body 28 in FIG.
6 is turned on when one of the both side surfaces 2c of the test device 1 is brought into contact with the test device 1, and the light emitting element 30a and the light receiving element 30b immediately record the time course of the color reaction in the reagent layer 8 of the specimen.
Measured by Thereafter, the measurement results are displayed on the display unit 51 to complete one measurement, and the measurement values are stored.

In the above explanation, only the case of blood sugar level measurement was described, but other methods include uric acid, GTO. The test device of the present invention is applicable to analyzers for GPT, cholesterol, etc.

Furthermore, in addition to blood, the specimen can be applied to body fluids such as urine and saliva. Further, the first and second openings are not limited to circular shapes, but may be elliptical, polygonal, or the like.

[Effects of the Invention] As described above, according to the present invention, it is possible to provide a test device in which the specimen is uniformly distributed in the opening to be measured, even if the specimen is not uniformly adhered and distributed over a wide range. I can do it. Furthermore, after the measurement is completed, the measurer only needs to check the uniformity of the coloring within the measurement window to determine whether a uniform coverage distribution has been obtained, that is, whether accurate measurements have been made. be able to.

[Brief explanation of drawings]

Fig. 1 is an external perspective view of the measuring device used for automatic measurement of the test device of the example, Fig. 2 is an external perspective view of the measuring section of the measuring device shown in Fig. 1, and Fig. 3 is an external perspective view of the measuring section of the measuring device shown in Fig. 2. 4 is a partially broken front view of the test device of the example, FIG. 5 is a sectional view taken along a plane passing through the center of the opening of the test device, and FIG. 6 is a specimen attached. Figure 7 is a cross-sectional diagram illustrating the situation, and Figure 7 is the first diagram of the test device proposed by the applicant. In the figure, 1, 1A, IB... test tool, 2... main body, 2
a...Opening part, 2b...Gripping convex part, 2c...Both sides, 2d...Joint part, 2e...Guide hole part, 4...
・Lid body, 4a...opening, 4b...protrusion, 4c・
...Outer surface part, 4d...Outer surface part, 4d...Joint part, 6
...Transparent layer part, 8...Reagent layer part, 10...Liquid developing layer part, 12...Liquid absorption layer part, 22...Sub cover integrated, 2
2a...Latching part, 22b...Stud, 24...
Insertion hole, 24a... Notch, 26... Spring body, 26
a... Contact part, 26b... Opening part, 28... Detection main body, 28a... Contact part, 28b... Both sides, 30
a... Light emitting element, 30b... Light receiving element, 32...
Translucent body, 38... Cover integrated, 40... Opening, 40
a...Latching part, 50...Measuring device, 5l...Display part, 52...Power switch, 54...Operation switch, C...Chamfer part, K...Specimen, X ...It is an unattached part. Patent applicant: Terumo Corporation

Claims (1)

[Scope of Claims] A test device in which a sample is spread on the test device and measured by a measuring device, comprising: a first opening for accessing the sample; and a front and back positional relationship with respect to the first opening. Along with being
and a second opening to be measured by the measuring means, wherein the opening area of the second opening is set smaller than the opening area of the first opening to ensure uniform adhesion of the specimen. A test device characterized in that a portion thereof is exposed to the second opening.