JPH0395460A - Testing tool - Google Patents

Abstract

PURPOSE:To avoid hindrance of measurement of a measuring means by forming an inclining part for a first opening for collecting a test specimen at an edge of a second opening which is measured by said measuring means. CONSTITUTION:A box part B is formed at the lower half of a main body 2, wherein a light passing layer 6 one surface of which is exposed from an opening 2a, a reagent layer 8 which reacts with blood or the like of a test specimen applied over the light passing layer 6, a cloth liquid developing layer 10 for uniformly applying specimens to be tested and, a liquid adsorbing layer 12 for adsorbing excessively supplied specimens to be tested are set sequentially from below. A chamfered part is formed all over the circumference of the opening 2a of a main body 2 of a testing instrument 1. When a light is radiated from a light emitting element to the opening 2a of the main body 2 for measuring the test specimen, the reflecting amount of light which changes generally proportionally to the color reaction is detected by a photo detecting element.

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 sample collected on 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 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 spreading layer for uniformly spreading the specimen is fixed integrally with the holding member by pressing the holding member so that the spreading layer is on the outside.

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, the main body 200 of the test device 1oO has an opening 200a with a diameter of d2, while the lid 40 has a diameter of d2.
0 is integrally provided with the main body 2o○ by gluing or the like as shown in the figure, and this lid body 400 has the main body 20
0 centerline of the opening 200a C. An opening 40 having a common central axis L and 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]O is exposed to the outside through the above-mentioned opening 400a. The lower surface of the developing 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 is permeated into the reagent layer section 8 and undergoes a coloring reaction, so this coloring 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 developing layer 10 are set as described above. Since the opening 400a of the liquid developing layer section 10 is approximately the same as that of
It is necessary to distribute the specimen that has reacted with the reagent layer uniformly over the entire range of the opening 200a of the light-transmitting layer 6 by spreading the specimen uniformly over a wide range. Since it is very difficult to distribute the sample uniformly across the area, the opening area of the second opening for sample measurement is made smaller than that of the first opening for attaching the sample. It has been proposed that if the sample adheres to the second opening as a guideline, it will adhere uniformly to the second opening.
For example, there is a problem in that the optical path of the measuring means is obstructed by the corner of the second opening.

Therefore, the test device of the present invention has been developed in view of the above-mentioned problems, and its purpose is to provide a second opening for measuring the sample rather than a first opening for attaching the sample. In a test device in which the opening area of the T opening is made small so that if the specimen is deposited near the center of the T-opening, it will adhere uniformly to the second opening. The objective is to provide a test device that is not inhibited by

[Means for Solving the Problems] and [Operation] In order to solve the above problems and achieve the objectives, the test device of the present invention has the following features:
In a test device in which a sample is spread on the test device and measured by a measuring device, the test device includes a first opening for collecting the sample, a front-back position relative to the first opening, and a measuring means. a second opening to be measured, and a sloped portion is formed at the opening edge of the second opening so as not to impede measurement by the measuring means.

[Example] Hereinafter, an example according to 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 instrument 50 has an integral cover 38 formed on its outer peripheral surface, and a display section 51 made of liquid crystal or the like is provided on the left half of the upper surface of the integral cover 38.
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 a detachable sub-cover unit 22 that has a tapered part T starting from the edge of the insertion hole 24 to facilitate insertion of the test tool. 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 integrated 22 is carved into the cover integrated 38 and attached detachably in this way.The first is that the sub-cover integrated 22
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 facing you 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 an external perspective view 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 is inserted. At the same time, the secondary cover unit 22 is inserted into the opening 40 of the cover unit 38.
It is shown removed from the cover, and the sub-cover 22 is attached to the cover 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
c is suppressed by the abutting tip of the spring body 26, and as a result, when the test device 1 is inserted from above and brought to a predetermined measurement position, it does not move from the measurement position due to the elastic 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 male hooking portion 22a that is hooked to the hooking portion 40a is formed in a part of the sub-cover unit 22 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 .
As a result of the male-male shape and positional relationship with the protrusion 4b formed on the lower right edge of c, 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 is formed, and this groove has both side portions 28b and an abutting portion 28a. 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 measurement can be started automatically by turning on the actuator 36a when the test device 1 is inserted. I have to.

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 irradiated onto 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 surface of the light-transmitting layer section is reflected by the receiver 11. 12 The basic operating principle is detection by the optical element 30b. A light transmitting hole 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.
Finally, it shows how the light receiving element 30b is illuminated by people.

In this figure, the test device 1 has its side parts 2C and outer surface part 2f in contact with both sides 28b and contact part 28a, which constitute the groove of the detection main body 28, respectively, as shown in the figure, while the above-mentioned spring A pair of arcuate contact portions 26 formed on the body 26
The light path L is maintained in the illustrated state by pressing the outer surface portion 4c with
2 shows a path through which light is emitted and received.

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 first embodiment. 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 with a shape on the surface as shown in the figure, while the lower half of the main body 2 has a rectangular shape centered on the opening 2a shown in broken lines with the above-mentioned chamfered part formed on the edge. A shaped joint portion 2d is formed, and a box portion B is formed in the lower half of the main body 2.

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 spreading layer section 1o made of cloth for uniformly applying the test object on the reagent layer section 8, and a liquid spreading layer section 1o made of cloth for uniformly applying the test object on the liquid spreading layer section 10. A liquid absorbing layer portion l2 for absorbing liquid is set as shown in the figure.

An opening 12a having a larger opening diameter than the opening 4a of the lid 4 is formed in the liquid absorbing layer 12, 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 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 diagram showing an external perspective view corresponding to the back side of the main body 2 in FIG.
A chamfered portion is formed around the entire circumference of the opening 2a of the main body 2.

15 1 6 As a result, in order to measure the specimen, the opening 2a of the main body 2 is irradiated with light from the light emitting element, and the amount of reflected light, which changes approximately in proportion to the color reaction, is detected by the light receiving element. For example, blood sugar levels are determined by measuring temporal changes in color reaction.
The light irradiated onto the light-transmitting layer section 6 at an angle of 1.5 degrees is reflected by the light-transmitting layer section 6 and then irradiated onto the light-receiving element 30b.

Next, FIG. 6 is an external perspective view of the main body 2 of the test device according to the second embodiment. This figure is the same as FIG. 5, and the same parts are given the same symbols as in FIG. 1. The explanation will be omitted and only the different parts will be explained.The opening 2a is formed as a straight hole, and there is a chamfered part C on a part of the edge.
The above-mentioned optical path L passes through the chamfered portion C. In this way, the opening 2a may be shaped as long as the optical path L is not obstructed.

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 then turn on the display section 5.
1, the test device 1 from which the specimen has been collected 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 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, the opening area of the second opening for specimen measurement is made smaller than that of the first opening for specimen attachment, so that the area near the center of the first opening is smaller than that of the first opening for specimen attachment. It is possible to provide a test device in which the measuring means is not obstructed by the corners of the second opening in a test device in which the specimen adheres uniformly to the second opening if the specimen is applied as a guideline.

[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 cutaway front view of the test device of the first embodiment, FIG. 5 is an external perspective view corresponding to the back side of the main body in FIG. 4, and FIG. 6 is a partially cutaway front view of the test device of the first embodiment. FIG. 7 is a perspective view of the appearance of the test device, and is the first view of the test device proposed by the applicant of the present application. In the figure, l, 1a...opening, 2d...junction, 2 4a...opening, 4d...outer surface part, 8...reagent layer part, A, IB... Test device, 2...Main body, 2b...Gripping convex portion, 2c...Both sides, 2e...Guide hole portion, 4.
...Lid body, 4b...Protrusion, 4c...Outer surface part, 4d...Joint part, 6...Transparent layer part, 10...Liquid spreading layer part, 12...
...Liquid absorption layer 1920 parts, 22...Sub-cover integrated, 22a...Latching part, 22
b... Stud, 24... Insertion hole, 24a... Notch, 26... Spring body, 26a... Contact part, 26b
. . . Opening portion, 28 . . . Detection main body, 28a . . . Contact portion, 28b .
b... Light receiving element, 32... Transparent body, 38... Cover integrated, 40... Opening portion, 40a... Latching portion, 50...
... Measuring device, 51... Display unit, 52... Power switch, 54... Operation switch, C... Chamfered portion.

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 collecting the sample; and a front and back positional relationship with respect to the first opening. Along with
a second opening to be measured by the measuring means, and a sloped portion is formed at an opening edge of the second opening so as not to impede measurement by the measuring means. Ingredients.