JPH0395434A - Measuring apparatus - Google Patents

Abstract

PURPOSE:To enable quick detection of and information on whether a test piece is set in a normal direction or not, by determining whether the intensity of a reflected light is within a prescribed range or not, when it is detected that the test piece is set. CONSTITUTION:A test piece provided with test paper developing a color in reaction with a specimen is set in the main body of an apparatus, a light emitted from LED (light-emitting element) 30a and reflected from the test paper is detected 76 from a photosensor 30b, and based on the intensity of the detected reflected light, the concentration of a component of the specimen is determined in a control unit 70. On the occasion, an actuator of a microswitch is pushed down by the lateral side of the test piece when the piece is set, and the setting of the test piece is detected from a signal of the switch. When the intensity of the reflected light is detected 76 by the sensor 30b, it is determined whether or not the intensity is within a prescribed range stored in ROM 73. When it is not within the range, it is displayed 51 and also informed by a buzzer 79 that measurement can not be executed.

Description

[Detailed Description of the Invention] [Industrial Application Field] The present invention relates to a measuring device that attaches an analyte to a test paper of a test strip, attaches the test strip, and measures the component concentration of the sample. In particular, the present invention relates to a blood component measuring device for determining the concentration of components in blood.

[Prior Art] In a conventional blood component measuring device, after attaching the blood whose component concentration is to be measured to a test strip, the test strip is attached to the measuring device, and a predetermined period of time elapses until the test strip reacts with the blood components. is configured to wait for the measurement to start. For ease of operation, such test strips are generally housed in a small disposable container called a test strip. Blood is applied to the test strip through an opening in the container, and the container is attached to the main body of the device. . After the test paper is attached to the device, light is irradiated onto the test paper through an opening provided on the back side of the test paper, and the intensity of the reflected light is measured.

[Problems to be Solved by the Invention] However, in the above conventional example, even if the container is mistakenly attached to the device body in the opposite direction during measurement, the predetermined time period for the reaction of the test strip to complete will still elapse. Afterwards, the measurement results are output. Even if it is discovered for the first time that the container was attached in the wrong direction due to an abnormal measurement result, the test strip must be used again for measurement because it has been more than a predetermined time since it reacted with blood. Therefore, it was necessary to repeat the measurement from the beginning using a different test paper. In addition, the measurement result could not be determined as an abnormal value, and information on the abnormal measurement value was to be notified to the measurer.

The present invention has been made in view of the above-mentioned conventional example, and when a test piece to which a specimen to be measured is attached is attached to a measuring device, it is checked whether the test piece is attached in the correct direction or not. The purpose of the present invention is to provide a measuring device that can immediately detect and notify when

[Means for Solving the Problems] In order to achieve the above object, the measuring device of the present invention has the following configuration. That is, a measuring device that measures the component concentration of the sample by attaching a test piece equipped with a test paper that changes color in response to a sample component to the device main body, the test strip being irradiated with light, and the test strip being colored in response to the sample component. detection means for detecting reflected light from paper; determining means for determining the component concentration of the sample based on the intensity of the reflected light detected by the detection means; and detection means for detecting that the test piece is attached to the apparatus main body. a determination means for determining whether the intensity of reflected light from the detection means is within a predetermined range when the attachment of the test strip is detected by the test strip detection means; and the determination means When it is detected that the reflected light intensity is not within a predetermined range, the measuring means notifies that measurement is impossible.

[For use] In the above configuration, the test piece is irradiated with light and the reflected light from the test piece is detected. Based on the reflected light intensity thus detected, the component concentration of the specimen is determined. During this measurement, when it is detected that the test piece is attached to the main body of the device, it is determined whether the reflected light intensity is within a predetermined range, and if the reflected light intensity is not within the predetermined range, measurement is not possible. I'm trying to let you know.

[Embodiments] Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the accompanying drawings.

[Overall Description (FIGS. 1 and 2)] FIG. 1 is an external perspective view of an automatic blood glucose measuring device 50 according to an embodiment.

In FIG. 1, 50 indicates the main body of the automatic blood glucose measuring device, and 51 indicates a display section such as a liquid crystal display for displaying measurement results and the like. 52 is a power switch, and when the power of the device 50 is turned off, pressing this switch 52 turns on the device 5.
0 is turned on, and if pressed while in the on state, the power of the device 50 is turned off. Reference numeral 53 denotes a memory recall switch, and each time this switch 53 is pressed, the measurement results stored in the memory built into the device are sequentially read out along with the measurement date and time and displayed on the display section 51. 1 is a blood glucose test strip, which is inserted into the opening 24 of the device 50 and attached. The blood applied to the opening 4 of the test strip 1 reacts with the test paper built into the test strip, and the color of this test paper changes to the opening on the back side of the opening 4 of the test strip. (2a in FIG. 3), the blood sugar level of the blood is measured by photoelectrically reading.

Reference numeral 54 denotes a memory cancel switch. When measuring blood sugar levels, if this switch 54 is not pressed within a predetermined period of time after the end of the measurement, the measured blood sugar level is automatically stored in the memory, but after the end of the measurement, By pressing this switch 54 within a predetermined time, it is possible to prevent the blood sugar level measured immediately before from being stored in the memory. This makes it possible to prevent the value from being stored in the memory if, for example, the blood adhesion to the test strip is defective or the measured value becomes abnormal due to an operational error.

55 is a date and time setting switch, and by pressing this switch 55, the values (month, day, hour, minute) can be set. Reference numeral 56 denotes a change switch, which allows the date and time specified by the setting switch 55 to be changed and set.

[Description of Device Configuration (FIG. 2)] FIG. 2 is a block diagram showing the configuration of the automatic blood sugar measuring device 50. Portions common to those in FIG. 1 are designated by the same numbers, and their explanation will be omitted.

In the figure, 70 is a control unit that controls the entire device, and is used as a work area for a CPU 72 such as a microprocessor, a ROM 73 that stores control programs and various data for the CPU 72 shown in the flowchart of FIG. It is equipped with a RAM 74 for storing measurement results and the like along with measurement dates and times. This control unit 70 inputs the states of various connected switches, performs processing corresponding to these inputs, and also performs processing corresponding to the inputs.
The blood sugar level can be determined by reading the signal value from 0b, and the measurement results and the contents of the memory (RAM 74) can be displayed on the liquid crystal display section 51.

36 is a switch that detects that the test piece 1 is inserted into the opening 24. When the test piece 1 is inserted, the switch is turned on, and when the power of the device 50 is on, the blood glucose level can be measured by this switch. Started automatically.

Reference numeral 75 denotes an LED driver, which lights and drives the LED 30a with a constant current according to instructions from the control unit 70. LED30
a is irradiated from the back side of the test piece 1 (the invisible part of the test piece 1 shown in Fig. 1), and the reflected light is reflected by the photo sensor 3.
0b, and the blood sugar level of the blood is determined based on the intensity of the reflected light. 76 is a signal detection circuit for converting the reflected light intensity detected by the photo sensor 30'b into a voltage value. The analog signal from the signal detection circuit 76 is input to the control section 70, A/D converted, and input to the CPU 72 as a digital signal corresponding to the intensity of the reflected light. A battery 77 serves as a power source that supplies power to the entire device 50. Reference numeral 78 denotes a timer provided in the control unit 70, which measures a predetermined time according to instructions from the CPU 72. Reference numeral 79 denotes a buzzer, which notifies the operator of a warning, or the elapse of one second during a countdown display, which will be described later, the end of measurement, an error, and the like.

[Explanation of the insertion part of the test strip (Figs. 3 and 4)] Fig. 3 is a diagram showing details of the insertion part of the test piece 1 of the blood glucose measuring device 50 of the embodiment, which is shown in the above-mentioned drawings. Identical parts are indicated by the same numbers.

FIG. 3 shows the state in which the sub cover unit 22 is removed from the main body part 50, and the portion indicated by the dotted line of the spring body 26 that presses the opening 24 and the test piece 1 is in the state where the sub cover unit 22 is attached. The position of each part is shown. device 50
The test piece 1 inserted and mounted is pressed toward the transparent plate 32 by the spring member 26. The light L from the LED (light emitting diode) 30a passes through the transparent plate 32 and illuminates the test paper from the opening 2a of the test piece l, and the reflected light reaches the photo sensor 30b. This configuration will be explained in detail with reference to FIG.

36 is a microswitch for detecting that the above-mentioned test piece 1 is attached, and when the test piece 1 is attached, the test piece l
The actuator 36a of the microswitch 311 l2 6 is pushed down by the side surface of the microswitch 311 l2 6 and turned on. Thereby, the control section 30 can input the signal from this switch 36 and detect that the test piece 1 is completely attached to the main body 50. Note that this actuator 36a does not turn on the switch 36 unless the test piece 1 is properly attached.
It is also possible to detect improper mounting of the test piece 1 using the signal from the test piece.

FIG. 4 is a sectional view showing the test piece 1 attached to the main body 50, taken along line AA' in FIG.

Blood adhering through the opening 4 of the test piece 1 spreads through the liquid development layer 10 and penetrates into the reagent layer (test paper) 8. Reference numeral 12 denotes a liquid absorbing layer section for absorbing excess blood that is not absorbed by the liquid spreading layer section 10. 6 is a transparent light-transmitting layer portion through which light passes.

The light L from the LED 30a passes through the transparent plate 32 and the light-transmitting layer 6 and is irradiated onto the test paper 8, and the photo sensor 30 is provided at a position making an angle of approximately 45 degrees with respect to the human light.
The reflected light from the reagent layer section (test paper) 8 reaches point b.

Thereby, the reaction color of the test strip 8 is read, and the blood sugar level of the blood is determined.

Here, blood is attached through the opening 4 and the liquid spreading layer 10
The time it takes for the reagent to penetrate into the reagent layer 8 and react is about 1 minute. Therefore, in this automatic blood sugar measuring device, the blood sugar level is measured after one minute has elapsed since the test piece 1 was inserted and attached. Note that 2 indicates the main body of the test piece 1. Reference numeral 4a denotes a tapered portion provided on the side of the opening 4, which facilitates the adhesion of blood. Further, 2b is a tapered portion of the opening 2a, which is approximately 45 mm.
It is formed at an angle of .degree., allowing light from the LED 30a to enter.

FIG. 5 is an external view showing the shape of test piece 1 of the example.
FIG. 5(A) is a front perspective view, and FIG. 5(B) is a back perspective view.

Here, blood adheres to the opening 4, and its color is red. On the other hand, the opening 2a is on the discoloration test paper side,
The color changes in intensity over time.

[Explanation of operation of blood sugar measuring device (Figs. 1 to 7)] Fig. 6 is a flowchart showing the operation of the blood sugar measuring device of the embodiment.
It is stored in 3.

The process shown in FIG. 6 is started when the power switch 52 of the device 50 is pressed to turn on the power, and step Sl
All the items that can be displayed are displayed on the display section 51 for about several seconds so that it can be confirmed whether the display section 51 is functioning normally. Next, the process proceeds to step S2, and it is checked whether the test piece 1 is attached by checking whether the switch 36 is turned on. If the switch 36 is not turned on (when the test piece 1 is not attached), the process proceeds to step S3. and check whether a predetermined period of time (for example, 5 minutes) has elapsed. When the predetermined time has elapsed, the process proceeds to step S5, and the power of the device is turned off. If the predetermined time is not counted in step S3, step S
The process advances to step S4 to check whether the power switch 52 has been pressed, and if the switch 52 has been pressed, the process advances to step S5 to turn off the power.

When it is detected in step S2 that the test piece 1 is attached, the process proceeds to step S6, where the LED 30a is turned on at 1 5 1 6, and after waiting for the LED 30a and the circuit to become stable,
The intensity of reflected light from the test piece 1 is detected by the photo sensor 30b. The reflected light intensity measured at that time is
If it is within the predetermined range stored in step S.
Proceed to step 10 to perform normal measurement processing. However, if it is not within the predetermined range, the process proceeds to step S8, where the buzzer 79 sounds and "Err" is displayed on the liquid crystal display section 5l.Then, in step S9, the test piece 1 is not attached or detached. Wait and return to step S2.

When proceeding from step S7 to step S8 in this way, the test piece l is inserted into the apparatus main body in the opposite direction, and the LED 30
This occurs when the light a illuminates the blood in the opening 4 and the reflected light is input to the photo sensor 30b. As mentioned above, the color of the test paper in the opening 2a is almost white at first, and its density increases with time, whereas the color of the test paper in the opening 4 is almost white.
is coated with blood, the color of which is highly concentrated and almost constant. Therefore, if the test piece 1 is inserted into the opening 24 of the device with the orientation opposite to that shown in Figure 1, the color of the blood adhering to the opening 4 will be measured, and the measured concentration value will be abnormal. It gets expensive.

FIG. 7 is a diagram showing the relationship between the measurement time and the measured concentration of the test strip 1 on which blood is applied.

When the test piece 1 is attached to the device main body at timing T1,
The concentration of test piece 1 gradually increases as shown by curves 81 to 83. In the blood sugar level measuring device 50 of this embodiment,
The measurement was performed approximately 1 minute after inserting the test piece 1. 81 is for high blood sugar level, 82 is for medium blood sugar level,
83 shows the change in reaction color of the test paper of test piece 1 in the case of a low blood sugar level. On the other hand, 84 indicates the measured concentration of the color of blood (the color of the opening 4), and this measured concentration maintains a substantially constant high concentration state regardless of time. Therefore, when the reflected light intensity is measured by the photo sensor 3ob at timing T2, it shows that when the test piece 1 is inserted in the opposite direction,
When the test piece 1 is inserted in the correct direction, the difference in measured concentration becomes large as shown at 86, and it is therefore possible to detect whether the test piece 1 is inserted in the opposite direction.

Further, FIG. 8 is a diagram showing the relationship between the reflected absorbance of the test paper and blood with respect to the wavelength of light.

88 shows the absorbance of blood (opening 4 side), and the other curves show the absorbance of the test paper (opening 2a side). Therefore, if the intensity of the reflected light from the test strip is detected using the LED 30a that outputs light with a wavelength (500 to 600 nm), the reflected light from the test strip or the blood will be detected. That is, the reflected light from the aperture 4,
Whether the light is reflected from the opening 2a can be easily identified just by the intensity of the reflected light. Therefore, it is possible to identify whether the test piece 1 is inserted in the normal direction (the direction shown in FIG. 1) or in the reverse direction.

In this way, when it is detected in step S7 that the test piece is inserted in the normal direction, the process proceeds to step S10, where "60" seconds is displayed on the display section 51 and the measurement process is started.

Note that at this time, the LED 30a is turned off in order to suppress power consumption. Next, wait for one second to elapse in step Sll.

When one second has elapsed, the process advances to step S12, where the buzzer 79 sounds, counts down one second, and displays the remaining time. Incidentally, the total of 1920 hours of each of these times may be determined by the above-mentioned timer 78, and the ROM
The time may also be measured by software using a control program stored in 73. When one minute has elapsed in step S13, the process advances to step S16 to perform measurement processing. During this time, if it is detected in step S14 that the test piece 1 has been attached or detached by a signal from the switch 36, the process proceeds to step S15, where an error message is displayed on the display section 51 and the buzzer 79 sounds.

In step S16, a signal is output to the LED driver 75 to cause the LED 30a, which had been off until then, to emit light, and in step S17, the intensity of reflected light detected by the photosensor 3ob is read. This reflected light intensity is output from the signal detection circuit 76, and is converted into a digital signal by the control section 70.
Manually powered by PU72. When the reflected light intensity is thus input, the process proceeds to step S18, where the LED 30a is turned off and the blood sugar level is determined based on the reflected light intensity. For example, a table storing reflected light intensity values corresponding to blood sugar levels is prepared in the ROM 72, and the blood sugar level is determined by referring to the table based on the input reflected light intensity. do it.

Once the blood sugar level is determined in this way, the process proceeds to step S19.
The measurement results are displayed on the display section 51.

At this time, if the measured value is below a predetermined range, data indicating that, for example, ゛L○゛゜, is displayed on the display section 51.
and if it is above a predetermined range, for example ゜'Hi'”
etc. may be displayed to inform the operator that the measured value is abnormal.

When the measurement process is completed in this way, it is checked in steps S20 and 322 whether the memory cancel switch 54 is pressed within a predetermined time (approximately 3 minutes). Switch 5 within a predetermined time
If 4 is not pressed, the process advances to step S23, and the measurement results are stored in the RAM 74 along with the current date and time. on the other hand,
When the memory cancel switch 54 is pressed in step S20, the process advances to step S21, where the display unit 51 displays that the memory has been canceled, and the process returns to step S9.

As explained above, according to this embodiment, by attaching blood to the test piece 1 and immediately inserting the test piece 1 into the device 50, the blood sugar level of the blood to be sampled is automatically determined. be measured. At this time, if the test piece 1 is inserted in the opposite direction, an error message is immediately displayed, so that the operator can insert the test piece 1 in the correct direction again and perform the measurement.

Note that in this example, the case of a blood sugar measuring device was explained, but
The present invention is not limited to this, for example, uric acid,
G.T.O. Of course, it can be applied to analyzers for GPT, cholesterol, etc. In addition to blood, the specimen may also be body fluids such as urine and saliva.

[Effect of the invention] As explained above, according to the present invention, the specimen to be measured is
This has the effect of immediately detecting and informing whether or not the test piece is installed in the correct direction when the test piece is placed in the measuring device.

[Brief explanation of drawings]

Fig. 1 is an external perspective view of the automatic blood sugar level measuring device of this embodiment, Fig. 2 is a block diagram showing the configuration of the automatic blood sugar level measuring device, and Fig. 3 shows details of the test piece mounting section. FIG. 4 is a diagram showing the AA' cross-sectional shape of FIG. 3 with the test piece attached, FIG. 5 is a diagram showing the external shape of the test piece of the example, and FIG. 6 is the example. Figure 7 is a diagram showing the relationship between the measurement time of a test strip with blood and its measured concentration, and Figure 8 is the reflection of the test strip and blood against the wavelength of light. FIG. 3 is a diagram showing the relationship with absorbance. In the figure, 1... test piece, 2a, 4... opening, 6...
・Transparent layer part, 8... Reagent layer part (test paper), 1o...
Liquid development layer part, l2...Liquid absorption layer part, 22...Sub cover integrated, 24...Opening part, 30a...LED (light emitting element), 3ob...Photo sensor, 32...Transparent board,
36... Micro switch, 50... Automatic blood sugar level measuring device, 52... Power switch, 53... Memory recall switch, 54... Memory cancel switch, 55...
Setting switch, 56... Change switch, 75...L
ED driver, 76...signal detection circuit, 77...battery, 78...timer, 79...buzzer.

Claims (2)

[Claims] (1) A measuring device that measures the component concentration of the sample by attaching a test piece equipped with a test paper that changes color in response to a sample component to the main body of the device, and irradiating the test paper with light, a detection means for detecting reflected light from the test strip; a determining means for determining the component concentration of the sample based on the intensity of the reflected light detected by the detection means; a test piece detection means for detecting; a determination means for determining whether the intensity of reflected light from the detection means is within a predetermined range when attachment of the test piece is detected by the test piece detection means; A measuring device comprising: notifying means for notifying that measurement is impossible when the means detects that the reflected light intensity is not within a predetermined range. (2) One surface of the test piece has a first surface on which the specimen is attached.
and a second opening on the back side of the surface at a position corresponding to the first opening for irradiating light onto the test paper and reading the reflected light. The measuring device according to claim 1, characterized in that: