KR20110003684A - Diagnosis strip and measuring apparatus for it - Google Patents

Abstract

PURPOSE: A diagnosis strip and measuring apparatus for the same is provided to detect the shortage of a sample and the kind of hematocrit and a sample by measuring by measuring the time it takes a reflectivity value to reach a setting value according to color change. CONSTITUTION: A sample(17) is loaded in a mesh(15) for sensing a sample. An electric signal created in the mesh for sensing the sample is detected to recognize a loading time of the sample. The sample is reacted with an enzyme reaction layer(14), and the color of the enzyme reaction layer is changed. Reflectivity according to color change is measured by radiating on the enzyme reaction layer. The time it takes a reflectivity value to reach a setting value from the loading time according to color change is measured.

Description

Diagnostic strip and measuring apparatus for it

The present invention relates to a diagnostic strip and a measuring apparatus thereof, and more particularly, to a diagnostic strip and a measuring apparatus for recognizing information about a sample loaded on the diagnostic strip.

In general, blood consists of about 55% of body fluid plasma and about 45% of tangible blood cells. Plasma is 92% water, 6.5-7% plasma protein, and the remaining 1-1.5% are inorganic salts, enzymes, hormones, vitamins, lipids and sugars. The tangible component of blood cells consists of erythrocyte (RBC), leukocyte (WBC) and platelets, most of which are occupied by red blood cells.

Diagnostic strips are commonly used for the purpose of quantitative analysis as well as qualitative analysis of biological samples (including blood). Quantitative analysis uses optical methods or electrochemical methods.

Among them, the quantitative analysis method using the optical method can be read by a transmission method using a conventional spectrophotometer, measured by reflectance using a conventional spectrophotometer, or the reaction results can be read as an image using a camera or the like. Various analysis methods are used, including post-processing and analysis.

Diagnostic strips using this optical method generally form a membrane treated with a coloring reagent that reacts with a biological sample on a support. Therefore, when the biological sample is dropped, the sample enters through the micropores formed in the membrane and reacts with the color developing reagent, thereby discoloring, and analyzing the degree of discoloration by the above-described quantitative analysis method.

The most problematic problem in biosensors using such a blood as a physiological sample is interference of tangible components, ie, red blood cells. The percentage of red blood cells in the blood can be expressed as a percentage value, which is called the red blood cell volume (hematocrit, Hct). The normal range of erythropoiesis varies according to adults, pregnant women, and newborns. Although there are differences among individuals, the normal range is 35-50% for normal adults, but lower for pregnant women and higher for newborns.

However, this wide range of red blood cell volume ratios can lead to errors in measurements in biosensor systems. For example, blood glucose measurement has important clinical significance for adults, pregnant women, newborns, etc. In general, blood with a high red blood cell volume shows lower than actual values for blood glucose measurement, while low red blood cells Blood with a volume fraction causes problems with higher values.

In addition, in order to accurately analyze the blood loaded on the diagnostic strip by an optical method, an appropriate amount of blood must react with the color developing reagent, but when the amount of blood is insufficient, accurate analysis is not performed.

On the other hand, the kinds of samples that can be used to collect a certain amount of the sample is a blood, plasma, control solution.

Here, the blood is composed of plasma and blood cells as described above, the plasma refers to plasma free of tangible components such as red blood cells, etc., the control solution is a solution artificially made to characterize the strip.

However, there is a problem in that there is no diagnostic strip and a measuring device thereof that can distinguish the type of the sample.

The present invention has been made in view of the above, when the sample is loaded into the diagnostic strip receives an electrical signal generated in the conductive mesh, the sample received when receiving the optical signal generated in the enzyme reaction layer due to the loaded sample By measuring the time taken from the time when the reflectance according to the degree of color change reaches the set value, this time difference can be used to recognize the lack of sample volume, hematocrit, and the type of sample. It is an object of the present invention to provide a diagnostic strip and a measuring device thereof that can be used as calibration information.

The above object is to provide a diagnostic strip for analyzing biological samples,

A strip body having a sample loading hole to allow a sample to flow therein;

A loading time detector for detecting an loading time of a sample by generating an electrical signal when loading a sample into the sample loading hole;

It is achieved by a diagnostic strip comprising a; enzyme reaction layer that changes color by reacting with the sample introduced into the inside of the strip body through the sample loading hole.

In addition, another aspect of the present invention is a diagnostic strip measuring apparatus in which the diagnostic strip is inserted through the strip insertion hole,

An electric signal detector which receives a signal from the loading time detector and detects a loading time of a sample;

An optical signal detector for measuring a reflectance of reflected light reflected by irradiating light onto the enzyme reaction layer;

Receive a signal from the electrical signal detection unit and the optical signal detection unit, respectively, from the loading time of the sample to measure the time taken for the reflectance according to the discoloration of the enzyme reaction layer to reach the set value, whether the amount of sample is sufficient, red blood cell volume ratio, Determination unit for grasping the type of the sample; is achieved by the diagnostic strip measuring apparatus comprising a.

Accordingly, according to the diagnostic strip measuring apparatus and the method for recognizing the sample information of the diagnostic strip according to the present invention, the enzyme from the sample loading time using the electrical signal generated when the sample is loaded and the optical signal generated by the reaction of the loaded sample By measuring the time it takes for the color change level of the reaction layer to reach a certain level, it recognizes the information of the sample and corrects the error of measurement value that may occur according to the sample amount, hematocrit (red blood cell volume ratio) and the type of the sample. can do.

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

1 is a perspective view showing an optical signal detection unit according to an embodiment of the present invention, Figure 4 is a cross-sectional view showing a state in which the optical signal detection unit is inserted into the strip measuring unit according to an embodiment of the present invention, Figure 5 A plan view showing a state before the optical signal detection unit is inserted into the strip measuring apparatus according to an embodiment of the present invention.

The present invention relates to an apparatus for measuring a diagnostic strip, which measures an electrical signal and an optical signal generated when loading a sample (17), and provides information about the sample (17) through a difference in time at which the electrical and optical signals are generated. The present invention relates to a measuring device for a diagnostic strip capable of correcting an error in a measured value according to the information of a sample (17).

The diagnostic strip according to an embodiment of the present invention includes a strip body 10 including a loading point detection unit and an enzyme reaction layer 14. The strip body 10 may include a strip cover 12 including a loading point detection unit and a strip base 11 including an enzyme reaction layer 14.

The strip cover 12 covers an upper portion of the strip base 11, one end of the strip cover 12 is hinged to one end of the strip base 11, and the other end of the strip cover 12 rotates up and down. Possibly combined.

In this case, a sample loading hole 13 in which the sample 17 is loaded is formed in the strip cover 12, and a loading point detection unit is mounted in the sample loading hole 13.

The loading time detection unit includes a mesh unit 15 for generating an electrical signal when a sample is loaded, and an electrode unit 16 connected with the mesh unit 15 to transmit an electrical signal to the strip meter 20. .

The mesh portion 15 may be coated with a metal surface to generate an electrical signal as a mesh structure.

Here, when the mesh unit 15 is coated with a metal, the mesh unit 15 itself may generate an electrical signal, but when the mesh unit 15 is not a conductive material, the metal wire may contact the sample 17. It should be inserted into a part of the mesh portion 15.

When power is applied to the mesh unit 15 and the sample 17 is loaded into the mesh unit 15, an electrical signal is generated in the mesh unit 15, and the electrical signal is stripped through the electrode unit 16. The signal is transmitted to the electric signal detector 21 of the measuring device 20.

In the lower portion of the sample loading hole 13, an enzyme reaction layer 14 is formed by treating a reaction reagent that is discolored by reacting with the sample 17.

2 illustrates a state in which a mesh unit 15 coated with a metal is installed in the sample loading hole 13 according to an embodiment of the present invention, and the electrode unit 16 is connected to the mesh unit 15.

At this time, the shape of the sample loading hole 13 may be formed in a rectangular or circular shape, the shape is not particularly limited.

3 is a mesh portion 15 of a non-conductive material is installed in the sample loading hole 13 according to an embodiment of the present invention, a metal wire is inserted into a portion of the mesh portion 15, the metal wire is an electrode The state in which the part 16 is integrally extended is shown.

In addition, the electrode portion 16 formed on the upper portion of the strip cover 12 may be formed on the lower portion of the strip cover 12.

Strip measuring device 20 according to an embodiment of the present invention is a strip insertion hole 27 formed on one side so that the strip body 10 can be inserted, and an electrical signal detection unit for detecting the electrical signal generated at the loading point detection unit ( 21), an optical signal detector 24 for measuring the reflectance of the reflected reflected light irradiated with the enzyme reaction layer 14, and the correction according to the lack of sample volume and red blood cell volume ratio using the electrical signal and the optical signal, It includes a determination unit for determining the type of sample.

The electrical signal detection unit 21 is installed around the strip insertion hole 27, and the installation position of the electrical signal detection unit 21 is the electrode unit 16 when the strip body 10 is inserted into the strip insertion hole 27. ).

The electrical signal detector 21 may receive an electrical signal generated from the sample loading hole 13 to recognize a time point at which the electrical signal is generated.

In addition, the optical signal detection unit 24 is provided in the vicinity of the strip insertion opening 27, the optical signal detection unit 24 and the light emitting unit 22 for irradiating light to the enzyme reaction layer 14, and the enzyme reaction A light receiving unit 23 for measuring the amount of light reflected from the layer 14 is included.

The enzyme reaction layer 14 may include a reaction reagent that changes color as it reacts with the sample 17, and as the reaction reagent reacts with the sample 17 introduced through the sample sensing mesh 15. The color of the enzyme reaction layer 14 is changed.

In this case, the amount of reflected light incident on the light receiving unit 23 is changed according to the degree of color change in the enzyme reaction layer 14, and the light receiving unit 23 may measure the reflectance according to the amount of reflected light incident on the light receiving unit 23. .

The determination unit measures the time taken for the degree of color change of the enzyme reaction layer 14 to reach a predetermined value from the time when the sample 17 is loaded using the reflectance measured by the light receiving unit 23, that is, the optical signal. Thus, information about the sample 17 can be obtained and used as the correction information of the measured value.

The information about the sample 17 is the amount of the sample 17 loaded in the sample loading hole 13, hematocrit (% value representing the percentage of red blood cells in the blood), the kind of the sample 17 (blood, Plasma, control solution).

A display window 26 is provided on the outer surface of the strip measuring instrument 20, and the display window 26 displays information about the sample 17, such as the amount of the sample 17, hematocrit, and the type of the sample 17. The user can recognize it.

In addition, an operation button 25 is provided at one side of the outer surface of the strip measuring device 20, through which the user can turn on or off the power of the measuring device 20 or perform a desired operation.

Referring to the method of recognizing the sample information of the strip body 10 according to an embodiment of the present invention by such a configuration as follows.

6 is a flowchart illustrating a method of recognizing sample information of a diagnostic strip according to an embodiment of the present invention.

First, the strip body 10 is inserted into the strip insertion hole 27 of the strip measuring device 20.

A power connection switch connected to a power supply unit is installed inside the strip insertion hole 27, and the strip main body 10 is inserted into the strip measuring instrument 20 according to whether the end of the strip main body 10 contacts the power connection switch. It can be recognized (S100).

As the end of the strip body 10 contacts the power connection switch, power is supplied to the strip meter 20.

Next, the sample 17 is loaded into the sample loading hole 13 of the strip body 10 (S110).

In this case, blood, plasma (plasma), and a control solution may be used as the sample 17.

The blood contains red blood cells, but the plasma refers to plasma without red blood cells, and the control solution is a solution made artificially to determine the characteristics of the strip, and most of the water component.

When the sample 17 is loaded in the sample loading hole 13, an electrical signal is generated in the conductive mesh 15 (S120), and the electrical signal is transmitted to the electrical signal detection unit 21 through the electrode unit 16. Then, the electrical signal detector 21 receives the electrical signal and records the time point t1 at which the sample 17 is loaded (S130).

The loaded sample 17 is introduced into the strip body 10 through the conductive mesh 15, and the introduced sample 17 reacts with the reaction reagent of the enzyme reaction layer 14 to cause the enzyme reaction layer 14. ) Will change color.

At this time, the light emitting unit 22 installed inside the strip measuring unit 20 irradiates light to the enzyme reaction layer 14, and the reflected light reflected from the enzyme reaction layer 14 is incident to the light receiving unit 23. The light receiving unit 23 may calculate the light reflectance by measuring the light amount of the reflected light, and it is possible to know how the color of the enzyme reaction layer 14 is changed according to the light reflectance (S140).

If it is assumed that the reflectance of the enzyme reaction layer 14 is 100% before the reaction of the sample 17, the color of the enzyme reaction layer 14 is changed by the reaction of the sample 17 and the reaction reagent. However, some of the light is absorbed by the changed color, so the light reflectance falls.

That is, the drop rate of light reflectance of the enzyme reaction layer 14 varies depending on the color of the enzyme reaction layer 14 or the degree of color change.

For example, if the set value of the light reflectance is 50%, the time t2 at which the light reflectance reaches 50% is recorded (S150 and S160).

Then, using the time difference between the time point at which the sample 17 is loaded and the time point at which the light reflectance reaches the set value, the time taken from the time point at which the sample 17 is loaded to the time point at which the light reflectance reaches the set value is obtained ( S170).

Information about the sample 17 can be known using the time taken from the loading time t1 of the sample 17 to the time t2 at which the light reflectance reaches the set value (hereinafter, the measurement time T).

For example, if the time taken from the time of loading the sample 17 to the time when the light reflectance reaches the set value (measurement time) exceeds 8 seconds, it is determined that the amount of blood loaded in the sample loading hole 13 is insufficient. In this case, an error message of 'low blood amount' is displayed on the display window 26 (S180, S190, and S191).

In addition, the red blood cell volume ratio (hematocrit) is between 20-60%, the higher the volume ratio, the longer the measurement time, and the lower the volume rate, the measurement time is reduced.

For example, if the measurement time is 3 seconds, hematocrit is 20%, if 4 seconds hematocrit is 35%, 5 seconds 40%, 6 seconds 45%, 7 seconds 55%, 8 seconds In this case, it can be seen that 60%, and the measured value of the sample 17 is corrected according to the corresponding hematocrit by the measurement time (S193).

Further, since the correction of the measured value of the sample varies according to the type of the sample 17, it is necessary to know the kind of the sample 17 before measuring the sample 17.

Therefore, the kind of the sample 17, that is, blood, plasma or serum, and the control solution can be known according to the measurement time, and the measured value of the sample is corrected according to the kind of the sample 17 (S193).

For example, when the measurement time is 7 seconds, the sample is blood, when the measurement time is 5 seconds, the sample 17 is plasma or serum, and when the measurement time is 3 seconds, it can be seen that it is a control solution. Correct the value.

1 is a perspective view showing a diagnostic strip according to an embodiment of the present invention

2 is a schematic diagram showing a sample loading hole in which a conductive mesh is installed according to an embodiment of the present invention, and a state in which electrodes are connected to the sample loading hole.

3 is a schematic diagram showing a sample loading hole in which a non-conductive mesh is installed according to an embodiment of the present invention, and a state in which electrodes are connected to the sample loading hole.

Figure 4 is a cross-sectional view showing a state in which the diagnostic strip is inserted into the strip measuring apparatus according to an embodiment of the present invention

Figure 5 is a plan view showing a state before the diagnostic strip is inserted into the strip measuring apparatus according to an embodiment of the present invention

6 is a flowchart illustrating a method of recognizing sample information of a diagnostic strip according to an embodiment of the present invention.

<Description of the symbols for the main parts of the drawings>

10: strip body 11: strip base

12: strip cover 13: sample loading hole

14: enzyme reaction layer 15: mesh portion

16 electrode part 17 sample

20: strip measuring instrument 21: electrical signal detector

22 light emitting unit 23 light receiving unit

24: optical signal detector 25: control button

26: display window 27: strip insertion opening

Claims (10)

In the method of recognizing the information about the sample 17 after loading the sample 17 on the strip body 10, Loading the sample (17) into a sample sensing mesh (15); Sensing an electrical signal generated by the sample detecting mesh 15 to recognize a loading time of the sample 17; Reacting the sample (17) with the enzyme reaction layer (14) to change the color of the enzyme reaction layer (14); Irradiating light on the enzyme reaction layer (14) and measuring a reflectance according to the change of color; And The time taken from the time of loading the sample 17 to the time when the reflectance reaches a set value is measured to recognize information on whether the amount of the sample 17 is sufficient, the red blood cell volume ratio, and the type of the sample 17. Steps for recognizing the sample information of the diagnostic strip, characterized in that comprises a. The method of claim 1, wherein when the time taken from the loading time of the sample 17 to the time when the reflectance reaches a set value exceeds the reference time, the blood volume is determined to be insufficient, and an error message is output. Recognition method of sample information on the strip. The diagnostic strip according to claim 1, wherein the red blood cell volume ratio is determined according to the time taken from the time of loading the sample 17 to the time when the reflectance reaches a set value, and the measured value is corrected according to the red blood cell volume ratio. How to recognize sample information The diagnostic method of claim 1, wherein the type of the sample is determined to be blood, plasma or serum, or a control solution according to a time taken from the time of loading the sample 17 to the time when the reflectance reaches a set value. How to recognize sample information on a strip. In diagnostic strips used to analyze biological samples, A strip base 11; A strip cover 12 covering an upper portion of the strip base 11 and having a sample loading hole 13 formed therein; A loading time detector for detecting an loading time of the sample by generating an electrical signal when loading the sample 17 into the sample loading hole 13; And an enzyme reaction layer (14) formed on the strip base (11) to change color in response to the sample (17) introduced into the strip base (11) through the sample loading hole (13). strip. The method of claim 1, wherein the loading time detection unit is coated with a metal to generate an electrical signal, the mesh unit 15 provided in the sample loading hole; And an electrode unit (16) connected to the mesh unit (15) to transmit an electrical signal. The diagnostic strip according to claim 6, wherein a metal wire is inserted in the middle of the mesh part (15). 8. The diagnostic strip according to claim 7, wherein the metal wire and the electrode portion (16) are formed in one piece. In the diagnostic strip measuring apparatus of any one of claims 1 to 4, the diagnostic strip is inserted through the strip insertion opening 27, An electrical signal detector 21 which receives a signal from the loading time detector and detects a loading time of the sample 17; An optical signal detector 24 for measuring the reflectance of the reflected light reflected by irradiating the enzyme reaction layer 14 with light; Receives signals from the electrical signal detector 21 and the optical signal detector 24, respectively, and measures the time taken for the reflectance due to the discoloration of the enzyme reaction layer 14 to reach the set value from the loading time of the sample 17. Determination unit for determining whether the amount of the sample (17) is sufficient, the red blood cell volume ratio, the type of the sample (17) used to correct the measured value. The method according to claim 1, wherein the optical signal detector 24 is a light emitting unit 22 for irradiating light to the enzyme reaction layer 14, and a light receiving unit 23 for measuring the amount of light reflected from the enzyme reaction layer 14 Measurement strip of the diagnostic strip comprising a).

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