KR20110022806A - Test strip and living creature analyzing device and analyzing method using it - Google Patents

Abstract

PURPOSE: An analysis method using a test strip and an apparatus is provided to accurately analyze bio samples and to predict errors regardless of blood application in case of a twisted test strip. CONSTITUTION: An analysis method using a test strip and apparatus for analyzing bio samples comprises: a step of irradiating light to a membrane in a first light emitting device and irradiating light to a blood recognizing unit in a second light emitting device(S110); a step of receiving the light reflected from the membrane and blood recognizing unit in an analyzing device(S120); a step of determining that the reflection level of the light is under a standard value(S130); a step of measuring the light reflection level to determine that the light reflection level is under the standard value(S140); a step of operating a measuring device in case the reflection level is under the standard value(S150); and a step of separating the test strip from the measuring device and applying a bio sample(S160).

Description

TEST STRIP AND LIVING CREATURE ANALYZING DEVICE AND ANALYZING METHOD USING IT}

The present invention relates to test strips used in colorimetric methods for quantitative analysis of biomaterials, and to measuring instruments and methods for analyzing biomaterials using the same, in particular test strips and tests for confirming whether the biomaterials are sufficiently applied for analysis. The present invention relates to an analytical measuring instrument and analytical method capable of accurately and quantitatively analyzing a biomaterial by predicting an error of reflectivity upon bending or warping of a strip.

Recently, several methods have been proposed to analyze biomaterials, including blood, in the medical field. Among them, biosensors using enzymatic assays are easy to apply, have excellent measurement sensitivity, and can obtain results quickly. Most widely used in.

Enzyme analysis can be largely divided into spectroscopic colorimetric method (also called colorimetric method) and electrochemical method electrode method. The colorimetric method is an analysis method that determines the concentration by comparing the color of an unknown sample solution with that of a standard solution. There are photoelectric method and spectrophotometric method.

Colorimetric methods are well described in US Pat. No. 4,935,346, and electrode methods are well known in US Pat. No. 5,997,817. In addition, Korean Patent No. 10-0540849 introduces a measuring device that can use the colorimetric method and the electrode method at the same time and a method that can inform the information of the target to be analyzed. US Patent No. 7,008,799 discloses a colorimetric test strip with a system for automatically inhaling blood. The content of the said document shall be included in this specification by this reference.

1 is a block diagram of a conventional measuring instrument and test strip using a colorimetric method that automatically inhales blood. The conventional colorimetric measuring device 100 is provided with a light emitting device 104 such as a light emitting diode (hereinafter referred to as "LED") and the detector 106 on the bottom of the mounting portion 102 to which the test strip is mounted. It is. In the reaction unit 122 of the test strip 120 inserted into the mounting unit 102, a reactant, which is a reagent that reacts with the biological material to be analyzed, is fixed. The measurement device 100 is turned on by manipulating buttons 108a and 108b by a user, and whether the test strip 120 is mounted is known to the measurement device 100. In addition, when the measuring device 100 has a function of analyzing various biomaterials, information about the biomaterial (hereinafter referred to as "subject material") to be analyzed by the buttons 108a and 108b may be measured. 100). The change in color according to the reaction of the reagent in the reaction unit 122 and the administered biomaterial is the degree of reflectance detected by the detector 106 by the light emitted by the light emitting device 104 is reflected from the reaction unit 122 Is measured according to. The measurement result is analyzed by an analysis algorithm (not shown) built in the measuring device and displayed on the display unit 110 such as a liquid crystal display (hereinafter referred to as "LCD").

Although these colorimetric biosensors are easy to implement, they have been developed for a variety of biomaterials, but they are generally difficult to analyze important biomaterials due to longer measurement times and measurement errors due to turbidity of biological samples. Follow. In particular, when the blood is not sufficiently applied to the test strip, it is difficult to accurately analyze, and when the bending or distortion of the test strip itself occurs, there is a problem in that the accurate analysis of the biomaterial is difficult because the reflectivity in the reaction part is not constant.

The present invention has been made in view of the above, the test strip of the structure that can confirm whether the blood is sufficiently applied for the analysis of the biological material and the error of reflectivity irrespective of whether the blood is applied when bending or twisting the test strip An object of the present invention is to provide a measuring device and analytical method for biological material analysis that can predict and perform accurate analysis.

The test strip according to the present invention provided to achieve the above object is a fixing hole provided so that the test strip is fastened and fixed to a fixture provided inside the analyzer for measuring, a measuring unit for receiving a biological material to be analyzed and the living body. Basic film formed with a blood sufficient recognition unit for determining whether the substance is applied; An intermediate layer in contact with an upper portion of the base film and having a main passage portion and a sub accommodation portion for accommodating the flow passage of the biomaterial and the biomaterial; A membrane adhered to the main receptacle of the intermediate layer and coated with a reactant and collecting the biomaterial; And a finishing layer in contact with an upper portion of the intermediate layer and covering the flow passage, the main accommodating part, and the auxiliary accommodating part.

Here, it is preferable to visually determine the moving distance of the biological material flowed to the main receiving part and the sub-receiving part of the intermediate layer through the measuring part and the blood sufficient recognition part of the base film.

The measuring device for analyzing a biomaterial using the test strip includes: a first light emitting device emitting light to the membrane in which the biomaterial is collected; a second light emitting device emitting light to the blood filling recognition unit, the membrane and a blood filling recognition A PCB substrate including a detector for detecting light reflected from a part is provided inside.

In addition, when the reflectivity of the light reflected from the blood recognizing unit is low, it is determined that the appropriate amount of the biological material is applied, and when the reflectance of the light reflected from the membrane is higher than the reference value, it is determined that the test strip is abnormally fastened. It is a good idea to notify the user of the retightening.

The code chip mounting unit may further include a code chip mounting unit for mounting the code chip in which the information of the bio material is stored for the recognition and analysis of the type of the bio material to be inserted into the test strip.

The analysis method using the test strip and the measuring material for analyzing the biomaterial is an analysis method using the test strip of claim 1 and the measuring material for biomaterial analysis of claim 3, wherein the first light emitting device emits light to the membrane Radiating light from the blood light recognizing unit in a second light emitting device (S110); Receiving the light reflected from the membrane and the blood filling recognition unit in the detector (S120); Determining whether the reflectivity of the light reflected from the blood sufficient recognition unit is equal to or less than a reference value (S130); If the reflectance is less than or equal to a reference value in step S130, determining whether the light is less than or equal to the reference value by measuring reflectance of light reflected from the membrane (S140); If the reflectance of the light is less than the reference value in step S140, the step of operating the measuring device (S150);

In addition, when the reflectance of the light in the step S130 or more than the reference value, the step of separating the test strip from the analysis measuring instrument and additionally applying the biomaterial (S160); preferably comprises a.

In addition, if the reflectance of the light in step S150 or more than the reference value, the step of notifying the re-fastening of the test strip to the user of the measuring instrument (S170); preferably comprises a.

According to the test strip and the analytical measuring instrument according to the present invention and an analysis method using the same, the test strip may be provided with a separate check unit to check whether the blood is sufficiently applied, thereby enabling more accurate analysis of the biomaterial, and also the bending of the test strip. In case of warping or warping, it is possible to predict the error of reflectivity regardless of whether blood is applied or not, thereby providing accurate analysis.

The above objects, features and other advantages of the present invention will become more apparent by describing the preferred embodiments of the present invention in detail with reference to the accompanying drawings. Hereinafter, with reference to the accompanying drawings will be described in detail a test strip, a biomaterial analysis measuring device and an analysis method using the same according to an embodiment of the present invention.

2 is a block diagram of the test strip 220 and the biomaterial analysis measuring device 200 using the same according to an embodiment of the present invention, Figure 3 is a test strip 220 in FIG. 4 is an exploded perspective view of the test strip 220 according to an embodiment of the present invention, FIG. 5 is a perspective view of the coupling of the test strip 220 according to FIG. 4, and FIG. 6 is according to FIG. 5. Side cross-sectional view along the AB line of the test strip 220.

Referring to FIGS. 2 to 6, the test strip 220 and the biomaterial analysis measuring device 200 will be described in detail as follows.

As shown in FIG. 2 and FIG. 3, the biomaterial analysis measuring device 200 according to the present invention is provided with a strip mounting part 202 to insert and mount a test strip 220. In addition, the user buttons (208a, 208b) is provided on one side of the front side so that the user can easily operate the analytical measuring device 200 and the LCD (B) to allow the user to recognize the analysis result of the biomaterial contained in the test strip 220. 214 is formed. Separately, a code chip mounting unit 216 may be provided to mount the code chip 218 in which the information of the bio material is stored for the recognition and analysis of the type of the bio material to be inserted into the test strip 220.

In addition, when the test strip 220 is inserted, the first light emitting device 204 for emitting light to the membrane 226 in which the biomaterial is collected, the second light emitting device for emitting light to the blood filling recognition unit 229 205, a PCB 235 including a detector 206 for detecting light reflected from the membrane 226 and the blood filling recognition unit 229 is provided therein.

4 to 6, the test strip 220 according to the present invention is composed of three layers of the base film 227, the intermediate layer 222, and the finish layer 221. The base film 227 is a fixing hole 230 provided to be fastened and fixed to the fastener 250 provided inside the analyzer 200 for measurement, the measurement unit 228 for receiving the biological material to be analyzed and the application of the biological material. Blood sufficient recognition unit 229 for determining whether or not is formed.

The intermediate layer 222 bonded to the upper portion of the base film 227 has a flow passage 225 of the biomaterial and a main accommodating part 223 and an auxiliary accommodating part 224 for accommodating the biomaterial. In addition, the finishing layer 221 is in contact with the upper portion of the intermediate layer 222 and covers the flow passage 225, the main receiving portion 223 and the secondary receiving portion 224.

A membrane 226 coated with a reactant is adhered to the inside of the main accommodating part 223 of the intermediate layer 222 to collect biomaterials introduced through the flow passage 225, and the test strip 220 is used for analysis. After being inserted into the strip mounting unit 202 of the measuring device 200, the reflectance may be measured in the process of receiving and reflecting light of the membrane 226 to analyze the state of the biomaterial. For example, when blood, which is a biomaterial, comes into contact with the reactant of the membrane 226, the blood sugar in the blood reacts with an enzyme of the reactant to change color, and the color change is measured by reflectance. Here, the term "reactant" means a reagent such as an enzyme that reacts with each biological substance.

Here, the moving distance of the biological material flowed to the main receiving portion 223 and the secondary receiving portion 224 of the intermediate layer 222 through the measuring unit 228 and the blood sufficient recognition unit 229 of the base film 227 Can be determined by

That is, when the user contacts the biomaterial to be analyzed at one end of the test strip 220, the biomaterial moves through the flow passage 225 and is moved to the main accommodation part 223 and the sub accommodation part 224. . The biomaterial moved to the main receiving unit 223 is collected on the membrane 226 and reacts with the enzyme, thereby changing the color of the membrane 226. The user visually monitors the moving distance of the biomaterial through the measuring unit 228. Can be observed. In this case, if the amount of the applied biomaterial is insufficient, the main accommodating part 223 may not be sufficiently filled, and the biomaterial may cause a problem that the result is incorrect because the reaction does not occur properly. In the present invention, in order to prevent this, even if the color change according to the reaction is observed in the main receiving unit 223, by monitoring the color change of the secondary receiving unit 224, if there is no change, it is determined that the biological material is not enough to enter the biological material to the user More input can be made.

7 is an operation diagram in the analytical measuring device 200 when the test strip 220 according to the present invention operates normally, FIG. 8 is an analytical measuring device 200 when the test strip 220 according to the present invention is bent. FIG. 9 is a graph showing the reflectivity of the membrane 226 and the blood filling recognition unit 229 of the test strip 220 according to the present invention.

Referring to FIGS. 7 and 8, the analysis process of the biomaterial contained in the test strip 220 using the biomaterial analysis measuring device 200 according to the present invention will be described below.

When the biomaterial to be analyzed is in contact with the end of the test strip 220, the inner material flows through the flow passage 225 formed at the center of the intermediate layer 222, and the main accommodating part 223 and the auxiliary accommodating part 224 are moved. Filled up. Inside the main receiving portion 223, a membrane 226 coated with a reactant is provided, and the flowed biomaterial is absorbed and collected by the membrane. Then, when the test strip 220 is inserted into the strip mount 202 of the biomaterial analyzer 200 and the analyzer 200 is operated, the test strip 220 is placed on the PCB substrate 235 provided at the bottom of the strip mount 202. The light emitted from the first light emitting device 204 and the second light emitting device 205 is provided. The light emitted from the first light emitting device 204 is reflected by the membrane 226 through the measuring unit 228 on the base film 227 and received and detected by the photo sensor 206 provided on the PCB substrate 235. The light emitted from the second light emitting device 205 is reflected by the sub accommodation part 224 through the blood sufficient recognition part 229 on the base film 227 and received and detected by the spectrophotometer 206. Here, the state of the biological material may be accurately analyzed by measuring the reflectance of the light detected by the spectroscopic sensor 206 (in the case of FIG. 7).

However, in general, the test strip 220 is made of a thin material and is easily changed shape when pressed, accordingly, when the test strip 220 is inserted into the measuring device 200 to analyze and test the biomaterial, the main accommodating part ( 223) and the sub accommodation part 224 becomes abnormal, making accurate analysis difficult (in the case of FIG. 8).

The test strip 220 and the biomaterial analyzer 200 according to the present invention may check whether the test strip 220 is properly fastened into the meter 200. That is, when the test strip 220 to which the biomaterial is applied is inserted into the measuring device 200, the reflectance of the light reflected from the blood sufficient recognition unit 229 is lower than the reference value 80 (Fig. 9 (b), Fig. 9 (d)), it is determined that an appropriate amount of the biomaterial is applied, and if the reflectance of the light reflected from the membrane 226 is 80 or less (Fig. 9 (a)), it is determined that the test strip 220 is properly engaged. If the reflectance of the light reflected from the membrane 226 is greater than or equal to the reference value 80 (FIG. 9C), the test strip 220 is determined to be abnormally fastened to notify the user of the refastening.

That is, when the test strip 220 is bent or twisted, the downward portion of the test strip 220 is measured instead of the position of the membrane 226 to be measured (see FIG. 8). The reflectivity of the light reflected at 226 is increased. It detects this and informs the user that it was incorrectly fastened to induce refastening of the test strip 220. In the present invention, the reference value of the reflectivity is set to 80. Of course, the reference value of the reflectivity may vary depending on the user's convenience.

10 is a flow chart illustrating an analysis method of the test strip 220 and the measuring material 200 for analyzing the biological material according to the present invention.

Looking at the analysis method in detail, the first light emitting device 204 to emit light to the membrane 226 and the second light emitting device 205 to radiate light to the blood filling recognition unit 229 (S110), Receiving the light reflected from the membrane 226 and the blood filling recognition unit 229 in the detector 206 (S120), determining whether the reflectivity of the light reflected from the blood filling recognition unit 229 is below the reference value (S130), when the reflectivity is less than the reference value in step S130, measuring the reflectivity of the light reflected from the membrane 226 (S140), if the reflectance of the light is less than the reference value in step S140, operating the measuring device 200 It is recommended to include (S150).

Here, when the reflectance of the light is greater than the reference value in the step S130, and separating the test strip 220 from the analytical measuring device 200 and additionally applying a biomaterial (S160), in step S150 If the reflectivity is greater than or equal to the reference value, it is preferable to include the step (S170) of notifying the user of the analysis meter 200 to refasten the test strip 220.

According to the test strip and the analytical measuring instrument according to the present invention and an analysis method using the same, the test strip may be provided with a separate check unit to check whether the blood is sufficiently applied, thereby enabling more accurate analysis of the biomaterial, and also the bending of the test strip. In case of warping or warping, it is possible to predict the error of reflectivity regardless of whether blood is applied or not, thereby providing accurate analysis. In addition, according to the test strip and the biomaterial analysis measuring apparatus using the same, it can be usefully used for the selective quantitative analysis of blood glucose, cholesterol, lactate, hepatic secretion, and the like in the blood.

While preferred embodiments of the present invention have been described above, the present invention is not limited to the above-described specific embodiments. That is, those skilled in the art to which the present invention pertains can make many changes and modifications to the present invention without departing from the spirit and scope of the appended claims, and all such appropriate changes and modifications are possible. Equivalents should be considered to be within the scope of the present invention.

1 is a block diagram of a conventional analytical measuring device for analyzing a biological material using the colorimetric method,

2 is a block diagram of a test strip and an analyzer for analysis according to an embodiment of the present invention;

3 is a view showing a state in which the test strip is inserted into the analytical measuring instrument in FIG.

4 is an exploded perspective view of a test strip according to an embodiment of the present invention;

5 is a perspective view of the coupling of the test strip according to FIG.

6 is a side cross-sectional view taken along line A-B of the test strip according to FIG. 5;

7 is an operation diagram in the analytical measuring instrument when the test strip according to the present invention operates normally;

8 is an operation diagram in the analyzer for analysis when the test strip according to the present invention is bent,

9 is a graph showing the reflectivity in the membrane and the blood sufficient recognition unit of the test strip according to the present invention, and

10 is a flowchart illustrating an analysis method of a test strip and a biomaterial analysis measuring device according to the present invention.

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

200: measuring instrument for biological material analysis 202: strip mounting portion

208a, 208b: User button 214: LCD

216: code chip mounting portion 218: code chip

220: test strip 221: finishing layer

222: intermediate layer 223: main accommodation

224: accommodating part 225: flow passage

226: membrane 227: base film

228 measurement unit 229 blood sufficient recognition unit

230: fixing hole 250: fixture

Claims (8)

A base film having a fixing hole provided to fasten and fix the test strip to a fixture provided inside the analyzer for measuring, a measuring part accommodating a biological material to be analyzed, and a blood filling recognition part for determining whether the biological material is applied; An intermediate layer in contact with an upper portion of the base film and having a main passage portion and a sub accommodation portion for accommodating the flow passage of the biomaterial and the biomaterial; A membrane adhered to the main receptacle of the intermediate layer and coated with a reactant and collecting the biomaterial; And a finishing layer in contact with an upper portion of the intermediate layer and covering the flow passage, the main accommodating part, and the auxiliary accommodating part. The method of claim 1, The test strip, characterized in that by visually determine the moving distance of the biological material flowed to the main receiving portion and the secondary receiving portion of the intermediate layer through the measuring unit and the blood sufficient recognition unit of the base film. In the measuring device for biological material analysis using a test strip according to claim 1, A first light emitting device emitting light to the membrane where the biomaterial is collected, a second light emitting device emitting light to the blood filling recognition unit, and a detector for detecting light reflected from the membrane and blood filling recognition unit Measuring instrument for biological material analysis, characterized in that provided with a PCB substrate including. The method of claim 3, wherein If the reflectivity of the light reflected from the blood sufficient recognition unit is low, it is determined that the appropriate amount of the biological material is applied, and if the reflectance of the light reflected from the membrane is higher than the reference value, the test strip is determined to be abnormally fastened to the user. Measuring instrument for biological material analysis, characterized in that the re-information. The method of claim 3, wherein And a code chip mounting unit for mounting a code chip in which information of the bio material is stored, for recognizing and analyzing the type of the bio material introduced into the test strip. In the analysis method using the test strip of claim 1 and the measuring device for biological material analysis of claim 3, Radiating light from the first light emitting device to the membrane and radiating light from the second light emitting device to the blood filling recognition unit (S110); Receiving the light reflected from the membrane and the blood filling recognition unit in the detector (S120); Determining whether the reflectivity of the light reflected from the blood sufficient recognition unit is equal to or less than a reference value (S130); If the reflectance is less than or equal to a reference value in step S130, determining whether the light is less than or equal to the reference value by measuring reflectance of light reflected from the membrane (S140); If the reflectivity of the light in the step S140 or less than the reference value, the step of operating the measuring device (S150); analysis method comprising a. The method of claim 6, And in step S130, if the reflectance of light is equal to or greater than a reference value, separating the test strip from the analytical measuring instrument and applying the biomaterial further (S160). The method of claim 6, And (S170) informing the user of the analytical measuring device to refasten the test strip when the reflectance of the light is greater than or equal to the reference value in step S150.

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