KR101698497B1 - Method and system for managing the test strip information of multi-parameter measurement device - Google Patents

Method and system for managing the test strip information of multi-parameter measurement device Download PDF

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Publication number
KR101698497B1
KR101698497B1 KR1020150102669A KR20150102669A KR101698497B1 KR 101698497 B1 KR101698497 B1 KR 101698497B1 KR 1020150102669 A KR1020150102669 A KR 1020150102669A KR 20150102669 A KR20150102669 A KR 20150102669A KR 101698497 B1 KR101698497 B1 KR 101698497B1
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South Korea
Prior art keywords
information
test
item
inspection
measurement
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KR1020150102669A
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Korean (ko)
Inventor
도재필
하정억
남학현
차근식
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주식회사 아이센스
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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
    • G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/64—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving ketones
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/66—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood sugars, e.g. galactose
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G06K9/6288—

Abstract

An inspection site information management system of a multi-item measurement inspection apparatus according to an embodiment of the present invention includes an inspection sheet having an independent information display unit on at least one or more independent information on a substrate provided with reagents; An independent information sensing unit for acquiring the at least one independent information from the independent information display unit; a dependent information memory unit for flexibly storing dependency information subordinate to the independent information; Determining whether the test sheet is for measuring a specific item among the plurality of items, calculating a measurement signal generated by reacting with the reagent of the test sheet, using the dependency information stored in the dependency information memory unit, And a multi-item measurement inspection apparatus having an operation control section.

Description

TECHNICAL FIELD The present invention relates to a method and system for managing test information of a multi-item measurement test apparatus,

The present invention relates to an inspection information management system and method of a multi-item measurement inspection apparatus, which is characterized in that one inspection apparatus recognizes inspection pages of at least one or more different items printed with independent information, And a method of managing and managing the inspection information of a multi-item measurement inspection apparatus having a separate dependent information memory unit.

In general, a multi-item measurement test apparatus is used professionally in hospitals and the like. It is possible to use a single measurement test apparatus to measure a plurality of items, for example, ketones or blood glucose levels, And is configured to measure blood sugar.

However, in the case of such a multi-item measurement test apparatus, only blood glucose calibration information may be recorded in a code form in the case where the test strip is a blood glucose strip in terms of structure of the test strip, or may be provided in the form of a code chip without a code. All remaining information on production date, production LOT information, control solution, expiration date, etc., may be provided separately from another medium such as a code chip, provided in the form of a barcode or a code chip in a container, It is very troublesome to recognize or input code chips or bar codes every time for multi-item measurement with each test paper.

In addition, when the code chip is lost or the container is reversed, it is impossible to use the test paper, resulting in a cost incurred due to the waste of the test paper. In the case of performing ketone or blood glucose measurement without knowing that the code chip is lost or reversed, And thus, it has caused a great problem in the stability of the user.

In addition, when the user uses each test sheet, he or she must check the contents displayed on the test sheet wrapping paper or storage container by operating the multi-item measuring device and download and install the multi-item measurement solution according to the contents displayed on the test paper wrapping paper or the storage container It is inconvenient to control the item measuring device.

It is an object of the present invention to solve the above problems, and it is an object of the present invention to provide a method and apparatus for measuring a plurality of items by inputting code information, such as a code chip, a bar code, The present invention also provides a system and method for controlling the inspection information of a multi-item measurement inspection apparatus, which improves user convenience and reduces the risk of input errors, thereby improving the accuracy of the measurement inspection.

It is an object of the present invention to provide a method and apparatus for monitoring the use of each test sheet used for measuring multi-item, thereby preventing wastage and cost, reducing the stability of use of the test sheet, The present invention provides a system and method for managing an inspection site information of a multi-item measurement inspection apparatus.

An inspection site information management system of a multi-item measurement inspection apparatus according to an embodiment of the present invention includes an inspection sheet having an independent information display unit on at least one or more independent information on a substrate provided with reagents; An independent information sensing unit for acquiring the at least one independent information from the independent information display unit; a dependent information memory unit for flexibly storing dependency information subordinate to the independent information; Determining whether the test sheet is for measuring a specific item among the plurality of items, calculating a measurement signal generated by reacting with the reagent of the test sheet, using the dependency information stored in the dependency information memory unit, And a multi-item measurement inspection apparatus having an operation control section.

The method of managing testee information of a multi-item measurement test apparatus according to an embodiment of the present invention includes:

Selecting an examination sheet on which independent information is recorded; Inserting the test page into an insertion unit of a multinomain measurement test apparatus including a dependency information memory unit in which dependency information dependent on the independent information is stored and an independent information sensing unit for reading the independent information; Determining whether a specific item among the plurality of items is an inspection item through the independent information detected by the independent information sensing unit; Extracting a sample and performing an inspection; Performing the test to detect a measured measurement signal; Calculating the measurement signal using the dependency information stored in the dependency information memory; And correcting the calculated measurement value using the dependency information stored in the dependency information memory unit.

According to the method and system for managing test item information of a multi-item measurement test apparatus according to an embodiment of the present invention, in order to measure multi items, test page information is inserted into a method of inserting or inspecting test papers or a method of inputting a code, a bar code, It is possible to improve the usability and reduce the risk of input errors, thereby improving the accuracy of the measurement test.

In addition, according to the system and method for managing information on the inspection sites of a multi-item measurement inspection apparatus according to an embodiment of the present invention, it is possible to track the use of each inspection site used for measuring multiple items, In addition, the stability of the use of the test sheet can be corrected, and the user's trouble such as a hospital can be reduced.

1 is a flow chart showing an inspection measurement method using a conventional multi-item inspection measurement apparatus.
FIG. 2 is a block diagram for explaining a configuration of a test site information management system of a multi-item measurement test apparatus according to an embodiment of the present invention.
3 is a diagram illustrating an independent information display method of a test page used in a test page information management system of a multi-item measurement test apparatus according to an embodiment of the present invention.
4 is an exemplary view for explaining a relation between independent information of a test sheet used in a test sheet information management system of a multi-item measurement test apparatus and multi-item dependency information stored in a memory unit separately from the test sheet according to an embodiment of the present invention.
FIG. 5 is a flowchart illustrating a method for managing testee information in the multi-item test apparatus according to an exemplary embodiment of the present invention. Referring to FIG.

Hereinafter, embodiments of the present invention will be described in detail with reference to the accompanying drawings so that those skilled in the art can easily carry out the present invention. The present invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. In order to clearly illustrate the present invention, parts not related to the description are omitted, and similar parts are denoted by like reference characters throughout the specification.

Throughout the specification, when an element is referred to as "comprising ", it means that it can include other elements as well, without excluding other elements unless specifically stated otherwise. Also, the terms " part, "" module," and " module ", etc. in the specification mean a unit for processing at least one function or operation and may be implemented by hardware or software or a combination of hardware and software have.

Now, with reference to FIG. 2 to FIG. 4, a method and a method of managing a check sheet information of a multi-item measurement testing apparatus according to an embodiment of the present invention will be described.

The inspection site information management system of the multi-item measurement inspection apparatus according to an embodiment of the present invention includes a dedicated inspection site 1 provided in the same shape to inspect each of ketones or blood sugar, And a multi-item inspection and measurement apparatus 100 provided so as to qualitatively or quantitatively analyze the components of the sample.

The test strip 1 comprises a pair of electrodes 3, 5 made in a manner of coating or vapor deposition on an insulator of a certain size made of a material capable of conducting electricity in order to cause an electrochemical reaction with the specimen, And an independent information display unit 50 indicating the above-described independent information 50A, 50B, 50C, and 50D.

The test strip 1 may be, for example, a dedicated biosensor strip having a dedicated reagent capable of measuring various items such as blood glucose or ketone by using whole blood as a test sample.

The at least one or more independent information items 50A, 50B, 50C, and 50D may be product IDs indicating types of test papers, such as whether the test papers are dedicated for ketone testing or blood glucose testing only, which is the most important unique information for identifying the test papers , Lot information may be included in the production date and the production day as the production lot information.

Since the at least one independent information 50A, 50B, 50C and 50D is provided for the test sheet 1, the at least one independent information 50A, 50B, 50C, and 50D can be read to measure various items such as blood glucose and ketone in the measurement sample.

The at least one piece of independent information 50A, 50B, 50C and 50D is recorded on the test strip 1 by coating or vapor deposition in the same manufacturing process as the pair of electrodes 3 and 5 Therefore, it is possible to reduce deviation in the manufacturing process of the inspection sheet 1 according to a separate process, and it is unnecessary to add a separate process, so that the manufacturing process of the inspection sheet 1 can be prevented from being contaminated and simplified.

In addition, since only the minimum and least important independent information 50A, 50B, 50C and 50D is provided for the inspector 1, the sharpness of the inspection information increases, Independent information sensing section can detect quickly and accurately.

The independent information display unit 50 may be an optical indicator such as a color or the like applied or deposited with a different brightness or saturation, and may be an indent pattern, a hole pattern, a strip width, or a combination thereof, An electrical indicator that is an indicator or a resistance pattern, a capacitance pattern, or a combination thereof, and may be at least one of a two-dimensional bar code, an EPDROM or a magnetic pattern or a magnetic indicator that is a combination of these.

The multi-item inspection and measurement apparatus of the multi-item measurement inspection apparatus according to an embodiment of the present invention may include a multi-item inspection and measurement apparatus provided to qualitatively or quantitatively analyze the components of the specimen regardless of the type of the inspection sheet (1) (100) comprises an inspection sheet connector (110) to which the inspection sheet (1) is inserted and electrically connected, a sensing unit (110) for detecting an independent information signal capable of recognizing a measurement signal or an inspection sheet from the test sheet An operation control unit 150 for calculating an accurate measurement result value using the measurement signal and the independent information signal sensed by the sensing unit 130, And a dependency information memory unit 170 for storing information.

A communication unit 190 for communicating with the correction support server 200 for periodically updating the dependent information memory unit 170; a display unit 180 for displaying measurement result values calculated by the operation control unit 150; ).

The sensing unit 130 senses both the measurement signal and the independent information using one sensing means. The sensing unit 130 may include a pair of electrodes 3 and 5 formed on the test sheet 1, And an independent information sensing unit 133 capable of reading the independent information 50A, 50B, 50C, and 50D from the independent information display unit 50. [

The independent information sensing unit 133 may include a light detecting unit when the independent information display unit 50 is a light indicator so that the independent information display unit 50 of the test sheet 1 can be automatically detected, Image detection means such as vision for detection, electrical signal detection means in the case of an electrical indicator, magnetic head in the case of the magnetic indicator, and the like.

The dependency information stored in the dependency information memory unit 170 may include not only control solution correction information for correcting deviations that may occur during manufacturing, but also glucose correction information for correcting blood glucose level.

For example, it may include a kind of reagent which may have an important influence on the blood glucose measurement, a quantity error of the reagent, a thickness error of the substrate, a slope error, a characteristic function for correcting the hematocrit of the whole blood, Postprandial, temperature, exercise, etc., which may have a significant effect on the body weight of the subject.

4, the independent information 50A, 50B, 50C, and 50D of the test sheet 1 and the dependent information 50a, 50b, 50c, and 50d associated therewith are stored in the dependent information memory unit 170 And may be stored in a down-graded manner in a stepwise manner.

The dependency information memory unit 170 may further include a separate test history information memory unit 171. The test item 1 may be inserted into the multi-item measurement and inspection apparatus 100 to perform a predetermined test The use information of the test sheet 1 can be recorded.

 Therefore, the suitability of the test sheet 1, such as whether or not the test sheet 1 is inserted for inspection of necessary items among multiple items, re-use of already used items, or a test site of a third party, The operation control unit 150 can determine whether or not the operation is possible.

The dependency information memory unit 170 may be embedded in the multi-item measurement testing apparatus 100 and may be electrically connected to the external apparatus when the communication unit 190 is a phone jack or a mini USB terminal.

In the case where the communication unit 190 is a wired / wireless communication unit, the dependency information memory unit 170 may be connected to the correction support server 200 via wired / wireless lines to download the dependency information 50a, 50b, 50c, and 50d , It is possible to increase the accuracy of the measurement result value by subdividing the subordinate information to provide a more accurate dependency information and to replace the dependency information 50a, 50b, 50c, 50d with more accurate dependency information or to update it afterwards .

As described above, in the multi-item inspection, the independent information 50 necessary for inspecting a specific item is recorded and the dependent information matching the independent information is stored in the multi-item inspection apparatus 100 The independent information and the dependent information about the test sheet 1 are stored in the dependency information memory unit 170 in a stepwise manner. Therefore, the multi-item measurement and inspection apparatus 100 can acquire independent information and dependent information by a code chip, a bar code, The user can simply input the test sheet 1 into the multi-item measurement and inspection apparatus 100 without inconvenience.

In addition, the multi-item measurement testing apparatus 100 can be provided with the assistance of the correction support server 200, for example, Information can be replaced, added, and updated, providing more accurate measurement results.

Therefore, the multi-item measurement such as blood glucose measurement, cholesterol measurement, HbA1c measurement, and ketone measurement can be performed using a multi-item measurement test apparatus using the test strip 1.

Referring to FIG. 5, a method of managing testee information of a multi-item measurement testing apparatus according to an embodiment of the present invention will be described.

In the method for managing inspection information of a multi-item measurement inspection apparatus according to an embodiment of the present invention, a specific inspection sheet (1) is selected for inspection of a specific item (S110), and the selected inspection sheet (1) And inserted into the slot of the inspecting apparatus 100 to be electrically connected to the check sheet connector 110 (S120).

The independent information detection unit 133 of the multi-item measurement and inspection apparatus 100 reads out the inspection information from the independent information display unit 50 of the inserted inspection sheet 1 before the inspection using the specimen such as the body fluid, the whole blood, The independent information 50A, 50B, 50C, and 50D of the image forming apparatus 1 is read (S130).

The operation control unit 150 of the multi-item measurement testing apparatus 100 reads the independent information 50A, 50B, 50C, and 50D of the test sheet 1 and determines whether or not a specific item among the items matches the measurement item (S140).

At this time, the multi-item measurement testing apparatus 100 displays the independent information 50A, 50B, 50C, and 50D of the test sheet 1 read through the display unit 180, It is possible to inquire whether or not the item matches the measurement item, and to input the confirmation as YES or NO from the user.

Before or after the step of inserting the inspection sheet (S120) or the subsequent inspection (S160), whether the inspection sheet is an inspection sheet for inspecting a specific item among the plurality of items, what is the production lot information, If the inspection sheet 1 is inserted through the independent information sensing unit 133 of the multi-item measurement testing apparatus 100 without a troublesome procedure of inputting chips, bar codes, handwriting input or the like manually or manually, It is very convenient to know.

If it is determined in step S141 that the test sheet 1 is a test item specific to a specific item among the items to be measured through the multi-item measuring apparatus 100, the operation control unit 150 may determine whether the test sheet information management unit 171 (S150), whether or not the test page 1 has already been used, whether or not the test page has been validated, and the like.

If it is determined in step S143 that the test page 1 is not the specific test item for the specific item among the items to be measured through the multi-item measurement apparatus 100, the test page 1 is already used, (S153), it is possible to prevent the inspection sheet 1 from being misused by removing the inspection sheet 1, thereby saving the cost (S145).

That is, if the inspection sheet 1 is an inspection sheet dedicated to a particular item among the plurality of items to be measured through the multi-item measuring apparatus 100 and the inspection is performed when it is determined that the inspection sheet is the party inspection sheet (S160), the measurement accuracy can be increased .

It is possible to judge whether or not the use of the test page 1 is used by using the test page information management unit 171 before and after the test is performed (S165) Data management can be performed entirely through the information supporting server 200 connected to the network through the measuring apparatus 100 and the communication unit 190. [

A measurement signal is detected from the specific item test sheet (S170).

If there is newly updated information among the dependent information corresponding to the independent information after detecting the measurement signal, the dependent information memory unit 170 may be updated (S175).

Of course, the dependency information memory unit 170 in the multi-item measurement testing apparatus 100 can be automatically updated after the independent information reading step (S130) with the assistance of the correction support server 200. [

The multi-item measurement testing apparatus 100 detects a measurement signal from a pair of electrodes 3 and 5 of the test sheet 1 using a measurement signal sensing unit 131 at step S170, A measurement signal generated by a reaction between a reagent of the test strip 1 and a sample is calculated using the dependency information stored in the dependency information memory unit 170 to obtain a measurement result of the measurement, (S180), and finally, the accurate measurement result value may be output to the display unit 190 (S190).

According to the method for managing test item information of a multi-item measurement test apparatus according to an embodiment of the present invention, in order to measure multi-items, test page information is input by a method of code chip, bar code, It is possible to improve the usability and reduce the risk of input errors so that the accuracy of the measurement test can be improved.

In addition, according to the method of managing inspection marks of a multi-item measurement inspection apparatus according to an embodiment of the present invention, it is possible not only to track waste of use of each inspection sheet used for measuring multi-items, It is possible to correct the stability according to the use of the test sheet, reduce the troubles of users such as hospitals, and manage data of the whole test sheet.

1: test sheet 50: independent information display unit
110: Test paper connector 133: Independent information sensing unit
150: operation control unit 170: multi-item dependent information memory unit
190: communication unit 200: correction support server

Claims (15)

An inspection sheet having an independent information display portion on the substrate provided with the reagent, the independent information display portion representing at least one or more independent information;
An independent information sensing unit for acquiring the at least one independent information from the independent information display unit; a dependent information memory unit for flexibly storing dependency information subordinate to the independent information; Determining whether the test sheet is for measuring a specific item among the plurality of items, calculating a measurement signal generated by reacting with the reagent of the test sheet, using the dependency information stored in the dependency information memory unit, An operation control unit,
Wherein the dependent information memory unit further comprises an examination sheet management information unit for registering whether to use the examination sheet,
A calibration support server for periodically updating the dependency information of the dependency information memory unit and for managing the check sheet management information of the check sheet management information unit and a communication unit for communicating with the correction support server The inspection information management system of the multi-item measurement inspection apparatus. delete The method according to claim 1,
The multi-item item includes blood glucose and ketone. The method according to claim 1,
Wherein the independent information comprises production lot information indicating a product ID indicating a measurement item of the test sheet, a production date and a production lot number during a day, the dependency information including control solution correction information, blood glucose correction information, Inspection site information management system of measurement test equipment. The method according to claim 1,
And a display unit for displaying a measurement result value calculated by the operation control unit. The method according to claim 1,
Wherein the dependency information memory unit is embedded in the multi-item measurement inspection apparatus or detached and attached to the outside of the multi-item measurement inspection apparatus. 6. The method of claim 5,
Wherein the communication unit further comprises a wireless or wired communication unit, a phone jack, or a mini USB terminal. Selecting an examination sheet on which independent information is recorded;
Inserting the test page into an insertion unit of a multinomain measurement test apparatus including a dependency information memory unit in which dependency information dependent on the independent information is stored and an independent information sensing unit for reading the independent information;
Determining whether a specific item among the plurality of items is an inspection item through the independent information detected by the independent information sensing unit;
Determining whether the test sheet is fraudulently used or not;
Removing the test page if the test page is not the test page for checking a specific item among the plurality of items or if the test page is judged to be fraudulent;
Extracting a sample and performing an inspection;
Performing the test to detect a measured measurement signal;
Calculating the measurement signal using the dependency information stored in the dependency information memory; And
And correcting the calculated measured value using dependency information stored in the dependency information memory unit. 9. The method of claim 8,
The step of determining whether a specific item among the plurality of items is an inspection item through the independent information of the inspection sheet includes the steps of displaying a specific item through the display unit of the multi-
And inputting whether the user matches the specific item with the inspection item. 10. The method of claim 9,
Further comprising the step of, if the user inputs no in the step of inputting whether the specific item matches the inspection item, carrying out the inspection sheet before the inspection. 9. The method of claim 8,
Wherein the step of determining whether the independent information of the test sheet is registered and used in the test sheet management information unit of the multi-item measurement test apparatus before the test step is performed or the valid period of the dependency information of the dependency information memory unit, The method comprising the steps of: 10. The method of claim 9,
And performing use registration of the test page in the test management information section after the step of performing the test. 9. The method of claim 8,
And updating the dependent information of the dependent information memory unit after the independent information reading step from the test sheet or before and after the test performing step by a communication unit connected to the correction support server via wired or wireless lines, . 9. The method of claim 8,
Wherein the multi-item item includes blood glucose and ketone. 9. The method of claim 8,
Wherein the independent information comprises production lot information indicating a product ID indicating a measurement item of the test sheet, a production date and a production lot number during a day, and the dependency information includes control solution correction information, blood glucose correction information, A method for managing information on a test sheet of a measurement test apparatus.


KR1020150102669A 2015-07-20 2015-07-20 Method and system for managing the test strip information of multi-parameter measurement device KR101698497B1 (en)

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KR20210012740A (en) * 2019-07-26 2021-02-03 주식회사 수젠텍 Multiplexing blot assay automation system

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