KR20220059973A - Hematocrit calibrated blood glucose meter strip - Google Patents

Hematocrit calibrated blood glucose meter strip Download PDF

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KR20220059973A
KR20220059973A KR1020200144004A KR20200144004A KR20220059973A KR 20220059973 A KR20220059973 A KR 20220059973A KR 1020200144004 A KR1020200144004 A KR 1020200144004A KR 20200144004 A KR20200144004 A KR 20200144004A KR 20220059973 A KR20220059973 A KR 20220059973A
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electrode
sample
strip
blood
impedance
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KR1020200144004A
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Korean (ko)
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김다니엘영민
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(주)유니케어
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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5025—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures for parallel transport of multiple samples
    • 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
    • G01N27/02—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating impedance
    • G01N27/028—Circuits therefor
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/06—Fluid handling related problems
    • B01L2200/0647—Handling flowable solids, e.g. microscopic beads, cells, particles
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0809—Geometry, shape and general structure rectangular shaped
    • B01L2300/0825—Test strips
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0887—Laminated structure
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00—Moving or stopping fluids
    • B01L2400/04—Moving fluids with specific forces or mechanical means
    • B01L2400/0403—Moving fluids with specific forces or mechanical means specific forces
    • B01L2400/0415—Moving fluids with specific forces or mechanical means specific forces electrical forces, e.g. electrokinetic

Abstract

The present invention relates to a strip only for a hematocrit calibrated blood glucose meter. The strip can be used only for a blood glucose meter which can analyze a proportion of volume occupied by blood glucose in blood through hematocrit (Ht, Hct) calibration and display the same in the form of a number. The strip according to the present invention includes: a lower plate having an electrode pattern layer; a middle plate attached to the lower plate and having a sample injection path for injecting a blood sample; and an upper plate attached to the middle plate and having hydrophilic surface treatment and an air vent hole to facilitate sample injection, wherein the electrode pattern layer includes: a reference electrode for applying voltage to determine electric current; a strip recognizing electrode for recognizing a strip upon the insertion of the strip to a blood glucose meter; an impedance input reference electrode for inputting sine waves to determine impedance; an impedance output work electrode for determining the sine waves input in the impedance input reference electrode and outputting the impedance; a sample recognizing electrode for detecting whether a sample is introduced into the sample injection path or not; a blood recognizing electrode for detecting whether blood is introduced or not in the sample strip recognizing electrode; and an electric current collecting work electrode for collecting the extent of electric current generated through the reaction of an enzyme with the sample.

Description

헤마토크릿 보정형 혈당 측정기 전용 스트립{Hematocrit calibrated blood glucose meter strip} Hematocrit calibrated blood glucose meter strip

본 발명은 헤마토크릿(Ht, Hct) 보정을 통하여 혈액에서 혈당이 차지하는 용적 비중을 보다 정밀하게 분석 후 수치로 표시할 수 있도록하는 혈당 측정기에 전용으로 사용이 가능한 새로운 헤마토크릿 보정형 혈당 측정기 전용 스트립에 관한 것이다.The present invention relates to a new hematocrit correction type blood glucose meter dedicated strip that can be used exclusively for a blood glucose meter that allows the volume ratio of blood glucose in blood to be analyzed more precisely and displayed as a numerical value through hematocrit (Ht, Hct) correction. will be.

최근 불규칙한 식사습관, 운동부족, 비만, 스트레스 등으로 당뇨병 환자 수가 점차늘고 있고, 이를 진단하고 예방하기 위해서는 혈액내의 포도당(혈당)의 농도를 주기적으로 측정하여 조절하는 것이 무엇보다 중요하다.Recently, the number of diabetic patients is increasing due to irregular eating habits, lack of exercise, obesity, and stress.

현재 혈당 검사 및 측정은 의료기기의 발전으로 혈액 시료를 채취한 다음 스트립 형태의 엷는 검사지(바이오 센서)를 이용하여 신속 간단하게 측정할 수 있는 기기들이 널리 보급되고 있다.Currently, with the development of medical devices, devices that can quickly and simply measure blood glucose levels using thin strips (biosensors) after taking a blood sample are widely used for blood glucose testing and measurement.

혈당측정방법은 당뇨 환자로 부터 채취된 혈액이 검사지 내의 화학물질과 전기 화학적 반응으로 나타나는 전기적 신호를 혈당값으로 연산하여 산출하는 방법으로, The blood glucose measurement method is a method of calculating the blood glucose value by calculating the electrical signal that is generated by the electrochemical reaction of the blood collected from the diabetic patient with the chemical substance in the test strip.

얇은 절연성 기판상에 복수의 전극을 형성하고 전극계상에 친수성 고분자와 산화환원효소 및 전자수용체로 이루어진 효소 반응층을 형성하고 있음에 따라 시료 주입구를 통해 효소 반응층에 기질(포도당(Glucose))을 포함한 혈액 시료를 주입하면, As a plurality of electrodes are formed on a thin insulating substrate and an enzyme reaction layer composed of a hydrophilic polymer, an oxidoreductase and an electron acceptor is formed on the electrode system, a substrate (glucose) is applied to the enzyme reaction layer through the sample inlet. When a blood sample containing

효소 반응층이 이를 용해하고 시료의 기질과 효소(Enzyme)가 반응하여 기질이 산화되면서 전자 수용체가 환원되고 이를 전용 장비를 이용하여 측정함으로써 혈액시료 중에 포함된 기질 농도를 구할 수 있게 된다.The enzyme reaction layer dissolves it, the substrate of the sample reacts with the enzyme, the substrate is oxidized, the electron acceptor is reduced, and the concentration of the substrate contained in the blood sample can be obtained by measuring it using a dedicated equipment.

이렇듯 당뇨 환자는 증상만으로는 정확히 인지하는 것이 쉽지 않음으로 혈액을 채취 후 그 혈액에 포함된 혈당을 정확하게 측정하고 진단하는 것이 매우 중요하다.As such, it is not easy for a diabetic patient to accurately recognize the symptoms alone, so it is very important to accurately measure and diagnose the blood sugar contained in the blood after taking blood.

하지만, 기존의 혈당 측정기 및 이에 사용되는 혈당 측정용 스트립(혈당 검사지)은, 측정할 기준장비에 농도를 맞춘 혈액을 준비한 다음 각각의 농도별 ADC 값을 구하고 혈당 계산수식을 적용하는 방식 및 구조와 전극 패턴으로 이루어지기 때문에 통상적인 혈당값의 도출은 가능하나, 혈액 성분값 검사과정에서 오차가 발생할 가능성이 높을 뿐 아니라 이에 의한 혈당값은 당뇨 환자의 중,장기적인 관리와 환자의 체질과 특성에 맞는 더욱 치밀한 치료를 위해 완벽한 백데어터로는 어느 한계를 갖는다.However, the existing blood glucose meters and the blood glucose measurement strips (blood glucose test strips) used therein are different from the method and structure of preparing blood that has the concentration of the reference equipment to be measured, then obtaining the ADC value for each concentration and applying the blood glucose calculation formula. Since it is made of an electrode pattern, it is possible to derive a normal blood sugar value, but there is a high possibility of errors occurring in the blood component value test process, and the blood sugar value by this is suitable for the mid- to long-term management of diabetic patients and the constitution and characteristics of the patient. It has certain limitations as a perfect back data for more detailed treatment.

이에 본 발명에서는 혈액의 각 농도별 ADC를 통해 수치화된 값을 구하고, 임피던스 값으로 헤마토크릿 농도를 결정한 다음 임피던스 값과 헤마토크릿(Ht, Hct) 농도 수식 적용 헤마토크릿 보정된 더욱 정밀한 최종 혈당값을 도출할 수 있는 새로운 개념의 헤마토크릿 보정형 혈당 측정기 전용 스트립을 제공함에 주안점을 두고 그 기술적 과제로서 완성한 것이다.Therefore, in the present invention, a digitized value is obtained through ADC for each concentration of blood, the hematocrit concentration is determined by the impedance value, and then the impedance value and the hematocrit (Ht, Hct) concentration formula are applied. A more precise final blood glucose value can be derived. It was completed as a technical task with a focus on providing a strip dedicated to a hematocrit-corrected blood glucose meter of a new concept.

위 기술적 과제를 달성하기 위한 본 발명은 전극 패턴층이 형성된 하판; 하판 상에 부착되며, 혈액 시료의 주입을 위한 시료주입통로가 형성된 중판; 중판 상에 부착되며, 시료 주입을 용이하도록 친수성 표면처리와 에어벤트홀이 형성된 상판; 상기 전극 패턴층은 전류를 측정하기 위하여 전압을인가 하는 전류측정용 기준전극; 혈당 측정기에 스트립 삽입시 이를 인식하기 위한 스트립 인식전극; 임피던스 측정을 위한 사인파를 입력하는 임피던스입력기준전극; 임피던스입력기준전극에서 입력한 사인파를 측정하여 인피던스를 출력하는 임피던스출력작업전극; 시료주입통로 내 시료의 유입 여부를 감지하는 시료인식전극; 시료스트립 인식전극에서 혈액의 유입여부를 감지하는 혈액인식전극; 효소와 시료가 반응하여 발생한 전류량을 수집하는 전류수집작업전극으로 이루어지는 것이다.The present invention for achieving the above technical problem is a lower plate formed with an electrode pattern layer; a middle plate attached to the lower plate and having a sample injection passage for injection of a blood sample; an upper plate attached to the middle plate and having a hydrophilic surface treatment and an air vent hole for easy sample injection; The electrode pattern layer includes a reference electrode for measuring a current to which a voltage is applied to measure the current; a strip recognition electrode for recognizing when a strip is inserted into a blood glucose meter; Impedance input reference electrode for inputting a sine wave for impedance measurement; an impedance output working electrode for outputting impedance by measuring a sine wave input from the impedance input reference electrode; a sample recognition electrode for detecting whether a sample is introduced into the sample injection passage; a blood recognition electrode for detecting whether or not blood flows from the sample strip recognition electrode; It consists of a current collecting working electrode that collects the amount of current generated by the reaction between the enzyme and the sample.

이상과 같은 본 발명의 헤마토크릿 보정형 혈당 측정기 전용 스트립은 혈액의 각 농도별 ADC를 통해 수치화된 값을 구하고, 임피던스 값으로 헤마토크릿 농도를 결정한 다음 임피던스 값과 헤마토크릿(Ht, Hct) 농도 수식 적용 헤마토크릿 보정된 더욱 정밀한 최종 혈당값을 도출할 수 있기 때문에 더욱 정밀하고 신속하면서 편리한 혈당 측정이 가능한 것은 물론 장기간에 걸친 당뇨 환자의 치료와 건강관리에 더욱 유용한 발명이다.The hematocrit correction type blood glucose meter-only strip of the present invention as described above obtains a numerical value through the ADC for each concentration of blood, determines the hematocrit concentration using the impedance value, and then applies the impedance value and the hematocrit (Ht, Hct) concentration formula to correct the hematocrit. Since it is possible to derive a more precise final blood sugar value, it is possible to measure blood sugar more precisely, quickly and conveniently, as well as a more useful invention for long-term treatment and health management of diabetic patients.

도 1은 본 발명의 바람직한 일실시예를 보인 예시도1 is an exemplary view showing a preferred embodiment of the present invention;

본 발명의 헤마토크릿 보정형 혈당 측정기 전용 스트립은 첨부된 각 도면에 의거 보다 상세히 설명하면 하기와 같다.The hematocrit correction type blood glucose meter dedicated strip of the present invention will be described in more detail based on the accompanying drawings as follows.

먼저, 본 발명에서 제기하는 혈당 측정기는, 아래측에 배터리 케이스가 체결되고 밑면을 지지하는 하부케이스가 구성되고, 위쪽에는 투명 렌즈가 결합된 상부 케이스가 조립되며, 상,하부 케이스 사이의 내부에는 PCB 기판이 구성되고, 전측에는 스트립 투입구가 형성되고, 타측에는 일측에는 스크립 압입용 잭이 구성되고, 내부 후측에는 스트립 커넥터가 장착되며, 상부와 내부 기판 사이에는 2~3개의 누름보턴이 구성되고, 스트립 투입구에는 혈당 측정용 스트립이 삽입되며, 투명 렌즈의 내면에는 LCD가 구성는 한편,First, in the blood glucose meter proposed by the present invention, a battery case is fastened to the lower side and a lower case supporting the lower surface is configured, and an upper case coupled with a transparent lens is assembled on the upper side, and the interior between the upper and lower cases is A PCB board is configured, a strip inlet is formed on the front side, a clip press-in jack is configured on one side on the other side, a strip connector is mounted on the inner rear side, and 2-3 push buttons are configured between the upper part and the inner board. , a blood glucose measurement strip is inserted into the strip inlet, and an LCD is configured on the inner surface of the transparent lens,

상기 혈당 측정기 및 PCB 기판에는, 배터리, 전원 커버터, 에귤레이터로 구성되는 POWER부가 설치되고, 3개의 보턴과 연결된 입력포트(GPIO), 서미스터(Thermistor)와 연결된 ADC 컨트롤러, ADC 증폭기(ADC OPAMP)를 포함하는 MCU(마이크로컨트롤러)가 설치되고, 외부 단말기를 연결할 수 있는 단말기잭(Phone Jack)과 LCD가 디스털표시용 LCD가 설치되며, ADC 증폭기(ADC OPAMP)의 일측에는 DKSKFHEM 신호를 디지털로 변환하는 AD 컨버터가 구성되고, 스크립의 삽입여부를 인식하는 스트립 인식 회로가 구성된다.The blood glucose meter and the PCB board are equipped with a power unit composed of a battery, a power coverter, and an regulator, an input port (GPIO) connected to three buttons, an ADC controller connected to a thermistor, and an ADC amplifier (ADC OPAMP) MCU (microcontroller) including An AD converter for converting is configured, and a strip recognition circuit for recognizing whether or not a script is inserted is configured.

상기한 구성 중 스트립 투입구에는 혈액 시료를 포함하여 삽입되는 본 발명의 혈당 측정용 스트립은,Among the above components, the blood glucose measurement strip of the present invention inserted into the strip inlet including a blood sample,

전극 패턴층이 형성된 하판;a lower plate on which an electrode pattern layer is formed;

상기 하판 상에 부착되며, 혈액 시료의 주입을 위한 시료주입통로가 형성된 중판; a middle plate attached to the lower plate and having a sample injection passage for injection of a blood sample;

상기 중판 상에 부착되며, 시료 주입을 용이하도록 친수성 표면처리와 에어벤트홀이 형성된 상판; an upper plate attached to the middle plate and having a hydrophilic surface treatment and an air vent hole for easy sample injection;

상기 전극 패턴층은 전류를 측정하기 위하여 전압을인가 하는 전류측정용 기준전극; The electrode pattern layer includes a reference electrode for measuring a current to which a voltage is applied to measure the current;

혈당 측정기에 스트립 삽입시 이를 인식하기 위한 스트립 인식전극; a strip recognition electrode for recognizing when a strip is inserted into a blood glucose meter;

임피던스 측정을 위한 사인파를 입력하는 임피던스입력기준전극; 임피던스입력기준전극에서 입력한 사인파를 측정하여 인피던스를 출력하는 임피던스출력작업전극; Impedance input reference electrode for inputting a sine wave for impedance measurement; an impedance output working electrode for outputting impedance by measuring a sine wave input from the impedance input reference electrode;

시료주입통로 내 시료의 유입 여부를 감지하는 시료인식전극; a sample recognition electrode for detecting whether a sample is introduced into the sample injection passage;

시료스트립 인식전극에서 혈액의 유입여부를 감지하는 혈액인식전극; a blood recognition electrode for detecting whether or not blood flows from the sample strip recognition electrode;

효소와 시료가 반응하여 발생한 전류량을 수집하는 전류수집작업전극으로 이루어지는 것을 그 특징적 요지로 하였다.Its characteristic gist was that it consisted of a current collecting working electrode that collects the amount of current generated by the reaction between the enzyme and the sample.

상기 하판은 전극 패턴층이 형성되는 기판으로 절연 물질인 ET(polyethylene terephthalate) 필름을 사용하고, 평면적으로 보면 장변 및 단변을 갖는 직사각형으로 형성된다.The lower plate uses an insulating material ET (polyethylene terephthalate) film as a substrate on which the electrode pattern layer is formed, and is formed in a rectangular shape having a long side and a short side when viewed in plan.

상기 전극 패턴층은 전기 전도성 물질로 카본, 금, 은, 알루미늄, 구리 중 어느 하나의 재료로 인쇄 또는 도금하는 방식으로 이루질 수 있다. The electrode pattern layer may be formed by printing or plating with any one of carbon, gold, silver, aluminum, and copper as an electrically conductive material.

이하, 헤마토크릿 보정형 혈당 측정기 전용 스트립을 이용한 혈당측정방법에 대하여 살펴보면, Hereinafter, a blood glucose measurement method using a dedicated hematocrit correction type blood glucose meter strip will be described.

스트립이 스트립 커넥터로 삽입 되면 카본으로 도금된(도체) (A) 부분이 스트립 커넥터의 (B), (C) 부분에 닿게되고, 스트립 커넥터의 (B), (C) 부분은 스트립 삽입으로 인하여 서로 전기적으로 연결된다.When the strip is inserted into the strip connector, the (A) part plated with carbon (conductor) comes into contact with the (B), (C) part of the strip connector, and the (B), (C) part of the strip connector is electrically connected to each other.

스트립 커넥터 내부적으로 (B)와 (D), (C)와 (E)는 연결되어 있끼 때문에 스트립 커넥터의 (D), (E) 부분을 PCB 회로에 연결하여 스트립 삽입을 인식하게 된다. Since (B) and (D), (C) and (E) are connected inside the strip connector, the strip connector (D), (E) is connected to the PCB circuit to recognize the strip insertion.

혈액인식은, 도 4와 같이 스트립에 W1(Work), W2(work), R(Reference) 전극이 있는데, 혈액이 주입 되었을 때 W1에서 R로 흐르는 전류가 감지 되고, W2에서 R로 흐르는 전류가 감지되면 혈액이 주입되었다고 인식한다.For blood recognition, there are W1 (Work), W2 (work), and R (Reference) electrodes on the strip as shown in FIG. 4 . When blood is injected, the current flowing from W1 to R is sensed, and the current flowing from W2 to R is When detected, it recognizes that blood has been injected.

혈액 감지 및 측정 회로를 사용하여 W2 와 W1 전극에 Ref V 를 인가한 상태에서 혈액이 주입 되면 전기화학 반응에 의해 W2, W1 전극에서 R 전극으로 전류가 흐른다. 이 전류는 OPAmp를 이용한 I-V Converter 회로를 통하여 전압이 생성되고,이 전압을 MCU 가 ADC (Ananlog to Digital Conveter) 하여 Digital화하여 수치화 시키며, ADC를 통해 수치화된 값이 일정 수준 이상일 경우 혈액이 주입 되었다고 인식한다.When blood is injected with Ref V applied to the W2 and W1 electrodes using the blood sensing and measurement circuit, a current flows from the W2 and W1 electrodes to the R electrode by an electrochemical reaction. This current generates a voltage through the I-V converter circuit using OPAmp, and the MCU converts this voltage to ADC (Analog to Digital Conveter) and digitizes it. Recognize.

혈당측정은, 도 5와 같이 혈액 주입이 감지 된 후 W2, W1 전극에서 R 전극으로 흐르는 전류를 혈액 감지 및 측정 회로를 통해 ADC값으로 측정 하며, 혈액 감지된 후 5초 이후에 측정이 된다.In blood glucose measurement, as shown in FIG. 5 , the current flowing from the W2 and W1 electrodes to the R electrode is measured as an ADC value through a blood sensing and measuring circuit after blood injection is sensed, and is measured 5 seconds after blood is sensed.

최종 ADC 값은 100회를 측정하고 100회 측정한 값들 중 메디안 방법(변량의 값을 크기의 차례로 모두 늘어놓았을 때 그 중앙에 놓이는)으로 ADC값 10개를 선정, 그 10개 ADC 값의 평균값으로 한다.The final ADC value is measured 100 times, and among the values measured 100 times, 10 ADC values are selected by the median method (which is placed in the middle when all values of a variable are arranged in order of magnitude), and the average value of the 10 ADC values do it with

임피던스측정은, 도 6과 같이 혈당 측정 데이터 처리가 완료 된 후 임피던스 측정 동작을 수행 하며, 두개의 (Z)와 (R) 전극 사이의 혈액의 임피던스를 측정하고, 임피던스 측정용 AFE (Analog Front End) 칩(AD5941)을 사용한다.Impedance measurement, as shown in FIG. 6, performs an impedance measurement operation after blood glucose measurement data processing is completed, measures the impedance of blood between two (Z) and (R) electrodes, and AFE (Analog Front End) for impedance measurement ) chip (AD5941).

임피던스 측정 AFE 블록도에서 처럼 AFE 칩은, 전극 (Z)에 정현파(sine wave) 신호를 발생(출력) 시키고, 혈액 샘플을 통과 하여 전극(R) 을 통하여 혈액 샘플을 통과한 신호가 입력되는데, 발생(출력) 정현파의 진폭은 800mv(peak to peak) 이고, 주파수는 30Khz 이다.As in the impedance measurement AFE block diagram, the AFE chip generates (outputs) a sine wave signal to the electrode (Z), passes through the blood sample, and passes the blood sample through the electrode (R). The amplitude of the generated (output) sine wave is 800mv (peak to peak) and the frequency is 30Khz.

입력된 신호는 ADC(Analog to Digital Converter), DFT (Discrete Fourier Transform) 을 거쳐 임피던스 값을 계산한다. 이때 최종 임피던스 값은 10회를 측정하고 그 중 메디안 방법으로 4개 값을 선정 후 그 4개 값의 평균으로 하였다.The input signal is subjected to ADC (Analog to Digital Converter) and DFT (Discrete Fourier Transform) to calculate the impedance value. At this time, the final impedance value was measured 10 times, and 4 values were selected by the median method among them, and the average of the 4 values was used.

혈당값 도출 방법은, 도 7과 같이 기준장비에 농도를 맞춘 혈액을 준비하고, 준비된 각각의 농도 별 혈액을 측정하여 각 농도별 ADC값을 구한다. 각각 측정된 ADC값을 기준장비 토대로 혈당 계산 수식을 선정한다.In the blood glucose value deriving method, as shown in FIG. 7 , blood having a concentration matched to the reference equipment is prepared, and the prepared blood for each concentration is measured to obtain an ADC value for each concentration. A blood glucose calculation formula is selected based on the reference equipment based on each measured ADC value.

헤마토크릿 보정된 혈당값 도출방법은, 헤마토크릿 농도 별로 임피던스를 측정한 다음, 헤마토크릿 별(임피던스 측정값) 혈당 계산 수식을 테이블화하여 정리한다.In the method of deriving the hematocrit-corrected blood glucose value, impedance is measured for each hematocrit concentration, and then, the blood glucose calculation formula for each hematocrit (impedance measurement value) is tabled and arranged.

측정된 임피던스 값으로 헤마토크릿 농도를 결정하고, 결정된 헤마토크릿 농도의 수식을 적용하여 측정된 ADC값으로부터 최종 혈당값을 계산한다.The hematocrit concentration is determined based on the measured impedance value, and a final blood glucose value is calculated from the measured ADC value by applying the formula for the determined hematocrit concentration.

예를 들어 측정된 임피던스가 6054이고, 이때 측정된 혈당ADC값이 1361이면For example, if the measured impedance is 6054 and the measured blood glucose ADC value is 1361

->y=0163x-93438 수식이 적용되고, 헤마토크릿 보정된 혈당값은 128mg/dL로 표시 된다.The formula ->y=0163x-93438 is applied, and the hematocrit-corrected blood glucose value is displayed as 128 mg/dL.

혈액헤마토크릿(Ht, Hct) 보정Blood hematocrit (Ht, Hct) correction

Claims (1)

전극 패턴층이 형성된 하판;
하판 상에 부착되며, 혈액 시료의 주입을 위한 시료주입통로가 형성된 중판;
중판 상에 부착되며, 시료 주입을 용이하도록 친수성 표면처리와 에어벤트홀이 형성된 상판;
상기 전극 패턴층은
전류를 측정하기 위하여 전압을인가 하는 전류측정용 기준전극;
혈당 측정기에 스트립 삽입시 이를 인식하기 위한 스트립 인식전극;
임피던스 측정을 위한 사인파를 입력하는 임피던스입력기준전극;
임피던스입력기준전극에서 입력한 사인파를 측정하여 인피던스를 출력하는 임피던스출력작업전극;
시료주입통로 내 시료의 유입 여부를 감지하는 시료인식전극;
시료스트립 인식전극에서 혈액의 유입여부를 감지하는 혈액인식전극;
효소와 시료가 반응하여 발생한 전류량을 수집하는 전류수집작업전극;
으로 이루어지는 것을 특징으로 한 헤마토크릿 보정형 혈당 측정기 전용 스트립.

a lower plate on which an electrode pattern layer is formed;
a middle plate attached to the lower plate and having a sample injection passage for injection of a blood sample;
an upper plate attached to the middle plate and having a hydrophilic surface treatment and an air vent hole for easy sample injection;
The electrode pattern layer is
a reference electrode for current measurement to which a voltage is applied to measure current;
a strip recognition electrode for recognizing when a strip is inserted into a blood glucose meter;
Impedance input reference electrode for inputting a sine wave for impedance measurement;
an impedance output working electrode for outputting an impedance by measuring a sine wave input from the impedance input reference electrode;
a sample recognition electrode for detecting whether a sample is introduced into the sample injection passage;
a blood recognition electrode for detecting whether or not blood flows from the sample strip recognition electrode;
a current collecting working electrode that collects the amount of current generated by the reaction between the enzyme and the sample;
Hematocrit correction type blood glucose meter dedicated strip, characterized in that consisting of.
KR1020200144004A 2020-11-01 2020-11-01 Hematocrit calibrated blood glucose meter strip KR20220059973A (en)

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