KR20090107165A - Bio-sensor for measurement of HbA1c - Google Patents

Bio-sensor for measurement of HbA1c Download PDF

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KR20090107165A
KR20090107165A KR1020080032526A KR20080032526A KR20090107165A KR 20090107165 A KR20090107165 A KR 20090107165A KR 1020080032526 A KR1020080032526 A KR 1020080032526A KR 20080032526 A KR20080032526 A KR 20080032526A KR 20090107165 A KR20090107165 A KR 20090107165A
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South Korea
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hemoglobin
glycated hemoglobin
glycated
blood
measuring
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KR1020080032526A
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Korean (ko)
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전성일
안연찬
류준오
김은중
윤현철
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주식회사 올메디쿠스
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    • 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
    • G01N33/72—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood pigments, e.g. haemoglobin, bilirubin or other porphyrins; involving occult blood
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
    • G01N1/2813—Producing thin layers of samples on a substrate, e.g. smearing, spinning-on
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
    • G01N1/2813—Producing thin layers of samples on a substrate, e.g. smearing, spinning-on
    • G01N2001/2826—Collecting by adsorption or absorption
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/04—Endocrine or metabolic disorders
    • G01N2800/042—Disorders of carbohydrate metabolism, e.g. diabetes, glucose metabolism

Abstract

PURPOSE: A biosensor for measuring glucosylated hemoglobin is provided to eliminate error of conventional measurement of the glucosylated hemoglobin. CONSTITUTION: A sensor for measuring glucosylated hemoglobin comprises a substrate (14), first and second hemoglobin measuring windows (15,16), blood inhalating porous matrix (13), and glucosylated hemoglobin absorbing part (17). The first and second hemoglobin measuring windows are formed in constant interval and measures total hemoglobin (10) and glucosylated hemoglobin (11). The blood inhalating porous matrix moves on the substrate. The glucosylated hemoglobin absorbing part absorbs between the first and second hemoglobin measuring windows through the blood inhalating porous matrix.

Description

당화혈색소 측정용 바이오센서{Bio-sensor for measurement of HbA1c}Biosensor for measurement of glycated hemoglobin {Bio-sensor for measurement of HbA1c}

본 발명은 최근 수개월 동안 당뇨병이 치료에 의해서 잘 관리가 되고 있는지 등을 알 수 있는 지표로 이용되는 당화혈색소 측정용 바이오센서에 관한 것이다.The present invention relates to a biosensor for measuring glycated hemoglobin, which is used as an index for knowing whether diabetes has been well managed by treatment in recent months.

사람의 적혈구(Red Blood Cell)에는 혈색소(헤모글로빈)라고 하는 산소 운반에 필요한 단백질이 들어있다. 혈액속에 혈당(포도당)이 상승하면 혈액내의 포도당의 일부가 혈색소에 결합된다. 이렇게 포도당과 결합된 혈색소를 당화혈색소라고 하며, 헤모글로빈 에이원씨(HbA1c)라고도 부른다.Human red blood cells contain proteins for oxygen transport called hemoglobin. When blood sugar (glucose) rises in the blood, some of the glucose in the blood is bound to hemoglobin. The hemoglobin combined with glucose is called glycated hemoglobin and is also called hemoglobin A1c (HbA1c).

정상 적혈구의 수명은 약 120일 정도이며, 우리 몸안에서는 매일 일부의 적혈구가 파괴되며, 이 파괴된 양과 비슷한 양의 적혈구가 생성되어 일정한 수준을 유지하게 된다. 그런데, 한번 포도당과 결합되어 당화혈색소가 만들어지면 그 적혈구 수명이 다 되어 분해될 때까지 당화혈색소를 가지고 있게 된다.The normal life of red blood cells is about 120 days, and some of the red blood cells in our body are destroyed every day, and the amount of red blood cells similar to this destroyed amount is generated and maintained at a constant level. However, once glycated hemoglobin is created by combining with glucose, the red blood cells have a glycated hemoglobin until their life span is broken down.

혈당검사는 매일 매일 피속의 당분이 얼마만큼 있는가를 체크하는 검사인 반면에, 당화혈색소 검사는 평균 8주간의 혈당치를 반영한다. Glucose testing is a test that checks how much sugar is in the blood every day, whereas glycated hemoglobin test reflects the average blood sugar level of eight weeks.

그리고, 혈당검사의 경우 공복시의 혈당치를 검사하기 위해서는 적어도 8시간 이상 금식해야 하며, 식후 혈당치를 검사하기 위해서는 보통 식후 2시간 정도 지나서 채혈하여 검사해야하지만, 당화혈색소 검사는 식사 시간과 무관하게 채혈하여 검사할 수 있는 장점을 가진다.In the case of blood glucose test, fasting blood glucose level should be fasted for at least 8 hours, and blood glucose level should be checked by blood collection 2 hours after eating, but glycated hemoglobin test should be done regardless of meal time. It has the advantage of being inspected.

한편, 당화혈색소 검사는 비교적 장기간의 혈당치를 반영하므로, 최근 수개월 동안 당뇨병이 치료에 의해서 잘 관리가 되고 있는지 등을 알 수 있는 지표로 이용된다. 즉, 당뇨병의 치료 목표는 합병증을 방지하기 위해서 정상 혈당을 유지하는 것이며, 당뇨병 관리가 잘 이루어지는 지를 알아보기 위해서는 빈번한 혈당 측정이 필요하다. On the other hand, the glycated hemoglobin test reflects a relatively long-term blood glucose level, it is used as an indicator to know whether diabetes is well managed by treatment in recent months. In other words, the treatment goal of diabetes is to maintain normal blood sugar in order to prevent complications, and frequent blood glucose measurement is necessary to determine whether diabetes management is performed well.

그러나, 혈당을 자주 측정하는 것은 번거로운 일이므로 혈당을 자주 측정할 수 없는 경우나, 자주 측정할 필요가 없을 경우에 당화혈색소 검사를 이용하면 한번 측정으로 비교적 장기간의 혈당 평균치를 알 수 있으므로, 혈당 조절이 잘되고 있는지를 쉽게 알 수 있게 된다.However, measuring blood glucose frequently is cumbersome, so when blood glucose cannot be measured frequently, or when there is no need to measure it frequently, the glycated hemoglobin test can be used to determine the average blood sugar level over a long period of time. It is easy to see if this is going well.

만일, 당화혈색소 측정치가 높으면 당뇨병 치료가 잘 이루어지지 않고 있는 상태라고 평가될 수 있으며, 환자는 이러한 측정을 통해 더욱 엄격한 식이요법을 적용하거나 또는 인슐린 주입 용량을 더 늘리는 등의 당뇨병 관리가 이루어 질 것이다.If the glycated hemoglobin level is high, it may be regarded as a condition that diabetes treatment is poorly performed, and the patient may manage diabetes by applying a stricter diet or increasing an insulin injection dose. .

그러나, 기존의 당화혈색소 측정은 병원의 임상병리실에서 측정되는 경우가 대부분이었고, 이 경우 시료전처리 과정이 필요하며, 장비의 부피가 크고, 시약 및 소모품이 고가인 단점이 있었다.However, the conventional glycated hemoglobin measurement was mostly measured in the clinical laboratory of the hospital, in which case the sample pretreatment process, the bulk of the equipment, the reagents and consumables were expensive.

상기한 당화혈색소의 단점을 극복하기 위해 등록특허 제602952호에는 결합체 패드와 흡수패드가 일부 적층된 니트로셀룰로오즈 멤브레인의 일정 구간에 형성된 당화혈색소 측정부에서 당화혈색소 항체와 혈색소 항체에 의해 혈액시료 내의 당화혈색소가 항원-항체 반응에 의해 결합되게 되고, 이를 정량적으로 분석함에 의해 당화혈색소를 측정할 수 있도록 구현하며, 동시에 혈색소의 양을 측정하여 혈색소에 대한 당화혈색소의 비율을 측정함으로써 저렴한 비용으로 간편하게 비교적 장기간의 혈당치를 알 수 있도록 한 면역크로마토그래피법을 이용한 당화혈색소 측정센서가 개시되어 있다.In order to overcome the drawbacks of the glycated hemoglobin, the registered patent No. 60601 has a glycosylated hemoglobin antibody and a hemoglobin antibody in the glycated hemoglobin antibody in a glycated hemoglobin measurement unit formed in a certain section of the nitrocellulose membrane in which the conjugate pad and the absorption pad are partially laminated. Hemoglobin is bound by antigen-antibody reactions and quantitatively analyzed to measure glycated hemoglobin, and at the same time by measuring the amount of hemoglobin to measure the ratio of glycated hemoglobin to hemoglobin at a relatively low cost Disclosed is a glycated hemoglobin sensor using an immunochromatography method that allows a long-term blood glucose level to be known.

상기 특허에서 당화혈색소의 기본원리는 혈액시료내에 존재하는 혈색소와 포도당이 결합하여 생성된 당화혈색소와 혈색소 각각을 동시에 정량 분석하여 그비율을 측정하는 것이다.The basic principle of glycated hemoglobin in the patent is to measure the ratio by simultaneously quantitatively analyzing each of the glycated hemoglobin and hemoglobin produced by combining hemoglobin and glucose present in the blood sample.

상기 혈색소 및 당화혈색소의 양을 측정하는 방법을 설명하면, 혈색소 및 당화혈색소가 니트로셀룰로오즈 멤브레인을 통해 혈색소 측정부 및 당화혈색소 측정부까지 이동되게 되면, 확산반사분광법을 이용하여 혈색소 측정창 및 당화혈색소 측정창을 통해 혈색소 및 당화혈색소의 양을 검출하게 된다. Referring to the method for measuring the amount of hemoglobin and glycated hemoglobin, when hemoglobin and glycated hemoglobin are transferred to the hemoglobin measurement unit and the glycated hemoglobin measurement unit through the nitrocellulose membrane, the hemoglobin measurement window and the glycated hemoglobin using diffuse reflection spectroscopy The measurement window detects the amount of hemoglobin and glycated hemoglobin.

이때, 상기 혈색소 및 당화혈색소는 제2항체-신호발생물질 결합체와 결합되어 혈색소 측정부 및 당화혈색소 측정부로 이동하게 된다.At this time, the hemoglobin and glycated hemoglobin are combined with the second antibody-signaling conjugate to be moved to the hemoglobin measuring unit and the glycated hemoglobin measuring unit.

그러나, 상기 당화혈색소 측정부에서 당화혈색소의 양을 측정할 때, 제2항체-신호발생물질 결합체가 당화혈색소와 결합되지 않은 채로 머무는 경우가 발생할 수 있다. However, when the amount of glycated hemoglobin is measured in the glycated hemoglobin measurement unit, the second antibody-signaling agent may remain unbound with the glycated hemoglobin.

이러한 경우에 당화혈색소 측정창을 통해 빛이 투과되어 당화혈색소를 정량할 때 당화혈색소에 결합되지 않은 제2항체-신호발생물질 결합체로 인해 측정오차가 발생할 수 있다.In this case, when the light is transmitted through the glycated hemoglobin measurement window to measure the glycated hemoglobin, a measurement error may occur due to the second antibody-signaling substance conjugate that is not bound to the glycated hemoglobin.

이러한 문제점을 해결하기 위해서는 당화혈색소 측정부에 존재하는 당화혈색소가 없는 제2항체-신호발생물질을 제거한(워싱(Washing)한) 후에 측정하여야만 정확한 당화혈색소를 측정할 수 있게 된다.In order to solve this problem, accurate glycated hemoglobin can be measured only after removing (washing) the second antibody-signaling substance without glycated hemoglobin present in the glycated hemoglobin measurement unit.

그러나, 상기 제2항체-신호발생물질을 제거하는 공정이 별도로 추가되어야 하므로, 공정 추가로 인한 제조원가의 증가를 초래하는 문제점이 있다.However, since the process of removing the second antibody-signaling substance has to be added separately, there is a problem that increases the manufacturing cost due to the addition of the process.

본 발명은 상기와 같은 점을 감안하여 안출한 것으로서, 기존의 당화혈색소 측정부에서 당화혈색소 측정창을 통해 당화혈색소의 양을 측정하는 것이 아니라, 당화혈색소 고정부에 의해 당화혈색소가 제거된 혈색소(A)의 양을 측정하여 총 혈색소(T)에서 당화혈색소가 제거된 혈색소(A)를 뺀 값으로 당화혈색소를 결정함으로써, 당화혈색소의 측정오차를 최소화 할 수 있도록 한 당화혈색소 측정용 센서를 제공하는데 그 목적이 있다.The present invention has been made in view of the above, and the glycated hemoglobin is removed by the glycated hemoglobin immobilization unit instead of measuring the amount of glycated hemoglobin through the glycated hemoglobin measurement window in the conventional glycated hemoglobin measurement unit ( By measuring the amount of A) and determining the glycated hemoglobin by subtracting the hemoglobin (A) from the total hemoglobin (T), providing a sensor for measuring the glycated hemoglobin to minimize the measurement error of glycated hemoglobin Its purpose is to.

상기한 목적을 달성하기 위한 본 발명은 당화혈색소 측정용 센서에 있어서,The present invention for achieving the above object in the sensor for measuring glycated hemoglobin,

기판; Board;

상기 기판에 일정한 간격으로 형성되어 총 혈색소 및 당화혈색소를 정량적으로 측정하기 위한 제1 및 제2혈색소 측정창; First and second hemoglobin measurement windows formed on the substrate at regular intervals to quantitatively measure total hemoglobin and glycated hemoglobin;

상기 기판 위에 적층되어 혈색소 및 당화혈색소가 이동되는 혈액흡입용 포러스 매트릭스; 및 A blood suctioning porous matrix stacked on the substrate to move hemoglobin and glycated hemoglobin; And

혈액이 혈액흡입용 포러스 매트릭스를 통해 이동 시 상기 제1 및 제2혈색소 측정창 사이에서 당화혈색소를 흡착시켜주도록 혈액흡입용 포러스 매트릭스의 일부 또는 혈액흡입용 포러스 매트릭스의 상부에 형성된 당화혈색소 흡착부를 포함하고,It includes a glycated hemoglobin adsorption portion formed on the upper part of the blood intake pores matrix or the blood intake pores matrix to adsorb the glycated hemoglobin between the first and second hemoglobin measurement window when blood moves through the blood intake pores matrix and,

상기 제1혈색소 측정창을 통해 총 혈색소(T)를 측정하고, 당화혈색소 흡착부 에 의해 당화혈색소가 제거된 후 이동되는 혈색소(A)를 제2혈색소 측정창을 통해 측정한 후, 이들의 차이로 계산한 값(T-A=B)을 이용하여 총 혈색소(T)에서 당화혈색소(B)가 차지하는 비율을 측정하는 것을 특징으로 한다.The total hemoglobin (T) was measured through the first hemoglobin measurement window, and the hemoglobin (A) moved after the glycated hemoglobin was removed by the glycated hemoglobin adsorption unit was measured through the second hemoglobin measurement window, and then the difference between them. Using the value calculated as (TA = B) is characterized by measuring the proportion of glycated hemoglobin (B) in the total hemoglobin (T).

바람직한 구현예로서, 상기 당화혈색소 흡착부는 당화혈색소와 결합할 수 있는 화학작용기가 화학적 또는 물리적으로 결합된 패드인 것을 특징으로 하는 당화혈색소 측정용 센서.In a preferred embodiment, the glycated hemoglobin adsorption unit is a glycated hemoglobin measurement sensor, characterized in that the pads chemically or physically bonded with a chemical functional group that can be combined with glycated hemoglobin.

더욱 바람직한 구현예로서, 상기 당화혈색소 흡착부는 당화혈색소 항체(Anti-HbA1c)를 화학적 또는 물리적으로 부착된 패드인 것을 특징으로 한다.In a more preferred embodiment, the glycosylated hemoglobin adsorption portion is characterized in that the pad is chemically or physically attached to the glycated hemoglobin antibody (Anti-HbA1c).

이상에서 본 바와 같이, 본 발명에 따른 당화혈색소 측정용 센서에 의하면, 당화혈색소를 직접 측정하지 않고 먼저 총 혈색소(T)의 양을 측정한 다음 혈색소 중에서 당화혈색소(B)만을 고정시킨 후 나머지 혈색소(A)의 양을 측정하고, 총 혈색소의 양에서 나머지 혈색소의 양을 뺀 값을 당화혈색소의 양으로 결정함으로써, 기존의 당화혈색소 측정시 오차발생을 해결할 수 있다.As described above, according to the sensor for measuring glycated hemoglobin according to the present invention, without measuring the glycated hemoglobin directly, first measuring the amount of total hemoglobin (T), and then fixing only the glycated hemoglobin (B) in the hemoglobin, and then rest the hemoglobin. By measuring the amount of (A) and subtracting the amount of hemoglobin from the amount of total hemoglobin as the amount of glycated hemoglobin, it is possible to solve the occurrence of errors in the conventional measurement of glycated hemoglobin.

이하, 본 발명의 바람직한 실시예를 첨부도면을 참조로 상세하게 설명한다.Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the accompanying drawings.

첨부한 도 1은 본 발명의 일실시예에 따른 당화혈색소 측정용 바이오센서를 나타내는 구성도이고, 도 2는 본 발명의 혈액흡입용 기판을 나타내는 평면도이다.1 is a block diagram showing a biosensor for measuring glycated hemoglobin according to an embodiment of the present invention, Figure 2 is a plan view showing a substrate for blood intake of the present invention.

본 발명에 따른 당화혈색소 측정용 센서는 기판(14)과, 기판(14) 위에 적층된 혈액흡입용 포러스 매트릭스(13)와, 혈액흡입용 포러스 매트릭스(13)의 양단에 일부가 걸치도록 적층된 시료패드(12) 및 흡수패드(18)와, 상기 시료패드(12) 및 흡수패드(18) 사이에 위치하도록 혈액흡입용 포러스 매트릭스(13)의 일정구간에 적층된 당화혈색소 고정부(17)를 포함한다.Sensor for measuring glycated hemoglobin according to the present invention is laminated so that a part across both ends of the substrate 14, the blood suction porous matrix 13 stacked on the substrate 14, and the blood suction porous matrix 13 A glycated hemoglobin fixing part 17 laminated on a predetermined section of the blood suctioning porous matrix 13 so as to be positioned between the sample pad 12 and the absorption pad 18 and the sample pad 12 and the absorption pad 18. It includes.

상기 기판(14)은 당화혈색소 측정용 센서를 구성하는 혈액흡입용 포러스 매트릭스(13)와, 시료패드(12) 및 흡수패드(18)와, 당화혈색소(11)를 잡아주는 당화혈색소 고정부(17)를 적층하기 위한 베이스 기판(14)이다. The substrate 14 is a glycosylated hemoglobin fixing part for holding a blood suctioning porous matrix 13, a sample pad 12, an absorption pad 18, and a glycated hemoglobin 11 constituting a sensor for measuring glycated hemoglobin ( 17 is a base substrate 14 for laminating.

상기 시료패드(12)에는 인체로부터 채취된 혈액시료를 시료패드(12)에 떨어뜨릴 때 적혈구로부터 당화혈색소(11)와 혈색소(10)로 분리될 수 있도록 계면활성제가 들어있는 완충용액이 일정량 포함되어 있다.The sample pad 12 includes a predetermined amount of a buffer solution containing a surfactant to separate the glycated hemoglobin 11 and hemoglobin 10 from red blood cells when the blood sample collected from the human body is dropped onto the sample pad 12. It is.

상기 흡수패드(18)는 혈액흡입용 포러스 매트릭스(13)를 통해 이동된 물질을 흡수하는 역할을 한다.The absorption pad 18 serves to absorb the material moved through the blood intake porous matrix 13.

상기 기판(14)에는 혈색소(10)를 정량적으로 측정하기 위한 제1혈색소 측정창(15)과, 당화혈색소(11)를 정량적으로 측정하기 위해 제1혈색소 측정창(15) 이후(혈액 진행방향 기준)에 정확하게는, 당화혈색소 고정부(17) 이후에 제2혈색소 측정창(16)이 형성되게 된다.The substrate 14 includes a first hemoglobin measurement window 15 for quantitatively measuring hemoglobin 10 and a first hemoglobin measurement window 15 for quantitatively measuring glycated hemoglobin 11 (blood flow direction). 2), the second hemoglobin measurement window 16 is formed after the glycated hemoglobin fixing part 17.

상기 혈액흡입용 포러스 매트릭스(13)는 기판(14) 상에 적층되고, 용혈된 혈액시료가 좌측에서 접촉되자마자 우측으로 이동하게 된다. 상기 제1 및 제2혈색소 측정창(15,16)을 통해 혈색소(10)와 당화혈색소(11)가 포함되지 않은 혈색소를 정 량적으로 측정한다. The blood suction porous matrix 13 is stacked on the substrate 14 and moves to the right as soon as the hemolyzed blood sample contacts the left side. The hemoglobin 10 and the hemoglobin hemoglobin 11 are not quantitatively measured through the first and second hemoglobin measurement windows 15 and 16.

상기 혈액흡입용 포러스 매트릭스(13)에는 혈액시료 내에 포함된 당화혈색소(11)를 고정하기 위해 당화혈색소 고정부(17)가 형성되어 있다.The glycosylated hemoglobin fixing part 17 is formed in the blood suctioning porous matrix 13 to fix the glycated hemoglobin 11 contained in the blood sample.

상기 당화혈색소 고정부(17)는 보론산(Boric Acid) 작용기가 붙어있는 패드에 의해 구현될 수 있으며, 상기 보론산이 당화혈색소(11)와 결합하여 당화혈색소(11)를 당화혈색소 고정부(17)에 잡아놓게 된다.The glycated hemoglobin fixing part 17 may be implemented by a pad to which a boronic acid functional group is attached, and the boronic acid is combined with the glycated hemoglobin 11 to bind the glycated hemoglobin 11 to the glycated hemoglobin fixing part 17 ).

이때, 상기 당화혈색소 고정부(17)는 일정한 면적 및 길이로 형성되어 통상적으로 피험자로부터 채혈되는 혈액량에 포함된 당화혈색소(11)를 수용할 수 있을 정도의 면적을 가진다.In this case, the glycated hemoglobin fixing part 17 is formed to have a constant area and length and has an area enough to accommodate the glycated hemoglobin 11 included in the blood volume that is usually collected from a subject.

또한, 상기 당화혈색소 흡착부(17)를 사이에 두고 좌측으로 제1혈색소 측정창(15)을 통해 총 혈색소를 측정할 수 있도록 제1혈색소 측정부(19)가 형성되고, 우측으로 제2혈색소 측정창(16)을 통해 당화혈색소(11)가 제거된 제2혈색소 측정부(20)가 형성되어 있다. 이때, 제1혈색소 측정부(19) 및 제2혈색소 측정부(20)는 기판 아래쪽에 위치한다. 측정 창 아래에서 빛을 가하고 표면에서 반사되어 나오는 빛을 다시 측정하게 된다.In addition, the first hemoglobin measurement unit 19 is formed to measure the total hemoglobin through the first hemoglobin measurement window 15 to the left with the glycated hemoglobin adsorption unit 17 therebetween, and the second hemoglobin to the right. The second hemoglobin measurement unit 20 from which the glycated hemoglobin 11 has been removed is formed through the measurement window 16. At this time, the first hemoglobin measuring unit 19 and the second hemoglobin measuring unit 20 are located under the substrate. Light is applied under the measurement window and the light reflected from the surface is measured again.

이와 같은 구성에 의한 본 발명에 따른 당화혈색소 측정용 센서의 작용상태를 설명하면 다음과 같다.Referring to the operation state of the glycated hemoglobin measurement sensor according to the present invention by such a configuration as follows.

전술한 바와 같이 당화혈색소(11)는 포도당이 결합된 혈색소를 말하며, 매일 매일 혈당검사를 하지 않고도 비교적 장기간 동안 혈당치료가 얼마나 잘 이루어지고 있는 지를 판단하기 위해 사용된다. As described above, glycated hemoglobin 11 refers to hemoglobin to which glucose is bound, and is used to determine how well blood glucose treatment is performed for a relatively long time without having to check blood glucose every day.

궁극적으로 본 발명에서 측정하고자 하는 값은 당화혈색소(11)가 총 혈색소에서 차지하는 비율을 측정한 값이고, 이 측정값이 크면 클수록 혈당치가 올라감을 의미한다.Ultimately, the value to be measured in the present invention is a measure of the ratio of glycated hemoglobin 11 to total hemoglobin, and the larger the measured value, the higher the blood glucose level.

또한, 본 발명의 측정 기본 원리는 당화혈색소(11)를 직접적으로 측정하는 것이 아니고, 당화혈색소(11)를 어느 한 곳에 고정시킨 상태에서 당화혈색소(11)가 포함된 혈색소 즉 총 혈색소의 양(T)을 먼저 측정한 다음, 당화혈색소(11)가 포함되지 않은 혈색소의 양(A)을 측정하여 이들의 차이값을 계산한 것이 당화혈색소(11)의 양이 된다는 것이다.In addition, the basic principle of the measurement of the present invention is not directly measuring the glycated hemoglobin 11, but the amount of hemoglobin, that is, the total hemoglobin in which the glycated hemoglobin 11 is contained in a state in which the glycated hemoglobin 11 is fixed at one place ( T) is measured first, and then the amount (A) of hemoglobin that does not contain the glycated hemoglobin 11 is calculated, and the difference value thereof is calculated as the amount of the glycated hemoglobin 11.

이때, 상기 혈색소는 고유의 색으로 측정되게 된다.In this case, the hemoglobin is measured in its own color.

따라서, 본 발명에 따르면, 제1 및 제2혈색소 측정창(15,16)을 통해 측정되는 것은 모두가 혈색소이므로, 동일한 파장대의 빛을 상기 측정창(15,16)에 투과함으로써 총 혈색소 및 당화혈색소(11)가 제거된 혈색소의 양을 검출할 수 있게 되고, 각 T 값과 A 값의 차이를 이용하여 당화혈색소(11)의 양(B)을 측정할 수 있다.Therefore, according to the present invention, since all measured through the first and second hemoglobin measurement windows 15 and 16 are all hemoglobin, total hemoglobin and glycosylation by transmitting the same wavelength band of light through the measurement windows 15 and 16. The amount of hemoglobin 11 from which hemoglobin 11 has been removed can be detected, and the amount B of glycated hemoglobin 11 can be measured using the difference between each T value and A value.

또한, 상기 측정된 총 혈색소의 양(T)에서 당화혈색소(B)가 차지하는 비율(B/T)을 측정하는 것이 가능해진다.In addition, it becomes possible to measure the ratio (B / T) of the glycated hemoglobin (B) in the amount (T) of the measured total hemoglobin.

이상에서는 본 발명을 특정의 바람직한 실시예에 대하여 도시하고 설명하였으나, 본 발명은 이러한 실시예에 한정되지 않으며, 당해 발명이 속하는 기술분야에서 통상의 지식을 가진 자가 특허청구범위에서 청구하는 본 발명의 기술적 사상을 벗어나지 않는 범위내에서 실시할 수 있는 다양한 형태의 실시예들을 모두 포함 한다.While the invention has been shown and described with respect to certain preferred embodiments thereof, the invention is not limited to these embodiments, and has been claimed by those of ordinary skill in the art to which the invention pertains. It includes all the various forms of embodiments that can be implemented without departing from the spirit.

도 1은 본 발명의 일실시예에 따른 당화혈색소 측정용 바이오센서를 나타내는 구성도이다.1 is a block diagram showing a biosensor for measuring glycated hemoglobin according to an embodiment of the present invention.

도 1a 및 도 1b는 도 1에서 혈액흡입용 포러스 매트릭스와 당화혈색소 결합부의 다른 실시예를 나타내는 도면이다.1A and 1B are views illustrating another embodiment of the blood suctioning porous matrix and glycated hemoglobin binding unit in FIG. 1.

도 2는 본 발명의 혈액흡입용 기판을 나타내는 평면도이다.2 is a plan view showing a blood suction substrate of the present invention.

<도면의 주요부분에 대한 부호의 설명><Description of the symbols for the main parts of the drawings>

10 : 혈색소 11 : 당화혈색소10 hemoglobin 11: glycated hemoglobin

12 : 시료패드 13,131~134 : 혈액흡입용 포러스 매트릭스12: sample pad 13,131 ~ 134: blood inhalation porous matrix

14 : 기판 15 : 제1혈색소 측정창14 substrate 15 first hemoglobin measurement window

16 : 제2혈색소 측정장 17 : 당화혈색소 고정부16: second hemoglobin measurement site 17: glycated hemoglobin fixing part

18 : 흡수패드 19 : 제1혈색소 측정부18: absorption pad 19: the first hemoglobin measuring unit

20 : 제2혈색소 측정부20: second hemoglobin measurement unit

Claims (3)

당화혈색소 측정용 센서에 있어서,In the sensor for measuring glycated hemoglobin, 기판; Board; 상기 기판에 일정한 간격으로 형성되어 총 혈색소 및 당화혈색소를 정량적으로 측정하기 위한 제1 및 제2혈색소 측정창; First and second hemoglobin measurement windows formed on the substrate at regular intervals to quantitatively measure total hemoglobin and glycated hemoglobin; 상기 기판 위에 적층되어 혈색소 및 당화혈색소가 이동되는 혈액흡입용 포러스 매트릭스; 및 A blood suctioning porous matrix stacked on the substrate to move hemoglobin and glycated hemoglobin; And 혈액이 혈액흡입용 포러스 매트릭스를 통해 이동 시 상기 제1 및 제2혈색소 측정창 사이에서 당화혈색소를 흡착시켜주도록 혈액흡입용 포러스 매트릭스의 일부 또는 혈액흡입용 포러스 매트릭스의 상부에 형성된 당화혈색소 흡착부를 포함하고,It includes a glycated hemoglobin adsorption portion formed on the upper part of the blood intake pores matrix or the blood intake pores matrix to adsorb the glycated hemoglobin between the first and second hemoglobin measurement window when blood moves through the blood intake pores matrix and, 상기 제1혈색소 측정창을 통해 총 혈색소(T)를 측정하고, 당화혈색소 흡착부에 의해 당화혈색소가 제거된 후 이동되는 혈색소(A)를 제2혈색소 측정창을 통해 측정한 후, 이들의 차이로 계산한 값(T-A=B)을 이용하여 총 혈색소(T)에서 당화혈색소(B)가 차지하는 비율을 측정하는 것을 특징으로 하는 당화혈색소 측정용 센서.The total hemoglobin (T) is measured through the first hemoglobin measurement window, and the hemoglobin (A) which is moved after the glycated hemoglobin is removed by the glycated hemoglobin adsorption unit is measured through the second hemoglobin measurement window, and then the difference between them. Sensor for measuring glycated hemoglobin, characterized in that for measuring the ratio of glycated hemoglobin (B) to the total hemoglobin (T) using the value calculated by (TA = B). 청구항 1에 있어서,The method according to claim 1, 상기 당화혈색소 흡착부는 당화혈색소와 결합할 수 있는 화학작용기가 화학적 또는 물리적으로 결합된 패드인 것을 특징으로 하는 당화혈색소 측정용 센서.The glycated hemoglobin adsorption unit is a glycated hemoglobin measurement sensor, characterized in that the chemical group that is capable of bonding with the glycated hemoglobin is physically bonded to the pad. 청구항 1에 있어서,The method according to claim 1, 상기 당화혈색소 흡착부는 당화혈색소 항체(Anti-HbA1c)를 화학적 또는 물리적으로 부착된 패드인 것을 특징으로 하는 당화혈색소 측정용 센서.The glycated hemoglobin adsorption unit is a glycated hemoglobin measurement sensor, characterized in that the pad is attached to the glycated hemoglobin (Anti-HbA1c) chemically or physically.
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KR102439474B1 (en) * 2021-09-29 2022-09-02 주식회사 오렌지바이오메드 Method and device for determining HbA1c levels using mechanical and electrical characteristics of RBCs

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KR101240962B1 (en) * 2011-04-08 2013-03-11 (주)미코바이오메드 Measuring device for glycosylated hemoglobin
KR20130066841A (en) * 2011-12-13 2013-06-21 (주)미코바이오메드 Glycosylated hemoglobin sensor strip, glycosylated hemoglobin measurement device and method for glycosylated hemoglobin measurement
WO2013118927A1 (en) * 2012-02-09 2013-08-15 엘지전자 주식회사 Blood sugar detecting method and cartridge using same
US9939402B2 (en) 2012-02-09 2018-04-10 Lg Electronics Inc. Blood sugar detecting method and cartridge using same
KR102439474B1 (en) * 2021-09-29 2022-09-02 주식회사 오렌지바이오메드 Method and device for determining HbA1c levels using mechanical and electrical characteristics of RBCs

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