CN107764881B - A portable blood test kit device based on electrochemical method - Google Patents
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Abstract
本发明涉及到检测血液中某物质的含量，可有效解决精准度，对HCT要求高等技术难题，其解决方案是利用电化学方法的方法检测本试剂盒装置中的液体试剂与血液反应过程中产生的电流信号，通过检测仪将检测到的电流信号转化为某物质的浓度。本发明是一个包括电极、试剂包、试剂反应池和采血区的便携式试剂盒装置，试剂包可根据检测血液中物质的不同装检测该物质的反应试剂。本发明结构简单，新颖独特，精准度高，对血液的血细胞积压大小没有要求，使用方便，可有效解决现有技术如光比色法和干式处理的试纸所造成精准度不高及对HCT大小要求高的难题。
The present invention relates to detecting the content of a substance in the blood, which can effectively solve technical problems such as high accuracy and high requirements for HCT. The solution is to use an electrochemical method to detect the current signal generated during the reaction between the liquid reagent and blood in the reagent kit device, and convert the detected current signal into the concentration of a substance through a detector. The present invention is a portable reagent kit device including electrodes, a reagent pack, a reagent reaction pool and a blood collection area. The reagent pack can be equipped with different reaction reagents for detecting the substance according to the substance in the blood. The present invention has a simple structure, is novel and unique, has high accuracy, has no requirements for the size of the blood cell overload, is easy to use, and can effectively solve the problems of low accuracy and high requirements for the size of HCT caused by existing technologies such as photocolorimetry and dry-processed test strips.
Description
技术领域Technical Field
本发明属于医学体外诊断领域，具体涉及到一种基于电化学方法的、可用于人多种血液检测项目的便携试剂盒装置。The invention belongs to the field of medical in vitro diagnosis, and in particular relates to a portable test kit device based on an electrochemical method and can be used for a variety of human blood testing items.
背景技术Background Art
目前血液检测已成为临床病人和健康人体检的常规检测方法，现在血液检测方法有：1、利用光比色法的原理在半自动或全自动生化分析仪上检测血液中某物质含量；2、利用光化学法或者电化学法试纸检测血液中某物质含量。At present, blood testing has become a routine test method for physical examinations of clinical patients and healthy people. The current blood testing methods are: 1. Using the principle of photocolorimetry to detect the content of a certain substance in the blood on a semi-automatic or fully automatic biochemical analyzer; 2. Using photochemical or electrochemical test strips to detect the content of a certain substance in the blood.
首先目前的半自动和全自动生化分析仪体积大，不能随时随地携带，需要到医院或者诊所进行血液检测，且检测所需时间长，不能快速出结果；其次光比色法利用光源和显色物质对血液中所含物质的量进行检测，这样的方法相比于电化学法，比电化学法精准度和灵敏度低；再次，如果用携带方便的试纸进行血液中物质含量的检测，即使用电化学法进行检测，试剂在试纸上进行干式处理，这样可能会造成造成血液和试剂混合不均匀，检测结果可能不准确；干式处理的试纸对血液中的血细胞积压(HCT)有一定的要求，如果血液达不到这个要求，会导致检测结果不准确。First, the current semi-automatic and fully automatic biochemical analyzers are large in size and cannot be carried anywhere at any time. Blood tests need to be performed in hospitals or clinics, and the test takes a long time and the results cannot be obtained quickly. Secondly, the photocolorimetry method uses a light source and a color-developing substance to detect the amount of a substance contained in the blood. Compared with the electrochemical method, this method has lower accuracy and sensitivity. Thirdly, if a portable test paper is used to detect the content of a substance in the blood, that is, the electrochemical method is used for detection, the reagent is dry-treated on the test paper, which may cause uneven mixing of the blood and the reagent, and the test result may be inaccurate. The dry-treated test paper has certain requirements for the hematocrit (HCT) in the blood. If the blood does not meet this requirement, the test result will be inaccurate.
发明内容Summary of the invention
有鉴于此，本发明提出一种可便携带的、基于电化学方法的、能装血液检测项目液体试剂的试剂盒装置。可有效的解决检测时间长，检测不方便，精准度和灵敏度低，对HCT要求高等问题。In view of this, the present invention proposes a portable test kit device based on electrochemical method, which can contain liquid reagents for blood test items, and can effectively solve the problems of long test time, inconvenient test, low accuracy and sensitivity, and high requirements for HCT.
为达到上述目的，本发明的技术方案是这样实现的：To achieve the above object, the technical solution of the present invention is achieved as follows:
一种基于电化学方法的便携式血液检测试剂盒装置，包括电极、试剂包、试剂反应池和采血区；所述试剂包为密闭容器，下方设有与试剂反应池相连的微型手动阀门；所述采血区与试剂反应池通过接口相连，将血液样本通过与试剂反应池之间的接口进入到试剂反应池中；所述电极设置于所述试剂反应池中，用于检测反应中产生的电流并与仪器相连、将检测到的反应中电流传输到仪器检测元件上。A portable blood test kit device based on an electrochemical method comprises an electrode, a reagent pack, a reagent reaction pool and a blood sampling area; the reagent pack is a closed container with a micro manual valve connected to the reagent reaction pool provided at the bottom; the blood sampling area is connected to the reagent reaction pool via an interface, and a blood sample enters the reagent reaction pool through the interface with the reagent reaction pool; the electrode is arranged in the reagent reaction pool, and is used to detect the current generated in the reaction and is connected to an instrument, and transmits the detected current in the reaction to the instrument detection element.
进一步的，所述电极为电极组，至少包括2个电极，即工作电极和参比电极；或者为多个电极。Furthermore, the electrode is an electrode group, including at least two electrodes, namely a working electrode and a reference electrode; or is a plurality of electrodes.
进一步的，所述电极组一端设在试剂反应池右下侧，另一端用于与仪器相连。Furthermore, one end of the electrode group is arranged at the lower right side of the reagent reaction pool, and the other end is used to connect to the instrument.
进一步的，所述电极组单独成型，使用时再与试剂反应池、仪器相连接；所述试剂反应池、仪器分别设有电极接口。Furthermore, the electrode group is formed separately and then connected to the reagent reaction pool and the instrument when in use; the reagent reaction pool and the instrument are respectively provided with electrode interfaces.
进一步的，所述试剂包是两个或者多个的联在一起的联体密闭容器，每个试剂包下方都有与试剂反应池相连的微型手动阀门。Furthermore, the reagent pack is two or more connected sealed containers, and each reagent pack has a micro manual valve connected to the reagent reaction pool under it.
更进一步的，所述微型手动阀门设有手动阀杆，手动阀杆位于试剂包内部、连接在所述微型手动阀门与试剂包最顶端；所述手动阀杆安装位置在试剂包外部有标记。Furthermore, the micro manual valve is provided with a manual valve stem, which is located inside the reagent pack and connected between the micro manual valve and the top of the reagent pack; the installation position of the manual valve stem is marked on the outside of the reagent pack.
进一步的，所述采血区是通过虹吸作用吸取指尖血或者静脉血的虹吸管，所述虹吸管与试剂反应池通过接口相连。Furthermore, the blood collection area is a siphon tube that draws fingertip blood or venous blood through siphon action, and the siphon tube is connected to the reagent reaction pool through an interface.
进一步的，所述接口为微型吸管，根据在大气压存在的情况下计算出的能让液体只进不出的临界口径，作为微型吸管的口径，保证血液能够进入试剂反应池而反应池中的液体试剂不会流出。Furthermore, the interface is a micropipette, and the critical caliber that allows liquid to enter but not exit is calculated under the condition of atmospheric pressure, which is used as the caliber of the micropipette to ensure that blood can enter the reagent reaction pool while the liquid reagent in the reaction pool will not flow out.
进一步的，所述试剂反应池为具有可生物降解环保材质的长方形盒体，所述试剂包位于盒体上方。Furthermore, the reagent reaction pool is a rectangular box body made of biodegradable and environmentally friendly material, and the reagent package is located above the box body.
相对于现有技术，本发明所述的一种基于电化学方法的便携式血液检测试剂盒装置具有以下优势：Compared with the prior art, the portable blood test kit device based on the electrochemical method described in the present invention has the following advantages:
本发明是针对现有技术的缺陷而设计的新颖的便携式电化学血液检测试剂盒装置，不仅可以检测血液中不同的物质含量，具有多运用性，还解决了大型的半自动和全自动生化分析仪检测时间长，及光比色法的精确度不高等一些缺陷，同时也克服了经过干式处理的试纸对试剂与血液混合不均、对 HCT要求高的难题。The present invention is a novel portable electrochemical blood test kit device designed to address the defects of the prior art. It can not only detect the content of different substances in the blood and has multiple applications, but also solves some defects of large semi-automatic and fully automatic biochemical analyzers, such as long detection time and low accuracy of photocolorimetry. At the same time, it also overcomes the problem of uneven mixing of reagents and blood and high HCT requirements of dry-treated test strips.
本发明与现有技术相比，具有以下突出的特点：Compared with the prior art, the present invention has the following outstanding features:
1、精准度高，电化学法测定血液中某物质含量比光比色法精准度高很多，本发明的试剂为液体试剂，与血液混合均匀，测量准确度高；1. High accuracy. The electrochemical method for determining the content of a substance in the blood is much more accurate than the photocolorimetric method. The reagent of the present invention is a liquid reagent, which is evenly mixed with the blood and has high measurement accuracy.
2、克服了对血液的血细胞积压(HCT)要求高的难题；2. Overcome the problem of high blood cell count (HCT) requirement;
3、检测时间短；3. Short detection time;
4、体积小，重量轻，便于携带，可随时随地进行血液检测。4. Small size, light weight, easy to carry, blood test can be performed anytime and anywhere.
附图说明BRIEF DESCRIPTION OF THE DRAWINGS
图1为本发明的基于电化学方法的便携式血液检测试剂盒装置(以三试剂为例)示意图。FIG1 is a schematic diagram of a portable blood test kit device based on an electrochemical method (taking three reagents as an example) of the present invention.
其中：in:
1、电极； 2、试剂包； 3、试剂反应池；1. Electrode; 2. Reagent pack; 3. Reagent reaction pool;
4、采血区； 5、微型手动阀门； 6、微型吸管；4. Blood collection area; 5. Micro manual valve; 6. Micro straw;
7、手动阀杆。7. Manual valve stem.
具体实施方式DETAILED DESCRIPTION
需要说明的是，在不冲突的情况下，本发明中的实施例及实施例中的特征可以相互组合。It should be noted that, in the absence of conflict, the embodiments of the present invention and the features in the embodiments may be combined with each other.
下面将参考附图并结合实施例来详细说明本发明。The present invention will be described in detail below with reference to the accompanying drawings and in conjunction with embodiments.
由图1所示，本发明包括电极1、试剂包2、试剂反应池3和采血区4；As shown in FIG1 , the present invention includes an electrode 1, a reagent package 2, a reagent reaction pool 3 and a blood sampling area 4;
其中电极1至少有2个电极(工作电极和参比电极)，也可以有多个电极，比如6-8个电极，形成电极组；所述电极组一端设在试剂反应池右下侧，另一端用于与仪器相连。或者所述电极组单独成型，使用时再与试剂反应池、仪器相连接；所述试剂反应池、仪器分别设有电极接口。The electrode 1 has at least two electrodes (working electrode and reference electrode), and may also have multiple electrodes, such as 6-8 electrodes, to form an electrode group; one end of the electrode group is arranged at the lower right side of the reagent reaction pool, and the other end is used to connect to the instrument. Alternatively, the electrode group is formed separately and then connected to the reagent reaction pool and the instrument when in use; the reagent reaction pool and the instrument are respectively provided with electrode interfaces.
对于试剂包2，如果是单试剂，则只有一个密闭的独立容器作为试剂包 2，试剂包2下方设有与试剂反应池3相连的微型手动阀门5；For the reagent package 2, if it is a single reagent, there is only one sealed independent container as the reagent package 2, and a micro manual valve 5 connected to the reagent reaction pool 3 is provided below the reagent package 2;
如果是双试剂或者是多试剂，则有2个或者多个联体密闭容器作为试剂包2，具体试剂包2中密闭容器的个数是是由不同的检测项目反应原理决定的，每个试剂包2下方都有与试剂反应池3相连的微型手动阀门5；If it is a double reagent or a multi-reagent, there are two or more conjoined sealed containers as the reagent package 2. The number of sealed containers in the specific reagent package 2 is determined by the reaction principle of different detection items. There is a micro manual valve 5 connected to the reagent reaction pool 3 under each reagent package 2;
上述结构中反应池内要不要包含试剂，由实际的溶液性质和设计需求具体决定。Whether or not the reaction pool in the above structure contains reagents is determined by the actual solution properties and design requirements.
所述的试剂包2和试剂反应池3之间的一个或者多个微型手动阀门5是一种手动驱动阀门，它是通过手动阀杆7来控制其开关状态，手动阀杆7连接在微型手动阀门5与试剂包2最顶端，试剂包2内部的手动阀杆安装位置在试剂包外部有标记。当进行血液检测时，在每个试剂包2正上方的手动阀杆7标记上用手指垂直向下施加一定的压力，阀杆连接的手动阀门打开，当压力没有时，阀门关闭。该阀门分别连接各个试剂包与试剂反应池，阀门打开时，使各个试剂包2中的试剂进入试剂反应池3。The one or more micro manual valves 5 between the reagent pack 2 and the reagent reaction pool 3 are manually driven valves, which are controlled by a manual valve stem 7. The manual valve stem 7 is connected to the top of the micro manual valve 5 and the reagent pack 2, and the installation position of the manual valve stem inside the reagent pack 2 is marked on the outside of the reagent pack. When performing blood testing, a certain pressure is applied vertically downward with a finger on the manual valve stem 7 mark just above each reagent pack 2, and the manual valve connected to the valve stem opens. When the pressure is gone, the valve closes. The valve connects each reagent pack to the reagent reaction pool respectively. When the valve is open, the reagent in each reagent pack 2 enters the reagent reaction pool 3.
试剂反应池3用于不同反应试剂与血液混合后进行电化学反应装置；当血液和试剂进入试剂反应池3后，手动颠倒混匀，使试剂和血液进行充分的电化学反应。试剂反应池3也可充当其中一种试剂的试剂包，即当检测试剂为单试剂时，试剂反应池3即为装有试剂的试剂包；当检测试剂为双试剂或者多试剂时，试剂反应池3即为装其中一种试剂的试剂包。其结构是上方有一个或者多个微型手动阀门5，用于连接每个试剂包2。The reagent reaction pool 3 is a device for electrochemical reaction after mixing different reaction reagents with blood; when the blood and reagents enter the reagent reaction pool 3, they are manually inverted and mixed to allow the reagents and blood to undergo a sufficient electrochemical reaction. The reagent reaction pool 3 can also serve as a reagent pack for one of the reagents, that is, when the detection reagent is a single reagent, the reagent reaction pool 3 is a reagent pack containing the reagent; when the detection reagent is a double reagent or a multi-reagent, the reagent reaction pool 3 is a reagent pack containing one of the reagents. Its structure is that there is one or more micro manual valves 5 on the top, which are used to connect each reagent pack 2.
采血区4为虹吸管，利用虹吸作用吸取血液样本，所述的采血区4与试剂反应池3相连的接口在试剂反应池3的左上侧，该接口是根据在大气压存在的情况下，计算出一个能让液体只进不出的临界口径这一原理而设计的一个微型吸管6，该微型吸管6口径小于0.5cm。该微型吸管能够保证血液能够进入试剂反应池而反应池中的液体试剂不会流出。The blood sampling area 4 is a siphon, which absorbs blood samples by siphoning. The interface connecting the blood sampling area 4 and the reagent reaction pool 3 is on the upper left side of the reagent reaction pool 3. The interface is a micro-pipette 6 designed based on the principle of calculating a critical caliber that allows liquid to enter but not exit under atmospheric pressure. The caliber of the micro-pipette 6 is less than 0.5 cm. The micro-pipette can ensure that blood can enter the reagent reaction pool while the liquid reagent in the reaction pool will not flow out.
图1中所示的试剂盒装置通过电极与仪器连接，连接试剂反应池3和不同试剂包的微型手动阀门5通过手动阀杆7打开，从而使不同的试剂进入试剂反应池3中，采血区4利用虹吸作用将采血针采取的指尖血或者静脉采血器抽取的静脉血通过微型吸管6进入到试剂反应池3中，手动颠倒使试剂和血液混合均匀，使血液中某物质与反应试剂进行充分的氧化还原反应，该反应产生电子e-，产生的电子e-将试剂混合液中导电剂从高价(如3+)被还原到低价(如2+)，然后仪器通过电极给反应试剂某个特定电压，导电剂又从低价(如2+)被氧化成高价(如3+)，从而释放出电子e-，电极检测到该电流信号，传输到仪器检测元件，然后仪器对电流信号进行检测并转换成浓度值，从而分析计算出该物质在血液中的含量。The reagent kit device shown in FIG1 is connected to the instrument through electrodes, and the micro manual valve 5 connecting the reagent reaction pool 3 and different reagent packages is opened by a manual valve stem 7, so that different reagents enter the reagent reaction pool 3, and the blood sampling area 4 uses a siphon effect to draw the fingertip blood collected by the blood collection needle or the venous blood drawn by the venous blood collector into the reagent reaction pool 3 through a micro pipette 6, and the reagent and blood are manually inverted to mix evenly, so that a certain substance in the blood and the reaction reagent undergo a sufficient redox reaction, and the reaction generates electrons e-, and the generated electrons e- reduce the conductive agent in the reagent mixture from a high valence (such as 3+) to a low valence (such as 2+), and then the instrument applies a certain voltage to the reaction reagent through the electrode, and the conductive agent is oxidized from a low valence (such as 2+) to a high valence (such as 3+), thereby releasing electrons e-, and the electrode detects the current signal and transmits it to the instrument detection element, and then the instrument detects the current signal and converts it into a concentration value, thereby analyzing and calculating the content of the substance in the blood.
以上所述仅为本发明的较佳实施例而已，并不用以限制本发明，凡在本发明的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
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