CN103995139B - Continuous glucose monitoring system sensor performance evaluation in vitro - Google Patents

Continuous glucose monitoring system sensor performance evaluation in vitro Download PDF

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CN103995139B
CN103995139B CN 201410238379 CN201410238379A CN103995139B CN 103995139 B CN103995139 B CN 103995139B CN 201410238379 CN201410238379 CN 201410238379 CN 201410238379 A CN201410238379 A CN 201410238379A CN 103995139 B CN103995139 B CN 103995139B
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control valve
injection
chamber
li
sample
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CN103995139A (en )
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陈裕泉
陈玮
王沧
陈大竞
管文军
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浙江大学
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Abstract

一种连续血糖监测传感器体外性能评测系统,包括:(1)试剂储备单元、(2)进样单元、(3)样品混合单元、(4)样品分流单元、(5)检测单元、(6)控制单元、(7)CGM传感器评测仪。 A continuous glucose monitoring system sensor performance evaluation in vitro, comprising: (1) a reagent storage unit, (2) injection means (3) mixed sample means (4) a sample splitter unit, (5) a detection unit (6) control unit, (7) CGM sensor evaluation instrument. 该系统可对连续血糖监测传感器的体外性能进行分析评价,包括对传感器的灵敏度、响应速度、检测范围、准确度、连续工作寿命、抗干扰性、温度相关系数、氧依赖程度等参数,以及被测传感器在连续工作状态下的性能变化情况等,能有效对被测传感器的体外检测性能进行检测评价。 The system can be analyzed in vitro evaluation of the performance of continuous glucose monitoring sensor comprising a sensor sensitivity, response speed, the detection range, accuracy, continuous working life, anti-interference, the temperature coefficient of correlation, degree of oxygen dependent parameter, and a detecting sensor performance changes in continuous operation and the like, can be effectively tested for in vitro detection sensor detects the performance evaluation.

Description

连续血糖监测传感器体外性能评测系统 Continuous glucose monitoring system sensor performance evaluation in vitro

技术领域 FIELD

[0001] 本发明涉及连续血糖监测领域,尤其涉及一种连续血糖监测传感器体外性能评测系统。 [0001] The present invention relates to a continuous glucose monitoring, and more particularly relates to a continuous glucose monitoring system sensor performance evaluation in vitro.

背景技术 Background technique

[0002] 近十年来,连续血糖监测系统(CGMS,Glucose Continuous Monitor System)发展迅速,主要包括植入皮下的血糖传感器和在体外与此相配的仪器。 [0002] Over the past decade, a continuous glucose monitoring system (CGMS, Glucose Continuous Monitor System) developed rapidly, including implantable glucose sensor subcutaneously and in vitro with this matching device. 现有系统存在着许多不完美的地方:(1)检测时间长,主要连续检测皮下组织液(ISF)的血糖水平需要监测72小时以上;(2)操作比较复杂,一般每天都需要另行用指血体外检测进行比较和校正;(3)由于血糖传感器植入皮下连续工作,其性能会不断下降,主要如灵敏度,精度,响应时间,测量范围等静态动特性都会变化,从而造成检测数据的不准确。 There are many existing systems are not perfect place: (1) detecting a long time, mainly the continuous subcutaneous tissue was detected (ISF) need to monitor blood glucose levels more than 72 hours; (2) the operation is complicated and requires a separate day with a finger blood comparing in vitro detection and correction; (3) since the blood glucose sensor implanted subcutaneously continuous operation, which will continue to decline in performance, mainly as sensitivity, accuracy, response time, dynamic measurement range and other characteristics will be static change, causing inaccurate test data . 所以对这些连续在皮下使用的传感器检测系统,在研发和生产过程中极需对此系统建立仿生理环境进行检测与评价,设计一种连续血糖监测传感器体外性能评测系统是十分有必要的。 Therefore, the detection system for these sensors use continuous subcutaneous great need to establish the system in the development and production process of this simulated physiological environment for testing and evaluation, design of a continuous glucose monitoring sensor vitro performance evaluation of the system is very necessary.

发明内容 SUMMARY

[0003] 本发明为克服上述的不足之处,目的在于提供一种连续血糖监测传感器体外性能评测系统,一种能部分模拟人体生理环境并在保持CGM传感器长期、连续工作的状态下,宽范围的精确调整检测腔内葡萄糖浓度及其浓度变化率、干扰物浓度、温度、溶氧浓度的分析检测系统,可对待测CGM传感器的灵敏度、精度、准确性、响应速度、测量范围、线性度、温度相关性、氧依赖程度、抗干扰性、连续工作寿命及其连续工作状态下的动态特性等参数进行分析评价,可有效的对被测传感器的体外性能进行评价,并据此对被测传感器的在体性能进行评估。 [0003] The present invention is to overcome the above shortcomings, the object is to provide a continuous glucose monitoring system sensor performance evaluation in vitro a partially simulate human physiological environment and CGM sensor holding long-term continuous operation state under a wide range of the precise adjustment of the glucose concentration in the test chamber and its rate of change of concentration, interferent concentration, temperature, dissolved oxygen concentration of an analyte detection system, can be treated sensitivity, precision, accuracy, response speed, measuring range, linearity of the measured CGM sensor, temperature dependence, oxygen dependence, interference, continuous working parameters of the dynamic characteristics and the life under continuous operation state analysis and evaluation, can be effective in vitro performance of the tested sensor is evaluated, and accordingly the measured sensor performance was evaluated in vivo.

[0004] 本发明是通过以下技术方案达到上述目的:一种连续血糖监测传感器体外性能评测系统,包括:试剂储备单元1、进样单元2、样品混合单元3、样品分流单元4、检测单元5、 控制单元6、CGM传感器性能评测仪7 ;试剂储备单元1、进样单元2、样品混合单元3、样品分流单元4、检测单元5、CGM传感器性能评测仪7依次相连;控制单元6分别与进样单元2、样品混合单元3、样品分流单元4、检测单元5、CGM传感器性能评测仪7相连。 [0004] The present invention is to achieve the above object is achieved by the following technical solution: A continuous glucose monitoring sensor performance evaluation in vitro system, comprising: a reagent storage unit, injection unit 2, the mixing unit 3 the sample, the sample branch unit 4, the detection unit 5 , the control unit 6, CGM sensor performance evaluation device 7; reagent storage unit 1, the sample cell 2, the sample mixing unit 3, the sample branch unit 4, the detection unit 5, CGM sensor performance evaluation device 7 sequentially connected; a control unit 6 respectively injection unit 2, the mixing unit 3 the sample, the sample branch unit 4, the detection unit 5, CGM sensor performance evaluation device 7 is connected.

[0005] 所述的试剂储备单元1包括:葡萄糖溶液腔11、干扰物溶液腔12、仿生溶液储液腔13、去离子水储液腔14、氧气腔15、氮气腔16 ;所述的进样单元2包括:葡萄糖微量注射栗201、干扰物微量注射栗202、进样蠕动栗203、氧气进样微型气栗204、氮气进样微型气栗205、葡萄糖进样控制阀206、干扰物进样控制阀207、仿生溶液进样阀208、去离子水进样控制阀209、氧气进样控制阀210、氮气进样控制阀211 ;所述的样品混合单元3包括:样品混合腔31、恒温水浴32、搅拌器33、液位传感器34,样品混合腔31包含混合腔腔体3101、混合腔密封盖3102、溶液进样口3103、氧气进样口3104、氮气进样口3105、葡萄糖溶液进样口3106、干扰物溶液进样口3107、备用进样口3108、采样口3109、单向出气口3110、快速进样口3111、搅拌器安装口3112、液位传感器安装口3113 ;所述的样品分流单元4包括:采样 Reagents backup unit [0005] 1 comprising: a glucose solution chamber 11, solution chamber 12 interference, simulated body fluid reservoir chamber 13, deionized water reservoir chamber 14, the oxygen chamber 15, a nitrogen chamber 16; the intake comp unit 2 comprises: glucose microinjection Li 201, interferent microinjection Li 202, into the peristaltic Li 203, the oxygen injection micro gas Li 204, a nitrogen injection micro gas Li 205, dextrose injection control valve 206, the interference thereof into like the control valve 207, simulated body fluid injection valve 208, deionized water injection control valve 209, the oxygen injection control valve 210, a nitrogen injection control valve 211; the sample mixing unit 3 comprises: mixing a sample chamber 31, the thermostat water bath 32, the agitator 33, the level sensor 34, mixing chamber 31 comprises a sample cavity 3101 of the mixing chamber, the mixing chamber sealing cap 3102, a solution inlet 3103, the inlet 3104 of oxygen, nitrogen inlet 3105, into a glucose solution inlet 3106, the inlet solution interference 3107, 3108 spare inlet, sampling port 3109, a one-way outlet 3110, 3111 rapid inlet, an agitator mounting opening 3112, opening 3113 is mounted the level sensor; the sample 4 split unit comprises: a sampling 动栗41、PH检测管路控制阀42、溶氧浓度检测管路控制阀43、葡萄糖浓度标定检测管路控制阀44及待测CGM传感器检测管路控制阀45 ;所述的检测单元5包括:在线PH计51、溶氧浓度传感器52、葡萄糖浓度计53、检测腔54、被测CGM传感器55、废液池56、恒电位仪/电化学仪57 ; Moving Li 41, PH detecting line control valve 42, the dissolved oxygen concentration detecting line control valve 43, calibration of the glucose concentration control valve 44 and the line detection test CGM sensor detecting passage control valve 45; said detection unit 5 comprises : PH meter line 51, the dissolved oxygen concentration sensor 52, the concentration of glucose meter 53, the detection chamber 54, the measured CGM sensor 55, waste reservoir 56, a potentiostat / electrochemical meter 57;

[0006] 葡萄糖溶液腔11安装于葡萄糖微量注射栗201内部,以聚四氟乙烯微细管为管路通过葡萄糖进样控制阀206与样品混合腔31的葡萄糖进样口3106相连;干扰物溶液腔12安装于干扰物微量注射栗202内部,以聚四氟乙烯微细管为管路通过干扰物进样控制阀207与样品混合腔31的干扰物进样口3107相连;仿生溶液储液腔13以栗管为管路通过仿生溶液进样阀208与进样蠕动栗203进样端相连;去离子水储液腔14以栗管为管路通过去离子水进样控制阀209与进样蠕动栗203进样端相连;氧气腔15以栗管为管路通过氧气进样控制阀210与氧气进样微型气栗204进样端相连;氮气腔16以栗管为管路通过氮气进样控制阀211与氮气进样微型气栗205进样端相连;进样蠕动栗203出样端通过栗管与样品混合腔31的进样口3103相连;氧气进样微型气栗204出样端通过栗管与样品混合腔31的氧气进样口3104相 [0006] glucose solution chamber 11 is mounted inside the Li glucose microinjection 201, fine polytetrafluoroethylene tube by the glucose injection conduit control valve 206 is mixed with the sample chamber 31 is connected to the inlet 3106 of glucose; interfering solution chamber 12 is mounted inside the interferer 202 microinjection Li, polytetrafluoroethylene fine tube interferer injection conduit control valve 207 and the sample mixed interferents chamber 31 is connected to the inlet by 3107; biomimetic solution reservoir chamber 13 Li tube biomimetic solution through conduit 208 connected to the injection valve 203 into the end of the injection peristaltic Li; deionized water chestnut reservoir chamber 14 via the injection pipe is a pipe deionized water control valve 209 and the intake peristaltic Li 203 is connected to the injection end; oxygen chamber 15 through the conduit tube in Li oxygen injection control valve 210 is connected with the injection of oxygen gas Li micro-injection end 204; Li nitrogen chamber 16 in tube conduit by nitrogen injection control valve 211 and nitrogen injection micro gas Li 205 injector connected to an end; injection peristaltic Li 203 comp terminal coupled Li tube mixed with the sample chamber inlet 31, 3103 by; oxygen injection micro gas Li 204 comp end by Li tube oxygen inlet and the mixing chamber 31 of the sample 3104 with 连;氮气进样微型气栗205出样端通过栗管与样品混合腔31的氮气进样口3105相连;样品混合腔31底部没入恒温水浴32中,搅拌器33通过搅拌器安装口3112 安装在样品混合腔31内,液位传感器34通过液位传感器安装口3113样品混合腔31内。 Even; Li nitrogen micro gas injector 205 is connected to end like Li nitrogen inlet tube and the mixing chamber 31 of the sample through 3105; the bottom of the sample into the mixing chamber 31 is not a constant temperature bath 32, the agitator 33 by a stirrer installed in the mounting opening 3112 mixing within the sample chamber 31, the level sensor 34 by a level sensor mounted within the opening 31 of the mixing chamber 3113 samples.

[0007] 采样蠕动栗41通过分流用栗管及三通接口组成的分流管路相连,PH检测管路控制阀42、溶氧浓度检测管路控制阀43、葡萄糖浓度标定检测管路控制阀44及待测CGM传感器检测管路控制阀45各占据一路分流通道;在线PH计51探头接入与PH检测管路控制阀42相连的分流管路中、溶氧浓度传感器52接入与溶氧浓度检测管路控制阀43相连的分流管路中、葡萄糖浓度计53接入与葡萄糖浓度标定检测管路控制阀44相连的分流管路中、检测腔54接入与待测CGM传感器检测管路控制阀45相连的分流管路中、被测CGM传感器55 探头植入检测腔54中、废液池56置于各分流管路出液口底部、恒电位仪/电化学仪57与被测CGM传感器55通过信号电缆相连。 [0007] Li peristaltic sampling conduit 41 through the shunt with a shunt tube and a three-way interfaces consisting of Li is connected, PH detecting line control valve 42, the dissolved oxygen concentration detecting line control valve 43, the glucose concentration detector calibration line control valve 44 CGM sensor for detecting the test line and the control valve 45 occupies each branch passage way; PH meter line 51 with the access probe PH detecting line connected to the control valve 42 in the bypass conduit, the concentration of dissolved oxygen and dissolved oxygen concentration sensor 52 access detecting line connected to the control valve bypass line 43, the glucose concentration meter 53 detects an access to the glucose concentration calibration line control valve 44 connected to the bypass line, the detection chamber 54 with a test access control CGM sensor detecting passage bypass conduit connected to the valve 45, the probe 55 measured CGM sensor implanted in the detection chamber 54, the waste reservoir 56 at the bottom of each of the bypass conduit outlet port, potentiostat / electrochemical instrument 57 and the measured CGM sensor 55 is connected via the signal cable.

[0008] 葡萄糖进样控制阀206、干扰物进样控制阀207、仿生溶液进样制阀208、去离子水进样控制阀209、氧气进样控制阀210、氮气进样控制阀211、PH检测管路控制阀42、溶氧浓度检测管路控制阀43、葡萄糖浓度标定检测管路控制阀44、待测CGM传感器检测管路控制阀45、葡萄糖微量注射栗201、干扰物微量注射栗202、进样蠕动栗203、氧气进样微型气栗204、氮气进样微型气栗205、采样蠕动栗41、恒温水浴32、搅拌器33、液位传感器34均通过电源及信号总线与控制单元6相连;在线PH计51、溶氧浓度传感器52、葡萄糖浓度计53、 恒电位仪/电化学仪57数据可通过人工导入或直接输入CGM传感器性能评测仪7。 [0008] Glucose injection control valve 206, the interference was injection control valve 207, simulated body fluid injection valve 208, deionized water injection control valve 209, the oxygen injection control valve 210, a nitrogen injection control valve 211, PH detecting line control valve 42, the dissolved oxygen concentration detecting line control valve 43, the glucose concentration detector calibration line control valve 44, CGM sensor detects the test line control valve 45, 201 glucose microinjection Li, Li microinjection interferer 202 , 203 into the peristaltic Li, Li oxygen injector 204 micro gas, a nitrogen gas injector 205 micro gas Li, Li peristaltic sample 41, water bath 32, a stirrer 33, the level sensor 34 by both power and signal bus and the control unit 6 connected; PH meter line 51, the dissolved oxygen concentration sensor 52, the glucose concentration meter 53, a potentiostat / electrochemical meter 57 CGM sensor data may be input directly to performance evaluation device 7 manually or imported.

[0009] 作为优选,所述的检测腔可并列设置一个到多个,每个检测腔配置相应的检测控制阀,可实现多通道并行测试,其配备可更换的密封膜,支持不同类型的CGM传感器植入。 [0009] Advantageously, the detection chamber may be provided in parallel to a plurality of each detection chamber configured to detect the respective control valve, and multiple channel parallel test, which is equipped with a replaceable sealing film, to support different types of CGM implantation of the sensor.

[0010] 作为优选,所述的样品混合腔各个接口均严格密封,快速进校口使用胶塞密闭,包含一个高精度水位计,一个单向排气孔,一个单向的快速进样口,二个单向的气体进样口。 [0010] Advantageously, the mixing chamber of each sample were tightly sealed interfaces, fast plug sealed into the school oral use, comprising a water level gauge precision, a one-way vent, a fast way of the inlet, two unidirectional gas inlet. [0011] 作为优选,所述葡萄糖浓度计为实验室标准计量仪器。 [0011] Advantageously, the concentration of glucose standard laboratory measuring instruments.

[0012] 作为优选,所述溶氧浓度传感器选用在线式溶氧检测传感器。 [0012] Advantageously, the dissolved oxygen concentration of the oxygen sensor on-line detection sensor selection.

[0013] 作为优选,所述的恒电位仪/电化学仪可以支持多通道信号采集或者根据检测腔数目配置多台设备。 [0013] Advantageously, said potentiostat / electrochemical meter can support multi-channel signal acquisition or configure multiple devices according to the number of the detection chamber.

[0014] 作为优选,所述的生理仿生溶液用于模拟人体体液检测基质,多采用生物流体,例如,组织液、全血、淋巴液、血浆、血清、唾液、尿液、粪便、汗水、粘液、眼泪、脑脊液、鼻分泌物、宫颈或阴道分泌物、精液、胸水、羊水、腹水、中耳液、关节液、胃液等或含有上述成份的生理缓冲溶液。 [0014] Advantageously, the biomimetic solution was used to simulate physiological body fluids detector matrix, the use of a biological fluid, e.g., interstitial fluid, whole blood, lymph, plasma, serum, saliva, urine, feces, sweat, mucus, tears, cerebrospinal fluid, nasal secretion, cervical or vaginal secretion, semen, pleural fluid, amniotic fluid, ascites fluid, middle ear fluid, joint fluid, gastric juice, or the like containing physiological buffer solution of the above ingredients. 此外,固体或粉状样本可以溶解在合适的溶剂中以提供适合分析的液体混合物。 Further, powdery or solid sample can be dissolved in a suitable solvent to provide a liquid mixture suitable for analysis.

[0015] 作为优选,所述的干扰化合物主要为醋氨酚、抗坏血酸、胆红素、胆固醇、血肌酐、 多巴胺、麻黄素、布洛芬、左旋多巴、甲基多巴、水杨酸盐、四环素、甲磺叮庚脲、甲苯磺丁脲、 甘油三酯或尿酸。 [0015] Advantageously, the interfering compound mainly acetaminophen, ascorbic acid, bilirubin, cholesterol, creatinine, dopamine, ephedrine, ibuprofen, levodopa, methyldopa, salicylate , tetracycline, methanesulfonic bite heptyl urea, tolbutamide, triglycerides, or uric acid.

[0016] 作为优选,所述的去离子水用于清洗液路系统及被测传感器。 [0016] Advantageously, the deionized water used in the washing liquid circuit system under test sensors.

[0017] 作为优选,所述的各微量注射栗的进样速度与进样量/蠕动栗的转速与流量/恒温水浴温度/搅拌器转速/电磁阀均配备控制电路的工作状态均可程序控制。 [0017] Advantageously, the speed and flow rate of each injector and microinjection Li sample volume / peristaltic chestnut / constant temperature water bath / stirrer speed / are equipped with a solenoid valve control circuit in the operating state can be programmed .

[0018] 本发明的有益效果在于:(1)葡萄糖浓度变化可调,浓度变化速率可调;(2)配套标准仪器可对葡萄糖浓度进行同步检测,通过分流机制,使多个检测腔之间,以及检测腔与样品参数监测相互独立,互不影响,实现了多参数、多传感器同步测试;(3)样品溶液温度、 溶氧浓度、干扰分析物浓度可调节,使得系统可以从温度、溶氧浓度、干扰分析物浓度等多个因素上,模拟生理环境,使得体外评测数据对在体性能的估计更具指导意义;(4)配套标准值输入、性能分析评价的软件系统及标准化的测试方法,可对单个、或多个传感器进行性能评估、对比或一致性测试,提高了CGM传感器研发、生产、标定、测试的效率与标准化水平;(5)可在CGM传感器保持长期工作的状态下,对葡萄糖浓度、溶液温度、溶氧浓度、干扰分析物浓度等参数进行调节,以对CGM传 [0018] Advantageous effects of the present invention is: (1) to glucose concentrations adjustable, adjustable rate of change of concentration; (2) supporting the standard instrument may synchronize the glucose concentration detected by the shunt mechanism, so that among the plurality of detection chambers and detecting the sample chamber and another parameter monitoring independent of each other, to achieve a multi-parameter, multi-sensor synchronization test; (3) a sample solution temperature, dissolved oxygen concentration, interfering analyte concentration may be adjusted so that the system temperature can be from, soluble a plurality of oxygen concentration on factor, interference analyte concentration, simulated physiological environment, so that the in vitro estimation of in vivo evaluation data performance more significance; (4) supporting the standard value of the input, analysis and evaluation of the performance of software systems and standardized test state (5) may be maintained long-term in CGM sensor; methods, can be a single, or a plurality of sensor performance evaluation, comparison or conformance testing, CGM sensor to improve the development, production, calibration, test efficiency and level of standardization , the glucose concentration, solution temperature, dissolved oxygen concentration, interfere with the analyte concentration and other parameters are adjusted in order to pass on the CGM 感器的连续工作寿命及连续工作状态下的动态特性进行分析、评价。 Dynamic characteristics in a continuous working life and continuous operation of the sensor is analyzed and evaluated.

附图说明 BRIEF DESCRIPTION

[0019] 图1是本发明的原理框图; [0019] FIG. 1 is a block diagram of the present invention;

[0020] 图2是本发明的结构示意图; [0020] FIG. 2 is a schematic view of the present invention;

[0021] 图3是上述样品混合腔的详细说明。 [0021] FIG. 3 is a detailed description of the above mixed sample chamber.

具体实施方式 detailed description

[0022] 下面结合具体实施例对本发明进行进一步描述,但本发明的保护范围并不仅限于此: [0022] The following embodiments in conjunction with specific embodiments of the present invention is further described, although the scope of the present invention is not limited thereto:

[0023] 实施例:如图1、图2、图3所示,本实施例提供一种连续血糖监测用传感器之体外性能评测系统,包括试剂储备单元1所属的葡萄糖溶液腔11、干扰物溶液腔12、仿生溶液储液腔13、去离子水储液腔14、氧气腔15、氮气腔16 ;进样单元2所属的葡萄糖微量注射栗201、干扰物微量注射栗202、进样蠕动栗203、氧气进样微型气栗204、氮气进样微型气栗205、葡萄糖进样控制阀206、干扰物进样控制阀207、仿生溶液进样制阀208、去离子水进样控制阀209、氧气进样控制阀210、氮气进样控制阀211 ;样品混合单元3所属的样品混合腔31、恒温水浴32、搅拌器33、液位传感器34,其中样品混合腔包括样品混合腔31包含混合腔腔体3101、混合腔密封盖3102、溶液进样口3103、氧气进样口3104、氮气进样口3105、葡萄糖溶液进样口3106、干扰物溶液进样口3107、备用进样口3108、采样口3109、单向出 [0023] Example: 1, 2, 3, the present embodiment provides a continuous glucose monitoring system using an in vitro evaluation of the performance of the sensor, the reagent comprising glucose solution chamber 11 of the stock unit 1 belongs, interferent solution chamber 12, simulated body fluid reservoir chamber 13, deionized water reservoir chamber 14, the oxygen chamber 15, a nitrogen chamber 16; glucose microinjection Li sample cell 2 belonging to 201, interferent microinjection Li 202, into the peristaltic Li 203 oxygen injection micro gas Li 204, a nitrogen injection micro gas Li 205, dextrose injection control valve 206, the interference was injection control valve 207, simulated body fluid injection valve 208, deionized water injection control valve 209, the oxygen the injection control valve 210, a nitrogen injection control valve 211; sample 3 sample mixing unit 31 belongs to the mixing chamber, constant temperature water bath 32, a stirrer 33, the level sensor 34, wherein the sample chamber comprises a mixing chamber 31 containing a sample mixing chamber mixing chamber body 3101, a mixing chamber sealing cap 3102, a solution inlet 3103, the inlet 3104 of oxygen, nitrogen inlet 3105, a glucose solution inlet 3106, the inlet solution interference 3107, 3108 spare inlet, sampling port 3109, a one-way 气口3110、快速进样口3111、搅拌器安装口3112、液位传感器安装口3113 ;样品分流单元4所属的采样蠕动栗41、PH检测管路控制阀42、溶氧浓度检测管路控制阀43、葡萄糖浓度标定检测管路控制阀44、待测CGM传感器检测管路控制阀45、检测单元5所属的在线PH计51、52 溶氧浓度传感器、葡萄糖浓度计53、检测腔54、被测CGM传感器55、废液池56、恒电位仪/ 电化学仪57、6_控制单元、7-CGM传感器评测仪。 Air inlet 3110, the inlet 3111 Fast, the agitator mounting opening 3112, opening 3113 is mounted the level sensor; Sample 4 Sample split unit belongs peristaltic Li 41, PH detecting line control valve 42, the dissolved oxygen concentration detecting line control valve 43 glucose concentration detector calibration line control valve 44, CGM sensor detects the test line control valve 45, line 51, the dissolved oxygen concentration sensor PH meter 5 detecting unit belongs, the glucose concentration meter 53, the detection chamber 54, the measured CGM sensor 55, waste reservoir 56, a potentiostat / 57,6_ electrochemical meter control unit, 7-CGM sensor evaluation instrument.

[0024] 葡萄糖溶液腔11安装于葡萄糖微量注射栗201内部,以聚四氟乙烯微细管为管路通过葡萄糖进样控制阀206与样品混合腔31的葡萄糖进样口3106相连;干扰物溶液腔12安装于干扰物微量注射栗202内部,以聚四氟乙烯微细管为管路通过干扰物进样控制阀207与样品混合腔31的干扰物进样口3107相连;仿生溶液储液腔13以栗管为管路通过仿生溶液进样阀208与进样蠕动栗203进样端相连;去离子水储液腔14以栗管为管路通过去离子水进样控制阀209与进样蠕动栗203进样端相连;氧气腔15以栗管为管路通过氧气进样控制阀210与氧气进样微型气栗204进样端相连;氮气腔16以栗管为管路通过氮气进样控制阀211与氮气进样微型气栗205进样端相连;进样蠕动栗203出样端通过栗管与样品混合腔31的进样口3103相连;氧气进样微型气栗204出样端通过栗管与样品混合腔31的氧气进样口3104相 [0024] glucose solution chamber 11 is mounted inside the Li glucose microinjection 201, fine polytetrafluoroethylene tube by the glucose injection conduit control valve 206 is mixed with the sample chamber 31 is connected to the inlet 3106 of glucose; interfering solution chamber 12 is mounted inside the interferer 202 microinjection Li, polytetrafluoroethylene fine tube interferer injection conduit control valve 207 and the sample mixed interferents chamber 31 is connected to the inlet by 3107; biomimetic solution reservoir chamber 13 Li tube biomimetic solution through conduit 208 connected to the injection valve 203 into the end of the injection peristaltic Li; deionized water chestnut reservoir chamber 14 via the injection pipe is a pipe deionized water control valve 209 and the intake peristaltic Li 203 is connected to the injection end; oxygen chamber 15 through the conduit tube in Li oxygen injection control valve 210 is connected with the injection of oxygen gas Li micro-injection end 204; Li nitrogen chamber 16 in tube conduit by nitrogen injection control valve 211 and nitrogen injection micro gas Li 205 injector connected to an end; injection peristaltic Li 203 comp terminal coupled Li tube mixed with the sample chamber inlet 31, 3103 by; oxygen injection micro gas Li 204 comp end by Li tube oxygen inlet and the mixing chamber 31 of the sample 3104 with 连;氮气进样微型气栗205出样端通过栗管与样品混合腔31的氮气进样口3105相连;样品混合腔31底部没入恒温水浴32中,搅拌器33通过搅拌器安装口3112 安装在样品混合腔31内,液位传感器34通过液位传感器安装口3113样品混合腔31内。 Even; Li nitrogen micro gas injector 205 is connected to end like Li nitrogen inlet tube and the mixing chamber 31 of the sample through 3105; the bottom of the sample into the mixing chamber 31 is not a constant temperature bath 32, the agitator 33 by a stirrer installed in the mounting opening 3112 mixing within the sample chamber 31, the level sensor 34 by a level sensor mounted within the opening 31 of the mixing chamber 3113 samples. 采样蠕动栗41通过分流用栗管及三通接口组成的分流管路相连,PH检测管路控制阀42、溶氧浓度检测管路控制阀43、葡萄糖浓度标定检测管路控制阀44及待测CGM传感器检测管路控制阀45各占据一路分流通道;在线PH计51探头接入与PH检测管路控制阀42相连的分流管路中、溶氧浓度传感器52接入与溶氧浓度检测管路控制阀43相连的分流管路中、葡萄糖浓度计53接入与葡萄糖浓度标定检测管路控制阀44相连的分流管路中、检测腔54接入与待测CGM传感器检测管路控制阀45相连的分流管路中、被测CGM传感器55探头植入检测腔54中、废液池56置于各分流管路出液口底部、恒电位仪/电化学仪57与被测CGM传感器55通过信号电缆相连。 Li peristaltic sampling conduit 41 through the shunt with a shunt tube and a three-way interfaces consisting of Li is connected, PH detecting line control valve 42, the dissolved oxygen concentration detecting line control valve 43, calibration of the glucose concentration control valve 44 and line detection test CGM sensor detecting line control valve 45 occupies each branch passage way; PH meter line 51 with the access probe PH detecting line connected to the control valve 42 in the bypass conduit, dissolved oxygen concentration and the dissolved oxygen concentration sensor 52 detects the access line a control valve connected to the bypass line 43, the glucose concentration of the glucose concentration calibration 53 detects an access line connected to the control line bypass valve 44, the detection chamber 54 with a test access CGM sensor detecting passage 45 is connected to the control valve shunt line, measured CGM sensor 55 detecting probe implantation chamber 54, the waste reservoir 56 at the bottom of each of the bypass conduit outlet port, potentiostat / electrochemical instrument 57 and the measured CGM sensor 55 by a signal cable is connected. 葡萄糖进样控制阀206、干扰物进样控制阀207、仿生溶液进样制阀208、去离子水进样控制阀209、氧气进样控制阀210、氮气进样控制阀211、PH检测管路控制阀42、溶氧浓度检测管路控制阀43、葡萄糖浓度标定检测管路控制阀44、待测CGM传感器检测管路控制阀45、葡萄糖微量注射栗201、干扰物微量注射栗202、进样蠕动栗203、氧气进样微型气栗204、氮气进样微型气栗205、采样蠕动栗41、恒温水浴32、搅拌器33、液位传感器34均通过电源及信号总线与控制单元6相连;在线PH计51、溶氧浓度传感器52、葡萄糖浓度计53、恒电位仪/电化学仪57数据可通过人工导入或直接输入CGM传感器性能评测仪7。 Glucose injection control valve 206, the injection control valve interferer 207, simulated body fluid injection valve 208, deionized water injection control valve 209, the oxygen injection control valve 210, a nitrogen injection control valve 211, PH detecting line control valve 42, the dissolved oxygen concentration detecting line control valve 43, the glucose concentration detector calibration line control valve 44, CGM sensor detects the test line control valve 45, 201 glucose microinjection Li, Li microinjection interferer 202, injection Li peristaltic 203, oxygen injector 204 micro gas Li, Li nitrogen injection micro gas 205, sampling peristaltic Li 41, water bath 32, a stirrer 33, are connected by a power level sensor and the signal bus 634 and the control unit; online PH meter 51, oxygen concentration sensor 52, the glucose concentration meter 53, a potentiostat / electrochemical meter 57 CGM sensor data may be input directly to performance evaluation device 7 manually or imported.

[0025] 其中: [0025] wherein:

[0026] 11、12 选用IOml 注射器; [0026] 11 selected IOml syringe;

[0027] 13、14 选用2L 烧杯; [0027] 13, 14 are selected 2L beaker;

[0028] 15、16选用2L双金属嘴密封气体采样袋(大连海得科技有限公司);201、202选用New Era Pump Systems NE-4000(American Health&Medical Supply International Corp. Co.,Ltd,New York,US A) ;204、205选用THOMAS微型气栗8003 (缘循智能科技上海有限公司);206、207选用0K62A-23系列精巧型二位三通电磁阀(上海欧凯电磁阀制造有限公司); [0028] 15 and 16 are selected double metal mouth 2L sealed gas sampling bags (Dalian Technology Co., Ltd.); 201 and 202 selection New Era Pump Systems NE-4000 (American Health & Medical Supply International Corp. Co., Ltd, New York, US A); 204,205 micro gas selected THOMAS Li 8003 (Shanghai edge liable intelligent Technology Ltd.); 206,207 Jingqiao Xing selection 0K62A-23 series two-way electromagnetic valve (solenoid valve manufacturing Co. Shanghai OK);

[0029] 208、209、42、43、44、45 选用CHEM202-V2-C203 微型电磁阀(Gems Sensor&Controls, US A); [0029] 208,209,42,43,44,45 selected CHEM202-V2-C203 miniature solenoid valves (Gems Sensor & Controls, US A);

[0030] 210、211 选用MB315-EB33-P-201 三通常闭微型电磁阀(Gems Sensor&Controls, US A); [0030] 210 and 211 are selected MB315-EB33-P-201 miniature three-way normally closed solenoid valve (Gems Sensor & Controls, US A);

[0031] 203、41选用科尔帕默微量4通道蠕动栗WX-78190_00(C〇1印armer,US A); [0031] Cole Parmer 203,41 Trace selected channel peristaltic Li 4 WX-78190_00 (C〇1 printing armer, US A);

[0032] 31混合腔定制加工,容量500ml,配备1路溶液进样口、1路采样口、3路微量进样口,2路单向进气口,1路快速进样口,1路单向排气口、1个搅拌器安装口,1个液位传感器安装口;接口部分选用硅胶良好密封,单向进气口末端的气液接界面选用单向进气硅胶阀EWB17-03-02-3 (塔罗斯,中国玉环)进行气液分离;单向排气孔选用长效型单向排气阀CPIP-G7(川本国际包装有限公司); [0032] Fabrication of the mixing chamber 31, the capacity of 500ml, provided with a solution inlet passage, a sample-and-mouth, 3 micro-way inlet, the one-way air intake passage 2, an inlet passage fast, single-1 to an exhaust port, an agitator mounting opening, a liquid level sensor mounting port; an interface part of the selection silica good seal, the one-way air inlet end of the gas-liquid contact surface selects the intake-way silicone valve EWB17-03-02 -3 (Talos, China Yuhuan) liquid separation; use long-acting one-way vent type single exhaust valve CPIP-G7 (Kawamoto packaging international Limited);

[0033] 32选用HK1084精密恒温液浴槽(杭州三浦精密仪器有限公司); [0033] 32 was chosen HK1084 precision thermostatic bath (Hangzhou Miura Precision Instrument Co.);

[0034] 33 选用EUR0STAR20digital 悬臂搅拌器(IKA,Germany); [0034] 33 selected EUR0STAR20digital boom stirrer (IKA, Germany);

[0035] 34 选用CT-1000 电位式液位传感器(Gems Sensor&Controls,US A) ;51 选用pHure Sensor™系列的在线pH 计(Mettler Toledo Thornton,US A); [0035] CT-1000 34 selected potential level sensor (Gems Sensor & Controls, US A); 51 pHure Sensor ™ Series selection line pH meter (Mettler Toledo Thornton, US A);

[0036] 52 选用0D03000 焚光法溶解氧传感器(Greenspan Analytical Pty Ltd, Australia); [0036] 52 selected 0D03000 burning light of dissolved oxygen sensor (Greenspan Analytical Pty Ltd, Australia);

[0037] 53 选用EKF BIOSEN C-LINE GLUCOSE AND LATATE ANALYSERS (EKF-diagnostic GmbH, Germany); [0037] 53 selected EKF BIOSEN C-LINE GLUCOSE AND LATATE ANALYSERS (EKF-diagnostic GmbH, Germany);

[0038] 54检测腔定制加工,容量10ml,由腔体、密封盖与传感器固定装置组成,其中密封盖可根据传感器植入的特性更换,传感器植入接界面选用PM-996封口膜(Parafilm, US A)密封; [0038] Fabrication detection chamber 54, the capacity of 10ml, by the cavity, the cover and the sensor mounting means, where the sealing cap according to the characteristics of sensor replacement implant, implant abutment surface sensor selection Parafilm PM-996 (of Parafilm, US A) sealing;

[0039] 56废液池选用23L强力塑料水桶; [0039] 56 waste reservoir strong selection 23L plastic buckets;

[0040] 57选用CHI1030C多通道恒电位仪(上海辰华); [0040] 57 selected CHI1030C multichannel potentiostat (Shanghai Hua Chen);

[0041] 6、7为申请单位自主设计开发; [0041] 6,7 applicant is independent design and development;

[0042] 葡萄糖与干扰物进样管路选用内径为0.3mm的PTFE聚四氟乙烯微细管06417-11(CoIeparmer,US A); [0042] Injection of glucose and interferents line selection polytetrafluoroethylene PTFE inner diameter of the microtube 06417-11 0.3mm (CoIeparmer, US A);

[0043] 仿生溶液与去离子水进样管路选用内径为2. 54mm的栗管78190-48 (Pharmed BPT,IL S. A),对应流速2-50ml/min ; [0043] biomimetic solution of deionized water injection line selection 2. 54mm internal diameter tube of Li 78190-48 (Pharmed BPT, IL S. A), corresponding to a flow rate of 2-50ml / min;

[0044] 气路选用内径为I. 03mm 的栗管78190-42 (Pharmed BPT,US A) [0044] The inner diameter of the gas passage selected chestnut I. 03mm tube 78190-42 (Pharmed BPT, US A)

[0045] 分流管路选用内径为I. 52mm的栗管78190-44 (Pharmed BPT,US A),对应流速0.l-10ml/min ; [0045] The bypass line selection I. 52mm internal diameter tube of Li 78190-44 (Pharmed BPT, US A), corresponding to a flow rate of 0.l-10ml / min;

[0046] 检测所用标准葡萄糖浓度选定为lmol/ml ; [0046] Standard detection of glucose concentrations selected lmol / ml with;

[0047] 检测所用生理仿生溶液采用标准PBS (PH7. 4),如表1所示,按下述配比配制磷酸盐缓冲液: [0047] detecting a physiological solution biomimetic standard PBS (PH7 4.), As shown in Table 1, according to the following formulation with phosphate buffer ratio:

[0048] [0048]

Figure CN103995139BD00081

[0049] 表1 [0049] TABLE 1

Figure CN103995139BD00091

[0050] 测试所用干扰物选用抗坏血酸、尿酸盐、醋氨酚。 [0050] Testing was chosen ascorbate interference, urate, acetaminophen use.

[0051] 具体监测方法的工作过程如下: [0051] The specific working process monitoring method is as follows:

[0052] 1.传感器灵敏度、响应速度、检测范围测试,按如下步骤实施,清洗检测腔一初始化检测环境一进行连续梯度响应测试一数据分析与结果计算; [0052] 1. Sensor sensitivity, response speed, the detection range of the test, as follows embodiment, a detection chamber cleaning detected ambient initializing a continuous gradient in response to a data analysis and test result of the calculation;

[0053] 2.传感器标定及准确性测试,按如下步骤实施,清洗检测腔一初始化检测环境一进行连续梯度响应测试一标定一准确性测试; [0053] 2. Sensor calibration and accuracy of the test, as follows embodiment, a detection chamber cleaning detected ambient initializing a continuous gradient in response to a calibration test the accuracy of a test;

[0054] 3.传感器抗干扰性测试,按如下步骤实施,清洗检测腔一初始化检测环境一进行单步或多步梯度响应测试一干扰物抑制性能测试一继续进行单步或多步梯度响应测试或中止测试; [0054] The sensor interference immunity testing, as follows embodiment, a detection chamber cleaning detected ambient initialize a single or multi-step gradient of a response to the test interference suppression performance test was continued for a single or multiple step gradient response test or abort the test;

[0055] 4.温度相关性测试,按如下步骤实施,清洗检测腔一初始化检测环境一温度调节-进行连续梯度响应测试;按设定的温度检测范围重复上述步骤序列,记录每次连续梯度响应测试数据,分析温度相关性; [0055] 4. The temperature dependence of the test, as follows embodiment, a detection chamber cleaning initializing a detected ambient temperature adjustment - continuous gradient response test; temperature detection range set by repeating the above sequence of steps, each record in response to continuous gradient test data, analyze the temperature dependence;

[0056] 5.动态性能测试,按如下步骤实施,清洗检测腔一初始化检测环境一调节葡萄糖浓度正向/反向变化速率;按设定的葡萄糖浓度与变化率重复上述步骤序列,记录各次测试数据,分析被测传感器的动态性能测试。 [0056] The dynamic performance tests, as follows embodiment, a detection chamber clean environment initializing a regulating glucose concentration detecting a forward / reverse change rate; repeating the above sequence of steps according to the rate of change of glucose concentration in a set, each time the recording test data, test dynamic performance test sensor.

[0057] 6.长期连续工作性能测试,按如下步骤实施,清洗检测腔一初始化检测环境一根据设定,在被测CGM传感器保持工作状态,每隔设定的时间,进行连续梯度响应测试一系统长期静置一调节葡萄糖浓度反向变化至零或检测底限的反复实验,记录各次测试数据,分析被测传感器在长期工作状态下,传感器各项性能指标的变化率及传感器的最大工作寿命等参数。 [0057] 6. The long-term continuous performance testing, as follows embodiment, a detection chamber clean environment initializing a detector according to the setting, to keep working condition CGM sensor under test, the set time intervals, a continuous gradient response test the system was allowed to stand a long-term repeated experiments adjusting glucose concentration to zero or reversed to detect the floor, each test record data, analyzing the measured maximum operating state of the sensor in a long-term work, the performance of the sensor and the rate of change of the sensor life and other parameters.

[0058] 以上的所述乃是本发明的具体实施例及所运用的技术原理,若依本发明的构想所作的改变,其所产生的功能作用仍未超出说明书及附图所涵盖的精神时,仍应属本发明的保护范围。 When the [0058] but the above specific embodiments of the invention and the use of the technical principles of the present invention contemplated Zoe changes made by the functional role they produce not depart from the spirit covered by the specification and drawings , should remain with the scope of the present invention.

Claims (5)

  1. 1. 连续血糖监测传感器体外性能评测系统,其特征在于包括:试剂储备单元(I)、进样单元(2)、样品混合单元(3)、样品分流单元(4)、检测单元(5)、控制单元(6)、CGM传感器性能评测仪(7);试剂储备单元(1)、进样单元(2)、样品混合单元(3)、样品分流单元(4)、检测单元(5)、CGM传感器性能评测仪(7)依次相连;控制单元(6)分别与进样单元(2)、样品混合单元(3)、样品分流单元(4)、检测单元(5)、CGM传感器性能评测仪(7)相连;所述的试剂储备单元(1)包括:葡萄糖溶液腔(11)、干扰物溶液腔(12)、仿生溶液储液腔(13)、去离子水储液腔(14)、氧气腔(15)、氮气腔(16);所述的进样单元(2)包括:葡萄糖微量注射栗(201) 、干扰物微量注射栗(202)、进样蠕动栗(203)、氧气进样微型气栗(204)、氮气进样微型气栗(205)、葡萄糖进样控制阀(206)、干扰 1. The continuous glucose monitoring system sensor performance evaluation in vitro, comprising: a reagent storage unit (the I), the injection unit (2), the sample mixing unit (3), the sample split unit (4), detection means (5), The control unit (6), CGM sensor performance evaluation device (7); reagent backup unit (1), the injection unit (2), the sample mixing unit (3), the sample split unit (4), detection means (5), CGM sensor performance evaluation device (7) sequentially connected; control means (6) respectively injection unit (2), the sample mixing unit (3), the sample split unit (4), detection means (5), CGM sensor performance evaluation instrument ( 7) is connected; said reagent storage means (1) comprising: a glucose solution chamber (11), interfering solution chamber (12), simulated body fluid reservoir chamber (13), deionized water reservoir chamber (14), oxygen chamber (15), a nitrogen gas chamber (16); said injection unit (2) comprising: glucose microinjection Li (201), microinjection Li interferer (202), into the peristaltic Li (203), the injection of oxygen Li micro gas (204), micro-injection of nitrogen gas Li (205), glucose injection control valve (206), the interference 物进样控制阀(207)、仿生溶液进样阀(208)、 去离子水进样控制阀(209)、氧气进样控制阀(210)、氮气进样控制阀(211);葡萄糖溶液腔(11)安装于葡萄糖微量注射栗(201)内部,葡萄糖微量注射栗(201)与葡萄糖进样控制阀(206)相连;干扰物溶液腔(12)安装于干扰物微量注射栗(202)内部,干扰物微量注射栗(202) 与干扰物进样控制阀(207)相连;仿生溶液储液腔(13)、仿生溶液进样阀(208)、进样蠕动栗(203)依次相连;去离子水储液腔(14)、去离子水进样控制阀(209)、进样蠕动栗(203) 依次相连;氧气腔(15)、氧气进样控制阀(210)、氧气进样微型气栗(204)依次相连; 氮气腔(16)、氮气进样控制阀(211)、氮气进样微型气栗(205)依次相连。 Was injection control valve (207), biomimetic solution injection valve (208), deionized water injection control valve (209), the oxygen injection control valve (210), a nitrogen injection control valve (211); glucose solution chamber (11) is mounted to glucose microinjection Li (201) inside, glucose microinjection Li (201) with glucose injection control valve (206) is connected; interfering solution chamber (12) is attached to the (202) inside the interferer microinjection Li interferor microinjection Li (202) and the interferer injection control valve (207) is connected; biomimetic solution reservoir chamber (13), biomimetic solution injection valve (208), into the peristaltic Li (203) are sequentially connected; to DI water reservoir chamber (14), deionized water injection control valve (209), into the peristaltic Li (203) are sequentially connected; oxygen chamber (15), the oxygen injection control valve (210), the oxygen injection micro gas Li (204) are sequentially connected; nitrogen chamber (16), a nitrogen injection control valve (211), micro-injection of nitrogen gas chestnut (205) are sequentially connected.
  2. 2. 根据权利要求1所述的连续血糖监测传感器体外性能评测系统,其特征在于:所述的样品混合单元(3)包括:样品混合腔(31)、恒温水浴(32)、搅拌器(33)、液位传感器(34),样品混合腔(31)包含混合腔腔体(3101)、混合腔密封盖(3102)、溶液进样口(3103)、 氧气进样口(3104)、氮气进样口(3105)、葡萄糖溶液进样口(3106)、干扰物溶液进样口(3107)、备用进样口(3108)、采样口(3109)、单向出气口(3110)、快速进样口(3111)、搅拌器安装口(3112)、液位传感器安装口(3113);样品混合腔(31)底部没入恒温水浴(32)中, 搅拌器(33)通过搅拌器安装口(3112)安装在样品混合腔(31)内,液位传感器(34)通过液位传感器安装口(3113)安装在样品混合腔(31)内。 The continuous glucose monitoring sensor vitro performance evaluation system according to claim 1, wherein: said sample mixing unit (3) comprising: mixing a sample chamber (31), constant temperature water bath (32), a stirrer (33 ), a level sensor (34), mixing the sample chamber (31) comprises a mixing chamber cavity (3101), the mixing chamber sealing cap (3102), a solution inlet (3103), an oxygen inlet (3104), nitrogen inlet injection port (3105), a glucose solution inlet (3106), interfere with the inlet solution (3107), alternate inlet (3108), a sampling port (3109), a one-way outlet (3110), fast injection I (3111), an agitator mounting opening (3112), a level sensor attachment port (3113); mixed sample chamber (31) into the bottom of the water bath did not (32), the agitator (33) by the agitator mounting opening (3112) sample is mounted in the mixing chamber (31), a level sensor (34) by a level sensor mounting opening (3113) is mounted within the sample mixing chamber (31).
  3. 3. 根据权利要求1所述的连续血糖监测传感器体外性能评测系统,其特征在于:所述的样品分流单元(4)包括:采样蠕动栗(41)、PH检测管路控制阀(42)、溶氧浓度检测管路控制阀(43)、葡萄糖浓度标定检测管路控制阀(44)及待测CGM传感器检测管路控制阀(45);所述的检测单元(5)包括:在线PH计(51)、溶氧浓度传感器(52)、葡萄糖浓度计(53)、检测腔(54)、被测CGM传感器(55)、废液池(56)、恒电位仪/电化学仪(57);采样蠕动栗(41)通过管路分别与PH检测管路控制阀(42)、溶氧浓度检测管路控制阀(43)、葡萄糖浓度标定检测管路控制阀(44)及待测CGM传感器检测管路控制阀(45)相连,在线PH计(51)探头接入与PH检测管路控制阀(42)相连的分流管路中,溶氧浓度传感器(52)接入与溶氧浓度检测管路控制阀(43)相连的分流管路中,葡萄糖浓度计(53)接入与葡萄糖浓 The continuous glucose monitoring sensor vitro performance evaluation system according to claim 1, wherein: said sample branch unit (4) comprising: a peristaltic Li sample (41), PH detecting line control valve (42), dissolved oxygen concentration detection conduit control valve (43), the glucose concentration detector calibration line control valve (44) and the measured CGM sensor detecting passage control valve (45); said detecting means (5) comprising: a line PH meter (51), dissolved oxygen concentration sensor (52), the glucose concentration meter (53), a detection chamber (54), the measured CGM sensor (55), a waste reservoir (56), potentiostat / electrochemical meter (57) ; Li peristaltic sample (41) respectively detecting line PH control valve (42), dissolved oxygen concentration detecting line control valve (43) via a line, the glucose concentration detector calibration line control valve (44) and the measured CGM sensor detecting line control valve (45) is connected, line PH meter (51) with the access probe PH detecting passage control valve (42) connected to the bypass line, dissolved oxygen concentration sensor (52) and the dissolved oxygen concentration detecting access line control valve (43) connected to the bypass line, the glucose concentration meter (53) and the access glucose concentration 标定检测管路控制阀(44)相连的分流管路中,检测腔(54)接入与待测CGM传感器检测管路控制阀(45)相连的分流管路中,被测CGM传感器(55)探头植入检测腔(54)中,废液池(56)置于各分流管路出液口底部,恒电位仪/电化学仪(57)与被测CGM传感器(55)通过信号电缆相连。 Calibration detecting line control valve (44) connected to the bypass line, the detection chamber (54) with a test access CGM sensor detecting passage control valve (45) connected to the bypass line, the measured CGM sensor (55) detection probe implantation chamber (54), a waste reservoir (56) disposed in each bypass line the bottom liquid outlet, potentiostat / electrochemical meter (57) and the measured CGM sensor (55) is connected via the signal cable.
  4. 4. 根据权利要求2所述的连续血糖监测传感器体外性能评测系统,其特征在于:葡萄糖进样控制阀(206)与样品混合腔(31)的葡萄糖进样口(3106)相连,干扰物进样控制阀(207)与样品混合腔(31)的干扰物进样口(3107)相连,进样蠕动栗(203)出样端与样品混合腔(31)的溶液进样口(3103)相连,氧气进样微型气栗(204)出样端与样品混合腔(31) 的氧气进样口(3104)相连,氮气进样微型气栗(205)出样端与样品混合腔(31)的氮气进样口(3105)相连;采样蠕动栗(41)通过管路与样品混合腔(31)相连。 The continuous glucose monitoring sensor performance evaluation in vitro system according to claim 2, wherein: glucose injection control valve (206) mixed with the sample chamber (31) glucose inlet (3106) is connected into the interferer like control valve (207) mixed with the sample chamber (31) interferents inlet (3107) connected to the injection peristaltic Li (203) the solution sample end mixed with the sample chamber (31) of the inlet (3103) is connected to oxygen injection micro gas chestnut (204) outlet end mixed with the sample chamber (31) an oxygen inlet (3104) is connected, a nitrogen injection micro gas chestnut (205) outlet end mixed with the sample chamber (31) a nitrogen inlet (3105) is connected; the sample is connected via a line to the mixing chamber (31) sampling peristaltic Li (41).
  5. 5.根据权利要求3所述的连续血糖监测传感器体外性能评测系统,其特征在于:葡萄糖进样控制阀(206)、干扰物进样控制阀(207)、仿生溶液进样制阀(208)、去离子水进样控制阀(209)、氧气进样控制阀(210)、氮气进样控制阀(211)、PH检测管路控制阀(42)、溶氧浓度检测管路控制阀(43)、葡萄糖浓度标定检测管路控制阀(44)、待测CGM传感器检测管路控制阀(45)、葡萄糖微量注射栗(201)、干扰物微量注射栗(202)、进样蠕动栗(203)、氧气进样微型气栗(204)、氮气进样微型气栗(205)、采样蠕动栗(41)、样品混合单元(3)的恒温水浴(32)、样品混合单元(3)的搅拌器(33)、样品混合单元(3)的液位传感器(34)均通过电源及信号总线与控制单元(6)相连;在线PH计(51)、溶氧浓度传感器(52)、葡萄糖浓度计(53)、恒电位仪/电化学仪(57)数据可通过人工导入或直 The continuous glucose monitoring system performance evaluation in vitro sensor according to claim 3, wherein: glucose injection control valve (206), the injection control valve interferer (207), biomimetic solution injection valve (208) deionized water injection control valve (209), the oxygen injection control valve (210), a nitrogen injection control valve (211), PH detecting line control valve (42), dissolved oxygen concentration detecting line control valve (43 ), glucose concentration detector calibration line control valve (44), measured CGM sensor detecting passage control valve (45), glucose microinjection Li (201), microinjection Li interferer (202), a peristaltic Li injection (203 ), oxygen injection micro gas Li (204), a nitrogen injection micro gas Li (205), stirred for sampling peristaltic Li (41), the sample mixing unit (3) of the constant temperature water bath (32), the sample mixing unit (3) (33), the sample mixing unit (3) a level sensor (34) are connected by a signal bus and power supply and the control unit (6); PH meter line (51), dissolved oxygen concentration sensor (52), the glucose concentration meter (53), potentiostat / electrochemical meter (57) data may be introduced by manual or straight 输入CGM传感器性能评测仪(7)。 CGM sensor input performance evaluation device (7).
CN 201410238379 2014-05-30 2014-05-30 Continuous glucose monitoring system sensor performance evaluation in vitro CN103995139B (en)

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CN102183639A (en) * 2011-03-14 2011-09-14 哈尔滨工业大学(威海) Full-automatic chemiluminescence immunity analyzer

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