CN103995139A - In vitro performance evaluating system of continuous blood sugar monitoring sensor - Google Patents
In vitro performance evaluating system of continuous blood sugar monitoring sensor Download PDFInfo
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- CN103995139A CN103995139A CN201410238379.XA CN201410238379A CN103995139A CN 103995139 A CN103995139 A CN 103995139A CN 201410238379 A CN201410238379 A CN 201410238379A CN 103995139 A CN103995139 A CN 103995139A
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Abstract
The invention discloses an in vitro performance evaluating system of a continuous blood sugar monitoring sensor. The in vitro performance evaluating system comprises a reagent storage unit (1), a sampling unit (2), a sample mixing unit (3), a sample distributing unit (4), a detecting unit (5), a control unit (6), and a CGM sensor evaluating instrument (7). The in vitro performance evaluating system is capable of analyzing and evaluating the in vitro performance including sensitivity, response speed, detection range, accuracy, continuous working service life, interference resistance, temperature association coefficient, oxygen dependence degree and other parameters of the continuous blood sugar monitoring sensor as well as the performance change of the to-be-monitored sensor in a continuous working state, and is capable of effectively detecting and evaluating the in vitro detection performance of the to-be-monitored sensor.
Description
Technical field
The present invention relates to continuous blood sugar monitoring field, relate in particular to the external performance evaluating system of a kind of continuous blood sugar monitoring sensor.
Background technology
Nearly ten years, continuous blood sugar monitoring system (CGMS, Glucose Continuous Monitor System) development rapidly, mainly comprises and implants subcutaneous blood glucose sensor and the instrument matching therewith in vitro.Existing system exists many faulty places: (1) is long detection time, and the blood sugar level of main continuous detecting hypodermis liquid (ISF) need to be monitored more than 72 hours; (2) operation more complicated, all need separately with referring to that blood vitro detection compares and proofreaies and correct general every day; (3) because blood glucose sensor is implanted subcutaneous continuous working, its performance can constantly decline, main as sensitivity, precision, and the response time, the static dynamic characteristic such as measurement range all can change, and detects the inaccurate of data thereby cause.So continuously at the sensor detecting system of subcutaneous use, in research and development and production run, the utmost point need detect and evaluate this system made physiology environment, designs the external performance evaluating system of a kind of continuous blood sugar monitoring sensor and is extremely necessary to these.
Summary of the invention
The present invention overcomes above-mentioned weak point, object is to provide a kind of continuous blood sugar monitoring sensor external performance evaluating system, a kind of energy partial simulation Human Physiology environment is also keeping CGM sensor long-term, under the state of continuous working, concentration of glucose and change rate of concentration thereof in the accurate adjustment test chamber of wide region, interferent concentration, temperature, the analyzing and testing system of oxyty, can be to the sensitivity of CGM sensor to be measured, precision, accuracy, response speed, measurement range, the linearity, temperature dependency, oxygen dependence degree, anti-interference, the parameters such as the dynamic perfromance under continuous working life-span and continuous duty thereof are carried out assay, can effectively evaluate the external performance of tested sensor, and assessing in body performance tested sensor accordingly.
The present invention achieves the above object by the following technical programs: the external performance evaluating system of a kind of continuous blood sugar monitoring sensor, comprising: reagent deposit unit 1, sample injection unit 2, sample mix unit 3, sample dividing cell 4, detecting unit 5, control module 6, CGM sensor performance evaluation and test instrument 7; Reagent deposit unit 1, sample injection unit 2, sample mix unit 3, sample dividing cell 4, detecting unit 5, CGM sensor performance evaluation and test instrument 7 are connected successively; Control module 6 is connected with sample injection unit 2, sample mix unit 3, sample dividing cell 4, detecting unit 5, CGM sensor performance evaluation and test instrument 7 respectively.
Described reagent deposit unit 1 comprises: glucose solution chamber 11, chaff interference solution cavity 12, bionical solution liquid storage cylinder 13, deionized water liquid storage cylinder 14, oxygen chamber 15, nitrogen chamber 16; Described sample injection unit 2 comprises: glucose micro-injection pump 201, chaff interference micro-injection pump 202, sample introduction peristaltic pump 203, oxygen sample introduction micro air pump 204, nitrogen sample introduction micro air pump 205, glucose sample control valve 206, chaff interference sample control valve 207, bionical solution sampling valve 208, deionized water sample control valve 209, oxygen sample control valve 210, nitrogen sample control valve 211; Described sample mix unit 3 comprises: sample mix chamber 31, water bath with thermostatic control 32, stirrer 33, liquid level sensor 34, and sample mix chamber 31 comprises hybrid chamber cavity 3101, hybrid chamber gland bonnet 3102, solution injection port 3103, oxygen injection port 3104, nitrogen injection port 3105, glucose solution injection port 3106, chaff interference solution injection port 3107, injection port for subsequent use 3108, thief hatch 3109, unidirectional gas outlet 3110, fast sample mouth 3111, stirrer installing port 3112, liquid level sensor installing port 3113; Described sample dividing cell 4 comprises: sampling peristaltic pump 41, PH signal piping operation valve 42, oxyty signal piping operation valve 43, concentration of glucose are demarcated signal piping operation valve 44 and CGM sensor signal piping operation valve 45 to be measured; Described detecting unit 5 comprises: online PH meter 51, oxyty sensor 52, concentration of glucose meter 53, test chamber 54, tested CGM sensor 55, waste liquid pool 56, potentiostat/galvanochemistry instrument 57;
Glucose solution chamber 11 is installed on glucose micro-injection pump 201 inside, passes through glucose sample control valve 206 be connected with the glucose injection port 3106 in sample mix chamber 31 taking teflon microcapillary as pipeline; Chaff interference solution cavity 12 is installed on chaff interference micro-injection pump 202 inside, passes through chaff interference sample control valve 207 be connected with the chaff interference injection port 3107 in sample mix chamber 31 taking teflon microcapillary as pipeline; Bionical solution liquid storage cylinder 13 passes through bionical solution sampling valve 208 and is connected with sample introduction peristaltic pump 203 sample introduction ends taking pump line as pipeline; Deionized water liquid storage cylinder 14 passes through deionized water sample control valve 209 and is connected with sample introduction peristaltic pump 203 sample introduction ends taking pump line as pipeline; Oxygen chamber 15 is passed through oxygen sample control valve 210 and is connected with oxygen sample introduction micro air pump 204 sample introduction ends taking pump line as pipeline; Nitrogen chamber 16 is passed through nitrogen sample control valve 211 and is connected with nitrogen sample introduction micro air pump 205 sample introduction ends taking pump line as pipeline; Sample introduction peristaltic pump 203 sample outlet ends are connected with the injection port 3103 in sample mix chamber 31 by pump line; Oxygen sample introduction micro air pump 204 sample outlet ends are connected with the oxygen injection port 3104 in sample mix chamber 31 by pump line; Nitrogen sample introduction micro air pump 205 sample outlet ends are connected with the nitrogen injection port 3105 in sample mix chamber 31 by pump line; Submerge in water bath with thermostatic control 32 in 31 bottoms, sample mix chamber, stirrer 33 is arranged in sample mix chamber 31 by stirrer installing port 3112, and liquid level sensor 34 is by liquid level sensor installing port 3113 sample mix chambeies 31.
Sampling peristaltic pump 41 uses the distribution pipeline of pump line and three-way interface composition to be connected by shunting, and PH signal piping operation valve 42, oxyty signal piping operation valve 43, concentration of glucose demarcate signal piping operation valve 44 and CGM sensor signal piping operation valve 45 to be measured respectively occupies a road split channel, in the distribution pipeline that online PH meter 51 probe accesses are connected with PH signal piping operation valve 42, oxyty sensor 52 accesses in the distribution pipeline being connected with oxyty signal piping operation valve 43, concentration of glucose meter 53 accesses in the distribution pipeline being connected with concentration of glucose demarcation signal piping operation valve 44, test chamber 54 accesses in the distribution pipeline being connected with CGM sensor signal piping operation valve 45 to be measured, tested CGM sensor 55 probes are implanted in test chamber 54, waste liquid pool 56 is placed in each distribution pipeline liquid outlet bottom, potentiostat/galvanochemistry instrument 57 is connected by signal cable with tested CGM sensor 55.
Glucose sample control valve 206, chaff interference sample control valve 207, bionical solution sample introduction valve 208 processed, deionized water sample control valve 209, oxygen sample control valve 210, nitrogen sample control valve 211, PH signal piping operation valve 42, oxyty signal piping operation valve 43, concentration of glucose is demarcated signal piping operation valve 44, CGM sensor signal piping operation valve 45 to be measured, glucose micro-injection pump 201, chaff interference micro-injection pump 202, sample introduction peristaltic pump 203, oxygen sample introduction micro air pump 204, nitrogen sample introduction micro air pump 205, sampling peristaltic pump 41, water bath with thermostatic control 32, stirrer 33, liquid level sensor 34 is all connected with control module 6 by power supply and signal bus, online PH meter 51, oxyty sensor 52, concentration of glucose meter 53, potentiostat/galvanochemistry instrument 57 data can or directly be inputted CGM sensor performance evaluation and test instrument 7 by artificial importing.
As preferably, described test chamber can be set up in parallel one to multiple, and the corresponding operation valve that detects of each test chamber configuration, can realize multi-channel parallel test, and it is equipped with removable diaphragm seal, supports dissimilar CGM sensor to implant.
As preferably, described each interface of sample mix chamber is strictly sealing all, enters fast school mouth and uses plug airtight, comprises a high precision water level meter, an one-way vent, a unidirectional fast sample mouth, two unidirectional gas sampling mouths.
As preferably, described concentration of glucose is counted laboratory standard gauging instrument.
As preferably, described oxyty sensor is selected online dissolved oxygen detecting sensor.
As preferably, described potentiostat/galvanochemistry instrument can be supported multi-channel signal acquiring or according to test chamber number configuration multiple devices.
As preferably, the bionical solution of described physiology detects matrix for simulated body fluid, the biofluids that adopt more, for example, tissue fluid, whole blood, lymph liquid, blood plasma, serum, saliva, urine, ight soil, sweat, mucus, tears, cerebrospinal fluid, nasal discharge, uterine neck or vaginal fluid, seminal fluid, hydrothorax, amniotic fluid, ascites, MEF, joint fluid, gastric juice etc. or the physiological buffer solution that contains above-mentioned composition.In addition, solid or powdery sample can be dissolved in suitable solvent so that the liquid mixture that is applicable to analysis to be provided.
As preferably, described interfering compound be mainly acetaminophen, ascorbic acid, cholerythrin, cholesterol, serum creatinine, dopamine, ephedrine, brufen, levodopa, ethyldopa, salicylate, tetracycline, tolazamide, orinase, triglyceride or uric acid.
As preferably, described deionized water is used for cleaning liquid-way system and tested sensor.
As preferably, the sample introduction speed of described each micro-injection pump and the rotating speed of sample size/peristaltic pump and flow/water bath with thermostatic control temperature/agitator speed/solenoid valve are all equipped with the duty of control circuit all can programmed control.
Beneficial effect of the present invention is: (1) concentration of glucose changes adjustable, and concentration change speed is adjustable; (2) planning standard instrument can synchronously detect concentration of glucose, by a point stream mechanism, make between multiple test chamber, and test chamber and sample parameters monitors separately, is independent of each other, and has realized multiparameter, multisensor synchronism detection; (3) sample solution temperature, oxyty, interference analysis substrate concentration are adjustable, make the system can be multiple factors such as temperature, oxyty, interference analysis substrate concentration, simulation physiological environment, makes external evaluation and test data to having more directive significance in the estimation of body performance; (4) software systems and standardized method of testing that planning standard value input, performance evaluation are evaluated, can carry out Performance Evaluation, contrast or uniformity test to single or multiple sensors, efficiency and the standardization of improved the research and development of CGM sensor, producing, demarcate, test; (5) can keep under the state of long-term work at CGM sensor, the parameters such as concentration of glucose, solution temperature, oxyty, interference analysis substrate concentration are regulated, analyze, evaluate with the dynamic perfromance under continuous working life-span and continuous duty to CGM sensor.
Brief description of the drawings
Fig. 1 is theory diagram of the present invention;
Fig. 2 is structural representation of the present invention;
Fig. 3 is the detailed description in above-mentioned sample mix chamber.
Embodiment
Below in conjunction with specific embodiment, the present invention is described further, but protection scope of the present invention is not limited in this:
Embodiment: as shown in Figure 1, Figure 2, Figure 3 shows, the present embodiment provides a kind of external performance evaluating system of continuous blood sugar monitoring sensor, comprises glucose solution chamber 11, chaff interference solution cavity 12, bionical solution liquid storage cylinder 13, deionized water liquid storage cylinder 14, oxygen chamber 15, nitrogen chamber 16 that reagent deposit unit 1 is affiliated; Glucose micro-injection pump 201, chaff interference micro-injection pump 202, sample introduction peristaltic pump 203, oxygen sample introduction micro air pump 204, nitrogen sample introduction micro air pump 205, glucose sample control valve 206, chaff interference sample control valve 207, bionical solution sample introduction valve 208 processed, deionized water sample control valve 209, oxygen sample control valve 210, nitrogen sample control valve 211 under sample injection unit 2; Sample mix chamber 31, water bath with thermostatic control 32, stirrer 33, liquid level sensor 34 under sample mix unit 3, wherein sample mix chamber comprises that sample mix chamber 31 comprises hybrid chamber cavity 3101, hybrid chamber gland bonnet 3102, solution injection port 3103, oxygen injection port 3104, nitrogen injection port 3105, glucose solution injection port 3106, chaff interference solution injection port 3107, injection port for subsequent use 3108, thief hatch 3109, unidirectional gas outlet 3110, fast sample mouth 3111, stirrer installing port 3112, liquid level sensor installing port 3113; Sampling peristaltic pump 41 under sample dividing cell 4, PH signal piping operation valve 42, oxyty signal piping operation valve 43, concentration of glucose are demarcated online PH meter 51,52 oxyty sensors, concentration of glucose meter 53, test chamber 54, tested CGM sensor 55, waste liquid pool 56, potentiostat/galvanochemistry instrument 57,6-control module, the 7-CGM sensor evaluation and test instrument under signal piping operation valve 44, CGM sensor signal piping operation valve 45 to be measured, detecting unit 5.
Glucose solution chamber 11 is installed on glucose micro-injection pump 201 inside, passes through glucose sample control valve 206 be connected with the glucose injection port 3106 in sample mix chamber 31 taking teflon microcapillary as pipeline; Chaff interference solution cavity 12 is installed on chaff interference micro-injection pump 202 inside, passes through chaff interference sample control valve 207 be connected with the chaff interference injection port 3107 in sample mix chamber 31 taking teflon microcapillary as pipeline; Bionical solution liquid storage cylinder 13 passes through bionical solution sampling valve 208 and is connected with sample introduction peristaltic pump 203 sample introduction ends taking pump line as pipeline; Deionized water liquid storage cylinder 14 passes through deionized water sample control valve 209 and is connected with sample introduction peristaltic pump 203 sample introduction ends taking pump line as pipeline; Oxygen chamber 15 is passed through oxygen sample control valve 210 and is connected with oxygen sample introduction micro air pump 204 sample introduction ends taking pump line as pipeline; Nitrogen chamber 16 is passed through nitrogen sample control valve 211 and is connected with nitrogen sample introduction micro air pump 205 sample introduction ends taking pump line as pipeline; Sample introduction peristaltic pump 203 sample outlet ends are connected with the injection port 3103 in sample mix chamber 31 by pump line; Oxygen sample introduction micro air pump 204 sample outlet ends are connected with the oxygen injection port 3104 in sample mix chamber 31 by pump line; Nitrogen sample introduction micro air pump 205 sample outlet ends are connected with the nitrogen injection port 3105 in sample mix chamber 31 by pump line; Submerge in water bath with thermostatic control 32 in 31 bottoms, sample mix chamber, stirrer 33 is arranged in sample mix chamber 31 by stirrer installing port 3112, and liquid level sensor 34 is by liquid level sensor installing port 3113 sample mix chambeies 31.Sampling peristaltic pump 41 uses the distribution pipeline of pump line and three-way interface composition to be connected by shunting, and PH signal piping operation valve 42, oxyty signal piping operation valve 43, concentration of glucose demarcate signal piping operation valve 44 and CGM sensor signal piping operation valve 45 to be measured respectively occupies a road split channel, in the distribution pipeline that online PH meter 51 probe accesses are connected with PH signal piping operation valve 42, oxyty sensor 52 accesses in the distribution pipeline being connected with oxyty signal piping operation valve 43, concentration of glucose meter 53 accesses in the distribution pipeline being connected with concentration of glucose demarcation signal piping operation valve 44, test chamber 54 accesses in the distribution pipeline being connected with CGM sensor signal piping operation valve 45 to be measured, tested CGM sensor 55 probes are implanted in test chamber 54, waste liquid pool 56 is placed in each distribution pipeline liquid outlet bottom, potentiostat/galvanochemistry instrument 57 is connected by signal cable with tested CGM sensor 55.Glucose sample control valve 206, chaff interference sample control valve 207, bionical solution sample introduction valve 208 processed, deionized water sample control valve 209, oxygen sample control valve 210, nitrogen sample control valve 211, PH signal piping operation valve 42, oxyty signal piping operation valve 43, concentration of glucose is demarcated signal piping operation valve 44, CGM sensor signal piping operation valve 45 to be measured, glucose micro-injection pump 201, chaff interference micro-injection pump 202, sample introduction peristaltic pump 203, oxygen sample introduction micro air pump 204, nitrogen sample introduction micro air pump 205, sampling peristaltic pump 41, water bath with thermostatic control 32, stirrer 33, liquid level sensor 34 is all connected with control module 6 by power supply and signal bus, online PH meter 51, oxyty sensor 52, concentration of glucose meter 53, potentiostat/galvanochemistry instrument 57 data can or directly be inputted CGM sensor performance evaluation and test instrument 7 by artificial importing.
Wherein:
11,12 select 10ml syringe;
13,14 select 2L beaker;
15,16 select 2L thermometal mouth sealing gas sampler bag (Dalian Hai get Science and Technology Ltd.); 201,202 select New Era Pump Systems NE-4000 (American Health & Medical Supply International Corp.Co., Ltd, New York, U.S.A); 204,205 select THOMAS micro air pump 8003 (edge follow intelligent scientific and technological Shanghai company limited); 206,207 select OK62A-23 series precision two-position three way magnetic valve (Shanghai OK Solenoid Valve Manufacturer Co., Ltd.);
208,209,42,43,44,45 select CHEM202-V2-C203 miniature electromagnetic valve (Gems Sensor & Controls, U.S.A);
210,211 select MB315-EB33-P-201 threeway normal close minisize solenoid valve (Gems Sensor & Controls, U.S.A);
203,41 select Cole's handkerchief micro-4 passage peristaltic pump WX-78190-00 (Coleparmer, U.S.A) that write from memory;
31 hybrid chamber customization processing, capacity 500ml, is equipped with 1 road solution injection port, 1 road thief hatch, 3 road micro-sampling mouths, 2 road one-way air inlet mouths, 1 road fast sample mouth, 1 road one-way exhaust mouth, 1 stirrer installing port, 1 liquid level sensor installing port; Silica gel excellent sealing is selected in interface section, and the gas liquid junction boundary of one-way air inlet mouth end selects one-way air inlet silica gel valve EWB17-03-02-3 (Talus, Chinese Yuhuan) to carry out gas-liquid separation; One-way vent is selected long-acting type one-way exhaust valve CPIP-G7 (the international packing Co., Ltd. of Chuan Ben);
32 select HK1084 exact constant temperature bath of liquid groove (Hangzhou San Pu exact instrument company limited);
33 select EUROSTAR20digital cantilever stirrer (IKA, Germany);
34 select CT-1000 electric potential type liquid level sensor (Gems Sensor & Controls, U.S.A); 51 select pHure Sensor
tMthe online pH meter (Mettler Toledo Thornton, U.S.A) of series;
52 select ODO3000 fluorescence method dissolved oxygen sensor (Greenspan Analytical Pty Ltd, Australia);
53 select EKF BIOSEN C-LINE GLUCOSE AND LATATE ANALYSERS (EKF-diagnostic GmbH, Germany);
54 test chamber customization processing, capacity 10ml, is made up of cavity, gland bonnet and sensor fastening device, and the characteristic that wherein gland bonnet can be implanted according to sensor is changed, sensor implantation connects interface and selects PM-996 sealed membrane (Parafilm, U.S.A) sealing;
56 waste liquid pools are selected 23L strong plastic bucket;
57 select CHI1030C hyperchannel potentiostat (Shanghai occasion China);
6,7 is applying unit's autonomous Design exploitation;
It is the PTFE teflon microcapillary 06417-11 (Coleparmer, U.S.A) of 0.3mm that glucose and chaff interference sample introduction pipeline are selected internal diameter;
It is the pump line 78190-48 (Pharmed BPT, U.S.A) of 2.54mm that bionical solution and deionized water sample introduction pipeline are selected internal diameter, corresponding flow velocity 2-50ml/min;
It is the pump line 78190-42 (Pharmed BPT, U.S.A) of 1.03mm that gas circuit is selected internal diameter
It is the pump line 78190-44 (Pharmed BPT, U.S.A) of 1.52mm that distribution pipeline is selected internal diameter, corresponding flow velocity 0.1-10ml/min;
Detect standard glucose concentration used and be chosen to be 1mol/ml;
Detect the bionical solution of physiology used and adopt standard P BS (PH7.4), as shown in table 1, prepare phosphate buffer by following proportioning:
| Composition | Concentration (mmol/L) |
| Sodium hydrogen phosphate | 24.6 |
| Sodium dihydrogen phosphate | 5.4 |
| Sodium chloride | 120 |
Table l
Test chaff interference used and select ascorbic acid, urate, acetaminophen.
The course of work of concrete monitoring method is as follows:
1. transducer sensitivity, response speed, sensing range test, implement as follows, cleans test chamber → initialization testing environment → carry out continuous gradient response test → data analysis and result calculating;
2. transducer calibration and accuracy test, implement as follows, cleaning test chamber → initialization testing environment → carry out continuous gradient response test → demarcation → accuracy to test;
3. sensor anti-interference test, implements as follows, cleans test chamber → initialization testing environment → carry out single step or multi-step gradient response test → chaff interference rejection is tested → proceeds single step or multi-step gradient response test or ends test;
4. temperature dependency test, implements as follows, cleans test chamber → initialization testing environment → temperature and regulates → carry out continuous gradient response test; Repeat above-mentioned steps sequence by the temperature detection scope of setting, record each continuous gradient response test data, analysis temperature correlativity;
5. dynamic performance testing, implements as follows, cleans test chamber → initialization testing environment → adjusting concentration of glucose forwards/reverse rate of change; Repeat above-mentioned steps sequence by the concentration of glucose of setting and rate of change, record test data each time, analyze the dynamic performance testing of tested sensor.
6. long-term continuous performance test, implement as follows, cleaning test chamber → initialization testing environment → according to setting, keep duty at tested CGM sensor, every the time of setting, carry out the experiment repeatedly that continuous gradient response test → system left standstill for a long time → regulated concentration of glucose inverse change to zero or detects the lowest limit, record test data each time, analyze tested sensor under long-term work state, the parameters such as the rate of change of sensor property indices and the maximum service life of sensor.
Described in above, be specific embodiments of the invention and the know-why used, if the change of doing according to conception of the present invention, when its function producing does not exceed spiritual that instructions and accompanying drawing contain yet, must belong to protection scope of the present invention.
Claims (9)
1. the external performance evaluating system of continuous blood sugar monitoring sensor, is characterized in that comprising: reagent deposit unit (1), sample injection unit (2), sample mix unit (3), sample dividing cell (4), detecting unit (5), control module (6), CGM sensor performance evaluation and test instrument (7); Reagent deposit unit (1), sample injection unit (2), sample mix unit (3), sample dividing cell (4), detecting unit (5), CGM sensor performance evaluation and test instrument (7) are connected successively; Control module (6) is connected with sample injection unit (2), sample mix unit (3), sample dividing cell (4), detecting unit (5), CGM sensor performance evaluation and test instrument (7) respectively.
2. the external performance evaluating system of a kind of continuous blood sugar monitoring sensor according to claim 1, is characterized in that: described reagent deposit unit (1) comprising: glucose solution chamber (11), chaff interference solution cavity (12), bionical solution liquid storage cylinder (13), deionized water liquid storage cylinder (14), oxygen chamber (15), nitrogen chamber (16), described sample injection unit (2) comprising: glucose micro-injection pump (201), chaff interference micro-injection pump (202), sample introduction peristaltic pump (203), oxygen sample introduction micro air pump (204), nitrogen sample introduction micro air pump (205), glucose sample control valve (206), chaff interference sample control valve (207), bionical solution sampling valve (208), deionized water sample control valve (209), oxygen sample control valve (210), nitrogen sample control valve (211), glucose solution chamber (11) is installed on glucose micro-injection pump (201) inside, and glucose micro-injection pump (201) is connected with glucose sample control valve (206), chaff interference solution cavity (12) is installed on chaff interference micro-injection pump (202) inside, and chaff interference micro-injection pump (202) is connected with chaff interference sample control valve (207), bionical solution liquid storage cylinder (13), bionical solution sampling valve (208), sample introduction peristaltic pump (203) are connected successively, deionized water liquid storage cylinder (14), deionized water sample control valve (209), sample introduction peristaltic pump (203) are connected successively, oxygen chamber (15), oxygen sample control valve (210), oxygen sample introduction micro air pump (204) are connected successively, nitrogen chamber (16), nitrogen sample control valve (211), nitrogen sample introduction micro air pump (205) are connected successively.
3. the external performance evaluating system of a kind of continuous blood sugar monitoring sensor according to claim 1, it is characterized in that: described sample mix unit (3) comprising: sample mix chamber (31), water bath with thermostatic control (32), stirrer (33), liquid level sensor (34), sample mix chamber (31) comprises hybrid chamber cavity (3101), hybrid chamber gland bonnet (3102), solution injection port (3103), oxygen injection port (3104), nitrogen injection port (3105), glucose solution injection port (3106), chaff interference solution injection port (3107), injection port for subsequent use (3108), thief hatch (3109), unidirectional gas outlet (3110), fast sample mouth (3111), stirrer installing port (3112), liquid level sensor installing port (3113), submerge in water bath with thermostatic control (32) in bottom, sample mix chamber (31), stirrer (33) is arranged in sample mix chamber (31) by stirrer installing port (3112), and liquid level sensor (34) is arranged in sample mix chamber (31) by liquid level sensor installing port (3113).
4. the external performance evaluating system of a kind of continuous blood sugar monitoring sensor according to claim 1, is characterized in that: described sample dividing cell (4) comprising: sampling peristaltic pump (41), PH signal piping operation valve (42), oxyty signal piping operation valve (43), concentration of glucose are demarcated signal piping operation valve (44) and CGM sensor signal piping operation valve to be measured (45); Described detecting unit (5) comprising: online PH meter (51), oxyty sensor (52), concentration of glucose meter (53), test chamber (54), tested CGM sensor (55), waste liquid pool (56), potentiostat/galvanochemistry instrument (57); sampling peristaltic pump (41) by pipeline respectively with PH signal piping operation valve (42), oxyty signal piping operation valve (43), concentration of glucose demarcates signal piping operation valve (44) and CGM sensor signal piping operation valve to be measured (45) is connected, in the distribution pipeline that the access of online PH meter (51) probe is connected with PH signal piping operation valve (42), oxyty sensor (52) accesses in the distribution pipeline being connected with oxyty signal piping operation valve (43), in the distribution pipeline that concentration of glucose meter (53) access is connected with concentration of glucose demarcation signal piping operation valve (44), test chamber (54) accesses in the distribution pipeline being connected with CGM sensor signal piping operation valve to be measured (45), tested CGM sensor (55) probe is implanted in test chamber (54), waste liquid pool (56) is placed in each distribution pipeline liquid outlet bottom, potentiostat/galvanochemistry instrument (57) is connected by signal cable with tested CGM sensor (55).
5. the external performance evaluating system of a kind of continuous blood sugar monitoring sensor according to claim 1, it is characterized in that: glucose sample control valve (206) is connected with the glucose injection port (3106) of sample mix chamber (31), chaff interference sample control valve (207) is connected with the chaff interference injection port (3107) of sample mix chamber (31), sample introduction peristaltic pump (203) sample outlet end is connected with the injection port (3103) of sample mix chamber (31), oxygen sample introduction micro air pump (204) sample outlet end is connected with the oxygen injection port (3104) of sample mix chamber (31), nitrogen sample introduction micro air pump (205) sample outlet end is connected with the nitrogen injection port (3105) of sample mix chamber (31), sampling peristaltic pump (41) is connected with sample mix chamber (31) by pipeline.
6. the external performance evaluating system of a kind of continuous blood sugar monitoring sensor according to claim 1, is characterized in that: glucose sample control valve (206), chaff interference sample control valve (207), bionical solution sample introduction valve processed (208), deionized water sample control valve (209), oxygen sample control valve (210), nitrogen sample control valve (211), PH signal piping operation valve (42), oxyty signal piping operation valve (43), concentration of glucose is demarcated signal piping operation valve (44), CGM sensor signal piping operation valve to be measured (45), glucose micro-injection pump (201), chaff interference micro-injection pump (202), sample introduction peristaltic pump (203), oxygen sample introduction micro air pump (204), nitrogen sample introduction micro air pump (205), sampling peristaltic pump (41), water bath with thermostatic control (32), stirrer (33), liquid level sensor (34) is all connected with control module (6) by power supply and signal bus, online PH meter (51), oxyty sensor (52), concentration of glucose meter (53), potentiostat/galvanochemistry instrument (57) data can or directly be inputted CGM sensor performance evaluation and test instrument (7) by artificial importing.
7. the external performance evaluating system of a kind of continuous blood sugar monitoring sensor according to claim 1, is characterized in that: described test chamber can be set up in parallel one to multiple, and the corresponding operation valve that detects of each test chamber configuration, is equipped with removable diaphragm seal.
8. the external performance evaluating system of a kind of continuous blood sugar monitoring sensor according to claim 1, it is characterized in that: described each interface of sample mix chamber is strictly sealing all, entering fast school mouth uses plug airtight, comprise a high precision water level meter, an one-way vent, a unidirectional fast sample mouth, two unidirectional gas sampling mouths.
9. the external performance evaluating system of a kind of continuous blood sugar monitoring sensor according to claim 1, is characterized in that: described concentration of glucose is counted laboratory standard gauging instrument.
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| CN111257394A (en) * | 2018-12-31 | 2020-06-09 | 深圳硅基传感科技有限公司 | Test platform for testing consistency of electrochemical parameters |
| CN111803088A (en) * | 2020-07-22 | 2020-10-23 | 浙江凯立特医疗器械有限公司 | Test method and device of implantable biological monitoring sensor |
| CN112450923A (en) * | 2020-08-24 | 2021-03-09 | 杭州微策生物技术股份有限公司 | Method for detecting performance of sensor |
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| CN117007807A (en) * | 2023-07-26 | 2023-11-07 | 南京晶捷生物科技有限公司 | Performance detection method, device, system, equipment and medium for glucose sensor |
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| CN108020508B (en) * | 2017-12-26 | 2024-02-09 | 深圳德夏生物医学工程有限公司 | Combined reagent cup |
| CN108020508A (en) * | 2017-12-26 | 2018-05-11 | 深圳德夏生物医学工程有限公司 | Composite reagent cup |
| CN111257394A (en) * | 2018-12-31 | 2020-06-09 | 深圳硅基传感科技有限公司 | Test platform for testing consistency of electrochemical parameters |
| CN111257394B (en) * | 2018-12-31 | 2021-08-31 | 深圳硅基传感科技有限公司 | Test platform for testing consistency of electrochemical parameters |
| CN111803088A (en) * | 2020-07-22 | 2020-10-23 | 浙江凯立特医疗器械有限公司 | Test method and device of implantable biological monitoring sensor |
| CN112450923A (en) * | 2020-08-24 | 2021-03-09 | 杭州微策生物技术股份有限公司 | Method for detecting performance of sensor |
| CN112450923B (en) * | 2020-08-24 | 2024-09-20 | 杭州微策生物技术股份有限公司 | Method for detecting performance of sensor |
| CN114081484A (en) * | 2021-11-24 | 2022-02-25 | 上海微创生命科技有限公司 | Continuous blood sugar detection method, system and readable storage medium |
| CN114081484B (en) * | 2021-11-24 | 2024-02-27 | 上海微创生命科技有限公司 | Continuous blood glucose detection method, system and readable storage medium |
| CN115201308A (en) * | 2022-07-18 | 2022-10-18 | 山东省医疗器械和药品包装检验研究院 | System and method for evaluating stability of continuous glucose monitoring system |
| CN115201308B (en) * | 2022-07-18 | 2024-01-26 | 山东省医疗器械和药品包装检验研究院 | System and method for evaluating stability of continuous glucose monitoring system |
| CN117007807A (en) * | 2023-07-26 | 2023-11-07 | 南京晶捷生物科技有限公司 | Performance detection method, device, system, equipment and medium for glucose sensor |
| CN117007807B (en) * | 2023-07-26 | 2024-09-20 | 南京晶捷生物科技有限公司 | Performance detection method, device, system, equipment and medium for glucose sensor |
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