CN105628747A - Blood coagulation time test and analysis device - Google Patents
Blood coagulation time test and analysis device Download PDFInfo
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- CN105628747A CN105628747A CN201510958572.5A CN201510958572A CN105628747A CN 105628747 A CN105628747 A CN 105628747A CN 201510958572 A CN201510958572 A CN 201510958572A CN 105628747 A CN105628747 A CN 105628747A
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
- G01N27/02—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating impedance
- G01N27/04—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating impedance by investigating resistance
- G01N27/12—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating impedance by investigating resistance of a solid body in dependence upon absorption of a fluid; of a solid body in dependence upon reaction with a fluid, for detecting components in the fluid
Abstract
The invention relates to a blood coagulation time test and analysis device which is characterized by comprising a test piece (22) and a portable main machine, wherein a sample hole (1) for containing a blood sample, a reagent hole (2) for containing a reagent and a capillary tube (3) with a conducting layer (5) are formed in the test piece (22); the sample hole (1), the reagent hole (2) and the capillary tube (3) are communicated with one another in sequence; an air hole (4) is formed in the tail end of the test piece (22), so that liquid can flow in the capillary tube (3); the conducting layer (5) is connected with an electrode interface (7); the electrode interface (7) is accessed into the portable main machine; when the blood sample is mixed with the reagent, the mixed liquid flows along the capillary tube (3); along with the flowing of the mixed liquid, the resistance of the conducting layer (5) changes; the portable main machine is used for measuring the time required by blood coagulation through obtaining a resistance change stop time point.
Description
Technical field
The present invention relates to a kind of clotting time device for testing and analyzing, especially the device of thrombin time test, belongs to blood coagulation test and analysis technology field.
Background technology
The process of blood coagulation is called for short blood coagulation, is that blood is become the process of gel state from flow regime, and it is the important component part of hemostatic function. Coagulation process is the process (academia is commonly called as endogenous and exogenous cruor pathway) that a series of thrombin is deactivated by sequential enzymatic, produces thrombin proteins, promotes Fibrinogen to form threadiness thrombosis grumeleuse. Method of testing conventional clinically includes activated partial thromboplastin time (APTT) and prothrombin time (PT) and some other parameter is used for preventing and cure the disease such as thrombosis or fibrinolytic. PT is one of conventional 4 of blood coagulation, is mainly used in examination exogenous factor and lacks, and the dosage of monitoring warfarin anticoagulation (Warfarin). Oral warfarin has been widely used in prevention and treatment thrombosis class disease. It is interval to guarantee that its medication effect is in best dose that the treatment using warfarin patient needs that parameter PT does regular monitoring and check. Because the PT reagent sensitivity of each manufacturer is different with normal value, cause very big obstacle to the use of PT readings. INR standardized PT value method (InternationalNormalizedRatio) can be established for this international in-vitro diagnosis industry and pathology. Thus, use the patient of Warfarin drug just can INR value at the consumption of 1.5 3.5 scope internal control pharmacy things. Certainly for different disease classes, the zone of reasonableness monitoring medication by the value of INR is slightly different. Being INR2.0 3.5 to surgical patient group, and be that 1.5 3.0. clinical datas show to phlebothrombosis patient group's INR scope, the regular PT that measures can effectively improve medication effect and guarantee the safety of antithrombotic reagent dosage. Effective monitoring can be lowered owing to warfarin is with wanting blood embolization that is very few and that cause. Drug safety is by occurring without or seldom occurring owing to warfarin uses the too much bleeding caused. Dosage can be maintained at the scope that safety is appropriate by domestic portable INR monitor easily, thus greatly improving the effect of anticoagulant therapy.
In recent years due to the innovation of science and technology, portable Blood coagulation instrument enters in-vitro diagnosis market, mostly adopts small analoids and sensor due to it, easy to use, and then substantially reduces the time obtaining patient information. Owing to using INR value Lai Kongyaoge manufacturer result the same, the INR portable tester of small-sized simplicity just can be used in Doctor's office or patients home.
Thrombosis and hemostasis are not only related to preclinical medicine, and closely related with the disease of multiple clinical sections (such as blood, breathing, digestion, cardiovascular, gynecological, department of general surgery etc.). Detection of blood coagulation is one of conventional inspection project, such as the Index for diagnosis etc. for checking project and monitoring clinical oral administration anticoagulant patient, prediction thrombosis, disseminated inravascular coagulation diagnosis, deficiency of coagulation factors diagnosis congenital or day after tomorrow, hepatic disease before operation consent inspection, thrombosis. Blood coagulation therein four inspection is more commonly used, before performing an operation in hospital such as patient, doctor always may require that patient takes blood and does Coagulation mechanism inspection, four inspections of blood coagulation include prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT), Fibrinogen (FIB), purpose is that the hemostatic function understanding patient in the preoperative has zero defect, to do some preparations in advance, it is prevented that massive hemorrhage in art and be caught unprepared.
For the detection of clotting time in prior art, adopt the method that the optical characteristics (printing opacity degree) of detection blood plasma and reagent mixture changes, or the method adopting magnetic force property change, and based on these method testing analytical tool, above two is not enough for the detection method visual of clotting time, and it is more complicated to detect equipment, and detection apparatus value is high, testing cost is higher, and the precision simultaneously monitored is also usually owing to the factor of equipment or environment is not as people's will.
Summary of the invention
It is an object of the invention to provide a kind of brand-new blood coagulation device for testing and analyzing, improve the visual of clotting time detection, reduce the detection condition requirement such as equipment needed thereby, environment simultaneously, make clotting time detection convenient, it is easy to use in the following small medical unit of out-patient department and county, simultaneously facilitates and be progressively generalized in patients home to use. Believing, this is populous, the China of the shortage of vast rural area and height tip, Podunk Medical Instruments, to operating execution, with to venothrombotic treatment, and the lifelong patient of use warfarin, will be a big Gospel.
The present invention takes techniques below scheme:
A kind of clotting time device for testing and analyzing, including test sheet 22, portable main machine; Described test sheet 22 is provided with the sample well 1 of accommodation blood plasma, holds the reagent wells 2 of reagent and the capillary channel 3 with conductive layer 5; Described sample well 1, reagent wells 2, capillary channel 3 three are sequentially communicated, and described test sheet 22 end has pore 4, allow the liquid to flow in capillary channel 3; Described conductive layer 5 is connected with electrode interface 7, and described electrode interface 7 accesses described portable main machine; After blood sample mixes with reagent, mixing liquid flows along capillary channel 3, and along with the flowing of mixing liquid, the resistance of conductive layer 5 produces change, and portable main machine stops the time point of change and records the time needed for blood coagulation by obtaining resistance.
The technical program design is ingenious, flowed in capillary tube by blood and reagent mixed liquor body and both can cause the resistance variations of conductive layer, automatically obtain resistance thereby through test system and stop the time point of change to record clotting time, again simultaneously because be the change detecting resistance, test system hardware and software is relatively easy, cost is greatly reduced, plus adopting portable test sheet, it is greatly improved a whole set of test portable degree of device, is conducive to more universal under various medical environments promoting widely.
Further, described test sheet 22 is transparent material, it is possible to observe that mixing liquid is finally stopped the position of flowing in capillary tube intuitively, thus seeing the length of clotting time and bleeding time intuitively, it is simple to contrast.
Further, one layer of conductivity silk of the inner homogeneous coating of described capillary channel 3, it is used for conducting electricity, described conductance silk is plated in the both sides of the y direction bottom surface of capillary channel.
Further, the described rectangular strip of test sheet 22, described electrode interface 7 is arranged at the one end of described test sheet 22, and described sample well 1, reagent wells 2 are arranged at the other end, the tortuous middle part being arranged on test sheet 22 of described capillary channel 3.
Further, what described capillary channel 3 spiraled is arranged on test sheet 22, to reduce the volume of test sheet, improves portability.
Further, described portable main machine is provided with for pointing out operating procedure and/or the LCDs 12 of display test data, and the data for data output outreach interface 14.
Further, the performance graph that described portable main machine changes with Coagulation test according to end point values the combined impedance of capillary miniflow, calculating the end point values of clotting time, performance graph contains the blood coagulation overall process of whole blood sample, and then for the mensuration of other coagulation parameters.
Further, test sheet 22 also sets up the Quality Control capillary channel 6 miniflow contrast pipeline as auxiliary, the miniflow contrast pipeline of auxiliary can provide double circuit harvester relatively on the occasion of, wherein contrasting pipeline without the miniflow of reagent can provide different blood sample because of viscosity, erythrocyte sedimentation rate, the current difference that blood cell concentration difference causes, carries out weight normalization thus the non-coagulation parameters between blood sample is affected.
Further, test sheet 22 by egative film 10 and upper slice form, both at hydrophilic plastic sheeting, and centre is that to be made capillary channel be formed on egative film and upper slice bonding by one layer of adhesive film 9 closed circuit.
The beneficial effects of the present invention is:
1) design ingenious.
2) visual of measurement result is substantially improved.
3) requirement of test equipment is greatly reduced, reduces testing cost and threshold, it is simple to use in the following small medical unit of out-patient department and county, simultaneously facilitate and be progressively generalized in patients home to use.
4) clotting time test process is convenient.
5) test equipment is smaller and more exquisite, more portable.
6) believing, this is populous, the China of the shortage of vast rural area and height tip, Podunk Medical Instruments, to operating execution, with to venothrombotic treatment, and the lifelong patient of use warfarin, will be a big Gospel.
7) performance graph that the present invention is the end point values according to capillary miniflow and combined impedance changes with Coagulation test, calculates the end point values of clotting time. Performance graph contains the blood coagulation overall process of whole blood sample, identical with the analysis method of traditional full-automatic optical method, thus degree of accuracy is high.
8) relative to the real impedance method of existing products in markets, only surveying the absolute value change of impedance, the whole blood of people varies less in coagulation process. And the impedance silk used in analoids of the present invention adds a high conductance material for the impedance of blood sample, thus impedance method is exaggerated, highly sensitive in traditional electrode method. It addition, the miniflow contrast pipeline of auxiliary can provide again double circuit harvester relatively on the occasion of. Wherein different blood sample can be provided because of viscosity, erythrocyte sedimentation rate, the current difference that blood cell concentration difference causes without the contrast pipeline of reagent, carry out weight normalization thus the non-coagulation parameters between blood sample is affected.
Accompanying drawing explanation
Fig. 1 is a kind of structural representation testing sheet adopting clotting time device for testing and analyzing of the present invention.
Fig. 2 is the longitudinal section that test sheet is positioned at sample well and reagent wells position.
Fig. 3 is the longitudinal section that test sheet is positioned at capillary channel position.
Fig. 4 is the schematic diagram of a kind of portable test main frame adopting clotting time device for testing and analyzing of the present invention.
In figure, 1. sample well, 2. reagent wells, 3. capillary channel, 4. group pore, 5. conductive layer, 6. Quality Control capillary channel, 7. electrode interface; 11. test device housings, 12. LCDs, 13. external power supply sockets, 14. data outreach interface, 15. " on " function menu selection key, 16. D score function menu selects key, 17. Menu key, 18. on & off switches, 19. determine key, 20. indicate power supply status and warm-up mode, 21. heating plates, 22. test sheets.
Detailed description of the invention
Below in conjunction with the drawings and specific embodiments, the present invention is further described.
Principles of the invention is the whole blood (including blood cell, platelet, and blood plasma) according to human body, can flow in the capillary channel of a kind of special disposable test sheet. Solidification under the effect of the dry Activated Coagulation agent that blood is prefabricated in test sheet, when blood clotting process completes, capillary miniflow can stop. Blood start with reagent touch blood miniflow stop time be clotting time. Impedance when being coated with conductive filament in capillary channel for measuring fluid via microchannel is over time. And then clotting time and bleeding time it is accurately determined over time according to impedance. This is to obtain by following the tracks of the time graph of impedance variation. Use PT reagent as activator, make blood sample coagulation, and then with the ISI calibration value according to agents useful for same, the PT value measured is normalized to the INR value for monitoring warfarin dosage. Owing to whole blood impedance is big, unstable, the impedance readings error in capillary flow can be very big, and change in impedance value is too little, the present invention utilizes capillary flow as dynamic basis, adds that impedance silk is as substrate, impedance contrast is amplified again, to reach sensitivity and the degree of accuracy of signal by micro-bridge method.
Referring to Fig. 1-Fig. 2, following all of diagram is all intended merely to the part set forth in the many designs of the present invention, is not intended to limit the scope of application of the present invention.
One portable blood coagulation measuring and analysing meter, in order to the whole blood to patient, especially takes warfarin and carries out the patient of oral anticoagulation thing treatment and be monitored. Fig. 1 shows the design of a test sheet in preferred embodiment, wherein 22 is the main body of test sheet, made by hydrophilic plastic material, comprise a sample well 1 for adding human whole blood sample, one reagent wells 2 is used for placing the reagent of test PT, article one, capillary channel 3 is so that sample is due to capillarity flow ipe, article one, sample is done normalization or is used as the instant Quality Control of liquid by Quality Control capillary channel 6, one group of printing conductance silk 5 completes the electrical measurement to tested blood sample and quality-control sample, one group of pore 4 is used to form capillarity causes liquid inflow pipe, electrode interface 7 is to be inserted card by four pins to be connected to system hardware. the test sheet pipeline of one typically preferred embodiment is as shown in Figure 2. this is the longitudinal section perspective view of a test sheet 22, including using the virtual prolongation to capillary channel part of the section tangent line. in Fig. 2 22 are the main bodys of test sheet, and sample well 1 is placed in the initiating terminal of the test sheet of elongated shape, and the bottom testing sheet is then capillary channel and is connected with the bottom of sample well, and reagent wells 2 is directly connected with sample well by capillary channel. capillary miniflow in capillary channel 3 is to be caused by the pore 4 being positioned at test sheet end, and blood sample can be made to be flowed by capillary channel. a pair conductance silk is plated in the two ends of capillary channel horizontal direction respectively through digital printed method, electrically insulated from one another, closed circuit in order to cause the connection of both sides conductance silk to make resistance wire be formed when blood flows through capillary channel, and then collect the signal of telecommunication at electrode interface 7. Fig. 3 is the cross section of test sheet capillary channel part. as shown in Figure 3, the entirety of test sheet is made up of three layers hydrophilic plastic material, wherein test sheet main body 22 by egative film 10 and upper slice form, both at hydrophilic plastic sheeting, and centre is that to be made capillary channel be formed on egative film and upper slice bonding by one layer of adhesive film 9 closed circuit. in figure 3, that a pair conductance silk is plated in the y direction of capillary channel, is designated part 5 in the drawings.
Fig. 4 is the schematic diagram of the instrument of the present invention most preferably one of example. in this case, including the shell 11 of a machine, LCDs 12 shows test result as to user, and can carry out some simple instruments behaviour according to the prompting of display screen and do option. 13 is the socket of external power supply in the drawings, 14 is that data outreach interface and can be used for being connected to the optional computer of user or concatenation printer, " menu " key 17 is used for the machine operation " menu " opening and closing on display screen, 15 and the 16 button whats representing "up" and "down" respectively select the option of menu, the switch of machine is by 18 " ON/OFF " key control, " OK " key 19 is used to receive option or continue next step operation, display lamp 20 identifies power supply status and warm-up mode, the beneath of heating plate 21 is used for heating and keep test sheet stable in the temperature pre-set equipped with a radiator valve circuit, disposable test sheet is shown as 22 in the drawings, sample well is 1.
Our employing of impedance silk adopts screen printing silver method plating graphite powder thin layer on 3M egative film. Its advantage is that structure is good, and coating is stable, conducts electricity very well, it is easy to do large-scale processing.
Host circuit board includes with lower part: 1) gathers the detecting head of data, mainly includes clock (oscillator), and resistance reads; 2) digital-to-analogue conversion; 3) power supply supply; 4) dry sound control system is subtracted; 5) internal memory software kit; 6) figure processes and conversion software; 7) display screen; 8) operated key; 9) printer (user's option).
The performance graph that the present invention is the end point values according to capillary miniflow and combined impedance changes with Coagulation test, calculates the end point values of clotting time. Performance graph contains the blood coagulation overall process of whole blood sample, identical with the analysis method of traditional full-automatic optical method, thus degree of accuracy is high. Relative to the real impedance method of existing products in markets, only surveying the absolute value change of impedance, the whole blood of people varies less in coagulation process. And the impedance silk used in analoids of the present invention adds a high conductance material for the impedance of blood sample, thus impedance method is exaggerated, highly sensitive in traditional electrode method. It addition, the miniflow contrast pipeline of auxiliary can provide again double circuit harvester relatively on the occasion of. Wherein different blood sample can be provided because of viscosity, erythrocyte sedimentation rate, the current difference that blood cell concentration difference causes without the contrast pipeline of reagent, carry out weight normalization thus the non-coagulation parameters between blood sample is affected.
Claims (9)
1. a clotting time device for testing and analyzing, it is characterised in that:
Including test sheet (22), portable main machine;
Described test sheet (22) is provided with the sample well (1) of accommodation blood sample, holds the reagent wells (2) of reagent and the capillary channel (3) with conductive layer (5);
Described sample well (1), reagent wells (2), capillary channel (3) three are sequentially communicated, described test sheet (22) end has pore (4), allows the liquid to flowing in capillary channel (3);
Described conductive layer (5) is connected with electrode interface (7), and described electrode interface (7) accesses described portable main machine;
After blood sample mixes with reagent, mixing liquid flows along capillary channel (3), along with the flowing of mixing liquid, the resistance of conductive layer (5) produces change, and portable main machine stops the time point of change and records the time needed for blood coagulation by obtaining resistance.
2. clotting time device for testing and analyzing as claimed in claim 1, it is characterised in that: described test sheet (22) is transparent material.
3. clotting time device for testing and analyzing as claimed in claim 1, it is characterised in that: one layer of conductivity silk of the inner homogeneous coating of described capillary channel (3), it is used for conducting electricity, described conductance silk is plated in the both sides of the y direction bottom surface of capillary channel.
4. clotting time device for testing and analyzing as claimed in claim 1, it is characterized in that: the rectangular strip of described test sheet (22), described electrode interface (7) is arranged at the one end of described test sheet (22), described sample well (1), reagent wells (2) are arranged at the other end, the tortuous middle part being arranged on test sheet (22) of described capillary channel (3).
5. clotting time device for testing and analyzing as claimed in claim 1, it is characterised in that: what described capillary channel (3) spiraled is arranged in test sheet (22), to reduce the volume of test sheet, improves portability.
6. clotting time device for testing and analyzing as claimed in claim 1, it is characterized in that: described portable main machine is provided with for pointing out operating procedure and/or the LCDs (12) of display test data, and the data for data output outreach interface (14).
7. clotting time device for testing and analyzing as claimed in claim 1, it is characterized in that: the performance graph that described portable main machine changes with Coagulation test according to end point values the combined impedance of capillary miniflow, calculate the end point values of clotting time, performance graph contains the blood coagulation overall process of whole blood sample, and then for the mensuration of other coagulation parameters.
8. clotting time device for testing and analyzing as claimed in claim 1, it is characterized in that: in test sheet (22), also set up the Quality Control capillary channel (6) the miniflow contrast pipeline as auxiliary, the miniflow contrast pipeline of auxiliary can provide double circuit harvester relatively on the occasion of, wherein contrasting pipeline without the miniflow of reagent can provide different blood sample because of viscosity, erythrocyte sedimentation rate, the current difference that blood cell concentration difference causes, carries out weight normalization thus the non-coagulation parameters between blood sample is affected.
9. clotting time device for testing and analyzing as claimed in claim 1, it is characterized in that: test sheet (22) by egative film (10) and upper slice form, both at hydrophilic plastic sheeting, and centre is that to be made capillary channel be formed on egative film and upper slice bonding by one layer of adhesive film (9) closed circuit.
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| CN109100394A (en) * | 2018-07-18 | 2018-12-28 | 浙江大学 | A kind of clotting time detector and its detection method |
| CN110057890A (en) * | 2019-03-26 | 2019-07-26 | 中国科学院苏州生物医学工程技术研究所 | A kind of hemostasis examination chip and electrochemical sensor |
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| CN110057890A (en) * | 2019-03-26 | 2019-07-26 | 中国科学院苏州生物医学工程技术研究所 | A kind of hemostasis examination chip and electrochemical sensor |
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| CN113702649A (en) * | 2021-08-25 | 2021-11-26 | 常州工程职业技术学院 | Microfluid biochip for measuring blood coagulation time |
| CN113702649B (en) * | 2021-08-25 | 2022-09-02 | 常州工程职业技术学院 | Microfluid biochip for measuring blood coagulation time |
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