CN105572397A - Blood clotting time test analysis method - Google Patents
Blood clotting time test analysis method Download PDFInfo
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- CN105572397A CN105572397A CN201511020456.5A CN201511020456A CN105572397A CN 105572397 A CN105572397 A CN 105572397A CN 201511020456 A CN201511020456 A CN 201511020456A CN 105572397 A CN105572397 A CN 105572397A
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- clotting time
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/86—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood coagulating time or factors, or their receptors
Abstract
The invention relates to a blood clotting time test analysis method, especially relates to thrombin time test, and belongs to the technical field of blood clotting test analysis. The blood clotting time test analysis method is characterized in that a test piece (22) is provided with a blood sample accommodating cavity, a reagent accommodating cavity and a capillary channel (3) coated with a conductive layer (5); and the blood sample accommodating cavity, the reagent accommodating cavity and the capillary channel (3) coated with the conductive layer (5) are sequentially interconnected, a mixed liquid obtained after mixing a blood sample with a reagent flows to the capillary channel (3), the resistance of the conductive layer (5) changes with the flow of the mixed liquid, and the resistance changing stop time point is obtained to measure the time required by blood clotting. The method has the advantages of ingenious design, great improvement of the visual degree of a measurement result, great reduction of requirements of a test device, reduction of the test cost and threshold, convenience for use in outpatient departments and below county level small medical units, and convenience for gradual promotion of use in patients' homes.
Description
Technical field
The present invention relates to a kind of clotting time method for testing and analyzing, especially thrombin time test.Belong to blood coagulation test and analysis technology field.
Background technology
The process of blood clotting is called for short blood coagulation, and be that blood becomes the process of gel state from flow state, it is the important component part of hemostatic function.The coagulation process process (academia is commonly called as endogenous and exogenous cruor pathway) that to be a series of clotting factor activated by enzymolysis in succession, produces thrombin proteins, impels fibrinogen to form fibrous thrombus grumeleuse.Method of testing conventional clinically comprises activated partial thromboplastin time (APTT) and prothrombin time (PT) and some other parameter and is used for prevention and cures the illness such as thrombus 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 therapy thrombus class illness.The treatment of warfarin patient is used to need to do regular monitoring to parameter PT and check to guarantee that its medication effect is in best dose interval.Because the PT reagent sensitivity of each manufacturer is different with normal value, the use of reading value to PT causes very large obstacle.International in-vitro diagnosis industry and pathology can establish INR standardized PT value method (InternationalNormalizedRatio) for this reason.Thus, the patient using Warfarin drug just can INR value at the consumption of 1.5 – 3.5 scope internal control pharmacies.Certainly for different illness classes, the zone of reasonableness monitoring medication by the value of INR is slightly different.Be INR2.0 – 3.5 to operation patients group, and be that 1.5 – 3.0. clinical datas show to phlebothrombosis patient group INR scope, regular measurement PT effectively can improve medication effect and guarantee the safety of antithrombotic reagent dosage.Effective monitoring can be lowered because warfarin use wants very few and blood embolization that is that cause.Drug safety is by not occurring or seldom occur because warfarin uses the too much bleeding caused.Dosage can be remained on the appropriate scope of safety by domestic portable INR monitor easily, thus greatly improves 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, because it adopts small analoids and sensor mostly, easy to use, and then substantially reduces the time obtaining patient information.Owing to using INR value Lai Kongyaoge manufacturer result the same, small-sized easy INR portable tester just can be used in Doctor's office or patients home.
Thrombosis and hemostasis not only relates to preclinical medicine, and closely related with the disease of multiple clinical section (as blood, breathing, digestion, cardiovascular, gynaecology, department of general surgery etc.).Detection of blood coagulation is one of conventional Interventions Requested, as the Index for diagnosis etc. for inspection item before operation consent inspection, thrombus and monitoring clinical oral administration anticoagulant patient, prediction thrombosis, disseminated intravascular coagulation diagnosis, the congenital or deficiency of coagulation factors diagnosis day after tomorrow, liver diseases.Blood coagulation wherein four checks more conventional, before patient performs an operation in hospital, doctor always requires that patient gets blood and does Coagulation mechanism inspection, blood coagulation four inspections comprise prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT), fibrinogen (FIB), object is that the hemostatic function understanding patient in the preoperative has zero defect, to do some preparations in advance, prevent massive haemorrhage in art and be caught unprepared.
For the detection in clotting time in prior art, adopt the method that the optical characteristics (printing opacity degree) detecting blood plasma and reagent mixture changes, or adopt the method for magnetic force property change, above-mentioned two kinds of detection method visual for the clotting time are not enough, and checkout equipment more complicated, checkout equipment is worth high, and testing cost is higher, and the precision of simultaneously monitoring is also usually because the factor of equipment or environment is not so good as people's will.
Summary of the invention
The object of the present invention is to provide a kind of brand-new blood coagulation method for testing and analyzing, improve the visual of clotting time detection, reduce simultaneously and detect the conditional request such as equipment needed thereby, environment, detected convenient in the clotting time, be convenient to use in following small medical unit of clinic and county, be convenient to progressively be generalized in patients home simultaneously and use.Believe, this is populous, and the China of the shortage of the high most advanced and sophisticated Medical Instruments in vast rural area and Podunk, to operating execution, with to venothrombotic treatment, and using the lifelong patient of warfarin, will be a large Gospel.
The present invention takes following technical scheme:
A kind of clotting time method for testing and analyzing, a test pieces 22 arranges the receiving cavity of blood sample and reagent, and is coated with the capillary channel 3 of conductive layer; The receiving cavity 1,2 of blood sample and reagent, conductive layer 5 three is interconnected successively, after blood sample mixes with reality, mixing material flows to capillary channel 3, along with the flowing of mixing material, the resistance of conductive layer 5 changes, and records the time needed for blood coagulation by the time point obtaining resistance stopping change.
The technical program design is ingenious, flowed in kapillary by blood and reagent mixed liquor body and both can cause the resistance variations of conductive layer, thus stop the time point of change to record the clotting time by test macro automatic acquisition resistance, mixing material final position stopping flowing in kapillary can be observed again intuitively, thus see the length of clotting time and bleeding time intuitively, be convenient to contrast.Simultaneously owing to being the change detecting resistance, test macro software and hardware is relatively simple, and cost significantly reduces, and adds and adopts portable test pieces, greatly improve the portable degree of a whole set of proving installation, be conducive to more universally under various medical environment promoting widely.
Further, adopt the test pieces 22 of transparent insulation material to observe the position that blood stops flowing in capillary channel 3 intuitively, compared intuitively by the length of length to the clotting time of observing blood flow distance.
Further, inner homogeneous coating one deck carbon dust conductive layer of described capillary channel 3, for conduction.
Further, described test pieces 22 being arranged the electrode interface 7 of instant plug, for inserting Test Host, promoting the portability of proving installation.
Further, what described capillary channel 3 spiraled is arranged in test pieces 22, to reduce the volume of test pieces, improves portability.
Further, according to the end point values of capillary miniflow and the performance graph that changes with Coagulation test of combined impedance, calculate the end point values in clotting time, performance graph contains the blood coagulation overall process of whole blood sample.
Further, test pieces 22 also arranges Quality Control capillary channel 6 as auxiliary miniflow contrast pipeline, auxiliary miniflow contrast pipeline can provide again double circuit collector comparatively on the occasion of, miniflow contrast pipeline wherein without reagent can provide different blood sample because of viscosity, erythrocyte sedimentation rate, the current difference that blood cell concentration difference causes, thus weight normalization is carried out on the non-coagulation parameters impact between blood sample.
Beneficial effect of the present invention is:
1) design ingenious.
2) visual of measurement result significantly promotes.
3) requirement of testing apparatus is significantly reduced, reduce testing cost and threshold, be convenient to use in following small medical unit of clinic and county, be convenient to progressively be generalized in patients home simultaneously and use.
4) test process is convenient the clotting time.
5) testing apparatus can be accomplished smaller and more exquisite, more portable.
6) believe, this is populous, and the China of the shortage of the high most advanced and sophisticated Medical Instruments in vast rural area and Podunk, to operating execution, with to venothrombotic treatment, and using the lifelong patient of warfarin, will be a large Gospel.
7) the present invention is end point values according to capillary miniflow and the performance graph that changes with Coagulation test of combined impedance, calculates the end point values in clotting time.Performance graph contains the blood coagulation overall process of whole blood sample, and identical with the analytical approach 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 survey the absolute value change of impedance, the whole blood of people changes very little 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 amplified, highly sensitive in traditional electrode method.In addition, auxiliary miniflow contrast pipeline can provide again double circuit collector comparatively on the occasion of.Contrast pipeline wherein without reagent can provide different blood sample because of viscosity, erythrocyte sedimentation rate, the current difference that blood cell concentration difference causes, thus carries out weight normalization to the non-coagulation parameters impact between blood sample.
Accompanying drawing explanation
Fig. 1 is the structural representation of a kind of test pieces adopting clotting time device for testing and analyzing of the present invention.
Fig. 2 is the longitudinal section that test pieces is positioned at sample well and reagent wells position.
Fig. 3 is the longitudinal section that test pieces is positioned at capillary channel position.
Fig. 4 is the schematic diagram of a kind of portable Test Host 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. testing apparatus shells, 12. LCDs, 13. external power supply sockets, 14. data outreach interface, 15. " on " function menu options button, 16. D score function menu options buttons, 17. Menu key, 18. on & off switches, 19. OK buttons, 20. indicate power supply status and warm-up mode, 21. heating plates, 22. test pieces.
Embodiment
Below in conjunction with the drawings and specific embodiments, the present invention is further described.
Principle of the present invention is whole blood according to human body (comprises blood cell, blood platelet, and blood plasma), can flow in a kind of capillary channel of special disposable test sheet.Solidify under the effect of the dry Activated Coagulation agent that blood is prefabricated in test pieces, when blood clotting process completes, capillary miniflow can stop.Blood starts to touch with reagent the time that blood miniflow stops and being the clotting time.In capillary channel, be coated with conductive filament be used for measuring fluid via impedance during microchannel over time.And then accurately determine the clotting time over time according to impedance.This is obtained by the time curve of tracking impedance variation.Use PT reagent as activator, make blood sample coagulation, and then follow the ISI calibration value according to agents useful for same the PT value measured to be normalized to INR value for monitoring warfarin dosage.Because whole blood impedance is large, unstable, the impedance readings error in capillary flow can be very large, 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, to reach sensitivity and the degree of accuracy of signal again by micro-bridge method.
See Fig. 1-Fig. 2, following all diagrams all just in order to set forth the part in the many designs of the present invention, and do not mean that the restriction scope of application of the present invention.
A portable blood coagulation measuring and analysing meter, in order to the whole blood to patient, especially takes the patient that warfarin carries out the treatment of oral anticoagulation thing and monitors.Fig. 1 shows the design of a test pieces in preferred embodiment, wherein 22 is main bodys of test pieces, made by hydrophilic plastic material, comprise a sample well 1 to be used for adding human whole blood sample, a reagent wells 2 is used for placing the reagent testing PT, article one, capillary channel 3 is to make sample due to capillarity flow ipe, article one, Quality Control capillary channel 6 pairs of samples do normalization or are used as the instant Quality Control of liquid, 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 capillary action causes liquid inflow pipe, electrode interface 7 inserts card by four pins to be connected to system hardware.The test pieces pipeline of a typical preferred embodiment as shown in Figure 2.This is the longitudinal section skeleton view of a test pieces 22, comprises and uses section tangent line to the virtual prolongation of capillary channel part.In Fig. 2 22 is main bodys of test pieces, and sample well 1 is placed in the initiating terminal of the test pieces of elongated shape, and the bottom of test pieces 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 caused by the pore 4 being positioned at test pieces 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 electric signal at electrode interface 7.Fig. 3 is the xsect of test pieces capillary channel part.As shown in Figure 3, the entirety of test pieces is made up of three layers of hydrophilic plastic material, wherein test pieces main body 22 by egative film 10 and upper slice form, the two is hydrophilic plastic sheeting, and centre is that capillary channel to be formed egative film and upper slice bonding by one deck 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 instrument of the present invention's most preferably one of example.In this case, shell 11, the LCDs 12 including a machine shows test results as to user, and can carry out some simple instruments behaviour according to the prompting of display screen and do option.13 is sockets 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 serial connection printer, " menu " key 17 is used for opening and closing the machine operation " menu " on display screen, 15 and 16 options representing the button what choice menus of "up" and "down" respectively, the switch of machine is by 18 " ON/OFF " key control, " OK " key 19 is used to receive option or continue next step operation, pilot lamp 20 identifies power supply status and warm-up mode, a radiator valve circuit is housed under heating plate 21 be used for heating and keep test pieces to be stabilized in the temperature pre-set, disposable test pieces is shown as 22 in the drawings, sample well is 1.
Our employing of impedance silk adopts screen printing silver method to plate dag thin layer on 3M egative film.Its advantage is that structure is good, and coating is stablized, and conducts electricity very well, easily does large-scale processing.
Host circuit board comprises with lower part: the 1) detecting head of image data, mainly comprises clock (oscillator), and resistance reads; 2) digital-to-analog conversion; 3) power supply supply; 4) dry sound control system is subtracted; 5) internal memory software package; 6) figure process and conversion software; 7) display screen; 8) operating key; 9) printer (user's option).
The present invention is end point values according to capillary miniflow and the performance graph that changes with Coagulation test of combined impedance, calculates the end point values in clotting time.Performance graph contains the blood coagulation overall process of whole blood sample, and identical with the analytical approach of traditional full-automatic optical method, thus degree of accuracy is high.Relative to the real impedance method of existing products in markets, only survey the absolute value change of impedance, the whole blood of people changes very little 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 amplified, highly sensitive in traditional electrode method.In addition, auxiliary miniflow contrast pipeline can provide again double circuit collector comparatively on the occasion of.Contrast pipeline wherein without reagent can provide different blood sample because of viscosity, erythrocyte sedimentation rate, the current difference that blood cell concentration difference causes, thus carries out weight normalization to the non-coagulation parameters impact between blood sample.
Claims (8)
1. a clotting time method for testing and analyzing, is characterized in that:
A test pieces (22) arranges the receiving cavity of blood sample and reagent, and the capillary channel (3) of band conductive layer (5);
Receiving cavity, conductive layer (5) three of blood sample and reagent are interconnected successively, after blood sample mixes with reagent, mixing material flows to capillary channel (3), along with the flowing of mixing material, the resistance of conductive layer (5) changes, and records the time needed for blood coagulation by the time point obtaining resistance stopping change.
2. clotting time method for testing and analyzing as claimed in claim 1, it is characterized in that: adopt the test pieces (22) of transparent insulation material to observe the position that blood stops flowing in capillary channel (3) intuitively, compared intuitively by the length of length to the clotting time of observing blood flow distance.
3. clotting time method for testing and analyzing as claimed in claim 1, is characterized in that: inner homogeneous coating one deck carbon dust conductive layer of described capillary channel (3), for conduction.
4. clotting time method for testing and analyzing as claimed in claim 1, is characterized in that: the electrode interface (7) described test pieces (22) being arranged instant plug, for inserting Test Host, promotes the portability of proving installation.
5. clotting time method for testing and analyzing as claimed in claim 1, is characterized in that: what described capillary channel (3) spiraled is arranged in test pieces (22), to reduce the volume of test pieces, improves portability.
6. clotting time method for testing and analyzing as claimed in claim 1, it is characterized in that: according to the end point values of capillary miniflow and the performance graph that changes with Coagulation test of combined impedance, calculate the end point values in clotting time, performance graph contains the blood coagulation overall process of whole blood sample, and then can be used for the mensuration of other coagulation parameters.
7. clotting time method for testing and analyzing as claimed in claim 1, it is characterized in that: Quality Control capillary channel (6) is also set in test pieces (22) as auxiliary miniflow contrast pipeline, auxiliary miniflow contrast pipeline can provide again double circuit collector comparatively on the occasion of, miniflow contrast pipeline wherein without reagent can provide different blood sample because of viscosity, erythrocyte sedimentation rate, the current difference that blood cell concentration difference causes, thus weight normalization is carried out on the non-coagulation parameters impact between blood sample.
8. clotting time method for testing and analyzing as claimed in claim 1, is characterized in that: at image data section in addition micro-electric bridge, use AC signal Wheatstone bridge method to amplify impedance variation, improve dynamic range and zero sensitivity of measurement data.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201511020456.5A CN105572397A (en) | 2015-12-30 | 2015-12-30 | Blood clotting time test analysis method |
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| CN201511020456.5A CN105572397A (en) | 2015-12-30 | 2015-12-30 | Blood clotting time test analysis method |
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| CN105572397A true CN105572397A (en) | 2016-05-11 |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| RU2669347C1 (en) * | 2017-06-27 | 2018-10-10 | Федеральное государственное бюджетное образовательное учреждение высшего образования "Тамбовский государственный технический университет" (ФГБОУ ВО "ТГТУ") | Method of determining functional state of the hemostasis system |
| CN109100394A (en) * | 2018-07-18 | 2018-12-28 | 浙江大学 | A kind of clotting time detector and its detection method |
| CN109211729A (en) * | 2018-10-29 | 2019-01-15 | 杨忠思 | A kind of blood stagnation condition checkout gear and method for precisely medical treatment detection |
| CN117741166A (en) * | 2024-02-19 | 2024-03-22 | 北京水木济衡生物技术有限公司 | Multi-project composite coagulation quality control product and preparation method thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1997882A (en) * | 2004-05-20 | 2007-07-11 | 因弗内斯医疗瑞士公司 | A device and method for detecting blood coagulation |
| CN205449864U (en) * | 2015-12-18 | 2016-08-10 | 上海奥普生物医药有限公司 | Clotting time test analytical equipment |
-
2015
- 2015-12-30 CN CN201511020456.5A patent/CN105572397A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1997882A (en) * | 2004-05-20 | 2007-07-11 | 因弗内斯医疗瑞士公司 | A device and method for detecting blood coagulation |
| CN205449864U (en) * | 2015-12-18 | 2016-08-10 | 上海奥普生物医药有限公司 | Clotting time test analytical equipment |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| RU2669347C1 (en) * | 2017-06-27 | 2018-10-10 | Федеральное государственное бюджетное образовательное учреждение высшего образования "Тамбовский государственный технический университет" (ФГБОУ ВО "ТГТУ") | Method of determining functional state of the hemostasis system |
| CN109100394A (en) * | 2018-07-18 | 2018-12-28 | 浙江大学 | A kind of clotting time detector and its detection method |
| CN109211729A (en) * | 2018-10-29 | 2019-01-15 | 杨忠思 | A kind of blood stagnation condition checkout gear and method for precisely medical treatment detection |
| CN117741166A (en) * | 2024-02-19 | 2024-03-22 | 北京水木济衡生物技术有限公司 | Multi-project composite coagulation quality control product and preparation method thereof |
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