CN115248318B - Detection method of blood coagulation analyzer - Google Patents

Detection method of blood coagulation analyzer Download PDF

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CN115248318B
CN115248318B CN202211153350.2A CN202211153350A CN115248318B CN 115248318 B CN115248318 B CN 115248318B CN 202211153350 A CN202211153350 A CN 202211153350A CN 115248318 B CN115248318 B CN 115248318B
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王霆
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Nanjing Yilanbei Biotechnology Co ltd
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Abstract

The invention belongs to the technical field of blood coagulation analyzers, and particularly relates to a detection method of a blood coagulation analyzer, which comprises the following steps: preparing a plasma sample, collecting venous blood into a clean blood tube with an anticoagulant, a fused quartz glass or plastic test tube, gently mixing the venous blood with the anticoagulant in the test tube, centrifuging at 3000rpm for 15 minutes, and collecting upper yellow plasma liquid; placing the cuvette into a detection hole, transferring the plasma into a blood coagulation cuvette, and then placing the magnetic rod into the blood coagulation cuvette; the stepping motor is started to drive the magnetic steel to do circular circulation motion, the magnetic rod is attracted to rotate through magnetic force, and therefore external power is transmitted to the inner rotor in a non-contact and non-friction mode, and stirring of blood plasma is achieved. The invention adopts a magnetic stirring mode, realizes stirring by realizing rotation of the self magnetism under the action of an external magnetic circuit, transmits external power to the internal rotor without contact and friction, and avoids damaging blood plasma generated by blood cells.

Description

Detection method of blood coagulation analyzer
Technical Field
The invention relates to the technical field of blood coagulation analyzers, in particular to a detection method of a blood coagulation analyzer.
Background
The blood coagulation analyzer is a conventional detection medical device which is used for clinically measuring the content of various components in human blood, quantifying the biochemical analysis result and providing a reliable digital basis for clinically diagnosing various diseases of patients. Four coagulation studies are common clinical trials investigating the involvement of extrinsic and intrinsic coagulation pathway factors. Mainly for diagnosing patients suspected of having a coagulation system pathology. Four blood coagulation items have been widely used at home and abroad in monitoring of oral anticoagulant therapy, monitoring of blood coagulation functions of operations, catheterization, dialysis and intensive care patients. Along with the development of clinical medicine, people's requirement to the blood coagulation analysis appearance also changes, and a commonality is strong, sensitivity is high, it is convenient to use, makes things convenient for the hospital to carry out blood coagulation monitoring at any time to deal with more and more needs of seeing a doctor.
In the measurement process of the blood coagulation instrument, the full stirring is vital, which is greatly helpful for the description of the blood coagulation process and the judgment of the coagulation end point, the purpose is achieved by common centrifugation in the existing instrument, the centrifugal force requirements of various detection items on blood samples are different, and different centrifugal forces have different influences on the separation of blood components; when the centrifugation is carried out at a low speed, plasma separation is insufficient, so that partial platelets in the plasma remain, and when the centrifugation speed is too high, hemolyzed plasma generated by blood cells can be damaged.
To this end, we propose a method of testing a coagulation analyzer to solve the above problems.
Disclosure of Invention
The invention aims to solve the defects in the prior art and provides a detection method of a blood coagulation analyzer.
In order to achieve the purpose, the invention adopts the following technical scheme:
a method of testing a coagulation analyzer, comprising the steps of:
s1, preparing a plasma sample, namely collecting venous blood into a clean blood tube with an anticoagulant, a fused quartz glass or plastic test tube, gently mixing the venous blood with the anticoagulant in the test tube, centrifuging at 3000rpm for 15 minutes, and collecting upper-layer yellow plasma liquid;
s2, placing the cuvette into a detection hole, transferring the plasma into a coagulation cuvette, and then placing the magnetic rod into the coagulation cuvette;
s3, turning on a stepping motor to drive the magnetic steel to do circular circulation motion, and attracting the magnetic rod to rotate through magnetic force, so that external power is transmitted to the inner rotor in a non-contact and non-friction mode, and plasma is stirred;
s4, selecting a reagent and a channel for detection by controlling the touch screen, and clicking a start button;
s5, parallelly irradiating the solution to be detected by a luminous source, absorbing a part of light source by the solution, transmitting the other part of light source to a photocell through the solution, converting light rays into current signals by the photocell, amplifying the current signals by an amplifying circuit of a processor, and monitoring the amplification factor; the data result of the amplified signal in step S5 shows: when the amplification factor is large, the light is weak, and the brightness of the light source is increased; when the magnification is small, the light intensity is indicated, and the brightness of the light source is reduced;
s6, finally displaying the amplified signal data obtained after system analysis and the result of the blood coagulation time on an LCD and printing paper;
the blood coagulation analyzer includes:
the analyzer structure comprises a coagulometer body, and a touch screen and a printer which are arranged at the upper end of the coagulometer body, wherein an edit box, a check box, a button box and an input panel are arranged in the touch screen, the edit box is used for inputting characters, the check box is used for selecting representative options, the input panel is used for inputting characters and numbers in each dialog box, a power switch, a dual-power adapter connector, a USB port and an ISP secret key are arranged on the side wall of the coagulometer body, which is far away from one side of a groove, a luminous source opposite to a photocell is arranged in the coagulometer body, a rotating light hole is arranged in the coagulometer body between the photocell and the luminous source, the aperture of the light hole is 1.5mm to 2.5mm, a central processing unit is arranged in the coagulometer body, the output end of the central processing unit is respectively connected with a reagent module, a test module and a result module, the reagent module, the test module and the result module are respectively connected with the touch screen, the reagent module is connected with the test module, a unit to be detected is arranged in the reagent module, and a reagent setting unit connected with the unit to be detected and used for adjusting parameters is also arranged in the reagent module; the test module is internally provided with a test unit for testing a sample, and the test module is also internally provided with an operation calibration unit which is connected with the test unit and is used for analyzing the sample; a result display unit is arranged in the result module, and a printing unit connected with a printer is also arranged in the result module;
magnetic structure, it is including setting up in the recess of coagulometer body upper end and connecting the sample frame in the recess, the equipartition is provided with a plurality of hatching positions in the recess of sample frame one side, the upper end of sample frame is provided with a plurality of samples that are used for placing the reaction cup and stores up the position groove, and the sample stores up and is equipped with the reaction cup packing ring that is used for fixed reaction cup on the position groove, be provided with the photocell that stores up the position groove with the sample on the lateral wall of sample frame and corresponds, the downside of sample frame is provided with the hot plate that is used for heating the sample, the downside of hot plate is provided with the tray, and the downside of tray is provided with the magnetic stirring unit of being connected with the reaction cup, the magnetic stirring unit is including setting up in the step motor of tray downside, step motor's drive shaft runs through the tray and is connected with the magnet steel, be provided with the magnon that corresponds with the magnet steel in the reaction cup, and the magnet steel attracts the rotation and play the effect of contactless stirring.
In the detection method of the coagulation analyzer, the temperature of an incubation position is ensured to be 36.9-37.1 ℃ when the coagulation analyzer is used, correct setting of a detection reagent is ensured, and sufficient amounts of a magnetic rod and a reaction cup are ensured.
In the detection method of the blood coagulation analyzer, in the step S5, a plurality of sets of experimental analyses are performed on the sample:
1. before the samples are stirred and mixed evenly by magnetic force, the turbid liquid with different contents is added into the samples to carry out a plurality of groups of experiments and obtain amplified signal data;
2. before the sample is stirred and mixed by magnetic force, turbid liquid with different concentrations is added into the sample, and light holes with different diameters are arranged at the front part of the reaction area, so that the influence of different light hole diameters on the signal reading capacity is obtained;
3. after the plasma sample of definite quantity is heated, the fib reagent is added, the magnetic stirring device is uniformly mixed, the light source irradiates the sample, a part of the light source penetrates through the solution and passes through the light holes to the photocell, the photocell converts light into an electric signal, and the data table and the CV value of the coagulation time, the AD signal reaction variable quantity and the read abnormal signal jumping quantity obtained by monitoring 3 blood samples penetrating through different light holes are monitored.
Compared with the prior art, the detection method of the blood coagulation analyzer has the advantages that:
1. the magnetic steel is driven by the stepping motor to circularly move in the reaction cup, and the magnetons are attracted to rotate by magnetic force, so that external power is transmitted to the inner rotor in a non-contact and non-friction manner, the stirring purpose is realized, and plasma generated by blood cells is prevented from being damaged.
2. According to the invention, the detection solution is analyzed through different light source currents, and an experimental result is obtained under the contrast of amplified signal data, so that the applicability of the device is improved, and the application range of the device is enlarged.
Drawings
FIG. 1 is a schematic external view of a method for detecting a blood coagulation analyzer according to the present invention;
FIG. 2 is a bottom view of a sample holder of the method for testing a blood coagulation analyzer according to the present invention;
FIG. 3 is a diagram of a structure of one side of a photocell of a sample rack in the detection method of a blood coagulation analyzer according to the present invention;
FIG. 4 is a disassembled structure diagram of a sample rack of a detection method of a blood coagulation analyzer according to the present invention;
FIG. 5 is a coagulation response graph of a detection method of a coagulation analyzer according to the present invention.
In the figure, 100 analyzer structure, 101 coagulometer body, 102 touch screen, 103 printer, 200 magnetic structure, 201 sample rack, 202 sample storage groove, 203 reaction cup gasket, 204 photocell, 205 heating plate, 206 tray, 207 stepping motor and 208 magnetic steel.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments.
Referring to fig. 1 to 4, a method for detecting a coagulation analyzer includes the steps of:
s1, preparing a plasma sample, namely collecting venous blood into a clean blood tube with an anticoagulant, fused quartz glass or a plastic test tube, gently mixing the venous blood with the anticoagulant in the test tube, centrifuging at 3000rpm for 15 minutes, and collecting upper-layer yellow plasma liquid;
s2, placing the cuvette into a detection hole, transferring the plasma into a blood coagulation cuvette, and then placing the magnetic rod into the blood coagulation cuvette;
s3, turning on the stepping motor 207, driving the magnetic steel 208 to do circular motion, and attracting the magnetic rod to rotate through magnetic force, so that external power is transmitted to the inner rotor in a non-contact and non-friction manner, and plasma is stirred;
s4, selecting a reagent and a channel for detection by controlling the touch screen, and clicking a start button;
s5, a luminous source irradiates the solution to be detected in parallel, the solution absorbs a part of light source, the other part of light source penetrates through the solution to a photocell, the photocell converts light into a current signal, the current signal is amplified by an amplifying circuit of a processor, and the amplification factor is monitored; the data result of the amplified signal in step S5 shows: when the amplification factor is large, the light is weak, and the brightness of the light source is increased; when the magnification is small, the light intensity is represented, and the brightness of the light source is reduced;
s6, finally displaying the amplified signal data obtained after system analysis and the result of the blood coagulation time on an LCD and printing paper;
the blood coagulation analyzer includes:
the analyzer structure 100 comprises a coagulometer body 101, and a touch screen 102 and a printer 103 which are arranged at the upper end of the coagulometer body 101, wherein an edit box, a check box, a button box and an input panel are arranged in the touch screen 102, the edit box is used for inputting characters, the check box is used for selecting representative options, the input panel is used for inputting characters and numbers in each dialog box, a power switch, a dual-power adapter connector, a USB port and an ISP key are arranged on the side wall of the coagulometer body 101, which is far away from one side of a groove, a luminous source opposite to a photocell 204 is arranged in the coagulometer body 101, a rotating light hole is arranged in the coagulometer body 101 between the photocell 204 and the luminous source, the aperture of the light hole is 1.5mm to 2.5mm, a central processing unit is arranged in the coagulometer body 101, the output end of the central processing unit is respectively connected with a reagent module, a test module and a result module, the reagent module, the test module and the result module are respectively connected with the touch screen, the reagent module is connected with the test module, a unit is arranged in the reagent module, and a unit to be detected is also arranged in the reagent module; the test module is internally provided with a test unit for testing a sample, and the test module is also internally provided with an operation calibration unit which is connected with the test unit and is used for analyzing the sample; a result display unit is arranged in the result module, and a printing unit connected with the printer 103 is also arranged in the result module;
magnetic structure 200, it is including setting up in the recess of coagulometer body 101 upper end and connecting the sample frame 201 in the recess, the equipartition is provided with a plurality of hatching positions in the recess of sample frame 201 one side, the upper end of sample frame 201 is provided with a plurality of sample storage tank 202 that are used for placing the reaction cup, and be equipped with the reaction cup packing ring 203 that is used for fixed reaction cup on the sample storage tank, be provided with the photocell 204 that corresponds with sample storage tank 202 on the lateral wall of sample frame 201, the downside of sample frame 201 is provided with the hot plate 205 that is used for heating the sample, the downside of hot plate 205 is provided with tray 206, and the downside of tray 206 is provided with the magnetic stirring unit who is connected with the reaction cup, the magnetic stirring unit is including setting up step motor 207 in tray 206 downside, step motor's 207 drive shaft runs through tray 206 and is connected with magnet steel 208, be provided with the magnet that corresponds with magnet steel 208 in the reaction cup, and magnet steel 208 attracts the magnet rotatory and plays contactless stirring's effect.
When the blood coagulation analyzer is used, the temperature of an incubation position is ensured to be 36.9-37.1 ℃, and the correct setting of a detection reagent and the sufficient quantity of a magnetic rod and a reaction cup are ensured.
Wherein, in the steps S5 and S6, a plurality of groups of experimental analyses are respectively carried out on the samples:
before the samples are stirred and mixed by magnetic force, the turbid liquid with different concentrations is added into the samples to carry out a plurality of groups of experiments, so that the detection capability of the light source self-adaptive control circuit on the samples with different concentrations is obtained, and the experimental data of the amplification factor/AD signal is obtained;
specific experimental data:
Figure 326534DEST_PATH_IMAGE002
the method comprises the following specific operation steps:
1) Adding the turbid solution to the sample;
2) Irradiating a luminous source on the solution to be detected, absorbing a part of light source by the solution, transmitting the other part of light source to a photocell through the solution, converting light rays into current signals by the photocell, monitoring and amplifying the signals, and recording the signals in a table 1;
note: "
Figure 243675DEST_PATH_IMAGE003
"indicates that the signal value exceeds the reading range of the AD chip because the light source intensity is higher;
before the sample is stirred and mixed by magnetic force, turbid liquid with different concentrations is added into the sample, and light holes with different diameters are arranged at the front part of the reaction area, so that the influence of different light hole diameters on the signal reading capacity is obtained;
Figure 554570DEST_PATH_IMAGE005
Figure DEST_PATH_IMAGE007
the method comprises the following specific operation steps:
1) Adding the turbid solution to the sample;
2) Irradiating a luminous source on the solution to be detected, absorbing a part of light source by the solution, transmitting the other part of light source to a photocell through the solution, converting light rays into current signals by the photocell, monitoring and amplifying the signals, and recording the signals in tables 2 and 3;
note: "
Figure 356304DEST_PATH_IMAGE003
"indicates that the signal value exceeds the reading range of the AD chip because the light source intensity is higher;
and (4) conclusion: the small light hole shields the light source to a certain extent, so that the rear-end analog circuit has to obtain an effective signal value by increasing the amplification factor. Meanwhile, a higher signal amplification factor also brings about amplification of noise, which affects reading of effective signals.
After a certain amount of plasma sample is heated, an FIB reagent is added, a magnetic stirring device is used for uniformly mixing, a light source irradiates the sample, a part of the light source penetrates through the solution and passes through a light hole to a photocell, the photocell converts light into an electric signal, and a solidification curve is read. Through FIB project actual measurement, the experimental data that the rear-end analog amplification circuit can control the background noise at a reasonable level after being matched with the light source self-adaptive adjusting circuit, the solidification time/AD signal reaction variable quantity/read abnormal signal jumping quantity obtained by monitoring 3 samples are obtained, and CV values are compared;
specific experimental data:
Figure DEST_PATH_IMAGE008
Figure DEST_PATH_IMAGE009
and (4) conclusion: the technical standard YY/T0659-2017 of the blood coagulation analyzer is that FIB precision CV of the semi-automatic blood coagulation analyzer is less than 10%, through the analysis of the experimental data, the interference of background noise on signal reading is effectively reduced due to the addition of the light source self-adaptive adjusting circuit, and meanwhile, the experimental data show that signals are more stable under a 2.5mm light hole.
In addition, the coagulation analyzer also provides a coagulation method for coagulation analysis, and the method comprises the following specific steps: adding a reagent to a sample to be tested, then illuminating the mixture by light emitted from a light emitting source, and detecting turbidity of the sample during coagulation by a change in transmitted light intensity, wherein the AD value is unchanged at the beginning of the coagulation reaction because the sample is not coagulated, referring to FIG. 5; when the coagulation starts, the AD value starts to decrease, and at the end of the coagulation reaction, the AD value becomes stable again; the starting point of the coagulation reaction is defined as 0%; the end point of the coagulation reaction is defined as 100% and the point of 50% is defined as the coagulation time, which shows the greatest change and the fibrin monomer polymerization rate.
The above description is only for the preferred embodiment of the present invention, but the scope of the present invention is not limited thereto, and any person skilled in the art should be considered to be within the technical scope of the present invention, and the technical solutions and the inventive concepts thereof according to the present invention should be equivalent or changed within the scope of the present invention.

Claims (3)

1. A detection method of a blood coagulation analyzer is characterized by comprising the following steps:
s1, preparing a plasma sample, namely collecting venous blood into a clean blood tube with an anticoagulant, a fused quartz glass or plastic test tube, gently mixing the venous blood with the anticoagulant in the test tube, centrifuging at 3000rpm for 15 minutes, and collecting upper-layer yellow plasma liquid;
s2, placing the cuvette into a detection hole, transferring the plasma into a blood coagulation cuvette, and then placing the magnetic rod into the blood coagulation cuvette;
s3, turning on a stepping motor (207), driving the magnetic steel (208) to do circular motion, and attracting the magnetic rod to rotate through magnetic force, so that external power is transmitted to the inner rotor in a non-contact and non-friction mode, and plasma is stirred;
s4, selecting a reagent and a channel for detection by controlling the touch screen, and clicking a start button;
s5, parallelly irradiating the solution to be detected by a luminous source, absorbing a part of light source by the solution, transmitting the other part of light source to a photocell through the solution, converting light rays into current signals by the photocell, amplifying the current signals by an amplifying circuit of a processor, and monitoring the amplification factor; the data result of the amplified signal in step S5 shows: when the amplification factor is large, the light is weak, and the brightness of the light source is increased; when the magnification is small, the light intensity is represented, and the brightness of the light source is reduced;
s6, finally displaying the amplified signal data obtained after system analysis and the result of the blood coagulation time on an LCD and printing paper;
the coagulation analyzer includes:
the analyzer structure (100) comprises a coagulometer body (101), and a touch screen (102) and a printer (103) which are arranged at the upper end of the coagulometer body (101), wherein an edit box, a check box, a button box and an input panel are arranged in the touch screen (102), the edit box is used for inputting characters, the check box is used for selecting representative options, the input panel is used for inputting characters and numbers in each dialog box, a side wall of the coagulometer body (101) far away from one side of a groove is provided with a power switch, a dual-power adapter connector, a USB port and an ISP secret key, a luminous source opposite to a photocell (204) is arranged in the coagulometer body (101), a rotating light hole is arranged in the coagulometer body (101) between the photocell (204) and the luminous source, the aperture of the light hole is 1.5mm to 2.5mm, a central processing unit is arranged in the coagulometer body (101), the output end of the central processing unit is respectively connected with a reagent module, a test module and a result module, the reagent module are respectively connected with the touch screen, the test module is connected with a reagent adjusting unit, and a to-be-detected parameter adjusting unit is arranged in the reagent module; the test module is internally provided with a test unit for testing a sample, and the test module is also internally provided with an operation calibration unit which is connected with the test unit and is used for analyzing the sample; a result display unit is arranged in the result module, and a printing unit connected with a printer (103) is also arranged in the result module;
magnetic structure (200), it is including setting up in recess and the sample frame (201) of connection in the recess of coagulometer body (101) upper end, the equipartition is provided with a plurality of hatching positions in the recess of sample frame (201) one side, the upper end of sample frame (201) is provided with a plurality of sample storage tank (202) that are used for placing the reaction cup, and is equipped with reaction cup packing ring (203) that are used for fixed reaction cup on the sample storage tank, be provided with photocell (204) that correspond with sample storage tank (202) on the lateral wall of sample frame (201), the downside of sample frame (201) is provided with hot plate (205) that are used for heating the sample, the downside of hot plate (205) is provided with tray (206), and the downside of tray (206) is provided with the magnetic stirring unit who is connected with the reaction cup, the magnetic stirring unit is including setting up in step motor (207) of tray (206) downside, the drive shaft of step motor (207) runs through tray (206) and is connected with magnet steel (208), be provided with the magnon the reaction cup corresponding magnon, and (208) contact the magnet rotation and play the effect of no stirring of attracting magnet.
2. The method for detecting the blood coagulation analyzer according to claim 1, wherein the blood coagulation analyzer ensures that the temperature of the hatching position is 36.9-37.1 ℃ in use, the setting of the inspection reagent is correct, and the quantity of the magnetic rod and the reaction cup is sufficient.
3. The method for detecting a blood coagulation analyzer according to claim 1, wherein the samples are respectively subjected to a plurality of sets of experimental analyses in step S5:
1. before the samples are stirred and mixed evenly by magnetic force, the turbid liquid with different contents is added into the samples to carry out a plurality of groups of experiments and obtain amplified signal data;
2. adding turbid liquid with different concentrations into a sample before uniformly stirring and mixing the sample by magnetic force, and installing light holes with different diameters at the front part of a reaction area to obtain the influence of different light hole diameters on the signal reading capacity;
3. after a plasma sample with a certain amount is heated, a fib reagent is added, a magnetic stirring device is uniformly mixed, a luminous source irradiates the sample, a part of the luminous source penetrates through the solution and passes through a light hole to a photocell, the photocell converts light into an electric signal, and the coagulation time, the AD signal reaction variation starting to ending, and a data table and a CV value of read abnormal signal jumping quantity obtained by 3 blood samples penetrating through different light holes are monitored.
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