CN108614017B - Prothrombin time detection method and device - Google Patents
Prothrombin time detection method and device Download PDFInfo
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- CN108614017B CN108614017B CN201611131978.7A CN201611131978A CN108614017B CN 108614017 B CN108614017 B CN 108614017B CN 201611131978 A CN201611131978 A CN 201611131978A CN 108614017 B CN108614017 B CN 108614017B
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Abstract
The invention belongs to the field of medical treatment, and discloses a prothrombin time PT detection method and a prothrombin time PT detection device. The method comprises the following steps: the blood sample generates a coagulation reaction under the action of the dry reagent to generate an oxidation current; generating a current-time curve of the oxidation current along with the change of time; acquiring a plurality of characteristic points on the processed current-time curve; and calculating and outputting a prothrombin time PT value according to the plurality of characteristic points. By smoothing the detection current, the signal-to-noise ratio of the detection current is improved, so that the influence of current noise on the accuracy and reliability of prothrombin time detection is avoided, and the accuracy of a test result is improved; in addition, the accuracy of the test result is further improved by acquiring a plurality of characteristic points on the processed current-time curve and calculating the prothrombin time PT value according to the plurality of characteristic points.
Description
Technical Field
The invention relates to the field of medical treatment, in particular to a prothrombin time PT detection method and a prothrombin time PT detection device.
Background
Many patients with cardiovascular diseases (e.g., venous thromboembolic disease, thromboembolism in atrial fibrillation, valvular disease, prosthetic valve replacement, and intracardiac thrombosis) require long-term administration of warfarin for anticoagulant therapy. However, excessive warfarin causes more than one bleeding, and too little warfarin affects its anti-thromboembolic effect, possibly leading to serious consequences of a heart attack or stroke. Therefore, the coagulation function of patients taking warfarin must be monitored regularly. Monitoring of existing anticoagulant therapy is typically accomplished by measuring the Prothrombin Time (PT) of the patient.
There are various methods for detecting PT, including optical methods, electrical impedance methods, magnetic bead methods, electrochemical methods, and the like. The first three methods monitor the optical characteristics, electrical impedance characteristics and the movement characteristics of the magnetic beads in the blood sample during the coagulation process to determine the formation of blood clots and obtain the coagulation time. The electrochemical method is to monitor the release of thrombin during the coagulation process to interpret PT.
The electrochemical method has the advantages of suitability for whole blood, simple equipment, reliable measurement and particular suitability for point-of-care testing (POCT). But the detected reaction signal may have noise due to various interferences, thereby affecting the detection precision and reliability of prothrombin time and causing inaccuracy of the test result; in addition, in the above detection process, the prothrombin time is usually calculated by collecting a single feature point on the detection current, and in the case that there is a possible error in the single feature point, the inaccuracy of the measurement result is also caused.
Disclosure of Invention
In order to avoid the influence of noise on the detection precision of the prothrombin time and improve the accuracy of a test result, the embodiment of the invention provides a method and a device for detecting the prothrombin time PT. The technical scheme is as follows:
in a first aspect, there is provided a method for detecting prothrombin time, the method comprising:
the blood sample generates a coagulation reaction under the action of the dry reagent to generate an oxidation current;
generating a current-time curve of the oxidation current over time;
acquiring a plurality of characteristic points on the processed current-time curve;
and calculating and outputting a prothrombin time PT value according to the plurality of characteristic points.
Preferably, the current-time curve is a smoothed current-time curve;
the smoothing process includes:
sampling the current-time curve according to a preset time interval to obtain n points;
when processing the jth point on the current-time curve, acquiring k points before and after the jth point, wherein the total number of the k points is 2k + 1;
calculating the average value and the standard deviation of the 2k +1 point current values;
calculating the difference value between the current value of each point in the 2k +1 points and the average value;
deleting the current value of a point corresponding to the difference value of the 2k +1 points, wherein the difference value is more than three times of the standard variance, and calculating the average value of the current values of the remaining points, wherein the average value of the current values of the remaining points is the current value of the smoothed jth point;
and continuing to process the j +1 th point until all the n points on the current-time curve are processed.
In a second aspect, there is provided a prothrombin time PT detection device, the device comprising:
a current detection module for detecting an oxidation current generated by the blood sample undergoing a coagulation reaction under the action of the dry reagent, whereby the released oxidizable substance is oxidized by the DC voltage applied to the working electrode;
the signal generation module is used for generating a current-time curve of the oxidation current along with the change of time;
a characteristic point acquisition module for acquiring a plurality of characteristic points on the processed current-time curve;
and the calculating module is used for calculating and outputting the prothrombin time PT value according to the plurality of characteristic points.
The data storage module is used for storing the current-time curve, the plurality of characteristic points, the PT value, the test strip batch number, the test date and time;
and the user interface module is used for displaying the PT value.
Preferably, the current-time curve is a smoothed current-time curve;
the signal processing module is specifically configured to:
sampling the current-time curve according to a preset time interval to obtain n points;
when processing the jth point on the current-time curve, acquiring k points before and after the jth point, wherein the total number of the k points is 2k + 1;
calculating the average value and the standard deviation of the 2k +1 point current values;
calculating the difference value between the current value of each point in the 2k +1 points and the average value;
deleting the current value of a point corresponding to the difference value of the 2k +1 points, wherein the difference value is more than three times of the standard variance, and calculating the average value of the current values of the remaining points, wherein the average value of the current values of the remaining points is the current value of the smoothed jth point;
and continuing to process the j +1 th point until all the n points on the current-time curve are processed.
In a third aspect, there is provided a prothrombin time PT detection apparatus, the apparatus comprising a memory and a processor coupled to the memory, the memory for storing a set of program codes, the processor invoking the codes stored in the memory for performing the following operations:
the blood sample generates a coagulation reaction under the action of the dry reagent to generate an oxidation current;
generating a current-time curve of the oxidation current over time;
acquiring a plurality of characteristic points on the processed current-time curve;
and calculating and outputting a prothrombin time PT value according to the plurality of characteristic points.
Preferably, the current-time curve is a smoothed current-time curve;
the processor calls the code stored by the memory to perform the following operations:
sampling the current-time curve according to a preset time interval to obtain n points;
when processing the jth point on the current-time curve, acquiring k points before and after the jth point, wherein the total number of the k points is 2k + 1;
calculating the average value and the standard deviation of the 2k +1 point current values;
calculating the difference value between the current value of each point in the 2k +1 points and the average value;
deleting the current value of a point corresponding to the difference value of the 2k +1 points, wherein the difference value is more than three times of the standard variance, and calculating the average value of the current values of the remaining points, wherein the average value of the current values of the remaining points is the current value of the smoothed jth point;
and continuing to process the j +1 th point until all the n points on the current-time curve are processed.
The embodiment of the invention provides a prothrombin time detection method and a prothrombin time detection device, which comprise the following steps: the blood sample generates a coagulation reaction under the action of the dry reagent to generate an oxidation current; generating a current-time curve of the oxidation current along with the change of time; acquiring a plurality of characteristic points on the processed current-time curve; and calculating and outputting a prothrombin time PT value according to the plurality of characteristic points. By smoothing the detection current, the signal-to-noise ratio of the detection current is improved, so that the influence of current noise on the detection precision of the prothrombin time is avoided, and the accuracy of a test result is improved; in addition, by acquiring a plurality of characteristic points on the processed detection current and calculating the prothrombin time PT value according to the plurality of characteristic points, compared with the method for calculating the prothrombin time PT value through a single characteristic point, the accuracy of the test result is further improved.
The present invention is important for the selection of the feature points. The calculated value in the prior art is generally calculated based on the median value of the current values. Such calculation methods have been used for a long time. However, in some incidental cases, the inventors have discovered that there are problems with the test strips from batch to batch, which can result in inaccurate or non-displayed readings. Also, problems such as differences in the uniformity of reagent attachment or the presence of impurities between different test strips have been associated with problems with reproducibility.
Since the reproducibility problem is usually caused by the sensor system, in order to improve the reproducibility, researchers often make improvements from factors affecting the sensor system, for example, improving the reagent addition process, improving the uniformity of the film, and the like, thereby improving the reproducibility of the test strip. However, such improvements generally require a significant investment and the cost of manufacturing the test strip is significantly increased.
The inventor finds out a new way that the PT zymogen reaction system is suitable for the reaction curve of the PT zymogen reaction system, and the difficult problem which troubles the field can be improved by improving the value calculation. Through the personalized research on the reaction of the reagent system and the current curve thereof, the inventor finds that the value calculation is carried out on three characteristic points at the same time, and a relatively satisfactory stable result can be obtained even under the condition that the conditions of a batch of test strips are not satisfactory. That is, only by improving the calculation method or software, the harsh requirement of the consumable manufacturing process with huge consumption, such as the test strip, can be removed, so that the manufacturing cost of the test strip can be saved on the basis of improving the accuracy of the test result.
In a preferred embodiment, t is usedminI、tmaxI、tmaxSlopeThe three powers are given by the formula PT ═ tminI+tmaxI+tmaxSlope) And/3, the calculated value of the point taking mode can weaken the problem of reproducibility caused by the heterogeneity of the PT detection test strip. For example, in one embodiment, the CV for a batch of test strips tested by the method of the present invention can be reduced to 4.5%.
In order to further weaken the influence of problematic test strips and improve the accuracy of test results, the invention further smoothes the current-time curve before value taking. Through such processing, the influence of defects on some test strips with problems, such as some test strips which generate unreliable values under the traditional calculation method due to various sensing system defects, can be greatly weakened. For example, in one embodiment of a problematic test strip, the curves before and after smoothing according to the present invention are shown in FIGS. 3a and 3b, respectively. In another example of a problematic strip, the curves before and after smoothing according to the present invention are shown in FIGS. 4a and 4b, respectively.
In the two cases of the problem test strip, the traditional intermediate value calculation method is adopted to compare with the three-point value calculation method after the smoothing treatment, and the comparison result is shown in the following table 1.
TABLE 1 test results on problem test strips
Therefore, even for some problematic test strips which are inevitable for each batch of test strips, the method can weaken the adverse effects of the problematic test strips, so that relatively reliable results can be obtained under the adverse conditions, thereby reducing wrong results, improving the accuracy of test results, and bringing better guarantee to a person to be tested, which is very important for patients.
Drawings
In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings needed to be used in the description of the embodiments will be briefly introduced below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and it is obvious for those skilled in the art to obtain other drawings based on these drawings without creative efforts.
FIG. 1 is a schematic flow chart of a method for detecting the prothrombin time PT according to an embodiment of the present invention;
FIG. 2 is a schematic structural diagram of a prothrombin time PT detection device provided by an embodiment of the invention;
FIG. 3a is a schematic diagram of a raw detected current-time curve according to an embodiment of the present invention;
FIG. 3b is a graph illustrating the raw sensed current-time curve of FIG. 3a after smoothing;
FIG. 4a is a schematic diagram of another raw detected current-time curve provided by an embodiment of the present invention;
FIG. 4b is a graph illustrating the original sensed current-time curve of FIG. 4a after smoothing;
fig. 5 is a diagram illustrating some characteristic points on a current-time curve provided by an embodiment of the present invention.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying 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. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
The embodiment of the invention provides a method for detecting prothrombin time PT, which is applied to the detection of blood coagulation function and the monitoring of the medication of an anticoagulant drug warfarin. By smoothing the detection current, the signal-to-noise ratio of the detection current is improved, so that the influence of current noise on the detection precision of the prothrombin time is avoided, and the accuracy of a test result is improved; in addition, by acquiring a plurality of characteristic points on the processed detection current and calculating the prothrombin time PT value according to the plurality of characteristic points, compared with the method for calculating the prothrombin time PT value through a single characteristic point, the accuracy of the test result is further improved. In addition, it should be noted that the oxidation current according to the embodiment of the present invention is generated by the blood sample undergoing a coagulation reaction under the action of the dry reagent, and the oxidizable substance thus released is oxidized by the dc voltage applied to the working electrode.
Example one
Fig. 1 is a schematic flow chart of a method for detecting prothrombin time PT according to an embodiment of the present invention, and as shown in fig. 1, the method includes:
101. the blood sample undergoes a coagulation reaction under the action of the dry reagent, whereby the released oxidizable substance is oxidized by the direct voltage applied to the working electrode to generate an oxidation current, which is detected in this process and can be referred to as the original reaction current.
102. Smoothing the current-time curve of the oxidation current changing along with time obtained in the step 101 to generate a processed current-time curve;
optionally, the smoothing process includes:
sampling the current-time curve according to a preset time interval to obtain n points; the specific preset time interval is not limited in the embodiment of the present invention.
When processing the jth point on the current-time curve, acquiring k points before and after the jth point, wherein the total number of the k points is 2k + 1;
calculating the average value and standard deviation of the current values of 2k +1 points;
calculating the difference value between the value of each point current value in the 2k +1 points and the average value;
deleting the current value corresponding to the difference value of 2k +1 points which is more than three times of the standard variance, and calculating the average value of the current values of the remaining points, wherein the average value of the current values of the remaining points is the current value of the jth point after smoothing;
and continuing to process the j +1 th point until all the n points on the current-time curve are processed.
For example, to further illustrate the method according to the embodiment of the present invention, taking five-point smoothing as an example, first skip the first and second points, and start from the third point, that is, k is 2.
Firstly, calculating an average value A of current values of first to fifth points;
secondly, calculating the average variance SD of the current values of the first point to the fifth point;
thirdly, calculating the deviation d of the value of the current value and the average value of each point;
fourthly, judging whether the deviation d is larger than 3SD, if not, the average value A is the current value of the third point after smoothing; if so, eliminating the point, and recalculating the average value of the remaining data points, wherein the new average value is the current value after the third point is smoothed.
And fifthly, repeating the steps to smooth the fourth point.
103. A plurality of feature points on the processed current-time curve are acquired.
Specifically, the plurality of characteristic points at least include the corresponding time value t with the minimum current value on the processed current-time curveminIAnd the time value t corresponding to the point with the maximum current value on the processed current-time curvemaxIAnd the maximum slope point of the processed current-time curve corresponds toTime value t ofmaxSlope。
104. And calculating and outputting a prothrombin time PT value according to the plurality of characteristic points.
Specifically, calculating a PT value by three characteristic points through a preset formula;
optionally, the preset formula includes:
PT＝(tminI+tmaxI+tmaxSlope)/3。
besides, the preset formula can also be:
PT＝(a*tminI+b*tmaxI+c*tmaxSlope)/[3*(a+b+c)]wherein a, b, and c are weighting coefficients, respectively, and the specific numerical values of the weighting coefficients are not limited in the embodiment of the present invention.
In summary, the method flows provided in the above steps 101 to 104 can be understood as a: detection of original reaction current, B: smoothing treatment and C: obtaining a characteristic point, D: four processes for calculating the PT value correspond to steps 101, 102, 103 and 104.
The method provided by the embodiment of the invention comprises the following steps: the method comprises the steps of current detection, smoothing of a current-time curve of current changing along with time, obtaining of a plurality of characteristic points on the processed current-time curve, calculation and output of a prothrombin time PT value according to the characteristic points, and smoothing of the detected current, so that the signal-to-noise ratio of the detected current is improved, the influence of current noise on the prothrombin time detection precision is avoided, and the accuracy of a test result is improved; in addition, by acquiring a plurality of characteristic points on the processed detection current and calculating the prothrombin time PT value according to the plurality of characteristic points, compared with the method for calculating the prothrombin time PT value through a single characteristic point, the accuracy of the test result is further improved.
Example two
Fig. 2 is a schematic structural diagram of a prothrombin time PT detection device provided in an embodiment of the present invention. Referring to fig. 2, the detector includes: a reaction current detection module 21, a data processing module 22, a user interface module 23 and a central control module 24.
Specifically, the reaction current detection module 21 is used to detect an oxidation current generated by the blood sample undergoing a coagulation reaction under the action of the dry reagent, whereby the released oxidizable substance is oxidized by the direct current voltage applied to the working electrode. The specific operation steps are as follows: a DC voltage is applied between the working electrode and the reference electrode, and the oxidation current generated at the working electrode is detected. Here, the dc voltage is provided by a dc voltage source circuit, typically several tens of millivolts to several hundreds of millivolts, such as 100 mv. The oxidation current is completed by a micro-current detection circuit, the sensitivity is very high, and the current of several nA can be measured.
The data processing module 22 is mainly used for implementing data processing, data storage and data transmission functions, and specifically includes a signal processing module, a feature point obtaining module, a calculating module, a data storage module and a data transmission module.
Specifically, the signal processing module is configured to perform smoothing processing on a current-time curve of the detected oxidation current changing with time, and generate a processed current-time curve. The calculation module is used for calculating and outputting a prothrombin time PT value according to the plurality of characteristic points; and the data storage module is used for storing the current-time curve, a plurality of characteristic points, the PT value and relevant data.
Preferably, the signal processing module comprises the following processing steps:
sampling the current-time curve according to a preset time interval to obtain n points; the specific preset time interval is not limited in the embodiment of the present invention.
When processing the jth point on the current-time curve, acquiring k points before and after the jth point, wherein the total number of the k points is 2k + 1;
calculating the average value and standard deviation of the current values of 2k +1 points;
calculating the difference value between the value of each point current value in the 2k +1 points and the average value;
deleting the current value corresponding to the difference value of 2k +1 points which is more than three times of the standard variance, and calculating the average value of the current values of the remaining points, wherein the average value of the current values of the remaining points is the current value of the jth point after smoothing;
and continuing to process the j +1 th point until all the n points on the current-time curve are processed.
FIG. 3a is a graph showing a response current raw curve, which is not smooth enough due to various noises. Fig. 3b shows the curve after the smoothing process, it is clear that the curve after the process is much smoother than before the process.
Fig. 4a is a graph of the response current of the present system in an electrical fast transient burst (EFT) environment, and fig. 4b is a graph of the response current after smoothing.
And the characteristic point acquisition module is used for acquiring a plurality of characteristic points on the processed current-time curve. Preferably, the plurality of characteristic points at least include the time value t corresponding to the point on the processed current-time curve where the current value is the smallestminIAnd the time value t corresponding to the point with the maximum current value on the processed current-time curvemaxIAnd the time value t corresponding to the maximum slope point of the processed current-time curvemaxSlope。
Optionally, the step of acquiring the feature points by the feature point acquisition module may be performed as follows: starting from the starting point of the smoothed current curve, the minimum point and the maximum point of the current value are firstly found out by a method of comparing two adjacent points one by one. Then, the slope of each point of the current curve is calculated, and the algorithm may have different methods, for example, calculating the difference between two points before and after the point, or calculating the slope of the point by linear regression between the point and one point before and after the point, or between two points, or between three points (the total number of three points, five points, or seven points, respectively) or more points. And finally, finding out the maximum slope point of the current curve by a method of comparing two adjacent points one by one. Fig. 5 shows the positions of the above three characteristic points on the reaction curve.
And the calculation module is used for calculating and outputting the prothrombin time PT value according to the plurality of characteristic points. Specifically, the prothrombin time PT is calculated from the above three characteristic points by an empirical formula, and for example, the formula PT ═ (t) is preferably usedminI+tmaxI+tmaxSlope) Calculating; or the respective time values may be weighted averaged：PT＝(a*tminI+b*tmaxI+c*tmaxSlope)/[3*(a+b+c)]。
The data storage module is used for storing a current-time curve, a plurality of characteristic points, a PT value, a test strip batch number, test date and time, and can also store patient information and operator information, and the embodiment of the invention is not limited.
The user interface module 23 is used for displaying the test results, related data and inputting related instructions. Optionally, the user interface module 23 may include buttons and a display screen, for example, buttons for setting up instruments and playing back test results.
Optionally, the user interface module 23 is further configured to display the detection date and time, and in addition, may display the test strip batch number, the test date and time, and store the patient information and the operator information.
The central control Module (MCU)24 is used to control the corresponding operations of the reaction current detection module 21, the data processing module 22, the user interface module 23, etc. of the detector.
In addition, it should be noted that there are various reasons for various noises appearing on the reaction current raw curve, and the occurrence of the problem on the test strip according to the present invention is merely exemplary, and is not specific herein in order to further illustrate that the method provided by the present invention can avoid the influence on the test result due to the problem on the test strip. The method provided by the embodiment of the invention can also solve the problem of noise sites appearing in the original curve of the reaction current due to other reasons, and the embodiment of the invention does not limit the specific noise sites.
The embodiment of the invention provides a prothrombin time detection device, which improves the signal-to-noise ratio of detection current by smoothing the detection current, thereby avoiding the influence of current noise on the prothrombin time detection precision and improving the accuracy of a test result; in addition, by acquiring a plurality of characteristic points on the processed detection current and calculating the prothrombin time PT value according to the plurality of characteristic points, compared with the method for calculating the prothrombin time PT value through a single characteristic point, the accuracy of the test result is further improved.
EXAMPLE III
The embodiment of the invention provides a prothrombin time PT detection device, which comprises a memory and a processor connected with the memory, wherein the memory is used for storing a group of program codes, and the processor calls the codes stored in the memory to execute the following operations:
smoothing the current-time curve of the oxidation current along with the change of time to generate a processed current-time curve; wherein the oxidation current is generated by the blood sample undergoing a coagulation reaction under the action of the dry reagent, whereby the released oxidizable substance is oxidized by the direct voltage applied to the working electrode;
acquiring a plurality of characteristic points on the processed current-time curve;
and calculating and outputting a prothrombin time PT value according to the plurality of characteristic points.
The apparatus according to the embodiment of the present invention is specifically configured to implement the method according to the embodiment of the present invention.
The embodiment of the invention provides a prothrombin time detection device, which improves the signal-to-noise ratio of detection current by smoothing the detection current, thereby avoiding the influence of current noise on the prothrombin time detection precision and improving the accuracy of a test result; in addition, by acquiring a plurality of characteristic points on the processed detection current and calculating the prothrombin time PT value according to the plurality of characteristic points, compared with the method for calculating the prothrombin time PT value through a single characteristic point, the accuracy of the test result is further improved.
In summary, the embodiments of the present invention provide a method and a device for detecting prothrombin time, including: performing a blood coagulation reaction on the blood sample under the action of the dry reagent, and smoothing a current-time curve of oxidation current, which is generated by oxidizing the released oxidizable substance by the direct-current voltage applied to the working electrode and changes along with time, to generate a processed current-time curve; acquiring a plurality of characteristic points on the processed current-time curve; and calculating and outputting a prothrombin time PT value according to the plurality of characteristic points. By smoothing the detection current, the signal-to-noise ratio of the detection current is improved, so that the influence of current noise on the detection precision of the prothrombin time is avoided, and the accuracy of a test result is improved; in addition, by acquiring a plurality of characteristic points on the processed detection current and calculating the prothrombin time PT value according to the plurality of characteristic points, compared with the method for calculating the prothrombin time PT value through a single characteristic point, the accuracy of the test result is further improved. For example, in one experiment, 20 test cards were used to test the same quality control plasma, with a repeatability (CV) of 5.0% to 5.6% for each of the three characteristic points and a CV of 4.5% for the combination of the three characteristic points.
It can be known from the comparison results of fig. 3a and 3b, the comparison results of fig. 4a and 4b, and the comparison results of table 1 that the method and the device provided by the embodiment of the present invention effectively avoid the influence of noise on the accuracy of the detection result, further avoid repeated detection, improve the detection efficiency, and save the manufacturing cost of the test strip in the scene that various noises occur due to various reasons of the original curve of the reaction current, especially when the test strip has a problem.
It should be noted that: in the prothrombin time detecting device provided in the above embodiment, when the prothrombin time detecting method is executed, only the division of the above functional modules is taken as an example, in practical application, the above function distribution can be completed by different functional modules according to needs, that is, the internal structure of the device is divided into different functional modules to complete all or part of the above described functions. In addition, the embodiments of the prothrombin time detection method and the prothrombin time detection device provided by the above embodiments belong to the same concept, and the specific implementation process thereof is described in the method embodiments, and will not be described herein again.
It will be understood by those skilled in the art that all or part of the steps for implementing the above embodiments may be implemented by hardware, or may be implemented by a program instructing relevant hardware, where the program may be stored in a computer-readable storage medium, and the above-mentioned storage medium may be a read-only memory, a magnetic disk or an optical disk, etc.
The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents, improvements and the like that fall within the spirit and principle of the present invention are intended to be included therein.
Claims (8)
1. A method for detecting a PT value of prothrombin time, which is characterized by comprising the following steps:
the blood sample generates a coagulation reaction under the action of the dry reagent to generate an oxidation current;
generating a current-time curve of the oxidation current over time;
obtaining a plurality of characteristic points on the current-time curve, wherein the plurality of characteristic points at least comprise a time value t corresponding to the point with the minimum current value on the current-time curveminIThe time value t corresponding to the point on the current-time curve where the current value is maximummaxIAnd a time value t corresponding to the maximum slope point of the current-time curvemaxSlope；
Calculating and outputting a prothrombin time PT value according to a preset formula and the plurality of characteristic points, wherein the preset formula is PT ═ t (t)minI+tmaxI+tmaxSlope) /3, or the preset formula is PT ═ (at)minI+btmaxI+ctmaxSlope)/[3*(a+b+c)]And a, b and c are preset coefficients.
2. The method of claim 1, wherein the current-time curve is a smoothed current-time curve;
the smoothing process includes:
sampling the current-time curve according to a preset time interval to obtain n points;
when processing the jth point on the current-time curve, acquiring k points before and after the jth point, wherein the total number of the k points is 2k + 1;
calculating the average value and the standard deviation of the 2k +1 point current values;
calculating the difference value between the current value of each point in the 2k +1 points and the average value;
deleting the current value of a point corresponding to the difference value of the 2k +1 points, wherein the difference value is more than three times of the standard variance, and calculating the average value of the current values of the remaining points, wherein the average value of the current values of the remaining points is the current value of the smoothed jth point;
and continuing to process the j +1 th point until all the n points on the current-time curve are processed.
3. A prothrombin time PT value detection device, characterized in that the device comprises:
a current detection module for detecting an oxidation current generated by the blood sample undergoing a coagulation reaction under the action of the dry reagent, whereby the released oxidizable substance is oxidized by the DC voltage applied to the working electrode;
the signal generation module is used for generating a current-time curve of the oxidation current along with the change of time;
a characteristic point obtaining module, configured to obtain a plurality of characteristic points on the current-time curve, where the plurality of characteristic points at least include a time value t corresponding to a point on the current-time curve where a current value is minimumminIThe time value t corresponding to the point on the current-time curve where the current value is maximummaxIAnd a time value t corresponding to the maximum slope point of the current-time curvemaxSlope；
A calculating module, configured to calculate and output a prothrombin time PT value according to a preset formula (PT ═ t) and the plurality of feature pointsminI+tmaxI+tmaxSlope) /3, or the preset formula is PT ═ (at)minI+btmaxI+ctmaxSlope)/[3*(a+b+c)]Wherein a, b and c are preset coefficients;
the device further comprises:
a data storage module for storing one or more of the following information: the current-time curve, the plurality of feature points, the prothrombin time PT value, test strip lot number, test date and time;
and the user interface module is used for displaying the PT value of the prothrombin time.
4. The apparatus of claim 3, wherein the signal generating module further comprises a signal processing module for smoothing the curve;
the signal processing module is specifically configured to:
sampling the current-time curve according to a preset time interval to obtain n points;
when processing the jth point on the current-time curve, acquiring k points before and after the jth point, wherein the total number of the k points is 2k + 1;
calculating the average value and the standard deviation of the 2k +1 point current values;
calculating the difference value between the current value of each point in the 2k +1 points and the average value;
deleting the current value of a point corresponding to the difference value of the 2k +1 points, wherein the difference value is more than three times of the standard variance, and calculating the average value of the current values of the remaining points, wherein the average value of the current values of the remaining points is the current value of the smoothed jth point;
and continuing to process the j +1 th point until all the n points on the current-time curve are processed.
5. The device of claim 3, wherein the data storage module is further configured to store patient information and operator information.
6. The device of claim 3, wherein the user interface module is further configured to display a date and time of detection.
7. A computer device comprising a memory, a processor and a computer program stored on the memory and executable on the processor, characterized in that the steps of the method of any of claims 1 to 2 are implemented by the processor when executing the computer program.
8. A computer-readable storage medium, on which a computer program is stored, which, when being executed by a processor, carries out the steps of the method of any one of claims 1 to 2.
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| CN201611131978.7A CN108614017B (en) | 2016-12-09 | 2016-12-09 | Prothrombin time detection method and device |
| PCT/CN2016/109483 WO2018103116A1 (en) | 2016-12-09 | 2016-12-12 | Prothrombin time detection method and device |
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| CN112161955A (en) * | 2020-07-22 | 2021-01-01 | 三诺生物传感股份有限公司 | Testing method for four blood coagulation items |
| CN114548189B (en) * | 2022-04-25 | 2022-08-09 | 可孚医疗科技股份有限公司 | Method and device for detecting prothrombin time and computer readable storage medium |
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