CN112161955B - A test method for four coagulation items - Google Patents
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- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
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Abstract
本发明提供了一种用于凝血四项的测试方法，包括以下步骤：a)在预定采样频率下连续采集一定时间内待测样品的光学特性数据，并将凝血四项中每个项目采集的上述光学特性数据按照时间顺序进行排列，得到第一数组；然后将第一数组中所有相连的n个数据做平均值处理，得到的多个平均值继续按照时间顺序进行排列，得到第二数组；再将第二数组中所有相连的两个数据做差值处理，得到取值数组；最后从取值数组中找到绝对值最大值对应的时间点作为初始凝固时间；b)对步骤a)得到的初始凝固时间进行校正，得到最终凝固时间。该测试方法采用特定数据处理方式确定凝固时间，并通过校正获得最终取值数据，准确性好且简单易行，对凝血四项测试有重要意义。
The present invention provides a test method for four coagulation items, comprising the following steps: a) continuously collecting optical characteristic data of a sample to be tested within a certain period of time at a predetermined sampling frequency, and arranging the optical characteristic data collected for each item in the four coagulation items in chronological order to obtain a first array; then processing all the connected n data in the first array as average values, and further arranging the obtained multiple average values in chronological order to obtain a second array; then processing all the two connected data in the second array as difference values to obtain a value array; finally, finding the time point corresponding to the maximum absolute value from the value array as the initial coagulation time; b) correcting the initial coagulation time obtained in step a) to obtain the final coagulation time. The test method uses a specific data processing method to determine the coagulation time, and obtains the final value data through correction, which has good accuracy and is simple and easy to implement, and is of great significance to the four coagulation tests.
Description
Technical Field
The invention relates to the technical field of clinical medical blood coagulation function detection, in particular to a test method for four blood coagulation items.
Background
The four-item (thrombin time, prothrombin time, activated partial thromboplastin time, fibrinogen) assay is a very important part of clinical medical coagulation function assays, which are currently being developed to measure by coagulation. The coagulation method can be divided into an optical method and a magnetic bead method, and in order to reduce the manufacturing cost of the apparatus, most coagulometers at present use the optical method for testing four coagulation items.
The optical method is to take a pretreated sample, add the pretreated sample into a reaction reagent, and uniformly mix and stir the pretreated sample to form a mixture of the sample and the reagent; the testing instrument emits a light source with specific wavelength to irradiate the mixture, the mixture is gradually solidified along with the increment of the reaction time, the light transmittance can be changed, and the instrument continuously collects the transmitted light intensity in a period of time; obtaining a set of test sequences corresponding in time to the transmitted light intensity; in the test sequence, a time point corresponding to a certain transmitted light intensity is selected according to a set rule, namely solidification time. The value of the testing process in the optical method is a crucial step, and whether the value is correct or not directly influences the accuracy of the result. Therefore, a simple, easy and accurate test method is established, and the method has important significance for testing four blood coagulation items.
Disclosure of Invention
Therefore, the invention aims to provide a testing method for four blood coagulation items, which has good accuracy and is simple and easy to implement.
The invention provides a testing method for four blood coagulation items, which comprises the following steps:
a) Continuously acquiring optical characteristic data of a sample to be detected within a certain time under a preset sampling frequency, and arranging the optical characteristic data acquired by each item in the four items of blood coagulation according to a time sequence to obtain a first array; then, carrying out average value processing on all the n connected data in the first array, and continuously arranging a plurality of obtained average values according to a time sequence to obtain a second array; performing difference processing on all the two connected data in the second array to obtain a value array; finally, a time point corresponding to the maximum value of the absolute value is found from the value array and used as initial solidification time;
b) Correcting the initial solidification time obtained in the step a) to obtain the final solidification time.
Preferably, the predetermined sampling frequency in step a) is specifically:
samples were taken 1 time every 0.1 s.
Preferably, the certain time in step a) is an integer multiple of 60 s.
Preferably, the optical characteristic data in step a) is transmitted light intensity data.
Preferably, the testing process of the transmitted light intensity data specifically includes:
placing the four blood coagulation detection reagents into a test system, adding a sample to be tested, uniformly mixing, and testing transmitted light intensity data under a light source; the wavelength of the light source is 650 nm-670 nm; the temperature of the test is 36-38 ℃.
Preferably, n in step a) is an integer greater than 1.
Preferably, the process of obtaining the second group in step a) is specifically:
And carrying out average value processing on all the n connected data in the first array, respectively replacing the data with the rearmost time point in the n data with the obtained multiple average value data, and continuously arranging the obtained new data according to the time sequence to obtain a second array.
Preferably, the corrected equation in step b) is a unitary one-time equation.
Preferably, the corrected equation is determined by:
Taking a plurality of groups of samples to be tested, and respectively obtaining solidification time as experimental group data according to the process of the step a); then, respectively carrying out four blood coagulation tests on the multiple groups of samples to be tested on a control four blood coagulation test system, and taking the obtained coagulated data as control group data; and (3) carrying out linear regression on the experimental group data and the control group data to obtain a unitary primary equation which is the corrected equation in the step b).
The invention provides a testing method for four blood coagulation items, which comprises the following steps: a) Continuously acquiring optical characteristic data of a sample to be detected within a certain time under a preset sampling frequency, and arranging the optical characteristic data acquired by each item in the four items of blood coagulation according to a time sequence to obtain a first array; then, carrying out average value processing on all the n connected data in the first array, and continuously arranging a plurality of obtained average values according to a time sequence to obtain a second array; performing difference processing on all the two connected data in the second array to obtain a value array; finally, a time point corresponding to the maximum value of the absolute value is found from the value array and used as initial solidification time; b) Correcting the initial solidification time obtained in the step a) to obtain the final solidification time. Compared with the prior art, the test method for the four blood coagulation items provided by the invention adopts a specific data processing mode to determine the solidification time, and obtains final value data through correction, so that the test method is good in accuracy, simple and feasible, and has important significance for the test of the four blood coagulation items.
Drawings
FIG. 1 is a scatter diagram of APTT data after processing, which is obtained according to an embodiment of the invention;
FIG. 2 is a scatter diagram after TT data processing according to an embodiment of the present invention;
FIG. 3 is a scatter diagram after PT data processing according to an embodiment of the present invention;
FIG. 4 is a scatter diagram of FIB data processed according to an embodiment of the present invention;
FIG. 5 is an APTT correction equation in an embodiment of the invention;
FIG. 6 is a PT correction equation in an embodiment of the present invention;
FIG. 7 is a TT correction equation in an embodiment of the present invention;
fig. 8 is a FIB correction equation in an embodiment of the present invention.
Detailed Description
The technical solutions of the present invention will be clearly and completely described in conjunction with the embodiments of the present invention, and it is apparent that the described embodiments are only some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
The invention provides a testing method for four blood coagulation items, which comprises the following steps:
a) Continuously acquiring optical characteristic data of a sample to be detected within a certain time under a preset sampling frequency, and arranging the optical characteristic data acquired by each item in the four items of blood coagulation according to a time sequence to obtain a first array; then, carrying out average value processing on all the n connected data in the first array, and continuously arranging a plurality of obtained average values according to a time sequence to obtain a second array; performing difference processing on all the two connected data in the second array to obtain a value array; finally, a time point corresponding to the maximum value of the absolute value is found from the value array and used as initial solidification time;
b) Correcting the initial solidification time obtained in the step a) to obtain the final solidification time.
The method comprises the steps of continuously collecting optical characteristic data of a sample to be tested within a certain time under a preset sampling frequency, and arranging the optical characteristic data collected by each item in four items of blood coagulation according to a time sequence to obtain a first array. In the present invention, the predetermined sampling frequency is preferably specifically:
samples were taken 1 time every 0.1 s.
In the present invention, the certain time is preferably an integer multiple time of 60s, more preferably 600s; the time interval of the chronological order is preferably 0.1s. On the basis, the invention preferably arranges the transmitted light intensity data acquired by each item in the four items of blood coagulation according to the sequence of 0.1 to 600s to obtain a first array; that is, data is continuously collected from 0.1s until 600s of the test is finished, and data is collected every 0.1s and recorded as transmitted light intensity data corresponding to the time point.
In the present invention, the optical characteristic data is preferably transmitted light intensity data; the test process of the transmitted light intensity data is preferably specifically as follows:
And (3) placing the four blood coagulation detection reagents into a test system, adding a sample to be tested, uniformly mixing, and testing transmitted light intensity data under a light source. The type and source of the four detection reagents for coagulation are not particularly limited, and commercially available reagents for four detection of coagulation, which are well known to those skilled in the art, are used in the present invention.
In the invention, the test system is a component part of a blood coagulation four-item test device, and besides, the blood coagulation four-item test device further comprises: the system comprises a light source system, a temperature control system, a data acquisition system and a data processing system.
In the invention, the sample to be tested is a clinical sample of four blood coagulation items to be tested; the present invention is not particularly limited thereto.
In the present invention, the light wavelength of the light source is preferably 650nm to 670nm, more preferably 660nm; provided by the above light source system. In the present invention, the temperature for the test is preferably 36℃to 38℃and more preferably 37 ℃; and the control is performed by the temperature control system.
In the invention, the transmitted light intensity data is recorded by the data acquisition system.
After the first array is obtained, all the n data connected in the first array are subjected to average processing, and the obtained multiple average values are continuously arranged according to the time sequence to obtain a second array. In the present invention, n is preferably an integer greater than 1, more preferably 5; on the basis, the requirements of the invention on the data processing accuracy can be met; in addition, since the first n-1 data cannot satisfy that n data is subjected to the average processing, the above average processing is not performed.
In the present invention, the process of obtaining the second array preferably specifically includes:
Processing all the n connected data in the first array by average value, and respectively replacing the data with the last time point in the n data by the obtained multiple average value data, and continuously arranging the obtained new data according to the time sequence to obtain a second array;
More preferably:
Processing all the n data connected in the first array by average value, and respectively replacing the data with the rearmost time point in the n data by the obtained multiple average value data, and continuously arranging the obtained new data according to the sequence of 0.1 multiplied by n to 600 seconds to obtain a second array; the 0.1 Xn is actually calculated as 0.1+ (n-1) X0.1.
After the second array is obtained, the invention carries out difference processing on all the two data connected in the second array to obtain a value array. The method is not particularly limited in the way of processing the difference value, and aims to obtain the change of the signal value so as to find out a time point with the maximum change of the signal; the difference processing mode can be performed by subtracting the previous data from the next data, or by subtracting the next data from the previous data; in a preferred embodiment of the invention, the difference processing is performed by subtracting the previous data from the next data.
In the present invention, the process of obtaining the value array preferably specifically includes:
and performing difference processing on all the two connected data in the second array, and replacing the data with the obtained difference data after the time points in the 2 data, and continuously arranging the obtained new data according to the sequence of 0.1 multiplied by n+0.1 to 600 seconds to obtain a value array.
After the value array is obtained, the time corresponding to the maximum value of the absolute value is found from the value array to serve as initial solidification time. The test method for the four tests of blood coagulation adopts a specific data processing mode to determine the initial coagulation time; meanwhile, the problem that the maximum time point of the signal value change can not be obtained only by taking the average value is solved, and the problem that the false judgment can be caused only by taking the difference signal fluctuation to cause the jump value is solved.
The invention obtains the coagulation time of the sample to be detected according to the method, and the coagulation time is marked as APTT-1, PT-1, TT-1 and FIB-1.
After the initial coagulation time of the sample to be tested is obtained, the obtained initial coagulation time is corrected to obtain the final coagulation time. In the present invention, the corrected equation is preferably a unitary once equation; the corrected equation is determined by:
Taking a plurality of groups of samples to be tested, and respectively obtaining solidification time as experimental group data according to the process of the step a); then, respectively carrying out four blood coagulation tests on the multiple groups of samples to be tested on a control four blood coagulation test system, and taking the obtained coagulated data as control group data; and (3) carrying out linear regression on the experimental group data and the control group data to obtain a unitary primary equation which is the corrected equation in the step b). In the present invention, the number of the groups of the plurality of groups of samples to be measured is preferably not less than 20 groups, more preferably 25 groups.
In the invention, the four-item blood coagulation detection is that the four-item blood coagulation test device directly selects a time point corresponding to a certain transmitted light intensity as a solidification time according to a set rule (the prior art takes 50% of solidification time as solidification time, and the time point corresponds to the point with the largest change from the point of change of a signal value) through a data processing system to respectively obtain APTT-2, PT-2, TT-2 and FIB-2.
Then, the invention carries out linear regression on experimental group data (APTT-1, PT-1, TT-1 and log (FIB-1)) and control group data (APTT-2, PT-2, TT-2 and log (FIB-2)) to obtain four correction equations of blood coagulation. In the present invention, the four-term correction equation for coagulation preferably includes:
APTT correction equation: y= 1.7819x-41.705, r 2 = 0.9934;
PT correction equation: y=0.949 x-1.0444, r 2 = 0.9922;
TT correction equation: y=0.961x+3.8131, r 2 = 0.9898;
FIB correction equation: y=0.8811x+0.2035, r 2 = 0.9705.
The invention provides a testing method for four blood coagulation items, which comprises the following steps: a) Continuously acquiring optical characteristic data of a sample to be detected within a certain time under a preset sampling frequency, and arranging the optical characteristic data acquired by each item in the four items of blood coagulation according to a time sequence to obtain a first array; then, carrying out average value processing on all the n connected data in the first array, and continuously arranging a plurality of obtained average values according to a time sequence to obtain a second array; performing difference processing on all the two connected data in the second array to obtain a value array; finally, a time point corresponding to the maximum value of the absolute value is found from the value array and used as initial solidification time; b) Correcting the initial solidification time obtained in the step a) to obtain the final solidification time. Compared with the prior art, the test method for the four blood coagulation items provided by the invention adopts a specific data processing mode to determine the solidification time, and obtains final value data through correction, so that the test method is good in accuracy, simple and feasible, and has important significance for the test of the four blood coagulation items.
In order to further illustrate the present invention, the following examples are provided. The test apparatus used in the following examples includes: the system comprises a light source system, a temperature control system, a test system, a data acquisition system and a data processing system; the testing process comprises the following steps: the four blood coagulation detection reagents are taken and put into a test system, and after the samples are added and mixed uniformly, the test is started: the temperature control system controls the temperature to be 37 ℃, the light source system emits light with 660nm wavelength to irradiate the mixture, the data acquisition system continuously acquires transmitted light intensity data in 600 seconds, acquires data every 0.1 seconds to obtain a transmitted light intensity-time test sequence, and finally selects a time point corresponding to a certain transmitted light intensity according to a set rule (the prior art takes the time of solidification of 50% as solidification time, and the time point corresponds to the point with the largest change from the change of a signal value) through the data processing system, namely the solidification time.
Examples
(1) Experimental group: taking 25 clinical samples, respectively testing for 1 time through the testing process, recording the testing data (the intensity of transmitted light) of four blood coagulation items of each sample, and arranging the data collected by each item in the testing process according to the sequence of 0.1 to 600 seconds to obtain a first array; then, all the connected 5 data in the first array are subjected to average processing (the first 4 data are not subjected to the processing), the obtained average data are used for replacing the data with the rearmost time point in the 5 data (namely, the average data of 0.1s, 0.2s, 0.3s, 0.4s and 0.5s are used as the data corresponding to 0.5s in the new array), and the obtained new data are continuously arranged according to the sequence of 0.5 to 600 seconds to obtain a second array; performing difference processing on all the two connected data in the second array according to the mode of subtracting the previous data from the next data, and replacing the data with the time point of the next data (namely, the difference data obtained by subtracting the data corresponding to 0.5s from the data corresponding to 0.6s in the 2 data is used as the data corresponding to 0.6s in the new array), wherein the obtained new data are continuously arranged according to the sequence of 0.6 to 600 seconds to obtain a value array; finally, finding the lowest value from the value array, and taking the time corresponding to the lowest value as solidification time; the clotting time of four blood coagulation items of a single sample is respectively obtained according to the method and is marked as APTT-1, PT-1, TT-1 and FIB-1, and the test results are shown in the table 1; after data processing (the time point of the value can be judged through the data processing, the corresponding lowest point of the y axis can be seen from the scatter diagram to be the value point), the scatter diagram is made, as shown in fig. 1 to 4. As can be seen from fig. 1 to 4, through the above data processing method, the value point (the lowest point of the y axis) can be easily found, that is, the feasibility of the value method is high.
Table 1 test result data of four blood coagulation tests of 25 clinical samples in the example of the present invention
(2) Control group: and (2) directly selecting a time point corresponding to a certain transmitted light intensity as solidification time according to a set rule of a data processing system without adopting the value mode of the step (1) for the 25 clinical samples, and respectively obtaining solidification time of four blood coagulation items of a single sample, namely APTT-2, PT-2, TT-2 and FIB-2, wherein test results are shown in a table 2.
Table 2 test result data of four blood coagulation tests of 25 clinical samples in control group
| Sample number | PT-2(s) | APTT-2(s) | TT-2(s) | log(FIB-2) |
| 1 | 24.5 | 82.4 | 21.9 | 1.265 |
| 2 | 21.2 | 70.9 | 21.8 | 1.262 |
| 3 | 18.8 | 65.9 | 22.2 | 1.258 |
| 4 | 15.9 | 60.7 | 21.7 | 1.258 |
| 5 | 14.0 | 56.9 | 21.8 | 1.233 |
| 6 | 12.3 | 53.2 | 21.7 | 1.238 |
| 7 | 11.5 | 50.5 | 21.4 | 1.225 |
| 8 | 9.6 | 45.2 | 21.0 | 1.204 |
| 9 | 8.7 | 42.5 | 20.9 | 1.188 |
| 10 | 7.6 | 39.6 | 20.6 | 1.152 |
| 11 | 6.9 | 38.4 | 20.5 | 1.124 |
| 12 | 7.3 | 20.5 | 28.6 | 1.104 |
| 13 | 7.1 | 24.2 | 32.8 | 1.173 |
| 14 | 6.9 | 30.8 | 18.2 | 1.286 |
| 15 | 7.5 | 45.1 | 18.6 | 1.465 |
| 16 | 7.9 | 31.2 | 38.5 | 1.190 |
| 17 | 6.6 | 32.3 | 17.9 | 1.053 |
| 18 | 8.7 | 31.3 | 17.9 | 1.049 |
| 19 | 8.2 | 32.8 | 19.5 | 1.121 |
| 20 | 12.1 | 24.6 | 18.9 | 1.097 |
| 21 | 11.3 | 23.8 | 16.9 | 0.991 |
| 22 | 8.5 | 102.4 | 21.1 | 1.193 |
| 23 | 6.5 | 33.6 | 18.3 | 1.072 |
| 24 | 7.5 | 34.0 | 18.8 | 1.097 |
| 25 | 21.6 | 89.6 | 24.1 | 0.934 |
Performing linear regression on test results of an experimental group (C1) and a control group (C0) of 25 samples to obtain an equation C0=kC1+b, wherein the equation C0=kC1+b is used as a blood coagulation four-term correction equation; the specific correction equation includes:
APTT correction equation: y= 1.7819x-41.705, r 2 = 0.9934;
PT correction equation: y=0.949 x-1.0444, r 2 = 0.9922;
TT correction equation: y=0.961x+3.8131, r 2 = 0.9898;
FIB correction equation: y=0.8811x+0.2035, r 2 = 0.9705;
see fig. 5-8.
And correcting the experimental group data by adopting the four correction equations for coagulation to obtain corrected data, wherein the corrected data are used as final value data, and the result is shown in table 3.
TABLE 3 final value data for four blood coagulation items of 25 clinical samples in the example of the present invention
| Sample number | PT(s) | APTT(s) | TT(s) | log(FIB) |
| 1 | 24.8 | 80.4 | 22.3 | 1.239 |
| 2 | 20.5 | 73.3 | 22.4 | 1.263 |
| 3 | 18.8 | 67.3 | 22.6 | 1.250 |
| 4 | 16.1 | 60.4 | 22.3 | 1.243 |
| 5 | 14.1 | 57.2 | 21.4 | 1.236 |
| 6 | 12.7 | 50.7 | 21.3 | 1.223 |
| 7 | 11.7 | 47.6 | 20.6 | 1.232 |
| 8 | 9.7 | 44.5 | 20.6 | 1.192 |
| 9 | 8.9 | 41.7 | 20.3 | 1.168 |
| 10 | 8.4 | 41.0 | 20.1 | 1.158 |
| 11 | 7.2 | 39.6 | 20.0 | 1.117 |
| 12 | 7.0 | 16.2 | 28.2 | 1.109 |
| 13 | 6.8 | 22.3 | 33.3 | 1.160 |
| 14 | 6.6 | 29.9 | 18.8 | 1.305 |
| 15 | 7.4 | 46.2 | 18.8 | 1.455 |
| 16 | 7.7 | 28.8 | 37.9 | 1.209 |
| 17 | 7.0 | 33.8 | 17.7 | 1.020 |
| 18 | 9.1 | 35.2 | 17.5 | 1.050 |
| 19 | 8.6 | 34.9 | 19.4 | 1.122 |
| 20 | 13.0 | 25.5 | 18.5 | 1.080 |
| 21 | 10.6 | 24.6 | 17.0 | 1.025 |
| 22 | 7.8 | 103.3 | 21.5 | 1.223 |
| 23 | 6.2 | 33.5 | 18.5 | 1.099 |
| 24 | 6.9 | 34.8 | 19.6 | 1.134 |
| 25 | 21.0 | 87.5 | 24.8 | 0.920 |
The deviation of the final value data from the control group was calculated and the results are shown in table 4.
TABLE 4 calculation results of the deviation of the final value data obtained in the examples of the present invention relative to the control group
The results show that the four blood coagulation data obtained by the test method provided by the embodiment of the invention have small deviation from the results of the control group and better consistency; the test method is simple and feasible, and has important significance for testing four blood coagulation items.
The previous description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.
Claims (7)
1. A test method for clotting four, comprising the steps of:
a) Continuously acquiring optical characteristic data of a sample to be detected within a certain time under a preset sampling frequency, and arranging the optical characteristic data acquired by each item in the four items of blood coagulation according to a time sequence to obtain a first array; then, carrying out average value processing on all the n connected data in the first array, and continuously arranging a plurality of obtained average values according to a time sequence to obtain a second array; performing difference processing on all the two connected data in the second array to obtain a value array; finally, a time point corresponding to the maximum value of the absolute value is found from the value array and used as initial solidification time;
b) Correcting the initial solidification time obtained in the step a) to obtain the final solidification time; the corrected equation is a unitary one-time equation; the corrected equation is determined by:
Taking a plurality of groups of samples to be tested, and respectively obtaining solidification time as experimental group data according to the process of the step a); then, respectively carrying out four blood coagulation tests on the multiple groups of samples to be tested on a control four blood coagulation test system, and taking the obtained coagulated data as control group data; and (3) carrying out linear regression on the experimental group data and the control group data to obtain a unitary primary equation which is the corrected equation in the step b).
2. The test method according to claim 1, wherein the predetermined sampling frequency in step a) is specifically:
samples were taken 1 time every 0.1 s.
3. The test method according to claim 1, wherein the certain time in step a) is an integer multiple of 60 s.
4. The method according to claim 1, wherein the optical characteristic data in step a) is transmitted light intensity data.
5. The method according to claim 4, wherein the testing process of the transmitted light intensity data specifically comprises:
placing the four blood coagulation detection reagents into a test system, adding a sample to be tested, uniformly mixing, and testing transmitted light intensity data under a light source; the wavelength of the light source is 650 nm-670 nm; the temperature of the test is 36-38 ℃.
6. The test method according to claim 1, wherein n in step a) is an integer greater than 1.
7. The method according to claim 1, wherein the process of obtaining the second set in step a) is specifically:
And carrying out average value processing on all the n connected data in the first array, respectively replacing the data with the rearmost time point in the n data with the obtained multiple average value data, and continuously arranging the obtained new data according to the time sequence to obtain a second array.
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