CN110988321A - Detection method and coagulation analysis control method of handheld coagulation analysis system - Google Patents

Detection method and coagulation analysis control method of handheld coagulation analysis system Download PDF

Info

Publication number
CN110988321A
CN110988321A CN201911164388.8A CN201911164388A CN110988321A CN 110988321 A CN110988321 A CN 110988321A CN 201911164388 A CN201911164388 A CN 201911164388A CN 110988321 A CN110988321 A CN 110988321A
Authority
CN
China
Prior art keywords
module
data
detection
coagulation analysis
curve
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CN201911164388.8A
Other languages
Chinese (zh)
Other versions
CN110988321B (en
Inventor
许行尚
杰弗瑞·陈
王秀涛
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Nanjing Lanyu Biological Technology Co Ltd
Original Assignee
Nanjing Lanyu Biological Technology Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Nanjing Lanyu Biological Technology Co Ltd filed Critical Nanjing Lanyu Biological Technology Co Ltd
Priority to CN201911164388.8A priority Critical patent/CN110988321B/en
Publication of CN110988321A publication Critical patent/CN110988321A/en
Application granted granted Critical
Publication of CN110988321B publication Critical patent/CN110988321B/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

Classifications

    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483Physical analysis of biological material
    • G01N33/487Physical analysis of biological material of liquid biological material
    • G01N33/48785Electrical and electronic details of measuring devices for physical analysis of liquid biological material not specific to a particular test method, e.g. user interface or power supply
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483Physical analysis of biological material
    • G01N33/487Physical analysis of biological material of liquid biological material
    • G01N33/48707Physical analysis of biological material of liquid biological material by electrical means
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483Physical analysis of biological material
    • G01N33/487Physical analysis of biological material of liquid biological material
    • G01N33/48785Electrical and electronic details of measuring devices for physical analysis of liquid biological material not specific to a particular test method, e.g. user interface or power supply
    • G01N33/48792Data management, e.g. communication with processing unit
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483Physical analysis of biological material
    • G01N33/487Physical analysis of biological material of liquid biological material
    • G01N33/49Blood
    • G01N33/4905Determining clotting time of blood

Abstract

The invention relates to a detection method and a coagulation analysis control method of a handheld coagulation analysis system, wherein the detection method comprises the following steps: (1) initializing the handheld coagulation analysis system to enter a main interface; (2) if the reagent card strip is directly detected, taking out the reagent card strip, placing the reagent card strip on a workbench, clicking a code scanning start button, aligning a code scanning module to a two-dimensional code on the reagent card strip, reading a batch number of the reagent card strip, if the batch number is valid, prompting to insert the reagent card strip, and otherwise, popping up an alarm prompt and returning to a code scanning interface; (3) heating after inserting the reagent card strip, entering an information entry interface, and entering the information of the effective batch number in the step (2) into the handheld coagulation analysis system; (4) after the information is input, prompting the sample adding; sampling by using a sampling device, adding a blood sample to be detected into a sampling hole of the reagent card strip, and starting detection and analysis; (5) and popping up a detection result after the detection is finished, and uploading and printing a detection report on a detection result interface.

Description

Detection method and coagulation analysis control method of handheld coagulation analysis system
Technical Field
The invention relates to the technical field of medical equipment, in particular to a blood coagulation detection method and a blood coagulation analysis control method of a handheld blood coagulation analysis system.
Background
In Vitro Diagnostics (IVD) is a product and service for obtaining clinical diagnostic information by testing samples (blood, body fluids, tissues, etc.) of the human body, including reagents, reagent products, calibration materials, control materials, kits, meters, devices, apparatuses or systems. The diagnostic reagent is a basic tool for detecting whether a patient is ill or not and the degree of illness, and whether the result is accurate or not directly influences the diagnosis of a doctor and the physical health and life safety of the patient. With the progress of modern medical science and technology, the requirements for medical examination are more and more accurate and quantitative, so that higher requirements are put on the quality of diagnostic reagents.
A Blood Coagulation Analyzer (Blood Coagulation Analyzer) is one of IVD products, is a conventional detection medical device for clinically measuring the content of various components in human Blood, quantitatively analyzing biochemical analysis results and providing reliable digital basis for clinically diagnosing various diseases of patients. The detection method mainly adopted by the blood coagulation reaction comprises the following steps: coagulation, substrate color development, immunization, latex agglutination, etc.
At present, semi-automatic blood coagulators produced by various manufacturers at home and abroad measure the blood coagulation process based on a coagulation method. Blood coagulation is the result of a series of coagulation factor-linked enzymatic reactions. The blood coagulation factors exist in the form of inactive zymogen, and when a certain coagulation factor is activated, a plurality of coagulation factors can be activated in sequence, and have complex catalytic actions among each other, so that the blood coagulation factors are called as 'waterfall theory'. The coagulation method is also called a biophysical method because it detects a change in a series of physical quantities (optical, electrical, mechanical movement, etc.) of plasma by a coagulation activator, analyzes the obtained data with a computer, and converts the data into a final result.
Therefore, there is a need to develop a method for accurately controlling and analyzing a coagulation assay that results in more accurate coagulation assay results.
Disclosure of Invention
The technical problem to be solved by the invention is to provide a blood coagulation detection method of a handheld blood coagulation analysis system, which can accurately control and analyze a blood coagulation analysis test, so that a blood coagulation test result is more accurate.
In order to solve the technical problems, the invention adopts the technical scheme that: the blood coagulation detection method of the handheld blood coagulation analysis system specifically comprises the following steps:
(1) initializing a handheld coagulation analysis system, and entering a main interface;
(2) if the blood coagulation analysis system is directly detected, taking out the reagent card strip, placing the reagent card strip on a workbench, clicking a code scanning start button, aligning a code scanning module at the lower part of the handheld blood coagulation analysis system with a two-dimensional code on the reagent card strip, reading a batch number of the reagent card strip, if the batch number is valid, prompting to insert the reagent card strip, and otherwise, popping up an alarm prompt and returning to a code scanning interface;
(3) after the reagent card strip is inserted, heating is started, an information input interface is entered, and the information of the effective batch number in the step (2) is input into the handheld coagulation analysis system;
(4) after the information is input, prompting the sample adding; sampling by using a sampling device, adding a blood sample to be detected into a sampling hole of the reagent card strip, and starting detection and analysis by using the handheld blood coagulation analysis system;
(5) and popping up a detection result after the detection is finished, and uploading and printing a detection report on a detection result interface.
The invention is further improved in that the method also comprises a step (6) and a step (7),
(6) after entering the main interface in the step (1), clicking a query button to enter a record query interface, clicking the query button to query after inputting a required query condition on the query interface, and for a record to be printed or uploaded, popping up a sample viewing interface after selecting the record to be printed or uploaded, and clicking a corresponding button to print or upload;
(7) and (2) clicking a setting button after entering the main interface in the step (1), wherein the setting button comprises functional setting, quality management and engineer debugging. By adopting the technical scheme, the display module is mainly realized by adopting a 4-inch capacitive touch screen, and the touch input function can be realized. The main interface displays a basic operation mode and has the functions of detection, query and setting; the user can realize the input of the sample information and the output of the detection result through the detection button. The query interface can realize the query of the patient information of the measured result and can store 200 data records; the system setting can realize the setting of basic parameters of the handheld coagulation analysis system, and realize the functions of quality control management, project management and the like of the handheld coagulation analysis system; starting the handheld coagulation analysis system, completing initialization, entering a main control interface, and popping up an alarm prompt on a display interface of the handheld coagulation analysis system if a problem exists; normal inspection can be carried out without alarm prompt; clicking a detection button to enter a card insertion prompt interface, entering an information input interface after normal card insertion, inputting the identity card information (name, sex, age and sample number) of a person to be tested, and automatically storing the information after the information is input into a memory in the equipment; then entering an incubation interface, entering a sample adding interface when the set temperature is reached, and prompting a user to add a sample; after adding the sample, entering a normal detection interface; popping up a detection result interface after detection is finished, and displaying detection result data; the user can select whether to print the current detection data; finishing the detection; the detection historical data can be browsed by clicking a query interface, and information such as a detection report can be displayed in detail by clicking a certain piece of data; the wifi and the Bluetooth can be set by clicking a setting interface, the current time can be set, and quality control operation can be performed by entering quality control management; and entering an engineer interface to operate corresponding functions.
The invention also aims to solve the technical problem of providing a method for accurately controlling and analyzing coagulation analysis control, so that a coagulation test result is more accurate.
In order to solve the technical problems, the invention adopts the technical scheme that: the method for carrying out coagulation analysis control by adopting the detection method of the handheld coagulation analysis system specifically comprises the following steps:
s41, a CPU core processing module generates a pulse voltage signal and applies the pulse voltage signal to a blood sample to be detected in a reaction area, the blood sample to be detected is excited to conduct a circuit of a reaction chamber and enable the blood sample to be detected to react with a reaction reagent in the reaction chamber and start to solidify, the blood sample is detected to react with the reaction reagent to cause the change of a current signal, and then a digital-to-analog converter acquires voltage data;
s42, recording the change data of the time and current signals, and obtaining a reaction curve;
s43 calculating the coagulation index data from the data obtained in step S43 by the data processing system.
By adopting the technical scheme, the current method in the coagulation method is adopted, and a reagent card strip, namely a coagulation detection card, is matched for blood coagulation detection of a human body sample; the current method utilizes the characteristic that fibrinogen has no conductivity and fibrin has conductivity, so that a pulse voltage signal is generated through a main control chip, the pulse voltage signal is added to a blood sample in a reaction area, a digital-analog converter collects voltage data, the blood sample is used as a part of a circuit, the circuit is switched on, so that blood is combined with a fixed reaction reagent to induce a series of biochemical reactions to start coagulation, the change of the current signal is generated, a coagulation reaction curve of the current and the time change is generated, and a coagulation index is obtained through calculation by a data processing system. Detectable items of coagulation include human coagulation 5 items: prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), Thrombin Time (TT), Fibrinogen (FIB), Activated Clotting Time (ACT).
The invention is further improved in that step S41 specifically includes:
s411: the CPU core processing module generates a pulse signal with the frequency of 1KHz and an analog signal with the frequency of 1V through the ADC, generates a pulse signal with the frequency of 1KHz and the frequency of 0-1V which are alternately changed through the excitation signal generating module, and applies the pulse signal to a common reference electrode of a reagent card strip through the reagent card connector;
s412: the CPU core processing module controls the incubation module to control the temperature to be in a range of 37 +/-0.5 through a PID algorithm so as to carry out incubation processing on the reaction area of the reagent card during use;
s413: after a blood sample to be detected is added into the reagent card strip, the blood automatically flows into the reaction area, and after entering the reaction area, the blood is combined with the fixed reaction reagent to generate biochemical reaction to start coagulation, so that the change of a current signal is generated; the current signal is converted into a voltage signal through the signal conditioning circuit module due to the change of the generated current signal, and a voltage output signal is generated;
s414: and generating an external trigger signal with the same frequency and the same time sequence as the reference signal in the excitation signal module, acquiring an analog-to-digital converter (ADC) analog signal by adopting an external interrupt mode through a Central Processing Unit (CPU) core processing module, and performing data processing after the acquisition is finished.
In order to accurately receive ADC analog signals of 5 channels, external trigger signals with the same frequency and the same time sequence as the reference signals are generated in the excitation signal module; and the CPU core processing module adopts an external interrupt mode to acquire and process the ADC analog signals of the 5 channels, and the sampling frequency is 0.1S.
The invention is further improved in that the specific steps of processing data by the data processing system in step S43 are as follows:
s431: the signal conditioning circuit module is used for carrying out operational amplification processing on the analog signals and transmitting the signals to the ADC data acquisition module;
s432: the ADC data acquisition module acquires data of the analog signal, converts the data into a digital signal for processing, and transmits the digital signal to the exponential smoothing filtering module;
s433: the exponential smoothing filtering module is used for filtering the acquired original data, filtering abnormal values and clutter signals in the data and smoothing a data curve;
s434: performing extraction processing on the data filtered in the step S433 by adopting a data extraction module;
s435: processing the data after the sparse processing by adopting a Douglas sparse algorithm module to form inflection point data of a curve;
s436: and (5) calibrating the result by the inflection point of the curve obtained in the step (S435) through a calibration curve, and displaying the obtained reaction curve through a data result display module. The calibration formula used is y ═ ax + b.
As a preferred technical solution of the present invention, in step S433, a preprocessing algorithm is used to perform filtering processing on the collected original data, where the preprocessing algorithm is an exponential data smoothing algorithm, and the exponential smoothing algorithm gives different weights to different observed values, that is, a new observed value gives a larger weight, and a previous observed value gives a smaller weight; the formula is as follows:
St=a×yt+(1-a)×St-1(1)
wherein S istIs a smoothed value at time t, ytIs the actual value at time t, S(t-1)Is the smooth value at the time of t-1, a is a smooth constant with a value range of [0, 1%]. The exponential smoothing method is one of moving average methods, and is characterized in that different weights are given to previous observed values, namely the weight of a more recent observed value is larger than that of a more distant observed value; the exponential smoothing method is classified into a first exponential smoothing method, a second exponential smoothing method, a third exponential smoothing method, and the like according to the smoothing frequency. But their basic ideas are: the predicted value is a weighted sum of previous observations, with different weights given to different data, with new data given more weight and old data given less weight.
As a preferred technical scheme of the invention, the exponential smoothing algorithm is divided into a first exponential smoothing method, a second exponential smoothing method and a third exponential smoothing method according to different smoothing times.
As a preferred technical solution of the present invention, when the step S435 is performed by using the douglas sparse algorithm module, the douglas sparse algorithm is combined with the calculation process of the inflection point searching algorithm, and the number of points of the reaction curve is reduced and the reaction curve is approximately represented as a series of feature points, so as to further screen the feature inflection points, wherein the inflection point searching algorithm specifically comprises the following steps:
s441 is characterized in that a straight line AB is connected between the head point A and the tail point B of the curve, and the straight line is a chord of the curve;
s442 obtaining a point C with the maximum distance from the curve to the straight line AB, and calculating the distance d between the point C and the straight line AB;
s443, comparing the distance d with a preset threshold value threshold, and if the distance d is smaller than the threshold value threshold, taking the straight line AB as an approximation of a curve, and finishing the processing of the section of curve;
s444, if the distance d is larger than the threshold, dividing the curve into two sections of AC and BC by using C, and respectively carrying out the processing of the steps S441-S443 on the two sections of the curve AC and BC until the distance d between the two sections of the curve AC and BC is smaller than the threshold value threshold;
and S445, when all the curves are processed, sequentially connecting the broken lines formed by the dividing points, wherein the continuous broken line is used as the approximation of the curve. By adopting the technical scheme, through measuring a large number of samples and clinical tests, the product can obtain a correct reaction curve, and obtain an accurate inflection point through calculation, namely, the inflection point searching algorithm is adopted to calculate the reaction curve after the filtering pretreatment to obtain the reaction time.
As a preferred technical scheme of the invention, the handheld coagulation analysis system comprises a detection module, a display touch module, a data storage module, a code scanning module, a bluetooth module, a WIFI module, a battery power supply and management module, an incubation module, a temperature detection module, a CPU core processing module, an excitation signal module and a data processing system, wherein the quintuplet card detection module, the display touch module, the data storage module, the code scanning module, the bluetooth module, the WIFI module, the battery power supply and management module, the incubation module, the temperature detection module, the data processing system and the excitation signal module are all in data connection with the CPU core processing module.
As a preferred technical scheme of the invention, the detection module is used for dropping a blood sample to be detected at a designated position of the reagent card strip by inserting the reagent card strip, after the blood sample is conducted with the electrode, the digital-analog converter collects a reaction curve obtained by voltage, then the reaction curve is subjected to filtering pretreatment, then the reaction curve is subjected to the inflection point searching algorithm to obtain reaction time, and the reaction time is transmitted to the display touch module to be displayed on a detection result page;
the display touch module adopts a capacitive touch screen and is used for realizing a touch input function;
the data storage module is used for storing basic information, detection results and setting parameters of patients corresponding to the blood samples, and is convenient to check and call at any time;
the code scanning module is used for acquiring the serial number of the reagent card strip item through code scanning;
the Bluetooth module is used for searching the usable Bluetooth equipment and carrying out pairing connection according to user selection;
the WIFI module is used for searching for a WIFI network which can be used and connecting according to user selection;
the battery power supply and management module is used for reading and displaying the battery power of the handheld coagulation analysis system in real time;
the incubation module is used for heating the temperature of the detection module to 37 degrees; the intelligent temperature control module comprises a ceramic heating sheet and a thermistor, wherein a CPU controls the conduction of a triode through an IO port to supply power to the heating sheet, an NTC thermistor monitors the temperature change condition of the current heating sheet in real time and feeds the temperature change condition back to the CPU, and the CPU reads temperature information in real time and controls the output frequency of the IO port through a PID algorithm, so that the temperature of the module is accurately controlled; the temperature detection module reads the detection module temperature by adopting a DS18b20 temperature chip.
As a preferred technical solution of the present invention, the data processing system includes a signal conditioning circuit module, an ADC data acquisition module, an exponential smoothing filter module, a data extraction module, a douglas thinning algorithm module, and a data result display module, the signal conditioning circuit module is connected to the ADC data acquisition module, the ADC data acquisition module is connected to the exponential smoothing filter module, the exponential smoothing filter module is connected to the extraction module, the extraction module is connected to the douglas thinning algorithm module, and the douglas thinning algorithm module is connected to the data result display module.
As a preferred technical scheme of the invention, the signal conditioning circuit module and the ADC data acquisition module are both 5 channels, namely an ACT channel, an FIB channel, a TT channel, an APTT channel and a PT 5 channel.
Compared with the prior art, the blood coagulation analysis control method can realize the detection of the blood sample to be detected and the accurate processing of the reaction curve obtained by the detection, thereby obtaining accurate blood coagulation index data.
Drawings
FIG. 1 is a block flow diagram of a detection method of a handheld coagulation analysis system;
FIGS. 2A-2E are graphs comparing original curves and algorithmic processing curves of a PT response curve based on different samples for a handheld coagulation analysis system;
wherein FIG. 2A is a graph comparing the original curve of the PT response curve of sample 1 with the algorithmic processing curve;
FIG. 2B is a graph comparing the original curve of the PT response curve of sample 2 with the algorithmic processing curve;
FIG. 2C is a graph comparing the original curve of the PT response curve of sample 3 with the algorithmic processing curve;
FIG. 2D is a graph comparing the original curve of the PT response curve of sample 4 to the algorithmic processing curve;
FIG. 2E is a graph comparing the original curve of the PT response curve of sample 5 with the algorithmic processing curve;
in fig. 2A to 2E, the star shape is a calculated inflection point, and a line having a star shape is an algorithm processing curve;
FIG. 3 shows the fitting curve, fitting equation and goodness of fit (R) of the PT value detection result and target value data of different samples for the handheld coagulation analyzer2);
FIG. 4 is a flowchart of a system data control method in the coagulation analysis control method using the detection method of the handheld coagulation analysis system according to the present invention;
FIG. 5 is a flow chart of a data processing system in the method for coagulation analysis control using the detection method of the handheld coagulation analysis system according to the present invention.
Detailed Description
For the purpose of enhancing the understanding of the present invention, the present invention will be described in further detail with reference to the accompanying drawings and examples, which are provided for the purpose of illustration only and are not intended to limit the scope of the present invention.
Example 1: as shown in fig. 1, the detection method of the handheld coagulation analysis system specifically includes the following steps:
(1) initializing a handheld coagulation analysis system, and entering a main interface;
(2) if the blood coagulation analysis system is directly detected, taking out the reagent card strip, placing the reagent card strip on a workbench, clicking a code scanning start button, aligning a code scanning module at the lower part of the handheld blood coagulation analysis system with a two-dimensional code on the reagent card strip, reading a batch number of the reagent card strip, if the batch number is valid, prompting to insert the reagent card strip, and otherwise, popping up an alarm prompt and returning to a code scanning interface;
(3) after the reagent card strip is inserted, heating is started, an information input interface is entered, and the information of the effective batch number in the step (2) is input into the handheld coagulation analysis system;
(4) after the information is input, prompting the sample adding; sampling by using a sampling device, adding a blood sample to be detected into a sampling hole of the reagent card strip, and starting detection and analysis by using the handheld blood coagulation analysis system;
(5) popping up a detection result after detection is finished, and uploading and printing a detection report on a detection result interface;
(6) after entering the main interface in the step (1), clicking a query button to enter a record query interface, clicking the query button to query after inputting a required query condition on the query interface, and for a record to be printed or uploaded, popping up a sample viewing interface after selecting the record to be printed or uploaded, and clicking a corresponding button to print or upload;
(7) and (2) clicking a setting button after entering the main interface in the step (1), wherein the setting button comprises functional setting, quality management and engineer debugging. By adopting the technical scheme, the current method in the coagulation method is adopted, and a reagent card strip, namely a coagulation detection card, is matched for blood coagulation detection of a human body sample; the current method utilizes the characteristic that fibrinogen has no conductivity and fibrin has conductivity, thereby generating pulse voltage signals through a main control chip, adding the pulse voltage signals to blood samples in a reaction area, acquiring voltage data by a digital-analog converter, enabling the blood samples to be used as a part of a circuit, and switching on the circuit, so that the blood starts to coagulate by combining with a fixed reaction reagent to induce a series of biochemical reactions, the change of current signals is generated, a coagulation curve of current and time change is generated, and blood coagulation index data is obtained by a data processing system through calculation.
The main interface displays a basic operation mode and has the functions of detection, inquiry and setting, and a user can realize the input of sample information and the output of a detection result through the detection button. The query interface can realize the query of the patient information of the measured result and can store 200 data records; the system setting can realize the setting of basic parameters of the handheld coagulation analysis system, and realize the functions of quality control management, project management and the like of the handheld coagulation analysis system; starting the handheld coagulation analysis system, completing initialization, entering a main control interface, and popping up an alarm prompt on a display interface of the handheld coagulation analysis system if a problem exists; normal inspection can be carried out without alarm prompt; clicking a detection button to enter a card insertion prompt interface, entering an information input interface after normal card insertion, inputting the identity card information (name, sex, age and sample number) of a person to be tested, and automatically storing the information after the information is input into a memory in the equipment; then entering an incubation interface, entering a sample adding interface when the set temperature is reached, and prompting a user to add a sample; after adding the sample, entering a normal detection interface; popping up a detection result interface after detection is finished, and displaying detection result data; the user can select whether to print the current detection data; finishing the detection; the detection historical data can be browsed by clicking a query interface, and information such as a detection report can be displayed in detail by clicking a certain piece of data; the wifi and the Bluetooth can be set by clicking a setting interface, the current time can be set, and quality control operation can be performed by entering quality control management; and entering an engineer interface to operate corresponding functions.
Example 2: the method for carrying out coagulation analysis control by adopting the detection method of the handheld coagulation analysis system specifically comprises the following steps:
s41, a CPU core processing module generates a pulse voltage signal and applies the pulse voltage signal to a blood sample to be detected in a reaction area, the blood sample to be detected is excited to conduct a circuit of a reaction chamber, the blood sample to be detected and a reaction reagent of the reaction chamber react and start to solidify, and a digital-to-analog converter acquires voltage data;
as shown in fig. 4, the step S41 specifically includes:
s411: the CPU generates a pulse signal with the frequency of 1KHz and an analog signal with the frequency of 1V through the ADC, generates a pulse signal with the frequency of 1KHz and the frequency of 0-1V which are alternately changed through the excitation signal generation module, and applies the pulse signal to a common reference electrode of a reagent card strip through the reagent card connector;
s412: during the use process, the CPU controls the incubation module to control the temperature to be in the range of 37 +/-0.5 through a PID algorithm so as to carry out the incubation treatment on the reaction area of the reagent card;
s413: after a blood sample to be detected is added into the reagent card strip, the blood automatically flows into the reaction area, and after entering the reaction area, the blood is combined with the fixed reaction reagent to generate biochemical reaction to start coagulation, so that the change of a current signal is generated; the generated current signal changes and is converted into a voltage signal through the signal conditioning circuit module, and voltage output signals of 5 channels are generated;
s414: generating an external trigger signal with the same frequency and the same time sequence as the reference signal in the excitation signal module, and acquiring an ADC (analog to digital converter) analog signal by adopting an external interrupt mode through a CPU (central processing unit) core processing module, wherein the sampling frequency is 0.1S; processing the data after the acquisition is finished;
in order to accurately receive ADC analog signals of 5 channels, external trigger signals with the same frequency and the same time sequence as the reference signals are generated in the excitation signal module; the CPU core processing module adopts an external interrupt mode to collect and process the ADC analog signals of the 5-path channel,
s42, the blood sample to be detected reacts with the reaction reagent to cause the change of the current signal;
s43, recording the change data of the time and current signals, and obtaining a reaction curve;
as shown in fig. 5, the specific steps of processing data by the data processing system in step S43 are as follows:
s431: the signal conditioning circuit module is used for carrying out operational amplification processing on the analog signals of the 5 channels and transmitting the signals to the ADC data acquisition module;
s432: the ADC data acquisition module acquires data of the analog signal, converts the data into a digital signal for processing, and transmits the digital signal to the exponential smoothing filtering module;
s433: the exponential smoothing filtering module is used for filtering the acquired original data, filtering abnormal values and clutter signals in the data and smoothing a data curve;
s434: performing extraction processing on the data filtered in the step S433 by adopting a data extraction module;
s435: processing the data after the sparse processing by adopting a Douglas sparse algorithm module to form inflection point data of a curve;
s436: calibrating the result by the inflection point of the curve obtained in the step S435 through a calibration curve, and displaying the obtained reaction curve through a data result display module; the adopted calibration formula is y ═ ax + b;
s44 calculating the coagulation index by the data processing system according to the data obtained in the step S43;
in step S433, a preprocessing algorithm is used to filter the collected original data, where the preprocessing algorithm is an exponential data smoothing algorithm, and the exponential smoothing algorithm gives different weights to different observed values, that is, a new observed value gives a larger weight, and a previous observed value gives a smaller weight; the formula is as follows:
St=a×yt+(1-a)×St-1(1)
wherein S istIs a smoothed value at time t, ytIs the actual value at time t, S(t-1)Is the smooth value at the time of t-1, a is a smooth constant with a value range of [0, 1%]. The exponential smoothing method is one of moving average methods, and is characterized in that different weights are given to previous observed values, namely the weight of a more recent observed value is larger than that of a more distant observed value; the exponential smoothing method is classified into a first exponential smoothing method, a second exponential smoothing method, a third exponential smoothing method, and the like according to the smoothing frequency. But their basic ideas are: the predicted value is a weighted sum of the previous observed values, different weights are given to different data, a larger weight is given to new data, and a smaller weight is given to old data; the exponential smoothing algorithm is divided into a primary exponential smoothing method, a secondary exponential smoothing method and a tertiary exponential smoothing method according to different smoothing times;
in the step S435, when the douglas sparse algorithm module is used for processing, the douglas sparse algorithm is combined with the calculation process of the inflection point searching algorithm, and the number of points of the reaction curve is reduced and is approximately represented as a series of feature points, so as to further screen the feature inflection points, wherein the inflection point searching algorithm specifically comprises the following steps:
s441 is characterized in that a straight line AB is connected between the head point A and the tail point B of the curve, and the straight line is a chord of the curve;
s442 obtaining a point C with the maximum distance from the curve to the straight line AB, and calculating the distance d between the point C and the straight line AB;
s443, comparing the distance d with a preset threshold value threshold, and if the distance d is smaller than the threshold value threshold, taking the straight line AB as an approximation of a curve, and finishing the processing of the section of curve;
s444, if the distance d is larger than the threshold, dividing the curve into two sections of AC and BC by using C, and respectively carrying out the processing of the steps S441-S443 on the two sections of the curve AC and BC until the distance d between the two sections of the curve AC and BC is smaller than the threshold value threshold;
and S445, when all the curves are processed, sequentially connecting the broken lines formed by the dividing points, wherein the continuous broken line is used as the approximation of the curve. By adopting the technical scheme, through measuring a large number of samples and clinical tests, the product can obtain a correct reaction curve, and obtain an accurate inflection point through calculation, namely, the inflection point searching algorithm is adopted to calculate the reaction curve after the filtering pretreatment to obtain the reaction time.
Taking PT (prothrombin time) as an example, based on a group of human clinical blood samples, the measured reaction curve is shown in FIGS. 2A-2E, and the found inflection point can ensure the accuracy. The specific result data and target value are shown in table 1 below, and the fitted curve of the two is shown in fig. 3, and the fitting goodness is as high as 0.96.
TABLE 1 LA100 hand-held blood coagulation analyzer PT value test results and target value data comparison (unit: s) based on different samples
Figure BDA0002287016910000111
The handheld coagulation analysis system comprises a detection module, a display touch module, a data storage module, a code scanning module, a Bluetooth module, a WIFI module, a battery power supply and management module, an incubation module, a temperature detection module, a CPU core processing module, an excitation signal module and a data processing system, wherein the quintuplet card detection module, the display touch module, the data storage module, the code scanning module, the Bluetooth module, the WIFI module, the battery power supply and management module, the incubation module, the temperature detection module, the data processing system and the excitation signal module are all in data connection with the CPU core processing module, the detection module is used for dropping a blood sample to be detected at a specified position of the reagent card strip by inserting the reagent card strip, after the blood sample is communicated with an electrode, a digital analog converter ADC acquires a reaction curve obtained by voltage, and after filtering pretreatment, a reaction time is obtained by the inflection point searching algorithm, then transmitting the data to a display touch module to be displayed on a detection result page;
the display touch module adopts a capacitive touch screen and is used for realizing a touch input function; the display module is mainly realized by adopting a 4-inch capacitive touch screen, and can realize a touch input function. The main interface displays a basic operation mode and has the functions of detection, query and setting;
the data storage module is used for storing basic information, detection results and setting parameters of patients corresponding to the blood samples, and is convenient to check and call at any time;
the code scanning module is used for acquiring the serial number of the reagent card strip item through code scanning;
the Bluetooth module is used for searching the usable Bluetooth equipment and carrying out pairing connection according to user selection;
the WIFI module is used for searching for a WIFI network which can be used and connecting according to user selection;
the battery power supply and management module is used for reading and displaying the battery power of the handheld coagulation analysis system in real time;
the incubation module is used for heating the temperature of the detection module to 37 degrees; the intelligent temperature control system comprises a ceramic heating sheet and a thermistor, wherein a CPU core processing module controls the conduction of a triode through an IO port to supply power to the heating sheet, an NTC thermistor monitors the current temperature change condition of the heating sheet in real time and feeds the temperature change condition back to the CPU core processing module, and the CPU core processing module reads temperature information in real time and controls the output frequency of the IO port through a PID algorithm, so that the temperature of the module is accurately controlled;
the temperature detection module reads the temperature of the detection module by adopting a DS18b20 temperature chip;
the data processing system comprises a signal conditioning circuit module, an ADC (analog-to-digital converter) data acquisition module, an exponential smoothing filter module, a data extraction module, a Douglas sparse algorithm module and a data result display module, wherein the signal conditioning circuit module is connected with the ADC data acquisition module, the ADC data acquisition module is connected with the exponential smoothing filter module, the exponential smoothing filter module is connected with the extraction module, the extraction module is connected with the Douglas sparse algorithm module, and the Douglas sparse algorithm module is connected with the data result display module;
the signal conditioning circuit module and the ADC data acquisition module are 5 channels which are respectively an ACT channel, an FIB channel, a TT channel, an APTT channel and a PT 5 channel.
It is obvious to those skilled in the art that the present invention is not limited to the above embodiments, and it is within the scope of the present invention to adopt various insubstantial modifications of the method concept and technical scheme of the present invention, or to directly apply the concept and technical scheme of the present invention to other occasions without modification.

Claims (12)

1. A detection method for blood coagulation of a handheld blood coagulation analysis system is characterized by comprising the following steps:
(1) initializing a handheld coagulation analysis system, and entering a main interface;
(2) if the blood coagulation analysis system is directly detected, taking out the reagent card strip, placing the reagent card strip on a workbench, clicking a code scanning start button, aligning a code scanning module at the lower part of the handheld blood coagulation analysis system with a two-dimensional code on the reagent card strip, reading a batch number of the reagent card strip, if the batch number is valid, prompting to insert the reagent card strip, and otherwise, popping up an alarm prompt and returning to a code scanning interface;
(3) after the reagent card strip is inserted, heating is started, an information input interface is entered, and the information of the effective batch number in the step (2) is input into the handheld coagulation analysis system;
(4) after the information is input, prompting the sample adding; sampling by using a sampling device, adding a blood sample to be detected into a sampling hole of the reagent card strip, and starting detection and analysis by using the handheld blood coagulation analysis system;
(5) and popping up a detection result after the detection is finished, and uploading and printing a detection report on a detection result interface.
2. The method for detecting coagulation in a handheld coagulation analysis system according to claim 1, further comprising the step (6) and the step (7),
(6) after entering the main interface in the step (1), clicking a query button to enter a record query interface, clicking the query button to query after inputting a required query condition on the query interface, and for a record to be printed or uploaded, popping up a sample viewing interface after selecting the record to be printed or uploaded, and clicking a corresponding button to print or upload;
(7) and (2) clicking a setting button after entering the main interface in the step (1), wherein the setting button comprises functional setting, quality management and engineer debugging.
3. A method for controlling coagulation analysis according to the detection method of the handheld coagulation analysis system of claims 1-2, characterized by comprising the following steps:
s41, a CPU core processing module generates a pulse voltage signal and applies the pulse voltage signal to a blood sample to be detected in a reaction area, the blood sample to be detected is excited to conduct a circuit of a reaction chamber and enable the blood sample to be detected to react with a reaction reagent in the reaction chamber and start to solidify, the blood sample is detected to react with the reaction reagent to cause the change of a current signal, and then a digital-to-analog converter acquires voltage data;
s42, recording the change data of the time and current signals, and obtaining a reaction curve;
s43 calculating the coagulation index data from the data obtained in step S43 by the data processing system.
4. The method for controlling blood coagulation analysis by using the detection method of the handheld blood coagulation analysis system according to claim 3, wherein the step S41 is specifically as follows:
s411: the CPU core processing module generates a pulse signal with the frequency of 1KHz and an analog signal with the frequency of 1V through the ADC, generates a pulse signal with the frequency of 1KHz and the frequency of 0-1V which are alternately changed through an excitation signal, and applies the pulse signal to a public reference electrode of a reagent card strip through a reagent card connector;
s412: the CPU core processing module controls the incubation module to control the temperature to be in a range of 37 +/-0.5 through a PID algorithm so as to carry out incubation processing on the reaction area of the reagent card during use;
s413: after a blood sample to be detected is added into the reagent card strip, the blood automatically flows into the reaction area, and after entering the reaction area, the blood is combined with the fixed reaction reagent to generate biochemical reaction to start coagulation, so that the change of a current signal is generated; the current signal is converted into a voltage signal through the signal conditioning circuit module due to the change of the generated current signal, and a voltage output signal is generated;
s414: and generating an external trigger signal with the same frequency and the same time sequence as the reference signal in the excitation signal module, acquiring an ADC (analog to digital converter) analog signal through the CPU core processing module, and performing data processing after the acquisition is finished.
5. The method for controlling coagulation analysis by using the detection method of the handheld coagulation analysis system according to claim 4, wherein the specific steps of processing data by the data processing system in the step S43 are as follows:
s431: the signal conditioning circuit module is used for carrying out operational amplification processing on the analog signals and transmitting the signals to the ADC data acquisition module;
s432: the ADC data acquisition module acquires data of the analog signal, converts the data into a digital signal for processing, and transmits the digital signal to the exponential smoothing filtering module;
s433: the exponential smoothing filtering module is used for filtering the acquired original data, filtering abnormal values and clutter signals in the data and smoothing a data curve;
s434: performing extraction processing on the data filtered in the step S433 by adopting a data extraction module;
s435: processing the data after the sparse processing by adopting a Douglas sparse algorithm module to form inflection point data of a curve;
s436: and (5) calibrating the result by the inflection point of the curve obtained in the step (S435) through a calibration curve, and displaying the obtained reaction curve through a data result display module.
6. The method for controlling coagulation analysis according to claim 4, wherein the blood coagulation analysis is performed by a hand-held coagulation analysis system,
in step S433, a preprocessing algorithm is used to filter the collected original data, where the preprocessing algorithm is an exponential data smoothing algorithm, and the exponential smoothing algorithm gives different weights to different observed values, that is, a new observed value gives a larger weight, and a previous observed value gives a smaller weight; the formula is as follows:
St=a×yt+(1-a)×St-1(1)
wherein S istIs a smoothed value at time t, ytIs the actual value at time t, S(t-1)Is the smooth value at the time of t-1, a is a smooth constant with a value range of [0, 1%]。
7. The method for controlling coagulation analysis using the detection method of handheld coagulation analysis system according to claim 6, wherein the exponential smoothing algorithm is divided into a first exponential smoothing method, a second exponential smoothing method and a third exponential smoothing method according to the smoothing times.
8. The method according to claim 5, wherein the calculation process of using the inflection point searching algorithm in the step S435 using the Douglas sparse algorithm module for processing includes the Douglas sparse algorithm, and the reaction curve is reduced in number of points and is approximately represented as a series of feature points, so as to further screen the feature inflection points, wherein the inflection point searching algorithm includes the following specific steps:
s441 is characterized in that a straight line AB is connected between the head point A and the tail point B of the curve, and the straight line is a chord of the curve;
s442 obtaining a point C with the maximum distance from the curve to the straight line AB, and calculating the distance d between the point C and the straight line AB;
s443, comparing the distance d with a preset threshold value threshold, and if the distance d is smaller than the threshold value threshold, taking the straight line AB as an approximation of a curve, and finishing the processing of the section of curve;
s444, if the distance d is larger than the threshold, dividing the curve into two sections of AC and BC by using C, and respectively carrying out the processing of the steps S441-S443 on the two sections of the curve AC and BC until the distance d between the two sections of the curve AC and BC is smaller than the threshold value threshold;
and S445, when all the curves are processed, sequentially connecting the broken lines formed by the dividing points, wherein the continuous broken line is used as the approximation of the curve.
9. The method for controlling coagulation analysis according to claim 8, wherein the handheld coagulation analysis system comprises a detection module, a display touch module, a data storage module, a code scanning module, a bluetooth module, a WIFI module, a battery power supply and management module, an incubation module, a temperature detection module, a CPU core processing module, an excitation signal module and a data processing system, and the quintuplet card detection module, the display touch module, the data storage module, the code scanning module, the bluetooth module, the WIFI module, the battery power supply and management module, the incubation module, the temperature detection module, the data processing system and the excitation signal module are all in data connection with the CPU core processing module.
10. The method for controlling blood coagulation analysis by using the detection method of the handheld blood coagulation analysis system according to claim 9, wherein the detection module is used for dropping a blood sample to be detected at a designated position of the reagent card strip by inserting the reagent card strip, acquiring a reaction curve obtained by voltage acquisition by the digital-analog converter after the blood sample is conducted with the electrode, obtaining reaction time by using the inflection point searching algorithm after performing filtering pretreatment, and transmitting the reaction curve to the display touch module for display on a detection result page;
the display touch module adopts a capacitive touch screen and is used for realizing a touch input function;
the data storage module is used for storing basic information, detection results and setting parameters of patients corresponding to the blood samples, and is convenient to check and call at any time;
the code scanning module is used for acquiring the serial number of the reagent card strip item through code scanning;
the Bluetooth module is used for searching the usable Bluetooth equipment and carrying out pairing connection according to user selection;
the WIFI module is used for searching for a WIFI network which can be used and connecting according to user selection;
the battery power supply and management module is used for reading and displaying the battery power of the handheld coagulation analysis system in real time;
the incubation module is used for heating the temperature of the detection module to 37 degrees;
the temperature detection module reads the detection module temperature by adopting a DS18b20 temperature chip.
11. The method according to claim 9, wherein the data processing system comprises a signal conditioning circuit module, an ADC data acquisition module, an exponential smoothing filter module, a data extraction module, a douglas rarefaction algorithm module, and a data result display module, the signal conditioning circuit module is connected to the ADC data acquisition module, the ADC data acquisition module is connected to the exponential smoothing filter module, the exponential smoothing filter module is connected to the extraction module, the extraction module is connected to the douglas rarefaction algorithm module, and the douglas rarefaction algorithm module is connected to the data result display module.
12. The method of claim 11, wherein the signal conditioning circuit module and the ADC data acquisition module are 5 channels, which are an ACT channel, a FIB channel, a TT channel, an APTT channel, and a PT 5 channel, respectively.
CN201911164388.8A 2019-11-25 2019-11-25 Detection method and coagulation analysis control method of handheld coagulation analysis system Active CN110988321B (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201911164388.8A CN110988321B (en) 2019-11-25 2019-11-25 Detection method and coagulation analysis control method of handheld coagulation analysis system

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN201911164388.8A CN110988321B (en) 2019-11-25 2019-11-25 Detection method and coagulation analysis control method of handheld coagulation analysis system

Publications (2)

Publication Number Publication Date
CN110988321A true CN110988321A (en) 2020-04-10
CN110988321B CN110988321B (en) 2022-06-03

Family

ID=70086471

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201911164388.8A Active CN110988321B (en) 2019-11-25 2019-11-25 Detection method and coagulation analysis control method of handheld coagulation analysis system

Country Status (1)

Country Link
CN (1) CN110988321B (en)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112162102A (en) * 2020-07-22 2021-01-01 三诺生物传感股份有限公司 Correction method for four-item blood coagulation test
CN113343899A (en) * 2021-06-19 2021-09-03 南京岚煜生物科技有限公司 Method for determining coagulation mutation point based on slope detection

Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1591010A (en) * 2002-08-30 2005-03-09 生命扫描有限公司 Method and system for determining acceptability of signal data collected from prothrombin time test strip
CN102539661A (en) * 2010-11-24 2012-07-04 希森美康株式会社 Sample analyzer
CN105102988A (en) * 2013-04-02 2015-11-25 株式会社日立高新技术 Automatic analysis device and analysis method
CN105530859A (en) * 2013-06-26 2016-04-27 华盛顿大学 Fluidics device for individualized coagulation measurements
CN105829877A (en) * 2013-10-16 2016-08-03 豪夫迈·罗氏有限公司 Communication interface clip for a handheld medical device
CN205581122U (en) * 2016-03-25 2016-09-14 丁鸿 Eight passageway automatic coagulation analyzer
CN107810412A (en) * 2015-06-29 2018-03-16 Ca卡西索有限公司 Blood profile system and method
CN109030837A (en) * 2017-06-09 2018-12-18 希森美康株式会社 The judgment method and blood sample analysis device of blood sample
CN109946444A (en) * 2019-03-29 2019-06-28 赫安仕科技(苏州)有限公司 A kind of full automatic thrombus detection device for elasticity and detection method

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1591010A (en) * 2002-08-30 2005-03-09 生命扫描有限公司 Method and system for determining acceptability of signal data collected from prothrombin time test strip
CN102539661A (en) * 2010-11-24 2012-07-04 希森美康株式会社 Sample analyzer
CN105102988A (en) * 2013-04-02 2015-11-25 株式会社日立高新技术 Automatic analysis device and analysis method
CN105530859A (en) * 2013-06-26 2016-04-27 华盛顿大学 Fluidics device for individualized coagulation measurements
CN105829877A (en) * 2013-10-16 2016-08-03 豪夫迈·罗氏有限公司 Communication interface clip for a handheld medical device
CN107810412A (en) * 2015-06-29 2018-03-16 Ca卡西索有限公司 Blood profile system and method
CN205581122U (en) * 2016-03-25 2016-09-14 丁鸿 Eight passageway automatic coagulation analyzer
CN109030837A (en) * 2017-06-09 2018-12-18 希森美康株式会社 The judgment method and blood sample analysis device of blood sample
CN109946444A (en) * 2019-03-29 2019-06-28 赫安仕科技(苏州)有限公司 A kind of full automatic thrombus detection device for elasticity and detection method

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112162102A (en) * 2020-07-22 2021-01-01 三诺生物传感股份有限公司 Correction method for four-item blood coagulation test
CN112162102B (en) * 2020-07-22 2023-09-08 三诺生物传感股份有限公司 Correction method for four blood coagulation tests
CN113343899A (en) * 2021-06-19 2021-09-03 南京岚煜生物科技有限公司 Method for determining coagulation mutation point based on slope detection
CN113343899B (en) * 2021-06-19 2022-10-14 南京岚煜生物科技有限公司 Method for determining coagulation mutation point based on slope detection

Also Published As

Publication number Publication date
CN110988321B (en) 2022-06-03

Similar Documents

Publication Publication Date Title
CN103392129B (en) There is the capacitance detecting in the electrochemical analysis of the response of improvement
US8890682B2 (en) Blood glucose measuring device
CN110988321B (en) Detection method and coagulation analysis control method of handheld coagulation analysis system
CN111735970B (en) Method for carrying out coagulation analysis by coagulation analysis system
CN112386226B (en) POCT-based disease prevention and control method and system
JP2010069193A (en) System for collecting biological information
WO2023035609A1 (en) Rapid gene screening method and device
CN109470879A (en) A kind of Portable type full-automatic micro-current control biochemical analyzer
JP2021501412A (en) Automatic rule generation for laboratory equipment
CN113343899B (en) Method for determining coagulation mutation point based on slope detection
CN101828188A (en) The estimation of diagnosis marker
US20220406426A1 (en) Clinical decision support on clinical analyzer
CN203572830U (en) Multi-channel thrombelastogram instrument
AU2019204797A1 (en) Analyte meter with operational range configuration technique
US20230168219A1 (en) Electrochemical-sensing apparatus and method therefor
JP2022130590A (en) User interface for managing multiple-diagnostic engine environment
CN111060703B (en) Test paper sensor analysis method, equipment and system
US9039875B2 (en) Liquid sample measuring device
CN211718185U (en) Detection device and detection system
CN113039439A (en) Sample analysis apparatus and method of evaluating reagent dispensing
US20240023815A1 (en) Portable, multi-functional health monitoring device
CN109328302A (en) Analyte detection system and method
US20200310395A1 (en) Method of operating a diagnostic instrument
CN113325048A (en) Detection device, method for detecting detection sample by using detection device and detection system
CN206618808U (en) A kind of rapid gene electric field discharges Acquisition Detection instrument

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination
GR01 Patent grant
GR01 Patent grant