阅读说明：本技术 一种凝血检测方法和凝血分析仪 (Blood coagulation detection method and blood coagulation analyzer ) 是由 武振兴 郭文恒 李聪 于 2020-06-01 设计创作，主要内容包括：本发明实施例公开了一种凝血检测方法和凝血分析仪,该方法包括：凝血分析仪在采用磁珠法对试样进行凝血检测的过程中,获取检测数据；基于随时间变化的磁珠振幅判断是否出现异常情况,在确定出现异常情况时,提升所述试样中待测物的浓度并采用磁珠法重新进行凝血检测；或者,所述凝血分析仪在确定出现所述异常情况时,生成提示信息,所述提示信息用于提示：所述试样中待测物的浓度偏低。如此,识别由低值样本引起的异常情况,针对该异常情况,通过提升试样中待测物的浓度并重新进行凝血检测,有利于得出血液凝固时间。(The embodiment of the invention discloses a blood coagulation detection method and a blood coagulation analyzer, wherein the method comprises the following steps: the method comprises the following steps that a blood coagulation analyzer acquires detection data in the process of carrying out blood coagulation detection on a sample by a magnetic bead method; judging whether an abnormal condition occurs or not based on the amplitude of the magnetic beads changing along with the time, and when the abnormal condition is determined, increasing the concentration of the substance to be detected in the sample and carrying out coagulation detection again by adopting a magnetic bead method; or, the blood coagulation analyzer generates prompt information when determining that the abnormal condition occurs, wherein the prompt information is used for prompting: the concentration of the substance to be detected in the sample is low. Therefore, the abnormal condition caused by the low-value sample is identified, and the blood coagulation detection is carried out again by improving the concentration of the object to be detected in the sample aiming at the abnormal condition, so that the blood coagulation time is favorably obtained.)

1. A coagulation detection method, for use in a coagulation analyzer, comprising:

the blood coagulation analyzer acquires detection data in the process of carrying out blood coagulation detection on a sample by adopting a magnetic bead method, wherein the detection data represents the amplitude of magnetic beads changing along with time;

the blood coagulation analyzer judges whether an abnormal condition occurs or not based on the magnetic bead amplitude changing along with the time, wherein the abnormal condition represents that the magnetic bead amplitude is reduced to be lower than a first amplitude threshold value and then is increased to be higher than the first amplitude threshold value; the first amplitude threshold represents a bead amplitude threshold used to determine clotting time;

when the blood coagulation analyzer determines that the abnormal condition occurs, the concentration of the substance to be detected in the sample is increased, and blood coagulation detection is carried out again by adopting a magnetic bead method; or, the blood coagulation analyzer generates prompt information when determining that the abnormal condition occurs, wherein the prompt information is used for prompting: the concentration of the substance to be detected in the sample is low.

2. The method of claim 1, wherein the coagulation analyzer determines whether an abnormal condition occurs based on the time-varying magnetic bead amplitude, comprising:

and when the amplitude of the magnetic bead changing along with the time meets a preset condition, the blood coagulation analyzer determines that the abnormal condition occurs, wherein the preset condition at least comprises the following steps: after continuously acquiring M magnetic bead amplitudes smaller than the first amplitude threshold value, continuously acquiring N magnetic bead amplitudes larger than a second amplitude threshold value, wherein the second amplitude threshold value is larger than or equal to the first amplitude threshold value; m and N are both integers greater than 1.

3. The method of claim 2, wherein the preset condition further comprises:

and for the acquired M bead amplitudes smaller than the first amplitude threshold, wherein the time point when the L-th magnetic bead amplitude is smaller than the first amplitude threshold is later than a preset time point, and L is an integer greater than or equal to 1.

4. The method of claim 3, wherein the time period between the preset time point and the start of the coagulation test is between 30 seconds and 40 seconds.

5. The method of claim 1, wherein the raising the concentration of the analyte in the sample and the performing the coagulation test again using a magnetic bead method comprises:

the blood coagulation analyzer automatically improves the concentration of the blood sample in the sample according to a preset multiple, and blood coagulation detection is carried out again by adopting a magnetic bead method.

6. The method of claim 1, further comprising:

after a concentration and re-measurement instruction input by a user is received, based on the concentration and re-measurement instruction, the concentration of the blood sample in the sample is increased, and the magnetic bead method is adopted for carrying out coagulation detection again.

7. The method of claim 6, wherein the instructions for re-concentration comprise a fold increase in blood sample concentration in the sample.

8. The method of claim 6, wherein the instructions for concentration retesting include at least one of an amount of a blood sample and an amount of a reagent.

9. The method of any one of claims 6 to 8, wherein the increasing the concentration of the analyte in the sample and performing the re-coagulation detection by using a magnetic bead method based on the concentration re-measurement instruction comprises:

and readjusting at least one of the amount of the blood sample and the amount of the reagent according to the concentration and remeasurement instruction to obtain a reconfigured sample, and performing coagulation detection on the reconfigured sample by using a magnetic bead method.

10. A coagulation analyzer is characterized by comprising a controller and a sample detection device, wherein the sample detection device comprises a driving coil and a measuring coil, and the driving coil is used for generating an electromagnetic field for driving magnetic beads in a container to move under the control of the controller; the measuring coil is used for acquiring induced current representing the magnetic bead motion information; a sample is also added into the container; the magnetic beads are positioned in the sample;

the controller is used for acquiring detection data based on the induced current in the process of controlling the sample detection device to perform coagulation detection on the sample by adopting a magnetic bead method, and the detection data represents the amplitude of magnetic beads changing along with time;

the controller is further configured to determine whether an abnormal condition occurs based on the amplitude of the magnetic bead changing with time, where the abnormal condition indicates that the amplitude of the magnetic bead decreases below a first amplitude threshold and then increases above the first amplitude threshold; the first amplitude threshold represents a bead amplitude threshold used to determine clotting time;

and the controller is also used for increasing the concentration of the object to be detected in the sample and controlling the sample detection device to perform coagulation detection again by adopting a magnetic bead method when the abnormal condition is determined.

11. The coagulation analyzer as claimed in claim 10, wherein the controller is configured to determine that the abnormal condition occurs when the amplitude of the magnetic beads changing with time satisfies a preset condition, and the preset condition at least includes: continuously acquiring N magnetic bead amplitudes larger than a second amplitude threshold value after continuously acquiring M magnetic bead amplitudes smaller than the first amplitude threshold value, wherein the second amplitude threshold value is larger than or equal to the first amplitude threshold value; m and N are both integers greater than 1.

12. The coagulation analyzer of claim 11, wherein the preset conditions further comprise: for the acquired M magnetic bead amplitudes smaller than the first amplitude threshold, the time point when the L-th magnetic bead amplitude smaller than the first amplitude threshold appears is later than a preset time point, and L is an integer greater than or equal to 1.

13. The coagulation analyzer as claimed in claim 10, wherein the controller is further configured to increase the concentration of the analyte in the sample and control the sample detection device to perform the coagulation detection again by using a magnetic bead method when the abnormal condition is determined, and the controller comprises:

and the controller is used for automatically increasing the concentration of the blood sample in the sample according to a preset multiple when the abnormal condition is determined to occur, and controlling the sample detection device to perform coagulation detection again by adopting a magnetic bead method.

14. The coagulation analyzer is characterized by comprising a controller, a sample detection device and a human-computer interaction unit, wherein the sample detection device comprises a driving coil and a measuring coil, and the driving coil is used for generating an electromagnetic field for driving magnetic beads in a container to move under the control of the controller; the measuring coil is used for acquiring induced current representing the magnetic bead motion information; a sample is also added into the container; the magnetic beads are positioned in the sample;

the controller is used for acquiring detection data based on the induced current in the process of controlling the sample detection device to perform coagulation detection on the sample by adopting a magnetic bead method, and the detection data represents the amplitude of magnetic beads changing along with time;

the controller is further configured to determine whether an abnormal condition occurs based on the amplitude of the magnetic bead changing with time, where the abnormal condition indicates that the amplitude of the magnetic bead decreases below a first amplitude threshold and then increases above the first amplitude threshold; the first amplitude threshold represents a bead amplitude threshold used to determine clotting time;

the controller is further configured to control the human-computer interaction unit to generate prompt information when the abnormal condition is determined to occur, where the prompt information is used to prompt: the concentration of the substance to be detected in the sample is low.

15. The coagulation analyzer of claim 14, wherein the controller is configured to determine that the abnormal condition occurs when the time-varying magnetic bead amplitude satisfies a preset condition, the preset condition at least comprising: after M magnetic bead amplitudes smaller than a first amplitude threshold value are continuously acquired, continuously acquiring N magnetic bead amplitudes larger than a second amplitude threshold value, wherein the second amplitude threshold value is larger than or equal to the first amplitude threshold value; m and N are both integers greater than 1.

16. The coagulation analyzer of claim 15, wherein the preset conditions further comprise: and for the acquired M bead amplitudes smaller than the first amplitude threshold, wherein the time point when the L-th magnetic bead amplitude is smaller than the first amplitude threshold is later than a preset time point, and L is an integer greater than or equal to 1.

17. The coagulation analyzer of claim 14, wherein the human-computer interaction unit is configured to receive a concentrated retest instruction input by a user and send the concentrated retest instruction to the controller;

and the controller is used for promoting the concentration of the blood sample in the sample and controlling the sample detection device to perform coagulation detection again by adopting a magnetic bead method based on the concentration and retesting instruction.

Technical Field

The invention relates to a blood coagulation detection technology, in particular to a blood coagulation detection method and a blood coagulation analyzer.

Background

In the related art, the blood coagulation analyzer can be used for blood coagulation detection, and in specific implementation, the magnetic bead method can be used for blood coagulation detection, and the principle of blood coagulation detection by the magnetic bead method is as follows: and a magnetic field generated by a coil is used for driving the magnetic beads to move, and the blood coagulation time is obtained by detecting the change of the moving amplitude of the magnetic beads. If the concentration of Fibrinogen (FIB) in the blood sample for coagulation detection is low, the sample viscosity is not high enough and the resistance on the magnetic beads is not large enough in the coagulation reaction stage of coagulation detection, so that the amplitude of the magnetic beads may be abnormally changed, the blood coagulation time cannot be determined, and the concentration of FIB in the blood sample cannot be obtained.

Disclosure of Invention

The embodiment of the invention is expected to provide a blood coagulation detection method and a blood coagulation analyzer, which can identify abnormal conditions caused by low-value samples, and are favorable for obtaining blood coagulation time by improving the concentration of an object to be detected in a sample and carrying out blood coagulation detection again aiming at the abnormal conditions.

The embodiment of the invention provides a blood coagulation detection method, which is applied to a blood coagulation analyzer and comprises the following steps:

the blood coagulation analyzer acquires detection data in the process of carrying out blood coagulation detection on a sample by adopting a magnetic bead method, wherein the detection data represents the amplitude of magnetic beads changing along with time;

the blood coagulation analyzer judges whether an abnormal condition occurs or not based on the magnetic bead amplitude changing along with the time, wherein the abnormal condition represents that the magnetic bead amplitude is reduced to be lower than the first amplitude threshold value and then is increased to be higher than the first amplitude threshold value; the first amplitude threshold represents a bead amplitude threshold used to determine clotting time;

when the blood coagulation analyzer determines that the abnormal condition occurs, the concentration of the substance to be detected in the sample is increased, and blood coagulation detection is carried out again by adopting a magnetic bead method; or, the blood coagulation analyzer generates prompt information when determining that the abnormal condition occurs, wherein the prompt information is used for prompting: and the concentration of the substance to be detected in the sample is low, or the concentration of the substance to be detected in the sample needs to be increased and the magnetic bead method is adopted to carry out coagulation detection again.

Wherein the sample comprises a blood sample and a reagent.

Optionally, the blood coagulation analyzer determines whether an abnormal condition occurs based on the amplitude of the magnetic beads changing with time, including:

and when the amplitude of the magnetic bead changing along with the time meets a preset condition, the blood coagulation analyzer determines that the abnormal condition occurs, wherein the preset condition at least comprises the following steps: after M magnetic bead amplitudes smaller than a first amplitude threshold value are continuously acquired, the continuously acquired N magnetic bead amplitudes are larger than a second amplitude threshold value, and the second amplitude threshold value is larger than or equal to the first amplitude threshold value; m and N are both integers greater than 1.

Optionally, M ranges from 2 to 8.

Optionally, the value of N ranges from 2 to 8.

Optionally, the second amplitude threshold is K times the first amplitude threshold, and a value range of K is 1.1 to 1.9.

Optionally, the preset condition further includes:

and for the acquired M bead amplitudes smaller than the first amplitude threshold, wherein the time point when the L-th magnetic bead amplitude is smaller than the first amplitude threshold is later than a preset time point, and L is an integer greater than or equal to 1.

Optionally, L has a value in the range of 1 to 3.

Optionally, the time period between the preset time point and the start of the coagulation detection is between 30 seconds and 40 seconds. The start time of the blood coagulation detection is a time at which the blood coagulation detection of the sample is started.

Optionally, the increasing the concentration of the analyte in the sample and performing the blood coagulation detection again by using a magnetic bead method includes:

the blood coagulation analyzer automatically improves the concentration of the blood sample in the sample according to a preset multiple, and blood coagulation detection is carried out again by adopting a magnetic bead method.

Optionally, the method further comprises:

after a concentration and re-measurement instruction input by a user is received, based on the concentration and re-measurement instruction, the concentration of the blood sample in the sample is increased, and the magnetic bead method is adopted for carrying out coagulation detection again.

Optionally, the instructions for re-concentration include a fold increase in the concentration of the blood sample in the sample (and also a fold increase in the analyte in the sample).

Optionally, the concentration of the blood sample represents a ratio of the amount of the blood sample to the amount of the sample.

Optionally, the instructions for re-concentration include at least one of an amount of the blood sample and an amount of the reagent.

Optionally, the reagent comprises at least one or more of a diluent for diluting the blood sample and a reagent for triggering a coagulation reaction of the blood sample.

Optionally, based on the instruction for concentration and retesting, increasing the concentration of the analyte in the sample and performing the blood coagulation detection again by using a magnetic bead method, including:

and readjusting at least one of the amount of the blood sample and the amount of the reagent according to the concentration and remeasurement instruction to obtain a reconfigured sample, and performing coagulation detection on the reconfigured sample by using a magnetic bead method.

The embodiment of the invention also provides a blood coagulation analyzer, which comprises a controller and a sample detection device, wherein the sample detection device comprises a driving coil and a measuring coil, and the driving coil is used for generating an electromagnetic field for driving magnetic beads in a container to move under the control of the controller; the measuring coil is used for acquiring induced current representing the magnetic bead motion information; a sample is added into the container, and comprises a blood sample and a reagent; the magnetic beads are positioned in the sample;

the controller is used for acquiring detection data based on the induced current in the process of controlling the sample detection device to perform coagulation detection on the sample by adopting a magnetic bead method, and the detection data represents the amplitude of magnetic beads changing along with time;

the controller is further configured to determine whether an abnormal condition occurs based on the amplitude of the magnetic bead changing with time, where the abnormal condition indicates that the amplitude of the magnetic bead decreases to be lower than the first amplitude threshold and then increases to be higher than the first amplitude threshold; the first amplitude threshold represents a bead amplitude threshold used to determine clotting time;

and the controller is also used for increasing the concentration of the object to be detected in the sample and controlling the sample detection device to perform coagulation detection again by adopting a magnetic bead method when the abnormal condition is determined.

Optionally, the controller is configured to determine that the abnormal condition occurs when it is determined that the amplitude of the magnetic bead changing with time satisfies a preset condition, where the preset condition at least includes: continuously acquiring the amplitudes of M magnetic beads smaller than a first amplitude threshold value, wherein the amplitudes of the N magnetic beads are larger than a second amplitude threshold value, and the second amplitude threshold value is larger than or equal to the first amplitude threshold value; m and N are both integers greater than 1.

Optionally, the preset condition further includes: for the acquired M magnetic bead amplitudes smaller than the first amplitude threshold, the time point when the L-th magnetic bead amplitude smaller than the first amplitude threshold appears is later than a preset time point, and L is an integer greater than or equal to 1.

Optionally, the controller is configured to automatically increase the concentration of the blood sample in the sample according to a preset multiple, and control the sample detection device to perform the blood coagulation detection again by using a magnetic bead method.

The embodiment of the invention also provides another blood coagulation analyzer, which comprises a controller, a sample detection device and a human-computer interaction unit, wherein the sample detection device comprises a driving coil and a measuring coil, and the driving coil is used for generating an electromagnetic field for driving magnetic beads in a container to move under the control of the controller; the measuring coil is used for acquiring induced current representing the magnetic bead motion information; a sample is added into the container, and comprises a blood sample and a reagent; the magnetic beads are positioned in the sample;

the controller is used for acquiring detection data based on the induced current in the process of controlling the sample detection device to perform coagulation detection on the sample by adopting a magnetic bead method, and the detection data represents the amplitude of magnetic beads changing along with time;

the controller is further configured to determine whether an abnormal condition occurs based on the amplitude of the magnetic bead changing with time, where the abnormal condition indicates that the amplitude of the magnetic bead decreases to be lower than the first amplitude threshold and then increases to be higher than the first amplitude threshold; the first amplitude threshold represents a bead amplitude threshold used to determine clotting time;

the controller is further configured to control the human-computer interaction unit to generate prompt information when the abnormal condition is determined to occur, where the prompt information is used to prompt: and the concentration of the substance to be detected in the sample is low, or the concentration of the substance to be detected in the sample needs to be increased and the magnetic bead method is adopted to carry out coagulation detection again.

Optionally, the controller is configured to determine that the abnormal condition occurs when the amplitude of the magnetic bead changing with time meets a preset condition, where the preset condition at least includes: after M magnetic bead amplitudes smaller than a first amplitude threshold value are continuously acquired, continuously acquiring N magnetic bead amplitudes larger than a second amplitude threshold value, wherein the second amplitude threshold value is larger than or equal to the first amplitude threshold value; m and N are both integers greater than 1.

Optionally, the preset condition further includes: and for the acquired M bead amplitudes smaller than the first amplitude threshold, wherein the time point when the L-th magnetic bead amplitude is smaller than the first amplitude threshold is later than a preset time point, and L is an integer greater than or equal to 1.

Optionally, the human-computer interaction unit is configured to receive a concentration retest instruction input by a user, and send the concentration retest instruction to the controller;

and the controller is used for promoting the concentration of the blood sample in the sample and controlling the sample detection device to perform coagulation detection again by adopting a magnetic bead method based on the concentration and retesting instruction.

Optionally, the concentration of the blood sample represents a ratio of the amount of the blood sample to the amount of the sample.

Optionally, the blood sample is a plasma sample.

Optionally, the test agent is Fibrinogen (FIB).

In the embodiment of the invention, a blood coagulation analyzer acquires detection data in the process of carrying out blood coagulation detection on a sample by a magnetic bead method, wherein the sample comprises a blood sample and a reagent, and the detection data represents the amplitude of magnetic beads changing along with time; the blood coagulation analyzer judges whether an abnormal condition occurs or not based on the amplitude of the magnetic beads changing along with time, wherein the abnormal condition represents that the amplitude of the magnetic beads is reduced to be lower than the first amplitude threshold value and then is increased to be higher than the first amplitude threshold value; the first amplitude threshold represents a bead amplitude threshold used to determine clotting time; when the blood coagulation analyzer determines that abnormal conditions occur, the concentration of the substance to be detected in the sample is increased, and the magnetic bead method is adopted to carry out blood coagulation detection on the substance to be detected again; or when the blood coagulation analyzer determines that an abnormal condition occurs, generating prompt information, wherein the prompt information is used for prompting: the concentration of the substance to be detected in the sample is low, or the concentration of the substance to be detected in the sample needs to be increased and the magnetic bead method is adopted to carry out the blood coagulation detection again. In the embodiment of the invention, when the blood coagulation analyzer determines that an abnormal condition occurs, the blood sample can be regarded as a low-value sample, and the blood coagulation time and the FIB concentration in the low-value plasma sample can be obtained by increasing the concentration of an object to be detected (such as FIB) in the sample and performing blood coagulation detection again. Compared with the prior art, the FIB concentration detection capability of the coagulation analyzer for low-value plasma samples is improved.

Drawings

FIG. 1 is a diagram illustrating a classification process for abnormal situations in the related art;

FIG. 2 is a schematic diagram of a coagulation analyzer according to an embodiment of the present invention;

FIG. 3 is a schematic structural diagram of a sample detection device according to an embodiment of the present invention;

FIG. 4 is a schematic diagram illustrating the principle of blood coagulation detection using the magnetic bead method in an embodiment of the present invention;

FIG. 5 is a schematic diagram illustrating voltage variations of the receiving coil according to an embodiment of the present invention;

FIG. 6 is a schematic diagram illustrating a force analysis of a magnetic bead during a blood coagulation detection using a magnetic bead method according to an embodiment of the present invention;

FIG. 7 is a diagram showing a standard curve of FIB concentration detection items according to an embodiment of the present invention;

FIG. 8 is a flow chart of a coagulation detection method according to an embodiment of the present invention;

FIG. 9 is a graph showing the variation of the magnetic bead amplitude with time according to an embodiment of the present invention;

FIG. 10 is a graph showing another variation of the magnetic bead amplitude with time according to an embodiment of the present invention;

FIG. 11 is a diagram illustrating classification processing for abnormal situations according to an embodiment of the present invention;

FIG. 12 is a graph showing another variation of the magnetic bead amplitude with time according to an embodiment of the present invention;

FIG. 13 is a schematic diagram of another coagulation analyzer according to an embodiment of the present invention;

fig. 14 is a schematic structural diagram of another coagulation analyzer according to an embodiment of the present invention.

Detailed Description

In the related art, a magnetic bead method may be used to perform a coagulation assay on a sample, which includes a blood sample and a reagent; wherein the blood sample may be a plasma sample and the reagent may comprise at least one of a diluent for diluting said blood sample and a reagent for triggering a coagulation reaction.

Fibrinogen (FIB) is a routine test item for coagulation analysis. In the process of blood coagulation detection by using the magnetic bead method, if the concentration of FIB in a plasma sample is low (i.e. low value plasma sample), the following abnormal conditions may occur:

abnormal case 1): the amplitude of the magnetic bead is smaller than or equal to the first amplitude threshold value after a long time, but is considered to be within the preset maximum measurement time. This is the case for magnetic beads during detection when the FIB concentration in the plasma sample is within a certain range, for example, between 1g/L and 1.5 g/L. At this time, the FIB concentration detection item standard curve can be inquired according to the solidification time to obtain the FIB concentration value in the plasma sample, and the instrument judges whether to trigger concentration retest according to the value.

Abnormal case 2): if the FIB concentration in the plasma sample is low, for example, the FIB concentration in the plasma sample is lower than 0.5g/L, the FIB content in the plasma sample is very low, which may result in the amplitude of the magnetic beads not being less than or equal to the first amplitude threshold (i.e., not being coagulated) within the predetermined maximum measurement time during the detection process. At this time, the FIB concentration detection item standard curve can be inquired according to the preset longest measurement time to obtain the FIB concentration value in the plasma sample, and the instrument judges whether to trigger concentration retest according to the value. In practical applications, the above-mentioned maximum measurement time may be set empirically, for example, the range of the maximum measurement time is 100 seconds to 200 seconds.

Abnormal case 3): in the detection process, after the amplitude of the magnetic bead is smaller than the first amplitude threshold, the situation that the amplitude of the magnetic bead is larger than the first amplitude threshold within a set time length (namely, the coagulation measurement fails) may also occur. For example: the anomaly may occur when the FIB concentration in the plasma sample is between the FIB concentration corresponding to anomaly 1) and the FIB concentration corresponding to anomaly 2).

In the embodiment of the present application, the first amplitude threshold represents a magnetic bead amplitude threshold for determining the coagulation time. The magnetic bead amplitude threshold may be determined according to an initial amplitude of the magnetic bead at the start time of the blood coagulation detection, for example, the magnetic bead amplitude threshold is a% of the initial amplitude of the magnetic bead at the start time of the blood coagulation detection, and for example, a may be 30 to 70. The coagulation time is a time interval from the start of the coagulation detection to the time when the bead amplitude decays to the bead amplitude threshold value. The start time of the blood coagulation detection is a time at which the blood coagulation detection of the sample is started.

Fig. 1 is a schematic diagram of classification processing for abnormal situations in the related art, and as shown in fig. 1, for the three abnormal situations that may occur in FIB low-value samples, the abnormal situations 1) and 2) are classified as class I, the abnormal situation 3) is classified as class II, and for class I: and when the sample is solidified after a long time or is not solidified within the preset longest measuring time, the instrument automatically judges whether to trigger concentration retest or not, and then reports a test result. For class II: when the solidification measurement fails, the current instrument can only terminate the test and then report an abnormal identifier.

As can be seen, currently, for the FIB low-value plasma sample in which the abnormal condition 3) occurs, the blood coagulation time cannot be determined, and thus the FIB concentration value in the plasma sample cannot be obtained. In order to solve the technical problem, the embodiment of the invention provides a blood coagulation detection method.

The technical solution in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention.

The embodiment of the invention provides a blood coagulation detection method and a blood coagulation analyzer. Fig. 2 is a schematic structural diagram of a blood coagulation analyzer according to an embodiment of the present invention, and as shown in fig. 2, the blood coagulation analyzer includes a controller 101 and a sample detection device 102, the controller 101 is configured to control the sample detection device 102 to perform blood coagulation detection, and the sample detection device 102 is configured to send detection data obtained by the blood coagulation detection to the controller 101.

In practical applications, the controller 101 may be at least one of an Application Specific Integrated Circuit (ASIC), a Digital Signal Processor (DSP), a Digital Signal Processing Device (DSPD), a Programmable Logic Device (PLD), a Field Programmable Gate Array (FPGA), a Central Processing Unit (CPU), a controller, a microcontroller, and a microcontroller.

The structure and function of the sample detection device are exemplarily explained below by fig. 3, fig. 3 is a schematic structural diagram of the sample detection device according to the embodiment of the present invention, and as shown in fig. 3, the sample detection device 102 includes: a consumable management module 201, a sample feeding module 202, a reagent management module 203, an incubation module 204, and a measurement module 205. The consumable management module 201 may transmit consumables, such as containers, which may be reaction cups, to the incubation module 204 under the control of the controller 101. The sample feed module 202 may provide samples; the sample may be a plasma sample without dilution. The reagent management module 203 may be configured to provide a reaction reagent for triggering a coagulation reaction, or a diluent for diluting the plasma sample and a reaction reagent for triggering a coagulation reaction, and the controller 101 may control the sample feeding module 202 to add the plasma sample to the container, and may also control the reagent management module 203 to add the reaction reagent, or the diluent and the reaction reagent to the container. The measurement module 205 includes a sensor for detecting a coagulation reaction, and is configured to perform the coagulation detection under the control of the controller 101, and in particular, the controller 101 may control the measurement module 205 to perform the coagulation detection when determining that the coagulation reaction is started; the measurement module 205 can send detection data from the coagulation detection to the controller 101.

In one embodiment, the controller 101 may control the sample feeding module 202 to add the plasma sample to the container located in the incubation module 204, and then may control the container to move to the measurement position of the measurement module 205, control the reagent management module 203 to add the reaction reagent, or the diluent and the reaction reagent, to the container, and control the measurement module 205 to start the coagulation test. In another embodiment, the reaction reagents may be divided into two types, and the controller 101 may first control the sample feeding module 202 to add the plasma sample to the container located in the incubation module 204, and control the reagent management module 203 to add the first reaction reagent, or the diluent and the first reaction reagent, to the container, so that the liquid in the container reacts under the given conditions; then, after waiting for a set time period, controlling the control container to move to a measurement position of the measurement module 205, controlling the reagent management module 203 to add a second reaction reagent for triggering a coagulation reaction to the container, and controlling the measurement module 205 to start coagulation detection; here, the given conditions may include: the temperature is 37 ℃, other conditions can be included, and the set time period can be set according to the actual application requirements, for example, the set time period is 3 minutes.

Optionally, the blood coagulation analyzer further comprises a human-computer interaction unit 103, wherein the human-computer interaction unit 103 is connected with the controller 101, and can realize human-computer interaction under the control of the controller 101; in one embodiment, the human-computer interaction unit 103 may include an input module for inputting data or instructions, and the input module may be a keyboard, a touch screen, a microphone, or the like; an operator of the blood coagulation analyzer can input a blood coagulation detection starting instruction to the controller 101 through the human-computer interaction unit 103; in another embodiment, the human-computer interaction unit 103 may include a display, and the controller 101 may display the detection result through the display after receiving the detection result, and it should be noted that the controller 101 may further control the display to display other data, for example, parameter information and current time information of the blood coagulation analyzer may be displayed, which is not limited in the embodiment of the present invention. In other embodiments: the human-computer interaction unit can also be a touch screen.

Optionally, the coagulation analyzer further comprises a storage device 104, and the storage device 104 may store data or instructions input by the user and may also store the detection result.

It should be noted that the human-computer interaction unit 103 and the storage device 104 shown in fig. 2 are optional devices, and the blood coagulation analyzer according to the embodiment of the present invention may not include the human-computer interaction unit 103 and/or the storage device 104.

In some embodiments of the present invention, the magnetic bead method may be used for coagulation detection based on the architecture of the coagulation analyzer; fig. 4 is a schematic diagram illustrating the principle of coagulation detection using the magnetic bead method in the embodiment of the present invention, as shown in fig. 4, a driving coil 301 and a measuring coil 302 are disposed around the testing position of the measuring module 205, the driving coil 301 can generate a constant alternating electromagnetic field, and after the container 300 is transferred to the testing position of the measuring module 205, the magnetic beads 303 in the container keep oscillating with equal amplitude under the electromagnetic field. The measuring coil 302 may include a transmitting coil and a receiving coil, the transmitting coil generates a high-frequency excitation electromagnetic field, and when the magnetic bead 303 moves inside the container 300, the receiving coil generates an induced current representing the movement information of the magnetic bead, and the induced current can obtain a voltage signal representing the movement information of the magnetic bead through circuit conversion and signal conditioning. Fig. 5 is a schematic diagram of voltage variation of the receiving coil in the embodiment of the present invention, in fig. 5, the horizontal axis represents time, and the vertical axis represents voltage value; referring to fig. 5, the voltage signal can be used to perform coagulation time calculation, and specifically, the voltage amplitude of each period can be extracted, the signal period needs to be set according to the parameters of the sensor of the measurement module, and the amplitude is the difference between the maximum value and the minimum value in each period. FIG. 6 is a schematic diagram illustrating a force analysis of a magnetic bead during a blood coagulation detection using a magnetic bead method according to an embodiment of the present invention, as shown in FIG. 6, the force applied to the magnetic bead includes a gravity G, a driving coil attraction force F1, a rolling friction force F1, a liquid resistance force F2, a liquid buoyancy force F2, and a supporting force N; referring to fig. 6, after adding the reagent for triggering the coagulation reaction to the container, the coagulation reaction starts, and fibrinogen generates fibrin through the coagulation reaction, that is, fibrin is gradually increased, the viscosity of the plasma sample is increased, the liquid resistance f2 is increased, and the motion amplitude is gradually decreased, and when the amplitude is attenuated to be less than or equal to a first amplitude threshold value, the coagulation reaction is considered to be completed, and the first amplitude threshold value represents a magnetic bead amplitude threshold value for determining the coagulation time, so that the whole time of the coagulation reaction, that is, the blood coagulation time can be determined. In an embodiment of the present invention, the first amplitude threshold (i.e., a magnetic bead amplitude threshold for determining the coagulation time) may be determined according to an initial amplitude of the magnetic bead at a start time of the coagulation detection, for example, the first amplitude threshold is a% of the initial amplitude of the magnetic bead, and the coagulation time is a time interval from the start time of the coagulation detection to a time corresponding to the decay of the magnetic bead amplitude to the magnetic bead amplitude threshold. A may range from 30 to 70. In one embodiment, a may range from 40 to 60. In a specific embodiment, a is 50.

After determining the blood coagulation time by coagulation detection, the FIB concentration in the plasma sample can be determined based on the blood coagulation time; in a specific example, the plasma sample, the diluent, and the reagent may be added to the container (e.g., 10uL, 90uL, 50uL) at a ratio of 10:90:50, the first two components are added first, and the reagent is added after pre-warming at 37 ℃ for 3min, and then the measurement of the coagulation reaction is performed.

After obtaining the blood coagulation time, the FIB concentration in the plasma sample can be obtained by referring to the FIB concentration detection item standard curve, and fig. 7 is a schematic diagram of the FIB concentration detection item standard curve in the embodiment of the present invention, as shown in fig. 7, in which the horizontal axis represents the FIB concentration in g/L and the vertical axis represents the blood coagulation time in seconds. The FIB concentration detection item has a linear range optimal for measurement, and if the linear range is 0.7 to 7g/L (for example, the concentration of FIB in a plasma sample), it is necessary to dilute or concentrate the sample and re-measure and analyze the sample if the linear range exceeds the linear range. For example, when the FIB concentration H1 in the plasma sample obtained by the first detection is greater than 7g/L, the concentration of the plasma sample in the sample may be diluted by a preset multiple, for example, the amounts of the plasma sample and the diluent corresponding to 2-fold dilution are 5uL and 95uL, respectively, the amount of the reaction reagent is kept at 50uL, and then the FIB concentration H2 is obtained by re-measurement and analysis, so that the FIB concentration in the final plasma sample may be represented as 2 × H2. Illustratively, the FIB concentration L1 in the plasma sample obtained by the first detection is less than 0.7g/L, the concentration of the plasma sample in the sample can be concentrated according to a preset multiple, for example, the plasma sample and the diluent corresponding to 2-fold concentration take values of 20 and 80uL respectively, the amount of the reaction reagent is kept unchanged by 50uL, and then the FIB concentration L2 is obtained by re-measurement analysis, so that the FIB concentration in the final plasma sample can be expressed as (1/2) × L2.

Fig. 8 is a flowchart of a blood coagulation detection method according to an embodiment of the present invention, and as shown in fig. 8, the flowchart may include:

step 701: the blood coagulation analyzer acquires detection data in the process of carrying out blood coagulation detection on a sample by adopting a magnetic bead method, wherein the detection data represents the amplitude of magnetic beads changing along with time.

In practical applications, based on the above description, the controller 101 may control the sample detection apparatus 102 to perform coagulation detection by the magnetic bead method; the sample testing device 102 can send test data from the coagulation test to the controller 101.

In the embodiment of the invention, the detection data can be represented as a change curve of the magnetic bead amplitude along with time; fig. 9 is a schematic diagram of a variation curve of the magnetic bead amplitude with time according to an embodiment of the present invention, as shown in fig. 9, in which the horizontal axis represents time, the vertical axis represents the magnetic bead amplitude, Tc represents a time point when the magnetic bead amplitude falls to a first amplitude threshold, and Tc is within a predetermined maximum measurement time. The curve shown in fig. 9 is a time-dependent change curve of the amplitude of the magnetic beads, which corresponds to the final coagulation in the sample coagulation detection process, and Tc can be directly used as the blood coagulation time to determine the FIB concentration value in the plasma sample.

Step 702: the blood coagulation analyzer judges whether an abnormal condition occurs or not based on the magnetic bead amplitude changing along with the time, wherein the abnormal condition represents that the magnetic bead amplitude is increased to be higher than a first amplitude threshold value after being reduced to be lower than the first amplitude threshold value; the first amplitude threshold represents a bead amplitude threshold used to determine clotting time;

in practical applications, this step may be performed by the controller 101.

Exemplarily, when the bead amplitude is smaller than or equal to the first amplitude threshold, and the bead amplitude larger than or equal to the first amplitude threshold appears within a certain time, it indicates that the foregoing abnormal condition 3) occurs.

Step 703: when the blood coagulation analyzer determines that the abnormal condition occurs, the concentration of the substance to be detected in the sample is increased, and the blood coagulation detection is carried out again by adopting a magnetic bead method; or when the blood coagulation analyzer determines that the abnormal condition occurs, generating prompt information, wherein the prompt information is used for prompting: the concentration of the substance to be detected in the sample is low, or the concentration of the substance to be detected in the sample needs to be increased and the magnetic bead method is adopted to carry out the blood coagulation detection again.

Wherein the sample comprises a plasma sample and a reagent.

Wherein, the object to be measured can be FIB.

In practical applications, when the controller 101 of the blood coagulation analyzer determines that the abnormal condition described in step 703 occurs, that is, when the abnormal condition 3) occurs, the controller can automatically control and increase the concentration of the analyte in the sample, and perform blood coagulation detection again by using a magnetic bead method; alternatively, the controller 101 may issue a prompt message to the user through the human-machine interaction unit 103.

Here, when the coagulation analyzer determines that the above-described abnormal condition 3) occurs, it may be determined that the plasma sample belongs to a low-value sample indicating a sample in which the FIB concentration in the plasma sample is lower than a preset concentration range (i.e., concentration threshold), for example, the preset concentration range is 0.5g/L to 1 g/L.

It can be seen that the abnormal condition 3 caused by the low-value sample can be identified by adopting the technical scheme of the embodiment of the invention, and the blood coagulation time and the FIB concentration in the low-value plasma sample can be obtained by increasing the plasma sample concentration in the sample (namely increasing the FIB concentration of the object to be detected in the sample) and carrying out coagulation detection again aiming at the abnormal condition. Compared with the prior art that only the test can be terminated and the abnormality is reported for the abnormal condition 3), the scheme of the embodiment of the application can not only identify the abnormal condition 3) caused by the low-value sample, but also carry out corresponding treatment for the abnormal condition, and finally obtain the FIB concentration in the low-value plasma sample, namely, the FIB concentration detection capability of the coagulation analyzer for the low-value sample is improved.

For the implementation of the blood coagulation analyzer that determines whether an abnormal situation occurs based on the magnetic bead amplitude that changes with time 3), it may be determined that an abnormal situation occurs, for example, when the magnetic bead amplitude that changes with time satisfies a preset condition. Wherein the preset conditions at least include: after M magnetic bead amplitudes smaller than a first amplitude threshold value are continuously acquired, the continuously acquired N magnetic bead amplitudes are larger than a second amplitude threshold value, and the second amplitude threshold value is larger than or equal to the first amplitude threshold value; m and N are integers greater than or equal to 1.

Here, the second amplitude threshold may be K times the first amplitude threshold, K being an integer greater than or equal to 1. In the embodiment of the present invention, values of M, N and K are not limited, and exemplarily, a value of M ranges from 2 to 8, and in a specific example, a value of M is 4 or 5; illustratively, N ranges from 2 to 8, and in a specific example, N is 4 or 5; illustratively, K has a value in the range of 1.1 to 1.9, and in a specific example, K has a value of 1.2 or 1.3.

FIG. 10 is a schematic diagram showing another variation curve of the magnetic bead amplitude with time according to the embodiment of the present invention, as shown in FIG. 10, in which the horizontal axis represents time, the vertical axis represents the magnetic bead amplitude, and T₁The time point when the magnetic bead amplitude first drops to the first amplitude threshold is shown, and the curve shown in fig. 10 shows a time-dependent change curve of the magnetic bead amplitude corresponding to the abnormal condition 3).

It can be seen that, in the embodiment of the present invention, after acquiring a time-dependent variation curve or data of magnetic bead amplitudes, if N continuously acquired magnetic bead amplitudes are greater than a second amplitude threshold after M continuously acquired magnetic bead amplitudes smaller than a first amplitude threshold, it may be determined that an abnormal condition 3) occurs. In determining the occurrence of the abnormal condition 3), the plasma sample may be considered to be a low value plasma sample, i.e., the embodiment of the present invention may identify the abnormal condition 3) caused by the low value plasma sample. For abnormal conditions 3) the coagulation analyzer can derive the blood coagulation time and FIB concentration in low-value plasma samples by raising the FIB concentration in the sample and performing coagulation detection again. Compared with the prior art, the FIB concentration detection capability of the coagulation analyzer for low-value samples is improved.

Fig. 11 is a schematic diagram of classification processing for abnormal situations in the embodiment of the present invention, and as shown in fig. 11, for the three abnormal situations that may occur in the FIB low-value sample, the abnormal situations 1) and 2) are classified as class I, the abnormal situation 3) is classified as class II, and for class I: and when the sample is solidified after a long time or is not solidified within the preset longest measuring time, the instrument automatically judges whether to trigger concentration retest or not, and then reports a test result. For class II: when the coagulation measurement fails, the coagulation analyzer can judge the trigger concentration retest by identifying a coagulation curve (namely a curve of the change of the amplitude of the magnetic beads along with time), and then report a test result.

Fig. 12 is a schematic diagram of still another variation curve of the bead amplitude with time according to the embodiment of the present invention, as shown in fig. 12, the horizontal axis represents time, the vertical axis represents the bead amplitude, and Tc represents a time point when the bead amplitude decreases to the first amplitude threshold, and it can be seen from the curve shown in fig. 12 that the bead amplitude does not increase again to be higher than the first amplitude threshold after the bead amplitude decreases to the first amplitude threshold. In this case, the case corresponding to the curve shown in fig. 12 may be considered to be not the above-described abnormal case 1), abnormal case 2), and abnormal case 3). The abnormal change in amplitude indicated by numeral 1 in fig. 12 may be caused by interference of a minute bubble in the sample, and does not affect the calculation of the coagulation time. With respect to the curve shown in fig. 12, Tc can be used as the blood coagulation time, and the FIB concentration value in the plasma sample can be determined.

That is to say, by adopting the technical solution of the embodiment of the present invention, the condition corresponding to the curve shown in fig. 12 is not erroneously identified as the abnormal condition 3), which is beneficial to improving the accuracy of detecting the FIB concentration in the low-value plasma sample.

Optionally, the preset conditions further include: and for the acquired M bead amplitudes smaller than the first amplitude threshold, wherein the time point when the L-th magnetic bead amplitude is smaller than the first amplitude threshold is later than a preset time point, and L is an integer greater than or equal to 1.

In the embodiment of the present invention, the value of L is not limited, and exemplarily, the value of L may be 1, 2, or 3; the preset time point can be set according to practical application requirements, and in one embodiment, the time length between the preset time point and the start time of the blood coagulation detection can be empirically set to be between 30 seconds and 40 seconds, and in a specific example, the value of the preset time point is 35 seconds.

It will be appreciated that for low value samples, the point in time when the bead amplitude is less than or equal to the first amplitude threshold is typically later due to the lower resistance received by the bead, and thus, the abnormal condition 3 may be more accurately identified when the predetermined condition includes that the point in time when the L-th occurrence of the bead amplitude is less than the amplitude threshold is later than the predetermined point in time).

It should be noted that the controller 101 may determine that the above-described abnormal condition 3) does not occur when determining that the detection data does not satisfy the preset condition. In this case, the blood coagulation analyzer can perform corresponding processing according to the specific conditions (such as abnormal conditions 1) and 2)), and the existing processing mode can be adopted. If not from exceptional 1) -3), nor from normal samples (e.g.: FIB concentration in the plasma sample is normal), the measurement may be deemed to have failed, at which point the controller 101 may terminate the coagulation detection process.

For the implementation manner that the blood coagulation analyzer increases the concentration of the analyte (such as FIB) in the sample and performs the blood coagulation detection again by using the magnetic bead method, the blood coagulation analyzer may automatically increase the concentration of the plasma sample in the sample by a preset factor (i.e., increase the concentration of FIB in the sample by the same factor), and perform the blood coagulation detection again by using the magnetic bead method. Here, the preset multiple is greater than 1, for example, the preset multiple is 2 or 3. In one embodiment, the controller 101 may adjust at least one of the amount of the plasma sample, the amount of the diluent, and the amount of the reactive agent to achieve a predetermined fold increase in the FIB concentration.

Furthermore, the blood coagulation analyzer can also promote the concentration of the substance to be detected in the sample and perform blood coagulation detection again by adopting a magnetic bead method based on the concentration retest instruction after receiving the concentration retest instruction input by the user.

In practical application, the blood coagulation analyzer can receive a concentration retest instruction input by a user through the human-computer interaction unit 103; the human-computer interaction unit 103 can send the concentrated retest instruction input by the user to the controller 101, and the controller 101 can control and promote the concentration of the substance to be detected in the sample according to the concentrated retest instruction and perform coagulation detection again by adopting a magnetic bead method.

In one embodiment, the instructions for concentration retesting may include a fold increase in the concentration of the blood sample in the sample (i.e., a fold increase in the concentration of the analyte in the sample), for example, the fold increase in the concentration of the blood sample may be 1.5 fold, 2 fold, 3 fold, etc.

For the implementation manner that based on the instruction of concentration and re-measurement, the concentration of the analyte in the sample is increased and the magnetic bead method is used to perform the blood coagulation detection again, for example, at least one of the amount of the plasma sample, the amount of the diluent, and the amount of the reaction reagent may be re-adjusted according to the increase multiple of the concentration of the plasma sample in the sample (i.e., the increase multiple of the concentration of the analyte in the sample), so as to obtain a re-configured sample, and the magnetic bead method is used to perform the blood coagulation detection on the re-configured sample.

For example, the plasma sample and the diluent are initially used in amounts of 10uL and 40uL, respectively, the reactive reagent is used in an amount of 50uL, and the plasma sample concentration in the sample is raised by a factor of 2, in the first example, the plasma sample may be readjusted to 22.5uL, and the diluent and the reactive reagent may be kept unchanged, so that the plasma sample concentration in the obtained sample is 2 times that in the previous coagulation test. In a second example, the amount of the plasma sample may be adjusted to 20uL, the amount of the diluent may be adjusted to 25uL, and the amount of the reagent may be adjusted to 55uL, so that the concentration of the plasma sample in the obtained sample is 2 times of the concentration of the plasma sample in the previous hemagglutination test, and the concentration of the analyte in the sample is increased by 2 times accordingly.

In another embodiment, the concentrated retest instructions may include at least one of an amount of the plasma sample, an amount of the diluent, and an amount of the reagent.

For the implementation manner of raising the concentration of the plasma sample and performing the coagulation detection again by using the magnetic bead method based on the concentration and re-measurement instruction, for example, at least one of the amount of the plasma sample, the amount of the diluent, and the amount of the reaction reagent may be re-adjusted according to the concentration and re-measurement instruction to obtain a reconfigured sample, and performing the coagulation detection on the reconfigured sample by using the magnetic bead method.

For example, if the plasma sample and the diluent are initially 10uL and 40uL, respectively, and the reagent is 50uL, in the first example, the plasma sample is 22.5uL in the concentrated re-measurement instruction, and the diluent and the reagent are kept unchanged, the plasma sample concentration in the obtained sample is 2 times that in the previous blood coagulation test. In a second example, the amount of the plasma sample in the concentration and re-measurement instruction is 30uL, the amount of the diluent is 20uL, and the amount of the reagent remains unchanged, so that the concentration of the plasma sample in the obtained reconfigured sample is 3 times of the concentration of the plasma sample in the previous blood coagulation detection, and the concentration of the analyte in the sample is correspondingly increased by 3 times.

Based on the coagulation detection method proposed by the foregoing embodiment, an embodiment of the present invention further proposes a coagulation analyzer, fig. 13 is a schematic structural diagram of another coagulation analyzer according to an embodiment of the present invention, as shown in fig. 13, the coagulation analyzer includes a controller 101 and a sample detection device 102, and with reference to fig. 2 and fig. 3, the sample detection device 102 includes a driving coil 301 and a measurement coil 302, the driving coil 301 is used for generating an electromagnetic field for driving magnetic beads in a container to move under the control of the controller; the measuring coil 302 is used for acquiring induced current representing the magnetic bead motion information; the container is also filled with a sample, wherein the sample comprises a plasma sample and a reaction reagent for triggering a coagulation reaction, and a diluent for diluting the plasma sample optionally; the magnetic beads are located in the sample.

The controller 101 is configured to, in a process of controlling the sample detection apparatus to perform coagulation detection on the sample by using a magnetic bead method, obtain detection data based on the induced current, where the detection data represents a magnetic bead amplitude that changes with time;

the controller 101 is further configured to determine whether an abnormal condition occurs based on the amplitude of the magnetic bead changing with time, where the abnormal condition indicates that the amplitude of the magnetic bead decreases to be lower than the first amplitude threshold and then increases to be higher than the first amplitude threshold; the first amplitude threshold represents a bead amplitude threshold used to determine clotting time.

The controller 101 is further configured to, when the abnormal condition is determined to occur, increase the concentration of the analyte in the sample and control the sample detection device to perform the blood coagulation detection again by using a magnetic bead method.

In one embodiment, the controller 101 is configured to determine that the abnormal condition occurs when it is determined that the amplitude of the magnetic bead changing with time satisfies a preset condition, where the preset condition at least includes: after M magnetic bead amplitudes smaller than a first amplitude threshold value are continuously acquired, the continuously acquired N magnetic bead amplitudes are larger than a second amplitude threshold value, and the second amplitude threshold value is larger than or equal to the first amplitude threshold value; m and N are both integers greater than 1.

In one embodiment, M ranges from 2 to 8.

In one embodiment, N ranges from 2 to 8.

In one embodiment, the second amplitude threshold is K times the first amplitude threshold, and K ranges from 1.1 to 1.9.

In one embodiment, the preset conditions further include: for the acquired M magnetic bead amplitudes smaller than the first amplitude threshold, the time point when the L-th magnetic bead amplitude smaller than the first amplitude threshold appears is later than a preset time point, and L is an integer greater than or equal to 1.

In one embodiment, L ranges from 1 to 3.

In one embodiment, the time period between the preset time point and the start of the coagulation test is between 30 seconds and 40 seconds.

In one embodiment, the controller 101 is specifically configured to automatically increase the concentration of the plasma sample in the sample by a preset factor (i.e., increase the concentration of the analyte, such as FIB, in the sample by the same factor), and control the sample detection device 102 to perform the coagulation detection again by using the magnetic bead method.

In one embodiment, the concentration of the plasma sample in the test sample is indicative of the ratio of the volume (e.g., volume) of the plasma sample to the volume (e.g., volume) of the test sample.

Based on the coagulation detection method proposed by the foregoing embodiment, a further coagulation analyzer is also proposed in the embodiment of the present invention, fig. 14 is a schematic structural diagram of the further coagulation analyzer in the embodiment of the present invention, as shown in fig. 14, the coagulation analyzer includes a controller 101, a sample detection device 102 and a human-computer interaction unit 103, with reference to fig. 2 and fig. 3, the sample detection device 102 includes a driving coil 301 and a measuring coil 302, and the driving coil 301 is used for generating an electromagnetic field for driving magnetic beads in a container to move under the control of the controller. The measuring coil 302 is used for acquiring induced current representing the magnetic bead motion information; the container is also filled with a sample, wherein the sample comprises a plasma sample and a reaction reagent for triggering a coagulation reaction, and a diluent for diluting the plasma sample optionally; the magnetic beads are located in the sample.

The controller 101 is configured to, in a process of controlling the sample detection apparatus 102 to perform blood coagulation detection on the sample by using a magnetic bead method, obtain detection data based on the induced current, where the detection data represents a magnetic bead amplitude that changes with time.

The controller 101 is further configured to determine whether an abnormal condition occurs based on the amplitude of the magnetic bead that changes with time, where the abnormal condition indicates that the amplitude of the magnetic bead decreases to an amplitude value lower than the first amplitude threshold and then increases to an amplitude value higher than the first amplitude threshold; the first amplitude threshold represents a bead amplitude threshold used to determine clotting time.

The controller 101 is further configured to control the human-computer interaction unit 103 to generate a prompt message when the abnormal condition is determined to occur, where the prompt message is used to prompt: and the concentration of the substance to be detected in the sample is low, or the concentration of the substance to be detected in the sample needs to be increased and the magnetic bead method is adopted to carry out coagulation detection again.

In one embodiment, the controller 101 is configured to determine that the abnormal condition occurs when it is determined that the amplitude of the magnetic bead changing with time satisfies a preset condition, where the preset condition at least includes: after M magnetic bead amplitudes smaller than a first amplitude threshold value are continuously acquired, the continuously acquired N magnetic bead amplitudes are larger than a second amplitude threshold value, and the second amplitude threshold value is larger than or equal to the first amplitude threshold value; m and N are both integers greater than 1.

In one embodiment, M ranges from 2 to 8. In one embodiment, M may be 3, 4, 5, 6, or 7.

In one embodiment, N ranges from 2 to 8. In one embodiment, N may be 3, 4, 5, 6, or 7.

In one embodiment, the second amplitude threshold is K times the first amplitude threshold, and K ranges from 1.1 to 1.9. In one embodiment, K may be 1.2, 1.3, 1.4, 1.5, or the like.

In one embodiment, the preset conditions further include: for the acquired M magnetic bead amplitudes smaller than the first amplitude threshold, the time point when the L-th magnetic bead amplitude smaller than the first amplitude threshold appears is later than a preset time point, and L is an integer greater than or equal to 1.

In one embodiment, L ranges from 1 to 3. In one embodiment, L may be 1, 2, or 3.

In one embodiment, the time period between the preset time point and the start of the coagulation test is between 30 seconds and 40 seconds.

In an embodiment, the controller 101 is further configured to, after receiving a concentration and retest instruction input by a user, based on the concentration and retest instruction, increase the concentration of the plasma sample in the sample (i.e., increase the concentration of the analyte in the sample) and control the sample detection apparatus 102 to perform the blood coagulation detection again by using a magnetic bead method.

In one embodiment, the concentration remeasurement instruction comprises a fold-up in concentration of the plasma sample in the specimen.

In an embodiment, the controller 101 is specifically configured to readjust at least one of the amount of the plasma sample, the amount of the diluent, and the amount of the reagent according to a multiple of increase in the concentration of the plasma sample in the sample to obtain a reconfigured sample, and control the sample detection apparatus 102 to perform the blood coagulation detection on the reconfigured sample by using a magnetic bead method.

In one embodiment, the concentration retest instruction includes at least one of an amount of the plasma sample, an amount of the diluent, and an amount of the reagent.

In an embodiment, the controller 101 is specifically configured to readjust at least one of the amount of the plasma sample, the amount of the diluent, and the amount of the reagent according to the concentration and re-measurement command to obtain a re-configured sample, and control the sample detection apparatus 102 to perform the blood coagulation detection on the re-configured sample by using a magnetic bead method.

The above-mentioned serial numbers of the embodiments of the present invention are merely for description and do not represent the merits of the embodiments.

Through the above description of the embodiments, those skilled in the art will clearly understand that the method of the above embodiments can be implemented by software plus a necessary general hardware platform, and certainly can also be implemented by hardware, but in many cases, the former is a better implementation manner. Based on such understanding, the technical solutions of the present invention may be embodied in the form of a software product, which is stored in a storage medium (such as ROM/RAM, magnetic disk, optical disk) and includes instructions for enabling a terminal (such as a mobile phone, a computer, a server, an air conditioner, or a network device) to execute the method according to the embodiments of the present invention.

While the present invention has been described with reference to the embodiments shown in the drawings, the present invention is not limited to the embodiments, which are illustrative and not restrictive, and it will be apparent to those skilled in the art that various changes and modifications can be made therein without departing from the spirit and scope of the invention as defined in the appended claims.