CN112955742B

CN112955742B - Blood sample analysis method and coagulation analyzer

Info

Publication number: CN112955742B
Application number: CN201880099356.1A
Authority: CN
Inventors: 郭文恒; 章姚辉; 闫华文; 孙骁
Original assignee: Shenzhen Mindray Bio Medical Electronics Co Ltd; Beijing Shen Mindray Medical Electronics Technology Research Institute Co Ltd
Current assignee: Shenzhen Mindray Bio Medical Electronics Co Ltd; Beijing Shen Mindray Medical Electronics Technology Research Institute Co Ltd
Priority date: 2018-12-26
Filing date: 2018-12-26
Publication date: 2024-07-05
Anticipated expiration: 2038-12-26
Also published as: CN112955742A; WO2020132926A1

Abstract

A blood sample analysis method and a blood coagulation analyzer, the blood sample analysis method based on the blood coagulation analyzer comprises the following steps: carrying out optical detection on a detected object contained in a reaction container to obtain an optical detection result, wherein the detected object at least comprises blood plasma of a detected blood sample; obtaining interference information reflecting the interference condition in the object to be detected according to the optical detection result (803); determining a coagulation detection method (804) to be applied to the measured blood sample based on the interferent information; when the interference object in the detected object does not influence the detection result of the coagulation detection item based on the optical method, the detected object performs coagulation detection based on the optical method (806); when an interfering substance in the object has an influence on the detection result of the coagulation detection item by the optical method, the object is subjected to coagulation detection by the magnetic bead method (805).

Description

Blood sample analysis method and coagulation analyzer

Technical Field

The invention relates to medical equipment, in particular to a blood sample analysis method and a blood coagulation analyzer.

Background

The coagulation analyzer is used for measuring the content of various components in human blood in medical clinic, quantifying biochemical analysis results, and providing reliable digital basis for clinical diagnosis of various diseases of patients. The measurement methods of the existing coagulation analyzer mainly comprise a coagulation method, an immunoturbidimetry method, a chromogenic substrate method and the like. Among them, the coagulation method is to detect a change in a series of physical quantities (optical, electrical, mechanical movements, etc.) of plasma by a trigger reagent (also called a coagulation activator), and then analyze the obtained data by a computer and convert it into a final result. At present, the coagulation method can be generally classified into a magnetic bead method and an optical method in terms of specific implementation, and is mainly applied to detection of derivative items such as Prothrombin Time (PT), activated Partial Thromboplastin Time (APTT), fibrinogen (FIB), thrombin Time (TT) and related coagulation factors.

Since the magnetic bead method and the optical method are two independent detection methods which are different in detection principle and detection component, the current mainstream instrument manufacturers use either magnetic bead method such as the company Stargao (STAGO) or optical method such as the company Wo Fen (IL) and the company hssenmeikang (SYSMEX) for the selection of the implementation mode of the solidification method.

The magnetic bead method is to directly utilize the coagulation reaction, then the fibrinogen in the blood plasma is converted into fibrin, the viscosity in the blood plasma is increased, and the test result is obtained by detecting the swing amplitude change of the magnetic beads in the test cup.

The optical method is to detect the change of turbidity of the tested sample in the test cup by utilizing the optical principle. The method has the advantages that an optical information curve in the testing process can be output, so that more valuable judgment can be given to the result and the instrument state relative to the magnetic bead method. However, the optical method has a disadvantage in that it is easily disturbed by the color of the sample itself, and thus a correct result cannot be obtained or a result cannot be outputted. As shown in fig. 5, a spectrum graph of an exemplary interference material such as hemoglobin, bilirubin, chyle and the like is shown, the horizontal axis is wavelength (unit nm) and the vertical axis is absorbance, and it can be found by observation that three materials have different absorbance at different wavelengths, and three interference materials have different absorption capacities for light with different wavelengths, especially chyle, and the interference materials have absorbance between 340nm and 790nm in visible light range, which means that when a large amount of chyle is contained in a measured material, a large amount of light is absorbed by chyle when the measured material is irradiated by visible light, thereby affecting the result of coagulation detection by an optical method.

Summary of The Invention

The invention mainly provides a blood sample analysis method and a blood coagulation analyzer, wherein the blood sample analysis method based on the blood coagulation analyzer judges whether a sample is interfered before blood coagulation project detection, and determines whether to apply an optical method or a magnetic bead method to detect the blood coagulation project according to a judging result, thereby solving the problems that the optical method detection is inaccurate or the detection result cannot be output due to interference.

Solution to the problem

Technical solution

According to a first aspect, in one embodiment there is provided a blood sample analysis method comprising:

carrying out optical detection on a detected object contained in a reaction container to obtain an optical detection result, wherein the detected object at least comprises blood plasma of a detected blood sample;

obtaining interference object information reflecting the interference object condition in the object to be detected according to the optical detection result, wherein the interference object refers to a substance which has influence on the detection result of the coagulation detection item based on an optical method;

determining a blood coagulation detection method adopted for the tested blood sample according to the interference information;

When the interference objects in the detected object cannot influence the detection result of the coagulation detection item based on the optical method, the processor controls the optical method detection device to perform coagulation detection on the detected object based on the optical method;

When the interference in the detected object can influence the detection result of the coagulation detection item based on the optical method, the processor controls the magnetic bead method detection device to perform coagulation detection on the detected object based on the magnetic bead method.

According to a second aspect, in one embodiment there is provided a blood sample analysis method based on a coagulation analyzer, comprising:

Obtaining interference object information reflecting the condition of an interference object in a blood sample to be detected, wherein the interference object is a substance which has influence on coagulation detection based on an optical method;

and judging whether to perform coagulation detection on the detected blood sample based on an optical method or a magnetic bead method according to the interference information.

According to a third aspect, in one embodiment, there is provided a coagulation analyzer comprising a pre-determination device, an optical method detection device, a magnetic bead method detection device, a subject transport mechanism, and a processor;

The pre-judging device is used for carrying out optical detection on the detected object before the coagulation detection is carried out under the control of the processor to obtain an optical detection result, wherein the detected object at least comprises blood plasma of a detected blood sample;

The optical method detection device is used for carrying out coagulation detection on the detected object based on an optical method under the control of the processor and outputting an electric signal reflecting the coagulation condition;

the magnetic bead method detection device is used for carrying out coagulation detection on the detected object based on a magnetic bead method under the control of the processor and outputting an electric signal reflecting the coagulation condition;

The measured object transferring mechanism is used for transferring the reaction container containing the measured object to a preset position under the control of the processor;

The processor is used for determining whether the optical detection device is used for carrying out coagulation detection on the detected object or the magnetic bead detection device is used for carrying out coagulation detection on the detected object according to the optical detection result, receiving an electric signal reflecting the coagulation condition, and obtaining the measurement parameters of the detected blood sample after processing.

According to a fourth aspect, there is provided in one embodiment a method comprising an optical method detection device, a magnetic bead method detection device, a subject transport mechanism, and a processor;

The processor is used for obtaining interference object information reflecting the condition of an interference object in a measured blood sample, judging whether the measured object is subjected to coagulation detection by the optical method detection device or the magnetic bead method detection device, receiving an electric signal reflecting the coagulation condition, and obtaining the measurement parameters of the measured blood sample after processing, wherein the interference object is a substance influencing the coagulation detection based on an optical method.

According to a fifth aspect, there is provided in one embodiment a coagulation analyzer comprising: an optical method detection device, a magnetic bead method detection device, a detected object transfer mechanism and a processor;

The magnetic bead method detection device is used for carrying out coagulation detection on the detected object based on a magnetic bead method under the control of the processor and outputting an electric signal reflecting the coagulation condition; the detection area of the magnetic bead method detection device and the detection area of the optical method detection device are the same detection area;

The measured object transferring mechanism is used for transferring the reaction container containing the measured object to the common detection area under the control of the processor;

the processor is used for controlling the optical detection device to perform coagulation detection on the detected object, and the magnetic bead detection device is used for performing coagulation detection on the detected object when the optical detection device detects inaccuracy or cannot output an electric signal reflecting coagulation conditions.

According to a sixth aspect, an embodiment provides a computer readable storage medium comprising a program, wherein the program is executable by a processor to implement the above method.

Advantageous effects of the invention

Advantageous effects

According to the blood sample analysis method and the blood coagulation analyzer of the above embodiments, before blood coagulation item detection, whether the sample has interference is judged, and whether the blood coagulation item detection is performed by an optical method or a magnetic bead method is determined according to the judgment result; or preferentially optically, for blood coagulation program detection. When the sample does not influence the detection result of the coagulation detection item based on the optical method, detecting the coagulation item of the sample by adopting the optical method; when the sample has influence on the detection result of the coagulation detection item based on the optical method, the magnetic bead method is adopted to detect the coagulation item of the sample. The method solves the problems that the optical method detection is inaccurate or the detection result can not be output due to interference.

Brief description of the drawings

Drawings

FIG. 1 is a schematic diagram showing constituent modules of a coagulation analyzer according to an embodiment;

FIG. 2 is a schematic diagram of a magnetic bead detection apparatus according to an embodiment;

FIG. 3a is a timing diagram of the application of PWM waves to a drive coil according to one embodiment;

FIG. 3b is a schematic diagram of an electrical signal of a magnetic bead motion according to one embodiment;

FIG. 4 is a schematic diagram of an optical detection device according to an embodiment;

FIG. 5 is a spectral plot of an interferent of an embodiment;

FIG. 6 is a schematic diagram of an embodiment in which the optical detection region and the magnetic bead detection region are located in the same detection region;

FIG. 7 is a schematic diagram of multi-channel detection according to one embodiment;

FIG. 8 is a flow chart of a method of analyzing a blood sample according to one embodiment;

FIG. 9 is a flow chart of an optical detection method according to an embodiment.

Inventive examples

Embodiments of the invention

Detailed Description

The application will be described in further detail below with reference to the drawings by means of specific embodiments. Wherein like elements in different embodiments are numbered alike in association. In the following embodiments, numerous specific details are set forth in order to provide a better understanding of the present application. However, one skilled in the art will readily recognize that some of the features may be omitted, or replaced by other elements, materials, or methods in different situations. In some instances, related operations of the present application have not been shown or described in the specification in order to avoid obscuring the core portions of the present application, and may be unnecessary to persons skilled in the art from a detailed description of the related operations, which may be presented in the description and general knowledge of one skilled in the art.

Furthermore, the described features, operations, or characteristics of the description may be combined in any suitable manner in various embodiments. Also, various steps or acts in the method descriptions may be interchanged or modified in a manner apparent to those of ordinary skill in the art. Thus, the various orders in the description and drawings are for clarity of description of only certain embodiments, and are not meant to be required orders unless otherwise indicated.

The numbering of the components itself, e.g. "first", "second", etc., is used herein merely to distinguish between the described objects and does not have any sequential or technical meaning. The term "coupled" as used herein includes both direct and indirect coupling (coupling), unless otherwise indicated.

In the embodiment of the invention, before the blood coagulation item detection, whether a sample is interfered is judged, and whether the blood coagulation item detection is carried out by an optical method or a magnetic bead method is determined according to a judging result. When the sample does not influence the detection result of the coagulation detection item based on the optical method, detecting the coagulation item of the sample by adopting the optical method; when the sample has influence on the detection result of the coagulation detection item based on the optical method, the magnetic bead method is adopted to detect the coagulation item of the sample.

Referring to fig. 1, fig. 1 shows a schematic structural diagram of a coagulation analyzer according to an embodiment of the present invention, where the coagulation analyzer includes a sample placement area 11, a sample collection mechanism 12, a reagent placement area 13, a reagent collection mechanism 14, a reaction vessel placement area 10, a test object transferring mechanism 15, a pre-determining device 16, an optical method detecting device 18, a magnetic bead method detecting device 17, and a processor 19.

The sample placement area 11 is used to provide a place where the sample 11a to be tested is placed, and the sample to be tested may be blood plasma after removing blood cells, for example, blood plasma obtained by centrifuging the blood sample. In the drawing, the sample placement area 11 is a rectangular area in which a plurality of samples 11a to be measured can be placed. In practical apparatus, the sample placement area 11 may be a strip-shaped or circular area, or may be just a place where the sample is placed.

The reagent placement area 13 is used to provide a place for placing the test reagent 13a. In the drawing, the reagent placement area 13 is a rectangular area in which a plurality of test reagents 13a can be placed. In practice, the reagent holding area 13 may be a strip-shaped or circular area. The reagent includes at least one of a diluent, a mixed reagent, and a trigger reagent.

The reaction vessel placement area 10 is used to provide a place for placing the reaction vessel 10a for testing. In the drawing, the reaction vessel placement area 10 is a rectangular area in which a plurality of reaction vessels 10a can be placed. In practice, the reaction vessel placement area 10 may be a strip or circular area.

The sample collection means 12 is for collecting a sample to be measured from the sample placement section 11 and adding the sample to be measured to the reaction vessel 10a placed on the reaction vessel placement section 10, and the reagent collection means 14 is for collecting a reagent from the reagent placement section 13 and adding the reagent to the reaction vessel 10a placed on the reaction vessel placement section 10. The sample to be measured and the reagent are mixed and reacted in the reaction vessel 10a to form a sample. In some embodiments, the sample collection means 12 and the reagent collection means 14 may be two-dimensional moving members having a sampler, and the sample or reagent to be measured collected in the sample placement area 11 or the reagent placement area 13 is added to the reaction container 10a placed on the reaction container placement area 10 by two-dimensional movement in a plane.

In one embodiment, the reaction vessel placement area 10 also has an incubation function, and the sample to be tested and the reagent are mixed in the reaction vessel 10a and then placed on the reaction vessel placement area 10 for incubation, and after incubation, the sample to be tested is transported to the corresponding detection position by the test object transport mechanism 15 for detection. In some embodiments, the reaction vessel placement area 10 does not have an incubation function, and the sample to be tested and the reagent need to be transported to the incubation position by the test object transporting mechanism 15 for incubation after being mixed in the reaction vessel 10 a.

The magnetic bead method detection device 17 is used for detecting a coagulation item of a sample (a test object) obtained by mixing a test sample and a reagent based on a magnetic bead method under the control of a processor, and outputting an electric signal reflecting the coagulation condition to the processor 19. The region in which the sample is subjected to the blood coagulation item detection by the magnetic bead method is referred to as a magnetic bead method detection region.

In one embodiment, the magnetic bead detection device 17 may include a driving coil 210 and a measuring coil 220 as shown in fig. 2, and the magnetic bead detection device may employ a reaction vessel as shown in fig. 2, where the reaction vessel 200 is illustrated in fig. 2 in a cross-section for the convenience of viewing the structure. The magnetic beads 201 are placed in the accommodating cavity of the reaction vessel 200, and the bottom of the reaction vessel is provided for the magnetic beads 201 to move under the drive of a magnetic field. For convenience of description, the reaction vessel 200 has a length direction extending along the magnetic bead movement track and a width direction perpendicular to the length direction. In the embodiment of the application, the magnetic beads are made of materials capable of being quickly magnetized and demagnetized, when the magnetic beads are in a magnetic field, the magnetic beads can be quickly magnetized by the magnetic field, and when the magnetic field disappears, the magnetic beads can be quickly demagnetized. The shape of the magnetic beads may be spherical, or may take other shapes, such as polyhedrons, for example only, and not particularly limited. Alternatively, the detecting device 16 may include an even number of driving coils 210, for example, the driving coils 210 may have two groups, and the two groups of driving coils 210 are disposed opposite to each other at a certain distance, and are located on both sides of the reaction vessel 200 along the length direction of the reaction vessel 200. The two driving coils 210 are applied with PWM waves having the same period but different timings, as shown in fig. 3a, the periods M1 and M2 are periods in which the driving coils M1 and M2 generate magnetic fields, respectively, so that intermittent magnetic fields are alternately generated (during the periods t1 and t2, the driving coils M1 generate magnetic fields in the illustrated period M1; during the periods t3 and t4, the driving coils M2 generate magnetic fields in the illustrated period M2; and so on), the magnetic beads 201 in the reaction vessel 200 are made to perform an oscillating motion along the track formed by the reaction vessel by repeatedly magnetizing the magnetic beads by the magnetic fields.

Alternatively, the detecting device 16 may include an even number of sets of measuring coils 220, for example, may include two sets of measuring coils 220, and the two sets of measuring coils 220 are disposed opposite to each other at a distance, and are located on both sides of the reaction vessel 200 in the width direction of the reaction vessel 200, respectively. The two sets of measuring coils 220 are divided into a transmitting coil, both ends of which are connected to a signal transmitting circuit (not shown) for inputting sine wave alternating current for generating a continuous magnetic field, and a receiving coil, both ends of which are connected to a signal receiving circuit (not shown) for detecting a moving electric signal generated by the oscillating movement of the magnetic beads 201. The motion electric signal refers to an electric signal capable of reflecting the motion state of the magnetic beads 201. The transmitting coil generates a magnetic field, the magnetic beads cut the magnetic force lines to move, the paths of the magnetic force lines are changed, and therefore the magnetic flux received by the receiving coil is changed, the receiving coil generates original induced electromotive force according to the received magnetic flux to generate corresponding induced current, and the induced current is subjected to circuit conversion and signal conditioning, so that voltage signals containing movement information of the magnetic beads 201, namely movement electric signals of the magnetic beads 201, can be obtained. Because the characteristics of the original induced current are changed due to the movement of the magnetic beads 201, the movement information of the magnetic beads 201 can be extracted from the changed induced current.

As shown in fig. 2, in one embodiment, two sets of drive coils 210 and two sets of measurement coils 220 are disposed across from each other, with the reaction vessel 200 between the two sets of drive coils 210 and simultaneously between the two sets of measurement coils 220. Under the action of the driving electromagnetic field, the magnetic beads 201 can move in the sample to be measured in the reaction vessel 200.

When the magnetic beads 201 move in the reaction vessel 200, the measuring coil 220 generates a corresponding induced current, and the induced current reflects the movement condition of the magnetic beads 201 and can be used as an electric signal of the movement of the magnetic beads 201. Of course, it is also possible to convert the induced current generated by the measuring coil 220 to obtain a voltage signal, and use the voltage signal as the motion electric signal of the magnetic bead 201.

The measuring coil 220 transmits the moving electric signal of the magnetic bead 201 obtained by its detection to the processor. Alternatively, the measurement coil 220 may be connected to the processor through a signal conversion circuit (not shown) and a signal conditioning circuit (not shown). For example, the signal conversion circuit can perform analog-to-digital conversion on the motion electric signal of the magnetic bead 201 obtained by the measurement coil 220 for at least one duration, and the signal conditioning circuit can perform pretreatment such as rectification, filtering, normalization, etc. on the motion electric signal of the magnetic bead 201 obtained by the measurement coil 220 for at least one duration. Fig. 3b is a schematic diagram of an electrical moving signal of the magnetic bead 201 for a duration, wherein the electrical moving signal of the magnetic bead 201 may be a voltage signal, and in this embodiment, the magnetic bead 201 reciprocates in the reaction vessel 200, and the electrical moving signal of the magnetic bead 201 for a duration is in a sine-like distribution, as shown in the figure.

The optical method detection device 18 is used for detecting the coagulation item of a sample (a measured object) obtained by mixing a measured sample and a reagent based on an optical method under the control of the processor 19, and outputting an electric signal reflecting the coagulation condition to the processor 19. The region in which the blood coagulation item detection is performed on the sample by the optical method is referred to as an optical method detection region.

In one embodiment, the optical detection apparatus 400 may include a light source 410, a lens assembly 420, a filter 430, and a receiving unit 450 for performing optical detection, as shown in fig. 4. In the present application, the light source 410 may be a halogen lamp, and preferably, the halogen lamp is housed in a lamp case having a plurality of heat radiating fins for cooling hot air generated by heat generated by the light source 410. The lens assembly 420 is composed of a plurality of condensing lenses for condensing and collimating the scattered light emitted from the light source 410. The lens unit 420 is disposed on an optical path for guiding the light irradiated from the light source 410 to the sample 440 (object to be measured).

In the embodiment of the present application, the optical filter 430 may be disc-shaped, polygonal, etc., and in the preferred embodiment, the optical filter 430 is disc-shaped, and may be rotated by a motor with the center of a circle as an axis. The filter 430 is provided with a plurality of holes, and in one embodiment of the present application, the filter 430 is provided with 6 holes, and other cases may be applied in the same or similar manner with reference to the present embodiment. As shown, the holes 431 are holes that are blocked from light, and the remaining 5 holes 432 are used to mount 5 filters with different transmission wavelengths, for example, the 5 filters transmit only 340nm, 405nm, 575nm, 660nm and 800nm, respectively, and the other wavelengths are not transmitted, and the holes 431 may be spare holes, and the optical film is mounted only when the optical film needs to be added. The 6 holes are provided at a certain angular interval along the rotation direction of the filter 430, and the filter may be rotated to the light path as the filter 430 rotates so that only light having a wavelength matching with that of the filter passes through the filter and is irradiated to the following reaction vessel for optical detection.

In performing coagulation item detection on a sample in a reaction vessel based on an optical method, different coagulation items require light irradiation of a specific wavelength, for example, a Prothrombin Time (PT) detection item requires light irradiation of a sample of 405nm wavelength, so that a processor controls a motor to rotate a filter of 405nm wavelength on a filter 430 onto an optical path. The Thrombin Time (TT) detection program requires light of 660nm wavelength to illuminate the sample, so the processor controls the motor to rotate the 660nm wavelength filter on filter 430 onto the light path.

The receiving unit 450 is connected to the processor, and the receiving unit 450 is used for collecting the transmitted light and/or scattered light of the sample after being irradiated by the light with a specific wavelength, converting the optical signal into an electrical signal, and transmitting the electrical signal to the processor. The processor processes the electrical signals to obtain measurement parameters of the measured blood sample.

Of course, in other embodiments, the optical method detection device 400 may use LEDs with multiple wavelengths instead of the above-mentioned halogen lamp, and the light beams emitted by the LEDs are combined by dichroic mirrors corresponding to the LEDs, or the light beams with multiple wavelengths are combined by using a light combining prism, that is, the detection structure or the detection mode of the optical method detection device 400 is not limited, and will not be described herein.

As shown in fig. 5, which is a spectrum graph of an exemplary interference material such as hemoglobin, bilirubin, chyle, etc., the horizontal axis is wavelength (unit nm) and the vertical axis is absorbance, the inventors noted that three materials have different absorbance at different wavelengths, and that three interference materials have different absorption capacities for light of different wavelengths, in particular, chyle, which has absorbance in the visible light range of 340nm to 790nm, means that when a large amount of chyle is contained in a test material, a large amount of light is absorbed by chyle when the test material is irradiated with visible light, thereby affecting the coagulation detection result based on an optical method.

Therefore, in the embodiment of the invention, a pre-judging link is added before the detection of the formal blood coagulation project, and whether the tested sample contains an interfering object which can influence the blood coagulation detection result based on an optical method is judged.

In this embodiment, the pre-determining device 16 is configured to perform optical detection on the object under control of the processor 19 before performing coagulation detection, so as to obtain an optical detection result. The sample to be detected by the predicting device 16 at least includes a sample to be detected, that is, the sample to be detected may be plasma or a mixture (sample) of plasma and a reagent, and the reagent includes at least one of a diluent, a mixed reagent and a trigger reagent. The detection position of the predicting device 16 for optically detecting the object may be a dedicated position, or may be an incubation area, an optical detection area, or a magnetic bead detection area.

In one embodiment of the present application, the pre-determining device 16 includes a photo-detecting device, which includes a light emitting end and a light receiving end, wherein the light emitting end is used for irradiating the object to be detected with at least one light with a specific wavelength or a light with a wavelength close to the specific wavelength, and the specific wavelength is a wavelength of light used when the sample is subjected to coagulation item detection by an optical method. The light receiving end is used for detecting optical information of light of the detected object after the light action, and an optical detection result of the detected object aiming at the light with the specific wavelength is obtained. The optical information may be the transmitted and/or scattered light intensity of the light beam after passing through the object under test. The light receiving end is in signal connection with the processor 19 and is used for sending the obtained optical detection result to the processor 19.

In some embodiments, the light emitting end of the pre-determining device 16 is connected to an optical method detecting device, and the light beam irradiated to the object to be detected is the light beam separated by the optical fiber after being filtered by the optical filter 430; when the detection position of the optical detection of the object to be detected by the pre-determining device 16 is the optical detection area, the light filtered by the optical filter 430 with the corresponding light transmittance can be directly used to irradiate the object to be detected, and no separate light source is needed. In some embodiments, the light emitting end of the pre-determination means 16 may also have a separate light source.

In another embodiment of the present application, the pre-determining device 16 includes an image capturing device, which is configured to capture image data (e.g. a photo) of the object to be tested, obtain an optical detection result, and send the optical detection result to the processor 19. In a specific embodiment, the image capturing device may be a camera for capturing image data.

The processor 19 is configured to obtain interferent information reflecting the condition of interferents in a measured blood sample, determine whether to perform coagulation detection on the measured object by the optical detection device or to perform coagulation detection on the measured object by the magnetic bead detection device according to the interferent information, and receive an electrical signal reflecting the coagulation condition, and process the electrical signal to obtain a measurement parameter of the measured blood sample, where the interferents are substances that affect coagulation detection by the optical method.

In an embodiment of the present application, the processor 19 obtains the interference object information reflecting the interference object condition in the measured object according to the optical detection result, for example, the light emitting end of the pre-determining device 16 irradiates the measured object with light of at least one specific wavelength, the light receiving end receives the transmitted light and/or scattered light of the measured object after the light irradiation, the processor 19 calculates the absorbance value of the measured object for each specific wavelength light according to the optical information received from the light receiving end of the pre-determining device 16, and when the absorbance value of at least one specific wavelength light is greater than the preset threshold, it is indicated that the sample absorbs the specific wavelength light, and it is determined that the interference object in the measured object affects the detection result of the coagulation detection item based on the optical method. The preset threshold has different values for different specific wavelengths of light, and can be a default set value of the system or a value set by a user according to experience or experimental data. In this embodiment, when the interference object in the object to be detected does not affect the detection result of the optical method-based coagulation detection item, or when the interference object in the object to be detected does not have an effect on the detection result of the optical method-based coagulation detection item, the processor controls the optical method detection device to perform the optical method-based coagulation detection on the object to be detected; when the interference in the detected object can influence the detection result of the coagulation detection item based on the optical method, or when the interference in the detected object can influence the detection result of the coagulation detection item based on the optical method, the processor controls the magnetic bead method detection device to perform coagulation detection on the detected object based on the magnetic bead method. The interfering substance is a substance that absorbs light of a specific wavelength, and the specific wavelength is at least one of wavelengths of light used for optically detecting coagulation of a mixed sample of plasma and a reagent.

In another embodiment, the object to be measured may be irradiated with light having a wavelength close to a specific wavelength, and it may be determined whether or not an interfering substance that affects the detection result of the optical coagulation detection item is present in the object to be measured.

In another embodiment of the present application, the processor 19 identifies the color of the object to be measured according to the image data (e.g. photo) received from the pre-determining device 16, compares the color of the object to be measured with a preset color, and determines that the interference in the object to be measured has an influence on the detection result of the coagulation detection item based on the optical method when the color of the object to be measured is the same as or similar to the preset color. The preset color is the color of the image data obtained when no interference object exists in the measured object, and can be the default set color of the system or the color set by the user according to experience or experimental data. In this embodiment, when an interfering object in the object to be detected does not affect the detection result of the optical method-based coagulation detection item, the processor controls the optical method detection device to perform coagulation detection on the object to be detected; when the interference in the detected object can influence the detection result of the coagulation detection item based on the optical method, the processor controls the magnetic bead method detection device to perform coagulation detection on the detected object.

In some examples, as shown in fig. 6, the optical detection region for performing the blood coagulation detection by the optical method and the magnetic bead detection region for performing the blood coagulation detection by the magnetic bead method are the same detection region. The reaction vessel for performing the blood coagulation test by the magnetic bead method and the vessel for holding the sample for performing the blood coagulation test by the optical method are the same device. When the magnetic bead method is used for detection, magnetic beads need to be placed at the bottom of the reaction container, when the magnetic bead method is used for coagulation detection, the magnetic beads move under the drive of the driving coil, and the measuring coil obtains a motion electric signal generated by the motion of the magnetic beads according to the generated induction electromagnetic field and sends the electric signal to the processor; when the coagulation detection is carried out by an optical method, the reaction container does not need to be provided with magnetic beads, the transmitting optical fiber irradiates the detected object in the reaction container by adopting at least one light with specific wavelength or light with wavelength close to the specific wavelength, and the receiving optical fiber transmits the received light information to the photoelectric conversion unit to be processed to obtain an electric signal. The magnetic beads can be placed in the reaction vessel only when the detection is performed by the magnetic bead method, but the magnetic beads are not in the reaction vessel when the detection is performed by the optical method, and in this case, the coagulation analyzer further comprises a taking and placing device for taking and placing the magnetic beads; of course, in some embodiments, the beads may be placed in the reaction vessel all the time, and the beads will remain stationary at the bottom of the reaction vessel for optical detection, in which case the coagulation analyzer does not require a pick-and-place device for picking and placing the beads.

As shown in fig. 7, in some embodiments, the analyzer may also be provided with a plurality of detection areas as shown in fig. 6, for detecting a plurality of samples at the same time, where each detection area may share an optical irradiation unit, and the beam is directed to each detection area by a beam splitter to irradiate each object to be detected. If the position where the optical detection of the object to be detected is not the area by the predicting device, the beam may be directed to the optical detection position (for example, a dedicated position, an incubation area, etc.) by the beam splitter.

In another embodiment of the present application, the coagulation analyzer may not include the pre-determining device, and the pre-determining result of the sample to be tested may come from other on-line modules, that is, the obtaining of the interferent information reflecting the interferent condition in the sample to be tested may come from other on-line instruments, without setting the pre-determining device in the coagulation analyzer itself. Or directly enabling the magnetic bead method detection device and the optical method detection device to share the same detection area; the measured object transferring mechanism transfers the reaction container containing the measured object to the common detection area under the control of the processor; the processor controls the optical detection device to perform coagulation detection on the detected object, and the magnetic bead detection device performs coagulation detection on the detected object when the optical detection device detects inaccuracy or cannot output an electric signal reflecting coagulation conditions.

The coagulation analyzer in the above embodiment of the application is mainly used for performing coagulation analysis on the measured object, and is different from the prior art in that the coagulation analyzer in the application can perform coagulation detection on the measured object by adopting an optical method detection device based on an optical method and can perform coagulation detection on the measured object by adopting a magnetic bead method detection device based on a magnetic bead method. And the optical method is preferable in practical application because the optical method can output an optical information curve in the test process, so that more valuable judgment can be given to the result and the instrument state relative to the magnetic bead method. However, when a large amount of interferents absorbing specific wavelengths exist in the sample to be detected, the magnetic bead method is adopted to detect the coagulation project, so that the influence of the interferents on the coagulation detection result based on the optical method can be avoided.

Referring to fig. 8, the blood sample analysis method for performing pre-determination and then coagulation analysis on the test object includes the following steps:

Step 801, a blood sample analysis procedure of a coagulation analyzer is initiated.

Step 802, acquiring an item for detecting a blood sample to be detected, judging whether the detected item is a clotting method item, if the detected item is a clotting method item, executing step 803, if the detected item is not a clotting method item, executing step 807, selecting other methods for detecting the object to be detected, and outputting a detection result.

Step 803, optical detection is performed on the object to be detected contained in the reaction vessel, an optical detection result is obtained, and interference object information reflecting the interference object condition in the object to be detected is obtained according to the optical detection result. According to the blood coagulation detection item of the detected blood sample, the specific wavelength used in the subsequent detection of the blood coagulation item by adopting an optical method can be known, in a preferred embodiment, the detected objects contained in the reaction container are irradiated with light one by adopting the specific wavelength, and the transmitted light and/or scattered light of the detected objects after the light irradiation is collected. Wherein the tested object at least comprises the blood plasma of the tested blood sample, and the tested object in the step can be the blood plasma or the mixture of the blood plasma and the reagent.

According to the waterfall effect theory of blood coagulation, after the tested sample is mixed with the diluent and/or the mixed reagent, and in a period of time just after the trigger reagent is added, the cascade reaction of the coagulation factors is mainly performed, and fibrin polymers combined by fibrin are not formed, so that the absorbance change caused by the cascade reaction is small. Thus, if analyzed for this period of time, substantially accurate absorbance data of the sample can be obtained, and thus the condition of the interferents can be judged.

For example, a blood coagulation test item, such as some based on the clotting method, with a baseline period of apparent luminous flux for a short period of time after the addition of the trigger reagent to the sample under test, will form a more apparent luminous flux baseline period. In the luminous flux baseline period, the tested object generates cascade reaction of coagulation factors, so that the luminous flux change is small, and the luminous flux curve is gentle. During this luminous flux baseline period, the absorbance data detected is simply the superposition of the absorbance data of the sample being measured and the absorbance data of the reagent. Since the reagent absorbance data is known, absorbance data of the sample to be measured can be obtained, and thus the condition of the interfering substance can be judged.

For another example, in a period of time after the diluent and the mixed reagent are added to the sample to be measured (before the trigger reagent is added), the item that the luminous flux of the sample is basically unchanged is detected, and the absorbance data of the sample to be measured before the trigger reagent is added is only superposition of absorbance data of the sample to be measured and the diluent and the mixed reagent. Since the absorbance data of the diluent and the mixed reagent are known, absorbance data of the sample to be measured can be obtained, and thus the condition of the interfering substance can be judged.

Typically, the diluent and mixed reagent are added first, followed by the trigger reagent. In some coagulation detection projects, the addition of diluents and mixing reagents may not be necessary.

Referring to fig. 9, the optical detection process of the object in the present embodiment includes the following steps 901-903:

Step 901, irradiating an object to be measured by adopting at least one wavelength of light. And within a set time period after the measured sample is added with the reagent to obtain the measured object, adopting light with a specific wavelength to irradiate the measured object, and obtaining optical information of scattered light and/or transmitted light after the light beam irradiates the measured object. The set time period is set according to the type of the reagent added to the tested sample and the time of adding the reagent. The light beam here comes from the optical detection means and in a further embodiment may also be a light source unique to the pre-determination means.

Step 902, detecting optical information of the object to be detected after the object to be detected is acted by light. The optical information includes absorbance information of the test object, which is mainly superposition of absorbance data of the test sample and absorbance data of the reagent, and absorbance data of the test sample can be obtained if absorbance data of the reagent itself is subtracted from absorbance information of the test sample. Typically, the pre-determination means detects light flux data, where the light flux data comprises light flux data of transmitted light and/or scattered light, and then determines absorbance information from the light flux data and the initial light flux of the light source, i.e. absorbance information is obtained from the light flux data. Thus, the optical information may also include luminous flux data of scattered light and/or transmitted light after the light beam irradiates the object to be measured.

Since the interference substances such as chyle, hemoglobin, bilirubin and the like have respective absorption spectra, the object to be measured can be irradiated with a plurality of light beams having different wavelengths, and after the light beams having the respective wavelengths are irradiated, the corresponding interference substance is determined based on the absorbance value of the object to be measured, for example, whether or not the interference substance is contained. For example, the light beams of various wavelengths may be applied to irradiate the object to be measured, and the light beams of various wavelengths correspond to three kinds of interference objects, that is, chyle, hemoglobin, and bilirubin, respectively, so that the condition of the corresponding interference object can be determined based on the absorbance values of the light beams of various wavelengths. Thus, in one embodiment, more than one wavelength of light beam is applied to illuminate the subject.

Step 903, obtaining an optical detection result of the object according to the optical information. And calculating the absorbance value of the measured object aiming at each specific wavelength light according to the optical information, and judging that the interference object in the measured object can influence the coagulation detection project based on the optical method when the absorbance value is larger than a preset threshold value. The preset threshold value is obtained according to the predicted absorbance information of the reagent, the predicted absorbance information of the tested sample under the condition of no interference and the predicted ratio information of the tested sample and the reagent. The absorbance information of the reagent, and the ratio information of the sample to be measured and the reagent can be obtained from the instrument setting information or the detection parameters, and are thus predicted. The ratio information may be volumetric ratio information or weight ratio information.

In some embodiments, the optical detection further comprises: image data (e.g., a photo) of the object to be measured is collected, color information is obtained according to the image data, and interference information reflecting the interference condition in the object to be measured is obtained according to the color information, so as to obtain an optical detection result.

In some embodiments, after obtaining the interferent information, prompt information and/or alarm information may be further sent according to the interferent condition in the measured sample, for example, the prompt information and/or alarm information may include: prompt information and/or alarm information about the condition of the interferents in the tested sample or prompt information for determining to adopt an optical method or a magnetic bead method.

After step 803, step 804 may be performed.

Step 804 determines whether the detection result of the optical method-based blood coagulation detection item will be affected according to the interferent information, determines the blood coagulation detection method to be adopted for the measured blood sample, performs step 806 when the interferent in the measured object will not affect the detection result of the optical method-based blood coagulation detection item, and performs step 805 when the interferent in the measured object will affect the detection result of the optical method-based blood coagulation detection item.

In step 805, the processor controls the magnetic bead method detection device to perform coagulation detection on the object to be detected based on the magnetic bead method, outputs an electrical signal reflecting the coagulation condition, and processes the electrical signal to obtain a measurement parameter of the blood sample to be detected.

In step 806, the processor controls the optical method detecting device to perform coagulation detection on the object to be detected based on the optical method, outputs an electric signal reflecting the coagulation condition, and processes the electric signal to obtain a measurement parameter of the blood sample to be detected.

In another embodiment, when it is determined that the detection item is a coagulation item, the optical detection of the object may be performed without using the method of step 803, but the coagulation detection may be performed directly by using the optical detection device, and when the optical detection device detects inaccurately or cannot output an electrical signal reflecting the coagulation condition, the coagulation detection may be performed on the object by using the magnetic bead detection device.

The application also provides a coagulation analyzer of an embodiment for determining and analyzing the amount of a specific substance related to blood coagulation/fibrinolysis function and the activity level thereof, and the sample is blood plasma. The coagulation analyzer of the present embodiment measures a sample by a clotting time method, a chromogenic substrate method, and an immunoturbidimetry. The clotting time method used in the present embodiment is a measurement method in which the clotting process of a specimen is detected as a change in transmitted light or a change in movement of a magnetic bead in the specimen under magnetic force. Examples of measurement items of the clotting time method include PT (prothrombin time), APTT (activated partial thrombin time), TT (thrombin time), and FIB (fibrinogen amount). Examples of the measurement items of the chromogenic substrate method include AT-III (antithrombin III) and the like, and examples of the measurement items of the immunoturbidimetry method include D-Dimer (D-Dimer) and FDP and the like.

Reference is made to various exemplary embodiments herein. However, those skilled in the art will recognize that changes and modifications may be made to the exemplary embodiments without departing from the scope herein. For example, the various operational steps and components used to perform the operational steps may be implemented in different ways (e.g., one or more steps may be deleted, modified, or combined into other steps) depending on the particular application or taking into account any number of cost functions associated with the operation of the system.

Additionally, as will be appreciated by one of skill in the art, the principles herein may be reflected in a computer program product on a computer readable storage medium preloaded with computer readable program code. Any tangible, non-transitory computer readable storage medium may be used, including magnetic storage devices (hard disks, floppy disks, etc.), optical storage devices (CD-ROMs, DVDs, blu-Ray disks, etc.), flash memory, and/or the like. These computer program instructions may be loaded onto a general purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine, such that the instructions which execute on the computer or other programmable data processing apparatus create means for implementing the functions specified. These computer program instructions may also be stored in a computer-readable memory that can direct a computer or other programmable data processing apparatus to function in a particular manner, such that the instructions stored in the computer-readable memory produce an article of manufacture including means which implement the function specified. The computer program instructions may also be loaded onto a computer or other programmable data processing apparatus to cause a series of operational steps to be performed on the computer or other programmable apparatus to produce a computer implemented process such that the instructions which execute on the computer or other programmable apparatus provide steps for implementing the functions specified.

While the principles herein have been shown in various embodiments, many modifications of structure, arrangement, proportions, elements, materials, and components, which are particularly adapted to specific environments and operative requirements, may be used without departing from the principles and scope of the present disclosure. The above modifications and other changes or modifications are intended to be included within the scope of this document.

The foregoing detailed description has been described with reference to various embodiments. However, those skilled in the art will recognize that various modifications and changes may be made without departing from the scope of the present disclosure. Accordingly, the present disclosure is to be considered as illustrative and not restrictive in character, and all such modifications are intended to be included within the scope thereof. Also, advantages, other advantages, and solutions to problems have been described above with regard to various embodiments. The benefits, advantages, solutions to problems, and any element(s) that may cause any benefit, advantage, or solution to occur or become more pronounced are not to be construed as a critical, required, or essential feature. The terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, system, article, or apparatus. Furthermore, the term "couple" and any other variants thereof are used herein to refer to physical connections, electrical connections, magnetic connections, optical connections, communication connections, functional connections, and/or any other connection.

Those skilled in the art will recognize that many changes may be made to the details of the above-described embodiments without departing from the underlying principles of the invention. Accordingly, the scope of the invention should be determined from the following claims.

Claims

1. A method of analyzing a blood sample, the method comprising:

The method comprises the steps that in a set time period after a reagent is added to a tested sample to obtain a tested object, the tested object is optically detected to obtain an optical detection result, the tested object at least comprises blood plasma of a tested blood sample, magnetic beads are placed in the reaction container, the reagent comprises at least one of diluent, mixed reagent and trigger reagent, the set time period is set according to the type of the reagent added to the tested sample and the time of adding the reagent, wherein for a first type item, the optical detection is carried out on the tested object in the set time period after the trigger reagent is added to the tested sample, and for a second type item, the optical detection is carried out on the tested object in the set time period before the diluent and the mixed reagent are added to the tested sample, the first type item is a coagulation detection item which needs to be added with the trigger reagent and has obvious luminous flux after the trigger reagent is added, and the second type item is a coagulation detection item which needs to be added with the diluent, the mixed reagent and the luminous flux does not change basically before the trigger reagent is added after the diluent and the mixed reagent is added after the trigger reagent is added;

obtaining interference object information reflecting the interference object condition in the detected object according to the optical detection result, wherein the interference object is a substance influencing the detection result of the coagulation detection item based on an optical method;

Determining a blood coagulation detection method adopted for the measured blood sample according to the interference information;

when an interfering object in the detected object can influence the detection result of the coagulation detection project based on the optical method, the processor controls the magnetic bead method detection device to perform coagulation detection on the detected object based on the magnetic bead method, wherein the optical method detection area for performing coagulation detection based on the optical method and the magnetic bead method detection area for performing coagulation detection based on the magnetic bead method are the same detection area.

2. The method of claim 1, wherein the interfering substance is a substance that absorbs light of a specific wavelength, and wherein the specific wavelength is at least one of wavelengths of light used for optically detecting coagulation of a sample mixture of plasma and a reagent.

3. The method of claim 2, wherein the optically detecting comprises:

illuminating the object to be measured with light of at least one wavelength;

Detecting optical information of the detected object after the light action;

and obtaining an optical detection result of the detected object according to the optical information.

4. A method according to claim 3, wherein the optical information is transmitted and/or scattered light intensity of the light beam after passing through the object under test.

5. The method of claim 3 or 4, further comprising calculating absorbance values of the test object for each specific wavelength of light based on the optical information.

6. The method of claim 5, wherein the determination that the interfering substance in the test object has an effect on the optically-based coagulation detection item is performed when the absorbance value is greater than a predetermined threshold value.

7. A method according to claim 3, wherein the test object is irradiated with light of at least one specific wavelength.

8. The method of claim 1, wherein the optically detecting comprises: and collecting image data of the object to be detected to obtain an optical detection result.

9. The method of claim 8, wherein color information is obtained from the image data, and wherein the disturbance information reflecting the condition of the disturbance in the test object is obtained from the color information.

10. The method of any one of claims 1-4, wherein the test substance in the optical detection of the test substance contained in the reaction vessel is plasma or a mixture of plasma and a reagent.

11. The method of any one of claims 1-4, wherein the optical detection of the test object is performed at a dedicated location, incubation zone, optical detection zone, or magnetic bead detection zone provided for optical detection.

12. The method of any one of claims 1-4, wherein the reaction vessel has a bottom portion for movement of the magnetic beads under a driving force.

13. A blood sample analysis method based on a coagulation analyzer, comprising:

Obtaining interference object information reflecting the condition of an interference object in a measured blood sample based on optical detection within a set time period after the measured blood sample is added with a reagent to obtain the measured object, wherein the interference object refers to a substance which has an influence on the coagulation detection based on an optical method, the measured blood sample is contained in a reaction container, magnetic beads are placed in the reaction container, the reagent comprises at least one of diluent, mixed reagent and trigger reagent, the set time period is set according to the type of the reagent added into the measured blood sample and the time of adding the reagent, the set time period is set according to the type of the reagent added into the measured blood sample, the first type of item is a detection item which needs to be added with the trigger reagent and has a baseline period of obvious light after the trigger reagent is added, the second type of item is a detection item which needs to be added with the trigger reagent and the mixed reagent, and has no change in the light flux after the trigger reagent is added, and the second type of item is basically obtained based on the optical detection;

and judging whether to perform coagulation detection on the detected blood sample based on an optical method or a magnetic bead method according to the interference object information, wherein an optical method detection area for performing coagulation detection based on the optical method and a magnetic bead method detection area for performing coagulation detection based on the magnetic bead method are the same detection area.

14. The method of claim 13, wherein determining whether to perform coagulation detection on the measured blood sample based on the interferent information by optical or magnetic bead method comprises:

When the interference in the detected object does not affect the coagulation detection based on the optical method, the optical method detection device is used for carrying out the coagulation detection on the detected object;

When an interfering object in the detected object can influence the coagulation detection based on an optical method, the magnetic bead method detection device is used for carrying out the coagulation detection on the detected object.

15. The method of claim 13, wherein the interfering substance is a substance that absorbs light of a specific wavelength that is at least one of the wavelengths of light used in optically detecting coagulation of a sample mixture of plasma and a reagent.

16. The method as claimed in claim 1 or 13, further comprising: and outputting prompt information for determining to adopt an optical method or a magnetic bead method.

17. The coagulation analyzer is characterized by comprising a pre-judging device, an optical method detection device, a magnetic bead method detection device, a tested object transferring mechanism and a processor;

The pre-judging device is used for carrying out optical detection on the detected object before the detected object is subjected to coagulation detection under the control of the processor within a set time period after a reagent is added to a detected sample to obtain a detected object, so as to obtain an optical detection result, wherein the detected object at least comprises blood plasma of a detected blood sample, the reagent comprises at least one of diluent, mixed reagent and trigger reagent, the set time period is set according to the type of the reagent added to the detected sample and the time of adding the reagent, the detected object is subjected to optical detection within the set time period after the trigger reagent is added to the detected sample, and the detected object is subjected to optical detection within the set time period before the diluent and the mixed reagent are added to the detected sample, the first type of item is a coagulation detection item which needs to be added with the trigger reagent and has a baseline period of obvious luminous flux after the trigger reagent is added, and the second type of item is a coagulation detection item which needs to be added with the diluent, the mixed reagent and the luminous flux does not change basically before the trigger reagent is added after the diluent and the mixed reagent is added;

The magnetic bead method detection device is used for carrying out coagulation detection on an object to be detected based on a magnetic bead method under the control of the processor and outputting an electric signal reflecting coagulation conditions, wherein an optical method detection area for carrying out coagulation detection based on an optical method and a magnetic bead method detection area for carrying out coagulation detection based on the magnetic bead method are the same detection area;

The measured object transferring mechanism is used for transferring the reaction container containing the measured object to a preset position under the control of the processor, and magnetic beads are placed in the reaction container;

The processor is used for determining whether the optical method detection device is used for carrying out coagulation detection on the detected object or the magnetic bead method detection device is used for carrying out coagulation detection on the detected object according to the optical detection result, receiving an electric signal reflecting coagulation conditions, and obtaining the measurement parameters of the detected blood sample after processing.

18. The coagulation analyzer of claim 17, wherein the processor is configured to obtain, based on the optical detection result, information of an interfering substance that reflects a condition of the interfering substance in the object, the interfering substance being a substance that affects a detection result of the optical-method-based coagulation detection item; when the interference objects in the detected object cannot influence the detection result of the coagulation detection item based on the optical method, the processor controls the optical method detection device to perform coagulation detection on the detected object; when the interference in the detected object can influence the detection result of the coagulation detection item based on the optical method, the processor controls the magnetic bead method detection device to perform coagulation detection on the detected object.

19. The coagulation analyzer of claim 18, wherein the interfering substance is a substance that absorbs light of a specific wavelength, and wherein the specific wavelength is at least one of wavelengths of light used for optically detecting coagulation of a sample mixture of plasma and a reagent.

20. The coagulation analyzer of claim 19, wherein the pre-determining device comprises a photoelectric detection device, the photoelectric detection device comprises a light emitting end and a light receiving end, the light emitting end is used for irradiating the object to be detected by at least one light with a specific wavelength or a light with a wavelength close to the specific wavelength, and the light receiving end is used for detecting the optical information of the object to be detected after the light action, so as to obtain the optical detection result of the object to be detected for each specific wavelength light.

21. The coagulation analyzer of claim 20, wherein the optical information is transmitted and/or scattered light intensity of the light beam after passing through the test object.

22. The coagulation analyzer of claim 20 or 21, wherein the processor calculates absorbance values of the test object for each specific wavelength light based on the optical information, and determines that an interfering object in the test object has an influence on a detection result of the optically-based coagulation detection item when the absorbance value of at least one specific wavelength light is greater than a preset threshold value.

23. The coagulation analyzer of claim 17, wherein the pre-determination means comprises image acquisition means for acquiring image data of the object under test to obtain an optical detection result; the processor identifies the color of the detected object according to the image data, compares the color of the detected object with a preset color, and judges that the interference object in the detected object can influence the detection result of the coagulation detection item based on the optical method when the color of the detected object is the same as or similar to the preset color.

24. The coagulation analyzer of claim 17, wherein the assay in which the predictive device optically detects an analyte is plasma or a mixture of plasma and a reagent.

25. The coagulation analyzer of claim 17, wherein the location at which the predictive device optically detects the analyte is a dedicated location, incubation area, optical detection area, or magnetic bead detection area.

26. The coagulation analyzer is characterized by comprising an optical method detection device, a magnetic bead method detection device, a tested object transfer mechanism and a processor;

The processor is used for obtaining interferent information reflecting the condition of interferents in a measured blood sample based on optical detection within a set time period after the measured blood sample is added with a reagent to obtain the measured objects, judging whether the measured objects are subjected to coagulation detection by the optical detection device or the magnetic bead detection device according to the interferent information, and receiving an electric signal reflecting the coagulation condition, obtaining measurement parameters of the measured blood sample after processing, wherein the interferent refers to substances which have influence on the coagulation detection based on the optical method, the reagent comprises at least one of a diluent, a mixed reagent and a trigger reagent, the set time period is set according to the type of the reagent added to the measured blood sample and the time of adding the reagent, wherein for a first type of items, the interferent information reflecting the condition of the interferents in the measured blood sample is obtained based on the optical detection within the set time period after the measured blood sample is added with the trigger reagent, for a second type of items, the interferent information reflecting the condition of the measured blood sample is obtained based on the optical detection within the set time period before the diluent and the mixed reagent is added with the trigger reagent, the second type of items are required to be added with the diluent and the trigger reagent is added with no obvious change after the first type of items and the trigger reagent is added with the trigger reagent.

27. A computer readable storage medium comprising a program executable by a processor to implement the method of any one of claims 1-16.