CN115201497A

CN115201497A - Device and method for blood analysis

Info

Publication number: CN115201497A
Application number: CN202110402683.3A
Authority: CN
Inventors: 郑文波; 叶波; 姚栋蓝; 叶燚; 祁欢
Original assignee: Shenzhen Mindray Bio Medical Electronics Co Ltd
Current assignee: Shenzhen Mindray Bio Medical Electronics Co Ltd
Priority date: 2021-04-14
Filing date: 2021-04-14
Publication date: 2022-10-18

Abstract

The application provides a device and a method for blood analysis, wherein the method comprises the steps of obtaining an optical signal of a first sample to be tested, the first sample to be tested is prepared from a blood sample and a first reagent containing a hemolytic agent, the optical signal of the first sample to be tested is used for obtaining a first detection result of the blood sample, the first detection result comprises any one or combination of immature platelet parameters, reticulocyte parameters and large-volume platelet parameters, and comprises a white blood cell counting result and/or a white blood cell classification result; judging whether the detection process of the first sample to be detected is abnormal or not; if so, preparing a second test sample by using the blood sample and a second reagent, obtaining an optical signal of the second test sample, and obtaining a second detection result of the blood sample according to the optical signal of the second test sample, wherein the second reagent comprises a fluorescent reagent and does not comprise a hemolytic agent; the second test result includes any one or a combination of immature platelet parameters, reticulocyte parameters, and bulk platelet parameters.

Description

Device and method for blood analysis

Technical Field

The present disclosure relates to the field of in vitro assays, and more particularly, to a device and method for blood analysis.

Background

Immature platelet (immature platelet) parameters (such as the ratio of immature platelet to total platelet count, immature platelet fraction, IPF), reticulocyte (RET) parameters, and large-volume platelet parameters are several important parameters for blood analysis. The reticulocyte parameters are important indexes for judging the hemopoietic condition of the bone marrow erythroid and observing the curative effect, and the immature platelet parameters can judge the activity of megakaryocytes. However, the accuracy of the existing detection device is still to be improved due to some interference during detection.

Disclosure of Invention

Based on the above-mentioned shortcomings of the prior art, the present application provides a device and method for blood analysis to improve the accuracy of detection of immature platelet parameters, reticulocyte parameters, and bulk platelet parameters.

The present application provides in a first aspect a device for blood analysis comprising:

a blood sample supply unit for supplying a blood sample;

a reagent supply unit for supplying a reagent;

at least one mixing chamber for receiving a blood sample provided by the blood sample supply and a reagent provided by the reagent supply to prepare a test sample;

a measurement unit including an optical detection unit; the optical detection portion comprises a flow chamber, a light source and an optical detector; the flow chamber is communicated with the mixing chamber and is used for allowing cells of a sample to be detected to pass through one by one, the light source is used for irradiating the cells passing through the flow chamber, and the optical detector is used for acquiring optical signals of the cells passing through the flow chamber;

a processor, wherein:

the processor controls the blood sample supply to supply the blood sample to the mixing chamber, and controls the reagent supply to supply at least a first reagent to the mixing chamber to prepare a first test sample in the mixing chamber; the processor controls the optical detection part to acquire an optical signal of a first sample to be detected; the optical signal of the first test sample is used for obtaining a first detection result of the blood sample, wherein the first detection result comprises any one or combination of an immature platelet parameter, a reticulocyte parameter and a large-volume platelet parameter, and comprises a white blood cell counting result and/or a white blood cell classification result; the first reagent comprises a hemolytic agent;

the processor judges whether the detection process of the first sample to be detected is abnormal or not;

when the detection process of the first sample to be detected is judged not to be abnormal, outputting the first detection result;

when the detection process of the first sample to be detected is judged to be abnormal, the processor controls the blood sample supply part to supply the blood sample to the mixing chamber, and controls the reagent supply part to supply at least a second reagent to the mixing chamber so as to prepare a second sample to be detected in the mixing chamber; the processor controls the optical detection part to acquire an optical signal of a second sample to be detected; the optical signal of the second test sample is used for obtaining a second detection result of the blood sample, and the second detection result comprises any one or combination of an immature platelet parameter, a reticulocyte parameter and a large-volume platelet parameter; the second reagent comprises a fluorescent reagent and does not comprise a hemolytic agent;

the processor judges whether the detection process of the second sample to be detected is abnormal or not; and if so, retesting the sample, otherwise, outputting the second detection result.

The second aspect of the present application also provides a device for blood analysis, comprising:

a blood sample supply unit for supplying a blood sample;

a reagent supply unit for supplying a reagent;

the apparatus for blood analysis comprises a first measurement mode and a second measurement mode;

the apparatus for blood analysis further comprises a processor, wherein:

the processor determining whether the second measurement mode is enabled;

when the second measurement mode is judged to be started, in the second measurement mode, the blood sample supply part is controlled to supply the blood sample to the mixing chamber, and the reagent supply part is controlled to supply at least a second reagent to the mixing chamber so as to prepare a second sample to be tested in the mixing chamber; the processor controls the optical detection part to obtain an optical signal of the second sample to be detected; the optical signal of the second sample to be detected is used for obtaining a second detection result of the blood sample; the second reagent comprises a fluorescent reagent and does not comprise a hemolytic agent;

and controlling the blood sample supply part to supply the blood sample to the mixing chamber, and controlling the reagent supply part to supply at least the first reagent to the mixing chamber to prepare a first test sample in the mixing chamber; the processor controls the optical detection part to acquire an optical signal of the first sample to be detected; the optical signal of the first sample to be detected is used for obtaining a first detection result of the blood sample; the first reagent comprises a hemolytic agent;

the first detection result comprises any one or combination of immature platelet parameters, reticulocyte parameters and large-volume platelet parameters, and comprises a white blood cell counting result and/or a white blood cell classification result;

the second detection result comprises any one or combination of immature platelet parameters, reticulocyte parameters and large-volume platelet parameters;

the processor judges whether the detection process of the second sample to be detected is abnormal or not; when the detection process of the second sample to be detected is judged not to be abnormal, outputting a second detection result; when the detection process of the second sample to be detected is judged to be abnormal, judging whether the detection process of the first sample to be detected is abnormal or not, and when the detection process of the first sample to be detected is judged to be abnormal, re-detecting the sample; when the detection process of the first sample to be detected is judged not to be abnormal, outputting the first detection result;

when the second measurement mode is not started, in the first measurement mode, controlling the blood sample supply part to supply the blood sample to the mixing chamber, and controlling the reagent supply part to supply at least the first reagent to the mixing chamber so as to prepare a first sample to be tested in the mixing chamber; the processor controls the optical detection part to obtain an optical signal of a first sample to be detected; the optical signal of the first sample to be detected is used for obtaining a first detection result of the blood sample;

the processor judges whether the detection process of the first sample to be detected is abnormal or not; when the detection process of the first sample to be detected is judged to be abnormal, the processor starts the second measurement mode; and when the detection process of the first sample to be detected is judged not to be abnormal, outputting the first detection result.

The third aspect of the present application further provides a device for blood analysis, comprising:

a blood sample supply unit for supplying a blood sample;

a reagent supply unit for supplying a reagent;

the apparatus for blood analysis further comprises a processor, wherein:

when the second measurement mode is judged to be started, controlling the blood sample supply part to supply the blood sample to the mixing chamber and controlling the reagent supply part to supply at least a second reagent to the mixing chamber in the second measurement mode so as to prepare a second sample to be tested in the mixing chamber; the processor controls the optical detection part to obtain an optical signal of the second sample to be detected; the optical signal of the second sample to be detected is used for obtaining a second detection result of the blood sample; the second reagent comprises a fluorescent reagent and does not comprise a hemolytic agent;

the processor judges whether the detection process of the second sample to be detected is abnormal or not; when the detection process of the second sample to be detected is judged not to be abnormal, outputting a second detection result; when the detection process of the second sample to be detected is judged to be abnormal, the first measurement mode is started, and in the first measurement mode, the blood sample supply part is controlled to supply the blood sample to the mixing chamber, and the reagent supply part is controlled to supply at least a first reagent to the mixing chamber, so that the first sample to be detected is prepared in the mixing chamber; the processor controls the optical detection part to acquire an optical signal of the first sample to be detected; the optical signal of the first sample to be detected is used for obtaining a first detection result of the blood sample; the first reagent comprises a hemolytic agent;

the processor judges whether the detection process of the first sample to be detected is abnormal or not; when the detection process of the first sample to be detected is judged to be abnormal, retesting the sample, and when the detection process of the first sample to be detected is judged not to be abnormal, outputting the first detection result; the first detection result comprises any one or combination of immature platelet parameters, reticulocyte parameters and large-volume platelet parameters, and comprises a white blood cell counting result and/or a white blood cell classification result;

when the second measurement mode is not started, in the first measurement mode, controlling the blood sample supply part to supply the blood sample to the mixing chamber, and controlling the reagent supply part to supply at least the first reagent to the mixing chamber so as to prepare a first sample to be tested in the mixing chamber; the processor controls the optical detection part to acquire an optical signal of a first sample to be detected; the optical signal of the first test sample is used for obtaining a first detection result of the blood sample;

the processor judges whether the detection process of the first sample to be detected is abnormal or not; when the detection process of the first sample to be detected is judged to be abnormal, the processor starts the second measurement mode; and outputting the first detection result when the detection process of the first sample to be detected is judged not to be abnormal.

A blood sample supply unit for supplying a blood sample;

a reagent supply unit for supplying a reagent;

a measurement section including an optical detection section; the optical detection portion comprises a flow chamber, a light source and an optical detector; the flow chamber is communicated with the mixing chamber and is used for allowing cells of a sample to be detected to pass through one by one, the light source is used for irradiating the cells passing through the flow chamber, and the optical detector is used for acquiring optical signals of the cells passing through the flow chamber;

a processor, wherein:

the processor controls the blood sample supply to supply the blood sample to the mixing chamber, and controls the reagent supply to supply at least a first reagent to the mixing chamber to prepare a first test sample in the mixing chamber; the processor controls the optical detection part to obtain an optical signal of a first sample to be detected; the optical signal of the first test sample is used for obtaining a first detection result of the blood sample, and the first detection result comprises any one or combination of an immature platelet parameter, a reticulocyte parameter, a large-volume platelet parameter, a white blood cell counting result and a white blood cell classification result; the first reagent comprises a hemolytic agent;

A fourth aspect of the present application provides a method of blood analysis, comprising:

acquiring an optical signal of a first sample to be tested, wherein the first sample to be tested is prepared from a blood sample and a first reagent; the optical signal of the first test sample is used for obtaining a first detection result of the blood sample, wherein the first detection result comprises any one or combination of immature platelet parameters, reticulocyte parameters and large-volume platelet parameters, and comprises a white blood cell counting result and/or a white blood cell classification result; the first reagent comprises a hemolytic agent;

judging whether the detection process of the first sample to be detected is abnormal or not;

when the first test sample is judged not to be abnormal in the test process, outputting the first test result;

when the detection process of the first sample to be detected is judged to be abnormal, controlling to prepare a second sample to be detected and acquiring an optical signal of the second sample to be detected, wherein the second sample to be detected is prepared from the blood sample and a second reagent; the optical signal of the second test sample is used for obtaining a second detection result of the blood sample, and the second detection result comprises any one or combination of an immature platelet parameter, a reticulocyte parameter and a large-volume platelet parameter; the second reagent comprises a fluorescent reagent and does not comprise a hemolytic agent;

and judging whether the detection process of the second sample to be detected is abnormal or not, if so, retesting the sample, and otherwise, outputting the second detection result.

The fifth aspect of the present application also provides a method of blood analysis, comprising:

determining whether a second measurement mode of the device for blood analysis is enabled; the apparatus for blood analysis comprises a first measurement mode and a second measurement mode;

when the second measurement mode is judged to be started, acquiring an optical signal of the second sample to be measured and an optical signal of the first sample to be measured in the second measurement mode; the optical signal of the second sample to be detected is used for obtaining a second detection result of the blood sample; the second detection result comprises any one or combination of immature platelet parameters, reticulocyte parameters and large-volume platelet parameters; the second test sample is prepared from a blood sample and a second reagent; the second reagent comprises a fluorescent reagent and does not comprise a hemolytic agent; the optical signal of the first test sample is used for obtaining a first detection result of the blood sample; the first detection result comprises any one or combination of immature platelet parameters, reticulocyte parameters and large-volume platelet parameters, and comprises a white blood cell counting result and/or a white blood cell classification result; the first test sample is prepared from a blood sample and a first reagent; the first reagent comprises a hemolytic agent;

judging whether the detection process of the second sample to be detected is abnormal or not, and outputting a second detection result when the detection process of the second sample to be detected is not abnormal; when the detection process of the second sample to be detected is judged to be abnormal, judging whether the detection process of the first sample to be detected is abnormal or not; when the detection process of the first sample to be detected is judged to be abnormal, retesting the sample, and when the detection process of the first sample to be detected is judged not to be abnormal, outputting the first detection result;

when the second measurement mode is not started, acquiring an optical signal of a first sample to be tested in the first measurement mode, wherein the first sample to be tested is prepared from a blood sample and a first reagent; the optical signal of the first sample to be detected is used for obtaining a first detection result of the blood sample;

judging whether the detection process of the first sample to be detected is abnormal or not, and starting the second measurement mode when the detection process of the first sample to be detected is abnormal; and when the detection process of the first sample to be detected is judged not to be abnormal, outputting the first detection result.

The sixth aspect of the present application further provides a method of blood analysis, comprising:

when the second measurement mode is judged to be started, acquiring an optical signal of the second sample to be measured in the second measurement mode; the optical signal of the second test sample is used for obtaining a second detection result of the blood sample; the second detection result comprises any one or combination of immature platelet parameters, reticulocyte parameters and large-volume platelet parameters; the second test sample is prepared from a blood sample and a second reagent; the second reagent comprises a fluorescent reagent and does not comprise a hemolytic agent;

judging whether the detection process of the second sample to be detected is abnormal or not, and outputting a second detection result when the detection process of the second sample to be detected is not abnormal;

when the detection process of the second sample to be detected is judged to be abnormal, acquiring an optical signal of a first sample to be detected, wherein the optical signal of the first sample to be detected is used for acquiring a first detection result of the blood sample; the first detection result comprises any one or combination of immature platelet parameters, reticulocyte parameters and large-volume platelet parameters, and comprises a white blood cell counting result and/or a white blood cell classification result; the first test sample is prepared from a blood sample and a first reagent; the first reagent comprises a hemolytic agent;

judging whether the detection process of the first sample to be detected is abnormal or not; when the detection process of the first sample to be detected is judged to be abnormal, sample retesting is carried out, and when the detection process of the first sample to be detected is judged not to be abnormal, the first detection result is output;

when the second measurement mode is not started, acquiring an optical signal of the first sample to be tested in the first measurement mode, wherein the first sample to be tested is prepared from a blood sample and a first reagent; the optical signal of the first sample to be detected is used for obtaining a first detection result of the blood sample;

The application provides a device and a method for blood analysis, wherein the method comprises the steps of obtaining an optical signal of a first sample to be tested, the first sample to be tested is prepared from a blood sample and a first reagent containing a hemolytic agent, the optical signal of the first sample to be tested is used for obtaining a first detection result of the blood sample, and the first detection result comprises any one or combination of immature platelet parameters, reticulocyte parameters, large-volume platelet parameters, white blood cell counting results and white blood cell classification results; judging whether the detection process of the first sample to be detected is abnormal or not; when the detection process of the first sample to be detected is judged to be abnormal, controlling to prepare a second sample to be detected, acquiring an optical signal of the second sample to be detected, and acquiring a second detection result of the blood sample according to the optical signal of the second sample to be detected, wherein the second sample to be detected is prepared from the blood sample and a second reagent, and the second reagent comprises a fluorescent reagent and does not comprise a hemolytic agent; the second test result includes any one or a combination of immature platelet parameters, reticulocyte parameters, and bulk platelet parameters. Therefore, the accuracy of the immature platelet parameter, the reticulocyte parameter and the large-volume platelet parameter in the detection result is improved by judging whether the detection process of the first sample to be detected is abnormal or not and replacing the measurement mode after the abnormality occurs.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the embodiments or the prior art descriptions will be briefly described below, it is obvious that the drawings in the following description are only embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to the provided drawings without creative efforts.

FIG. 1 is a schematic view of a blood analysis apparatus according to an embodiment;

FIG. 2 is a schematic view of an optical detection unit according to an embodiment;

FIG. 3 is a schematic structural diagram of an optical detection unit according to another embodiment;

FIG. 4 is a schematic structural diagram of an optical detection unit according to yet another embodiment;

fig. 5 is an example of a scattergram of a first sample to be measured generated based on fluorescence and forward scattered light;

fig. 6 is an example of a scattergram of a second sample to be measured generated based on fluorescence and forward scattered light;

FIG. 7 is an example of a scatter plot of two different blood samples generated from an optical signal;

FIG. 8 is a tabular diagram illustrating some of the test patterns for the BC-6800, BC-6000 and BC-6800Plus blood analyzers manufactured by Shenzhen Merry biomedical electronics, inc.;

FIG. 9 is a comparison of measured signals for a normal case and a noisy interference case;

FIG. 10 is a diagram illustrating a pulse signal of a particle to be measured;

FIG. 11 is a histogram of the optical signal intensity distribution of each particle under test identified from the target optical signal;

fig. 12 is a schematic diagram of the numbers of particles to be detected in a plurality of second unit times;

fig. 13 is a distribution histogram of optical signals in a plurality of first unit times;

FIG. 14 is a flow chart of a method of blood analysis in one embodiment;

FIG. 15 is a flowchart of a method of blood analysis in another embodiment;

FIG. 16 is a flow chart of a method of blood analysis in yet another embodiment.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be obtained by a person skilled in the art without making any creative effort based on the embodiments in the present invention, belong to the protection scope of the present invention.

Reticulocytes (RET) are transitional stage cells between late erythroblasts and mature erythrocytes, slightly larger than mature erythrocytes. Reticulocytes are the red blood cells with nucleus just lost and still belong to immature red blood cells, and have residual basophilic substances such as ribosome and ribonucleic acid in the cytoplasm, so that after living body infection with brilliant tar blue or new methylene blue, blue or blue-green branch points and even a reticular structure can be seen in the cytoplasm, thus being named reticulocytes. Reticulocytes are an important stage in the process of red blood cell maturation. Reticulocyte count is an important index for judging the hematopoietic condition of bone marrow erythroid and observing the curative effect. In recent years, instruments for performing RET counting by using a flow analysis technology are gradually developed, and are adopted by more and more hospitals due to the advantages of good repeatability, high accuracy, time saving and the like. The instrument method RET counting uses dye to dye RET, and adopts principles of sheath flow technology, radio frequency technology and the like to detect RET. The principle of the fluorometric determination of reticulocytes is that reticulocytes are stained with a fluorescent dye, the forward scattered light intensity and the fluorescence intensity of the cells are measured by flow cytometry, and the mature erythrocytes and reticulocytes are classified mainly by using the difference in fluorescence intensity.

Reticulocytes (RPs, also known as immature platelet Immature platelets) represent newly generated platelets that release human peripheral blood from bone marrow megakaryocytes, which contain no nuclei and DNA in the cytoplasm, retain only mRNA and rough endoplasmic reticulum, and retain the ability to synthesize a small amount of protein. It reflects the youngest platelets in the circulation, and the percentage of RP (% RP) and its absolute count are of great importance for the analysis of the kinetics of thrombopoiesis and the mechanism of thrombocytopenia. The information available to thrombocytopenic patients is limited and does not reflect platelet production in the bone marrow. The RP count reflects the rate of platelet production, and in particular the ratio of RP to total platelet count (IPF) more accurately reflects platelet production. IPF increases when thrombopoiesis increases, and vice versa. Research shows that RNA components in RP cytoplasm are closely related to megakaryocyte activity, and the RNA content is increased when the megakaryocyte activity is enhanced, namely the IPF ratio is increased. Thus, the detection of IPF can determine megakaryocyte activity, identifying thrombocytopenia as a result of myelogenous dysfunction or increased platelet destruction in peripheral blood.

Regarding measurement of reticulocytes and immature platelets, the currently mainstream blood cell analyzer in the industry uses an independent channel and reagent to perform reticulocytes and immature platelets detection, for example, U.S. Pat. No. 7,892,850, which proposes a method for detecting immature platelets. It carries on fluorescent reagent dyeing (insoluble blood) to the blood sample, then detects the scattered light and fluorescence of single blood cell, uses the above scattered light and fluorescence information to classify and count the immature blood platelet; another method exists in the industry, which uses a normally open hemolysis channel to detect reticulocytes and immature platelets, and uses a specific reagent to simultaneously measure leukocytes, reticulocytes, and immature platelets.

The invention provides a blood analysis device and a method, which can directly obtain reticulocyte parameters, immature platelet parameters and large-volume platelet parameters of a hemolysis channel in a first measurement mode (also called as a conventional measurement mode, herein, the first measurement mode refers to a measurement mode that an independent reticulocyte detection channel is not opened), and also can obtain reticulocyte parameters, immature platelet parameters and large-volume platelet parameters of the independent reticulocyte detection channel in a second measurement mode (refers to a measurement mode that the independent reticulocyte detection channel is opened), so that when the parameters are detected, if the detection process of the hemolysis channel is abnormal, the detection channel can be switched to the reticulocyte detection channel for detection, the detection result of the reticulocyte detection channel is output, and if the detection process of the reticulocyte detection channel is abnormal, the hemolysis channel can be switched to, the detection result of the hemolysis channel is output, and therefore, the accuracy of the parameters in the detection result is improved.

In some embodiments, a device for testing a blood sample is disclosed. Referring to fig. 1, the blood sample testing device in some embodiments may include a blood sample supply part 10, a reagent supply part 20, a mixing chamber 30, a testing part 40, and a processor 50. Specifically, the blood sample supply part 10 supplies a blood sample; the reagent supply unit 20 supplies a reagent; the mixing chamber 30 is used for receiving the blood sample provided by the blood sample supply part 10 and the reagent provided by the reagent supply part 20 to prepare a sample to be tested; the measurement unit 40 is used to detect the prepared sample to be tested. This will be explained in detail below.

In some embodiments, the blood sample supply portion 10 may include a sample needle that is spatially moved in two or three dimensions by a two or three dimensional drive mechanism so that the sample needle may be moved to aspirate a blood sample in a container (e.g., a sample tube) carrying the blood sample, and then moved to provide a reaction site for the blood sample and a reagent to be measured, such as the mixing chamber 30, and discharge the blood sample to the mixing chamber 30.

In some embodiments, the reagent supply part 20 may include a reagent disk and a reagent needle, the reagent disk is disposed in a disk-shaped structure and has a plurality of positions for carrying reagent containers, and the reagent disk can rotate and drive the reagent containers carried by the reagent disk to rotate for rotating the reagent containers to a specific position, for example, a position for sucking reagent by the reagent needle; the reagent needle can be moved in two or three dimensions by a two or three dimensional drive mechanism so that the reagent needle can be moved to aspirate reagent carried by the reagent tray and discharge it into the mixing chamber 30. In other embodiments, the reagent supplying part 20 may also include a reagent bearing region and a reagent needle, the reagent is fixedly disposed, and the reagent needle moves to suck different reagents and discharge the reagents into the mixing chamber 30.

The number of the mixing chambers 30 may be one or more. The mixing chamber 30 is used to provide a processing or reaction site for the blood sample and reagents. Different test items may share the same mixing chamber 30; different mixing chambers 30 can be used for different items of testing, for example, one mixing chamber 30 can be used for the item of testing for classifying leukocytes, and another mixing chamber 30 can be used for the item of testing for counting nucleated red blood cells.

The sample to be measured can be obtained by treating a blood sample with a reagent. In some embodiments, the reagent comprises a hemolytic agent and/or a fluorescent agent. The hemolytic agent is a reagent capable of lysing erythrocytes in the blood sample, and specifically, it may be any one or a combination of cationic surfactant, nonionic surfactant, anionic surfactant, and amphiphilic surfactant. A fluorescent agent is used to stain the blood sample, for example the fluorescent agent may be pyronine, acridine orange, thiazole orange, and the like.

The measurement unit 40 is used to detect the prepared sample to be tested. In some embodiments, the measurement portion 40 may include an optical detection portion 60, and the optical detection portion 60 may be capable of measuring the blood sample by using the principle of laser scattering: the cells are sorted and counted by collecting the optical signals, such as scattered light and fluorescence, generated after the cells are irradiated by irradiating laser light on the cells-although in some embodiments, if the cells are not treated with a fluorescent reagent, no fluorescence is naturally collected. The optical detection unit 60 in the measurement unit 40 will be described below.

Referring to fig. 2, the optical detection unit 60 may include a light source 61, a flow cell 62, and an optical detector 69. The flow chamber 62 is communicated with the mixing chamber 30 and is used for allowing cells of a sample to be tested to pass through one by one; light source 61 is used to illuminate the cells passing through flow chamber 62 and optical detector 69 is used to acquire optical signals of the cells passing through flow chamber 62. Fig. 3 shows a specific example of the optical detection portion 60, and the optical detector 69 may include a lens group 63 for collecting forward scattered light, a photodetector 64 for converting the collected forward scattered light from an optical signal into an electrical signal, a lens group 65 for collecting side scattered light and side fluorescent light, a dichroic mirror 66, a photodetector 67 for converting the collected side scattered light from an optical signal into an electrical signal, and a photodetector 68 for converting the collected side fluorescent light from an optical signal into an electrical signal; the dichroic mirror 66 is used for splitting light, and divides the side scattered light and the side fluorescent light mixed together into two paths, one path is the side scattered light, and the other path is the side fluorescent light. It should be noted that the optical signal may refer to an optical signal, or to an electrical signal converted from an optical signal, and the information contained in the characterization cell detection result is substantially consistent.

How the optical detection unit 60 specifically acquires the optical signal of the sample to be measured will not be described by taking the configuration of the optical detection unit 60 shown in fig. 3 as an example.

The flow cell 62 is used for passing cells of a sample to be tested one by one. For example, after lysing red blood cells in a blood sample with a reagent such as a hemolysing agent in the mixing chamber 30, or further staining with a fluorescent agent, the prepared cells in the test sample are queued one after the other from the flow chamber 62 using sheath flow techniques. The Y-axis direction in the figure is a direction in which cells in a sample to be tested move, and the Y-axis direction in the figure is a direction perpendicular to the plane of the drawing. Light source 61 is used to illuminate cells passing through flow cell 62. In some embodiments, the light source 61 is a laser, such as a helium-neon laser or a semiconductor laser. When light from the light source 61 is applied to the cells in the flow cell 62, scattering occurs to the surroundings. Therefore, when the cells in the prepared sample to be tested pass through the flow chamber 62 one by one under the action of the sheath flow, the light emitted from the light source 61 irradiates the cells passing through the flow chamber 62, the light irradiated on the cells is scattered all around, and forward scattered light, such as the direction of the Z axis in the figure, is collected by the lens group 63 and reaches the photodetector 64, so that the processor 50 can acquire the forward scattered light information of the cells from the photodetector 64; meanwhile, lateral light, for example, the direction of the X axis in the figure, is collected through the lens group 65 in the direction perpendicular to the light rays irradiating the cells, and the collected lateral light is reflected and refracted through the dichroic mirror 66, wherein the lateral scattered light in the lateral light is reflected when passing through the dichroic mirror 66 and then reaches the corresponding photodetector 67, and the lateral fluorescent light in the lateral light is also reached the corresponding photodetector 68 after being refracted or transmitted, so that the processor 50 can obtain the lateral scattered light information of the cells from the photodetector 67 and obtain the lateral fluorescent light information of the cells from the photodetector 68. Fig. 4 shows another example of the optical detection unit 60. In order to improve the light performance of the light source 61 irradiating the flow chamber 62, a collimating lens 61a may be introduced between the light source 61 and the flow chamber 62, and the light emitted from the light source 61 is collimated by the collimating lens 61a and then irradiated to the cell passing through the flow chamber 62. In some examples, in order to make the collected fluorescence less noisy (i.e. without interference from other light), a filter 66a may be disposed in front of the photodetector 68, and the side fluorescence split by the dichroic mirror 66 may reach the photodetector 68 after passing through the filter 66 a. In some embodiments, after the lens assembly 63 collects the forward scattered light, a stop 63a is introduced to define the angle of the forward scattered light that finally reaches the photodetector 64, for example, to define the forward scattered light as low-angle (or small-angle) forward scattered light.

The processor 50 in some embodiments of the present invention includes, but is not limited to, a Central Processing Unit (CPU), a Micro Control Unit (MCU), a Field-Programmable Gate Array (FPGA), a Digital Signal Processor (DSP), and other devices for parsing computer instructions and Processing data in computer software. In some embodiments, processor 50 is configured to execute computer applications of the non-transitory computer readable storage medium, so as to enable the blood sample detection device to perform a corresponding detection procedure and analyze the light signal detected by optical detector 69, thereby obtaining a related detection result.

In some embodiments, the processor 50 can control the blood sample supply part 10 and the reagent supply part 20 to supply the blood sample and the first reagent to the mixing chamber 30, respectively, wherein the first reagent contains a hemolytic agent, and after the first sample to be tested is prepared in the mixing chamber 30 by the blood sample and the first reagent, the processor 50 controls the testing part 40 to obtain an optical signal of the first sample to be tested, and finally, the processor 50 analyzes the optical signal of the first sample to be tested to obtain a testing result of the blood sample in the hemolytic channel, i.e. a first testing result. The optical signal of the first test sample may include fluorescence and forward scattered light.

The first detection result may include any one or a combination of immature platelet parameter, reticulocyte parameter, large-volume platelet parameter, white blood cell count result and white blood cell classification result according to actual use requirements.

For example, if the first detection result includes the immature platelet parameter and the reticulocyte parameter, the processor 50 may generate a scatter diagram as shown in fig. 5, in which the abscissa represents the intensity of the forward scattered light and the ordinate represents the intensity of the fluorescence, from the fluorescence and forward scattered light of the first test sample, and then generate the immature platelet parameter and the reticulocyte parameter of the blood sample based on the scatter diagram.

In some embodiments, the processor 50 can control the blood sample supplier 10 and the reagent supplier 20 to respectively supply the blood sample and the second reagent to the mixing chamber 30, wherein the second reagent at least contains a fluorescent reagent and does not contain a hemolytic agent, after the blood sample and the second reagent are prepared in the mixing chamber 30 to obtain the second test sample, the processor 50 controls the measuring unit 40 to obtain an optical signal of the second test sample, and finally, the processor 50 analyzes the optical signal of the second test sample to obtain a detection result of the blood sample in the reticulocyte detection channel, that is, a second detection result. The optical signal of the second test sample may include fluorescence and forward scattered light.

The second test result may include any one or a combination of immature platelet parameter, reticulocyte parameter, and bulk platelet parameter, depending on the actual usage requirements.

For example, if the second detection result includes the immature platelet parameter and the reticulocyte parameter, the processor 50 may generate a scatter diagram as shown in fig. 6 according to the fluorescence and forward scattered light of the second test sample, and then generate the immature platelet parameter and the reticulocyte parameter of the blood sample based on the scatter diagram.

Alternatively, when any of the above detection results includes a large-volume platelet parameter, the processor 50 may generate a scatter diagram as shown in fig. 7 according to the corresponding optical signal of the sample to be detected, and obtain the large-volume platelet parameter of the blood sample based on the analysis of the scatter diagram shown in fig. 7. It is understood that the scattergrams generated from the optical signals of the test sample may be different according to the blood sample used to prepare the test sample, and the two scattergrams shown in fig. 7 correspond to two different blood samples. The abscissa of fig. 7 is the intensity of forward scattered light, and the ordinate is the intensity of fluorescence.

The left scattergram is an example of a scattergram generated from an optical signal of a sample after the sample is prepared from a blood sample (i.e., a large PLT sample) of large platelets (i.e., a large PLT). The scattergram on the right side is an example of a scattergram generated from an optical signal of a sample after the sample is prepared using a blood sample (i.e., a normal sample) not containing large-volume platelets.

Devices for general blood analysis may include one or more detection channels. Laser or optical methods to count white blood cells may be used as a separate detection channel, not called a hemolysis channel (WBC) count, but called BASO channel for short. Laser or optical light scattering to classify white blood cells may be used as a separate detection channel, not referred to as a hemolysis channel WBC count, DIFF for short. The impedance method for counting red blood cells can be used as a separate detection channel and is not called an impedance channel. The impedance method for counting platelets can be used as a separate detection channel, and is not called a platelet impedance channel. In some examples, the red blood cell impedance channel and the platelet impedance channel may be the same impedance channel. The optical platelet measurement can also be used as an independent detection channel, which can be recorded as R, namely, a reticulocyte detection channel, and the detection channel can be simultaneously used for detecting reticulocytes, immature platelets and large-volume platelets. The nucleated red blood cell measurement or count can also be used as an independent detection channel, which can be denoted as N, i.e., a nucleated red blood detection channel.

In order to quickly select a combination of one or more detection channels, measurement patterns, which are combinations of the detection channels, may be generally defined in the blood analyzer. In the present application, the measurement mode may be divided into two types, i.e., a first measurement mode (i.e., a measurement mode not including the R channel) and a second measurement mode (i.e., a measurement mode including the R channel), according to whether the measurement mode includes the reticule detection channel (i.e., the R channel).

The following description will be given by taking a specific apparatus as an example.

Referring to fig. 8, in an example, the blood analyzer of the present invention may be a BC-6800 blood cell analyzer manufactured by shenzhen meirui biomedical corporation. For the blood cell analyzer of BC-6800, the first measurement mode may include a CBC measurement mode, a CD measurement mode, a CN measurement mode, and a CDN measurement mode; the second measurement mode may include a CDR measurement mode, a CR measurement mode, an R measurement mode, and a CDRN measurement mode, and it can be seen that the CDR mode may be obtained by combining a CD mode and an R mode, the CDRN mode may be obtained by combining a CDN mode and an R mode, and the CR mode may be obtained by combining a CBC mode and an R mode.

For the BC-6800 blood cell analyzer, the CBC measurement mode can complete white blood cell count, red blood cell count and platelet count; the CD measurement mode can accomplish white blood cell count and classification, red blood cell count and platelet count; the CDR measurement mode can accomplish white blood cell count and classification, red blood cell count, platelet count and reticulocyte count; CR measurement mode can accomplish white blood cell count, red blood cell count and platelet count; the R measurement mode can be accomplished by counting of the erythrocytes; the CN measurement mode can complete white blood cell counting, red blood cell counting, platelet counting and nucleated red blood cell counting; the CDN measurement mode can accomplish white blood cell counting and sorting, red blood cell counting, platelet counting, and nucleated red blood cell counting; the CDRN measurement mode can accomplish white blood cell count and classification, red blood cell count, platelet count, reticulocyte count, and nucleated red blood cell count.

Still referring to FIG. 8, in another example, the blood analyzer of the present invention can be BC-6000, BC-6800Plus blood cell analyzer manufactured by Shenzhen Meyer biomedical corporation. For BC-6000 and BC-6800Plus blood cell analyzers, the first measurement mode may include a CBC measurement mode and a CD measurement mode, and the second measurement mode may include an R measurement mode, a CR measurement mode and a CDR measurement mode.

For BC-6000 and BC-6800Plus blood cell analyzers, the CBC measurement mode can complete white blood cell count, red blood cell count, platelet count and nucleated red blood cell count; the CD measurement mode can accomplish white blood cell count and classification, red blood cell count, platelet count, and nucleated red blood cell count; the CDR measurement mode can complete white blood cell counting and classification, red blood cell counting, platelet counting, nucleated red blood cell counting and reticulocyte counting; the CR measurement mode can accomplish white blood cell count, red blood cell count, platelet count, nucleated red blood cell count, and reticulocyte count.

It can be seen that the blood cell analyzers described above generally have the BASO channel or the DIFF channel except for some measurement modes including only one detection channel, such as the R measurement mode, so that when the present application is applied to the blood cell analyzers described above, the reticulocyte detection channel can be maintained in the normally closed state, and the hemolysis channel can be maintained in the normally open state. That is, during a conventional test, the blood cell analyzer may prepare a first test sample using a blood sample and a first reagent in a first measurement mode, and obtain a first detection result of the blood sample through a hemolysis channel (which may be a BASO channel or a DIFF channel).

After the first detection result is obtained, the blood cell analyzer can judge whether the detection process of the first sample to be detected is abnormal, if not, the first detection result is directly output to complete the test, if so, the reticulocyte detection channel is opened (namely, the second measurement mode comprising the R channel is started), then a second sample to be detected is prepared by utilizing the blood sample and the second reagent, and the second detection result of the blood sample is obtained by the reticulocyte detection channel.

In some embodiments, before the processor 50 starts the detection, it may be default that the current hemolysis channel is normally open, the reticulocyte detection channel is normally closed, that is, it is default that the current first measurement mode is enabled, and the second measurement mode is not enabled, at this time, the processor may control to prepare the first sample to be detected, then obtain the optical signal of the first sample to be detected through the measurement unit, and obtain the first detection result of the blood sample according to the optical signal of the first sample to be detected.

And then, the processor judges whether the detection process of the first sample to be detected is abnormal or not.

And when the detection process of the first sample to be detected is judged not to be abnormal, outputting a first detection result, and finishing the detection.

When the detection process of the first sample to be detected is judged to be abnormal, the processor can open the reticule red detection channel, namely, the second measurement mode is started, then the second sample to be detected is controlled and prepared, the optical signal of the second sample to be detected is obtained through the measurement portion, and the second detection result of the blood sample is obtained according to the optical signal of the second sample to be detected.

After the second detection result is obtained, the processor can judge whether the detection process of the second sample to be detected is abnormal, if so, the sample is retested, and if not, the second detection result is output.

Wherein, the retesting of the sample can be repeatedly executed once, namely:

controlling and preparing a first sample to be detected → obtaining a first detection result according to an optical signal of the first sample to be detected → judging whether the detection process of the first sample to be detected is abnormal or not → outputting the first detection result if not and ending, controlling and preparing a second sample to be detected → obtaining a second detection result according to an optical signal of the second sample to be detected → judging whether the detection process of the second sample to be detected is abnormal or not → outputting the second detection result if not and ending.

If the detection process of the first test sample and the detection process of the second test sample are still abnormal after the sample is retested, any one of the first detection result and the second detection result can be selected to be output, and the abnormal state of the instrument is prompted to a user.

In other embodiments, the second measurement mode may or may not be enabled before the processor 50 begins the test, and thus the processor may determine whether the second measurement mode is enabled before beginning the test.

In a first aspect, when it is determined that the second measurement mode is not enabled, it may be determined that the blood analysis apparatus is currently in the first measurement mode, and then the processor may control to prepare a first sample to be tested, obtain an optical signal of the first sample to be tested through the measurement portion, and obtain a first detection result of the blood sample according to the optical signal of the first sample to be tested; after the first detection result is obtained, the processor judges whether the detection process of the first sample to be detected is abnormal or not, and when the detection process of the first sample to be detected is not abnormal, the processor outputs the first detection result; when the detection process of the first sample to be detected is judged to be abnormal, the blood sample needs to be detected through the reticule red detection channel, so that the processor starts a second measurement mode comprising the reticule red detection channel and judges whether the second measurement mode is started again.

It can be seen that, after the processor starts the second measurement mode, the processor determines whether the second measurement mode is started again, and then the processor controls to prepare a second sample to be detected after determining that the detection process of the first sample to be detected is abnormal, and then obtains a second detection result of the reticule red detection channel by detecting the second sample to be detected.

After controlling to prepare a second sample to be detected and obtaining a second detection result, the processor can judge whether the detection process of the second sample to be detected is abnormal, if not, the second detection result is output, if yes, the sample retest is carried out, namely:

the processor controls and prepares a new first sample to be tested, detects the new first sample to be tested to obtain a new first detection result of the blood sample, then judges whether the detection process of the new first sample to be tested is abnormal or not, outputs the new first detection result if the detection process of the new first sample to be tested is abnormal, controls and prepares a new second sample to be tested if the detection process of the new first sample to be tested is abnormal, detects the new second sample to be tested to obtain a new second detection result of the blood sample, judges whether the detection process of the new second sample to be tested is abnormal or not, outputs the new second detection result if the detection process of the new second sample to be tested is abnormal or not, outputs the new first detection result and/or the new second detection result if the detection process of the new second sample to be tested is abnormal, and then prompts the abnormal state of the instrument to a user.

In a second aspect, when the second measurement mode is judged to be started, the processor controls to prepare a second sample to be detected, then controls to prepare the second sample to be detected, obtains an optical signal of the second sample to be detected through the measurement part, and obtains a second detection result of the blood sample according to the optical signal of the second sample to be detected; and after the second detection result is obtained, the processor judges whether the detection process of the second sample to be detected is abnormal or not, and outputs the second detection result when the detection process of the second sample to be detected is judged not to be abnormal.

In the aforementioned second measurement modes, the R mode only includes the reticulocyte detection channel, and the other second measurement modes, such as the CR mode, the CDR mode, and the CDRN mode, all include the hemolysis channel.

In a case of the second aspect, if the currently enabled second measurement mode belongs to a measurement mode including a hemolysis channel, the processor may control the measurement unit to prepare the first test sample for hemolysis channel detection in addition to controlling the preparation of the second test sample after determining that the second measurement mode is enabled, and correspondingly, the processor may control the measurement unit to detect the first test sample and the second test sample to obtain an optical signal of the first test sample and an optical signal of the second test sample, and further obtain a first detection result according to the optical signal of the first test sample, and obtain a second detection result according to the optical signal of the second test sample.

Wherein, when the processor controls the measuring part to detect the first sample to be detected and the second sample to be detected, if the blood analysis device is provided with two or more measuring parts, or the measuring part is provided with two or more optical detecting parts, the measuring part can simultaneously detect the first sample to be detected and the second sample to be detected; if the blood analysis device is provided with only one measurement portion, and the measurement portion only includes one optical detection portion, the measurement portion may first detect the first sample to be detected to obtain an optical signal of the first sample to be detected, and then detect the second sample to be detected after detecting the first sample to be detected to obtain an optical signal of the second sample to be detected, or may also first detect the second sample to be detected and then detect the first sample to be detected.

If the second measurement mode belongs to a measurement mode including a hemolysis channel, in the second aspect, after the processor determines that the detection process of the second sample to be detected is abnormal, the processor may determine whether the detection process of the first sample to be detected is abnormal, and if it is determined that the detection process of the first sample to be detected is not abnormal, the processor may output a first detection result; if the detection process of the first sample to be detected is judged to be abnormal, sample retesting can be carried out, namely, a new first sample to be detected and a new second sample to be detected are prepared again, the measuring part is controlled to obtain an optical signal of the new first sample to be detected and an optical signal of the new second sample to be detected, a new first detection result is obtained according to the optical signal of the new first sample to be detected, a new second detection result is obtained according to the optical signal of the new second sample to be detected, whether the detection process of the new second sample to be detected is abnormal or not is judged, after the detection process of the new second sample to be detected is judged to be abnormal, whether the detection process of the new first sample to be detected is abnormal or not is judged, if the detection process of the new second sample to be detected or the detection process of the new first sample to be detected is not abnormal or not, a corresponding detection result is output, and if the detection process of the new second sample to be detected and the detection process of the new first sample to be detected are both abnormal, the state of the instrument is abnormal or the abnormal, and the new first detection result and/or the new second detection result is output.

In another case of the second aspect, the currently enabled second measurement mode may be a second measurement mode that does not include a hemolysis channel, such as the R mode, in which the hemolysis channel is in a closed state, and at this time, after it is determined that the detection process of the second sample to be detected is abnormal, the processor may enable a measurement mode that includes a hemolysis channel, such as the CDR mode, the CBC mode, and the like, and then control to prepare the first sample to be detected, control to obtain the optical signal of the first sample to be detected, obtain the first detection result according to the optical signal of the first sample to be detected, determine whether the detection process of the first sample to be detected is abnormal, if it is determined that the detection process of the first sample to be detected is not abnormal, output the first detection result, and if it is determined that the detection process of the first sample to be detected is abnormal, perform a sample retest.

For another situation in the second aspect, the sample retesting refers to controlling to prepare a new second test sample, detecting to obtain an optical signal of the new second test sample, obtaining a new second detection result according to the optical signal of the new second test sample, determining whether the detection process of the new second test sample is abnormal, if the detection process of the new second test sample is not abnormal, outputting the new second detection result, if the detection process of the new second test sample is abnormal, controlling to prepare a new first test sample, detecting to obtain an optical signal of the new first test sample, obtaining a new first detection result according to the optical signal of the new first test sample, determining whether the detection process of the new first test sample is abnormal, if the detection process of the new first test sample is not abnormal, outputting the new first detection result, and/or outputting the new second detection result, and then prompting the user of the instrument for the abnormal state.

In the blood analysis device provided by the application, the processor can judge whether noise interference or unstable liquid flow exists in the detection process of the first sample to be detected according to the target optical signal; and if not, determining that the detection process of the first sample to be tested is not abnormal.

Specifically, if noise interference exists in the detection process of the first sample to be detected, or the liquid flow is unstable, or both the noise interference and the liquid flow are unstable, it is determined that the detection process of the first sample to be detected is abnormal;

and if the detection process of the first sample to be detected has no noise interference and no unstable liquid flow, determining that the detection process of the first sample to be detected has no abnormality.

Wherein the target optical signal comprises an optical signal of the first test sample or an optical signal of a non-blood sample substance.

For whether the detection process of the second sample to be detected is abnormal, the processor can also judge whether noise interference or unstable liquid flow exists in the detection process of the second sample to be detected according to the target optical signal, the specific process is basically consistent with that of the first sample to be detected, and detailed description is omitted.

The above-mentioned non-blood sample material generally refers to a material free of blood cells, such as: and the diluent, the air, the reagent and the like, wherein if the reagent is used as a non-blood sample substance, the non-blood sample substance is used as the first reagent when judging whether the detection process of the first sample to be detected is abnormal, and the non-blood sample substance is used as the second reagent when judging whether the detection process of the second sample to be detected is abnormal.

Generally, both the optical signal of the sample to be detected and the optical signal of the non-blood sample substance can be used for judging whether noise interference exists in the detection process, and the optical signal of the sample to be detected can be used for judging whether liquid flow instability exists in the detection process.

Taking the detection process of the first sample to be detected as an example, whether noise interference exists in the detection process of the first sample to be detected or not can be judged by adopting any one of the following judgment methods:

firstly, judging whether noise interference exists in the detection process of a first sample to be detected or not according to the variation coefficient, standard deviation or variance of an optical signal of a non-blood sample substance;

secondly, identifying the number of particles to be detected of the non-blood sample substance according to the optical signal of the non-blood sample substance, and judging whether noise interference exists in the detection process of the first sample to be detected or not according to the number of the particles to be detected of the non-blood sample substance;

thirdly, obtaining a first time of the particles to be detected according to the target optical signal, wherein the first time is the time of the particles to be detected passing through the flow chamber, and judging whether noise interference exists in the detection process of the first sample to be detected according to the proportion of the particles to be detected exceeding a preset normal range in the first time;

fourthly, the proportion of the particles to be detected in the preset signal area is obtained according to the target optical signal, and whether noise interference exists in the detection process is judged according to the proportion of the particles to be detected in the preset signal area.

Judging whether the liquid flow instability exists in the detection process of the first sample to be detected, wherein any one of the following judging methods can be adopted:

fifthly, obtaining a plurality of particles to be detected in second unit time according to the optical signal of the first sample to be detected, and judging whether the liquid flow instability exists in the detection process of the first sample to be detected according to the difference of the numbers of the particles to be detected;

and sixthly, counting distribution histograms of optical signals of the first to-be-detected samples in a plurality of first unit times, and judging whether the liquid flow instability exists in the detection process of the first to-be-detected samples according to the difference of the distribution histograms.

The method for judging whether the noise interference exists in the detection process of the second sample to be detected can be also applied to any one of the methods in the first to fourth methods, and the method for judging whether the noise liquid flow instability exists in the detection process of the second sample to be detected can be also applied to the fifth or sixth method, and only the optical signal of the first sample to be detected in the method needs to be replaced by the optical signal of the second sample to be detected.

The following describes a method for determining whether an abnormality occurs in the detection process of the first test sample, taking the detection process of the first test sample as an example. In the method for judging whether the detection process of the first sample to be detected is abnormal, the optical signal of the first sample to be detected replaces the optical signal of the second sample to be detected, so that the method for judging whether the detection process of the second sample to be detected is abnormal can be obtained, and the description is omitted.

It should be noted that, for each determination method, if the method is performed according to the optical signal of the first sample to be tested, the processor may determine whether the detection process of the first sample to be tested is abnormal according to the optical signal of the first sample to be tested immediately after the optical signal of the first sample to be tested is obtained by the measurement portion; if the method is performed according to the optical signal of the non-blood sample substance, the processor may control the mixing chamber to provide the non-blood sample substance to the measuring portion immediately after the optical signal of the first sample to be tested is measured, control the measuring portion to detect the optical signal of the non-blood sample substance, and perform the corresponding determination method according to the optical signal of the non-blood sample substance detected at this time.

Referring to fig. 9, fig. 9 shows an optical signal representation of a non-blood sample substance in the presence of noise interference (lower graph) and an optical signal representation of the non-blood sample substance in the absence of noise interference (upper graph), where the abscissa in fig. 9 is time and the ordinate is signal intensity, it can be seen that the optical signal of the non-blood sample substance is not stable over time in the presence of noise interference, and therefore the first determination method may be performed as follows:

the intensity of the optical signal of the non-blood sample substance is sampled at certain sampling intervals, and a sequence of the intensity composition of the optical signal of the non-blood sample substance at different time points is obtained and is marked as X = [ X1, X2, X3 \8230; xn ], wherein X1 to xn represent the intensity values of the optical signal of the non-blood sample substance at different time points.

The standard deviation of the optical signal of the non-blood sample material can then be calculated as follows:

the coefficient of variation of the optical signal of the non-blood sample substance was calculated as the following equation (2):

the variance of the optical signal of the non-blood sample material was calculated as follows:

variance = standard deviation ²

When the variation coefficient is judged, if the variation coefficient of the optical signal of the non-blood sample substance is larger than the set variation coefficient threshold, the noise interference in the detection process of the first sample to be detected can be judged, otherwise, if the variation coefficient is smaller than or equal to the variation coefficient threshold, the noise interference in the detection process of the first sample to be detected can be judged to be absent.

When the variance is judged, if the variance of the optical signal of the non-blood sample substance is larger than a set variance threshold, the noise interference in the detection process of the first sample to be detected can be judged, otherwise, if the variance is smaller than or equal to the variance threshold, the noise interference in the detection process of the first sample to be detected can be judged.

When the standard deviation is judged, if the standard deviation of the optical signal of the non-blood sample substance is larger than the set standard deviation threshold, the noise interference in the detection process of the first sample to be detected can be judged, otherwise, if the standard deviation is smaller than or equal to the standard deviation threshold, the noise interference in the detection process of the first sample to be detected can be judged to be absent.

Optionally, in the first determining method, the number of intensity values greater than the intensity threshold in the sequence X may also be calculated, that is, several values from X1 to xn are counted as greater than the intensity threshold, and an obtained statistical result, that is, the number of intensity values greater than the intensity threshold is recorded as P, if a proportion P/n of P in a total number n of intensity values included in the sequence X is greater than a preset threshold, it may be determined that noise interference exists in the detection process of the first sample to be detected, and otherwise, if the proportion P/n is less than or equal to the preset threshold, it may be determined that noise interference does not exist in the detection process of the first sample to be detected.

The second determination method is performed based on the optical signal of the non-blood sample substance, which generally contains a small amount of particles to be measured that can be detected by the measurement portion, and therefore, if the non-blood sample substance is identified to contain too many particles to be measured based on the optical signal of the non-blood sample substance, it can be considered that the detection process of the first sample to be measured has noise interference. Specifically, in the second determination method, the number of particles to be detected of the non-blood sample substance may be identified according to an optical signal of the non-blood sample substance, and if the number of particles to be detected obtained through identification is greater than a given particle number threshold, it is determined that noise interference exists in the detection process of the first sample to be detected, otherwise, if the number of particles to be detected obtained through identification is less than or equal to the particle number threshold, it is determined that noise interference does not exist in the detection process of the first sample to be detected.

And a third judging method. Referring to fig. 10, fig. 10 is a schematic diagram of pulse signals of particles to be measured, where the abscissa of fig. 10 is time and the ordinate is signal intensity. The upper graph represents the schematic diagram of the pulse signal of the particle to be detected when no noise interference exists, and the lower two graphs represent the schematic diagram of the pulse signal of the particle to be detected when the noise interference exists. As shown, the pulse signal of each particle under test can be measured to obtain the corresponding pulse width.

The pulse signal of the particle to be measured, specifically, the electrical signal converted from the optical signal of the particle to be measured means the time taken by the particle to be measured to pass through the flow chamber, and the wider the pulse signal, the longer the pulse signal.

Therefore, in the third determination method, the pulse width of the pulse signal of each particle to be detected may be measured according to the target optical signal, and the first time of each particle to be detected, that is, the time for the particle to be detected to pass through the flow chamber, may be determined according to the pulse width of each particle to be detected, so as to detect the particle to be detected, where each first time exceeds the preset first time range; finally, counting the proportion of the particles to be detected with the first time exceeding a preset first time range, wherein the proportion of the particles to be detected in all the particles to be detected is obtained by identification according to the target optical signal and is not marked as an abnormal pulse proportion; and judging whether the pulse abnormal ratio is greater than a preset pulse abnormal threshold, if so, judging that noise interference exists in the detection process of the first sample to be detected, and if not, judging that noise interference does not exist in the detection process of the first sample to be detected.

Optionally, in the third determination method, since the pulse width itself represents the length of the first time of the particle to be detected, the particle to be detected whose pulse width of the pulse signal exceeds the preset pulse width range may also be directly detected, and the proportion of the particle to be detected whose pulse width of the pulse signal exceeds the preset pulse width range in all the particles to be detected, which is identified according to the target optical signal, that is, the pulse anomaly proportion is counted.

And a fourth judging method. Referring to fig. 11, fig. 11 is a distribution histogram of optical signal intensity of each of the particles to be measured identified based on the target optical signal, fig. 11 shows a distribution histogram in the presence of noise interference (the distribution histogram at the upper side of fig. 11) and a distribution histogram in the absence of noise interference (the distribution histogram at the lower side of fig. 11), in the distribution histogram shown in fig. 11, the abscissa indicates the signal intensity of the optical signal of the particle to be measured, and the ordinate indicates the number of particles, which indicates the number of particles to be measured having the optical signal of corresponding intensity among the plurality of particles to be measured identified. And the signal intensity of the optical signal of the particle to be detected represents the size of the particle to be detected.

As shown in fig. 11, when the fourth determination method is executed, an intensity threshold Line _ S0 (corresponding to the straight Line in fig. 11) may be preset, and the threshold may be fixed or floating, and may also be a value input from the outside, in the distribution histogram shown in fig. 11, the region on the left side of the straight Line corresponding to Line _ S0 is a preset signal region, which may also be referred to as a small signal region, and if the signal intensity of the particle to be measured is lower than Line _ S0, the particle to be measured may be considered to be located in the small signal region shown in fig. 11.

If noise interference exists in the detection process of the first sample to be detected, particles in a small signal area are more significant in the particles to be detected obtained through identification according to the target optical signal, namely the number of the small signal particles is more significant, and particle distribution information in the small signal area is abnormal, so that whether noise interference exists in the detection process can be judged according to the occupation ratio of the particles to be detected in the small signal area.

Specifically, the distribution histogram shown in fig. 11 may be generated from the target optical signal, the area of the histogram on the left side of Line _ S0 in the distribution histogram may be calculated to obtain the area information A0, the area of the histogram on the right side of Line _ S0 in the distribution histogram may be calculated to obtain the area information A1, A0 and A1 may be substituted into a preset function C = f (A0, A1), and the function value C may be calculated.

Wherein if the expression of f (A0, A1) is:

and if the calculated function value C is larger than the preset function threshold, judging that the noise interference exists in the detection process of the first sample to be detected, otherwise, judging that the noise interference does not exist in the detection process of the first sample to be detected.

If the expression of f (A0, A1) is:

if the calculated function value C is smaller than the preset function threshold, it is determined that noise interference exists in the detection process of the first sample to be detected, otherwise, if the calculated function value C is greater than or equal to the preset function threshold, it is determined that noise interference does not exist in the detection process of the first sample to be detected.

Referring to fig. 12, fig. 12 is a schematic diagram of the number of particles to be measured identified according to the optical signal of the first sample to be measured in a plurality of second unit times, where a graph on the left side is a schematic diagram when there is no unstable liquid flow, a graph on the right side is a schematic diagram when there is unstable liquid flow, and the meanings of the abscissa and the ordinate are shown in fig. 12.

In other words, the number of particles to be detected from the first sample to be detected in each second can be counted according to the optical signal of the first sample to be detected, the number of particles to be detected in the 1 st second is set to be S1, the number of particles to be detected in the 2 nd second is set to be S2, and so on, the number of particles to be detected in the i th second is set to be Si, and assuming that the measuring section detects the optical signal of the first sample to be detected in m seconds, the number of particles S1 to Sm can be obtained finally, and the number of particles m is connected into a curve, so that the schematic diagram of the number of particles to be detected, which is shown in fig. 12 and is obtained by identifying the optical signal of the first sample to be detected in a plurality of second unit times.

On the one hand, after obtaining the schematic diagram shown in fig. 12 from the optical signal of the first sample to be tested, the population to be tested in each second unit time may be regarded as a population sequence, such as the foregoing S1 to Sm, and then the variance, the standard deviation, or the coefficient of variation of the population sequence is calculated according to the calculation formula of the variance, the standard deviation, or the coefficient of variation in the first determination method.

If the variance of the particle number sequence is obtained through calculation, whether the variance of the particle number sequence is larger than a particle number variance threshold value or not can be judged, if yes, the fact that the flow instability exists in the detection process of the first sample to be detected is judged, and if the variance of the particle number sequence is smaller than or equal to the particle number variance threshold value, the fact that the flow instability does not exist in the detection process of the first sample to be detected is judged.

If the standard deviation of the particle number sequence is obtained through calculation, whether the standard deviation of the particle number sequence is larger than a particle number standard deviation threshold value or not can be judged, if yes, the fact that the liquid flow instability exists in the detection process of the first sample to be detected is judged, and if the standard deviation of the particle number sequence is smaller than or equal to the particle number standard deviation threshold value, the fact that the liquid flow instability does not exist in the detection process of the first sample to be detected is judged.

If the variation coefficient of the particle number sequence is obtained through calculation, whether the variation coefficient of the particle number sequence is larger than a particle number variation coefficient threshold value or not can be judged, if yes, the fact that the liquid flow instability exists in the detection process of the first sample to be detected is judged, and if the variation coefficient of the particle number sequence is smaller than or equal to the particle number variation coefficient threshold value, the fact that the liquid flow instability does not exist in the detection process of the first sample to be detected is judged.

On the other hand, in the graph shown in fig. 12, it may be counted that the range of the number of particles per second or the deviation of the number of any two adjacent segments of particles is greater than a certain set range threshold or the deviation of the number of particles in two adjacent segments is greater than a set deviation threshold, it is determined that there is flow instability in the detection process of the first sample to be detected, and if the range is not greater than the range threshold or the deviation of the number of particles in two adjacent segments is not greater than the deviation threshold, it is determined that there is no flow instability in the detection process of the first sample to be detected.

And a sixth judging method. Referring to fig. 13, fig. 13 is a distribution histogram of the optical signals in the first unit times, wherein an upper histogram of fig. 13 is a distribution histogram of the optical signals in the first unit times when there is no unstable liquid flow, and a lower histogram of fig. 13 is a distribution histogram of the optical signals in the first unit times when there is unstable liquid flow. In the distribution histogram shown in fig. 13, the abscissa represents the signal intensity of the optical signal of the particle to be measured, and the ordinate represents the number of particles, and represents the number of particles to be measured having the optical signal of the corresponding intensity among the plurality of particles to be measured obtained by the recognition.

The first unit time may be set based on the time at which the measuring section detects the first optical signal to be tested. For example, assuming that the measuring section detects the optical signal of the first sample to be measured for 12 seconds, the 12 seconds can be equally divided into 3 time periods, where 1 to 4 seconds is a time period 1 (i.e., a first unit time), 5 to 8 seconds is a time period 2 (i.e., a second first unit time), and 9 to 12 seconds is a time period 3 (i.e., a third first unit time), and in this case, the first unit time is equal to 4 seconds.

With reference to the above example, the signal intensity of the to-be-tested particle and each to-be-tested particle identified according to the first to-be-tested sample in the time period 1 are counted to obtain the distribution histogram of the time period 1, and similarly, the signal intensity of the to-be-tested particle and each to-be-tested particle identified according to the first to-be-tested sample in the time period 2 and the signal intensity of each to-be-tested particle in the time period 3 are counted respectively to obtain the distribution histogram of the time period 2 and the distribution histogram of the time period 3.

After the distribution histograms of the time periods are obtained, the difference degrees of the distribution histograms of different time periods can be compared, if the distribution histograms of the time periods are basically consistent, the detection process of the first sample to be detected can be judged to have no unstable liquid flow, and if the distribution histograms of the time periods have larger difference, the detection process of the first sample to be detected can be judged to have unstable liquid flow.

According to the above blood analysis device, the embodiments of the present application also provide several methods for blood analysis.

Referring to fig. 14, when the apparatus for blood analysis starts to test a blood sample in the first measurement mode by default, a method for blood analysis provided by an embodiment of the present application may include the following steps:

s501, obtaining an optical signal of the first sample to be detected, and obtaining a first detection result of the blood sample according to the optical signal of the first sample to be detected.

The first to-be-detected sample is prepared from a blood sample and a first reagent; the optical signal of the first test sample is used for obtaining a first detection result of the blood sample, and the first detection result comprises any one or combination of an immature platelet parameter, a reticulocyte parameter, a large-volume platelet parameter, a white blood cell counting result and a white blood cell classification result; the first reagent comprises a hemolytic agent.

S502, judging whether the detection process of the first sample to be detected is abnormal or not.

When it is determined that the detection process of the first sample to be detected is not abnormal, step S503 is executed.

And executing step S504 when it is determined that the detection process of the first sample to be detected is abnormal.

And S503, outputting a first detection result.

S504, controlling to prepare a second sample to be detected, obtaining an optical signal of the second sample to be detected, and obtaining a second detection result of the blood sample according to the optical signal of the second sample to be detected.

The second test sample is prepared from a blood sample and a second reagent; the second detection result comprises any one or combination of immature platelet parameters, reticulocyte parameters and large-volume platelet parameters; the second reagent includes a fluorescent reagent and does not include a hemolytic agent.

And S505, judging whether the detection process of the second sample to be detected is abnormal or not.

If no abnormality occurs in the detection process of the second test sample, step S506 is executed.

If the detection process of the second sample to be detected is abnormal, step S507 is executed.

And S506, outputting a second detection result.

And S507, carrying out sample retesting.

The retesting of the sample in step S507 refers to controlling to prepare a new first test sample, and then executing step S501 again for the new first test sample.

And if the detection process of the new first sample to be detected and the detection process of the new second sample to be detected are still abnormal after the sample is retested, prompting the user that the state of the instrument is abnormal, and outputting a new first detection result (obtained according to the detection of the new first sample to be detected) and/or a new second detection result (obtained according to the detection of the new second sample to be detected).

When the apparatus for blood analysis is not determined to detect a blood sample in the first measurement mode or the second measurement mode, an embodiment of the present application further provides a method for blood analysis, please refer to fig. 15, which may include the following steps:

s601, judging whether a second measurement mode of the blood analysis device is started or not.

When it is determined that the second measurement mode is enabled, it is determined that the blood sample is detected in the second measurement mode, and step S602 is performed.

When it is determined that the second measurement mode is not enabled, it is determined that the blood sample is detected in the first measurement mode, and step S608 is performed.

S602, obtaining a first detection result and a second detection result of the blood sample.

Wherein, step S602 specifically includes:

the method comprises the steps of controlling preparation of a first sample to be detected and a second sample to be detected, obtaining an optical signal of the first sample to be detected and an optical signal of the second sample to be detected, and obtaining a first detection result and a second detection result of a blood sample according to the optical signal of the first sample to be detected and the optical signal of the second sample to be detected respectively.

The second detection result comprises any one or combination of immature platelet parameters, reticulocyte parameters and large-volume platelet parameters; the second test sample is prepared from a blood sample and a second reagent; the second reagent includes a fluorescent reagent and does not include a hemolytic agent.

The first detection result comprises any one or combination of immature platelet parameters, reticulocyte parameters, large-volume platelet parameters, white blood cell counting results and white blood cell classification results; the first reagent comprises a hemolytic agent.

In this embodiment, the second measurement mode is a measurement mode including a reticulocyte detection channel and a hemolysis channel.

And S603, judging whether the detection process of the second sample to be detected is abnormal.

When it is determined that the detection process of the second sample to be detected is not abnormal, step S604 is performed, and when it is determined that the detection process of the second sample to be detected is abnormal, step S605 is performed.

And S604, outputting a second detection result.

S605, judging whether the detection process of the first sample to be detected is abnormal.

When the detection process of the first test sample is not abnormal, step S606 is executed, and when the detection process of the first test sample is abnormal, step S607 is executed.

And S606, outputting a first detection result.

And S607, retesting the sample.

The retesting of the sample in step S607 refers to returning to step S602, preparing a new first test sample and a new second test sample again, and then repeating the processes in steps S602 to S606.

S608, obtaining a first detection result of the blood sample.

Wherein, step S608 specifically includes:

and controlling to prepare a first sample to be detected, acquiring an optical signal of the first sample to be detected, and acquiring a first detection result of the blood sample according to the optical signal of the first sample to be detected.

And S609, judging whether the detection process of the first sample to be detected is abnormal.

When the detection process of the first sample to be detected is judged to be abnormal, executing step S610; and executing step S611 when it is determined that the detection process of the first test sample is not abnormal.

S610, the second measurement mode is enabled, and step S601 is executed again.

It can be seen that, after the execution of step S610 is finished, when step S601 is executed again, the determination result of step S601 is that the second measurement mode is enabled.

Optionally, after step S610 returns to execute step S601, in step S602, only the second test sample may be prepared, only the optical signal of the second test sample is correspondingly obtained, and the second detection result is obtained according to the optical signal of the second test sample, after the second detection result is obtained, if it is determined that the detection process of the second test sample is not abnormal, the second detection result is output, and if it is determined that the detection process of the second test sample is abnormal, the sample retesting may be performed, that is, the preparation of the new first test sample and the new second test sample is controlled respectively, the optical signal of the new first test sample and the optical signal of the new second test sample are obtained, and the new first detection result and the new second detection result are obtained according to the optical signal of the new first test sample and the optical signal of the new second test sample respectively.

And prompting the user that the state of the instrument is abnormal and outputting a new first detection result and/or a new second detection result if the detection process of the new first sample to be detected and the detection process of the new second sample to be detected are still abnormal after the sample is retested.

And S611, outputting a first detection result.

When the apparatus for blood analysis is not determined to detect a blood sample in the first measurement mode or the second measurement mode, an embodiment of the present application further provides a method for blood analysis, please refer to fig. 16, which may include the following steps:

s701, judging whether a second measurement mode of the blood analysis device is started or not.

When it is determined that the second measurement mode is enabled, it is determined that the blood sample is detected in the second measurement mode, and step S702 is performed.

When it is determined that the second measurement mode is not enabled, it is determined that the blood sample is detected in the first measurement mode, and step S709 is performed.

S702, obtaining a second detection result of the blood sample.

Wherein, step S702 specifically includes:

and controlling to prepare a second sample to be detected, acquiring an optical signal of the second sample to be detected, and acquiring a second detection result of the blood sample according to the optical signal of the second sample to be detected.

In this embodiment, the second measurement mode includes a reticule-only detection channel measurement mode.

And S703, judging whether the detection process of the second sample to be detected is abnormal.

When it is determined that the abnormality has not occurred in the detection process of the second sample to be detected, step S704 is performed, and when it is determined that the abnormality has occurred in the detection process of the second sample to be detected, step S705 is performed.

And S704, outputting a second detection result.

S705, obtaining a first detection result of the blood sample.

Wherein, step S705 specifically includes:

Specifically, in step S705, a measurement mode including a hemolysis channel may be enabled, and then step S705 is performed in the measurement mode.

S706, judging whether the detection process of the first sample to be detected is abnormal or not.

Step S707 is executed when the detection process of the first test sample is not abnormal, and step S708 is executed when the detection process of the first test sample is abnormal.

And S707, outputting a first detection result.

And S708, carrying out sample retesting.

The re-testing of the sample in step S708 refers to returning to step S702, re-preparing a new first test sample and a new second test sample, and then repeating the processes in steps S702 to S707.

S709, obtaining a first detection result of the blood sample.

Wherein, step S709 specifically includes:

And S710, judging whether the detection process of the first sample to be detected is abnormal.

When the detection process of the first sample to be detected is judged to be abnormal, the step S711 is executed; when it is determined that the detection process of the first test sample is not abnormal, step S712 is executed.

S711, the second measurement mode is enabled, and step S701 is performed again.

It can be seen that, when step S701 is executed again after step S711 is finished, the determination result of step S701 is that the second measurement mode is enabled.

Optionally, after step S711 returns to execute step S701, if it is determined that the detection process of the second test sample is not abnormal, the second detection result is output, if it is determined that the detection process of the second test sample is abnormal, the sample retest may be performed, that is, step S709 is executed again, a new first test sample is prepared, a new first test result of the blood sample is obtained, if the detection process of the new first test sample is not abnormal, the new first test result of the blood sample is output, if the detection process of the new first test sample is abnormal, step 702 is executed, a new second test sample is prepared, a new second test result of the blood sample is obtained, if the detection process of the new second test sample is not abnormal, the new second test result of the blood sample is output, if the detection process of the new second test sample is abnormal, the user is prompted that the apparatus is abnormal, and the new first test result and/or the new second test result is output.

And S712, outputting the first detection result.

Optionally, determining whether the detection process of the first sample to be detected is abnormal includes:

judging whether noise interference or unstable liquid flow exists in the detection process of the first sample to be detected or not according to the target optical signal, and if so, determining that the detection process of the first sample to be detected is abnormal; wherein the target optical signal comprises an optical signal of the first test sample or an optical signal of the non-blood sample substance.

Optionally, judging whether noise interference or unstable liquid flow exists in the detection process of the first sample to be detected according to the target optical signal includes:

judging whether noise interference exists in the detection process of the first sample to be detected or not according to the variation coefficient, standard deviation or variance of the target optical signal; or,

identifying the number of particles to be detected of the non-blood sample substances according to the optical signals of the non-blood sample substances, and judging whether noise interference exists in the detection process of the first sample to be detected according to the number of the particles to be detected of the non-blood sample substances; or,

obtaining first time of the particles to be detected according to the target optical signal, wherein the first time is the time of the particles to be detected passing through the flow chamber, and judging whether noise interference exists in the detection process of the first sample to be detected according to the proportion of the particles to be detected exceeding a preset normal range in the first time; or;

obtaining the size of the particles to be detected according to the target optical signal, and judging whether noise interference exists in the detection process according to the proportion of the particles to be detected with the size smaller than the preset size; or,

obtaining a plurality of particles to be detected in second unit time according to the optical signal of the first sample to be detected, and judging whether the liquid flow instability exists in the detection process of the first sample to be detected according to the difference of the particle numbers to be detected; or,

and counting distribution histograms of optical signals of the first to-be-detected sample in a plurality of first unit times, and judging whether the detection process of the first to-be-detected sample has unstable liquid flow according to the difference of the distribution histograms.

Optionally, determining whether the detection process of the second sample to be detected is abnormal includes:

judging whether noise interference or unstable liquid flow exists in the detection process of the second sample to be detected or not according to the target optical signal, and if so, determining that the detection process of the second sample to be detected is abnormal; wherein the target optical signal comprises an optical signal of the second test sample or an optical signal of the non-blood sample substance.

Optionally, the determining, according to the target optical signal, whether noise interference or unstable liquid flow exists in the detection process of the second sample to be detected includes:

judging whether noise interference exists in the detection process of the second sample to be detected or not according to the variation coefficient, the standard deviation or the variance of the target optical signal; or,

identifying the number of particles to be detected of the non-blood sample substances according to the optical signals of the non-blood sample substances, and judging whether noise interference exists in the detection process of the second sample to be detected according to the number of the particles to be detected of the non-blood sample substances; or,

obtaining a second time of the particles to be detected according to the target optical signal, wherein the second time is the time of the particles to be detected passing through the flow chamber, and judging whether noise interference exists in the detection process of the second sample to be detected according to the proportion of the particles to be detected exceeding a preset normal range in the second time; or;

obtaining a plurality of particles to be detected in second unit time according to the optical signal of the second sample to be detected, and judging whether the liquid flow instability exists in the detection process of the second sample to be detected according to the difference of the number of the particles to be detected; or,

and counting distribution histograms of optical signals of the second to-be-detected samples in a plurality of second unit times, and judging whether the liquid flow instability exists in the detection process of the second to-be-detected samples according to the difference of the distribution histograms.

Therefore, when a first sample to be detected is prepared at first and a first detection result of a blood sample is obtained according to the first sample to be detected, the invention prepares a second sample to be detected and obtains a second detection result of the blood sample according to the second sample to be detected by judging whether the detection process of the first sample to be detected is abnormal or not and replacing the measurement mode after the abnormality occurs; when the second test sample is prepared and the second test result of the blood sample is obtained according to the second test sample, whether the detection process of the second test sample is abnormal or not can be judged, if not, the second test result is output, if yes, whether the detection process of the first test sample is abnormal or not is judged, and if not, the first test result is output. In summary, the present invention can output the second detection result obtained from the second test sample when the detection process of the first test sample is abnormal (i.e. the blood lysis channel is abnormal), and output the first detection result obtained from the first test sample when the detection process of the second test sample is abnormal (i.e. the reticulocyte detection channel is abnormal), so as to improve the accuracy of the immature platelet parameter, the reticulocyte parameter and the large-volume platelet parameter in the detection results.

Finally, it should also be noted that, herein, relational terms such as first and second, and the like may be used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Also, 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, article, or apparatus. Without further limitation, an element defined by the phrases "comprising one of 8230; \8230;" 8230; "does not exclude the presence of additional like elements in a process, method, article, or apparatus that comprises the element.

It should be noted that the terms "first", "second", and the like in the present invention are only used for distinguishing different devices, modules or units, and are not used for limiting the order or interdependence relationship of the functions performed by the devices, modules or units.

A person skilled in the art can make or use the present application. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the application. Thus, the present application is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A device for blood analysis, comprising:

a blood sample supply unit for supplying a blood sample;

a reagent supply unit for supplying a reagent;

a processor, wherein:

the processor controls the blood sample supply to supply the blood sample to the mixing chamber, and controls the reagent supply to supply at least a first reagent to the mixing chamber to prepare a first test sample in the mixing chamber; the processor controls the optical detection part to acquire an optical signal of a first sample to be detected; the optical signal of the first test sample is used for obtaining a first detection result of the blood sample, wherein the first detection result comprises any one or combination of immature platelet parameters, reticulocyte parameters and large-volume platelet parameters, and comprises a white blood cell counting result and/or a white blood cell classification result; the first reagent comprises a hemolytic agent;

2. A device for blood analysis, comprising:

a blood sample supply unit for supplying a blood sample;

a reagent supply unit for supplying a reagent;

the apparatus for blood analysis further comprises a processor, wherein:

the processor determining whether the second measurement mode is enabled;

when the second measurement mode is judged to be started, controlling the blood sample supply part to supply the blood sample to the mixing chamber and controlling the reagent supply part to supply at least a second reagent to the mixing chamber in the second measurement mode so as to prepare a second sample to be tested in the mixing chamber; the processor controls the optical detection part to acquire an optical signal of the second sample to be detected; the optical signal of the second sample to be detected is used for obtaining a second detection result of the blood sample; the second reagent comprises a fluorescent reagent and does not comprise a hemolytic agent;

and controlling the blood sample supply to supply the blood sample to the mixing chamber, and controlling the reagent supply to supply at least the first reagent to the mixing chamber to prepare a first test sample in the mixing chamber; the processor controls the optical detection part to acquire an optical signal of the first sample to be detected; the optical signal of the first sample to be detected is used for obtaining a first detection result of the blood sample; the first reagent comprises a hemolytic agent;

the second detection result comprises any one or combination of immature platelet parameters, reticulocyte parameters and large-volume platelet parameters; the second reagent comprises a fluorescent reagent and does not comprise a hemolytic agent;

controlling the blood sample supplier to supply the blood sample to the mixing chamber and controlling the reagent supplier to supply at least the first reagent to the mixing chamber to prepare a first test sample in the mixing chamber in the first measurement mode when it is determined that the second measurement mode is not enabled; the processor controls the optical detection part to obtain an optical signal of a first sample to be detected; the optical signal of the first test sample is used for obtaining a first detection result of the blood sample;

the processor judges whether the detection process of the first sample to be detected is abnormal or not; when the first test sample is judged not to be abnormal in the test process, outputting the first test result; when the detection process of the first sample to be detected is judged to be abnormal, the processor starts the second measurement mode, controls to prepare the second sample to be detected in the second measurement mode, and controls the optical detection part to acquire an optical signal of the second sample to be detected; the optical signal of the second sample to be detected is used for obtaining a second detection result of the blood sample;

and judging whether the detection process of the second sample to be detected is abnormal or not, if so, retesting the sample, and if not, outputting the second detection result.

3. A device for blood analysis, comprising:

a blood sample supply unit for supplying a blood sample;

a reagent supply unit for supplying a reagent;

the apparatus for blood analysis further comprises a processor, wherein:

when the second measurement mode is judged to be started, in the second measurement mode, the blood sample supply part is controlled to supply the blood sample to the mixing chamber, and the reagent supply part is controlled to supply at least a second reagent to the mixing chamber so as to prepare a second sample to be tested in the mixing chamber; the processor controls the optical detection part to obtain an optical signal of the second sample to be detected; the optical signal of the second test sample is used for obtaining a second detection result of the blood sample; the second reagent comprises a fluorescent reagent and does not comprise a hemolytic agent;

the processor judges whether the detection process of the second sample to be detected is abnormal or not; when the detection process of the second sample to be detected is judged not to be abnormal, outputting a second detection result; when the detection process of the second test sample is judged to be abnormal, starting the first measurement mode, and controlling the blood sample supply part to supply the blood sample to the mixing chamber and controlling the reagent supply part to supply at least a first reagent to the mixing chamber so as to prepare the first test sample in the mixing chamber in the first measurement mode; the processor controls the optical detection part to obtain an optical signal of the first sample to be detected; the optical signal of the first sample to be detected is used for obtaining a first detection result of the blood sample; the first reagent comprises a hemolytic agent;

the processor judges whether the detection process of the first sample to be detected is abnormal or not; when the detection process of the first sample to be detected is judged to be abnormal, sample retesting is carried out, and when the detection process of the first sample to be detected is judged not to be abnormal, the first detection result is output; the first detection result comprises any one or combination of immature platelet parameters, reticulocyte parameters and large-volume platelet parameters, and comprises a white blood cell counting result and/or a white blood cell classification result;

the processor judges whether the detection process of the first sample to be detected is abnormal or not; when the first test sample is judged not to be abnormal in the test process, outputting the first test result; when the detection process of the first sample to be detected is judged to be abnormal, the processor starts the second measurement mode, controls to prepare the second sample to be detected in the second measurement mode, and controls the optical detection part to acquire an optical signal of the second sample to be detected; the optical signal of the second test sample is used for obtaining a second detection result of the blood sample;

4. The apparatus according to any one of claims 1 to 3, wherein the processor determining whether an abnormality occurs in the detection process of the first test sample comprises:

judging whether noise interference or unstable liquid flow exists in the detection process of the first sample to be detected or not according to the target optical signal, and if so, determining that the detection process of the first sample to be detected is abnormal; wherein the target optical signal comprises an optical signal of the first test sample or an optical signal of a non-blood sample substance.

5. The apparatus of claim 4, wherein the processor determines whether there is noise interference or unstable liquid flow during the detection of the first sample to be detected according to the target optical signal, and comprises:

judging whether noise interference exists in the detection process of the first sample to be detected or not according to the variation coefficient, standard deviation or variance of the optical signal of the non-blood sample substance; or,

identifying the number of particles to be detected of the non-blood sample substances according to the optical signals of the non-blood sample substances, and judging whether noise interference exists in the detection process of the first sample to be detected or not according to the number of the particles to be detected of the non-blood sample substances; or,

obtaining a first time of the particles to be detected according to the target optical signal, wherein the first time is the time of the particles to be detected passing through the flow chamber, and judging whether noise interference exists in the detection process of the first sample to be detected according to the proportion of the particles to be detected exceeding a preset normal range; or;

determining the proportion of the particles to be detected in a preset signal area according to the target optical signal, and judging whether noise interference exists in the detection process according to the proportion of the particles to be detected in the preset signal area; or,

obtaining a plurality of particles to be detected in second unit time according to an optical signal of a first sample to be detected, and judging whether unstable liquid flow exists in the detection process of the first sample to be detected according to the difference of the numbers of the particles to be detected; or,

6. A method of blood analysis, comprising:

7. A method of blood analysis, comprising:

when the second measurement mode is judged to be started, acquiring an optical signal of the second sample to be measured and an optical signal of the first sample to be measured in the second measurement mode; the optical signal of the second test sample is used for obtaining a second detection result of the blood sample; the second detection result comprises any one or combination of immature platelet parameters, reticulocyte parameters and large-volume platelet parameters; the second test sample is prepared from a blood sample and a second reagent; the second reagent comprises a fluorescent reagent and does not comprise a hemolytic agent; the optical signal of the first sample to be detected is used for obtaining a first detection result of the blood sample; the first detection result comprises any one or combination of immature platelet parameters, reticulocyte parameters and large-volume platelet parameters, and comprises a white blood cell counting result and/or a white blood cell classification result; the first test sample is prepared from a blood sample and a first reagent; the first reagent comprises a hemolytic agent;

judging whether the detection process of the first sample to be detected is abnormal or not, and outputting the first detection result when the detection process of the first sample to be detected is not abnormal;

when the detection process of the first sample to be detected is judged to be abnormal, the second measurement mode is started, under the second measurement mode, the second sample to be detected is controlled to be prepared, and the optical detection part is controlled to obtain an optical signal of the second sample to be detected; the optical signal of the second sample to be detected is used for obtaining a second detection result of the blood sample;

8. A method of blood analysis, comprising:

when the second measurement mode is judged to be started, acquiring an optical signal of the second sample to be measured in the second measurement mode; the optical signal of the second sample to be detected is used for obtaining a second detection result of the blood sample; the second detection result comprises any one or combination of immature platelet parameters, reticulocyte parameters and large-volume platelet parameters; the second test sample is prepared from a blood sample and a second reagent; the second reagent comprises a fluorescent reagent and does not comprise a hemolytic agent;

when the detection process of the first sample to be detected is judged to be abnormal, the second measurement mode is started; under the second measurement mode, controlling to prepare the second sample to be detected and controlling the optical detection part to acquire an optical signal of the second sample to be detected; the optical signal of the second sample to be detected is used for obtaining a second detection result of the blood sample;

9. The method according to any one of claims 6 to 8, wherein the determining whether the detection process of the first sample to be detected is abnormal comprises:

10. The method of claim 9, wherein the determining whether there is noise interference or unstable liquid flow in the detection process of the first sample to be detected according to the target optical signal comprises:

obtaining a first time of the particles to be detected according to the target optical signal, wherein the first time is the time of the particles to be detected passing through the flow chamber, and judging whether noise interference exists in the detection process of the first sample to be detected according to the proportion of the particles to be detected exceeding a preset normal range in the first time; or;