Hematocrit measurement method, sample analyzer, and sample analysis system

Abstract

The present application relates to a blood sedimentation measurement method, a sample analyzer and a sample analysis system. A sample to be measured is sucked from a test tube containing the sample to be measured after a mixing operation, at least a part of the sample to be measured is transported to a detection line and stopped in the detection line; the sample to be measured stopped in the detection line is irradiated with light, and information of transmitted light or information of scattered light scattered by the sample to be measured is obtained; a red blood cell aggregation parameter of the sample to be measured is obtained based on the information of transmitted light or the information of scattered light; the sample to be measured in the test tube is allowed to stand for a predetermined period of time from a predetermined time after the mixing operation, so as to obtain a red blood cell sedimentation parameter of the sample to be measured, and the predetermined period of time is not more than 20 minutes; and a red blood cell sedimentation rate of the sample to be measured is calculated based on the red blood cell aggregation parameter and the red blood cell sedimentation parameter. Thus, an accurate red blood cell sedimentation rate can be quickly obtained.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of in vitro diagnostics, in particular to a method for measuring erythrocyte sedimentation rate, a sample analyzer and a sample analysis system. BACKGROUND

[0002] Erythrocyte sedimentation rate (ESR), also known as blood sedimentation rate, is the rate of natural sedimentation of erythrocytes in anticoagulated whole blood under specified conditions. Although the specificity and sensitivity of ESR for diagnosis are not ideal, it is still considered a reliable indicator for detecting acute phase response of inflammation, and has great reference value for the diagnosis and observation of certain diseases. It is widely used in clinical practice for monitoring infection, inflammatory diseases and certain neoplastic diseases.

[0003] It is known that the traditional Westergren method for measuring ESR is the international reference method. However, since the traditional Westergren method requires manual operation, technical errors are prone to occur, the clinical repeatability is poor, the results are easily disturbed by anemic samples, and there is a biological safety risk in the operation process.

[0004] Therefore, more and more automated ESR measurement methods are used. Currently, there are three types of automated ESR measurement methods. The first method is an instrument replacement method, i.e., an instrument completely simulates the manual operation method of the traditional Westergren method, and the detection method and principle are the same as the traditional Westergren method; the second method is a modified Westergren method based on the principle of erythrocyte sedimentation, which accelerates the sedimentation of erythrocytes by heating, centrifugation, tilting, etc., and estimates the ESR result of one hour of traditional Westergren method according to the sedimentation of erythrocytes in half an hour; the third method is based on the aggregation of erythrocytes, and the ESR result is calculated in a very short time of seconds according to the aggregation between erythrocytes.

[0005] However, these three methods have certain defects. Although the first method avoids manual operation, the detection time is still one hour due to the same detection principle as the traditional Westergren method, which is low in efficiency; although the second modified Westergren method can shorten the ESR measurement time from 60 minutes to 30 minutes, it still has the defects of inconvenient operation and poor consistency of instrument results with the Westergren method; although the third erythrocyte aggregation method greatly shortens the ESR measurement time, the ESR result obtained by the method has poor consistency with the Westergren method, and the clinical acceptance is not high. SUMMARY

[0006] Based on this background, the task of the present application is to provide a technical solution for correcting the ESR measurement result obtained by the erythrocyte aggregation method, by which the ESR measurement result with good consistency with the traditional Westergren method can be quickly obtained.

[0007] To achieve the above-mentioned tasks, the first aspect of the present application provides a blood sedimentation measurement method, comprising:

[0008] sucking a part of the blood sample to be measured from a test tube containing the blood sample to be measured after a mixing operation, and transporting at least a part of the blood sample of the part of the blood sample to be measured to a first detection pipeline and stopping the flow of the at least a part of the blood sample in the first detection pipeline;

[0009] irradiating the at least a part of the blood sample stopped in the first detection pipeline with light, and acquiring information of transmitted light transmitted through the at least a part of the blood sample or information of scattered light scattered by the at least a part of the blood sample;

[0010] acquiring a red blood cell aggregation parameter of the blood sample to be measured based on the acquired information of the transmitted light or the scattered light, the red blood cell aggregation parameter representing a degree of red blood cell aggregation of the at least a part of the blood sample after the flow of the at least a part of the blood sample is stopped in the first detection pipeline;

[0011] causing the blood sample to be measured in the test tube to stand for a predetermined period of time from a predetermined time point after the mixing operation, to acquire a red blood cell sedimentation parameter of the blood sample to be measured, the red blood cell sedimentation parameter representing a degree of sinking of red blood cells in the blood sample to be measured in the test tube within the predetermined period of time, wherein the predetermined period of time is not more than 20 minutes; and

[0012] calculating a red blood cell sedimentation rate of the blood sample to be measured based on the red blood cell aggregation parameter and the red blood cell sedimentation parameter.

[0013] To achieve the above-mentioned tasks, the second aspect of the present application provides a blood sedimentation measurement method, comprising:

[0014] sucking a part of the blood sample to be measured from a test tube containing the blood sample to be measured, and transporting at least a part of the blood sample of the part of the blood sample to be measured to a first detection pipeline and stopping the flow of the at least a part of the blood sample in the first detection pipeline;

[0015] irradiating the at least a part of the blood sample stopped in the first detection pipeline with light, to acquire information of transmitted light transmitted through the at least a part of the blood sample or information of scattered light scattered by the at least a part of the blood sample;

[0016] acquiring a red blood cell aggregation parameter of the blood sample to be measured based on the acquired information of the transmitted light or the scattered light, the red blood cell aggregation parameter representing a degree of red blood cell aggregation of the at least a part of the blood sample after the flow of the at least a part of the blood sample is stopped in the first detection pipeline;

[0017] performing a mixing operation on the remaining blood sample in the test tube after the portion of the blood sample is drawn out;

[0018] causing the remaining blood sample in the test tube to stand for a predetermined time period from a predetermined time after the mixing operation, to obtain a red blood cell sedimentation parameter of the blood sample, the red blood cell sedimentation parameter representing a degree of sinking of red blood cells in the remaining blood sample in the test tube within the predetermined time period, wherein the predetermined time period is not greater than 20 minutes; and

[0019] calculating a red blood cell sedimentation rate of the blood sample based on the red blood cell aggregation parameter and the red blood cell sedimentation parameter.

[0020] To achieve the above-mentioned task, the third aspect of the present application provides a sample analyzer, comprising:

[0021] a mixing device configured to perform a mixing operation on a blood sample in a test tube;

[0022] a first blood sedimentation detection device, comprising a sampling and distributing component, a first detection pipeline, and a blood sedimentation optical detection component, the sampling and distributing component being configured to draw out a portion of the blood sample from the test tube after the mixing operation, to transport at least a portion of the portion of the blood sample to the first detection pipeline and to stop the flow of the at least a portion of the blood sample in the first detection pipeline, the blood sedimentation optical detection component being configured to irradiate the at least a portion of the blood sample stopped in the first detection pipeline with light, and to obtain information of transmitted light transmitted through the at least a portion of the blood sample or information of scattered light scattered by the at least a portion of the blood sample, so as to obtain a red blood cell aggregation parameter of the blood sample based on the obtained information of the transmitted light or the scattered light, the red blood cell aggregation parameter representing a degree of aggregation of red blood cells in the at least a portion of the blood sample after the flow of the at least a portion of the blood sample is stopped in the first detection pipeline;

[0023] a second blood sedimentation detection device configured to obtain a red blood cell sedimentation parameter of the blood sample, the red blood cell sedimentation parameter representing a degree of sinking of red blood cells in the blood sample in the test tube within a predetermined time period from a predetermined time after the mixing operation, wherein the blood sample in the test tube is in a standing state within the predetermined time period, and the predetermined time period is not greater than 20 minutes; and

[0024] a data processing device configured to calculate a red blood cell sedimentation rate of the blood sample based on the red blood cell aggregation parameter and the red blood cell sedimentation parameter.

[0025] To achieve the above-mentioned tasks, the fourth aspect of the present application provides a sample analyzer, comprising:

[0026] A first blood sedimentation detection device, comprising a sampling distribution component, a first detection pipeline and a blood sedimentation optical detection component, the sampling distribution component is configured to draw a part of a blood sample to be tested from a test tube containing the blood sample to be tested, transport at least a part of the blood sample to be tested in the part to the first detection pipeline and stop the flow of the at least a part of the blood sample in the first detection pipeline, the blood sedimentation optical detection component is configured to irradiate the at least a part of the blood sample stopped in the first detection pipeline with light, and obtain information of transmitted light transmitted through the at least a part of the blood sample or information of scattered light scattered by the at least a part of the blood sample, so as to obtain a red blood cell aggregation parameter of the blood sample to be tested based on the obtained information of the transmitted light or the scattered light, the red blood cell aggregation parameter characterizing the degree of red blood cell aggregation of the at least a part of the blood sample after stopping the flow in the first detection pipeline;

[0027] A mixing device configured to perform a mixing operation on the remaining blood sample to be tested in the test tube after the sampling distribution component draws the part of the blood sample to be tested;

[0028] A second blood sedimentation detection device configured to obtain a red blood cell sedimentation parameter of the blood sample to be tested, the red blood cell sedimentation parameter characterizing the degree of sinking of red blood cells in the remaining blood sample to be tested in the test tube from a predetermined time after the mixing operation to a predetermined time period, wherein the remaining blood sample to be tested in the test tube is in a static state during the predetermined time period, and the predetermined time period is not more than 20 minutes; and

[0029] A data processing device configured to calculate a red blood cell sedimentation rate of the blood sample to be tested based on the red blood cell aggregation parameter and the red blood cell sedimentation parameter.

[0030] To achieve the above-mentioned tasks, the fifth aspect of the present application provides a sample analysis system, comprising:

[0031] A mixing device configured to perform a mixing operation on a blood sample to be tested in a test tube;

[0032] a first sample analyzer and a second sample analyzer independent of each other, wherein the first sample analyzer and / or the second sample analyzer comprises a first blood sedimentation detection device, the first blood sedimentation detection device comprising a sample dispensing component, a first detection pipeline and a blood sedimentation optical detection component, the sample dispensing component being configured to draw a portion of the blood sample to be tested from the test tube after the mixing operation, transport at least a portion of the blood sample to the first detection pipeline and stop the flow of the at least a portion of the blood sample in the first detection pipeline, the blood sedimentation optical detection component being configured to irradiate the at least a portion of the blood sample stopped in the first detection pipeline with light and acquire information of transmitted light or information of scattered light scattered by the at least a portion of the blood sample, so as to acquire a red blood cell aggregation parameter of the blood sample to be tested based on the acquired information of the transmitted light or the scattered light, the red blood cell aggregation parameter representing a degree of red blood cell aggregation of the at least a portion of the blood sample after the flow is stopped in the first detection pipeline;

[0033] a second blood sedimentation detection device configured to acquire a red blood cell sedimentation parameter of the blood sample to be tested, the red blood cell sedimentation parameter representing a degree of sinking of red blood cells in the blood sample to be tested in the test tube within a predetermined time period since a predetermined time after the mixing operation, wherein the blood sample to be tested in the test tube is in a static state within the predetermined time period, and the predetermined time period is not greater than 20 minutes;

[0034] a sample transport track configured to transport the test tube containing the blood sample to be tested to the first sample analyzer and / or the second sample analyzer; and

[0035] a data processing device configured to calculate a red blood cell sedimentation rate of the blood sample to be tested based on the red blood cell aggregation parameter and the red blood cell sedimentation parameter.

[0036] In the technical solutions provided in the first aspect to the fifth aspect of the present application, the degree of red blood cell aggregation and the degree of sinking of red blood cells of the blood sample to be tested are considered simultaneously when calculating the red blood cell sedimentation rate of the blood sample to be tested, that is, the red blood cell aggregation parameter of the blood sample to be tested obtained based on the red blood cell aggregation method and the degree of sinking of red blood cells in the blood sample to be tested within a certain time are combined, so that the red blood cell sedimentation rate which is more consistent with the result of the traditional Westergren method can be calculated more quickly, and thus the detection efficiency and the detection accuracy of blood sedimentation can be taken into account.

[0037] Another task of the present application is to provide a sample analysis system and a corresponding blood sedimentation detection method, which can automatically perform re-inspection in the case that the aggregation method ESR is unreliable, so as to reduce the clinical risk.

[0038] To achieve the task, the sixth aspect of the present application provides a sample analysis system, comprising a sampling and dispensing device, a first blood sedimentation detection device, a second blood sedimentation detection device and a data processing device, wherein,

[0039] The sampling and dispensing device is configured to draw a portion of the blood sample to be tested from a test tube containing the blood sample to be tested of a subject, and to dispense at least part of the blood sample in the portion of the blood sample to be tested to the first blood sedimentation detection device;

[0040] The first blood sedimentation detection device comprises a first detection pipeline, a power component and a first optical detection component, the first detection pipeline is configured to receive the at least part of the blood sample dispensed by the sampling and dispensing device, the power component is configured to make the dispensed at least part of the blood sample flow back and forth in the first detection pipeline to perform disaggregation treatment on the red blood cells in the at least part of the blood sample, and to stop the disaggregation treatment so that the red blood cells in the at least part of the blood sample in the first detection pipeline aggregate, and the first optical detection component is configured to obtain disaggregation optical data of the at least part of the blood sample in the process of red blood cell disaggregation and / or aggregation optical data of the at least part of the blood sample in the process of red blood cell aggregation;

[0041] The second blood sedimentation detection device comprises a second detection pipeline and a second optical detection component, the second detection pipeline is configured to receive the blood sample of the subject, and the second optical detection component is configured to obtain the erythrocyte sedimentation rate of the blood sample in the second detection pipeline based on the Westergren method; and

[0042] The data processing device is configured to determine whether the first erythrocyte sedimentation rate of the subject to be obtained based on the aggregation optical data is reliable according to the disaggregation optical data and / or the aggregation optical data, output the first erythrocyte sedimentation rate when it is determined that the first erythrocyte sedimentation rate is reliable, and control the second blood sedimentation detection device to recheck the blood sample of the subject based on the Westergren method to obtain and output the second erythrocyte sedimentation rate of the subject when it is determined that the first erythrocyte sedimentation rate is not reliable.

[0043] To achieve the task, the seventh aspect of the present application provides a blood sedimentation measurement method, comprising:

[0044] Drawing a portion of the blood sample to be tested from a test tube containing the blood sample to be tested of a subject, and transporting at least part of the blood sample in the portion of the blood sample to be tested to a first detection pipeline;

[0045] The at least portion of the blood sample is circulated back and forth in the first detection tube to deaggregate the red blood cells in the at least portion of the blood sample, and the deaggregation process is stopped, causing the red blood cells in the at least portion of the blood sample in the first detection tube to aggregate, so as to obtain the deaggregation optical data of the at least portion of the blood sample during the red blood cell deaggregation process and / or the aggregation optical data during the red blood cell aggregation process by optical measurement;

[0046] Based on the depolymerization optical data and / or the aggregation optical data, determine whether the first erythrocyte sedimentation rate of the subject obtained based on the aggregation optical data is reliable;

[0047] When the first erythrocyte sedimentation rate is deemed reliable, the first erythrocyte sedimentation rate is output; and

[0048] When the first erythrocyte sedimentation rate is determined to be unreliable, the blood sample of the subject is automatically re-examined using an erythrocyte sedimentation rate detection device based on the Widmanstätten method to obtain and output the subject's second erythrocyte sedimentation rate.

[0049] Therefore, when the first erythrocyte sedimentation rate (ESR) obtained from the degree of erythrocyte aggregation of the blood sample is unreliable, the blood sample can be automatically retested using an ESR detection device based on the Widmanstätten method to obtain a more reliable ESR, thus balancing the detection efficiency and accuracy of ESR. Attached Figure Description

[0050] The present application will now be described more clearly with reference to the embodiments and accompanying drawings. Through the detailed description of the embodiments of the present application, the above-mentioned and other advantages will become clear to those skilled in the art. The accompanying drawings are only for illustrating preferred embodiments and should not be considered as limiting the present application. In the accompanying drawings:

[0051] Figure 1 The graph shows the correlation between ESR results obtained based on the erythrocyte aggregation method and ESR results obtained based on the Widmanstätten method.

[0052] Figure 2 This is a schematic block diagram of a sample analyzer according to an embodiment of the present invention.

[0053] Figure 3 for Figure 2 A schematic diagram of the appearance of the sample analyzer 100.

[0054] Figure 4 This is a graph showing the relationship between settlement parameters and settlement time according to an embodiment of the present invention.

[0055] Figure 5 The graph shows the correlation between the ESR results obtained based on the embodiments of the present invention and the ESR results obtained based on the Widmanstätten method.

[0056] Figure 6 for Figure 2 A partial cross-sectional view of the sample analyzer.

[0057] Figure 7 This is a schematic diagram of a sample holder and test tubes according to an embodiment of the present invention.

[0058] Figure 8 and Figure 9 This is a schematic diagram of a mixing apparatus according to an embodiment of the present invention.

[0059] Figure 10 This is a schematic diagram of a mixing apparatus according to another embodiment of the present invention.

[0060] Figure 11 This is a schematic diagram of the structure of a first erythrocyte sedimentation rate (ESR) detection device according to an embodiment of the present invention.

[0061] Figure 12 This is a red blood cell aggregation curve according to one embodiment of the present invention.

[0062] Figure 13 This is a calibration curve for calculating the erythrocyte aggregation method ESR according to one embodiment of the present invention.

[0063] Figure 14 The graph shows the correlation between the erythrocyte sedimentation parameters obtained based on the embodiments of the present invention and the ESR results obtained based on the Widmanstätten method.

[0064] Figure 15 This is a schematic block diagram of a sample analyzer according to another embodiment of the present invention.

[0065] Figure 16 for Figure 1 The diagram shows the workflow of the sample analyzer.

[0066] Figure 17 This is a schematic block diagram of another sample analyzer according to one embodiment of the present invention.

[0067] Figure 18 This is a schematic block diagram of a sample analysis system according to an embodiment of the present invention.

[0068] Figure 19 This is a schematic block diagram of a sample analysis system according to another embodiment of the present invention.

[0069] Figure 20 This is a schematic block diagram of a sample analysis system according to yet another embodiment of the present invention.

[0070] Figure 21A schematic block diagram of a sample analysis system according to yet another embodiment of the present application.

[0071] Figure 22 A schematic flow chart of a blood sedimentation measurement method according to one embodiment of the present application.

[0072] Figure 23 A schematic flow chart of a blood sedimentation measurement method according to another embodiment of the present application.

[0073] Figure 24 A schematic block diagram of a sample analysis system according to yet another embodiment of the present application.

[0074] Figure 25 A curve comparison diagram of a red blood cell disaggregation curve in a disaggregation process of an abnormal sample with sample abnormality and a normal sample without sample abnormality according to one embodiment of the present application.

[0075] Figure 26 A red blood cell aggregation curve measured by a red blood cell aggregation method by a blood sedimentation detection module of a blood sedimentation detection device according to the present application.

[0076] Figure 27 A curve comparison diagram of a red blood cell aggregation curve in an aggregation process of an abnormal sample with sample abnormality and a normal sample without sample abnormality according to one embodiment of the present application.

[0077] Figure 28 A schematic flow chart of a blood sedimentation measurement method according to yet another embodiment of the present application. DETAILED DESCRIPTION

[0078] The embodiments of the present application will be described below in detail with reference to the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present application, but not all the embodiments of the present application. Based on the embodiments of the present application, all the other embodiments obtained by those of ordinary skill in the art without creative work fall within the scope of the present application.

[0079] It should be noted that the terms “first”, “second”, “third” in the embodiments of the present application are only to distinguish similar objects, and do not represent a specific order of the objects. Understandably, the “first”, “second”, “third” can be interchanged in a specific order or sequence as allowed.

[0080] Those skilled in the art can understand that, unless otherwise defined, all the terms (including technical terms and scientific terms) used herein have the same meaning as that generally understood by those of ordinary skill in the art to which the present application belongs.

[0081] As mentioned in the background, the ESR result obtained based on the red blood cell aggregation method is not consistent with the Westergren method, as shown in the following table. Figure 1 As shown, the correlation is only 0.5516.

[0082] Applicants found through research that by combining the quantitative index representing the red blood cell aggregation and the quantitative index reflecting the sinking degree of the red blood cells within a certain time of the same blood sample to be tested, a blood sedimentation value more consistent with the traditional Westergren method result can be obtained through formula calculation. Applicants believe that this is because the blood sedimentation reflects the combination of red blood cell aggregation and red blood cell sinking, while the existing red blood cell aggregation method only considers the aggregation of red blood cells and does not consider the influence of factors such as sedimentation force and resistance in the sinking process of red blood cells. Therefore, the ESR result cannot be obtained based on the red blood cell aggregation method.

[0083] Based on the above research of the applicants, the embodiments of the present application provide a technical scheme for calculating the erythrocyte sedimentation rate according to the red blood cell aggregation parameter obtained based on the red blood cell aggregation method and the sinking degree of the red blood cells within a certain time, so as to quickly obtain the erythrocyte sedimentation rate more consistent with the traditional Westergren method result.

[0084] Figure 2 A schematic block diagram of a sample analyzer 100 according to an embodiment of the present application is shown. Figure 3 A schematic diagram of the appearance of the sample analyzer 100 in Figure 2 is shown.

[0085] As shown in Figure 2 , the sample analyzer 100 includes a mixing device 110, a first blood sedimentation detection device 120, a second blood sedimentation detection device 130, and a data processing device 140.

[0086] The mixing device 110 is configured to perform a mixing operation on the blood sample to be tested, especially the whole blood sample to be tested, in the test tube 10.

[0087] The first blood sedimentation detection device 120 is configured to perform blood sedimentation detection on the blood sample to be tested based on the erythrocyte aggregation method. The first blood sedimentation detection device 120 comprises a sample dispensing component 121, a first detection pipeline 122, and a blood sedimentation optical detection component 123. The sample dispensing component 121 is configured to, after the mixing operation, draw a portion of the blood sample to be tested from the test tube 10, transport at least a portion of the blood sample to be tested in the first detection pipeline 122, and stop the flow of the at least a portion of the blood sample in the first detection pipeline 122. The blood sedimentation optical detection component 123 is configured to irradiate the at least a portion of the blood sample stopped in the first detection pipeline 122 with light, and obtain information of transmitted light transmitted through the at least a portion of the blood sample or information of scattered light scattered by the at least a portion of the blood sample, so as to obtain an erythrocyte aggregation parameter of the blood sample to be tested based on the obtained information of the transmitted light or the scattered light. In this context, the erythrocyte aggregation parameter represents the degree of erythrocyte aggregation or the erythrocyte aggregation characteristic of the at least a portion of the blood sample after being stopped in the first detection pipeline 122.

[0088] The second blood sedimentation detection device 130 is configured to obtain an erythrocyte sedimentation parameter of the blood sample to be tested, which represents the degree of sinking of erythrocytes in the blood sample to be tested in the test tube 10 within a predetermined time period from a predetermined time point after the mixing operation, wherein the blood sample to be tested in the test tube 10 is in a static state within the predetermined time period, and the predetermined time period is not greater than 20 minutes.

[0089] It is pointed out here that "the blood sample to be tested in the test tube 10 is in a static state within the predetermined time period" means that no mixing operation, especially no contact operation, is performed on the blood sample to be tested in the test tube 10 within the predetermined time period, i.e. the blood sample to be tested is kept static relative to the test tube 10. It can be understood that "the blood sample to be tested in the test tube 10 is in a static state within the predetermined time period" does not mean that the test tube 10 is in a static state within the predetermined time period, but the test tube 10 can be moving or static as long as the blood sample to be tested is kept substantially static in the test tube 10. For example, the test tube 10 can be transported within the predetermined time period, but no contact operation is performed on the blood sample to be tested in the test tube 10 during the transportation, so that the blood sample to be tested is kept substantially static relative to the test tube 10.

[0090] The data processing device 140 is configured to process and calculate data to obtain the required results. Here, the data processing device 140 is configured to calculate the erythrocyte sedimentation rate of the blood sample to be tested based on the erythrocyte aggregation parameter obtained by the first blood sedimentation detection device 120 and the erythrocyte sedimentation parameter obtained by the second blood sedimentation detection device 130.

[0091] In some alternative embodiments, the data processing apparatus 140 can be further configured to:

[0092] determine whether the first erythrocyte sedimentation rate calculated based on the erythrocyte aggregation parameter is reliable;

[0093] when determining that the first erythrocyte sedimentation rate is unreliable, calculate a second erythrocyte sedimentation rate of the blood sample to be tested based on the erythrocyte sedimentation parameter only;

[0094] when determining that the first erythrocyte sedimentation rate is reliable, calculate the erythrocyte sedimentation rate of the blood sample to be tested based on the erythrocyte aggregation parameter only, or based on both the erythrocyte aggregation parameter and the erythrocyte sedimentation parameter.

[0095] Embodiments of how to determine whether the first erythrocyte sedimentation rate is reliable will be described in detail below.

[0096] Applicants have found through repeated research that for most mixed whole blood samples, the erythrocytes settle fastest within 0-20 minutes after mixing, and there is a linear relationship with the results at 60 minutes (traditional manual Westergren method), as shown in Figure 4 . Figure 4 shows the degree of settling of 10 EDTA anticoagulation test tubes containing different whole blood samples after being placed on a platform for different periods of time after mixing, wherein the 10 test tubes are placed on the platform after mixing, and the settling images of the 10 samples are collected at 0 min, 5 min, 10 min, 20 min, 30 min and 60 min, respectively, and the images are analyzed to obtain the proportion of plasma in the whole blood sample at each time point (sedimentation parameter). In Figure 4 , the abscissa represents the settling time, and the ordinate represents the proportion of plasma in the whole blood sample.

[0097] Therefore, as shown in Figure 5 , compared with the prior art, the sample analyzer 100 provided by the present application can obtain accurate ESR detection results with good consistency with the ESR detection results based on the traditional Westergren method relatively quickly, and the correlation is as high as 0.9768. In Figure 5 , the abscissa represents the ESR detection result based on the traditional Westergren method, and the ordinate represents the ESR detection result based on the present application.

[0098] ​In some embodiments, the data processing device 140 may include a processor, including but not limited to a central processing unit (CPU), a micro controller unit (MCU), a field-programmable gate array (FPGA), a digital signal processor (DSP), and other devices used to interpret computer instructions and process data in computer software.

[0099] In some embodiments, such as Figure 6 As shown, the sample analyzer 100 may further include a sample transport device 150 and a barcode scanner 160. The sample transport device 150 is used to transport the test tube 10 containing the blood sample to be tested, and the barcode scanner 160 is used to scan the sample identification section 11 on the test tube 10 to obtain information about the blood sample to be tested in the test tube 10, such as identification information and detection mode. Here, the sample transport device 150 first transports the test tube 10 to the barcode scanner 160 for scanning, and then transports the test tube 10 to the mixing device 110 for mixing.

[0100] exist Figure 6 In the illustrated embodiment, the sample transport device 150 transports test tubes 10 in the form of a sample rack 20. The sample transport device 150 can transport the sample rack 20 from the loading area 151 to the analysis area 152 along the Y2 direction, transport the sample rack 20 in the analysis area 152 along the X1 or X2 direction, and unload the sample rack 20 from the analysis area 152 to the unloading area 153 along the Y1 direction. In the analysis area 152, the barcode scanning device 160, the mixing device 110, and the first erythrocyte sedimentation rate (ESR) detection device 120 perform barcode scanning, mixing, and sample aspiration operations on the blood samples to be tested in the test tubes 10 on the sample rack 20, respectively.

[0101] like Figure 7 As shown, the sample rack 20 includes multiple receiving cavities 201 for placing test tubes 10. A sample identification section 11 may be affixed to the outer wall of the test tube 10. The form of the identification on the sample identification section 11 is not limited and can be a barcode, QR code, etc. The sample identification section 11 records a unique identifier for the sample, such as a sample number. Furthermore, in order to scan the sample identification section 11 on the test tube 10, each receiving cavity 201 has an opening 202, which forms a window for scanning the sample identification section 11 of the test tube 10. Moreover, the sample rack 20 also has a sample rack label pasting area 203, which can be used to paste barcode labels, QR code labels, or RFID tags, etc.

[0102] In some embodiments, the mixing device 110 can be configured to mix the blood sample in the test tube 10 by rotation, oscillation or vibration.

[0103] In one specific example, as shown in Figure 8 and Figure 9 , the mixing device 110 can include a gripper 111, a first motor 112, a second motor 113 and a third motor 114. The gripper 111 can be driven by the first motor 112 to move linearly in the direction of Z1 or Z2, by the second motor 113 to move in the direction of Y1 or Y2, and by the third motor 114 to oscillate in the direction of R1 or R2. As shown in Figure 9 , the gripper 111 can grasp the test tube 10 fixed on the sample rack 20 by moving in the direction of Y1, Y2 and Z1, Z2, and can mix the blood sample in the test tube 10 by oscillation. After the mixing operation is completed, the gripper 111 can put the test tube 10 back into the sample rack 20.

[0104] In another example, as shown in Figure 10 , the mixing device 110 includes a fourth motor 115 and a test tube fixing seat 116, and the test tube fixing seat 116 is provided with a test tube fixing hole 117 on the top thereof, in which the test tube 10 can be placed. The fourth motor 115 can drive the test tube fixing seat 116 to rotate in the direction of R3 or R4, so that the blood sample in the test tube 10 placed in the test tube fixing hole 117 can be mixed by the rotating force.

[0105] In some embodiments, as shown in Figure 11 , the sampling and distributing component 121 of the first blood sedimentation detection device 120 includes a sampling needle 1211 and a power assembly 1212, and the power assembly 1212 is configured to draw the blood sample in the test tube 10 into the detection zone 1221 of the first detection pipeline 122 through the sampling needle 1211. The power assembly 1212 is preferably configured as a syringe.

[0106] In Figure 11In the embodiment shown, the blood sedimentation optical detection component 123 has a light emitter 1231 and a light receiver 1232, which are respectively located on two sides of the detection zone 1221 of the first detection pipeline 122. The light emitter 1231 is used to irradiate the blood sample to be detected in the detection zone 1221. The light receiver 1232 is used to detect the amount of light emitted by the light emitter 1231 after irradiating the blood sample to be detected (e.g. receiving the transmitted light and / or scattered light of the blood sample to be detected), and detect the degree of absorption or scattering of light by the blood sample to be detected in the detection zone 1221 by detecting the amount of received light. Since the scattering or transmission of light irradiated on the blood sample to be detected will change in the process of aggregation (forming a coin shape) of red blood cells in the blood sample to be detected, the degree of scattering or absorption of light by the blood sample to be detected can be detected by detecting the amount of transmitted or scattered light after irradiating the blood sample to be detected, so as to measure the degree of aggregation of red blood cells. Here, the blood sedimentation optical detection component 123 detects the blood sample to be detected by the transmission turbidimetry method in particular.

[0107] When the first blood sedimentation detection device 120 is started to detect, the power assembly 1212 drives the blood sample to be detected to flow into the first detection pipeline 122, and stops the movement of the blood sample to be detected after flowing into the detection zone 1221, and then keeps the blood sample to be detected still. The light emitter 1231 irradiates the blood sample to be detected in the detection zone, and the light receiver 1232 detects the degree of scattering or transmission of the light emitted by the light emitter 1231 after irradiating the blood sample to be detected in the detection zone 1221, so as to detect the degree of aggregation of red blood cells, such as the speed of aggregation of red blood cells, of the blood sample to be detected.

[0108] In some embodiments, the power assembly 1212 can also be configured to: before stopping the movement of the blood sample to be detected flowing in the first detection pipeline 122, disperse the red blood cells in the blood sample to be detected by making the blood sample to be detected flow back and forth in the detection zone 1221 of the first detection pipeline 122. Thus, the red blood cells in the blood sample in the detection zone 1221 are kept in a dispersed state as much as possible before the blood sedimentation optical detection component 123 with the light emitter and the light receiver detects the degree of aggregation of red blood cells, so as to be able to more accurately measure the degree of aggregation of red blood cells. After the power assembly 1212 drives the blood sample in the detection zone 1221 to flow back and forth for a predetermined number of times, the power assembly 1212 immediately stops driving, so that the blood sample in the detection zone 1221 stops flowing, and the red blood cells in the blood sample in the detection zone 1221 aggregate, causing the change of light transmittance.

[0109] Here, the power assembly 1212 is particularly configured as a syringe, and since the movement speed and direction of the syringe can be flexibly set, the blood sample can be dispersed flexibly, and the amount of blood can be saved.

[0110] In some embodiments, the red blood cell aggregation parameters are obtained from a red blood cell aggregation curve of the light intensity of the transmitted light through the blood sample in the first detection tube 122 or the scattered light scattered by the blood sample in the first detection tube 122 over time.

[0111] Figure 12 A red blood cell aggregation curve according to an embodiment of the present application is shown, which is a red blood cell aggregation curve of the light intensity of the transmitted light through the blood sample to be measured over time, i.e. a transmitted light intensity-time curve, wherein the light transmittance (also referred to as transmissivity) is the relative light intensity and is equal to the ratio of the transmitted light intensity to the background light intensity. Here, various curve characteristic values in the red blood cell aggregation curve can be extracted as red blood cell aggregation parameters.

[0112] In some embodiments, the red blood cell aggregation parameters can include at least one of the following parameters calculated based on the red blood cell aggregation curve: an area AUC (Area Under Curve) enclosed by the red blood cell aggregation curve and the time axis within a time period between a measurement start time point T1 and a measurement end time point T2, and a red blood cell aggregation method ESR calculated based on the area AUC and a pre-stored calibration curve.

[0113] In some embodiments, the pre-stored calibration curve is stored in the data processing device 140, for example. Figure 13 A calibration curve (also referred to as a scaling curve) for calculating the red blood cell aggregation method ESR is shown, wherein the abscissa is AUC and the ordinate is the red blood cell aggregation method ESR. Through research, the red blood cell aggregation curve AUC of a blood sample has a correlation with the Westergren method ESR, and therefore the calibration curve can be statistically fitted out based on the red blood cell aggregation curve AUC and the Westergren method ESR of a large number of blood samples. That is, a large number of blood samples are detected simultaneously by a blood sedimentation measuring device or system according to the present application and a Westergren method measuring device (including a sedimentation tube) to obtain the red blood cell aggregation curve AUC and the Westergren method ESR of these blood samples, and then the calibration curve is obtained based on these data. The calibration curve can be stored in the data processing device 140 in the form of a fitting function or a series of discrete points. For example, the calibration curve is stored in the data processing device 140 in the form of a lookup table, and the red blood cell aggregation method ESR is obtained by AUC through table lookup and interpolation.

[0114] In some embodiments, the second blood sedimentation detection device 130 can include at least one optical sensor, such as an infrared scanning device or an optical image sensor.

[0115] As some implementations, the second blood sedimentation detection device 130 can be configured to detect a change in light transmittance or a change in light absorbance of the plasma layer or the red blood cell layer of the blood sample in the test tube within the predetermined time period. Here, the red blood cell sedimentation parameter includes a parameter characterizing the change in light transmittance or the change in light absorbance.

[0116] Specifically, in one example, the second blood sedimentation detection device 130 can be further configured to obtain a first light transmittance or a first light absorbance of the plasma layer or the red blood cell layer of the blood sample in the test tube at the predetermined time; and obtain a second light transmittance or a second light absorbance of the plasma layer or the red blood cell layer of the blood sample in the test tube after the predetermined time period from the predetermined time. Here, the red blood cell sedimentation parameter is calculated according to a difference between the second light transmittance or the second light absorbance and the first light transmittance or the first light absorbance. In one simple example, the red blood cell sedimentation parameter is the difference between the second light transmittance or the second light absorbance and the first light transmittance or the first light absorbance.

[0117] As some other implementations, the second blood sedimentation detection device 130 can be configured to detect a change in height of the plasma layer or the red blood cell layer of the blood sample in the test tube within the predetermined time period. Here, the red blood cell sedimentation parameter includes a parameter characterizing the change in height. In particular, the second blood sedimentation detection device 130 can include an infrared scanning device or an optical image sensor, such as a camera, for detecting the change in height.

[0118] Specifically, in one example, the second blood sedimentation detection device 130 can be further configured to obtain a first height of the plasma layer or the red blood cell layer of the blood sample in the test tube at the predetermined time; and obtain a second height of the plasma layer or the red blood cell layer of the blood sample in the test tube after the predetermined time period from the predetermined time. Here, the red blood cell sedimentation parameter is calculated according to a difference between the second height and the first height. In one simple example, the red blood cell sedimentation parameter is the difference between the second height and the first height.

[0119] Here, the second blood sedimentation detection device 130 can be further configured to obtain a third height of the blood sample in the test tube at the predetermined time; and obtain a fourth height of the blood sample in the test tube after the predetermined time period from the predetermined time. Here, the red blood cell sedimentation parameter is calculated according to a difference between a ratio of the first height and the third height and a ratio of the second height and the fourth height. In one simple example, the red blood cell sedimentation parameter is the difference between the ratio of the first height and the third height and the ratio of the second height and the fourth height. Since the amount of the blood sample in different test tubes can be different, the change in the proportion of the plasma layer or the red blood cell layer to the whole blood sample can more accurately reflect the red blood cell sedimentation.

[0120] In some embodiments, the second blood sedimentation detection device 130 can comprise a first optical sensor 131 and a second optical sensor 132. The first optical sensor 131 is configured to obtain a first light transmittance or a first light absorbance of the plasma layer or the red blood cell layer of the blood sample under test in the test tube at a predetermined time, and the second optical sensor 132 is configured to obtain a second light transmittance or a second light absorbance of the plasma layer or the red blood cell layer of the blood sample under test in the test tube after a predetermined time period from the predetermined time. Alternatively, the first optical sensor 131 is configured to obtain a first height of the plasma layer or the red blood cell layer of the blood sample under test in the test tube at a predetermined time and / or to obtain a third height of the blood sample under test in the test tube at a predetermined time, and the second optical sensor 132 is configured to obtain a second height of the plasma layer or the red blood cell layer of the blood sample under test in the test tube after a predetermined time period from the predetermined time and / or to obtain a fourth height of the blood sample under test in the test tube after a predetermined time period from the predetermined time.

[0121] For example, the first optical sensor 131 and the second optical sensor 132 are both configured as cameras. After the test tube 10 on the sample rack 20 is subjected to the mixing operation by the mixing device 110, in particular, the aspiration operation by the first blood sedimentation detection device 120, the first optical sensor 131 obtains a first image of the test tube 10 at a predetermined time, and the second optical sensor 132 obtains a second image of the test tube 10 after the test tube 10 has been left on the sample rack 20 for the predetermined time period from the predetermined time. Thereby, the first height and / or the third height can be obtained from the first image and the second height and / or the fourth height can be obtained from the second image by image analysis.

[0122] As some implementations, the first optical sensor 131 and the second optical sensor 132 can be configured independently from each other. For example, in the embodiment shown in FIG. 1, the first optical sensor 131 and the second optical sensor 132 can be configured independently from each other. Figure 6 In the embodiment shown in FIG. 1, the first optical sensor 131 can be arranged beside the analysis area 152, and the second optical sensor 132 can be arranged in the unloading area 153. Alternatively, the first optical sensor 131 and the second optical sensor 132 can be arranged at different positions beside the analysis area 152 or at different positions in the unloading area 153.

[0123] As some implementations, the first optical sensor 131 and the second optical sensor 132 can be configured independently from each other. For example, in the embodiment shown in FIG. 1, the first optical sensor 131 and the second optical sensor 132 can be configured independently from each other. Figure 6 In the embodiment shown in FIG. 1, the first optical sensor 131 and the second optical sensor 132 can be configured independently from each other.

[0124] In some alternative embodiments, the second blood sedimentation detection device 130 can obtain the change in light transmittance or the change in light absorbance based on the same detection principle as the blood sedimentation optical detection component 123 of the first blood sedimentation detection device 120, or can further obtain the change in height based on the change in light transmittance or the change in light absorbance.

[0125] In some alternative embodiments, the second blood sedimentation detection device 130 can include a sedimentation rack provided with scales and a user interface for receiving user input. After the test tube 10 containing the blood sample to be tested is drawn by the first blood sedimentation detection device 120, the test tube 10 is placed in the sedimentation rack, the first scale of the blood sample to be tested in the test tube 10 when the test tube 10 is placed in the sedimentation rack is read by the user, and the second scale of the blood sample to be tested in the test tube 10 after the predetermined period of time elapses, so that the user can obtain the red blood cell sedimentation parameter according to the first scale and the second scale and input it into the sample analyzer 100 through the user interface.

[0126] In some embodiments, the predetermined time can be selected as any time within 30 seconds, preferably within 15 seconds, more preferably within 10 seconds, after the mixing device 110 completes the mixing operation. In this way, a red blood cell sedimentation parameter that more accurately reflects the sedimentation of red blood cells in the blood sample to be tested can be obtained.

[0127] Further, the predetermined time can be selected as a time after the sampling and dispensing component 121 draws the portion of the blood sample to be tested. In this way, the influence of the sampling operation after the mixing operation on the red blood cell sedimentation can be avoided, so that a red blood cell sedimentation parameter that more accurately reflects the sedimentation of red blood cells in the blood sample to be tested can be obtained.

[0128] In some embodiments, the predetermined time is selected as any time within 20 seconds, preferably within 10 seconds, more preferably within 5 seconds, after the sampling and dispensing component 121 draws the portion of the blood sample to be tested. At this time, no further contact operation is performed on the blood sample to be tested in the test tube 10 within the predetermined period of time.

[0129] In some embodiments, the predetermined period of time is not more than 15 minutes, preferably not more than 10 minutes. For this, the applicant has found through repeated research that for most mixed whole blood samples, red blood cells settle faster within 0-10 minutes after mixing, and there is a linear relationship with the result at 60 minutes (traditional manual Westergren method), as shown in Figure 4 and Figure 14 Thus, accurate red blood cell sedimentation rate can be obtained more quickly. For example, the predetermined period of time can be within 2 minutes to 15 minutes, preferably within 2 minutes to 10 minutes, more preferably within 5 minutes to 10 minutes. For example, the predetermined period of time can be about 10 minutes.

[0130] In some embodiments, the data processing device 140 can be further configured to input the red blood cell aggregation parameter and the red blood cell sedimentation parameter as input parameters into a calculation model, obtain an output of the calculation model as the red blood cell sedimentation rate of the blood sample to be tested, wherein the calculation model comprises a nonlinear function or a neural network structure. For example, the red blood cell sedimentation rate is a nonlinear function of the red blood cell aggregation parameter and the red blood cell sedimentation parameter.

[0131] In some embodiments, as shown in Figure 15 The sample analyzer 100 further comprises a Coulter-based impedance detection device 170 and / or a flow cytometry-based optical detection device 180. Here, the sample distribution component 121 is further configured to deliver another portion of the blood sample of the portion of the blood sample to be tested to the impedance detection device 170 and / or the optical detection device 180, so that at least one red blood cell parameter of the blood sample to be tested is measured by the impedance detection device 170 and / or the optical detection device 180. The data processing device 140 is further configured to correct the red blood cell sedimentation rate of the blood sample to be tested using the at least one red blood cell parameter.

[0132] In some specific embodiments, the at least one red blood cell parameter can include at least one of the following parameters: red blood cell volume distribution histogram, red blood cell scatter plot, red blood cell pulse signal, red blood cell count, hematocrit value, mean red blood cell volume, red blood cell volume variation coefficient, and red blood cell distribution width standard deviation, etc.

[0133] In some alternative embodiments, as shown in Figure 15 The sample analyzer 100 further comprises a Coulter-based impedance detection device 170 and / or a flow cytometry-based optical detection device 180. Here, the sample distribution component 121 is further configured to deliver another portion of the blood sample of the portion of the blood sample to be tested to the impedance detection device 170 and / or the optical detection device 180, so that at least one red blood cell parameter of the blood sample to be tested is measured by the impedance detection device 170 and / or the optical detection device 180. At this time, the data processing device 140 can be further configured to input the red blood cell aggregation parameter, the red blood cell sedimentation parameter, and the red blood cell parameter as input parameters into a calculation model, obtain an output of the calculation model as the red blood cell sedimentation rate of the blood sample to be tested. The calculation model comprises a nonlinear function or a neural network structure. The calculation model is particularly a neural network model, which is pre-trained and stored in the data processing device 140.

[0134] The following will be described in conjunction with Figure 6 and Figure 16An exemplary workflow of the sample analyzer 100 of the present application is described. The sample transport device 150 transports the sample rack 20 in the loading area 151 to the analysis area 152 along the Y2 direction, and then transports the test tube 10 on the sample rack 20 to the code scanning position P1 in the analysis area 152 along the X1 direction. The code scanning device 160 scans the test tube 10 located at the code scanning position P1 to obtain the identity information and the detection mode (the routine blood test mode and / or the ESR mode) of the test tube 10. Then, the sample transport device 150 continues to transport the sample rack 20 along the X1 direction to carry the scanned test tube 10 to the mixing position P2 in the analysis area 152, and the mixing device 110 performs the mixing operation on the test tube 10 located at the mixing position P2. Then, the sample transport device 150 continues to transport the sample rack 20 along the X1 direction to carry the mixed test tube 10 to the sample suction position P1 in the analysis area 152. If the detection mode of the test tube 10 includes the routine blood test mode and the ESR mode, the sample dispensing component 121 sucks a portion of the blood sample to be tested from the test tube 10 located at the sample suction position P1, and dispenses the sucked blood sample to be tested to the first detection pipeline 122, the impedance detection device 170 and the optical detection device 180 respectively. The blood sedimentation optical detection component 123 detects the dispensed blood sample to be tested to obtain the red blood cell aggregation parameter, and the impedance detection device 170 and the optical detection device 180 detect the dispensed blood sample to be tested to obtain the red blood cell parameter. If the detection mode of the test tube 10 only includes the ESR mode, the sample dispensing component 121 sucks a portion of the blood sample to be tested from the test tube 10 located at the sample suction position P3, and dispenses the sucked blood sample to be tested to the first detection pipeline 122. The blood sedimentation optical detection component 123 detects the dispensed blood sample to be tested to obtain the red blood cell aggregation parameter. At a predetermined time after the sample dispensing component 121 performs the sample suction operation on the test tube 10 located at the sample suction position P3, the second blood sedimentation detection device 130 obtains the first light transmittance or the first light absorbance or the first height of the plasma layer or the red blood cell layer in the test tube 10. Subsequently, the sample transport device 150 unloads the sample rack 20 in the analysis area 152 to the unloading area 153 along the Y1 direction. The second blood sedimentation detection device 130 obtains the second light transmittance or the second light absorbance or the second height of the plasma layer or the red blood cell layer in the test tube 10 after a predetermined interval, for example, 2 minutes or 5 minutes or 10 minutes, from the predetermined time, to obtain the red blood cell sedimentation parameter. The data processing device 140 calculates the red blood cell sedimentation rate of the blood sample to be tested according to the red blood cell aggregation parameter and the red blood cell sedimentation parameter and the optional red blood cell parameter.

[0135] The present application also provides another sample analyzer 200, as shown in Figure 17 The sample analyzer 200 includes a mixing device 210, a first blood sedimentation detection device 220, a second blood sedimentation detection device 230 and a data processing device 240.

[0136] The first blood sedimentation detection device 220 comprises a sample dispensing component 221, a first detection pipeline 222, and a blood sedimentation optical detection component 223. The sample dispensing component 221 is configured to draw a portion of the blood sample to be tested from the test tube 10 containing the blood sample to be tested, transport at least a portion of the blood sample in the portion of the blood sample to be tested to the first detection pipeline 222, and stop the flow of the at least a portion of the blood sample in the first detection pipeline 222. The blood sedimentation optical detection component 223 is configured to irradiate the at least a portion of the blood sample stopped in the first detection pipeline 222 with light, and obtain information of transmitted light transmitted through the at least a portion of the blood sample or information of scattered light scattered by the at least a portion of the blood sample, so as to obtain a red blood cell aggregation parameter of the blood sample to be tested based on the obtained information of the transmitted light or the scattered light. In this context, the red blood cell aggregation parameter represents the degree of red blood cell aggregation or the characteristic of red blood cell aggregation of the at least a portion of the blood sample after the at least a portion of the blood sample is stopped in the first detection pipeline 222.

[0137] The mixing device 210 is configured to perform a mixing operation on the remaining blood sample to be tested in the test tube 10 after the sample dispensing component 221 draws the portion of the blood sample to be tested.

[0138] The second blood sedimentation detection device 230 is configured to obtain a red blood cell sedimentation parameter of the blood sample to be tested, the red blood cell sedimentation parameter representing the degree of sinking of red blood cells in the remaining blood sample to be tested in the test tube 10 from a predetermined time after the mixing operation to a predetermined time period, wherein the remaining blood sample to be tested in the test tube 10 is in a static state during the predetermined time period, and the predetermined time period is not greater than 20 minutes.

[0139] The data processing device 240 is configured to calculate a red blood cell sedimentation rate of the blood sample to be tested based on the red blood cell aggregation parameter obtained by the first blood sedimentation detection device 220 and the red blood cell sedimentation parameter obtained by the second blood sedimentation detection device 230.

[0140] The above embodiments and advantages of the sample analyzer 100 provided by the present application are applicable to the sample analyzer 200 provided by the present application in a corresponding manner, and will not be described here again.

[0141] The present application also provides a sample analysis system 300, as shown in the figure, the sample analysis system 300 comprises a mixing device 310, a first sample analyzer 320 and a second sample analyzer 330 which are independent of each other, a second blood sedimentation detection device 340, a sample conveying track 350, and a data processing device 360. Figure 18

[0142] ​The mixing device 310 is configured to perform a mixing operation on the blood sample in the test tube 10. More embodiments and advantages of the mixing device 310 can be found in the above description of the mixing device 110, which will not be repeated here.

[0143] The first sample analyzer 320 and / or the second sample analyzer 330 comprises the above-mentioned first sedimentation detection device 120. Preferably, the first sample analyzer 320 integrates a routine blood detection device and the above-mentioned first sedimentation detection device 120, and the mixing device 310 is preferably integrated in the first sample analyzer 320. The second sample analyzer 330 may, for example, comprise a routine blood detection device but not a sedimentation detection device.

[0144] The second sedimentation detection device 340 is configured to obtain a red blood cell sedimentation parameter of the blood sample, the red blood cell sedimentation parameter representing a degree of sinking of red blood cells in the blood sample in the test tube within a predetermined time period since a predetermined time point after the mixing operation, wherein the blood sample in the test tube is in a resting state within the predetermined time period, and the predetermined time period is not greater than 20 minutes. More embodiments and advantages of the second sedimentation detection device 340 can be found in the above description of the second sedimentation detection device 130, which will not be repeated here.

[0145] The sample transport track 350 is configured to transport the test tube 10 containing the blood sample to the first sample analyzer 320 and / or the second sample analyzer 330.

[0146] The data processing device 360 is configured to calculate a red blood cell sedimentation rate of the blood sample based on the red blood cell aggregation parameter and the red blood cell sedimentation parameter. More embodiments and advantages of the data processing device 360 can be found in the above description of the data processing device 140, which will not be repeated here.

[0147] In some embodiments, as shown in FIG. 4, the sample analysis system 300 further comprises a loading area 370 and an unloading area 380, wherein the loading area 370 is configured to place the test tube 10 containing the blood sample, for example, in a manner of being placed on the sample rack 20, and the unloading area 380 is configured to place the test tube 10 containing the detected blood sample, for example, in a manner of being placed on the sample rack 20. Figure 19 In some embodiments, the second sedimentation detection device 340 can be arranged beside the sample transport track 350, in which case the test tube after the mixing operation can be rested in the sample transport track 350. Alternatively, the second sedimentation detection device 340 can be arranged in the unloading area 380, in which case the test tube after the mixing operation can be rested in the unloading area 380.

[0148] In some embodiments, as shown in FIG. 4, the sample analysis system 300 further comprises a loading area 370 and an unloading area 380, wherein the loading area 370 is configured to place the test tube 10 containing the blood sample, for example, in a manner of being placed on the sample rack 20, and the unloading area 380 is configured to place the test tube 10 containing the detected blood sample, for example, in a manner of being placed on the sample rack 20.

[0149] In some embodiments, as shown in FIG. 4, the sample analysis system 300 further comprises a loading area 370 and an unloading area 380, wherein the loading area 370 is configured to place the test tube 10 containing the blood sample, for example, in a manner of being placed on the sample rack 20, and the unloading area 380 is configured to place the test tube 10 containing the detected blood sample, for example, in a manner of being placed on the sample rack 20.Figure 20 As shown, the first sample analyzer 320 can be configured the same as the sample analyzer 100 as described above, and has a sample transport device configured the same as the sample transport device 150 as described above and a code scanning device configured the same as the code scanning device 160 as described above. The sample transport device transports the test tubes 10 in the form of the sample racks 20. The sample transport device can transport the sample racks 20 in the loading area 321 to the analysis area 322, transport the sample racks 20 in the analysis area 322, and unload the sample racks 20 in the analysis area 322 to the unloading area 323. In the analysis area 322, the code scanning device, the mixing device 310, and the first blood sedimentation detection device 120 perform the code scanning operation, the mixing operation, and the sample suction operation on the blood samples to be tested in the test tubes 10 on the sample racks 20, respectively. Here, the second blood sedimentation detection device 340 can be arranged in the unloading area 323 of the first sample analyzer 320, and the specific details can be referred to the description of the sample analyzer 100 above.

[0150] Alternatively or additionally, as Figure 21 As shown, the second sample analyzer 320 can also have a sample transport device configured the same as the sample transport device 150 as described above. The sample transport device transports the test tubes 10 in the form of the sample racks 20. The sample transport device can transport the sample racks 20 in the loading area 331 to the analysis area 332, transport the sample racks 20 in the analysis area 332, and unload the sample racks 20 in the analysis area 332 to the unloading area 333. Here, the second blood sedimentation detection device 340 can also be arranged in the unloading area 333 of the second sample analyzer 330, and the specific details can be referred to the description of the sample analyzer 100 above.

[0151] Figure 19An exemplary workflow of the sample analysis system 300 is as follows: the sample transport track 350 transports the sample rack 20 in the loading area 370 to the first sample analyzer 320, the first sample analyzer 320 sequentially performs code scanning, mixing and sample suction on the test tubes 10 in the sample rack 20, and analyzes the sucked blood sample to be tested to obtain the red blood cell aggregation parameter and the optional red blood cell parameter. At a predetermined time after the sample analyzer 320 performs the sample suction operation on the test tubes 10, the second blood sedimentation detection device 340 obtains the first transmittance or first absorbance or first height of the plasma layer or red blood cell layer in the test tubes 10. Subsequently, the sample transport track 350 unloads the sample rack 20 from the first sample analyzer to the unloading area 380. After a predetermined interval, for example, 2 minutes or 5 minutes or 10 minutes, etc., from the predetermined time, the second blood sedimentation detection device 340 obtains the second transmittance or second absorbance or second height of the plasma layer or red blood cell layer in the test tubes 10, thereby obtaining the red blood cell sedimentation parameter. The data processing device 360 calculates the red blood cell sedimentation rate of the blood sample to be tested according to the red blood cell aggregation parameter and the red blood cell sedimentation parameter and the optional red blood cell parameter.

[0152] More embodiments and advantages of the sample analysis system 300 provided by the present application can be referred to the above description of the sample analyzer 100 provided by the present application, which will not be repeated here.

[0153] The present application also provides a blood sedimentation measurement method 400, as shown in the following. Figure 22 The blood sedimentation measurement method 400 includes steps S410 to S450.

[0154] In step S410, a portion of the blood sample to be tested is sucked from a test tube containing the blood sample to be tested after mixing operation, and at least a portion of the blood sample to be tested is transported to a first detection pipeline and stopped flowing in the first detection pipeline.

[0155] In step S420, the at least a portion of the blood sample to be tested stopped flowing in the first detection pipeline is irradiated with light, and information of transmitted light transmitted through the at least a portion of the blood sample to be tested or information of scattered light scattered by the at least a portion of the blood sample to be tested is obtained.

[0156] In step S430, the red blood cell aggregation parameter of the blood sample to be tested is obtained based on the obtained information of transmitted light or scattered light, and the red blood cell aggregation parameter represents the degree of red blood cell aggregation of the at least a portion of the blood sample to be tested after stopping flowing in the first detection pipeline.

[0157] In step S440, the blood sample under test in the test tube is allowed to stand for a predetermined time period from a predetermined time point after the mixing operation, to obtain a red blood cell sedimentation parameter of the blood sample under test, the red blood cell sedimentation parameter characterizing a degree of sinking of red blood cells in the blood sample under test in the test tube in the predetermined time period.

[0158] In step S450, a red blood cell sedimentation rate of the blood sample under test is calculated based on the red blood cell aggregation parameter and the red blood cell sedimentation parameter.

[0159] In some embodiments, the red blood cell sedimentation parameter comprises a parameter characterizing a change in light transmittance or a change in light absorbance of the plasma layer or the red blood cell layer of the blood sample under test in the test tube in the predetermined time period, or a parameter characterizing a change in height of the plasma layer or the red blood cell layer of the blood sample under test in the test tube in the predetermined time period.

[0160] As some implementations, step S440 can comprise:

[0161] obtaining a first light transmittance or a first light absorbance of the plasma layer or the red blood cell layer of the blood sample under test in the test tube at the predetermined time point; and

[0162] obtaining a second light transmittance or a second light absorbance of the plasma layer or the red blood cell layer of the blood sample under test in the test tube after the predetermined time period from the predetermined time point; wherein the red blood cell sedimentation parameter is calculated based on a difference between the second light transmittance or the second light absorbance and the first light transmittance or the first light absorbance.

[0163] As some other implementations, step S440 can comprise:

[0164] obtaining a first height of the plasma layer or the red blood cell layer of the blood sample under test in the test tube at the predetermined time point; and

[0165] obtaining a second height of the plasma layer or the red blood cell layer of the blood sample under test in the test tube after the predetermined time period from the predetermined time point; wherein the red blood cell sedimentation parameter is calculated based on a difference between the second height and the first height.

[0166] Further, step S440 can further comprise:

[0167] obtaining a third height of the blood sample under test in the test tube in the test tube at the predetermined time point; and

[0168] acquiring a fourth height of the blood sample in the test tube after the predetermined time period from the predetermined time point; wherein the erythrocyte sedimentation parameter is calculated according to a difference between a ratio of the first height and the third height and a ratio of the second height and the fourth height.

[0169] In some embodiments, a parameter characterizing a change in height of the plasma layer or the erythrocyte layer of the blood sample in the test tube during the predetermined time period can be acquired using an infrared scanning device or an optical image sensor.

[0170] In some embodiments, the predetermined time point can be selected as any time point within 30 seconds, preferably within 15 seconds, more preferably within 10 seconds, after the end of the mixing operation.

[0171] In some embodiments, the predetermined time point can be selected as a time point after the withdrawal of the portion of the blood sample. For example, the predetermined time point can be selected as any time point within 15 seconds, preferably within 10 seconds, more preferably within 5 seconds, after the withdrawal of the portion of the blood sample.

[0172] In some embodiments, the predetermined time period is not more than 15 minutes, preferably not more than 10 minutes.

[0173] In some embodiments, step S450 can comprise inputting the erythrocyte aggregation parameter and the erythrocyte sedimentation parameter as input parameters into a calculation model, and obtaining an output of the calculation model as the erythrocyte sedimentation rate, wherein the calculation model comprises a nonlinear function or a neural network structure.

[0174] Further, the method 400 can further comprise:

[0175] transporting another portion of the portion of the blood sample to an impedance detection device based on the Coulter method and / or an optical detection device based on flow cytometry, so as to measure at least one erythrocyte parameter of the blood sample by the impedance detection device and / or the optical detection device; and

[0176] correcting the erythrocyte sedimentation rate of the blood sample using the at least one erythrocyte parameter.

[0177] In some alternative embodiments, the method 400 can further include: transporting another portion of the portion of the blood sample under test to the impedance detection device based on the Coulter method and / or the optical detection device based on flow cytometry, so as to measure at least one red blood cell parameter of the blood sample under test by the impedance detection device and / or the optical detection device. In this case, the step S450 includes: inputting the red blood cell aggregation parameter, the red blood cell sedimentation parameter and the at least one red blood cell parameter as input parameters into the calculation model, so as to obtain the output of the calculation model as the red blood cell sedimentation rate, wherein the calculation model includes a nonlinear function or a neural network structure.

[0178] The blood sedimentation measurement method 400 provided by the present application can be applied to the sample analyzer 100 or the sample analysis system 300 provided by the present application. Therefore, the above embodiments and advantages of the sample analyzer 100 and the sample analysis system 300 provided by the present application are applicable to the blood sedimentation measurement method 400 provided by the present application in a corresponding manner, which will not be described here again.

[0179] The present application further provides another blood sedimentation measurement method 500, as shown in Figure 23 The blood sedimentation measurement method 500 includes steps S510 to S560.

[0180] In step S510, a portion of the blood sample under test is taken from a test tube containing the blood sample under test, and at least a portion of the portion of the blood sample under test is transported to a first detection pipeline and stopped flowing in the first detection pipeline.

[0181] In step S520, the at least a portion of the blood sample stopped flowing in the first detection pipeline is irradiated with light to obtain information of transmitted light transmitted through the at least a portion of the blood sample or information of scattered light scattered by the at least a portion of the blood sample.

[0182] In step S530, a red blood cell aggregation parameter of the blood sample under test is obtained based on the obtained information of transmitted light or scattered light, the red blood cell aggregation parameter characterizing the degree of red blood cell aggregation of the at least a portion of the blood sample after stopping flowing in the first detection pipeline.

[0183] In step S540, the remaining blood sample under test in the test tube is mixed after the portion of the blood sample under test is taken.

[0184] In step S550, the remaining blood sample under test in the test tube is allowed to stand for a predetermined time period from a predetermined time point after the mixing operation, to obtain a red blood cell sedimentation parameter of the blood sample under test, the red blood cell sedimentation parameter characterizing a degree of sinking of red blood cells in the remaining blood sample under test in the test tube within the predetermined time period, wherein the predetermined time period is not greater than 20 minutes.

[0185] In step S560, a red blood cell sedimentation rate of the blood sample under test is calculated based on the red blood cell aggregation parameter and the red blood cell sedimentation parameter.

[0186] In some embodiments, the red blood cell sedimentation parameter can include a parameter characterizing a change in light transmittance or a change in light absorbance of the plasma layer or the red blood cell layer of the remaining blood sample under test within the predetermined time period, or a parameter characterizing a change in height of the plasma layer or the red blood cell layer of the remaining blood sample under test in the test tube within the predetermined time period.

[0187] In some embodiments, step S550 can include:

[0188] obtaining a first light transmittance or a first light absorbance of the plasma layer or the red blood cell layer of the remaining blood sample under test at the predetermined time point; and

[0189] obtaining a second light transmittance or a second light absorbance of the plasma layer or the red blood cell layer of the remaining blood sample under test after the predetermined time period from the predetermined time point; wherein the red blood cell sedimentation parameter is calculated based on a difference between the second light transmittance or the second light absorbance and the first light transmittance or the first light absorbance.

[0190] In some embodiments, step S550 can include:

[0191] obtaining a first height of the plasma layer or the red blood cell layer of the remaining blood sample under test in the test tube at the predetermined time point; and

[0192] obtaining a second height of the plasma layer or the red blood cell layer of the remaining blood sample under test in the test tube after the predetermined time period from the predetermined time point; wherein the red blood cell sedimentation parameter is calculated based on a difference between the second height and the first height.

[0193] In some embodiments, the predetermined time point is selected to be any time point within 30 seconds, preferably within 15 seconds, more preferably within 10 seconds, after the end of the mixing operation; and / or the predetermined time period is not greater than 15 minutes, preferably not greater than 10 minutes.

[0194] In some embodiments, the method 500 can further include:

[0195] sending another part of the portion of the blood sample under test to a Coulter-based impedance detection device and / or a flow cytometry-based optical detection device, so as to measure at least one red blood cell parameter of the blood sample under test by the impedance detection device and / or the optical detection device; and

[0196] correcting the erythrocyte sedimentation rate of the blood sample under test using the at least one red blood cell parameter.

[0197] In some alternative embodiments, the method 500 can further comprise sending another part of the portion of the blood sample under test to a Coulter-based impedance detection device and / or a flow cytometry-based optical detection device, so as to measure at least one red blood cell parameter of the blood sample under test by the impedance detection device and / or the optical detection device. In this regard, the step S560 comprises inputting the red blood cell aggregation parameter, the red blood cell sedimentation parameter and the at least one red blood cell parameter as input parameters into a calculation model to obtain an output of the calculation model as the erythrocyte sedimentation rate, wherein the calculation model comprises a non-linear function or a neural network structure.

[0198] The blood sedimentation measurement method 500 provided by the present application can be applied to the sample analyzer 200 provided by the present application in particular. Therefore, the above embodiments and advantages of the sample analyzer 200 provided by the present application are applicable to the blood sedimentation measurement method 500 provided by the present application in a corresponding manner, which will not be described here again.

[0199] As shown in Figure 24 The present application further provides another sample analysis system 600, comprising a sampling and dispensing device 610, a first blood sedimentation detection device 620, a second blood sedimentation detection device 630 and a data processing device 640.

[0200] The sampling and dispensing device 610 is configured to draw a portion of a blood sample under test from a test tube containing the blood sample under test of a subject, and dispense at least a part of the portion of the blood sample under test to the first blood sedimentation detection device 620. Optionally, the sampling and dispensing device 610 can also be configured to collect another part of the blood sample of the subject, for example, draw another part of the blood sample from the test tube, and dispense the another part of the blood sample to the second blood sedimentation detection device 630.

[0201] For more embodiments of the sampling and dispensing device 610, please refer to the above description of the sampling and dispensing component 221.

[0202] The first blood sedimentation detection device 620 is configured to perform blood sedimentation detection on the blood sample to be tested based on the erythrocyte aggregation method. Specifically, the first blood sedimentation detection device 620 comprises a first detection pipeline, a power component, and a first optical detection component. The first detection pipeline is configured to receive the at least part of the blood sample distributed by the sampling and distributing device 610. The power component is configured to make the distributed at least part of the blood sample flow back and forth in the first detection pipeline to perform disaggregation treatment on the erythrocytes in the at least part of the blood sample, and stop the disaggregation treatment so that the erythrocytes in the at least part of the blood sample in the first detection pipeline aggregate, and the first optical detection component is configured to acquire disaggregation optical data of the erythrocytes in the at least part of the blood sample in the process of erythrocyte disaggregation and / or aggregation optical data of the erythrocytes in the process of erythrocyte aggregation.

[0203] For more embodiments of the first detection pipeline, the power component, and the first optical detection component of the first blood sedimentation detection device 620, please refer to the above description of the sampling and distributing component 221, the first detection pipeline 222, and the blood sedimentation optical detection component 223 of the first blood sedimentation detection device 220.

[0204] The second blood sedimentation detection device 630 is configured to acquire the erythrocyte sedimentation parameter of the blood sample to be tested. Specifically, the second blood sedimentation detection device 630 comprises a second detection pipeline and a second optical detection component, wherein the second detection pipeline is configured to receive the blood sample of the subject, and the second optical detection component is configured to acquire the erythrocyte sedimentation rate of the blood sample in the second detection pipeline based on the Westergren method. The second detection pipeline may, for example, be a vertically placed tube or a tube placed obliquely relative to the vertical direction.

[0205] For more embodiments of the second optical detection component of the second blood sedimentation detection device 630, please refer to the above description of the second blood sedimentation detection device 130.

[0206] The data processing device 640 is configured to: determine whether the first erythrocyte sedimentation rate obtained only according to the aggregation optical data is credible, output the first erythrocyte sedimentation rate when it is determined that the first erythrocyte sedimentation rate is credible, and control the second blood sedimentation detection device to recheck the blood sample of the subject based on the Westergren method to acquire and output the second erythrocyte sedimentation rate of the subject when it is determined that the first erythrocyte sedimentation rate is not credible.

[0207] In some embodiments, the first blood sedimentation detection device 620 and the second blood sedimentation detection device 630 can be independently arranged from each other. In other embodiments, the first blood sedimentation detection device 620 and the second blood sedimentation detection device 630 can also be integrated together.

[0208] In some embodiments, the sample analysis system 600 further comprises a blood analyzer comprising the sampling and dispensing device and the blood routine test device (e.g. the above-mentioned impedance test device 170 based on the Coulter method and / or the optical test device 180 based on flow cytometry). Here, the first blood sedimentation test device 620 and / or the second blood sedimentation test device 630 are integrated in the blood analyzer.

[0209] For example, the blood analyzer of the sample analysis system 600 can be configured like the first sample analyzer 320 shown in Figure 18 , i.e. integrated with a blood routine test device and the first blood sedimentation test device 620. The second blood sedimentation test device 630 is arranged separately from the blood analyzer.

[0210] For example, the sample analysis system 600 can comprise a first blood analyzer and a second blood analyzer with respective blood routine test devices, as shown in Figures 18 to 21 . Here, the first blood sedimentation test device 620 can be integrated in the first blood analyzer and the second blood sedimentation test device 630 can be integrated in the second blood analyzer.

[0211] In some embodiments, the sample analysis system 600 can further comprise a sample transport device arranged for transporting a test tube to the sampling and dispensing device 610 for the sampling and dispensing device 610 to draw the portion of the blood sample to be tested from the test tube. Accordingly, the data processing device 640 can be further arranged for, when determining that the first erythrocyte sedimentation rate is not reliable, controlling the sample transport device 610 to transport the test tube to the second blood sedimentation test device 630 for controlling the second blood sedimentation test device 630 to perform a retest of the blood sample of the subject.

[0212] For example, similar to the configuration shown in Figures 18 to 21 , the sample transport device can be configured as a sample transport track.

[0213] Further, similar to the configuration shown in Figures 18 to 21 , the sample analysis system 600 can further comprise a buffer zone, e.g. an unloading zone. The sample transport device can be further arranged for transporting a test tube drawn by the sampling and dispensing device to the buffer zone. Here, it can be possible that the data processing device 640 controlling the sample transport device to transport the test tube to the second blood sedimentation test device 630 can comprise the data processing device 640 controlling the sample transport device to transfer the test tube from the buffer zone to the second blood sedimentation test device.

[0214] In some embodiments, the second blood sedimentation test device 630 further comprises a mixing component arranged for performing a mixing operation on the blood sample in the second test tube line.

[0215] The structure of the mixing component of the second sedimentation detection device 630 can refer to the above description of the mixing devices 110, 210, 310.

[0216] In some embodiments, the test tube for loading the blood sample to be tested can itself be used as the second detection tube. Accordingly, the data processing device 640 is further configured to, when determining that the first erythrocyte sedimentation rate is not reliable:

[0217] controlling the mixing component to mix the remaining blood sample in the test tube,

[0218] controlling the second optical detection component to obtain the sinking degree or sedimentation height of the red blood cells in the test tube in the remaining blood sample in the test tube within a predetermined time period after the mixing operation, especially from a predetermined time point after the mixing operation; and

[0219] calculating and outputting the second erythrocyte sedimentation rate based on the sinking degree.

[0220] In other embodiments, the data processing device 640 can be further configured to, when determining that the first erythrocyte sedimentation rate is not reliable:

[0221] controlling the sampling and dispensing device to collect another portion of the blood sample of the subject and load the another portion of the blood sample into the second detection tube;

[0222] controlling the mixing component to mix the another portion of the blood sample in the second detection tube;

[0223] controlling the second optical detection component to obtain the sinking degree or sedimentation height of the red blood cells in the second detection tube in the mixed blood sample in the second detection tube within a predetermined time period after the mixing operation, especially from a predetermined time point after the mixing operation; and

[0224] calculating and outputting the second erythrocyte sedimentation rate based on the sinking degree.

[0225] Embodiments of the predetermined time point and the predetermined time period can refer to the above description.

[0226] Here, the data processing device 640 is preferably configured to determine whether the first erythrocyte sedimentation rate is reliable according to the disaggregation optical data and / or the aggregation optical data.

[0227] The following further describes how the data processing device 640 determines whether the first erythrocyte sedimentation rate is reliable according to the disaggregation optical data and / or the aggregation optical data in combination with some embodiments.

[0228] The inventors of the present application have noticed that one of the key influencing factors of the erythrocyte aggregation-based blood sedimentation detection is the degree of erythrocyte disaggregation before detection.

[0229] For some abnormal blood samples to be detected, such as erythrocyte in vivo aggregation samples, when the erythrocyte aggregation method is used for blood sedimentation detection, because the erythrocytes are in an aggregated state in vivo before re-aggregation, the light transmittance level of such samples in the erythrocyte disaggregation process is generally higher than that of normal samples in the erythrocyte disaggregation process.

[0230] Figure 25 A curve comparison diagram of erythrocyte disaggregation curves (here, the light intensity curve through the blood sample over time during the disaggregation process) of abnormal samples with erythrocyte in vivo aggregation and normal samples is shown, wherein the abnormal samples and the normal samples have similar actual aggregation results. As shown in Figure 25 Compared with the normal samples with similar actual aggregation results, the erythrocyte disaggregation curve of the abnormal samples has a higher light transmittance, and the fluctuation of the curve is also relatively large.

[0231] Therefore, whether the sample abnormality that causes the abnormal blood sedimentation detection result exists in the blood sample to be detected can be determined according to the disaggregation optical data of the erythrocyte disaggregation process of the blood sample to be detected. That is, the data processing apparatus 640 determines whether the first erythrocyte sedimentation rate is reliable according to the disaggregation optical data.

[0232] In some embodiments, the data processing apparatus 640 determining whether the first erythrocyte sedimentation rate is reliable according to the disaggregation optical data and / or the aggregation optical data can include that the data processing apparatus 640

[0233] obtaining a first aggregation feature value according to the aggregation optical data;

[0234] obtaining a disaggregation feature value according to the disaggregation optical data and / or obtaining a second aggregation feature value different from the first aggregation feature value according to the aggregation optical data;

[0235] determining a first judgment threshold range and / or a second judgment threshold range according to the first aggregation feature value;

[0236] when the disaggregation feature value exceeds the first judgment threshold range and / or the second aggregation feature value exceeds the second judgment threshold range, determining that the first erythrocyte sedimentation rate is unreliable.

[0237] As some implementations, the data processing apparatus 640 determining whether the first erythrocyte sedimentation rate is reliable according to the disaggregation optical data and / or the aggregation optical data can include that the data processing apparatus 640

[0238] obtaining a first aggregation feature value according to the aggregation optical data;

[0239] obtaining a disaggregation feature value according to the disaggregation optical data;

[0240] determining a first judgment threshold range according to the first aggregation feature value; and

[0241] when the disaggregation feature value exceeds the first judgment threshold range, judging that there is a sample abnormality in the to-be-tested blood sample which leads to an abnormal blood sedimentation detection result, i.e., the first erythrocyte sedimentation rate is not credible.

[0242] Here, after obtaining the first aggregation feature value, it is determined that the disaggregation feature value of the blood sample with the first aggregation feature value should be in which theoretical range (i.e., the first judgment threshold range is determined according to the first aggregation feature value). When the disaggregation feature value of the to-be-tested blood sample exceeds the theoretical range, it indicates that there is a sample abnormality in the to-be-tested blood sample which leads to an abnormal blood sedimentation detection result, i.e., the first erythrocyte sedimentation rate is not credible.

[0243] In some embodiments, the aggregation optical data can include a red blood cell aggregation curve of the light intensity of the transmitted light or the scattered light scattered by the at least part of the blood sample allocated over time in the red blood cell aggregation process.

[0244] Figure 26 A red blood cell aggregation curve C measured by the first blood sedimentation detection device provided by the embodiments of the present application is shown, in which the light transmittance (which can also be referred to as the transmittance) is the relative light intensity, equal to the ratio of the transmitted light intensity to the background light intensity. The first aggregation feature value can be obtained from the red blood cell aggregation curve C.

[0245] In some embodiments, the first aggregation feature value can be the blood sedimentation detection result. In other embodiments, the first aggregation feature value can be a corrected blood sedimentation detection result obtained by correcting the blood sedimentation detection result according to the blood routine detection data. In yet other embodiments, the first aggregation feature value can also be an area AUC (Area Under Curve) enclosed by the red blood cell aggregation curve C and the time axis within a time period from a measurement start time point T1 to a measurement end time point T2.

[0246] In some embodiments, the disaggregation optical data can include a red blood cell disaggregation curve of the light intensity of the transmitted light or the scattered light scattered by the at least part of the blood sample allocated over time in the red blood cell disaggregation process.

[0247] In some embodiments, the disaggregation feature value can be a mean value of the light intensity of the red blood cell disaggregation curve in the time period between the measurement start time point and the measurement end time point, or a standard deviation of the light intensity of the red blood cell disaggregation curve in the time period between the measurement start time point and the measurement end time point. For example, the red blood cell disaggregation curve is a curve of the transmitted light through the at least part of the blood sample over time during the red blood cell disaggregation process, and the disaggregation feature value can be a mean value or a standard deviation of the transmitted light intensity in the time period between the measurement start time point and the measurement end time point.

[0248] For example, the theoretical range (i.e., the first judgment threshold range) of the disaggregation feature value obtained can be determined according to the blood sedimentation detection result or the corrected blood sedimentation detection result or the AUC of the red blood cell aggregation curve (i.e., the first aggregation feature value) of the blood sample to be tested, and then the theoretical range can be used as a judgment basis for the disaggregation feature value to determine whether there is a sample abnormality in the blood sample to be tested that causes the blood sedimentation detection result to be abnormal. For example, if the disaggregation feature value obtained exceeds the theoretical range, it indicates that there is data abnormality in the red blood cell disaggregation process of the blood sample to be tested, and then it can be determined that there is a sample abnormality in the blood sample to be tested that causes the blood sedimentation detection result to be abnormal; if the disaggregation feature value obtained does not exceed the theoretical range, it indicates that there is no sample abnormality in the blood sample to be tested that causes the blood sedimentation detection result to be abnormal.

[0249] In addition, for some abnormal blood samples to be tested, such as red blood cell in vivo aggregation samples, when the red blood cell aggregation method is used for blood sedimentation detection, because the red blood cells thereof are in an aggregated state before the red blood cells are re-aggregated, the light transmittance level of such samples in the red blood cell aggregation process is also generally higher than that of normal samples in the red blood cell aggregation process.

[0250] Figure 27 A curve comparison diagram of the red blood cell aggregation curves (i.e., the curves of the light intensity through the blood sample over time during the aggregation process) of the abnormal sample with red blood cell in vivo aggregation and the normal sample is shown, wherein the abnormal sample and the normal sample have similar actual aggregation results. As shown in Figure 27 Compared with the normal sample with similar actual aggregation results, the red blood cell aggregation curve of the abnormal sample has a higher light transmittance, and the starting point of the curve is also relatively high.

[0251] Therefore, whether there is a sample abnormality in the blood sample to be tested that causes the blood sedimentation detection result to be abnormal can be determined according to the aggregation optical data of the red blood cell aggregation process of the blood sample to be tested. That is, the data processing apparatus 640 can determine whether the first red blood cell sedimentation rate is reliable according to the aggregation optical data.

[0252] As some implementations, the data processing apparatus 640 determining whether the first erythrocyte sedimentation rate is reliable according to the disaggregation optical data and / or the aggregation optical data can comprise: the data processing apparatus 640

[0253] obtaining a first aggregation characteristic value according to the aggregation optical data;

[0254] obtaining a second aggregation characteristic value different from the first aggregation characteristic value according to the aggregation optical data;

[0255] determining a second judgment threshold range according to the first aggregation characteristic value;

[0256] when the second aggregation characteristic value is out of the second judgment threshold range, determining that there is a sample abnormality in the blood sample to be tested which leads to an abnormal blood sedimentation detection result, i.e. the first erythrocyte sedimentation rate is unreliable.

[0257] Here, after obtaining the first aggregation characteristic value and the second aggregation characteristic value, it is determined that the second aggregation characteristic value of the blood sample with the first aggregation characteristic value should be in which theoretical range (i.e. determining the second judgment threshold range according to the first aggregation characteristic value). When the second aggregation characteristic value of the blood sample to be tested exceeds the theoretical range, it indicates that there is a sample abnormality in the blood sample to be tested which leads to an abnormal blood sedimentation detection result.

[0258] In some embodiments, please continue to refer to Figure 26 The second aggregation characteristic value can be selected from one of the following parameters: the light intensity minimum value L1 of the erythrocyte aggregation curve C in the time period between the measurement start time point T1 and the measurement end time point T2; the difference D = L2 - L1 between the light intensity L1 at the measurement start time point T1 and the light intensity L2 at the measurement end time point T2; and the time point T3 corresponding to 1 / 2 of the light intensity L2 at the measurement end time point T2.

[0259] Preferably, the second aggregation characteristic value can be the time point T3 corresponding to 1 / 2 of the transmitted light intensity L2 at the measurement end time point T2 (L3 = L2 / 2).

[0260] For example, the theoretical range (i.e., the second judgment threshold range) of the obtained second aggregation characteristic value can be determined according to the erythrocyte sedimentation rate detection result or the corrected erythrocyte sedimentation rate detection result or the AUC (i.e., the first aggregation characteristic value) of the red blood cell aggregation curve of the to-be-tested blood sample, and then the theoretical range can be used as the judgment basis of the second aggregation characteristic value to determine whether the to-be-tested blood sample has sample abnormalities that cause abnormal erythrocyte sedimentation rate detection results. For example, if the obtained second aggregation characteristic value exceeds the theoretical range, it indicates that there is data abnormality in the red blood cell aggregation process of the to-be-tested blood sample, and then it can be determined that the to-be-tested blood sample has sample abnormalities that cause abnormal erythrocyte sedimentation rate detection results. If the obtained second aggregation characteristic value does not exceed the theoretical range, it indicates that the to-be-tested blood sample does not have sample abnormalities that cause abnormal erythrocyte sedimentation rate detection results.

[0261] In some preferred embodiments, whether the to-be-tested blood sample has sample abnormalities that cause abnormal erythrocyte sedimentation rate detection results can be determined according to the disaggregation optical data in the red blood cell disaggregation process and the aggregation optical data in the red blood cell aggregation process of the to-be-tested blood sample. That is, the data processing module 30 can also be configured to determine whether the to-be-tested blood sample has sample abnormalities that cause abnormal erythrocyte sedimentation rate detection results according to the disaggregation optical data and the aggregation optical data.

[0262] As some implementations, the data processing apparatus 640 determining whether the first erythrocyte sedimentation rate is credible according to the disaggregation optical data and / or the aggregation optical data can include that the data processing apparatus 640

[0263] obtaining a first aggregation characteristic value and a second aggregation characteristic value different from each other according to the aggregation optical data;

[0264] obtaining a disaggregation characteristic value according to the disaggregation optical data;

[0265] determining a first judgment threshold range and a second judgment threshold range according to the first aggregation characteristic value;

[0266] when the disaggregation characteristic value exceeds the first judgment threshold range and the second aggregation characteristic value exceeds the second judgment threshold range, determining that the to-be-tested blood sample has sample abnormalities that cause abnormal erythrocyte sedimentation rate detection results, i.e., the first erythrocyte sedimentation rate is not credible.

[0267] Here, after the first aggregation characteristic value and the second aggregation characteristic value are acquired, it is determined in which theoretical range the disaggregation characteristic value of the blood sample with the first aggregation characteristic value should be (i.e., the first judgment threshold range is determined according to the first aggregation characteristic value), and it is determined in which theoretical range the second aggregation characteristic value of the blood sample with the first aggregation characteristic value should be (i.e., the second judgment threshold range is determined according to the first aggregation characteristic value). When the disaggregation characteristic value and the second aggregation characteristic value of the blood sample to be tested both exceed the corresponding theoretical range, it is indicated that there is a sample abnormality in the blood sample to be tested that causes the erythrocyte sedimentation rate detection result to be abnormal.

[0268] For example, the theoretical range of the acquired disaggregation characteristic value (i.e., the first judgment threshold range) and the theoretical range of the acquired second aggregation characteristic value (i.e., the second judgment threshold range) can be determined according to the erythrocyte sedimentation rate detection result or the corrected erythrocyte sedimentation rate detection result or the AUC of the erythrocyte aggregation curve (i.e., the first aggregation characteristic value) of the blood sample to be tested, and then whether there is a sample abnormality in the blood sample to be tested that causes the erythrocyte sedimentation rate detection result to be abnormal can be determined according to whether the disaggregation characteristic value and the second aggregation characteristic value both exceed the corresponding theoretical range. It can be seen that in this way, the determination of whether there is a sample abnormality in the blood sample to be tested that causes the erythrocyte sedimentation rate detection result to be abnormal can be more accurate, and the corresponding determination result is also more reliable.

[0269] As shown in Figure 28 The present application also provides another erythrocyte sedimentation rate measurement method 700, which comprises:

[0270] S710, collecting a blood sample to be tested of a subject;

[0271] S720, acquiring a first erythrocyte sedimentation rate of the blood sample to be tested based on an erythrocyte aggregation method;

[0272] S730, determining whether the first erythrocyte sedimentation rate is reliable;

[0273] S740, when it is determined that the first erythrocyte sedimentation rate is reliable, outputting the first erythrocyte sedimentation rate; and

[0274] S750, when it is determined that the first erythrocyte sedimentation rate is not reliable, automatically rechecking the blood sample of the subject by means of an erythrocyte sedimentation rate detection device based on the Westergren method to acquire and output a second erythrocyte sedimentation rate of the subject.

[0275] In some embodiments, in S710, a portion of the blood sample under test is drawn from the test tube containing the blood sample under test of the subject, and at least part of the blood sample in the portion of the blood sample under test is transported to the first detection pipeline. In step S720, the at least part of the blood sample is made to flow back and forth in the first detection pipeline to perform disaggregation treatment on red blood cells in the at least part of the blood sample, and the disaggregation treatment is stopped so that the red blood cells of the at least part of the blood sample in the first detection pipeline are aggregated in order to obtain disaggregation optical data of the at least part of the blood sample in the red blood cell disaggregation process and / or aggregation optical data of the at least part of the blood sample in the red blood cell aggregation process by optical measurement. And in step S730, it is determined according to the disaggregation optical data and / or the aggregation optical data whether the first erythrocyte sedimentation rate of the subject to be obtained according to the aggregation optical data is reliable.

[0276] In some embodiments, automatically rechecking the blood sample of the subject by the Westergren method-based blood sedimentation detection device to obtain and output a second erythrocyte sedimentation rate of the subject can include: performing a mixing operation on the remaining blood sample in the test tube, obtaining the sinking degree of red blood cells in the remaining blood sample in the test tube within a predetermined time period after the mixing operation, and calculating and outputting the second erythrocyte sedimentation rate based on the sinking degree.

[0277] In other embodiments, automatically rechecking the blood sample of the subject by the Westergren method-based blood sedimentation detection device to obtain and output a second erythrocyte sedimentation rate of the subject can include:

[0278] Collecting another portion of the blood sample of the subject and loading the other portion of the blood sample into a second detection pipeline;

[0279] Performing a mixing operation on the other portion of the blood sample in the second detection pipeline; and

[0280] Obtaining the sinking degree of red blood cells in the mixed blood sample in the second detection pipeline within a predetermined time period after the mixing operation, and calculating and outputting the second erythrocyte sedimentation rate based on the sinking degree.

[0281] In some embodiments, determining whether the first erythrocyte sedimentation rate is reliable according to the disaggregation optical data and / or the aggregation optical data can include:

[0282] Obtaining a first aggregation feature value according to the aggregation optical data;

[0283] obtaining a disaggregation characteristic value from the disaggregation optical data and / or obtaining a second aggregation characteristic value different from the first aggregation characteristic value from the aggregation optical data;

[0284] determining a first decision threshold range and / or a second decision threshold range from the first aggregation characteristic value;

[0285] judging the first erythrocyte sedimentation rate as being not reliable when the disaggregation characteristic value exceeds the first decision threshold range and / or the second aggregation characteristic value exceeds the second decision threshold range.

[0286] Preferably, judging whether the first erythrocyte sedimentation rate is reliable or not from the disaggregation optical data and / or the aggregation optical data can comprise:

[0287] obtaining a first aggregation characteristic value and a second aggregation characteristic value different from each other from the aggregation optical data;

[0288] obtaining a disaggregation characteristic value from the disaggregation optical data;

[0289] determining a first decision threshold range and a second decision threshold range from the first aggregation characteristic value;

[0290] judging the first erythrocyte sedimentation rate as being not reliable when the disaggregation characteristic value exceeds the first decision threshold range and the second aggregation characteristic value exceeds the second decision threshold range.

[0291] The blood sedimentation measurement method 700 provided by the present application can be applied to the sample analysis system 600 provided by the present application in particular. Therefore, the above-mentioned embodiments and advantages of the sample analysis system 600 provided by the present application are applicable to the blood sedimentation measurement method 700 provided by the present application in a corresponding manner, which will not be described here again.

[0292] The features or combinations thereof mentioned in the description, drawings and claims, as long as they are meaningful and do not contradict each other within the scope of the present application, can be used or used alone. The advantages and features described for the sample analysis system and the sample analysis system provided by the present application are applicable to the blood sedimentation measurement method in a corresponding manner, and vice versa.

[0293] The above is only the preferred embodiment of the present application, and does not limit the patent scope of the present application. Any equivalent transformation made by using the content of the present application specification and drawings, or direct / indirect application in other related technical fields within the inventive concept of the present application is included in the patent protection scope of the present application.

Claims

1. A method for measuring erythrocyte sedimentation rate (ESR), comprising: A portion of the blood sample to be tested is drawn from a test tube containing a mixed blood sample to be tested, and at least a portion of the blood sample to be tested is transported to a first detection line and the flow of the at least a portion of the blood sample is stopped in the first detection line. Illuminate the at least part of the blood sample that has stopped flowing in the first detection tube with light, and obtain information on the transmitted light that passes through the at least part of the blood sample or information on the scattered light that is scattered by the at least part of the blood sample. The red blood cell aggregation parameters of the blood sample to be tested are obtained based on the information of transmitted light or scattered light. These red blood cell aggregation parameters characterize the degree of red blood cell aggregation of at least a portion of the blood sample after it stops flowing in the first detection tube. Starting from a predetermined time after the mixing operation, the blood sample to be tested in the test tube is left to stand for a predetermined period of time to obtain the erythrocyte sedimentation parameter of the blood sample to be tested. The erythrocyte sedimentation parameter characterizes the degree to which the erythrocytes in the blood sample to be tested in the test tube settle in the test tube during the predetermined period of time, wherein the predetermined period of time is no more than 20 minutes. as well as The erythrocyte sedimentation rate of the blood sample to be tested is calculated based on the erythrocyte aggregation parameters and the erythrocyte sedimentation parameters.

2. The erythrocyte sedimentation rate (ESR) measurement method according to claim 1, characterized in that, The erythrocyte sedimentation parameters include one of the following parameters: A parameter characterizing the change in transmittance or absorbance of the plasma layer or erythrocyte layer of the blood sample to be tested in the test tube during the predetermined time period; or A parameter characterizing the height variation of the plasma layer or red blood cell layer of the blood sample to be tested in the test tube during the predetermined time period.

3. The erythrocyte sedimentation rate (ESR) measurement method according to claim 2, characterized in that, The blood sample to be tested in the test tube is left to stand for a predetermined period of time after the mixing operation to obtain the erythrocyte sedimentation parameters of the blood sample, including: Obtain the first transmittance or first absorbance of the plasma layer or red blood cell layer of the blood sample to be tested in the test tube at the predetermined time; and The second transmittance or second absorbance of the plasma layer or erythrocyte layer of the blood sample to be tested in the test tube is obtained after the predetermined time period from the predetermined time. The erythrocyte sedimentation parameter is calculated based on the difference between the second transmittance or second absorbance and the first transmittance or first absorbance.

4. The erythrocyte sedimentation rate (ESR) measurement method according to claim 2, characterized in that, The blood sample to be tested in the test tube is left to stand for a predetermined period of time after the mixing operation to obtain the erythrocyte sedimentation parameters of the blood sample, including: At the predetermined time, the plasma layer or red blood cell layer of the blood sample to be tested in the test tube is measured at a first height in the test tube; and The second height of the plasma layer or erythrocyte layer of the blood sample to be tested in the test tube is obtained after the predetermined time period from the predetermined time; wherein the erythrocyte sedimentation parameter is calculated based on the difference between the second height and the first height.

5. The erythrocyte sedimentation rate (ESR) measurement method according to claim 4, characterized in that, The blood sample to be tested in the test tube is allowed to stand for a predetermined period of time after the mixing operation to obtain the erythrocyte sedimentation parameters of the blood sample, further including: Obtain the third height of the blood sample to be tested in the test tube at the predetermined time; and The fourth height of the blood sample to be tested in the test tube is obtained after the predetermined time period from the predetermined time. The erythrocyte sedimentation rate parameter is calculated based on the difference between the ratio of the first height to the third height and the ratio of the second height to the fourth height.

6. The erythrocyte sedimentation rate (ESR) measurement method according to claim 2, characterized in that, The parameters characterizing the height changes of the plasma layer or red blood cell layer in the test tube of the blood sample to be tested during the predetermined time period are acquired using an infrared scanning device or an optical image sensor.

7. The erythrocyte sedimentation rate (ESR) measurement method according to any one of claims 1 to 6, characterized in that, The predetermined time is selected as any time within 30 seconds after the mixing operation is completed.

8. The erythrocyte sedimentation rate (ESR) measurement method according to claim 7, characterized in that, The predetermined time is selected as any time within 15 seconds after the mixing operation is completed.

9. The erythrocyte sedimentation rate (ESR) measurement method according to claim 8, characterized in that, The predetermined time is selected as any time within 10 seconds after the mixing operation is completed.

10. The erythrocyte sedimentation rate (ESR) measurement method according to any one of claims 1 to 6, characterized in that, The predetermined time is selected as the time after the portion of the blood sample to be tested is drawn.

11. The erythrocyte sedimentation rate (ESR) measurement method according to claim 10, characterized in that, The predetermined time is selected as any time within 15 seconds after the portion of the blood sample to be tested is drawn.

12. The erythrocyte sedimentation rate (ESR) measurement method according to claim 11, characterized in that, The predetermined time is selected as any time within 10 seconds after the portion of the blood sample to be tested is drawn.

13. The erythrocyte sedimentation rate (ESR) measurement method according to claim 12, characterized in that, The predetermined time is selected as any time within 5 seconds after the portion of the blood sample to be tested is drawn.

14. The erythrocyte sedimentation rate (ESR) measurement method according to any one of claims 1 to 6, characterized in that, The predetermined time period shall not exceed 15 minutes.

15. The erythrocyte sedimentation rate (ESR) measurement method according to claim 14, characterized in that, The predetermined time period shall not exceed 10 minutes.

16. The erythrocyte sedimentation rate (ESR) measurement method according to any one of claims 1 to 6, characterized in that, The erythrocyte sedimentation rate of the blood sample to be tested is calculated based on the erythrocyte aggregation parameters and the erythrocyte sedimentation parameters, including: The erythrocyte aggregation parameter and the erythrocyte sedimentation parameter are input into the calculation model as input parameters, and the output of the calculation model is obtained as the erythrocyte sedimentation rate. The calculation model includes a nonlinear function or a neural network structure.

17. The method for measuring erythrocyte sedimentation rate according to any one of claims 1 to 6, characterized in that, The method further includes: Another portion of the blood sample to be tested is transported to an impedance detection device based on the Coulter method and / or an optical detection device based on flow cytometry, so that at least one red blood cell parameter of the blood sample to be tested can be measured by the impedance detection device and / or the optical detection device; and The erythrocyte sedimentation rate of the blood sample to be tested is corrected using at least one of the erythrocyte parameters.

18. The erythrocyte sedimentation rate (ESR) measurement method according to any one of claims 1 to 6, characterized in that, The method further includes: transporting another portion of the blood sample to be tested to an impedance detection device based on the Coulter method and / or an optical detection device based on flow cytometry, so that at least one red blood cell parameter of the blood sample to be tested can be measured by the impedance detection device and / or the optical detection device; and Calculating the erythrocyte sedimentation rate of the blood sample to be tested based on the erythrocyte aggregation parameter and the erythrocyte sedimentation parameter includes: inputting the erythrocyte aggregation parameter, the erythrocyte sedimentation parameter and the at least one erythrocyte parameter as input parameters into a calculation model, and obtaining the output of the calculation model as the erythrocyte sedimentation rate, wherein the calculation model includes a nonlinear function or a neural network structure.

19. A method for measuring erythrocyte sedimentation rate (ESR), comprising: A portion of the blood sample to be tested is drawn from a test tube containing the blood sample to be tested, and at least a portion of the blood sample to be tested is transported to a first detection line and the flow of the at least a portion of the blood sample in the first detection line is stopped. Illuminate the at least portion of the blood sample that has stopped flowing in the first detection tube with light to obtain information about the transmitted light passing through the at least portion of the blood sample or information about the scattered light scattered by the at least portion of the blood sample. The red blood cell aggregation parameters of the blood sample to be tested are obtained based on the information of transmitted light or scattered light. These red blood cell aggregation parameters characterize the degree of red blood cell aggregation of at least a portion of the blood sample after it stops flowing in the first detection tube. After aspirating a portion of the blood sample to be tested, the remaining blood sample in the test tube is mixed thoroughly. Starting from a predetermined time after the mixing operation, the remaining blood sample to be tested in the test tube is allowed to stand for a predetermined period of time to obtain the erythrocyte sedimentation parameter of the blood sample to be tested. The erythrocyte sedimentation parameter characterizes the degree to which the erythrocytes in the remaining blood sample to be tested settle in the test tube within the predetermined period of time, wherein the predetermined period of time is no more than 20 minutes. as well as The erythrocyte sedimentation rate of the blood sample to be tested is calculated based on the erythrocyte aggregation parameters and the erythrocyte sedimentation parameters.

20. The erythrocyte sedimentation rate (ESR) measurement method according to claim 19, characterized in that, The erythrocyte sedimentation parameters include one of the following parameters: A parameter characterizing the change in transmittance or absorbance of the plasma layer or erythrocyte layer of the remaining blood sample to be tested within the predetermined time period; or A parameter characterizing the height variation of the plasma layer or red blood cell layer of the remaining blood sample to be tested in the test tube during the predetermined time period.

21. The erythrocyte sedimentation rate (ESR) measurement method according to claim 20, characterized in that, The remaining blood sample in the test tube is allowed to stand for a predetermined period of time, starting from a predetermined time after the mixing operation, to obtain the erythrocyte sedimentation parameters of the blood sample, including: Acquire the first transmittance or first absorbance of the plasma layer or red blood cell layer of the remaining blood sample to be tested at the predetermined time; and The second transmittance or second absorbance of the plasma layer or erythrocyte layer of the remaining blood sample to be tested after the predetermined time period from the predetermined time is obtained; wherein the erythrocyte sedimentation parameter is calculated based on the difference between the second transmittance or second absorbance and the first transmittance or first absorbance.

22. The erythrocyte sedimentation rate (ESR) measurement method according to claim 20, characterized in that, The remaining blood sample in the test tube is allowed to stand for a predetermined period of time, starting from a predetermined time after the mixing operation, to obtain the erythrocyte sedimentation parameters of the blood sample, including: Obtain the first height of the plasma layer or red blood cell layer of the remaining blood sample to be tested in the test tube at the predetermined time; and The second height of the plasma layer or erythrocyte layer of the remaining blood sample to be tested in the test tube is obtained after the predetermined time period from the predetermined time; wherein the erythrocyte sedimentation parameter is calculated based on the difference between the second height and the first height.

23. The erythrocyte sedimentation rate (ESR) measurement method according to any one of claims 19 to 22, characterized in that, The predetermined time is selected as any time within 30 seconds after the mixing operation is completed.

24. The erythrocyte sedimentation rate (ESR) measurement method according to claim 23, characterized in that, The predetermined time is selected as any time within 15 seconds after the mixing operation is completed.

25. The erythrocyte sedimentation rate (ESR) measurement method according to claim 24, characterized in that, The predetermined time is selected as any time within 10 seconds after the mixing operation is completed.

26. The erythrocyte sedimentation rate (ESR) measurement method according to any one of claims 19 to 22, characterized in that, The predetermined time period shall not exceed 15 minutes.

27. The erythrocyte sedimentation rate (ESR) measurement method according to claim 26, characterized in that, The predetermined time period shall not exceed 10 minutes.

28. The method for measuring erythrocyte sedimentation rate according to any one of claims 19 to 22, characterized in that, The method further includes: Another portion of the blood sample to be tested is transported to an impedance detection device based on the Coulter method and / or an optical detection device based on flow cytometry, so that at least one red blood cell parameter of the blood sample to be tested can be measured by the impedance detection device and / or the optical detection device; and The erythrocyte sedimentation rate of the blood sample to be tested is corrected using at least one of the erythrocyte parameters.

29. The erythrocyte sedimentation rate (ESR) measurement method according to any one of claims 19 to 22, characterized in that, The method further includes: transporting another portion of the blood sample to be tested to an impedance detection device based on the Coulter method and / or an optical detection device based on flow cytometry, so that at least one red blood cell parameter of the blood sample to be tested can be measured by the impedance detection device and / or the optical detection device; and Calculating the erythrocyte sedimentation rate of the blood sample to be tested based on the erythrocyte aggregation parameter and the erythrocyte sedimentation parameter includes: inputting the erythrocyte aggregation parameter, the erythrocyte sedimentation parameter and the at least one erythrocyte parameter as input parameters into a calculation model, and obtaining the output of the calculation model as the erythrocyte sedimentation rate, wherein the calculation model includes a nonlinear function or a neural network structure.

30. A sample analyzer, comprising: A mixing device is provided for mixing blood samples to be tested in test tubes. A first erythrocyte sedimentation rate (ESR) detection device includes a sampling dispensing component, a first detection tube, and an ESR optical detection component. The sampling dispensing component is configured to draw a portion of the blood sample to be tested from the test tube after the mixing operation, transport at least a portion of the blood sample to be tested to the first detection tube, and stop the flow of the at least a portion of the blood sample in the first detection tube. The ESR optical detection component is configured to irradiate the at least a portion of the blood sample that has stopped flowing in the first detection tube with light, and acquire information on the transmitted light transmitted through the at least a portion of the blood sample or information on the scattered light scattered by the at least a portion of the blood sample, so as to acquire the erythrocyte aggregation parameter of the blood sample to be tested based on the acquired transmitted light information or scattered light information. The erythrocyte aggregation parameter characterizes the degree of erythrocyte aggregation after the at least a portion of the blood sample stops flowing in the first detection tube. The second erythrocyte sedimentation rate (ESR) detection device is configured to acquire the erythrocyte sedimentation parameters of the blood sample to be tested. The erythrocyte sedimentation parameters characterize the degree to which the erythrocytes in the blood sample to be tested in the test tube settle in the test tube within a predetermined time period starting from a predetermined time after the mixing operation. The blood sample to be tested in the test tube is in a static state during the predetermined time period, and the predetermined time period is no more than 20 minutes. as well as A data processing device is configured to calculate the erythrocyte sedimentation rate of the blood sample to be tested based on the erythrocyte aggregation parameters and the erythrocyte sedimentation parameters.

31. The sample analyzer according to claim 30, characterized in that, The second erythrocyte sedimentation rate (ESR) detection device is configured to detect changes in the transmittance or absorbance of the plasma layer or erythrocyte layer of the blood sample to be tested in the test tube within the predetermined time period, wherein the erythrocyte sedimentation parameters include parameters characterizing the changes in transmittance or absorbance; or The second erythrocyte sedimentation rate (ESR) detection device is configured to detect the height change of the plasma layer or erythrocyte layer of the blood sample to be tested in the test tube within the predetermined time period, and the erythrocyte sedimentation parameters include parameters characterizing the height change.

32. The sample analyzer according to claim 31, characterized in that, The second erythrocyte sedimentation rate (ESR) detection device is further configured as follows: Obtain the first transmittance or first absorbance of the plasma layer or red blood cell layer of the blood sample to be tested in the test tube at the predetermined time; and The second transmittance or second absorbance of the plasma layer or erythrocyte layer of the blood sample to be tested in the test tube is obtained after the predetermined time period from the predetermined time. The erythrocyte sedimentation parameter is calculated based on the difference between the second transmittance or second absorbance and the first transmittance or first absorbance.

33. The sample analyzer according to claim 31, characterized in that, The second erythrocyte sedimentation rate (ESR) detection device is further configured as follows: At the predetermined time, the plasma layer or red blood cell layer of the blood sample to be tested in the test tube is measured at a first height in the test tube; and The second height of the plasma layer or erythrocyte layer of the blood sample to be tested in the test tube is obtained after the predetermined time period from the predetermined time; wherein the erythrocyte sedimentation parameter is calculated based on the difference between the second height and the first height.

34. The sample analyzer according to any one of claims 30 to 33, characterized in that, The second erythrocyte sedimentation rate (ESR) detection device includes at least one optical sensor.

35. The sample analyzer according to any one of claims 30 to 33, characterized in that, The predetermined time is selected as any time within 30 seconds after the mixing device finishes its mixing operation.

36. The sample analyzer according to claim 35, characterized in that, The predetermined time is selected as any time within 15 seconds after the mixing device finishes its mixing operation.

37. The sample analyzer according to claim 36, characterized in that, The predetermined time is selected as any time within 10 seconds after the mixing device finishes its mixing operation.

38. The sample analyzer according to any one of claims 30 to 33, characterized in that, The predetermined time is selected as the time after the sampling and dispensing component has absorbed a portion of the blood sample to be tested.

39. The sample analyzer according to claim 38, characterized in that, The predetermined time is selected as any time within 20 seconds after the sampling and dispensing component draws a portion of the blood sample to be tested.

40. The sample analyzer according to claim 39, characterized in that, The predetermined time is selected as any time within 10 seconds after the sampling and dispensing component draws a portion of the blood sample to be tested.

41. The sample analyzer according to claim 40, characterized in that, The predetermined time is selected as any time within 5 seconds after the sampling and dispensing component absorbs a portion of the blood sample to be tested.

42. The sample analyzer according to any one of claims 30 to 33, characterized in that, The predetermined time period shall not exceed 15 minutes.

43. The sample analyzer according to claim 42, characterized in that, The predetermined time period shall not exceed 10 minutes.

44. The sample analyzer according to any one of claims 30 to 33, characterized in that, The data processing device is further configured to input the erythrocyte aggregation parameters and the erythrocyte sedimentation parameters as input parameters into a calculation model, and obtain the output of the calculation model as the erythrocyte sedimentation rate, wherein the calculation model includes a nonlinear function or a neural network structure.

45. The sample analyzer according to any one of claims 30 to 33, characterized in that, The sample analyzer also includes an impedance detection device based on the Coulter method and / or an optical detection device based on flow cytometry. The sampling and dispensing component is further configured to transport another portion of the blood sample to the impedance detection device and / or the optical detection device, so that at least one red blood cell parameter of the blood sample to be tested can be measured by the impedance detection device and / or the optical detection device; and The data processing device is further configured to correct the erythrocyte sedimentation rate of the blood sample to be tested using the at least one red blood cell parameter.

46. ​​The sample analyzer according to any one of claims 30 to 33, characterized in that, The sample analyzer also includes an impedance detection device based on the Coulter method and / or an optical detection device based on flow cytometry. The sampling and dispensing component is further configured to transport another portion of the blood sample to the impedance detection device and / or the optical detection device, so that at least one red blood cell parameter of the blood sample to be tested can be measured by the impedance detection device and / or the optical detection device; and The data processing device is further configured to: The erythrocyte aggregation parameter, the erythrocyte sedimentation parameter, and at least one erythrocyte parameter are input into the calculation model as input parameters, and the output of the calculation model is obtained as the erythrocyte sedimentation rate. The calculation model includes a nonlinear function or a neural network structure.

47. The sample analyzer according to claim 34, characterized in that, The optical sensor is an optical image sensor.

48. A sample analyzer, comprising: A first erythrocyte sedimentation rate (ESR) detection device includes a sampling dispensing component, a first detection tube, and an ESR optical detection component. The sampling dispensing component is configured to draw a portion of the blood sample to be tested from a test tube containing the blood sample to be tested, transport at least a portion of the blood sample to be tested to the first detection tube, and stop the flow of the at least a portion of the blood sample in the first detection tube. The ESR optical detection component is configured to irradiate the at least a portion of the blood sample that has stopped flowing in the first detection tube with light, and acquire information on the transmitted light transmitted through the at least a portion of the blood sample or information on the scattered light scattered by the at least a portion of the blood sample, so as to acquire the erythrocyte aggregation parameter of the blood sample to be tested based on the acquired transmitted light information or scattered light information. The erythrocyte aggregation parameter characterizes the degree of erythrocyte aggregation after the at least a portion of the blood sample stops flowing in the first detection tube. A mixing device is configured to mix the remaining blood sample in the test tube after the sampling and dispensing component has absorbed a portion of the blood sample to be tested. The second erythrocyte sedimentation rate (ESR) detection device is configured to acquire the erythrocyte sedimentation parameters of the blood sample to be tested. The erythrocyte sedimentation parameters characterize the degree to which the erythrocytes in the remaining blood sample to be tested in the test tube settle in the test tube within a predetermined time period starting from a predetermined time after the mixing operation. The remaining blood sample to be tested in the test tube is in a static state during the predetermined time period, and the predetermined time period is no more than 20 minutes. as well as A data processing device is configured to calculate the erythrocyte sedimentation rate of the blood sample to be tested based on the erythrocyte aggregation parameters and the erythrocyte sedimentation parameters.

49. A sample analysis system, comprising: A mixing device is provided for mixing blood samples to be tested in test tubes. The first and second sample analyzers are independent of each other, wherein the first sample analyzer and / or the second sample analyzer includes a first erythrocyte sedimentation rate (ESR) detection device. The first ESR detection device includes a sampling dispensing component, a first detection tube, and an ESR optical detection component. The sampling dispensing component is configured to draw a portion of the blood sample to be tested from the test tube after the mixing operation, transport at least a portion of the blood sample to be tested to the first detection tube, and stop the flow of the at least a portion of the blood sample in the first detection tube. The ESR optical detection component is configured to irradiate the at least a portion of the blood sample that has stopped flowing in the first detection tube with light, and acquire information on the transmitted light transmitted through the at least a portion of the blood sample or information on the scattered light scattered by the at least a portion of the blood sample, so as to acquire the erythrocyte aggregation parameter of the blood sample to be tested based on the acquired transmitted light information or scattered light information. The erythrocyte aggregation parameter characterizes the degree of erythrocyte aggregation after the at least a portion of the blood sample stops flowing in the first detection tube. The second erythrocyte sedimentation rate (ESR) detection device is configured to acquire the erythrocyte sedimentation parameters of the blood sample to be tested. The erythrocyte sedimentation parameters characterize the degree to which the erythrocytes in the blood sample to be tested in the test tube settle in the test tube within a predetermined time period starting from a predetermined time after the mixing operation. The blood sample to be tested in the test tube is in a static state during the predetermined time period, and the predetermined time period is no more than 20 minutes. A sample transport track, configured to transport test tubes containing blood samples to be tested to a first sample analyzer and / or a second sample analyzer; and A data processing device is configured to calculate the erythrocyte sedimentation rate of the blood sample to be tested based on the erythrocyte aggregation parameters and the erythrocyte sedimentation parameters.

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