Erythrocyte sedimentation measuring method, sample analyzer and sample analysis system

Abstract

The invention relates to an erythrocyte sedimentation measuring method, a sample analyzer and a sample analysis system. Sucking the to-be-detected blood sample from the test tube filled with the to-be-detected blood sample subjected to the uniform mixing operation, conveying at least one part of the to-be-detected blood sample to the detection pipeline, and enabling the part of the to-be-detected blood sample to stop flowing in the detection pipeline; irradiating the to-be-detected blood sample which stops flowing in the detection pipeline with light, and acquiring information of transmitted light penetrating through the to-be-detected blood sample or information of scattered light scattered by the to-be-detected blood sample; acquiring erythrocyte aggregation parameters of the to-be-detected blood sample based on the information of the transmitted light or the information of the scattered light; allowing the to-be-detected blood sample in the test tube to stand for a predetermined time period from a predetermined moment after the uniform mixing operation so as to obtain erythrocyte sedimentation parameters of the to-be-detected blood sample, the predetermined time period being not more than 20 minutes; and calculating the erythrocyte sedimentation rate of the to-be-detected blood sample based on the erythrocyte aggregation parameter and the erythrocyte sedimentation parameter. Therefore, the accurate erythrocyte sedimentation rate can be quickly obtained.

Description

[0001] This application is a divisional application of Chinese invention patent application number "202310777059.0". The original application was filed on June 27, 2023, and the invention was entitled "Erythrocyte sedimentation rate measurement method, sample analyzer and sample analysis system". Technical Field

[0002] This invention relates to the field of in vitro diagnostics, and in particular to erythrocyte sedimentation rate (ESR) measurement methods, sample analyzers, and sample analysis systems. Background Technology

[0003] Erythrocyte sedimentation rate (ESR) is the rate at which red blood cells naturally settle in isolated anticoagulated whole blood under specified conditions. Although ESR's specificity and sensitivity for diagnosis are not ideal, it is still considered a reliable indicator of the acute phase of inflammation and has significant reference value for the diagnosis and monitoring of certain diseases. It is widely used clinically to monitor infections, inflammatory diseases, and certain neoplastic diseases.

[0004] The traditional Widmanstätten method for measuring ESR is known and is an international reference method. However, the traditional Widmanstätten method requires manual operation, is prone to technical errors, has poor clinical reproducibility, is susceptible to interference from anemic samples, and poses biosafety risks during the procedure.

[0005] Therefore, automated ESR measurement methods are increasingly being used. Currently, three types of automated ESR measurement methods are known. The first method is the instrument substitution method, which uses instruments to completely simulate the traditional Widmanstätten method's manual operation, with the detection method and principle being the same as the traditional Widmanstätten method. The second method is a modified Widmanstätten method based on the principle of erythrocyte sedimentation, which accelerates erythrocyte sedimentation through methods such as heating, centrifugation, and tilting, and estimates the ESR result of the traditional Widmanstätten method after one hour based on the erythrocyte sedimentation rate over half an hour. The third method is based on erythrocyte aggregation, which calculates the ESR result in an extremely short time, within seconds, based on the aggregation properties between erythrocytes.

[0006] However, all three methods have certain drawbacks. While the first method avoids manual operation, the detection principle is the same as the traditional Westergren method, resulting in a detection time of one hour and low efficiency. The second method, the modified Westergren method, reduces ESR measurement time from 60 minutes to 30 minutes, but still suffers from inconvenience and poor consistency between the instrument results and the Westergren method. The third method, the erythrocyte aggregation method, significantly shortens ESR measurement time, but the ESR results obtained using this method are inconsistent with the Westergren method, leading to low clinical acceptance. Summary of the Invention

[0007] Against this background, the objective of this invention is to provide a technical solution for correcting erythrocyte sedimentation rate (ESR) measurement results obtained using the erythrocyte aggregation method. This technical solution enables the rapid acquisition of ESR measurement results that are in good agreement with the traditional Widmanstätten method.

[0008] To achieve the above-mentioned objectives, a first aspect of the present invention provides a method for measuring erythrocyte sedimentation rate (ESR), comprising:

[0009] 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.

[0010] 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.

[0011] 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.

[0012] 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 parameter of the blood sample. The erythrocyte sedimentation parameter characterizes the degree to which the red blood cells in the blood sample settle in the test tube during the predetermined period of time, wherein the predetermined period of time is no more than 20 minutes; and

[0013] The erythrocyte sedimentation rate of the blood sample to be tested is calculated based on the erythrocyte aggregation parameters and the erythrocyte sedimentation parameters.

[0014] To achieve the above-mentioned task, a second aspect of the present invention provides a method for measuring erythrocyte sedimentation rate (ESR), comprising:

[0015] 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.

[0016] 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.

[0017] 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.

[0018] After aspirating a portion of the blood sample to be tested, the remaining blood sample in the test tube is mixed thoroughly.

[0019] The remaining blood sample in the test tube is allowed to stand for a predetermined period of time after the mixing operation to obtain the erythrocyte sedimentation parameter of the blood sample. The erythrocyte sedimentation parameter characterizes the degree to which the erythrocytes in the remaining blood sample settle in the test tube within the predetermined period of time, wherein the predetermined period of time is no more than 20 minutes; and

[0020] The erythrocyte sedimentation rate of the blood sample to be tested is determined based on the erythrocyte aggregation parameters and the erythrocyte sedimentation rate.

[0021] To achieve the above-mentioned tasks, a third aspect of the present invention provides a sample analyzer, comprising:

[0022] A mixing device is provided for mixing blood samples to be tested in test tubes.

[0023] 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.

[0024] The second erythrocyte sedimentation rate (ESR) detection device is configured to acquire the erythrocyte sedimentation parameter of the blood sample to be tested. The erythrocyte sedimentation parameter characterizes the degree to which red blood cells in the blood sample to be tested 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 greater than 20 minutes.

[0025] 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.

[0026] To achieve the above-mentioned tasks, a fourth aspect of the present invention provides a sample analyzer, comprising:

[0027] 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.

[0028] 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.

[0029] The second erythrocyte sedimentation rate (ESR) detection device is configured to acquire the erythrocyte sedimentation parameter of the blood sample to be tested. The erythrocyte sedimentation parameter characterizes the degree to which the remaining erythrocytes in the test tube settle within a predetermined time period from a predetermined time after the mixing operation. The remaining blood sample in the test tube is in a static state during the predetermined time period, and the predetermined time period is no greater than 20 minutes.

[0030] 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.

[0031] To achieve the above-mentioned tasks, a fifth aspect of the present invention provides a sample analysis system, comprising:

[0032] A mixing device is provided for mixing blood samples to be tested in test tubes.

[0033] The first sample analyzer and the second sample analyzer are independent of each other. At least the first sample analyzer includes a first erythrocyte sedimentation rate (ESR) detection device, which 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.

[0034] 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.

[0035] 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

[0036] 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.

[0037] In the technical solutions provided in the first to fifth aspects of the present invention, when calculating the erythrocyte sedimentation rate of the blood sample to be tested, the degree of erythrocyte aggregation and the degree of erythrocyte sedimentation of the blood sample to be tested are considered simultaneously. That is, the erythrocyte aggregation parameters obtained from the erythrocyte aggregation method of the blood sample to be tested and the degree of erythrocyte sedimentation in the blood sample to be tested over a certain period of time are combined to calculate the erythrocyte sedimentation rate more quickly than the results of the traditional Widmanstätten method, thereby taking into account both the detection efficiency and detection accuracy of erythrocyte sedimentation rate.

[0038] Another objective of this application is to provide a sample analysis system and a corresponding erythrocyte sedimentation rate (ESR) detection method that can automatically perform retesting when aggregated ESR is unreliable, thereby reducing clinical risks.

[0039] To achieve this task, a sixth aspect of this application provides a sample analysis system, including a sample dispensing device, a first erythrocyte sedimentation rate (ESR) detection device, a second ESR detection device, and a data processing device, wherein...

[0040] The sampling and dispensing device is configured to draw a portion of the blood sample to be tested from a test tube containing the subject's blood sample to be tested, and to dispense at least a portion of the blood sample to be tested to the first erythrocyte sedimentation rate (ESR) detection device.

[0041] The first erythrocyte sedimentation rate (ESR) detection device includes a first detection tube, a power unit, and a first optical detection unit. The first detection tube is configured to receive at least a portion of the blood sample distributed by the sampling and dispensing device. The power unit is configured to deagglomerate the red blood cells in the at least a portion of the blood sample by causing the distributed blood sample to flow back and forth in the first detection tube, and to stop the deagglomeration process, thereby causing the red blood cells in the at least a portion of the blood sample in the first detection tube to aggregate. The first optical detection unit is configured to acquire deagglomeration optical data of the at least a portion of the blood sample during the red blood cell deagglomeration process and / or aggregation optical data during the red blood cell aggregation process.

[0042] The second erythrocyte sedimentation rate (ESR) detection device includes a second detection tube and a second optical detection component. The second detection tube is configured to receive a blood sample from the subject, and the second optical detection component is configured to obtain the erythrocyte sedimentation rate of the blood sample in the second detection tube based on the Widmanstätten method.

[0043] The data processing device is configured to determine whether the first erythrocyte sedimentation rate (ESR) obtained by the subject based on the depolymerization optical data and / or the aggregation optical data is reliable, output the first ESR when the first ESR is determined to be reliable, and control the second ESR detection device to re-examine the subject's blood sample based on the Widmanstätten method when the first ESR is determined to be unreliable, so as to obtain and output the subject's second ESR.

[0044] To achieve this task, the seventh aspect of this application provides a method for measuring erythrocyte sedimentation rate (ESR), comprising:

[0045] A portion of the blood sample to be tested is drawn from a test tube containing the subject's blood sample, and at least a portion of the blood sample is transported to a first detection tube.

[0046] 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;

[0047] 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;

[0048] When the first erythrocyte sedimentation rate is deemed reliable, the first erythrocyte sedimentation rate is output; and

[0049] 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.

[0050] 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

[0051] 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:

[0052] 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.

[0053] Figure 2 This is a schematic block diagram of a sample analyzer according to one embodiment of the present invention.

[0054] Figure 3 for Figure 2 A schematic diagram of the appearance of the sample analyzer 100.

[0055] Figure 4 This is a graph showing the relationship between settlement parameters and settlement time according to an embodiment of the present invention.

[0056] 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.

[0057] Figure 6 for Figure 2 A partial cross-sectional view of the sample analyzer.

[0058] Figure 7 This is a schematic diagram of a sample holder and test tubes according to an embodiment of the present invention.

[0059] Figure 8 and Figure 9 This is a schematic diagram of a mixing apparatus according to an embodiment of the present invention.

[0060] Figure 10 This is a schematic diagram of a mixing apparatus according to another embodiment of the present invention.

[0061] 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.

[0062] Figure 12 This is a red blood cell aggregation curve according to one embodiment of the present invention.

[0063] Figure 13 This is a calibration curve for calculating the erythrocyte aggregation method ESR according to one embodiment of the present invention.

[0064] 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.

[0065] Figure 15 This is a schematic block diagram of a sample analyzer according to another embodiment of the present invention.

[0066] Figure 16 for Figure 1 The diagram shows the workflow of the sample analyzer.

[0067] Figure 17 This is a schematic block diagram of another sample analyzer according to one embodiment of the present invention.

[0068] Figure 18 This is a schematic block diagram of a sample analysis system according to an embodiment of the present invention.

[0069] Figure 19 This is a schematic block diagram of a sample analysis system according to another embodiment of the present invention.

[0070] Figure 20 This is a schematic block diagram of a sample analysis system according to yet another embodiment of the present invention.

[0071] Figure 21This is a schematic block diagram of a sample analysis system according to another embodiment of the present invention.

[0072] Figure 22 This is a schematic flowchart of a method for measuring erythrocyte sedimentation rate according to an embodiment of the present invention.

[0073] Figure 23 This is a schematic flowchart of a method for measuring erythrocyte sedimentation rate according to another embodiment of the present invention.

[0074] Figure 24 This is a schematic block diagram of a sample analysis system according to another embodiment of the present invention.

[0075] Figure 25 This is a curve comparison diagram of one embodiment of the red blood cell depolymerization curves during the depolymerization process of abnormal samples with sample anomalies and normal samples without sample anomalies, according to the present invention.

[0076] Figure 26 The erythrocyte aggregation curve is obtained by the erythrocyte aggregation method of the erythrocyte sedimentation rate (ESR) detection module of the ESR detection device according to the present invention.

[0077] Figure 27 This is a curve comparison diagram of one embodiment of the red blood cell aggregation curves during the aggregation process of abnormal samples with sample abnormalities and normal samples without sample abnormalities, according to the present invention.

[0078] Figure 28 This is a schematic flowchart of a method for measuring erythrocyte sedimentation rate according to yet another embodiment of the present invention. Detailed Implementation

[0079] The embodiments of this application will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of this application, and not all of them. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0080] It should be noted that the terms "first, second, and third" used in the embodiments of this application are merely to distinguish similar objects and do not represent a specific order of objects. It can be understood that "first, second, and third" can be interchanged in a specific order or sequence where permitted.

[0081] It will be understood by those skilled in the art that, unless otherwise defined, all terms used herein (including technical and scientific terms) have the same meaning as commonly understood by one of ordinary skill in the art to which this application pertains.

[0082] As mentioned in the background section, the ESR results obtained based on the erythrocyte aggregation method do not show good agreement with the Widmanstätten method. Figure 1 As shown, the correlation is only 0.5516.

[0083] The applicant's research revealed that by combining quantitative indicators of erythrocyte aggregation and erythrocyte sedimentation rate (ESR) over a given time with those of the same blood sample, a formula can be used to calculate an ESR value that is more consistent with the traditional Widmanstätten method. The applicant argues that this is because ESR reflects both erythrocyte aggregation and sedimentation, while existing erythrocyte aggregation methods only consider aggregation and do not account for the effects of sedimentation forces and resistance during sedimentation. Therefore, ESR results cannot be obtained accurately based on erythrocyte aggregation methods.

[0084] Based on the applicant's above research, the embodiments of the present invention provide a technical solution for calculating the erythrocyte sedimentation rate based on the erythrocyte aggregation parameters obtained by the erythrocyte aggregation method and the degree of erythrocyte sedimentation over a certain period of time, so as to quickly obtain the erythrocyte sedimentation rate that is more consistent with the traditional Widmanstätten method.

[0085] Figure 2 A schematic block diagram of a sample analyzer 100 according to an embodiment of the present invention is shown. Figure 3 Show Figure 2 A schematic diagram of the appearance of the sample analyzer 100.

[0086] like Figure 2 As shown, the sample analyzer 100 includes a mixing device 110, a first erythrocyte sedimentation rate (ESR) detection device 120, a second ESR detection device 130, and a data processing device 140.

[0087] The mixing device 110 is configured to mix the blood sample to be tested, especially the whole blood sample to be tested, in the test tube 10.

[0088] A first erythrocyte sedimentation rate (ESR) detection device 120 is configured to perform ESR detection on a blood sample to be tested based on erythrocyte aggregation. The first ESR detection device 120 includes a sampling dispensing component 121, a first detection tube 122, and an ESR optical detection component 123. The sampling dispensing component 121 is configured to draw a portion of the blood sample to be tested from the test tube 10 after the mixing operation, transport at least a portion of the blood sample to the first detection tube 122, and stop the flow of the at least a portion of the blood sample in the first detection tube 122. The ESR optical detection component 123 is configured to illuminate the at least a portion of the blood sample that has stopped flowing in the first detection tube 122 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 obtain the erythrocyte aggregation parameters of the blood sample to be tested based on the acquired transmitted light information or scattered light information. In this document, the erythrocyte aggregation parameters characterize the degree of erythrocyte aggregation or erythrocyte aggregation characteristics of the at least a portion of the blood sample after it has stopped flowing in the first detection tube 122.

[0089] The second erythrocyte sedimentation rate (ESR) detection device 130 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 10 settle in the test tube 10 within a predetermined time period starting from a predetermined time after the mixing operation. The 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 no more than 20 minutes.

[0090] It should be noted that "the blood sample in test tube 10 is in a static state during the predetermined time period" means that no mixing operation, especially no contact operation, is performed on the blood sample in test tube 10 during the predetermined time period; that is, it remains stationary relative to test tube 10. It is understood that "the blood sample in test tube 10 is in a static state during the predetermined time period" does not mean that test tube 10 is static during the predetermined time period. Rather, test tube 10 can move or remain stationary, as long as the blood sample remains substantially stationary within test tube 10. For example, test tube 10 may be transported during the predetermined time period, but no contact operation is performed on the blood sample in test tube 10 during this transport, so that the blood sample remains substantially stationary relative to test tube 10.

[0091] The data processing device 140 is used to process and calculate the data to obtain the required result. 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 parameters obtained by the first erythrocyte sedimentation rate detection device 120 and the erythrocyte sedimentation parameters obtained by the second erythrocyte sedimentation rate detection device 130.

[0092] In some alternative embodiments, the data processing device 140 may also be configured to:

[0093] To determine whether the first erythrocyte sedimentation rate calculated solely based on erythrocyte aggregation parameters is reliable;

[0094] When the first erythrocyte sedimentation rate is deemed unreliable, the second erythrocyte sedimentation rate of the blood sample to be tested is calculated based solely on the erythrocyte sedimentation parameters.

[0095] When the first erythrocyte sedimentation rate is deemed reliable, the erythrocyte sedimentation rate of the blood sample to be tested is calculated based solely on the erythrocyte aggregation parameter, or based on both the erythrocyte aggregation parameter and the erythrocyte sedimentation parameter.

[0096] An example of how to determine the reliability of the first erythrocyte sedimentation rate will be described in detail below.

[0097] The applicant, through repeated research, discovered that for the vast majority of well-mixed whole blood samples, red blood cells settle fastest within 0-20 minutes after mixing, and there is a linear relationship between this and the results after 60 minutes of settling (traditional manual Westergren method). Figure 4 As shown. Figure 4 This study shows the sedimentation of 10 EDTA anticoagulant tubes containing different whole blood samples after mixing and standing on a platform for different time periods. The 10 tubes were placed on the platform after mixing, and sedimentation images of the 10 samples were acquired at 0 min, 5 min, 10 min, 20 min, 30 min, and 60 min. The images were analyzed to obtain the proportion of plasma in the whole blood sample at each time point (sedimentation parameter). Figure 4 In the graph, the horizontal axis represents sedimentation time, while the vertical axis represents the proportion of plasma in the whole blood sample.

[0098] Therefore, as Figure 5 As shown, compared with the prior art, the sample analyzer 100 provided by this invention can obtain accurate ESR detection results with good consistency with the traditional Widmanstätten method-based ESR detection results relatively quickly, with a correlation as high as 0.9768. Figure 5 In the figure, the horizontal axis represents the ESR detection results based on the traditional Widmanstätten method, and the vertical axis represents the ESR detection results based on the present invention.

[0099] 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.

[0100] 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.

[0101] 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.

[0102] 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.

[0103] In some embodiments, the mixing device 110 may be configured to mix the blood sample to be tested in the test tube 10 by rotation, oscillation or vibration.

[0104] In a specific example, such as Figure 8 and Figure 9 As shown, the mixing device 110 may include a gripper 111, a first motor 112, a second motor 113, and a third motor 114. The gripper 111 can move linearly in the Z1 or Z2 direction under the drive of the first motor 112, move along the Y1 or Y2 direction under the drive of the second motor 113, and oscillate around an axis in the R1 or R2 direction under the drive of the third motor 114. Figure 9 As shown, the gripper 111 grasps the test tube 10 fixed to the sample holder 20 by moving along the Y1, Y2 and Z1, Z2 directions, and performs a swing-type mixing of the blood sample in the test tube 10 by swinging along the R1, R2 directions. After the mixing operation is completed, the gripper 111 puts the test tube 10 back into the sample holder 20.

[0105] In another example, such as Figure 10 As shown, the mixing device 110 includes a fourth motor 115 and a test tube holder 116. A test tube holder 117 is provided at the top of the test tube holder 116, through which a test tube 10 can be placed. The fourth motor 115 can drive the test tube holder 116 to rotate along the R3 or R4 direction, thereby mixing the blood sample to be tested in the test tube 10 placed in the test tube holder 117 through the rotational power.

[0106] In some embodiments, such as Figure 11 As shown, the sampling and dispensing component 121 of the first erythrocyte sedimentation rate (ESR) detection device 120 includes a sampling needle 1211 and a power assembly 1212. The power assembly 1212 is configured to draw the blood sample to be tested from the test tube 10 into the detection area 1221 of the first detection tube 122 through the sampling needle 1211. The power assembly 1212 is preferably configured as a syringe.

[0107] exist Figure 11In the illustrated embodiment, the erythrocyte sedimentation rate (ESR) optical detection component 123 includes a light emitter 1231 and a light receiver 1232, which are located on opposite sides of the detection area 1221 of the first detection channel 122. The light emitter 1231 is used to irradiate the blood sample to be tested within the detection area 1221. The light receiver 1232 is used to detect the change in the amount of light emitted by the light emitter 1231 after irradiating the blood sample to be tested (e.g., receiving light transmitted and / or scattered by the blood sample to be tested). The degree of absorption or scattering of light by the blood sample to be tested in the detection area 1221 is detected by detecting the amount of light received. Since the scattering or transmission of light irradiating the blood sample changes during the aggregation (formation of rouleaux) of red blood cells in the blood sample to be tested, the degree of scattering or absorption of light by the blood sample to be tested can be detected by detecting the amount of light transmitted or scattered after irradiation, thereby measuring the degree of red blood cell aggregation. Here, the erythrocyte sedimentation rate (ESR) optical detection component 123 is used to detect the blood sample to be tested, particularly by means of transmission turbidimetry.

[0108] When the first erythrocyte sedimentation rate (ESR) detection device 120 is activated, the power unit 1212 drives the blood sample to be tested to flow into the first detection tube 122, and stops the flow after the blood sample reaches the detection area 1221, then keeps the blood sample stationary. The light emitter 1231 irradiates the blood sample in the detection area, and the light receiver 1232 detects the degree to which the light emitted by the light emitter 1231 is scattered or transmitted after irradiating the blood sample in the detection area 1221, in order to detect the degree of red blood cell aggregation in the blood sample, such as the red blood cell aggregation rate.

[0109] In some embodiments, the power assembly 1212 may also be configured to: before stopping the flow of the blood sample to be tested within the first detection channel 122, deagglomerate the red blood cells in the blood sample by flowing the blood sample back and forth in the detection zone 1221 of the first detection channel 122. This ensures that the red blood cells in the blood sample in the detection zone 1221 are as dispersed as possible before the erythrocyte sedimentation rate (ESR) optical detection component 123, which has a light emitter and a light receiver, detects the degree of red blood cell aggregation, thereby enabling more accurate measurement of the degree of red blood cell aggregation. After the power assembly 1212 drives the blood sample in the detection zone 1221 to flow back and forth a predetermined number of times, the power assembly 1212 immediately stops driving, causing the blood sample in the detection zone 1221 to stop flowing, and the red blood cells in the blood sample in the detection zone 1221 aggregate, causing a change in light transmittance.

[0110] Here, the power unit 1212 is specifically constructed as a syringe, which can flexibly set the movement speed and direction of the syringe, thus enabling flexible deaggregation of blood samples and saving blood volume.

[0111] In some embodiments, the erythrocyte aggregation parameters are obtained from the erythrocyte aggregation curves showing the change in light intensity over time of transmitted light through the blood sample in the first detection tube 122 or scattered light scattered by the blood sample in the first detection tube 122.

[0112] Figure 12 The diagram illustrates a erythrocyte aggregation curve according to an embodiment of the present invention. This curve represents the change in intensity of transmitted light through a blood sample over time, i.e., a transmitted light intensity-time curve. Transmittance (also known as transmittance) is the relative light intensity and is equal to the ratio of transmitted light intensity to background light intensity. Various characteristic values ​​from the erythrocyte aggregation curve can be extracted as erythrocyte aggregation parameters.

[0113] In some embodiments, the erythrocyte aggregation parameters may include at least one of the following parameters calculated based on the erythrocyte aggregation curve: the area under the curve (AUC) between the erythrocyte aggregation curve and the time axis during the time interval from the measurement start time point T1 to the measurement end time point T2, and the erythrocyte aggregation method ESR calculated based on the area AUC and the pre-stored calibration curve.

[0114] In some embodiments, the pre-stored calibration curves are stored, for example, in the data processing device 140. Figure 13 A calibration curve (also called a standardization curve) for calculating the erythrocyte aggregation method (ESR) is shown, where the x-axis is AUC and the y-axis is the erythrocyte aggregation method ESR. Studies have shown a correlation between the erythrocyte aggregation curve AUC and the Widmanstätten method ESR of blood samples. Therefore, the calibration curve can be statistically fitted using the erythrocyte aggregation curve AUC and Widmanstätten method ESR of a large number of blood samples. That is, a large number of blood samples are simultaneously tested using the erythrocyte sedimentation rate (ESR) measuring device or system according to the present invention and a Widmanstätten method measuring device (including a sedimentation tube) to obtain the erythrocyte aggregation curve AUC and Widmanstätten 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 in the form of 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 erythrocyte aggregation method ESR is obtained from the AUC by looking up the table and interpolating.

[0115] In some embodiments, the second erythrocyte sedimentation rate (ESR) detection device 130 may include at least one optical sensor, such as an infrared scanning device or an optical image sensor.

[0116] As one implementation, the second erythrocyte sedimentation rate (ESR) detection device 130 can be configured to detect changes in the transmittance or absorbance of the plasma layer or blood cell layer of the blood sample to be tested in the test tube during the predetermined time period. Here, erythrocyte sedimentation parameters include parameters characterizing changes in transmittance or absorbance.

[0117] Specifically, in one example, the second erythrocyte sedimentation rate (ESR) detection device 130 may be further configured to: acquire a first transmittance or a first absorbance of the plasma layer or blood cell layer of the blood sample to be tested in the test tube at a predetermined time; and acquire a second transmittance or a second absorbance of the plasma layer or blood cell layer of the blood sample to be tested in the test tube after a predetermined time period from the predetermined time; 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. In a simple example, the erythrocyte sedimentation parameter is the difference between the second transmittance or second absorbance and the first transmittance or first absorbance.

[0118] In other implementations, the second erythrocyte sedimentation rate (ESR) detection device 130 may be configured to detect changes in the height of the plasma layer or blood cell layer of the blood sample in the test tube during the predetermined time period. Here, the erythrocyte sedimentation parameters include parameters characterizing these height changes. In particular, the second ESR detection device 130 may include an infrared scanning device or an optical image sensor, such as a camera, for detecting these height changes.

[0119] Specifically, in one example, the second erythrocyte sedimentation rate (ESR) detection device 130 may be further configured to: acquire a first height of the plasma layer or erythrocyte layer of the blood sample to be tested in the test tube at a predetermined time; and acquire a second height of the plasma layer or erythrocyte layer of the blood sample to be tested in the test tube after a 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. In a simple example, the erythrocyte sedimentation parameter is the difference between the second height and the first height.

[0120] Here, the second erythrocyte sedimentation rate (ESR) detection device 130 can be further configured to: acquire the third height of the blood sample to be tested in the test tube at a predetermined time; and acquire the fourth height of the blood sample to be tested in the test tube after a predetermined time period from the predetermined time; wherein the erythrocyte sedimentation 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. In a simple example, the erythrocyte sedimentation parameter is the difference between the ratio of the first height to the third height and the ratio of the second height to the fourth height. Since the amount of blood sample to be tested in different test tubes may vary, using the change in the proportion of plasma layer or erythrocyte layer to the total blood sample to be tested can more accurately reflect the erythrocyte sedimentation status.

[0121] In some embodiments, the second erythrocyte sedimentation rate (ESR) detection device 130 may include a first optical sensor 131 and a second optical sensor 132. The first optical sensor 131 is configured to acquire a first transmittance or a first absorbance of the plasma layer or red blood cell layer of the blood sample to be tested in the test tube at a predetermined time, while the second optical sensor 132 is configured to acquire a second transmittance or a second absorbance of the plasma layer or red blood cell layer of the blood sample to be tested in the test tube after a predetermined time period from the predetermined time. Alternatively, the first optical sensor 131 is configured to acquire a first height of the plasma layer or red blood cell layer of the blood sample to be tested in the test tube at a predetermined time and / or acquire a third height of the blood sample to be tested in the test tube at a predetermined time, while the second optical sensor 132 is configured to acquire a second height of the plasma layer or red blood cell layer of the blood sample to be tested in the test tube after a predetermined time period from the predetermined time and / or acquire a fourth height of the blood sample to be tested in the test tube after a predetermined time period from the predetermined time.

[0122] For example, both the first optical sensor 131 and the second optical sensor 132 are configured as cameras. When the test tube 10 on the sample rack 20 is mixed by the mixing device 110, especially after being aspirated by the first erythrocyte sedimentation rate (ESR) detection device 120, the first optical sensor 131 acquires a first image of the test tube 10 at a predetermined time. After the test tube 10 has been resting on the sample rack 20 for the predetermined time period from the predetermined time, the second optical sensor 132 acquires a second image of the test tube 10. Thus, a first height and / or a third height can be obtained from the first image, and a second height and / or a fourth height can be obtained from the second image through image analysis.

[0123] As some implementations, the first optical sensor 131 and the second optical sensor 132 can be constructed independently of each other. For example, in Figure 6 In the illustrated embodiment, the first optical sensor 131 may be disposed next to the analysis area 152, while the second optical sensor 132 may be disposed in the unloading area 153. Alternatively, the first optical sensor 131 and the second optical sensor 132 may be disposed at different locations next to the analysis area 152, or at different locations in the unloading area 153.

[0124] In some other implementations, the first optical sensor 131 and the second optical sensor 132 can be the same optical sensor. For example, in Figure 6 In the embodiment shown, the same optical sensor can be located in the unloading area 153.

[0125] In some alternative embodiments, the second erythrocyte sedimentation rate (ESR) detection device 130 may obtain changes in transmittance or absorbance based on the same detection principle as the ESR optical detection component 123 of the first ESR detection device 120, or may further obtain changes in height based on changes in transmittance or absorbance.

[0126] In other alternative embodiments, the second erythrocyte sedimentation rate (ESR) detection device 130 may include a graduated sedimentation rack and a user interface for receiving user input. After the blood sample to be tested in test tube 10 is drawn by the first ESR detection device 120, the test tube 10 is placed in the sedimentation rack. The user reads the first graduation of the blood sample in test tube 10 when it is placed in the sedimentation rack, and the second graduation of the blood sample in test tube 10 after the predetermined time period. Thus, the user can obtain the erythrocyte sedimentation parameters based on the first and second graduations and input them into the sample analyzer 100 through the user interface.

[0127] In some embodiments, the predetermined time can be selected as any time within 30 seconds, preferably within 15 seconds, and more preferably within 10 seconds after the mixing device 110 finishes the mixing operation. This allows for obtaining erythrocyte sedimentation parameters that more accurately reflect the sedimentation of erythrocytes in the blood sample being tested.

[0128] Furthermore, the predetermined time can be selected as the time after the sampling dispensing unit 121 aspirates a portion of the blood sample to be tested. This avoids the influence of the aspiration operation after the mixing operation on erythrocyte sedimentation, thereby obtaining erythrocyte sedimentation parameters that more accurately reflect the sedimentation of erythrocytes in the blood sample to be tested.

[0129] In some embodiments, the predetermined time is selected as any time within 20 seconds, preferably within 10 seconds, and more preferably within 5 seconds after the sampling dispensing component 121 aspirates a portion of the blood sample to be tested. During this predetermined time period, no further contact manipulation is performed on the blood sample to be tested in the test tube 10.

[0130] In some embodiments, the predetermined time period is no more than 15 minutes, preferably no more than 10 minutes. In this regard, the applicant, through repeated research, found that for most well-mixed whole blood samples, red blood cells settle rapidly within 0-10 minutes after mixing, and there is a linear relationship between this and the results after 60 minutes of settling (traditional manual Westergren method). Figure 4 and Figure 14 As shown. This allows for a faster and more accurate acquisition of erythrocyte sedimentation rate. For example, the predetermined time period can be between 2 and 15 minutes, preferably between 2 and 10 minutes, and more preferably between 5 and 10 minutes. For example, the predetermined time period can be approximately 10 minutes.

[0131] In some embodiments, the data processing device 140 may be further configured to input erythrocyte aggregation parameters and erythrocyte sedimentation parameters as input parameters into a computational model, and obtain the output of the computational model as the erythrocyte sedimentation rate of the blood sample to be tested, wherein the computational model includes a nonlinear function or a neural network structure. For example, the erythrocyte sedimentation rate is a nonlinear function of the erythrocyte aggregation parameters and the erythrocyte sedimentation parameters.

[0132] In some embodiments, such as Figure 15 As shown, the sample analyzer 100 also includes an impedance detection device 170 based on the Coulter method and / or an optical detection device 180 based on flow cytometry. Here, the sampling dispensing unit 121 is further configured to transport another portion of the blood sample 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 can be measured by the impedance detection device 170 and / or the optical detection device 180. The data processing unit 140 is further configured to correct the erythrocyte sedimentation rate of the blood sample using the at least one red blood cell parameter.

[0133] In some specific embodiments, the at least one red blood cell parameter may 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, red blood cell hematocrit, mean red blood cell volume, red blood cell volume coefficient of variation, and red blood cell distribution width standard deviation, etc.

[0134] In some alternative embodiments, the same applies. Figure 15 As shown, the sample analyzer 100 also includes an impedance detection device 170 based on the Coulter method and / or an optical detection device 180 based on flow cytometry. Here, the sampling dispensing unit 121 is further configured to transport another portion of the blood sample 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 can be measured by the impedance detection device 170 and / or the optical detection device 180. At this time, the data processing unit 140 can be further configured to input red blood cell aggregation parameters, red blood cell sedimentation parameters, and red blood cell parameters as input parameters into a calculation model, and obtain the output of the calculation model as the red blood cell sedimentation rate of the blood sample. This calculation model includes a nonlinear function or a neural network structure. In particular, the calculation model is a neural network model, which is pre-trained and stored in the data processing unit 140.

[0135] The following is combined with Figure 6 and Figure 16An exemplary workflow of the sample analyzer 100 of the present invention is described. The sample transport device 150 transports the sample rack 20 from the loading area 151 to the analysis area 152 along the Y2 direction. Then, it transports the test tubes 10 on the sample rack 20 to the scanning position P1 in the analysis area 152 along the X1 direction. The scanning device 160 scans the test tubes 10 located at the scanning position P1 to obtain the identification information and detection mode (complete blood count mode and / or ESR mode) of the test tubes 10. Next, the sample transport device 150 continues to transport the sample rack 20 along the X1 direction to transport the scanned test tubes 10 to the mixing position P2 in the analysis area 152. The mixing device 110 mixes the test tubes 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 transport the mixed test tubes 10 to the sampling position P1 in the analysis area 152. If the test tube 10's detection modes include a complete blood count (CBC) mode and an ESR mode, the sampling dispensing unit 121 draws a portion of the blood sample to be tested from the test tube 10 located at the sampling position P1, and distributes the drawn blood sample to the first detection line 122, the impedance detection device 170, and the optical detection device 180, respectively. The erythrocyte sedimentation rate (ESR) optical detection unit 123 detects the distributed blood sample to obtain erythrocyte aggregation parameters, and the impedance detection device 170 and the optical detection device 180 detect the distributed blood sample to obtain erythrocyte parameters. If the test tube 10's detection modes only include the ESR mode, the sampling dispensing unit 121 draws a portion of the blood sample to be tested from the test tube 10 located at the sampling position P3, and distributes the drawn blood sample to the first detection line 122. The erythrocyte sedimentation rate (ESR) optical detection unit 123 detects the distributed blood sample to obtain erythrocyte aggregation parameters. At a predetermined time after the sampling dispensing unit 121 performs a sample aspiration operation on the test tube 10 located at the aspiration position P3, the second erythrocyte sedimentation rate (ESR) detection device 130 acquires the first transmittance, first absorbance, or first height of the plasma layer or erythrocyte layer in the test tube 10. Subsequently, the sample transport device 150 unloads the sample rack 20 from the analysis area 152 to the unloading area 153 along the Y1 direction. After a predetermined interval from the predetermined time, such as 2 minutes, 5 minutes, or 10 minutes, the second ESR detection device 130 again acquires the second transmittance, second absorbance, or second height of the plasma layer or erythrocyte layer in the test tube 10, thereby obtaining the erythrocyte sedimentation parameters. The data processing device 140 calculates the erythrocyte sedimentation rate of the blood sample to be tested based on the erythrocyte aggregation parameters, the erythrocyte sedimentation parameters, and optional erythrocyte parameters.

[0136] The present invention also provides another sample analyzer 200, such as Figure 17 As shown, the sample analyzer 200 includes a mixing device 210, a first erythrocyte sedimentation rate (ESR) detection device 220, a second ESR detection device 230, and a data processing device 240.

[0137] The first erythrocyte sedimentation rate (ESR) detection device 220 includes a sampling dispensing component 221, a first detection line 222, and an ESR optical detection component 223. The sampling dispensing component 221 is configured to draw a portion of the blood sample to be tested from a test tube 10 containing the blood sample to be tested, transport at least a portion of the blood sample to the first detection line 222, and stop the flow of the at least a portion of the blood sample in the first detection line 222. The ESR optical detection component 223 is configured to illuminate the at least a portion of the blood sample that has stopped flowing in the first detection line 222 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 obtain the erythrocyte aggregation parameters of the blood sample to be tested based on the acquired transmitted light information or scattered light information. In this document, the erythrocyte aggregation parameters characterize the degree of erythrocyte aggregation or erythrocyte aggregation characteristics of the at least a portion of the blood sample after it has stopped flowing in the first detection line 222.

[0138] The mixing device 210 is configured to mix the remaining blood sample in the test tube 10 after the sampling and dispensing component 221 has absorbed a portion of the blood sample to be tested.

[0139] The second erythrocyte sedimentation rate (ESR) detection device 230 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 10 settle in the test tube 10 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 10 is in a static state during the predetermined time period, and the predetermined time period is no more than 20 minutes.

[0140] The data processing device 240 is configured to calculate the erythrocyte sedimentation rate of the blood sample to be tested based on the erythrocyte aggregation parameters obtained by the first erythrocyte sedimentation detection device 220 and the erythrocyte sedimentation parameters obtained by the second erythrocyte sedimentation detection device 230.

[0141] The above-described embodiments and advantages of the sample analyzer 100 provided by the present invention are applied in a corresponding manner to the sample analyzer 200 provided by the present invention, and will not be repeated here.

[0142] The present invention also provides a sample analysis system 300, such as Figure 18 As shown, the sample analysis system 300 includes a mixing device 310, a first sample analyzer 320 and a second sample analyzer 330 that are independent of each other, a second erythrocyte sedimentation rate (ESR) detection device 340, a sample transport track 350 and a data processing device 360.

[0143] The mixing device 310 is configured to perform a mixing operation on the blood sample to be tested in the test tube 10. Further embodiments and advantages of the mixing device 310 can be found in the above description of the mixing device 110, and will not be repeated here.

[0144] At least the first sample analyzer 320 includes the aforementioned first erythrocyte sedimentation rate (ESR) detection device 120. Preferably, the first sample analyzer 320 integrates a routine blood count (RBC) detection device and the aforementioned first ESR detection device 120, and the mixing device 310 is preferably integrated into the first sample analyzer 320. The second sample analyzer 330 may, for example, include a RBC detection device but does not include an ESR detection device.

[0145] The second erythrocyte sedimentation rate (ESR) detection device 340 is configured to acquire the erythrocyte sedimentation parameters of the blood sample to be tested. These parameters characterize the degree to which red blood cells in the blood sample settle within the test tube during a predetermined time period, starting from a predetermined time after the mixing operation. The blood sample in the test tube is in a static state during the predetermined time period, which is no more than 20 minutes. Further embodiments and advantages of the second ESR detection device 340 can be found in the above description of the second ESR detection device 130, and will not be repeated here.

[0146] The sample transport track 350 is configured to transport test tubes 10 containing blood samples to be tested to the first sample analyzer 320 and / or the second sample analyzer 330.

[0147] The data processing device 360 ​​is configured to calculate the erythrocyte sedimentation rate of the blood sample to be tested based on erythrocyte aggregation parameters and erythrocyte sedimentation parameters. Further embodiments and advantages of the data processing device 360 ​​can be found in the above description of the data processing device 140, and will not be repeated here.

[0148] In some embodiments, such as Figure 19 As shown, the sample analysis system 300 also includes a loading area 370 and an unloading area 380. The loading area 370 is used to place test tubes 10 containing blood samples to be tested, for example, by placing them on a sample rack 20, while the unloading area 380 is used to place test tubes 10 containing blood samples to be tested, for example, by placing them on a sample rack 20.

[0149] In some embodiments, the second erythrocyte sedimentation rate (ESR) detection device 340 may be disposed next to the sample transport track 350, in which case the test tubes after mixing can be left to stand in the sample transport track 350. Alternatively, the second ESR detection device 340 may be disposed in the unloading area 380, in which case the test tubes after mixing can be left to stand in the unloading area 380.

[0150] In some embodiments, such as Figure 20As shown, the first sample analyzer 320 can be constructed in the same manner as the sample analyzer 100 described above, and has a sample transport device constructed in the same manner as the sample transport device 150 described above, and a barcode scanning device constructed in the same manner as the barcode scanning device 160 described above. The sample transport device transports test tubes 10 in the form of a sample rack 20. The sample transport device can transport the sample rack 20 in the loading area 321 to the analysis area 322, transport the sample rack 20 in the analysis area 322, and unload the sample rack 20 in the analysis area 322 to the unloading area 323. In the analysis area 322, the barcode scanning device, the mixing device 310, and the first erythrocyte sedimentation rate (ESR) detection device 120 perform barcode scanning, mixing, and aspiration operations on the blood sample to be tested in the test tubes 10 on the sample rack 20, respectively. Here, the second ESR detection device 340 can be set in the unloading area 323 of the first sample analyzer 320, and for details, please refer to the above description of the sample analyzer 100.

[0151] Alternative or additional land, such as Figure 21 As shown, the second sample analyzer 320 may also have a sample transport device constructed in the same manner as the sample transport device 150 described above. The sample transport device transports test tubes 10 in the form of sample racks 20. The sample transport device can transport the sample racks 20 from 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 from the analysis area 332 to the unloading area 333. Here, the second erythrocyte sedimentation rate (ESR) detection device 340 may also be disposed in the unloading area 333 of the second sample analyzer 330; for details, please refer to the above description of the sample analyzer 100.

[0152] Figure 19 An exemplary workflow of the sample analysis system 300 shown is as follows: A sample transport track 350 transports the sample rack 20 from the loading area 370 to a first sample analyzer 320. The first sample analyzer 320 sequentially scans, mixes, and aspirates the test tubes 10 in the sample rack 20, and analyzes the aspirated blood samples to obtain erythrocyte aggregation parameters and optional erythrocyte parameters. At a predetermined time after the sample analyzer 320 aspirates the test tubes 10, a second erythrocyte sedimentation rate (ESR) detection device 340 acquires the first transmittance, first absorbance, or first height of the plasma layer or erythrocyte layer in the test tube 10. Subsequently, the sample transport track 350 unloads the sample rack 20 from the first sample analyzer into the unloading area 380. After a predetermined interval from the predetermined time, such as 2 minutes, 5 minutes, or 10 minutes, the second ESR detection device 340 again acquires the second transmittance, second absorbance, or second height of the plasma layer or erythrocyte layer in the test tube 10, thereby obtaining erythrocyte sedimentation parameters. The data processing device 360 ​​calculates the erythrocyte sedimentation rate of the blood sample to be tested based on the erythrocyte aggregation parameters, erythrocyte sedimentation parameters, and optional erythrocyte parameters.

[0153] For more embodiments and advantages of the sample analysis system 300 provided by the present invention, please refer to the above description of the sample analyzer 100 provided by the present invention, which will not be repeated here.

[0154] The present invention also provides a method 400 for measuring erythrocyte sedimentation rate, such as... Figure 22 As shown, the erythrocyte sedimentation rate (ESR) measurement method 400 includes steps S410 to S450.

[0155] In step S410, 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 tube and the flow of the at least a portion of the blood sample in the first detection tube is stopped.

[0156] In step S420, light is used to illuminate the at least part of the blood sample that has stopped flowing in the first detection tube, and information about the transmitted light passing through the at least part of the blood sample or the scattered light scattered by the at least part of the blood sample is obtained.

[0157] In step S430, the red blood cell aggregation parameters of the blood sample to be tested are obtained based on the information of the transmitted light or the information of the scattered light. The red blood cell aggregation parameters characterize the degree of red blood cell aggregation of at least a portion of the blood sample after the flow stops in the first detection tube.

[0158] In step S440, the blood sample to be tested in the test tube is allowed to stand for a predetermined period of time starting from a predetermined time after the mixing operation, so as 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.

[0159] In step S450, the erythrocyte sedimentation rate of the blood sample to be tested is calculated based on the erythrocyte aggregation parameters and the erythrocyte sedimentation parameters.

[0160] In some embodiments, the erythrocyte sedimentation parameters include: parameters characterizing changes in the transmittance or absorbance of the plasma layer or blood cell layer of the blood sample to be tested in the test tube during the predetermined time period; or parameters characterizing changes in the height of the plasma layer or blood cell layer of the blood sample to be tested in the test tube during the predetermined time period.

[0161] As some implementations, step S440 may include:

[0162] Acquire the first transmittance or first absorbance of the plasma layer or blood cell layer of the blood sample to be tested in the test tube at the predetermined time; and

[0163] The second transmittance or second absorbance of the plasma layer or blood cell layer of the blood sample to be tested in the test tube is obtained after the predetermined time period has elapsed from the predetermined time; 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.

[0164] In other implementations, step S440 may include:

[0165] 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

[0166] 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.

[0167] Furthermore, step S440 may also include:

[0168] Obtain the third height of the blood sample to be tested in the test tube at the predetermined time; and

[0169] 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.

[0170] In some embodiments, an infrared scanning device or an optical image sensor may be used to acquire parameters characterizing the height changes of the plasma layer or blood cell layer of the blood sample to be tested in the test tube during the predetermined time period.

[0171] In some embodiments, the predetermined time can be selected as any time within 30 seconds, preferably within 15 seconds, and more preferably within 10 seconds after the mixing operation is completed.

[0172] In some embodiments, the predetermined time can be selected as the time after the portion of the blood sample to be tested is drawn. For example, the predetermined time can be selected as any time within 15 seconds, preferably within 10 seconds, and more preferably within 5 seconds after the portion of the blood sample to be tested is drawn.

[0173] In some embodiments, the predetermined time period is no more than 15 minutes, preferably no more than 10 minutes.

[0174] In some embodiments, step S450 may include: inputting the erythrocyte aggregation parameter and the erythrocyte sedimentation 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.

[0175] Furthermore, method 400 may also include:

[0176] 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

[0177] The erythrocyte sedimentation rate of the blood sample to be tested is corrected using at least one of the erythrocyte parameters.

[0178] In some alternative embodiments, method 400 may further include: 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 erythrocyte parameter of the blood sample to be tested can be measured by the impedance detection device and / or the optical detection device. Accordingly, step S450 includes: inputting the erythrocyte aggregation parameter, the erythrocyte sedimentation parameter, and the at least one erythrocyte parameter as input parameters into a computational model to obtain the output of the computational model as the erythrocyte sedimentation rate, wherein the computational model includes a nonlinear function or a neural network structure.

[0179] The erythrocyte sedimentation rate (ESR) measurement method 400 provided by this invention can be applied in particular to the sample analyzer 100 or sample analysis system 300 provided by this invention. Therefore, the above-described embodiments and advantages of the sample analyzer 100 and sample analysis system 300 provided by this invention are correspondingly applied to the ESR measurement method 400 provided by this invention, and will not be repeated here.

[0180] This invention also provides another method 500 for measuring erythrocyte sedimentation rate, such as... Figure 23 As shown, the erythrocyte sedimentation rate (ESR) measurement method 500 includes steps S510 to S560.

[0181] In step S510, 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 tube and the flow of the at least a portion of the blood sample in the first detection tube is stopped.

[0182] In step S520, light is used to illuminate the at least part of the blood sample that has stopped flowing in the first detection tube to obtain information about the transmitted light passing through the at least part of the blood sample or information about the scattered light scattered by the at least part of the blood sample.

[0183] In step S530, the red blood cell aggregation parameters of the blood sample to be tested are obtained based on the information of the transmitted light or the information of the scattered light. The red blood cell aggregation parameters characterize the degree of red blood cell aggregation of at least a portion of the blood sample after the flow stops in the first detection tube.

[0184] In step S540, after aspirating a portion of the blood sample to be tested, the remaining blood sample to be tested in the test tube is mixed.

[0185] In step S550, 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.

[0186] In step S560, the erythrocyte sedimentation rate of the blood sample to be tested is calculated based on the erythrocyte aggregation parameters and the erythrocyte sedimentation parameters.

[0187] In some embodiments, the erythrocyte sedimentation parameter may include: a parameter characterizing the change in transmittance or absorbance of the plasma layer or blood cell layer of the remaining blood sample to be tested within the predetermined time period; or a parameter characterizing the change in the height of the plasma layer or blood cell layer of the remaining blood sample to be tested in the test tube within the predetermined time period.

[0188] In some embodiments, step S550 may include:

[0189] Acquire the first transmittance or first absorbance of the plasma layer or blood cell layer of the remaining blood sample to be tested at the predetermined time; and

[0190] The second transmittance or second absorbance of the plasma layer or blood cell 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.

[0191] In some embodiments, step S550 may include:

[0192] 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

[0193] 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.

[0194] In some embodiments, the predetermined time is selected as any time within 30 seconds, preferably within 15 seconds, and more preferably within 10 seconds after the mixing operation ends; and / or the predetermined time period is no more than 15 minutes, preferably no more than 10 minutes.

[0195] In some embodiments, method 500 may further include:

[0196] 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

[0197] The erythrocyte sedimentation rate of the blood sample to be tested is corrected using at least one of the erythrocyte parameters.

[0198] In some alternative embodiments, method 500 may further include: 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 erythrocyte parameter of the blood sample to be tested can be measured by the impedance detection device and / or the optical detection device. Accordingly, step S560 includes: inputting the erythrocyte aggregation parameter, the erythrocyte sedimentation parameter, and the at least one erythrocyte parameter as input parameters into a computational model to obtain the output of the computational model as the erythrocyte sedimentation rate, wherein the computational model includes a nonlinear function or a neural network structure.

[0199] The erythrocyte sedimentation rate (ESR) measurement method 500 provided by this invention can be particularly applied to the sample analyzer 200 provided by this invention. Therefore, the above-described embodiments and advantages of the sample analyzer 200 provided by this invention are correspondingly applicable to the ESR measurement method 500 provided by this invention, and will not be repeated here.

[0200] like Figure 24 As shown, the present invention also provides another sample analysis system 600, including a sampling distribution device 610, a first erythrocyte sedimentation rate (ESR) detection device 620, a second ESR detection device 630, and a data processing device 640.

[0201] The sampling dispensing device 610 is configured to draw a portion of the blood sample from a test tube containing the subject's blood sample and distribute at least a portion of the blood sample to the first erythrocyte sedimentation rate (ESR) detection device 620. Optionally, the sampling dispensing device 610 may also be configured to collect another portion of the subject's blood sample, for example, draw another portion of the blood sample from the test tube, and distribute the other portion of the blood sample to the second ESR detection device 630.

[0202] For further embodiments of the sampling distribution device 610, please refer to the above description of the sampling distribution component 221.

[0203] The first erythrocyte sedimentation rate (ESR) detection device 620 is configured to perform ESR detection on a blood sample based on erythrocyte aggregation. Specifically, the first ESR detection device 620 includes a first detection line, a power unit, and a first optical detection unit. The first detection line is configured to receive at least a portion of the blood sample dispensed by the sampling dispensing device 610. The power unit is configured to deaggregate the erythrocytes in the at least a portion of the blood sample by causing the dispensed blood sample to flow back and forth in the first detection line, and to stop the deaggregation process, thereby causing the erythrocytes in the at least a portion of the blood sample in the first detection line to aggregate. The first optical detection unit is configured to acquire deaggregation optical data of the at least a portion of the blood sample during the erythrocyte deaggregation process and / or aggregation optical data during the erythrocyte aggregation process.

[0204] For further embodiments of the first detection pipeline, power component, and first optical detection component of the first erythrocyte sedimentation rate (ESR) detection device 620, please refer to the above description of the sampling distribution component 221, the first detection pipeline 222, and the ESR optical detection component 223 of the first ESR detection device 220.

[0205] The second erythrocyte sedimentation rate (ESR) detection device 630 is configured to acquire the erythrocyte sedimentation parameters of the blood sample to be tested. Specifically, the second ESR detection device 630 includes a second detection tube and a second optical detection component. The second detection tube is configured to receive the blood sample from the subject, and the second optical detection component is configured to acquire the erythrocyte sedimentation rate of the blood sample in the second detection tube based on the Widmanstätten method. The second detection tube may be, for example, a vertically placed tube or a tube tilted relative to the vertical direction.

[0206] Further embodiments of the second optical detection component of the second erythrocyte sedimentation rate (ESR) detection device 630 can be found in the above description of the second ESR detection device 130.

[0207] The data processing device 640 is configured to: determine whether the first erythrocyte sedimentation rate obtained solely from focused optical data is reliable; when the first erythrocyte sedimentation rate is determined to be reliable, output the first erythrocyte sedimentation rate; and when the first erythrocyte sedimentation rate is determined to be unreliable, control the second erythrocyte sedimentation rate detection device to re-examine the blood sample of the subject based on the Widmanstätten method to obtain and output the second erythrocyte sedimentation rate of the subject.

[0208] In some embodiments, the first erythrocyte sedimentation rate (ESR) detection device 620 and the second ESR detection device 630 can be configured independently of each other. In other embodiments, the first ESR detection device 620 and the second ESR detection device 630 can also be integrated together.

[0209] In some embodiments, the sample analysis system 600 further includes a blood analyzer, which includes the sampling dispensing device and a routine blood count device (e.g., the Coulter-based impedance detection device 170 and / or the flow cytometry-based optical detection device 180 described above). Here, a first erythrocyte sedimentation rate (ESR) detection device 620 and / or a second ESR detection device 630 are integrated into the blood analyzer.

[0210] For example, the blood analyzer in the Sample Analysis System 600 can, as Figure 18 The first sample analyzer 320 shown is constructed in the manner of integrating a routine blood count testing device and a first erythrocyte sedimentation rate (ESR) testing device 620. The second ESR testing device 630, however, is separate from the blood analyzer.

[0211] For example, the sample analysis system 600 can be as follows: Figures 18 to 21 As shown, the system includes a first blood analyzer and a second blood analyzer, each with its own complete blood count (CBC) testing device. Here, the first erythrocyte sedimentation rate (ESR) testing device 620 can be integrated into the first blood analyzer, while the second ESR testing device 630 can be integrated into the second blood analyzer.

[0212] In some embodiments, the sample analysis system 600 may further include a sample transport device configured to transport test tubes to a sampling dispensing device 610, so that the sampling dispensing device 610 can aspirate a portion of the blood sample to be tested from the test tubes. Correspondingly, the data processing device 640 is further configured to, when the first erythrocyte sedimentation rate is determined to be unreliable, control the sample transport device 610 to transport the test tubes to a second erythrocyte sedimentation rate detection device 630, so that the second erythrocyte sedimentation rate detection device 630 can re-examine the blood sample of the subject.

[0213] For example, similar to Figures 18 to 21 The structure shown is such that the sample transport device is constructed as a sample transport track.

[0214] Furthermore, similar to Figures 18 to 21As shown in the diagram, the sample analysis system 600 may further include a buffer area, such as an unloading area. The sample transport device is also configured to transport test tubes aspirated by the sampling dispensing device to the buffer area. It is possible that the data processing device 640 controls the sample transport device to transport the test tubes to the second erythrocyte sedimentation rate (ESR) detection device 630, which may include: the data processing device 640 controlling the sample transport device to transfer the test tubes from the buffer area to the second ESR detection device.

[0215] In some embodiments, the second erythrocyte sedimentation rate (ESR) detection device 630 further includes a mixing component configured to mix the blood sample in the second detection line.

[0216] For the structure of the mixing component of the second erythrocyte sedimentation rate (ESR) detection device 630, please refer to the above description of mixing devices 110, 210, and 310.

[0217] In some embodiments, the test tube used to hold the blood sample to be tested can itself be used as a second detection tube. Accordingly, the data processing device 640 is also configured to, when it is determined that the first erythrocyte sedimentation rate is unreliable:

[0218] The mixing unit is controlled to mix the remaining blood sample in the test tube.

[0219] The second optical detection component is controlled to acquire the degree or height of settling of red blood cells in the remaining blood sample in the test tube within a predetermined time period after the mixing operation, particularly from a predetermined time after the mixing operation.

[0220] The sedimentation rate of the second red blood cell is calculated based on the degree of sedimentation and then output.

[0221] In other embodiments, the data processing device 640 may also be configured to, when it is determined that the first erythrocyte sedimentation rate is unreliable:

[0222] The sampling and dispensing device is controlled to collect another portion of the subject's blood sample and load the other portion of the blood sample into the second detection tubing;

[0223] The mixing component is controlled to mix the other portion of the blood sample in the second detection tubing.

[0224] The second optical detection component is controlled to acquire the degree or height of settling of red blood cells in the mixed blood sample within the second detection tube during a predetermined time period after the mixing operation, particularly from a predetermined time after the mixing operation; and

[0225] The sedimentation rate of the second red blood cell is calculated based on the degree of sedimentation and then output.

[0226] For examples of scheduled times and scheduled time periods, please refer to the above description.

[0227] Here, the data processing device 640 is preferably configured to determine whether the first erythrocyte sedimentation rate is reliable based on the depolymerization optical data and / or aggregation optical data.

[0228] The following examples further illustrate how the data processing device 640 determines the reliability of the first erythrocyte sedimentation rate based on depolymerization optical data and / or aggregation optical data.

[0229] The inventors of this application have noted that one of the key influencing factors in erythrocyte sedimentation rate (ESR) detection based on erythrocyte aggregation method is the degree of erythrocyte deaggregation before detection.

[0230] For some abnormal blood samples, such as those with erythrocyte aggregation, when using the erythrocyte aggregation method for erythrocyte sedimentation rate (ESR) testing, the transmittance of such samples during the erythrocyte deaggregation process is generally higher than that of normal samples during the erythrocyte deaggregation process because the erythrocytes are already in an aggregated state before reaggregation.

[0231] Figure 25 This diagram shows a comparison of the red blood cell deagglomeration curves (in this case, the change in light intensity transmitted through the blood sample over time during the deagglomeration process) of abnormal and normal samples exhibiting red blood cell aggregation. The abnormal and normal samples show practically similar aggregation results. Figure 25 As shown, compared with normal samples that have similar aggregation results, the red blood cell disaggregation curves of abnormal samples have higher transmittance and relatively larger fluctuations.

[0232] Therefore, based on the depolymerization optical data during the depolymerization process of the blood sample, it can be determined whether there is any sample abnormality in the blood sample that would cause abnormal erythrocyte sedimentation rate (ESR) test results. In other words, the data processing device 640 determines the reliability of the first erythrocyte sedimentation rate based on the depolymerization optical data.

[0233] In some embodiments, the data processing device 640 may determine the reliability of the first erythrocyte sedimentation rate based on the depolymerization optical data and / or the aggregation optical data, which may include: the data processing device 640

[0234] The first aggregation characteristic value is obtained based on the aggregation optical data;

[0235] De-aggregation characteristic values ​​are obtained based on de-aggregation optical data and / or a second aggregation characteristic value different from the first aggregation characteristic value is obtained based on aggregation optical data;

[0236] Determine the first judgment threshold range and / or the second judgment threshold range based on the first aggregation feature value;

[0237] When the deagglomeration characteristic value exceeds the first judgment threshold range and / or the second aggregation characteristic value exceeds the second judgment threshold range, the first erythrocyte sedimentation rate is deemed unreliable.

[0238] As one implementation, the data processing device 640 may determine the reliability of the first erythrocyte sedimentation rate based on the deagglomeration optical data and / or the aggregation optical data, which may include: data processing device 640

[0239] The first aggregation characteristic value is obtained based on the aggregation optical data;

[0240] Decoupling characteristic values ​​are obtained based on decoupling optical data;

[0241] Determine the first judgment threshold range based on the first aggregation feature value; and

[0242] When the depolymerization characteristic value exceeds the first judgment threshold range, it is determined that there is a sample abnormality in the blood sample to be tested that causes abnormal erythrocyte sedimentation rate test results, that is, the first erythrocyte sedimentation rate is unreliable.

[0243] Here, after obtaining the first aggregation characteristic value, it is determined what theoretical range the deaggregation characteristic value of the blood sample with the first aggregation characteristic value should fall within (i.e., determining the first judgment threshold range based on the first aggregation characteristic value). When the deaggregation characteristic value of the blood sample to be tested exceeds this theoretical range, it indicates that there is a sample abnormality in the blood sample to be tested that leads to abnormal erythrocyte sedimentation rate test results, i.e., the first erythrocyte sedimentation rate is unreliable.

[0244] In some embodiments, the aggregation optical data may include a red blood cell aggregation curve showing the change in light intensity over time of transmitted light through at least a portion of the allocated blood sample or scattered light scattered by said at least a portion of the blood sample during red blood cell aggregation.

[0245] Figure 26 The diagram shows a red blood cell aggregation curve C measured by a first erythrocyte sedimentation rate (ESR) detection device provided according to an embodiment of this application, wherein transmittance (also known as light transmittance) is a relative light intensity, equal to the ratio of transmitted light intensity to background light intensity. A first aggregation characteristic value can be obtained from the red blood cell aggregation curve C.

[0246] In some embodiments, the first aggregation feature value can be the erythrocyte sedimentation rate (ESR) test result. In other embodiments, the first aggregation feature value can be the corrected ESR test result obtained by correcting the ESR test result based on routine blood test data. In still other embodiments, the first aggregation feature value can also be the area under the curve (AUC) of the erythrocyte aggregation curve C over the time interval from the measurement start time point T1 to the measurement end time point T2, along with the time axis.

[0247] In some embodiments, the depolymerization optical data may include a red blood cell depolymerization curve showing the change in light intensity over time of transmitted light through at least a portion of the allocated blood sample or scattered light scattered by said at least a portion of the blood sample during the red blood cell depolymerization process.

[0248] In some embodiments, the depolymerization characteristic value can be the mean light intensity of the erythrocyte depolymerization curve during the time interval from the start time point to the end time point of the measurement, or the standard deviation of the light intensity of the erythrocyte depolymerization curve during the time interval from the start time point to the end time point of the measurement. For example, the erythrocyte depolymerization curve is a curve showing the change of transmitted light through the at least part of the blood sample over time during the erythrocyte depolymerization process, and the depolymerization characteristic value can be the mean or standard deviation of the transmitted light intensity during the time interval from the start time point to the end time point of the measurement.

[0249] For example, the theoretical range (i.e., the first judgment threshold range) of the obtained deagglomeration characteristic value can be determined based on the erythrocyte sedimentation rate (ESR) test results, the corrected ESR test results, or the AUC (i.e., the first aggregation characteristic value) of the erythrocyte aggregation curve of the blood sample to be tested. This theoretical range can then be used as the judgment criterion for the deagglomeration characteristic value to determine whether there is a sample anomaly in the blood sample to be tested that would cause abnormal ESR test results. For instance, if the obtained deagglomeration characteristic value exceeds this theoretical range, it indicates that there is a data anomaly in the erythrocyte deagglomeration process of the blood sample to be tested, thus indicating that there is a sample anomaly in the blood sample to be tested that would cause abnormal ESR test results; if the obtained deagglomeration characteristic value does not exceed this theoretical range, it indicates that there is no sample anomaly in the blood sample to be tested that would cause abnormal ESR test results.

[0250] In addition, for some abnormal blood samples to be tested, such as samples with erythrocyte aggregation, when using the erythrocyte aggregation method for erythrocyte sedimentation rate (ESR) testing, since the erythrocytes are already in an aggregated state before re-aggregation, the transmittance level of such samples during the erythrocyte aggregation process is generally higher than that of normal samples during the erythrocyte aggregation process.

[0251] Figure 27This diagram shows a comparison of erythrocyte aggregation curves (in this case, the change in light intensity transmitted through the blood sample over time during aggregation) in abnormal and normal samples exhibiting erythrocyte aggregation. The abnormal and normal samples show practically similar aggregation results. Figure 27 As shown, compared with normal samples that have similar aggregation results, the red blood cell aggregation curves of abnormal samples have higher transmittance and a relatively higher starting point.

[0252] Therefore, based on the aggregation optical data during the aggregation process of erythrocytes in the blood sample to be tested, it can be determined whether there is any sample abnormality in the blood sample that would cause abnormal erythrocyte sedimentation rate (ESR) test results. In other words, the data processing device 640 can determine whether the first erythrocyte sedimentation rate is reliable based on the aggregation optical data.

[0253] As one implementation, the data processing device 640 may determine the reliability of the first erythrocyte sedimentation rate based on the deagglomeration optical data and / or the aggregation optical data, which may include: data processing device 640

[0254] The first aggregation characteristic value is obtained based on the aggregation optical data;

[0255] A second aggregation feature value, different from the first aggregation feature value, is obtained based on the aggregation optical data;

[0256] The second judgment threshold range is determined based on the first aggregation feature value;

[0257] When the second aggregation feature value exceeds the range of the second judgment threshold, it is determined that there is a sample abnormality in the blood sample to be tested that causes the erythrocyte sedimentation rate to be abnormal, that is, the first erythrocyte sedimentation rate is unreliable.

[0258] Here, after obtaining the first and second aggregation characteristic values, it is determined what theoretical range the second aggregation characteristic value of a blood sample with the first aggregation characteristic value should fall within (i.e., determining the second judgment threshold range based on the first aggregation characteristic value). When the second aggregation characteristic value of the blood sample to be tested exceeds this theoretical range, it indicates that there is a sample abnormality in the blood sample to be tested that leads to abnormal erythrocyte sedimentation rate (ESR) test results.

[0259] In some embodiments, please refer to Figure 26 The second aggregation characteristic value can be selected from one of the following parameters: the minimum light intensity L1 of the erythrocyte aggregation curve C during the time period from the measurement start time point T1 to 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 half of the light intensity L2 at the measurement end time point T2.

[0260] Preferably, the second aggregation characteristic value can be the time point T3 corresponding to half of the transmitted light intensity L2 at the measurement end time point T2 (L3=L2 / 2).

[0261] For example, the theoretical range (i.e., the second judgment threshold range) of the obtained second aggregation characteristic value can be determined based on the erythrocyte sedimentation rate (ESR) test result, the corrected ESR test result, or the AUC (i.e., the first aggregation characteristic value) of the erythrocyte aggregation curve of the blood sample to be tested. This theoretical range can then be used as the judgment criterion for the second aggregation characteristic value to determine whether there is a sample anomaly in the blood sample to be tested that would cause abnormal ESR test results. For instance, if the obtained second aggregation characteristic value exceeds this theoretical range, it indicates that there is a data anomaly in the erythrocyte aggregation process of the blood sample to be tested, thus determining that there is a sample anomaly in the blood sample to be tested that would cause abnormal ESR test results; if the obtained second aggregation characteristic value does not exceed this theoretical range, it indicates that there is no sample anomaly in the blood sample to be tested that would cause abnormal ESR test results.

[0262] In some preferred embodiments, the presence of sample abnormalities that would cause abnormal erythrocyte sedimentation rate (ESR) test results can be determined based on the depolymerization optical data during the erythrocyte depolymerization process and the aggregation optical data during the erythrocyte aggregation process in the blood sample to be tested. That is, the data processing module 30 can also be configured to: determine, based on the depolymerization optical data and the aggregation optical data, whether the blood sample to be tested contains sample abnormalities that would cause abnormal ESR test results.

[0263] As one implementation, the data processing device 640 may determine the reliability of the first erythrocyte sedimentation rate based on the deagglomeration optical data and / or the aggregation optical data, which may include: data processing device 640

[0264] First and second aggregation characteristic values, which are different from each other, are obtained based on the aggregation optical data;

[0265] Decoupling characteristic values ​​are obtained based on decoupling optical data;

[0266] The first and second judgment threshold ranges are determined based on the first aggregation feature value;

[0267] When the deagglomeration characteristic value exceeds the first judgment threshold range and the second aggregation characteristic value exceeds the second judgment threshold range, it is determined that there is a sample abnormality in the blood sample to be tested that causes the erythrocyte sedimentation rate to be abnormal, that is, the first erythrocyte sedimentation rate is unreliable.

[0268] Here, after obtaining the first and second aggregation characteristic values, it is determined what theoretical range the deaggregation characteristic value of the blood sample with the first aggregation characteristic value should fall within (i.e., determining the first judgment threshold range based on the first aggregation characteristic value), and it is also determined what theoretical range the second aggregation characteristic value of the blood sample with the first aggregation characteristic value should fall within (i.e., determining the second judgment threshold range based on the first aggregation characteristic value). When both the deaggregation characteristic value and the second aggregation characteristic value of the blood sample to be tested exceed the corresponding theoretical range, it indicates that there is a sample anomaly in the blood sample to be tested that leads to abnormal erythrocyte sedimentation rate (ESR) test results.

[0269] For example, the theoretical range of the obtained deagglomeration characteristic value (i.e., the first judgment threshold range) and the theoretical range of the obtained second aggregation characteristic value (i.e., the second judgment threshold range) can be determined based on the erythrocyte sedimentation rate (ESR) test results, the corrected ESR test results, or the AUC (i.e., the first aggregation characteristic value) of the erythrocyte aggregation curve of the blood sample to be tested. Then, by checking whether both the deagglomeration characteristic value and the second aggregation characteristic value exceed their respective theoretical ranges, it can be determined whether there is a sample anomaly in the blood sample to be tested that would cause abnormal ESR test results. Therefore, this method can more accurately determine whether there is a sample anomaly in the blood sample to be tested that would cause abnormal ESR test results, and the corresponding judgment results are more reliable.

[0270] like Figure 28 As shown, the present invention also provides another method 700 for measuring erythrocyte sedimentation rate (ESR), comprising:

[0271] S710, collects the subject's blood sample for testing;

[0272] S720, the first erythrocyte sedimentation rate of the blood sample to be tested is obtained based on the erythrocyte aggregation method;

[0273] S730, determine whether the first erythrocyte sedimentation rate is reliable;

[0274] S740, when the first erythrocyte sedimentation rate is determined to be reliable, output the first erythrocyte sedimentation rate; and

[0275] S750, when the first erythrocyte sedimentation rate is determined to be unreliable, the blood sample of the subject is automatically re-examined using a erythrocyte sedimentation rate detection device based on the Widmanstätten method to obtain and output the second erythrocyte sedimentation rate of the subject.

[0276] In some embodiments, in step S710, a portion of the blood sample to be tested is drawn from a test tube containing the subject's blood sample, and at least a portion of the blood sample is transported to a first detection tube. In step S720, the at least a 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 a portion of the blood sample, and the deaggregation process is stopped, causing the red blood cells in the at least a portion of the blood sample in the first detection tube to aggregate, so as to acquire deaggregation optical data of the at least a portion of the blood sample during the red blood cell deaggregation process and / or aggregation optical data during the red blood cell aggregation process by optical measurement. Furthermore, in step S730, the reliability of the subject's first erythrocyte sedimentation rate to be obtained based on the deaggregation optical data and / or the aggregation optical data is determined.

[0277] In some embodiments, automatically retesting the subject's blood sample using a Widmanstätten-based erythrocyte sedimentation rate (ESR) detection device to obtain and output the subject's second ESR may include: mixing the remaining blood sample in the test tube, obtaining the degree of sedimentation of the 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 ESR based on the degree of sedimentation.

[0278] In other embodiments, automatically retesting the subject's blood sample using a Widmanstätten-based erythrocyte sedimentation rate (ESR) detection device to obtain and output the subject's second erythrocyte sedimentation rate may include:

[0279] Collect another blood sample from the subject and load the other blood sample into a second testing tube;

[0280] The other portion of the blood sample in the second detection tubing is mixed; and

[0281] The degree of sedimentation of red blood cells in the mixed blood sample within the second detection tube during a predetermined time period after the mixing operation is obtained, and the second red blood cell sedimentation rate is calculated and output based on the sedimentation degree.

[0282] In some embodiments, determining the reliability of the first erythrocyte sedimentation rate based on the depolymerization optical data and / or the aggregation optical data may include:

[0283] The first aggregation feature value is obtained based on the aggregation optical data;

[0284] Based on the decoupling optical data, a decoupling characteristic value is obtained and / or based on the aggregation optical data, a second aggregation characteristic value different from the first aggregation characteristic value is obtained;

[0285] Determine the first judgment threshold range and / or the second judgment threshold range based on the first aggregation feature value;

[0286] When the deagglomeration characteristic value exceeds the first judgment threshold range and / or the second aggregation characteristic value exceeds the second judgment threshold range, the first erythrocyte sedimentation rate is determined to be unreliable.

[0287] Preferably, determining the reliability of the first erythrocyte sedimentation rate based on the depolymerization optical data and / or the aggregation optical data may include:

[0288] Based on the focused optical data, obtain a first and a second focused feature value that are different from each other;

[0289] Depolymerization characteristic values ​​are obtained based on the depolymerization optical data;

[0290] The first and second judgment threshold ranges are determined based on the first aggregation feature value;

[0291] When the deagglomeration characteristic value exceeds the first judgment threshold range and the second aggregation characteristic value exceeds the second judgment threshold range, the first erythrocyte sedimentation rate is determined to be unreliable.

[0292] The erythrocyte sedimentation rate (ESR) measurement method 700 provided by this invention can be particularly applied to the sample analysis system 600 provided by this invention. Therefore, the above-described embodiments and advantages of the sample analysis system 600 provided by this invention are correspondingly applied to the ESR measurement method 700 provided by this invention, and will not be repeated here.

[0293] All features or combinations of features mentioned above in the specification, drawings, and claims, as long as they are meaningful within the scope of this invention and do not contradict each other, can be used in any combination or individually. The advantages and features described for the sample analyzer and sample subsystem provided by this invention are applicable in a corresponding manner to the erythrocyte sedimentation rate (ESR) measurement method, and vice versa.

[0294] The above description is merely a preferred embodiment of the present invention and does not limit the patent scope of the present invention. All equivalent transformations made based on the inventive concept of the present invention and the contents of the specification and drawings of the present invention, or direct / indirect applications in other related technical fields, are included within the patent protection scope of the present invention.

Claims

1. A sample analysis system, comprising a sample dispensing device, a first erythrocyte sedimentation rate (ESR) detection device, a second ESR detection device, and a data processing device, wherein, The sampling and dispensing device is configured to draw a portion of the blood sample to be tested from a test tube containing the subject's blood sample to be tested, and to dispense at least a portion of the blood sample to be tested to the first erythrocyte sedimentation rate (ESR) detection device. The first erythrocyte sedimentation rate (ESR) detection device includes a first detection tube, a power unit, and a first optical detection unit. The first detection tube is configured to receive at least a portion of the blood sample distributed by the sampling and dispensing device. The power unit is configured to deagglomerate the red blood cells in the at least a portion of the blood sample by causing the distributed blood sample to flow back and forth in the first detection tube, and to stop the deagglomeration process, thereby causing the red blood cells in the at least a portion of the blood sample in the first detection tube to aggregate. The first optical detection unit is configured to acquire deagglomeration optical data of the at least a portion of the blood sample during the red blood cell deagglomeration process and / or aggregation optical data during the red blood cell aggregation process. The second erythrocyte sedimentation rate (ESR) detection device includes a second detection tube and a second optical detection component. The second detection tube is configured to receive a blood sample from the subject, and the second optical detection component is configured to obtain the erythrocyte sedimentation rate of the blood sample in the second detection tube based on the Widmanstätten method. The data processing device is configured to determine whether the first erythrocyte sedimentation rate (ESR) obtained by the subject based on the depolymerization optical data and / or the aggregation optical data is reliable, output the first ESR when the first ESR is determined to be reliable, and control the second ESR detection device to re-examine the subject's blood sample based on the Widmanstätten method when the first ESR is determined to be unreliable, so as to obtain and output the subject's second ESR.

2. The sample analysis system according to claim 1, characterized in that, The first erythrocyte sedimentation rate (ESR) detection device and the second ESR detection device are set independently of each other; and / or the sample analysis system further includes a blood analyzer, which includes the sampling dispensing device and the routine blood test device, wherein the first ESR detection device and / or the second ESR detection device are integrated in the blood analyzer.

3. The sample analysis system according to claim 2, characterized in that, The sample analysis system further includes a sample transport device configured to transport the test tube to the sampling dispensing device, so that the sampling dispensing device can aspirate a portion of the blood sample to be tested from the test tube; and The data processing device is also configured to, when it is determined that the first erythrocyte sedimentation rate is unreliable, control the sample transport device to transport the test tube to the second erythrocyte sedimentation rate detection device, so as to control the second erythrocyte sedimentation rate detection device to re-examine the blood sample of the subject.

4. The sample analysis system according to claim 3, characterized in that, The sample transport device is also equipped with a buffer area for transporting test tubes aspirated by the sampling and dispensing device to the sample analysis system; as well as The data processing device controls the sample transport device to transport the test tube to the second erythrocyte sedimentation rate (ESR) detection device, including: the data processing device controls the sample transport device to transfer the test tube from the buffer area to the second ESR detection device.

5. The sample analysis system according to any one of claims 1 to 4, characterized in that, The second erythrocyte sedimentation rate (ESR) detection device also includes a mixing component, configured to mix the blood sample in the second detection pipeline.

6. The sample analysis system according to claim 5, characterized in that, The test tube is used as the second detection conduit; and The data processing device is further configured to, when it is determined that the first erythrocyte sedimentation rate is unreliable: The mixing component is controlled to mix the remaining blood sample in the test tube. The second optical detection component is controlled to acquire the degree of settling of red blood cells in the remaining blood sample in the test tube within a predetermined time period after the mixing operation. The sedimentation rate of the second red blood cell is calculated based on the degree of sedimentation and then output.

7. The sample analysis system according to claim 5, characterized in that, The data processing device is further configured to, when it is determined that the first erythrocyte sedimentation rate is unreliable: The sampling and dispensing device is controlled to collect another portion of the subject's blood sample and load the other portion of the blood sample into the second detection tubing; The mixing component is controlled to perform a mixing operation on the other portion of the blood sample in the second detection pipeline; The second optical detection component is controlled to acquire the degree of settling of red blood cells in the mixed blood sample in the second detection tube within a predetermined time period after the mixing operation; and The sedimentation rate of the second red blood cell is calculated based on the degree of sedimentation and then output.

8. The sample analysis system according to any one of claims 1 to 7, characterized in that, The data processing device determines whether the first erythrocyte sedimentation rate is reliable based on the depolymerization optical data and / or the aggregation optical data, including: the data processing device The first aggregation feature value is obtained based on the aggregation optical data; Based on the decoupling optical data, a decoupling characteristic value is obtained and / or based on the aggregation optical data, a second aggregation characteristic value different from the first aggregation characteristic value is obtained; Determine the first judgment threshold range and / or the second judgment threshold range based on the first aggregation feature value; When the deagglomeration characteristic value exceeds the first judgment threshold range and / or the second aggregation characteristic value exceeds the second judgment threshold range, the first erythrocyte sedimentation rate is determined to be unreliable.

9. The sample analysis system according to claim 8, characterized in that, The data processing device determines whether the first erythrocyte sedimentation rate is reliable based on the depolymerization optical data and / or the aggregation optical data, including: the data processing device Based on the focused optical data, obtain a first and a second focused feature value that are different from each other; Depolymerization characteristic values ​​are obtained based on the depolymerization optical data; The first and second judgment threshold ranges are determined based on the first aggregation feature value; When the deagglomeration characteristic value exceeds the first judgment threshold range and the second aggregation characteristic value exceeds the second judgment threshold range, the first erythrocyte sedimentation rate is determined to be unreliable.

10. 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 subject's blood sample, and at least a portion of the blood sample is transported to a first detection tube. 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; Based on the depolymerization optical data and / or the aggregation optical data, determine whether the first erythrocyte sedimentation rate obtained by the subject based on the aggregation optical data is reliable; When the first erythrocyte sedimentation rate is determined to be reliable, the first erythrocyte sedimentation rate is output. and 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.

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