A sample analysis system, method, apparatus, device, and storage medium

Abstract

Embodiments of the present application disclose a sample analysis system, method, device, equipment and storage medium, the sample analysis system comprises a sampling device, a sample preparation device, a detection device and an analysis device; the sampling device is used for collecting blood samples to be tested of COVID-19 patients at different times; the sample preparation device is used for preparing sample liquids to be tested according to the blood samples to be tested; the detection device is used for detecting the concentration of specific proteins in the sample liquids to be tested; the analysis device is used for analyzing the concentration of specific proteins to obtain an analysis result; when the COVID-19 patient is classified as severe or critical, and a preset change trend appears in the analysis result, the prognosis information and the prompt information of the COVID-19 patient are generated according to the analysis result; the preset change trend includes the trend that the concentration of specific proteins first increases and then decreases, and the prompt information is used for prompting the prognosis information of the COVID-19 patient.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of prognosis, and relates to, but is not limited to, a sample analysis system, method, device, equipment and storage medium. BACKGROUND

[0002] In the related art, three ways can be used to generate prognosis information of COVID-19 patients, wherein, way 1 is to obtain the prognosis information of COVID-19 patients based on the existing diagnosis and treatment scheme, way 2 is to obtain the prognosis information of COVID-19 patients based on the age and underlying diseases of COVID-19 patients, and way 3 is to obtain the prognosis information of COVID-19 patients based on the progressive change index.

[0003] However, way 1 is a judgment on the current condition of the patient, and does not reflect the predictability of prognosis; the prognosis information obtained by way 2 or way 3 is not accurate enough. SUMMARY

[0004] The embodiments of the present application expect to provide a sample analysis system, method, device, equipment and storage medium, which can solve the problems of inaccurate prognosis information and lack of predictability of prognosis in the related art.

[0005] The embodiments of the present application provide a sample analysis system, which comprises a sampling device, a sample preparation device, a detection device and an analysis device; the sampling device is used to collect blood samples to be tested of COVID-19 patients at different times; the sample preparation device is used to prepare sample liquids to be tested according to the blood samples to be tested; the detection device is used to detect the concentration of a specific protein in the sample liquids to be tested.

[0006] The analysis device is used to analyze the concentration of the specific protein to obtain an analysis result; when the type of the COVID-19 patient to which the blood sample to be tested belongs is severe or critical, and the preset change trend appears in the analysis result, the prognosis information and the prompt information of the COVID-19 patient are generated according to the analysis result; the preset change trend includes a trend that the concentration of the specific protein first increases and then decreases, and the prompt information is used to prompt the prognosis information of the COVID-19 patient.

[0007] In some embodiments, the specific protein is C-reactive protein (CRP), D-dimer or interleukin-6.

[0008] In some embodiments, in the case that the specific protein is CRP, the sample liquid to be tested is a whole blood sample, a serum sample or a plasma sample, and the detection device comprises a blood analyzer.

[0009] In the case that the specific protein is D-dimer, the sample liquid to be tested is a plasma sample, and the detection device comprises a biochemical analyzer.

[0010] In the case that the specific protein is interleukin-6, the sample liquid to be tested is a plasma sample or a serum sample, and the detection device comprises an immune analyzer.

[0011] In some embodiments, the analysis device is specifically configured to, when the COVID-19 patient to which the blood sample to be tested belongs is of a severe or critical type, obtain prognosis information of the COVID-19 patient according to the first concentration data, wherein the first concentration data represent at least one concentration value of the specific protein after the preset change trend occurs.

[0012] In some embodiments, the analysis device is specifically configured to, when there is a concentration value greater than a first concentration threshold in the first concentration data, generate prognosis information representing poor prognosis.

[0013] The analysis device is specifically configured to, when all concentration values in the first concentration data are less than a second concentration threshold, generate prognosis information representing good prognosis, wherein the second concentration threshold is less than the first concentration threshold.

[0014] The analysis device is specifically configured to, when the maximum concentration value in the first concentration data is between the first concentration threshold and the second concentration threshold, generate prognosis information representing suspicious prognosis.

[0015] In some embodiments, in the case that the specific protein is CRP, the first concentration threshold is between 45 mg / L and 55 mg / L, and the second concentration threshold is between 15 mg / L and 25 mg / L.

[0016] In some embodiments, the analysis device is further configured to, when the COVID-19 patient to which the blood sample to be tested belongs is of a mild or common type, generate prognosis information and prompt information of the COVID-19 patient according to a change trend of a first specific indicator of the sample liquid to be tested for N consecutive times, wherein N is an integer greater than or equal to 3, and the first specific indicator is CRP, D-dimer, neutrophil to lymphocyte ratio (NLR), interleukin-6 or lymphocyte count (Lym#).

[0017] In some embodiments, when the first specific indicator is CRP, D-dimer, neutrophil / lymphocyte ratio (NLR), or interleukin-6, the analysis device is specifically configured to generate the prognosis information indicating a poor prognosis when the first specific indicator appears N consecutive times of rising;

[0018] When the first specific indicator is lymphocyte count, the analysis device is specifically configured to generate the prognosis information indicating a poor prognosis when the first specific indicator appears N consecutive times of rising.

[0019] The NLR or lymphocyte count of the sample liquid to be tested is detected by the detection device.

[0020] In some embodiments, the analysis device is specifically configured to generate the prognosis information of the COVID-19 patient according to the trend of N consecutive changes of the first specific indicator of the sample liquid to be tested and the second specific indicator of the sample liquid to be tested.

[0021] The second specific indicator is different from the first specific indicator, and the second specific indicator is detected by the detection device.

[0022] In some embodiments, the analysis device is further configured to generate an alarm information after generating the prognosis information indicating a poor prognosis or a suspicious prognosis.

[0023] In some embodiments, the analysis device is further configured to verify the prognosis information based on the second specific indicator of the sample liquid to be tested after generating the prognosis information indicating a poor prognosis or a suspicious prognosis.

[0024] The second specific indicator is different from the specific protein or the first specific indicator, and the second specific indicator is detected by the detection device.

[0025] In some embodiments, the analysis device is specifically configured to generate the prognosis information of the COVID-19 patient according to the analysis result and the second specific indicator of the sample liquid to be tested when a preset trend appears in the analysis result.

[0026] The second specific indicator is different from the specific protein, and the second specific indicator is detected by the detection device.

[0027] In some embodiments, the sample analysis system further comprises a display device.

[0028] The analysis device is further configured to control the display device to display the prompt information.

[0029] In some embodiments, the analysis device is further configured to control the display device to display at least part of the analysis result.

[0030] The embodiments of the present application also provide a sample analysis method, which is applied to the sample analysis system, and the sample analysis system comprises a sampling device, a sample preparation device, a detection device and an analysis device; the sampling device is configured to collect blood samples to be tested of a COVID-19 patient at different times; the sample preparation device is configured to prepare a sample liquid to be tested according to the blood samples to be tested; and the detection device is configured to detect the concentration of a specific protein in the sample liquid to be tested.

[0031] The method comprises: the analysis device analyzes the concentration of the specific protein to obtain an analysis result; when the COVID-19 patient to which the blood sample to be tested belongs is of a severe or critical type, and a preset change trend appears in the analysis result, generating prognosis information and prompt information of the COVID-19 patient according to the analysis result; the preset change trend comprises a trend that the concentration of the specific protein first increases and then decreases, and the prompt information is used to prompt the prognosis information of the COVID-19 patient.

[0032] The embodiments of the present application also provide another sample analysis method, which comprises:

[0033] Obtaining the concentration of a specific protein in a sample liquid to be tested;

[0034] Analyzing the concentration of the specific protein to obtain an analysis result;

[0035] When the COVID-19 patient to which the blood sample to be tested belongs is of a severe or critical type, and a preset change trend appears in the analysis result, generating prognosis information and prompt information of the COVID-19 patient according to the analysis result; the preset change trend comprises a trend that the concentration of the specific protein first increases and then decreases, and the prompt information is used to prompt the prognosis information of the COVID-19 patient.

[0036] In some embodiments, the specific protein is CRP, D-dimer or interleukin-6.

[0037] In some embodiments, when the specific protein is CRP, the sample liquid to be tested is a whole blood sample, a serum sample or a plasma sample;

[0038] When the specific protein is D-dimer, the sample liquid to be tested is a plasma sample;

[0039] In the case that the specific protein is interleukin-6, the sample liquid to be tested is a plasma sample or a serum sample.

[0040] In some embodiments, the generating the prognosis information of the COVID-19 patient according to the analysis result comprises:

[0041] In the case that the COVID-19 patient to which the blood sample to be tested belongs is of a severe or critical type, the prognosis information of the COVID-19 patient is obtained according to the first concentration data, wherein the first concentration data represent at least one concentration value of the specific protein after the preset change trend occurs.

[0042] In some embodiments, the obtaining the prognosis information of the COVID-19 patient according to the first concentration data comprises:

[0043] In the case that there is a concentration value greater than a first concentration threshold in the first concentration data, the prognosis information indicating a poor prognosis is generated.

[0044] In the case that all the concentration values in the first concentration data are less than a second concentration threshold, the prognosis information indicating a good prognosis is generated, wherein the second concentration threshold is less than the first concentration threshold.

[0045] In the case that the maximum concentration value in the first concentration data is between the first concentration threshold and the second concentration threshold, the prognosis information indicating a suspicious prognosis is generated.

[0046] In some embodiments, in the case that the specific protein is CRP, the first concentration threshold is between 45 mg / L and 55 mg / L, and the second concentration threshold is between 15 mg / L and 25 mg / L.

[0047] In some embodiments, the method further comprises:

[0048] In the case that the COVID-19 patient to which the blood sample to be tested belongs is of a mild or common type, the prognosis information and the prompt information of the COVID-19 patient are generated according to the change trend of the first specific indicator of the sample liquid to be tested for consecutive N times, wherein N is an integer greater than or equal to 3, and the first specific indicator is CRP, D-dimer, NLR, interleukin-6, or lymphocyte count.

[0049] In some embodiments, the generating the prognosis information of the COVID-19 patient according to the change trend of the first specific indicator of the sample liquid to be tested for consecutive N times comprises:

[0050] In the case where the first specific indicator is CRP, D-dimer, NLR or interleukin-6, when the first specific indicator appears N consecutive times, the prognosis information indicating a poor prognosis is generated.

[0051] In the case where the first specific indicator is lymphocyte count, when the first specific indicator appears N consecutive times, the prognosis information indicating a poor prognosis is generated.

[0052] In some embodiments, the generating of the prognosis information of the COVID-19 patient according to the change trend of the first specific indicator of the to-be-tested sample liquid for N consecutive times comprises:

[0053] The prognosis information of the COVID-19 patient is generated according to the change trend of the first specific indicator of the to-be-tested sample liquid for N consecutive times and a second specific indicator of the to-be-tested sample liquid; wherein the second specific indicator is an indicator different from the first specific indicator.

[0054] In some embodiments, the method further comprises:

[0055] After the prognosis information indicating a poor prognosis or a suspicious prognosis is generated, an alarm information is generated.

[0056] In some embodiments, the method further comprises:

[0057] After the prognosis information indicating a poor prognosis or a suspicious prognosis is generated, the prognosis information is verified based on a second specific indicator of the to-be-tested sample liquid;

[0058] The second specific indicator is an indicator different from the specific protein or the first specific indicator.

[0059] In some embodiments, the generating of the prognosis information of the COVID-19 patient according to the analysis result comprises:

[0060] When a preset change trend is determined in the analysis result, the prognosis information of the COVID-19 patient is generated according to the analysis result and a second specific indicator of the to-be-tested sample liquid; wherein the second specific indicator is an indicator different from the specific protein.

[0061] In some embodiments, the method further comprises:

[0062] The prompt information is displayed.

[0063] In some embodiments, the method further comprises:

[0064] At least part of the analysis result is displayed.

[0065] The embodiment of the present application also provides a sample analysis device, the device comprising a processor and a memory for storing a computer program capable of running on the processor; wherein,

[0066] The processor is used for running the computer program to execute any one of the sample analysis methods.

[0067] The embodiment of the present application also provides a computer storage medium, which stores a computer program, and the computer program is executed by a processor to implement any one of the sample analysis methods.

[0068] In the embodiment of the present application, the sample analysis system comprises a sampling device, a sample preparation device, a detection device and an analysis device; the sampling device is used for collecting blood samples to be tested of a COVID-19 patient at different times; the sample preparation device is used for preparing sample liquids to be tested according to the blood samples to be tested; the detection device is used for detecting the concentration of a specific protein in the sample liquids to be tested; the analysis device is used for analyzing the concentration of the specific protein to obtain an analysis result; when the COVID-19 patient to which the blood sample to be tested belongs is of a severe or critical type, and a preset change trend appears in the analysis result, generating prognosis information and prompt information of the COVID-19 patient according to the analysis result; the preset change trend comprises a trend that the concentration of the specific protein first increases and then decreases, and the prompt information is used for prompting the prognosis information of the COVID-19 patient. In this way, in the embodiment of the present application, after the preset change trend appears in the analysis result, the prognosis of the COVID-19 patient can be prompted in advance accurately. BRIEF DESCRIPTION OF DRAWINGS

[0069] Figure 1 The structure diagram of the sample analysis system in the embodiment of the present application Figure 1 ;

[0070] Figure 2 The structure diagram of the sample analysis system in the embodiment of the present application Figure 2 ;

[0071] Figure 3 The schematic diagram of the optical detection unit in the embodiment of the present application

[0072] Figure 4 The schematic diagram of the impedance detection unit in the embodiment of the present application

[0073] Figure 5 The structure diagram of the analysis device in the embodiment of the present application

[0074] Figure 6 The schematic diagram of the pipeline system in the embodiment of the present application

[0075] Figure 7A structure diagram of a pretreatment module of an embodiment of the present application;

[0076] Figure 8 A structure diagram of a post-treatment module of an embodiment of the present application;

[0077] Figure 9A A schematic diagram of CRP changes of a severe or critical COVID-19 patient in an embodiment of the present application;

[0078] Figure 9B A schematic diagram of CRP changes of a severe or critical COVID-19 patient in an embodiment of the present application; Figure 9A A schematic diagram of CRP changes of a severe or critical COVID-19 patient after alignment based on the first CRP peak of the patient;

[0079] Figure 10 A schematic diagram of a connection relationship of an expert system, an information system and a laboratory detection instrument in an embodiment of the present application;

[0080] Figure 11 A schematic diagram of a treatment process of a COVID-19 patient in the related art;

[0081] Figure 12 A schematic diagram of a treatment process of a COVID-19 patient after using an expert system in an embodiment of the present application;

[0082] Figure 13 A flowchart of a sample analysis method in an embodiment of the present application;

[0083] Figure 14 A structure diagram of a sample analysis device in an embodiment of the present application. DETAILED DESCRIPTION

[0084] COVID-19 is a pulmonary inflammatory disease caused by a coronavirus; its overall mortality rate in the world is about 6%, but when it develops to a severe or critical stage, the mortality rate can be more than 60%. Therefore, it is necessary to dynamically monitor the condition of a COVID-19 patient during hospitalization, especially to make an early prediction of the prognosis of the patient, so that the clinician can intervene earlier. Here, the prognosis means the prediction of the development process and the final result of a certain disease.

[0085] In the related art, three ways can be used to generate the prognosis prompt information of a COVID-19 patient, which are described below.

[0086] Method 1:

[0087] According to the Diagnosis and Treatment Scheme for Novel Coronavirus Pneumonia, COVID-19 is divided into four types: mild (Mild), moderate (Moderate), severe (Severe) and critical (Critical); which are described below.

[0088] Mild: mild clinical symptoms, no pneumonia on imaging.

[0089] Moderate: fever, respiratory symptoms, and pneumonia on imaging.

[0090] Severe: any of the following in adults: a. respiratory rate (RR) ≥ 30 times / min; b. oxygen saturation ≤ 93% at rest; c. arterial partial pressure of oxygen (PaO2) or oxygen concentration (FiO2) ≤ 300 mmHg; d. lung imaging showing 24-48h progression of lesions > 50%.

[0091] Critical: any of the following: a. respiratory failure requiring mechanical ventilation; b. shock; c. combined with other organ dysfunction requiring intensive care unit (ICU) monitoring and treatment.

[0092] Method 2:

[0093] Using patient age and underlying diseases to determine prognosis information, the older the patient, the worse the prognosis; in the same age group, patients with other underlying diseases have a worse prognosis, such underlying diseases include but are not limited to hypertension, diabetes, chronic kidney disease, hyperglycemia, etc.

[0094] Method 3:

[0095] Based on the progressive change indicators, the prognosis of COVID-19 patients is obtained, for example, a progressive decrease in lymphocyte count (Lym#) indicates a poor prognosis of the patient; a progressive increase in D-dimer and CRP also indicates a poor prognosis of the patient; a progressive increase in NLR also indicates a poor prognosis of the patient.

[0096] As can be seen, method 1 is to judge the patient's condition based on the patient's clinical manifestations, oxygen saturation and lung imaging; when the patient presents clinical manifestations consistent with the classification, the patient's disease classification can be determined. This method is actually a judgment of the patient's current condition and does not reflect the predictability of the prognosis.

[0097] For method 2, since the patient's condition is affected by many factors other than age and underlying diseases, such as the degree of timely admission, treatment measures, medical condition level, etc., it is not scientific to use fixed factors to predict the change of the disease, i.e. only based on the patient's age and underlying diseases, the prognosis information of COVID-19 patients cannot be accurately obtained.

[0098] For mode 3, the progressive change refers to the continuous change of an index in one direction, which emphasizes the change direction of the index, but ignores the change amount and the base level of the index. For example, the normal level of Lym# is (0~1) x 10 9 / L, the change trend of Lym# of patient A is 0.8 x 10 9 / L~1.0 x 10 9 / L~1.2 x 10 9 / L, the change trend of Lym# of patient B is 0.8 x 10 9 / L~0.81 x 10 9 / L~0.82 x 10 9 / L, the change trend of Lym# of patient C is 0.1 x 10 9 / L~0.2 x 10 9 / L~0.3 x 10 9 / L, the Lym# of the three patients can all be considered as progressive rise, but the clinical significance is quite different. In addition, the progressive change of the index requires the doctor to statistically analyze the test results of multiple times in the past, which is a heavy workload for the doctor. The problem of using the progressive change of NLR to judge the prognosis of the patient is that the neutrophil count and lymphocyte count values will change during the treatment process, so there may be different NLR test values at different time points. Using test results at different time points for judgment may produce different prompt results. In summary, the prognosis information obtained by mode 3 is not accurate enough.

[0099] To solve the technical problems in the related art, an embodiment of the present application provides a sample analysis system.

[0100] Figure 1 Structure diagram of the sample analysis system of the embodiment of the present application Figure 1 As shown in Figure 1 , the sample analysis system 100 at least includes a sampling device 110, a sample preparation device 120, a detection device 130 and an analysis device 150.

[0101] The sampling device 110 collects blood samples to be tested at different times of COVID-19 patients; in some embodiments, the sampling device 110 has a pipette (such as a sampling needle) with a pipette nozzle and has a driving part for driving the pipette to quantitatively suck the blood sample to be tested through the pipette nozzle, for example, the sampling needle moves to suck the blood sample to be tested from the sample container containing the blood sample to be tested under the driving of the driving part.

[0102] Figure 2 Structure diagram of the sample analysis system of the embodiment of the present application Figure 2 As shown in Figure 2As shown, in some embodiments, the sample component 11 is the sampling device 110 described above; in some examples, the sample component 11 can include a sample delivery module (SDM) and a front-end track; in other examples, the sample component can also be a sample tray including a plurality of sample sites, such as sample tubes, which can be arranged in a tray structure that can be rotated to dispatch samples to corresponding sites.

[0103] The sample preparation device 120 prepares a sample liquid from the blood sample to be tested. In embodiments of the present application, the sample liquid to be tested can be a whole blood sample, a plasma sample or a serum sample.

[0104] In some embodiments, the blood sample to be tested can be mixed with an anticoagulant, such as ethylenediaminetetraacetic acid disodium salt (EDTA-K2), to obtain a whole blood sample; in some embodiments, the blood sample to be tested can be mixed with an anticoagulant, such as heparin, and the mixed liquid can be subjected to centrifugal treatment to obtain a plasma sample; in some embodiments, the blood sample to be tested can be left to stand or placed in a 37°C environment to promote coagulation, and after the blood sample to be tested coagulates, the supernatant can be obtained by centrifugal treatment to obtain a serum sample.

[0105] In some embodiments, the sample preparation device 120 has at least one reaction cup and a reagent supply device. The at least one reaction cup is configured to receive the blood sample to be tested drawn by the sampling device 110, and the reagent supply device is configured to supply a predetermined processing reagent to the at least one reaction cup, so that the blood sample to be tested drawn by the sampling device 110 and the processing reagent supplied by the reagent supply device are mixed in the reaction cup to prepare the sample liquid to be tested.

[0106] In some embodiments, the predetermined processing reagent can be the anticoagulant described above.

[0107] In some embodiments, the reagent supply device includes a first reagent supply unit for supplying a white blood cell reagent, such as a hemolytic agent capable of dissolving red blood cells in the blood sample and capable of distinguishing different types of white blood cells, and optionally a fluorescent reagent capable of staining white blood cells.

[0108] In some embodiments, the reagent supply device includes a second reagent supply unit for supplying a red blood cell reagent, such as a diluent.

[0109] In other embodiments, the reagent supply device includes a third reagent supply part for supplying a hemoglobin reagent, such as a hemolytic agent capable of dissolving red blood cells in the blood sample, releasing hemoglobin in the red blood cells, and converting the hemoglobin into methemoglobin. In some embodiments, the white blood cell reagent and the hemoglobin reagent are the same hemolytic agent, i.e., the first reagent supply part and the third reagent supply part are the same reagent supply part.

[0110] In some embodiments, the sample preparation device 120 can include a sample dispensing mechanism, a reagent part, a reagent dispensing mechanism, a mixing mechanism, and a reaction part. For example, the sample dispensing mechanism 12 can include a sample needle, which is moved by a two-dimensional or three-dimensional drive mechanism to move in two dimensions or three dimensions in space, so that the sample needle can move to suck the sample carried by the sample part 11 and move to the reaction cup to be added, and discharge the sample to the reaction cup. Figure 3 , the sample dispensing mechanism 12 can include a sample needle, which is moved by a two-dimensional or three-dimensional drive mechanism to move in two dimensions or three dimensions in space, so that the sample needle can move to suck the sample carried by the sample part 11 and move to the reaction cup to be added, and discharge the sample to the reaction cup.

[0111] The reagent part 13 is used to carry reagents. In an embodiment, the reagent part 13 can be a reagent disc, which is arranged in a disc structure and has a plurality of positions for carrying reagent containers. The reagent part 13 can rotate and drive the reagent containers it carries to rotate, so as to rotate the reagent containers to a specific position, such as a position for sucking reagents by the reagent dispensing mechanism 14. The number of reagent parts 13 can be one or more.

[0112] The reagent dispensing mechanism 14 is used to suck reagents and discharge them to the reaction cup to be added reagents. In an embodiment, the reagent dispensing mechanism 14 can include a reagent needle, which is moved by a two-dimensional or three-dimensional drive mechanism to move in two dimensions or three dimensions in space, so that the reagent needle can move to suck the reagents carried by the reagent part 13 and move to the reaction cup to be added reagents, and discharge the reagents to the reaction cup.

[0113] The mixing mechanism 15 is used to mix the reaction liquid in the reaction cup that needs to be mixed. The number of mixing mechanisms 15 can be one or more.

[0114] The reaction part 16 has at least one placement position for placing the reaction cup and incubating the reaction liquid in the reaction cup. For example, the reaction part 16 can be a reaction disc, which is arranged in a disc structure and has one or more placement positions for placing the reaction cup. The reaction disc can rotate and drive the reaction cup in the placement position to rotate, so as to schedule the reaction cup in the reaction disc and incubate the reaction liquid in the reaction cup.

[0115] In some embodiments, the detection device 130 can detect the concentration of a specific protein in the sample liquid to be tested, i.e., the detection device 130 is configured to detect the sample liquid to be tested prepared by the sample preparation device 120 to obtain the concentration of the specific protein.

[0116] In some embodiments, the specific protein is CRP, D-dimer, or interleukin-6.

[0117] In some embodiments, in the case where the specific protein is CRP, the sample liquid to be tested is a whole blood sample, a serum sample, or a plasma sample, and the detection device 130 comprises a blood analyzer, also known as a hematology analyzer; here, the blood analyzer refers to an instrument for detecting CRP, for example, the blood analyzer can be a CRP analyzer, or an instrument that simultaneously has the functions of CRP analysis and blood routine test.

[0118] In the case where the specific protein is D-dimer, the sample liquid to be tested is a plasma sample, and the detection device 130 comprises a biochemical analyzer.

[0119] In the case where the specific protein is interleukin-6, the sample liquid to be tested is a plasma sample or a serum sample, and the detection device 130 comprises an immunoassay analyzer.

[0120] In some embodiments, in the case where the detection device 130 comprises a blood analyzer, the detection device 130 further has an optical detection unit configured to detect the sample liquid prepared from a portion of the blood sample to be tested and a leukocyte reagent supplied from the first reagent supply unit to obtain a leukocyte parameter, and optionally a platelet parameter. For example, Figure 4As shown, the optical detection unit 131 has a light source 1311, a beam shaping component 1312, a first flow cell 1313 and a forward scattering light detector 1314 arranged in sequence on a straight line. On one side of the first flow cell 1313, a dichroic mirror 1316 is arranged at an angle of 45° to the straight line. The side light emitted by the blood cells in the first flow cell 1313, a part of which transmits through the dichroic mirror 1316 and is captured by a fluorescence detector 1315 arranged behind the dichroic mirror 1316 at an angle of 45° to the dichroic mirror 1316, and the other part of the side light is reflected by the dichroic mirror 1316 and captured by a side scattering light detector 1317 arranged in front of the dichroic mirror 1316 at an angle of 45° to the dichroic mirror 1316. According to the forward scattering light signal captured by the forward scattering light detector 1314, the side scattering light signal captured by the side scattering light detector 1317 and the fluorescence signal captured by the fluorescence detector 1315, the white blood cells in the blood sample can be counted and classified, for example, the white blood cells can be classified into at least neutrophils, lymphocytes and monocytes, and optionally further detect the platelet parameters in the sample liquid to be tested, for example, obtain the number of platelets.

[0121] In some embodiments, the detection device 130 includes an impedance detection unit, such as Figure 2As shown, the impedance detection unit 132 is configured to detect the test sample liquid prepared from a portion of the blood sample to be tested and the red blood cell reagent supplied from the second reagent supply unit to obtain red blood cell parameters and platelet parameters. For example, the impedance detection unit 132 is configured as a sheath flow impedance detection unit including a second flow chamber 1321 having a hole 1322 with an electrode 1323. The sheath flow impedance detection unit 132 detects the direct current impedance generated when the particles in the test sample liquid pass through the hole 1322 and outputs an electrical signal reflecting the information when the particles pass through the hole. Specifically, after the blood sample is drawn, the sampling device 110 is driven by the driving device thereof and moved to the reaction cup of the sample preparation device 120, and the drawn blood sample is injected into the reaction cup. The delivery pipeline delivers the test sample liquid treated by the diluent in the reaction cup into the sheath flow impedance detection unit 132, i.e., into the second flow chamber 1321. The sheath flow impedance detection unit 132 can also be provided with a sheath liquid tank not shown for providing sheath liquid to the second flow chamber 1321. In the second flow chamber 1322, the test sample liquid flows under the wrapping of the sheath liquid, and the hole 1322 makes the test sample liquid flow into a thin stream, so that the particles (formed elements) contained in the test sample liquid pass through the hole 1322 one by one. The electrode 1323 is electrically connected to a direct current power supply 1324, and the direct current power supply 1324 provides direct current between the pair of electrodes 1323. During the provision of direct current by the direct current power supply 1324, the impedance between the pair of electrodes 1323 can be detected. The resistance signal representing the change in impedance is amplified by an amplifier 1325 and delivered to the analysis device 150. The size of the resistance signal corresponds to the volume (size) of the particles, so that the red blood cell parameters and platelet parameters of the test sample liquid can be obtained by the analysis device 150 performing signal processing on the resistance signal.

[0122] In some embodiments, the detection device 130 further includes a colorimetric detection unit configured to detect the third test sample liquid prepared from a portion of the blood sample to be tested and the hemoglobin reagent supplied from the third reagent supply unit to obtain hemoglobin parameters.

[0123] In some embodiments, in the case where the detection device 130 includes a blood analyzer, the blood analyzer includes a routine blood measurement module and a CRP measurement module.

[0124] In some embodiments, the blood routine measurement module is configured to provide a measurement site for a sample liquid to be measured, and perform a measurement on the sample liquid to be measured for at least one blood routine parameter and output a measurement result. In a specific embodiment, the blood routine measurement module can be further subdivided into various sub-measurement modules according to measurement needs: a white blood cell (WBC) classification measurement module, a WBC / hemoglobin (HGB) measurement module, and a red blood cell (RBC) / blood platelet (PLT) measurement module. The WBC classification measurement module is configured to provide a site for a sample liquid to be measured to complete a reaction, and measure and obtain a classification result of WBC; the WBC / HGB measurement module is configured to complete measurement of WBC count and morphological parameters, and has a function of measuring HGB; and the RBC / PLT measurement module is configured to complete measurement of RBC and PLT count and morphological parameters. It should be noted that in an actual blood routine measurement process, other blood routine measurement sub-modules can be added, or some of the above sub-modules can be reduced.

[0125] In some embodiments, the CRP measurement module is configured to provide a measurement site for a sample liquid to be measured, and perform a measurement on the sample liquid to be measured for CRP and output a measurement result. After the sample liquid to be measured is distributed to the CRP measurement module, the sample liquid to be measured first reacts with a hemolytic agent added, then a latex reagent is added to the reaction liquid, and finally the reaction liquid to which the latex reagent is added is detected by photoelectric detection for light transmission or light scattering, and a measurement result is output.

[0126] In some embodiments, the detection device 130 includes an immunological analyzer or a biochemical analyzer, and the immunological analyzer or the biochemical analyzer includes a light measurement component 17. Referring to Figure 5 , the light measurement component 17 is configured to perform light measurement on the incubated reaction liquid to obtain reaction data of the sample liquid to be measured. For example, the light measurement component 17 detects the luminescence intensity of the reaction liquid to be measured, and calculates the concentration of the component to be measured in the sample through a calibration curve, etc. In an embodiment, the light measurement component 17 is separately arranged outside the reaction component 16.

[0127] Optionally, the sample analysis system 100 described above further includes a display device 140.

[0128] The display device 140 is configured to display information, and in some embodiments, the display device 140 displays information related to blood routine parameters. In some embodiments, the analysis device 150 includes a processor and a storage medium storing a computer program, and the analysis device 150 is configured to perform the following steps when the computer program is executed by the processor: obtaining prognosis information of a COVID-19 patient according to the concentration of a specific protein.

[0129] In practical applications, the processor in the analysis device 150 can be at least one of an Application Specific Integrated Circuit (ASIC), a Digital Signal Processor (DSP), a Digital Signal Processing Device (DSPD), a Programmable Logic Device (PLD), a Field Programmable Gate Array (FPGA), a Central Processing Unit (CPU), a controller, a microcontroller, or a microcontroller.

[0130] In some embodiments, the analysis device 150 can also be connected to a computer device (e.g., a computer) to display information through a display unit (e.g., a display screen) of the computer device, which falls within the scope of the display device 140 defined and protected by the embodiments of the present application.

[0131] In some embodiments, as Figure 1As shown, the analysis device 150 comprises at least a processing component 151, a Random Access Memory (RAM) 152, a Read-Only Memory (ROM) 153, a communication interface 154, a storage 156 and an Input / Output (I / O) interface 155. The processing component 151, the RAM 152, the ROM 153, the communication interface 154, the storage 156 and the I / O interface 155 communicate through a bus 157. The processing component can be a CPU, a Graphics Processing Unit (GPU) or other chip with computing ability. The storage 156 stores various computer programs for the processing component 151 to execute, such as an operating system and application programs, and data required for executing the computer programs. In addition, data required to be stored locally during blood sample analysis can also be stored in the storage 156. The I / O interface 155 comprises a serial interface such as a Universal Serial Bus (USB) or Institute of Electrical and Electronics Engineers (IEEE) 1394, a parallel interface such as a Small Computer System Interface (SCSI) or Integrated Drive Electronics (IDE), and an analog signal interface comprising a digital-to-analog converter and an analog-to-digital converter. The I / O interface 155 is connected to an input device comprising a keyboard, a mouse, a touch screen or other control buttons, and a user can input data directly to the analysis device 150 using the input device. In addition, the I / O interface 155 can also be connected to a display device 140 having a display function, such as a liquid crystal screen, a touch screen, a Light Emitting Diode (LED) display screen, etc. The analysis device 150 can output processed data in the form of image display data to the display device 140 for display, such as analysis data, instrument operating parameters, etc. The communication interface 154 can be an interface of any communication protocol known in the art. The communication interface 154 communicates with the outside through a network. The analysis device 150 can transmit data with any device connected through the network through the communication interface 154 in a certain communication protocol.

[0132] In some embodiments, as Figure 6As shown, the sample analysis system 100 further comprises a first housing 160 and a second housing 170. The detection device 130 and the analysis device 150 are arranged inside the second housing 170, respectively on two sides of the second housing 170. The sample preparation device 120 is arranged inside the first housing 160. The display device 140 is arranged on the outer surface of the first housing 160.

[0133] In some embodiments, the sample analysis system 100 described above further comprises a blood sample distribution device (not shown) for distributing the blood sample to be tested drawn by the sampling device 110 into different at least two parts of blood sample for preparing the sample liquid to be tested for detecting different blood routine parameters. For example, the blood sample distribution device is used to distribute the blood sample to be tested into a first part of blood sample and a second part of blood sample, the first sample liquid to be tested for detecting white blood cells is prepared from the first part of blood sample and the white blood cell reagent, the second sample liquid to be tested for detecting red blood cells is prepared from the second part of blood sample and the red blood cell reagent, and the third sample liquid to be tested for detecting hemoglobin is optionally prepared from the first part of blood sample or the second part of blood sample and the hemoglobin reagent. Alternatively, the blood sample distribution device is used to distribute the blood sample to be tested into a first part of blood sample, a second part of blood sample and a third part of blood sample, the first sample liquid to be tested for detecting white blood cells is prepared from the first part of blood sample and the white blood cell reagent, the second sample liquid to be tested for detecting red blood cells is prepared from the second part of blood sample and the red blood cell reagent, and the third sample liquid to be tested for detecting hemoglobin is prepared from the third part of blood sample and the hemoglobin reagent. The blood sample distribution device can be configured as a blood distribution valve, for example. Alternatively, the blood sample distribution device can also be the sampling needle of the sampling device 110, in which case the driving part of the sampling device 110 drives the sampling needle to move to the positions of different reaction cups of the sample preparation device 120 to respectively distribute a part of the blood sample to be tested into different reaction cups to react with the corresponding processing reagent.

[0134] In some embodiments, the sampling device 110, the sample preparation device 120, the detection device 130, the display device 140 and the analysis device 150 can be integrated in a pipeline system; Figure 6 A schematic diagram of the pipeline system of the embodiments of the present application is shown in FIG. 1, in which Figure 7As shown, the pipeline system comprises an input module 10, a pre-processing module 20, one or more analysis modules 30, a post-processing module 40, a track 50, a scheduling device 60, an analysis device 150 and a display device 140; wherein the input module 10 is the sampling device 110, the pre-processing module 20 is the sample preparation device 120, and the analysis module 30 comprises the detection device 130; the track 50 is used to connect each module in the pipeline system, such as connecting the input module 10, the pre-processing module 20, the analysis module 30 and the post-processing module 40, etc., the scheduling device 60 schedules the samples to the corresponding module through the track, and the analysis device 150 can also be used to control the working state of the scheduling device 60. It should be noted that the post-processing module 40 and the display device 140 are not necessary in some pipeline systems, and are optional modules.

[0135] In some embodiments, the input module 10 is used to receive the samples put in by the user. The input module 10 in the pipeline system is generally the area where the user puts in the samples, and when the pipeline system is working, the input module 10 can automatically scan the code of the samples put in and sort the samples, etc., for the next module, such as the pre-processing module 20, to process. In an embodiment, the input module 10 has an input area for the user to put in the samples, such as quality control samples and patient samples. In an embodiment, the input module 10 can also identify the sample type, and there are various specific embodiments. In one embodiment, after the input module 10 receives the samples put in by the user, the sample type is identified according to the area where the user puts in the samples or according to the sample rack where the samples are located. For example, it can be pre-set which areas in the input module 10 are for quality control samples and which areas are for patient samples, so that the input module 10 can identify the sample type by identifying which areas the samples are located in. For example, a specific type of sample rack can also be pre-introduced, and the sample type on the sample rack is identified through the sample rack, such as introducing two types of sample racks, each type of sample rack corresponding to one type of sample, such as one type of sample rack corresponding to quality control samples and one type of sample rack corresponding to patient samples, and the input module 10 identifies the sample type on the sample rack by identifying the type of the sample rack, such as by identifying the bar code on the sample rack, to obtain the sample type on the sample rack.

[0136] The pre-processing module 20 is used to complete the pre-processing of the samples. In an embodiment, the sample to be tested is a serum sample, please refer to Figure 8The pre-processing module 20 can include one or more of a centrifugation module 21, a serum detection module 22, a decapping module 23, and a dispensing module 24. The centrifugation module 21 is used to centrifuge the samples to be centrifuged, and the number of centrifugation modules 21 can be one or more. The serum detection module 22 is used to detect whether the serum volume of the sample is sufficient and / or to detect whether the serum quality of the sample is qualified, to determine whether the centrifuged sample can be used for subsequent determination. The decapping module 23 is used to decap the sample after centrifugation is completed. Understandably, in the embodiments of the present application, capping, film covering, decapping, and film uncovering of the sample refer to capping, film covering, decapping, and film uncovering of the sample tube containing the sample. Generally, the sample needs to be decapped after centrifugation, so as to be dispensed or aspirated by the subsequent dispensing module 24 or analysis module. The dispensing module 24 is used to dispense the sample, for example, to divide one sample into multiple samples to be sent into different analysis modules 30 for determination. A general pre-processing flow of the pre-processing module 20 is as follows: the centrifugation module 21 receives the sample dispatched by the input module 10, and centrifuges the sample; the serum detection module 22 detects the serum of the sample after centrifugation, and determines whether it can be used for subsequent determination. If the serum volume is insufficient or the serum quality is unqualified, it cannot be used for subsequent determination. If the detection is passed, the sample is dispatched to the decapping module 23, the decapping module 23 removes the cap of the sample, and if there is a dispensing module 24, the dispensing module 24 dispenses the sample after removal, and then dispatches the dispensed sample to the corresponding analysis module 30 for determination. If there is no dispensing module 24, the sample is dispatched from the decapping module 23 to the corresponding analysis module 30 for determination.

[0137] The analysis module 30 is used to test the sample after centrifugation and decapping. In order to improve efficiency and test throughput, generally, the pipeline system has multiple analysis modules 30, such as biochemical analysis modules, immune analysis modules, and coagulation analysis modules. These analysis modules 30 can be the same analysis module, i.e., the analysis module for determining the same item, or different analysis modules, i.e., the analysis module for determining different items, which can be configured according to the needs of users and departments.

[0138] The post-processing module 40 is used to complete the post-processing of the sample. In an embodiment, please refer to Figure 9AThe post-processing module 40 includes one or more of a film-applying / capping module 41, a cold storage module 42, and a film-removing / capping module 43. The film-applying / capping module 41 is used to apply a film or cap to the sample; the cold storage module 42 is used to store the sample; and the film-removing / capping module is used to remove the film or cap from the sample. A typical post-processing flow for the post-processing module 40 is as follows: after the sample is aspirated in the analysis module 30, it is dispatched to the film-applying / capping module 41, where the sample is filmed or capped after measurement, and then dispatched to the cold storage module 42 for storage. If the sample needs to be retested, it is dispatched from the cold storage module 42, decapped in the film-removing / capping module 43, and then dispatched to the analysis module 30 for measurement.

[0139] The analysis device 150 is used to analyze the concentration of a specific protein and obtain analysis results; when a preset trend of change appears in the analysis results, prognostic information and prompt information for the COVID-19 patient are generated based on the analysis results; the preset trend of change indicates that the concentration of the specific protein first increases and then decreases, and the prompt information is used to indicate the prognostic information of the COVID-19 patient.

[0140] In this embodiment of the invention, during the study of the prognosis of COVID-19 patients, the appearance of a preset trend in the analysis results can accurately indicate the prognosis of COVID-19 patients. In the case where the specific protein is CRP, the process of generating prognostic information based on the preset trend is illustrated below with reference to the accompanying drawings.

[0141] Figure 9A This is a schematic diagram illustrating CRP changes in severe or critically ill COVID-19 patients according to an embodiment of the present invention. Figure 9A As shown, the horizontal axis represents time in days, and the vertical axis represents CRP concentration in mg / L. Figure 9A The line with a solid dot in the middle represents the group with a good prognosis. The group with a good prognosis means that by the set time limit, the condition of severe or critically ill COVID-19 patients has improved or they have recovered and been discharged from the hospital. The group with a good prognosis represents a group of patients with a good prognosis. Figure 9A The line with a black square represents the poor prognosis group. The poor prognosis group indicates that the condition of severe or critically ill COVID-19 patients remains critical or results in death by the set time limit. The poor prognosis group represents a group of patients with a poor prognosis. In some embodiments, the condition of COVID-19 patients can be determined based on the COVID-19 diagnosis and treatment guidelines.

[0142] To eliminate the influence of individual differences and differences in treatment methods, it is possible to Figure 9BBased on this, by aligning the CRP change curves of severe or critically ill COVID-19 patients with the first CRP peak (i.e., the first peak value of CRP concentration) at each patient's first occurrence as a baseline, we can obtain... Figure 9B The diagram shows the CRP variation. Figure 9B In the diagram, the horizontal axis represents time in days, and the vertical axis represents CRP concentration in mg / L. Figure 9A Lines with solid dots indicate a good prognosis, while lines with black squares indicate a poor prognosis.

[0143] from Figure 9B It can be seen that in the first two weeks after the onset of severe or critical COVID-19, the CRP concentration in both groups (good prognosis group and poor prognosis group) showed a trend of first increasing and then decreasing. However, after 4 weeks of illness, the CRP concentration in patients with poor prognosis showed a significant rebound and remained at a high level (>50 mg / L), while the CRP concentration in patients with good prognosis did not rebound.

[0144] from Figure 9A It can be seen that almost all patients showed a trend of CRP concentration first rising and then falling. However, patients with poor prognosis had a significant rebound in CRP concentration after the decrease (>50 mg / L), while patients with good prognosis had a persistently low level of CRP concentration after the decrease (<20 mg / L).

[0145] Combination Figure 9B and Figure 10 The analysis shows that, in this embodiment of the invention, the appearance of a preset trend in the analysis results is beneficial for accurately providing early prognostic guidance for COVID-19 patients.

[0146] In some embodiments, the analysis device 150 is specifically used to obtain prognostic information of a COVID-19 patient based on first concentration data when the COVID-19 patient to which the blood sample belongs is classified as severe or critically ill; wherein the first concentration data represents at least one concentration value of the specific protein after the occurrence of the preset trend. That is, the first concentration data can be all concentration values ​​of the specific protein detected after the occurrence of the preset trend, or it can be a partial concentration value of the specific protein detected after the occurrence of the preset trend.

[0147] In some embodiments, the analysis device 150 is specifically used to generate prognostic information indicating a poor prognosis when there is a concentration value in the first concentration data that is greater than a first concentration threshold.

[0148] The analysis device 150 is specifically configured to generate the prognosis information indicating a good prognosis when all the concentration values in the first concentration data are less than a second concentration threshold value; and the second concentration threshold value is less than the first concentration threshold value.

[0149] The analysis device 150 is specifically configured to generate the prognosis information indicating a suspicious prognosis when the maximum concentration value in the first concentration data is between the first concentration threshold value and the second concentration threshold value.

[0150] In some embodiments, when the specific protein is CRP, the first concentration threshold value is between 45 mg / L and 55 mg / L, and the second concentration threshold value is between 15 mg / L and 25 mg / L. Alternatively, the first concentration threshold value is 50 mg / L, and the second concentration threshold value is 20 mg / L.

[0151] In some embodiments, the analysis device 150 is further configured to verify the prognosis information based on a second specific indicator of the sample liquid to be tested after the prognosis information indicating a poor prognosis or a suspicious prognosis is generated according to the first concentration data.

[0152] The second specific indicator is an indicator different from the specific protein, and the second specific indicator is detected by the detection device from the sample liquid to be tested. For example, the second specific indicator is CRP, D-dimer, NLR, interleukin-6, or lymphocyte count.

[0153] It can be understood that, after the prognosis information indicating a poor prognosis or a suspicious prognosis is generated, verifying the prognosis information based on the second specific indicator of the sample liquid to be tested can determine the credibility and accuracy of the generated prognosis information.

[0154] Of course, in some other embodiments, the detection device 130 further includes a blood gas analyzer that can detect blood lactic acid in the sample liquid to be tested, and the analysis device 150 can generate the prognosis information and the prompt information of the COVID-19 patient according to the concentration of the blood lactic acid in the sample liquid to be tested.

[0155] In some embodiments, the analysis device 150 is further configured to control the display device 140 to display at least part of the analysis result, that is, the analysis device 150 is configured to control the display device 140 to display the analysis result or part of the analysis result; in this way, the analysis result or part of the analysis result can be intuitively displayed.

[0156] In some embodiments, when the COVID-19 patient is classified as a mild or ordinary type, the analysis device 150 is further configured to generate the prognosis information and the prompt information of the COVID-19 patient according to the change trend of the first specific indicator of the sample liquid to be tested for N consecutive times; N is an integer greater than or equal to 3.

[0157] Here, the first specific indicator can be CRP, D-dimer, NLR, interleukin-6, or lymphocyte count; the value of N can be set according to actual needs, for example, N can be set to 3 empirically.

[0158] In actual application, the first specific indicator of the to-be-tested sample liquid can be detected continuously for multiple times, and according to the first specific indicators detected in adjacent two times, the variation trend of the first specific indicator can be determined; after the continuous N+1 first specific indicators of the to-be-tested sample liquid are detected, the variation trend of the first specific indicator for continuous N times can be determined according to the continuous N+1 first specific indicators; here, the continuous N+1 first specific indicators can be represented as the 1st indicator to the N+1th indicator, and the variation trend of the jth indicator to the j+1th indicator when j is 1 to N represents the jth variation trend of the first specific indicator.

[0159] Compared with the manner 3 of the related technology, the prognosis information of the mild or common COVID-19 patient is determined by the progressive variation indicators for multiple times, which is beneficial to more accurately obtain the prognosis information of the mild or common COVID-19 patient.

[0160] In some embodiments, in the case that the first specific indicator is CRP, D-dimer, neutrophil / lymphocyte ratio NLR, or interleukin-6, the analysis device 150 is specifically configured to generate the prognosis information indicating poor prognosis when the first specific indicator appears continuous N times of rising.

[0161] In the case that the first specific indicator is lymphocyte count, the analysis device 150 is specifically configured to generate the prognosis information indicating poor prognosis when the first specific indicator appears continuous N times of rising.

[0162] Here, the NLR or lymphocyte count of the to-be-tested sample liquid is detected by the detection device on the to-be-tested sample liquid.

[0163] In some embodiments, the analysis device 150 is further configured to verify the prognosis information based on a second specific indicator of the to-be-tested sample liquid after the prognosis information indicating poor prognosis is generated according to the first specific indicator.

[0164] Here, the second specific indicator is an indicator different from the specific protein, and the second specific indicator is detected by the detection device on the to-be-tested sample liquid.

[0165] It can be understood that, after the prognosis information indicating poor prognosis is generated, verifying the prognosis information based on the second specific indicator of the to-be-tested sample liquid can determine the credibility and accuracy of the generated prognosis information.

[0166] In some embodiments, the analysis device 150 is further configured to control the display device 140 to display the prompt information. In this way, by intuitively displaying the prompt information, the doctor is facilitated to perform targeted treatment.

[0167] In some embodiments, the analysis device 150 is further configured to generate an alarm information after generating the prognosis information indicating poor prognosis or suspicious prognosis; in one implementation, an alarm signal can be sent to an alarm device connected to the sample analysis system after generating the prognosis information indicating poor prognosis or suspicious prognosis, so as to trigger the alarm device to alarm; in another implementation, the external equipment can obtain the alarm information through interaction with the analysis device; it can be seen that by generating the alarm information, the doctor is facilitated to timely obtain the relevant prompt information.

[0168] In some embodiments, the analysis device 150 is further configured to verify the prognosis information based on a second specific index of the sample liquid to be tested after generating the prognosis information indicating poor prognosis or suspicious prognosis.

[0169] The second specific index is an index different from the specific protein or the first specific index, and the second specific index is detected by the detection device from the sample liquid to be tested. For example, the second specific index is CRP, D-dimer, NLR, interleukin-6 or lymphocyte count.

[0170] In some embodiments, the analysis device 150 is specifically configured to generate the prognosis information of the COVID-19 patient according to the analysis result and the second specific index of the sample liquid to be tested when a preset change trend occurs according to the analysis result.

[0171] It can be seen that by comprehensively considering the analysis result and the second specific index of the sample liquid to be tested, the prognosis information of the patient is more accurately obtained.

[0172] In some embodiments, the analysis device 150 is specifically configured to generate the prognosis information of the COVID-19 patient according to the continuous N times of change trends of the first specific index of the sample liquid to be tested and the second specific index of the sample liquid to be tested after obtaining the continuous N times of change trends of the first specific index.

[0173] It can be seen that by comprehensively considering the continuous N times of change trends of the first specific index of the sample liquid to be tested and the second specific index of the sample liquid to be tested, the prognosis information of the patient is more accurately obtained.

[0174] In some embodiments, the embodiments of the present application can also be implemented based on an expert system, which is an auxiliary system that can automatically review, recheck and alarm the detection result; for details, please refer to Figure 11The expert system 1001 can connect to the information system 1002 and the laboratory testing instrument 1003. The information system can be a hospital information system (HIS) or a laboratory information system (LIS). The information system 1002 can send the disease classification results of COVID-19 patients to the expert system 1001. The laboratory testing instrument 1003 can include a sampling device 110, a sample preparation device 120, and a testing device 130. The laboratory testing instrument 1003 can be used to obtain the test results of the sample liquid to be tested (e.g., the above-mentioned analysis results or the trend of N consecutive changes of a first specific indicator) and send the test results to the expert system 1001. The expert system 1001 can perform the same functions as the above-mentioned analysis device 150, that is, the expert system 1001 can generate prognostic information and prompt information. In some embodiments, the expert system 1001 can also control the alarm device to sound an alarm after generating prognostic information indicating a poor prognosis or a suspicious prognosis. In some embodiments, doctors can review and re-examine the prognostic information and prompt information output by the expert system.

[0175] In other embodiments, the expert system is not limited to the functions described above. For example, the expert system can also judge the reliability of the test results of the sample solution to be tested, and when the test results are determined to be abnormal (the abnormal results include not only results with low reliability, but also results with high reliability but deviating from the normal range), the system can control the alarm device to sound an alarm.

[0176] Figure 11 This is a schematic diagram of the treatment process for COVID-19 patients in related technologies, such as... Figure 12 As shown, if a COVID-19 patient's condition changes after hospitalization, the treatment measures will be changed accordingly. In one specific embodiment, if the condition worsens, the measures taken include, but are not limited to: increasing the dosage of antiviral drugs, upgrading or increasing the dosage of antibiotics, increasing the dosage of hormones, clearing the lesions, and using invasive ventilators or extracorporeal membrane oxygenation (ECMO) technology. If the condition persists, the measures taken include, but are not limited to: maintaining the current treatment measures and providing symptomatic supportive treatment. If the condition improves, the measures taken include, but are not limited to: downgrading or reducing the dosage of antiviral drugs or antibiotics.

[0177] Figure 12 A schematic diagram of the treatment process for COVID-19 patients using an expert system in this embodiment of the invention, as shown below. Figure 13As shown, after using the above expert system, the expert system can output prediction information of the condition change before the patient has a condition change, and then corresponding measures can be taken in advance.

[0178] On the basis of the sample analysis system described in the foregoing embodiments, the embodiments of the present application further propose a sample analysis method, which can be implemented by the above analysis device.

[0179] Figure 13 A flowchart of the sample analysis method of the embodiments of the present application is shown as Figure 14 The flowchart can include the following steps.

[0180] Step 1301: Obtain the concentration of a specific protein in the sample liquid to be tested.

[0181] Step 1302: Analyze the concentration of the specific protein to obtain an analysis result.

[0182] Step 1303: When the COVID-19 patient to which the blood sample to be tested belongs is classified as severe or critical, and a preset change trend appears in the analysis result, generate prognosis information and prompt information of the COVID-19 patient according to the analysis result; the preset change trend includes a trend that the concentration of the specific protein first increases and then decreases, and the prompt information is used to prompt the prognosis information of the COVID-19 patient.

[0183] In some embodiments, the specific protein is CRP, D-dimer, or interleukin-6.

[0184] In some embodiments, when the specific protein is CRP, the sample liquid to be tested is a whole blood sample, a serum sample, or a plasma sample;

[0185] When the specific protein is D-dimer, the sample liquid to be tested is a plasma sample;

[0186] When the specific protein is interleukin-6, the sample liquid to be tested is a plasma sample or a serum sample.

[0187] In some embodiments, the generation of the prognosis information of the COVID-19 patient according to the analysis result includes:

[0188] When the COVID-19 patient to which the blood sample to be tested belongs is classified as severe or critical, obtain the prognosis information of the COVID-19 patient according to first concentration data; wherein the first concentration data represents at least one concentration value of the specific protein after the preset change trend appears.

[0189] In some embodiments, the obtaining of the prognosis information of the COVID-19 patient according to the first concentration data includes:

[0190] generating prognosis information indicating a poor prognosis when there is a concentration value in the first concentration data that is greater than a first concentration threshold;

[0191] generating prognosis information indicating a good prognosis when all concentration values in the first concentration data are less than a second concentration threshold; wherein the second concentration threshold is less than the first concentration threshold;

[0192] generating prognosis information indicating a questionable prognosis when a maximum concentration value in the first concentration data is between the first concentration threshold and the second concentration threshold.

[0193] In some embodiments, when the specific protein is CRP, the first concentration threshold is between 45 mg / L and 55 mg / L, and the second concentration threshold is between 15 mg / L and 25 mg / L.

[0194] In some embodiments, the method further comprises:

[0195] generating prognosis information and prompt information of the COVID-19 patient according to a change trend of the first specific indicator of the to-be-tested sample liquid for consecutive N times when the COVID-19 patient to which the to-be-tested blood sample belongs is of a mild or common type; N is an integer greater than or equal to 3; and the first specific indicator is CRP, D-dimer, NLR, interleukin-6, or lymphocyte count.

[0196] In some embodiments, the generating prognosis information of the COVID-19 patient according to the change trend of the first specific indicator of the to-be-tested sample liquid for consecutive N times comprises:

[0197] generating prognosis information indicating a poor prognosis when the first specific indicator appears consecutive N times of rising when the first specific indicator is CRP, D-dimer, NLR, or interleukin-6.

[0198] generating prognosis information indicating a poor prognosis when the first specific indicator appears consecutive N times of rising when the first specific indicator is lymphocyte count.

[0199] In some embodiments, the generating prognosis information of the COVID-19 patient according to the change trend of the first specific indicator of the to-be-tested sample liquid for consecutive N times comprises:

[0200] generating prognosis information of the COVID-19 patient according to a change trend of the first specific indicator of the to-be-tested sample liquid for consecutive N times and a second specific indicator of the to-be-tested sample liquid; wherein the second specific indicator is different from the first specific indicator.

[0201] In some embodiments, the method further comprises:

[0202] generating an alarm information after generating the prognosis information indicating poor prognosis or suspicious prognosis.

[0203] In some embodiments, the method further comprises:

[0204] verifying the prognosis information based on a second specific index of the sample liquid to be tested after generating the prognosis information indicating poor prognosis or suspicious prognosis.

[0205] The second specific index is different from the specific protein or the first specific index.

[0206] In some embodiments, the generating the prognosis information of the COVID-19 patient according to the analysis result comprises:

[0207] generating the prognosis information of the COVID-19 patient according to the analysis result and a second specific index of the sample liquid to be tested when the preset change trend appears in the analysis result, wherein the second specific index is different from the specific protein.

[0208] In some embodiments, the method further comprises:

[0209] displaying the prompt information.

[0210] In some embodiments, the method further comprises:

[0211] displaying at least part of the analysis result.

[0212] It should be noted that the implementation of the sample analysis method of the embodiments of the present application has been described in the foregoing embodiments of the sample analysis system, and will not be repeated here.

[0213] It can be seen that in the embodiments of the present application, the concentration of the specific protein is analyzed to obtain an analysis result; when the COVID-19 patient to which the sample to be tested belongs to a severe or critical type and a preset change trend appears in the analysis result, the prognosis information and the prompt information of the COVID-19 patient are generated according to the analysis result. In this way, in the embodiments of the present application, after the preset change trend appears in the analysis result, the prognosis of the COVID-19 patient can be accurately prompted in advance.

[0214] The computer program instructions corresponding to the sample analysis method in the embodiment of the present application can be stored on a storage medium such as an optical disc, a hard disk, a U disk, etc. When the computer program instructions corresponding to the sample analysis method in the storage medium are read by an electronic device or executed, any one of the sample analysis methods of the foregoing embodiments is realized. The storage medium can be a volatile or non-volatile storage medium.

[0215] Based on the same technical concept as the foregoing embodiments, the sample analysis device provided in the embodiments of the present application is provided. Figure 14 The sample analysis device in the embodiments of the present application is shown in the structural schematic diagram. ​ The sample analysis device 1400 can include a memory 1401 and a processor 1402; wherein,

[0216] The memory 1401 is configured to store computer programs and data.

[0217] The processor 1402 is configured to execute the computer programs stored in the memory to realize any one of the sample analysis methods of the foregoing embodiments.

[0218] In actual applications, the memory 1401 can be a volatile memory such as RAM, or a non-volatile memory such as ROM, a flash memory, a hard disk (HDD) or a solid-state disk (SSD), or a combination of the above types of memories, and provide instructions and data to the processor 1402.

[0219] The processor 1402 can be at least one of an ASIC, a DSP, a DSPD, a PLD, an FPGA, a CPU, a controller, a microcontroller, and a microprocessor. It can be understood that for different sample analysis devices, the electronic devices used to realize the functions of the processor can also be other electronic devices, and the embodiments of the present application do not make specific limitations.

[0220] Based on the sample analysis system described in the foregoing embodiments, another sample analysis method is further provided in the embodiments of the present application. The sample analysis method can be applied to the sample analysis system described above, which includes a sampling device, a sample preparation device, a detection device, and an analysis device. The sampling device is configured to collect blood samples to be tested of a COVID-19 patient at different times. The sample preparation device is configured to prepare a sample liquid to be tested according to the blood samples to be tested. The detection device is configured to detect the concentration of a specific protein in the sample liquid to be tested.

[0221] The foregoing another sample analysis method can include:

[0222] The analysis device analyzes the concentration of the specific protein to obtain an analysis result; when the COVID-19 patient to which the blood sample to be tested belongs is of a severe or critical type, and a preset change trend appears in the analysis result, the analysis result is used to generate prognosis information and prompt information of the COVID-19 patient; the preset change trend includes a trend that the concentration of the specific protein first increases and then decreases, and the prompt information is used to prompt the prognosis information of the COVID-19 patient.

[0223] In the above another sample analysis method, the specific implementation modes of the sampling device, the sample preparation device, the detection device and the analysis device have been described in the foregoing embodiment description, and will not be repeated here.

[0224] The above description of each embodiment tends to emphasize the differences between each embodiment, and the same or similar parts can be mutually referred to, and for the sake of brevity, will not be repeated here

[0225] The methods disclosed in the various method embodiments provided in the present application can be combined in any manner without conflict to obtain new method embodiments.

[0226] The features disclosed in the various product embodiments provided in the present application can be combined in any manner without conflict to obtain new product embodiments.

[0227] The features disclosed in the various method or device embodiments provided in the present application can be combined in any manner without conflict to obtain new method or device embodiments.

[0228] From the above description of the embodiments, those skilled in the art can clearly understand that the above-mentioned embodiment methods can be realized by means of software and necessary general hardware platforms, of course, they can also be realized by hardware, but in many cases, the former is a better embodiment. Based on this understanding, the technical solutions of the present application or the parts that contribute to the prior art can be embodied in the form of software products, which are stored in a storage medium (such as ROM / RAM, magnetic disk, optical disk) and include a plurality of instructions to make a terminal (which can be a mobile phone, computer, server, air conditioner, or network device, etc.) execute the methods described in various embodiments of the present application.

[0229] The embodiments of the present application are described above with reference to the accompanying drawings, but the present application is not limited to the above-described specific embodiments, and the above-described specific embodiments are merely illustrative, but not restrictive, and a person of ordinary skill in the art can make many forms under the inspiration of the present application without departing from the purpose of the present application and the scope protected by the claims, and these all belong to the protection of the present application.

Claims

1. A sample analysis system, characterized by, The system includes a sampling device, a sample preparation device, a detection device, and an analysis device; the sampling device is used to collect blood samples from COVID-19 patients at different times; the sample preparation device is used to prepare a test sample solution based on the blood samples; and the detection device is used to detect the concentration of a specific protein in the test sample solution. The analytical device is used to analyze the concentration of a specific protein in the blood sample to be tested at different times, and to obtain analytical results; the analytical results reflect the change in the concentration of the specific protein over time. When the COVID-19 patient to whom the blood sample to be tested belongs is classified as severe or critical, and a preset trend of change appears in the analysis results, prognostic information and prompt information for the COVID-19 patient are generated based on the first concentration data in the analysis results; The preset trend of change includes a trend in which the concentration of the specific protein first increases and then decreases, and the first concentration data represents at least one concentration value of the specific protein after the preset trend of change occurs; When the COVID-19 patient to whom the blood sample to be tested belongs is classified as mild or moderate, prognostic information and warning information for the COVID-19 patient are generated based on the N consecutive changes in a first specific indicator of the sample fluid and a second specific indicator of the sample fluid; wherein, N is an integer greater than or equal to 3; the first specific indicator is CRP, D-dimer, neutrophil / lymphocyte ratio (NLR), interleukin-6, or lymphocyte count; the second specific indicator is an indicator different from the specific protein or the first specific indicator, and the second specific indicator is obtained by the detection device from the sample fluid to be tested; The notification information is used to provide prognostic information for the COVID-19 patient; The analytical device is specifically used to generate prognostic information indicating a poor prognosis when there is a concentration value in the first concentration data that is greater than a first concentration threshold. The analytical device is specifically used to generate prognostic information indicating a good prognosis when all concentration values ​​in the first concentration data are less than a second concentration threshold; wherein the second concentration threshold is less than the first concentration threshold. The analytical device is specifically used to generate prognostic information indicating a suspicious prognosis when the maximum concentration value in the first concentration data is between the first concentration threshold and the second concentration threshold.

2. The system of claim 1, wherein, The specific protein is C-reactive protein (CRP), D-dimer, or interleukin-6.

3. The system of claim 2, wherein, When the specific protein is CRP, the sample solution to be tested is a whole blood sample, serum sample, or plasma sample, and the detection device includes a blood analyzer; In the case that the specific protein is a D-dimer, the sample solution to be tested is a plasma sample, and the detection device includes a biochemical analyzer; In the case where the specific protein is interleukin-6, the sample solution to be tested is a plasma sample or a serum sample, and the detection device includes an immunoassay analyzer.

4. The system of claim 1, wherein, When the specific protein is CRP, the first concentration threshold is between 45 mg / L and 55 mg / L, and the second concentration threshold is between 15 mg / L and 25 mg / L.

5. The system of claim 1, wherein, When the first specific indicator is CRP, D-dimer, neutrophil / lymphocyte ratio (NLR), or interleukin-6, the analytical device is specifically used to generate prognostic information indicating a poor prognosis when the first specific indicator shows a continuous increase for N times. When the first specific indicator is lymphocyte count, the analysis device is specifically used to generate prognostic information indicating a poor prognosis when the first specific indicator shows a continuous increase for N times. The NLR or lymphocyte count of the sample solution to be tested is obtained by the detection device from the sample solution to be tested.

6. The system of claim 1 or 5, wherein, The analysis device is also used to generate alarm information after generating prognostic information indicating a poor or doubtful prognosis.

7. The system of claim 1 or 5, wherein, The analytical device is also used to verify the prognostic information based on a second specific indicator of the test sample solution after generating prognostic information indicating a poor or suspicious prognosis.

8. The system of claim 1, wherein, It also includes a display device; The analysis device is also used to control the display device to display the prompt information.

9. The system of claim 1, wherein, It also includes a display device; The analysis device is also used to control the display device to display at least a portion of the analysis results.

10. A sample analysis method, characterized in that, This invention is applied to a sample analysis system, which includes a sampling device, a sample preparation device, a detection device, and an analysis device. The sampling device is used to collect blood samples from COVID-19 patients at different times. The sample preparation device is used to prepare a sample solution based on the blood samples. The detection device is used to detect the concentration of a specific protein in the sample solution to be tested; The method includes: the analytical device analyzing the concentration of a specific protein in the blood sample to be tested at different times to obtain analytical results; the analytical results reflect the change in the concentration of the specific protein over time; When the COVID-19 patient to whom the blood sample to be tested belongs is classified as severe or critical, and a preset trend of change appears in the analysis results, prognostic information and prompt information for the COVID-19 patient are generated based on the first concentration data in the analysis results; the preset trend of change includes a trend of the concentration of the specific protein first increasing and then decreasing, and the first concentration data represents at least one concentration value of the specific protein after the preset trend of change appears. When the COVID-19 patient to whom the blood sample to be tested belongs is classified as mild or moderate, prognostic information and warning information for the COVID-19 patient are generated based on the N consecutive changes in a first specific indicator of the sample fluid and a second specific indicator of the sample fluid; wherein, N is an integer greater than or equal to 3; the first specific indicator is CRP, D-dimer, neutrophil / lymphocyte ratio (NLR), interleukin-6, or lymphocyte count; the second specific indicator is an indicator different from the specific protein or the first specific indicator, and the second specific indicator is obtained by the detection device from the sample fluid to be tested; The notification information is used to provide prognostic information for the COVID-19 patient; The process of obtaining prognostic information for the COVID-19 patient based on the first concentration data includes: When there is a concentration value in the first concentration data that is greater than the first concentration threshold, prognostic information indicating a poor prognosis is generated; When all concentration values ​​in the first concentration data are less than the second concentration threshold, prognostic information indicating a good prognosis is generated; wherein the second concentration threshold is less than the first concentration threshold; When the maximum concentration value in the first concentration data is between the first concentration threshold and the second concentration threshold, prognostic information indicating a doubtful prognosis is generated.

11. A sample analysis method, characterized in that, The method includes: The concentration of a specific protein in the test sample solution at different times is obtained; the test sample solution is prepared based on the blood sample to be tested; The concentration of the specific protein was analyzed to obtain analytical results; the analytical results show the change in the concentration of the specific protein over time. When the COVID-19 patient to whom the blood sample to be tested belongs is classified as severe or critical, and a preset trend of change appears in the analysis results, prognostic information and prompt information for the COVID-19 patient are generated based on the first concentration data in the analysis results; the preset trend of change includes a trend of the concentration of the specific protein first increasing and then decreasing, and the first concentration data represents at least one concentration value of the specific protein after the preset trend of change appears; When the COVID-19 patient to whom the blood sample to be tested belongs is classified as mild or moderate, prognostic information and warning information for the COVID-19 patient are generated based on the N consecutive changes in a first specific indicator of the sample fluid and a second specific indicator of the sample fluid; wherein, N is an integer greater than or equal to 3; the first specific indicator is CRP, D-dimer, neutrophil / lymphocyte ratio (NLR), interleukin-6, or lymphocyte count; the second specific indicator is an indicator different from the specific protein or the first specific indicator. The notification information is used to provide prognostic information for the COVID-19 patient; The process of obtaining prognostic information for the COVID-19 patient based on the first concentration data includes: When there is a concentration value in the first concentration data that is greater than the first concentration threshold, prognostic information indicating a poor prognosis is generated; When all concentration values ​​in the first concentration data are less than the second concentration threshold, prognostic information indicating a good prognosis is generated; wherein the second concentration threshold is less than the first concentration threshold; When the maximum concentration value in the first concentration data is between the first concentration threshold and the second concentration threshold, prognostic information indicating a doubtful prognosis is generated.

12. The method according to claim 11, characterized in that, The specific protein is C-reactive protein (CRP), D-dimer, or interleukin-6.

13. The method according to claim 11, characterized in that, When the specific protein is CRP, the first concentration threshold is between 45 mg / L and 55 mg / L, and the second concentration threshold is between 15 mg / L and 25 mg / L.

14. The method according to claim 11, characterized in that, The method further includes: After generating prognostic information indicating a poor or questionable prognosis, the prognostic information is verified based on a second specific indicator of the test sample solution.

15. A sample analysis device, characterized in that, The device includes a processor and a memory for storing computer programs capable of running on the processor; wherein, The processor is used to run the computer program to perform the method according to any one of claims 11 to 14.

16. A computer storage medium having a computer program stored thereon, characterized in that, When the computer program is executed by a processor, it implements the method described in any one of claims 11 to 14.

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