A sample analysis device and a sample analysis method

Abstract

A sample analysis device and a sample analysis method for sucking a sample from a sample container filled with normal plasma and dispensing into a fifth buffer container, incubating for a predetermined time under certain conditions; sucking the incubated sample from the fourth buffer container and the fifth buffer container respectively and dispensing into a seventh reaction container, adding a coagulation time determination reagent to the seventh reaction container to prepare a seventh test sample. The present application has very good effect on identifying such as micro-clotting factor inhibitor by designing and introducing the seventh coagulation item into the full-automatic correction test.

Description

TECHNICAL FIELD

[0001] The present application relates to a sample analysis device and a sample analysis method. BACKGROUND

[0002] Blood coagulation is the process of blood changing from a liquid state to a gel state, and measuring blood coagulation time is of great significance to grasp blood information and understand the state of hemostatic function. When it is confirmed that the blood coagulation time is prolonged, the mixed plasma correction test is an important means to identify the cause of the prolonged coagulation time. The mixed plasma correction test (also known as: mixing test, correction test) is a screening test in which, after excluding the use of anticoagulants by the patient, the patient's plasma is mixed with normal mixed plasma (hereinafter referred to as: normal plasma) according to a certain proportion, and the coagulation time is re-detected. Since the APTT (activated partial thromboplastin time) test can screen the most types of coagulation factors and coagulation inhibitors, and the most common cause of unexplained APTT prolongation in clinical practice, the mixed plasma correction test is mainly applied to APTT, and can also be applied to prothrombin time (PT), thrombin time (TT), kaolin coagulation time (KCT), and dRVVT (dilute Russell viper venom time).

[0003] The suspected causes of prolonged coagulation time are mainly divided into two categories: a. congenital coagulation factor deficiency or abnormality leading to congenital coagulopathy (hereinafter referred to as coagulation factor deficiency), and patients with moderate to severe coagulation factor deficiency have bleeding symptoms; b. acquired coagulation inhibition caused by autoantibodies that inhibit coagulation. In the mixed plasma correction test, congenital coagulopathy can be corrected by normal mixed plasma, and the coagulation time is shortened or even returned to normal level, while acquired coagulation inhibition cannot be corrected due to the presence of inhibitors. The state of patients with acquired coagulation inhibition varies depending on the difference in autoantibodies. For example, patients with autoantibodies against coagulation factors (coagulation factor antibodies, or coagulation factor inhibitors) have a risk of bleeding or bleeding symptoms, and patients with autoantibodies against phospholipids, including lupus anticoagulant (LA), although the phospholipids necessary for the coagulation process are inhibited, the patients often present with thrombotic symptoms. Therefore, it is of great significance in clinical practice to distinguish between coagulation factor inhibitors and lupus anticoagulants. Whether it is coagulation factor deficiency, or coagulation factor inhibitor, lupus anticoagulant will cause coagulation time to be prolonged, and it is difficult to distinguish between them only by coagulation time screening test.

[0004] Currently, there are instruments for identifying prolonged coagulation time of patients through correction tests, but they have disadvantages such as inconvenient operation (e.g. manual incubation of samples, etc.) and poor effect. SUMMARY

[0005] To solve at least one of the above problems, the present application provides a sample analysis device and a sample analysis method, which will be described in detail below.

[0006] According to a first aspect, a sample analysis apparatus is provided in one embodiment including:

[0007] a reaction container loading section for supplying a container; the container including a reaction container and / or a buffer container;

[0008] a sample loading section for supplying a sample container for holding a sample, wherein the sample is patient plasma or normal plasma;

[0009] a sample dispensing section for taking up the sample in the sample container and dispensing it into the reaction container or the buffer container;

[0010] a reagent holding section for holding a reagent container; the reagent container for holding a reagent; the reagent including a reagent for coagulation time measurement;

[0011] a reagent dispensing section for taking up the reagent from the reagent container and dispensing it into the reaction container;

[0012] a reaction section for incubating the reaction container and / or the buffer container holding the sample, and for incubating the reaction container holding the sample and the reagent;

[0013] a scheduling mechanism for scheduling the reaction container and the buffer container; the scheduling mechanism capable of scheduling the reaction container to the reaction section, and capable of scheduling the buffer container to the reaction section;

[0014] a measurement section for measuring a test sample mixed from the sample and the reagent;

[0015] wherein:

[0016] the sample dispensing section takes up the patient plasma from a sample container holding the patient plasma and the normal plasma from a sample container holding the normal plasma, and dispenses them into a third reaction container to form a mixed plasma, and the reagent dispensing section takes up the reagent for coagulation time measurement from the reagent container, and adds the reagent for coagulation time measurement to the third reaction container to prepare a third test sample;

[0017] The sample dispensing part sucks the patient plasma from the sample container containing the patient plasma and dispenses it into a sixth buffer container, and the reaction part incubates the mixed plasma in the sixth buffer container at a temperature of 30 to 45°C for 0.5 to 4 hours, wherein the sixth buffer container is dispatched to the reaction part by the dispatch mechanism; the sample dispensing part sucks the incubated mixed plasma from the sixth buffer container and dispenses it into a sixth reaction container, and the reagent dispensing part sucks the reagent for coagulation time measurement from the reagent container and adds the reagent for coagulation time measurement to the sixth reaction container to prepare a sixth test sample;

[0018] The sample dispensing part sucks the patient plasma from the sample container containing the patient plasma and dispenses it into a fourth buffer container, and the reaction part incubates the patient plasma in the fourth buffer container at a temperature of 30 to 45°C for 0.5 to 4 hours, wherein the fourth buffer container is dispatched to the reaction part by the dispatch mechanism; the sample dispensing part sucks the normal plasma from the sample container containing the normal plasma and dispenses it into a fifth buffer container, and the reaction part incubates the normal plasma in the fifth buffer container at a temperature of 30 to 45°C for 0.5 to 4 hours, wherein the fifth buffer container is dispatched to the reaction part by the dispatch mechanism; the sample dispensing part sucks the incubated patient plasma and normal plasma from the fourth buffer container and the fifth buffer container, respectively, and dispenses them into a seventh reaction container, and the reagent dispensing part sucks the reagent for coagulation time measurement from the reagent container and adds the reagent for coagulation time measurement to the seventh reaction container to prepare a seventh test sample;

[0019] The determination part determines a third coagulation time from the third test sample, a sixth coagulation time from the sixth test sample, and a seventh coagulation time from the seventh test sample.

[0020] In one embodiment:

[0021] The sample dispensing part also sucks the incubated patient plasma from the fourth buffer container and dispenses it into a fourth reaction container, and the reagent dispensing part sucks the reagent for coagulation time measurement from the reagent container and adds the reagent for coagulation time measurement to the fourth reaction container to prepare a fourth test sample;

[0022] The sample dispensing part also sucks the incubated normal plasma from the fifth buffer container and dispenses it into a fifth reaction container, and the reagent dispensing part sucks the reagent for coagulation time measurement from the reagent container and adds the reagent for coagulation time measurement to the fifth reaction container to prepare a fifth test sample.

[0023] The measuring unit is further configured to measure the fourth test sample to obtain a fourth clotting time and measure the fifth test sample to obtain a fifth clotting time.

[0024] In one embodiment, the sample dispensing component dispenses the patient plasma in the fourth buffer container to the reaction component at a temperature of 30-45℃ for incubation.

[0025] After the sample dispensing component draws the incubated patient plasma from the fourth buffer container, the reaction component continues to incubate the patient plasma in the fourth buffer container at a temperature of 30-45℃, so that the patient plasma in the fourth buffer container can be used for re-inspection; and / or,

[0026] After the sample dispensing component draws the incubated normal plasma from the fifth buffer container, the reaction component continues to incubate the normal plasma in the fifth buffer container at a temperature of 30-45℃, so that the normal plasma in the fifth buffer container can be used for re-inspection; and / or,

[0027] After the sample dispensing component draws the incubated mixed plasma from the sixth buffer container, the reaction component continues to incubate the mixed plasma in the sixth buffer container at a temperature of 30-45℃, so that the mixed plasma in the sixth buffer container can be used for re-inspection.

[0028] In one embodiment, the sample dispensing component dispenses the mixed plasma in the third reaction container to the third reaction component in a third amount, the sample dispensing component dispenses the mixed plasma in the sixth buffer container to the reaction component in a sixth amount, and the sample dispensing component dispenses the patient plasma in the fourth buffer container and the normal plasma in the fifth buffer container to the reaction component in a seventh amount; the seventh amount is greater than the third amount, and the sixth amount is greater than the third amount.

[0029] In one embodiment, the seventh amount is five to six times the third amount, and the sixth amount is five to six times the third amount.

[0030] In one embodiment, the sample analysis device further comprises a water supplementing device configured to supplement water to at least one of the fourth buffer container, the fifth buffer container, and the sixth buffer container according to a preset water supplementing time interval and a preset water supplementing amount.

[0031] In one embodiment, the depth-diameter ratio of the fourth buffer container is greater than a depth-diameter ratio threshold, the depth-diameter ratio of the fifth buffer container is greater than the depth-diameter ratio threshold, and the depth-diameter ratio of the sixth buffer container is greater than the depth-diameter ratio threshold; the depth-diameter ratio threshold is greater than 5.

[0032] In one embodiment, the sample dispensing component dispenses the patient plasma in the fourth buffer container to the reaction component at a temperature of 30-45℃ for incubation.

[0033] The sample dispensing component also sucks the patient plasma from the sample container containing the patient plasma and dispenses the patient plasma into a first reaction container, and the reagent dispensing component also sucks the reagent for coagulation time determination from the reagent container and adds the reagent for coagulation time determination to the first reaction container to prepare a first test sample;

[0034] The sample dispensing component also sucks the normal plasma from the sample container containing the normal plasma and dispenses the normal plasma into a second reaction container, and the reagent dispensing component also sucks the reagent for coagulation time determination from the reagent container and adds the reagent for coagulation time determination to the second reaction container to prepare a second test sample;

[0035] The determination component is also configured to determine a first coagulation time of the first test sample and a second coagulation time of the second test sample.

[0036] In one embodiment, the sample analysis device further comprises a processor configured to determine a coagulation time prolongation cause of the patient plasma according to the sixth coagulation time and the seventh coagulation time.

[0037] In one embodiment, the sample analysis device further comprises a processor configured to determine a coagulation time prolongation cause of the patient plasma according to the first coagulation time, the second coagulation time, the third coagulation time, the fourth coagulation time, the fifth coagulation time, the sixth coagulation time and the seventh coagulation time.

[0038] In one embodiment, the fourth buffer container, the fifth buffer container, the sixth buffer container, the third reaction container, the sixth reaction container and the seventh reaction container have the same structure, so that the fourth buffer container, the fifth buffer container and the sixth buffer container can be scheduled to the reaction component for incubation.

[0039] In one embodiment, the determination component is an optical detection component, a double-magnetic-bead detection component or an optical-magnetic integrated detection component.

[0040] According to a second aspect, one embodiment provides a sample analysis device, comprising:

[0041] a test sample preparation component configured to:

[0042] suck the patient plasma and the normal plasma from the sample container containing the patient plasma and the sample container containing the normal plasma respectively, and dispense the patient plasma and the normal plasma into a third reaction container to form a mixed plasma, and add a reagent for coagulation time determination to the third reaction container to prepare a third test sample;

[0043] The patient plasma and the normal plasma are respectively sucked from the sample container containing the patient plasma and the sample container containing the normal plasma, and are separately injected into a sixth buffer container to form mixed plasma. The mixed plasma in the sixth buffer container is incubated at a temperature of 30-45°C for 0.5-4 hours in the sample preparation unit. The incubated mixed plasma is sucked from the sixth buffer container and is separately injected into a sixth reaction container. The coagulation time determination reagent is added to the sixth reaction container to prepare a sixth sample.

[0044] The patient plasma is sucked from the sample container containing the patient plasma and is separately injected into a fourth buffer container. The patient plasma in the fourth buffer container is incubated at a temperature of 30-45°C for 0.5-4 hours in the sample preparation unit. The normal plasma is sucked from the sample container containing the normal plasma and is separately injected into a fifth buffer container. The normal plasma in the fifth buffer container is incubated at a temperature of 30-45°C for 0.5-4 hours in the sample preparation unit. The incubated patient plasma and the incubated normal plasma are respectively sucked from the fourth buffer container and the fifth buffer container and are separately injected into a seventh reaction container. The coagulation time determination reagent is added to the seventh reaction container to prepare a seventh sample.

[0045] The determination unit is configured to determine a third coagulation time of the third sample, a sixth coagulation time of the sixth sample, and a seventh coagulation time of the seventh sample.

[0046] In an embodiment, the sample preparation unit is further configured to suck the incubated patient plasma from the fourth buffer container and separately inject the incubated patient plasma into a fourth reaction container. The coagulation time determination reagent is added to the fourth reaction container to prepare a fourth sample. The sample preparation unit is further configured to suck the incubated normal plasma from the fifth buffer container and separately inject the incubated normal plasma into a fifth reaction container. The coagulation time determination reagent is added to the fifth reaction container to prepare a fifth sample.

[0047] The determination unit is further configured to determine a fourth coagulation time of the fourth sample and a fifth coagulation time of the fifth sample.

[0048] In an embodiment:

[0049] After the sample preparation unit sucks the incubated patient plasma from the fourth buffer container, the sample preparation unit continues to incubate the patient plasma in the fourth buffer container at a temperature of 30-45°C, so that the patient plasma in the fourth buffer container can be used for re-inspection; and / or,

[0050] The sample preparation unit continues to incubate the normal plasma in the fifth buffer container at a temperature of 30-45℃ after the sample preparation unit draws the incubated normal plasma from the fifth buffer container, so that the normal plasma in the fifth buffer container can be used for re-inspection; and / or,

[0051] The sample preparation unit continues to incubate the mixed plasma in the sixth buffer container at a temperature of 30-45℃ after the sample preparation unit draws the incubated mixed plasma from the sixth buffer container, so that the mixed plasma in the sixth buffer container can be used for re-inspection.

[0052] In an embodiment, the sample preparation unit injects the mixed plasma into the third reaction container in a third amount, injects the mixed plasma into the sixth buffer container in a sixth amount, and injects the total amount of the patient plasma in the fourth buffer container and the normal plasma in the fifth buffer container in a seventh amount; the seventh amount is greater than the third amount, and the sixth amount is greater than the third amount.

[0053] In an embodiment, the seventh amount is five to six times the third amount, and the sixth amount is five to six times the third amount.

[0054] In an embodiment, the sample analysis device further comprises a water supplement device configured to inject water into at least one of the fourth buffer container, the fifth buffer container, and the sixth buffer container according to a preset water supplement time interval and a preset water supplement amount.

[0055] In an embodiment, the fourth buffer container has a depth-diameter ratio greater than a depth-diameter ratio threshold, the fifth buffer container has a depth-diameter ratio greater than the depth-diameter ratio threshold, and the sixth buffer container has a depth-diameter ratio greater than the depth-diameter ratio threshold; the depth-diameter ratio threshold is greater than 5.

[0056] In an embodiment, the fourth buffer container, the fifth buffer container, the sixth buffer container, the third reaction container, the sixth reaction container, and the seventh reaction container have the same structure, so that the fourth buffer container, the fifth buffer container, and the sixth buffer container can be incubated in the sample preparation unit.

[0057] In an embodiment, the sample analysis device further comprises a processor configured to obtain a coagulation time extension reason of the patient plasma according to at least the sixth coagulation time and the seventh coagulation time.

[0058] In an embodiment, the sample analysis device comprises a sample preparation unit and a measurement unit; the sample analysis device is capable of performing an immediate correction test and an incubation correction test; the immediate correction test comprises at least a third coagulation item, and the incubation correction test comprises at least a sixth coagulation item and a seventh coagulation item;

[0059] The immediate correction test comprises: the sample preparation unit prepares a sample for the immediate correction test, which is prepared by mixing a sample for the immediate correction test and a coagulation time determination reagent; and the measurement unit measures the coagulation time of the sample for the immediate correction test.

[0060] In the third coagulation item, the sample for the immediate correction test is a mixed plasma prepared by mixing a patient plasma and a normal plasma; the sample preparation unit obtains the patient plasma and the normal plasma, mixes the patient plasma and the normal plasma to prepare a mixed plasma, and mixes the mixed plasma and the coagulation time determination reagent to prepare a third sample; and the measurement unit measures the third coagulation time of the third sample.

[0061] The incubation correction test comprises: the sample preparation unit prepares a sample for the incubation correction test, which is prepared by mixing a sample for the incubation correction test and the coagulation time determination reagent; and the measurement unit measures the coagulation time of the sample for the incubation correction test.

[0062] In the sixth coagulation item, the sample for the incubation correction test is a mixed plasma prepared by mixing the patient plasma and the normal plasma; the sample preparation unit obtains the patient plasma and the normal plasma, mixes the patient plasma and the normal plasma to prepare a mixed plasma, incubates the mixed plasma under certain conditions for a preset time, and mixes the incubated mixed plasma and the coagulation time determination reagent to prepare a sixth sample; and the measurement unit measures the sixth coagulation time of the sixth sample.

[0063] In the seventh coagulation item, the sample for the incubation correction test is a mixed plasma prepared by mixing the patient plasma and the normal plasma; the sample preparation unit obtains the patient plasma and the normal plasma, respectively incubates the obtained patient plasma and the normal plasma under certain conditions for a preset time, mixes the incubated patient plasma and the incubated normal plasma to prepare a mixed plasma, and mixes the incubated patient plasma and the incubated normal plasma to prepare the mixed plasma and the coagulation time determination reagent to prepare a seventh sample; and the measurement unit measures the seventh coagulation time of the seventh sample.

[0064] In one embodiment, the immediate correction test further includes a first coagulation item and / or a second coagulation item; and the incubation correction test further includes a fourth coagulation item and / or a fifth coagulation item.

[0065] In the first coagulation item, the sample of the immediate correction test is the patient's plasma, and the sample preparation unit mixes the patient's plasma and the coagulation time measurement reagent to prepare a first sample; and the measurement unit measures the first sample to obtain a first coagulation time.

[0066] In the second coagulation item, the sample of the immediate correction test is the normal plasma, and the sample preparation unit mixes the normal plasma and the coagulation time measurement reagent to prepare a second sample; and the measurement unit measures the second sample to obtain a second coagulation time.

[0067] In the fourth coagulation item, the sample of the incubation correction test is the patient's plasma, and the sample preparation unit incubates the patient's plasma under the certain condition for a preset time, and then mixes the incubated patient's plasma and the coagulation time measurement reagent to prepare a fourth sample; and the measurement unit measures the fourth sample to obtain a fourth coagulation time.

[0068] In the fifth coagulation item, the sample of the incubation correction test is the normal plasma, and the sample preparation unit incubates the normal plasma under the certain condition for a preset time, and then mixes the incubated normal plasma and the coagulation time measurement reagent to prepare a fifth sample; and the measurement unit measures the fifth sample to obtain a fifth coagulation time.

[0069] In one embodiment, the immediate correction test further includes a first coagulation item and / or a second coagulation item; and the incubation correction test further includes a fourth coagulation item and / or a fifth coagulation item.

[0070] In the first coagulation item, the sample preparation unit draws the patient's plasma from a sample container containing the patient's plasma, dispenses the patient's plasma into a first reaction container, and adds the coagulation time measurement reagent to the first reaction container to prepare a first sample, wherein the amount of the patient's plasma dispensed into the first reaction container is a first amount.

[0071] In the second coagulation item, the sample preparation unit draws the normal plasma from a sample container containing the normal plasma, dispenses the normal plasma into a second reaction container, and adds the coagulation time measurement reagent to the second reaction container to prepare a second sample, wherein the amount of the normal plasma dispensed into the second reaction container is a second amount.

[0072] In the third coagulation project, the sample preparation unit sucks the patient plasma and the normal plasma from the sample container containing the patient plasma and the sample container containing the normal plasma, respectively, injects the patient plasma and the normal plasma into a third reaction container to form mixed plasma, and adds the coagulation time measurement reagent to the third reaction container to prepare a third sample, wherein the amount of the mixed plasma injected into the third reaction container is a third amount.

[0073] In the sixth coagulation project, the sample preparation unit sucks the patient plasma and the normal plasma from the sample container containing the patient plasma and the sample container containing the normal plasma, respectively, injects the patient plasma and the normal plasma into a sixth buffer container to form mixed plasma, incubates the sixth buffer container under the certain condition for a preset time, sucks the incubated mixed plasma from the sixth buffer container and injects it into a sixth reaction container, and adds the coagulation time measurement reagent to the sixth reaction container to prepare a sixth sample, wherein the amount of the mixed plasma injected into the sixth buffer container is a sixth amount.

[0074] In the seventh coagulation project, the sample preparation unit sucks the patient plasma from the sample container containing the patient plasma, injects the patient plasma into a fourth buffer container, incubates the fourth buffer container under the certain condition for a preset time, sucks the normal plasma from the sample container containing the normal plasma, injects the normal plasma into a fifth buffer container, incubates the fifth buffer container under the certain condition for a preset time, sucks the incubated patient plasma and normal plasma from the fourth buffer container and the fifth buffer container, respectively, and injects them into a seventh reaction container, and adds the coagulation time measurement reagent to the seventh reaction container to prepare a seventh sample, wherein the amount of the patient plasma injected into the fourth buffer container is a fourth amount, and wherein the amount of the normal plasma injected into the fifth buffer container is a fifth amount.

[0075] In one embodiment:

[0076] In the fourth coagulation project, the sample preparation unit sucks the incubated patient plasma from the fourth buffer container and injects it into a fourth reaction container, and adds the coagulation time measurement reagent to the fourth reaction container to prepare a fourth sample.

[0077] In the fifth coagulation project, the sample preparation unit sucks the incubated normal plasma from the fifth buffer container and injects it into a fifth reaction container, and adds the coagulation time measurement reagent to the fifth reaction container to prepare a fifth sample.

[0078] In one embodiment:

[0079] the sixth amount is greater than the third amount;

[0080] the total of the fourth amount and the fifth amount is greater than the total of the first amount, the second amount and the third amount, and the fourth amount is greater than the first amount and the fifth amount is greater than the second amount.

[0081] In one embodiment, the sixth amount is five to six times the third amount.

[0082] the total of the fourth amount and the fifth amount is five to six times the total of the first amount, the second amount and the third amount, and the fourth amount is at least five times the first amount and the fifth amount is at least five times the second amount.

[0083] In one embodiment, the sample analysis device further comprises a water supplementing device for supplementing water to the sample under incubation of the incubation corrective test according to a preset water supplementing time interval and water supplementing amount.

[0084] In one embodiment, the depth-diameter ratio of the buffer container is greater than a depth-diameter ratio threshold, and the depth-diameter ratio threshold is greater than 5.

[0085] In one embodiment, after the sample preparation unit draws the incubated patient plasma from the fourth buffer container, the sample preparation unit continues to incubate the patient plasma in the fourth buffer container under the certain condition so as to use the patient plasma in the fourth buffer container for re-inspection; and / or,

[0086] after the sample preparation unit draws the incubated normal plasma from the fifth buffer container, the sample preparation unit continues to incubate the normal plasma in the fifth buffer container under the certain condition so as to use the normal plasma in the fifth buffer container for re-inspection; and / or,

[0087] after the sample preparation unit draws the incubated mixed plasma from the sixth buffer container, the sample preparation unit continues to incubate the mixed plasma in the sixth buffer container under the certain condition so as to use the mixed plasma in the sixth buffer container for re-inspection.

[0088] In one embodiment, the fourth buffer container, the fifth buffer container, the sixth buffer container, the third reaction container, the sixth reaction container and the seventh reaction container have the same structure so that the fourth buffer container, the fifth buffer container and the sixth buffer container can be incubated in the sample preparation unit.

[0089] In one embodiment, the sample analysis device further comprises a processor configured to obtain a coagulation time extension reason of the patient plasma according to at least the sixth coagulation time and the seventh coagulation time.

[0090] In one embodiment, the sample analysis device further includes a processor, which determines the cause of prolonged coagulation time of the patient's plasma based on the first coagulation time, the second coagulation time, the third coagulation time, the fourth coagulation time, the fifth coagulation time, the sixth coagulation time, and the seventh coagulation time.

[0091] In one embodiment, the measuring unit is an optical detection unit, a dual magnetic bead detection unit, or an integrated optical and magnetic detection unit.

[0092] According to a third aspect, one embodiment provides a sample analysis method, including:

[0093] Perform immediate corrective testing; the immediate corrective testing includes:

[0094] Prepare the sample for the immediate correction test, wherein the sample for the immediate correction test is prepared by mixing the sample for the immediate correction test with a reagent for determining the solidification time;

[0095] The solidification time of the specimens subjected to the immediate correction test can be obtained.

[0096] Conduct an incubation correction test; the incubation correction test includes:

[0097] Prepare a sample for the incubation correction test, wherein the sample for the incubation correction test is prepared by mixing the sample for the incubation correction test and the reagent for the solidification time determination;

[0098] The solidification time of the sample obtained by measuring the incubation correction test can be obtained;

[0099] in:

[0100] The immediate correction test includes at least a third coagulation test, wherein the sample for the immediate correction test is a mixed plasma formed by mixing patient plasma and normal plasma.

[0101] Obtain the patient's plasma and the normal plasma, mix the patient's plasma and the normal plasma to form a mixed plasma, and mix the mixed plasma with the reagent for coagulation time determination to prepare a third sample;

[0102] The third solidification time was determined by measuring the third sample.

[0103] in:

[0104] The incubation correction test includes at least the sixth solidification item and the seventh solidification item;

[0105] In the sixth coagulation test, the sample for the incubation correction test is a mixed plasma formed by mixing the patient's plasma and the normal plasma.

[0106] obtaining the patient plasma and the normal plasma, mixing the patient plasma and the normal plasma to form a mixed plasma, incubating the mixed plasma under the certain condition for a preset time, and mixing the incubated mixed plasma and the reagent for coagulation time determination to prepare a sixth sample;

[0107] measuring the sixth sample to obtain a sixth coagulation time;

[0108] In the seventh coagulation item, the sample for incubation correction test is the mixed plasma formed by mixing the patient plasma and the normal plasma:

[0109] obtaining the patient plasma and the normal plasma, respectively incubating the obtained patient plasma and the normal plasma under the certain condition for a preset time, mixing the incubated patient plasma and the incubated normal plasma to form a mixed plasma, and mixing the mixed plasma formed by mixing the incubated patient plasma and the incubated normal plasma and the reagent for coagulation time determination to prepare a seventh sample;

[0110] measuring the seventh sample to obtain a seventh coagulation time.

[0111] According to the sample analysis device and the sample analysis method of the above embodiment, by designing and introducing the seventh coagulation item into the full-automatic correction test, the effect of identifying micro-coagulation factor inhibitors is very good;

[0112] According to the sample analysis device and the sample analysis method of the above embodiment, by setting the initial amount of the plasma sample for incubation correction test at the beginning of incubation to be greater than the amount of the plasma sample for immediate correction test, the difficulty of incubation correction test is solved by increasing the amount of incubation sample;

[0113] According to the sample analysis device and the sample analysis method of the above embodiment, different detection processes are designed for immediate correction test and incubation correction test, so as to minimize the waste of patient plasma to be tested and improve the utilization rate. BRIEF DESCRIPTION OF DRAWINGS

[0114] Figure 1 FIG. 1 is a structural schematic diagram of a sample analysis device according to an embodiment;

[0115] Figure 2 FIG. 2 is a structural schematic diagram of a sample analysis device according to an embodiment;

[0116] Figure 3 FIG. 3 is a structural schematic diagram of a sample analysis device according to an embodiment;

[0117] FIG. 4(a) and FIG. 4(b) are structural schematic diagrams of reagent carrying components of two embodiments;

[0118] FIG. 4(a) and FIG. 4(b) are structural schematic diagrams of reagent carrying components of two embodiments;Figure 5 Structure diagram of a reagent carrying member of an embodiment;

[0119] Figure 6 An example of the first coagulation item to the seventh coagulation item, taking the APTT correction test as an example;

[0120] Figure 7 Structure diagram of a sample analysis device of an embodiment;

[0121] Figure 8 Structure diagram of a reaction container and a buffer container of an embodiment;

[0122] Figure 9 Test experiment of evaporation rates of different incubation sample amounts of an embodiment;

[0123] Figure 10 Test experiment of evaporation rates of different incubation sample amounts under different conditions of an embodiment;

[0124] Figure 11 Structure diagram of a buffer container of an embodiment;

[0125] Figure 12 Test experiment of evaporation rates of different incubation sample amounts of an embodiment;

[0126] Figure 13 Comparison of automatic test results and manual method results of a sample analysis device of an embodiment;

[0127] Figure 14 An example of a formula editing interface;

[0128] Figure 15 An example of viewing default formulas and calculation formulas;

[0129] Figure 16 An example of a correction test report template;

[0130] Figure 17 An example of a result report sheet;

[0131] Figure 18 Structure diagram of an immediate correction curve and an incubation correction curve of an embodiment;

[0132] Figure 19 Structure diagram of an immediate correction curve and an incubation correction curve of an embodiment;

[0133] Figure 20 Two structure diagrams of an immediate correction curve and an incubation correction curve of an embodiment;

[0134] Figure 21A schematic diagram of the enclosed area of the immediate correction curve and the incubation correction curve for heparin, LA positive, hereditary hemophilia, etc. in one embodiment;

[0135] Figure 22 A flow chart of the sample analysis method in one embodiment. DETAILED DESCRIPTION

[0136] The application will be further described in details through specific embodiments and the accompanying drawings. In different embodiments, similar elements are designated by similar reference numerals. In the following embodiments, many details are described in order to make the application better understood. However, those skilled in the art can easily recognize that some features can be omitted in different cases, or can be replaced by other elements, materials, methods. In some cases, some operations related to the application are not shown or described in the specification, in order to avoid the core part of the application being overwhelmed by too much description, and it is not necessary to describe these related operations in details for those skilled in the art, who can fully understand the related operations according to the description in the specification and the general technical knowledge in the art.

[0137] In addition, the features, operations or characteristics described in the specification can be combined in any appropriate manner to form various embodiments. At the same time, the steps or actions in the method description can also be sequentially adjusted or adjusted in a manner that those skilled in the art can easily see. Therefore, the various sequences in the specification and the drawings are only for the purpose of clearly describing a certain embodiment, and do not mean that the sequence is necessary, unless otherwise stated that a certain sequence must be followed.

[0138] In this paper, the serial numbers of components, such as "first", "second", etc., are only used to distinguish the described objects, and have no sequence or technical meaning. Unless otherwise specified, "connection" and "coupling" in this application include direct and indirect connection (coupling).

[0139] Some embodiments of the application disclose a sample analysis device. Please refer to Figure 1 or Figure 2 The sample analysis device in some embodiments includes a sample preparation unit 100 and a measurement unit 200, and in some embodiments, it can also include a processor 300 and a display 400; the sample preparation unit 100 can prepare a sample by using a sample or a plasma sample and a reagent, the measurement unit 200 is used to measure the sample to obtain a detection result, such as the coagulation time of a plasma sample; the processor 300 can further analyze the detection result to obtain a diagnosis result, such as the reason for the prolongation of the coagulation time; the display 400 can be used for display; a more detailed description is given below.

[0140] Please refer toFigure 3 In some embodiments, the sample preparation unit 100 can include a reaction container loading component 10, a sample loading component 20, a sample dispensing component 30, a reagent carrying component 40, a reaction component 50, a reagent dispensing component 60, and a dispatching mechanism 70.

[0141] The reaction container loading component 10 is used to supply and carry containers such as reaction containers and / or buffer containers. During the operation of the sample analysis device, empty reaction containers are constantly used to complete one detection item after another. The sample analysis device prepares a sample by adding a sample and a reagent into an empty reaction container, and then determines the sample by the determination component 200 to obtain a detection result. The reaction container loading component 10 can load empty reaction containers to a predetermined position, for example, a cup distribution position which can have one or more, and the sample dispensing mechanism 30 can suck the sample from the sample loading component 20 and then discharge it into the empty reaction container on the cup distribution position.

[0142] The sample loading component 20 is used to supply a sample rack carrying sample containers. The sample containers carry samples, and the sample rack can hold multiple sample containers. The sample loading component 20 can have various implementations. For example, the sample loading component 20 can include a loading area 21, a sample loading channel 22, an unloading area 23, and a buffer area 24. The sample loading channel 22 can be provided with a sample suction position. A user can place a sample rack carrying sample containers into the loading area 21. The loading area 21 moves the sample rack in the Y1 direction in the drawing to enter the sample loading channel 22. The sample rack can move in the X1 direction in the drawing in the sample loading channel 22 and pass through the sample suction position. The sample containers on the sample rack can be sucked by the sample dispensing component 30 to suck the samples in the sample containers when passing through the sample suction position (one, two, or more sample suction positions can be provided on the sample loading channel 22). The sample rack can then enter the unloading area 23 from the sample loading channel 22 in the Y2 direction. The user can take out the sample rack from the unloading area 23. In some other examples, the sample rack can enter the buffer area 24 after the sample containers on the sample rack are sucked by the sample dispensing component 30 to suck the samples. When all the samples on the sample rack do not need to be rechecked, the sample rack is dispatched to the unloading area 23 for the user to take out. If there is a sample on the sample rack that needs to be rechecked, the sample rack is dispatched back to the sample loading channel 22 from the buffer area 24. When the sample container with the sample to be rechecked on the sample rack passes through the rechecking position (which can be the same position as the sample suction position described above) on the sample loading channel 22, the sample in the sample container is sucked by the sample dispensing component 30 for rechecking. The sample loading component 20 is more suitable for large batch sample testing occasions. The sample loading component 20 can be independently provided from the sample analysis device. When the sample analysis device needs to be connected to a testing system in a flow line form, the sample loading component 20 can be directly removed.

[0143] The sample dispensing component 30 is used to aspirate the sample in the sample container at the sample aspiration position and dispense the sample into the reaction container and / or the buffer container. In some embodiments, the sample dispensing mechanism 30 can include a sample needle that is driven by a two-dimensional or three-dimensional driving mechanism to move in two-dimensional or three-dimensional directions. In some embodiments, the sample needle can be one or more.

[0144] The reagent carrying component 40 is used to carry reagents, for example, the reagent carrying component 40 can have a plurality of positions for carrying reagent containers that are used to carry reagents. Generally, the reagent carrying component 40 can provide refrigeration or the like for the reagents it carries, thereby ensuring the activity of the reagents. In some embodiments, the reagent carrying component 40 is provided in a disc-like structure and has a plurality of positions for carrying reagent containers, and the reagent carrying component 40 can rotate and carry the reagent containers it carries to be transported, thereby rotating the reagent containers to the reagent aspiration position for the reagent dispensing component 60 to aspirate the reagents - for example, the reagent carrying component 40 includes a first driving assembly for driving the rotation thereof, and the first driving assembly drives the reagent carrying component 40 to rotate for rotating the reagent containers to the reagent aspiration position. The reagent carrying component 40 provided in a disc-like structure is described in detail below.

[0145] Please refer to FIG. 4(a), in some specific embodiments, the reagent carrying component 40 is provided in a disc-like structure and has a plurality of positions for placing reagent coupling cups 41, and each reagent coupling cup 41 includes one or more cavities for containing reagents required for the test of an item, and one reagent is placed in one cavity; the reagent carrying component 40 includes a first driving assembly for driving the rotation thereof, and the first driving assembly drives the reagent carrying component 40 to rotate for rotating the cavities of the reagent coupling cups 41 containing the reagents required for the test of an item to the corresponding reagent aspiration positions. In one example, each reagent coupling cup 41 includes at least a first cavity 41a for carrying a first reagent and a second cavity 41b for carrying a second reagent, for example, the reagent coupling cup 41 includes at least a first cavity 41a for carrying a mixed reagent R1 and a second cavity 41b for carrying a trigger reagent R2; the reagent carrying component 40 includes a first reagent aspiration position and a second reagent aspiration position different from the first reagent aspiration position, and the first driving assembly drives the reagent carrying component 40 to rotate and carry the reagent coupling cups 41 to rotate, so as to rotate the first cavities 41a of the reagent coupling cups 41 to the first reagent aspiration position; the first driving assembly drives the reagent carrying component 40 to rotate and carry the reagent coupling cups 41 to rotate, so as to rotate the second cavities 41b to the second reagent aspiration position.

[0146] Referring to Fig. 4(b), in some embodiments, the reagent carrying component 40 is in the form of a disc, which has a plurality of positions for carrying the first reagent containers 42 and a plurality of positions for carrying the second reagent containers 43. The reagent carrying component 40 comprises a first driving assembly for driving the rotation of the reagent carrying component 40, which drives the rotation of the reagent carrying component 40 and the first reagent containers 42 to rotate the first reagent containers 42 to the first reagent suction position, and drives the rotation of the reagent carrying component 40 and the second reagent containers 43 to rotate the second reagent containers 43 to the second reagent suction position. In one example, the reagent carrying component 40 can comprise a plurality of tracks that can rotate independently. For example, the reagent carrying component 40 can comprise two tracks, an inner track and an outer track, and the outer track can have a plurality of positions for carrying the first reagent containers 42, and the inner track can have a plurality of positions for carrying the second reagent containers 43, and the first driving assembly drives the rotation of the inner track and the outer track independently.

[0147] The above describes two reagent carrying components 40, for example, Fig. 4(a) is an example of placing the reagent coupling cups 41, and Fig. 4(b) is an example of implementing the reagent carrying component 40 by a plurality of tracks that can rotate independently, and those skilled in the art can understand that the reagent carrying component 40 can also be implemented by a plurality of tracks that can rotate independently in combination with the two ways, and at least one track or each track has a plurality of positions for placing the reagent coupling cups 41, for example Figure 5 For example, the reagent carrying component 40 can comprise two tracks, an inner track and an outer track, and the outer track can have a plurality of positions for placing the reagent coupling cups 41, and the inner track can also have a plurality of positions for placing the reagent coupling cups 41, and the first driving assembly drives the rotation of the inner track and the outer track independently.

[0148] The above is some description of the reagent carrying component 40. The reagent carrying component 40 can rotate the corresponding reagents required for the test items to the corresponding reagent suction positions of the reagent dispensing component 60 by rotation during the working cycle, for example, the first reagent is dispatched to the first reagent suction position, and the second reagent is dispatched to the second reagent suction position.

[0149] The reaction component 50 is used for incubation, for example, incubation of a sample, further for example, incubation of a reaction solution formed by mixing of a sample and a reagent, for example, a reaction solution formed by mixing of a sample and a first reagent, further for example, a reaction solution formed by mixing of a sample, a first reagent and a second reagent. In some embodiments, the reaction component 50 is in a rectangular shape and has a plurality of container placement positions, which can be used for placing reaction containers and buffer containers. Generally, the reaction component 50 can incubate substances in containers on each container placement position, for example, incubate a reaction solution in a reaction container formed by mixing of a sample and a reagent, further for example, incubate a sample in a buffer container; specifically, the substances in the containers can be heated and maintained at 37±0.5°C, and the specific heating time and temperature can be determined by heating parameters corresponding to different detection items.

[0150] The reagent dispensing component 60 is used for sucking reagents from reagent containers in the reagent carrying component 40 and dispensing the reagents into reaction containers. The reagent dispensing component 60 can be implemented by reagent needles. Therefore, in some embodiments, the reagent dispensing component 60 includes reagent needles, which are used for sucking reagents from reagent containers in the reagent carrying component 40 and dispensing the reagents into reaction containers. From the perspective of the number of reagent needles, in some embodiments, the reagent dispensing component 60 can have a plurality of reagent needles, each of which is arranged in a manner capable of independent movement. For example, a set of reagent needles can be configured for the reaction component 50, and a set of reagent needles can be configured for the detection component 200.

[0151] The scheduling mechanism 70 is used for scheduling containers, for example, reaction containers and buffer containers. For example, the scheduling mechanism schedules containers (reaction containers and / or buffer containers) between the cup distribution position 71, the standby sample position 72, the reaction component 50 and the detection component 200. The cup distribution position 71 can have one or more, and the standby sample position 72 can also have one or more, or the standby sample position 72 can also be absent.

[0152] The detection component 200 is used for detecting a sample. In some embodiments, the detection component 200 is an optical detection component, a double-magnetic-bead detection component or an optical-magnetic integrated detection component. The optical detection component and the optical-magnetic integrated detection component mainly acquire the transmission light intensity or the scattering light intensity of a sample, while the double-magnetic-bead detection component mainly acquires the viscosity of a sample.

[0153] In some embodiments, the detection component 200 is used for carrying reaction containers and capable of detecting samples in the reaction containers; in some embodiments, the detection component 200 is in a rectangular shape and has one or more reaction container placement positions.

[0154] For some single reagent detection items, after adding sample and reagent into the reaction container, the reagent preparation unit 100 can send it to the measurement unit 200 for measurement. If the sample needs to be incubated, the sample is first dispatched to the reaction unit 50 for incubation before being sent to the measurement unit 200 for measurement. For some double reagent detection items, after adding sample and, for example, the first reagent into the reaction container, the reagent preparation unit first sends it to the reaction unit 50 for incubation, and after incubation, it is sent to the measurement unit 200, and then, for example, the second reagent is added, and then measurement is performed.

[0155] For detection items or projects that do not require incubation of the sample, a process can be as follows: the sample container containing the sample is dispatched by the sample holder to the sample loading position, the sample is aspirated from the sample container by the sample dispensing unit 30 and dispensed into the reaction container in the reaction cup position 71 at this time, the reaction container is then dispatched by the dispatching mechanism 70 to the reagent position (not shown in the figure, which can be designed inside or outside the reaction unit 50 according to requirements), the reagent is aspirated from the reagent carrying unit 40 by the reagent dispensing unit 60 and dispensed into the reaction container, the mixed solution in the reaction container is dispatched by the dispatching mechanism 70 into the reaction unit 50 for incubation under certain conditions for a predetermined time, and then the reaction container is dispatched by the dispatching mechanism 70 to the measurement unit 200 for measurement or further reagent dispensing by the reagent dispensing unit 60 and then measurement.

[0156] For a detection item or item that requires incubation of a sample, a process can be as follows: the sample container in which the sample is located is dispatched by the sample rack to the sample-in position of the sample-in component 20, the sample is drawn from the sample container by the sample dispensing component 30 and dispensed into the buffer container at the time-dividing position 71 - in some embodiments, the buffer container and the reaction container can be the same, except that they are referred to as buffer container and reaction container here for functional differentiation; the buffer container generally does not contain magnetic beads or other substances that are prone to oxidation or can react with plasma, so if the sample analysis device is a magnetic bead method, the buffer container will be different from the reaction container, i.e., the magnetic beads in the reaction container will be removed; the buffer container is then dispatched by the dispatching mechanism 70 to the reaction component 50 for incubation under certain conditions for a predetermined time, after which the buffer container is dispatched by the dispatching mechanism 70 to the standby sample position 72, the sample dispensing component 30 then draws the incubated sample from the buffer container at the standby sample position 72 and dispenses it into the reaction container at the time-dividing position 71, the reaction container is then dispatched by the dispatching mechanism 70 to the reagent position, the reagent dispensing component 60 draws the reagent from the reagent carrying component 40 and dispenses it into the reaction container, the mixed solution in the reaction container is then dispatched by the dispatching mechanism 70 to the reaction component 50 for incubation under certain conditions for a predetermined time, and then the reaction container is dispatched by the dispatching mechanism 70 to the measurement component 200 for measurement or further reagent dispensing by the reagent dispensing component 60 and then measurement; in some embodiments, after the sample is drawn from the buffer container at the standby sample position 72, the dispatching mechanism 70 can continue to dispatch it back to the reaction component 50 for re-inspection.

[0157] In the above example in which the sample analysis device is provided with the spare sample site 72, in some examples, the spare sample site 72 can not be provided, and instead the sample dispensing member 30 can be designed to directly draw liquid from the reaction member 50, so for a detection item that requires incubation, the process can be as follows: the sample introduction member 20 dispatches the sample container in which the sample is located to the sample site by the sample rack, the sample dispensing member 30 draws the sample from the sample container and dispenses it into the buffer container in the buffer site 71 at this time, the dispatching mechanism 70 dispatches the buffer container into the reaction member 50 for incubation under certain conditions for a predetermined time, after the incubation is completed, the sample dispensing member 30 draws the incubated sample from the buffer container in the reaction member 50 and dispenses it into the reaction container in the buffer site 71 at this time, the dispatching mechanism 70 dispatches the reaction container to the reagent site, the reagent dispensing member 60 draws the reagent from the reagent carrying member 40 and dispenses it into the reaction container, the mixed liquid in the reaction container is dispatched by the dispatching mechanism 70 into the reaction member 50 for incubation under certain conditions for a predetermined time, and then the dispatching mechanism 70 dispatches the reaction container to the measurement member 200 for measurement or continues to dispense the reagent by the reagent dispensing member 60 before measurement. In some embodiments, the buffer container in the reaction member 50 can remain in the reaction member 50 after being drawn with the sample for re-inspection.

[0158] The above is a description of the sample analysis device.

[0159] In some embodiments, the sample analysis device can perform immediate correction tests and incubation correction tests.

[0160] In some embodiments, the immediate correction test includes: the sample preparation member 100 mixes the plasma sample for the immediate correction test and the reagent for coagulation time measurement to prepare a sample for the immediate correction test; and the measurement member 200 measures the sample to obtain a detection result such as coagulation time. In some specific embodiments, for the immediate correction test, the sample preparation member 100 draws the sample from the sample container and dispenses it into the reaction container to prepare a sample for the immediate correction test in the reaction container.

[0161] The immediate correction test and the incubation correction test are described further below.

[0162] The plasma sample for the immediate correction test can be one or more of the following: (1) patient plasma, (2) normal plasma, (3) mixed plasma obtained by mixing patient plasma and normal plasma in at least one ratio, for example, a ratio of 1 to 4 and / or 1 to 1 between patient plasma and normal plasma, which is described in detail below.

[0163] In some embodiments, the sample preparation section 100 prepares a sample for the immediate correction test by mixing the patient plasma and the reagent for the coagulation time assay, for example, which can be referred to as a first sample. In some specific embodiments, the sample preparation section 100 draws the sample from the sample container containing the patient plasma to dispense a first amount of the sample into a first reaction container, and adds the reagent for the coagulation time assay to the first reaction container to prepare the first sample. The measurement section 200 measures the first sample to obtain a first coagulation time.

[0164] In some embodiments, the sample preparation section 100 prepares a sample for the immediate correction test by mixing the normal plasma and the reagent for the coagulation time assay, for example, which can be referred to as a second sample. In some specific embodiments, the sample preparation section 100 draws the sample from the sample container containing the normal plasma to dispense a second amount of the sample into a second reaction container, and adds the reagent for the coagulation time assay to the second reaction container to prepare the second sample. The measurement section 200 measures the second sample to obtain a second coagulation time.

[0165] In some embodiments, the sample preparation section 100 prepares a sample for the immediate correction test by mixing the mixed plasma obtained by mixing the patient plasma and the normal plasma in at least one ratio and the reagent for the coagulation time assay, for example, which can be referred to as a third sample. In some specific embodiments, the sample preparation section 100 draws the sample from the sample container containing the patient plasma and the sample container containing the normal plasma to dispense into a third reaction container, the total amount of the sample dispensed into the third reaction container being a third amount, and adds the reagent for the coagulation time assay to the third reaction container to prepare the third sample. The measurement section 200 measures the third sample to obtain a third coagulation time.

[0166] In some embodiments, the incubation correction test includes: the sample preparation section 100 prepares a sample for the incubation correction test by mixing the plasma sample for the incubation correction test and the reagent for the coagulation time assay; and the measurement section 200 measures the sample to obtain a detection result, for example, a coagulation time; wherein the plasma sample for the incubation correction test is a sample or plasma sample obtained by incubating a sample under certain conditions for a predetermined time. In some specific embodiments, for the incubation correction test, the sample preparation section 100 draws the sample from the sample container and dispenses into a buffer container to incubate under certain conditions for a predetermined time, and then draws the incubated sample or plasma sample from the buffer container and dispenses into a reaction container to prepare the sample for the incubation correction test in the reaction container.

[0167] The plasma sample for the immediate correction test can be one or more of (4) patient plasma incubated for a predetermined time under certain conditions, (5) normal plasma incubated for a predetermined time under certain conditions, (6) mixed plasma obtained by mixing patient plasma and normal plasma in at least one ratio, for example, 1 to 4 and / or 1 to 1, (7) a sample obtained by mixing patient plasma incubated for a predetermined time under certain conditions and normal plasma incubated for a predetermined time under certain conditions, and mixing them in at least one ratio, for example, 1 to 4 and / or 1 to 1. Details are described below.

[0168] In some embodiments, the sample preparation section 100 incubates patient plasma for a predetermined time under certain conditions, and mixes the incubated patient plasma and the reagent for coagulation time measurement to prepare a sample for incubation correction test, for example, which can be referred to as a fourth sample. In some specific embodiments, the sample preparation section 100 sucks the sample from the sample container containing patient plasma to dispense a fourth amount of the sample into a fourth buffer container, incubates for a predetermined time under certain conditions, sucks the sample from the fourth buffer container and dispenses it into a fourth reaction container, and adds the reagent for coagulation time measurement to the fourth reaction container to prepare the fourth sample. The measurement section 200 measures the fourth coagulation time from the fourth sample.

[0169] In some embodiments, the sample preparation section 100 incubates normal plasma for a predetermined time under certain conditions, and mixes the incubated normal plasma and the reagent for coagulation time measurement to prepare a sample for incubation correction test, for example, which can be referred to as a fifth sample. In some specific embodiments, the sample preparation section 100 sucks the sample from the sample container containing normal plasma to dispense a fifth amount of the sample into a fifth buffer container, incubates for a predetermined time under certain conditions, sucks the sample from the fifth buffer container and dispenses it into a fifth reaction container, and adds the reagent for coagulation time measurement to the fifth reaction container to prepare the fifth sample. The measurement section 200 measures the fifth coagulation time from the fifth sample.

[0170] In some embodiments, the sample preparation section 100 incubates the patient plasma and the normal plasma under predetermined conditions for a predetermined time, and then mixes the incubated patient plasma and the incubated normal plasma to prepare a mixed plasma in at least one ratio, and mixes the mixed plasma with the coagulation time measuring reagent to prepare the sample for the incubation correction test, for example, the sixth sample. In some specific embodiments, the sample preparation section 100 aspirates the sample from the sample container containing the patient plasma and the sample container containing the normal plasma into the sixth buffer container, respectively, and incubates the sample in the sixth buffer container under predetermined conditions for a predetermined time, and then aspirates the sample from the sixth buffer container and dispenses it into the sixth reaction container, and adds the coagulation time measuring reagent to the sixth reaction container to prepare the sixth sample. The measuring section 200 measures the sixth sample to obtain the sixth coagulation time.

[0171] In some embodiments, the sample preparation section 100 incubates the patient plasma and the normal plasma under predetermined conditions for a predetermined time, and then mixes the incubated patient plasma and the incubated normal plasma to prepare a mixed plasma in at least one ratio, and mixes the mixed plasma with the coagulation time measuring reagent to prepare the sample for the incubation correction test, for example, the sixth sample. In some specific embodiments, the sample preparation section 100 aspirates the sample from the sample container containing the patient plasma and the sample container containing the normal plasma into the sixth buffer container, respectively, and incubates the sample in the sixth buffer container under predetermined conditions for a predetermined time, and then aspirates the sample from the sixth buffer container and dispenses it into the sixth reaction container, and adds the coagulation time measuring reagent to the sixth reaction container to prepare the sixth sample. The measuring section 200 measures the sixth sample to obtain the sixth coagulation time.

[0172] In the above-described detection items, the detection items for measuring the first sample, the second sample, the third sample, the fourth sample, the fifth sample, the sixth sample, and the seventh sample can be referred to as the first coagulation item, the second coagulation item, the third coagulation item, the fourth coagulation item, the fifth coagulation item, the sixth coagulation item, and the seventh coagulation item, respectively.

[0173] In some embodiments, the fourth coagulation item and the seventh coagulation item can share or reuse the plasma sample, for example, both of them incubate the patient plasma through the same buffer container. In some embodiments, the fifth coagulation item and the seventh coagulation item can share or reuse the plasma sample, for example, both of them incubate the normal plasma through the same buffer container. One specific embodiment can be to perform the fourth coagulation item, the fifth coagulation item, and the seventh coagulation item, or to prepare the fourth sample, the fifth sample, and the seventh sample, as follows:

[0174] The sample preparation section 100 aspirates the sample from the sample container containing the patient's plasma and dispenses it into another buffer container, for example, the fourth buffer container, and incubates it under certain conditions for a predetermined time.

[0175] The sample preparation section 100 aspirates the sample from the sample container containing the normal plasma and dispenses it into another buffer container, for example, the fifth buffer container, and incubates it under certain conditions for a predetermined time.

[0176] The sample preparation section 100 aspirates the sample from the fourth buffer container and dispenses it into the fourth reaction container, and adds a coagulation time measurement reagent to the fourth reaction container to prepare a fourth sample.

[0177] The sample preparation section 100 aspirates the sample from the fifth buffer container and dispenses it into the fifth reaction container, and adds a coagulation time measurement reagent to the fifth reaction container to prepare a fifth sample.

[0178] The sample preparation section 100 aspirates the incubated sample or plasma sample from the fourth buffer container and the fifth buffer container, respectively, and dispenses it into the seventh reaction container, and adds a coagulation time measurement reagent to the seventh reaction container to prepare a seventh sample.

[0179] To further simplify the process, the sample preparation section 100 aspirates the incubated sample from the fourth buffer container and dispenses it into the fourth reaction container and the seventh reaction container, respectively; the sample preparation section 100 aspirates the incubated sample from the fifth buffer container and dispenses it into the fifth reaction container and the seventh reaction container.

[0180] The above is a description of the immediate correction test and the incubation correction test, or a description of the first coagulation item to the seventh coagulation item. The coagulation items included in the immediate correction test and the incubation correction test can be designed according to the purpose, or can be specified by the user through the human-computer interaction interface.

[0181] In some embodiments, the immediate correction test includes at least the third coagulation item, and the incubation correction test includes at least the sixth coagulation item and the seventh coagulation item; in other embodiments, the immediate correction test further includes the first coagulation item and / or the second coagulation item; and the incubation correction test further includes the fourth coagulation item and / or the fifth coagulation item.

[0182] In some embodiments, the immediate correction test includes the first coagulation item, the second coagulation item, and the third coagulation item; the incubation correction test includes at least the fourth coagulation item, the fifth coagulation item, and the sixth coagulation item; in other embodiments, the incubation correction test further includes the seventh coagulation item.

[0183] Figure 6is an example of the first coagulation item to the seventh coagulation item, wherein the first coagulation item to the seventh coagulation item correspond to APTT1 to APTT7, respectively.

[0184] In the item detection, retesting is often required due to abnormal results. After the incubated sample is drawn from the buffer container (e.g., the fourth buffer container, the fifth buffer container, the sixth buffer container, etc.), the sample in the buffer container of the sample preparation unit 100 continues to be incubated so that the sample in the buffer container can be used for retesting. For example, after the incubated sample is drawn from the fourth buffer container, the sample preparation unit 100 continues to incubate the sample in the fourth buffer container under certain conditions so that the sample in the fourth buffer container can be used for retesting, such as retesting of the fourth coagulation item and / or the seventh coagulation item. For another example, after the incubated sample is drawn from the fifth buffer container, the sample preparation unit 100 continues to incubate the sample in the fifth buffer container under certain conditions so that the sample in the fifth buffer container can be used for retesting, such as retesting of the fifth coagulation item and / or the seventh coagulation item. For another example, after the incubated sample is drawn from the sixth buffer container, the sample preparation unit 100 continues to incubate the sample in the sixth buffer container under certain conditions so that the sample in the sixth buffer container can be used for retesting, such as retesting of the sixth coagulation item.

[0185] In some embodiments, the amount of sample or plasma sample that the sample preparation unit 100 dispenses into the buffer container for incubation in the correction test is greater than the amount of sample or plasma sample that the sample preparation unit 100 dispenses into the reaction container for immediate correction test. Alternatively, the initial amount of plasma sample for incubation in the correction test is greater than the amount of plasma sample for immediate correction test.

[0186] For example, the amount of sample that is dispensed into the fourth buffer container for preparation of the fourth sample is greater than the amount of sample that is dispensed into the first reaction container for preparation of the first sample. For another example, the amount of sample that is dispensed into the fifth buffer container for preparation of the fifth sample is greater than the amount of sample that is dispensed into the second reaction container for preparation of the second sample. For example, the total amount of sample that is dispensed into the sixth buffer container for preparation of the sixth sample is greater than the total amount of sample that is dispensed into the third reaction container for preparation of the third sample. For example, the total amount of sample that is dispensed into the two buffer containers for preparation of the seventh sample is greater than the total amount of sample that is dispensed into the third reaction container for preparation of the third sample.

[0187] In the example where the fourth coagulation item and the seventh coagulation item do not share or reuse the plasma sample, and the fifth coagulation item and the seventh coagulation item do not share or reuse the plasma sample, the fourth amount is greater than the first amount, the fifth amount is greater than the second amount, the sixth amount is greater than the third amount, and the total amount of sample that is dispensed into the two buffer containers for preparation of the seventh sample is greater than the third amount.

[0188] In the case of the fourth coagulation item and the seventh coagulation item share or reuse the plasma sample, the fifth coagulation item and the seventh coagulation item share or reuse the plasma sample, the sixth amount is greater than the third amount; the fourth amount and the fifth amount are greater than the first amount, the second amount and the third amount, and the fourth amount is greater than the first amount, and the fifth amount is greater than the second amount.

[0189] It should be noted that, whether it is an incubation correction test or an immediate correction test, the amount of sample finally dispensed into the reaction container can be a standard amount, which is a sample amount required for the detection item.

[0190] In addition, the amount of sample in this paper, the first amount, the second amount, the third amount, the fourth amount, the fifth amount and the sixth amount, etc. can be a volume amount, such as ul.

[0191] The reagent for coagulation time determination in this paper can include one or more reagents, which can be designed according to the detection principle and detection method.

[0192] The normal plasma in this paper can be mixed with not less than 20 normal plasma samples, or can be directly purchased from commercial NPP (normal human plasma, IL, Stago) and SHP (standard human plasma, Sysmex).

[0193] The incubation conditions mentioned in this paper, such as the "incubation under certain conditions for a predetermined time" described in this paper, can be incubated at a temperature of 30-45℃ for half an hour to 4 hours, for example, incubated at a temperature of 37℃ for two hours.

[0194] In the description of the first coagulation item to the seventh coagulation item in this paper, or the preparation of the first sample to the seventh sample, the preparation of the sample, such as the incubation of the sample, the dispensing of the reagent, the dispensing of the sample, the scheduling of the reaction container, the debugging of the buffer container, etc. can be referred to the description of the detection item or the process of the item which does not need to incubate the sample, and the description of the detection item or the process of the item which needs to incubate the sample, which will not be repeated here.

[0195] Please refer to Figure 7In some embodiments, the sample analysis device further comprises a water replenishing device 500 configured to replenish water to the plasma sample for incubating the correction test in the incubation process according to a water replenishing time interval and a water replenishing amount, for example, replenishing water to the sample in the buffer container. In some embodiments, the water replenishing device 500 obtains the water replenishing time interval and the water replenishing amount according to the initial amount of the plasma sample for incubating the correction test at the beginning of the incubation, for example, obtains the water replenishing time interval and the water replenishing amount according to the initial amount of the sample in the fourth buffer container (the fourth amount in the above); for another example, obtains the water replenishing time interval and the water replenishing amount according to the initial amount of the sample in the fifth buffer container (the fifth amount in the above); for another example, obtains the water replenishing time interval and the water replenishing amount according to the initial amount of the sample in the sixth buffer container (the sixth amount in the above). In some embodiments, the initial amount and the water replenishing time interval are positively correlated, that is, the larger the initial amount, the larger the water replenishing interval; the initial amount and the water replenishing amount are inversely correlated. In some embodiments, the water replenishing device 500 further obtains the initial amount in the above, and when it is determined that the initial amount is greater than an initial amount threshold, the water replenishing device 500 does not replenish water.

[0196] The water replenishing time interval and the water replenishing amount are mainly related to the initial amount of the sample in the incubation, and in addition, the local temperature and humidity and the shape of the buffer container can also be considered.

[0197] Figure 8 is an example of the reaction container corresponding to the determination unit 200 being a double-magnetic-bead detection unit or a light-magnetic integrated detection unit. The left side of the figure is a perspective view of the reaction container, and the right side is a corresponding perspective view. The cross section of the reaction container in the figure is rectangular, and the bottom is provided with a magnetic bead track; the magnetic beads will be arranged on the track (not shown in the figure). In the test process, the driving coil along the long axis of the reaction container will drive the magnetic beads to swing, and the magnetic beads will have their amplitude reduced due to the increased viscosity of the reaction system, and even stop swinging. The magnetic beads are determined to have reached the coagulation time when the swing amplitude is reduced to 50% of the initial amplitude. Since this type of reaction container contains magnetic beads, the magnetic beads will rust in the plasma for a period of time, causing the reaction system to be disturbed by rust, and the coagulation time to be extended. Therefore, the buffer container for sample incubation does not contain magnetic beads, that is, the buffer container is a reaction container without magnetic beads.

[0198] The depth-diameter ratio (the ratio of the depth of the container to the diameter, here taking the diameter of the circumscribed circle of the upper surface) of the above-mentioned container is very small, about equal to 1.5; the surface area of the liquid is large, and the liquid surface is more easily affected by air flow, so the evaporation rate is high. Please refer to Figure 9In one example, after incubating for 2 hours with the sample volume required for routine testing (e.g., 50 µL), only 61% (30.32 µL) remained. Directly adding APTT or PT reagents for testing resulted in coagulation timeouts. Increasing the incubation sample to 300 µL (the maximum volume of the above reaction / buffer container is 320 µL; considering the volume occupied by the sample needle during sample dispensing, 300 µL is the maximum incubation sample volume) reduced the sample evaporation rate to half that of 50 µL (evaporation rate changed from 39% to 17%). At this point, the coagulation time could be obtained, but the deviation was significant.

[0199] Please refer to Figure 10 This experiment uses different water replenishment conditions to confirm whether the effects of evaporation can be corrected, in order to study the water replenishment effect under different conditions. Under condition 1, the losses caused by evaporation can be compensated by the water replenishment process, and the repeatability and accuracy are consistent with the manual method (see...). Figure 13 In conditions 2 and 3, the loss caused by the evaporation process is excessively replenished with water, leading to dilution of the incubated sample and resulting in elevated test results. The main reasons for this phenomenon are: the water replenishment interval is too long or the amount of incubated sample is too small, causing the salt ion concentration of the incubated sample to exceed the threshold, resulting in sample stratification, which in turn causes the evaporation rate of the incubated sample to be inconsistent with the previous one, and the water replenishment to fail. The test results of samples under these conditions are mostly abnormal, or even report errors.

[0200] Please refer to Figure 11 This is another example of a container with a large depth-to-diameter ratio, whose evaporation rate for a typical test volume (30 μL) is already comparable to... Figure 8 The evaporation rates of the containers increased to the maximum incubation volume were comparable (16.3% and 17.1%, respectively, see...). Figure 12 After increasing the incubation solution volume to 150 μL, the evaporation rate was only 6.2% within 2 hours. Considering the buffering capacity of the APTT reagent itself, an evaporation rate below 7% will not affect the test results. Therefore, this type of container with a large aspect ratio no longer requires water replenishment, or only requires a small amount of water replenishment, to obtain test results equivalent to those obtained by manual methods.

[0201] Therefore, in some embodiments, the aspect ratio of the buffer container is greater than a depth-to-diameter ratio threshold. For example, the aspect ratio of the fourth buffer container is greater than the depth-to-diameter ratio threshold; the aspect ratio of the fifth buffer container is greater than the depth-to-diameter ratio threshold; and the aspect ratio of the sixth buffer container is greater than the depth-to-diameter ratio threshold. In some embodiments, the depth-to-diameter ratio threshold is, for example, greater than 5, such as 5.6.

[0202] In some examples, not all sample incubation cases require replenishment. The incubation time can be used to determine whether replenishment is needed. For example, if the incubation time is less than half an hour, replenishment is not considered. If the incubation time is more than half an hour, replenishment is considered. Of course, the specific time threshold can be evaluated by the developer according to the evaporation effect of the instrument. It is not necessarily half an hour because the time threshold obtained under different conditions such as different instruments, different reagents, and different reaction parameters may be different.

[0203] In addition, a common reaction container and a buffer container can also be used herein. By increasing the incubation sample amount and the replenishment operation, the sample evaporation during incubation can be controlled, and the difficulty of incubation correction test can be solved. Therefore, in some embodiments, the method of using a common reaction container and a buffer container to carry out an incubation correction test has the advantages of high automation, simple materials, low cost, and the like compared with manual incubation or using a special sample incubation container.

[0204] The above is a description of sample replenishment during incubation correction test.

[0205] The above is a description of sample replenishment during incubation correction test.

[0206] An automatic detection process can be as follows:

[0207] Preparation process: The user needs to prepare normal plasma before carrying out the test and place it in a designated position, such as a sample holder in the loading area 21, as a sample to be tested. Alternatively, the normal plasma can be placed on a dilution holder dedicated for dilution as a “dilution” for patient plasma. Alternatively, a fixed position can be provided in the sample analysis device for placing the normal plasma. Then, a test order is created in the software interface or through the LIS, and the sample analysis device is in standby state.

[0208] Step 1: The user starts the detection, and the sample analysis device automatically transports the patient sample to the sample site. The sample analysis device is ready to carry out the test according to the test order issued by the user.

[0209] Step 2: The sample analysis device determines which type of correction test this test belongs to. For immediate correction test, the sample analysis device will carry out the test according to the general test procedure; for incubation correction test, considering the sample evaporation during incubation, the loss of sample transfer from sample container to reaction container, automatic recheck sample preparation, etc., the sample amount required for incubation correction test will exceed that of immediate correction test. This step supports the preparation of patient plasma only, normal plasma only, and mixed plasma mixed according to a certain ratio, and the "certain ratio" here means that it has been defined before the test, which can be one or more mixing ratios, for example, the ratio of patient plasma to normal plasma is 1:4, and for example, the ratio of patient plasma to normal plasma is 1:1.

[0210] Step 3: Immediate correction test is carried out immediately, reagent is injected, and corresponding clotting time is obtained.

[0211] Step 4: The sample required for incubation correction will be injected into the buffer container first, and then incubation will be carried out under the specified conditions. The incubation temperature can be 37°C, and the incubation time can be between half an hour and four hours, which can be defined by the user; the default value can be two hours. It should be noted here that two buffer containers are required for the seventh coagulation item to perform incubation.

[0212] Step 5: After incubation is completed, the buffer container will be transferred to the standby sample site, and then the sample will be sucked from the buffer container on the standby sample site and injected into the reaction container.

[0213] Step 6: Incubation correction test is carried out, reagent is injected, and corresponding clotting time is obtained.

[0214] It can be seen that different test procedures are designed for immediate correction test and incubation correction test in some embodiments, which not only guarantees the reliability of the results of incubation correction, but also reduces the waste of injection containers and patient plasma for immediate correction, and improves the test speed. For example, Figure 13 The comparison of the automatic test results of the sample analysis device in this paper with the manual method results, the instrument in the table refers to the sample analysis device in this paper. By intercepting the APTT clotting time results of three representative patient samples, it can be seen that the automatic test results of the sample analysis device are basically consistent with the manual test results. It should be noted that the manual method here refers to: manually processing the sample, and then completing the test by the relevant instrument; specifically, for immediate correction test: manually preparing the sample, and then testing its APTT clotting time by the instrument; for incubation correction test: manually preparing the sample, and then incubating it in a water bath incubator for 2 hours before testing its APTT clotting time by the instrument.

[0215] In some embodiments, different detection processes are designed for immediate correction test and incubation correction test, which can minimize the waste of patient plasma and improve the utilization rate. In addition, the liquid volume in the buffer container is determined by the evaporation required, which not only further reduces the waste of patient plasma, but also prepares samples for automatic review, improves the automatic retest speed of incubation correction test, and shortens the reporting time.

[0216] After the detection unit 200 obtains the detection result, for example, the clotting time, in some embodiments, the processor 300 obtains the reason for the prolongation of the clotting time of the patient's plasma according to at least the sixth clotting time and the seventh clotting time. For example, the processor determines whether the prolongation of the clotting time is caused by the presence of a non-time-dependent inhibitor or a time-dependent inhibitor in the patient's plasma according to the sixth clotting time and the seventh clotting time, and generates a corresponding prompt; in some embodiments, the display 400 can be used to display the prompt.

[0217] In other embodiments, the processor 300 obtains the reason for the prolongation of the clotting time according to the third clotting time, the sixth clotting time, and the seventh clotting time. For example, when the third clotting time indicates correction, the sixth clotting time indicates correction, and the seventh clotting time indicates correction, the processor 300 determines that the prolongation of the clotting time of the patient's plasma is caused by the lack of coagulation factors and the absence of inhibitors, and generates a corresponding prompt; when the third clotting time indicates correction, the seventh clotting time indicates correction, and the sixth clotting time indicates non-correction and its prolongation time exceeds the critical value, the processor 300 determines that the prolongation of the clotting time of the patient's plasma is caused by the presence of time and temperature-dependent inhibitors, and generates a corresponding prompt; when the third clotting time indicates non-correction, the sixth clotting time indicates non-correction, the seventh clotting time indicates non-correction, and the prolongation time of the sixth clotting time does not exceed the critical value compared to the prolongation time of the seventh clotting time, the processor 300 determines that the prolongation of the clotting time of the patient's plasma is caused by the presence of non-time and temperature-dependent inhibitors, and generates a corresponding prompt; when the third clotting time indicates non-correction, the sixth clotting time indicates non-correction, the seventh clotting time indicates non-correction, and the prolongation time of the sixth clotting time exceeds the critical value compared to the prolongation time of the seventh clotting time, the processor 300 determines that the prolongation of the clotting time of the patient's plasma is caused by the presence of time and temperature-dependent inhibitors, and generates a corresponding prompt.

[0218] When analyzing the reason for the prolongation of the clotting time according to the clotting times obtained from the immediate correction test and the incubation correction test, some default formulas of the sample analysis device can be used. For example, taking the correction test of APTT as an example, the following default formulas can be used:

[0219] Formula 1: RI=(APTT 3-APTT 2) / APTT 1x100%;

[0220] Formula 2: APTT 6 - APTT 7.

[0221] In addition, after the correction test confirms the presence of coagulation factor inhibitors, the Nijmegen method and the Bethesda method can be used to determine the titer of the inhibitor (unit: BU / mL). In the "Chinese Guidelines for Diagnosis and Treatment of Coagulation Factor VIII / IX Inhibitors (2018 Edition)", the Bethesda method is determined as the standard method for testing the titer of FVIII / FIX coagulation factor inhibitors. The specific operation is: sequentially dilute the patient's plasma by a certain ratio, mix it with normal plasma, incubate at 37°C for 2 hours, test the residual activity of coagulation factors in each sample, and compare it with the coagulation factor activity of the standard sample. Find the dilution ratio corresponding to the ratio close to 50%, and the reciprocal is the titer of the coagulation factor inhibitor (i.e. titer). This process requires 2 hours of incubation and testing of multiple points of coagulation factor activity, which is time-consuming, labor-intensive, has poor repeatability, and low standardization.

[0222] A large number of hospitals have carried out a large amount of work and accumulated a large amount of data. For example: a hospital developed a new test method when researching the activity test of FVIII coagulation factor inhibitors, which has the following advantages compared to the traditional method:

[0223] Synchronous testing with APTT correction test, realizing synchronous screening and diagnosis;

[0224] Determination of FVIII coagulation factor inhibitor titer within 20 minutes, saving a lot of time compared to the 2-hour incubation process of the Bethesda method;

[0225] Full automation, the 2-hour automatic incubation process of the Bethesda method has not been claimed by any manufacturer, but the method provided by the hospital can be fully automated, not only saving manpower, but also improving repeatability and accuracy.

[0226] However, there is currently no fully automatic coagulation analyzer that can support users to carry out the above research process, and medical workers can only summarize and organize data through daily office software.

[0227] Therefore, in some embodiments, the user can also customize the calculation formula to further calculate and analyze the detection result. Therefore, in some embodiments, the display 400 displays a formula editing interface, which is used to display the calculation formula input by the user through an input unit (not shown in the figure). The input unit can be a mouse, a keyboard, etc., or the input unit can be integrated into the display 400, so that the display 400 can be a display screen with touch function. The processor 300 obtains the calculation formula and the detection result (for example, one or more of the first clotting time to the seventh clotting time) involved in the calculation formula to obtain the calculation result of the calculation formula; the display 400 also displays the calculation result. In some embodiments, the display 400 also displays the diagnostic result associated with the calculation result, which can be the reason for the prolongation of the clotting time, such as "suspected presence of anticoagulant drug interference", "coagulation factor inhibitor titer > 3.5 BU / mL", etc. The diagnostic result can be obtained by the processor 4300 according to the calculation result, or input by the user through the input unit.

[0228] The following are two examples of user-defined calculation formulas:

[0229] Formula 3: APTTD = APTT6 - APTT3;

[0230] Formula 4: APTTCI = APTT1 x APTT3 x APTT6 x APTTD 3 / 10 6 .

[0231] Figure 14 An example of a formula editing interface. In some embodiments, the formula editing interface includes:

[0232] An editing item of the name of the calculation formula or the name of the calculation result, for the user to input the name of the calculation formula or the name of the calculation result through the input unit;

[0233] A formula editing item of the calculation formula, for the user to input the calculation formula through the input unit;

[0234] In some embodiments, the formula editing interface further includes at least one of the following:

[0235] A unit editing item of the calculation formula, for the user to input the unit of the calculation formula through the input unit;

[0236] An accuracy editing item of the calculation result of the calculation formula, for the user to input the accuracy of the calculation result through the input unit;

[0237] A reference range editing item of the calculation result of the calculation formula, for the user to input the reference range of the calculation result through the input unit;

[0238] For providing one or more detected result items capable of participating in the calculation, for the user to input the selected detected result item into the formula editing item through the input unit; for example, APTT / Sec contained in the "Parameter Abbreviation" item in the figure.

[0239] For providing one or more operator symbol items for editing the formula, for the user to input the selected operator symbol item into the formula editing item through the input unit; for example, numbers and symbols contained in the "Operator Symbol" item in the figure.

[0240] It should be noted that in some examples, the formula editing interface allows the use of detected results not limited to APTT correction test. Of course, it can be understood that in some embodiments, the calculation formula can only carry out calculation when all the detected results participating in the calculation are valid. Here, valid contains two meanings: one, the detection item is performed, and the clinical research system cannot actively initiate the associated detection, and all detection items need to be initiated by the user; two, the detection has been completed and the normal result has been obtained, and the result such as instrument failure unable to complete detection or exceeding the linear range needs to be diluted is not considered as a normal result.

[0241] In some embodiments, the display 400 also provides an interface for the user to view the default formula and the calculation formula input by the user; Figure 15 For an example.

[0242] In some embodiments, the processor 300 also acquires a correction test report template, and generates a result report according to the correction test report template and the above calculation result.

[0243] In some embodiments, the correction test report template can include: the name, the detected result item and the reference range item of the first coagulation item; the name, the detected result item and the reference range item of the second coagulation item; the name, the detected result item and the reference range item of the third coagulation item; the name, the detected result item and the reference range item of the fourth coagulation item; the name, the detected result item and the reference range item of the fifth coagulation item; the name, the detected result item and the reference range item of the sixth coagulation item; the name, the detected result item and the reference range item of the seventh coagulation item. Please refer to Figure 16 For an example of the correction test report template.

[0244] In some embodiments, the result report form can include: the name of the first coagulation item, the test result and the reference range; the name of the second coagulation item, the test result and the reference range; the name of the third coagulation item, the test result and the reference range; the name of the fourth coagulation item, the test result and the reference range; the name of the fifth coagulation item, the test result and the reference range; the name of the sixth coagulation item, the test result and the reference range; the name of the seventh coagulation item, the test result and the reference range; the name of the calculation formula, the name of the calculation result or the formula itself of the calculation formula; the calculation result of the calculation formula and / or the diagnosis result.

[0245] In some embodiments, the user can edit the result report form through the input unit, for example, the user can add custom parameter content in the result report form. In some embodiments, each added parameter (calculation result) needs to have the following information: the name of the parameter; the calculation formula of the parameter, the default parameter does not output the calculation formula, but the user-defined parameter outputs the calculation formula in the note area in the lower half; the result of the parameter; the reference range of the parameter, most of the added parameters do not have reference range, which is replaced by "-"; the clinical significance of the parameter, which can be empty. Please refer to Figure 17 , for an example of the result report form.

[0246] Some embodiments provide a tool for correcting test clinical research by allowing users to customize calculation formulas, which includes an operation interface and database support, and can facilitate medical workers to carry out correction test and clinical research, and improve the screening and diagnosis ability of correction test.

[0247] The above is an example of analyzing and calculating the test result by formula to obtain the reason for prolonging the coagulation time.

[0248] In some embodiments, the test result can also be analyzed by means of a curve chart.

[0249] For example, two curves are plotted with the coagulation time or the prolongation rate of the coagulation time as the vertical axis and the mixing ratio or mixing rate of the patient's plasma or normal plasma as the horizontal axis, into immediate correction (CT1, CT2 and CT3) and incubation correction (CT4, CT5 and CT6), CT1, CT2, CT3, CT4, CT5 and CT6 represent the first to the sixth coagulation time respectively; each curve contains at least three points; the mixed plasma formed by at least one mixing ratio of the patient's plasma and the normal plasma is to identify the lower titer of the coagulation factor inhibitor, and here it is recommended to select two mixing ratios of 1 / 4 and 1 / 1. The prolongation rate of the coagulation time refers to the difference between the coagulation time of the patient's plasma and the normal plasma as 1, the difference between the coagulation time of the mixed plasma prepared by the patient's plasma and the normal plasma at a certain mixing ratio and the coagulation time of the normal plasma, divided by the difference between the coagulation time of the patient's plasma and the normal plasma as the plotting value. When the mixing ratio or mixing rate of the patient's plasma or normal plasma is the horizontal axis, the value of the plasma sample of the patient's plasma alone can be set to 1, and the value of the plasma sample of the normal plasma alone can be 0, or vice versa.

[0250] Therefore, in some embodiments, the processor is configured to plot an immediate correction line according to the detection results of the samples of each immediate correction test (e.g., the detection results of the first sample, the second sample and the third sample) and plot an incubation correction line according to the detection results of the samples of each incubation correction test (e.g., the detection results of the fourth sample, the fifth sample and the sixth sample) as a coordinate system with the mixing ratio or mixing rate of the patient's plasma or normal plasma as the horizontal axis and the coagulation time or the prolongation rate of the coagulation time as the vertical axis. The display 400 displays the above-mentioned immediate correction line and incubation correction line under the above-mentioned coordinate system.

[0251] In some embodiments, the processor 300 further calculates the area enclosed by the above-mentioned immediate correction line and the above-mentioned incubation correction line. It can be understood that the area enclosed by the immediate correction line and the above-mentioned incubation correction line is calculated here by connecting the first point of the immediate correction line (e.g., the point plotted for the first sample) and the first point of the incubation correction line (e.g., the point plotted for the fourth sample), and connecting the last point of the immediate correction line (e.g., the point plotted for the third sample) and the last point of the incubation correction line (e.g., the point plotted for the fourth sample); it can be understood that the order of the points here is determined by the size of the horizontal coordinates of the points.

[0252] The above test and calculation process is performed on the sample positive for the time-dependent coagulation factor inhibitor (commonly FVIII coagulation factor inhibitor), and a set of standard area values can be determined in advance. In this way, the processor 300 also obtains the reason for the prolongation of the coagulation time of the patient's plasma according to the above area and an area threshold value (i.e. the standard area value above) for display on the display 400; and / or, the display 400 also displays the value of the above area and the above area threshold value. In some embodiments, when it is judged that the area is less than the area threshold value, the processor 300 judges that there is no time-dependent coagulation inhibitor; otherwise, the processor 300 judges that there is a time-dependent coagulation inhibitor.

[0253] For the reasons for prolongation of coagulation time that are not time-dependent (coagulation factor deficiency, coagulation factor inhibitor other than FVIII, and most LA), the conclusions of the immediate correction and incubation correction tests are basically consistent; for the reasons for prolongation of coagulation time that are time-dependent (FVIII coagulation factor inhibitor and a small amount of LA), the immediate correction test generally shows correctable or partially correctable, and the incubation correction test generally shows uncorrectable.

[0254] As Figure 18 and Figure 19 are two reasons for prolongation of coagulation time that are not time-dependent, coagulation factor deficiency (hereditary hemophilia) and LA (lupus), the area enclosed by the curves of immediate correction and incubation correction is very small; for example Figure 18 in which the two curves of immediate correction and incubation correction are basically coincident, and the area enclosed by the two curves is only 0.0125; while Figure 19 in which it can be seen that the two curves of immediate correction and incubation correction are basically coincident, and the area enclosed by the two curves is only 0.0090. It should be noted that: here the APTT reagent of Mindray is used, and the LAC of the sample is 2.76, which belongs to strong positive LA.

[0255] As Figure 20 is a reason for prolongation of coagulation time that is time-dependent, containing FVIII coagulation factor inhibitor (acquired hemophilia), the area enclosed by the curves of immediate correction and incubation correction is relatively large, and increases with the increase of titer. Specifically, Figure 20 shows the plotting results of two patients with acquired hemophilia (about 2 BU / mL in the first graph, i.e. the lower graph, and about 5 BU / mL in the second graph, i.e. the upper graph), it can be seen that the area enclosed by the two curves of immediate correction and incubation correction has a certain increase, which is because the patient's plasma contains FVIII coagulation factor inhibitor with time dependence. The size of the enclosed area can represent the titer of the coagulation factor inhibitor.

[0256] Figure 18 to Figure 20In some embodiments, the area threshold of the area surrounded by the curves of immediate correction and incubation correction means the detection limit of identifying the time-dependent coagulation factor inhibitor, which is compared with the coagulation factor deficiency and LA positive, as shown in the following table:

[0257] In some embodiments, the area threshold of the area surrounded by the curves of immediate correction and incubation correction means the detection limit of identifying the time-dependent coagulation factor inhibitor, which is compared with the coagulation factor deficiency and LA positive, as shown in the following table: Figure 21 As shown in the figure, the areas surrounded by heparin, LA positive, and hereditary hemophilia are generally <0.08, which can be used as the area threshold of the detection system. When the FVIII coagulation factor inhibitor is at a low titer (<1 BU / mL), it is basically indistinguishable from the non-time-dependent coagulation time extension reason, and only when it reaches a certain titer, it can be easily distinguished. The area threshold is closely related to the reagent components, test methodology, etc., and each detection system should independently establish its own area threshold. However, in order to identify whether there is time dependence, only plotting can be performed without judgment.

[0258] In some embodiments, the processor 300 is further configured to take the mixing ratio or mixing rate of the patient plasma or normal plasma as the horizontal axis, the prolongation rate of the coagulation time or clotting time as the vertical axis as the coordinate system, draw at least four points according to the detection results of the samples of each incubation correction test (for example, the detection results of the fourth sample to the seventh sample), and connect the at least four points in turn to form a polygon; the processor 300 further calculates the area of the polygon; the processor 300 further obtains the coagulation time extension reason of the patient plasma according to the area of the polygon and an area threshold, so as to be displayed on the display 400; and / or, the display further displays the value of the area of the polygon and the area threshold thereof. In some embodiments, when it is judged that the area of the polygon is less than the area threshold thereof, the processor 300 judges that there is no time-dependent coagulation inhibitor; otherwise, the processor 300 judges that there is a time-dependent coagulation inhibitor.

[0259] In some embodiments, the coagulation inhibitor includes a coagulation factor inhibitor and a lupus anticoagulant.

[0260] In some embodiments of the present application, a sample analysis method is also disclosed. Please refer to Figure 22 In some embodiments, the sample analysis method includes the following steps:

[0261] Step S100: performing the immediate correction test. In one embodiment, step S100 performing the immediate correction test comprises: mixing the plasma sample for the immediate correction test and the reagent for coagulation time determination to prepare a test sample for the immediate correction test; and determining the coagulation time of the test sample for the immediate correction test. In some embodiments, for the immediate correction test: step S100 draws the sample from the sample container and dispenses into a reaction container to prepare the test sample for the immediate correction test in the reaction container.

[0262] Step S200: performing the incubation correction test. In one embodiment, step S200 performing the incubation correction test comprises: mixing the plasma sample for the incubation correction test and the reagent for coagulation time determination to prepare a test sample for the incubation correction test; and determining the coagulation time of the test sample for the incubation correction test. In some embodiments, for the incubation correction test: step S200 draws the sample from the sample container and dispenses into a buffer container to incubate for a preset time under certain conditions, and then draws the incubated sample from the buffer container and dispenses into a reaction container to prepare the test sample for the incubation correction test in the reaction container.

[0263] In some embodiments, the initial amount of the plasma sample for the incubation correction test at the beginning of the incubation is greater than the amount of the plasma sample for the immediate correction test.

[0264] The immediate correction test and the incubation correction test are described in more detail below.

[0265] In some embodiments, the immediate correction test comprises at least the third coagulation item; in some embodiments, the immediate correction test further comprises the first coagulation item and / or the second coagulation item, which are described in detail below.

[0266] The first coagulation item is used to detect whether the plasma sample for the immediate correction test is patient plasma: step S100 mixes the patient plasma and the reagent for coagulation time determination to prepare a first test sample; in one specific embodiment, step S100, when preparing the first test sample, draws the sample from the sample container containing the patient plasma to dispense a first amount of the sample into a first reaction container, and adds the reagent for coagulation time determination to the first reaction container to prepare the first test sample; and determines the first coagulation time of the first test sample.

[0267] The second coagulation item is used to detect that the plasma sample for the immediate correction test is normal plasma: step S100 prepares a second test sample by mixing normal plasma and coagulation time determination reagent; in one embodiment, step S100, when preparing the second test sample, draws sample from a sample container containing normal plasma to inject a second amount of sample into a second reaction container, and adds coagulation time determination reagent to the second reaction container to prepare the second test sample; and determines the second test sample to obtain a second coagulation time.

[0268] The immediate correction test includes at least a third coagulation item, which is used to detect that the plasma sample for the immediate correction test is mixed plasma formed by mixing patient plasma and normal plasma: step S100 prepares a third test sample for the immediate correction test by mixing mixed plasma formed by mixing patient plasma and normal plasma and coagulation time determination reagent; in one embodiment, step S100, when preparing the third test sample, draws sample from a sample container containing patient plasma and a sample container containing normal plasma respectively to inject into a third reaction container, the total amount of sample injected into the third reaction container is a third amount, and adds coagulation time determination reagent to the third reaction container to prepare the third test sample; and determines the third test sample to obtain a third coagulation time.

[0269] In some embodiments, the incubation correction test includes a sixth coagulation item and a seventh coagulation item; in some embodiments, the incubation correction test further includes a fourth coagulation item and / or a fifth coagulation item, which are described in detail below.

[0270] The fourth coagulation item is used to detect that the plasma sample for the incubation correction test is patient plasma after incubation for a preset time under certain conditions: step S200 incubates patient plasma for a preset time under certain conditions, and then mixes the incubated patient plasma and coagulation time determination reagent to prepare a fourth test sample; in one embodiment, step S200, when preparing the fourth test sample, draws sample from a sample container containing patient plasma to inject a fourth amount of sample into a fourth buffer container, incubates for a preset time under certain conditions, draws sample from the fourth buffer container and injects into a fourth reaction container, and adds coagulation time determination reagent to the fourth reaction container to prepare the fourth test sample; and determines the fourth test sample to obtain a fourth coagulation time.

[0271] The fifth coagulation item is used to detect that the plasma sample for incubation correction test is normal plasma after incubation under certain conditions for a preset time: step S200 incubates normal plasma under certain conditions for a preset time, and then mixes the incubated normal plasma and coagulation time determination reagent to prepare a fifth test sample; in a specific embodiment, when the fifth test sample is prepared, step S200 sucks the sample from the sample container containing normal plasma to inject a fifth amount of sample into a fifth buffer container, incubates under certain conditions for a preset time, then sucks the sample from the fifth buffer container and injects it into a fifth reaction container, and adds coagulation time determination reagent to the fifth reaction container to prepare the fifth test sample; the fifth coagulation time is obtained by measuring the fifth test sample.

[0272] The sixth coagulation item is used to detect that the plasma sample for incubation correction test is mixed plasma obtained by mixing patient plasma and normal plasma in at least one ratio: step S200 incubates the mixed sample formed by patient plasma and normal plasma under certain conditions for a preset time, and then mixes the incubated mixed sample and coagulation time determination reagent to prepare a sixth test sample; in a specific embodiment, step S200 sucks the sample from the sample container containing patient plasma and the sample container containing normal plasma to inject into a sixth buffer container, the total amount of sample injected into the sixth buffer container is a sixth amount, incubates under certain conditions for a preset time, then sucks the sample from the sixth buffer container and injects it into a sixth reaction container, and adds coagulation time determination reagent to the sixth reaction container to prepare the sixth test sample; the sixth coagulation time is obtained by measuring the sixth test sample.

[0273] The seventh coagulation item is used to detect that the plasma sample for incubation correction test is patient plasma after incubation under certain conditions for a preset time, and the plasma sample obtained by mixing the patient plasma after incubation under certain conditions for a preset time and the normal plasma after incubation under certain conditions for a preset time: step S200 incubates patient plasma and normal plasma under certain conditions for a preset time, and then mixes the incubated patient plasma, normal plasma, and coagulation time determination reagent to prepare a seventh test sample; in a specific embodiment, step S200 sucks the incubated sample from the fourth buffer container and the fifth buffer container and injects it into a seventh reaction container, adds coagulation time determination reagent to the seventh reaction container to prepare the seventh test sample; the seventh coagulation time is obtained by measuring the seventh test sample.

[0274] Various exemplary embodiments are described herein. However, it will be recognized by those skilled in the art that changes and modifications can be made to the exemplary embodiments without departing from the scope of the present disclosure. For example, various operational steps and components for carrying out the operational steps can be implemented in different sequences and / or omitted, combined, or combined in various ways than presented in the figures and / or descriptions without departing from the principles of the present disclosure.

[0275] In the above-described embodiments, all or part of the embodiments can be realized by software, hardware, firmware, or any combination thereof. In addition, as understood by those skilled in the art, the principles herein can be reflected in a computer program product on a computer readable storage medium preloaded with computer readable program code. Any tangible, non-transitory computer readable storage medium can be used, including magnetic storage devices (hard disk, floppy disk, etc.), optical storage devices (CD-ROM, DVD, Blu Ray disc, etc.), flash memory, and / or the like. These computer program instructions can be loaded onto a general-purpose computer, a special-purpose computer, or other programmable data processing apparatus to form a machine, so that these instructions executed on the computer or other programmable data processing apparatus can generate a device that implements the specified functions. These computer program instructions can also be stored in a computer readable storage medium, which can instruct the computer or other programmable data processing apparatus to operate in a specific way, so that the instructions stored in the computer readable storage medium can form a manufactured item, including an implementation device that implements the specified functions. Computer program instructions can also be loaded onto a computer or other programmable data processing apparatus, so as to execute a series of operational steps on the computer or other programmable data processing apparatus to generate a computer-implemented process, so that the instructions executed on the computer or other programmable data processing apparatus can provide steps for implementing the specified functions.

[0276] Although the principles herein have been illustrated in various embodiments, many modifications in structure, arrangement, proportions, elements, materials, and components specially adapted to specific environments and operational requirements can be used without departing from the principles and scope of the present disclosure. The above modifications and other changes or modifications will be included within the scope of the principles herein.

[0277] The foregoing detailed description has been presented for purposes of illustration and description. However, various modifications and changes can be made without departing from the scope of the disclosure. Accordingly, the disclosure is intended to be illustrative, but not restrictive. It is therefore intended to fall within the scope of the appended claims, including in a broader form in which the above-mentioned advantages, together with other advantages, that will become apparent to those of ordinary skill in the art, are embodied. Also, the terminology used has been chosen for the purpose of clarity and expedience, rather than to limit the disclosure. The use of the terms "including," "comprising," or "having" and variations thereof herein is meant to encompass the items listed thereafter, and equivalents thereof as well as additional items not specifically listed. Further, the use of the terms "coupled," "connected," and variations thereof herein is meant to encompass a direct connection between two elements, an indirect connection between two elements through one or more intervening elements, and / or a connection in which the craft of ordinary skill in the art has recognized a functional, mechanical, and / or communicative relationship between the elements. Those skilled in the art will recognize that the foregoing description has been presented for the purpose of illustration and description only. It is not intended to be exhaustive or to limit the disclosure to the precise form disclosed. Many modifications and variations will be apparent to those skilled in the art upon reading this disclosure. It is intended that the scope of the disclosure should only be defined by the claims and their equivalents.

Claims

1. A sample analysis device, characterized by: The present application includes: a reaction container loading section for supplying a container; the container includes a reaction container and / or a buffer container; a sample loading section for supplying a sample container for carrying a sample, wherein the sample is patient plasma or normal plasma; a sample dispensing section for aspirating the sample in the sample container and dispensing it into the reaction container or the buffer container; a reagent carrying section for carrying a reagent container; the reagent container is for carrying a reagent; the reagent includes a coagulation time assay reagent; a reagent dispensing section for aspirating the reagent from the reagent container and dispensing it into the reaction container; a reaction section for incubating the reaction container and / or the buffer container carrying the sample, and for incubating the reaction container carrying the sample and the reagent; a scheduling mechanism for scheduling the reaction container and the buffer container; the scheduling mechanism can schedule the reaction container to the reaction section, and can schedule the buffer container to the reaction section; an assay section for assaying a test sample mixed from the sample and the reagent; wherein: the sample dispensing section aspirates the patient plasma from the sample container containing the patient plasma and aspirates the normal plasma from the sample container containing the normal plasma, and dispenses them into a third reaction container to form a mixed plasma; the reagent dispensing section aspirates the coagulation time assay reagent from the reagent container, and adds the coagulation time assay reagent to the third reaction container to prepare a third test sample; the sample dispensing section aspirates the patient plasma from the sample container containing the patient plasma and aspirates the normal plasma from the sample container containing the normal plasma, and dispenses them into a sixth buffer container to form a mixed plasma; the reaction section incubates the mixed plasma in the sixth buffer container at a temperature of 30-45°C for 0.5-4 hours, wherein the sixth buffer container is scheduled to the reaction section by the scheduling mechanism; the sample dispensing section aspirates the incubated mixed plasma from the sixth buffer container and dispenses it into a sixth reaction container; the reagent dispensing section aspirates the coagulation time assay reagent from the reagent container, and adds the coagulation time assay reagent to the sixth reaction container to prepare a sixth test sample; The sample dispensing unit sucks the patient plasma from the sample container containing the patient plasma and dispenses it into a fourth buffer container, the reaction unit incubates the patient plasma in the fourth buffer container at a temperature of 30 to 45°C for 0.5 to 4 hours, wherein the fourth buffer container is scheduled to the reaction unit by the scheduling mechanism; the sample dispensing unit sucks the normal plasma from the sample container containing the normal plasma and dispenses it into a fifth buffer container, the reaction unit incubates the normal plasma in the fifth buffer container at a temperature of 30 to 45°C for 0.5 to 4 hours, wherein the fifth buffer container is scheduled to the reaction unit by the scheduling mechanism; the sample dispensing unit sucks the incubated patient plasma and normal plasma from the fourth buffer container and the fifth buffer container, respectively, and dispenses them into a seventh reaction container, the reagent dispensing unit sucks the coagulation time determination reagent from the reagent container and adds the coagulation time determination reagent to the seventh reaction container to prepare a seventh sample; The determination unit determines a third coagulation time from the third sample, a sixth coagulation time from the sixth sample, and a seventh coagulation time from the seventh sample.

2. The sample analysis device according to claim 1, wherein: The sample dispensing unit further sucks the incubated patient plasma from the fourth buffer container and dispenses it into a fourth reaction container, and the reagent dispensing unit sucks the coagulation time determination reagent from the reagent container and adds the coagulation time determination reagent to the fourth reaction container to prepare a fourth sample; The sample dispensing unit further sucks the incubated normal plasma from the fifth buffer container and dispenses it into a fifth reaction container, and the reagent dispensing unit sucks the coagulation time determination reagent from the reagent container and adds the coagulation time determination reagent to the fifth reaction container to prepare a fifth sample; The determination unit further determines a fourth coagulation time from the fourth sample and a fifth coagulation time from the fifth sample.

3. The sample analysis device according to claim 1 or 2, wherein: After the sample dispensing unit sucks the incubated patient plasma from the fourth buffer container, the reaction unit continues to incubate the patient plasma in the fourth buffer container at a temperature of 30 to 45°C so that the patient plasma in the fourth buffer container can be used for rechecking; and / or After the sample dispensing unit sucks the incubated normal plasma from the fifth buffer container, the reaction unit continues to incubate the normal plasma in the fifth buffer container at a temperature of 30 to 45°C so that the normal plasma in the fifth buffer container can be used for rechecking; and / or After the sample dispensing unit sucks the incubated mixed plasma from the sixth buffer container, the reaction unit continues to incubate the mixed plasma in the sixth buffer container at a temperature of 30 to 45°C so that the mixed plasma in the sixth buffer container can be used for rechecking.

4. The sample analysis device of claim 1, wherein: The sample dispensing component dispenses the mixed blood plasma into the third reaction container in a third amount, the sample dispensing component dispenses the mixed blood plasma into the sixth buffer container in a sixth amount, and the sample dispensing component dispenses the total amount of the patient blood plasma from the fourth buffer container and the normal blood plasma from the fifth buffer container in a seventh amount; the seventh amount is greater than the third amount, and the sixth amount is greater than the third amount.

5. The sample analysis device of claim 4, wherein, The seventh amount is five to six times the third amount, and the sixth amount is five to six times the third amount.

6. The sample analysis device of claim 1, wherein, A water supply device is further included for dispensing water to at least one of the fourth buffer container, the fifth buffer container, and the sixth buffer container in a preset water supply time interval and water supply amount.

7. The sample analysis device of claim 1, wherein: The fourth buffer container has a depth-diameter ratio greater than a depth-diameter ratio threshold, the fifth buffer container has a depth-diameter ratio greater than the depth-diameter ratio threshold, and the sixth buffer container has a depth-diameter ratio greater than the depth-diameter ratio threshold; the depth-diameter ratio threshold is greater than 5.

8. The sample analysis device according to claim 1, wherein: The sample dispensing component further aspirates the patient blood plasma from a sample container containing the patient blood plasma and dispenses the patient blood plasma into a first reaction container, and the reagent dispensing component further aspirates the coagulation time determination reagent from the reagent container and adds the coagulation time determination reagent to the first reaction container to prepare a first test sample; The sample dispensing component further aspirates the normal blood plasma from a sample container containing the normal blood plasma and dispenses the normal blood plasma into a second reaction container, and the reagent dispensing component further aspirates the coagulation time determination reagent from the reagent container and adds the coagulation time determination reagent to the second reaction container to prepare a second test sample; The determination unit further determines a first coagulation time of the first test sample and a second coagulation time of the second test sample.

9. The sample analysis device of claim 1, wherein: A processor is further included for determining a coagulation time extension cause of the patient blood plasma based on at least the sixth coagulation time and the seventh coagulation time.

10. The sample analysis device according to claim 1, wherein: The sample dispensing component further aspirates the patient blood plasma from the fourth buffer container after incubation and dispenses the patient blood plasma into a fourth reaction container, and the reagent dispensing component aspirates the coagulation time determination reagent from the reagent container and adds the coagulation time determination reagent to the fourth reaction container to prepare a fourth test sample; the sample dispensing component further aspirates the normal blood plasma from the fifth buffer container after incubation and dispenses the normal blood plasma into a fifth reaction container, and the reagent dispensing component aspirates the coagulation time determination reagent from the reagent container and adds the coagulation time determination reagent to the fifth reaction container to prepare a fifth test sample; and the determination unit further determines a fourth coagulation time of the fourth test sample and a fifth coagulation time of the fifth test sample. The sample dispensing component also sucks the patient plasma from a sample container containing the patient plasma and dispenses it into a first reaction container, and the reagent dispensing component also sucks the reagent for coagulation time determination from the reagent container and adds the reagent for coagulation time determination to the first reaction container to prepare a first test sample; the sample dispensing component also sucks the normal plasma from a sample container containing the normal plasma and dispenses it into a second reaction container, and the reagent dispensing component also sucks the reagent for coagulation time determination from the reagent container and adds the reagent for coagulation time determination to the second reaction container to prepare a second test sample; the determination component also determines a first coagulation time for the first test sample and a second coagulation time for the second test sample. The sample analysis device further comprises a processor configured to determine a coagulation time extension reason of the patient plasma based on the first coagulation time, the second coagulation time, the third coagulation time, the fourth coagulation time, the fifth coagulation time, the sixth coagulation time, and the seventh coagulation time.

11. The sample analysis device of claim 1, wherein: The fourth buffer container, the fifth buffer container, the sixth buffer container, the third reaction container, the sixth reaction container, and the seventh reaction container have the same structure, so that the fourth buffer container, the fifth buffer container, and the sixth buffer container can be scheduled to the reaction component for incubation.

12. The sample analysis device of claim 1, wherein: The determination component is an optical detection component, a double-magnetic-bead detection component, or an optical-magnetic integrated detection component.

13. A sample analysis device, characterized by: The sample analysis device further comprises a processor configured to determine a coagulation time extension reason of the patient plasma based on the first coagulation time, the second coagulation time, the third coagulation time, the fourth coagulation time, the fifth coagulation time, the sixth coagulation time, and the seventh coagulation time. The sample preparation component is configured to: suck the patient plasma and the normal plasma from sample containers containing the patient plasma and the normal plasma, respectively, and dispense them into a third reaction container to form mixed plasma, and add a reagent for coagulation time determination to the third reaction container to prepare a third test sample; suck the patient plasma and the normal plasma from sample containers containing the patient plasma and the normal plasma, respectively, and dispense them into a sixth buffer container to form mixed plasma, incubate the mixed plasma in the sixth buffer container at a temperature of 30-45°C for 0.5-4 hours in the sample preparation component, suck the incubated mixed plasma from the sixth buffer container and dispense it into a sixth reaction container, and add the reagent for coagulation time determination to the sixth reaction container to prepare a sixth test sample; The patient plasma is sucked from the sample container containing the patient plasma and injected into a fourth buffer container, and the patient plasma in the fourth buffer container is incubated at a temperature of 30-45°C for 0.5-4 hours in the sample preparation unit; the normal plasma is sucked from the sample container containing the normal plasma and injected into a fifth buffer container, and the normal plasma in the fifth buffer container is incubated at a temperature of 30-45°C for 0.5-4 hours in the sample preparation unit; the incubated patient plasma and normal plasma are respectively sucked from the fourth buffer container and the fifth buffer container and injected into a seventh reaction container, and the coagulation time determination reagent is added to the seventh reaction container to prepare a seventh sample; The determination unit is used for determining a third coagulation time of the third sample, determining a sixth coagulation time of the sixth sample, and determining a seventh coagulation time of the seventh sample.

14. The sample analysis device of claim 13, wherein: The sample preparation unit is also used for sucking the incubated patient plasma from the fourth buffer container and injecting it into a fourth reaction container, and adding the coagulation time determination reagent to the fourth reaction container to prepare a fourth sample; the sample preparation unit is also used for sucking the incubated normal plasma from the fifth buffer container and injecting it into a fifth reaction container, and adding the coagulation time determination reagent to the fifth reaction container to prepare a fifth sample; The determination unit is also used for determining a fourth coagulation time of the fourth sample and determining a fifth coagulation time of the fifth sample.

15. The sample analysis device of claim 13, wherein: after the sample preparation unit sucks the incubated patient plasma from the fourth buffer container, the sample preparation unit continues to incubate the patient plasma in the fourth buffer container at a temperature of 30-45°C, so that the patient plasma in the fourth buffer container can be used for rechecking; and / or after the sample preparation unit sucks the incubated normal plasma from the fifth buffer container, the sample preparation unit continues to incubate the normal plasma in the fifth buffer container at a temperature of 30-45°C, so that the normal plasma in the fifth buffer container can be used for rechecking; and / or after the sample preparation unit sucks the incubated mixed plasma from the sixth buffer container, the sample preparation unit continues to incubate the mixed plasma in the sixth buffer container at a temperature of 30-45°C, so that the mixed plasma in the sixth buffer container can be used for rechecking.

16. The sample analysis device of claim 13, wherein, The amount of mixed plasma injected by the sample preparation unit into the third reaction container is a third amount, the amount of mixed plasma injected by the sample preparation unit into the sixth buffer container is a sixth amount, and the total amount of patient plasma injected by the sample preparation unit into the fourth buffer container and normal plasma injected by the sample preparation unit into the fifth buffer container is a seventh amount; the seventh amount is greater than the third amount, and the sixth amount is greater than the third amount.

17. The sample analysis device of claim 16, wherein, The seventh amount is five to six times the third amount, and the sixth amount is five to six times the third amount.

18. The sample analysis device of claim 13, wherein, The water supplement device is configured to supplement water to at least one of the fourth buffer container, the fifth buffer container and the sixth buffer container according to a preset water supplement time interval and a water supplement amount.

19. The sample analysis device of claim 13, wherein, The fourth buffer container has a depth-diameter ratio greater than a depth-diameter ratio threshold, the fifth buffer container has a depth-diameter ratio greater than the depth-diameter ratio threshold, and the sixth buffer container has a depth-diameter ratio greater than the depth-diameter ratio threshold; the depth-diameter ratio threshold is greater than 5.

20. The sample analysis device of claim 13, wherein: The fourth buffer container, the fifth buffer container, the sixth buffer container, the third reaction container, the sixth reaction container and the seventh reaction container have the same structure, so that the fourth buffer container, the fifth buffer container and the sixth buffer container can be incubated in the sample preparation unit.

21. The sample analysis device of claim 13, wherein: The processor is configured to determine a coagulation time extension reason of the patient's plasma according to at least the sixth coagulation time and the seventh coagulation time.

22. A sample analysis device, characterized by: The sample analysis device comprises a sample preparation unit and a measurement unit; the sample analysis device is capable of performing an immediate correction test and an incubation correction test; the immediate correction test comprises at least a third coagulation item, and the incubation correction test comprises at least a sixth coagulation item and a seventh coagulation item; The immediate correction test comprises: the sample preparation unit prepares a sample for the immediate correction test, the sample for the immediate correction test being prepared by mixing a sample for the immediate correction test and a coagulation time determination reagent; and the measurement unit measures the coagulation time of the sample for the immediate correction test; In the third coagulation item, the sample for the immediate correction test is a mixed plasma formed by mixing a patient's plasma and a normal plasma; the sample preparation unit obtains the patient's plasma and the normal plasma, mixes the patient's plasma and the normal plasma to form a mixed plasma, and mixes the mixed plasma and the coagulation time determination reagent to prepare a third sample; and the measurement unit measures the third sample to obtain a third coagulation time; The incubation correction test comprises: the sample preparation unit prepares a sample for the incubation correction test, the sample for the incubation correction test being prepared by mixing a sample for the incubation correction test and the coagulation time determination reagent; and the measurement unit measures the coagulation time of the sample for the incubation correction test; In the sixth coagulation item, the sample for the incubation correction test is a mixed plasma formed by mixing the patient's plasma and the normal plasma; the sample preparation unit obtains the patient's plasma and the normal plasma, mixes the patient's plasma and the normal plasma to form a mixed plasma, incubates the mixed plasma under certain conditions for a preset time, and then mixes the incubated mixed plasma and the coagulation time determination reagent to prepare a sixth sample; and the measurement unit measures the sixth sample to obtain a sixth coagulation time. In the seventh coagulation item, the sample of the incubation correction test is a mixed plasma formed by mixing the patient's plasma and the normal plasma: the sample preparation unit obtains the patient's plasma and the normal plasma, incubates the obtained patient's plasma and the normal plasma under the certain condition for a preset time, and mixes the incubated patient's plasma and the incubated normal plasma to form a mixed plasma, and then mixes the mixed plasma and the coagulation time measuring reagent to prepare a seventh sample; the measuring unit measures the seventh sample to obtain a seventh coagulation time.

23. The sample analysis device of claim 22, wherein: The immediate correction test further includes a first coagulation item and / or a second coagulation item; the incubation correction test further includes a fourth coagulation item and / or a fifth coagulation item; In the first coagulation item, the sample of the immediate correction test is the patient's plasma, and the sample preparation unit mixes the patient's plasma and the coagulation time measuring reagent to prepare a first sample; the measuring unit measures the first sample to obtain a first coagulation time; In the second coagulation item, the sample of the immediate correction test is the normal plasma, and the sample preparation unit mixes the normal plasma and the coagulation time measuring reagent to prepare a second sample; the measuring unit measures the second sample to obtain a second coagulation time; In the fourth coagulation item, the sample of the incubation correction test is the patient's plasma, and the sample preparation unit incubates the patient's plasma under the certain condition for a preset time, and then mixes the incubated patient's plasma and the coagulation time measuring reagent to prepare a fourth sample; the measuring unit measures the fourth sample to obtain a fourth coagulation time; In the fifth coagulation item, the sample of the incubation correction test is the normal plasma, and the sample preparation unit incubates the normal plasma under the certain condition for a preset time, and then mixes the incubated normal plasma and the coagulation time measuring reagent to prepare a fifth sample; the measuring unit measures the fifth sample to obtain a fifth coagulation time.

24. The sample analysis apparatus according to claim 23, wherein: In the first coagulation item, the sample preparation unit sucks the patient's plasma from a sample container containing the patient's plasma, dispenses the patient's plasma into a first reaction container, and adds the coagulation time measuring reagent to the first reaction container to prepare a first sample, wherein the amount of the patient's plasma dispensed into the first reaction container is a first amount; In the second coagulation item, the sample preparation unit sucks the normal plasma from a sample container containing the normal plasma, dispenses the normal plasma into a second reaction container, and adds the coagulation time measuring reagent to the second reaction container to prepare a second sample, wherein the amount of the normal plasma dispensed into the second reaction container is a second amount; In the third coagulation item, the sample preparation section draws the patient plasma and the normal plasma from the sample container containing the patient plasma and the sample container containing the normal plasma, respectively, injects the patient plasma and the normal plasma into a third reaction container to form mixed plasma, and adds the coagulation time measurement reagent to the third reaction container to prepare a third sample, wherein the amount of the mixed plasma injected into the third reaction container is a third amount; In the sixth coagulation item, the sample preparation section draws the patient plasma and the normal plasma from the sample container containing the patient plasma and the sample container containing the normal plasma, respectively, injects the patient plasma and the normal plasma into a sixth buffer container to form mixed plasma, incubates the sixth buffer container under the certain condition for a preset time, draws the incubated mixed plasma from the sixth buffer container and injects it into a sixth reaction container, and adds the coagulation time measurement reagent to the sixth reaction container to prepare a sixth sample, wherein the amount of the mixed plasma injected into the sixth buffer container is a sixth amount; In the seventh coagulation item, the sample preparation section draws the patient plasma from the sample container containing the patient plasma, injects the patient plasma into a fourth buffer container, incubates the fourth buffer container under the certain condition for a preset time, draws the normal plasma from the sample container containing the normal plasma, injects the normal plasma into a fifth buffer container, incubates the fifth buffer container under the certain condition for a preset time, draws the incubated patient plasma and the incubated normal plasma from the fourth buffer container and the fifth buffer container, respectively, and injects them into a seventh reaction container, and adds the coagulation time measurement reagent to the seventh reaction container to prepare a seventh sample, wherein the amount of the patient plasma injected into the fourth buffer container is a fourth amount, and wherein the amount of the normal plasma injected into the fifth buffer container is a fifth amount.

25. The sample analysis device according to claim 24, wherein: In the fourth coagulation item, the sample preparation section draws the incubated patient plasma from the fourth buffer container and injects it into a fourth reaction container, and adds the coagulation time measurement reagent to the fourth reaction container to prepare a fourth sample; In the fifth coagulation item, the sample preparation section draws the incubated normal plasma from the fifth buffer container and injects it into a fifth reaction container, and adds the coagulation time measurement reagent to the fifth reaction container to prepare a fifth sample.

26. The sample analysis device according to claim 25, wherein: the sixth amount is greater than the third amount; the total of the fourth amount and the fifth amount is greater than the total of the first amount, the second amount, and the third amount, and the fourth amount is greater than the first amount and the fifth amount is greater than the second amount.

27. The sample analysis device of claim 26, wherein, the sixth amount is five to six times the third amount; The total of the fourth amount and the fifth amount is five to six times the total of the first amount, the second amount and the third amount, and the fourth amount is at least five times the first amount, and the fifth amount is at least five times the second amount.

28. The sample analysis apparatus of claim 22, wherein: The water supplement device is further configured to supplement water to the sample of the incubation correction test in incubation according to a preset water supplement time interval and a water supplement amount.

29. The sample analysis apparatus of claim 24, wherein: The fourth buffer container has a depth-diameter ratio greater than a depth-diameter ratio threshold, the fifth buffer container has a depth-diameter ratio greater than the depth-diameter ratio threshold, and the sixth buffer container has a depth-diameter ratio greater than the depth-diameter ratio threshold; the depth-diameter ratio threshold is greater than 5.

30. The sample analysis device of claim 24, wherein: The sample preparation unit continues to incubate the patient plasma in the fourth buffer container under the certain condition after the patient plasma in the fourth buffer container is drawn, so that the patient plasma in the fourth buffer container can be used for re-inspection; and / or, The sample preparation unit continues to incubate the normal plasma in the fifth buffer container under the certain condition after the normal plasma in the fifth buffer container is drawn, so that the normal plasma in the fifth buffer container can be used for re-inspection; and / or, The sample preparation unit continues to incubate the mixed plasma in the sixth buffer container under the certain condition after the mixed plasma in the sixth buffer container is drawn, so that the mixed plasma in the sixth buffer container can be used for re-inspection.

31. The sample analysis apparatus of claim 25, wherein: The fourth buffer container, the fifth buffer container, the sixth buffer container, the third reaction container, the sixth reaction container and the seventh reaction container have the same structure, so that the fourth buffer container, the fifth buffer container and the sixth buffer container can be incubated in the sample preparation unit.

32. The sample analysis apparatus of claim 22, wherein: The processor is further configured to obtain a coagulation time extension reason of the patient plasma according to the sixth coagulation time and the seventh coagulation time.

33. The sample analysis device of claim 23, further comprising a processor configured to obtain a coagulation time extension reason of the patient plasma according to the first coagulation time, the second coagulation time, the third coagulation time, the fourth coagulation time, the fifth coagulation time, the sixth coagulation time and the seventh coagulation time.

34. The sample analysis apparatus of claim 22, wherein: The measurement unit is an optical detection unit, a double-magnetic-bead detection unit or an optical-magnetic integrated detection unit.

35. A method of sample analysis, characterized by, The method comprises: performing an immediate correction test; The immediate correction test comprises: preparing a sample of the immediate correction test, the sample of the immediate correction test being mixed with a coagulation time determination reagent; determining a coagulation time of the sample of the immediate correction test; performing an incubation correction test; the incubation correction test comprises: preparing a sample of the incubation correction test, the sample of the incubation correction test being mixed with the coagulation time determination reagent; determining a coagulation time of the sample of the incubation correction test; wherein: The immediate correction test comprises at least a third coagulation item, in which the sample of the immediate correction test is a mixed plasma formed by mixing the patient plasma and normal plasma: The patient plasma and the normal plasma are obtained, mixed to form a mixed plasma, and mixed with the coagulation time determination reagent to prepare a third test sample; The third test sample is determined to obtain a third coagulation time; Wherein: The incubation correction test comprises at least a sixth coagulation item and a seventh coagulation item; In the sixth coagulation item, the sample of the incubation correction test is a mixed plasma formed by mixing the patient plasma and the normal plasma: The patient plasma and the normal plasma are obtained, mixed to form a mixed plasma, and incubated under certain conditions for a preset time, and then the incubated mixed plasma is mixed with the coagulation time determination reagent to prepare a sixth test sample; The sixth test sample is determined to obtain a sixth coagulation time; In the seventh coagulation item, the sample of the incubation correction test is a mixed plasma formed by mixing the patient plasma and the normal plasma: The patient plasma and the normal plasma are obtained, respectively incubated under the certain conditions for the preset time, and then the incubated patient plasma and the incubated normal plasma are mixed to form a mixed plasma, and then the incubated patient plasma and the incubated normal plasma mixed to form the mixed plasma are mixed with the coagulation time determination reagent to prepare a seventh test sample; The seventh test sample is determined to obtain a seventh coagulation time.

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