CN116047041A

CN116047041A - Sample analysis device and sample analysis method

Info

Publication number: CN116047041A
Application number: CN202111266387.1A
Authority: CN
Inventors: 李聪; 李冬冬; 武振兴
Original assignee: Beijing Mindray Medical Instrument Co ltd; Beijing Shen Mindray Medical Electronics Technology Research Institute Co Ltd
Current assignee: Beijing Mindray Medical Instrument Co ltd; Beijing Shen Mindray Medical Electronics Technology Research Institute Co Ltd
Priority date: 2021-10-28
Filing date: 2021-10-28
Publication date: 2023-05-02

Abstract

A sample analysis device and a sample analysis method for preparing a sample for an immediate correction test by mixing a plasma sample for the immediate correction test with a reagent for measuring clotting time; preparing a sample for an incubation correction test by mixing a plasma sample for the incubation correction test with a reagent for clotting time determination; the plasma sample for the incubation correction test is a sample obtained after incubation for a preset time under a certain condition, and the amount of the plasma sample for the incubation correction test is greater than the amount of the plasma sample for the immediate correction test. The sample analysis device and sample analysis method of the present invention solve the difficulty of the incubation correction test by increasing the amount of the incubation sample by setting such that the initial amount of the plasma sample for the incubation correction test at the start of the incubation is larger than the amount of the plasma sample for the immediate correction test.

Description

Sample analysis device and sample analysis method

Technical Field

The present invention relates to a sample analysis device and a sample analysis method.

Background

Blood coagulation is a process of converting blood from a liquid state to a gel state, and measuring blood coagulation time is of great importance to grasp blood information and understand the state of hemostatic function. When it is determined that the blood coagulation time is prolonged, it is necessary to find out the cause of the prolongation thereof. The mixed plasma correction test is an important means of identifying the cause of the prolonged clotting time. The mixed plasma correction test (also called mixing test, correction test) is: screening tests in which clotting time is re-measured after patient plasma has been mixed with normal mixed plasma (herein simply referred to as normal plasma) in a certain ratio after removal of anticoagulants from the patient. Because the APTT (activated partial thromboplastin time) test has the most screened coagulation factors and coagulation inhibitors, and the prolongation of APTT for unknown reasons in clinical practice is also the most common, the mixed plasma correction test is mainly applied to APTT, prothrombin Time (PT), thrombin Time (TT), kaolin Clotting Time (KCT) and dRVVT (diluted Russell viper venom time).

The correction test mainly comprises: immediate correction test and incubation correction test. The immediate correction test needs to be carried out on the machine immediately after the plasma of the patient and normal plasma are mixed, so that the realization is simple and is supported by most of full-automatic coagulation analyzers; incubation correction tests require mixing patient plasma with normal plasma and incubating for a further period of time (e.g., half to four hours at 37 ℃) before the incubated mixed sample is tested on-machine, but the sample can cause abnormal detection results due to evaporation during incubation and even cannot be reported. Thus, most manufacturers' instruments are able to support immediate correction tests, but support very few incubation correction tests.

Disclosure of Invention

In order to solve the above problems, the present invention provides a sample analysis device and a sample analysis method.

According to a first aspect, an embodiment provides a sample analysis device including a sample preparation section and a measurement section; the sample analysis device is capable of performing an immediate correction test and an incubation correction test;

the immediate correction test includes: the sample preparation section prepares a sample for an immediate correction test by mixing a plasma sample for the immediate correction test with a reagent for measuring clotting time; the measuring section measures the coagulation time of the sample;

The incubation correction assay comprises: the sample preparation unit mixes a plasma sample for an incubation correction test with a reagent for measuring clotting time to prepare a sample for the incubation correction test; the measuring section measures the coagulation time of the sample; the plasma sample for the incubation correction test is a sample obtained after incubation for a preset time under a certain condition;

wherein 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.

In one embodiment, the sample analysis device further comprises a water replenishing device for replenishing the plasma sample for the incubation correction test during the incubation process with a certain water replenishing time interval and water replenishing amount.

In one embodiment, the water replenishment device obtains the replenishment time interval and the replenishment amount based on an initial amount of the plasma sample for the incubation correction test at the start of the incubation.

In one embodiment, the initial amount and the water replenishment time interval are positively correlated, and the initial amount and the water replenishment amount are inversely correlated.

In an embodiment, the water replenishing device further obtains the initial amount, and when the initial amount is determined to be greater than the initial amount threshold, the water replenishing device does not replenish water.

In one embodiment:

for the immediate correction test, the sample preparation section suctions a sample from a sample container and dispenses into a reaction container to prepare a sample for the immediate correction test in the reaction container;

for the incubation correction test, the sample preparation section aspirates a sample from a sample container and dispenses into a buffer container to incubate for a preset time under a certain condition, and aspirates the incubated sample from the buffer container and dispenses into a reaction container to prepare a sample for the incubation correction test in the reaction container.

In one embodiment:

if the plasma sample for the immediate correction test is patient plasma: the sample preparation section suctions a sample from a sample container containing patient plasma to dispense a first amount of the sample into a first reaction container, and adds a reagent for measuring clotting time to the first reaction container to prepare a first sample; the measurement unit measures the first sample to obtain a first solidification time;

if the plasma sample for the immediate correction test is normal plasma: the sample preparation section suctioning a sample from a sample container containing normal plasma to dispense a second amount of the sample into a second reaction container, and adding a clotting time measurement reagent to the second reaction container to prepare a second sample; the measurement unit measures the second sample to obtain a second solidification time;

If the plasma sample for the immediate correction test is a sample obtained after mixing the patient's plasma with normal plasma: the sample preparation unit sucks a sample from a sample container containing patient plasma and a sample container containing normal plasma, respectively, to be dispensed into a third reaction container, and adds a reagent for measuring clotting time to the third reaction container so as to prepare a third sample, wherein the total amount of the sample dispensed into the third reaction container is a third amount; the measurement unit measures the third sample to obtain a third solidification time;

if the plasma sample for the incubation correction test is patient plasma after a preset time of incubation under certain conditions: the sample preparation section suctions a sample from a sample container containing patient plasma to dispense a fourth amount of the sample into a fourth buffer container, suctions the sample from the fourth buffer container and dispenses the sample into a fourth reaction container after incubating for a preset time under a certain condition, and adds a reagent for measuring clotting time to the fourth reaction container to prepare a fourth sample; the measurement unit measures the fourth sample to obtain a fourth solidification time;

if the plasma sample for the incubation correction test is normal plasma after incubation for a preset time under certain conditions: the sample preparation unit aspirates a sample from a sample container containing normal plasma to dispense a fifth amount of the sample into a fifth buffer container, aspirates the sample from the fifth buffer container and dispenses the sample into a fifth reaction container after incubating for a preset time under a certain condition, and adds a clotting time measurement reagent to the fifth reaction container to prepare a fifth sample; the measurement unit measures the fifth sample to obtain a fifth solidification time;

If the plasma sample for the incubation correction test is a sample obtained by mixing the plasma of the patient with normal plasma and then incubating for a preset time under a certain condition: the sample preparation unit aspirates a sample from a sample container containing plasma of a patient and a sample container containing normal plasma, respectively, to dispense the sample into a sixth buffer container, wherein the total amount of the sample dispensed into the sixth buffer container is a sixth amount, and after incubating for a predetermined time under a certain condition, aspirates the sample from the sixth buffer container and dispenses the sample into a sixth reaction container, and adds a reagent for measuring clotting time to the sixth reaction container to prepare a sixth sample; the measurement unit measures the sixth sample to obtain a sixth solidification time.

In one embodiment: the sixth amount is greater than the third amount, the fifth amount is greater than the second amount, and the fourth amount is greater than the first amount.

In one embodiment, if the plasma sample used in the incubation correction test is a sample obtained by mixing patient plasma after incubation for a predetermined time under a certain condition and normal plasma after incubation for a predetermined time under a certain condition: the sample preparation unit sucks the incubated sample from the fourth buffer container and the fifth buffer container, and dispenses the sample into a seventh reaction container, and adds a reagent for measuring clotting time to the seventh reaction container to prepare a seventh sample; the measurement unit measures the seventh sample to obtain a seventh solidification time.

In one embodiment:

the sixth amount is greater than the third amount;

the fourth and fifth amounts add together by an amount greater than the first, second, and third amounts, and the fourth amount is greater than the first amount, and the fifth amount is greater than the second amount.

In one embodiment, the sample preparation unit draws the incubated sample from the fourth buffer container and dispenses the sample into the fourth reaction container and the seventh cuvette container, respectively; the sample preparation unit aspirates the incubated sample from the fifth buffer container and then dispenses the aspirated sample into the fifth reaction container and the seventh reaction container, respectively.

In one embodiment:

after the incubated sample is sucked from the fourth buffer container, the sample preparation section continues to incubate the sample in the fourth buffer container under the certain condition so as to be able to use the sample in the fourth buffer container for retesting;

after the incubated sample is sucked from the fifth buffer container, the sample preparation section continues to incubate the sample in the fifth buffer container under the certain condition so as to be able to use the sample in the fifth buffer container for retesting;

after the incubated sample is sucked from the sixth buffer container, the sample preparation section continues to incubate the sample in the sixth buffer container under the certain condition so that the sample in the sixth buffer container can be used for retesting.

In one embodiment, the depth-to-diameter ratio of the fourth buffer container is greater than 5.6; the depth-to-diameter ratio of the fifth buffer container is greater than 5.6; the depth-to-diameter ratio of the sixth buffer container is greater than 5.6.

In one embodiment, the measuring part is an optical detecting part, a dual magnetic bead method detecting part or a magneto-optical integrated detecting part.

According to a second aspect, an embodiment provides a sample analysis method comprising:

preparing a sample for an immediate correction test by mixing a plasma sample for the immediate correction test with a reagent for clotting time determination;

determining the sample for the immediate correction test to obtain a clotting time;

preparing a sample for an incubation correction test by mixing a plasma sample for the incubation correction test with a reagent for clotting time determination;

determining the sample of the incubation correction test to obtain the solidification time;

wherein the plasma sample for the incubation correction test is a sample obtained after incubation for a preset time under a certain condition, and the amount of the plasma sample for the incubation correction test is greater than the amount of the plasma sample for the immediate correction test.

In one embodiment, the preparing a sample for an immediate correction test by mixing a plasma sample for an immediate correction test with a clotting time determination reagent comprises: aspirating a sample from a sample container and dispensing into a reaction container to prepare a sample in the reaction container for an immediate correction test;

A method for preparing a sample for an incubation correction test by mixing a plasma sample for the incubation correction test with a clotting time determination reagent, comprising: the sample is sucked from the sample container and dispensed into the buffer container to incubate for a preset time under a certain condition, and the incubated sample is sucked from the buffer container and dispensed into the reaction container to prepare a sample for an incubation correction test in the reaction container.

In one embodiment:

if the plasma sample for the immediate correction test is patient plasma: drawing a sample from a sample container containing patient plasma to dispense a first amount of the sample into a first reaction container, and adding a clotting time measurement reagent to the first reaction container to prepare a first sample; measuring the first sample to obtain a first solidification time;

if the plasma sample for the immediate correction test is normal plasma: drawing a sample from a sample container containing normal plasma to dispense a second amount of the sample into a second reaction container, and adding a clotting time measurement reagent to the second reaction container to prepare a second sample; measuring the second sample to obtain a second solidification time;

if the plasma sample for the immediate correction test is a sample obtained after mixing the patient's plasma with normal plasma: drawing up samples from a sample container containing patient plasma and a sample container containing normal plasma, respectively, to be dispensed into a third reaction container, the total amount of the samples dispensed into the third reaction container being a third amount, and adding a reagent for measuring clotting time to the third reaction container to prepare a third sample; measuring the third sample to obtain a third solidification time;

If the plasma sample for the incubation correction test is patient plasma after a preset time of incubation under certain conditions: drawing up a sample from a sample container containing patient plasma to dispense a fourth amount of the sample into a fourth buffer container, drawing up the sample from the fourth buffer container and dispensing into a fourth reaction container after incubating for a preset time under a certain condition, and adding a clotting time measurement reagent to the fourth reaction container to prepare the fourth sample; measuring the fourth sample to obtain a fourth solidification time;

if the plasma sample for the incubation correction test is normal plasma after incubation for a preset time under certain conditions: drawing up a sample from a sample container containing normal plasma to dispense a fifth amount of the sample into a fifth buffer container, drawing up the sample from the fifth buffer container and dispensing into a fifth reaction container after incubating for a preset time under a certain condition, and adding a clotting time measurement reagent to the fifth reaction container to prepare the fifth sample; measuring the fifth sample to obtain a fifth solidification time;

if the plasma sample for the incubation correction test is a sample obtained by mixing the plasma of the patient with normal plasma and then incubating for a preset time under a certain condition: drawing up a sample from a sample container containing plasma of a patient and a sample container containing normal plasma, respectively, to be dispensed into a sixth buffer container, the total amount of the sample dispensed into the sixth buffer container being a sixth amount, drawing up the sample from the sixth buffer container and being dispensed into a sixth reaction container after incubating for a preset time under a certain condition, and adding a clotting time measuring reagent into the sixth reaction container to prepare the sixth sample; and measuring the sixth sample to obtain a sixth solidification time.

In one embodiment, if the plasma sample used in the incubation correction test is a sample obtained by mixing patient plasma after incubation for a predetermined time under a certain condition and normal plasma after incubation for a predetermined time under a certain condition: drawing up the incubated sample from the fourth buffer container and the fifth buffer container, respectively, and dispensing the sample into a seventh reaction container, and adding a reagent for measuring clotting time to the seventh reaction container to prepare a seventh sample; and measuring the seventh sample to obtain a seventh solidification time.

According to the sample analysis device and the sample analysis method of the above embodiments, the difficulty of the incubation correction test is solved by increasing the amount of the incubation sample by setting such that the initial amount of the plasma sample for the incubation correction test at the start of the incubation is larger than the amount of the plasma sample for the immediate correction test.

Drawings

FIG. 1 is a schematic diagram of a sample analyzer according to an embodiment;

FIG. 2 is a schematic diagram of a sample analyzer according to an embodiment;

FIG. 3 is a schematic diagram of a sample analyzer according to an embodiment;

FIGS. 4 (a) and 4 (b) are schematic structural views of reagent carrying members of two embodiments;

FIG. 5 is a schematic view of the structure of a reagent carrying component according to one embodiment;

FIG. 6 is an example of the first to seventh solidification items, taking the APTT correction test as an example;

FIG. 7 is a schematic diagram of a sample analyzer according to an embodiment;

FIG. 8 is a schematic structural view of a reaction vessel and a buffer vessel according to an embodiment;

FIG. 9 is a test experiment of evaporation rate for different incubation sample amounts for one example;

FIG. 10 is a test experiment of evaporation rate of incubation sample amounts under different conditions for one example;

FIG. 11 is a schematic view of a buffer container according to an embodiment;

FIG. 12 is a test experiment of evaporation rate for different incubation sample amounts for one example;

FIG. 13 is a comparison of automated test results with manual results for a sample analysis device according to one embodiment;

FIG. 14 is an example of a formula editing interface;

FIG. 15 is an example of looking at default formulas and calculation formulas;

FIG. 16 is an example of a correction test report template;

FIG. 17 is an example of a results report;

FIG. 18 is a schematic diagram of an immediate correction curve and an incubation correction curve for one embodiment;

FIG. 19 is a schematic diagram of an immediate correction curve and an incubation correction curve for one embodiment;

FIG. 20 is two schematic diagrams of an immediate correction curve and an incubation correction curve for one embodiment;

FIG. 21 is a schematic diagram of the area enclosed by the immediate correction curve and the incubation correction curve corresponding to heparin, LA positive, hereditary hemophilia, etc. in one embodiment;

FIG. 22 is a flow chart of a sample analysis method according to an embodiment.

Detailed Description

The invention will be described in further detail below with reference to the drawings by means of specific embodiments. Wherein like elements in different embodiments are numbered alike in association. In the following embodiments, numerous specific details are set forth in order to provide a better understanding of the present application. However, one skilled in the art will readily recognize that some of the features may be omitted, or replaced by other elements, materials, or methods in different situations. In some instances, some operations associated with the present application have not been shown or described in the specification to avoid obscuring the core portions of the present application, and may not be necessary for a person skilled in the art to describe in detail the relevant operations based on the description herein and the general knowledge of one skilled in the art.

Furthermore, the described features, operations, or characteristics of the description may be combined in any suitable manner in various embodiments. Also, various steps or acts in the method descriptions may be interchanged or modified in a manner apparent to those of ordinary skill in the art. Thus, the various orders in the description and drawings are for clarity of description of only certain embodiments, and are not meant to be required orders unless otherwise indicated.

The numbering of the components itself, e.g. "first", "second", etc., is used herein merely to distinguish between the described objects and does not have any sequential or technical meaning. The terms "coupled" and "connected," as used herein, are intended to encompass both direct and indirect coupling (coupling), unless otherwise indicated.

Sample analysis devices are disclosed in some embodiments of the invention. Referring to fig. 1 or 2, the sample analysis device in some embodiments includes a sample preparation portion 100 and a measurement portion 200, and in some embodiments may further include a processor 300 and a display 400; the sample preparation unit 100 is capable of preparing a sample from a sample or a plasma sample and a reagent, and the measurement unit 200 is configured to measure the sample to obtain a detection result, for example, a clotting time of the plasma sample; the process 300 can be further analyzed with the detection results to obtain diagnostic results, such as a cause of prolonged clotting time; the display 400 can be used for display; one of the descriptions is described in more detail below.

Referring to fig. 3, in some embodiments, the sample preparation portion 100 may include a reaction vessel loading section 10, a sample introduction section 20, a sample dispensing section 30, a reagent carrying section 40, a reaction section 50, and a reagent dispensing section 60, and a scheduling mechanism 70.

The reaction vessel loading part 10 is used for supplying and carrying vessels such as reaction vessels and/or buffer vessels. In operation, the sample analyzer needs to use an empty reaction vessel to complete each test item, and the sample analyzer prepares a sample by adding a sample and a reagent to the empty reaction vessel, and then obtains a test result by measuring the sample by the measuring unit 200. The reaction vessel loading part 10 may load an empty reaction vessel to a predetermined position such as a cuvette position, which may have one or more, and the sample dispensing mechanism 30 sucks a sample from the sample introduction part 20 and discharges the sample into the empty reaction vessel at the cuvette position.

The sample introduction part 20 is used for supplying a sample rack carrying samples to be tested, in particular sample containers carrying samples, the sample rack being capable of placing a plurality of sample containers. Various implementations of the sample feeding section 20 are possible, for example, the sample feeding section 20 may include a loading area 21, a sample feeding channel 22, an unloading area 23, and a buffer area 24, wherein the sample feeding channel 22 may be provided with a sample sucking position. The user can place the sample rack carrying the sample containers in the loading area 21, the loading area 21 moves the sample rack in the Y1 direction in the figure to enter the sample injection channel 22, the sample rack can move along the X1 direction and pass through the sample suction position, the sample containers on the sample rack can be sucked by the sample dispensing component 30 when passing through the sample suction position (one, two or more sample suction positions can be arranged on the sample injection channel 22), and the sample rack enters the unloading area 23 from the sample injection channel 22 along the Y2 direction after the sample rack is taken out from the unloading area 23 by the user; in other examples, after the sample container on the sample rack is sucked by the sample dispensing component 30, the sample rack may enter the buffer area 24 to wait, when all samples on the sample rack do not need to be re-inspected, 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 re-inspected, the sample rack is dispatched from the buffer area 24 back to the sample channel 22, and when the sample container where the sample to be re-inspected on the sample rack is located passes through the re-inspection position (may be the same position as the sample suction position) on the sample channel 22, the sample in the sample container is sucked by the sample dispensing component 30 for re-inspection. The sample injection part 20 is suitable for a large number of sample testing occasions, the sample injection part 20 can be arranged independently of the sample analysis device, and when the sample analysis device needs to be connected into a pipeline type testing system, the sample injection part 20 can be directly removed.

The sample dispensing part 30 is used to aspirate the sample in the sample container at the sample aspiration site and dispense the sample into the reaction container and/or the buffer container. In some embodiments, the sample dispensing mechanism 30 may include a sample needle that is driven for movement in two or three dimensions by a two or three dimensional drive mechanism. In some embodiments, the sample needle may be one or more.

The reagent carrier 40 is used for carrying a reagent, for example the reagent carrier 40 may have a plurality of positions for carrying reagent containers for carrying reagents. Generally, the reagent carrying apparatus 40 may provide a cooling function or the like for the carried reagent, thereby securing the activity of the reagent. In some embodiments, the reagent carrier 40 is provided in a disc-like structure having a plurality of positions for carrying reagent containers, the reagent carrier 40 being capable of rotating and transporting the reagent containers carried thereby to rotate the reagent containers to a reagent sucking position for the reagent dispensing member 60 to suck reagent, e.g. the reagent carrier 40 comprises a first drive assembly for driving rotation thereof, the first drive assembly driving rotation of the reagent carrier 40 for rotating the reagent containers to the reagent sucking position. The reagent carrying member 40 provided in a disk-like structure will be described in detail below.

Referring to fig. 4 (a), in some embodiments, the reagent carrying member 40 is configured in a disc-shaped structure, and has a plurality of positions for placing the reagent cups 41, and each of the reagent cups 41 includes one or more cavities for containing reagents required for testing items, and one reagent is placed in each cavity; the reagent carrier 40 comprises a first drive assembly for driving it in rotation, which first drive assembly drives the reagent carrier 40 in rotation for rotating the cavity of the reagent cup 41 containing the reagent required for the item into the corresponding reagent sucking station. In one example, the reagent cup 41 comprises at least a first cavity 41a for carrying a first reagent and a second cavity 41b for carrying a second reagent, e.g. the reagent cup 41 comprises 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 bearing part 40 comprises a first reagent sucking position and a second reagent sucking position different from the first reagent sucking position, and the first driving component drives the reagent bearing part 40 to rotate and drives the reagent connecting cup 41 to rotate so as to rotate the first cavity 41a of the reagent connecting cup 41 to the first reagent sucking position; the first driving component drives the reagent carrying component 40 to rotate and drives the reagent connecting cup 41 to rotate so as to rotate the second cavity 41b to the second reagent sucking position.

Referring to fig. 4 (b), in some embodiments, the reagent carrying member 40 is configured in a disc-shaped structure having a plurality of positions for carrying a first reagent container 42 and a plurality of positions for carrying a second reagent container 43. The reagent carrying part 40 comprises a first driving component for driving the reagent carrying part 40 to rotate, and the first driving component drives the reagent carrying part 40 to rotate and drives the first reagent container 42 to rotate so as to rotate the first reagent container 42 to a first reagent sucking position; the first driving assembly drives the reagent carrying part 40 to rotate and drives the second reagent container 43 to rotate so as to rotate the second reagent container 43 to the second reagent sucking position. In one example, the reagent carrier 40 may comprise a plurality of independently rotatable tracks. For example, the reagent carrier 40 may comprise two ring tracks, an inner ring track and an outer ring track, on which a plurality of first reagent containers 42 may be positioned, and correspondingly, on which a plurality of second reagent containers 43 may be positioned, the inner ring and outer ring tracks being driven to rotate independently by the first drive assembly.

While two types of reagent carrying members 40 have been described above, for example, fig. 4 (a) is an example of placing the reagent cup 41, fig. 4 (b) is an example of realizing the reagent carrying member 40 by a plurality of tracks capable of rotating independently, and as will be understood by those skilled in the art, the two types of reagent carrying members 40 may be realized by a plurality of tracks capable of rotating independently, and at least one track or each track has a plurality of positions for placing the reagent cup 41, for example, fig. 5 is an example, the reagent carrying member 40 may include two tracks, an inner track and an outer track, and a plurality of positions for placing the reagent cup 41 may be provided on the outer track, and accordingly, a plurality of positions for placing the reagent cup 41 may be provided on the inner track, and the inner track and the outer track may be driven to rotate independently by the first driving assembly.

The above are some of the descriptions of the reagent carrying section 40. The reagent carrier 40 may rotate and dispense the respective reagent required for the test item to the reagent aspirating position corresponding to the reagent dispensing member 60 by rotating during the working cycle, for example, a first reagent to a first reagent aspirating position and a second reagent to a second reagent aspirating position.

The reaction member 50 is used for incubation, for example, for incubating a sample, for example, for incubating a reaction solution obtained by mixing a sample with a reagent, for example, a reaction solution obtained by mixing a sample with a first reagent, and for example, a reaction solution obtained by mixing a sample with a first reagent and a second reagent. In some embodiments, reaction component 50 is rectangular in shape with multiple vessel placement sites that may be used to place reaction vessels and buffer vessels. In general, the reaction unit 50 may incubate the material in the container placed on each container, for example, incubate the reaction solution in the reaction container in which the sample and the reagent are mixed, and incubate the sample in the buffer container; in particular, the contents of the container may be heated and maintained at 37±0.5 ℃, and the specific heating time and temperature to which the contents are heated may be determined by the heating parameters corresponding to the different test items.

The reagent dispensing part 60 is used to aspirate a reagent from the reagent container in the reagent carrying part 40 and dispense it into the reaction container. The reagent dispensing member 60 may be implemented by a reagent needle. Thus, in some embodiments, reagent dispensing component 60 comprises a reagent needle for aspirating reagent from reagent carrier component 40 and dispensing into a reaction vessel. From the perspective of the number of reagent needles, in some embodiments, reagent dispensing component 60 may have a plurality of reagent needles, each of which is disposed in a manner that enables independent movement relative to the other. For example, a set of reagent pins may be provided for the reaction member 50, and a set of reagent pins may be provided for the measurement member 200.

The scheduling mechanism 70 is used to schedule containers such as reaction containers and buffer containers. For example, the dispatch mechanism dispatches containers (reaction containers and/or buffer containers) among the cuvette separating position 71, the standby sample position 72, the reaction part 50, and the measurement part 200. The number of the cup separating positions 71 may be one or more, the number of the spare sample positions 72 may be one or more, and the number of the spare sample positions 72 may be none.

The measurement unit 200 is used for measuring a sample. In some embodiments, the assay 200 is an optical detection unit, a dual bead assay detection unit, or a magneto-optical integrated detection unit. The optical detection part and the optomagnetic integrated detection part mainly acquire the transmitted light intensity or scattered light intensity of the sample; the dual-bead method detection part is mainly used for acquiring the viscosity of the sample.

In some embodiments, the assay component 200 is configured to carry a reaction vessel and to be capable of performing an assay on a sample in the reaction vessel; in some embodiments, the assay component 200 is rectangular in shape with one or more reaction vessel placement sites.

For some single-reagent detection items, the reagent preparing section 100 may send the sample and the reagent to the measuring section 200 after adding them to the reaction vessel, and if the sample needs to be incubated, send the sample to the measuring section 200 for measurement after the incubation is completed, and send the sample to the measuring section 200 for measurement after the incubation is completed by dispatching the sample to the reaction section 50 for measurement. For some dual reagent test items, the reagent preparation unit adds a sample and, for example, a first reagent to the reaction vessel, then sends the sample and, for example, the first reagent to the reaction unit 50 for incubation, and after incubation, sends the sample and, for example, the second reagent to the measurement unit 200, and then continues to perform the measurement.

In detection items or items where incubation of the sample is not required, one procedure may be such that: the sample injection part 20 dispatches a sample container where a sample is located to a sample sucking position through a sample rack, the sample dispensing part 30 sucks the sample from the sample container and then dispenses the sample into a reaction container on the dispensing cup position 71 at the moment, the dispatching mechanism 70 dispatches the reaction container to a reagent position (not shown in the figure, can be designed in the reaction part 50 or outside the reaction part 50 according to requirements), the reagent dispensing part 60 sucks the reagent from the reagent bearing part 40 and dispenses the reagent into the reaction container, a mixed solution in the reaction container is dispatched by the dispatching mechanism 70 into the reaction part 50 to incubate for a preset time under a certain condition, then the dispatching mechanism 70 dispatches the reaction container to the measuring part 200 for measurement or continues to dispatch the reagent by the reagent dispensing part 60 and then carries out measurement.

For a test item or items for which a sample needs to be incubated, one flow may be as follows: the sample introduction part 20 dispatches the sample container where the sample is located to the sample suction position through the sample rack, the sample dispensing part 30 sucks the sample from the sample container and then dispenses the sample into the buffer container at the time cup dispensing position 71—in some embodiments, the buffer container and the reaction container may be the same, except that in order to functionally distinguish them, one is referred to as a buffer container and the other is referred to as a reaction container; since the buffer container generally does not contain a substance such as magnetic beads that are easily oxidized or that may react with plasma, if the sample analyzer according to the magnetic bead method is used, the buffer container is different from the reaction container, namely: the magnetic beads in the reaction vessel are taken out; the dispatching mechanism 70 dispatches the buffer container into the reaction part 50 to incubate for a preset time under a certain condition, after incubation is completed, the dispatching mechanism 70 dispatches the buffer container from the reaction part 50 to the standby sample position 72, the sample dispensing part 30 draws the incubated sample from the buffer container on the standby sample position 72 and dispenses the sample into the reaction container on the cup dispensing position 71 at the moment, the dispatching mechanism 70 dispatches the reaction container to the reagent position, the reagent dispensing part 60 draws the reagent from the reagent bearing part 40 and dispenses the reagent into the reaction container, the mixed solution in the reaction container is dispatched into the reaction part 50 by the dispatching mechanism 70 to incubate for the preset time under a certain condition, and then the dispatching mechanism 70 dispatches the reaction container to the measuring part 200 to carry out measurement or continues to dispense the reagent from the reagent dispensing part 60 and then carries out measurement; in some embodiments, after the sample is aspirated, the buffer container at the standby sample site 72, the dispatch mechanism 70 may continue to dispatch it back into the reaction component 50 for review.

In the above example in which the spare sample site 72 is provided in the sample analyzer, in some examples, the spare sample site 72 may not be provided, but the sample dispensing member 30 may be configured to directly draw the liquid from the reaction member 50, so that for a detection item or item in which the sample needs to be incubated, one flow may be as follows: the sample injection part 20 dispatches the sample container where the sample is located to the sample sucking position through the sample rack, the sample dispensing part 30 sucks the sample from the sample container, then dispatches the sample to the buffer container on the time dividing position 71, the dispatching mechanism 70 dispatches the buffer container to the reaction part 50 to incubate for a preset time under a certain condition, after incubation is completed, the sample dispensing part 30 sucks the incubated sample from the buffer container in the reaction part 50 and dispatches the sample to the reaction container on the time dividing position 71, the dispatching mechanism 70 dispatches the reaction container to the reagent position, the reagent dispensing part 60 sucks the reagent from the reagent bearing part 40 and dispatches the reagent to the reaction container, the mixed liquid in the reaction container is dispatched to the reaction part 50 by the dispatching mechanism 70 to incubate for a preset time under a certain condition, and then the dispatching mechanism 70 dispatches the reaction container to the position of the measuring part 200 for measurement or continues reagent dispensing by the reagent dispensing part 60 and then for measurement. In some embodiments, the buffer container in the reaction part 50 may remain in the reaction part 50 after the sample is aspirated for re-inspection.

The above are some illustrations of sample analysis devices.

In some embodiments, the sample analysis device is capable of performing an immediate correction test and an incubation correction test.

In some embodiments, the immediate correction test comprises: the sample preparation unit 100 prepares a sample for the immediate correction test by mixing a plasma sample for the immediate correction test with a reagent for measuring clotting time; the measurement unit 200 measures the sample to obtain a detection result such as a clotting time. In some embodiments, for an immediate correction test, the sample preparation portion 100 aspirates a sample from a sample container and dispenses into a reaction container to prepare a sample in the reaction container for the immediate correction test.

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

The plasma sample for the immediate correction test may be one or more of the following: (1) patient plasma, (2) normal plasma, (3) mixed plasma in which patient plasma and normal plasma are mixed in at least one ratio, for example, the ratio of patient plasma to normal plasma is 1 to 4, and/or 1 to 1; the following is a detailed description.

In some embodiments, the sample preparation unit 100 prepares a sample for an immediate correction test, for example, a first sample by mixing patient plasma and a reagent for measuring clotting time. In some embodiments, the sample preparation portion 100 aspirates a sample from a sample container containing patient plasma to dispense a first amount of the sample into a first reaction container and adds a clotting time measurement reagent to the first reaction container to prepare a first sample. The measurement unit 200 measures the first sample to obtain a first solidification time.

In some embodiments, the sample preparation unit 100 prepares a sample for the immediate correction test, for example, a second sample by mixing normal plasma with a reagent for measuring clotting time. In some embodiments, the sample preparation portion 100 aspirates a sample from a sample container containing normal plasma to dispense a second amount of the sample into a second reaction container and adds a clotting time measurement reagent to the second reaction container to prepare a second sample. The measurement unit 200 measures the second sample to obtain a second solidification time.

In some embodiments, the sample preparation unit 100 may prepare a sample for an immediate correction test, for example, a three-sample by mixing a mixed plasma obtained by mixing the patient plasma and normal plasma in at least one ratio with a reagent for measuring clotting time. In some embodiments, the sample preparation section 100 draws a sample from a sample container containing patient plasma and a sample container containing normal plasma, respectively, to be dispensed into a third reaction container, the total amount of the sample dispensed into the third reaction container being a third amount, and adds a reagent for measuring clotting time to the third reaction container to prepare a third sample. The measurement unit 200 measures a third sample to obtain a third solidification time.

In some embodiments, the incubation correction assay comprises: the sample preparation unit 100 prepares a sample for an incubation correction test by mixing a plasma sample for an incubation correction test with a reagent for measuring clotting time; the measurement unit 200 measures the sample to obtain a detection result such as a clotting time; the plasma sample used for the incubation correction test is a sample obtained after incubation for a preset time under certain conditions or a plasma sample. In some embodiments, for an incubation correction test, the sample preparation portion 100 aspirates a sample from a sample container and dispenses it into a buffer container to incubate for a predetermined time under certain conditions, and aspirates an incubated sample or plasma sample from the buffer container and dispenses it into a reaction container to prepare a sample for the incubation correction test in the reaction container.

The plasma sample for the immediate correction test may be one or more of the following: (4) Incubating the patient plasma after a predetermined time under certain conditions, (5) incubating the normal plasma after a predetermined time under certain conditions, (6) mixing plasma in which the patient plasma and the normal plasma are mixed in at least one ratio, for example, the ratio of the patient plasma and the normal plasma is 1 to 4, and/or 1 to 1; (7) The patient plasma after incubation for a predetermined period of time under certain conditions and the normal plasma after incubation for a predetermined period of time under certain conditions may be mixed in at least one ratio, for example, the ratio of patient plasma to normal plasma is 1 to 4 and/or 1 to 1; the following is a detailed description.

In some embodiments, the sample preparation unit 100 incubates the patient's plasma under a predetermined condition for a predetermined period of time, and mixes the incubated patient's plasma with a reagent for measuring clotting time to prepare a sample for the incubation correction test, which may be referred to as a fourth sample. In some embodiments, the sample preparation portion 100 aspirates a sample from a sample container containing patient plasma to dispense a fourth amount of the sample into a fourth buffer container, aspirates the sample from the fourth buffer container and dispenses into a fourth reaction container after incubating for a predetermined time under certain conditions, and adds a clotting time measurement reagent to the fourth reaction container to prepare a fourth sample. The measurement unit 200 measures a fourth sample to obtain a fourth solidification time.

In some embodiments, the sample preparation unit 100 incubates normal plasma under a predetermined condition for a predetermined time, and mixes the incubated normal plasma with a reagent for measuring clotting time to prepare a sample for an incubation correction test, which may be referred to as a fifth sample. In some embodiments, the sample preparation part 100 aspirates a sample from a sample container containing normal plasma to dispense a fifth amount of the sample into a fifth buffer container, aspirates the sample from the fifth buffer container and dispenses the sample into a fifth reaction container after incubating for a preset time under a certain condition, and adds a clotting time measurement reagent to the fifth reaction container to prepare a fifth sample. The measurement unit 200 measures the fifth sample to obtain a fifth solidification time.

In some embodiments, the sample preparation unit 100 may prepare a sample for an incubation correction test, for example, a sixth sample by incubating a mixed plasma obtained by mixing patient plasma and normal plasma in at least one ratio for a predetermined period of time under a predetermined condition, and then mixing the incubated mixed plasma with a reagent for measuring clotting time. In some embodiments, the sample preparation unit 100 aspirates a sample from a sample container containing plasma of a patient and a sample container containing normal plasma, respectively, to dispense the sample into a sixth buffer container, the total amount of the sample dispensed into the sixth buffer container is a sixth amount, aspirates the sample from the sixth buffer container and dispenses the sample into a sixth reaction container after incubating for a predetermined time under a certain condition, and adds a reagent for measuring clotting time to the sixth reaction container to prepare a sixth sample. The measurement unit 200 measures the sixth sample to obtain a sixth solidification time.

In some embodiments, the sample preparation unit 100 incubates the patient plasma and the normal plasma under a predetermined condition for a predetermined time, and prepares a sample for the incubation correction test, for example, a seventh sample by mixing the incubated patient plasma and normal plasma to prepare a mixed plasma in which at least one ratio is mixed, and mixing the mixed plasma with a reagent for measuring clotting time. In some embodiments, the sample preparation portion 100 aspirates a sample from a sample container containing patient's plasma and dispenses the sample into a buffer container, and incubates under certain conditions for a predetermined period of time; sucking a sample from a sample container filled with normal plasma, dispensing the sample into another buffer container, and incubating for a preset time under certain conditions; the incubated sample was aspirated from each of the two buffer containers and dispensed into a seventh reaction container, and a reagent for measuring clotting time was added to the seventh reaction container to prepare a seventh sample. The measurement unit 200 measures the seventh sample to obtain a seventh solidification time.

In the above-described detection items, 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 may be referred to as a first solidification item, a second solidification item, a third solidification item, a fourth solidification item, a fifth solidification item, a sixth solidification item, and a seventh solidification item, respectively.

In some embodiments, the fourth clotting item and the seventh clotting item can be common or multiplexed with the plasma sample, e.g., both incubated with patient plasma via the same buffer container. In some embodiments, the fifth clotting item and the seventh clotting item can be common or multiplexed with the plasma sample, e.g., both incubated with normal plasma via the same buffer container. One specific example may be to perform the fourth solidification item, the fifth solidification item, and the seventh solidification item, or to prepare the fourth sample, the fifth sample, and the seventh sample:

the sample preparation section 100 aspirates a sample from a sample container containing patient plasma and dispenses into a buffer container such as a fourth buffer container, and incubates for a preset time under certain conditions;

the sample preparation section 100 aspirates a sample from a sample container containing normal plasma and dispenses into another buffer container such as a fifth buffer container, incubating for a preset time under certain conditions;

The sample preparation unit 100 aspirates a sample from the fourth buffer container and dispenses the sample into the fourth reaction container, and adds a reagent for measuring clotting time to the fourth reaction container to prepare a fourth sample;

the sample preparation unit 100 aspirates a sample from the fifth buffer container and dispenses the sample into the fifth reaction container, and adds a reagent for measuring clotting time to the fifth reaction container to prepare a fifth sample;

the sample preparation unit 100 aspirates the incubated sample or plasma sample from the fourth buffer container and the fifth buffer container, respectively, and dispenses the aspirated sample or plasma sample into the seventh reaction container, and adds a reagent for measuring clotting time to the seventh reaction container to prepare a seventh sample.

In order to further simplify the flow, the sample preparation unit 100 suctions the incubated sample from the fourth buffer container and then dispenses the sample into the fourth reaction container and the seventh cuvette container, respectively; the sample preparation unit 100 aspirates the incubated sample in the fifth buffer container and then dispenses the sample into the fifth reaction container and the seventh reaction container, respectively.

The above are some descriptions of the immediate correction test and the incubation correction test, or, in other words, some descriptions of the first coagulation item through the seventh coagulation item. The solidification items contained in the immediate correction test and the incubation correction test can be designed according to purposes, and can be designated by a user through a human-computer interaction interface.

In some embodiments, the immediate correction test includes at least a third coagulation item, and the incubation correction test includes at least a sixth coagulation item and a seventh coagulation item; in other embodiments, the immediate correction test further comprises a first solidification item and/or a second solidification item; the incubation correction assay further comprises a fourth clotting item and/or a fifth clotting item.

In some embodiments, the immediate correction trial includes a first solidification item, a second solidification item, and a third solidification item; the incubation correction testing comprises at least a fourth clotting item, a fifth clotting item, and a sixth clotting item; in other embodiments, the incubation correction assay further comprises a seventh clotting item.

Fig. 6 shows an example of the first to seventh solidification items, which correspond to the APTT1 to APTT7, respectively, by taking the APTT correction test as an example.

In item detection, re-detection is often required due to abnormal results. After the incubated sample is sucked from the buffer container (e.g., fourth buffer container, fifth buffer container, sixth buffer container, etc.), the sample in the buffer container of the sample preparation unit 100 continues incubation so that the sample in the buffer container can be used for retesting. For example, after the incubated sample is suctioned from the fourth buffer container, the sample preparation unit 100 continues to incubate the sample in the fourth buffer container under a certain condition so that the sample in the fourth buffer container can be used for a review, for example, a review of the fourth coagulation item and/or the seventh coagulation item. For another example, after the incubated sample is sucked from the fifth buffer container, the sample preparation unit 100 continues to incubate the sample in the fifth buffer container under a certain condition so that the sample in the fifth buffer container can be used for retesting; such as a review of the fifth coagulation item and/or the seventh coagulation item. For another example, after the incubated sample is sucked from the sixth buffer container, the sample preparation unit 100 continues to incubate the sample in the sixth buffer container under a certain condition so that the sample in the sixth buffer container can be used for a retest, for example, a retest of the sixth coagulation item.

In some embodiments, the amount of sample or plasma sample dispensed from the sample preparation portion 100 into the buffer container during the incubation correction test is greater than the amount of sample or plasma sample dispensed from the sample preparation portion 100 into the reaction container during the instant correction test. Alternatively, the initial amount of plasma sample used for the incubation correction test at the beginning of the incubation is greater than the amount of plasma sample used for the immediate correction test.

For example, the amount of sample dispensed into the fourth buffer container when the fourth sample is prepared is greater than the amount of sample dispensed into the first reaction container when the first sample is prepared; for another example, the amount of sample dispensed into the fifth buffer container when the fifth sample is prepared is greater than the amount of sample dispensed into the second reaction container when the second sample is prepared; for example, the total amount of sample dispensed into the sixth buffer container when the sixth sample is prepared is greater than the total amount of sample dispensed into the third reaction container when the third sample is prepared; for example, the total amount of sample dispensed into the two buffer containers when the seventh sample is prepared is greater than the total amount of sample dispensed into the third reaction container when the third sample is prepared.

In the case where the fourth coagulation item and the seventh coagulation item do not share or multiplex a plasma sample, the fourth amount is larger than the first amount, the fifth amount is larger than the second amount, the sixth amount is larger than the third amount, and the total amount of samples dispensed into the two buffer containers at the time of preparing the seventh sample is larger than the third amount.

In the case where the fourth coagulation item and the seventh coagulation item are common or multiplexed with the plasma sample, the fifth coagulation item and the seventh coagulation item are common or multiplexed with the plasma sample, then: the sixth amount above is greater than the third amount; the fourth and fifth amounts above add up by an amount greater than the first, second and third amounts, and the fourth amount is greater than the first amount and the fifth amount is greater than the second amount.

Whether it is an incubation correction test or an immediate correction test, the amount of sample that is eventually dispensed into the reaction vessel may be a standard amount, i.e., a sample amount that is specified or required for performing the test item.

In addition, the amounts of the samples herein, the first amount, the second amount, the third amount, the fourth amount, the fifth amount, the sixth amount, and the like, may be volume amounts and the like, for example, in ul.

The reagents for determining clotting time herein may include one or more reagents, which may be designed according to the detection principle and detection method.

The normal plasma herein may be obtained by mixing not less than 20 normal human plasma samples, or may be obtained by directly purchasing commercial NPP (normal human plasma, supplied by IL, stago) or SHP (standard human plasma, supplied by Sysmex).

The incubation conditions referred to herein, such as "incubation under certain conditions for a preset time" as described herein, may be incubation for half an hour to 4 hours at a temperature of 30 to 45 ℃, such as two hours at a temperature of 37 ℃.

In the description of the first to seventh solidification items, or the preparation of the first to seventh samples, reference is made to preparation of samples, such as incubation of samples, dispensing of reagents, dispensing of samples, scheduling of reaction vessels, and debugging of buffer vessels, etc., and description of the procedure of the detection item or the description of the procedure of the sample that does not need to be incubated may be referred to above, and description of the procedure of the detection item or the description of the procedure of the sample that does need to be incubated will not be repeated herein.

Referring to fig. 7, in some embodiments, the sample analysis device further includes a water replenishing device 500, where the water replenishing device 500 is configured to replenish the plasma sample used for the incubation correction test during the incubation process, for example, the sample in the buffer container, with water at a certain water replenishing time interval and water replenishing amount. In some embodiments, the water replenishment device 500 derives a replenishment time interval and a replenishment amount from an initial amount of the plasma sample used for the incubation correction test at the beginning of the incubation, for example, when replenishing the sample of the fourth buffer container, the replenishment time interval and the replenishment amount are derived from an initial amount of the sample in the fourth buffer container (the fourth amount above); for another example, when the sample of the fifth buffer container is replenished, the replenishing time interval and the replenishing amount are obtained from the initial sample amount (fifth amount in the above) in the fifth buffer container; for another example, when the sample in the sixth buffer container is replenished, the replenishing time interval and the replenishing amount are obtained based on the initial sample amount (sixth amount in the above) in the sixth buffer container. In some embodiments, the initial amount and the water replenishment time interval are positively correlated, i.e., the greater the initial amount, the greater the water replenishment interval; the initial amount and the water make-up amount are inversely related. In some embodiments, the water replenishment device 500 further obtains the initial amount above, and when the initial amount is determined to be greater than the initial amount threshold, the water replenishment device 500 does not replenish water.

The water replenishment time interval and the water replenishment amount are mainly related to the initial amount of incubation of the sample, and the local temperature and humidity and the shape of the buffer container can be taken into consideration.

Fig. 8 is a perspective view of a corresponding reaction vessel, and a corresponding perspective view is shown on the left side of the figure, when the measuring unit 200 is a dual bead detection unit or a magneto-optical integrated detection unit. The cross section of the reaction vessel in the figure is rectangular, and the bottom is provided with a magnetic bead track; the beads are disposed on a track (not shown). In the test process, the driving coil along the long axis direction of the reaction container drives the magnetic beads to swing, the magnetic beads are subjected to the increase of viscosity of the reaction system to reduce the amplitude, even the swing is stopped, and the solidification time is judged when the swing amplitude of the magnetic beads is reduced to 50% of the initial amplitude; because the magnetic beads are arranged in the reaction container of the type, and rust can be generated on the magnetic beads in plasma for a period of time, the reaction system is disturbed by rust, and the solidification time is prolonged, the buffer container for sample incubation does not contain the magnetic beads, namely the buffer container is a reaction container without the magnetic beads.

The depth-to-diameter ratio of the container (the ratio of the depth to the diameter of the container, here the diameter of the circumscribing circle of the upper surface) is very small and is about 1.5; the surface area of the liquid is larger, and the surface of the liquid is more easily influenced by air flow, so the evaporation rate is higher. Referring to FIG. 9, in one example, after incubation for 2 hours according to the amount of sample (e.g., 50 uL) necessary for the conventional test, only 61% (30.32 uL) remains, and APTT or PT reagent is directly added to perform detection, and the results are all coagulation timeout; the sample was incubated to 300uL (the maximum volume of the reaction vessel/buffer vessel described above 320uL, 300uL being the maximum incubation sample amount considering the sample needle occupied volume at the time of sample dispensing), and the sample evaporation rate was reduced to half of 50uL (evaporation rate changed from 39% to 17%), at which time the clotting time was obtained, but the deviation was large.

Referring to fig. 10, experiments for confirming whether the evaporation effect can be corrected using different water replenishing conditions are performed to study the water replenishing effect under different conditions. In condition 1, the loss caused by the evaporation process can be compensated by the water replenishing process, and the repeatability and accuracy can be consistent with the manual method (see fig. 13). In

conditions

2 and 3, the loss caused by the evaporation process is excessively supplemented with water, so that the incubation sample is diluted, and the detection result is increased, which occurs mainly because: the water supplementing time interval is too large or the incubated sample quantity is too small, the salt ion concentration of the incubated sample breaks through the threshold value, so that the sample is layered, and the evaporation rate of the incubated sample is inconsistent with that of the previous sample and the water supplementing is invalid; the test results of the samples under the condition are mostly abnormal and even reported wrong.

Referring to FIG. 11, another example of a large aspect ratio container is shown, in which the evaporation rate of the conventional liquid detection amount (30 uL) is equal to the evaporation rate of the container of FIG. 8 increased to the maximum incubation liquid amount (16.3% and 17.1% respectively, see FIG. 12). After the amount of the incubation liquid is increased to 150uL, the evaporation rate in 2 hours is only 6.2 percent, and the evaporation rate is not influenced after being lower than 7 percent by considering the buffer capacity of the APTT reagent. Therefore, the container with large depth-to-diameter ratio does not need water supplementing operation, or only needs a small amount of water supplementing, and the detection result equivalent to the manual method can be obtained.

Thus, in some embodiments, the depth to diameter ratio of the buffer vessel is greater than a depth to diameter ratio threshold, e.g., the depth to diameter ratio of the fourth buffer vessel is greater than a depth to diameter ratio threshold; the depth-to-diameter ratio of the fifth buffer container is greater than the depth-to-diameter ratio threshold; the sixth buffer container has a depth to diameter ratio greater than a depth to diameter ratio threshold. In some embodiments, the depth to diameter ratio threshold is greater than 5, for example, and may be 5.6, for example.

In some examples, if the sample needs to be replenished under all conditions of incubation, the incubation time can be identified to determine whether the replenishment is needed, for example, the replenishment is not needed to be considered for less than half an hour, the water replenishment is needed to be considered for more than half an hour, and of course, a specific time threshold can be estimated by a developer according to the evaporation influence of the instrument, and is not necessarily half an hour, because the time thresholds obtained under the conditions of different instruments, different reagents, different reaction parameters and the like may be different.

In addition, the common reaction container and buffer container can be used, and the sample evaporation condition in the incubation process can be controlled by increasing the incubation sample amount and the operation of midway water supplementing, so that the difficulty of the incubation correction test is solved. Therefore, in some embodiments, the method for performing the incubation correction test by using the common reaction container and the buffer container has the advantages of high automation degree, simple materials, difficult operation error, lower cost and the like compared with manual incubation or using special containers for sample incubation and other schemes.

The above are some illustrations of the incubation correction test for replenishing water during sample incubation.

That is, some description of the immediate correction test and the incubation correction test, or, in other words, the first to seventh coagulation items.

A fully automatic detection process may be such that:

the preparation process comprises the following steps: the user needs to prepare normal plasma and place it in a designated location, such as a sample rack of the loading area 21, as a sample to be tested before performing the test; alternatively, normal plasma may be placed on a diluent rack dedicated for dilution, and used as a "diluent" for patient plasma; alternatively, a fixed location may be provided within the sample analysis device for placement of normal plasma. And then creating a test order on a software interface or through the LIS, wherein the sample analysis device is in a standby state.

Step 1: the user starts the detection, the sample analysis device can automatically carry the patient sample to the sample suction position, and the sample analysis device is ready to carry out the detection according to the test order issued by the user.

Step 2: the sample analysis device judges which type of correction test the test belongs to. For the immediate correction test, the sample analysis device will perform the test according to the general detection flow; for the incubation correction test, considering sample evaporation during incubation, transfer loss from the sample container to the reaction container, automatic re-detection of sample preparation, etc., the amount of sample required for the incubation correction test may exceed the immediate correction sample amount. This step supports the preparation of a mixed plasma of patient-only plasma, normal-only plasma, patient plasma and normal plasma in a ratio, and "ratio" herein means that it is defined before the test that one or more mixing ratios, for example, the ratio of patient plasma to normal plasma is 1:4, for example, the ratio of patient plasma to normal plasma is 1:1.

Step 3: immediately carrying out detection by the immediate correction test, dispensing the reagent and obtaining corresponding solidification time.

Step 4: incubation correction the required sample will be dispensed into a buffer container and then incubation will be performed under the indicated conditions. The incubation temperature may be 37 ℃, and the incubation time may be between half an hour and four hours, which may be defined by the user; the default value may be two hours. It should be noted here that: the seventh clotting item requires the use of two buffer containers to perform the incubation.

Step 5: after incubation, the buffer container is transported to the standby sample site, and the sample is aspirated from the buffer container at the standby sample site and dispensed into the reaction container.

Step 6: and (3) performing detection by an incubation correction test, dispensing the reagent and obtaining corresponding solidification time.

It can be seen that in some embodiments, different detection flows are designed for the immediate correction test and the incubation correction test, which not only ensures the reliable result of the incubation correction, but also reduces the waste of the immediate correction to the dispensing container and the plasma of the patient, and improves the test speed. For example, fig. 13 is a comparison of the results of an automatic test with the results of a manual process for a sample analyzer, and the instruments in the table refer to the sample analyzer herein. By intercepting three representative patient sample test APTT clotting time results, it can be seen that the sample analysis device automated test is substantially consistent with the manual test results. It should be noted that, the manual method herein refers to: manually processing the sample, and then completing detection through a related instrument; specifically, for the immediate correction test: manually preparing a sample, and testing the APTT setting time of the sample by an instrument; for the incubation correction test: after manually preparing the sample, placing the sample into a water bath incubator for incubation for 2 hours, and testing the APTT setting time by an instrument.

In some embodiments, different detection flows are designed for the immediate correction test and the incubation correction test, so that the waste of the plasma of the patient to be detected can be reduced as much as possible and the utilization rate can be improved; in addition, the liquid amount in the buffer container is determined by evaporation, so that the waste of plasma of a patient is further reduced, a sample can be prepared for automatic retesting, the automatic retesting speed of an incubation correction test is improved, and the reporting time is shortened.

After the measurement unit 200 measures the measurement result, for example, the clotting time, the processor 300 may, in some embodiments, obtain the cause of the prolongation of the clotting time of the patient's plasma based on at least the sixth clotting time and the seventh clotting time. For example, the processor judges whether the time-independent inhibitor exists in the plasma of the patient or the time-dependent inhibitor causes the coagulation time to be prolonged according to the sixth coagulation time and the seventh coagulation time, and generates a corresponding prompt; in some embodiments, display 400 may be used to display the prompt.

In other embodiments, the processor 300 obtains the cause of the extended clotting time based on 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 due to lack of clotting factors and absence of inhibitors, and generates a corresponding cue; when the third clotting time indicates correction, the seventh clotting time indicates correction, the sixth clotting time indicates no correction and the extension time exceeds the threshold, the processor 300 determines that the cause of the extension time of the patient's plasma is the presence of the time and temperature dependent inhibitor and generates a corresponding cue; when the third clotting time indicates uncorrectable, the sixth clotting time indicates uncorrectable, the seventh clotting time indicates uncorrectable, and the extension time of the sixth clotting time does not exceed the extension time of the seventh clotting time by more than a threshold value, the processor 300 determines that the cause of the extension time of the patient's plasma is the presence of a non-time and temperature dependent inhibitor and generates a corresponding cue; when the third clotting time indicates uncorrected, the sixth clotting time indicates uncorrected, the seventh clotting time indicates uncorrected, and the extension time of the sixth clotting time exceeds the extension time of the seventh clotting time by more than a threshold, the processor 300 determines that the cause of the extension time of the patient's plasma is the presence of a time and temperature dependent inhibitor and generates a corresponding cue.

In analyzing the cause of the prolonged clotting time based on the clotting time obtained by the immediate correction test and the incubation correction test, some default formulas of the sample analysis device may be used, for example, the correction test of APTT may be given as the following default formulas:

equation 1: ri= (APTT 3-APTT 2)/APTT 1×100%;

equation 2: APTT 6-APTT 7.

In some embodiments, the user can also customize the calculation formula to further calculate and analyze the detection result. Thus, in some embodiments, the display 400 displays a formula editing interface for displaying that a user inputs a calculation formula through an input unit (not shown); the input part may be a mouse, a keyboard, or the like, or the input part may be integrated with the display 400, so that the display 400 may be a display screen with a touch function. The processor 300 obtains the above calculation formula and the detection result (e.g., one or more of the first to seventh solidification times) related to the above calculation formula to obtain the calculation result of the above calculation formula; the display 400 also displays the calculation result. In some embodiments, display 400 also displays diagnostic results associated with the calculated results, which may be the cause of prolonged clotting time, such as "suspected anticoagulant interference", "clotting factor inhibitor titre > 3.5BU/mL", etc. The diagnosis result may be obtained by the processor 4300 based on the calculation result described above, or may be input by the user through an input section.

The following are examples of two user-defined formulas:

equation 3: apttd=aptt6-APTT 3;

equation 4: apttci=aptt1×aptt3×aptt6×apttd ³ /10 ⁶ 。

Fig. 14 is an example of a formula editing interface. In some embodiments, the formula editing interface includes:

the name of the calculation formula or the editing item of the calculation result name is used for a user to input the name of the calculation formula or the calculation result name through the input part;

a formula editing term of a calculation formula for a user to input the calculation formula through the input part;

in some embodiments, the formula editing interface further comprises at least one of:

a unit editing term of the calculation formula for a user to input a unit of the calculation formula through the input part;

an accuracy editing term of a calculation result of the calculation formula is used for a user to input the accuracy of the calculation result through the input part;

a reference range editing item of a calculation result of the calculation formula, so that a user can input a reference range of the calculation result through the input part;

for providing one or more detection result items capable of participating in calculation for a user to input a detection result represented by a selected detection result item into the formula editing item through the input section; such as APTT/Sec contained in the "parameter abbreviation" item in the figure, etc.

One or more operator items for providing an edit formula for a user to input an operator represented by a selected operator item into the formula edit item through the input section; such as numbers and symbols contained in the "operator" item in the figure.

It should be noted that, in some examples, the formula editing interface allows the use of detection results that are not limited to the APTT correction test. Of course, it will be appreciated that in some embodiments, the calculation formula may not be able to perform the calculation unless all of the detection results involved in the calculation are valid. The validity herein includes two-layer meaning: 1. the detection items are executed, the clinical research system cannot actively initiate the association detection, and all the detection items are required to be initiated by a user; 2. the detection is completed and normal results are obtained, and the results that the detection is not completed due to the failure of the instrument or that dilution is required beyond the linear range are not considered to be normal results.

In some embodiments, display 400 also provides an interface for a user to view default formulas and user-entered formulas; fig. 15 shows an example.

In some embodiments, the processor 300 also obtains a correction test report template and generates a result report based on the correction test report template and the calculation results described above.

In some embodiments, the correction test report template may include: the name of the first solidification item, the detection result item and the reference range item; the name of the second solidification item, the detection result item and the reference range item; the name of the third solidification item, the detection result item and the reference range item; a name of a fourth solidification item, a detection result item and a reference range item; a name of a fifth solidification item, a detection result item and a reference range item; a name of a sixth solidification item, a detection result item and a reference range item; a name of a seventh solidification item, a detection result item, and a reference range item. Referring to fig. 16, an example of a correction test report template is shown.

In some embodiments, the results report may include: name, detection result and reference range of the first solidification item; the name, detection result and reference range of the second solidification project; the name, detection result and reference range of the third solidification project; name, detection result and reference range of the fourth solidification project; name, detection result and reference range of the fifth solidification project; a name, a detection result and a reference range of a sixth solidification item; a name, a detection result and a reference range of a seventh solidification item; the name of the calculation formula, the name of the calculation result or the formula of the calculation formula; calculation results of the calculation formula and/or diagnosis results.

In some embodiments, the user may edit the results report through an input, for example, the user may add custom parameter content to the results report. In some embodiments, each newly added parameter (calculation result) needs the following information: the name of the parameter; the calculation formula of the parameter is not output by default, but the user-defined parameter can output the calculation formula in the remark area of the lower half; results of the parameter; the reference range of the parameter is not the reference range of most newly added parameters, and the reference range is replaced by "-"; the clinical significance of this parameter suggests that it is allowed to be null. Referring to fig. 17, an example of a result report is shown.

Some embodiments provide a tool for correcting clinical studies of a test by allowing a user to customize a calculation formula, which comprises an operation interface and database support, can facilitate medical workers to develop the study of the correction test and the clinic, and improves the screening and diagnosis capability of the correction test.

The above is an example in which the cause of the extension of the coagulation time is obtained by analyzing and calculating the detection result by a formula.

In some embodiments, the detection result may also be analyzed by way of a graph.

For example, two curves are drawn with coagulation time or the extension rate of coagulation time as the vertical axis and the mixing ratio or mixing rate of patient plasma or normal plasma as the horizontal axis, divided into immediate correction (CT 1, CT2, and CT 3) and incubation correction (CT 4, CT5, and CT 6), with CT1, CT2, CT3, CT4, CT5, and CT6 representing the first to sixth coagulation times, respectively; such that each curve contains at least three points; the patient plasma and normal plasma are mixed at least at one mixing ratio to form a mixed plasma in order to be able to identify a lower titer of the inhibitor of coagulation factor, it is recommended here to choose two mixing ratios of 1/4 and 1/1. The elongation of the clotting time is a plot value obtained by dividing the difference between the clotting time of the patient plasma and the clotting time of the normal plasma by the difference between the clotting time of the mixed plasma prepared by a predetermined mixing ratio of the patient plasma and the normal plasma and the clotting time of the normal plasma, which is set to 1. When the mixing ratio or mixing ratio of the patient plasma or normal plasma is on the horizontal axis, the value of the plasma sample of only the patient plasma may be 1, and the value of the plasma sample of only the normal plasma may be 0, or vice versa.

Thus, in some embodiments, the processor is configured to draw an immediate correction line based on the detection results of each of the samples for the immediate correction test (e.g., the detection results of the first sample, the second sample, and the third sample) and to draw an incubation correction line based on the detection results of each of the samples for the incubation correction test (e.g., the detection results of the fourth sample, the fifth sample, and the sixth sample) using the mixing ratio or the mixing ratio of the patient's plasma or the normal plasma as the horizontal axis and the extension ratio of the clotting time as the vertical axis. The display 400 displays the immediate correction line and the incubation correction line in the coordinate system.

In some embodiments, processor 300 also calculates the area enclosed by the immediate correction line and the incubation correction line. It will be appreciated that calculating the area enclosed by the immediate correction line and the above described incubation correction line requires connecting the first point of the immediate correction line (e.g. the point plotted for the first sample) with 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) with the last point of the incubation correction line (e.g. the point plotted for the fourth sample); it will be appreciated that the order of the points is determined by the size of the abscissa of the points.

The above-described test and calculation procedure is performed on samples positive for the presence of a time-dependent coagulation factor inhibitor (typically a FVIII coagulation factor inhibitor), and a set of standard area values may be predetermined. Thus, the processor 300 also obtains the cause of the extended clotting time of the patient's plasma for display by the display 400 based on the area and an area threshold (i.e., the standard area value above); and/or the display 400 also displays the value of the area and the area threshold. In some embodiments, when the area is determined to be less than the area threshold, the processor 300 determines that no time-dependent coagulation inhibitor is present; otherwise, the processor 300 determines that a time-dependent coagulation inhibitor is present.

For the absence of time-dependent causes of clotting time extension (clotting factor deficiency, clotting factor inhibitors other than FVIII, most LA), the immediate correction was essentially consistent with the conclusion of whether the incubation correction test was correct; for reasons of extended clotting time that are time dependent (FVIII clotting factor inhibitor, small amounts of LA) immediate correction tests generally appear to be correctable or partially corrected and incubation correction tests generally appear to be uncorrectable.

As shown in fig. 18 and 19, which are two causes of prolonged clotting time without time dependence, clotting factor deficiency (hereditary hemophilia) and LA (lupus), the area enclosed by the immediate correction and incubation correction curves is small; for example, in fig. 18, the two curves of immediate correction and incubation correction are substantially coincident, and the area enclosed by the two curves is only 0.0125; in fig. 19, it can be seen that the two curves for immediate correction and incubation correction substantially coincide, and the area enclosed by the two curves is only 0.0090. It should be noted that: here, the aprt reagent from merey was used, and lac=2.76 for the sample, which is a strong positive for LA.

As shown in fig. 20, which is a cause of prolonged clotting time in time dependence, the area enclosed by the immediate correction and incubation correction curves is relatively large with FVIII clotting factor inhibitor (acquired hemophilia) and increases with increasing titer. Specifically, fig. 20 shows the results of two plots of acquired hemophiliacs (about 2BU/mL in the first plot, the lower plot, and about 5BU/mL in the second plot, the upper plot), showing a certain increase in the area enclosed by the two curves for immediate correction and incubation correction, due to the presence of time-dependent FVIII clotting factor inhibitors in the patient's plasma. The size of the enclosed area can be used for representing the titer of the blood coagulation factor inhibitor.

In fig. 18 to 20, the curve indicated by the broken line is an incubation correction curve, and the net line indicated by the solid line is an immediate correction curve. The patient plasma concentration herein refers to the mixing ratio or mixing ratio of patient plasma or normal plasma.

In some embodiments, the area threshold of the area enclosed by the immediate correction and incubation correction curves is meant to be the detection limit that can identify time-dependent inhibitors of coagulation factors, the control of which is deficiency of coagulation factors and positive for LA, as shown in fig. 21, where heparin, positive for LA, hereditary hemophilia, etc. are all seen to generally be less than 0.08, as the area threshold of the detection system. FVIII clotting factor inhibitors at lower titers (< 1 BU/mL) are essentially indistinguishable from the non-time dependent cause of prolonged clotting time, and can only be readily distinguished after a certain titer is reached. The area threshold is closely related to reagent composition, assay methodology, etc., and each detection system should independently establish its own area threshold. However, only to identify whether there is time dependency, only drawing may be performed without determination.

In some embodiments, the processor 300 is further configured to draw at least four points according to the detection results of the samples (e.g., the detection results of the fourth sample to the seventh sample) of each incubation correction test and sequentially connect the at least four points to form a polygon, with the mixing ratio or mixing ratio of the patient's plasma or normal plasma being on the horizontal axis and the extension ratio of the clotting time or clotting time being on the vertical axis as the coordinate system; processor 300 also calculates the area of the polygon; the processor 300 also obtains the cause of the extended clotting time of the patient's plasma for display by the display 400 based on the area of the polygon and an area threshold; and/or the display also displays the value of the area of the polygon and its area threshold. In some embodiments, when the area of the polygon is determined to be less than its area threshold, the processor 300 determines that no time-dependent coagulation inhibitor is present; otherwise, the processor 300 determines that a time-dependent coagulation inhibitor is present.

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

A sample analysis method is also disclosed in some embodiments of the invention. Referring to fig. 22, the sample analysis method in some embodiments includes the following steps:

step S110: the sample for the immediate correction test is prepared by mixing a plasma sample for the immediate correction test with a reagent for clotting time determination.

For example, step S110 aspirates a sample from a sample container and dispenses into a reaction container to prepare a sample for an immediate correction test in the reaction container.

If the plasma sample for the immediate correction test is patient plasma: step S110 of sucking up a sample from a sample container containing patient plasma to dispense a first amount of the sample into a first reaction container, and adding a reagent for measuring clotting time to the first reaction container to prepare a first sample; measuring the first sample to obtain a first solidification time;

If the plasma sample for the immediate correction test is normal plasma: step S110 of sucking up a sample from a sample container containing normal plasma to dispense a second amount of the sample into a second reaction container, and adding a reagent for measuring clotting time to the second reaction container to prepare a second sample; measuring the second sample to obtain a second solidification time;

if the plasma sample for the immediate correction test is a sample obtained after mixing the patient's plasma with normal plasma: step S110 of respectively sucking up a sample from a sample container containing patient plasma and a sample container containing normal plasma to be dispensed into a third reaction container, the total amount of the sample dispensed into the third reaction container being a third amount, and adding a reagent for measuring clotting time to the third reaction container to prepare a third sample; and measuring the third sample to obtain a third solidification time.

Step S130: the setting time of the test specimen for the immediate correction test was determined.

Step S150: the samples of the incubation correction test are prepared by mixing the plasma samples for the incubation correction test with reagents for clotting time determination.

Step S150 draws a sample from the sample container and dispenses into the buffer container to incubate for a preset time under a certain condition, and draws the incubated sample from the buffer container and dispenses into the reaction container to prepare a sample for an incubation correction test in the reaction container.

If the plasma sample for the incubation correction test is patient plasma after a preset time of incubation under certain conditions: step S150 of sucking up a sample from a sample container containing patient plasma to dispense a fourth amount of the sample into a fourth buffer container, sucking up the sample from the fourth buffer container and dispensing into a fourth reaction container after incubating for a preset time under a certain condition, and adding a clotting time measurement reagent to the fourth reaction container to prepare the fourth sample; measuring the fourth sample to obtain a fourth solidification time;

If the plasma sample for the incubation correction test is normal plasma after incubation for a preset time under certain conditions: step S150 of sucking up a sample from a sample container containing normal plasma to dispense a fifth amount of the sample into a fifth buffer container, sucking up the sample from the fifth buffer container and dispensing into a fifth reaction container after incubating for a preset time under a certain condition, and adding a clotting time measurement reagent to the fifth reaction container to prepare the fifth sample; measuring the fifth sample to obtain a fifth solidification time;

if the plasma sample for the incubation correction test is a sample obtained by mixing the plasma of the patient with normal plasma and then incubating for a preset time under a certain condition: step S150 of sucking up a sample from a sample container containing patient plasma and a sample container containing normal plasma, respectively, to be dispensed into a sixth buffer container, the total amount of the sample dispensed into the sixth buffer container being a sixth amount, sucking up the sample from the sixth buffer container and dispensing into a sixth reaction container after incubating for a preset time under a certain condition, and adding a clotting time measuring reagent into the sixth reaction container to prepare the sixth sample; measuring the sixth sample to obtain a sixth solidification time;

If the plasma sample for the incubation correction test is a sample obtained by mixing patient plasma after incubation for a preset time under a certain condition and normal plasma after incubation for a preset time under a certain condition: step S150 of preparing a seventh sample by sucking up the incubated sample from the fourth buffer container and the fifth buffer container, respectively, and dispensing the sample into a seventh reaction container, and adding a reagent for measuring clotting time to the seventh reaction container; and measuring the seventh sample to obtain a seventh solidification time.

Wherein the plasma sample for the incubation correction test is a sample obtained after incubation for a preset time under a certain condition, and the amount of the plasma sample for the incubation correction test is greater than the amount of the plasma sample for the immediate correction test. For example, the sixth amount above is greater than the third amount; the fourth and fifth amounts above add up by an amount greater than the first, second and third amounts, and the fourth amount is greater than the first amount and the fifth amount is greater than the second amount.

Step S170: and determining the sample of the incubation correction test to obtain the solidification time.

Reference is made to various exemplary embodiments herein. However, those skilled in the art will recognize that changes and modifications may be made to the exemplary embodiments without departing from the scope herein. For example, the various operational steps and components used to perform the operational steps may be implemented in different ways (e.g., one or more steps may be deleted, modified, or combined into other steps) depending on the particular application or taking into account any number of cost functions associated with the operation of the system.

In the above embodiments, it may be implemented in whole or in part by software, hardware, firmware, or any combination thereof. Additionally, as will be appreciated by one of skill in the art, the principles herein may 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 may be used, including magnetic storage devices (hard disks, floppy disks, etc.), optical storage devices (CD-to-ROM, DVD, blu-Ray disks, etc.), flash memory, and/or the like. These computer program instructions may be loaded onto a general purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine, such that the instructions which execute on the computer or other programmable data processing apparatus create means for implementing the functions specified. These computer program instructions may also be stored in a computer-readable memory that can direct a computer or other programmable data processing apparatus to function in a particular manner, such that the instructions stored in the computer-readable memory produce an article of manufacture including means which implement the function specified. The computer program instructions may also be loaded onto a computer or other programmable data processing apparatus to cause a series of operational steps to be performed on the computer or other programmable apparatus to produce a computer implemented process such that the instructions which execute on the computer or other programmable apparatus provide steps for implementing the functions specified.

While the principles herein have been shown in various embodiments, many modifications of structure, arrangement, proportions, elements, materials, and components, which are particularly adapted to specific environments and operative requirements, may be used without departing from the principles and scope of the present disclosure. The above modifications and other changes or modifications are intended to be included within the scope of this document.

The foregoing detailed description has been described with reference to various embodiments. However, those skilled in the art will recognize that various modifications and changes may be made without departing from the scope of the present disclosure. Accordingly, the present disclosure is to be considered as illustrative and not restrictive in character, and all such modifications are intended to be included within the scope thereof. Also, advantages, other advantages, and solutions to problems have been described above with regard to various embodiments. The benefits, advantages, solutions to problems, and any element(s) that may cause any benefit, advantage, or solution to occur or become more pronounced are not to be construed as a critical, required, or essential feature. The terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, system, article, or apparatus. Furthermore, the term "couple" and any other variants thereof are used herein to refer to physical connections, electrical connections, magnetic connections, optical connections, communication connections, functional connections, and/or any other connection.

Those skilled in the art will recognize that many changes may be made to the details of the above-described embodiments without departing from the underlying principles of the invention. Accordingly, the scope of the invention should be determined only by the following claims.

Claims

1. A sample analyzer is characterized by comprising 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;

2. The sample analysis device of claim 1, further comprising a water replenishment device for replenishing the plasma sample for the incubation correction test during the incubation period with a certain water replenishment time interval and water replenishment amount.

3. The sample analysis device of claim 2, wherein the water replenishment device obtains the replenishment time interval and the replenishment amount based on an initial amount of the plasma sample for the incubation correction test at the start of incubation.

4. The sample analysis device of claim 3, wherein the initial amount and the replenishment time period are positively correlated, and wherein the initial amount and the replenishment amount are inversely correlated.

5. The sample analysis device of claim 3, wherein the water replenishment device further obtains the initial amount, and when the initial amount is determined to be greater than an initial amount threshold, the water replenishment device does not replenish water.

6. The sample analysis device of claim 1, wherein:

7. The sample analysis device of claim 6, wherein:

8. The sample analysis device of claim 7, wherein: the sixth amount is greater than the third amount, the fifth amount is greater than the second amount, and the fourth amount is greater than the first amount.

9. The sample analysis device of claim 7, wherein if the plasma sample for the incubation correction test is a sample obtained by mixing patient plasma after incubation for a predetermined time under a predetermined condition and normal plasma after incubation for a predetermined time under a predetermined condition: the sample preparation unit sucks the incubated sample from the fourth buffer container and the fifth buffer container, and dispenses the sample into a seventh reaction container, and adds a reagent for measuring clotting time to the seventh reaction container to prepare a seventh sample; the measurement unit measures the seventh sample to obtain a seventh solidification time.

10. The sample analysis device of claim 9, wherein:

the sixth amount is greater than the third amount;

11. The sample analyzer according to claim 9, wherein the sample preparation section aspirates the incubated sample from the fourth buffer container and dispenses the aspirated sample into the fourth reaction container and the seventh cuvette container, respectively; the sample preparation unit aspirates the incubated sample from the fifth buffer container and then dispenses the aspirated sample into the fifth reaction container and the seventh reaction container, respectively.

12. The sample analysis device of claim 7 or 9, wherein:

13. The sample analysis device of claim 7, wherein the fourth buffer container has a depth to diameter ratio greater than 5.6; the depth-to-diameter ratio of the fifth buffer container is greater than 5.6; the depth-to-diameter ratio of the sixth buffer container is greater than 5.6.

14. The sample analyzer according to claim 1, wherein the measuring section is an optical detecting section, a double magnetic bead method detecting section, or a magneto-optical integrated detecting section.

15. A method of sample analysis, comprising:

16. The sample analysis method of claim 15, wherein the preparing the sample for the immediate correction test by mixing the plasma sample for the immediate correction test with the clotting time determination reagent comprises: aspirating a sample from a sample container and dispensing into a reaction container to prepare a sample in the reaction container for an immediate correction test;

17. The sample analysis method of claim 16, wherein:

18. The method of claim 17, wherein if the plasma sample for the incubation correction test is a sample obtained by mixing patient plasma after incubation for a predetermined time under a predetermined condition and normal plasma after incubation for a predetermined time under a predetermined condition: drawing up the incubated sample from the fourth buffer container and the fifth buffer container, respectively, and dispensing the sample into a seventh reaction container, and adding a reagent for measuring clotting time to the seventh reaction container to prepare a seventh sample; and measuring the seventh sample to obtain a seventh solidification time.