CN116047088A

CN116047088A - Sample analyzer, sample analysis system and detection method of sample analyzer

Info

Publication number: CN116047088A
Application number: CN202111266356.6A
Authority: CN
Inventors: 王腾飞; 李聪; 武振兴
Original assignee: Shenzhen Mindray Bio Medical Electronics Co Ltd; Beijing Shen Mindray Medical Electronics Technology Research Institute Co Ltd
Current assignee: Shenzhen Mindray Bio Medical Electronics 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

The application discloses a sample analyzer, a sample analysis system and a detection method of the sample analyzer. The sample analyzer comprises a sample adding device for sucking the original sample and adding the original sample into the reaction container; a reagent adding device for sucking a reagent and adding the reagent into the reaction vessel containing the original sample to obtain a sample to be measured; the detection device is used for acquiring optical information of the sample to be detected in the solidification process and solidification time of the sample to be detected; the input device is used for receiving the evaluation rule set by the user; and the processing device is used for acquiring the parameter value of at least one waveform parameter of the coagulation waveform of the sample to be tested, and outputting the evaluation information of the coagulation time extension reason of the sample to be tested according to the parameter value of the at least one waveform parameter and the evaluation rule when the coagulation time extension is detected.

Description

Sample analyzer, sample analysis system and detection method of sample analyzer

Technical Field

The invention relates to the technical field of sample analysis, in particular to a sample analyzer, a detection method thereof and a sample analysis system.

Background

Blood coagulation tests are one of the usual blood test means, which is carried out by measuring the coagulation time of blood. Optical coagulation is a common method for detecting such items, and the basic principle is as follows: adding a measuring reagent into the plasma of a patient to obtain a sample to be measured, irradiating the sample to be measured with analytical light, forming a solidification curve according to the change of luminous flux or absorbance reflected in the solidification process, determining a detection endpoint and calculating solidification time.

The clotting time is one of the main report results of the clotting program, which can provide diagnostic references for clinic, but causes of abnormal clotting time of blood are numerous, and there are common causes of clotting factor deficiency, coagulation factor inhibitor, antiphospholipid antibody (LA positive, lupus screening positive), heparin, warfarin or novel oral anticoagulant interference, etc., and further analysis experiments, such as correction experiments, factor activity measurement experiments, LA screening experiments, etc., are often needed to further distinguish the causes. How to obtain more information about the cause of the abnormal blood coagulation time based on blood coagulation examination, so that clinical diagnosis provides more references to improve the screening efficiency of the cause of the abnormal blood coagulation time is one of the problems to be improved or solved at present.

Disclosure of Invention

According to a first aspect, there is provided in one embodiment a sample analyzer comprising:

the sample adding device comprises a sampling needle, a sampling device and a sample collecting device, wherein the sampling needle is used for sucking a sample to be tested and adding the sample to be tested into the reaction container;

reagent adding means for sucking a reagent and adding the reagent to a reaction container containing the sample to be measured;

the detection device is used for acquiring optical information of the sample to be detected in the solidification process and solidification time of the sample to be detected;

the input device is used for receiving the evaluation rule set by the user;

and the processing device is used for acquiring parameter values of at least one waveform parameter of a solidification waveform of the sample to be tested according to the optical information and the solidification time, wherein the solidification waveform comprises a solidification curve of the sample to be tested and/or a differential curve of the solidification curve, and when the solidification time is detected to be prolonged, the evaluation information of the solidification time prolonged reason of the sample to be tested is output according to the parameter values of the at least one waveform parameter and the evaluation rule.

According to a second aspect, there is provided in one embodiment a sample analysis system comprising:

at least one sample analyzer, wherein the sample analyzer is used for acquiring optical information of a sample to be measured in a solidification process and solidification time of the sample to be measured;

the input device is used for receiving the evaluation rule set by the user;

processing means for acquiring parameter values of at least one waveform parameter concerning a coagulation waveform of the sample to be measured, the coagulation waveform including a coagulation curve of the sample to be measured and/or a differential curve of the coagulation curve, based on the optical information and the coagulation time, and outputting evaluation information of a cause of extension of the coagulation time of the sample to be measured, based on the parameter values of the at least one waveform parameter and the evaluation rule, when extension of the coagulation time is detected;

and a display device for displaying the evaluation information.

According to a third aspect, in one embodiment there is provided a method of detection of a sample analyzer, comprising:

acquiring optical information of a sample to be measured in a solidification process and solidifying time of the sample to be measured;

acquiring parameter values of at least one waveform parameter of a solidification waveform of the sample to be detected according to the optical information and the solidification time, wherein the solidification waveform comprises a solidification curve of the sample to be detected and/or a differential curve of the solidification curve;

when the solidification time is detected to be prolonged, according to the parameter value of the at least one waveform parameter and an evaluation rule set by a user, outputting evaluation information of the solidification time prolonged reason of the sample to be tested.

In the above embodiment, at least one waveform parameter is obtained from the solidification curve or the differential curve of the solidification curve, and the evaluation information of the solidification time extension reason of the sample to be tested is output according to the parameter value of the waveform parameter and the evaluation rule, so that the solidification curve is fully excavated and utilized, more diagnostic references are provided for users, the evaluation rule can be set by the users, and the users can update the evaluation rule according to the latest medical theory or clinical experience to obtain more accurate evaluation information.

Drawings

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

FIG. 2 is a schematic diagram of an evaluation rule of an embodiment;

FIG. 3 is a schematic diagram of an evaluation rule according to another embodiment;

FIG. 4 is a schematic diagram of evaluation information of an embodiment;

FIG. 5 is a schematic diagram of a sample analysis system according to one embodiment;

FIG. 6 is a flow chart of a detection method of a sample analyzer 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.

The sample analyzer referred to in this application can be used for testing of coagulation programs to obtain coagulation test results of samples. For example, the clotting items may include APTT (Active Partial Thromboplast inTime, activated partial Prothrombin Time), PT (Prothrombin Time), TT (Thrombintime), FIB (Fibrinogen), clotting factors, clinical anticoagulant species or other custom items, and the like, without specific limitation herein.

In the present application, a sample before being mixed with a reagent is referred to as an original sample, and an original sample after being mixed with a reagent is referred to as a sample to be measured.

The coagulation waveform refers to a coagulation curve and a derivative curve of the coagulation curve, wherein the derivative curve comprises, but is not limited to, a first-order differential curve and/or a second-order differential curve, and the coagulation curve can reflect the change of the scattered light quantity, the transmittance or the absorbance of a sample to be detected along with the time.

Referring to the sample analyzer 100 shown in fig. 1, the sample analyzer 100 may include a sample carrier 110, a sample adding device 120, a reagent carrier 130, a reagent adding device 140, an incubation device 150, a detection device 160, an input device 170, and a processing device 180. The above-described arrangements are merely illustrative of sample analyzer 100 and are not limiting, and more or fewer components may be included in some specific types of sample analyzers 100. For example, in other embodiments, the sample analyzer 100 may further include a sample feeding device that may be used for automatic transport of the sample to be measured.

The sample carrier 110 is used to carry a raw sample, which in this example comprises patient plasma. In some embodiments, the sample carrier 110 may be a disc structure, where a sample sucking position is provided on the sample carrier 110, and the disc structure moves the original sample to be sucked to the sample sucking position by rotating to wait for sucking the sample.

The sample addition device 120 includes a sampling needle for sucking up the raw sample at the sample sucking position and adding the sucked raw sample into a reaction vessel, which may be a reaction cup, a test tube, a sample tube, or the like.

The reagent carrier 130 is used to carry various reagents required for the coagulation reaction, such as diluents, mixing reagents, triggering reagents, etc. The reagent carrying apparatus 130 may be a rotatable reagent disk or an orbital transfer apparatus or the like.

A reagent adding device 140 for sucking up a reagent and adding the reagent to the reaction container containing the original sample to obtain a sample to be measured.

The incubation device 150 is used for incubation and heating of the sample to be tested in the reaction vessel, so as to complete the incubation process under the given conditions. The predetermined conditions herein may include predetermined temperature conditions (e.g., 37 degrees celsius) and predetermined time (e.g., 5 minutes).

In this embodiment, the sample to be measured may be irradiated with the light beam within a set period of time after the sample to be measured is obtained, and the amount of scattered light, transmittance or absorbance of the sample to be measured may be changed during the solidification process. The detection device 160 is configured to obtain optical information of the sample to be measured in a solidification process and solidification time of the sample to be measured, where the optical information is continuously or intermittently measured scattered light quantity, transmittance or absorbance, and the solidification time may be a time when the sample to be measured is obtained by adding a reagent to an original sample to solidify the sample to be measured.

The input means 170 may comprise one or more of a keyboard, a mouse, a scroll wheel, a mobile input device (a mobile device with a touch screen, a mobile phone, etc.), etc. In the present embodiment, the input device 170 is used to receive the evaluation rule set by the user. The evaluation rules include scoring relationships between different threshold ranges of waveform parameters associated with the coagulation waveform and different causes of coagulation time extension.

Having described the coagulation waveform as including a coagulation curve and/or a differential curve of the coagulation curve, various waveform parameters involved in the present embodiment are described below.

Waveform parameters that can be determined based on the coagulation profile include, but are not limited to: setting start time, setting end time, setting time, response time and steady state deviation, wherein the response time refers to the time corresponding to the setting curve change percentage to 63.2%; steady state deviation refers to the deviation from the expected result after steady state has been reached, which requires the first corrective experiment to be created.

Waveform parameters that can be determined based on the differential curve include, but are not limited to, standard deviation, variance, ratio of left to right slopes of the peak, fitting integral area, peak, valley, moment of inertia, skewness Skew, and Kurt, where the ratio of left to right slopes of the peak refers to the ratio of fitted values of left to right slopes of the peak in the differential curve; fitting the integral area refers to the area of the curve formed by slope fitting of the left and right sides of the wave crest in the differential curve and the original curve; the peak and valley are the maximum and minimum values of the differential curve, respectively; the moment of inertia may be based on the formula: j= ≡mdr ² Obtaining; the moment of inertia may be based on the formula:

obtained.

Waveform parameters that can be determined based on the solidification curve and the differential curve include, but are not limited to, absorbance difference contrast of the two-point method and the rate method, peak time, peak to baseline period ratio, maximum overshoot, and adjustment time, wherein the absorbance difference contrast of the two-point method and the rate method can identify hetero/oligo; the peak time refers to the time to peak; the peak to baseline ratio refers to the ratio between the peak time and the onset of clotting time; the maximum overshoot refers to the extent to which the solidification curve exceeds the steady state endpoint, which often means the fibrinolysis process; the adjustment time refers to the time required from the occurrence of the reaction to the achievement of the specified deviation range (3-5%).

The waveform parameters correspond to a parameter library, which includes which waveform parameters and which threshold ranges are set in the sample analyzer 100, or may be edited by a user by inputting instructions through the input device 170, or a combination of the two, for example, a default parameter library is set in the sample analyzer 100, and the user may increase or decrease waveform parameters in the parameter library, or change threshold ranges. The user can edit the parameter library and the evaluation relationship by using the input device 170, so that the latest theory and the like can be applied to the sample analyzer 100.

The reasons for the prolonged clotting time described above are distinguished by large classification criteria and may include, but are not limited to, clotting factor deficiency, the presence of clotting factor inhibitors, the presence of anti-phospholipid antibodies, the presence of heparin, warfarin and novel oral anticoagulant disturbances.

As shown in fig. 2 and 3, the evaluation rule is shown in an embodiment, and the reason for the prolonged solidification time is more specific in fig. 2 and 3. In fig. 2, the factor VIII is insufficient in activity due to the extended clotting time, and the corresponding waveform parameters include at least a bias and a fitting integral area, both of which include four threshold ranges, although the threshold ranges of the waveform parameters corresponding to the same factor VIII may be different. In fig. 3, the coagulation time extension is due to insufficient factor II activity, and the corresponding waveform parameters include at least skewness and kurtosis. As can be seen from fig. 2 and 3, if the deviation of the coagulation waveform based on a certain sample to be tested is between 0 and 0.25, the factor VIII activity is less than 0 and the factor II activity is less than 1, in fig. 2 and 3, the score of a certain type of coagulation time extension factor based on a certain waveform parameter means that the probability of the occurrence of the type of coagulation time extension factor of the sample to be tested is high or low from the perspective of the waveform parameter, that is, from fig. 2 and 3, if the deviation of the coagulation waveform based on a certain sample to be tested is between 0 and 0.25, the sample to be tested is more likely to be based on the factor II activity deficiency to cause the coagulation time extension.

Fig. 2 and 3 are only examples of evaluation rules, and in other embodiments, evaluation rules with a higher probability with a lower value may be adopted, or the probability may be characterized in other ways without scoring. It can also be seen from fig. 2 and 3 that the waveform parameters corresponding to different coagulation time extension causes may be different, for example, the a coagulation time extension cause may be evaluated based on three waveform parameters, and the B coagulation time extension cause may be based on four waveform parameters.

In this embodiment, the processing device 180 is configured to obtain a parameter value of at least one waveform parameter of a coagulation waveform of a sample to be tested according to the optical information and the coagulation time. For example, the processing device 180 may generate a solidification curve of the sample to be measured, calculate the parameter value of the waveform parameter of the solidification curve, differentiate the solidification curve, obtain a differential curve, and calculate the parameter value of the waveform parameter of the differential curve. It has been described above that the sample analyzer 100 may set up a parameter library, and for a specific sample detection, it may not be necessary to calculate parameter values of all waveform parameters in the parameter library, and in this embodiment, the input device 170 is further configured to receive a parameter selection instruction input by a user, and the processing device 180 is further configured to select at least one waveform parameter from a plurality of waveform parameters based on the parameter selection instruction, for example, 10 waveform parameters in the parameter library, and based on the selection by the user, the processing device 180 may obtain parameter values of only 5 waveform parameters of the sample to be measured.

When it is detected that the coagulation time is prolonged, the processing device 180 may output evaluation information of the cause of the coagulation time prolonged of the sample to be measured according to the parameter value of the at least one waveform parameter and the evaluation rule. In some embodiments, the sample analyzer 100 further includes a display device 190 for displaying the assessment information.

Specifically, the processing device 180 may obtain a comparison result between the parameter value of each waveform parameter in the at least one waveform parameter and the corresponding different threshold ranges, and calculate and output a scoring result of different coagulation time extension reasons according to the comparison result and the scoring relation. Also taking fig. 2 and 3 as an example, assuming that the bias degree of the sample to be tested is 0.23, the kurtosis is 1.6, and the fitting integral area is 300, the score of factor VIII activity deficiency is equal to 0 score based on bias degree plus 3 score based on fitting integral area, the score of factor II activity deficiency is equal to 1 score based on bias degree and 1 score based on kurtosis, the score result is factor VIII activity deficiency 3 score, factor II activity deficiency 2 score, and for the user, the factor VIII activity deficiency is higher than factor II activity deficiency, although there is no way to directly determine the factor VIII activity deficiency based on the result, the user can more specifically check the factor VIII activity deficiency after the difference of the possibilities, for example, design an experiment to detect whether the sample to be tested is factor VIII activity deficiency.

In some embodiments, the scoring results of the different coagulation time extension reasons are displayed in a form of a comparison table, for example, in fig. 4, the scoring results are sorted according to the height of the scoring results in the comparison table, so that a user can more intuitively understand the scoring results.

Referring to fig. 5, fig. 5 also provides a sample analysis system 1000, which includes an input device 200, a processing device 300, a display apparatus 400, and at least one sample analyzer 100.

The functions of the input device 200 and the processing device 300 in this embodiment are basically the same as those in the previous embodiment, except that:

the input device 200 and the processing device 300 in this embodiment are independent of the sample analyzer 100 and are not part of the sample analyzer 100. The evaluation rule received by the input device 200 is applicable to any one of the sample analyzers 100 other than a specific sample analyzer 100, and when a sample analyzer 100 in the sample analysis system 1000 completes detection of a sample to be tested, if the sample to be tested has a prolonged coagulation time, the processing device 300 may output evaluation information of the cause of the prolonged coagulation time of the sample to be tested, and the display apparatus 400 may display the evaluation information.

That is, in the present embodiment, the input device 200 and the sample analyzer 100 may be in one-to-many relationship, and the processing device 300 and the sample analyzer 100 may be in one-to-many relationship.

Referring to the embodiment shown in fig. 6, the embodiment further provides a detection method of the sample analyzer 100, including:

and S100, acquiring optical information of the sample to be measured in the solidification process and solidification time of the sample to be measured.

The sample to be measured refers to a sample obtained by adding a reagent to an original sample. The sample to be measured can be irradiated by the light beam within a set time after the sample to be measured is obtained, the optical information (scattered light quantity, transmittance or absorbance) of the sample to be measured can be changed in the solidification process of the sample to be measured, and the solidification time can be the time when the reagent is added into the original sample to obtain the sample to be measured to solidify the sample to be measured.

Step 200, obtaining a parameter value of at least one waveform parameter of the coagulation waveform of the sample to be tested according to the optical information.

In this step, a solidification curve of the sample to be measured may be generated according to the optical information and the solidification time, and then a parameter value of a waveform parameter of the solidification curve may be calculated, and the solidification curve may be differentiated to obtain a differential curve, and then a parameter value of the waveform parameter of the differential curve may be calculated, so as to obtain a parameter value of at least one waveform parameter. Wherein, the at least one waveform parameter may be one or more selected from a preset plurality of waveform parameters. The preset plurality of waveform parameters comprise waveform parameters which can be determined based on a coagulation curve and/or a differential curve of the coagulation curve, in particular:

obtained.

The waveform parameters are equivalent to forming a parameter library, which includes waveform parameters and threshold ranges, which may be preset, or edited by a user through input instructions, or a combination of the two, for example, a default parameter library is preset, and the user may increase or decrease waveform parameters in the parameter library, or change threshold ranges. The advantage of being able to edit by the user is that the parameter library and the evaluation relationships can be updated, thus applying the latest theory etc. to sample detection.

Since there may be more waveform parameters in the parameter library, in a specific sample detection, it may not be necessary to calculate the parameter values of all waveform parameters in the parameter library, so in step S200, at least one waveform parameter may be selected from a plurality of waveform parameters based on a parameter selection instruction input by a user, for example, 10 waveform parameters are in the parameter library, and only the parameter values of 5 waveform parameters of the sample to be detected may be obtained based on the selection of the user. Of course, the parameter values of all kinds of waveform parameters in the parameter library may also be obtained.

Step S300, judging whether the solidification time is prolonged, and if so, executing step S400.

Step S400, according to the parameter value of at least one waveform parameter and the evaluation rule set by the user, outputting the evaluation information of the coagulation time extension reason of the sample to be tested. The causes of prolonged clotting time are distinguished according to large classification criteria and may include, but are not limited to, clotting factor deficiency, the presence of clotting factor inhibitors, the presence of anti-phospholipid antibodies, the presence of heparin, warfarin, and novel oral anticoagulant disturbances.

In this step, the evaluation rule includes a scoring relationship between different threshold ranges of each waveform parameter related to the coagulation waveform and different causes of coagulation time extension. As shown in fig. 2 and 3, the evaluation rule is shown in an embodiment, and the reason for the prolonged solidification time is more specific in fig. 2 and 3. In fig. 2, the factor VIII is insufficient in activity due to the extended clotting time, and the corresponding waveform parameters include at least a bias and a fitting integral area, both of which include four threshold ranges, although the threshold ranges of the waveform parameters corresponding to the same factor VIII may be different. In fig. 3, the coagulation time extension is due to insufficient factor II activity, and the corresponding waveform parameters include at least skewness and kurtosis. As can be seen from fig. 2 and 3, if the deviation of the coagulation waveform based on a certain sample to be tested is between 0 and 0.25, the factor VIII activity is less than 0 and the factor II activity is less than 1, in fig. 2 and 3, the score of a certain type of coagulation time extension factor based on a certain waveform parameter means that the probability of the coagulation time extension factor of the sample to be tested is high or low from the perspective of the waveform parameter, that is, from fig. 2 and 3, if the deviation of the coagulation waveform based on a certain sample to be tested is between 0 and 0.25, the sample to be tested is more likely to be based on the factor II activity deficiency to cause the coagulation time extension.

In this step, the process of outputting the evaluation information may specifically be:

and obtaining comparison results between parameter values of each waveform parameter in at least one waveform parameter and corresponding different threshold ranges, and calculating and outputting scoring results of different coagulation time extension reasons according to the comparison results and scoring relations. Also taking fig. 2 and 3 as an example, assuming that the bias degree of the sample to be measured is 0.23, the kurtosis is 1.6, and the fitting integral area is 300, the score of factor VIII activity deficiency is equal to 0 score based on bias degree plus 3 score based on fitting integral area, the score of factor II activity deficiency is equal to 1 score based on bias degree and 1 score based on kurtosis, the score result is factor VIII activity deficiency 3 score, factor II activity deficiency 2 score, and for the user, the factor VIII activity deficiency is higher than factor II activity deficiency, although there is no way to directly determine the factor VIII activity deficiency based on the result, after the difference of the possibilities, the user can more specifically check the factor VIII activity deficiency, for example, design an experiment to detect whether the sample to be measured is factor VIII activity deficiency.

The above embodiment fully excavates and utilizes the coagulation curve, helps to provide more diagnostic references for users, and the evaluation rules can be set by users, and the users can update the evaluation rules according to the latest medical theory or clinical experience to obtain more accurate evaluation information.

Those skilled in the art will appreciate that all or part of the functions of the various methods in the above embodiments may be implemented by hardware, or may be implemented by a computer program. When all or part of the functions in the above embodiments are implemented by means of a computer program, the program may be stored in a computer readable storage medium, and the storage medium may include: read-only memory, random access memory, magnetic disk, optical disk, hard disk, etc., and the program is executed by a computer to realize the above-mentioned functions. For example, the program is stored in the memory of the device, and when the program in the memory is executed by the processor, all or part of the functions described above can be realized. In addition, when all or part of the functions in the above embodiments are implemented by means of a computer program, the program may be stored in a storage medium such as a server, another computer, a magnetic disk, an optical disk, a flash disk, or a removable hard disk, and the program in the above embodiments may be implemented by downloading or copying the program into a memory of a local device or updating a version of a system of the local device, and when the program in the memory is executed by a processor.

The foregoing description of the invention has been presented for purposes of illustration and description, and is not intended to be limiting. Several simple deductions, modifications or substitutions may also be made by a person skilled in the art to which the invention pertains, based on the idea of the invention.

Claims

1. A sample analyzer, comprising:

a sample addition device comprising a sampling needle for sucking up an original sample and adding the original sample into a reaction vessel;

a reagent adding device for sucking a reagent and adding the reagent into a reaction container containing the original sample to obtain a sample to be measured;

the input device is used for receiving the evaluation rule set by the user;

2. The sample analyzer of claim 1, wherein the input device is further configured to receive a plurality of waveform parameters set by a user and different threshold ranges for each of the plurality of waveform parameters, the evaluation rule comprising a scoring relationship between the different threshold ranges for each waveform parameter and different coagulation time extension reasons.

3. The sample analyzer of claim 2, wherein the outputting of the evaluation information of the cause of the prolonged coagulation time of the sample to be measured according to the parameter value of the at least one waveform parameter and a preset evaluation rule comprises:

obtaining comparison results between parameter values of each waveform parameter in the at least one waveform parameter and corresponding different threshold ranges;

and calculating and outputting grading results of different coagulation time extension reasons according to the comparison result and the grading relation.

4. The sample analyzer of claim 2, wherein the input device is further configured to receive a user-entered parameter selection instruction, and wherein the processing device is further configured to select the at least one waveform parameter from the plurality of waveform parameters based on the parameter selection instruction.

5. The sample analyzer of any one of claims 2 to 4, wherein the input device is further configured to update the scoring relationship based on a first operating instruction entered by a user and/or the input device is configured to increase or decrease the plurality of waveform parameters set based on a second operating instruction entered by a user;

the processing device is further used for recalculating and outputting the scoring result according to the updated scoring relation.

6. The sample analyzer of claim 5, wherein outputting scoring results for different coagulation time extension causes comprises:

generating a comparison table comprising scoring results corresponding to different coagulation time extension reasons and each coagulation time extension reason;

outputting the comparison table.

7. The sample analyzer of claim 6, wherein the different causes of coagulation time extension in the lookup table are ordered according to the level of the corresponding scoring result.

8. The sample analyzer of claim 1, wherein the cause of the prolonged clotting time comprises at least one of a deficiency of clotting factors, the presence of clotting factor inhibitors, the presence of anti-phospholipid antibodies, the presence of heparin, warfarin, or novel oral anticoagulant interference.

9. The sample analyzer of claim 1, wherein the waveform parameters include at least one of a clotting start time, a clotting end time, a clotting time, a response time, a steady state deviation, and a standard deviation, a variance, a peak-to-right slope ratio, a fit integration area, a peak value, a valley value, a moment of inertia, a skewness, a kurtosis, and a two-point versus rate absorbance difference comparison, a peak to baseline period ratio, a maximum overshoot, a peak time, and an adjustment time determinable from the clotting curve and the differential curve.

10. The sample analyzer of claim 1, wherein the differential curve comprises a primary differential curve and/or a secondary differential curve.

11. A sample analysis system, comprising:

the input device is used for receiving the evaluation rule set by the user;

and a display device for displaying the evaluation information.

12. The system of claim 11, wherein the input device is further configured to receive a plurality of waveform parameters set by a user and different threshold ranges for each of the plurality of waveform parameters, the evaluation rule including a scoring relationship between the different threshold ranges for each waveform parameter and different coagulation time extension reasons;

the outputting the evaluation information of the coagulation time extension reason of the sample to be tested according to the parameter value of the at least one waveform parameter and a preset evaluation rule comprises the following steps:

13. The system of claim 12, wherein outputting scoring results for different coagulation time extension causes comprises:

outputting the comparison table.

14. A method of detecting a sample analyzer, comprising:

15. The method of claim 14, wherein the evaluation rules include scoring relationships between different threshold ranges of each of the at least one waveform parameter and different coagulation time extension causes;

16. The method of claim 15, wherein outputting scoring results for different coagulation time extension causes comprises:

outputting the comparison table.