Sample number determination method, apparatus, and device

Abstract

The application provides a sample quantity determination method, device and equipment, wherein the method comprises: determining an estimated sample quantity according to a sample lower limit quantity and a sample step quantity; obtaining sample information of a preset number of groups from total sample data; wherein each group of sample information in the sample information of the preset number of groups comprises sample information of the estimated sample quantity; determining a sample quantity identification value corresponding to the estimated sample quantity according to the sample information of the preset number of groups; and determining the estimated sample quantity as a target sample quantity or redetermining the estimated sample quantity according to the sample quantity identification value.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of intelligent medical devices, in particular to a sample quantity determination method, device and equipment. BACKGROUND

[0002] The reference interval is an interval containing two endpoints, usually the distribution range of 95% of healthy people. In the medical field, establishing a suitable reference interval is crucial for clinical decision-making.

[0003] The current method for establishing a reference interval includes direct sampling method and indirect sampling method. The direct sampling method establishes a reference interval by recruiting apparently healthy people, which is the mainstream method for establishing a reference interval at present. In the related art, the minimum sample size required to establish a reference interval is 120 cases, which is proposed in EP28-A3c for non-parametric method, because at least 120 samples are required to calculate the 90% confidence interval when establishing a reference interval by non-parametric method.

[0004] However, the variation of test items is different. For biomarkers with large variation, the reference interval calculated by only 120 samples is far from enough, which shows that the 90% confidence interval of the reference interval limit value is too wide, resulting in low stability of the reference interval limit value and making it impossible to use. Therefore, there is no clear method to evaluate and calculate the sample size required to establish a reference interval for different test markers. SUMMARY

[0005] The present application provides a sample quantity determination method, device and equipment.

[0006] According to a first aspect of an embodiment of the present application, a sample quantity determination method is provided for determining the sample quantity for establishing a reference interval of a test marker, the method comprising:

[0007] determining an estimated sample quantity according to the sample lower limit quantity and the sample step size;

[0008] obtaining sample information of a preset number of groups from total sample data, wherein each group of sample information in the sample information of the preset number of groups includes sample information of the estimated sample quantity;

[0009] determining a sample size identifier value corresponding to the estimated sample quantity according to the sample information of the preset number of groups;

[0010] determining the estimated sample quantity as a target sample quantity according to the sample size identifier value, or re-determining the estimated sample quantity.

[0011] According to a second aspect of an embodiment of the present application, a sample quantity determination device is provided for determining the sample quantity for establishing a reference interval of a test marker, the device comprising:

[0012] an estimated sample number determination module configured to determine an estimated sample number according to the sample lower limit number and the sample step size;

[0013] a sample information acquisition module configured to acquire sample information of a preset number of groups from total sample data, wherein each group of the sample information of the preset number of groups includes sample information of the estimated sample number;

[0014] an identification value determination module configured to determine a sample quantity identification value corresponding to the estimated sample number according to the sample information of the preset number of groups;

[0015] a target sample number determination module configured to determine the estimated sample number as a target sample number according to the sample quantity identification value, or to redetermine the estimated sample number.

[0016] According to a third aspect of the embodiments of the present application, a computer device is provided, which includes a memory, a processor, and a computer program stored in the memory and executable on the processor, and the processor implements the sample number determination method of any one of the first aspect when executing the program.

[0017] In the embodiments of the present application, based on big data mining, a method for automatically calculating the required sample quantity for establishing a reference interval of a test marker is provided, which provides a basis and a tool for calculating the sample quantity when a reference interval is established in a clinic and a clinical laboratory, and provides a guarantee for ensuring the establishment of a stable and reliable reference interval.

[0018] It should be understood that the foregoing general description and the following detailed description are only exemplary and explanatory, rather than limiting the present application. BRIEF DESCRIPTION OF DRAWINGS

[0019] The accompanying drawings, which are incorporated in and constitute a part of the specification, illustrate embodiments consistent with the present application and, together with the description, serve to explain the principles of the present application.

[0020] Figure 1 is a sample number determination method flow chart according to an exemplary embodiment;

[0021] Figure 2 is a sample quantity identification value determination method flow chart according to an exemplary embodiment;

[0022] Figure 3 is a sample number determination device schematic diagram according to an exemplary embodiment;

[0023] Figure 4 is a structure schematic diagram of a computer device according to an exemplary embodiment. DETAILED DESCRIPTION

[0024] The exemplary embodiments will be described in detail herein with reference to the attached drawings. The description herein refers to the accompanying drawings, which show by way of examples specific embodiments in which the application can be placed. The following description, in relation to the drawings, is not intended to represent an exhaustive description of all embodiments in accordance with the present application. Rather, it is intended to represent only some embodiments in accordance with the present application, as detailed in the attached claims.

[0025] The terminology used in the present application is for the purpose of describing particular embodiments only and is not intended to be limiting of the present application. As used in the present application and the appended claims, the singular forms "a," "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will also be understood that the term "and / or" as used herein refers to and encompasses any and all possible combinations of one or more of the associated listed items.

[0026] It is to be understood that the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. It is to be understood that the term "and / or" as used herein encompasses all possible combinations of one or more of the associated listed items and that terms, such as "first," "second," and the like can be used solely for purposes of description and do not in any way limit the scope of the application. It is to be understood that the word "example" as used herein means "serving as an example, instance, or illustration." At the very least, therefore, the word "example" is not to be used in the sense of preferred or favorable or ideal. Moreover, the word "example" is not to be interpreted as implying any sort of limitation or suggesting that a large number of alternatives are available to implement the application.

[0027] In order to make the sample quantity determination method provided by the present application more clear, the process of the scheme provided by the present application is described in detail below in combination with the drawings and specific embodiments.

[0028] Referring to Figure 1 , Figure 1 is a flowchart of a sample quantity determination method according to an embodiment of the present application. As Figure 1 shown, the flow includes steps 101 to 104.

[0029] In step 101, the estimated sample quantity is determined according to the sample lower limit quantity and the sample step quantity.

[0030] In the embodiment of the present application, the upper limit and the lower limit of the determined sample quantity can be set in advance as the sample lower limit quantity and the sample upper limit quantity, respectively. For example, based on the medical record data or experience, it is known that the pre-experiment result prompts that various hormones of the human body all reach the stable point before 2000 samples, so the sample lower limit quantity can be determined as 40 and the sample upper limit quantity can be determined as 2000.

[0031] The sample step quantity is a step that the sample lower limit quantity increases by. For example, the sample step quantity can be set as 1, and the sample lower limit quantity can increase by the sample step quantity 1 to obtain different estimated sample quantities.

[0032] In some optional embodiments, the step 101 of determining the estimated sample quantity according to the sample lower limit quantity and the sample step quantity comprises: adding the sample lower limit quantity and a step multiple of the sample step quantity to obtain the estimated sample quantity; wherein the step multiple is an integer that increases sequentially and is greater than or equal to 0.

[0033] For example, the sample lower limit quantity 40 can increase to obtain the estimated sample quantities 41, 42, 43, and so on, based on the sample step quantity 1, until the estimated sample quantity reaches the sample upper limit quantity 2000.

[0034] The step 102 comprises: obtaining a preset number of groups of sample information from the total sample data; wherein each group of sample information in the preset number of groups of sample information comprises sample information of the estimated sample quantity.

[0035] In the embodiments of the present application, the total sample data is pre-collected sample information, for example, 10000 pieces of sample information are pre-collected as the total sample data. The step can obtain a preset number of groups of sample information from the total sample data, and each group of information extracted is sample information of the estimated sample quantity. For example, 1000 groups of sample information can be extracted from the total sample data 10000 pieces of sample information with replacement, and each group of sample information is sample information of the estimated sample quantity 40.

[0036] The step 103 comprises: determining a sample quantity identification value corresponding to the estimated sample quantity according to the preset number of groups of sample information.

[0037] After obtaining 1000 groups of sample information, the step can analyze and process the 1000 groups of sample information to determine whether the estimated sample quantity is suitable as the target sample quantity, that is, to obtain a sample quantity identification value representing whether it is suitable. For example, the sample quantity identification value 1 represents that it is suitable, and the sample quantity identification value 0 represents that it is not suitable.

[0038] In some optional embodiments, the step 103 of determining the sample quantity identification value corresponding to the estimated sample quantity according to the preset number of groups of sample information comprises steps 201 and 202.

[0039] The step 201 comprises: determining an upper limit parameter and a lower limit parameter of a reference interval of an inspection marker corresponding to the estimated sample quantity according to the preset number of groups of sample information.

[0040] After obtaining the sample information of 1000 groups, the upper limit parameter and the lower limit parameter of the reference interval of the test marker corresponding to the estimated sample quantity 40 can be determined according to the sample information of the 1000 groups. The upper limit parameter and the lower limit parameter are both parameters for representing whether the estimated sample quantity is suitable as the target sample quantity.

[0041] In a possible implementation, the upper limit parameter and the lower limit parameter of the reference interval of the test marker corresponding to the estimated sample quantity are determined according to the sample information of the preset number of groups, that is, step 201, which includes:

[0042] The upper limit value, the lower limit value, and the width value of the reference interval of the test marker of the preset number of groups are determined according to the sample information of the preset number of groups.

[0043] The ratio of the first confidence interval of the upper limit value of the preset number to the first quantile of the width value of the preset number is taken as the upper limit parameter.

[0044] The ratio of the second confidence interval of the lower limit value of the preset number to the second quantile of the width value of the preset number is taken as the lower limit parameter.

[0045] In the above implementation, after obtaining the sample information of the preset number of 1000 groups, the upper limit value and the lower limit value of the reference interval of the test marker can be calculated according to the sample information of the estimated sample quantity 40 in each group. For example, according to the sample information of 40 samples in each group, the upper limit value and the lower limit value of the reference interval of the test marker are obtained by using the conversion parameter method and the non-parameter method, and finally 1000 upper limit values and 1000 lower limit values are obtained. Further, the width values of the 1000 upper limit values and the 1000 lower limit values can be calculated.

[0046] The ratio of the 90% confidence interval of the 1000 upper limit values to the 5th quantile of the 1000 width values is taken as the upper limit parameter, and the ratio of the 90% confidence interval of the 1000 lower limit values to the 5th quantile of the 1000 width values is taken as the lower limit parameter.

[0047] It should be noted that the first confidence interval, the second confidence interval, the first quantile, and the second quantile can be flexibly set or customized according to actual application, and the present implementation is not limited.

[0048] In step 202, if the upper limit parameter and the lower limit parameter of the reference interval of the test marker corresponding to the estimated sample quantity are both less than a preset threshold, the sample quantity identification value corresponding to the estimated sample quantity is determined as a first identification value. The first identification value is used to represent the degree to which the estimated sample quantity is the target sample quantity.

[0049] The preset threshold is a threshold preset for comparison with the upper limit parameter and the lower limit parameter, and can be flexibly set. For example, in a case where the upper limit parameter and the lower limit parameter are both less than 0.2, the sample quantity identifier corresponding to the estimated sample quantity is determined as a first identifier in this step. The first identifier indicates that the estimated sample quantity can be used as the target sample quantity. For example, when the estimated sample quantity is 120, the sample quantity identifier corresponding to the estimated sample quantity is determined as the first identifier, indicating that 120 can be used as the target sample quantity.

[0050] In step 104, the estimated sample quantity is determined as the target sample quantity or the estimated sample quantity is redetermined according to the sample quantity identifier.

[0051] Through steps 101 to 103, the sample quantity identifier corresponding to the estimated sample quantity can be determined. In this step, the sample quantity identifier can be judged and analyzed. If it is suitable, the estimated sample quantity can be directly used as the target sample quantity. If it is not suitable, the estimated sample quantity is redetermined by returning to step 101.

[0052] In some optional embodiments, the determination of the estimated sample quantity as the target sample quantity or the redetermination of the estimated sample quantity according to the sample quantity identifier, i.e., step 104, includes:

[0053] In a case where the sample quantity identifier is a first identifier, the estimated sample quantity corresponding to the first identifier is used as the target sample quantity.

[0054] In a case where the sample quantity identifier is a second identifier, the step of determining the estimated sample quantity according to the sample lower limit quantity and the sample step quantity is returned to.

[0055] The first identifier or the second identifier is used to represent the degree to which the estimated sample quantity is the target sample quantity.

[0056] For example, if it is determined that the sample quantity identifier corresponding to the estimated sample quantity 40 is 0 (second identifier), it indicates that the estimated sample quantity 40 is not suitable as the target sample quantity, and the estimated sample quantity is redetermined as 41 by returning to step 101. Optionally, after the estimated sample quantity is redetermined as 41, steps 101 to 104 can be continued to be executed.

[0057] For example, if the sample quantity identifiers corresponding to the estimated sample quantity 40 to the estimated sample quantity 119 are 0, it is determined that the sample quantity identifier corresponding to the estimated sample quantity 120 is 1 (first identifier), indicating that the estimated sample quantity 120 is suitable as the target sample quantity, and the estimated sample quantity 120 can be used as the target sample quantity.

[0058] In some optional embodiments, the determining, according to the sample quantity identifier, the estimated sample number as the target sample number or the re-determining the estimated sample number, i.e., step 104, comprises:

[0059] In the case that the estimated sample number is equal to the upper limit sample number, obtaining all sample quantity identifiers corresponding to the estimated sample number;

[0060] Performing moving summation on all obtained sample quantity identifiers to obtain a set of sample identifier summation values; wherein the width of the moving window for the moving summation is a preset width value;

[0061] Determining, according to the sample identifier summation value, the corresponding estimated sample number as the target sample number.

[0062] In the above embodiments, the estimated sample number increases from the lower limit sample number to the upper limit sample number, and the sample quantity identifier corresponding to each different estimated sample number is determined during the increase of the estimated sample number. For example, in the case that the lower limit sample number is 40, the upper limit sample number is 2000, and the sample step quantity is 1, then the estimated sample number is an integer between 40 and 2000 (1960 integers), and each different estimated sample number corresponds to a sample quantity identifier 1 or 0, i.e., a sequence of 1960 bits of 1 or 0 is obtained. For example, a first sequence of 1960 bits of 1 or 0 is [0, 0, 0, 0…1, 0, 0, 1, 1, 1, 1, 1].

[0063] After obtaining 1960 sample quantity identifiers, the sequence can be further subjected to moving summation to obtain a set of sample identifier summation values. The width of the moving window for the moving summation is a preset width value, for example, the width value of the moving window can be preset to 10. For example, the first sequence can be subjected to moving summation (the width of the moving window is 10) to obtain a set of sample identifier summation values, i.e., a second sequence [0, 0, 0, 0…, 8, 9, 10, 10, 10, 10, 10] is obtained.

[0064] Further, the corresponding estimated sample number can be determined as the target sample number according to the values in the second sequence.

[0065] In a possible implementation, the determining, according to the sample identifier summation value, the corresponding estimated sample number as the target sample number comprises: in the case that the set of sample identifier summation values is equal to a preset sample summation value for the first time, determining the estimated sample number corresponding to the first sample quantity identifier in the moving window corresponding to the sample identifier summation value as the target sample number.

[0066] For example, in the case that the value in the second sequence [0, 0, 0, 0, …, 8, 9, 10, 10, 10, 10, 10] is equal to the preset sample summation value 10 for the first time, the preset sample quantity corresponding to the first sample quantity identifier value in the moving window corresponding to the preset sample summation value 10 can be determined as the target sample quantity in the implementation mode.

[0067] In the case that the value in the second sequence is equal to 10 for the first time, it is indicated that the 10 sample quantity identifier values in the moving window are all equal to 1 for the first time, and at this time, the first estimated sample quantity in the window can be determined as the target sample quantity.

[0068] In a possible implementation mode, the determining of the corresponding estimated sample quantity as the target sample quantity according to the sample identifier summation value comprises:

[0069] The moving median processing is performed on the group of sample identifier summation values to obtain a group of sample median values, wherein the moving window width for the moving median processing is set as a preset median width.

[0070] In the case that the sample median value is equal to a preset median value for the first time in the group of sample median values, the preset sample quantity corresponding to the first sample quantity identifier value in the moving window corresponding to the sample median value is determined as the target sample quantity.

[0071] In the above implementation mode, after the moving summation is performed on all the obtained sample quantity identifier values to obtain a group of sample identifier summation values, the moving median processing is further performed on the group of sample identifier summation values to obtain a group of sample median values. The width of the moving window for the moving median processing can also be preset, for example, can be preset as 10.

[0072] For example, the moving median calculation (the moving window width is set as 10) is performed on the second sequence [0, 0, 0, 0, …, 8, 9, 10, 10, 10, 10, 10] to obtain a third sequence [0, 0, 0, 0, …, 8, 8, 8.5, 9, 10, 10, 10, 10].

[0073] Further, the preset sample quantity corresponding to the first sample quantity identifier value in the moving window corresponding to the first time that the value in the third sequence [0, 0, 0, 0, …, 8, 8, 8.5, 9, 10, 10, 10, 10] is equal to a preset median value (for example, can be preset as 10) is determined as the target sample quantity.

[0074] Based on big data mining, a method for automatically calculating the required sample quantity for establishing a reference interval of a test marker is proposed, which provides a basis and a tool for calculating the sample quantity when a reference interval is established in a clinic and a clinical laboratory, and provides a guarantee for ensuring that a stable and reliable reference interval is established.

[0075] Figure 3 As shown, the present application provides a sample quantity determination apparatus, which can perform the sample quantity determination method of any embodiment of the present application. The apparatus can include an estimated sample determination module 301, a sample information acquisition module 302, an identification value determination module 303, and a target sample quantity determination module 304. Wherein:

[0076] The estimated sample determination module 301 is configured to determine an estimated sample quantity according to a sample lower limit quantity and a sample step size.

[0077] The sample information acquisition module 302 is configured to acquire a preset number of groups of sample information from total sample data, wherein each group of the preset number of groups of sample information includes sample information of the estimated sample quantity.

[0078] The identification value determination module 303 is configured to determine a sample quantity identification value corresponding to the estimated sample quantity according to the preset number of groups of sample information.

[0079] The target sample quantity determination module 304 is configured to determine the estimated sample quantity as a target sample quantity or to re-determine the estimated sample quantity according to the sample quantity identification value.

[0080] For the apparatus embodiment, since it basically corresponds to the method embodiment, the related part can refer to the part of the method embodiment. The apparatus embodiment described above is only schematic, wherein the units described as separate components can or can not be physically separate, and the components displayed as units can or can not be physical units, i.e., they can be located in one place or distributed on multiple network units. According to actual needs, some or all of the modules can be selected to achieve the purpose of at least one embodiment of the present application. Those skilled in the art can understand and implement without creative labor.

[0081] The present application also provides a computer device, which includes a memory, a processor, and a computer program stored in the memory and executable on the processor, wherein the processor can implement the sample quantity determination method of any embodiment of the present application when executing the program.

[0082] Figure 4A more specific computer device hardware structure diagram provided by the embodiment of the application is shown, which can include: a processor 1010, a memory 1020, an input / output interface 1030, a communication interface 1040 and a bus 1050. The processor 1010, the memory 1020, the input / output interface 1030 and the communication interface 1040 are connected to each other through the bus 1050 for internal communication.

[0083] The processor 1010 can be implemented by a general-purpose CPU (Central Processing Unit), a microprocessor, an ASIC (Application Specific Integrated Circuit) or one or more integrated circuits, etc., for executing related programs to implement the technical solutions provided by the embodiments of the present application.

[0084] The memory 1020 can be implemented by a ROM (Read Only Memory), a RAM (Random Access Memory), a static storage device, a dynamic storage device, etc. The memory 1020 can store an operating system and other application programs, and when the technical solutions provided by the embodiments of the present application are implemented by software or firmware, the related program codes are stored in the memory 1020 and called and executed by the processor 1010.

[0085] The input / output interface 1030 is used to connect input / output modules to realize information input and output. The input / output modules can be configured as components in the device (not shown in the figure) or externally connected to the device to provide corresponding functions. The input device can include a keyboard, a mouse, a touch screen, a microphone, various sensors, etc., and the output device can include a display, a speaker, a vibrator, an indicator light, etc.

[0086] The communication interface 1040 is used to connect a communication module (not shown in the figure) to realize the communication interaction between the device and other devices. The communication module can realize communication through a wired manner (such as USB, network cable, etc.) or a wireless manner (such as mobile network, WIFI, Bluetooth, etc.).

[0087] The bus 1050 includes a channel for transmitting information between various components (such as the processor 1010, the memory 1020, the input / output interface 1030 and the communication interface 1040) of the device.

[0088] It should be noted that, although the above device only shows the processor 1010, the memory 1020, the input / output interface 1030, the communication interface 1040 and the bus 1050, in the specific implementation process, the device can also include other components necessary for normal operation. In addition, those skilled in the art can understand that the above device can also only contain components necessary to implement the embodiments of the present application, and does not necessarily contain all the components shown in the figure.

[0089] The application also provides a computer readable storage medium, which stores a computer program, and the program can implement the sample quantity determination method of any embodiment of the application when executed by a processor.

[0090] The non-transitory computer readable storage medium can be a ROM, a random access memory (RAM), a CD-ROM, a magnetic tape, a floppy disk, and an optical data storage device, etc., and the application is not limited thereto.

[0091] In some optional embodiments, the embodiments of the application provide a computer program product, which includes computer readable code, and when the computer readable code runs on a device, a processor in the device executes the sample quantity determination method provided by any of the above embodiments. The computer program product can be specifically realized by hardware, software or a combination thereof.

[0092] Other embodiments of the application will be apparent to those skilled in the art from consideration of the specification and practice of the application disclosed herein. It is intended that the application be limited only by the scope of the claims, including any appropriate equivalents. The specification and examples given are exemplary only and are not intended to be limiting.

[0093] It should be understood that the application is not limited to the precise construction that has been described above and shown in the accompanying drawings, and that various modifications and changes can be made by those skilled in the art without departing from the scope of the application. The scope of the application is limited only by the claims that follow.

[0094] The above only describes the preferred embodiments of the application and is not intended to limit the application. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the application shall be included in the scope of protection of the application.

Claims

1. A method for determining the number of samples, characterized in that, The method for determining the number of samples needed to establish a reference interval for a diagnostic biomarker includes: The estimated sample size is determined based on the lower limit of the sample size and the sample step size. Sample information of a preset number of groups is obtained from the total sample data; wherein, each group of sample information in the preset number of groups includes sample information of the estimated number of samples; Based on the sample information of the preset number group, determine the upper limit and lower limit parameters of the reference interval for the test marker corresponding to the estimated sample number; If both the upper and lower limits of the reference interval for the test markers corresponding to the estimated sample number are less than a preset threshold, the sample size identifier corresponding to the estimated sample number is determined to be the first identifier value; otherwise, it is the second identifier value. The method of determining the estimated sample quantity as the target sample quantity based on the sample quantity identifier value, or re-determining the estimated sample quantity, further includes: if the sample quantity identifier value is a first identifier value, using the estimated sample quantity corresponding to the first identifier value as the target sample quantity or returning to the step of determining the estimated sample quantity based on the lower limit sample quantity and the sample step size; if the sample quantity identifier value is a second identifier value, returning to the step of determining the estimated sample quantity based on the lower limit sample quantity and the sample step size. When the estimated number of samples equals the upper limit of the sample size, obtain the sample size identifier value corresponding to all the estimated sample sizes; perform a moving summation on all the obtained sample size identifier values ​​to obtain a set of sample identifier summation values; wherein, the width of the moving window for performing the moving summation is a preset width value; and determine the corresponding estimated sample size as the target sample size based on the sample identifier summation value.

2. The method according to claim 1, characterized in that, The process of determining the estimated sample size based on the lower limit of the sample size and the sample step size includes: The estimated sample size is obtained by adding the lower limit of the sample size to the sample step size, which is a multiple of the step size; wherein the multiple of the step size is an integer that increases sequentially and is greater than or equal to zero.

3. The method according to claim 1, characterized in that, The step of determining the upper and lower limits of the reference interval for the diagnostic marker corresponding to the estimated sample size based on the sample information of the preset sample group includes: Based on the sample information of the preset number group, determine the upper limit, lower limit and width of the preset number of reference intervals for the test markers; The ratio of the first confidence interval of the upper limit value of the preset quantity to the first quantile of the width value of the preset quantity is used as the upper limit parameter; The ratio of the second confidence interval of the preset number of lower limit values ​​to the second quantile of the preset number of width values ​​is used as the lower limit parameter.

4. The method according to claim 1, characterized in that, The step of determining the corresponding estimated sample number as the target sample number based on the summation value of the sample identifiers includes: If the sum of the sample identifiers equals the preset sample sum for the first time, the estimated number of samples corresponding to the first sample size identifier in the moving window corresponding to the sum of the sample identifiers is determined as the target number of samples.

5. The method according to claim 1, characterized in that, The step of determining the corresponding estimated sample number as the target sample number based on the summation value of the sample identifiers includes: The summation values ​​of the set of sample identifiers are processed by moving median to obtain a set of sample median values; wherein, the width of the moving window for the moving median processing is set to a preset median width; If the median value of the set of samples equals the preset median value for the first time, the estimated number of samples corresponding to the first sample size identifier value in the moving window corresponding to the median value of the samples is determined as the target number of samples.

6. A sample quantity determination device, characterized in that, The apparatus for determining the number of samples needed to establish a reference interval for a diagnostic marker includes: The estimated sample determination module is used to determine the estimated sample size based on the lower limit of the sample size and the sample step size. The sample information acquisition module is used to acquire sample information of a preset number of groups from the total sample data; wherein, each group of sample information in the preset number of groups includes sample information of the estimated number of samples; The identifier value determination module is used to determine the upper limit parameter and lower limit parameter of the reference interval of the test marker corresponding to the estimated sample quantity based on the sample information of the preset quantity group; If both the upper and lower limits of the reference interval for the test markers corresponding to the estimated sample number are less than a preset threshold, the sample size identifier corresponding to the estimated sample number is determined to be the first identifier value; otherwise, it is the second identifier value. The target sample quantity determination module is used to determine the estimated sample quantity as the target sample quantity based on the sample quantity identifier value, or to redetermine the estimated sample quantity, and further includes: when the sample quantity identifier value is a first identifier value, using the estimated sample quantity corresponding to the first identifier value as the target sample quantity or returning to the step of determining the estimated sample quantity based on the lower limit sample quantity and the sample step size; when the sample quantity identifier value is a second identifier value, returning to the step of determining the estimated sample quantity based on the lower limit sample quantity and the sample step size. When the estimated number of samples equals the upper limit of the sample size, obtain the sample size identifier value corresponding to all the estimated sample sizes; perform a moving summation on all the obtained sample size identifier values ​​to obtain a set of sample identifier summation values; wherein, the width of the moving window for performing the moving summation is a preset width value; and determine the corresponding estimated sample size as the target sample size based on the sample identifier summation value.

7. A computer device, comprising a memory, a processor, and a computer program stored in the memory and executable on the processor, characterized in that, When the processor executes the program, it implements the method of any one of claims 1-5.

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