Performance evaluation method and device of marker detection system, equipment and medium

Abstract

The embodiment of the invention discloses a method, a device, equipment and a medium for evaluating the performance of a marker detection system, and the method comprises the following steps: obtaining reagent batch difference data output by a to-be-detected marker detection system for performing a reagent batch number verification test on a plurality of standard to-be-detected specimens, indoor quality control data output by performing indoor quality control test on the plurality of quality control specimens; performing reagent stability performance evaluation processing on the to-be-detected marker detection system based on the reagent batch difference data of the plurality of standard to-be-detected specimens to obtain a first evaluation attribute; based on the indoor quality control data corresponding to the plurality of quality control specimens, performing precision performance evaluation processing on the to-be-detected marker detection system to obtain a second evaluation attribute; and determining the target performance attribute result corresponding to the to-be-detected marker detection system based on the first evaluation attribute and the second evaluation attribute, thereby providing an effective method for objectively and quantitatively evaluating the detection performance of the marker detection system, and improving the universality of a detection report output by the marker detection system.

Description

Technical Field

[0001] The embodiments of the present invention relate to the technical field of system performance evaluation, and in particular, to a method, device, equipment and medium for evaluating the performance of a biomarker detection system. Background Art

[0002] During the occurrence, development and treatment of diseased tissues, biomarkers are molecular indicators that can reflect the diseased state, predict the curative effect and prognosis. Biomarkers can not only be used for the early detection and diagnosis of diseases, but also detect disease progression, evaluate the treatment effect, and predict an individual's response to a specific treatment. Therefore, the detection of biomarkers in diseased tissues has broad development prospects.

[0003] Currently, the detection task of biomarkers in diseased tissues can be completed through a biomarker detection system platform. There are a large number of different biomarker detection system platforms on the market currently, and the measurement results of these biomarker detection system platforms have a large dispersion. For example, when specimens from the same source are detected on different detection system platforms at the same time, it often happens that the biomarker results of the diseased tissues are inconsistent. Thus, the performance of the biomarker detection system platforms produced by different detection system platform providers varies. In addition, after the biomarker detection system platform is officially put into use, as the service life of the instrument increases, the hardware equipment will be worn, resulting in a change in the performance of the biomarker detection system.

[0004] However, there is currently a lack of an effective method for objectively and quantitatively evaluating the biomarker detection performance of different biomarker detection system platforms and the same biomarker detection system platform at different times. Summary of the Invention

[0005] The present invention provides a method, device, equipment and medium for evaluating the performance of a biomarker detection system, so as to provide an effective method for objectively and quantitatively evaluating the detection performance of a biomarker detection system, making the biomarker detection performances of different biomarker detection system platforms and the same biomarker detection system platform at different times comparable, and improving the generality of the detection reports output by the biomarker detection system.

[0006] In a first aspect, an embodiment of the present invention provides a method for evaluating the performance of a biomarker detection system, the method including:

[0007] Obtaining the inter-batch reagent difference data output by the biomarker detection system to be tested for reagent batch number verification tests on a plurality of standard specimens to be tested, and the in-house quality control data output by the in-house quality control tests on a plurality of quality control specimens;

[0008] Based on the inter-batch reagent difference data of the plurality of standard specimens to be tested, performing an evaluation process on the reagent stability performance of the biomarker detection system to be tested, and obtaining a first evaluation attribute corresponding to the biomarker detection system to be tested;

[0009] Based on the in - house quality control data corresponding to the multiple quality control specimens, perform precision performance evaluation processing on the detection system of the biomarker to be measured, and obtain a second evaluation attribute corresponding to the detection system of the biomarker to be measured;

[0010] Based on the first evaluation attribute and the second evaluation attribute, determine the target performance attribute result corresponding to the detection system of the biomarker to be measured.

[0011] Further, the method further includes: the first evaluation attribute is a reagent stability evaluation attribute value, and based on the reagent batch - to - batch difference data of the multiple standard specimens to be measured, perform reagent stability performance evaluation processing on the detection system of the biomarker to be measured, and obtain the first evaluation attribute corresponding to the detection system of the biomarker to be measured, including:

[0012] Perform pre - processing on the multiple reagent batch - to - batch difference data based on a preset pre - processing method to obtain multiple reagent batch - to - batch difference data to be applied;

[0013] Determine the normal distribution compliance attribute of the multiple reagent batch - to - batch difference data to be applied;

[0014] Based on the normal distribution compliance attribute, perform reagent stability performance evaluation on the detection system of the biomarker to be measured, and determine the reagent stability evaluation attribute value corresponding to the detection system of the biomarker to be measured.

[0015] Further, the method further includes: the preset pre - processing method is a standardization pre - processing method, and performing pre - processing on the multiple reagent batch - to - batch difference data based on the preset pre - processing method to obtain multiple reagent batch - to - batch difference data to be applied, including:

[0016] Determine the standard value and the mean value of the multiple reagent batch - to - batch difference data;

[0017] For the multiple reagent batch - to - batch difference data, perform standardization pre - processing on each reagent batch - to - batch difference data respectively based on the standard value and the mean value to obtain the reagent batch - to - batch difference data to be applied corresponding to each reagent batch - to - batch difference data.

[0018] Further, the method further includes: the determining the normal distribution compliance attribute of the multiple reagent batch - to - batch difference data to be applied includes:

[0019] Based on the multiple reagent batch - to - batch difference data to be applied, determine the kurtosis value and the skewness value;

[0020] Based on the kurtosis value and the skewness value, determine the normal distribution compliance attribute of the multiple reagent batch - to - batch difference data to be applied.

[0021] Further, the method further includes: determining that the normal distribution of the batch - to - batch difference data of the multiple reagents to be applied conforms to the property, including:

[0022] Constructing a histogram of reagent batch - to - batch difference values corresponding to the batch - to - batch difference data of the multiple reagents to be applied;

[0023] Fitting a probability density distribution curve based on the histogram of reagent batch - to - batch difference values;

[0024] Based on the similarity between the probability density distribution curve and a preset standard normal distribution curve, determining that the normal distribution of the batch - to - batch difference data of the multiple reagents to be applied conforms to the property.

[0025] Further, the method further includes: the second evaluation property is the precision evaluation property value, and performing a precision performance evaluation process on the detection system of the biomarker to be measured based on the in - house quality control data corresponding to the multiple quality control specimens, to obtain the second evaluation property corresponding to the detection system of the biomarker to be measured, including:

[0026] Based on the in - house quality control data corresponding to the multiple quality control specimens, determining the specimen observation offset and the coefficient of variation;

[0027] Based on the specimen observation offset and the coefficient of variation, determining the quality target index;

[0028] Based on the quality target index, performing a precision performance evaluation on the detection system of the biomarker to be measured, and determining the precision evaluation property value corresponding to the detection system of the biomarker to be measured.

[0029] Further, the method further includes: determining the target performance property result corresponding to the detection system of the biomarker to be measured based on the first evaluation property and the second evaluation property, including:

[0030] Based on a preset precision weight, a preset reagent stability weight, the first evaluation property, and the second evaluation property, determining the target performance property result corresponding to the detection system of the biomarker to be measured.

[0031] In a second aspect, an embodiment of the present invention further provides a performance evaluation device for a biomarker detection system, and the device includes:

[0032] A data acquisition module, configured to acquire the batch - to - batch difference data output by the detection system of the biomarker to be measured for reagent lot verification tests on multiple standard specimens to be measured, and the in - house quality control data output by the in - house quality control tests on multiple quality control specimens;

[0033] The first attribute determination module is configured to perform reagent stability performance evaluation processing on the to-be-detected marker detection system based on the reagent batch-to-batch difference data of the multiple standard to-be-tested specimens, and obtain a first evaluation attribute corresponding to the to-be-detected marker detection system;

[0034] The second attribute determination module is configured to perform precision performance evaluation processing on the to-be-detected marker detection system based on the in-house quality control data corresponding to the multiple quality control specimens, and obtain a second evaluation attribute corresponding to the to-be-detected marker detection system;

[0035] The target result determination module is configured to determine a target performance attribute result corresponding to the to-be-detected marker detection system based on the first evaluation attribute and the second evaluation attribute.

[0036] In a third aspect, an embodiment of the present invention further provides an electronic device, which includes:

[0037] One or more processors;

[0038] A storage device for storing one or more programs, which when executed by one or more processors, cause the one or more processors to implement the performance evaluation method of the marker detection system according to any one of the embodiments of the present invention.

[0039] In a fourth aspect, an embodiment of the present invention further provides a storage medium containing computer-executable instructions, which are used to execute the performance evaluation method of the marker detection system according to any one of the embodiments of the present invention when executed by a computer processor.

[0040] The technical solution of the embodiment of the present invention is to obtain the reagent batch-to-batch difference data output by the to-be-detected marker detection system for performing reagent lot verification tests on multiple standard to-be-tested specimens, and the in-house quality control data output by performing in-house quality control tests on multiple quality control specimens; furthermore, based on the reagent batch-to-batch difference data of the multiple standard to-be-tested specimens, perform reagent stability performance evaluation processing on the to-be-detected marker detection system to obtain a first evaluation attribute corresponding to the to-be-detected marker detection system, and based on the in-house quality control data corresponding to the multiple quality control specimens, perform precision performance evaluation processing on the to-be-detected marker detection system to obtain a second evaluation attribute corresponding to the to-be-detected marker detection system, thereby determining a target performance attribute result corresponding to the to-be-detected marker detection system based on the first evaluation attribute and the second evaluation attribute. The technical solution of this embodiment provides an effective method for objectively and quantitatively evaluating the detection performance of a marker detection system, making the detection performances of different marker detection system platforms and the same marker detection system platform at different times comparable, and improving the generality of the detection reports output by the marker detection system. Description of the Drawings

[0041] To more clearly illustrate the technical solutions of the exemplary embodiments of the present invention, the following provides a brief introduction to the drawings required for describing the embodiments. Obviously, the introduced drawings are only the drawings of a part of the embodiments to be described in the present invention, rather than all the drawings. For those of ordinary skill in the art, without creative efforts, other drawings can also be obtained based on these drawings.

[0042] Figure 1 It is a schematic flowchart of a method for evaluating the performance of a biomarker detection system provided by an embodiment of the present invention;

[0043] Figure 2 It is a schematic flowchart of another method for evaluating the performance of a biomarker detection system provided by an embodiment of the present invention;

[0044] Figure 3 It is a schematic diagram of a probability density distribution curve involved in an embodiment of the present invention;

[0045] Figure 4 It is a schematic structural diagram of a device for evaluating the performance of a biomarker detection system provided by an embodiment of the present invention;

[0046] Figure 5 It is a schematic structural diagram of an electronic device provided by an embodiment of the present invention. Detailed Embodiments

[0047] The following further elaborates on the present invention in conjunction with the drawings and embodiments. It can be understood that the specific embodiments described herein are only used to explain the present invention, rather than limiting the present invention. Additionally, it should be noted that for the sake of description, only the parts related to the present invention rather than all the structures are shown in the drawings.

[0048] Before introducing the technical solution, the application scenario of the embodiments of the present invention can be described first. The technical solutions provided by the embodiments of the present invention can be applied to any scenario where an objective quantitative evaluation of the biomarker detection performance of a biomarker detection system platform is required.

[0049] Malignant lesion tissues are major chronic diseases that seriously threaten human health. Early detection and early treatment play an important role in improving the quality of life and prolonging the survival period of patients with malignant lesions. During the development and treatment of lesion tissues, biomarker of lesion tissues can reflect the state of lesion tissues, and molecular indicators for predicting the curative effect and prognosis. Biomarkers can not only be used for the early detection and diagnosis of lesion tissues, but also for detecting disease progression, evaluating the treatment effect, and predicting an individual's response to a specific treatment. Therefore, the detection of lesion tissue biomarkers is crucial in the detection of lesion tissues.

[0050] Currently, the detection task of lesion tissue markers can be completed through a marker detection system platform. On the one hand, in order to reduce repeated examinations, simplify the medical treatment process, and relieve the economic burden on patients, the mutual recognition of lesion test results from different institutions is a major trend in future development. On the other hand, as the service life of the marker detection system platform increases, the hardware equipment will wear out, resulting in changes in the performance of the marker detection system. Based on this, higher requirements are put forward for the comparability of the detection results of different marker detection system platforms and the detection results of the same marker detection system platform at different times. In fact, this requires an objective quantitative evaluation of the detection performance of different marker detection system platforms. The technical solution of the embodiment of the present invention aims to provide an effective method for objectively quantifying the marker detection performance of different marker detection system platforms and the same marker detection system platform at different times.

[0051] Embodiment 1

[0052] Figure 1 It is a schematic flowchart of a method for evaluating the performance of a marker detection system provided by an embodiment of the present invention. This embodiment is applicable to any situation where an objective quantitative evaluation of the marker detection performance of a marker detection system platform is required. This method can be executed by a performance evaluation device of the marker detection system, and this device can be implemented in the form of software and / or hardware. The hardware can be an electronic device, such as a mobile terminal, a PC, or a server, etc.

[0053] As Figure 1 shown, the method for evaluating the performance of the marker detection system includes:

[0054] S110. Obtain the inter-batch reagent difference data output by the reagent batch verification test of the marker detection system to be tested on multiple standard specimens to be tested, and the in-house quality control data output by the in-house quality control test on multiple quality control specimens.

[0055] Among them, the marker detection system to be tested is the marker detection system platform whose marker detection performance is to be quantitatively evaluated.

[0056] In the actual application process, a detection reagent is required for the marker detection system to detect markers in specimens. To ensure the continuity and consistency of the detection results, before a new batch number of detection reagent is put into use, it must be subjected to quality verification with the old batch number of detection reagent; in addition, verification is also required for detection reagents of the same batch number but with different arrival times. Based on this, the process of verifying the detection reagent can be called the reagent batch number verification test. When conducting the reagent batch number verification test, real specimens of patients are usually not used, but some pre-prepared test specimens are used, and these test specimens can be called standard specimens to be tested. For each standard specimen to be tested, the marker detection system to be tested can use the new batch number of test reagent to test the marker, obtaining the new batch number test result data; the old batch number test result data obtained by using the old batch number of test reagent by the marker detection system to be tested can be directly retrieved; thus, the difference operation can be performed on the new batch number test result data and the old batch number test result data to obtain the reagent batch-to-batch difference data. Based on the same processing method, the corresponding reagent batch-to-batch difference data of multiple standard specimens to be tested can be obtained.

[0057] In the actual application process, the inspection personnel continuously measure specific components in stable samples at a certain frequency, and use a series of methods to analyze the continuously measured data, and infer and evaluate the reliability of the measurement results of this batch according to statistical laws, so as to judge whether the inspection report can be issued, and timely discover and eliminate unsatisfactory factors in the quality link. This process can be called the in-house quality control test. Usually, quality control products provided by a third party (quality control products are reference substances for quality control and quality assurance, mainly used to verify the performance of analytical instruments, evaluate measurement precision and accuracy, to ensure the accuracy and reliability of experimental results) are used to complete the in-house quality control test, and these quality control products are the quality control specimens. For each quality control specimen, the marker detection system to be tested can use a certain test reagent to test the marker, obtaining the in-house quality control data. Based on the same processing method, the corresponding in-house quality control data of multiple quality control specimens can be obtained.

[0058] It should be particularly noted that quality control products are usually divided into positive quality control products and negative quality control products. The quality control specimens in this embodiment can be positive quality control products or negative quality control products, but if positive quality control products are used, then for different marker detection systems to be tested, positive quality control products are all used; if negative quality control products are used, then for different marker detection systems to be tested, negative quality control products are all used.

[0059] In this embodiment, any biomarker detection system that needs to evaluate its biomarker detection performance can be used as the biomarker detection system to be tested. The reagent batch - to - batch difference data and in - house quality control data corresponding to the biomarker detection system to be tested can be pre - stored in a specified target storage space. When it is necessary to evaluate the biomarker detection performance of a certain biomarker detection system to be tested, multiple reagent batch - to - batch difference data and multiple in - house quality control data corresponding to the biomarker detection system to be tested can be retrieved from the storage target storage space.

[0060] S120. Based on the reagent batch - to - batch difference data of multiple standard specimens to be tested, perform a reagent stability performance evaluation process on the biomarker detection system to be tested, and obtain a first evaluation attribute corresponding to the biomarker detection system to be tested.

[0061] Among them, the first evaluation attribute is a quantitative attribute value used to characterize the stability of the reagent of the biomarker detection system to be tested. For example, the higher the quantitative value of the first evaluation attribute, the better the stability of the reagent of the biomarker detection system to be tested; the lower the quantitative value of the first evaluation attribute, the worse the stability of the reagent of the biomarker detection system to be tested.

[0062] In this embodiment, for the multiple reagent batch - to - batch difference data corresponding to multiple standard specimens to be tested, the process of performing a reagent stability performance evaluation process on the biomarker detection system to be tested can be achieved by analyzing the distribution of these data. Specifically, a normal distribution analysis can be performed on these reagent batch - to - batch difference data. If the distribution of these reagent batch - to - batch difference data is more in line with the normal distribution, the higher the quantitative value of the first evaluation attribute corresponding to the biomarker detection system to be tested; if the distribution of these reagent batch - to - batch difference data is less in line with the normal distribution, the lower the quantitative value of the first evaluation attribute corresponding to the biomarker detection system to be tested.

[0063] S130. Based on the in - house quality control data corresponding to multiple quality control specimens, perform an accuracy performance evaluation process on the biomarker detection system to be tested, and obtain a second evaluation attribute corresponding to the biomarker detection system to be tested.

[0064] Among them, the second evaluation attribute is a quantitative attribute value used to characterize the instrument precision and accuracy of the biomarker detection system to be tested. For example, the higher the quantitative value of the second evaluation attribute, the better the instrument precision and accuracy of the biomarker detection system to be tested; the lower the quantitative value of the second evaluation attribute, the worse the instrument precision and accuracy of the biomarker detection system to be tested.

[0065] In this embodiment, for multiple sets of in - house quality control data corresponding to multiple standard specimens to be tested, quality target indices can be calculated for these data, and the process of evaluating the accuracy performance of the biomarker detection system can be achieved through the quality target indices. Specifically, multiple sets of in - house quality control data can be processed through a preset quality target index formula to obtain the quality target index. The larger the value of the quality target index, the higher the quantified value of the second evaluation attribute corresponding to the biomarker detection system; the smaller the value of the quality target index, the lower the quantified value of the second evaluation attribute corresponding to the biomarker detection system.

[0066] It should be particularly noted that there is no necessary sequence between S120 and S130 in this embodiment. S120 can be executed first and then S130; S130 can be executed first and then S120; or S120 and S130 can be executed simultaneously.

[0067] S140. Based on the first evaluation attribute and the second evaluation attribute, determine the target performance attribute result corresponding to the biomarker detection system.

[0068] Among them, the target performance attribute result is a quantified attribute value used to characterize the comprehensive performance of the biomarker detection system.

[0069] In this embodiment, the target performance attribute result corresponding to the biomarker detection system can be determined according to the comprehensive quantified value based on the first evaluation attribute and the second evaluation attribute.

[0070] Optionally, the specific implementation method for determining the target performance attribute result corresponding to the biomarker detection system based on the first evaluation attribute and the second evaluation attribute includes: determining the target performance attribute result corresponding to the biomarker detection system based on a preset precision weight, a preset reagent stability weight, the first evaluation attribute, and the second evaluation attribute.

[0071] Among them, both the preset precision weight and the preset reagent stability weight are preset weight values. For example, the preset precision weight can be represented as W1, and the preset reagent stability weight can be represented as W2. It should be particularly noted that the values of the preset precision weight and the preset reagent stability weight are not specifically limited and can be adjusted according to the actual scenario.

[0072] In this embodiment, on the basis of obtaining the quantified values of the first evaluation attribute and the second evaluation attribute, the weighted sum of the quantified value of the first evaluation attribute and the quantified value of the second evaluation attribute can be calculated according to the preset precision weight and the preset reagent stability weight, and the final weighted sum result can be determined as the target performance attribute result corresponding to the biomarker detection system.

[0073] Based on the above embodiments, if it is necessary to compare the performance of multiple different marker detection systems, the steps of S110-S140 can be used to perform performance evaluation processing on each marker detection system to obtain the target performance attribute results corresponding to each marker detection system. In this way, by calculating the target performance attribute results, different marker detection systems become comparable. Therefore, according to the magnitude values of the target performance attribute results corresponding to each marker detection system, the performance of each marker detection system is sorted and compared.

[0074] It should be noted that in the technical solution of the present application, the acquisition, storage, use, processing, etc. of data all comply with the relevant regulations of national laws and regulations. For example, intercept and process network requests with the authorization of the user.

[0075] The technical solution of the embodiment of the present invention obtains the reagent batch-to-batch difference data output by the marker detection system to be tested for reagent batch number verification tests on multiple standard specimens to be tested, and the in-house quality control data output by in-house quality control tests on multiple quality control specimens; furthermore, based on the reagent batch-to-batch difference data of multiple standard specimens to be tested, the reagent stability performance of the marker detection system to be tested is evaluated and processed to obtain the first evaluation attribute corresponding to the marker detection system to be tested, and based on the in-house quality control data corresponding to multiple quality control specimens, the precision performance of the marker detection system to be tested is evaluated and processed to obtain the second evaluation attribute corresponding to the marker detection system to be tested. Thus, based on the first evaluation attribute and the second evaluation attribute, the target performance attribute result corresponding to the marker detection system to be tested is determined. The technical solution of this embodiment provides an effective method for objectively quantifying and evaluating the detection performance of a marker detection system, making the detection performances of different marker detection system platforms and the same marker detection system platform at different times comparable, and improving the universality of the detection reports output by the marker detection system.

[0076] Embodiment 2

[0077] Figure 2 It is a schematic diagram of a method for evaluating the performance of a marker detection system provided by an embodiment of the present invention. Based on the foregoing embodiments, S120-S130 are described in detail, and the specific implementation manner can refer to the technical solution of this embodiment. Among them, the same or corresponding technical terms as those in the above embodiments will not be elaborated here.

[0078] As Figure 2 shown, the method specifically includes the following steps:

[0079] S210. Obtain the reagent batch-to-batch difference data output by the marker detection system to be tested for reagent batch number verification tests on multiple standard specimens to be tested, and the in-house quality control data output by in-house quality control tests on multiple quality control specimens.

[0080] S220. Preprocess multiple reagent batch - to - batch difference data based on a preset preprocessing method to obtain multiple reagent batch - to - batch difference data to be applied.

[0081] Among them, the preset preprocessing method is a data preprocessing method set in advance. For example, the preset preprocessing method may include, but is not limited to, the following four preprocessing methods: standardization preprocessing method, normalization preprocessing method, principal component analysis preprocessing method, feature selection preprocessing method, etc. Among them, the principle of the standardization preprocessing method is: to make the data have zero mean and unit variance; the principle of the normalization preprocessing method is: to scale all data to a specific range; the principle of the principal component analysis preprocessing method is: to project high - dimensional data into a low - dimensional space; the principle of the feature selection preprocessing method is: to select the most representative part of the features from a high - dimensional data set. The reagent batch - to - batch difference data to be applied refers to the data content obtained after preprocessing multiple original reagent batch - to - batch difference data through the preset preprocessing method.

[0082] In this embodiment, at least one preset preprocessing method can be integrated into a data preprocessing tool. Based on the obtained multiple original reagent batch - to - batch difference data, these original reagent batch - to - batch difference data can be input into the data preprocessing tool. After the data preprocessing tool processes the multiple original reagent batch - to - batch difference data according to the integrated preprocessing method, multiple reagent batch - to - batch difference data to be applied are obtained.

[0083] Based on the above - mentioned embodiment, optionally, the preset preprocessing method is the standardization preprocessing method. The specific implementation method of preprocessing multiple reagent batch - to - batch difference data based on the preset preprocessing method to obtain multiple reagent batch - to - batch difference data to be applied may include: determining the standard value and mean value of the multiple reagent batch - to - batch difference data; for the multiple reagent batch - to - batch difference data, respectively perform standardization preprocessing on each reagent batch - to - batch difference data based on the standard value and mean value to obtain the reagent batch - to - batch difference data to be applied corresponding to each reagent batch - to - batch difference data.

[0084] In this embodiment, standard deviation operation and mean operation can be performed on multiple reagent batch - to - batch difference data to obtain the standard value and mean value of all reagent batch - to - batch difference data. Furthermore, for each data in the multiple reagent batch - to - batch difference data, respectively perform standardization preprocessing on each reagent batch - to - batch difference data according to the standard value and mean value, so as to obtain the reagent batch - to - batch difference data to be applied corresponding to each reagent batch - to - batch difference data.

[0085] S230. Determine the normal distribution compliance attribute of multiple reagent batch - to - batch difference data to be applied.

[0086] Among them, the normal distribution compliance attribute is used to characterize the degree to which the distribution of the batch - to - batch differences of multiple reagents to be applied conforms to the normal distribution. For example, the larger the quantization value of the normal distribution compliance attribute, the higher the degree to which the batch - to - batch differences of multiple reagents to be applied conform to the normal distribution; the smaller the quantization value of the normal distribution compliance attribute, the lower the degree to which the batch - to - batch differences of multiple reagents to be applied conform to the normal distribution.

[0087] In this embodiment, the normal distribution verification of the batch - to - batch differences of multiple reagents to be applied can be carried out by means such as the graphical judgment method, the numerical method, and the statistical test method, so as to determine the normal distribution compliance attribute of the batch - to - batch differences of multiple reagents to be applied.

[0088] Based on the above - mentioned embodiment, optionally, the specific implementation methods for determining the normal distribution compliance attribute of the batch - to - batch differences of multiple reagents to be applied can at least include the following two methods:

[0089] The first one is: based on the mean and standard deviation of the batch - to - batch differences of multiple reagents to be applied, determine the kurtosis value and the skewness value; based on the kurtosis value and the skewness value, determine the normal distribution compliance attribute of the batch - to - batch differences of multiple reagents to be applied.

[0090] Among them, the kurtosis value is used to describe the sharpness of the data distribution. The kurtosis of the normal distribution should be 3. If the kurtosis of the data is close to 3, then the data may follow the normal distribution. The skewness value is used to describe the symmetry of the data distribution. The skewness of the normal distribution should be 0. If the skewness of the data is close to 0, then the data may follow the normal distribution.

[0091] In this embodiment, the calculation formula of the kurtosis value can be expressed as:

[0092]

[0093] The calculation formula of the skewness value can be expressed as:

[0094]

[0095] In the formula, n represents the total number of the batch - to - batch differences of multiple reagents to be applied, x i represents the i - th batch - to - batch difference data of the reagents to be applied, and x represents the mean of the batch - to - batch differences of multiple reagents to be applied.

[0096] In this embodiment, the batch - to - batch differences of multiple reagents to be applied can be calculated according to formula (1) and formula (2) to obtain the kurtosis value and the skewness value; furthermore, according to the absolute value of the difference between the kurtosis value and 3, determine the first normal distribution compliance attribute value; according to the absolute value of the difference between the skewness value and 0, determine the second normal distribution compliance attribute value; finally, according to the first normal distribution compliance attribute value and the second normal distribution compliance attribute value, determine the normal distribution compliance attribute of the batch - to - batch differences of multiple reagents to be applied.

[0097] The second method is: constructing a reagent batch - to - batch difference histogram corresponding to multiple reagent batch - to - batch difference data to be applied; fitting a probability density distribution curve based on the reagent batch - to - batch difference histogram; and determining the normal distribution compliance attribute of the multiple reagent batch - to - batch difference data to be applied based on the similarity between the probability density distribution curve and a preset standard normal distribution curve.

[0098] Among them, the reagent batch - to - batch difference histogram is a histogram drawn based on multiple reagent batch - to - batch difference data to be applied. The preset standard normal distribution curve is a pre - set standard normal distribution curve.

[0099] In this embodiment, a histogram drawing tool can be used to draw a reagent batch - to - batch difference histogram corresponding to multiple reagent batch - to - batch difference data to be applied. Furthermore, the reagent batch - to - batch difference histogram is subjected to a fitting process according to a preset fitting algorithm to obtain a probability density distribution curve. Exemplarily, a schematic diagram of the probability density distribution curve is shown in Figure 3 , such as Figure 3 shown, Figure 3 which includes probability density distribution curves corresponding to two different detection systems for the markers to be measured. Further, the similarity between the probability density distribution curve and the preset standard normal distribution curve can be calculated. For example, the similarity between the two curves can be calculated by means of Euclidean distance, Hausdorff distance, Fréchet distance, etc.; and the normal distribution compliance attribute of the multiple reagent batch - to - batch difference data to be applied is determined according to the similarity and the first mapping relationship between the preset similarity and the degree of normal distribution compliance.

[0100] S240: Based on the normal distribution compliance attribute, evaluate the reagent stability of the detection system for the markers to be measured, and determine the reagent stability evaluation attribute value corresponding to the detection system for the markers to be measured.

[0101] In this embodiment, the quantified value of the normal distribution compliance attribute can be determined as the reagent stability evaluation attribute value corresponding to the detection system for the markers to be measured.

[0102] S250: Based on the in - house quality control data corresponding to multiple quality control specimens, determine the specimen observation offset and the coefficient of variation.

[0103] Among them, the specimen observation offset refers to the cumulative amount of the offset values between each in - house quality control data and the corresponding standard reference value (the standard reference value is a fixed value corresponding to a certain quality control product and is a directly obtainable quantity). The coefficient of variation refers to the quotient of the standard deviation and the mean of multiple in - house quality control data.

[0104] In this embodiment, for each internal quality control data, the difference between the current internal quality control data and the corresponding standard reference value is calculated, and the differences corresponding to all the internal quality control data are summed up to obtain the specimen observation offset. Standard deviation calculation and mean calculation can be performed on the internal quality control data corresponding to multiple quality control specimens to obtain the standard value and mean value of all the internal quality control data; furthermore, a division operation is performed on the standard value and the mean value to obtain the coefficient of variation.

[0105] S260. Determine the quality target index based on the specimen observation offset and the coefficient of variation.

[0106] Among them, the quality target index (Quality Objective Index, abbreviated as QGI) is an index used to evaluate the performance of a test item and can also be used to determine the main reasons for quality defects in test results.

[0107] In this embodiment, the calculation formula of the quality target index can be expressed as:

[0108]

[0109] In the formula, QGI represents the quality target index, Bias represents the specimen observation offset, and CV represents the coefficient of variation.

[0110] In this embodiment, after obtaining the specimen observation offset and the coefficient of variation, they can be substituted into formula (3) for calculation to obtain the quality target index.

[0111] Based on the above embodiment, the quality target index QGI can also be used to characterize the defects existing in the test marker detection system. Specifically, if QGI < 0.8, it indicates that the precision of the test marker detection system is poor; if QGI > 1.2, it indicates that the accuracy of the test marker detection system is poor; when QGI is between 0.8 and 1.2, it indicates that both the accuracy and precision of the test marker detection system need to be improved.

[0112] S270. Perform precision performance evaluation on the test marker detection system based on the quality target index, and determine the precision evaluation attribute value corresponding to the test marker detection system.

[0113] In this embodiment, a target mapping relationship between the quality target index and the precision evaluation attribute value can be established in advance. After obtaining the quality target index, the precision evaluation attribute value corresponding to the test marker detection system can be determined according to the quality target index and the target mapping relationship.

[0114] S280. Determine the target performance attribute result corresponding to the test marker detection system based on the first evaluation attribute and the second evaluation attribute.

[0115] In the technical solution of the embodiment of the present invention, when performing reagent stability performance evaluation processing on the to-be-tested marker detection system to obtain the first evaluation attribute corresponding to the to-be-tested marker detection system, first, preprocess a plurality of reagent batch-to-batch difference data based on a preset preprocessing method to obtain a plurality of to-be-applied reagent batch-to-batch difference data. Then, determine the normal distribution compliance attribute of the plurality of to-be-applied reagent batch-to-batch difference data. Thus, based on the normal distribution compliance attribute, perform reagent stability performance evaluation on the to-be-tested marker detection system to determine the reagent stability evaluation attribute value corresponding to the to-be-tested marker detection system. By determining the normal distribution compliance attribute of the to-be-applied reagent batch-to-batch difference data and performing reagent stability performance evaluation on the to-be-tested marker detection system, a quantitative index representing the reagent stability performance of the detection system is provided, and the reagent stability evaluation attribute value corresponding to the to-be-tested marker detection system can be obtained through a simple calculation process. When performing precision performance evaluation processing on the to-be-tested marker detection system to obtain the second evaluation attribute corresponding to the to-be-tested marker detection system, first, determine the specimen observation offset and the coefficient of variation based on the in-house quality control data corresponding to a plurality of quality control specimens. Then, determine the quality target index based on the specimen observation offset and the coefficient of variation. Thus, based on the quality target index, perform precision performance evaluation on the to-be-tested marker detection system to determine the precision evaluation attribute value corresponding to the to-be-tested marker detection system. By determining the quality target index of the in-house quality control data and performing precision performance evaluation on the to-be-tested marker detection system, a quantitative index representing the precision performance is provided, and the precision evaluation attribute value can be determined quickly and efficiently.

[0116] Embodiment III

[0117] Figure 4 FIG. 7 is a schematic structural diagram of a performance evaluation device for a marker detection system provided by an embodiment of the present invention. The device includes: a data acquisition module 310, a first attribute determination module 320, a second attribute determination module 330, and a target result determination module 340.

[0118] Among them, the data acquisition module 310 is configured to acquire the reagent batch-to-batch difference data output by the to-be-tested marker detection system for performing reagent lot number verification tests on a plurality of standard to-be-tested specimens, and the in-house quality control data output by performing in-house quality control tests on a plurality of quality control specimens;

[0119] The first attribute determination module 320 is configured to perform reagent stability performance evaluation processing on the to-be-tested marker detection system based on the reagent batch-to-batch difference data of the plurality of standard to-be-tested specimens to obtain the first evaluation attribute corresponding to the to-be-tested marker detection system;

[0120] The second attribute determination module 330 is configured to perform precision performance evaluation processing on the to-be-tested marker detection system based on the in-house quality control data corresponding to the plurality of quality control specimens to obtain the second evaluation attribute corresponding to the to-be-tested marker detection system;

[0121] A target result determination module 340, configured to determine a target performance attribute result corresponding to the to-be-detected marker detection system based on the first evaluation attribute and the second evaluation attribute.

[0122] Based on the above device, optionally, the first evaluation attribute is a reagent stability evaluation attribute value, and the first attribute determination module 320 includes:

[0123] A to-be-applied data determination unit, configured to preprocess the multiple reagent batch-to-batch difference data based on a preset preprocessing method to obtain multiple to-be-applied reagent batch-to-batch difference data;

[0124] A data distribution determination unit, configured to determine the normal distribution compliance attribute of the multiple to-be-applied reagent batch-to-batch difference data;

[0125] An evaluation attribute value determination unit, configured to perform reagent stability performance evaluation on the to-be-detected marker detection system based on the normal distribution compliance attribute, and determine the reagent stability evaluation attribute value corresponding to the to-be-detected marker detection system.

[0126] Based on the above device, optionally, the preset preprocessing method is a standardization preprocessing method, and the to-be-applied data determination unit is specifically configured to determine the standard value and the mean value of the multiple reagent batch-to-batch difference data; for the multiple reagent batch-to-batch difference data, perform standardization preprocessing on each reagent batch-to-batch difference data respectively based on the standard value and the mean value to obtain the to-be-applied reagent batch-to-batch difference data corresponding to each reagent batch-to-batch difference data.

[0127] Based on the above device, optionally, the data distribution determination unit is specifically configured to determine the kurtosis value and the skewness value based on the multiple to-be-applied reagent batch-to-batch difference data; and determine the normal distribution compliance attribute of the multiple to-be-applied reagent batch-to-batch difference data based on the kurtosis value and the skewness value.

[0128] Based on the above device, optionally, the data distribution determination unit is specifically further configured to construct a reagent batch-to-batch difference value histogram corresponding to the multiple to-be-applied reagent batch-to-batch difference data; fit a probability density distribution curve based on the reagent batch-to-batch difference value histogram; and determine the normal distribution compliance attribute of the multiple to-be-applied reagent batch-to-batch difference data based on the similarity between the probability density distribution curve and a preset standard normal distribution curve.

[0129] Based on the above device, optionally, the second evaluation attribute is a precision evaluation attribute value, and the second attribute determination module 330 includes:

[0130] A data calculation unit, configured to determine a specimen observation offset and a coefficient of variation based on the in-house quality control data corresponding to the multiple quality control specimens;

[0131] A quality target index determination unit, configured to determine a quality target index based on the specimen observation offset and the coefficient of variation;

[0132] A second attribute determination unit, configured to perform an accuracy performance evaluation on the marker detection system to be tested based on the quality target index, and determine an accuracy evaluation attribute value corresponding to the marker detection system to be tested.

[0133] Based on the above device, optionally, a target result determination module is specifically configured to determine a target performance attribute result corresponding to the marker detection system to be tested based on a preset accuracy weight, a preset reagent stability weight, the first evaluation attribute, and the second evaluation attribute.

[0134] The technical solution of the embodiment of the present invention obtains reagent batch - to - batch difference data output by a reagent lot verification test of a marker detection system to be tested on multiple standard specimens to be tested, and in - house quality control data output by an in - house quality control test on multiple quality control specimens; furthermore, based on the reagent batch - to - batch difference data of multiple standard specimens to be tested, a reagent stability performance evaluation process is performed on the marker detection system to be tested to obtain a first evaluation attribute corresponding to the marker detection system to be tested, and based on the in - house quality control data corresponding to multiple quality control specimens, an accuracy performance evaluation process is performed on the marker detection system to be tested to obtain a second evaluation attribute corresponding to the marker detection system to be tested. Thus, based on the first evaluation attribute and the second evaluation attribute, a target performance attribute result corresponding to the marker detection system to be tested is determined. The technical solution of this embodiment provides an effective method for objectively quantifying the detection performance of a marker detection system, making the detection performances of different marker detection system platforms and the same marker detection system platform at different times comparable, and improving the universality of the detection reports output by the marker detection system.

[0135] The performance evaluation device of the marker detection system provided by the embodiment of the present invention can execute the performance evaluation method of the marker detection system provided by any embodiment of the present invention, and has corresponding functional modules and beneficial effects for executing the method.

[0136] It should be noted that the various units and modules included in the above - mentioned system are only divided according to functional logic, but are not limited to the above division, as long as the corresponding functions can be realized; in addition, the specific names of the functional units are only for the convenience of mutual distinction and do not limit the protection scope of the embodiments of the present invention.

[0137] Embodiment 4

[0138] Figure 5 It is a schematic structural diagram of an electronic device provided by an embodiment of the present invention. Figure 5A block diagram of an exemplary electronic device 40 suitable for implementing the embodiments of the present invention is shown. Figure 5 The displayed electronic device 40 is only an example and should not impose any limitations on the functions and usage scope of the embodiments of the present invention.

[0139] As Figure 5 shown, the electronic device 40 is presented in the form of a general-purpose computing device. The components of the electronic device 40 may include, but are not limited to: one or more processors or processing units 401, a system memory 402, and a bus 403 connecting different system components (including the system memory 402 and the processing unit 401).

[0140] The bus 403 represents one or more of several types of bus structures, including a memory bus or a memory controller, a peripheral bus, a graphics acceleration port, a processor, or a local bus using any of the various bus structures. For example, these architectures include, but are not limited to, Industry Standard Architecture (ISA) bus, Micro Channel Architecture (MAC) bus, Enhanced ISA bus, Video Electronics Standards Association (VESA) local bus, and Peripheral Component Interconnect (PCI) bus.

[0141] The electronic device 40 typically includes a variety of computer system-readable media. These media can be any available media accessible by the electronic device 40, including volatile and non-volatile media, removable and non-removable media.

[0142] The system memory 402 may include computer system-readable media in the form of volatile memory, such as random access memory (RAM) 404 and / or cache memory 405. The electronic device 40 may further include other removable / non-removable, volatile / non-volatile computer system storage media. By way of example only, a storage system 406 can be used to read and write non-removable, non-volatile magnetic media ( Figure 5 not shown, commonly referred to as a "hard disk drive"). Although Figure 5 not shown in the figure, a disk drive for reading and writing removable non-volatile disks (such as "floppy disks") and an optical disk drive for reading and writing removable non-volatile optical disks (such as CD-ROM, DVD-ROM, or other optical media) can be provided. In these cases, each drive can be connected to the bus 403 through one or more data media interfaces. The memory 402 may include at least one program product having a set (e.g., at least one) of program modules configured to perform the functions of the embodiments of the present invention.

[0143] A program / utilities 404 having a set (at least one) of program modules 407 can be stored, for example, in a memory 402. Such program modules 407 include, but are not limited to, an operating system, one or more application programs, other program modules, and program data. Each or some combination of these examples may include an implementation of a network environment. The program modules 407 generally perform the functions and / or methods in the embodiments described in the present invention.

[0144] The electronic device 40 can also communicate with one or more external devices 409 (such as a keyboard, a pointing device, a display 410, etc.), and can also communicate with one or more devices that enable a user to interact with the electronic device 40, and / or communicate with any device that enables the electronic device 40 to communicate with one or more other computing devices (such as a network card, a modem, etc.). Such communication can be carried out through an input / output (I / O) interface 411. Moreover, the electronic device 40 can also communicate with one or more networks (such as a local area network (LAN), a wide area network (WAN), and / or a public network, such as the Internet) through a network adapter 412. As shown in the figure, the network adapter 412 communicates with other modules of the electronic device 40 through a bus 403. It should be understood that although Figure 5 not shown in the figure, other hardware and / or software modules can be used in combination with the electronic device 40, including but not limited to: microcode, device drivers, redundant processing units, external disk drive arrays, RAID systems, tape drives, and data backup storage systems, etc.

[0145] The processing unit 401 executes various functional applications and page processing by running programs stored in the system memory 402, such as implementing the performance evaluation method of the marker detection system provided by the embodiments of the present invention.

[0146] Embodiment 5

[0147] The embodiments of the present invention also provide a storage medium containing computer-executable instructions, and the computer-executable instructions are used to execute a performance evaluation method of a marker detection system when executed by a computer processor. The method includes:

[0148] Obtaining reagent batch-to-batch difference data output by a reagent lot verification test of a to-be-tested marker detection system for a plurality of standard to-be-tested specimens, and in-house quality control data output by an in-house quality control test for a plurality of quality control specimens;

[0149] Based on the reagent batch-to-batch difference data of the plurality of standard to-be-tested specimens, performing a reagent stability performance evaluation process on the to-be-tested marker detection system to obtain a first evaluation attribute corresponding to the to-be-tested marker detection system;

[0150] Based on the in - house quality control data corresponding to the multiple quality control specimens, perform precision performance evaluation processing on the detection system of the biomarker to be measured, and obtain a second evaluation attribute corresponding to the detection system of the biomarker to be measured;

[0151] Based on the first evaluation attribute and the second evaluation attribute, determine a target performance attribute result corresponding to the detection system of the biomarker to be measured.

[0152] The computer storage medium of the embodiments of the present invention can adopt any combination of one or more computer - readable media. The computer - readable medium can be a computer - readable signal medium or a computer - readable storage medium. The computer - readable storage medium can be, for example, but not limited to, an electrical, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device, or any combination of the above. More specific examples (non - exhaustive list) of the computer - readable storage medium include: an electrical connection having one or more wires, a portable computer disk, a hard disk, a random access memory (RAM), a read - only memory (ROM), an erasable programmable read - only memory (EPROM or flash memory), an optical fiber, a portable compact disk read - only memory (CD - ROM), an optical storage device, a magnetic storage device, or any suitable combination of the above. In this document, the computer - readable storage medium can be any tangible medium that contains or stores a program, and this program can be used by or in combination with an instruction execution system, apparatus, or device.

[0153] The computer - readable signal medium can include a data signal propagated in a baseband or as part of a carrier wave, which carries computer - readable program code. Such a propagated data signal can take various forms, including but not limited to electromagnetic signals, optical signals, or any suitable combination of the above. The computer - readable signal medium can also be any computer - readable medium other than the computer - readable storage medium, and this computer - readable medium can send, propagate, or transmit a program for use by or in combination with an instruction execution system, apparatus, or device.

[0154] The program code contained on the computer - readable medium can be transmitted by any appropriate medium, including - - but not limited to - - wireless, wire, optical cable, RF, etc., or any suitable combination of the above.

[0155] Computer program code for performing the operations of the embodiments of the present invention may be written in one or more programming languages or combinations thereof. The programming languages include object-oriented programming languages such as Java, Smalltalk, C++, and also include conventional procedural programming languages such as the "C" language or similar programming languages. The program code may be executed entirely on the user's computer, partially on the user's computer, executed as a stand-alone software package, partially on the user's computer and partially on a remote computer, or entirely on a remote computer or server. In the case of a remote computer, the remote computer may be connected to the user's computer through any type of network including a local area network (LAN) or a wide area network (WAN), or may be connected to an external computer (e.g., connected through the Internet using an Internet service provider).

[0156] Note that the above is only the preferred embodiment of the present invention and the applied technical principles. Those skilled in the art will understand that the present invention is not limited to the specific embodiments here. Various obvious changes, re-adjustments, and substitutions can be made by those skilled in the art without departing from the protection scope of the present invention. Therefore, although the present invention has been described in more detail through the above embodiments, the present invention is not limited to the above embodiments. Without departing from the concept of the present invention, more other equivalent embodiments may be included, and the scope of the present invention is determined by the scope of the appended claims.

Claims

1. A performance evaluation method for a marker detection system, characterized in that: include: Obtaining reagent batch difference data output by the marker detection system for multiple standard test specimens through reagent batch verification tests, and indoor quality control data output by indoor quality control tests on multiple quality control specimens; Based on the reagent batch difference data of the plurality of standard test specimens, performing reagent stability performance evaluation processing on the test marker detection system to obtain a first evaluation attribute corresponding to the test marker detection system; Based on the indoor quality control data corresponding to the multiple quality control samples, the accuracy performance evaluation process is performed on the detection system of the marker to be tested to obtain a second evaluation attribute corresponding to the detection system of the marker to be tested; Based on the first evaluation attribute and the second evaluation attribute, a target performance attribute result corresponding to the marker detection system is determined.

2. The method according to claim 1, characterized in that The first evaluation attribute is a reagent stability evaluation attribute value, and the reagent stability performance evaluation processing is performed on the marker detection system to be tested based on the reagent batch difference data of the plurality of standard test specimens to obtain the first evaluation attribute corresponding to the marker detection system to be tested, including: Preprocessing the plurality of reagent batch difference data based on a preset preprocessing method to obtain a plurality of reagent batch difference data to be used; Determining that the normal distribution of the batch difference data of the plurality of reagents to be used conforms to the attribute; Based on the normal distribution conformity attribute, the reagent stability performance of the detection system of the marker to be detected is evaluated to determine the reagent stability evaluation attribute value corresponding to the detection system of the marker to be detected.

3. The method according to claim 2, characterized in that The preset preprocessing method is a standardized preprocessing method, and the preprocessing of the plurality of reagent batch difference data based on the preset preprocessing method to obtain a plurality of reagent batch difference data to be applied includes: Determine the standard value and mean value of the plurality of reagent batch difference data; For the plurality of reagent batch difference data, standardization preprocessing is performed on each of the reagent batch difference data based on the standard value and the mean value to obtain the reagent batch difference data to be used corresponding to each of the reagent batch difference data.

4. The method according to claim 3, characterized in that The determining that the normal distribution of the plurality of inter-batch difference data of the reagents to be used conforms to the property comprises: Determine the kurtosis value and the skewness value based on the batch difference data of multiple reagents to be used; Based on the kurtosis value and the skewness value, it is determined whether the normal distribution conforms to the attributes of the multiple inter-batch difference data of the reagents to be used.

5. The method according to claim 3, characterized in that: The determining that the normal distribution of the plurality of inter-batch difference data of the reagents to be used conforms to the property comprises: Constructing a reagent batch difference histogram corresponding to multiple reagent batch difference data to be used; Fitting a probability density distribution curve based on the reagent batch difference histogram; Based on the similarity between the probability density distribution curve and a preset standard normal distribution curve, it is determined that the normal distribution of the plurality of inter-batch difference data of the reagents to be used conforms to the attribute.

6. The method according to claim 1, characterized in that The second evaluation attribute is an accuracy evaluation attribute value, and the accuracy performance evaluation processing is performed on the detection system of the marker to be tested based on the indoor quality control data corresponding to the multiple quality control samples to obtain the second evaluation attribute corresponding to the detection system of the marker to be tested, including: Determining the sample observation offset and coefficient of variation based on the indoor quality control data corresponding to the multiple quality control samples; Determining a quality target index based on the sample observation offset and the coefficient of variation; Based on the quality target index, the accuracy performance of the marker detection system is evaluated to determine the accuracy evaluation attribute value corresponding to the marker detection system.

7. The method according to claim 1, characterized in that The determining, based on the first evaluation attribute and the second evaluation attribute, a target performance attribute result corresponding to the marker detection system to be tested comprises: Based on the preset accuracy weight, the preset reagent stability weight, the first evaluation attribute, and the second evaluation attribute, a target performance attribute result corresponding to the marker detection system is determined.

8. A performance evaluation device for a marker detection system, characterized in that: include: The data acquisition module is used to acquire the reagent batch difference data output by the marker detection system for multiple standard test specimens through the reagent batch number verification test, and the indoor quality control data output by the indoor quality control test for multiple quality control specimens; A first attribute determination module is used to perform a reagent stability performance evaluation process on the marker detection system to be tested based on the reagent batch difference data of the multiple standard test specimens to obtain a first evaluation attribute corresponding to the marker detection system to be tested; A second attribute determination module is used to perform accuracy performance evaluation processing on the marker detection system to be tested based on the indoor quality control data corresponding to the multiple quality control samples, so as to obtain a second evaluation attribute corresponding to the marker detection system to be tested; A target result determination module is used to determine a target performance attribute result corresponding to the marker detection system based on the first evaluation attribute and the second evaluation attribute.

9. An electronic device, characterized in that: The electronic device comprises: one or more processors; A memory for storing one or more programs; when the one or more programs are executed by the one or more processors, the one or more processors implement the performance evaluation method of the marker detection system as described in any one of claims 1-7.

10. A computer-readable storage medium having a computer program stored thereon, characterized in that: When the program is executed by a processor, the performance evaluation method of the marker detection system as described in any one of claims 1 to 7 is implemented.

Images