A respiratory reagent quality inspection method, system and medium
By calculating the detection reliability, sensitivity, stability and specificity index, the detection accuracy of respiratory reagents is evaluated, and the problems of false positive and false negative results in the prior art are solved, and the accuracy and stability of the detection results are improved.
Patent Information
- Application Number
- CN202411306292.1
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2024-09-19
- Publication Date
- 2025-01-10
- Estimated Expiration
- 2044-09-19
AI Technical Summary
Existing respiratory reagent testing has problems with false positive and false negative results, and storage and transportation conditions affect the stability and accuracy of the test results.
By collecting characteristic information of respiratory reagents and standard sample data, the detection reliability, sensitivity, stability and specificity index are calculated, the detection accuracy is comprehensively evaluated, and the detection results are adjusted to improve the accuracy of the detection results.
It improves the accuracy and stability of respiratory reagent detection, reduces the occurrence of false positive and false negative results, and enhances the reliability of test results.
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Figure CN118818075B_ABST
Abstract
Description
Technical Field
[0001] The present application relates to the technical field of reagent quality inspection, and in particular, to a method, system and medium for quality inspection of respiratory reagents. Background Art
[0002] With the prevalence of viruses such as influenza and mycoplasma, respiratory reagent testing plays an increasingly important role in our lives, so the accuracy of the test results is crucial.
[0003] In actual use, due to the low specificity and sensitivity of some reagents, interference from other pathogens, improper sample collection and processing and other factors, some respiratory reagents may have false positive results, that is, they detect positive but are not actually infected; or false negative results, failing to detect actual infection. In addition, due to the influence of storage and transportation conditions, the performance of the reagents may decline, affecting the stability of the test results and the accuracy of visual interpretation.
[0004] In view of the above problems, effective technical solutions are urgently needed. Summary of the invention
[0005] The purpose of the present application is to provide a respiratory reagent quality inspection method, system and medium, which can process and obtain the detection reliability index, detection sensitivity index, detection stability index and detection specificity index of the respiratory reagent, and conduct comprehensive processing to evaluate the accuracy and obtain the detection accuracy index. The detection effect of the respiratory reagent is judged according to the detection accuracy index, thereby realizing the technology of respiratory reagent quality inspection.
[0006] The present application also provides a respiratory tract reagent quality inspection method, comprising the following steps:
[0007] Collect characteristic information of preset respiratory reagents, extract characteristic data of reagent raw materials, and process to obtain reagent detection capability evaluation data;
[0008] Acquire characteristic data of preset standard samples and detection environment characteristic data, process to obtain sample virus intensity index and detection environment interference factor, and process in combination with the reagent detection capability evaluation data to obtain target detection affinity data;
[0009] According to the sample virus intensity index of group n1 and the detection environment interference factor, combined with the corresponding reagent detection ability evaluation data and target detection affinity data, the detection reliability index is obtained;
[0010] Performing standard tests on the n2 group of standard samples containing target substances at different concentrations according to the respiratory reagent to obtain a test sensitivity index;
[0011] The standard samples are tested according to the respiratory reagent under n3 groups of different test environments to obtain a test stability index;
[0012] Interference detection was performed based on the same standard samples in group n4 to obtain the detection specificity index;
[0013] According to the detection reliability index, the detection sensitivity index and the detection stability index, in combination with the detection specificity index, an accuracy assessment is performed to obtain a detection accuracy index;
[0014] A threshold comparison is performed based on the detection accuracy index and a preset accuracy threshold, and whether the detection result of the respiratory reagent is accurate is determined based on the comparison result, and corresponding adjustments are made.
[0015] Optionally, in the respiratory reagent quality inspection method described in the present application, the collecting of characteristic information of the preset respiratory reagent, extracting characteristic data of the reagent raw material, and processing to obtain reagent detection capability evaluation data include:
[0016] Collect characteristic information of preset respiratory reagents, including primer information, enzyme activity information, antibody information, buffer information, nucleotide information and colorimetric information, and generate a cognitive map of reagent characteristics;
[0017] Extracting reagent raw material characteristic data according to the reagent characteristic cognitive map, including primer complementarity data, enzyme activity data, antibody specificity data, buffer stability data, nucleotide concentration data, and color developer sensitivity data;
[0018] The primer complementarity data, enzyme activity data, antibody specificity data, buffer stability data, nucleotide concentration data and developer sensitivity data are processed to obtain reagent detection ability evaluation data.
[0019] Optionally, in the respiratory reagent quality inspection method described in the present application, the characteristic data of the preset standard sample and the detection environment characteristic data are obtained, the sample virus intensity index and the detection environment interference factor are processed, and the target detection affinity data is obtained by combining the reagent detection ability evaluation data for processing, including:
[0020] Obtain characteristic data of preset standard samples, including viral load data and viral nucleic acid content data, and process them to obtain the sample virus intensity index;
[0021] Acquire the characteristic data of the testing environment, including temperature data, humidity data and air quality record data, and process them to obtain the interference factors of the testing environment;
[0022] The target detection affinity data is obtained by processing the sample virus intensity index and the detection environment interference factors in combination with the reagent detection ability evaluation data.
[0023] Optionally, in the respiratory reagent quality inspection method described in the present application, the sample virus intensity index and the detection environment interference factor of group n1 are processed in combination with the corresponding reagent detection capability evaluation data and the target detection affinity data to obtain the detection reliability index, including:
[0024] According to the sample virus intensity index of group n1 and the detection environment interference factor, the corresponding reagent detection ability evaluation data and the target detection affinity data are processed through a preset reagent detection evaluation model to obtain a detection reliability index;
[0025] The calculation formula of the detection reliability index is:
[0026] ;
[0027] in, To test the reliability index, They are The target detection affinity data, sample virus strength index, reagent detection capability evaluation data, and detection environment interference factors corresponding to the i-th group in the group detection, is the preset characteristic coefficient.
[0028] Optionally, in the respiratory tract reagent quality inspection method described in the present application, the step of performing standard inspection on n2 groups of standard samples containing target substances of different concentrations according to the respiratory tract reagent to obtain the detection sensitivity index includes:
[0029] Testing the standard samples of group n2 containing target substances at different concentrations according to the respiratory reagent, and obtaining corresponding test result data, including target substance concentration data and cycle threshold data;
[0030] Obtaining standard test result data corresponding to the standard samples of the target substances with different concentrations according to the preset respiratory reagent detection and monitoring platform database, including standard target substance concentration data and standard cycle threshold data;
[0031] The target concentration data and cycle threshold data corresponding to the n2 group detection are processed in combination with the standard target concentration data and the standard cycle threshold data to obtain a detection sensitivity index.
[0032] Optionally, in the respiratory reagent quality inspection method described in the present application, the standard samples are tested under n3 groups of different test environments according to the respiratory reagent to obtain the test stability index, including:
[0033] The standard samples are tested under n3 groups of different test environments according to the respiratory reagent, and the same test is repeated m times in each group of test environments, and the m groups of test results are processed to obtain the corresponding coefficient of variation;
[0034] Processing is performed according to the coefficient of variation corresponding to the n3 group to obtain a detection stability index;
[0035] The calculation formula of the detection stability index is:
[0036] ;
[0037] in, To test the stability index, for The coefficient of variation corresponding to the jth group of different test environments is, is the preset characteristic coefficient.
[0038] Optionally, in the respiratory tract reagent quality inspection method described in the present application, the interference detection is performed according to n4 groups of the same standard samples to obtain the detection specificity index, including:
[0039] Adding different concentrations of interfering substances similar to the target substance to the same standard samples in group n4, and performing tests according to the respiratory reagents, respectively, to obtain post-interference test result data corresponding to the test results, including post-interference target substance concentration data;
[0040] Processing the interfered target concentration data in combination with the standard target concentration data to obtain a detection specificity index;
[0041] The calculation formula of the detection specificity index is:
[0042] ;
[0043] in, To test the specificity index, for The kth corresponding target concentration data after interference in the group test results, is the standard target concentration data, is the preset characteristic coefficient.
[0044] Optionally, in the respiratory reagent quality inspection method described in the present application, the accuracy assessment is performed according to the detection reliability index, the detection sensitivity index and the detection stability index in combination with the detection specificity index to obtain the detection accuracy index, including:
[0045] According to the detection reliability index, the detection sensitivity index and the detection stability index, in combination with the detection specificity index, an accuracy assessment is performed through a preset reagent detection test model to obtain a detection accuracy index;
[0046] The calculation formula of the detection accuracy index is:
[0047] ;
[0048] in, is the detection accuracy index, They are detection accuracy index, detection sensitivity index, detection stability index, and detection specificity index. is the preset characteristic coefficient.
[0049] In a second aspect, the present application provides a respiratory reagent quality inspection system, the system comprising: a memory and a processor, the memory comprising a program of a respiratory reagent quality inspection method, and the program of the respiratory reagent quality inspection method is executed by the processor to implement the following steps:
[0050] Collect characteristic information of preset respiratory reagents, extract characteristic data of reagent raw materials, and process to obtain reagent detection capability evaluation data;
[0051] Acquire characteristic data of preset standard samples and detection environment characteristic data, process to obtain sample virus intensity index and detection environment interference factor, and process in combination with the reagent detection capability evaluation data to obtain target detection affinity data;
[0052] According to the sample virus intensity index of group n1 and the detection environment interference factor, combined with the corresponding reagent detection ability evaluation data and target detection affinity data, the detection reliability index is obtained;
[0053] Performing standard tests on the n2 group of standard samples containing target substances at different concentrations according to the respiratory reagent to obtain a test sensitivity index;
[0054] The standard samples are tested according to the respiratory reagent under n3 groups of different test environments to obtain a test stability index;
[0055] Interference detection was performed based on the same standard samples in group n4 to obtain the detection specificity index;
[0056] According to the detection reliability index, the detection sensitivity index and the detection stability index, in combination with the detection specificity index, an accuracy assessment is performed to obtain a detection accuracy index;
[0057] A threshold comparison is performed based on the detection accuracy index and a preset accuracy threshold, and whether the detection result of the respiratory reagent is accurate is determined based on the comparison result, and corresponding adjustments are made.
[0058] In a third aspect, the present application also provides a computer-readable storage medium, which stores a respiratory reagent quality inspection method program. When the respiratory reagent quality inspection method program is executed by a processor, the steps of the respiratory reagent quality inspection method as described in any one of the above items are implemented.
[0059] As can be seen from the above, the respiratory reagent quality inspection method, system and medium disclosed in the present invention collect the characteristic information of the preset respiratory reagent and generate the reagent characteristic cognitive map, then extract the reagent raw material characteristic data and process it to obtain the reagent detection ability evaluation data, obtain the characteristic data of the preset standard sample and the detection environment characteristic data, respectively process to obtain the sample virus intensity index and the detection environment interference factor, and process them in combination with the reagent detection ability evaluation data to obtain the target object detection affinity data, further process to obtain the detection reliability index, detect the n2 group of standard samples containing different concentrations of target substances according to the respiratory reagent, and process the detection result data in combination with the standard detection result data to obtain the detection sensitivity index according to the respiratory The respiratory reagent tests the standard samples under n3 different test environments, processes them according to the corresponding coefficient of variation, and obtains the test stability index. Different concentrations of interfering substances similar to the target substances are added to the same standard samples in n4 and tested. The test result data after interference are processed with the corresponding standard test result data to obtain the test specificity index. Finally, the accuracy is evaluated based on the test reliability index, test sensitivity index and test stability index combined with the test specificity index to obtain the test accuracy index. The threshold is compared with the preset accuracy threshold. According to the comparison results, it is judged whether the test results of the respiratory reagent are accurate, and corresponding adjustments are made, thereby realizing the technology of respiratory reagent quality inspection.
[0060] Other features and advantages of the present application will be described in the following description, and partly become apparent from the description, or understood by practicing the embodiments of the present application. The purpose and other advantages of the present application can be realized and obtained by the structures specifically pointed out in the written description and the drawings. BRIEF DESCRIPTION OF THE DRAWINGS
[0061] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings required for use in the embodiments of the present application will be briefly introduced below. It should be understood that the following drawings only show certain embodiments of the present application and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other related drawings can be obtained based on these drawings without paying creative work.
[0062] Figure 1 A flow chart of a respiratory tract reagent quality inspection method provided in an embodiment of the present application;
[0063] Figure 2 A flow chart of obtaining reagent detection capability evaluation data for a respiratory reagent quality inspection method provided in an embodiment of the present application;
[0064] Figure 3 A flow chart of obtaining target detection affinity data for the respiratory tract reagent quality inspection method provided in an embodiment of the present application;
[0065] Figure 4 A flow chart for obtaining a detection sensitivity index for a respiratory reagent quality inspection method provided in an embodiment of the present application. DETAILED DESCRIPTION
[0066] The technical solutions in the embodiments of the present application will be clearly and completely described below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all of the embodiments. The components of the embodiments of the present application described and shown in the drawings here can be arranged and designed in various different configurations. Therefore, the following detailed description of the embodiments of the present application provided in the drawings is not intended to limit the scope of the application claimed for protection, but merely represents the selected embodiments of the present application. Based on the embodiments of the present application, all other embodiments obtained by those skilled in the art without making creative work belong to the scope of protection of the present application.
[0067] It should be noted that similar reference numerals and letters represent similar items in the following drawings, so once an item is defined in one drawing, it does not need to be further defined and explained in subsequent drawings. At the same time, in the description of this application, the terms "first", "second", etc. are only used to distinguish the description and cannot be understood as indicating or implying relative importance.
[0068] Please refer to Figure 1 , Figure 1 Flow chart of the respiratory reagent quality inspection method in some embodiments of the present application. The respiratory reagent quality inspection method is used in a terminal device, such as a computer, a mobile phone terminal, etc. The respiratory reagent quality inspection method comprises the following steps:
[0069] S11, collecting characteristic information of preset respiratory reagents, extracting characteristic data of reagent raw materials, and processing to obtain reagent detection capability evaluation data;
[0070] S12, obtaining characteristic data of a preset standard sample and characteristic data of a detection environment, processing to obtain a sample virus intensity index and a detection environment interference factor, and processing in combination with the reagent detection capability evaluation data to obtain target detection affinity data;
[0071] S13, according to the sample virus intensity index and the detection environment interference factor of group n1, combined with the corresponding reagent detection ability evaluation data and target detection affinity data, processing is performed to obtain a detection reliability index;
[0072] S14, performing standard testing on the n2 group of standard samples containing target substances at different concentrations according to the respiratory tract reagent to obtain a detection sensitivity index;
[0073] S15, testing the standard samples according to the respiratory reagent under n3 groups of different testing environments to obtain a testing stability index;
[0074] S16, performing interference detection based on the same standard samples in group n4 to obtain the detection specificity index;
[0075] S17, performing accuracy assessment according to the detection reliability index, the detection sensitivity index and the detection stability index in combination with the detection specificity index to obtain a detection accuracy index;
[0076] S18. Perform a threshold comparison between the detection accuracy index and a preset accuracy threshold, determine whether the detection result of the respiratory reagent is accurate based on the comparison result, and make corresponding adjustments.
[0077] It should be noted that with the prevalence of viruses such as influenza and mycoplasma, respiratory reagent testing plays an increasingly important role in life, so the accuracy of the test results is crucial. In order to improve the quality of respiratory reagents and the accuracy of test results, it is necessary to ensure that the factors considered in the quality inspection process are comprehensive enough and the quality inspection effect is efficient enough. Therefore, in this embodiment, first, the characteristic information of the preset respiratory reagent is collected and a reagent characteristic cognitive map is generated, and then the reagent raw material characteristic data is extracted and processed to obtain the reagent detection ability evaluation data, the characteristic data of the preset standard sample and the detection environment characteristic data are obtained, and the sample virus intensity index and the detection environment interference factor are respectively processed to obtain the target object detection affinity data, and further processed to obtain the detection reliability index, according to the respiratory reagent for n2 group containing different concentrations of targets The standard samples of the substance are tested, and the test result data are processed in combination with the standard test result data to obtain the test sensitivity index; the standard samples are tested under n3 different test environments according to the respiratory reagents, and processed according to the corresponding coefficient of variation to obtain the test stability index; different concentrations of interfering substances similar to the target substance are added to the same standard samples in n4 groups and tested, and the test result data after interference are processed with the corresponding standard test result data to obtain the test specificity index; finally, the accuracy is evaluated according to the test reliability index, the test sensitivity index and the test stability index, combined with the test specificity index, to obtain the test accuracy index, and the threshold is compared with the preset accuracy threshold; whether the test result of the respiratory reagent is accurate is judged according to the comparison result, and corresponding adjustments are made, thereby realizing the technology of respiratory reagent quality inspection.
[0078] Please refer to Figure 2 , Figure 2 The present invention is a flowchart of obtaining reagent detection capability evaluation data of a respiratory reagent quality inspection method in some embodiments of the present application. According to an embodiment of the present invention, the characteristic information of the preset respiratory reagent is collected, and the characteristic data of the reagent raw material is extracted, and the reagent detection capability evaluation data is obtained by processing, including:
[0079] S21, collecting characteristic information of preset respiratory reagents, including primer information, enzyme activity information, antibody information, buffer information, nucleotide information and color developer information, and generating a reagent characteristic recognition map;
[0080] S22, extracting reagent raw material characteristic data according to the reagent characteristic recognition map, including primer complementarity data, enzyme activity data, antibody specificity data, buffer stability data, nucleotide concentration data, and color developer sensitivity data;
[0081] S23, processing the primer complementarity data, enzyme activity data, antibody specificity data, buffer stability data, nucleotide concentration data and developer sensitivity data to obtain reagent detection capability evaluation data.
[0082] It should be noted that, first of all, for respiratory reagents that need to be quality inspected, their detection capabilities need to be tested first. Therefore, the characteristic information of the preset respiratory reagents is collected, including primer information, enzyme activity information, antibody information, buffer information, nucleotide information and color developer information, and a reagent characteristic cognitive map is generated. Among them, the reagent characteristic cognitive map can represent the characteristic information of the above-mentioned respiratory reagents in a structured form, and through reasoning and analysis, discover the implicit relationship and pattern between the characteristic information. Furthermore, according to the reagent characteristic cognitive map, the reagent raw material characteristic data is extracted, including primer complementarity data, enzyme activity data, antibody specificity data, buffer stability data, nucleotide concentration data and color developer sensitivity data, and then the above data are processed to obtain the reagent detection capability evaluation data.
[0083] Please refer to Figure 3 , Figure 3 The present invention is a flowchart of obtaining the target object detection affinity data of the respiratory reagent quality inspection method in some embodiments of the present application. According to the embodiment of the present invention, the characteristic data of the preset standard sample and the characteristic data of the detection environment are obtained, and the sample virus intensity index and the detection environment interference factor are processed and combined with the reagent detection ability evaluation data to obtain the target object detection affinity data, including:
[0084] S31. Obtain characteristic data of a preset standard sample, including viral load data and viral nucleic acid content data, and process the data to obtain a sample virus intensity index;
[0085] S32, obtaining detection environment characteristic data, including temperature data, humidity data, and air quality record data, and processing to obtain detection environment interference factors;
[0086] S33. According to the sample virus intensity index and the detection environment interference factors, the reagent detection ability evaluation data is processed to obtain the target detection affinity data.
[0087] It should be noted that before evaluating whether the reagent is reliable, it is necessary to first evaluate the affinity level of the reagent for the target detection. Therefore, the characteristic data of the preset standard sample, including the viral load data and the viral nucleic acid content data, is first obtained, and the sample virus intensity index is obtained by processing. Then, the detection environment characteristic data, including temperature data, humidity data and air quality record data, is obtained, and the detection environment interference factor is obtained by processing. Then, according to the sample virus intensity index and the detection environment interference factor, combined with the reagent detection ability evaluation data, the target detection affinity data is obtained;
[0088] Among them, the calculation formula of the sample virus intensity index is:
[0089] ;
[0090] in, is the sample virus intensity index, They are viral load data and viral nucleic acid content data, is a preset characteristic coefficient (the characteristic coefficient is obtained by querying the preset reagent detection database);
[0091] The calculation formula for the detection environment interference factor is:
[0092] ;
[0093] in, To detect environmental interference factors, They are temperature data, humidity data, and air quality record data. is the preset characteristic coefficient (the characteristic coefficient is obtained by querying the preset reagent detection database).
[0094] According to an embodiment of the present invention, the sample virus intensity index and the detection environment interference factor of group n1 are processed in combination with the corresponding reagent detection capability evaluation data and the target detection affinity data to obtain the detection reliability index, including:
[0095] According to the sample virus intensity index of group n1 and the detection environment interference factor, the corresponding reagent detection ability evaluation data and the target detection affinity data are processed through a preset reagent detection evaluation model to obtain a detection reliability index;
[0096] The calculation formula of the detection reliability index is:
[0097] ;
[0098] in, To test the reliability index, They are The target detection affinity data, sample virus strength index, reagent detection capability evaluation data, and detection environment interference factors corresponding to the i-th group in the group detection, is the preset characteristic coefficient (the characteristic coefficient is obtained by querying the preset reagent detection database).
[0099] It should be noted that after obtaining the target detection affinity data of the reagent, further processing is required to obtain the detection reliability index of the reagent, that is, according to the virus intensity index of the n1 group of samples and the detection environment interference factor, combined with the corresponding reagent detection capability evaluation data and the target detection affinity data, the calculation formula of the preset reagent detection evaluation model is used for processing to obtain the detection reliability index.
[0100] Please refer to Figure 4 , Figure 4 Flow chart of obtaining the detection sensitivity index of the respiratory reagent quality inspection method in some embodiments of the present application. According to the embodiment of the present invention, the method of performing standard inspection on n2 groups of standard samples containing target substances of different concentrations according to the respiratory reagent to obtain the detection sensitivity index includes:
[0101] S41, testing the standard samples of group n2 containing target substances of different concentrations according to the respiratory reagent, and obtaining corresponding test result data, including target substance concentration data and cycle threshold data;
[0102] S42, obtaining standard test result data corresponding to the standard samples of the target substances with different concentrations according to the preset respiratory reagent detection and monitoring platform database, including standard target substance concentration data and standard cycle threshold data;
[0103] S43, processing the target concentration data and cycle threshold data corresponding to the detection of group n2 in combination with the standard target concentration data and standard cycle threshold data to obtain a detection sensitivity index.
[0104] It should be noted that the sensitivity detection of the reagent is one of the key indicators of quality inspection. In order to obtain the detection sensitivity index, first, the standard samples of group n2 containing target substances with different concentrations are detected according to the respiratory reagents, and the corresponding test result data are obtained, including the target concentration data and the cycle threshold data. At the same time, the standard test result data corresponding to the standard samples of target substances with different concentrations are obtained, including the standard target concentration data and the standard cycle threshold data. Then, the above data are processed to obtain the detection sensitivity index.
[0105] According to an embodiment of the present invention, the respiratory reagent is used to test the standard sample under n3 groups of different test environments to obtain the test stability index, including:
[0106] The standard samples are tested under n3 groups of different test environments according to the respiratory reagent, and the same test is repeated m times in each group of test environments, and the m groups of test results are processed to obtain the corresponding coefficient of variation;
[0107] Processing is performed according to the coefficient of variation corresponding to the n3 group to obtain a detection stability index;
[0108] The calculation formula of the detection stability index is:
[0109] ;
[0110] in, To test the stability index, for The coefficient of variation corresponding to the jth group of different test environments is, is the preset characteristic coefficient (the characteristic coefficient is obtained by querying the preset reagent detection database).
[0111] It should be noted that the stability test of the reagent is another key indicator of quality inspection. Therefore, according to the respiratory reagent, the standard samples were tested under n3 different test environments, and the same test was repeated m times in each test environment. The m groups of test results were processed to obtain the corresponding coefficient of variation. The corresponding coefficient of variation of the n3 groups was then processed to obtain the test stability index.
[0112] According to an embodiment of the present invention, performing interference detection based on n4 groups of identical standard samples to obtain a detection specificity index includes:
[0113] Adding different concentrations of interfering substances similar to the target substance to the same standard samples in group n4, and performing tests according to the respiratory reagents, respectively, to obtain post-interference test result data corresponding to the test results, including post-interference target substance concentration data;
[0114] Processing the interfered target concentration data in combination with the standard target concentration data to obtain a detection specificity index;
[0115] The calculation formula of the detection specificity index is:
[0116] ;
[0117] in, To test the specificity index, for The kth corresponding target concentration data after interference in the group test results, is the standard target concentration data, is the preset characteristic coefficient (the characteristic coefficient is obtained by querying the preset reagent detection database).
[0118] It should be noted that confirming that the reagent has specific recognition ability for the target substance can ensure that the reagent will not misjudge similar substances. The method includes: adding different concentrations of interfering substances similar to the target substance to the same standard samples in group n4, and detecting them respectively with respiratory reagents to obtain post-interference detection result data of the corresponding detection results, including post-interference target concentration data, and then processing the post-interference target concentration data in combination with the standard target concentration data to obtain the detection specificity index, wherein the post-interference target concentration data refers to the actual target concentration data obtained by the reagent when detecting the sample after the addition of interfering substances similar to the target substance.
[0119] According to an embodiment of the present invention, the accuracy evaluation is performed based on the detection reliability index, the detection sensitivity index and the detection stability index in combination with the detection specificity index to obtain the detection accuracy index, including:
[0120] According to the detection reliability index, the detection sensitivity index and the detection stability index, in combination with the detection specificity index, an accuracy assessment is performed through a preset reagent detection test model to obtain a detection accuracy index;
[0121] The calculation formula of the detection accuracy index is:
[0122] ;
[0123] in, is the detection accuracy index, They are detection accuracy index, detection sensitivity index, detection stability index, and detection specificity index. is the preset characteristic coefficient (the characteristic coefficient is obtained by querying the preset reagent detection database).
[0124] It should be noted that the detection accuracy of the reagent is affected by many factors and needs to be considered comprehensively. Therefore, based on the obtained detection reliability index, detection sensitivity index and detection stability index, combined with the detection specificity index, the accuracy is evaluated through the calculation formula of the preset reagent detection test model to obtain the detection accuracy index.
[0125] In a second aspect, the present invention further discloses a respiratory reagent quality inspection system, comprising a memory and a processor, wherein the memory comprises a respiratory reagent quality inspection method program, and when the respiratory reagent quality inspection method program is executed by the processor, the following steps are implemented:
[0126] Collect characteristic information of preset respiratory reagents, extract characteristic data of reagent raw materials, and process to obtain reagent detection capability evaluation data;
[0127] Acquire characteristic data of preset standard samples and detection environment characteristic data, process to obtain sample virus intensity index and detection environment interference factor, and process in combination with the reagent detection capability evaluation data to obtain target detection affinity data;
[0128] According to the sample virus intensity index of group n1 and the detection environment interference factor, combined with the corresponding reagent detection ability evaluation data and target detection affinity data, the detection reliability index is obtained;
[0129] Performing standard tests on the n2 group of standard samples containing target substances at different concentrations according to the respiratory reagent to obtain a test sensitivity index;
[0130] The standard samples are tested according to the respiratory reagent under n3 groups of different test environments to obtain a test stability index;
[0131] Interference detection was performed based on the same standard samples in group n4 to obtain the detection specificity index;
[0132] According to the detection reliability index, the detection sensitivity index and the detection stability index, in combination with the detection specificity index, an accuracy assessment is performed to obtain a detection accuracy index;
[0133] A threshold comparison is performed based on the detection accuracy index and a preset accuracy threshold, and whether the detection result of the respiratory reagent is accurate is determined based on the comparison result, and corresponding adjustments are made.
[0134] It should be noted that with the prevalence of viruses such as influenza and mycoplasma, respiratory reagent testing plays an increasingly important role in life, so the accuracy of the test results is crucial. In order to improve the quality of respiratory reagents and the accuracy of test results, it is necessary to ensure that the factors considered in the quality inspection process are comprehensive enough and the quality inspection effect is efficient enough. Therefore, in this embodiment, first, the characteristic information of the preset respiratory reagent is collected and a reagent characteristic cognitive map is generated, and then the reagent raw material characteristic data is extracted and processed to obtain the reagent detection ability evaluation data, the characteristic data of the preset standard sample and the detection environment characteristic data are obtained, and the sample virus intensity index and the detection environment interference factor are respectively processed to obtain the target object detection affinity data, and further processed to obtain the detection reliability index, according to the respiratory reagent for n2 group containing different concentrations of targets The standard samples of the substance are tested, and the test result data are processed in combination with the standard test result data to obtain the test sensitivity index; the standard samples are tested under n3 different test environments according to the respiratory reagents, and processed according to the corresponding coefficient of variation to obtain the test stability index; different concentrations of interfering substances similar to the target substance are added to the same standard samples in n4 groups and tested, and the test result data after interference are processed with the corresponding standard test result data to obtain the test specificity index; finally, the accuracy is evaluated according to the test reliability index, the test sensitivity index and the test stability index, combined with the test specificity index, to obtain the test accuracy index, and the threshold is compared with the preset accuracy threshold; whether the test result of the respiratory reagent is accurate is judged according to the comparison result, and corresponding adjustments are made, thereby realizing the technology of respiratory reagent quality inspection.
[0135] According to an embodiment of the present invention, the step of collecting characteristic information of a preset respiratory reagent, extracting characteristic data of the reagent raw material, and processing to obtain reagent detection capability evaluation data includes:
[0136] Collect characteristic information of preset respiratory reagents, including primer information, enzyme activity information, antibody information, buffer information, nucleotide information and colorimetric information, and generate a cognitive map of reagent characteristics;
[0137] Extracting reagent raw material characteristic data according to the reagent characteristic cognitive map, including primer complementarity data, enzyme activity data, antibody specificity data, buffer stability data, nucleotide concentration data, and color developer sensitivity data;
[0138] The primer complementarity data, enzyme activity data, antibody specificity data, buffer stability data, nucleotide concentration data and developer sensitivity data are processed to obtain reagent detection ability evaluation data.
[0139] It should be noted that, first of all, for respiratory reagents that need to be quality inspected, their detection capabilities need to be tested first. Therefore, the characteristic information of the preset respiratory reagents is collected, including primer information, enzyme activity information, antibody information, buffer information, nucleotide information and color developer information, and a reagent characteristic cognitive map is generated. Among them, the reagent characteristic cognitive map can represent the characteristic information of the above-mentioned respiratory reagents in a structured form, and through reasoning and analysis, discover the implicit relationship and pattern between the characteristic information. Furthermore, according to the reagent characteristic cognitive map, the reagent raw material characteristic data is extracted, including primer complementarity data, enzyme activity data, antibody specificity data, buffer stability data, nucleotide concentration data and color developer sensitivity data, and then the above data are processed to obtain the reagent detection capability evaluation data.
[0140] According to an embodiment of the present invention, the method of obtaining characteristic data of a preset standard sample and characteristic data of a detection environment, processing to obtain a sample virus intensity index and a detection environment interference factor, and combining the reagent detection capability evaluation data for processing to obtain target detection affinity data includes:
[0141] Obtain characteristic data of preset standard samples, including viral load data and viral nucleic acid content data, and process them to obtain the sample virus intensity index;
[0142] Acquire the characteristic data of the testing environment, including temperature data, humidity data and air quality record data, and process them to obtain the interference factors of the testing environment;
[0143] The target detection affinity data is obtained by processing the sample virus intensity index and the detection environment interference factors in combination with the reagent detection ability evaluation data.
[0144] It should be noted that before evaluating whether the reagent is reliable, it is necessary to first evaluate the affinity level of the reagent for the target detection. Therefore, the characteristic data of the preset standard sample, including the viral load data and the viral nucleic acid content data, is first obtained, and the sample virus intensity index is obtained by processing. Then, the detection environment characteristic data, including temperature data, humidity data and air quality record data, is obtained, and the detection environment interference factor is obtained by processing. Then, according to the sample virus intensity index and the detection environment interference factor, combined with the reagent detection ability evaluation data, the target detection affinity data is obtained;
[0145] Among them, the calculation formula of the sample virus intensity index is:
[0146] ;
[0147] in, is the sample virus intensity index, They are viral load data and viral nucleic acid content data, is a preset characteristic coefficient (the characteristic coefficient is obtained by querying the preset reagent detection database);
[0148] The calculation formula for the detection environment interference factor is:
[0149] ;
[0150] in, To detect environmental interference factors, They are temperature data, humidity data, and air quality record data. is the preset characteristic coefficient (the characteristic coefficient is obtained by querying the preset reagent detection database).
[0151] According to an embodiment of the present invention, the sample virus intensity index and the detection environment interference factor of group n1 are processed in combination with the corresponding reagent detection capability evaluation data and the target detection affinity data to obtain the detection reliability index, including:
[0152] According to the sample virus intensity index of group n1 and the detection environment interference factor, the corresponding reagent detection ability evaluation data and the target detection affinity data are processed through a preset reagent detection evaluation model to obtain a detection reliability index;
[0153] The calculation formula of the detection reliability index is:
[0154] ;
[0155] in, To test the reliability index, They are The target detection affinity data, sample virus strength index, reagent detection capability evaluation data, and detection environment interference factors corresponding to the i-th group in the group detection, is the preset characteristic coefficient (the characteristic coefficient is obtained by querying the preset reagent detection database).
[0156] It should be noted that after obtaining the target detection affinity data of the reagent, further processing is required to obtain the detection reliability index of the reagent, that is, according to the virus intensity index of the n1 group of samples and the detection environment interference factor, combined with the corresponding reagent detection capability evaluation data and the target detection affinity data, the calculation formula of the preset reagent detection evaluation model is used for processing to obtain the detection reliability index.
[0157] According to an embodiment of the present invention, the method of performing standard testing on the n2 groups of standard samples containing target substances of different concentrations according to the respiratory reagent to obtain the detection sensitivity index includes:
[0158] Testing the standard samples of group n2 containing target substances at different concentrations according to the respiratory reagent, and obtaining corresponding test result data, including target substance concentration data and cycle threshold data;
[0159] Obtaining standard test result data corresponding to the standard samples of the target substances with different concentrations according to the preset respiratory reagent detection and monitoring platform database, including standard target substance concentration data and standard cycle threshold data;
[0160] The target concentration data and cycle threshold data corresponding to the n2 group detection are processed in combination with the standard target concentration data and the standard cycle threshold data to obtain a detection sensitivity index.
[0161] It should be noted that the sensitivity detection of the reagent is one of the key indicators of quality inspection. In order to obtain the detection sensitivity index, first, the standard samples of group n2 containing target substances with different concentrations are detected according to the respiratory reagents, and the corresponding test result data are obtained, including the target concentration data and the cycle threshold data. At the same time, the standard test result data corresponding to the standard samples of target substances with different concentrations are obtained, including the standard target concentration data and the standard cycle threshold data. Then, the above data are processed to obtain the detection sensitivity index.
[0162] According to an embodiment of the present invention, the respiratory reagent is used to test the standard sample under n3 groups of different test environments to obtain the test stability index, including:
[0163] The standard samples are tested under n3 groups of different test environments according to the respiratory reagent, and the same test is repeated m times in each group of test environments, and the m groups of test results are processed to obtain the corresponding coefficient of variation;
[0164] Processing is performed according to the coefficient of variation corresponding to the n3 group to obtain a detection stability index;
[0165] The calculation formula of the detection stability index is:
[0166] ;
[0167] in, To test the stability index, for The coefficient of variation corresponding to the jth group of different test environments is, is the preset characteristic coefficient (the characteristic coefficient is obtained by querying the preset reagent detection database).
[0168] It should be noted that the stability test of the reagent is another key indicator of quality inspection. Therefore, according to the respiratory reagent, the standard samples were tested under n3 different test environments, and the same test was repeated m times in each test environment. The m groups of test results were processed to obtain the corresponding coefficient of variation. The corresponding coefficient of variation of the n3 groups was then processed to obtain the test stability index.
[0169] According to an embodiment of the present invention, performing interference detection based on n4 groups of identical standard samples to obtain a detection specificity index includes:
[0170] Adding different concentrations of interfering substances similar to the target substance to the same standard samples in group n4, and performing tests according to the respiratory reagents, respectively, to obtain post-interference test result data corresponding to the test results, including post-interference target substance concentration data;
[0171] Processing the interfered target concentration data in combination with the standard target concentration data to obtain a detection specificity index;
[0172] The calculation formula of the detection specificity index is:
[0173] ;
[0174] in, To test the specificity index, for The kth corresponding target concentration data after interference in the group test results, is the standard target concentration data, is the preset characteristic coefficient (the characteristic coefficient is obtained by querying the preset reagent detection database).
[0175] It should be noted that confirming that the reagent has specific recognition ability for the target substance can ensure that the reagent will not misjudge similar substances. The method includes: adding different concentrations of interfering substances similar to the target substance to the same standard samples in group n4, and detecting them respectively with respiratory reagents to obtain post-interference detection result data of the corresponding detection results, including post-interference target concentration data, and then processing the post-interference target concentration data in combination with the standard target concentration data to obtain the detection specificity index, wherein the post-interference target concentration data refers to the actual target concentration data obtained by the reagent when detecting the sample after the addition of interfering substances similar to the target substance.
[0176] According to an embodiment of the present invention, the accuracy evaluation is performed based on the detection reliability index, the detection sensitivity index and the detection stability index in combination with the detection specificity index to obtain the detection accuracy index, including:
[0177] According to the detection reliability index, the detection sensitivity index and the detection stability index, in combination with the detection specificity index, an accuracy assessment is performed through a preset reagent detection test model to obtain a detection accuracy index;
[0178] The calculation formula of the detection accuracy index is:
[0179] ;
[0180] in, is the detection accuracy index, They are detection accuracy index, detection sensitivity index, detection stability index, and detection specificity index. is the preset characteristic coefficient (the characteristic coefficient is obtained by querying the preset reagent detection database).
[0181] It should be noted that the detection accuracy of the reagent is affected by many factors and needs to be considered comprehensively. Therefore, based on the obtained detection reliability index, detection sensitivity index and detection stability index, combined with the detection specificity index, the accuracy is evaluated through the calculation formula of the preset reagent detection test model to obtain the detection accuracy index.
[0182] A third aspect of the present invention provides a readable storage medium, which stores a respiratory reagent quality inspection method program. When the respiratory reagent quality inspection method program is executed by a processor, the steps of the respiratory reagent quality inspection method as described in any one of the above items are implemented.
[0183] The respiratory reagent quality inspection method, system and medium disclosed in the present invention collect characteristic information of preset respiratory reagents and generate a reagent characteristic cognitive map, then extract the reagent raw material characteristic data and process it to obtain reagent detection ability evaluation data, obtain characteristic data of preset standard samples and detection environment characteristic data, respectively process to obtain sample virus intensity index and detection environment interference factor, and process them in combination with the reagent detection ability evaluation data to obtain target object detection affinity data, further process to obtain detection reliability index, detect n2 groups of standard samples containing target substances with different concentrations according to the respiratory reagents, process the detection result data in combination with the standard detection result data to obtain the detection sensitivity index, and calculate the detection reliability index according to the respiratory reagents. The standard samples of the reagents are tested under different test environments in group n3, and processed according to the corresponding coefficient of variation to obtain the test stability index. Different concentrations of interfering substances similar to the target substances are added to the same standard samples in group n4 and tested. The test result data after interference are processed with the corresponding standard test result data to obtain the test specificity index. Finally, the accuracy is evaluated based on the test reliability index, test sensitivity index and test stability index combined with the test specificity index to obtain the test accuracy index. The threshold is compared with the preset accuracy threshold. According to the comparison results, it is judged whether the test results of the respiratory reagents are accurate, and corresponding adjustments are made, thereby realizing the technology of respiratory reagent quality inspection.
[0184] In the several embodiments provided in the present application, it should be understood that the disclosed devices and methods can be implemented in other ways. The device embodiments described above are only schematic. For example, the division of the units is only a logical function division. There may be other division methods in actual implementation, such as: multiple units or components can be combined, or can be integrated into another system, or some features can be ignored or not executed. In addition, the coupling, direct coupling, or communication connection between the components shown or discussed can be through some interfaces, and the indirect coupling or communication connection of the devices or units can be electrical, mechanical or other forms.
[0185] The units described above as separate components may or may not be physically separated, and the components displayed as units may or may not be physical units; they may be located in one place or distributed on multiple network units; some or all of the units may be selected according to actual needs to achieve the purpose of the present embodiment.
[0186] In addition, all functional units in the embodiments of the present invention may be integrated into one processing unit, or each unit may be separately used as a unit, or two or more units may be integrated into one unit; the above-mentioned integrated units may be implemented in the form of hardware or in the form of hardware plus software functional units.
[0187] Those skilled in the art can understand that: all or part of the steps of implementing the above method embodiments can be completed by hardware related to program instructions, the aforementioned program can be stored in a readable storage medium, and when the program is executed, it executes the steps of the above method embodiments; and the aforementioned storage medium includes: mobile storage devices, read-only memories (ROM, Read-Only Memory), random access memories (RAM, Random Access Memory), disks or optical disks, and other media that can store program codes.
[0188] Alternatively, if the above-mentioned integrated unit of the present invention is implemented in the form of a software function module and sold or used as an independent product, it can also be stored in a readable storage medium. Based on this understanding, the technical solution of the embodiment of the present invention can be essentially or partly reflected in the form of a software product that contributes to the prior art. The software product is stored in a storage medium and includes several instructions for a computer device (which can be a personal computer, server, or network device, etc.) to execute all or part of the methods described in each embodiment of the present invention. The aforementioned storage medium includes: various media that can store program codes, such as mobile storage devices, ROM, RAM, magnetic disks or optical disks.
Claims
1. A respiratory tract reagent quality inspection method, characterized in that: The following steps are involved: Collect characteristic information of preset respiratory reagents, extract characteristic data of reagent raw materials, and process to obtain reagent detection capability evaluation data; Acquire characteristic data of preset standard samples and detection environment characteristic data, process to obtain sample virus intensity index and detection environment interference factor, and process in combination with the reagent detection capability evaluation data to obtain target detection affinity data; According to the sample virus intensity index of group n1 and the detection environment interference factor, combined with the corresponding reagent detection ability evaluation data and target detection affinity data, the detection reliability index is obtained; Performing standard tests on the n2 group of standard samples containing target substances at different concentrations according to the respiratory reagent to obtain a test sensitivity index; The standard samples are tested according to the respiratory reagent under n3 groups of different test environments to obtain a test stability index; Interference detection was performed based on the same standard samples in group n4 to obtain the detection specificity index; According to the detection reliability index, the detection sensitivity index and the detection stability index, in combination with the detection specificity index, an accuracy assessment is performed to obtain a detection accuracy index; Performing a threshold comparison between the detection accuracy index and a preset accuracy threshold, determining whether the detection result of the respiratory reagent is accurate based on the comparison result, and making corresponding adjustments; The detection reliability index is obtained by processing the sample virus intensity index and the detection environment interference factor of group n1 in combination with the corresponding reagent detection capability evaluation data and the target detection affinity data, including: According to the sample virus intensity index of group n1 and the detection environment interference factor, the corresponding reagent detection ability evaluation data and the target detection affinity data are processed through a preset reagent detection evaluation model to obtain a detection reliability index; The calculation formula of the detection reliability index is: ; in, To test the reliability index, They are The target detection affinity data, sample virus strength index, reagent detection capability evaluation data, and detection environment interference factors corresponding to the i-th group in the group detection, is the preset characteristic coefficient; The method of testing the standard sample under n3 groups of different testing environments according to the respiratory reagent to obtain the testing stability index includes: The standard samples are tested under n3 groups of different test environments according to the respiratory reagent, and the same test is repeated m times in each group of test environments, and the m groups of test results are processed to obtain the corresponding coefficient of variation; Processing is performed according to the coefficient of variation corresponding to the n3 group to obtain a detection stability index; The calculation formula of the detection stability index is: ; in, To test the stability index, for The coefficient of variation corresponding to the jth group of different test environments is, is the preset characteristic coefficient; The accuracy evaluation is performed according to the detection reliability index, the detection sensitivity index and the detection stability index in combination with the detection specificity index to obtain the detection accuracy index, including: According to the detection reliability index, the detection sensitivity index and the detection stability index, in combination with the detection specificity index, an accuracy assessment is performed through a preset reagent detection test model to obtain a detection accuracy index; The calculation formula of the detection accuracy index is: ; in, is the detection accuracy index, They are detection accuracy index, detection sensitivity index, detection stability index, and detection specificity index. is the preset characteristic coefficient.
2. The respiratory tract reagent quality inspection method according to claim 1, characterized in that: The collecting of characteristic information of the preset respiratory reagent, extracting characteristic data of the reagent raw material, and processing to obtain reagent detection capability evaluation data include: Collect characteristic information of preset respiratory reagents, including primer information, enzyme activity information, antibody information, buffer information, nucleotide information and colorimetric information, and generate a cognitive map of reagent characteristics; Extracting reagent raw material characteristic data according to the reagent characteristic cognitive map, including primer complementarity data, enzyme activity data, antibody specificity data, buffer stability data, nucleotide concentration data, and color developer sensitivity data; The primer complementarity data, enzyme activity data, antibody specificity data, buffer stability data, nucleotide concentration data and developer sensitivity data are processed to obtain reagent detection ability evaluation data.
3. The respiratory tract reagent quality inspection method according to claim 2, characterized in that: The method of obtaining characteristic data of a preset standard sample and characteristic data of a detection environment, processing to obtain a sample virus intensity index and a detection environment interference factor, and combining the reagent detection capability evaluation data for processing to obtain target detection affinity data includes: Obtain characteristic data of preset standard samples, including viral load data and viral nucleic acid content data, and process them to obtain the sample virus intensity index; Acquire the characteristic data of the testing environment, including temperature data, humidity data and air quality record data, and process them to obtain the interference factors of the testing environment; The target detection affinity data is obtained by processing the sample virus intensity index and the detection environment interference factors in combination with the reagent detection ability evaluation data.
4. The respiratory tract reagent quality inspection method according to claim 3, characterized in that: The method of performing standard testing on the n2 group of standard samples containing target substances of different concentrations according to the respiratory reagent to obtain the detection sensitivity index includes: Testing the standard samples of group n2 containing target substances at different concentrations according to the respiratory reagent, and obtaining corresponding test result data, including target substance concentration data and cycle threshold data; Obtaining standard test result data corresponding to the standard samples of the target substances with different concentrations according to the preset respiratory reagent detection and monitoring platform database, including standard target substance concentration data and standard cycle threshold data; The target concentration data and cycle threshold data corresponding to the n2 group detection are processed in combination with the standard target concentration data and the standard cycle threshold data to obtain a detection sensitivity index.
5. The respiratory tract reagent quality inspection method according to claim 4, characterized in that: The interference detection is performed according to the same standard samples of n4 groups to obtain the detection specificity index, including: Confirming that the reagent has specific recognition ability for the target substance can ensure that the reagent will not misjudge similar substances, adding different concentrations of interfering substances similar to the target substance to the same standard samples in group n4, and performing tests according to the respiratory reagents to obtain the post-interference test result data of the corresponding test results, including the post-interference target concentration data; Processing the interfered target concentration data in combination with the standard target concentration data to obtain a detection specificity index; The calculation formula of the detection specificity index is: ; in, To test the specificity index, for The kth corresponding target concentration data after interference in the group test results, is the standard target concentration data, is the preset characteristic coefficient.
6. A respiratory reagent quality inspection system, characterized in that: The system includes: a memory and a processor, wherein the memory includes a program of a respiratory reagent quality inspection method, and when the program of the respiratory reagent quality inspection method is executed by the processor, the following steps are implemented: Collect characteristic information of preset respiratory reagents, extract characteristic data of reagent raw materials, and process to obtain reagent detection capability evaluation data; Acquire characteristic data of preset standard samples and detection environment characteristic data, process to obtain sample virus intensity index and detection environment interference factor, and process in combination with the reagent detection capability evaluation data to obtain target detection affinity data; According to the sample virus intensity index of group n1 and the detection environment interference factor, combined with the corresponding reagent detection ability evaluation data and target detection affinity data, the detection reliability index is obtained; Performing standard tests on the n2 group of standard samples containing target substances at different concentrations according to the respiratory reagent to obtain a test sensitivity index; The standard samples are tested according to the respiratory reagent under n3 groups of different test environments to obtain a test stability index; Interference detection was performed based on the same standard samples in group n4 to obtain the detection specificity index; According to the detection reliability index, the detection sensitivity index and the detection stability index, in combination with the detection specificity index, an accuracy assessment is performed to obtain a detection accuracy index; Performing a threshold comparison between the detection accuracy index and a preset accuracy threshold, determining whether the detection result of the respiratory reagent is accurate based on the comparison result, and making corresponding adjustments; The detection reliability index is obtained by processing the sample virus intensity index and the detection environment interference factor of group n1 in combination with the corresponding reagent detection capability evaluation data and the target detection affinity data, including: According to the sample virus intensity index of group n1 and the detection environment interference factor, the corresponding reagent detection ability evaluation data and the target detection affinity data are processed through a preset reagent detection evaluation model to obtain a detection reliability index; The calculation formula of the detection reliability index is: ; in, To test the reliability index, They are The target detection affinity data, sample virus strength index, reagent detection capability evaluation data, and detection environment interference factors corresponding to the i-th group in the group detection, is the preset characteristic coefficient; The method of testing the standard sample under n3 groups of different testing environments according to the respiratory reagent to obtain the testing stability index includes: The standard samples are tested under n3 groups of different test environments according to the respiratory reagent, and the same test is repeated m times in each group of test environments, and the m groups of test results are processed to obtain the corresponding coefficient of variation; Processing is performed according to the coefficient of variation corresponding to the n3 group to obtain a detection stability index; The calculation formula of the detection stability index is: ; in, To test the stability index, for The coefficient of variation corresponding to the jth group of different test environments is, is the preset characteristic coefficient; The accuracy evaluation is performed according to the detection reliability index, the detection sensitivity index and the detection stability index in combination with the detection specificity index to obtain the detection accuracy index, including: According to the detection reliability index, the detection sensitivity index and the detection stability index, in combination with the detection specificity index, an accuracy assessment is performed through a preset reagent detection test model to obtain a detection accuracy index; The calculation formula of the detection accuracy index is: ; in, is the detection accuracy index, They are detection accuracy index, detection sensitivity index, detection stability index, and detection specificity index. is the preset characteristic coefficient.
7. A computer-readable storage medium, characterized in that: The computer-readable storage medium includes a respiratory tract reagent quality inspection method program, and when the respiratory tract reagent quality inspection method program is executed by a processor, the respiratory tract reagent quality inspection method according to any one of claims 1 to 5 is implemented.
Citation Information
Patent Citations
HIV reagent quality inspection method, system and medium
CN118362745A