CN118818075B

CN118818075B - A respiratory reagent quality inspection method, system and medium

Info

Publication number: CN118818075B
Application number: CN202411306292.1A
Authority: CN
Inventors: 郭诗静; 彭运平; 曾剑明; 熊正
Original assignee: Guangzhou Wanfu Health Technology Co ltd
Current assignee: Guangzhou Wanfu Health Technology Co ltd
Priority date: 2024-09-19
Filing date: 2024-09-19
Publication date: 2025-01-10
Anticipated expiration: 2044-09-19
Also published as: CN118818075A

Abstract

The application provides a respiratory tract reagent quality inspection method, a respiratory tract reagent quality inspection system and a respiratory tract reagent quality inspection medium. Collecting characteristic information of a respiratory tract reagent, generating a reagent characteristic cognition map, extracting reagent raw material characteristic data, processing to obtain reagent detection capability evaluation data, processing to obtain target object detection affinity data by combining characteristic data of standard samples and detection environment characteristic data, further processing to obtain detection reliability indexes, detecting a plurality of groups of different standard samples according to the respiratory tract reagent, respectively processing according to detection result data to obtain corresponding detection sensitivity indexes, detection stability indexes and detection specificity indexes, performing accuracy evaluation by combining the detection reliability indexes, obtaining detection accuracy indexes, comparing with a preset accuracy threshold, judging whether detection results of the respiratory tract reagent are accurate and correspondingly adjusted according to comparison results, and thus realizing the technology of respiratory tract reagent quality inspection.

Description

Respiratory tract reagent quality inspection method, system and medium

Technical Field

The application relates to the technical field of reagent quality inspection, in particular to a respiratory tract reagent quality inspection method, a respiratory tract reagent quality inspection system and a respiratory tract reagent quality inspection medium.

Background

With the epidemic of viruses such as influenza and mycoplasma, the respiratory tract reagent detection plays an increasingly important role in life, so that the accuracy of detection results is very important.

In practical use, due to the fact that the specificity and sensitivity of some reagents are not high enough and are influenced by the interference of other pathogens, improper sample collection and treatment and other factors, false positive results can appear on part of respiratory tract reagents, namely positive detection but actual infection is not detected, or false negative results can not detect actual infected conditions, in addition, the reagent performance can be reduced due to the influence of storage and transportation conditions, and the stability of detection results and the accuracy of naked eye judgment can be influenced.

In view of the above problems, an effective technical solution is currently needed.

Disclosure of Invention

The application aims to provide a method, a system and a medium for detecting the quality of a respiratory tract reagent, which can process and obtain a detection reliability index, a detection sensitivity index, a detection stability index and a detection specificity index of the respiratory tract reagent, comprehensively process, evaluate accuracy, obtain a detection accuracy index, judge the detection effect of the respiratory tract reagent according to the detection accuracy index and realize the technology of detecting the quality of the respiratory tract reagent.

The application also provides a respiratory tract reagent quality inspection method, which comprises the following steps:

collecting characteristic information of a preset respiratory tract reagent, extracting characteristic data of a reagent raw material, and processing to obtain reagent detection capability evaluation data;

Acquiring characteristic data of a preset standard sample and detection environment characteristic data, processing to acquire a sample virus intensity index and detection environment interference factors, and processing by combining the reagent detection capability evaluation data to acquire target object detection affinity data;

according to n1 groups of sample virus intensity indexes and detection environment interference factors, processing by combining corresponding reagent detection capacity evaluation data and target detection affinity data to obtain detection reliability indexes;

carrying out standard detection on n2 groups of standard samples containing target substances with different concentrations according to the respiratory tract reagent to obtain a detection sensitivity index;

detecting the standard sample under n3 groups of different detection environments according to the respiratory tract reagent to obtain a detection stability index;

performing interference detection according to n4 groups of identical standard samples to obtain a detection specificity index;

according to the detection reliability index, the detection sensitivity index and the detection stability index, carrying out accuracy assessment by combining the detection specificity index to obtain a detection accuracy index;

And comparing the threshold value according to the detection accuracy index with a preset accuracy threshold value, judging whether the detection result of the respiratory tract reagent is accurate according to the comparison result, and correspondingly adjusting.

Optionally, in the respiratory tract reagent quality inspection method of the present application, the collecting characteristic information of a preset respiratory tract reagent, extracting characteristic data of a reagent raw material, and processing to obtain reagent detection capability evaluation data includes:

Characteristic information of a preset respiratory tract reagent is collected, wherein the characteristic information comprises primer information, enzyme activity information, antibody information, buffer information, nucleotide information and color reagent information, and a reagent characteristic cognition map is generated;

extracting reagent raw material characteristic data according to the reagent characteristic cognition spectrum, wherein the reagent raw material characteristic data comprises primer complementarity data, enzyme activity data, antibody specificity data, buffer stability data, nucleotide concentration data and color reagent sensitivity data;

And processing according to the primer complementarity data, enzyme activity data, antibody specificity data, buffer stability data, nucleotide concentration data and color reagent sensitivity data to obtain reagent detection capability evaluation data.

Optionally, in the respiratory tract reagent quality inspection method of the present application, the obtaining the characteristic data of the preset standard sample and the detection environment characteristic data, the processing to obtain the sample virus intensity index and the detection environment interference factor, and the processing in combination with the reagent detection capability evaluation data to obtain the target object detection affinity data includes:

Acquiring characteristic data of a preset standard sample, including viral load data and viral nucleic acid content data, and processing to obtain a sample virus intensity index;

acquiring detection environment characteristic data, including temperature data, humidity data and air quality record data, and processing to obtain detection environment interference factors;

And processing according to the sample virus intensity index and the detection environment interference factor and combining the reagent detection capability evaluation data to obtain target object detection affinity data.

Optionally, in the respiratory tract reagent quality inspection method of the present application, the processing according to n1 groups of the sample virus intensity indexes and the detection environment interference factors, in combination with the corresponding reagent detection capability evaluation data and target detection affinity data, to obtain detection reliability indexes includes:

According to n1 groups of sample virus intensity indexes and detection environment interference factors, processing the corresponding reagent detection capacity evaluation data and target detection affinity data through a preset reagent detection evaluation model to obtain detection reliability indexes;

the calculation formula of the detection reliability index is as follows:

;

Wherein, In order to detect the reliability index of the device,Respectively isThe i-th group of target object detection affinity data, sample virus intensity index, reagent detection capability evaluation data and detection environment interference factors,Is a preset characteristic coefficient.

Optionally, in the respiratory tract reagent quality inspection method of the present application, the standard detection is performed on n2 sets of standard samples containing target substances with different concentrations according to the respiratory tract reagent to obtain a detection sensitivity index, including:

detecting n2 groups of standard samples containing target substances with different concentrations according to the respiratory tract reagent, and obtaining corresponding detection result data, wherein the detection result data comprises target substance concentration data and cycle threshold value data;

Obtaining standard detection result data corresponding to standard samples of different concentration target substances according to a preset respiratory tract reagent detection monitoring platform database, wherein the standard detection result data comprises standard target substance concentration data and standard cycle threshold value data;

And according to the n2 groups of detection corresponding target object concentration data and the circulation threshold value data, processing the combination of the standard target object concentration data and the standard circulation threshold value data to obtain a detection sensitivity index.

Optionally, in the respiratory tract reagent quality inspection method of the present application, the detecting the standard sample according to the respiratory tract reagent under n3 groups of different detection environments respectively to obtain a detection stability index includes:

Detecting the standard sample under n3 groups of different detection environments according to the respiratory tract reagent, repeating the same detection for m times in each group of detection environments, and processing m groups of detection results to obtain corresponding variation coefficients;

processing according to the variation coefficient corresponding to the n3 groups to obtain a detection stability index;

the calculation formula of the detection stability index is as follows:

;

Wherein, In order to detect the stability index of the test piece,Is thatThe j-th group of different detection environments corresponds to the coefficient of variation,Is a preset characteristic coefficient.

Optionally, in the respiratory tract reagent quality inspection method of the present application, the performing interference detection according to n4 groups of identical standard samples to obtain a detection specificity index includes:

respectively adding interference substances with different concentrations similar to the target substances into n4 groups of same standard samples, and respectively detecting according to the respiratory tract reagents to obtain post-interference detection result data corresponding to detection results, wherein the post-interference detection result data comprises post-interference target substance concentration data;

processing according to the interfered target object concentration data and the standard target object concentration data to obtain a detection specificity index;

The calculation formula of the detection specificity index is as follows:

;

Wherein, In order to detect the index of specificity,Is thatThe kth corresponding post-interference target concentration data in the group detection result,As a result of the standard concentration data of the target,Is a preset characteristic coefficient.

Optionally, in the respiratory tract reagent quality testing method of the present application, the 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 includes:

according to the detection reliability index, the detection sensitivity index and the detection stability index, combining the detection specificity index to carry out accuracy assessment through a preset reagent detection test model, so as to obtain a detection accuracy index;

The calculation formula of the detection accuracy index is as follows:

;

Wherein, In order to detect the index of accuracy of the measurement,Respectively a detection accuracy index, a detection sensitivity index, a detection stability index and a detection specificity index,Is a preset characteristic coefficient.

In a second aspect, the application provides a respiratory tract reagent quality inspection system, comprising a memory and a processor, wherein the memory comprises a program of a respiratory tract reagent quality inspection method, and the program of the respiratory tract reagent quality inspection method realizes the following steps when being executed by the processor:

In a third aspect, the present application also provides a computer readable storage medium having stored therein a respiratory tract agent quality inspection method program which, when executed by a processor, implements the steps of a respiratory tract agent quality inspection method as described in any preceding claim.

According to the respiratory tract reagent quality inspection method, system and medium disclosed by the invention, characteristic information of a preset respiratory tract reagent is acquired, a reagent characteristic cognition map is generated, reagent raw material characteristic data is extracted and processed to obtain reagent detection capability evaluation data, characteristic data and detection environment characteristic data of a preset standard sample are obtained, sample virus intensity indexes and detection environment interference factors are respectively processed and obtained, and the detection capability evaluation data is combined to process, target object detection affinity data is obtained, further processing is carried out, detection reliability indexes are obtained, n2 groups of standard samples containing target substances with different concentrations are detected according to the respiratory tract reagent, the detection sensitivity indexes are obtained according to the detection result data and combined with the standard detection result data, the standard samples are detected under n3 groups of different detection environments respectively according to the respiratory tract reagent, the detection stability indexes are obtained, interference substances with different concentrations similar to the target substances are respectively added into n4 groups of standard samples and detected, the interference substances are processed according to the detection result data, the detection specificity indexes are obtained, the detection reliability and the detection sensitivity indexes are combined with the corresponding standard detection result data, the detection accuracy is adjusted according to the detection accuracy, the detection accuracy is adjusted, the detection accuracy is compared with the detection accuracy is adjusted, and the detection accuracy is compared with the threshold, and the detection accuracy is measured, and the detection accuracy is compared with the detection accuracy is adjusted.

Additional features and advantages of the application will be set forth in the description which follows, and in part will be apparent from the description, or may be learned by practice of the embodiments of the application. The objectives and other advantages of the application may be realized and attained by the structure particularly pointed out in the written description and drawings.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings that are needed in the embodiments of the present application will be briefly described below, it should be understood that the following drawings only illustrate some embodiments of the present application and should not be considered as limiting the scope, and other related drawings can be obtained according to these drawings without inventive effort for a person skilled in the art.

FIG. 1 is a flow chart of a method for quality testing of respiratory tract agents according to an embodiment of the present application;

FIG. 2 is a flow chart of obtaining reagent detection capability evaluation data of a respiratory tract reagent quality inspection method according to an embodiment of the present application;

FIG. 3 is a flowchart of a method for obtaining target object detection affinity data according to an embodiment of the present application;

fig. 4 is a flowchart of a method for obtaining a detection sensitivity index in a respiratory tract reagent quality inspection according to an embodiment of the present application.

Detailed Description

The following description of the embodiments of the present application will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present application, but not all embodiments. The components of the embodiments of the present application generally described and illustrated in the figures herein may be arranged and designed in a wide variety of different configurations. Thus, the following detailed description of the embodiments of the application, as presented in the figures, is not intended to limit the scope of the application, as claimed, but is merely representative of selected embodiments of the application. All other embodiments, which can be made by a person skilled in the art without making any inventive effort, are intended to be within the scope of the present application.

It should be noted that like reference numerals and letters refer to like items in the following figures, and thus once an item is defined in one figure, no further definition or explanation thereof is necessary in the following figures. Meanwhile, in the description of the present application, the terms "first", "second", and the like are used only to distinguish the description, and are not to be construed as indicating or implying relative importance.

Referring to fig. 1, fig. 1 is a flowchart illustrating a method for quality inspection of respiratory tract agents according to some embodiments of the application. The respiratory tract reagent quality inspection method is used in terminal equipment, such as computers, mobile phone terminals and the like. The respiratory tract reagent quality inspection method comprises the following steps:

s11, acquiring characteristic information of a preset respiratory tract reagent, extracting characteristic data of a reagent raw material, and processing to obtain reagent detection capability evaluation data;

s12, acquiring characteristic data and detection environment characteristic data of a preset standard sample, processing to acquire a sample virus intensity index and detection environment interference factors, and processing by combining the reagent detection capability evaluation data to acquire target object detection affinity data;

S13, according to n1 groups of sample virus intensity indexes and detection environment interference factors, processing by combining corresponding reagent detection capacity evaluation data and target detection affinity data to obtain detection reliability indexes;

s14, carrying out standard detection on n2 groups of standard samples containing target substances with different concentrations according to the respiratory tract reagent to obtain a detection sensitivity index;

s15, detecting the standard sample under n3 groups of different detection environments according to the respiratory tract reagent to obtain a detection stability index;

s16, performing interference detection according to n4 groups of identical standard samples to obtain a detection specificity index;

S17, according to the detection reliability index, the detection sensitivity index and the detection stability index, carrying out accuracy assessment by combining the detection specificity index to obtain a detection accuracy index;

S18, comparing the detection accuracy index with a preset accuracy threshold value, judging whether the detection result of the respiratory tract reagent is accurate according to the comparison result, and correspondingly adjusting.

It should be noted that, along with the popularity of viruses such as influenza and mycoplasma, the role played by respiratory tract reagent detection in life is increasingly important, so that the accuracy of a detection result is crucial, in order to improve the quality of respiratory tract reagents and the accuracy of the detection result, it is necessary to ensure that factors considered in the quality inspection process are comprehensive enough, and the quality inspection effect is efficient enough, therefore, in this embodiment, firstly, by collecting characteristic information of preset respiratory tract reagents and generating a reagent characteristic cognition map, then extracting reagent raw material characteristic data and processing to obtain reagent detection capability evaluation data, obtaining characteristic data and detection environment characteristic data of preset standard samples, respectively processing to obtain sample virus intensity indexes and detection environment interference factors, processing to combine with the detection capability evaluation data to obtain target object detection affinity data, further processing to obtain detection reliability indexes, detecting n2 groups of standard samples containing target substances with different concentrations according to the respiratory tract reagents, processing to combine with standard detection result data to obtain detection sensitivity indexes, respectively detecting n3 groups of different detection environments according to the respiratory tract reagents, respectively extracting the corresponding detection raw material characteristic data and processing to obtain the corresponding detection environment interference factors, respectively combining with the detection sensitivity indexes, and obtaining the detection sensitivity indexes and the similar to the detection result detection indexes after the detection indexes are respectively processed according to the detection sensitivity indexes, obtaining a detection accuracy index, comparing the detection accuracy index with a preset accuracy threshold, judging whether the detection result of the respiratory tract reagent is accurate according to the comparison result, and correspondingly adjusting the detection result, so that the technology of respiratory tract reagent quality inspection is realized.

Referring to fig. 2, fig. 2 is a flowchart of a method for obtaining reagent detection capability evaluation data according to a method for respiratory tract reagent quality inspection according to some embodiments of the present application. According to an embodiment of the present application, the collecting characteristic information of a preset respiratory tract reagent, extracting characteristic data of a raw material of the reagent, and processing to obtain reagent detection capability evaluation data includes:

s21, acquiring characteristic information of a preset respiratory tract reagent, including primer information, enzyme activity information, antibody information, buffer information, nucleotide information and color reagent information, and generating a reagent characteristic cognitive map;

s22, extracting reagent raw material characteristic data according to the reagent characteristic cognition map, wherein the reagent raw material characteristic data comprise primer complementarity data, enzyme activity data, antibody specificity data, buffer stability data, nucleotide concentration data and developer sensitivity data;

S23, processing according to 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.

Firstly, for the respiratory tract reagent to be tested, firstly, testing the detection capability of the respiratory tract reagent, so that characteristic information of the preset respiratory tract reagent, including primer information, enzyme activity information, antibody information, buffer information, nucleotide information and color reagent information, is acquired, and a reagent characteristic cognitive map is generated, wherein the reagent characteristic cognitive map can represent the characteristic information of the respiratory tract reagent in a structured form, and through reasoning and analysis, implicit relation and mode among the characteristic information are found, and further reagent raw material characteristic data, including primer complementarity data, enzyme activity data, antibody specificity data, buffer stability data, nucleotide concentration data and color reagent sensitivity data, are extracted according to the reagent characteristic cognitive map, and then are processed according to the data, so as to obtain reagent detection capability evaluation data.

Referring to fig. 3, fig. 3 is a flowchart of a method for detecting a respiratory tract agent according to some embodiments of the application for obtaining target detection affinity data. According to an embodiment of the present application, the obtaining feature data of a preset standard sample and detecting environmental feature data, processing to obtain a sample virus intensity index and detecting an environmental interference factor, and processing in combination with the reagent detection capability evaluation data to obtain target object detection affinity data includes:

S31, acquiring characteristic data of a preset standard sample, including viral load data and viral nucleic acid content data, and processing to obtain a sample virus intensity index;

s32, acquiring detection environment characteristic data, including temperature data, humidity data and air quality record data, and processing to acquire detection environment interference factors;

S33, processing according to the sample virus intensity index and the detection environment interference factor and combining the reagent detection capability evaluation data to obtain target object detection affinity data.

It should be noted that, before evaluating whether the reagent is reliable, the affinity level of the reagent for detecting the target object needs to be evaluated, so that the characteristic data of the preset standard sample, including the virus load data and the virus nucleic acid content data, is firstly obtained, the sample virus intensity index is obtained by processing, then the detection environment characteristic data, including the temperature data, the humidity data and the air quality record data, is obtained by processing, the detection environment interference factor is obtained, and then the target object detection affinity data is obtained by processing according to the sample virus intensity index and the detection environment interference factor and in combination with the reagent detection capability evaluation data;

the calculation formula of the sample virus intensity index is as follows:

;

Wherein, As an index of the intensity of the sample virus,Respectively viral load data and viral nucleic acid content data,Is a preset characteristic coefficient (the characteristic coefficient is obtained by inquiring a preset reagent detection database);

The calculation formula for detecting the environmental interference factor is as follows:

;

Wherein, In order to detect the environmental interference factor,Respectively temperature data, humidity data and air quality record data,Is a preset characteristic coefficient (the characteristic coefficient is obtained by inquiring a preset reagent detection database).

According to an embodiment of the present invention, the processing according to the n1 sets of the sample virus intensity index and the detection environment interference factor, in combination with the corresponding reagent detection capability evaluation data and target detection affinity data, to obtain a detection reliability index includes:

the calculation formula of the detection reliability index is as follows:

;

Wherein, In order to detect the reliability index of the device,Respectively isThe i-th group of target object detection affinity data, sample virus intensity index, reagent detection capability evaluation data and detection environment interference factors,Is a preset characteristic coefficient (the characteristic coefficient is obtained by inquiring a preset reagent detection database).

It should be noted that, after obtaining the target detection affinity data of the reagent, to obtain the detection reliability index of the reagent, further processing is required, that is, according to the n1 groups of sample virus intensity indexes and the detection environment interference factors, the detection reliability index is obtained by processing the corresponding reagent detection capability evaluation data and the target detection affinity data through a calculation formula of a preset reagent detection evaluation model.

Referring to fig. 4, fig. 4 is a flowchart of a method for obtaining a detection sensitivity index according to a respiratory tract reagent quality inspection method according to some embodiments of the present application. According to an embodiment of the present application, the standard detection of n2 sets of standard samples containing target substances with different concentrations according to the respiratory tract reagent, to obtain a detection sensitivity index, includes:

S41, detecting n2 groups of standard samples containing target substances with different concentrations according to the respiratory tract reagent, and obtaining corresponding detection result data, wherein the detection result data comprises target substance concentration data and cycle threshold value data;

S42, acquiring standard detection result data corresponding to standard samples of the target substances with different concentrations according to a preset respiratory tract reagent detection monitoring platform database, wherein the standard detection result data comprises standard target substance concentration data and standard cycle threshold value data;

S43, according to the n2 groups of detection corresponding target object concentration data and cycle threshold data, processing is carried out by combining the standard target object concentration data and the standard cycle threshold data, and a detection sensitivity index is obtained.

It should be noted that, sensitivity detection of the reagent is one of key indexes of quality inspection, in order to obtain a detection sensitivity index, first, n2 groups of standard samples containing target substances with different concentrations are detected according to respiratory tract reagents, corresponding detection result data including target concentration data and cycle threshold data are obtained, standard detection result data corresponding to standard samples of target substances with different concentrations including standard target concentration data and standard cycle threshold data are obtained at the same time, and then processing is performed according to the above data to obtain a detection sensitivity index.

According to an embodiment of the present invention, the detecting the standard sample according to the respiratory tract reagent under n3 different detection environments respectively to obtain a detection stability index includes:

the calculation formula of the detection stability index is as follows:

;

Wherein, In order to detect the stability index of the test piece,Is thatThe j-th group of different detection environments corresponds to the coefficient of variation,Is a preset characteristic coefficient (the characteristic coefficient is obtained by inquiring a preset reagent detection database).

It should be noted that, the stability detection of the reagent is another key index of quality inspection, so that the standard sample is detected under n3 groups of different detection environments according to the respiratory tract reagent, and each group of detection environments is repeated for m times to perform the same detection, and the m groups of detection results are processed to obtain the corresponding variation coefficient, and then the obtained n3 groups of corresponding variation coefficients are processed to obtain the detection stability index.

According to an embodiment of the present invention, the interference detection is performed according to n4 groups of identical standard samples to obtain a detection specificity index, including:

The calculation formula of the detection specificity index is as follows:

;

Wherein, In order to detect the index of specificity,Is thatThe kth corresponding post-interference target concentration data in the group detection result,As a result of the standard concentration data of the target,Is a preset characteristic coefficient (the characteristic coefficient is obtained by inquiring a preset reagent detection database).

It should be noted that, the method for confirming that the reagent has specific recognition capability to the target substance and can ensure that the reagent can not misjudge similar substances includes that the n4 groups of identical standard samples are respectively added with different concentrations of interference substances similar to the target substance, and the respiratory tract reagent is used for respectively detecting to obtain post-interference detection result data corresponding to detection results, including post-interference target substance concentration data, and then processing is carried out according to the post-interference target substance concentration data combined with the standard target substance concentration data to obtain a detection specificity index, wherein the post-interference target substance concentration data refers to actual target substance concentration data obtained by detecting samples added with the interference substances similar to the target substance by the reagent.

According to an embodiment of the present invention, the 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 includes:

The calculation formula of the detection accuracy index is as follows:

;

Wherein, In order to detect the index of accuracy of the measurement,Respectively a detection accuracy index, a detection sensitivity index, a detection stability index and a detection specificity index,Is a preset characteristic coefficient (the characteristic coefficient is obtained by inquiring a preset reagent detection database).

It should be noted that, the detection accuracy of the reagent is affected by various factors and needs to be considered comprehensively, so that according to the obtained detection reliability index, detection sensitivity index and detection stability index, the accuracy evaluation is performed by combining the detection specificity index through a calculation formula of a preset reagent detection test model, and the detection accuracy index is obtained.

In a second aspect, the invention also discloses a respiratory tract reagent quality inspection system, which comprises a memory and a processor, wherein the memory comprises a respiratory tract reagent quality inspection method program, and the respiratory tract reagent quality inspection method program realizes the following steps when being executed by the processor:

According to an embodiment of the present invention, the collecting characteristic information of a preset respiratory tract reagent, extracting characteristic data of a raw material of the reagent, and processing to obtain reagent detection capability evaluation data includes:

According to an embodiment of the present invention, the obtaining feature data of a preset standard sample and detecting environmental feature data, processing to obtain a sample virus intensity index and detecting an environmental interference factor, and processing in combination with the reagent detection capability evaluation data to obtain target object detection affinity data includes:

the calculation formula of the sample virus intensity index is as follows:

;

the calculation formula of the detection reliability index is as follows:

;

According to an embodiment of the present invention, the standard detection of n2 sets of standard samples containing target substances with different concentrations according to the respiratory tract reagent, to obtain a detection sensitivity index, includes:

the calculation formula of the detection stability index is as follows:

;

The calculation formula of the detection specificity index is as follows:

;

The calculation formula of the detection accuracy index is as follows:

;

A third aspect of the present invention provides a readable storage medium having stored therein a respiratory tract agent quality inspection method program which, when executed by a processor, implements the steps of a respiratory tract agent quality inspection method as described in any one of the preceding claims.

The invention discloses a respiratory tract reagent quality inspection method, a system and a medium, which are characterized in that characteristic information of a preset respiratory tract reagent is acquired, a reagent characteristic cognition map is generated, reagent raw material characteristic data are extracted and processed to obtain reagent detection capability evaluation data, characteristic data and detection environment characteristic data of a preset standard sample are obtained, the characteristic data and detection environment interference factors of the sample virus are respectively processed to obtain sample intensity indexes and the detection environment interference factors, the detection capability evaluation data are combined to process to obtain target object detection affinity data, further processing is performed to obtain detection reliability indexes, n2 groups of standard samples containing target substances with different concentrations are detected according to the respiratory tract reagent, the detection sensitivity indexes are obtained according to the detection result data and combined with the standard detection result data, the standard samples are detected in n3 groups of different detection environments respectively according to the respiratory tract reagent, the detection stability indexes are obtained according to the corresponding variation coefficients, the detection similar interference substances with the target substances are respectively added into n4 groups of the standard samples, the detection result indexes are processed according to the interference result data and the corresponding standard detection result data, the detection reliability indexes are obtained, finally, the detection accuracy is improved according to the detection reliability, the detection sensitivity is combined with the detection accuracy and the detection sensitivity indexes, the detection accuracy is adjusted, and the detection accuracy is compared with the detection accuracy is adjusted according to the detection accuracy, and the detection accuracy is compared with the detection threshold, and the detection accuracy is compared with the detection accuracy is accurately, and is compared with the detection threshold is achieved.

In the several embodiments provided by the present application, it should be understood that the disclosed apparatus and method may be implemented in other ways. The above-described embodiments of the apparatus are merely illustrative, and for example, the division of the units is merely a logical function division, and there may be additional divisions of actual implementation, such as multiple units or components may be combined or integrated into another system, or some features may be omitted or not performed. In addition, the various components shown or discussed may be coupled or directly coupled or communicatively coupled to each other via some interface, whether indirectly coupled or communicatively coupled to devices or units, whether electrically, mechanically, or otherwise.

The units described as separate components may or may not be physically separate, and components displayed as units may or may not be physical units, may be located in one place or distributed on a plurality of network units, and may select some or all of the units according to actual needs to achieve the purpose of the embodiment.

In addition, each functional unit in each embodiment of the present invention may be integrated in one processing unit, or each unit may be separately used as a unit, or two or more units may be integrated in one unit, where the integrated units may be implemented in a form of hardware or a form of hardware plus a form of software functional unit.

It will be appreciated by those of ordinary skill in the art that implementing all or part of the steps of the above method embodiments may be implemented by hardware associated with program instructions, where the above program may be stored in a readable storage medium, where the program when executed performs the steps comprising the above method embodiments, where the above storage medium includes various media that may store program code, such as a removable storage device, a Read-Only Memory (ROM), a random access Memory (RAM, random Access Memory), a magnetic disk, or an optical disk.

Or the above-described integrated units of the invention may be stored in a readable storage medium if implemented in the form of software functional modules and sold or used as separate products. Based on such understanding, the technical solution of the embodiments of the present invention may be embodied in essence or a part contributing to the prior art in the form of a software product stored in a storage medium, including several instructions for causing a computer device (which may be a personal computer, a server, or a network device, etc.) to execute all or part of the methods described in the embodiments of the present invention. The storage medium includes various media capable of storing program codes such as a removable storage device, a ROM, a RAM, a magnetic disk or an optical disk.

Claims

1. A respiratory tract reagent quality inspection method, which is characterized by comprising the following steps:

Threshold value comparison is carried out according to the detection accuracy index and a preset accuracy threshold value, whether the detection result of the respiratory tract reagent is accurate or not is judged according to the comparison result, and corresponding adjustment is carried out;

The processing according to n1 groups of the sample virus intensity indexes and detection environment interference factors, and combining corresponding reagent detection capability evaluation data and target detection affinity data to obtain detection reliability indexes, including:

the calculation formula of the detection reliability index is as follows:

;

Wherein, In order to detect the reliability index of the device,Respectively isThe i-th group of target object detection affinity data, sample virus intensity index, reagent detection capability evaluation data and detection environment interference factors,Is a preset characteristic coefficient;

The detection of the standard sample according to the respiratory tract reagent is performed under n3 groups of different detection environments to obtain a detection stability index, including:

the calculation formula of the detection stability index is as follows:

;

Wherein, In order to detect the stability index of the test piece,Is thatThe j-th group of different detection environments corresponds to the coefficient of variation,Is a preset characteristic coefficient;

The performing accuracy assessment according to the detection reliability index, the detection sensitivity index and the detection stability index by combining the detection specificity index to obtain a detection accuracy index comprises the following steps:

The calculation formula of the detection accuracy index is as follows:

;

2. The method for testing the quality of the respiratory tract reagent according to claim 1, wherein the steps of collecting the characteristic information of the preset respiratory tract reagent, extracting the characteristic data of the raw materials of the reagent, and processing to obtain the evaluation data of the detection capability of the reagent comprise the following steps:

3. The method for detecting respiratory tract reagent quality according to claim 2, wherein the steps of obtaining the characteristic data of the preset standard sample and the detection environment characteristic data, obtaining the sample virus intensity index and the detection environment interference factor by processing, and processing in combination with the reagent detection capability evaluation data to obtain the target detection affinity data comprise:

4. A method for testing the quality of a respiratory tract reagent according to claim 3, wherein the standard test of n2 standard samples containing target substances with different concentrations according to the respiratory tract reagent is performed to obtain a detection sensitivity index, and the method comprises the following steps:

5. The method of claim 4, wherein the performing the interference detection based on n4 sets of identical standard samples to obtain a detection specificity index comprises:

confirming that the reagent has specific recognition capability on the target substance, ensuring that the reagent does not misjudge similar substances, respectively adding interference substances with different concentrations similar to the target substance into n4 groups of same standard samples, respectively detecting according to the respiratory tract reagent, and obtaining post-interference detection result data corresponding to detection results, including post-interference target substance concentration data;

The calculation formula of the detection specificity index is as follows:

;

6. The respiratory tract reagent quality inspection system is characterized by comprising a memory and a processor, wherein the memory comprises a program of a respiratory tract reagent quality inspection method, and the program of the respiratory tract reagent quality inspection method realizes the following steps when being executed by the processor:

the calculation formula of the detection reliability index is as follows:

;

the calculation formula of the detection stability index is as follows:

;

The calculation formula of the detection accuracy index is as follows:

;

7. A computer readable storage medium, characterized in that it comprises a respiratory tract reagent quality inspection method program, which when executed by a processor, implements the respiratory tract reagent quality inspection method according to any one of claims 1 to 5.