Method for generating component for analysis, and device for generating component for analysis for performing said method

Abstract

According to one embodiment of the present invention, an analysis component generation method for generating a molecular diagnosis analysis component for use in molecular diagnosis by amplification of a target nucleic acid molecule, the method being performed by an analysis component generation device, the method comprises: a step for obtaining molecular diagnosis amplification data generated by molecular diagnosis analysis for a plurality of target nucleic acid molecules; and a step of generating an analytic component based at least in part on the molecular diagnostic amplification data, the analytic component comprising: a processing / analysis module, the processing / analyzing module comprises a sub-module for processing and analyzing molecular diagnosis amplification data aiming at a plurality of target nucleic acid molecules in the target existence reading software; and a parameter value, the parameter value being referenced by the sub-module.

Description

Technical Field

[0001] The present invention relates to a method and apparatus for generating assay components for molecular diagnosis of multiple target nucleic acid molecules. Background Art

[0002] Molecular diagnosis is a rapidly growing field in the in vitro diagnostic market for early disease diagnosis. Among them, the method using nucleic acid is used to diagnose pathogenic genetic factors related to infections caused by viruses and bacteria due to its high specificity and high sensitivity.

[0003] Most nucleic acid-based diagnostic methods utilize nucleic acid amplification reactions to amplify target nucleic acids (e.g., viral or bacterial nucleic acids). As a typical example, the polymerase chain reaction (PCR) in nucleic acid amplification reactions includes the following repeated cyclic processes: denaturation of double-stranded DNA, annealing of oligonucleotide primers to the DNA template, and primer extension mediated by DNA polymerase (Mullis et al., U.S. Patent Nos. 4,683,195, 4,683,202, and 4,800,159; Saiki et al., Science 230:1350-1354 (1985)). As other methods of nucleic acid amplification, include: ligase chain reaction (LCR) (U.S. Patent Nos. 4,683,195 and 4,683,202; 《PCR Protocols: A Guide to Methods and Applications》(edited by Innis et al., 1990)), strand displacement amplification (SDA) (Walker et al., Nucleic Acids Res. 20(7):1691-6 (1992); Walker, PCR Methods Appl 3(1):1-6 (1993)), transcription-mediated amplification (Phyffer et al., Clin. Microbiol. 34:834-841 (1996); Vuorinen, et al., J. Clin. Microbiol. 33:1856-1859 (1995)), nucleic acid sequence-based amplification (NASBA) (Compton, Nature 350(6313):91-2 (1991)), rolling circle amplification (RCA) (Lisby, Mol. Biotechnol. 12(1):75-99 (1999); Hatche et al., Genet. Anal. 15(2):35-40 (1999)) and Q-beta replicase (Lizardi et al., BiolTechnology 6:1197(1988)), loop-mediated isothermal amplication (LAMP, Y. Mori, H. Kanda and T. Notomi, J. Infect. Chemother., 2013, 19, 404-411), recombinase polymerase amplication (RPA, J. Li, J. Macdonald and F. von Stetten, Analyst, 2018, 144:31-67.), etc.

[0004] In recent years, based on such nucleic acid amplification reactions, multiplex diagnostic techniques that can detect multiple target nucleic acids in a single tube have been used. For example, as an example of nucleic acid amplification reactions, there are various multiplex detection techniques that use the above-mentioned methods such as PCR and LAMP to detect multiple viruses at once.

[0005] In these nucleic acid amplification reaction technologies, first, an amplification process is performed on the target nucleic acid, and then, using the data set obtained during the amplification process, a reading process for detecting the presence of the target nucleic acid molecule is performed. The data set obtained during the above-mentioned amplification process is obtained from the device that performs the amplification. For such a data set, more than one reading module can be applied to read the presence or absence of the target nucleic acid molecule. Looking at such a reading module, depending on the characteristics of the target nucleic acid molecule, the type or execution order of the functions performed may be different, or additional functions may be performed or some functions may not be performed. In addition, the type of parameters that such a reading module needs to refer to may be different depending on the characteristics of the target nucleic acid molecule, or even if the parameter types are the same, the specific values may also differ.

[0006] In addition, the data set obtained during such an amplification process will be used for the reading process of detecting the presence or absence of the target. Here, the aforementioned reading process can be implemented by software.

[0007] The above software can apply the data set obtained during the amplification process of the target nucleic acid molecule to the reading module to confirm the presence or absence of the target.

[0008] Such a reading module needs to refer to parameter values during the process of applying the data set to confirm the presence or absence of the target nucleic acid molecule, and usually, the development of the above software uses a hard-coding method to solidify the reading module and the parameter values it references. Hard coding refers to a programming method in which data is directly written into the source code when implementing software.

[0009] However, when it is necessary to add parameters or modules to be detected by the software or change the execution order of the reading modules used in the original target analysis, the above changes must be implemented in the software one by one. After the development of the new version of the software is completed, the new version of the software is deployed, and this process has the problem of cumbersome operation. Summary of the Invention

[0010] Technical Problems to be Solved

[0011] One problem to be solved by an embodiment is to generate different assay components for different assays in molecular diagnosis.

[0012] Another problem to be solved by an embodiment is to achieve efficient deployment and management of processing / analysis modules and parameter values through assay components separated from the target presence reading software.

[0013] It should be noted that the problems to be solved by the present invention are not limited to the above content, and other problems not mentioned can be clearly understood by those skilled in the art based on the following description.

[0014] Methods for Solving Technical Problems

[0015] According to an embodiment of the assay component generation method, it is executed by an assay component generation device used in a target presence reading software that displays molecular diagnostic amplification data. The method includes: a step of obtaining molecular diagnostic amplification data generated by molecular diagnostic assays for a plurality of target nucleic acid molecules; and a step of generating assay components at least partially based on the molecular diagnostic amplification data, wherein the assay components include: a processing / analysis module, the processing / analysis module includes sub-modules for processing and analyzing molecular diagnostic amplification data for a plurality of target nucleic acid molecules in the target presence reading software; and parameter values, the parameter values are for reference by the sub-modules, and in the sub-modules, when processing and analyzing the molecular diagnostic amplification data, the pre-defined sub-modules to be called are requested by the target presence reading software, and the molecular diagnostic amplification data for the plurality of target nucleic acid molecules are processed and analyzed with reference to the parameter values.

[0016] An analytical component generation method according to an embodiment is executed by an analytical component generation device used in a target presence / absence reading software that displays molecular diagnostic amplification data. The method includes: a step of obtaining molecular diagnostic amplification data generated by molecular diagnostic analysis for a plurality of target nucleic acid molecules; a step of generating analytical components at least partially based on the molecular diagnostic amplification data; and a step of deploying the analytical components to a target presence / absence reading terminal storing the target presence / absence reading software. Wherein, the analytical components include: a processing / analysis module, the processing / analysis module includes sub-modules for processing and analyzing molecular diagnostic amplification data for a plurality of target nucleic acid molecules in the target presence / absence reading software; and parameter values for reference by the sub-modules. Wherein, in the sub-modules, when processing and analyzing the molecular diagnostic amplification data, the sub-modules predefined to be called are requested by the target presence / absence reading software, and the molecular diagnostic amplification data for the plurality of target nucleic acid molecules is processed and analyzed with reference to the parameter values.

[0017] A target presence / absence reading method executed by a target presence / absence reading terminal according to another embodiment. The target presence / absence reading terminal uses analytical components used in a target presence / absence reading software that displays molecular diagnostic amplification data to perform target presence / absence reading. The target presence / absence reading method includes: a step of obtaining analytical components generated at least partially based on molecular diagnostic amplification data generated by molecular diagnostic analysis for a plurality of target nucleic acid molecules; and a step of processing and analyzing the molecular diagnostic amplification data for the plurality of target nucleic acid molecules using the analytical components. Wherein, the analytical components include: a processing / analysis module, the processing / analysis module includes sub-modules for processing and analyzing molecular diagnostic amplification data for a plurality of target nucleic acid molecules in the target presence / absence reading software; and parameter values for reference by the sub-modules. Wherein, in the sub-modules, when processing and analyzing the molecular diagnostic amplification data, the sub-modules predefined to be referenced are requested by the target presence / absence reading software, and the molecular diagnostic amplification data for the plurality of target nucleic acid molecules is processed and analyzed with reference to the parameter values.

[0018] An apparatus for generating analysis components according to another embodiment, the apparatus comprising: a processor; a memory; and a computer program, the computer program being loaded into the memory and executed by the processor, the computer program comprising: instructions for obtaining molecular diagnostic amplification data generated by molecular diagnostic analysis for a plurality of target nucleic acid molecules; instructions for generating analysis components at least partially based on the molecular diagnostic amplification data, wherein the analysis components include: a processing / analysis module, the processing / analysis module including sub-modules for processing and analyzing the molecular diagnostic amplification data for the plurality of target nucleic acid molecules in the presence / absence reading software of the target; and parameter values for reference by the sub-modules, wherein in the sub-modules, when processing and analyzing the molecular diagnostic amplification data, the sub-modules predefined to be referenced are requested by the presence / absence reading software of the target, and the molecular diagnostic amplification data for the plurality of target nucleic acid molecules is processed and analyzed with reference to the parameter values.

[0019] An apparatus for generating analysis components according to another embodiment, the apparatus comprising: a processor; a memory; and a computer program, the computer program being loaded into the memory and executed by the processor, the computer program comprising: instructions for obtaining molecular diagnostic amplification data generated by molecular diagnostic analysis for a plurality of target nucleic acid molecules; instructions for generating analysis components at least partially based on the molecular diagnostic amplification data; and instructions for deploying the analysis components to a presence / absence reading terminal of the target storing the presence / absence reading software of the target, wherein the analysis components include: a processing / analysis module, the processing / analysis module including sub-modules for processing and analyzing the molecular diagnostic amplification data for the plurality of target nucleic acid molecules in the presence / absence reading software of the target; and parameter values for reference by the sub-modules, wherein in the sub-modules, when processing and analyzing the molecular diagnostic amplification data, the sub-modules predefined to be referenced are requested by the presence / absence reading software of the target, and the molecular diagnostic amplification data for the plurality of target nucleic acid molecules is processed and analyzed with reference to the parameter values.

[0020] Advantages of the Invention

[0021] According to one embodiment, analysis components can be generated and deployed for different assays in molecular diagnostics, and the analysis components include a processing / analysis module and parameter values referenced by the processing / analysis module.

[0022] According to one embodiment, through analysis components separated from the presence / absence reading software of the target, efficient deployment and management of the processing / analysis module and parameter values are achieved. Brief Description of the Drawings

[0023] Figure 1It is a flowchart of a method for generating an assay component according to an embodiment.

[0024] Figure 2 The conceptual diagram illustrates a nucleic acid detection device and a component optimization device connected to an assay component management device in an embodiment.

[0025] Figure 3 It is a block diagram of an assay component management device according to an embodiment.

[0026] Figure 4 It is a schematic diagram for explaining assay components generated for different assays in molecular diagnosis according to an embodiment.

[0027] Figure 5 It is an example diagram showing a processing / analysis module, parameters, and assay information included in an assay component according to an embodiment.

[0028] Figure 6 It is an example diagram showing a processing / analysis module, parameters, and assay information included in an assay component for different targets according to an embodiment.

[0029] Figure 7 It is a flowchart of a method for generating an assay component according to another embodiment.

[0030] Figure 8 It is a diagram schematically showing the network relationship between an assay component generation device and a target presence / absence reading terminal in an embodiment. Detailed Description of the Embodiment

[0031] Advantages, features, and implementation methods of the present invention will become clear through embodiments described in detail with reference to the accompanying drawings. However, the present invention is not limited to the embodiments disclosed below, but can be implemented in various different forms. These embodiments are provided only to make the present disclosure fully complete and to fully convey the scope of the present invention to those skilled in the art. The protection scope of the present invention is defined only by the claims.

[0032] When describing embodiments of the present invention, if a detailed description of a well-known function or structure is considered to unnecessarily obscure the gist of the present invention, that part of the description will be omitted. The terms used below are defined based on the functions in the embodiments of the present invention and may vary depending on the intention or convention of the user or operator. Therefore, the definitions of these terms should be interpreted based on the overall content of the specification.

[0033] When describingFigure 1 Before that, let's first take a look at the terms used in this application.

[0034] The term "sample" includes biological samples (such as cells, tissues, and body fluids) and non-biological samples (such as food, water, and soil). Among them, biological samples may contain at least one of viruses, bacteria, tissues, cells, blood (including whole blood, plasma, and serum), lymph, bone marrow fluid, saliva, sputum, swab, aspiration, milk, urine, stool, eye fluid, semen, brain extract, spinal fluid, synovial fluid, thymus fluid, bronchoalveolar lavage fluid, ascites, and amniotic fluid. These samples may or may not contain the aforementioned target nucleic acid molecules.

[0035] In addition, when the aforementioned target nucleic acid molecule is a nucleic acid molecule or contains a nucleic acid molecule, a nucleic acid extraction process well-known in the art (reference: Sambrook, J. et al., Molecular Cloning. A Laboratory Manual, 3rd ed. Cold Spring Harbor Press (1101)) can be performed on the sample presumably containing the target nucleic acid molecule. The nucleic acid extraction process may vary depending on the type of sample. Additionally, when the extracted nucleic acid is RNA, a reverse transcription process for synthesizing cDNA can be additionally performed (reference: Sambrook, J. et al., Molecular Cloning. A Laboratory Manual, 3rd ed. Cold Spring Harbor Press (1101)).

[0036] The term "target" includes various substances (such as biological materials and non-biological materials) and can refer to the same object as the term "target nucleic acid molecule" or "target analyte".

[0037] These targets may specifically include at least one of biological materials, more specifically nucleic acid molecules (such as DNA and RNA), proteins, peptides, carbohydrates, lipids, amino acids, biological compounds, hormones, antibodies, antigens, metabolites, and cells. The target may contain the target nucleic acid molecule.

[0038] The term "target of interest" can refer to the object in the "target" that needs to be read during the presence / absence reading process.

[0039] The term "cycle" refers to the unit of change in conditions during multiple measurements accompanied by certain changes in conditions. The change in certain conditions means an increase or decrease in, for example, temperature, reaction time, number of reactions, concentration, pH, number of replications of the analyte (such as nucleic acid), etc. Therefore, a cycle can be a time or process cycle, a unit operation cycle, and a reproductive cycle.

[0040] More specifically, the term "cycle" refers to a unit of repetition when a reaction of a certain process is repeated, or when reactions are repeated according to a standard at certain time intervals.

[0041] Alternatively, the term "cycle" refers to a unit of repetition when a certain action is repeated as the reaction proceeds.

[0042] As an example, when performing a nucleic acid amplification reaction, the action of detecting signals generated at certain time intervals can be repeated, and in this case, it can refer to a unit of repetition. In this situation, the cycle may have a time unit.

[0043] As an example, for a nucleic acid amplification reaction, one cycle refers to the following reaction, which includes a denaturation step of nucleic acid, an annealing step of primers, and an extension step of primers. In this case, the change in certain conditions is an increase in the number of reaction repetitions, and a reaction repetition unit including a series of steps is set as one cycle. The number of cycles can include the number of reactions or the reaction time.

[0044] On the one hand, to amplify the signal indicating the presence of the target (target nucleic acid molecule or target of interest), the amplification reaction can be carried out by a method of synchronously amplifying the target and the signal (for example: real-time PCR (Polymerase Chain Reaction) method). According to another embodiment, the amplification reaction can also be carried out by a method of only amplifying the signal indicating the presence of the target while the target itself is not amplified (for example: CPT method (Duck P et al., Biotechnology, Volume 9, pages 142 - 148 (1990)), Invader assay (U.S. Patent Nos. 6,358,691 and 6,194,149)).

[0045] On the other hand, the aforementioned target or target analyte, especially the target nucleic acid molecule, can be amplified by various methods, including polymerase chain reaction (PCR), ligase chain reaction (LCR) (U.S. Patent Nos. 4,683,195 and 4,683,202; "PCR Protocols: A Guide to Methods and Applications" (edited by Innis et al., 1990)), strand displacement amplification (SDA) (Walker et al., Nucleic Acids Res. 20(7):1691-6 (1992), Walker, PCR Methods Appl 3(1):1-6 (1993)), transcription-mediated amplification (Phyffer et al., J. Clin. Microbiol. 34:834-841 (1996), Vuorinen et al., J. Clin. Microbiol. 33:1856-1859 (1995)), nucleic acid sequence-based amplification (NASBA) (Compton, Nature 350(6313):91-2 (1991)), rolling circle amplification (RCA) (Lisby, Mol. Biotechnol. 12(1):75-99 (1999), Hatche et al., Genet. Anal. 15(2):35-40 (1999)) and Q-beta replicase (Lizardi et al., BiolTechnology 6:1197 (1988)), loop-mediated isothermal amplication (LAMP, Y. Mori, H. Kanda and T. Notomi, J. Infect. Chemother., 2013, 19, 404-411), recombinase polymerase amplication (RPA, J. Li, J. Macdonald and F. von Stetten, "The Analyst", 2018, 144:31-67.), etc.

[0046] On the other hand, the amplification reaction is accompanied by the amplification of the target (specifically, the target nucleic acid molecule), thereby amplifying the signal. For example, the amplification reaction is either carried out according to PCR, specifically real-time PCR, or by an isothermal amplification reaction (such as LAMP (Loop-mediated Isothermal Amplification) or RPA (Recombinase Polymerase Amplification)).

[0047] Here, the term "signal value" refers to a value obtained by quantifying the signal generated in a reaction according to a certain scale, particularly the signal level (e.g., signal intensity) actually measured during the cycles of the amplification reaction, or a modified value thereof. The modified value may include a signal value obtained by mathematically processing the actually measured signal value. Examples of the signal value obtained by mathematically processing the actually measured signal value (i.e., the signal value of the original data set) may include logarithmic values or derivative values.

[0048] The term "presence or absence reading process of the target" refers to an operation of determining the presence or absence of the target in a sample using the signal value, and also includes an operation of analyzing the data used to determine the presence or absence of the target.

[0049] Various embodiments of the present invention will be described below with reference to the accompanying drawings.

[0050] Figure 1 is a flowchart of a method for generating an assay component according to an embodiment.

[0051] Reference Figure 1 In step S100, by performing an assay for molecular diagnosis on a plurality of target nucleic acid molecules, generated molecular diagnostic amplification data can be obtained.

[0052] In one embodiment, the assay for molecular diagnosis may refer to a detection reagent for molecular diagnosis. The molecular diagnostic amplification data generated using the assay for molecular diagnosis is specifically described in Figure 2 .

[0053] The method for generating an assay component according to an embodiment can be implemented by an assay component generation device (100) used in software for reading the presence or absence of a target representing molecular diagnostic amplification data. The assay component generation device (100) is a device that obtains molecular diagnostic amplification data and generates an assay component using the molecular diagnostic amplification data.

[0054] In step S200, an assay component can be generated at least in part based on molecular diagnostic amplification data.

[0055] The assay component is a component used in the target presence / absence reading software for the target presence / absence reading operation, and can include at least one of a processing / analysis module, a parameter value, and analysis information.

[0056] Here, the processing / analysis module is a module for processing and analyzing molecular diagnostic amplification data for multiple target nucleic acid molecules in the target presence / absence reading software.

[0057] The target presence / absence reading software is software that applies the obtained molecular diagnostic amplification data to one or more reading processing / analysis modules in a predetermined order to confirm the presence or absence of target nucleic acid molecules. In one embodiment, the target presence / absence reading software can be a program installed in a terminal for reading the target presence / absence.

[0058] The target presence / absence reading software can include a function of displaying the working result of the assay component. For example, the target presence / absence reading software can be a program that displays the results of the processing and analysis performed in the assay component as at least one of numbers, charts, or curves.

[0059] The processing / analysis module includes sub-modules. In one embodiment, the sub-modules can be algorithms or software. Among these sub-modules, the sub-modules called during the processing and analysis of molecular diagnostic amplification data can be predefined. For example, when performing the processing and analysis of molecular diagnostic data, all sub-modules can be called, or some necessary sub-modules can be called, or only one sub-module can be called.

[0060] The above predefined sub-modules can process and analyze molecular diagnostic amplification data for multiple target nucleic acid molecules by referring to parameter values. At this time, the predefined sub-modules can process and analyze molecular diagnostic amplification data in the presence / absence reading terminal according to the request of the target presence / absence reading software.

[0061] The parameter values can be referred to by the sub-modules. The definition of the parameter values is as follows.

[0062] In the presence / absence reading terminal, molecular diagnostic amplification data for multiple target nucleic acid molecules can be processed and analyzed by referring to parameter values. In the presence / absence reading terminal, the processing / analysis module, parameter values, and assay information included in the assay component can be used to perform the work of reading the presence or absence of target nucleic acid molecules.

[0063] Figure 2The conceptual diagram illustrates a nucleic acid detection device and a component optimization device connected to an Assay component management device in one embodiment.

[0064] Figure 2 Shown therein is an Assay component management device (100), a nucleic acid detection device (110), and a component optimization device (120) for generating Assay components according to one embodiment. They (100, 110, 120) can be connected to each other through wired or wireless communication. However, Figure 2 merely exemplary, the idea of the present disclosure is not limited to Figure 2 .

[0065] On the other hand, different from the above, the component optimization device (120) and the target presence / absence reading software can also be included in the Assay component generation device (100) to be implemented. However, the following will be described on the premise that the above configuration (100, 110, 120) is implemented or connected in the manner as Figure 1 shown. Hereinafter, each configuration will be carefully observed.

[0066] The nucleic acid detection device (110) implements nucleic acid amplification reaction and nucleic acid detection work for a sample. According to an embodiment, the nucleic acid detection device (110) can perform nucleic acid detection operation without performing nucleic acid amplification reaction, but the following will be described on the premise that the nucleic acid detection device (110) also performs nucleic acid amplification reaction.

[0067] On the other hand, as the aforementioned nucleic acid amplification reaction proceeds, if the sample in the reaction vessel contains target nucleic acid molecules, not only can its amount be amplified, but also the size of the signal generated by the aforementioned signal generation device can be amplified as described above. If a nucleic acid amplification reaction is carried out, the size of the signal generated by the signal generation device can also be amplified. From this point of view, the nucleic acid amplification reaction can trigger a signal generation reaction as described above.

[0068] Therefore, the nucleic acid detection device (110) is implemented to detect the size of these signals. Specifically, the nucleic acid detection device (110) can monitor in real time the size of the signal that changes as the nucleic acid amplification reaction proceeds. The monitoring result can be output from the nucleic acid detection device (110) in the form of a data set as described in the term definition section (for example, in the form of signal intensities for different cycles). Here, the signal intensities for different cycles are information serving as a basis for reading whether there are target nucleic acid molecules in the sample. The nucleic acid detection device (110) can generate molecular diagnostic amplification data by using molecular diagnostic assays performed on multiple target nucleic acid molecules.

[0069] Molecular diagnostic amplification data can be obtained from the results of nucleic acid polymerase chain reaction (PCR) targeting multiple target nucleic acid molecules.

[0070] The analysis component (Assay component) management device (110) can obtain the generated molecular diagnostic amplification data from the nucleic acid detection device (110) by using molecular diagnostic analysis performed on multiple target nucleic acid molecules.

[0071] The component optimization device (120) can be implemented by a PC or a server. Such a component optimization device (120) can optimize the composition included in the analysis component (Assay component). It can optimize the processing / analysis module, parameter value, or execution order of the processing / analysis module for the processing / analysis of molecular diagnostic amplification data. Here, specific examples of the processing / analysis module, parameter value, or execution order of the processing / analysis module will be described in detail in Figure 5 below.

[0072] Hereinafter, the analysis component (Assay component) generation device (100) shown in Figure 3 will be observed in more detail in Figure 2 below.

[0073] Figure 3 is a block diagram of an analysis component (Assay component) management device according to an embodiment. Referring to Figure 3 , the analysis component (Assay component) generation device (100) includes, but is not limited to: a communication unit (110), a memory (120), a processor (130), and a display unit (140).

[0074] First, the communication unit (110) is implemented by a wired or wireless communication module. Through such a communication unit (110), the analysis component (Assay component) generation device (100) can communicate with the outside. For example, the analysis component (Assay component) generation device (100) can receive molecular diagnostic amplification data regarding the amplification result from the nucleic acid detection device (110) through the communication unit (110). In addition, the analysis component (Assay component) generation device (100) can receive information required for generating the analysis component (Assay component) from the outside, such as Figure 2 the component optimization device (120).

[0075] A variety of data and even information including at least one command are stored in the memory (120). Among the stored data, data received from the component optimization device (120) through the communication unit (110) or data processed by the processor (130) can be stored. These data and information can include various types of information required to generate assay components, etc.

[0076] On the other hand, in Figure 3 , the memory (120) is illustrated as being separately configured from the processor (130), but the memory (120) can be implemented as one device with the processor (130). For example, the memory (120) can be a cache - like storage device included inside the processor (130).

[0077] The display unit (140) can be driven by the processor (130) as follows.

[0078] First, information can be displayed on this display unit (140). In addition, the user can input predetermined information through the display unit (140). For such display or input, the display unit (140) can be implemented through a touch screen or a touchpad, etc. On the contrary, it can be implemented by combining an LCD monitor and a keyboard, etc. Here, the information displayed on the display unit (140) may be received from the outside through the communication unit (110) by the assay component generation device (100) or loaded from the memory (120), but is not limited thereto.

[0079] According to an embodiment, the display unit (140) displays an input interface for generating assay components. Specifically, an input interface for inputting the type or order of modules, parameter values based on the modules, etc. is displayed. The module type or order and parameter values included in these interfaces can be received from the outside such as the component optimization device (120) through the communication unit (110) by the assay component generation device (100), or loaded from the memory (120), but are not limited thereto.

[0080] Next, the processor (130) can be implemented by a central processing unit (CPU), a graphics processing unit (GPU), a microcontroller (MCU), or a dedicated processor that executes the method according to an embodiment. Hereinafter, such a processor (130) can be collectively referred to as a single processor or multiple processors, such as a multi - core processor.

[0081] This processor (130) can record data in the memory (120). Additionally, the processor (130) can execute instructions stored in the memory (120). For example, by executing the instructions stored in the memory (120), the processor (130) causes the assay component generating device (100) to perform the following operations.

[0082] First, molecular diagnostic amplification data is obtained from the nucleic acid detection device (110).

[0083] Second, at least partially based on the obtained molecular diagnostic amplification data, an assay component for molecular diagnosis is generated.

[0084] The above-mentioned molecular diagnostic amplification data can be obtained from the results of polymerase chain reaction (PCR) for target nucleic acid molecules.

[0085] In one embodiment, the molecular diagnostic amplification data can also be data obtained through real-time amplification.

[0086] During the detection reagent development process, the molecular diagnostic amplification data should be calculated according to the molecular diagnosis development protocol. According to one embodiment, the assay component generating device (100) can input the experimental information of the experiment that is the basis of the molecular diagnostic amplification data through the input interface.

[0087] For example, in the input interface, the name of the target nucleic acid molecule for which the assay component is desired to be generated, the experimenter, the panel composition for performing the amplification reaction in the nucleic acid detection device (110) by receiving candidate oligonucleotides for multiple wells respectively, PCR components, PCR protocol, PCR equipment, and experimental information related to PCR consumables can be input.

[0088] Specifically, the experimental information in at least one experimental item selected from a group of experimental items is input through the input interface, including the type, experimental materials, experimental procedure, experimental equipment, and combinations of the above elements of the performance verification experiment for candidate oligonucleotides for target nucleic acid molecule detection.

[0089] The candidate oligonucleotides at this time are used to detect the target nucleic acid in the target nucleic acid molecule through polymerase chain reaction (PCR), and refer to the test object for whether the detection performance for the target nucleic acid molecule meets the specified level or for optimizing the detection performance.

[0090] As described above, by providing an input interface for inputting experimental information, the Assay component generation device (100) according to an embodiment can receive necessary experimental information according to a molecular diagnosis development protocol during the detection reagent development process.

[0091] Next, in the Assay component generation device (100) according to an embodiment, a data set is uploaded from the nucleic acid detection device (110), and the nucleic acid detection device (110) performs an amplification reaction on a reaction vessel prepared based on the composition information of the panel input through the input interface. That is, the Assay component generation device (100) obtains molecular diagnosis amplification data generated using a detection reagent for a target nucleic acid molecule.

[0092] The Assay component generation device (100) generates an Assay component for molecular diagnosis at least partially based on the obtained molecular diagnosis amplification data.

[0093] The Assay component for molecular diagnosis is used for molecular diagnosis amplification data and / or the processing and analysis of molecular diagnosis amplification data.

[0094] In the display unit of such a target presence / absence reading software, a data set for molecular diagnosis amplification data, noise cancellation data, an amplification curve, etc. can be displayed.

[0095] In addition, in the display unit of the target presence / absence reading software, it can be displayed whether a target nucleic acid molecule exists in each sample, and detection results such as a Ct value (Cycle Threshold) and a signal value (e.g., an RFU value (Relative Fluorescence Units)) can be displayed.

[0096] In addition, in the display unit of the target presence / absence reading software, a list of detection reagents for a target nucleic acid molecule of interest and its composition can be displayed. At this time, each detection reagent in the detection reagent list can be assigned the generated Assay component. Alternatively, a list of detection reagents for which Assay components are to be generated can be displayed in a standby state.

[0097] Figure 4 It is a schematic diagram for explaining Assay components generated for different Assays in molecular diagnosis according to an embodiment.

[0098] As Figure 4As shown, the assay component management device can generate different assay components for each molecular diagnostic assay.

[0099] For example, to generate assay components for molecular diagnostic assays 1 to 3, the assay component management device can separately generate assay component 1 for molecular diagnostic assay 1, assay component 2 for molecular diagnostic assay 2, and assay component 3 for molecular diagnostic assay 3.

[0100] The processing / analysis modules for the assay components corresponding to each molecular diagnostic assay need to be designed based on the characteristics of the target drug. Therefore, there are differences in the above modules for different molecular diagnostic assays. Because according to the characteristics of the detection reagent, the order of the sub-modules included in the processing / analysis module, some sub-modules are added or excluded. Even if the processing / analysis modules for some molecular diagnostic assays are the same, the parameter values of the processing / analysis modules will be different.

[0101] Figure 5 It is an example diagram showing the processing / analysis modules, parameters, and assay information included in the assay components according to an embodiment.

[0102] As Figure 5 shown, the assay component can include a processing / analysis module, parameter values, and assay information. The assay component exists in the form of an integrated package, including the processing / analysis modules and parameter values for different molecular diagnostic assays.

[0103] The processing / analysis module can include at least one sub-module. As Figure 5 shown, the processing / analysis module can include sub-module a, sub-module b, and sub-module c.

[0104] In one embodiment, it may be a common module for at least two or more of the target nucleic acid molecules among multiple target nucleic acid molecules.

[0105] It can include a common sub-module shared by at least two or more of the target nucleic acid molecules among multiple target nucleic acid molecules. That is, the assay component can include sub-modules shared by each of the multiple target nucleic acid molecules.

[0106] The sub-module can be various modules for processing and analysis. In one embodiment, the sub-module can be an algorithm for analyzing or mathematically processing a data set obtained during the amplification of multiple target nucleic acid molecules.

[0107] For example, the sub-module can include an algorithm that performs the following tasks: outputting the number of cycles when the data set obtained during the amplification of multiple target nucleic acid molecules reaches a threshold, and reading the presence or absence of target nucleic acid molecules at least partially based on the output number of cycles. Here, the number of cycles can be defined as the number of reactions or time.

[0108] In addition, the sub-module can be an algorithm that performs any one of the following tasks: (i) analyzing signals detected at a relatively high detection temperature and a relatively low detection temperature during the amplification of multiple target nucleic acid molecules; (ii) normalizing multiple data sets obtained during the amplification of multiple target nucleic acid molecules; (iii) using a parameter representing the maximum derivative of the sigmoidal fitting curve for the data set obtained during the amplification of multiple target nucleic acid molecules to read the presence or absence of target nucleic acid molecules; (iv) reading the morphology of the sigmoidal fitting curve by using a value representing the morphology of the data set obtained during the amplification of multiple target nucleic acid molecules; (v) performing regression analysis on the data set obtained during the amplification of multiple target nucleic acid molecules; and (vi) performing regression model diagnosis on a part of the data set obtained from the signal generation reaction of target nucleic acid molecules.

[0109] The sub-module can be a sub-module that subtracts the baseline signal included in the molecular diagnostic amplification data, a sub-module that obtains a predetermined curve by fitting a non-linear function to the molecular diagnostic amplification data, and a module that reads the presence or absence of the target nucleic acid molecule from the obtained curve.

[0110] Specifically, the sub-module for subtracting the baseline signal included in the molecular diagnostic amplification data includes a module that applies the normalization coefficient disclosed in the applicant's WO2017 / 086762 to the signal value to obtain corrected data.

[0111] The above normalization coefficients are provided using a reference value, a reference cycle, and a data set. The reference cycle is selected from the cycles in the data set, and the reference value is an arbitrarily determined value. The normalization coefficient is provided by determining the relationship between the signal value of the cycle corresponding to the reference cycle in the data set and the reference value, and the normalization coefficient is applied to the signal values of the original data set to obtain corrected signal values, which are provided to the original data set. For example, the reference value. The reference value is the value used to provide the normalization coefficient. In this specification, the reference value refers to any value applied to the reference cycle to correct the signal values of the data set. Data sets to be normalized to the same standard will apply the same reference value. When the data sets to be corrected are multiple data sets, multiple data sets can be corrected by the same reference value. The reference value can be an arbitrarily determined value. Preferably, the reference value is not 0, but an arbitrarily determined value from real numbers. As long as the presence of the target nucleic acid molecule in the sample can be determined by using the corrected data set of the reference value, the reference value can be arbitrarily selected by the experimenter. Therefore, the reference value for data set correction can be determined within the range of the signal values obtained from the reference cycle in a signal generation reaction of the same type as the signal generation reaction for obtaining the data set. The reference value can be obtained separately from the data set to be corrected. Specifically, the reference value can be determined from the data set obtained from the signal generation reaction for the target nucleic acid molecule of the same type as the target nucleic acid molecule to be analyzed. Optionally, the reference value can be obtained from a set of data sets including the data set to be corrected. Preferably, the reference value can be a value of the same type as the signal value of the data set to be corrected, or can be of the same unit or dimension as the data set to be corrected. However, even if the reference value and the signal value of the data set have different units or dimensions, or the reference value has no unit or dimension, normalization coefficients suitable for each reaction can be provided from the reference value and the signal value of the data set to be corrected, and the corrected data set can be obtained by using the normalization coefficients for each reaction.

[0112] Next, the sub-module that obtains a predetermined curve by fitting the molecular diagnostic amplification data with a non-linear function can perform the presence or absence reading analysis of the target nucleic acid molecule by using DSP (WO2019 / 066572) technology.

[0113] The parameters set using the above DSP technology include the parameters used in the processed performance data set obtained by mathematically processing the original data set. Here, the processed performance data set includes not only the data set obtained by mathematically processing the original data set, but also the data obtained by re-mathematically processing the mathematically processed data obtained in this way. For example, the first derivative of the original data set and the data including the second, third, etc. derivatives obtained from the derivative.

[0114] The parameters of the DSP can be applied to the function of setting the above Ct parameter values. For example, the fitting accuracy of the DSP to the data set with a non-linear function is used as a direct index for analyzing the target analyte. To analyze the target nucleic acid molecule under the condition of no false positive and false negative results, especially false positive results, a data set of the target nucleic acid molecule is obtained from the signal generation reaction using the signal generation device, the obtained data set including multiple data points of cycle numbers and signal values is corrected, a non-linear function of the corrected data set is generated, so as to determine the fitting accuracy of the non-linear function of the corrected data set, and the presence or absence of the target analyte in the sample is determined using the fitting accuracy. This analysis method requires various parameters, and can be optimized according to the values set for each parameter. Using the DSP (WO2019 / 066572) technology, the parameters are specified for reading the presence or absence of the target nucleic acid molecule, and the analysis is carried out by setting the DSP parameter values.

[0115] Next, the sub-module for obtaining a curve by fitting the molecular diagnostic amplification data to a non-linear function and reading the presence or absence of the target nucleic acid molecule from the curve may include the following functional modules: extracting only the data for each target nucleic acid from the data obtained for multiple target nucleic acids at multiple different temperatures. For example, using the modules disclosed in the applicant's WO2015-147370, WO2015 / 147412, WO2015 / 147382 and WO2016 / 093619, the parameters are specified for the reading process of the presence or absence of the target nucleic acid molecule, and the data of the original data set is analyzed by setting the specified parameter values.

[0116] Even when setting and analyzing the values of the technical parameters using the DSP and multiple target detection temperatures, the parameter values can still be adjusted and set through comparative analysis based on the standard data marked with positive and negative, just as when setting and analyzing the values of the Ct parameters. For example, for the samples marked as positive and the samples marked as negative in the standard data, the parameter values can be adjusted by setting the parameter values to make them consistent with the analysis results.

[0117] In one embodiment, the parameter is characterized in that: it is used for the signal processing of the software for reading the presence or absence of the target, or serves as a determination criterion based on the signal processing.

[0118] In one embodiment, the parameter may be (i) a parameter defining a criterion for determining whether the size of a data set obtained during the amplification of multiple target nucleic acid molecules exceeds a threshold, or (ii) a parameter defining a criterion for determining the presence or absence of target nucleic acid molecules by using the number of cycles at which the size of the data set obtained during the amplification of multiple target nucleic acid molecules reaches the threshold. For example, it can be used for mathematical processing of molecular diagnostic amplification data or as a criterion for reading the presence or absence of target nucleic acid molecules in a sample. The criterion may include the threshold intensity value of the signal for determining the Ct (Threshold Cycle) of the sample.

[0119] In one embodiment, the parameter may be any one of the following parameters: (i) a parameter representing the relationship between the signal sizes detected at a relatively high detection temperature and the signal sizes detected at a relatively low detection temperature in a data set obtained during the amplification of multiple target nucleic acid molecules, (ii) a parameter for normalizing multiple data sets obtained during the amplification of multiple target nucleic acid molecules, i.e., a parameter defining a normalization coefficient, (iii) a parameter defining a criterion for determining the absence of target nucleic acid molecules by using the maximum derivative of the sigmoidal fitting curve applied to multiple data sets obtained during the amplification of the multiple target nucleic acid molecules, (iv) a parameter defining a criterion for determining the presence of target nucleic acid molecules by using a parameter representing the maximum derivative of the sigmoidal fitting curve applied to multiple data sets obtained during the amplification of the multiple target nucleic acid molecules, (v) a parameter defining a criterion for determining the morphology of the sigmoidal fitting curve applied to multiple data sets obtained during the amplification of the multiple target nucleic acid molecules, (vi) a parameter defining the starting cycle required for performing a regression analysis on multiple data sets obtained during the amplification of multiple target nucleic acid molecules, (vii) a parameter representing the minimum cycle of the final cycle required for performing a regression analysis on multiple data sets obtained during the amplification of multiple target nucleic acid molecules, (viii) a parameter defining a criterion for determining the absence of target nucleic acid molecules by applying a regression model and using the obtained fitting accuracy, the regression model being applied to a part of multiple data sets obtained during the amplification of the multiple target nucleic acid molecules, (ix) a parameter defining a criterion for determining the absence of target nucleic acid molecules by applying the following regression model diagnosis and using the obtained fitting accuracy, the regression model diagnosis being for the diagnosis of all of multiple data sets obtained during the amplification of the multiple target nucleic acid molecules, and (x) a parameter defining a criterion for determining the absence of target nucleic acid molecules by using a mathematical operation of the maximum and minimum values of the sizes of multiple data sets obtained during the amplification of the multiple target nucleic acid molecules, or by using a mathematical operation of the last cycle value and the minimum value.

[0120] These parameters can be referred to during the processing and analysis in the sub - modules described above.

[0121] In one embodiment, the assay components can include assay information. The assay information can include one of the following types of information: information describing multiple target nucleic acid molecules for a molecular diagnostic assay, information matching sub - modules and parameter values for the sub - modules to each target nucleic acid molecule, or information defining the execution order of the sub - modules for processing and analysis.

[0122] The information describing multiple target nucleic acid molecules for a molecular diagnostic assay can be information describing genes or analytes, etc. of the multiple target nucleic acid molecules. Such assay information can be used to display the attributes of the assay components in the target presence / absence reading software.

[0123] In addition, according to the information matching sub - modules and parameter values for each target nucleic acid molecule, the assay information can include information on which processing / analysis should be used and which parameter values should be referred to when working on each of the multiple target nucleic acid molecules.

[0124] The information defining the execution order of the sub - modules for processing and analysis can include information on the order in which each target nucleic acid molecule executes the sub - modules. At this time, the execution order for processing and analysis can be predefined for each of the multiple target nucleic acid molecules.

[0125] Figure 6 It is an example diagram showing the processing / analysis modules, parameters, and assay information for different targets included in the assay components according to one embodiment.

[0126] As Figure 6 shown, the processing / analysis modules can be independent modules provided for each of the multiple target nucleic acid molecules. That is, when the target nucleic acid molecules are target 1, target 2, and target 3, the processing / analysis module for target 1, the processing / analysis module for target 2, and the processing / analysis module for target 3 can be different from each other. The processing / analysis modules can include independent sub - modules used separately for each of the multiple target nucleic acid molecules.

[0127] In addition, when the assay components include at least two or more processing / analysis modules, each of the at least two or more processing / analysis modules may include at least partially identical sub-modules. The sub-modules can be implemented or fine-tuned in different ways according to different targets, and thus may be partially identical or partially different according to different targets respectively.

[0128] In one embodiment, it may include a common module provided for a part of multiple target nucleic acid molecules, and an independent module provided for a part of multiple target nucleic acid molecules.

[0129] Hereinafter, a method for optimizing the assay components will be described.

[0130] Figure 2 The component optimization device (120) described in [reference] can "optimize" the processing / analysis module. Such optimization may be designed during the performance optimization process of the detection reagent.

[0131] Here, during the performance optimization process of the detection reagent, the process of determining the parameter values referred to in a given processing / analysis module is repeatedly executed until the performance of the detection reagent meets the specified standard. If the performance still does not meet the standard even after repeated execution, the given processing / analysis module can be redesigned, and the process of generating the processing / analysis module can be carried out.

[0132] At this time, during the process of redesigning the given processing / analysis module, at least one of the following processes can be implemented: the process of modifying one or more sub-modules included in the given processing / analysis module, the process of adding sub-processing / analysis modules not included in the given processing / analysis module to the assay components, and when the given processing / analysis module includes two or more sub-processing / analysis modules, the process of deleting at least one of them or changing the execution order of two or more sub-processing / analysis modules. For example, according to the characteristics of the detection reagent, when it is necessary to update one or more sub-modules and / or parameter values from the initial version, one or more sub-modules included in the given processing / analysis module can be modified.

[0133] For example, when the first processing / analysis module needs to be updated to version 2 of the first processing / analysis module. For example, when a fourth processing / analysis module needs to be added to the assay composition (assay component) composed of the first processing / analysis module, the second processing / analysis module, and the third processing / analysis module, the process of adding a sub-processing / analysis module not included in the established processing / analysis module to the assay composition (assay component) can be performed. When the established processing / analysis module includes two or more sub-processing / analysis modules, the process of deleting at least one of them can be performed, for example, in the assay composition (assay component) composed of the first processing / analysis module, the second processing / analysis module, and the third processing / analysis module, for example, when the second processing / analysis module does not need to be executed. The process of changing the execution order of two or more sub-processing / analysis modules can be performed when the third processing / analysis module needs to be executed before the first processing / analysis module and the second processing / analysis module in the order of the first processing / analysis module, the second processing / analysis module, and the third processing / analysis module.

[0134] On the other hand, the optimized processing / analysis module as described above can be provided from Figure 2 the composition optimization device (120) to the assay composition (assay component) generation device (100). Here, such provision may be in response to a request from the assay composition (assay component) management device (100).

[0135] On the other hand, during the optimization process of the processing / analysis module, molecular diagnostic amplification data is required as described above. These molecular diagnostic amplification data can be obtained from the assay composition (assay component) generation device (100), or can also be directly obtained from the detection device (110).

[0136] In the assay composition (assay component) generation device (100) according to an embodiment, molecular diagnostic amplification data generated using a detection reagent for a target nucleic acid molecule is obtained, and a molecular diagnostic assay composition (assay component) is generated at least in part based on the molecular diagnostic amplification data thus obtained.

[0137] Here, the assay composition (assay component) includes a processing / analysis module used in the processing and analysis of the molecular diagnostic amplification data and a parameter value referred to by the processing / analysis module, which shows the presence or absence of a target for reading the molecular diagnostic amplification data and / or the analysis result of the molecular diagnostic amplification data.

[0138] Thus, according to one embodiment, in molecular diagnosis using a detection reagent, by following the assay components generated by the detection reagent, it is possible to easily manage which processing / analysis modules are applied to process or analyze molecular diagnosis amplification data, and which values of which parameters should be referred to at this time.

[0139] The assay component generation device (100) can generate assay components for different molecular diagnostic assays.

[0140] The assay component generation device (100) performs experimental data analysis on the data set uploaded from the nucleic acid detection device (110) to determine the processing / analysis modules for the process of reading the presence or absence of the corresponding target nucleic acid molecule in order to generate assay components for molecular diagnostic assays.

[0141] The processing / analysis module can be a module that processes or analyzes the signal values obtained during the detection process of the target nucleic acid molecule. The analysis of the signal value refers to determining the positivity or negativity of the presence or absence of the target nucleic acid molecule from the signal value, obtaining the Ct value using the signal value, or analyzing the End-RFU (relative fluorescence unit) using the signal value, but is not limited thereto. Processing the signal value means performing a mathematical change or modification on the signal value, but is not limited thereto.

[0142] Determining these processing / analysis modules requires a fair amount of proficiency, and there may be significant deviations and errors especially depending on the developers. In the present disclosure, by optimizing the processing / analysis modules according to the molecular diagnostic assay to generate assay components, the processing / analysis modules and parameter values most suitable for the detection reagent are designed.

[0143] To this end, by converting the original data set determined by the uploaded data set into a processed performance-optimized data set, it is possible to accurately obtain the processing / analysis modules that can optimize the performance of the detection reagent.

[0144] The original data set is an unprocessed data set first obtained from the nucleic acid detection device (110), and this original data set can be converted into a processed performance data set using various parameters. Since different types of detection reagents may have different parameters that can cause false positives or false negatives, using established parameter values may not be appropriate in some reactions and may lead to false positive or false negative results.

[0145] Therefore, it is necessary to perform precise experimental data analysis on the uploaded data set to determine the presence or absence of the corresponding target nucleic acid molecule and the processing / analysis module used in the reading process. For this purpose, when analyzing experimental data, parameters that cause false positives or false negatives can be determined based on various factors such as the type and quantity of the target nucleic acid molecule, the amplification reaction environment and conditions, etc. By setting the parameter values, a processing / analysis module for finding parameter values optimized for the detection reagent can be determined.

[0146] Here, the processing / analysis module includes but is not limited to processing / analysis software, processing / analysis application programs, or processing / analysis modules, etc.

[0147] This disclosure packages such a processing / analysis module and parameter values into different molecular diagnostic assays to generate assay components for molecular diagnosis.

[0148] For this purpose, the assay component generating device (100) according to an embodiment can apply the optimal processing / analysis module and parameter values according to the molecular diagnostic assay by designing a processing / analysis module and parameter values that are most suitable for the detection reagent.

[0149] The processing / analysis module and parameter values included in the assay component according to an embodiment are designed during the performance optimization process of the detection reagent.

[0150] To optimize the performance of the detection reagent, the best processing / analysis module and parameter values are designed during this process. During the performance optimization process of the detection reagent, the process of selecting parameter values referred to in the established processing / analysis module is repeatedly executed until the performance of the detection reagent meets the specified standard. If the performance still does not meet the standard even after repeated execution, the established processing / analysis module can be redesigned, and the process of generating the processing / analysis module can be carried out.

[0151] The design of the processing / analysis module and parameter values for optimizing the performance of the detection reagent in the assay component generating device (100) depends on the experimental data analysis results, and the experimental data analysis can be carried out as follows.

[0152] According to an embodiment, the experimental data analysis can be performed by comparing with standard data marked with positive and negative, taking the reaction vessels prepared based on the composition information of the panel on which the amplification reaction is performed as the object.

[0153] Standard data refers to the results actually confirmed after the experimenter adjusts the concentration of target nucleic acid molecules in each well of the reaction vessel, and can be determined as actually positive or negative results by actual clinical experiments (such as amplification reactions), but is not limited to this.

[0154] For example, when analyzing experimental data, first, the results of experimental data analysis can be compared with the standard data by using established processing / analysis modules and parameter values of the processing / analysis modules, so as to compare and analyze whether the samples marked as positive and negative in the standard data are consistent with the results of experimental data analysis.

[0155] The above-mentioned established processing / analysis modules have predetermined the module and parameter values, that is, the parameter values. For example, the processing / analysis modules and parameter values for respiratory detection reagents, the processing / analysis modules and parameter values for intestinal bacteria, or the processing / analysis modules and parameter values for sexually transmitted diseases are respectively packaged, and there are established processing / analysis modules and parameter values that may be specific according to the molecular diagnostic assay.

[0156] In the present disclosure, the molecular diagnostic amplification data obtained by the amplification reaction of the samples providing the standard data is applied to the established processing / analysis modules and parameter values, and the results are compared with the standard data to perform experimental data analysis. According to the results of experimental data analysis, it is possible to determine whether to generate assay components by using the established processing / analysis modules and parameter values.

[0157] According to an embodiment, the assay component generation device (100) uses the established processing / analysis modules and parameter values. When the reading result of the presence or absence reading process is consistent with the standard data, it generates assay components for the corresponding molecular diagnosis by using the established processing / analysis modules and parameter values.

[0158] When the results of analyzing experimental data are inconsistent with the standard data through the established processing / analysis modules and parameter values, or when more effective presence or absence reading is desired, in the case where the stored processing / analysis modules and parameter values need to be updated, the established processing / analysis modules can be redesigned.

[0159] To this end, in the assay component generation device (100) according to an embodiment, the experimental data (molecular diagnostic amplification data) can be provided to the component optimization device (120) to optimize the processing / analysis modules required in the presence or absence reading process of the corresponding detection reagent, so as to be able to request the processing / analysis modules optimized for the detection reagent.

[0160] The composition optimization device (120) stores a plurality of processing / analysis modules, and the processing / analysis modules are used to analyze their performance to optimize the performance of the detection reagent and set the optimal operating conditions.

[0161] The composition optimization device (120) analyzes the experimental data (molecular diagnostic amplification data) provided by the assay component generation device (100), thereby identifying the processing / analysis modules and / or parameter values that cause false positives or false negatives under various conditions, and thus determining the optimal processing / analysis module.

[0162] As a result of the experimental data analysis of the composition optimization device (120), the assay component generation device (100) for the detection reagent-optimized processing / analysis module generates the corresponding molecular diagnostic assay component using the received processing / analysis module and parameter values.

[0163] As described above, the processing / analysis module and parameter values can be used in the process of reading the presence or absence, and the processing / analysis module and parameter values can vary according to the type of target nucleic acid molecule or the type of composition used for molecular diagnosis. The assay component generation device (100) according to the present disclosure can design the processing / analysis module and parameter values optimized for molecular diagnostic assay and generate them as assay components.

[0164] As described above, when using the target presence / absence reading software capable of confirming the presence or absence of the target nucleic acid molecule, in the case of adding the target nucleic acid molecule to be detected, even if changes such as adding / changing the type or order of new processing / analysis modules occur, there is no need to perform overall verification on the target presence / absence reading software.

[0165] Conventional target presence / absence reading software refers to the target presence / absence reading software that can confirm the presence or absence of the target nucleic acid molecule according to the molecular diagnostic assay in a plurality of detection reagent lists. Each detection reagent shares or links at least one presence / absence reading module for reading, and performs the presence / absence reading through independent instructions and branches for different molecular diagnostic assays. Therefore, even if only the processing / analysis module and / or parameter values are changed or added for any one of the plurality of detection reagents, it is still necessary to re-verify the plurality of detection reagents to obtain the regulatory approval for the updated target presence / absence reading software.

[0166] However, the assay component generation device (100) according to an embodiment separately generates and deploys assay components corresponding to each molecular diagnostic assay that includes a processing / analysis module and parameter values. Therefore, even when the target assay component changes, or when a target nucleic acid molecule and a detection reagent are added, each single unit of the target assay component can be separately verified, and thus there is no need to perform overall verification on the software for reading the presence or absence of a target.

[0167] According to an embodiment, since the assay component generation device (100) bundles the processing / analysis module and parameter values into a dedicated package (pack) corresponding to each molecular diagnostic assay to generate assay components, access can be performed in a single unit corresponding to each molecular diagnostic assay, enabling effective update of the update target and deployment of update information.

[0168] These assay components can be generated according to the detection reagent, or can be separately generated in the following manner, that is, according to the parameter value setting version, the detection reagent prototype performance confirmation version, the detection reagent authorization information confirmation version, and the detection reagent clinical stage result confirmation version, or can also be generated according to different target nucleic acid molecules.

[0169] For example, the parameter value setting version means that during the development of the detection reagent, it is necessary to go through reagent development, fine oligonucleotide screening for commercialization, and various performance experiments. During each performance experiment, the assay components are used to select the best oligonucleotide from multiple candidate oligonucleotides.

[0170] The performance confirmation version of the prototype means the assay components used when checking the manufacturing quality due to process errors during the manufacturing process of the target detection reagent.

[0171] The authorization information confirmation version means the assay components for license / certification in various countries for selling the detection reagent as a medical device.

[0172] The version confirmed according to the clinical stage results refers to the assay components for analyzing the parameter values of the optimal processing / analysis module, which vary according to different factors such as the template type (artificial template or locally obtained clinical specimens or strains), the type of reaction vessel (plate, strip), and the concentration of the template. Therefore, in order to exhibit appropriate performance even when these conditions and environments change, the assay components are used.

[0173] On the other hand, in the present disclosure, the target nucleic acid molecules include a plurality of different target nucleic acid molecules, and a processing / analysis module and parameter values can be provided for each different target nucleic acid molecule.

[0174] In this case, the molecular diagnostic amplification data obtained from the nucleic acid detection device (110) may have different detection channels. The detection channels are detected by selectively detecting light in a specific wavelength region. Therefore, among the optical labels contained in the sample, only specific optical labels generate optical signals and are detected for a specific wavelength region. The optical labels can be, for example, optical labels selected from the group consisting of FAM, HEX, CAL Fluor Red610, Quasar 670, and Quasar 705.

[0175] In addition, when multiple target nucleic acid molecules (low temperature / high temperature) are detected through a single detection channel, and / or when multiple target nucleic acid molecules are detected through multiple detection channels, a processing / analysis module and parameter values can be provided for each of such multiple target nucleic acid molecules.

[0176] According to an embodiment, the assay component generation device (100) generates assay components for molecular diagnosis and sets the processing / analysis module and parameter values of the generated assay components so as to exhibit appropriate performance even when applying clinical data.

[0177] Since the presence or absence reading result may depend on various factors such as the type of target nucleic acid molecule (i.e., artificial template or locally obtained clinical specimens or reference strains), the type of reaction vessel (plate, strip), and the concentration of the target nucleic acid molecule, etc., in order to exhibit appropriate performance even when these conditions and environments change, the presence or absence reading result applicable to multiple factors can be analyzed, and the processing / analysis module and parameter values of the generated assay components can be verified for various factors.

[0178] In this process, as described above, the best processing / analysis modules and parameter values for various factors are designed and the best processing / analysis modules and parameter values are applied. The process of selecting the parameter values to be referred to in a given processing / analysis module is repeatedly executed until the performance of the corresponding factor meets the specified standard. If the performance still does not meet the standard even after repeated execution, the given processing / analysis module is redesigned and the process of generating the processing / analysis module is carried out.

[0179] In the assay component generation device (100), during the process of reading the presence or absence of the corresponding factor to optimize the processing / analysis module required, experimental data (molecular diagnostic amplification data) can be provided to the component optimization device (120), so as to be able to request a processing / analysis module optimized for the detection reagent.

[0180] As a result of the experimental data analysis of the component optimization device (120), the assay component generation device (100) that receives the processing / analysis module optimized for the detection reagent designs the processing / analysis modules and parameter values applicable to various factors by using the received processing / analysis module and parameter values, and thus generates assay components respectively.

[0181] The assay components for molecular diagnosis generated through the above process are verified in the final target presence or absence reading software and then deployed to the target presence or absence reading terminal.

[0182] Figure 7 It is a flowchart of a method for generating assay components according to another embodiment.

[0183] The method for generating assay components according to other embodiments includes the same method as that of an embodiment described above, and the following describes the different content.

[0184] Reference Figure 7 , in step S100, molecular diagnostic amplification data generated by using an assay for molecular diagnosis of multiple target nucleic acid molecules is obtained. In step S200, assay components can be generated at least partially based on the molecular diagnostic amplification data. Thereafter, in step S300, the assay components can be deployed to a target presence or absence reading terminal storing the target presence or absence reading software.

[0185] Figure 8 It is a diagram schematically showing the network relationship between an assay component generation device and a target presence reading terminal in an embodiment.

[0186] As Figure 8 shown, the assay components generated for different molecular diagnostic assays can be deployed to the target presence / absence reading terminal (200). The processing / analysis module for each molecular diagnostic assay component and the processing and analysis results of the parameter values can be confirmed through the target presence / absence reading software of the target presence / absence reading terminal (200). In Figure 8 the display section of the target presence / absence reading software, a list of detection reagents assigned to the assay components is displayed, and the reading results of the detection reagents selected from the list are also displayed on the corresponding interface.

[0187] At this time, the assay components can be deployed for updating. In one embodiment, the deployment for updating can be performed to solve the problem that the assay components existing in the target presence / absence reading terminal (200) cannot eliminate noise or abnormal signals in the molecular diagnostic amplification data. For example, when the processing / analysis module or the parameter values are minor changes such as noise removal and abnormal signal removal, such a deployment can be made.

[0188] In one embodiment, the deployment for updating can overwrite the stored assay components existing in the target presence / absence reading terminal (200), or the target presence / absence reading terminal (200) can also deploy the assay components together with the stored assay components existing in the target presence / absence reading terminal (200).

[0189] In one embodiment, the assay components deployed as described above can be authorized for the user who sets the assay components to set in the target presence / absence reading terminal (200).

[0190] In one embodiment, the assay components can be authorized for the user who deletes the assay components to delete from the target presence / absence reading terminal (200).

[0191] Hereinafter, a target presence / absence reading method using assay components according to another embodiment will be described. This embodiment can be implemented by a target presence / absence reading terminal (200) that performs target presence / absence reading.

[0192] First, a target presence / absence reading terminal (200) can obtain an assay component, which is generated at least in part based on molecular diagnostic amplification data generated by a molecular diagnostic assay using multiple target nucleic acid molecules.

[0193] The target presence / absence reading terminal (200) can process and analyze the molecular diagnostic amplification data of multiple target nucleic acid molecules using the obtained assay component.

[0194] At this time, as described above, the assay component can include a processing / analysis module including the following sub-modules and parameter values for reference by the sub-modules, where the sub-modules are used to process and analyze the molecular diagnostic amplification data of multiple target nucleic acid molecules in the target presence / absence reading software.

[0195] Here, a sub-module predefined to be referenceable during the processing and analysis of molecular diagnostic amplification data can process and analyze the molecular diagnostic amplification data of multiple target nucleic acid molecules with reference to the parameter values according to the request of the target presence / absence reading software.

[0196] In one embodiment, the above-described component generation device (100) for assay can be embodied as a computing device.

[0197] The computing device can include one or more processors, a bus, a communication interface, a memory for loading a computer program executed by the processor, and a storage medium for storing the computer program. If it is a person of ordinary skill in the technical field to which this embodiment belongs, other general components can also be included in addition to these components.

[0198] The processor controls the overall operation of each component of the computing device. The processor can include at least one of a CPU (Central Processing Unit), an MPU (Micro Processor Unit), an MCU (Micro Controller Unit), a GPU (Graphic Processing Unit), or any form of processor well-known in the technical field of this embodiment. In addition, the processor can operate at least one application program or program for executing the methods / operations according to various embodiments described in this specification. The computing device can be equipped with one or more processors.

[0199] The memory stores various data, instructions, and / or information. The memory can load more than one program from a storage medium to execute the methods / operations according to various embodiments described in this specification. Examples of the memory can be RAM (Random Access Memory), but are not limited thereto.

[0200] The bus provides a communication function between the components of the computing device. The bus can be embodied in various forms such as an address bus, a data bus, and a control bus.

[0201] The communication interface supports wired and wireless network communications of the computing device. The communication interface can also support various communication methods other than Internet communication. For this purpose, the communication interface can include communication modules well-known in the technical field of this embodiment.

[0202] The storage medium can non-temporarily store more than one computer program. The storage medium can include non-volatile memories such as ROM (Read Only Memory), EPROM (Erasable Programmable ROM), EEPROM (Electrically Erasable Programmable ROM), flash memory, hard disks, removable disks, or any form of computer-readable recording medium well-known in the technical field to which this embodiment belongs.

[0203] The computer program can include more than one instruction for implementing the methods / operations according to various embodiments described in this specification. When the computer program is loaded into the memory, the processor can implement the methods / operations according to various embodiments described in this specification by executing more than one instruction.

[0204] In one embodiment, the computer program can include the following instructions: an acquisition instruction: molecular diagnostic amplification data generated by an assay for molecular diagnosis of a plurality of target nucleic acid molecules; a generation instruction: generating an assay component at least partially based on the molecular diagnostic amplification data. At this time, the assay component includes a processing / analysis module including a sub-module for processing and analyzing the molecular diagnostic amplification data of a plurality of target nucleic acid molecules in the target presence / absence reading software, and parameter values for reference by the sub-module. And in the sub-module, the sub-module predefined for reference during the processing and analysis of the molecular diagnostic amplification data can, according to the request of the target presence / absence reading software, refer to the parameter values and perform the processing and analysis of the molecular diagnostic amplification data of a plurality of target nucleic acid molecules.

[0205] In one embodiment, a computer program may include the following instructions: an acquisition instruction: molecular diagnostic amplification data generated by an assay for molecular diagnosis of a plurality of target nucleic acid molecules; a generation instruction: generating an assay component at least partially based on the molecular diagnostic amplification data; a deployment instruction: deploying the assay component to a target presence / absence reading terminal storing target presence / absence reading software. At this time, the assay component includes a processing / analysis module including a sub-module for processing and analyzing the molecular diagnostic amplification data of the plurality of target nucleic acid molecules in the target presence / absence reading software, and parameter values for reference by the sub-module. In the sub-module, a pre-defined sub-module for reference during the processing and analysis of the molecular diagnostic amplification data may, according to a request of the target presence / absence reading software, refer to the parameter values and process and analyze the molecular diagnostic amplification data of the plurality of target nucleic acid molecules.

[0206] The methods of the embodiments described so far may be implemented by executing a computer program implemented by computer-readable code. The computer program may be sent from a first computing device to a second computing device via a network such as the Internet and installed in the second computing device, so that it can be used in the second computing device. The above-mentioned first computing device and the second computing device include fixed computing devices such as server devices, physical servers belonging to a server pool for cloud services, and desktop computers.

[0207] The above computer program may be stored in a recording medium such as a DVD-ROM and a flash device.

[0208] These programs may also be stored in a computer-readable recording medium to implement functions by a specific method. In addition, the terms "including", "comprising" or "having" as described above mean that, in the absence of a particularly contrary record, the constituent element may be built-in, and thus should be interpreted as further including other constituent elements rather than excluding other constituent elements. All terms, including technical or scientific terms, unless otherwise defined, have the same meaning as commonly understood by those of ordinary skill in the technical field to which the present disclosure pertains (i.e., those skilled in the art). Commonly used terms, such as pre-defined terms, should be interpreted as having a meaning consistent with the context of the related technology, and will not be interpreted in an ideal or excessive formal sense unless clearly defined in the present disclosure.

[0209] The above description only illustrates the technical idea of the present disclosure. Those with ordinary knowledge in the technical field to which the present disclosure pertains can make various modifications and variations without departing from the essential characteristics of the present disclosure. Therefore, the embodiments of the present disclosure are not intended to limit the technical idea of the present disclosure, but to illustrate that the scope of the technical idea of the present disclosure is not limited according to these embodiments. The protection scope of the present disclosure should be interpreted according to the following claims, and all technical ideas within the same scope should be interpreted as being included in the scope of the claims of the present disclosure.

[0210] The specific part of the present disclosure has been described in detail above. For those with ordinary knowledge in this industry, this specific technology is only a preferred embodiment. Therefore, it is obvious that the scope of the present disclosure is not limited. Therefore, the actual scope of the present disclosure is defined by the appended claims and their equivalent technical features.

Claims

1. A method for generating analysis components, which is executed by an analysis component generation device used in software for reading the presence or absence of targets that displays molecular diagnostic amplification data. The method includes: The step of obtaining molecular diagnostic amplification data generated by molecular diagnostic analysis for multiple target nucleic acid molecules; And The step of generating analysis components at least partially based on the molecular diagnostic amplification data, wherein the analysis components include: A processing / analysis module, which includes sub-modules for processing and analyzing molecular diagnostic amplification data for multiple target nucleic acid molecules in the software for reading the presence or absence of targets; and Parameter values for reference by the sub-modules, wherein in the sub-modules, when processing and analyzing the molecular diagnostic amplification data, the pre-defined sub-modules to be called are requested by the software for reading the presence or absence of targets, and the molecular diagnostic amplification data for the multiple target nucleic acid molecules are processed and analyzed with reference to the parameter values.

2. A method for deploying analysis components, which is executed by an analysis component generation device used in software for reading the presence or absence of targets that displays molecular diagnostic amplification data. The method includes: The step of obtaining molecular diagnostic amplification data generated by molecular diagnostic analysis for multiple target nucleic acid molecules; The step of generating analysis components at least partially based on the molecular diagnostic amplification data; And The step of deploying the analysis components to a target presence / absence reading terminal storing the software for reading the presence or absence of targets, wherein the analysis components include: A processing / analysis module, which includes sub-modules for processing and analyzing molecular diagnostic amplification data for multiple target nucleic acid molecules in the software for reading the presence or absence of targets; and Parameter values for reference by the sub-modules, wherein in the sub-modules, when processing and analyzing the molecular diagnostic amplification data, the pre-defined sub-modules to be referenced are requested by the software for reading the presence or absence of targets, and the molecular diagnostic amplification data for the multiple target nucleic acid molecules are processed and analyzed with reference to the parameter values.

3. The method according to claim 1 or 2, characterized in that The processing / analysis module is A common module for at least two or more of the multiple target nucleic acid molecules.

4. The method according to claim 1 or 2, characterized in that The processing / analysis module is An independent module provided for each of the multiple target nucleic acid molecules.

5. The method according to claim 1 or 2, characterized in that The processing / analysis module includes A common module provided for a part of the multiple target nucleic acid molecules and an independent module provided for a part of the multiple target nucleic acid molecules.

6. The method according to claim 3, characterized in that The common module includes common sub-modules, The common sub-modules can be commonly used for at least two or more of the multiple target nucleic acid molecules.

7. The method according to claim 3, characterized in that The independent module includes independent sub-modules, The independent sub-modules can be respectively used for each of the multiple target nucleic acid molecules.

8. The method according to claim 1 or 2, characterized in that, when the analysis component includes at least two or more processing / analysis modules, each of the at least two or more processing / analysis modules includes at least partially identical sub-modules.

9. The method according to any one of claims 1 or 2, characterized in that, when analyzing another set of multiple target nucleic acid molecules different from the multiple target nucleic acid molecules to generate additional analysis components, the additional analysis components include a processing and analysis module for processing and analyzing molecular diagnostic amplification data of the another set of multiple target nucleic acid molecules.

10. The method according to claim 1 or 2, characterized in that, when the processing / analysis module performs the processing and analysis, the parameter value is predefined for differential reference for each of the multiple target nucleic acid molecules.

11. The method according to any one of claims 1 or 2, characterized in that, the sub-module includes, an algorithm for analyzing or mathematically processing a data set obtained during the amplification process of the multiple target nucleic acid molecules.

12. The method according to any one of claims 1 or 2, characterized in that, the sub-module includes an algorithm for performing the following operations: outputting the cycle number when the data set obtained during the amplification process of the multiple target nucleic acid molecules reaches a threshold, and reading the presence or absence of the target nucleic acid molecule at least partially based on the output cycle number.

13. The method according to any one of claims 1 or 2, characterized in that, the sub-module includes an algorithm for performing any one of the following operations: (i) analyzing signals detected at a relatively high temperature detection temperature and a relatively low temperature detection temperature during the amplification process of the multiple target nucleic acid molecules; (ii) normalizing multiple data sets obtained during the amplification process of the multiple target nucleic acid molecules; (iii) using a parameter representing the maximum derivative of an S-shaped fitting curve for a data set obtained during the amplification process of the multiple target nucleic acid molecules to read the presence or absence of the target nucleic acid molecule; (iv) reading the shape of the S-shaped fitting curve by using a value representing the shape of a data set obtained during the amplification process of the multiple target nucleic acid molecules; (v) performing regression analysis on a data set obtained during the amplification process of the multiple target nucleic acid molecules; and (vi) performing regression model diagnosis on a part of a data set obtained through a signal generation reaction for the target nucleic acid molecule.

14. The method according to any one of claims 1 or 2, characterized in that, the parameter, is used for signal processing of the target presence / absence reading software or serves as a determination criterion based on the signal processing.

15. The method according to any one of claims 1 or 2, characterized in that, the parameter is, (i) A parameter defining a criterion for determining whether the size of a data set obtained during the amplification of the plurality of target nucleic acid molecules exceeds a threshold, or (ii) A parameter defining a criterion for determining the presence or absence of a target nucleic acid molecule by using the number of cycles at which the size of a data set obtained during the amplification of the plurality of target nucleic acid molecules reaches the threshold.

16. The method according to any one of claims 1 or 2, characterized in that The parameter is any one of the following parameters: (i) A parameter representing the relationship between the signal sizes detected at a relatively high detection temperature and the signal sizes detected at a relatively low detection temperature of a data set obtained during the amplification of the plurality of target nucleic acid molecules, (ii) A parameter for normalizing a plurality of data sets obtained during the amplification of the plurality of target nucleic acid molecules, that is, a parameter defining a normalization coefficient, (iii) A parameter for defining a criterion for determining the absence of a target nucleic acid molecule by using the maximum derivative of a sigmoid fitting curve applied to a plurality of data sets obtained during the amplification of the plurality of target nucleic acid molecules, (iv) A parameter for defining a criterion for determining the presence of a target nucleic acid molecule by using a parameter representing the maximum derivative of a sigmoid fitting curve applied to a plurality of data sets obtained during the amplification of the plurality of target nucleic acid molecules, (v) A parameter for defining a criterion for determining the shape of a sigmoid fitting curve applied to a plurality of data sets obtained during the amplification of the plurality of target nucleic acid molecules, (vi) A parameter for defining the starting cycle required for performing a regression analysis on a plurality of data sets obtained during the amplification of the plurality of target nucleic acid molecules, (vii) A parameter representing the minimum cycle of the final cycle required for performing a regression analysis on a plurality of data sets obtained during the amplification of the plurality of target nucleic acid molecules, (viii) A parameter for defining a criterion for determining the absence of a target nucleic acid molecule by applying a regression model and using the obtained fitting accuracy, the regression model being applied to a part of a plurality of data sets obtained during the amplification of the plurality of target nucleic acid molecules, (ix) A parameter for defining a criterion for determining the absence of a target nucleic acid molecule by applying the following regression model diagnosis and using the obtained fitting accuracy, the regression model diagnosis being a diagnosis for all of a plurality of data sets obtained during the amplification of the plurality of target nucleic acid molecules, and (x) A parameter for defining a criterion for determining the absence of a target nucleic acid molecule by using a mathematical operation of the maximum value and the minimum value of the sizes of a plurality of data sets obtained during the amplification of the plurality of target nucleic acid molecules, or by using a mathematical operation of the last cycle value and the minimum value.

17. The method according to any one of claims 1 or 2, characterized in that The analysis component further includes: Analysis information describing the plurality of target nucleic acid molecules for the molecular diagnostic analysis (a record that details the content including genes and analytes).

18. The method according to any one of claims 1 or 2, characterized in that The analysis component includes: Analysis information that matches the sub-module and the parameter values for reference by the sub-module according to each target nucleic acid molecule.

19. The method according to any one of claims 1 or 2, characterized in that, when the processing / analysis module includes more than two sub-modules, the analysis components further include, analysis information that predefines the execution order of the sub-modules for processing and analysis.

20. The method according to claim 20, characterized in that, the execution order for processing and analysis, is predefined for each of the plurality of target nucleic acid molecules.

21. The method according to any one of claims 1 or 2, characterized in that, the processing / analysis module and the parameter values, are designed through the performance optimization process of the molecular diagnostic analysis.

22. The method according to claim 22, characterized in that, the performance optimization process of the molecular diagnostic analysis includes, repeatedly determining the parameter values referred to by the predefined sub-module until the performance of the molecular diagnostic analysis meets the specified criteria, if after performing the repetition, the performance of the molecular diagnostic analysis does not meet the specified criteria, then further perform the redesign of the predefined sub-module.

23. The method according to claim 23, characterized in that, during the process of redesigning the predefined sub-module, implement at least one of the following processes: the process of modifying one or more sub-modules included in the predefined sub-module, the process of adding sub-modules not included in the predefined sub-module to the analysis components, when the predefined sub-module includes more than two sub-modules, the process of deleting at least one of them or changing the execution order of the sub-modules.

24. The method according to claim 2, characterized in that, perform the deployment of the analysis components for the target presence / absence reading terminal to solve the problem that the analysis components existing in the target presence / absence reading terminal cannot eliminate noise or abnormal signals in the molecular diagnostic amplification data.

25. The method according to claim 2, characterized in that, the deployment of the analysis components for the target presence / absence reading terminal, covers the stored analysis components existing in the target presence / absence reading terminal.

26. The method according to claim 2, characterized in that, the deployment of the analysis components for the target presence / absence reading terminal includes, the target presence / absence reading terminal deploys the analysis components together with the stored analysis components existing in the target presence / absence reading terminal.

27. The method according to claim 2, characterized in that, the analysis components are set in the target presence / absence reading terminal by the user authorized to set the analysis components.

28. The method according to claim 2, characterized in that, the analysis components are deleted from the target presence / absence reading terminal by the user authorized to delete the analysis components.

29. The method according to any one of claims 1 or 2, characterized in that, the molecular diagnostic amplification data is, obtained from the results of nucleic acid polymerase chain reaction targeting the plurality of target nucleic acid molecules.

30. A method for reading the presence or absence of a target executed by a target presence / absence reading terminal, wherein the target presence / absence reading terminal uses analysis components used in target presence / absence reading software for displaying molecular diagnostic amplification data to read the presence or absence of the target. The method for reading the presence or absence of the target includes: A step of obtaining analysis components generated at least partially based on molecular diagnostic amplification data generated by molecular diagnosis analysis for a plurality of target nucleic acid molecules; And A step of processing and analyzing the molecular diagnostic amplification data for a plurality of target nucleic acid molecules using the analysis components, wherein the analysis components include: A processing / analysis module, which includes sub-modules for processing and analyzing the molecular diagnostic amplification data for a plurality of target nucleic acid molecules in the target presence / absence reading software; and Parameter values for reference by the sub-modules, wherein, in the sub-modules, when processing and analyzing the molecular diagnostic amplification data, the pre-defined sub-modules to be referenced are requested by the target presence / absence reading software, and the molecular diagnostic amplification data for the plurality of target nucleic acid molecules are processed and analyzed with reference to the parameter values.

31. A computer-readable recording medium storing a computer program for generating analysis components used in target presence / absence reading software for displaying molecular diagnostic amplification data, The computer program includes: Instructions for obtaining molecular diagnostic amplification data generated by molecular diagnosis analysis for a plurality of target nucleic acid molecules; And Instructions for generating analysis components at least partially based on the molecular diagnostic amplification data, wherein the analysis components include: A processing / analysis module, which includes sub-modules for processing and analyzing the molecular diagnostic amplification data for a plurality of target nucleic acid molecules in the target presence / absence reading software; and Parameter values for reference by the sub-modules, wherein, in the sub-modules, when processing and analyzing the molecular diagnostic amplification data, the pre-defined sub-modules to be referenced are requested by the target presence / absence reading software, and the molecular diagnostic amplification data for the plurality of target nucleic acid molecules are processed and analyzed with reference to the parameter values.

32. A computer-readable recording medium storing a computer program for deploying analysis components used in target presence / absence reading software for displaying molecular diagnostic amplification data, The computer program includes: Instructions for obtaining molecular diagnostic amplification data generated by molecular diagnosis analysis for a plurality of target nucleic acid molecules; Instructions for generating analysis components at least partially based on the molecular diagnostic amplification data; And Instructions for deploying the analysis components to a target presence / absence reading terminal storing the target presence / absence reading software, wherein the analysis components include: A processing / analysis module, which includes sub-modules for processing and analyzing the molecular diagnostic amplification data for a plurality of target nucleic acid molecules in the target presence / absence reading software; and Parameter values for reference by the sub-modules, Among them, in the sub-module, when processing and analyzing the molecular diagnostic amplification data, the sub-module predefined to be referenced is requested by the target presence / absence reading software, and the molecular diagnostic amplification data for the multiple target nucleic acid molecules is processed and analyzed with reference to the parameter values.

33. A generating device for analysis components, which is used for a target presence / absence reading software that displays molecular diagnostic amplification data. The device includes: A processor; A memory; And A computer program, which is loaded into the memory and executed by the processor. The computer program includes: Instructions for obtaining molecular diagnostic amplification data generated by molecular diagnostic analysis for multiple target nucleic acid molecules; Instructions for generating analysis components at least partially based on the molecular diagnostic amplification data. Among them, the analysis components include: A processing / analysis module, which includes a sub-module for processing and analyzing the molecular diagnostic amplification data for multiple target nucleic acid molecules in the target presence / absence reading software; and Parameter values for reference by the sub-module. Among them, in the sub-module, when processing and analyzing the molecular diagnostic amplification data, the sub-module predefined to be referenced is requested by the target presence / absence reading software, and the molecular diagnostic amplification data for the multiple target nucleic acid molecules is processed and analyzed with reference to the parameter values.

34. A generating device for analysis components, which is used for a target presence / absence reading software that displays molecular diagnostic amplification data. The device includes: A processor; A memory; And A computer program, which is loaded into the memory and executed by the processor. The computer program includes: Instructions for obtaining molecular diagnostic amplification data generated by molecular diagnostic analysis for multiple target nucleic acid molecules; Instructions for generating analysis components at least partially based on the molecular diagnostic amplification data; and Instructions for deploying the analysis components to a target presence / absence reading terminal storing the target presence / absence reading software. Among them, the analysis components include: A processing / analysis module, which includes a sub-module for processing and analyzing the molecular diagnostic amplification data for multiple target nucleic acid molecules in the target presence / absence reading software; and Parameter values for reference by the sub-module. Among them, in the sub-module, when processing and analyzing the molecular diagnostic amplification data, the sub-module predefined to be referenced is requested by the target presence / absence reading software, and the molecular diagnostic amplification data for the multiple target nucleic acid molecules is processed and analyzed with reference to the parameter values.

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