Method and apparatus for editing display of detection results of plurality of biological target analytes

Abstract

The present invention provides technology for selectively editing the results of determining the presence / absence of a plurality of target nucleic acids using a detection reagent for a multiplex nucleic acid amplification reaction, wherein a plurality of target nucleic acids that can be amplified using the detection reagent are displayed, and the plurality of target nucleic acids can be edited so that the results of determining the presence / absence of some of the target nucleic acids are masked so as not to be displayed according to user selection.

Description

Method and device for editing display of detection results of multiple biological target analytes

[0001] The present disclosure relates to editing the display of detection results of multiple biological target analytes using a detection reagent for a multiplex nucleic acid amplification reaction.

[0002] Molecular diagnostics is a rapidly growing field in the in vitro diagnostics market for early disease detection. Among these, methods utilizing nucleic acids, based on their high specificity and sensitivity, are being used to diagnose genetic factors responsible for viral and bacterial infections.

[0003] Most diagnostic methods using nucleic acids utilize nucleic acid amplification reactions to amplify target nucleic acids (e.g., viral or bacterial nucleic acids). A representative example of a nucleic acid amplification reaction is the polymerase chain reaction (PCR), which involves repeated cycles of denaturation of double-stranded DNA, annealing of oligonucleotide primers to a DNA template, and extension of the primers 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). Other methods for amplifying nucleic acids include ligase chain reaction (LCR) (U.S. Pat. Nos. 4,683,195 and 4,683,202; PCR Protocols: A Guide to Methods and Applications (Innis et al., eds, 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)), and 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.These may include 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] Recently, multiplex diagnostic technologies based on these nucleic acid amplification reactions have been used to detect multiple target nucleic acids within a single tube. For example, various multiplex technologies exist for detecting multiple types of viruses simultaneously, using methods such as PCR and LAMP, as examples of nucleic acid amplification reactions.

[0005] Multiplex nucleic acid amplification reaction techniques require the use of target nucleic acid detection reagents, including oligonucleotides (e.g., primers and / or probes) that specifically hybridize to the target nucleic acid of interest, labels, DNA polymerase, dNTPs, Mg ions, and buffers, to amplify and detect the target nucleic acid of interest.

[0006] Since these target nucleic acid detection reagents can simultaneously amplify multiple target nucleic acids in a single reaction through multiplex technology, the amplifiable analysis target is set according to the characteristics of the target nucleic acid detection reagent.

[0007] Reagents for detecting target nucleic acids are commercialized as diagnostic kits along with amplification reaction-related components. Patients can select a diagnostic kit according to the suspected disease and be diagnosed with the infection by detecting at least one target nucleic acid through an amplification reaction using the detection reagents of the selected diagnostic kit.

[0008] In this way, in the case of a detection reagent using multiplex technology, multiple target nucleic acids can be amplified simultaneously through a single test, so it is possible to confirm the presence or absence of multiple target nucleic acids depending on the characteristics of the detection reagent.

[0009] However, depending on the patient, only a subset of multiple target nucleic acids—that is, the presence of a specific target nucleic acid—may be of interest. This is because confirming the presence of only viruses clearly suspected of causing disease can be practical for individual patients, avoiding unnecessary medical interventions and reducing costs.

[0010] Nonetheless, when using a diagnostic kit with multiplex technology, the presence or absence of each of the multiple amplifiable target nucleic acids, i.e. the analysis target of the detection reagent, is simultaneously and collectively confirmed, so medical treatment or costs are being paid for the presence or absence of target nucleic acids that are not of interest.

[0011] The problem to be solved according to one embodiment is to provide a method that can selectively edit the results of determining the presence or absence of a plurality of target nucleic acids using the detection reagent described above.

[0012] Specifically, this task may include providing a technology capable of editing a plurality of target nucleic acids so that a plurality of amplifiable target nucleic acids are displayed using a detection reagent for a multiplex nucleic acid amplification reaction, but the presence or absence detection results for some target nucleic acids are not displayed according to a user's selection, thereby masking the target nucleic acids so that the target nucleic acids are hidden.

[0013] However, the problems to be solved by the present invention are not limited to those mentioned above, and other problems to be solved that are not mentioned can be clearly understood by a person having ordinary skill in the art to which the present disclosure pertains from the description below.

[0014] A computer-implemented method for performing detection result display editing of a plurality of biological target analytes performed in a detection result display editing device according to one embodiment, the method comprising: a step in which the detection result display editing device accesses plate setting information for a reaction plate on which an amplification reaction is to be performed using a detection reagent for a multiplex nucleic acid amplification reaction capable of detecting the plurality of biological target analytes; the detection result display editing device includes (i) a memory, (ii) a processor, and (iii) one or more programs stored in the memory and configured to be executed by the processor, wherein the plate setting information includes setting information for each reaction well, and the reaction well setting information includes identifiers for a plurality of biological target analytes to be amplified in the reaction well, and a step in which the identifiers are displayed on a masking data input screen of the detection result display editing device;

[0015] A method for determining whether to mask an amplification reaction result in a detection result display device for an identifier of at least one biological target analyte among identifiers of a plurality of biological target analytes amplified in the above reaction well, comprising: a step of inputting editing information through the masking data input screen; and a step of editing and providing the plate setting information received according to the editing information.

[0016] In addition, the accessing step is characterized in that it accesses the plate setting information, which is i) stored in the detection result display device or an external device, or ii) stored inside the detection result display editing device, and the plate setting information stored inside the detection result display editing device is received from the detection result display device or the external device.

[0017] In addition, the identifier is the name of a plurality of biological target analytes to be amplified using the detection reagent, and when the detection reagent includes a plurality of detection reagents, the identifier of the target analytes for the plurality of detection reagents is displayed on the masking data input screen according to each detection reagent.

[0018] In addition, the step of displaying the above is characterized by displaying the identifier for each biological target analyte as an object that can be individually selected by the user.

[0019] In addition, the step of displaying is characterized in that at least one object selected by the user and an object not selected among the objects displayed on the masking data input screen are displayed in a distinct manner.

[0020] In addition, the selected object is characterized in that the masking of the corresponding identifier and the amplification reaction result is determined in the detection result display device, and the non-selected object is characterized in that the corresponding identifier and the amplification reaction result are displayed in the detection result display device.

[0021] In addition, the above editing information is characterized in that it is generated by using whether the individually selectable object is selected from the accessed plate setting information.

[0022] In addition, the plate setting information stored inside the detection result display editing device is characterized in that it is further edited according to a template that predetermines an identifier to be masked among a plurality of detectable biological target analytes based on the detection reagent.

[0023] In addition, the template is preset editing information, and the preset editing information is characterized in that whether or not to mask the amplification reaction result for the identifier of at least one preset biological target analyte among the identifiers for the plurality of biological target analytes is stored.

[0024] In addition, the above template is characterized by being edited information in which target analytes other than the target analytes that are suspected first by time, symptom, and age group are masked.

[0025] In addition, the template is characterized in that it is classified by at least one selected from among time of symptom onset, symptom, and / or gender and age group.

[0026] In addition, the time elapsed since the onset of the symptom is characterized by being 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours or more, or 96 hours, 72 hours, 48 ​​hours, 36 hours, or 24 hours or less.

[0027] Additionally, the above symptoms are characterized by being either mild or severe in terms of symptom type.

[0028] In addition, the step of exporting the plate setting information further edited according to the template to the detection result display device and / or the external storage device is further performed.

[0029] In addition, when the plate setting information is stored in the detection result display device or an external device, the step of exporting the editing information to the detection result display device and / or the external storage device is further performed.

[0030] In addition, in the exporting step, the editing information on whether or not to mask the identifiers of the plurality of biological target analytes is converted to hexadecimal and exported.

[0031] A memory storing at least one command according to one embodiment; and a processor, wherein the at least one command is executed by the processor to access plate setting information for a reaction plate on which an amplification reaction is to be performed using a detection reagent for a multiplex nucleic acid amplification reaction capable of detecting a plurality of biological target analytes, wherein the plate setting information includes setting information for each reaction well, and the reaction well setting information includes identifiers for a plurality of biological target analytes amplified in the reaction vessel, and the identifiers are displayed on a masking data input screen of a detection result display editing device, and editing information for determining whether to mask an amplification reaction result in the detection result display device for the identifier of at least one biological target analyte among the identifiers for the plurality of biological target analytes amplified in the reaction well is input through the masking data input screen, and the plate setting information received according to the editing information is edited and provided.

[0032] A computer-readable recording medium storing a computer program according to one embodiment, wherein the computer program is executed by one or more processors included in a computer device, and includes the steps of: accessing plate setting information for a reaction plate on which an amplification reaction is to be performed using a detection reagent for a multiplex nucleic acid amplification reaction capable of detecting a plurality of biological target analytes; wherein the plate setting information includes setting information for each reaction well, and the reaction well setting information includes identifiers for a plurality of biological target analytes amplified in the reaction well, and displaying the identifiers on a masking data input screen of a detection result display editing device; receiving, through the masking data input screen, editing information for determining whether to mask an amplification reaction result in a detection result display device for an identifier of at least one biological target analyte among the identifiers for a plurality of biological target analytes amplified in the reaction well; and editing and providing the plate setting information received according to the editing information.

[0033] In one embodiment, a practical diagnosis can be made by simply confirming the presence or absence of a virus that is clearly suspected of causing a disease, thereby avoiding unnecessary medical interventions or costly procedures.

[0034] In another embodiment, rapid diagnosis and treatment are possible by first identifying the suspected causative agent by symptom, age, and incubation time.

[0035] FIG. 1 illustrates a display editing device for detecting a plurality of biological target analytes according to one embodiment and devices connected thereto.

[0036] FIG. 2 is a block diagram of an editing device for displaying detection results of multiple biological target analytes according to one embodiment.

[0037] FIG. 3 is a flowchart of a method for editing display of detection results of multiple biological target analytes according to one embodiment.

[0038] Fig. 4 is an example of an implementation of a masking data input screen of a detection result display editing device (100).

[0039] FIG. 5 is an example of an implementation of a screen in which amplification reaction results for all target analytes are displayed before masking an identifier for a target analyte using the detection result display editing device (100) of the present disclosure or before using the detection result display editing device (100).

[0040] FIG. 6 is an example of an implementation of a screen in which a masked identifier is displayed as amplification reaction result data in a detection result display device (300) in a detection result display editing device (100) according to the present disclosure.

[0041] The advantages and features of the present invention, and the methods for achieving them, will become clearer with reference to the embodiments described in detail below together with the accompanying drawings. However, the present invention is not limited to the embodiments disclosed below and may be implemented in various different forms. These embodiments are provided solely to ensure that the disclosure of the present invention is complete and to fully inform those skilled in the art of the scope of the invention, and the present invention is defined solely by the scope of the claims.

[0042] When describing embodiments of the present invention, detailed descriptions of known functions or configurations will be omitted if they are deemed to unnecessarily obscure the gist of the invention. Furthermore, the terms described below are defined in light of their functions in the embodiments of the present invention and may vary depending on the intent or custom of the user or operator. Therefore, their definitions should be based on the overall content of this specification.

[0043] Before explaining Figure 1, let us look at the terms used herein.

[0044] The term "target analyte" encompasses a variety of substances (e.g., biological and non-biological substances), which may refer to the same entity as the term "target analyte".

[0045] Such target analytes may specifically include biological materials, more specifically at least one of nucleic acid molecules (e.g., DNA and RNA), proteins, peptides, carbohydrates, lipids, amino acids, biological compounds, hormones, antibodies, antigens, metabolites, and cells.

[0046] The term "sample" refers to biological samples (e.g., cells, tissues, and body fluids) and non-biological samples (e.g., food, water, and soil). Among these, the biological samples may include at least one of, for example, viruses, bacteria, tissues, cells, blood (including whole blood, plasma, and serum), lymph, bone marrow fluid, saliva, sputum, swabs, aspirations, milk, urine, stool, eye fluid, semen, brain extracts, spinal fluid, joint fluid, thymus fluid, bronchial lavage fluid, ascites, and amniotic fluid. These samples may or may not contain the aforementioned target analytes.

[0047] Meanwhile, if the target analyte described above is a nucleic acid molecule or contains a nucleic acid molecule, a nucleic acid extraction process known in the art may be performed on the sample presumed to contain the target analyte (see: Sambrook, J. et al., Molecular Cloning. A Laboratory Manual, 3 rded. Cold Spring Harbor Press (2001)). The nucleic acid extraction process may vary depending on the type of sample. In addition, if the extracted nucleic acid is RNA, a reverse transcription process may be additionally performed to synthesize cDNA (Reference: Sambrook, J. et al., Molecular Cloning. A Laboratory Manual, 3rd ed. Cold Spring Harbor Press (2001)).

[0048] The term "data set" refers to data obtained from a signal generation response for the target analyte using a signal generation means (the signal generation means will be described later).

[0049] In this case, the term "signal generating reaction" refers to a reaction that generates a signal dependent on the properties of a target analyte in a sample, such as activity, amount, or presence (or absence), specifically the presence (or absence). Such signal generating reactions include biological reactions and chemical reactions. Among these, biological reactions include genetic analysis processes such as PCR, real-time PCR, isothermal amplification, and microarray analysis, immunological analysis processes, and bacterial growth analysis. In addition, chemical reactions include processes that analyze the production, change, or destruction of a chemical substance. According to one embodiment, the signal generating reaction may be a genetic analysis process, or may be a nucleic acid amplification reaction, an enzymatic reaction, or microbial growth.

[0050] Meanwhile, the aforementioned signal generation response is accompanied by a signal change. Therefore, the progress of this signal generation response can be assessed by measuring the signal change.

[0051] Here, the term "signal" refers to a measurable output. Furthermore, the measured magnitude or change in this signal serves as an indicator, either qualitatively or quantitatively, of the characteristics of the target analyte, specifically the presence or absence of the target analyte in the sample.

[0052] Here, examples of indicators include, but are not limited to, fluorescence intensity, luminescence intensity, chemiluminescence intensity, bioluminescence intensity, phosphorescence intensity, charge transfer, voltage, current, power, energy, temperature, viscosity, light scatter, radiation intensity, reflectance, transmittance, and absorbance.

[0053] The term "signal generating means" as mentioned above means a means for providing a signal indicating the characteristics, specifically the presence or absence, of the target analyte to be analyzed.

[0054] Such signal generating means include the label itself or an oligonucleotide to which the label is linked.

[0055] Among these, the labels include fluorescent labels, luminescent labels, chemiluminescent labels, electrochemical labels, and metal labels. The labels may be used as labels themselves, such as intercalating dyes. Alternatively, the labels may be used in the form of a single label or an interactive dual label comprising a donor molecule and an acceptor molecule, bound to one or more oligonucleotides.

[0056] When using a fluorescent label, the signal value can be expressed as a RFU (Relative Fluorescence Unit) value.

[0057] The signal generating means may additionally include an enzyme having a nucleic acid cleavage activity to generate a signal (e.g., an enzyme having a 5' nucleic acid cleavage activity or an enzyme having a 3' nucleic acid cleavage activity).

[0058] Meanwhile, various methods for generating a signal indicating the presence of a target analyte, particularly a target nucleic acid molecule, using the above signal generating means are known. Representative examples include: TaqMan TMProbe method (US Patent No. 5,210,015), molecular beacon method (Tyagi, Nature Biotechnology, v.14 MARCH 1996), Scorpion method (Whitcombe et al., Nature Biotechnology 17:804-807 (1999)), Sunrise (or Amplifluor) method (Nazarenko et al., Nucleic Acids Research, 25(12):2516-2521 (1997), and US Patent No. 6,117,635), Lux method (US Patent No. 7,537,886), CPT (Duck P, et al. Biotechniques, 9:142-148 (1990)), LNA method (US Patent No. 6,977,295), Plexor method (Sherrill CB, et al., Journal of the American Chemical Society, 126:4550-4556(2004)), Hybeacons (DJ French, et al., Molecular and Cellular Probes 13:363-374(2001) and U.S. Pat. No. 7,348,141), dual-labeled, self-quenched probes (U.S. Pat. No. 5,876,930), hybridization probes (Bernard PS, et al., Clin Chem 2000, 46, 147-148), PTOCE (PTO cleavage and extension) method (WO 2012 / 096523), PCE-SH (PTO Cleavage and Extension-Dependent Signaling Oligonucleotide Hybridization) method (WO2013 / 115442), PCE-NH (PTO Cleavage and Extension-Dependent Non-Hybridization) method (PCT / KR2013 / 012312) and CER method (WO 2011 / 037306).

[0059] Meanwhile, the aforementioned term "signal generation reaction" may include a signal amplification reaction. In this case, the term "amplification reaction" refers to a reaction that increases or decreases a signal generated by the signal generation means. Specifically, the amplification reaction refers to a reaction that increases (or amplifies) a signal generated by the signal generation means depending on the presence of a target analyte.

[0060] In such amplification reactions, amplification of a target analyte (e.g., a nucleic acid molecule) may or may not be accompanied. More specifically, the amplification reaction may refer to a signal amplification reaction accompanied by amplification of a target analyte.

[0061] Meanwhile, the data set obtained through the above amplification reaction may include an amplification cycle.

[0062] Here, the term "cycle" refers to a unit of change in a condition in a plurality of measurements involving a change in said condition. The change in said constant condition may refer to an increase or decrease in, for example, temperature, reaction time, number of reactions, concentration, pH, or the number of replications of the measurement target (e.g., nucleic acid). Accordingly, a cycle may be a time or process cycle, a unit operation cycle, or a reproductive cycle.

[0063] More specifically, the term "cycle" means one unit of repetition, when a reaction is repeated in a certain process or at certain time intervals.

[0064] Alternatively, the term "cycle" may mean one unit of repetition when a certain action is repeated as the reaction progresses.

[0065] For example, when a nucleic acid amplification reaction is performed, the act of detecting a signal generated at regular time intervals may be repeated, and may represent one unit of said repetition. In this case, a cycle may have a unit of time.

[0066] For example, in the case of a nucleic acid amplification reaction, one cycle refers to a reaction that includes the steps of nucleic acid denaturation, primer annealing, and primer extension. In this case, a change in a certain condition is an increase in the number of reaction repetitions, and the unit of repetition of the reaction comprising the above series of steps is defined as one cycle. The number of cycles may include the number of reactions or the reaction time.

[0067] Meanwhile, the aforementioned target analytes or target analytes, especially target nucleic acid molecules, can be amplified by various methods: 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 (Innis et al., eds, 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); Hatchet 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).

[0068] Meanwhile, an amplification reaction amplifies the signal while amplifying the target analyte (specifically, the target nucleic acid molecule). For example, the amplification reaction is performed according to PCR, specifically real-time PCR, or an isothermal amplification reaction (e.g., LAMP or RPA).

[0069] Meanwhile, the data set obtained by the signal generation reaction includes a plurality of data points including cycles of the signal generation reaction and signal values ​​in the cycles.

[0070] Here, the term "signal value" means a numerical value of the level of a signal (e.g., signal intensity) actually measured in a cycle of a signal generation reaction, particularly an amplification reaction, or a modified value thereof, according to a certain scale. The modified value may include a mathematically processed signal value of the actually measured signal value. Examples of mathematically processed signal values ​​of the actually measured signal value (i.e., the signal value of the raw data set) may include logarithmic values ​​or derivatives.

[0071] The term "data point" refers to a single coordinate value that includes a cycle and a signal value. Furthermore, the term "data" refers to all information that constitutes a data set. For example, each cycle and signal value of an amplification reaction can be considered data.

[0072] Data points obtained by a signal generation reaction, particularly an amplification reaction, can be expressed as coordinate values ​​that can be represented in a two-dimensional rectangular coordinate system. In the coordinate values, the X-axis represents the corresponding cycle number, and the Y-axis represents the signal value measured or processed in the corresponding cycle.

[0073] The term "data set" refers to a collection of data points. For example, the data set may be a collection of data points obtained directly through an amplification reaction performed in the presence of a signal generation means, or may be a modified data set obtained by modifying such a data set. The data set may be a portion or all of a plurality of data points obtained through the amplification reaction, or a modified data set thereof.

[0074] Meanwhile, the data set may be obtained by processing multiple data sets. When analyzing multiple target analytes in a single reaction well, the data set for the multiple target analytes may be obtained by processing the data sets obtained from the reactions performed in the single reaction well. For example, the data set for multiple target analytes in a single reaction well may be obtained by processing multiple data sets obtained from signals measured at different temperatures.

[0075] The aforementioned data set can be plotted, thereby obtaining an amplification curve.

[0076] The term "plate" refers to the basic unit where an amplification reaction is performed in an amplification device, and also refers to the basic unit where the data generated after the amplification reaction is stored. Different plates may be plates where the amplification reaction was performed at different times using the same amplification device, or plates where the amplification reaction was performed at the same time by different amplification devices.

[0077] The plate comprises a plurality of reaction wells, i.e., reaction vessels. The plate may comprise N x M reaction wells. Typically, the plate comprises 12 x 8 or 8 x 12 reaction wells. The reaction wells of the plate may be integral with the plate or may be in the form of detachable tubes. The plate may be rectangular in shape, but the plate may also be implemented in various shapes, such as circular, ladder-shaped, and diamond-shaped, as long as it comprises one or more reaction wells.

[0078] The wells of the plate contain the sample to be analyzed and the detection reagents required for the nucleic acid amplification reaction. With reference to the drawings below, various embodiments of the present invention will be described.

[0079] FIG. 1 illustrates a detection result display editing device (100) for a plurality of biological target analytes according to one embodiment, a nucleic acid preparation device (200), a detection result display device (300), and a cloud server (400) connected thereto. These devices (100, 200, 300, 400) may be connected to each other by wired or wireless communication. However, FIG. 1 is merely exemplary, and the spirit of the present disclosure is not limited to that illustrated in FIG. 1. For example, these devices (100, 200, 300, 400) may be additionally connected, and these devices may include, but are not limited to, a nucleic acid detection device (500) and / or a barcode recognition device (not illustrated) and / or a connection device (not illustrated) that generates setting information for a reaction plate to be amplified in the nucleic acid detection device (500) and transmits the information to the detection result display editing device (100).

[0080] Meanwhile, unlike what is shown, the detection result display editing device (100, hereinafter referred to as the detection result display editing device) for multiple biological target analytes may be implemented by being included in the detection result display device (300). However, the following description will be made on the assumption that the above-described components (100, 200, 300, 400, 500) are implemented or connected as shown in Fig. 1. Hereinafter, each component will be examined in detail.

[0081] First, the nucleic acid preparation device (200) can use a conventional, known automated preparation device (e.g., Liquid Handling Instruments), and can extract different nucleic acids from various types of biological samples containing nucleic acids and prepare a reaction solution for amplification using the extracted nucleic acids.

[0082] The nucleic acid preparation device (200) is an automated liquid handling apparatus.

[0083] Automated liquid handling devices can automatically and programmatically aspirate and / or dispense a desired amount of reagents, samples, or other liquids from designated containers for automation in chemical or biochemical laboratories. Various configurations of automated liquid handling devices are known to those skilled in the art.

[0084] For example, devices made by the Hamilton company in Switzerland, such as the Hamilton STAR, Hamilton NIMBUS, Hamilton STARplus, and Hamilton STARlet.

[0085] All components of the nucleic acid preparation device (200) are designed as an integrated device and positioned within a housing. For example, the nucleic acid preparation device (200) may include a nucleic acid extraction reagent placement unit, a nucleic acid amplification detection reagent placement unit, a specimen placement unit, a nucleic acid extraction unit, a nucleic acid extract placement unit, a nucleic acid amplification reaction solution preparation unit, and a pipetting unit.

[0086] In addition, it may include an extraction reagent cartridge containing various biological samples including nucleic acids and buffers used to extract nucleic acids from them, a nucleic acid amplification detection reagent cartridge for preparing an amplification reaction solution for an amplification reaction, a refrigeration block, a high-temperature block, a waste container, a pipetting block, a pipettor cartridge, and a pipettor, which can be mounted and detached within the nucleic acid preparation device (100).

[0087] A pipetting block may include one or more pipettes that move and operate independently or dependently. A tip or needle is attached to the end of the pipette to be used for aspirating and dispensing a solution.

[0088] A nucleic acid preparation device (200) for extracting nucleic acid from a biological sample containing nucleic acid and preparing a nucleic acid amplification reaction may add a bar code recognition device. Biological sample information recognized by the bar code recognition device may be databased and stored in a real-time medical server cloud, LIMS (Laboratory Information Management System), LIS (Laboratory Information System), and such information may also be automatically applied to a real-time nucleic acid detection device. The bar code indicates information that can be used to identify biological samples, such as gender, age, and type, and to classify the samples based on necessary information.

[0089] Through this configuration, the preparatory work performed by the nucleic acid preparation device (200) includes, but is not limited to, a nucleic acid extract preparation work, a nucleic acid amplification reaction solution preparation work, or a preparatory work in which the nucleic acid extract preparation work and the nucleic acid amplification reaction solution preparation work are performed simultaneously.

[0090] These preparatory steps are for preparing a reaction plate that will be the target of an amplification reaction in a nucleic acid detection device by extracting nucleic acids, dispensing the extracted nucleic acids into reaction wells included in the plate, and dispensing reagents necessary for an amplification reaction into the reaction wells into which the nucleic acids have been dispensed. The reaction plate includes a plurality of wells (reaction vessels), which accommodate the sample to be analyzed (extracted nucleic acids, i.e., patient specimens) and the detection reagents necessary for the nucleic acid amplification reaction.

[0091] When the above preparation operations are performed, the nucleic acid preparation device (200) generates setting information for the plate that is the target of the amplification reaction in the nucleic acid detection device (500).

[0092] The reaction plate includes a plurality of reaction wells, and each reaction well is arranged at a different location on the reaction plate, so that different samples and different detection reagents can be accommodated. The samples accommodated in each reaction well are read as positive or negative based on the results of the amplification reaction, thereby determining whether the patient has a disease.

[0093] In addition, not only are the specific target analytes that can be amplified different depending on the type of detection reagent, but the amplification reaction conditions in the nucleic acid detection device that performs the amplification reaction may also differ depending on the detection reagent. Therefore, in the environment where the target analytes are detected and analyzed, the information needs to be clearly identified, stored, and shared.

[0094] To this end, in the present disclosure, when a nucleic acid extract preparation operation and / or a nucleic acid amplification reaction solution preparation operation is performed in a nucleic acid preparation device (200), setting information for a plate that is the target of the amplification reaction input in each preparation operation process is generated.

[0095] Here, the plate setup information may include amplification reaction protocol information, setup information for each reaction well (e.g., detection channel information for each reaction well, sample type), extraction reagent and detection reagent information, type of reaction plate, type of reaction well, patient identification information, and patient identification information for each reaction vessel.

[0096] For example, a specific form of plate setting information is created by creating a file with the file name '.plrn', and the file created in this way can be stored in a specific location (medical service cloud server and / or HIS (medical information system)) and exported to a detection result display editing device (100).

[0097] A detection result display editing device (100) according to the present disclosure is a device that uses a memory, a processor, and one or more programs stored in the memory and configured to be executed by the processor, and is particularly for editing a display of detection results of a plurality of biological target analytes in a detection result display device (300).

[0098]

[0099] Below, the detection result display editing device (100) will be examined in more detail.

[0100] FIG. 2 is a block diagram of a detection result display editing device (100) according to one embodiment.

[0101] Referring to FIG. 2, the detection result display editing device (100) includes a communication unit (110), a memory (120), a processor (130), and a display unit (140), but is not limited thereto.

[0102] First, the communication unit (110) is implemented as a wired or wireless communication module. Through this communication unit (110), the detection result display editing device (100) can communicate with the outside. For example, the detection result display editing device (100) can receive amplification result data from the nucleic acid detection device (200) through the communication unit (110). In addition, the detection result display editing device (100) can receive information necessary for editing the detection result display from the outside, for example, from a medical information system including a device (200, 300, 400, 500, LIS) illustrated in FIG. 1 and / or a LIMS (laboratory information management system) and an HIS (hospital information system, integrated medical information system) not illustrated in FIG. 1.

[0103] The memory (120) stores various types of data or information including at least one command. The stored data may include data received from an external device (200, 300, 400, 500, LIS) via a communication unit (110) or data processed by a processor (130). These data or information may include various types of editing information necessary for editing the display of detection results.

[0104] Meanwhile, in FIG. 2, the memory (120) is depicted as a separate configuration from the processor (130), but the memory (120) may be implemented as a single device with the processor (130). For example, the memory (120) may be a storage such as a cache included within the processor (130).

[0105] Next, the processor (130) may be implemented by a central processing unit (CPU), a graphics processing unit (GPU), a microcontroller unit (MCU), or a dedicated processor in which the methods according to one embodiment are performed. Hereinafter, such a processor (130) may collectively refer to a single processor or multiple processors, for example, a multi-core processor.

[0106] This processor (130) can write data to the memory (120). In addition, the processor (130) can read out and execute instructions stored in the memory (120). For example, the processor (130) can cause the research and development data management device (100) to perform the functions described below by executing instructions stored in the memory (120). These functions will be described later.

[0107] The display unit (140) can be driven by the processor (130) as follows.

[0108] First, information can be displayed on the display unit (140). In addition, a user can input certain information through the display unit (140). For such display or input, the display unit (140) can be implemented as a touch screen or a touch pad, or alternatively, can be implemented in combination with an LCD monitor and a keyboard. Here, the information displayed on the display unit (140) may be transmitted from the outside to the research and development data management device (100) through the communication unit (110) or loaded from the memory (120), but is not limited thereto.

[0109] Depending on the embodiment, the display unit (140) may display a masking data input screen (40) described below for receiving detection result display editing information. The content included in this screen may be transmitted from the outside to the detection result display editing device (100) via the communication unit (110) or loaded from the memory (120), but is not limited thereto.

[0110] The detection result display editing information input to the display unit (140) can be generated by a user input action through the masking data input screen (40).

[0111] Below, each functional configuration of the detection result display editing device (100) that provides such a masking data input screen (40) will be examined in more detail with reference to FIGS. 3 to 6.

[0112] According to one implementation example, the detection result display editing device (100) can access plate setup information for a reaction plate on which an amplification reaction is to be performed using a detection reagent for a multiplex nucleic acid amplification reaction capable of detecting a plurality of biological target analytes.

[0113] According to an embodiment, accessing the detection result display editing device (100) means accessing the plate setting information that is i) stored in the detection result display device or an external device, or ii) stored internally in the detection result display editing device, and the plate setting information stored internally in the detection result display editing device (100) may be received from the detection result display device (300) or an external device.

[0114] In addition, according to an embodiment, accessing plate setting information in the detection result display editing device (100) means receiving plate setting information from the outside, accessing an external device to read plate setting information, or retrieving plate setting information stored in the detection result display editing device (100). At this time, the outside of the detection result display editing device (100) may be, according to one embodiment, a nucleic acid preparation device (200), a detection result display device (300), and a medical service cloud server (400), but is not limited thereto and may include all devices existing outside / inside the detection result display editing device (100). Specifically, it means accessing data stored in the detection result display device (300) and / or data stored inside the detection result display editing device (100) and / or data stored outside the detection result display editing device (100) and the detection result display device (300) and / or data generated internally based on at least one data received from the outside or the detection result display device (300).

[0115] The accessed plate setup information includes setup information for each reaction well, and the reaction well setup information may include identifiers for a plurality of biological target analytes amplified in the reaction well.

[0116] The detection result display editing device (100) according to the present disclosure can display an identifier on a masking data input screen.

[0117] At this time, the identifier refers to the name of each of the multiple biological target analytes that can be amplified using the detection reagent.

[0118] When the detection reagent includes multiple detection reagents, the identifier of the target analyte for the multiple detection reagents may be displayed on the masking data input screen according to each detection reagent.

[0119] Nucleic acid amplification reaction technologies require the use of detection reagents for target nucleic acid detection, including oligonucleotides (e.g., primers and / or probes) that specifically hybridize to the target analyte of interest, labels, DNA polymerase, dNTPs, Mg ions, and buffers to amplify and detect the target analyte of interest.

[0120] These detection reagents can be commercialized in the form of diagnostic kits along with amplification reaction related components, for example, Allplex from seegene TM The Respiratory Panel 1 diagnostic kit is designed to detect respiratory infections by amplifying Influenza A virus (Flu A), Influenza A virus A-H1 (Flu A-H1), Influenza A virus A-H3 (Flu A-H3), Respiratory syncytial virus A (RSV A), and Respiratory syncytial virus B (RSV B).

[0121] Therefore, a patient sample, for example, a nasopharyngeal swab or a nasopharyngeal aspirate, is dispensed into a reaction well together with a nucleic acid extraction reagent through a nucleic acid preparation device (200) to extract nucleic acid, and the extracted nucleic acid is Allplex TM Allplex is amplified using a nucleic acid detection device using the Respiratory Panel1 diagnostic kit. TMThe Respiratory Panel1 diagnostic kit can detect infection with at least one of the following: Influenza A virus (Flu A), Influenza A virus A-H1 (Flu A-H1), Influenza A virus A-H3 (Flu A-H3), Respiratory syncytial virus A (RSV A), and Respiratory syncytial virus B (RSV B).

[0122] At this time, the analysis target means an identifier according to the present disclosure.

[0123] These detection reagents are for a multiplex amplification reaction capable of simultaneously amplifying multiple biological target analytes, and the target analytes, i.e., the analytes, for each detection reagent may be different from each other.

[0124] Accordingly, the detection result display editing device (100) can display identifiers of different analysis subjects for each detection reagent through the masking data input screen, as shown in FIG. 4.

[0125] At this time, the detection result display editing device (100) can selectively display only the analysis targets of interest. For example, if a patient's sample named Kim undergoes an amplification reaction using detection reagents A, B, C, and D, the detection result display targets will be the analysis targets set for each detection reagent, i.e., identifiers for multiple biological target analytes.

[0126] However, even though the identifier of the analysis target is set for each detection reagent, some of the analysis target identifiers may not be of interest.

[0127] In addition, when each of the specimens of patients Kim, Lee, and Park is subjected to an amplification reaction using a detection reagent called A, multiple identifiers of the analysis targets set for the detection reagent A for each patient are the targets of the detection result display, but the identifiers of the targets of interest for each patient may be different from each other.

[0128] To this end, in the present disclosure, editing information for determining whether to mask the amplification reaction result for the identifier of at least one biological target analyte among the identifiers of a plurality of biological target analytes amplified in a reaction well containing a specific patient sample and a detection reagent can be input through a masking data input screen in a detection result display editing device (100).

[0129] According to one implementation example, when identifiers for multiple biological target analytes that are analysis targets set for each detection reagent are displayed on the masking data input screen (40), the user can selectively select identifiers that are not targets of interest for each detection reagent through a selection action such as a click and check the identifiers to indicate an intention to mask the corresponding identifiers.

[0130] That is, for identifiers for which you do not want to check the detection result, regardless of whether they are read positively or negatively, you can mask the identifiers by designating them as off-target.

[0131] These masking methods include, for example, displaying the identifier in a specific color or with a specific symbol, but are not limited to this, and masking is possible in various ways as long as it is distinguished from the identifier of interest.

[0132] As illustrated in FIG. 4, according to one implementation example, the detection result display editing device (100) displays different identifiers for each detection reagent (Product Name in FIG. 4) as analysis targets through a masking data input screen (40), and a specific identifier selected by the user from among the displayed identifiers for each detection reagent (Target in FIG. 4) can be displayed as an off-target, for example, using a gray color, through user selection.

[0133] For example, referring to FIG. 4, in order to confirm the presence of Gastrointestinal Tract Infections using a GI-V detection reagent, identifiers (ASV, NVG2, ADV-F, SV, NVG1, ROV) for multiple biological target analytes detectable in a 1_difficile barcoded sample, that is, set in the GI-V detection reagent, are displayed on a masking data input screen (40). Among these, NVG2 is distinct from ASV, ADV-F, SV, NVG1, and ROV, and means that it is an identifier for which the detection result is not desired to be confirmed, and NVG2 is selected by the user and designated as an off-target, thereby masking the corresponding identifier.

[0134] Additionally, in the identifiers (Yer, Sh / EI, O157, CdA / B, stx1 / 2, Sat, Cam) of multiple biological target analytes detectable using the GI-EB detection reagent in the 2_difficile barcoded sample, Sh / EI is masked and displayed as an identifier for which the detection result is not desired.

[0135] Meanwhile, in the samples barcoded with 5_difficile and receiving GI-V and GI-EB detection reagents, no target identifiers were masked, meaning that detection results for all identifiers detectable by the corresponding detection reagents will be displayed.

[0136] It will be obvious that the different identifiers for each detection reagent displayed through the masking data input screen (40) are prepared in the nucleic acid preparation device (200) and the sample received in the plate on which the amplification reaction was performed by the nucleic acid detection device is the target.

[0137] In some embodiments, the masking data input screen (40) may display identifiers for each detection reagent as barcodes. This is because patient samples are accommodated singly in a single reaction well, and patient samples accommodated in a reaction well together with a detection reagent can be barcoded with patient identification information and classified by reaction well.

[0138] The barcode may be a patient identification code and / or patient specimen code read by a barcode recognition device. Additionally, the barcode may contain information that allows for identification and classification of biological samples based on necessary information, such as gender, age, and type.

[0139] Accordingly, the masking data input screen (40) displays the identifier of the detection reagent for which the virus that the patient wants to confirm is set as the analysis target based on the patient code recognized by the barcode, and among them, identifiers that are not the target of interest can be masked and displayed.

[0140] However, this masking data input screen is only an implementation example according to the present disclosure and is not limited thereto.

[0141] Accordingly, in the masking data input screen, the identifier for each detection reagent described above may be displayed by barcode or by reaction well.

[0142] Meanwhile, the identifier displayed on the masking data input screen (40) in the detection result display editing device (100) may be received from the detection result display device (300) according to one implementation example.

[0143] The detection result display device (300) obtains an amplification reaction result, i.e., a data set, from the nucleic acid detection device (200). As illustrated in FIG. 5, the detection result display device (300) can generate an amplification curve (52) using the data set. The detection result display device (300) can remove noise from the data set and generate an amplification curve (52) using the noise-removed data set. The detection result display device (300) can analyze the data generated from the plate reaction well (50) to determine positive / negative for each sample, a Ct (Cycle threshold) value, a signal value at a specific cycle (e.g., an RFU value), etc.

[0144] Removing noise from a data set, generating an amplification curve, analyzing the data set, determining positive / negative, etc. may also be performed by the nucleic acid detection device (500).

[0145] This detection result display device (300) has information, i.e., identifiers, about a plurality of biological target analytes that can be amplified for each detection reagent.

[0146] For example, Allplex, a detection reagent for detecting infection in respiratory infections. TMRespiratory Panel 1 contains Influenza A virus (Flu A), Influenza A virus A-H1 (Flu A-H1), Influenza A virus A-H3 (Flu A-H3), Respiratory syncytial virus A (RSV A), Respiratory syncytial virus B (RSV B)… … … as amplifiable analysis targets. Allplex, a detection reagent for confirming Gastrointestinal Tract Infections TM Adenoivirus, Astrovirus, and Norovirus are set as amplifiable analysis targets in the GI-Virus Assay.

[0147] Accordingly, the detection result display device (300) can obtain a data set according to the amplification reaction result from the nucleic acid detection device, and display the amplification data based on the obtained data set and the analysis target for each preset detection reagent, as shown in FIG. 5.

[0148] FIG. 5 is a screen showing the amplification reaction results for all target analytes before masking the identifier for the target analyte using the detection result display editing device (100) of the present disclosure or before using the detection result display editing device (100).

[0149] As illustrated in FIG. 5, the detection result display device (300) may display an image of a plate (50) on which an amplification reaction was performed, and may display amplification data of a plurality of reaction wells included in the plate (50) as a graph (52) and / or a well information table (54). At this time, the amplification data may include at least one of a cycle number and a signal value set, a signal value at a specific cycle, a positive / negative judgment result, and a Ct value.

[0150] The table (54) displayed in the detection result display device (300) may display amplification data including the names of target genes to be detected in each channel (FAM, HEX, Cal Red 610, Quasar 670), i.e., identifiers for target analytes, positive / negative judgment results for each reaction well (A01, B01, C01, D01, E01), Ct values, etc.

[0151] To this end, the detection result display device (300) stores information on a plurality of biological target analytes that are analysis targets for each detection reagent in advance, and when a data set is obtained from the nucleic acid detection device (500), analyzes it to determine whether target analytes are present or absent in the sample, detects data on the sample and stores it in memory, and can display detection results such as Ct values ​​and signal values ​​(e.g., RFU values) for each sample.

[0152] According to one implementation example, the detection result display editing device (100) receives an identifier from the detection result display device (300) and identifies a detection reagent through plate setup information received from the nucleic acid preparation device (200), so that identifiers for a plurality of detectable biological target analytes for each detection reagent can be displayed on a masking data input screen, as illustrated in FIG. 4.

[0153] Alternatively, according to an embodiment, the detection result display editing device (100) may pre-store the analysis target identifier for each detection reagent in its memory. In this case, the detection result display editing device (100) may receive plate setup information from the nucleic acid preparation device (200) to identify detection reagent information for each reaction well for a reaction plate on which an amplification reaction will be performed, and may then display the pre-stored identifier corresponding to the identified detection reagent on the masking data input screen as illustrated in FIG. 4.

[0154] And, according to an embodiment, the detection result display editing device (100) may receive an identifier from an external source other than the nucleic acid preparation device (200) and / or the detection result display device (300) and / or the nucleic acid detection device, for example, a medical server cloud (400).

[0155] Plate setup information can also be received from an external source other than the nucleic acid preparation device (200), for example, a connection device, and displayed on the masking data input screen (40) as shown in Fig. 4 by matching the identifier set in the detection reagent. In this case, a '.plrn' file, which is plate setup information, is created in the connection device.

[0156] In addition, according to an embodiment, the detection result display editing device (100) may receive all identifiers for each detection reagent displayed on the masking data input screen (40) from the outside at once, and according to an embodiment, the detection result display editing device (100) may display only identifiers for a plurality of biological target analytes on the masking data input screen (40).

[0157] In this way, the identifier displayed on the masking data input screen (40) is displayed to determine whether to mask when displaying amplification data on the detection result display device (300), and the detection result display editing device (100) can display a plurality of detectable biological target analytes based on the detection reagent included in the reaction well as an object that can be individually selected by the user with an identifier for each biological target analyte. Here, the object may be in a selectable form such as text or icons of various shapes, but is not limited thereto, and may be implemented in various forms as long as it is an individually selectable object.

[0158] Accordingly, the identifiers displayed on the masking data input screen (40) can be displayed in such a way that identifiers selected for masking and identifiers not selected for masking are distinguished depending on whether or not masking is performed on the detection result display device (300).

[0159] According to one implementation example, masking for the corresponding identifier is determined in the detection result display device (300) through object selection, and if object selection does not occur, the corresponding identifier may be displayed in the detection result display device.

[0160] However, in the present disclosure, it will be clear that the selection action is not particularly limited to masking when selecting an identifier, and non-masking when not selected, and if the selection of an object is distinguished on the masking data input screen (40), whether or not to mask each object will be ultimately displayed as a result on the detection result display device (300) according to the result.

[0161] In the present disclosure, editing information can be generated through identifiers for detection reagents and multiple biological target substances for each detection reagent obtained from accessed plate setting information, i.e., whether or not an object is selected.

[0162] In the masking data input screen (40) of the detection result display editing device (100) according to the present disclosure, identifiers for a plurality of amplifiable biological target analytes are set as analysis targets for each detection reagent, and identifiers for each detection reagent included in each sample for each reaction well for the reaction plate are displayed when the amplification reaction is started or during the amplification reaction in the nucleic acid detection device (500) or after the amplification reaction is completed. At this time, as described above, the identifier information may be received from the detection result display device (300) or from another external device.

[0163] When a user selection occurs among the identifiers displayed on the masking data input screen (40), the identifier for which a user selection occurred will be masked when the detection result is displayed on the detection result display device (300), making it impossible to confirm the detection result.

[0164] FIG. 6 illustrates an example of an implementation of a screen in which a masked identifier is displayed as amplification reaction result data in a detection result display device (300) in a detection result display editing device (100) according to the present disclosure. FIG. 6 illustrates that a detection result display device (300) obtains an amplification reaction result data set from a nucleic acid detection device (500) and displays the amplification reaction result data through the obtained data set, and a reaction plate (60) on which an amplification reaction was performed, an amplification reaction result graph (62) in each reaction well, and a table (64) can each be simultaneously displayed on one screen.

[0165] As illustrated in FIG. 6, in the detection result display device (300), it can be confirmed in the table (64) displaying the amplification reaction result data that the target analytes O0157 and CdA / B for the HEX channel in well A01 have been masked, and the target analyte Sal has been masked for the Cal Red 610 channel. In the C01 well, it can be confirmed that the target analytes stx11 / 2 and Sal have been masked for the Cal Red 610 channel.

[0166] As shown in the plate (60) of FIG. 6, although the A01 well and the C01 well are samples for which an amplification reaction has been performed, some of the target analytes among the plurality of biological target analytes that can be amplified by the detection reagent contained in each of the samples are displayed as masked, as shown in the table (64), if the detection results are not of interest.

[0167] In addition, according to an embodiment, the detection result display device (300) may additionally display information on the name of the detection reagent used in the target reaction plate on which the amplification reaction result data is displayed (Assay Name in FIG. 6), the number of samples on which the amplification reaction was performed in the reaction plate, and whether or not it is valid (Sample Count Valid in FIG. 6).

[0168] In this way, the target analytes displayed in a masked manner in the detection result display device (300) are based on the plate setting information edited through the masking data input screen (40) in the detection result display editing device (100) of the present disclosure.

[0169] The plate setup information transmitted from the detection result display editing device (100) to the detection result display device (300) may be in the form of a plrn file depending on the embodiment. In this case, information on the identifier that has been masked and edited is written in a specific field of the plrn file. Specifically, the plrn file related to the plate setup information records setting information for each reaction well, an amplification reaction path, a plate type, and detection reagent information in each of various fields including a header. In particular, the detection reagent information may be written in a Well Note field, and information on the identifier that has been masked and edited may be written in a Run Notes field. At this time, the detection result display editing device (100) may convert whether or not the identifier is masked into a hexadecimal number and write it in the Run Notes field. For example, if 6 identifiers are edited, the binary number expressed as 10101100 can be converted to hexadecimal and recorded as AC, and if 14 identifiers are edited, the binary number expressed as 1010110101011100 can be converted to hexadecimal and recorded as AD5C. In this case, even if the number of identifiers being edited increases, the Run Note field size may not be affected.

[0170] As described above, the plate setup information is received from the nucleic acid preparation device (200) according to one implementation example, and when the detection result display editing device (100) receives the plate setup information, the detection result display editing device (100) displays information on the corresponding detection reagent according to patient identification information per barcode unit or per reaction well based on the received plate setup information on the masking data input screen (40), and displays identifier information for each detection reagent received from the detection result display device (300) by matching it with the data displayed on the masking data input screen (40), thereby performing editing to determine whether to mask the identifier to be displayed as amplification reaction result data on the detection result display device (300).

[0171] Here, the plate setting information received from the nucleic acid preparation device (200) can be referred to as an original file, and in order to transmit information about a masked identifier to the detection result display device (100) through the masking data input screen in the detection result display editing device (100), editing of the original file must be performed.

[0172] Accordingly, by editing to store editing information about which identifier is the target of masking in a new file rather than the original file, a file different from the original file can be stored in the detection result display editing device (100). The edited file different from the original file is a file containing masked identifier information, i.e., Target on / off information, and a file containing new plate setting information different from the original file.

[0173] Accordingly, in the detection result display editing device (100), a file for plate setting information before editing and / or plate setting information after editing can be stored, and the plate setting information for the original file can be updated or new plate setting information can be generated through editing that determines whether to mask a specific identifier.

[0174] According to an embodiment, each plate setting information in the above update or creation may include at least one of storage time, storage date, editor, detection reagent information, and nucleic acid preparation device name.

[0175] Such editing information may be displayed (42) on the masking data input screen (40) by counting the number of modifications that have occurred from the original file, depending on the embodiment.

[0176] The masking data input screen (40) can basically display the number of On identifiers in the On state where all identifiers for each detection reagent are displayed, and the number of Off identifiers masked in the On state. In this case, the total of On / Off can be the total number of identifiers set for each detection reagent. This is to enable the generation of re-editing information after the generation of the edit information by counting the number of On and Off identifiers when re-editing information required for the second, third... or second, third... generation files is required from the update or generation file for the edit information generated by masking at least one specific identifier.

[0177] Each file updated or created in this way can be saved in the form of a template. Depending on the storage method, it is possible to check whether the identifier for each detection reagent in each template is masked. These templates are intended to enable the simultaneous masking of multiple identifiers at once by loading them without having to individually select the identifiers displayed on the masking data input screen (40).

[0178] Further edited plate setup information according to these templates can also be exported to the detection result display device (300) and / or an external storage device.

[0179] For example, even if it is a detection reagent that can amplify all common pathogens by age group, since the common pathogens of infectious diarrhea differ depending on age group, the results for the presence or absence of common pathogens by age group are displayed, and the remaining pathogens are masked and stored in the form of a template. Then, the corresponding template can be loaded first based on the patient identification information obtained through the barcode and the results can be quickly confirmed.

[0180] These templates can also be created by symptom. Identifiers that should be prioritized for each symptom are displayed, and the remaining identifiers can be masked and created as templates. Templates can also be created by time. For short incubation periods (1 to 6 hours), 8 to 16 hours, and 16 to 72 hours), templates can be created in advance based on suspected identifiers for each time period. Templates can then be selectively loaded based on time to quickly review the results.

[0181] For example, it can be 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours or more, and 96 hours, 72 hours, 48 ​​hours, 36 hours, 24 hours or less. In this way, the template can be pre-saved by time zone, symptom, and age group by setting editing information in advance. Symptoms include the type of symptom, the degree of mildness or severity, and the age group can include all age groups from newborns, infants, children, adolescents, middle-aged people, and the elderly.

[0182] Meanwhile, in the present disclosure, the detection result display editing device (100) allows the selection of a version when there are two or more versions of the detection result display device (300) that displays a specific identifier by masking it.

[0183] To this end, the detection result display editing device (100) allows selection of which detection result display device to pair with before displaying the detection result display editing screen (40) according to an embodiment, and accesses identifier information from the selected detection result display device. Since the analysis target of the detection reagent can be continuously updated (added, deleted) and the detection result display device can also be continuously updated due to limitations on licensing, the detection result display editing device (100), which can perform masking by receiving identifier information dependent on the detection result display device according to an embodiment, can allow selection of the detection result display device to be paired before performing masking.

[0184] FIG. 3 is a flowchart illustrating a method for generating editing information for determining whether to mask an amplification reaction result for an identifier of at least one biological target analyte among identifiers for a plurality of biological target analytes in a detection result display editing device (100) according to one embodiment.

[0185] The method according to the present disclosure is a computer-implemented method for performing editing of a display of detection results of a plurality of biological target analytes, which is performed in a device for editing a display of detection results of a plurality of biological target analytes using a memory, a processor, and one or more programs stored in the memory and configured to be executed by the processor.

[0186] Referring to FIG. 3, in S310, the detection result display editing device (100) accesses plate setting information for a reaction plate on which an amplification reaction is to be performed using a detection reagent for a multiplex nucleic acid amplification reaction capable of detecting a plurality of biological target analytes.

[0187] At this time, the plate setting information includes setting information for each reaction well, and the reaction well setting information includes identifiers for a plurality of biological target analytes amplified in the reaction well.

[0188] In S312, the identifier is displayed on the masking data input screen.

[0189] In S314, editing information for determining whether to mask the amplification reaction result for the identifier of at least one biological target analyte among the identifiers of the plurality of biological target analytes amplified in the reaction well is input through the masking data input screen in the detection result display device.

[0190] The plate setting information received according to the editing information in S316 is edited and saved.

[0191] In S318, the detection result display device (300) and / or the edit information stored externally are exported.

[0192] Since the operation of each step illustrated in Fig. 3 is the same as the function of the detection result display editing device (100) discussed above, the description of Figs. 1-2 and 4-6 described above will be used.

[0193] The block diagrams attached to this disclosure and the combinations of each block and each step of the flowchart may be performed by a computer program.

[0194] These computer programs, when executed by one or more processors, cause the one or more processors to perform the following steps: accessing plate setting information for a reaction plate on which an amplification reaction is to be performed using a detection reagent for a multiplex nucleic acid amplification reaction capable of detecting a plurality of biological target analytes, for a detection result display editing device for a plurality of biological target analytes; the plate setting information including setting information for each reaction well, the reaction well setting information including identifiers for the plurality of biological target analytes amplified in the reaction well, and displaying the identifiers on a masking data input screen; receiving, through the masking data input screen, editing information for determining whether to mask an amplification reaction result for the identifier of at least one biological target analyte among the identifiers for the plurality of biological target analytes amplified in the reaction well, in a detection result display device; and editing and storing the plate setting information received according to the editing information. These programs may also be stored in a computer-readable recording medium to implement a function in a specific manner. Furthermore, terms such as "include," "comprise," or "have" described above, unless specifically stated otherwise, imply that the corresponding component may be included, and therefore should be interpreted to include other components rather than excluding other components. All terms, including technical or scientific terms, have the same meaning as commonly understood by a person of ordinary skill in the art to which this disclosure pertains, unless otherwise defined.Commonly used terms, such as terms defined in the dictionary, should be interpreted to be consistent with their meaning in the context of the relevant technology and not in an idealized or overly formal sense unless expressly defined in this disclosure.

[0195] The above description is merely an example of the technical idea of ​​the present disclosure, and those skilled in the art to which the present disclosure pertains will appreciate that various modifications and variations can be made without departing from the essential characteristics of the present disclosure. Therefore, the embodiments disclosed in the present disclosure are not intended to limit the technical idea of ​​the present disclosure, but rather to explain it, and the scope of the technical idea of ​​the present disclosure is not limited by these embodiments. The scope of protection of the present disclosure should be interpreted by the claims below, and all technical ideas within a scope equivalent thereto should be interpreted as being included in the scope of rights of the present disclosure.

[0196] While specific aspects of the present disclosure have been described in detail above, it should be apparent to those skilled in the art that these specific descriptions are merely preferred implementation examples and do not limit the scope of the present disclosure. Therefore, the substantial scope of the present disclosure is defined by the appended claims and their equivalents.

Claims

1. A computer-implemented method for performing display editing of detection results of multiple biological target analytes performed in a detection result display editing device, A step for a detection result display editing device to access plate setting information for a reaction plate on which an amplification reaction is to be performed using a detection reagent for a multiplex nucleic acid amplification reaction capable of detecting the plurality of biological target analytes; The detection result display editing device includes (i) a memory, (ii) a processor, and (iii) one or more programs stored in the memory and configured to be executed by the processor, wherein the plate setting information includes setting information for each reaction well, and the reaction well setting information includes identifiers for the plurality of biological target analytes to be amplified in the reaction well. A step of displaying the above identifier on a masking data input screen of a display editing device of the above detection result; A step of receiving editing information for determining whether to mask the amplification reaction result in the detection result display device for at least one of the identifiers of the plurality of biological target analytes amplified in the above reaction well through the masking data input screen; and A step of editing and providing the plate setting information received according to the above editing information; 2. In the first paragraph, the accessing step comprises: i) stored in the above detection result display device or external device, or ii) Stored inside the above detection result display editing device, Accessing the above plate setting information, A method for editing the display of detection results of a plurality of biological target analytes, characterized in that the plate setting information stored inside the detection result display editing device is received from the detection result display device or the external device.

3. In paragraph 1, the identifier is, A method for editing the display of detection results of multiple biological target analytes, characterized in that the names of multiple biological target analytes to be amplified using the detection reagent are displayed on the masking data input screen according to each detection reagent, and when the detection reagent includes multiple detection reagents, the identifiers of the target analytes for the multiple detection reagents are displayed.

4. In the first paragraph, the step of indicating, A method for editing the display of detection results of multiple biological target analytes, characterized in that the identifier for each biological target analyte is displayed as an object that can be individually selected by the user.

5. In the fourth paragraph, the step of indicating said A method for editing the display of detection results of a plurality of biological target analytes, characterized in that at least one object selected by the user and an object not selected among the objects displayed on the masking data input screen are displayed separately.

6. In paragraph 5, The above selected object is determined by masking the identifier and amplification reaction result in the above detection result display device, A method for editing the display of detection results of a plurality of biological target analytes, characterized in that the above unselected objects are displayed with their corresponding identifiers and amplification reaction results on the detection result display device.

7. In paragraph 4, the editing information is: A method for editing display of detection results of a plurality of biological target analytes, characterized in that the display is generated by using the selection of the individually selectable objects from the accessed plate setting information.

8. In the second paragraph, the plate setting information stored inside the detection result display editing device is A method for editing a display of detection results of a plurality of biological target analytes, characterized in that an identifier to be masked among a plurality of biological target analytes detectable using the above detection reagent is further edited according to a template in which an identifier is determined in advance.

9. In paragraph 8, The above template is, A method for editing the display of detection results of a plurality of biological target analytes, characterized in that the preset editing information is preset for each detection reagent, and the preset editing information stores whether or not to mask the amplification reaction result for the identifier of at least one biological target analyte among the identifiers of the plurality of biological target analytes.

10. In paragraph 8, The above template is characterized in that the detection result display editing method of a plurality of biological target analytes is classified by at least one selected from among symptom onset time, symptom, and / or gender and age group.

11. In clause 10, the time elapsed since the onset of the symptom is A method for editing display of detection results of multiple biological target analytes, characterized in that the detection time is 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours or more, or 96 hours, 72 hours, 48 ​​hours, 36 hours, 24 hours or less.

12. A method for editing the display of detection results of multiple biological target analytes, characterized in that the symptom in clause 10 is one of symptom type, mild, and severe.

13. In paragraph 10, the gender includes female and male, A method for editing display of detection results of multiple biological target analytes, characterized in that the above age groups include from newborns to the elderly.

14. In the second paragraph, if the plate setting information is stored in the detection result display device or the external device, A method for editing display of detection results of a plurality of biological target analytes, characterized by further performing a step of exporting the plate setting information edited according to the editing information to the detection result display device and / or the external storage device.

15. A method for editing display of detection results of a plurality of biological target analytes, characterized in that in the 8th paragraph, the step of exporting the plate setting information further edited according to the template to the detection result display device and / or the external storage device is further performed.

16. In the step of exporting in clause 14 or 15, A method for editing display of detection results of a plurality of biological target analytes, characterized in that the editing information on whether or not to mask identifiers of the plurality of biological target analytes is converted into hexadecimal and exported.

17. Memory storing at least one instruction; and Contains a processor, By executing at least one instruction by said processor, Accessing plate setup information for a reaction plate on which an amplification reaction is to be performed using a detection reagent for a multiplex nucleic acid amplification reaction capable of detecting a plurality of biological target analytes, wherein the plate setup information includes setup information for each reaction well, and the reaction well setup information includes identifiers for a plurality of biological target analytes to be amplified in the reaction well. The above identifier is displayed on the masking data input screen of the detection result display editing device, The editing information for determining whether to mask the amplification reaction result in the detection result display device for at least one of the identifiers of the plurality of biological target analytes amplified in the above reaction well is input through the masking data input screen, Provided by editing the plate setting information received according to the above editing information. Computer devices.

18. A computer-readable recording medium storing a computer program, wherein the computer program is executed by one or more processors included in a computer device, A step of accessing plate setting information for a reaction plate on which an amplification reaction is to be performed using a detection reagent for a multiplex nucleic acid amplification reaction capable of detecting a plurality of biological target analytes; the plate setting information includes setting information for each reaction well, and the reaction well setting information includes identifiers for a plurality of biological target analytes to be amplified in the reaction well. A step of displaying the above identifier on a masking data input screen of a detection result display editing device; A step of receiving editing information for determining whether to mask the amplification reaction result in the detection result display device for at least one identifier of a plurality of biological target analytes amplified in the above reaction well through the masking data input screen; and A step of editing and providing the plate setting information received according to the above editing information; including; Computer readable recording medium.

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