Method and apparatus for displaying detection results of multiple biological target analytes

Abstract

The present disclosure provides a technology that allows for selective editing of the results of reading the presence or absence of multiple target nucleic acids using a detection reagent for a multiplex nucleic acid amplification reaction, wherein multiple target nucleic acids capable of amplification through the detection reagent are displayed, but the results of reading the presence or absence of some target nucleic acids are masked so that the corresponding target nucleic acids are obscured according to user selection.

Description

Technology Field

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

[0002] Molecular diagnostics is currently a rapidly growing field within the in vitro diagnostics market for the early diagnosis of diseases. Among these, methods utilizing nucleic acids are being effectively used to diagnose causative genetic factors associated with viral and bacterial infections, based on their high specificity and sensitivity.

[0003] Most nucleic acid-based diagnostic methods utilize a nucleic acid amplification reaction to amplify a target nucleic acid (e.g., viral or bacterial nucleic acid). As a representative example, the Polymerase Chain Reaction (PCR), a nucleic acid amplification reaction, involves a repeated cycle of double-stranded DNA denaturation, annealing of oligonucleotide primers into a DNA template, and primer extension by DNA polymerase (Mullis et al., U.S. Patents No. 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 the ligase chain reaction (LCR) (U.S. Patents No. 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.Biotechnol. 12(1):75-99 (1999); Hatchet al., Genet. Anal. 15(2):35-40 (1999)) and Q-beta replicase (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. may be included.

[0004] Recently, multiplex diagnostic technology based on such nucleic acid amplification reactions is being used to detect multiple target nucleic acids within a single tube. For example, there are various multiplex technologies for detecting multiple types of viruses simultaneously using methods such as the aforementioned PCR and LAMP as examples of nucleic acid amplification reactions.

[0005] Multiplex nucleic acid amplification reaction technologies require the use of reagents for detecting target nucleic acids, including oligonucleotides (e.g., primers and / or probes) that specifically hybridize to the target nucleic acid, labels, DNA polymerase, dNTPs, Mg ions, and buffers, in order 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 analytes capable of amplification are determined according to the characteristics of the target nucleic acid detection reagents.

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

[0008] As such, detection reagents utilizing multiplex technology can simultaneously amplify various target nucleic acids through a single test, making it possible to confirm the presence or absence of multiple corresponding target nucleic acids depending on the characteristics of the detection reagent.

[0009] However, depending on the patient, interest may be focused solely on the presence of a specific virus among multiple target nucleic acids—that is, the presence of a particular target nucleic acid. This is because confirming only the presence of the virus clearly suspected of causing the disease can be practical for individual patients in terms of avoiding unnecessary medical procedures and costs.

[0010] Nevertheless, when using diagnostic kits equipped with multiplex technology, the presence or absence of each of the multiple amplifiable target nucleic acids—that is, the subjects of analysis for the detection reagent—is confirmed simultaneously and collectively; consequently, medical procedures or costs are being incurred for the presence or absence of target nucleic acids that are not of interest. The problem to be solved

[0011] The problem to be solved according to one embodiment is to provide a method capable of selectively editing the results of reading the presence or absence of a plurality of target nucleic acids using the aforementioned detection reagent.

[0012] Specifically, this task may include providing a technology that can edit multiple target nucleic acids by displaying multiple target nucleic acids that can be amplified using a detection reagent for multiplex nucleic acid amplification reactions, while masking the presence or absence reading of some target nucleic acids so that the corresponding target nucleic acids are hidden, depending on the user's selection.

[0013] However, the problems that the present invention aims to solve are not limited to those mentioned above, and other problems not mentioned will be clearly understood by those skilled in the art to which the present disclosure belongs from the description below. means of solving the problem

[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, 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; wherein the detection result display editing device comprises (i) a memory, (ii) a processor, and (iii) one or more programs configured to be stored in the memory and 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 amplified in the reaction wells, and the identifiers are displayed on a masking data input screen of the detection result display editing device.

[0015] The method includes: receiving, through the masking data input screen, editing information for determining whether to mask the amplification reaction result of at least one biological target analyte among the identifiers of 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.

[0016] Additionally, the accessing step is to access the plate setting information that is i) stored in the detection result display device or 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 characterized by being received from the detection result display device or 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 analyte for the plurality of detection reagents is displayed on the masking data input screen according to each detection reagent.

[0018] In addition, the above-mentioned display step is characterized by displaying the identifier for each biological target analyte as an object that the user can individually select.

[0019] In addition, the display step is characterized by distinguishing and displaying at least one object selected by the user and an object not selected among the objects displayed on the masking data input screen.

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

[0021] In addition, the above editing information is characterized by being generated 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 by further editing the identifier to be masked among a plurality of biological target analytes detectable based on the detection reagent according to a predetermined template.

[0023] In addition, the above template is a preset editing information, and the preset editing information is characterized by storing whether the amplification reaction result for at least one of the identifiers for the plurality of biological target analytes is masked.

[0024] In addition, the above template is characterized by being an editing information in which the remaining target analytes are masked, excluding the target analytes that are primarily suspected by time, symptom, and age group.

[0025] In addition, the above template is characterized by being classified into at least one selected from the time elapsed since symptom onset, by symptom and / or by gender and age group.

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

[0027] In addition, the above symptoms are characterized by being one of the types, mild, or severe.

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

[0029] Additionally, if the plate setting information is stored in the detection result display device or an external device, the method is further characterized by performing the step of exporting the editing information to the detection result display device and / or the external storage device.

[0030] In addition, in the step of exporting, the editing information regarding whether the identifiers of the plurality of biological target analytes are masked is converted into hexadecimal and exported.

[0031] A memory storing at least one instruction according to one embodiment; and a processor are included, wherein 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 is accessed by executing the at least one instruction 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 amplified in the reaction vessel, wherein the identifiers are displayed on a masking data input screen of a detection result display editing device, and editing information determining whether to mask the amplification reaction result of at least one biological target analyte among the identifiers for a plurality of biological target analytes amplified in the reaction well is received 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 the method comprises the steps of: accessing plate setting information for a reaction plate 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 editing information through the masking data input screen to determine whether to mask the amplification reaction result for at least one biological target analyte among the identifiers for a plurality of biological target analytes amplified in the reaction well, in a detection result display device; and editing and providing the received plate setting information according to the editing information. Effects of the invention

[0033] According to one embodiment, a practical diagnosis can be made in terms of unnecessary medical procedures or costs by confirming only the presence or absence of a virus that is clearly suspected of being a disease.

[0034] According to another embodiment, rapid diagnosis and prescription are possible by first identifying the suspected causative agent based on symptoms, age, and incubation time. Brief explanation of the drawing

[0035] FIG. 1 illustrates a device for displaying detection results of a plurality of biological target analytes and devices connected thereto according to one embodiment. FIG. 2 is a block diagram of a detection result display editing device for a plurality of biological target analytes according to one embodiment. FIG. 3 is a flowchart of a method for editing detection result displays of a plurality of biological target analytes according to one embodiment. FIG. 4 is an example of the implementation of a masking data input screen of a detection result display editing device (100). FIG. 5 is an example of an implementation of a screen displaying 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). FIG. 6 is an example of an implementation of a screen in which a masked identifier in a detection result display editing device (100) according to the present disclosure is displayed as amplified reaction result data in a detection result display device (300). Specific details for implementing the invention

[0036] The advantages and features of the present invention and the methods for achieving them will become clear by referring to the embodiments described below in detail together with 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 merely 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 only by the scope of the claims.

[0037] In describing the embodiments of the present invention, specific descriptions of known functions or configurations will be omitted if it is determined that such detailed descriptions could unnecessarily obscure the essence of the invention. Furthermore, the terms described below are defined in consideration of their functions in the embodiments of the present invention, and these definitions may vary depending on the intentions or practices of the user or operator. Therefore, such definitions should be based on the content throughout this specification.

[0038] Before explaining Figure 1, let us examine the terms used herein.

[0039] The term "target analyte" includes various substances (e.g., biological and non-biological substances) and may refer to the same object as the term "target analyte."

[0040] These target analytes may specifically include at least one of biological substances, more specifically nucleic acid molecules (e.g., DNA and RNA), proteins, peptides, carbohydrates, lipids, amino acids, biological compounds, hormones, antibodies, antigens, metabolites, and cells.

[0041] 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, for example, 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, ocular fluid, semen, brain extracts, cerebrospinal fluid, joint fluid, thymic fluid, bronchial lavage fluid, ascites, and amniotic fluid. These samples may or may not contain the aforementioned target analyte.

[0042] Meanwhile, if the aforementioned target analyte 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 rd ed. Cold Spring Harbor Press (2001)). The above 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 (see: Sambrook, J. et al., Molecular Cloning. A Laboratory Manual, 3rd ed. Cold Spring Harbor Press (2001).

[0043] The term "data set" refers to data obtained from a signal generation reaction for the target analyte using a signal generation means (the signal generation means will be described later).

[0044] 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, quantity, or presence (or absence), specifically its 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. Additionally, chemical reactions include processes that analyze the generation, alteration, or destruction of chemical substances. 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.

[0045] Meanwhile, the aforementioned signal generation response is accompanied by a change in the signal. Therefore, the extent of progress of this signal generation response can be evaluated by measuring the change in the signal.

[0046] Here, the term "signal" refers to a measurable output. Furthermore, the measured magnitude or change of this signal serves as an indicator that qualitatively or quantitatively indicates the characteristics of the target analyte, specifically the presence or absence of the target analyte within the sample.

[0047] 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, radioactivity intensity, reflectance, transmittance, and absorbance.

[0048] The aforementioned term "signal generating means" refers to a means of providing a signal indicating the characteristics of a target analyte to be analyzed, specifically its presence or absence.

[0049] These signal generating means include the label itself or an oligonucleotide to which the label is attached.

[0050] 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 as single labels or as interactive double labels comprising a donor molecule and an acceptor molecule, in a form bound to one or more oligonucleotides.

[0051] When using fluorescent labels, the signal value can be expressed as an RFU (Relative Fluorescence Unit) value.

[0052] The above signal generating means may additionally include an enzyme having nucleic acid cleavage activity to generate a signal (e.g., an enzyme having 5' nucleic acid cleavage activity or an enzyme having 3' nucleic acid cleavage activity).

[0053] Meanwhile, various methods are known for generating a signal indicating the presence of a target analyte, particularly a target nucleic acid molecule, using the above-mentioned signal generating means. Representative examples may include the following: TaqMan TMProbe method (U.S. 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 U.S. Patent No. 6,117,635), Lux method (U.S. Patent No. 7,537,886), CPT (Duck P, et al., Biotechniques, 9:142-148 (1990)), LNA method (U.S. 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. Patent No. 7,348,141), Dual-labeled, self-quenched probe (U.S. Patent No. 5,876,930), Hybridization probe (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 (WO 2013 / 115442), PCE-NH (PTO Cleavage and Extension-Dependent Non-Hybridization) method (PCT / KR2013 / 012312) and CER method (WO 2011 / 037306).

[0054] Meanwhile, the aforementioned term "signal generation response" may include a signal amplification response. In this case, the term "amplification response" refers to a response that increases or decreases the signal generated by the signal generation means. Specifically, the amplification response refers to a signal increase (or amplification) response generated by the signal generation means that depends on the presence of the target analyte.

[0055] In such amplification reactions, amplification of the 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 the target analyte.

[0056] Meanwhile, the data set obtained through the above amplification reaction may include an amplification cycle.

[0057] Here, the term "cycle" refers to a unit of change in a certain condition in a plurality of measurements involving a change in said condition. The change in said certain condition refers to an increase or decrease, for example, in 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.

[0058] More specifically, the term "cycle" refers to a unit of repetition when a reaction of a certain process is repeated or when a reaction is repeated based on a certain time interval.

[0059] Alternatively, the term "cycle" may refer to a unit of repetition in cases where a certain action is repeated according to the progress of a reaction.

[0060] For example, when a nucleic acid amplification reaction is performed, the act of detecting a signal generated at regular time intervals can be repeated, and this may refer to a single unit of the repetition. In this case, the cycle may have a unit of time.

[0061] For example, in the case of a nucleic acid amplification reaction, one cycle refers to a reaction that includes the denaturation of the nucleic acid, the annealing of the primer, and the extension of the primer. In this case, a change in certain conditions results in an increase in the number of reaction repetitions, and a unit of reaction repetition including the aforementioned series of steps is defined as one cycle. The number of cycles may include the number of reactions or the reaction time.

[0062] Meanwhile, the aforementioned target analytes or target analytes, in particular target nucleic acid molecules, can be amplified by various methods: polymerase chain reaction (PCR), ligase chain reaction (LCR) (U.S. Patents No. 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 al., Genet. Anal. 15(2):35-40 (1999)), and Q-beta replicase (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).

[0063] Meanwhile, the amplification reaction amplifies the signal while accompanied by the amplification of the target analyte (specifically, the target nucleic acid molecule). For example, the amplification reaction is carried out according to PCR, specifically real-time PCR, or by an isothermal amplification reaction (e.g., LAMP or RPA).

[0064] Meanwhile, the data set obtained by the signal generation response includes a plurality of data points containing cycles of the signal generation response and signal values ​​in the cycles.

[0065] Here, the term "signal value" refers to a value or a modified value thereof that quantifies the level of a signal (e.g., signal strength) actually measured in a cycle of a signal generation response, particularly an amplification response, according to a certain scale. The modified value may include a mathematically processed signal value of the actually measured signal value. Examples of a mathematically processed signal value of the actually measured signal value (i.e., the signal value of the raw data set) may include logarithmic values ​​or derivatives.

[0066] The term "data point" refers to a coordinate value that includes cycles and signal values. Additionally, the term "data" refers to all information that constitutes a data set. For example, the cycles and signal values ​​of an amplification reaction can each correspond to data.

[0067] Data points obtained by a signal generation response, particularly an amplification response, can be represented as coordinate values ​​that can be displayed in a two-dimensional orthogonal coordinate system. In the said coordinate values, the X-axis represents the number of cycles, and the Y-axis represents the signal value measured or processed in the corresponding cycle.

[0068] The term "data set" refers to a set of the above data points. For example, the data set may be a set of data points obtained directly through an amplification reaction performed in the presence of a signal generating means, or a modified data set obtained by modifying such a data set. The data set may be part or all of a plurality of data points or modified data points obtained by the amplification reaction.

[0069] Meanwhile, the data set may be a data set obtained by processing multiple data sets. When analysis of multiple target analytes is performed in a single reaction well, the data set for the multiple target analytes may, in some cases, be obtained through the processing of data sets obtained from the reaction performed in the single reaction well. For example, the data set for multiple target analytes performed in a single reaction well may be obtained by processing multiple data sets obtained from signals measured at different temperatures.

[0070] The aforementioned data set can be plotted, and thereby an amplification curve can be obtained.

[0071] The term "plate" refers to the standard unit in which an amplification reaction is performed in an amplification device, and signifies the basic unit in which data generated after the amplification reaction is stored. Different plates may be plates in which amplification reactions were performed at different times using the same amplification device, or plates in which amplification reactions were performed by different amplification devices at the same time.

[0072] The plate includes a plurality of reaction wells, i.e., reaction vessels. The plate may include N x M reaction wells. Typically, the plate includes 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 since the plate includes one or more reaction wells, it may be implemented in various shapes other than rectangular, such as circular, ladder, or rhombus.

[0073] The wells of the plate contain the sample to be analyzed and the detection reagents required for the nucleic acid amplification reaction. Various embodiments of the present invention will be examined below with reference to the drawings.

[0074] 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) connected thereto, a detection result display device (300), and a cloud server (400). These (100, 200, 300, 400) may be connected to each other by wired or wireless communication. However, FIG. 1 is merely illustrative, and the concept of the present disclosure is not to be interpreted as being limited to that depicted in FIG. 1. For example, configurations may be additionally connected to these (100, 200, 300, 400), which may include a nucleic acid detection device (500) and / or a barcode recognition device (not shown) and / or a connection device (not shown) that generates setting information for a reaction plate to be amplified in the nucleic acid detection device (500) and transmits it to the detection result display editing device (100), but is not limited thereto.

[0075] Meanwhile, unlike what is illustrated, the detection result display editing device (100, hereinafter 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 is based on the premise that the aforementioned configurations (100, 200, 300, 400, 500) are implemented or connected as illustrated in FIG. 1. Below, each configuration will be examined in detail.

[0076] First, the nucleic acid preparation device (200) may use a conventional known automated preparation device (e.g., Liquid Handling Instruments), 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.

[0077] The nucleic acid preparation device (200) is an automated liquid handling apparatus.

[0078] Automated liquid handling devices can automatically and programmatically draw and / or dispense a desired amount of reagents, samples, or other liquids from a designated container for the automation of chemical or biochemical laboratories. Various configurations of automated liquid handling devices are known to those skilled in the art.

[0079] For example, it is a device by the Hamilton company based in Switzerland. Examples include Hamilton STAR, Hamilton NIMBUS, Hamilton STARplus, and Hamilton STARlet.

[0080] All parts of such nucleic acid preparation device (200) are designed as an integrated device and located within a housing. For example, the nucleic acid preparation device (200) may include a reagent batching section for nucleic acid extraction, a detection reagent batching section for nucleic acid amplification, a specimen batching section, a nucleic acid extraction section, a nucleic acid extract batching section, a reaction solution preparation section for nucleic acid amplification, and a pipetting section.

[0081] Additionally, it may include an extraction reagent cartridge containing various biological samples containing nucleic acids and buffers used to extract nucleic acids from them, a detection reagent cartridge for nucleic acid amplification for preparing a reaction solution for amplification reaction, a refrigeration block, a high-temperature block, a waste liquid container, a pipetting block, a pipette cartridge, and a pipette, and these may be mounted and detached within the nucleic acid preparation device (100).

[0082] 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.

[0083] A nucleic acid preparation device (200) for preparing a nucleic acid amplification reaction by extracting nucleic acid from a biological sample containing nucleic acid may include a barcode recognition device. Biological sample information recognized by the barcode recognition device can be databased and stored in a real-time medical server cloud, LIMS (Laboratory Information Management System), or LIS (Laboratory Information System), and this information can also be automatically applied to a real-time nucleic acid detection device. The barcode represents information that allows for identification between samples, such as gender, age, and type of the biological sample, and can be classified based on necessary details.

[0084] The preparation work performed by the nucleic acid preparation device (200) through this configuration includes a nucleic acid extract preparation work or a reaction solution preparation work for nucleic acid amplification, or a preparation work in which a nucleic acid extract preparation work and a reaction solution preparation work for nucleic acid amplification are performed simultaneously, but is not limited thereto.

[0085] These preparatory steps are intended to prepare the reaction plate to be subjected to the amplification reaction in the nucleic acid detection device by extracting nucleic acids, dispensing the extracted nucleic acids into reaction wells contained in the plate, and dispensing the reagents required for the amplification reaction into the reaction wells containing the nucleic acids. The reaction plate contains multiple wells (reaction vessels), in which the sample to be analyzed (extracted nucleic acids, i.e., patient specimens) and the detection reagents required for the nucleic acid amplification reaction are contained.

[0086] When the above preparation operations are executed, the nucleic acid preparation device (200) generates setting information for the plate to be subjected to the amplification reaction in the nucleic acid detection device (500).

[0087] 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 received. The sample received in each reaction well can be read as positive or negative based on the result of the amplification reaction to determine the presence or absence of disease in the patient.

[0088] Furthermore, since specific target analytes capable of amplification differ depending on the type of detection reagent, and the amplification reaction conditions in the nucleic acid detection device performing the amplification reaction may also vary by detection reagent, it is necessary to clearly identify, store, and share information regarding the environment in which target analytes are detected and analyzed.

[0089] To this end, in the present disclosure, when a nucleic acid extract preparation operation and / or a reaction solution preparation operation for nucleic acid amplification is executed in a nucleic acid preparation device (200), setting information for a plate to be the target of the amplification reaction input in each preparation operation is generated.

[0090] Here, the plate setting information may include amplification reaction protocol information, setting information per reaction well (e.g., detection channel information per 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 per reaction vessel.

[0091] For example, regarding the specific form of plate setting information, a file with the filename '.plrn' is created, and the created file can be stored in a specific location (medical service cloud server and / or HIS (medical information system)) and can be exported to a detection result display editing device (100).

[0092] The 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 the display of detection results of a plurality of biological target analytes in the detection result display device (300).

[0093] Below, we will examine the detection result display editing device (100) in more detail.

[0094] FIG. 2 is a block diagram of a detection result display editing device (100) according to one embodiment.

[0095] 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.

[0096] 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 the device (200, 300, 400, 500, LIS) shown in FIG. 1 and / or from a medical information system including LIMS (Laboratory Information Management System) and HIS (Hospital Information System, Integrated Medical Information System) which is not shown in FIG. 1.

[0097] Various types of data or information, including at least one instruction, are stored in the memory (120). The stored data may include data received from an external device (200, 300, 400, 500, LIS) through the communication unit (110) or data processed by the processor (130), and these data or information may include various types of editing information required for editing the detection result display.

[0098] Meanwhile, in FIG. 2, the memory (120) is shown as being configured separately 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 inside the processor (130).

[0099] Next, the processor (130) can be implemented by a central processing unit (CPU), a graphics processing unit (GPU), a microcontroller unit (MCU), or a dedicated processor on which methods according to one embodiment are performed. Hereinafter, such a processor (130) may collectively refer to a single processor or a plurality of processors, such as a multi-core processor.

[0100] This processor (130) can write data to memory (120). Additionally, the processor (130) can read out and execute instructions stored in memory (120). For example, by executing instructions stored in memory (120), the processor (130) can enable the research and development data management device (100) to perform the functions described below, which will be described later.

[0101] The display unit (140) can be driven by the processor (130) as follows.

[0102] First, information can be displayed on this display unit (140). Additionally, the user may input certain information through the display unit (140). For such display or input, the display unit (140) may be implemented as a touchscreen or touchpad, or alternatively, it may be implemented through a combination of an LCD monitor and a keyboard. Here, the information displayed on the display unit (140) may be received from the outside by the research and development data management device (100) through the communication unit (110) or loaded from the memory (120), but is not limited thereto.

[0103] According to the embodiment, the display unit (140) may display a masking data input screen (40) described later for receiving detection result display editing information. The content or contents included in this screen may be received from the outside by the detection result display editing device (100) through the communication unit (110) or loaded from memory (120), but are not limited thereto.

[0104] The detection result display editing information input to the display unit (140) can be generated by user input actions through the masking data input screen (40).

[0105] Below, we will examine each functional configuration of the detection result display editing device (100) that provides such masking data input screen (40) in more detail with reference to FIGS. 3 to 6.

[0106] According to one embodiment, the detection result display editing device (100) can 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.

[0107] Accessing the detection result display editing device (100) according to the embodiment means accessing the plate setting information that 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 (100) may be received from the detection result display device (300) or an external device.

[0108] Additionally, according to the 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 within the detection result display editing device (100). At this time, the outside of the detection result display editing device (100) may, according to one embodiment, be 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 or inside the detection result display editing device (100). Specifically, it means accessing data generated internally based on 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 at least one data received from the outside or the detection result display device (300).

[0109] The accessed plate setting information includes setting information per reaction well, and the reaction well setting information may include identifiers for a plurality of biological target analytes amplified in the reaction well.

[0110] The detection result display editing device (100) according to the present disclosure can display an identifier on a masking data input screen.

[0111] In this case, the identifier refers to the respective names of multiple biological target analytes that can be amplified by the detection reagent using the detection reagent.

[0112] When the detection reagent includes multiple detection reagents, the identifier of the target analyte for the multiple detection reagents can be displayed on the masking data input screen according to each detection reagent.

[0113] Nucleic acid amplification reaction technologies require the use of detection reagents for detecting target nucleic acids, including oligonucleotides (e.g., primers and / or probes) that specifically hybridize to the target analyte, labels, DNA polymerase, dNTPs, Mg ions, and buffers, in order to amplify and detect the target analyte of interest.

[0114] These detection reagents can be commercialized in the form of diagnostic kits along with components related to amplification reactions; for example, Seegene's Allplex TM The Respiratory Panel1 diagnostic kit is configured to detect the presence of respiratory infections by setting 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) as amplification targets.

[0115] Accordingly, a patient specimen, such as a nasopharyngeal swab or nasopharyngeal aspirate, is dispensed into a reaction well along with a nucleic acid extraction reagent through a nucleic acid preparation device (200) to extract nucleic acid, and the extracted nucleic acid is used in Allplex TM When the Respiratory Panel 1 diagnostic kit is used to amplify the reaction through a nucleic acid detection device, Allplex TMIt is possible to determine whether there is an infection with at least one of the 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), which are set as analysis targets in the Respiratory Panel 1 diagnostic kit, through detection.

[0116] At this time, the subject of analysis refers to the identifier according to the present disclosure.

[0117] These detection reagents are intended for a multiplex amplification reaction capable of simultaneously amplifying multiple biological target analytes, and the target analytes for each detection reagent, that is, the subjects of analysis, may differ from one another.

[0118] Accordingly, the detection result display editing device (100) can display identifiers of different analysis targets for each detection reagent through a masking data input screen as shown in FIG. 4.

[0119] At this time, the detection result display editing device (100) can selectively display only the analysis targets of interest. For example, if a sample of a patient named Kim undergoes an amplification reaction using detection reagents A, B, C, and D respectively, the detection result display targets will be the analysis targets set for each detection reagent, that is, identifiers for multiple biological target analytes.

[0120] However, even if the identifier of the target of analysis is set for each detection reagent, some of the identifiers of the target of analysis may not be of interest.

[0121] In addition, when each of the patient samples named Kim, Lee, and Park undergoes an amplification reaction using detection reagent A, the multiple identifiers set for detection reagent A for each patient are the targets of analysis for displaying the detection results, but the identifiers of interest for each patient may differ from one another.

[0122] To this end, in the present disclosure, editing information determining whether to mask the amplification reaction result of at least one biological target analyte among identifiers of a plurality of biological target analytes amplified in a reaction well containing a specific patient sample and a detection reagent can be received through a masking data input screen in the detection result display editing device (100).

[0123] According to one embodiment, when identifiers for multiple biological target analytes that are set as analysis targets 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 clicking, and check the identifiers to indicate an intention to mask the corresponding identifiers.

[0124] That is, for identifiers that you do not want to check the detection result for, regardless of whether it is a positive or negative reading, you can mask the identifier by designating it as off-target.

[0125] Such masking methods may, for example, display the identifier using a specific color or a specific symbol, but are not limited to this; masking can be performed through various methods as long as it is distinguishable from the identifier of the object of interest.

[0126] As illustrated in FIG. 4, according to one embodiment, a detection result display editing device (100) displays different identifiers for each detection reagent (Product Name in FIG. 4) as targets for analysis through a masking data input screen (40), and among the displayed identifiers for each detection reagent (Target in FIG. 4), a specific identifier selected by the user can be displayed as off-target, for example, using a gray color through user selection.

[0127] For example, referring to FIG. 4, identifiers (ASV, NVG2, ADV-F, SV, NVG1, ROV) for multiple biological target analytes set in the GI-V detection reagent that are detectable in a difficile barcoded sample to check for Gastrointestinal Tract Infections using a GI-V detection reagent are displayed on the masking data input screen (40). Among these, NVG2 is distinguished from ASV, ADV-F, SV, NVG1, and ROV, and means that the detection result is not to be checked, and the identifier is masked by selecting NVG2 by the user and designating it as an off-target.

[0128] In addition, among the identifiers (Yer, Sh / EI, O157, CdA / B, stx1 / 2, Sat, Cam) for multiple biological target analytes detectable using the GI-EB detection reagent in a sample barcoded in 2_Difficil, Sh / EI is masked and indicated as an identifier for which the detection result is not to be verified.

[0129] Meanwhile, in the sample barcoded with 5_Difficil and containing the GI-V and GI-EB detection reagents, no target was masked for the identifier, so it means that the detection results for all identifiers detectable by the corresponding detection reagent will be displayed.

[0130] It is 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 are the target of the sample contained in the plate where the amplification reaction is performed by the nucleic acid detection device.

[0131] According to the embodiment, the identifier for each detection reagent can be displayed in barcode units on the masking data input screen (40). This is because, since the patient sample is received exclusively in a single reaction well, the patient sample received in the reaction well along with the detection reagent can be barcoded with patient identification information and classified by reaction well.

[0132] The barcode may be a patient identification code and / or patient specimen code read through a barcode reader. Additionally, the barcode may display information that enables identification between specimens and classification based on necessary details, such as the gender, age, and type of the biological specimen.

[0133] Accordingly, the masking data input screen (40) displays the identifier of the detection reagent that is set as the target of analysis for the virus that the patient wants to identify based on the patient code recognized by the barcode, and among them, the identifier that is not of interest can be masked and displayed.

[0134] However, such masking data input screens are merely examples of implementations according to the present disclosure and are not limited thereto.

[0135] Accordingly, on the masking data input screen, the identifier for each detection reagent described above may be displayed by barcode, or by reaction well.

[0136] Meanwhile, according to one embodiment, the identifier displayed on the masking data input screen (40) in the detection result display editing device (100) can be received from the detection result display device (300).

[0137] The detection result display device (300) obtains the amplification reaction result, i.e., the 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 the positive / negative, Ct (Cycle threshold) value, signal value at a specific cycle (e.g., RFU value), etc., for each sample.

[0138] Removing noise from a data set, generating an amplification curve, analyzing the data set, and determining positive / negative, etc., may be performed by a nucleic acid detection device (500).

[0139] This detection result display device (300) has information, i.e., identifiers, for multiple biological target analytes that can be amplified for each detection reagent.

[0140] For example, Allplex, a detection reagent for confirming the presence of respiratory infections. TMIn Respiratory Panel 1, 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), etc., are set as amplifiable analytical targets. Allplex is a detection reagent used to confirm the presence of Satrointestinal Tract Infections. TM In the GI-Virus Assay, Adenoivirus, Astrovirus, and Norovirus are set as amplifiable analysis targets.

[0141] Accordingly, the detection result display device (300) obtains a data set based on the amplification reaction result from the nucleic acid detection device, and can display the amplification data as shown in FIG. 5 based on the obtained data set and the analysis target for each detection reagent that is preset.

[0142] 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).

[0143] As illustrated in FIG. 5, the detection result display device (300) may display an image of the plate (50) on which the amplification reaction is performed, and may display the 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 set of signal values, a signal value at a specific cycle, a positive / negative judgment result, and a Ct value.

[0144] In the table (54) displayed in the detection result display device (300), amplification data including the name of the target gene to be detected in each channel (FAM, HEX, Cal Red 610, Quasar 670), that is, the identifier for the target analytes, the positive / negative judgment result for each reaction well (A01, B01, C01, D01, E01), and the Ct value may be displayed.

[0145] To this end, the detection result display device (300) stores information about a plurality of biological target analytes that are the subject of analysis for each detection reagent in advance, and when it obtains a data set from the nucleic acid detection device (500), it analyzes it to determine whether the target analytes are present or absent in the sample, detects the data for the sample and stores it in memory, and can display detection results such as Ct value and signal value (e.g., RFU value) for each sample.

[0146] According to one embodiment, the detection result display editing device (100) receives an identifier from the detection result display device (300) and identifies the detection reagent through plate setting information received from the nucleic acid preparation device (200), so that identifiers for a plurality of biological target analytes detectable by detection reagent can be displayed on the masking data input screen as shown in FIG. 4.

[0147] Alternatively, according to an embodiment, the detection result display editing device (100) may store an analysis target identifier for each detection reagent in its memory in advance. In this case, when the detection result display editing device (100) receives plate setting information from the nucleic acid preparation device (200) and identifies the detection reagent information for each reaction well of the reaction plate to be amplified, it may display the masking data input screen as shown in FIG. 4 using the pre-stored identifier corresponding to the identified detection reagent.

[0148] In addition, according to the embodiment, the detection result display editing device (100) may receive an identifier from an external source, for example, a medical server cloud (400), excluding the nucleic acid preparation device (200) and / or the detection result display device (300) and / or the nucleic acid detection device described above.

[0149] Plate setting information can also be received from an external source, such as a connection device, rather than the nucleic acid preparation device (200), 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 setting information, is generated from the connection device.

[0150] Additionally, according to an embodiment, the detection result display editing device (100) may receive all of the identifiers for each detection reagent displayed on the masking data input screen (40) from an external source at once, and according to an embodiment, the detection result display editing device (100) may display only the identifiers for a plurality of biological target analytes on the masking data input screen (40).

[0151] In this way, the identifier displayed on the masking data input screen (40) is displayed to determine whether to mask the amplified data when displaying it on the detection result display device (300). The detection result display editing device (100) can display multiple biological target analytes detectable based on the detection reagent contained in the reaction well as objects that can be individually selected by the user as identifiers for each biological target analyte. Here, the object may be a selectable form such as text or icons of various shapes, but is not limited thereto and can be implemented in various forms as long as it is an individually selectable object.

[0152] Accordingly, the identifier displayed on the masking data input screen (40) can be distinguished and displayed as an identifier selected for masking and an identifier not selected for masking depending on whether the masking is performed on the detection result display device (300).

[0153] According to one embodiment, masking for the corresponding identifier in the detection result display device (300) is determined through object selection, and if no object selection occurs, the corresponding identifier can be displayed in the detection result display device.

[0154] However, in the present disclosure, when selecting an identifier, it will be obvious that the selection act is not specifically limited to masking or non-masking if not selected, and if the object selection status is distinguished on the masking data input screen (40), the object-specific masking status will be finally displayed as a result on the detection result display device (300) according to the result.

[0155] In the present disclosure, editing information can be generated through an identifier for a detection reagent and a plurality of biological target substances per detection reagent, i.e., whether an object is selected, obtained from accessed plate setting information.

[0156] 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 biological target analytes that are set as analysis targets for each detection reagent and can be amplified are displayed, and identifiers for each detection reagent included in the sample for each reaction well of the reaction plate of the reaction target for amplification is displayed in the nucleic acid detection device (500) at the start of the amplification reaction, during the amplification reaction, or after the completion of the amplification reaction. At this time, as described above, the information of the identifier may be received from the detection result display device (300) or from other external devices.

[0157] When a user selection occurs among the identifiers displayed on the masking data input screen (40), the identifier selected by the user will be masked when the detection result is displayed on the detection result display device (300), making it impossible to verify the detection result.

[0158] FIG. 6 illustrates an example of an implementation of a screen in which an identifier masked in a detection result display editing device (100) according to the present disclosure is displayed as amplification reaction result data in a detection result display device (300). FIG. 6 shows that the 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 the reaction plate (60) in which the amplification reaction was performed, the amplification reaction result graph (62) and the table (64) in each reaction well can each be displayed simultaneously on a single screen.

[0159] As shown in FIG. 6, in the detection result display device (300), in the table (64) displaying the amplification reaction result data, it can be seen that the target analytes O0157 and CdA / B for the HEX channel in well A01 are masked, and the target analyte Sal for the Cal Red 610 channel is masked. In well C01, it can be seen that the target analytes stx11 / 2 and Sal for the Cal Red 610 channel are masked.

[0160] As shown in the plate (60) of FIG. 6, although the A01 well and C01 well are samples in which an amplification reaction is performed, some of the multiple biological target analytes that can be amplified by the detection reagent contained in each of the samples are masked and displayed as shown in the illustrated table (64) when the detection result is not of interest.

[0161] In addition, according to the embodiment, the detection result display device (300) may additionally display information regarding the name of the detection reagent used in the target reaction plate where 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 the validity is valid (Sample Count Valid in FIG. 6).

[0162] The target analytes displayed as masked in the detection result display device (300) in this manner are based on plate setting information edited through the masking data input screen (40) in the detection result display editing device (100) of the present disclosure.

[0163] Plate setting 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 according to the embodiment, in which case information regarding the masked and edited identifier is recorded in a specific field of the plrn file. Specifically, the plrn file related to plate setting information records setting information per reaction well, amplification reaction path, plate type, and detection reagent information in each of the various fields including the header, and in particular, the detection reagent information may be recorded in the Well Note field, and information regarding the masked and edited identifier may be recorded in the Run Notes field. At this time, the detection result display editing device (100) may convert whether the identifier is masked into hexadecimal and record it in the Run Notes field. For example, if 6 identifiers are edited, the binary number represented as 10101100 can be converted to hexadecimal and recorded as AC, and if 14 identifiers are edited, the binary number represented as 10101101011100 can be converted to hexadecimal and recorded as AD5C. In this case, the Run Note field size may not be affected even if the number of identifiers being edited increases.

[0164] As previously explained, according to one embodiment, plate setting information is received from a nucleic acid preparation device (200). When the detection result display editing device (100) receives plate setting information, it displays information about a corresponding detection reagent on a masking data input screen (40) based on the received plate setting information and patient identification information by barcode unit or by reaction well. By matching the detection reagent identifier information received from the detection result display device (300) with the data displayed on the masking data input screen (40) and displaying it, the device can perform editing to determine whether to mask the identifier to be displayed as amplification reaction result data on the detection result display device (300).

[0165] Here, the plate setting information received from the nucleic acid preparation device (200) can be said to be the original file, and in order to transmit information about the masked identifier through the masking data input screen in the detection result display editing device (100) to the detection result display device (100), editing of the original file must be performed.

[0166] Accordingly, a file different from the original file can be stored in the detection result display editing device (100) by editing to save editing information regarding which identifier is the masking target to a new file other than the original file. The edited file different from the original file is a file containing masked identifier information, that is, Target on / off information, and is a file containing new plate setting information different from the original file.

[0167] Accordingly, in the detection result display editing device (100), a file for plate setting information prior to editing and / or plate setting information after editing may be stored, and through editing that determines whether to mask a specific identifier, the plate setting information for the original file may be updated or new plate setting information may be created.

[0168] According to the embodiment, each plate setting information in the update or generation may include at least one of a storage time, a storage date, an editor, detection reagent information, and the name of a nucleic acid preparation device.

[0169] This editing information can be displayed (42) on the masking data input screen (40) by counting how many modifications have occurred from the original file according to the embodiment.

[0170] In the masking data input screen (40), the number of identifiers in the On state, where all identifiers for each detection reagent are basically displayed, and the number of identifiers in the On state that are masked can be counted and displayed. In this case, the total sum of On / Off can be the total number of identifiers set for each detection reagent. This allows for the creation of re-editing information after the creation of editing information by counting the number of identifiers that are On and Off when an update to editing information created by masking at least one specific identifier, or re-editing information required for the second, third... or second, third... creation file is needed from the creation file.

[0171] Each file updated or generated in this way may be saved in the form of a template. Depending on the saving method, it may be possible to check whether the identifier for each template and each detection reagent is masked. This template is intended to enable masking of multiple identifiers at once through loading without the need for individual selection of identifiers displayed on the masking data input screen (40).

[0172] Plate setting information further edited according to this template can also be exported to the detection result display device (300) and / or external storage device.

[0173] For example, even if it is a detection reagent capable of amplifying all common causative bacteria for each age group, since the common causative bacteria of infectious diarrhea differ depending on age, the results regarding the presence or absence of the common causative bacteria for each age group are displayed, and the remaining causative bacteria are masked and stored in a template form, the corresponding template can be retrieved first according to the patient identification information obtained through the barcode to quickly check the results.

[0174] These templates can also be generated by symptom. They can be created by displaying identifiers that should be prioritized for each symptom, while masking the remaining identifiers. Additionally, templates can be generated by time. Templates can be pre-generated based on suspected identifiers for short incubation periods of 1 to 6 hours, 8 to 16 hours, and 16 to 72 hours, and the results can be quickly verified by selectively loading templates according to the time.

[0175] For example, it may 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. As such, the template may be pre-saved by time of day, symptom, and age group by pre-setting editing information. Symptoms include the type of symptom and the degree of mildness or severity, and age groups may include all age groups from newborns, infants, children, adolescents, middle-aged adults, to the elderly.

[0176] Meanwhile, in the present disclosure, the detection result display editing device (100) allows for 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.

[0177] To this end, the detection result display editing device (100) selects whether to pair with a detection result display device before displaying the detection result display editing screen (40) according to the embodiment, and accesses identifier information from the selected detection result display device. Since the target of analysis of the detection reagent can be continuously updated (added, deleted) and the detection result display device can also be continuously updated due to licensing limitations, the detection result display editing device (100), which can perform masking by receiving identifier information dependently on the detection result display device according to the embodiment, can select the detection result display device to pair before performing masking.

[0178] FIG. 3 is a flowchart for explaining a method for generating editing information that determines whether to mask the amplification reaction result for 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.

[0179] The method according to the present disclosure is 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 for 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.

[0180] 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 multiple biological target analytes.

[0181] At this time, the plate setting information includes the 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.

[0182] Displays the identifier in S312 on the masked data input screen.

[0183] In S314, editing information determining whether to mask the amplification reaction result for at least one biological target analyte identifier among the identifiers for a plurality of biological target analytes amplified in the reaction well of the detection result display device is received through the masking data input screen.

[0184] In S316, the received plate setting information is edited and saved according to the editing information.

[0185] In S318, the detection result display device (300) and / or externally stored editing information is exported.

[0186] Since the operation of each step illustrated in Fig. 3 is identical to the function of the detection result display editing device (100) examined earlier, the descriptions of Figs. 1-2 and 4-6 described above will be used.

[0187] The block diagrams attached to this disclosure and the combinations of each step of each block and flowchart may also be performed by a computer program.

[0188] When these computer programs are executed by one or more processors, the one or more processors 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, with respect to a detection result display editing device for 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 amplified in the reaction well, and displaying the identifiers on a masking data input screen; receiving editing information through the masking data input screen to determine whether to mask the amplification reaction result for at least one biological target analyte among the identifiers for a plurality of biological target analytes amplified in the reaction well at the detection result display device; and editing and saving the received plate setting information according to the editing information. Such programs may also be stored on a computer-readable recording medium to implement functions in a specific way. Furthermore, terms such as "include," "compose," or "have" as described above, unless specifically stated otherwise, mean that the relevant component may be inherent; thus, they should be interpreted as allowing for the inclusion of additional components rather than excluding them. All terms, including technical or scientific terms, have the same meaning as generally understood by those skilled in the art to which this disclosure pertains, unless otherwise defined.Commonly used terms, such as those defined in advance, should be interpreted in accordance with their meaning in the context of the relevant technology and, unless explicitly defined in this disclosure, should not be interpreted in an ideal or overly formal sense.

[0189] The foregoing description is merely an illustrative explanation of the technical concept of the present disclosure, and those skilled in the art to which the present disclosure pertains will be able to make various modifications and variations within the scope of the essential characteristics of the present disclosure. Accordingly, the embodiments disclosed in the present disclosure are intended to explain, not limit, the technical concept of the present disclosure, and the scope of the technical concept of the present disclosure is not limited by such embodiments. The scope of protection of the present disclosure shall be interpreted by the claims below, and all technical concepts within an equivalent scope shall be interpreted as being included within the scope of rights of the present disclosure.

[0190] Foregoing, specific parts of the present disclosure have been described in detail. It is evident to those skilled in the art that such specific descriptions are merely preferred embodiments and that the scope of the present disclosure is not limited thereto. Accordingly, the actual scope of the present disclosure shall be defined by the appended claims and their equivalents.

Claims

Claim 1 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 comprises: 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; a step in which the detection result display editing device comprises (i) a memory, (ii) a processor, and (iii) one or more programs configured to be stored in the memory and executed by the processor, wherein the plate setting information comprises setting information per reaction well, and the reaction well setting information comprises identifiers for a plurality of biological target analytes amplified in the reaction well, and the identifiers are displayed on a masking data input screen of the detection result display editing device; a step in which editing information determining whether to mask the amplification reaction result of the detection result display device is received through the masking data input screen for at least one identifier of a biological target analyte among the identifiers for a plurality of biological target analytes amplified in the reaction well; and a step in which the plate setting information received according to the editing information is edited and provided. Claim 2 A method for editing detection result displays of a plurality of biological target analytes, wherein the accessing step is i) accessing plate setting information stored in the detection result display device or 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. Claim 3 A method for editing the detection results of a plurality of biological target analytes according to claim 1, wherein 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 analyte for the plurality of detection reagents is displayed on the masking data input screen according to each detection reagent. Claim 4 A method for editing the detection results of a plurality of biological target analytes according to claim 1, wherein the displaying step is characterized by displaying an identifier for each biological target analyte as an object that can be individually selected by a user. Claim 5 A method for editing the detection results of a plurality of biological target analytes according to claim 4, wherein the displaying step is characterized in that, among the objects displayed on the masking data input screen, at least one object selected by the user and an unselected object are distinguished and displayed. Claim 6 A method for editing detection result displays of a plurality of biological target analytes, characterized in that, in claim 5, the masking of the corresponding identifier and amplification reaction result for the selected object is determined in the detection result display device, and the corresponding identifier and amplification reaction result for the unselected object is displayed in the detection result display device. Claim 7 A method for editing detection results of a plurality of biological target analytes, characterized in that, in claim 4, the editing information is generated by utilizing whether the individually selectable object is selected from the accessed plate setting information. Claim 8 A method for editing detection results of a plurality of biological target analytes according to claim 2, wherein the plate setting information stored inside the detection result display editing device is further edited according to a predetermined template for an identifier to be masked among a plurality of biological target analytes detectable using the detection reagent. Claim 9 A method for editing detection results of a plurality of biological target analytes according to claim 8, wherein the template is pre-set editing information for each detection reagent, and the pre-set editing information stores whether the amplification reaction result for at least one biological target analyte identifier among the identifiers for the plurality of biological target analytes is masked. Claim 10 A method for editing detection results of a plurality of biological target analytes according to claim 8, wherein the template is classified into at least one selected from the time elapsed since symptom onset, by symptom and / or by gender and age group. Claim 11 A method for displaying detection results of a plurality of biological target analytes according to claim 10, characterized in that the time elapsed since the onset of symptoms is 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, or 10 hours or more, or 96 hours, 72 hours, 48 ​​hours, 36 hours, or 24 hours or less. Claim 12 A method for displaying detection results of a plurality of biological target analytes according to claim 10, characterized in that the above symptom is one of the type, mild, or severe of the symptom. Claim 13 A method for editing detection results of a plurality of biological target analytes according to claim 10, characterized in that the gender includes females and males, and the age group includes from newborns to the elderly. Claim 14 A method for editing detection result displays of a plurality of biological target analytes, characterized in that, in claim 2, if the plate setting information is stored in the detection result display device or the external device, the method further performs the 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. Claim 15 A method for editing detection result displays of a plurality of biological target analytes, characterized in that, in claim 8, the plate setting information further edited according to the template is also exported to the detection result display device and / or the external storage device. Claim 16 A method for editing detection results of a plurality of biological target analytes according to claim 14 or 15, characterized in that, in the exporting step, the editing information regarding whether the identifiers of the plurality of biological target analytes are masked is converted into hexadecimal and exported. Claim 17 A computer device comprising: a memory storing at least one instruction; and a processor, wherein the at least one instruction 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 well, wherein the identifiers are displayed on a masking data input screen of a detection result display editing device, and editing information determining whether to mask the amplification reaction result of at least one biological target analyte among the identifiers for a plurality of biological target analytes amplified in the reaction well is received through the masking data input screen, and the plate setting information received is edited according to the editing information and provided. Claim 18 A computer-readable recording medium for storing a computer program, wherein the computer program is executed by one or more processors included in a computer device, and the method comprises the steps of: accessing plate setting information for a reaction plate to be performed using a detection reagent for a multiplex nucleic acid amplification reaction capable of detecting multiple biological target analytes; wherein the plate setting information includes setting information for each reaction well, and the reaction well setting information includes identifiers for multiple 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 editing information through the masking data input screen for determining whether to mask the amplification reaction result of at least one biological target analyte among the identifiers for multiple biological target analytes amplified in the reaction well; and editing and providing the received plate setting information according to the editing information.

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