Molecular diagnostic test result reporting device and molecular diagnostic test result reporting method using the same

Abstract

A molecular diagnostic test result reporting device is provided. A molecular diagnostic test result reporting method according to one embodiment comprises the steps of: receiving the multiplex MDx test results of a patient; wherein the multiplex MDx is for detecting multiple targets, and the multiplex MDx test results of the patient include positive / negative determination results and Ct values; retrieving a reference test result obtained through a multiplex MDx that includes a target identical to one or more targets determined positive among the multiplex MDx test results of the patient, among the multiplex MDx test results stored in a database (DB) connected to the reporting device; wherein the reference test results include positive / negative determination results and Ct values; processing and analyzing the retrieving reference test result; and reporting the multiplex MDx test results of the patient.

Description

Technology Field

[0001] The present invention relates to a molecular diagnostic test result reporting device and a molecular diagnostic test result reporting method using the same. Background Technology

[0002] Conventionally, in the process where clinicians treat patients by referring to molecular diagnostic test results or examiners analyze them, the treatment of patients or the analysis of molecular diagnostic test results was performed based solely on the results of the patients who underwent the tests.

[0003] For example, when a clinician treats a patient based on PCR (polymerase chain reaction) test results, they provided medical services to the patient while referring only to the patient's PCR test results. Alternatively, when a medical examiner analyzes PCR test results, they analyzed the data based solely on the subject's PCR test results.

[0004] Previously, the statistical significance of molecular diagnostic test results was not clear, and even if there was data with revealed statistical significance among the molecular diagnostic test results, it was difficult for clinicians or examiners to compare and refer to statistical data related to a patient's PCR test results.

[0005] In particular, conventional software for analyzing molecular diagnostic test results did not perform statistical analysis of PCR test results, nor did it provide additional information specifically focused on the patient's PCR test results. When relevant statistical data was required, clinicians or examiners had to go to the trouble of searching for related papers or academic materials, and finding suitable supplementary materials for referencing the patient's PCR test results consumed significant time and cost.

[0006] (Prior Art) Korean Patent Publication No. 10-2485460 (Registered Jan. 2, 2023) The problem to be solved

[0007] The problem to be solved by the present specification is to report molecular diagnostic test results to a medical practitioner's terminal.

[0008] Another problem that this specification aims to solve is to report statistical processing / analysis results that can be referenced for the treatment of patients.

[0009] However, the problems to be solved described in this specification are not limited to those mentioned above, and other unmentioned problems will be clearly understood by a person skilled in the art from the description below. means of solving the problem

[0010] A molecular diagnostic test result reporting method according to one embodiment comprises the steps of: receiving the multiplex MDx test results of a patient; wherein the multiplex MDx is for detecting multiple targets, and the multiplex MDx test results of the patient include positive / negative determination results and Ct values; retrieving a reference test result obtained through a multiplex MDx that includes a target identical to one or more targets determined positive among the multiplex MDx test results of the patient, among the multiplex MDx test results stored in a database (DB) connected to the reporting device; wherein the reference test result includes positive / negative determination results and Ct values; processing and analyzing the retrieving reference test result; and reporting the multiplex MDx test results of the patient, wherein the reporting includes the multiplex MDx test results of the patient and the processing / analysis results of the reference test result.

[0011] In one embodiment, the multiplex MDx test result stored in the database of the reporting device may be labeled with at least one meta-information selected from the group consisting of a test subject identifier, test subject information including age and gender, test date, product name, product version information, and catalog number.

[0012] In one embodiment, the processing / analysis result of the reference test result may include the statistical result of the reference test result.

[0013] In one embodiment, the statistical results of the reference test results may include at least one selected from a group consisting of prevalence statistics, Ct value statistics, infection statistics by age / gender, infection pattern statistics for solitary infection and co-infection, and follow-up observation statistics of Ct values ​​for a predetermined target of the test subject.

[0014] In one embodiment, follow-up statistics of Ct values ​​for a specific target of a test subject can be processed and analyzed using follow-up Ct values ​​for the test subject's HPV test.

[0015] In one embodiment, the processing / analysis result of the reference test result in the reporting step may include statistical results of Ct values ​​in single infection and statistical results of Ct values ​​in multiple infections corresponding to each of the one or more targets in the reference test result.

[0016] In one embodiment, the processing / analysis result of the reference test result in the reporting step may include statistical results of the number of patients in a single infection and statistical results of the number of patients in a co-infection corresponding to each of the one or more targets in the reference test result.

[0017] In one embodiment, the reporting step may display the statistical distribution of the reference test results included in the processing / analysis result on a UI and display the statistical position of the multiplex MDx test results of the patient on the statistical distribution of the UI.

[0018] In one embodiment, the reporting step may display a controller UI that can change the processing analysis conditions for the reference inspection result.

[0019] In one embodiment, the step of processing and analyzing the reference test results may select similarity cases among the reference test results that are similar to the multiplex MDx test results of the patient.

[0020] In one embodiment, the similarity case can be selected by considering the positive / negative judgment result and Ct value of the multiplex MDx test result.

[0021] In one embodiment, the similarity case may be selected by further considering the shape of the data set of the amplification response of the multiplex MDx test result.

[0022] In one embodiment, the similarity case may be selected by further considering age and / or gender in the multiplex MDx test results.

[0023] In one embodiment, the step of processing and analyzing the reference test results involves, after the selection of the similarity case, obtaining at least one EMR data selected from a group consisting of the type of symptoms, severity of symptoms, patient's age, gender, underlying disease, medication record, treatment record and treatment progress record, vaccination history, and lifestyle of the similarity case, and the processing / analysis result of the reference test results in the reporting step may further include the similarity case and at least one EMR (Electronic Health Record) data thereof.

[0024] In one embodiment, the reporting step may display the statistical distribution of the EMR data of the similarity case included in the at least one EMR data on a UI, and further display the statistical position of the EMR data corresponding to the patient on the statistical distribution of the UI.

[0025] In one embodiment, the similarity case selection can be performed by comparing the multiplex MDx test result of the subject with the reference test result to search for a reference test result having a similarity greater than or equal to a preset threshold.

[0026] In one embodiment, the step of retrieving the reference test result may involve obtaining a filtering-in condition of the reference test result and retrieving the reference test result that satisfies the obtained filtering-in condition.

[0027] In one embodiment, the multiplex MDx test result may include at least one of an infection test or a genetic test.

[0028] In one embodiment, the processing / analysis result of the reference test result in the reporting step may include the multiplex MDx test result of the patient and the comparison result of the processing / analysis result of the reference test result.

[0029] In one embodiment, the multiplex MDx test result of the subject and the reference test result may be MDx test results using one or more of the MDx test reagent products of the same series to which the same MDx technology is applied.

[0030] In one embodiment, the same MDx technology may be the same as at least one technology selected from the group consisting of a target gene sequence and amplicon determination technology, an oligonucleotide candidate design technology for primers and probes, an oligonucleotide structure, a signal generation mechanism indicating the presence of a target, a technology for differentiating multiple signals generated from a single label in a single channel, a signal processing technology, a positive / negative determination technology, and a nucleic acid extraction technology.

[0031] In one embodiment, a medical device for using one or more of the MDx test reagent products of the same series may use the same analysis software.

[0032] In one embodiment, the analysis software may include at least one selected from the group consisting of a Baselining algorithm, an amplification curve fitting algorithm, a Ct value determination algorithm, and a positive / negative determination algorithm.

[0033] A molecular diagnostic test result reporting device according to another embodiment includes a memory for storing at least one command, a network, and a processor configured to execute the at least one command stored in the memory, wherein when the at least one command is executed by the processor, the processor is configured to perform the following method, the method comprising: receiving a multiplex MDx test result of a patient, wherein the multiplex MDx is for detecting multiple targets, and the multiplex MDx test result of the patient includes a positive / negative result and a Ct value, and among the multiplex MDx test results stored in a database (DB) connected to the reporting device, a reference test result obtained through a multiplex MDx that includes a target identical to one or more targets determined to be positive among the multiplex MDx test results of the patient, wherein the reference test result includes a positive / negative result and a Ct value, and the method comprises processing and analyzing the retrieving reference test result, and reporting the multiplex MDx test result of the patient. The reporting may include the multiplex MDx test results of the above-mentioned patient and the processing / analysis results of the above-mentioned reference test results.

[0034] A computer-readable, non-transient recording medium storing a computer program according to another embodiment, wherein the computer program includes instructions that cause the one or more processors to perform the following method when executed by one or more processors, the method comprises: receiving the results of a multiplex molecular diagnostic (multiplex MDx) test of a patient; wherein the multiplex MDx is for detecting multiple targets, and the multiplex MDx test results of the patient include positive / negative determination results and Ct values, and among the multiplex MDx test results stored in a database (DB) connected to the reporting device, a reference test result obtained through a multiplex MDx that includes targets identical to one or more targets determined to be positive among the multiplex MDx test results of the patient; wherein the reference test result includes positive / negative determination results and Ct values, and the method comprises processing and analyzing the retrieving reference test result; and reporting the multiplex MDx test results of the patient, wherein the reporting comprises the multiplex MDx test results of the patient and the It may include the processed / analyzed results of reference inspection results.

[0035] A computer program stored on a computer-readable non-transient recording medium according to another embodiment, wherein the computer program includes instructions that cause the one or more processors to perform the following method when executed by one or more processors, the method comprises: receiving the results of a multiplex molecular diagnostic (multiplex MDx) test of a patient; wherein the multiplex MDx is for detecting multiple targets, and the multiplex MDx test results of the patient include positive / negative determination results and Ct values, and among the multiplex MDx test results stored in a database (DB) connected to the reporting device, a reference test result obtained through a multiplex MDx that includes targets identical to one or more targets determined to be positive among the multiplex MDx test results of the patient; wherein the reference test result includes positive / negative determination results and Ct values, and the method comprises processing and analyzing the retrieving reference test result; and reporting the multiplex MDx test results of the patient, wherein the reporting comprises the multiplex MDx test results of the patient and the It can be programmed to perform operations including the processing / analysis results of the reference inspection results. Effects of the invention

[0036] According to one embodiment, statistical analysis results related to the molecular diagnostic test results of a patient can be provided to the patient's terminal.

[0037] According to one embodiment, a medical professional can accurately determine the condition of a patient by comparing the patient's molecular diagnostic test results with the processing / analysis results.

[0038] A molecular diagnostic test result reporting method according to one embodiment allows a medical professional to provide medical services to a patient by referring to the processed / analyzed results, thereby presenting more analytical data to the patient and providing high-quality medical services. Brief explanation of the drawing

[0039] FIG. 1 is a diagram conceptually illustrating the relationship in which a molecular diagnostic test result reporting device according to one embodiment is connected to a medical patient's terminal via a network. FIG. 2 is a flowchart showing the steps of a molecular diagnostic test result reporting method according to one embodiment. Figure 3 is a diagram showing an example of displaying processing / analysis results based on molecular diagnostic test result reporting at a medical practitioner's terminal. Figure 4 is an example showing labeling meta information for reference inspection results stored in a DB. Figure 5 is an example of a statistical result showing the detection rate for specific targets. Figure 6 is an example of statistical results showing the detection rate and trend over a period for a specific target. Figure 7 is an example of statistical results showing the number of confirmed cases per quarter for a specific target. Figure 8 is an example of statistical results showing the ratio of confirmed cases by gender for a specific target. Figure 9 is an example of statistical results showing the infection rate by age for a specific target. Figure 10 is an example of a statistical result showing the distribution of Ct values ​​by age for a specific target. Figure 11 is an example of statistical results showing the trend of increase or decrease over time for multiple targets. Figure 12 is an example of a statistical result showing various statistical data regarding co-infection. Figure 13 is a diagram showing an example of searching for a reference test result that has similarity by comparing the multiplex MDx test result of a patient with the reference test result. FIG. 14 is a diagram conceptually illustrating the operation of providing a medical professional with a similarity case similar to the multiplex MDx test results of the patient. FIG. 15 is a hardware configuration diagram of a molecular diagnostic test result reporting device according to one embodiment. Specific details for implementing the invention

[0040] 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, and only one embodiment is provided 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.

[0041] 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.

[0042] Before explaining Figure 1, let us examine the terms used herein.

[0043] In this specification, the term “target analyte” may refer to various substances (e.g., biological substances and non-biological substances). Such target analytes may specifically include 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.

[0044] The term "sample" includes 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.

[0045] 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 rded. 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).

[0046] The term "target" includes various substances (e.g., biological and non-biological substances) and may refer to the same object as the terms "target analyte" or "target analyte."

[0047] These targets 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. The targets may include target nucleic acid molecules.

[0048] The term "target of interest" may refer to an object among the "targets" that is the subject of reading in the existence / non-existence reading process.

[0049] The term "cycle" refers to a unit of change in certain conditions in a plurality of measurements involving a change in said conditions. Such change in certain conditions implies 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.

[0050] 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.

[0051] 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.

[0052] For example, when a nucleic acid amplification reaction is performed, the act of detecting a signal occurring at regular time intervals can be repeated, and this may refer to a unit of such repetition. In this case, the cycle may have a unit of time.

[0053] 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.

[0054] Meanwhile, an amplification reaction to amplify a signal indicating the presence of a target (target analyte or target of interest) may be carried out in a manner where the signal is amplified as the target is amplified (e.g., real-time PCR method). Alternatively, according to one embodiment, the amplification reaction may be carried out in a manner where the target is not amplified, and only the signal indicating the presence of the target is amplified (e.g., CPT method (Duck P, et al., Biotechniques, 9:142-148(1990)), Invader assay (U.S. Patents No. 6,358,691 and 6,194,149)).

[0055] Meanwhile, the aforementioned target or target analyte, in particular the target nucleic acid molecule, 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 et 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.

[0056] Meanwhile, the amplification reaction amplifies the signal while accompanying the amplification of the target (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).

[0057] Based on such nucleic acid amplification reactions, multiplex diagnostic technology can be utilized 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.

[0058] 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.

[0059] FIG. 1 is a diagram conceptually showing the relationship in which a molecular diagnostic test result reporting device (100) according to one embodiment is connected to a patient's terminal (200) via a network.

[0060] The molecular diagnostic test result reporting device (100) can be connected to a medical patient's terminal (200) via a network. Here, since FIG. 1 is merely illustrative, the concept of the present invention is not to be interpreted as being limited to that depicted in FIG. 1. For example, the molecular diagnostic test result reporting device (100) can be connected to two or more medical patient terminals (200) via a network. In addition, the molecular diagnostic test result reporting device (100) can access DB (1) through a network. In one embodiment, the molecular diagnostic test result reporting device (100) and DB (1) may not be separate components but may be integrated into one with the molecular diagnostic test result reporting device (100).

[0061] The network may refer to a wireless or wired network that provides data transmission and reception between a molecular diagnostic test result reporting device (100) and a patient's terminal (200). Among these, the wireless network may include at least one of, for example, LTE (long-term evolution), LTE-A (LTE advance), CDMA (code division multiple access), WCDMA (wideband CDMA), UMTS (universal mobile telecommunications system), WiBro (Wireless BroadDB (1) and), WiFi (wireless fidelity), Bluetooth, NFC (near field communication), and GNSS (global navigation stellite system). Additionally, the wired network may include at least one of, for example, USB (universal serial bus), HDMI (high definition multimedia interface), RS-232 (recommended standard 232), LAN (Local Area Network), WAN (Wide Area Network), the Internet, and a telephone network, but is not limited thereto.

[0062] The molecular diagnostic test result reporting device (100) can obtain a reference test result using the multiplex MDx test result of the patient, process and analyze the obtained reference test result, and report the multiplex MDx test result to the patient's terminal (200).

[0063] In this specification, a subject refers to a subject who has undergone an MDx test and receives medical services from a medical professional using the MDx test results. In one embodiment, it refers to any subject who receives services from a medical professional using the MDx test results, and the subject may be referred to as a patient, a test subject, a person undergoing examination, etc.

[0064] In this specification, MDx refers to molecular diagnostics that detect or analyze biomarkers such as DNA, RNA, and proteins using molecular biology technology. In one embodiment, the meaning of MDx may encompass molecular diagnostic technology or reagent products for performing molecular diagnostics.

[0065] In one embodiment, the multiplex MDx is intended to detect multiple targets, and the multiplex MDx test results of the patient may include positive / negative results and Ct values. In one embodiment, the multiplex MDx test results may include at least one of an infection test or a genetic test. Here, the infection test may include an MDx test related to an infectious disease. In one embodiment, the infection test may include, but is not limited to, a test to detect infection by one or more pathogens or viruses related to respiratory infection, gastrointestinal tract infection, sexually transmitted infection, and human papillomavirus infection. For example, the infection test may include tests for tuberculosis, antimicrobial resistance, and meningitis, and may include various other known similar types of tests. For example, viruses related to respiratory infection may include Sarbecovirus, SARS-CoV-2, Influenza A virus (Flu A), Influenza B virus (Flu B), and Respiratory syncytial virus (RSV). Additionally, the genetic test may include MDx testing for pathogenic genes or SNPs (single nucleotide polymorphisms). In one embodiment, the genetic test may include tests to detect the type of genotype and whether specific mutations are included. For example, the type of genotype may include genotyping and haplotyping.

[0066] In this specification, multiplex MDx refers to a molecular diagnostic technology or reagent product that detects two or more targets. In one embodiment, multiplex MDx may be a molecular diagnostic technology or reagent product that detects five targets.

[0067] In this specification, molecular diagnostic test results may be stored in a database (DB).

[0068] In one embodiment, DB (1) may be a database included in an LIS (Laboratory Information System) that stores molecular diagnostic test results. In one embodiment, DB (1) may be a database included in an EMR (Electronic Health Record) that stores molecular diagnostic test results. DB (1) may be implemented as a cloud DB (1) that is accessible via a network by a molecular diagnostic test result reporting device (100).

[0069] DB (1) can store molecular diagnostic test results of other patients performed using MDx. DB (1) can also store the molecular diagnostic test results of the patient. That is, the molecular diagnostic test results of the patient may be obtained from the patient's terminal (200), but may also be obtained from DB (1).

[0070] The molecular diagnostic test result reporting device (100) can store reference test results obtained from DB (1). The reference test result may be a multiplex MDx containing at least one identical target to the multiplex MDx test result of the patient among the MDx test results stored in DB (1). In one embodiment, the reference test result may be a test result in which one or more targets are determined to be positive.

[0071] A molecular diagnostic test result reporting device (100) can process and analyze retrieving reference test results and report the multiplex MDx test results of a patient. The reporting may include the multiplex MDx test results of the patient and the processing / analysis results of the reference test results. In one embodiment, the reporting includes the operation of the molecular diagnostic test result reporting device (100) generating processing / analysis results and the operation of transmitting processing / analysis results to the patient's terminal (200). In one embodiment, processing / analysis means processing and / or analysis, and may include at least one of (i) an operation of processing target data, such as preprocessing, data format conversion, and modification of form or display method, and (ii) an operation of analyzing target data or processed data, such as statistical analysis or result analysis, or may include both.

[0072] Hereinafter, operations performed by the molecular diagnostic test result reporting device (100) will be described with reference to FIG. 2. A molecular diagnostic test result reporting method according to one embodiment may be performed by a computing device. A computing device according to one embodiment may be the molecular diagnostic test result reporting device (100).

[0073] FIG. 2 is a flowchart showing the steps of a molecular diagnostic test result reporting method according to one embodiment.

[0074] In step S100, the multiplex MDx test results of the patient may be received. At this time, the multiplex MDx test results of the patient may be obtained from the patient's terminal (200) or from DB (1). In another embodiment, the multiplex MDx test results of the patient may be molecular diagnostic test results directly input from the molecular diagnostic test result reporting device (100).

[0075] In one embodiment, the multiplex MDx test result of the patient may be a molecular diagnostic test result using PCR (polymerase chain reaction). In this case, the multiplex MDx test result of the patient may include a positive / negative result and a Ct value. The multiplex MDx test result of the patient may include a data set obtained from the target amplification reaction. In one embodiment, the data set may include an amplification curve. The positive / negative result may mean positive or negative, indicating the presence or absence of the target detected by MDx. The Ct value may be the cycle at the point where the amplification curve included in the data set exceeds a predetermined threshold. In one embodiment, the multiplex MDx test result of the patient may also include additional information such as the patient's age and gender. In one embodiment, the multiplex MDx test result may include a patient identification ID capable of identifying the test subject or patient.

[0076] In step S200, a reference check result can be retrieving from among the multiplex MDx check results already stored in DB(1).

[0077] The reference test result may be a test result obtained through a multiplex MDx that includes one or more targets identical to the target determined to be positive among the multiplex MDx test results of the patient, among the multiplex MDx test results stored in DB(1).

[0078] For example, if the multiplex MDx received by the patient is a product targeting 5 targets, the reference test result may be the result of a molecular diagnostic test by an MDx targeting the same target as at least one target determined to be positive in the molecular diagnostic test result.

[0079] In one embodiment, the aforementioned multiplex MDx test result may be an MDx test result obtained using an MDx test reagent product of the same series to which the same MDx technology is applied. Specifically, among the multiplex MDx test result of the patient, the multiplex MDx test result stored in DB (1), and the reference test result, at least one may be a test result obtained using an MDx test reagent product of the same series to which the same MDx technology is applied.

[0080] The fact that MDx technology is identical means that it is identical to at least one technology selected from the group consisting of target gene sequence and amplicon determination technology, oligonucleotide candidate design technology for primers and probes, oligonucleotide structure, signal generation mechanism indicating the presence of a target, technology for differentiating multiple signals generated from a single label in a single channel, signal processing technology, positive / negative determination technology, and nucleic acid extraction technology.

[0081] The aforementioned multiplex MDx test results may include MDx test results output from the same analysis software within the device providing the test results. For example, a medical practitioner's terminal (200) for using one or more of the aforementioned MDx test reagent products of the same series may obtain the multiplex MDx test results of the patient using the same analysis software, and other multiplex MDx test results stored in the DB (1) may also likewise be obtained through the same analysis software installed on each medical practitioner's terminal (200).

[0082] Here, the analysis software may include at least one selected from the group consisting of a Baselining algorithm, an amplification curve fitting algorithm, a Ct value determination algorithm, and a positive / negative judgment algorithm.

[0083] In this step, the operation of retrieving the reference inspection result may include accessing DB (1) to obtain or retrieve data.

[0084] In one embodiment, when step S200 is performed, a filtering-in condition of the reference test result is obtained, and the reference test result satisfying the obtained filtering-in condition can be retrieving. For example, if a medical practitioner wants to obtain a processing / analysis result using only data of a predetermined condition, the molecular diagnostic test result reporting device (100) can obtain the filtering-in condition of the reference test result through the medical practitioner's terminal (200). At this time, the filtering-in condition may be at least one of the meta-information labeled on the multiplex MDx test result stored in the DB (1).

[0085] The molecular diagnostic test result reporting device (100) can obtain reference test results from DB (1) according to filtering-in conditions.

[0086] In step S300, the reference test results retrieving can be processed and analyzed. In this step, the molecular diagnostic test result reporting device (100) can statistically process the reference test results to generate processed / analyzed results. The molecular diagnostic test result reporting device (100) can perform statistical processing using MDx molecular diagnostic test results already stored in DB (1) and generate processed / analyzed results using the statistically processed results.

[0087] In one embodiment, the molecular diagnostic test result reporting device (100) can perform statistical processing using multiplex MDx test results already stored in DB (1). For example, the molecular diagnostic test result reporting device (100) can generate processing / analysis results using multiplex MDx test results of other patients excluding the patient. The medical practitioner can compare the processing / analysis results generated using the multiplex MDx test results of other patients stored in DB (1) with the multiplex MDx test results of the patient and use them as a reference for medical treatment.

[0088] In one embodiment, the molecular diagnostic test result reporting device (100) may generate a processing / analysis result by integrating the multiplex MDx test results of the patient. That is, the processing / analysis result may be statistically processed by integrating the multiplex MDx test results of the patient with the multiplex MDx test results of other patients stored in DB (1), or statistically processed using only the multiplex MDx test results of other patients stored in DB (1) while excluding the multiplex MDx test results of the patient.

[0089] In one embodiment, whether the multiplex MDx test results of the patient are integrated into the multiplex MDx test results of other patients stored in DB (1) in the processing / analysis result can be changed by a setting entered by the user.

[0090] In step S400, the multiplex MDx test results of the patient may be reported. The molecular diagnostic test result reporting device (100) may transmit the processed / analyzed results to the patient's terminal (200). Here, the reporting may include the processed / analyzed results of the patient's multiplex MDx test results and reference test results. At this time, the processed / analyzed results may include content that allows the patient's current results to be compared / contrasted with the statistical results by reflecting the patient's multiplex MDx test results in the processed / analyzed results, which are statistical results.

[0091] The medical practitioner's terminal (200) can display the processed / analyzed results obtained from the molecular diagnostic test result reporting device (100). The medical practitioner's terminal (200) can display the multiplex MDx test results of the patient while simultaneously displaying the processed / analyzed results. In one embodiment, the medical practitioner's terminal (200) may be connected to an EMR server to access the EMR server and display the patient's health information.

[0092] In this way, the medical practitioner's terminal (200) can display the processing / analysis results related to the patient's multiplex MDx test results on the display.

[0093] A molecular diagnostic test result reporting method according to one embodiment allows a medical professional to provide medical services to a patient by referring to the processed / analyzed results, thereby presenting more analytical data to the patient and providing high-quality medical services.

[0094] FIG. 3 is a diagram showing an example of displaying processing / analysis results according to molecular diagnostic test result reporting on a medical device terminal (200).

[0095] As shown in Fig. 3, the PCR test results and processing / analysis results of the subject can be output from the medical doctor's terminal (200).

[0096] The processed / analyzed results of the reference test results can display corresponding comparison results between the patient's multiplex MDx test results and the processed / analyzed results of the reference test results.

[0097] Since the patient's PCR test result and the processing / analysis result are output together on the medical practitioner's terminal (200), the patient's PCR test result can be compared and contrasted by referring to the processing / analysis result. For example, the medical practitioner can compare the Ct value in the processing / analysis result of the patient's multiplex MDx test result and the reference test result, or compare the positive / negative determination result, through the medical practitioner's terminal (200).

[0098] The medical practitioner's terminal (200) can access the EMR server to obtain health information of the patient. The health information may include details related to the patient's profile, diagnosis, treatment progress, medication information, and underlying disease information.

[0099] The medical practitioner can analyze the current condition of the patient by comparing the processing / analysis result, which is data displayed on the medical practitioner's terminal (200), with the patient's multiplex MDx test result.

[0100] In one embodiment, the processing / analysis result may display the statistical distribution of the reference test result on the UI, and the statistical position of the patient's multiplex MDx test result may be displayed on the statistical distribution of the UI.

[0101] In one embodiment, the processing / analysis result may display a controller UI that can change the processing analysis conditions for the reference inspection result.

[0102] Figure 4 is an example showing labeling meta information for reference inspection results stored in DB (1).

[0103] In one embodiment, the multiplex MDx test result may be labeled with meta-information that is information about the test subject or information about the multiplex MDx test.

[0104] Meta information may include a test subject identifier, test subject information including age and gender, test date, product name, product version information, and catalog number.

[0105] In one embodiment, the subject identifier may be an arbitrarily assigned ID to distinguish the subject. In one embodiment, the subject identifier may include at least one of the subject's age, gender, name, physical information, and disease name.

[0106] The molecular diagnostic test result reporting device (100) can obtain reference test results by filtering some of the MDx test results stored in DB (1), and can filter data using meta information.

[0107] For example, a molecular diagnostic test result reporting device (100) can obtain a reference test result by filtering only the MDx test results corresponding to the same product name as the patient's multiplex MDx test result from the MDx test results included in DB (1).

[0108] In another embodiment, the meta-information may include target information to be detected by multiplex MDx, the number of detected targets, oligo information, and positive / negative judgment result information.

[0109] For example, in the test result of multiplex MDx, target information Flu A can be labeled as meta-information. Using the meta-information labeled Flu A, a reference test result can be obtained from DB (1) based on the multiplex MDx test result targeting Flu A.

[0110] In one embodiment, the name of the company that manufactured the multiplex MDx product may be labeled, and the molecular diagnostic test result reporting device (100) can obtain a reference test result labeled with the same target of the same company as the multiplex MDx test result of the patient.

[0111] The statistical results of the reference test may include at least one selected from a group consisting of prevalence statistics, Ct value statistics, infection statistics by age / gender, infection pattern statistics for solitary and co-infections, and follow-up statistics of Ct values ​​for a specific target of the test subject.

[0112] For example, the statistical result may be statistical data in which Ct values ​​are processed and analyzed with respect to gender, age, and statistical period, or statistical data in which positive / negative judgment results are processed and analyzed with respect to gender, age, and statistical period.

[0113] Since infections in molecular diagnostics have the nature of being transmitted to people by various factors, an analysis of the infection can be performed using statistical information. In particular, among the statistical information, statistical results regarding prevalence statistics can serve as meaningful information for the analysis of the infection. In one embodiment, the statistical results may be included in the processing / analysis results.

[0114] Hereinafter, various examples of processing / analysis results will be described with reference to FIGS. 5 to 12.

[0115] Figure 5 is an example of statistical results showing the detection rate by respiratory target.

[0116] In one embodiment, the statistical result may be statistical data regarding the detection rate by respiratory target for the total respiratory target detection in the second quarter of 2023. In the statistical result, Flu A may be detected 20 times at 43%, Flu B 8 times at 17%, RSV 7 times at 15%, AdV 3 times at 7%, PIV 2 times at 4%, and MPV 1 time at 2%.

[0117] The statistical results of detection rates by respiratory target may indicate that Flu A is currently dominant among respiratory targets.

[0118] Based on these statistical results, it can be estimated that Flu A will be detected with high frequency when detecting respiratory targets, followed by Flu A. Additionally, based on these statistics, it can be estimated that MPV will be detected with the lowest frequency.

[0119] When a medical professional provides medical services to a patient, if the patient exhibits similar symptoms among respiratory infectious disease symptoms, it can be presumed that the patient was infected by a target with a higher detection frequency.

[0120] In addition, since the statistical results are statistical data for the second quarter of 2023, when a medical professional provides medical services to a patient in the second quarter of 2024, the medical professional can perform a more reliable analysis by referring to the statistical data for the second quarter of 2023, which is the same quarter of the immediately preceding year.

[0121] Figure 6 is an example of statistical results showing the detection rate and trend over a period for a specific target.

[0122] The statistical results in Figure 6 are the detection rates of the Flu A target during January 23.

[0123] Flu A was not detected from January 1, 2023 to January 20, 2023, and was detected about once a day from January 21 to 26, 2023. Flu A was detected twice on January 27, 2023, and the detection rate increased to five times by the end of January.

[0124] Through statistical results, it can be analyzed that Flu A was not detected in early January 2023, but showed a trend of rapid increase from mid-January 2023 onwards.

[0125] Medical practitioners can predict the detection rate of the Flu A target in early February 2023 through these statistical results. Additionally, medical practitioners can predict the trend of the detection rate of the Flu A target in January 2024 through these statistical results.

[0126] The period shown in the statistical results can be changed by the user's UI. In the case of Fig. 6, the statistical results show the detection rate for one month, but the period can be changed to two months, three months, etc. by the user's UI, and the statistical results can show the detection rate of Flu A during the changed period.

[0127] Figure 7 is an example of statistical results showing the quarterly number of confirmed cases for a specific target.

[0128] The statistical results may be statistical data that allows for quarterly comparison of the number of confirmed cases for each quarter of 2021, 2022, and 2023.

[0129] The statistical results indicate that among the years 21 to 23, the number of confirmed cases of Flu A in the first quarter was highest in 2023, followed by 2021 and 2022. Additionally, the statistical results indicate that the number of confirmed cases of Flu A in the second, third, and fourth quarters was highest in 2023, followed by 2022 and 2021.

[0130] In particular, the statistical results may indicate that the number of confirmed cases of Flu A in the fourth quarter of 2023 increased sharply compared to the number of confirmed cases of Flu A in the fourth quarters of 2021 and 2022.

[0131] Figure 8 is an example of statistical results showing the ratio of confirmed cases by gender for a specific target.

[0132] The statistical results show that the total number of confirmed cases for a specific target is 46, with 19 women accounting for 41% and 27 men accounting for 59%. In one embodiment, the medical professional may determine that the infection rate of a specific target is higher in men than in women.

[0133] Figure 9 is an example of statistical results showing the infection rate by age for a specific target.

[0134] The statistical results in Figure 9 show the infection rates for each age group for one month of Flu A.

[0135] The statistical results show that the one-month infection rate for Flu A is 36.4% with 59 cases in the 20–29 age group, followed by 17.9% with 29 cases in the 50–59 age group. Additionally, the statistical results show that the one-month infection rate for Flu A is 1.2% with 2 cases in the 0–9 age group.

[0136] Medical professionals can use these statistical results to analyze whether the infection rate of a specific target is high or low in certain age groups. In this case, medical professionals can estimate that patients in age groups with high infection rates are highly likely to be infected with the target, and can take preemptive preventive measures in advance for those age groups.

[0137] In particular, since active prevention and treatment assistance from guardians is needed when the infection rate is high among children aged 0 to 9, medical professionals can provide guardians with information on prevention and treatment.

[0138] Figure 10 is an example of a statistical result showing the distribution of Ct values ​​by age for a specific target.

[0139] The statistical results can display the distribution of Ct values ​​by age group in a plotting manner. For example, the statistical results can show that the distribution of Ct values ​​for 25-34 year olds infected with a specific target is 20-27, and the distribution of Ct values ​​for 35-44 year olds infected with a specific target is 18-29.

[0140] In this way, the statistical results display the distribution of Ct values ​​by age group using a plotting method, and can also indicate the corresponding location of the Ct values ​​included in the patient's multiplex MDx test results within the statistical results.

[0141] The patient's age is 35 to 44 years and the Ct value is 18. Among the distribution of Ct values ​​for ages 35 to 44 displayed in a plotting manner, the position corresponding to the patient's Ct value of 18 can be indicated with an arrow.

[0142] Although the Ct value of the patient shown in the statistical results may be analyzed as somewhat low when viewed against the entire age group, it may be analyzed as falling within an unexceptional normal distribution range when viewed against the age group to which the patient belongs.

[0143] Figure 11 is an example of statistical results showing the trend of increase or decrease over time for multiple targets.

[0144] The statistical results in Figure 11 may indicate that the sensitivity rates of the Flu A target and RSV target fluctuate between 15 and 20 times from early January to late January. Additionally, the statistical results may indicate that the sensitivity rates of the Flu B target and HRV target temporarily decrease from early January to mid-January and then increase again to 30 times at the end of January.

[0145] The medical practitioner can display these statistical results on the medical practitioner's terminal (200), and the medical practitioner can compare the increase and decrease trends of multiple targets at once.

[0146] In one embodiment, follow-up statistics on Ct values ​​for a specific target of a subject may include follow-up observation of Ct values ​​for the subject's HPV test. Since STI-related targets such as HPV require follow-up observation, it is necessary to continuously monitor the trend of Ct values ​​for the corresponding target.

[0147] When the vertical axis value of Fig. 11 is the Ct value, the statistical result can show the trend of the Ct value of a specific target over a specific period.

[0148] For example, if the Ct value of a target requiring follow-up observation in the statistical results is determined to be trending downward over time, it is determined that the amount of the target for that patient has increased, and the medical professional may perform treatment and prescribe accordingly for that patient.

[0149] The follow-up statistics of Ct values ​​for a specific target of a test subject may include statistical results processed and analyzed using the follow-up of Ct values ​​for the test subject's HPV test.

[0150] Figure 12 is an example of a statistical result showing various statistical data regarding co-infection.

[0151] The statistical results represent the statistical results of Ct values ​​in single infection and Ct values ​​in co-infection corresponding to each of the five or more targets in the reference test results. Single infection means infection with one target, and co-infection means infection with two or more targets. The statistical results may include the statistical results of the number of patients in single infection and the statistical results of the number of patients in co-infection corresponding to each of the five or more targets in the reference test results.

[0152] Twenty out of 100 patients tested positive for respiratory infectious diseases, and the positivity rate was 20%. Among the patients who tested positive for respiratory infectious diseases, 10 had a single infection, accounting for 50% of the total.

[0153] Among the patients who tested positive for respiratory infections, there were 80 patients who had co-infections with targets other than respiratory infections, 4 patients infected with 2 targets (20%), 3 patients infected with 3 targets (15%), 2 patients infected with 4 targets (10%), and 1 patient infected with 5 targets (5%).

[0154] Among the 20 patients who tested positive, 10 patients had a single infection, 5 patients had a single infection with Flu A, 1 patient had a single infection with Flu B, 2 patients had a single infection with RSV, and 1 patient had a single infection with HRV.

[0155] The remaining 10 patients are co-infected, and 4 patients are infected with 2 targets.

[0156] The statistical results indicate that two patients infected with two targets were infected with RSV and Flu A. In one of these patients, the Ct values ​​for both RSV and Flu A were detected as 20. In the other patient, the Ct value for RSV was detected as 30, and the Ct value for Flu A was detected as 10.

[0157] The statistical results indicate that the remaining patient infected with two targets was infected with RSV and Flu B. This patient's RSV Ct value was detected as 30, and Flu B Ct value was detected as 10.

[0158] The statistical results indicate that the other patient infected with two targets was infected with HRV and PIV. The Ct value of HRV in this patient was detected as 15, and the Ct value of PIV was detected as 15.

[0159] The statistical results show that there are 3 patients infected with 3 targets, and indicate the type of target infected by each patient and the Ct value of each target.

[0160] By referring to statistical results, the medical professional can predict the targets that may be statistically infected together if the patient is infected with a single target.

[0161] In addition, the medical professional can estimate the Ct values ​​of co-infected targets by referring to the statistical results.

[0162] In one embodiment, if the multiplex MDx test result of the patient corresponds to a co-infection, the physician may refer to treatment information, such as the symptoms and treatment process of patients co-infected with multiple targets identical to the patient's Ct value, in the statistical results and Ct values ​​for multiple targets of the patient.

[0163] Figure 13 is a diagram showing an example of searching for a reference test result that has similarity by comparing the multiplex MDx test result of a patient with the reference test result.

[0164] Referring again to step S300 of Fig. 2, when the retrieving reference test results are processed and analyzed, similarity cases similar to the patient's multiplex MDx test results can be selected from among the reference test results.

[0165] At this time, selecting similarity cases refers to the operation of comparing the multiplex MDx test result of the patient with the reference test result to search for a reference test result having a similarity greater than or equal to a preset threshold. In one embodiment, a reference test result having a similarity greater than or equal to a preset threshold means a case where at least some of the predefined elements are identical by synthesizing various data, metadata, and related health information included in the patient's multiplex MDx. In another embodiment, a reference test result having a similarity greater than or equal to a preset threshold may be an MDx test result having a similarity score greater than or equal to a preset criterion based on a similarity score that matches the doctor's multiplex MDx test result.

[0166] In one embodiment, similarity cases may be selected by considering the positive / negative judgment results and Ct values ​​of the multiplex MDx test results. For example, a similarity case may be a reference test result in which the positive / negative judgment results are identical to the patient's multiplex MDx test results and the Ct value falls within a predetermined range.

[0167] Similarity cases can be selected by further considering the shape of the data set of the amplification response of the multiplex MDx test results. For example, a similarity case may be a reference test result where the parameter values ​​for the amplification curve are identical to the patient's multiplex MDx test result.

[0168] In one embodiment, similarity cases may be selected from multiplex MDx test results with further consideration of age and / or gender. For example, a similarity case may be a reference test result of a patient of the same gender as the patient's multiplex MDx test result, corresponding to an age within a predetermined range.

[0169] FIG. 14 is a diagram conceptually illustrating the operation of a molecular diagnostic test result reporting device (100) selecting similarity cases and providing them to a patient's terminal (200) along with statistical results.

[0170] In one embodiment, after the selection of similarity cases in step S300 of processing and analyzing reference test results, at least one EMR data selected from a group consisting of the type of symptoms, severity of symptoms, patient's age, gender, underlying disease, medication record, treatment record and treatment progress record, vaccination history, and lifestyle of the similarity case may be obtained.

[0171] In one embodiment, the statistical result may further include a similarity case and at least one EMR data.

[0172] The statistical distribution of EMR data of similarity cases included in the processing / analysis results can be displayed as a UI on the patient's terminal (200), and the statistical position of the EMR data corresponding to the patient can be displayed on the statistical distribution of the UI. The processing / analysis results may display a controller UI that can change the processing analysis conditions for the reference test results.

[0173] A molecular diagnostic test result reporting method according to one embodiment can provide an infection trend for a specific target by utilizing information regarding at least one of a patient's co-infection, gender, age group, and Ct value through statistical results. Additionally, a medical professional can obtain similarity cases regarding the multiplex MDx test results of a patient and retrieve health information of patients corresponding to similarity cases from the EMR to perform diagnosis and treatment, while referring to the infection trend of the aforementioned statistical results.

[0174] FIG. 15 is a hardware configuration diagram of a molecular diagnostic test result reporting device (100) according to one embodiment.

[0175] Components, modules, or parts in this disclosure include routines, procedures, programs, components, reference databases, etc., that perform specific tasks or implement specific abstract data types. Furthermore, those skilled in the art will fully recognize that the methods presented in this disclosure may be implemented in other computer system configurations, including single-processor or multi-processor computing systems, minicomputers, mainframe computers, as well as personal computers, handheld computing devices, microprocessor-based or programmable consumer electronics, etc. (each of which may operate in conjunction with one or more associated devices).

[0176] The embodiments described in this disclosure may also be implemented in a distributed computing environment in which tasks are performed by remote processing devices connected via a communication network. In a distributed computing environment, program modules may be located in both local and remote memory storage devices.

[0177] Computing devices typically include various computer-readable media. Any medium accessible by a computer may be a computer-readable medium, and such computer-readable media include volatile and non-volatile media, transitory and non-transitory media, and removable and non-removable media. By example, but not limiting, computer-readable media may include computer-readable storage media and computer-readable transmission media.

[0178] Computer-readable storage media include volatile and non-volatile media, ephemeral and non-ephemeral media, removable and non-removable media implemented by any method or technology for storing information such as computer-readable instructions, reference databases, program modules, or other data. Computer-readable storage media include, but are not limited to, RAM, ROM, EEPROM, flash memory, or other memory technologies, CD-ROM, DVD (digital video disk), or other optical disk storage devices, magnetic cassettes, magnetic tapes, magnetic disk storage devices, or other magnetic storage devices, or any other media that can be accessed by a computer and used to store desired information.

[0179] Computer-readable transmission media typically include all information transmission media that implement computer-readable instructions, reference databases, program modules, or other data, etc., on a modulated data signal, such as a carrier wave or other transport mechanism. The term modulated data signal means a signal in which one or more of the characteristics of the signal are set or modified to encode information within the signal. By example, not limiting, computer-readable transmission media include wired media, such as wired networks or direct-wired connections, and wireless media, such as acoustic, RF, infrared, and other wireless media. Any combination of the media described above is also considered to be within the scope of computer-readable transmission media.

[0180] An exemplary environment (2000) for implementing various aspects of the present invention, including a computer (2002), is shown, wherein the computer (2002) includes a processing unit (2004), system memory (2006), and a system bus (2008). The computer (200) in this specification may be used interchangeably with a computing device. The system bus (2008) connects system components, including system memory (2006) (but not limited thereto), to the processing unit (2004). The processing unit (2004) may be any processor among various commercial processors. Dual processors and other multiprocessor architectures may also be used as the processing unit (2004).

[0181] The system bus (2008) may be any of several types of bus structures that can be additionally interconnected to a local bus using any of the memory bus, peripheral bus, and various commercial bus architectures. System memory (2006) includes read-only memory (ROM) (2010) and random access memory (RAM) (2012). The Basic Input / Output System (BIOS) is stored in non-volatile memory (2010), such as ROM, EPROM, EEPROM, etc., and this BIOS includes basic routines that help transfer information between components within the computer (2002) at times such as during startup. The RAM (2012) may also include high-speed RAM, such as static RAM, for caching data.

[0182] The computer (2002) also includes an internal hard disk drive (HDD) (2014) (e.g., EIDE, SATA), a magnetic floppy disk drive (FDD) (2016) (e.g., for reading from or writing to a removable diskette (2018)), an SSD, and an optical disk drive (2020) (e.g., for reading from a CD-ROM disk (2022) or reading from or writing to other high-capacity optical media such as a DVD). The hard disk drive (2014), the magnetic disk drive (2016), and the optical disk drive (2020) may each be connected to the system bus (2008) by a hard disk drive interface (2024), a magnetic disk drive interface (2026), and an optical drive interface (2028). The interface (2024) for implementing an external drive includes, for example, at least one or both of USB (Universal Serial Bus) and IEEE 1394 interface technologies.

[0183] These drives and associated computer-readable media provide non-volatile storage of data, data structures, computer-executable instructions, etc. In the case of a computer (2002), the drives and media correspond to storing any data in a suitable digital format. Although the description of computer-readable storage media above refers to HDDs, removable magnetic disks, and removable optical media such as CDs or DVDs, those skilled in the art will know that other types of computer-readable storage media, such as zip drives, magnetic cassettes, flash memory cards, cartridges, etc., may also be used in exemplary operating environments and that any of these media may contain computer-executable instructions for carrying out the methods of the present invention.

[0184] A number of program modules, including an operating system (2030), one or more application programs (2032), other program modules (2034), and program data (2036), may be stored in the drive and RAM (2012). All or part of the operating system, application, module and / or data may also be cached in RAM (2012). It will be well known that the present invention may be implemented in various commercially available operating systems or combinations of operating systems.

[0185] The user can input commands and information into the computer (2002) through one or more wired / wireless input devices, such as a pointing device like a keyboard (2038) and a mouse (2040). Other input devices (not shown) may include a microphone, an IR remote control, a joystick, a game pad, a stylus pen, a touch screen, etc. These and other input devices are often connected to the processing unit (2004) via an input device interface (2042) connected to the system bus (2008), but may also be connected via other interfaces such as a parallel port, an IEEE 1394 serial port, a game port, a USB port, an IR interface, etc.

[0186] A monitor (2044) or other type of display device is also connected to the system bus (2008) via an interface such as a video adapter (2046). In addition to the monitor (2044), the computer generally includes other peripheral output devices (not shown), such as speakers, a printer, and so on.

[0187] The computer (2002) may operate in a networked environment using a logical connection to one or more remote computers, such as remote computer(s) (2048), via wired and / or wireless communication. The remote computer(s) (2048) may be a workstation, server computer, router, personal computer, portable computer, microprocessor-based entertainment device, peer device, or other conventional network node, and generally include many or all of the components described for the computer (2002), but for brevity, only the memory storage device (2050) is illustrated. The illustrated logical connection includes a wired / wireless connection to a local area network (LAN) (2052) and / or a larger network, e.g., a wide area network (WAN) (2054). Such LAN and WAN networking environments are common in offices and companies and facilitate enterprise-wide computer networks, such as intranets, all of which can be connected to a global computer network, e.g., the Internet.

[0188] When used in a LAN networking environment, the computer (2002) is connected to a local network (2052) via a wired and / or wireless communication network interface or adapter (2056). The adapter (2056) may facilitate wired or wireless communication to the LAN (2052), and the LAN (2052) may also include a wireless access point installed therein to communicate with the wireless adapter (2056). When used in a WAN networking environment, the computer (2002) may include a modem (2058), be connected to a communication server on the WAN (2054), or have other means of communicating through the WAN (2054), such as via the Internet. The modem (2058), which may be an internal or external and a wired or wireless device, is connected to the system bus (2008) via a serial port interface (2042). In a networked environment, the program modules described for the computer (2002) or parts thereof may be stored in a remote memory / storage device (2050). It will be well known that the illustrated network connection is exemplary and that other means of establishing a communication link between computers may be used.

[0189] The computer (2002) operates to communicate with any wireless device or object that is deployed and operated by wireless communication, e.g., a printer, scanner, desktop and / or portable computer, PDA (portable data assistant), communication satellite, any equipment or place associated with a wireless detectable tag, and a telephone. This includes at least Wi-Fi and Bluetooth wireless technologies. Accordingly, the communication may be a predefined structure as in a conventional network, or simply ad hoc communication between at least two devices.

[0190] Meanwhile, the method according to the various embodiments described above may be implemented in the form of a computer program stored on a computer-readable recording medium programmed to perform each step of the method, and may also be implemented in the form of a computer-readable recording medium storing a computer program programmed to perform each step of the method.

[0191] The above description is merely an illustrative explanation of the technical concept of the present invention, and those skilled in the art to which the present invention pertains will be able to make various modifications and variations within the scope of the essential quality of the present invention. Accordingly, the embodiments disclosed in the present invention are intended to explain, not limit, the technical concept of the present invention, and the scope of the technical concept of the present invention is not limited by such embodiments. The scope of protection of the present invention shall be interpreted by the claims below, and all technical concepts within the equivalent scope shall be interpreted as being included within the scope of rights of the present invention.

Claims

Claim 1 A molecular diagnostic test result reporting method comprising the following steps performed in a molecular diagnostic test result reporting device: receiving a multiplex MDx test result of a patient, wherein the multiplex MDx is for detecting multiple targets, and the multiplex MDx test result of the patient includes a positive / negative result and a Ct value; retrieving a reference test result obtained through a multiplex MDx that includes a target identical to one or more targets determined positive among the multiplex MDx test results of the patient, among the multiplex MDx test results stored in a database (DB) connected to the reporting device, wherein the reference test result includes a positive / negative result and a Ct value; processing and analyzing the retrieving reference test result; and reporting the multiplex MDx test result of the patient; wherein the reporting includes the multiplex MDx test result of the patient and the processing / analysis result of the reference test result. Claim 2 A molecular diagnostic test result reporting method according to claim 1, wherein the multiplex MDx test result stored in the database of the reporting device is labeled with at least one meta-information selected from the group consisting of a test subject identifier, test subject information including age and gender, test date, product name, product version information, and catalog number. Claim 3 A molecular diagnostic test result reporting method according to claim 1, characterized in that the processing / analysis result of the reference test result includes a statistical result of the reference test result. Claim 4 A molecular diagnostic test result reporting method according to claim 1, wherein the statistical results of the reference test results include at least one selected from a group consisting of prevalence statistics, Ct value statistics, infection statistics by age / gender, infection pattern statistics for single infection and co-infection, and follow-up observation statistics of Ct values ​​for a predetermined target of the test subject. Claim 5 A molecular diagnostic test result reporting method according to claim 4, characterized in that the follow-up statistics of the Ct value for a specific target of the test subject are processed and analyzed using the follow-up statistics of the Ct value for the HPV test of the test subject. Claim 6 A molecular diagnostic test result reporting method according to claim 4, wherein the processing / analysis result of the reference test result in the reporting step comprises statistical results of Ct values ​​in single infection and statistical results of Ct values ​​in co-infection corresponding to each of the one or more targets in the reference test result. Claim 7 A molecular diagnostic test result reporting method according to claim 4, wherein the processing / analysis result of the reference test result in the reporting step comprises a statistical result of the number of patients in a single infection and a statistical result of the number of patients in a co-infection corresponding to each of the one or more targets in the reference test result. Claim 8 A molecular diagnostic test result reporting method according to claim 4, wherein the reporting step is characterized by displaying the statistical distribution of the reference test result included in the processing / analysis result on a UI and displaying the statistical position of the multiplex MDx test result of the patient on the statistical distribution of the UI. Claim 9 A molecular diagnostic test result reporting method according to claim 8, wherein the reporting step is characterized by displaying a controller UI capable of changing the processing analysis conditions for the reference test result. Claim 10 A molecular diagnostic test result reporting method according to claim 1, wherein the step of processing and analyzing the reference test results is characterized by selecting similarity cases similar to the multiplex MDx test results of the subject among the reference test results. Claim 11 A molecular diagnostic test result reporting method according to claim 10, characterized in that the similarity case is selected by considering the positive / negative determination result and Ct value of the multiplex MDx test result. Claim 12 A molecular diagnostic test result reporting method according to claim 11, characterized in that the similarity case is selected by further considering the shape of the data set of the amplification reaction of the multiplex MDx test result. Claim 13 A molecular diagnostic test result reporting method according to claim 11, characterized in that the similarity case is selected by further considering age and / or gender in the multiplex MDx test results. Claim 14 A molecular diagnostic test result reporting method according to claim 10, wherein the step of processing and analyzing the reference test result involves, after the selection of the similarity case, obtaining at least one EMR (Electronic Health Record) data selected from a group consisting of the type of symptoms, severity of symptoms, patient's age, gender, underlying disease, medication record, treatment record and treatment progress record, vaccination history, and lifestyle of the similarity case, and wherein the processing / analysis result of the reference test result in the reporting step further includes the similarity case and at least one EMR data. Claim 15 A molecular diagnostic test result reporting method according to claim 14, wherein the reporting step is characterized by displaying the statistical distribution of the EMR data of the similarity case included in the at least one EMR data on a UI and further displaying the statistical position of the EMR data corresponding to the patient on the statistical distribution of the UI. Claim 16 A molecular diagnostic test result reporting method according to claim 14, wherein the selection of the similarity case is characterized by comparing the multiplex MDx test result of the patient with the reference test result and searching for a reference test result having a similarity greater than or equal to a preset threshold. Claim 17 A molecular diagnostic test result reporting method according to claim 1, wherein the step of retrieving the reference test result comprises obtaining a filtering-in condition of the reference test result and retrieving the reference test result that satisfies the obtained filtering-in condition. Claim 18 A molecular diagnostic test result reporting method according to claim 1, characterized in that the multiplex MDx test result includes at least one of an infection test or a genetic test. Claim 19 A molecular diagnostic test result reporting method according to claim 1, wherein the processing / analysis result of the reference test result in the reporting step comprises a comparison result between the multiplex MDx test result of the patient and the processing / analysis result of the reference test result. Claim 20 A molecular diagnostic test result reporting method according to claim 1, characterized in that the multiplex MDx test result of the subject and the reference test result are MDx test results using one or more of the MDx test reagent products of the same series to which the same MDx technology is applied. Claim 21 A molecular diagnostic test result reporting method according to claim 1, wherein the same MDx technology is characterized by being identical to at least one technology selected from the group consisting of a target gene sequence and amplicon determination technology, an oligonucleotide candidate design technology for primers and probes, an oligonucleotide structure, a signal generation mechanism indicating the presence of a target, a technology for differentiating multiple signals generated from a single label in a single channel, a signal processing technology, a positive / negative determination technology, and a nucleic acid extraction technology. Claim 22 A molecular diagnostic test result reporting method according to claim 1, characterized in that a medical practitioner's terminal for using one or more of the MDx test reagent products of the same series uses the same analysis software. Claim 23 A molecular diagnostic test result reporting method according to claim 1, wherein the analysis software comprises at least one selected from the group consisting of a Baselining algorithm, an amplification curve fitting algorithm, a Ct value determination algorithm, and a positive / negative determination algorithm. Claim 24 A molecular diagnostic test result reporting device for reporting multiplex MDx test results of a patient, comprising: a memory for storing at least one command; a network; and a processor configured to execute the at least one command stored in the memory, wherein when the at least one command is executed by the processor, the processor is configured to perform the following method, the method comprising: receiving the multiplex MDx test results of the patient; wherein the multiplex MDx is for detecting multiple targets, and the multiplex MDx test results of the patient include positive / negative determination results and Ct values; among the multiplex MDx test results stored in a database (DB) connected to the reporting device, a reference test result obtained through a multiplex MDx that includes a target identical to one or more targets determined to be positive among the multiplex MDx test results of the patient, wherein the reference test result includes positive / negative determination results and Ct values; and a step of processing and analyzing the retrieving reference test results. A molecular diagnostic test result reporting device comprising the step of reporting the multiplex MDx test results of the subject; wherein the reporting includes the multiplex MDx test results of the subject and the processing / analysis results of the reference test results. Claim 25 A computer-readable, non-transient recording medium for storing a computer program, wherein the computer program includes instructions that cause the one or more processors to perform the following method when executed by one or more processors, and the method comprises: receiving the results of a multiplex molecular diagnostic (multiplex MDx) test of a patient, wherein the multiplex MDx is for detecting multiple targets, and the results of the multiplex MDx test of the patient include positive / negative determination results and Ct values; retrieving a reference test result obtained through a multiplex MDx that includes a target identical to one or more targets determined positive among the results of the multiplex MDx test of the patient, among the multiplex MDx test results stored in a database (DB) connected to the reporting device, wherein the reference test result includes positive / negative determination results and Ct values; processing and analyzing the retrieving reference test result; and reporting the results of the multiplex MDx test of the patient. The above reporting is a computer-readable, non-transient recording medium that stores a computer program containing the processing / analysis results of the multiplex MDx test results of the above patient and the above reference test results. Claim 26 A computer program stored on a computer-readable non-transient recording medium, wherein the computer program includes instructions that cause the one or more processors to perform the following method when executed by one or more processors, the method comprising: receiving the results of a multiplex molecular diagnostic (multiplex MDx) test of a patient, wherein the multiplex MDx is for detecting multiple targets, and the results of the multiplex MDx test of the patient include positive / negative determination results and Ct values; retrieving a reference test result obtained through a multiplex MDx that includes a target identical to one or more targets determined positive among the results of the multiplex MDx test of the patient, among the multiplex MDx test results stored in a database (DB) connected to the reporting device, wherein the reference test result includes positive / negative determination results and Ct values; processing and analyzing the retrieving reference test result; and reporting the results of the multiplex MDx test of the patient. The above reporting is a computer program stored on a computer-readable, non-transient recording medium containing the processing / analysis results of the multiplex MDx test results of the above patient and the above reference test results.

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