Molecular diagnosis test result reporting apparatus and molecular diagnosis test result reporting method using same

Abstract

A molecular diagnosis test result reporting apparatus is provided. A molecular diagnosis test result reporting method, according to an embodiment, comprises the steps of: receiving multiplex molecular diagnosis (multiplex MDx) test results of a patient, wherein multiplex MDx is for detecting a plurality of targets, and the multiplex MDx test results of the patient include positive / negative determination results and Ct values; from among multiplex MDx test results pre-stored in a database (DB) connected to the molecular diagnosis test result reporting apparatus, retrieving reference test results obtained through multiplex MDx including the same targets as one or more targets determined to be positive among the multiplex MDx test results of the patient, wherein the reference test results include positive / negative determination results and Ct values; processing and analyzing the retrieved reference test results; and reporting the multiplex MDx test results of the patient.

Description

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

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

[0002] In the past, in the process of treating patients by referring to the results of molecular diagnostic tests or in the process of examining patients by analyzing the results of molecular diagnostic tests, treatment of patients or analysis of molecular diagnostic test results was performed based only on the results of patients who underwent molecular diagnostic tests.

[0003] For example, when treating a patient based on polymerase chain reaction (PCR) test results, a clinician may provide medical services solely based on the patient's PCR test results. Alternatively, a medical examiner may analyze data solely based on the subject's PCR test results.

[0004] Previously, the statistical significance of molecular diagnostic test results was unclear, and even if there were data with statistical significance among molecular diagnostic test results, it was difficult for clinicians or examining doctors to compare and reference statistical data related to patients' PCR test results.

[0005] In particular, existing molecular diagnostic test analysis software did not perform statistical analysis of PCR test results and, in particular, did not provide supplementary information focused on the patient's PCR test results. When relevant statistical data was needed, clinicians or medical examiners had to search relevant papers or academic materials, requiring additional effort. Finding supplementary materials suitable for referencing a patient's PCR test results was a time-consuming and costly process.

[0006] (Prior art document) Korean Patent Publication No. 10-2485460 (registered on January 2, 2023)

[0007] The problem to be solved by this specification is to report molecular diagnostic test results to a clinician's terminal.

[0008] Another challenge that this specification aims to address is reporting statistical processing / analysis results that can be used as a reference for the treatment of patients.

[0009] However, the problems to be solved described in this specification are not limited to the problems mentioned above, and other problems not mentioned can be clearly understood by those skilled in the art of the present invention from the description below.

[0010] According to one embodiment, a method for reporting molecular diagnostic test results includes the steps of: receiving a multiplex molecular diagnostic (multiplex MDx) test result of a patient; the multiplex MDx is for detecting a plurality of targets; the multiplex MDx test result of the patient includes a positive / negative determination result and a Ct value; retrieving a reference test result obtained through the multiplex MDx, which includes the same target as at least one target determined positive among the multiplex MDx test results of the patient, from among the multiplex MDx test results previously stored in a database (DB) connected to the reporting device; the reference test result includes a positive / negative determination result and a Ct value; processing and analyzing the retrieved reference test result; and reporting the multiplex MDx test result of the patient, the reporting including the processing / analysis result of the multiplex MDx test result of the patient and the reference test result.

[0011] In one embodiment, the multiplex MDx test results previously stored in the database of the reporting device may be labeled with at least one piece of 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 a statistical result of the reference test result.

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

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

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

[0017] In one embodiment, the reporting step may display a statistical distribution of the reference test results included in the processing / analysis results as a UI and display a statistical location 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 test results.

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

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

[0021] In one embodiment, the similarity case may be selected by further considering the modification of the data set of the amplification reaction 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 may include, after selection of a similarity case, obtaining at least one EMR data selected from the group consisting of the type of symptom, the degree of symptom, the patient's age, sex, underlying disease, medication record, treatment record, treatment progress record, vaccination history, and lifestyle habits of the similarity case, and the processing / analysis result of the reference test results of the step of reporting 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 a statistical distribution of EMR data of the similarity case included in the at least one EMR data as a UI and further display a statistical location of EMR data corresponding to the patient on the statistical distribution of the UI.

[0025] In one embodiment, selecting the similarity case may include 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 a preset threshold value.

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

[0027] In one embodiment, the multiplex MDx test results 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 of the reporting step may include a comparison result of the processing / analysis result of the multiplex MDx test result of the patient and 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 same series of MDx test reagent products 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 candidates 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 one label in one channel, a signal processing technology, a positive / negative determination technology, and a nucleic acid extraction technology.

[0031] In one embodiment, a clinician's terminal 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] According to another embodiment, a molecular diagnostic test result reporting device includes a memory storing at least one command, a network, and a processor configured to execute the at least one command stored in the memory, wherein the at least one command, when executed by the processor, causes the processor to perform the following method, the method comprising: a step of receiving a multiplex molecular diagnostic (multiplex MDx) test result of a subject, wherein the multiplex MDx is for detecting a plurality of targets, and the multiplex MDx test result of the subject includes a positive or negative determination result and a Ct value; a step of retrieving a reference test result obtained through the multiplex MDx, which includes the same target as at least one target determined positive among the multiplex MDx test results of the subject, from among the multiplex MDx test results previously stored in a database (DB) connected to the reporting device; a step of processing and analyzing the retrieved reference test result, wherein the reference test result includes a positive or negative determination result and a Ct value; and a step of reporting the multiplex MDx test result of the subject. Including, the above reporting may include the results of processing / analysis of the multiplex MDx test results of the above patient and the results of the reference test results.

[0034] A computer-readable, non-transitory recording medium storing a computer program according to another embodiment, wherein the computer program includes instructions that, when executed by one or more processors, cause the one or more processors to perform the following method, the method comprising: receiving a multiplex molecular diagnosis (multiplex MDx) test result of a patient, wherein the multiplex MDx is for detecting a plurality of targets, and the multiplex MDx test result of the patient includes a positive or negative determination result and a Ct value; retrieving a reference test result obtained through the multiplex MDx, which includes the same target as one or more targets determined positive among the multiplex MDx test results of the patient, from among the multiplex MDx test results previously stored in a database (DB) connected to the reporting device; processing and analyzing the retrieved reference test result, wherein the reference test result includes a positive or negative determination result and a Ct value; and reporting the multiplex MDx test result of the patient, wherein the reporting comprises: processing and analyzing the multiplex MDx test result of the patient And it may include the processing / analysis results of the above reference test results.

[0035] According to another embodiment, a computer program stored in a computer-readable non-transitory recording medium, wherein the computer program includes instructions that, when executed by one or more processors, cause the one or more processors to perform the following method, the method comprising: receiving a multiplex molecular diagnosis (multiplex MDx) test result of a patient, wherein the multiplex MDx is for detecting a plurality of targets, and the multiplex MDx test result of the patient includes a positive or negative determination result and a Ct value; retrieving a reference test result obtained through the multiplex MDx, which includes the same target as one or more targets determined positive among the multiplex MDx test results of the patient, from among the multiplex MDx test results previously stored in a database (DB) connected to the reporting device; processing and analyzing the retrieved reference test result, wherein the reference test result includes a positive or negative determination result and a Ct value; and reporting the multiplex MDx test result of the patient, wherein the reporting comprises: processing and analyzing the multiplex MDx test result of the patient And can be programmed to perform processing / analysis results including the results of the above reference inspection.

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

[0037] In one embodiment, a clinician can accurately determine the condition of a patient by comparing the results of a molecular diagnostic test of the patient with the results of processing / analysis.

[0038] A molecular diagnostic test result reporting method according to one embodiment can provide more analytical data to patients and provide high-quality treatment services by allowing the doctor to provide treatment services to patients by referring to the processed / analyzed results.

[0039] FIG. 1 is a diagram conceptually illustrating a relationship between a molecular diagnostic test result reporting device according to one embodiment and a clinician's terminal connected to a network.

[0040] Figure 2 is a flowchart showing the steps of a molecular diagnostic test result reporting method according to one embodiment.

[0041] Figure 3 is a drawing showing an example of displaying the processing / analysis results according to the molecular diagnostic test result reporting at the clinician's terminal.

[0042] Figure 4 is an example showing labeling meta information in reference inspection results stored in a DB.

[0043] Figure 5 is an example of statistical results showing the detection rate for specific targets.

[0044] Figure 6 is an example of statistical results showing the detection rate and trend by period for a specific target.

[0045] Figure 7 is an example of statistical results showing the number of confirmed cases per quarter for a specific target.

[0046] Figure 8 is an example of statistical results showing the gender-specific confirmed case ratio for a specific target.

[0047] Figure 9 is an example of statistical results showing the infection rate by age for a specific target.

[0048] Figure 10 is an example of statistical results showing the distribution of Ct values ​​by age for a specific target.

[0049] Figure 11 is an example of statistical results showing period-by-period increase / decrease trends for multiple targets.

[0050] Figure 12 is an example of statistical results showing various statistical data on duplicate infections.

[0051] Figure 13 is a diagram showing an example of searching for reference test results having similarity by comparing the multiplex MDx test results of a patient with the reference test results.

[0052] Figure 14 is a diagram conceptually illustrating an operation of providing a similarity case similar to the multiplex MDx test results of a patient to a clinician.

[0053] Figure 15 is a hardware configuration diagram of a molecular diagnostic test result reporting device according to one embodiment.

[0054] The advantages and features of the present invention, and the methods for achieving them, will become clearer with reference to the embodiments described in detail below together with the accompanying drawings. However, the present invention is not limited to the embodiments disclosed below and may be implemented in various different forms. 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 solely by the scope of the claims.

[0055] When describing embodiments of the present invention, detailed descriptions of known functions or configurations will be omitted if they are deemed to unnecessarily obscure the gist of the invention. Furthermore, the terms described below are defined in light of their functions in the embodiments of the present invention and may vary depending on the intent or custom of the user or operator. Therefore, their definitions should be based on the overall content of this specification.

[0056] Before explaining Figure 1, let us look at the terms used herein.

[0057] As used herein, the term "target analyte" may refer to a variety of substances (e.g., biological and non-biological substances). Such target analytes may specifically include biological substances, and more specifically, at least one of nucleic acid molecules (e.g., DNA and RNA), proteins, peptides, carbohydrates, lipids, amino acids, biological compounds, hormones, antibodies, antigens, metabolites, and cells.

[0058] 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 sample may include at least one of, for example, viruses, bacteria, tissues, cells, blood (including whole blood, plasma, and serum), lymph, bone marrow fluid, saliva, sputum, swabs, aspirations, milk, urine, stool, eye fluid, semen, brain extracts, spinal fluid, joint fluid, thymus fluid, bronchial lavage fluid, ascites, and amniotic fluid. Such samples may or may not contain the aforementioned target analytes.

[0059] Meanwhile, if the target analyte described above is a nucleic acid molecule or contains a nucleic acid molecule, a nucleic acid extraction process known in the art may be performed on the sample presumed to contain the target analyte (see: Sambrook, J. et al., Molecular Cloning. A Laboratory Manual, 3 rded. Cold Spring Harbor Press (2001)). The nucleic acid extraction process may vary depending on the type of sample. In addition, if the extracted nucleic acid is RNA, a reverse transcription process may be additionally performed to synthesize cDNA (Reference: Sambrook, J. et al., Molecular Cloning. A Laboratory Manual, 3rd ed. Cold Spring Harbor Press (2001)).

[0060] The term "target" encompasses a variety of substances (e.g., biological substances and non-biological substances), which may refer to the same object as the term "target analyte" or "target analyte."

[0061] Such targets may specifically include biological materials, more specifically at least one of nucleic acid molecules (e.g., DNA and RNA), proteins, peptides, carbohydrates, lipids, amino acids, biological compounds, hormones, antibodies, antigens, metabolites, and cells. The target may include a target nucleic acid molecule.

[0062] The term "target of interest" may refer to a target among the "targets" that is the subject of a judgment in the presence / absence judgment process.

[0063] The term "cycle" refers to a unit of change in a condition in a series of measurements involving a change in said condition. The change in said condition may refer to an increase or decrease in, for example, temperature, reaction time, number of reactions, concentration, pH, or the number of replications of a measurement target (e.g., nucleic acid). Therefore, a cycle may be a time or process cycle, a unit operation cycle, or a reproductive cycle.

[0064] More specifically, the term "cycle" means one unit of repetition, when a reaction is repeated in a certain process or at certain time intervals.

[0065] Alternatively, the term "cycle" may mean one unit of repetition when a certain action is repeated as the reaction progresses.

[0066] For example, when a nucleic acid amplification reaction is performed, the act of detecting a signal generated at regular time intervals may be repeated, and may represent one unit of said repetition. In this case, a cycle may have a unit of time.

[0067] For example, in the case of a nucleic acid amplification reaction, one cycle refers to a reaction that includes the steps of nucleic acid denaturation, primer annealing, and primer extension. In this case, a change in a certain condition is an increase in the number of reaction repetitions, and the unit of repetition of the reaction comprising the above series of steps is defined as one cycle. The number of cycles may include the number of reactions or the reaction time.

[0068] Meanwhile, the amplification reaction for amplifying a signal indicating the presence of a target (target analyte or target of interest) can be performed in a manner in which the signal is amplified as the target is amplified (e.g., real-time PCR method). Alternatively, according to one embodiment, the amplification reaction can be performed in a manner in which only the signal indicating the presence of the target is amplified without the target being amplified (e.g., CPT method (Duck P, et al., Biotechniques, 9:142-148 (1990)), Invader assay (U.S. Patent Nos. 6,358,691 and 6,194,149)).

[0069] Meanwhile, the aforementioned target or target analyte, especially the target nucleic acid molecule, can be amplified by various methods: polymerase chain reaction (PCR), ligase chain reaction (LCR) (U.S. Patent Nos. 4,683,195 and 4,683,202; PCR Protocols: A Guide to Methods and Applications (Innis et al., eds, 1990)), strand displacement amplification (SDA) (Walker, et al. Nucleic Acids Res. 20(7):1691-6 (1992); Walker PCR Methods Appl 3(1):1-6 (1993)), transcription-mediated amplification (Phyffer, et al., J. Clin. Microbiol. 34:834-841 (1996); Vuorinen, et al., J. Clin. Microbiol. 33:1856-1859 (1995)), nucleic acid sequence-based amplification (NASBA) (Compton, Nature 350(6313):91-2 (1991)), rolling circle amplification (RCA) (Lisby, Mol. Biotechnol. 12(1):75-99 (1999); Hatchet et al., Genet. Anal. 15(2):35-40 (1999)) and Q-Beta Replicase (Lizardi et al., BiolTechnology 6:1197(1988)), loop-mediated isothermal amplication (LAMP, Y. Mori, H. Kanda and T. Notomi, J. Infect. Chemother., 2013, 19, 404-411), recombinase polymerase amplication (RPA, J. Li, J. Macdonald and F. von Stetten, Analyst, 2018, 144, 31-67), etc.

[0070] Meanwhile, an amplification reaction amplifies a signal while amplifying a target (specifically, a target nucleic acid molecule). For example, the amplification reaction is performed according to PCR, specifically real-time PCR, or an isothermal amplification reaction (e.g., LAMP or RPA).

[0071] Based on these nucleic acid amplification reactions, multiplex diagnostic technologies can be utilized to detect multiple target nucleic acids within a single tube. For example, various multiplex technologies exist for simultaneously detecting multiple types of viruses, using methods such as PCR and LAMP, as examples of nucleic acid amplification reactions.

[0072] Here, the term "signal value" means a numerical value of the level of a signal (e.g., signal intensity) actually measured in a cycle of a signal generation reaction, particularly an amplification reaction, or a modified value thereof, according to a certain scale. The modified value may include a mathematically processed signal value of the actually measured signal value. Examples of mathematically processed signal values ​​of the actually measured signal value (i.e., the signal value of the raw data set) may include logarithmic values ​​or derivatives.

[0073] FIG. 1 is a diagram conceptually illustrating a relationship in which a molecular diagnostic test result reporting device (100) according to one embodiment is connected to a clinician's terminal (200) via a network.

[0074] The molecular diagnostic test result reporting device (100) can be connected to a clinician's terminal (200) via a network. Here, since FIG. 1 is merely an example, the spirit of the present invention is not limited to what is illustrated in FIG. 1. For example, the molecular diagnostic test result reporting device (100) can be connected to two or more clinician's terminals (200) via a network. In addition, the molecular diagnostic test result reporting device (100) can access the DB (1) via a network. In one embodiment, the molecular diagnostic test result reporting device (100) and the DB (1) may not be separate components, but may be integrated into one with the molecular diagnostic test result reporting device (100).

[0075] The network may refer to a wireless or wired network that provides data transmission and reception between the molecular diagnostic test result reporting device (100) and the clinician's terminal (200). Among these, in the case of a wireless network, for example, at least one of LTE (long-term evolution), LTE-A (LTE advance), CDMA (code division multiple access), WCDMA (wideband CDMA), UMTS (universal mobile telecommunications system), WiBro (Wireless Broadband (1)and), WiFi (wireless fidelity), Bluetooth (Bluetooth), NFC (near field communication), and GNSS (global navigation stellite system) may be included. In addition, in the case of a wired network, for example, at least one of 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 may be included, but is not limited thereto.

[0076] 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).

[0077] In this specification, the "patient" refers to a subject who has undergone an MDx test and who receives treatment services from a doctor using the MDx test results. In one embodiment, the term "patient" refers to all subjects who receive services from a doctor using the MDx test results. The "patient" may be referred to as a patient, a test subject, or a person being examined.

[0078] In this specification, MDx refers to molecular diagnostics that detects or analyzes biomarkers such as DNA, RNA, and proteins using molecular biology techniques. In one embodiment, the term MDx may encompass molecular diagnostic techniques or reagent products for performing molecular diagnostics.

[0079] In one embodiment, the multiplex MDx is for detecting multiple targets, and the multiplex MDx test result of the subject may include a positive or negative judgment result and a Ct value. In one embodiment, the multiplex MDx test result 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 a test to detect infection with one or more pathogens or viruses related to respiratory infection, gastrointestinal tract infection, sexually transmitted infection, and human papillomavirus infection, but is not limited thereto. For example, the infection test may include tests for tuberculosis, antimicrobial resistance, and meningitis, and may include various other tests of a similar type known in the art. 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, genetic testing may include MDx testing for causative genes or single nucleotide polymorphisms (SNPs). In one embodiment, genetic testing may include testing to detect the type of genotype and whether a specific mutation is present. For example, the type of genotype may include genotyping and haplotyping.

[0080] 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.

[0081] In this specification, the molecular diagnostic test results can be stored in a database (DB).

[0082] In one embodiment, DB (1) may be a database included in a Laboratory Information System (LIS) that stores molecular diagnostic test results. In one embodiment, DB (1) may be a database included in an Electronic Health Record (EMR) that stores molecular diagnostic test results. DB (1) may be implemented as a cloud DB (1) that the molecular diagnostic test result reporting device (100) can access via a network.

[0083] DB(1) can store the 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 can be obtained from the doctor's terminal (200), but can also be obtained from DB(1).

[0084] The molecular diagnostic test result reporting device (100) can store reference test results obtained from DB (1). The reference test results may be multiplex MDx that includes at least one identical target as the multiplex MDx test result of the subject among the MDx test results stored in DB (1). In one embodiment, the reference test results may be test results in which one or more targets are determined to be positive.

[0085] The molecular diagnostic test result reporting device (100) can process and analyze the retrieved reference test result and report the multiplex MDx test result of the patient. The reporting can include the processed / analyzed result of the multiplex MDx test result of the patient and the processed / analyzed result of the reference test result. In one embodiment, reporting includes an operation in which the molecular diagnostic test result reporting device (100) generates a processed / analyzed result and an operation in which the processed / analyzed result is transmitted to the terminal (200) of the doctor. In one embodiment, processing / analysis means processing and / or analysis, and may include at least one of, for example, (i) an operation of processing target data such as preprocessing, data format conversion, and modification of a form or display method, and (ii) an operation of analyzing target data or processed data such as statistical analysis or result analysis, or both.

[0086] 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. The computing device according to one embodiment may be the molecular diagnostic test result reporting device (100).

[0087] Figure 2 is a flowchart showing the steps of a molecular diagnostic test result reporting method according to one embodiment.

[0088] In step S100, the multiplex MDx test results of the patient can be received. At this time, the multiplex MDx test results of the patient can be obtained from the doctor's terminal (200) or from the DB (1). In another embodiment, the multiplex MDx test results of the patient can be molecular diagnostic test results directly input from the molecular diagnostic test result reporting device (100).

[0089] In one embodiment, the multiplex MDx test result of the subject may be a molecular diagnostic test result using polymerase chain reaction (PCR). In this case, the multiplex MDx test result of the subject may include a positive / negative judgment result and a Ct value. The multiplex MDx test result of the subject may include a data set obtained from an amplification reaction of a target. In one embodiment, the data set may include an amplification curve. The positive / negative judgment result may mean positive or negative indicating the presence or absence of a target detected by MDx. The Ct value may be a cycle at which an amplification curve included in the data set exceeds a predetermined threshold. In one embodiment, the multiplex MDx test result of the subject may also include additional information such as the subject's age and gender. In one embodiment, the multiplex MDx test result may include a patient identification ID that can identify the subject or patient.

[0090] In step S200, a reference test result can be retrieved from among the multiplex MDx test results stored in DB (1).

[0091] The reference test result may be a test result obtained through multiplex MDx that includes the same target as one or more targets determined positive among the multiplex MDx test results of the subject of treatment, among the multiplex MDx test results already stored in DB(1).

[0092] For example, the reference test result may be a molecular diagnostic test result by MDx that targets at least one target that is the same as the target determined to be positive in the molecular diagnostic test result when the multiplex MDx received by the patient is a product that targets 5 targets.

[0093] In one embodiment, the multiplex MDx test result described above may be an MDx test result using an MDx test reagent product of the same series to which the same MDx technology is applied. Specifically, at least one of the multiplex MDx test result of the subject, the multiplex MDx test result previously stored in the DB (1), and the reference test result may be a test result obtained using an MDx test reagent product of the same series to which the same MDx technology is applied.

[0094] The MDx technology being identical means that 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 target presence, technology for differentiating multiple signals generated from one label in one channel, signal processing technology, positive / negative determination technology, and nucleic acid extraction technology is identical.

[0095] The multiplex MDx test results described above may include MDx test results output from the same analysis software within the device that provides the test results. For example, a terminal (200) of a doctor using one or more of the MDx test reagent products of the same series described above may obtain the multiplex MDx test results of the patient using the same analysis software, and other multiplex MDx test results previously stored in the DB (1) may also be obtained through the same analysis software installed on each terminal (200) of the doctor.

[0096] 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 determination algorithm.

[0097] The action of retrieving the reference inspection results at this stage may include an action of accessing DB (1) to acquire or retrieve data.

[0098] In one embodiment, when step S200 is performed, a filtering-in condition of the reference test result is acquired, and a reference test result satisfying the acquired filtering-in condition can be retrieved. For example, if a doctor wants to acquire a processing / analysis result using only data with a predetermined condition, the molecular diagnostic test result reporting device (100) can acquire the filtering-in condition of the reference test result through the doctor's terminal (200). At this time, the filtering-in condition may be at least one of the meta information labeled in the multiplex MDx test result stored in the DB (1).

[0099] The molecular diagnostic test result reporting device (100) can obtain reference test results from the DB (1) according to filtering-in conditions.

[0100] The reference test results retrieved in step S300 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 the MDx molecular diagnostic test results previously stored in the DB (1) and generate processed / analyzed results using the statistically processed results.

[0101] In one embodiment, the molecular diagnostic test result reporting device (100) can perform statistical processing using multiplex MDx test results previously stored in DB (1). For example, the molecular diagnostic test result reporting device (100) can generate processed / analyzed results using multiplex MDx test results of other patients excluding the subject of treatment. The doctor can compare the processed / analyzed results generated using the multiplex MDx test results of other patients stored in DB (1) with the subject of treatment's multiplex MDx test results and use them as reference for treatment.

[0102] In one embodiment, the molecular diagnostic test result reporting device (100) may generate a processed / analyzed result by integrating the multiplex MDx test results of the subject. That is, the processed / analyzed result may be statistically processed by integrating the multiplex MDx test results of the subject with the multiplex MDx test results of other patients stored in the DB (1), or may be statistically processed only with the multiplex MDx test results of other patients stored in the DB (1) excluding the multiplex MDx test results of the subject.

[0103] In one embodiment, whether the multiplex MDx test results of the patient are integrated with the multiplex MDx test results of other patients stored in DB (1) in the processing / analysis results can be changed by a setting entered by the user.

[0104] 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 terminal (200) of the doctor. Here, the reporting may include the processed / analyzed results of the multiplex MDx test results of the patient and the reference test results. At this time, the processed / analyzed results may include content that allows the patient's multiplex MDx test results to be reflected in the processed / analyzed results, which are statistical results, to compare / contrast the current patient's results with the statistical results.

[0105] The clinician's terminal (200) can display the processed / analyzed results obtained from the molecular diagnostic test result reporting device (100). The clinician's terminal (200) can display the multiplex MDx test results of the patient while simultaneously displaying the processed / analyzed results. In one embodiment, the clinician's terminal (200) can be connected to an EMR server and access the EMR server to display the patient's health information.

[0106] In this way, the clinician's terminal (200) can display the processing / analysis results related to the multiplex MDx test results of the patient on the display.

[0107] A molecular diagnostic test result reporting method according to one embodiment can provide more analytical data to patients and provide high-quality treatment services by allowing the doctor to provide treatment services to patients by referring to the processed / analyzed results.

[0108] Figure 3 is a drawing showing an example of displaying the processing / analysis results according to the molecular diagnostic test result reporting on the clinician's terminal (200).

[0109] As shown in Fig. 3, the PCR test results and processing / analysis results of the subject can be output from the clinician's terminal (200).

[0110] The processing / analysis results of the reference test results can display the corresponding comparison results between the multiplex MDx test results of the patient and the processing / analysis results of the reference test results.

[0111] Since the PCR test results and the processed / analyzed results of the test subject are output together on the clinician's terminal (200), the clinician can compare and contrast the PCR test results of the test subject by referring to the processed / analyzed results. For example, the clinician can compare the Ct values ​​in the processed / analyzed results of the multiplex MDx test results and the reference test results of the test subject through the clinician's terminal (200), or compare the positive / negative judgment results.

[0112] The clinician's terminal (200) can access the EMR server to obtain the subject's health information. The health information may include information related to the subject's profile, disease name, treatment progress, medication information, and underlying disease information.

[0113] The doctor can analyze the current condition of the patient by comparing the processed / analyzed data displayed on the doctor's terminal (200) with the multiplex MDx test results of the patient.

[0114] In one embodiment, the processing / analysis results may be displayed in a UI such that the statistical distribution of the reference test results is displayed in a UI, and the statistical location of the multiplex MDx test results of the patient is displayed on the statistical distribution of the UI.

[0115] In one embodiment, the processing / analysis results may be displayed with a controller UI that can change processing / analysis conditions for the reference inspection results.

[0116] Figure 4 is an example showing labeling meta information in reference inspection results stored in DB (1).

[0117] In one embodiment, the multiplex MDx test results may be labeled with meta information, which is information about the test subject or information about the multiplex MDx test.

[0118] Meta information may include subject identifier, subject information including age and gender, test date, product name, product version information, and catalog number.

[0119] In one embodiment, the subject identifier may be a randomly assigned ID that can be used 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.

[0120] The molecular diagnostic test result reporting device (100) can obtain reference test results by filtering some of the MDx test results stored in the DB (1), and can filter data using meta information.

[0121] For example, the 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 multiplex MDx test result of the patient among the MDx test results included in the DB (1).

[0122] 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.

[0123] For example, in the test result of multiplex MDx, target information Flu A can be labeled as meta information. Using the meta information labeled with Flu A, a reference test result can be obtained based on the multiplex MDx test result targeting Flu A from DB(1).

[0124] 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) may obtain a reference test result labeled with the same target from the same company as the multiplex MDx test result of the subject.

[0125] The statistical output of the reference test results may include at least one selected from the group consisting of prevalence statistics, Ct value statistics, age / gender-specific infection statistics, infection pattern statistics for single infection and multiple infection, and follow-up statistics of Ct values ​​for a predetermined target of the test subject.

[0126] For example, the statistical results may be statistical data produced by processing and analyzing the Ct value with respect to gender, age, and statistical period, or statistical data produced by processing and analyzing the positive / negative judgment result with respect to gender, age, and statistical period.

[0127] Because infections in molecular diagnostics are transmitted to people through various factors, statistical analysis can be performed on infections. In particular, statistical results regarding prevalence statistics can be valuable for infection analysis. In one embodiment, statistical results can be included in the processing / analysis results.

[0128] Hereinafter, various examples of processing / analysis results will be described with reference to FIGS. 5 to 12.

[0129] Figure 5 is an example of statistical results showing the detection rate by respiratory target.

[0130] In one embodiment, the statistical output may be statistical data on the detection rate by respiratory target for the entire respiratory target detection in the second quarter of 2023. The statistical output may show that Flu A was detected 20 times or 43%, Flu B 8 times or 17%, RSV 7 times or 15%, AdV 3 times or 7%, PIV 2 times or 4%, and MPV 1 time or 2%.

[0131] Statistical results of detection rates by respiratory target may indicate that Flu A is currently dominant among respiratory targets.

[0132] These statistical results suggest that when detecting respiratory targets, Flu A will be detected most frequently, followed by Flu A. Furthermore, these statistical results suggest that MPV will be detected least frequently.

[0133] When providing medical services to a patient, if the patient exhibits similar symptoms to a target with a respiratory infection, the doctor may assume that the patient was infected by a target with a higher detection frequency.

[0134] Additionally, since the statistical results are statistical data for the second quarter of 2023, if a practitioner provides treatment services to a patient in the second quarter of 2024, the practitioner 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 previous year.

[0135] Figure 6 is an example of statistical results showing the detection rate and trend by period for a specific target.

[0136] The statistical results in Figure 6 are the detection rates for the Flu A target for January 23.

[0137] Flu A was not detected from January 1, 2023 to January 20, 2023, and was detected approximately once a day from January 21, 2023 to January 26, 2023. Flu A was detected twice on January 27, 2023, and the detection rate increased to five times by the end of January.

[0138] The statistical results show that Flu A was not detected in early January 2023, but began to increase rapidly from mid-January 2023.

[0139] These statistical results allow clinicians to predict the detection rate of the Flu A target in early February 2023. Furthermore, the statistical results allow clinicians to predict the trend in the detection rate of the Flu A target in January 2024.

[0140] The period shown in the statistical results can be changed via the user interface. In the case of Figure 6, the statistical results show the detection rate for one month, but the period can be changed to two months, three months, etc. via the user interface, and the statistical results can show the detection rate of Flu A during the changed period.

[0141] Figure 7 is an example of statistical results showing the number of confirmed cases per quarter for a specific target.

[0142] The statistical output may be statistical data that can compare the number of confirmed cases for each quarter of 2021, 2022, and 2023 on a quarterly basis.

[0143] The statistical results show that among the 2021-23 years, the number of confirmed cases of Flu A in the first quarter was the highest in 2023, followed by 2021 and 2022. Furthermore, the statistical results show that the number of confirmed cases of Flu A in the second, third, and fourth quarters was the highest in 2023, followed by 2022 and 2021.

[0144] In particular, the statistical results may indicate that the number of confirmed cases of Flu A in Q4 2023 was significantly higher than the number of confirmed cases of Flu A in Q4 2021 and Q4 2022.

[0145] Figure 8 is an example of statistical results showing the gender-specific confirmed case ratio for a specific target.

[0146] The statistical results indicate that the total number of confirmed cases for a specific target is 46, with 19 (41%) being female and 27 (59%) being male. In one example, the clinician may determine that the infection rate for a specific target is higher among males than females.

[0147] Figure 9 is an example of statistical results showing the infection rate by age for a specific target.

[0148] The statistical results in Figure 9 show the infection rate for each age group for one month of Flu A.

[0149] The statistical results show that the monthly infection rate for Flu A was 36.4% (59 infections) for those aged 20-29, followed by 17.9% (29 infections) for those aged 50-59. Furthermore, the statistical results show that the monthly infection rate for Flu A was 1.2% (2 infections) for those aged 0-9.

[0150] Clinicians can use these statistical results to analyze whether specific age groups have higher or lower infection rates for specific targets. In this case, clinicians can estimate the likelihood of infection for patients in high-infection age groups and take proactive preventive measures in those age groups.

[0151] In particular, in cases where the infection rate is high among children aged 0 to 9, active prevention and treatment assistance from guardians is needed, so clinicians can provide information on prevention and treatment to guardians.

[0152] Figure 10 is an example of statistical results showing the distribution of Ct values ​​by age for a specific target.

[0153] Statistical results can be plotted to show the distribution of Ct values ​​by age. For example, statistical results may show that the distribution of Ct values ​​for infected individuals aged 25-34 for a specific target is 20-27, and that the distribution of Ct values ​​for infected individuals aged 35-44 for a specific target is 18-29.

[0154] In this way, the statistical results can display the distribution of Ct values ​​for each age group in a plot format, and the corresponding location of the Ct value included in the multiplex MDx test results of the patient can be displayed within the statistical results.

[0155] The age of the patient is 35 to 44 years old, and the Ct value is 18. Among the distribution of Ct values ​​for patients aged 35 to 44 displayed in a plot format, the location where the Ct value of the patient, 18, corresponds can be indicated with an arrow.

[0156] The Ct value of the patient shown in the statistical results may be analyzed as being somewhat low when compared to the entire age group, but when compared to the age group to which the patient belongs, it may be analyzed as being within a normal distribution range that is not unusual.

[0157] Figure 11 is an example of statistical results showing period-by-period increase / decrease trends for multiple targets.

[0158] The statistical results in Figure 11 may indicate that the fever rates of the Flu A target and the RSV target fluctuated between 15 and 20 times from early January to late January. Furthermore, the statistical results may indicate that the fever rates of the Flu B target and the HRV target temporarily decreased from early January to mid-January, and then increased again to 30 times at the end of January.

[0159] The practitioner can display these statistical results on the practitioner's terminal (200), and the practitioner can compare the increase / decrease trends of multiple targets at once.

[0160] In one embodiment, the follow-up statistics for Ct values ​​for a given target of a subject may include follow-up Ct values ​​for the subject's HPV test. Because STI-related targets, such as HPV, require follow-up observation, it is necessary to continuously monitor trends in Ct values ​​for such targets.

[0161] When the vertical axis value of Fig. 11 is the Ct value, the statistical results can represent the trend of the Ct value of a specific target over a specific period of time.

[0162] For example, if the Ct value of a target requiring follow-up observation is judged to be decreasing over time in the statistical results, the amount of the target for that patient is judged to have increased, and the doctor can perform treatment and prescription for that patient accordingly.

[0163] The follow-up statistics of the Ct value for a given target of the subject may include statistical results processed and analyzed using the follow-up observation of the Ct value for the HPV test of the subject.

[0164] Figure 12 is an example of statistical results showing various statistical data on duplicate infections.

[0165] The statistical results represent the Ct value statistics for single infections corresponding to each of the five or more targets in the reference test results and the Ct value statistics for multiple infections. Single infection means infection of one target, and multiple infection means infection of two or more targets. The statistical results may include the statistical results for the number of patients in single infections corresponding to each of the five or more targets in the reference test results and the statistical results for the number of patients in multiple infections.

[0166] Among 100 patients, 20 tested positive for respiratory infectious diseases in molecular diagnostic tests, representing a positivity rate of 20%. Among those who tested positive for respiratory infectious diseases, 10 (50%) were infected solely with the virus.

[0167] Among the patients who tested positive for respiratory infectious diseases, 80 patients were infected with other targets in addition to respiratory infectious diseases. Four patients (20%) were infected with two targets, three patients (15%) were infected with three targets, two patients (10%) were infected with four targets, and one patient (5%) was infected with five targets.

[0168] 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.

[0169] The remaining 10 patients were infected with multiple infections, with 4 patients infected with 2 targets.

[0170] The statistical results indicate that two patients infected with two targets were infected with RSV and Flu A. One of these patients had Ct values ​​of 20 for both RSV and Flu A. The other patient had Ct values ​​of 30 for RSV and 10 for Flu A.

[0171] The statistical results indicate that the remaining patient, who was infected with two targets, was infected with both RSV and Flu B. The Ct value for RSV in this patient was detected as 30, and the Ct value for Flu B was detected as 10.

[0172] The statistical results indicate that the remaining patient, who was infected with two targets, was infected with both HRV and PIV. This patient's HRV Ct value was detected as 15, and the PIV Ct value was detected as 15.

[0173] The statistical results show that there were 3 patients infected with 3 targets, and each patient shows the type of target infected and the Ct value of each target.

[0174] By referring to the statistical results, the clinician can predict which targets are statistically likely to be infected together when the patient is infected with one target.

[0175] Additionally, clinicians can estimate the Ct values ​​of duplicate infected targets by referring to the statistical results.

[0176] In one embodiment, if the multiplex MDx test result of the patient corresponds to a multiple infection, the doctor can refer to the Ct values ​​for the multiple targets of the patient and treatment information such as symptoms and treatment process of patients who are multiple infected with the multiple targets that are identical to the Ct values ​​of the patient in the statistical results.

[0177] Figure 13 is a diagram showing an example of searching for reference test results having similarity by comparing the multiplex MDx test results of a patient with the reference test results.

[0178] Referring again to step S300 of FIG. 2, when the retrieved reference test results are processed and analyzed, similarity cases similar to the multiplex MDx test results of the patient can be selected from among the reference test results.

[0179] At this time, selecting a similarity case means an operation of comparing the multiplex MDx test result of the patient with the reference test result and searching for a reference test result having a similarity higher than a preset threshold. In one embodiment, a reference test result having a similarity higher than a preset threshold means a case in which at least some elements defined in advance are identical by synthesizing various data, metadata, and related health information included in the multiplex MDx of the patient. In another embodiment, a reference test result having a similarity higher than a preset threshold may be an MDx test result having a similarity score higher than a preset criterion based on a similarity score matching the multiplex MDx test result of the therapist.

[0180] In one embodiment, a similarity case may be selected based on the positive / negative judgment result and Ct value of a multiplex MDx test result. For example, a similarity case may be a reference test result in which the positive / negative judgment result of the multiplex MDx test result of the subject is identical to the positive / negative judgment result and the Ct value falls within a predetermined range.

[0181] Similarity cases can be selected by further considering the modification of the data set of amplification responses of multiplex MDx test results. For example, a similarity case may be a reference test result with identical parameters for the amplification curve as the subject's multiplex MDx test result.

[0182] In one embodiment, similarity cases may be selected from multiplex MDx test results, further considering age and / or gender. For example, a similarity case may be a reference test result from a patient of the same gender and age within a predetermined range as the multiplex MDx test result of the patient.

[0183] Figure 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 clinician's terminal (200) along with statistical results.

[0184] In one embodiment, after selection of a similarity case in step S300 of processing and analyzing the reference test results, at least one EMR data selected from the group consisting of the type of symptom of the similarity case, the degree of symptom, the patient's age, sex, underlying disease, medication record, treatment record, treatment progress record, vaccination history, and lifestyle habits may be acquired.

[0185] In one embodiment, the statistical output may further include a similarity case and at least one EMR data thereof.

[0186] The statistical distribution of EMR data of similarity cases included in the processing / analysis results can be displayed as a UI on the clinician's terminal (200), and the statistical location of EMR data corresponding to the patient can be displayed on the statistical distribution of the UI. The processing / analysis results can be displayed as a controller UI that can change the processing / analysis conditions for the reference test results.

[0187] According to one embodiment, a molecular diagnostic test result reporting method can provide infection trends for a specific target by utilizing information regarding at least one of a patient's multiple infections, gender, age group, and Ct value through statistical results. In addition, a doctor can obtain similarity cases for the patient's multiplex MDx test results and retrieve the patient's health information corresponding to the similarity case from the EMR to perform diagnosis and treatment, and can refer to the infection trends in the aforementioned statistical results.

[0188] Fig. 15 is a hardware configuration diagram of a molecular diagnostic test result reporting device (100) according to one embodiment.

[0189] A component, module, or portion in the present disclosure includes a routine, procedure, program, component, reference database, or the like that performs a particular task or implements a particular abstract data type. Furthermore, those skilled in the art will readily appreciate that the methods presented in the present disclosure can be implemented with other computer system configurations, including single-processor or multiprocessor computing systems, minicomputers, mainframe computers, as well as personal computers, handheld computing devices, microprocessor-based or programmable consumer electronics, and the like, each of which may be operatively connected to one or more associated devices.

[0190] The embodiments described in this disclosure can also be implemented in distributed computing environments, where certain tasks are performed by remote processing devices that are connected through a communications network. In a distributed computing environment, program modules may be located in both local and remote memory storage devices.

[0191] Computing devices typically include a variety of computer-readable media. Computer-readable media can be any media accessible by a computer, including volatile and nonvolatile media, transitory and non-transitory media, removable and non-removable media. By way of example, and not limitation, computer-readable media can include computer-readable storage media and computer-readable transmission media.

[0192] Computer-readable storage media includes volatile and nonvolatile media, transitory and non-transitory media, removable and non-removable media implemented in any method or technology for storing information such as computer-readable instructions, reference databases, program modules, or other data. Computer-readable storage media includes, but is not limited to, RAM, ROM, EEPROM, flash memory or other memory technology, CD-ROM, digital video disks (DVD) or other optical disk storage, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices, or any other medium that can be accessed by a computer and used to store the desired information.

[0193] Computer-readable transmission media typically embodies computer-readable instructions, reference databases, program modules, or other data in a modulated data signal, such as a carrier wave or other transport mechanism, and includes any information delivery media. The term modulated data signal means a signal that has one or more of its characteristics set or changed so as to encode information in the signal. By way of example, and not limitation, computer-readable transmission media includes wired media, such as a wired network or direct-wired connection, and wireless media, such as acoustic, RF, infrared, or other wireless media. Combinations of any of the above are also intended to be included within the scope of computer-readable transmission media.

[0194] An exemplary environment (2000) implementing various aspects of the present invention is illustrated, including a computer (2002), which includes a processing unit (2004), a system memory (2006), and a system bus (2008). The computer (2000) herein may be used interchangeably with a computing device. The system bus (2008) connects system components, including but not limited to the system memory (2006), to the processing unit (2004). The processing unit (2004) may be any of a variety of commercially available processors. Dual processors and other multiprocessor architectures may also be utilized as the processing unit (2004).

[0195] The system bus (2008) may be any of several types of bus structures that may be additionally interconnected to a memory bus, a peripheral bus, and a local bus using any of a variety of commercial bus architectures. The system memory (2006) includes read-only memory (ROM) (2010) and random access memory (RAM) (2012). A basic input / output system (BIOS) is stored in non-volatile memory (2010), such as ROM, EPROM, or EEPROM, and contains basic routines that help transfer information between components within the computer (2002), such as during start-up. The RAM (2012) may also include high-speed RAM, such as static RAM, for caching data.

[0196] 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)), a solid state drive (SSD), and an optical disk drive (2020) (e.g., for reading from or writing to a CD-ROM disk (2022) or 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 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), respectively. The interface (2024) for implementing an external drive includes, for example, at least one or both of Universal Serial Bus (USB) and IEEE 1394 interface technologies.

[0197] These drives and their associated computer-readable media provide nonvolatile storage of data, data structures, computer-executable instructions, and the like. In the case of the computer (2002), the drives and media correspond to storing any data in a suitable digital format. While 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 appreciate that other types of computer-readable storage media, such as zip drives, magnetic cassettes, flash memory cards, cartridges, and the like, may also be used in the exemplary operating environment, and that any such media may contain computer-executable instructions for performing the methods of the present invention.

[0198] 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 portions of the operating system, applications, modules, and / or data may also be cached in RAM (2012). It will be appreciated that the present invention may be implemented in various commercially available operating systems or combinations of operating systems.

[0199] A user may enter commands and information into the computer (2002) via one or more wired / wireless input devices, such as a keyboard (2038) and a pointing device such as 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, and the like. These and other input devices are often connected to the processing unit (2004) via an input device interface (2042) that is connected to the system bus (2008), but may be connected by other interfaces such as a parallel port, an IEEE 1394 serial port, a game port, a USB port, an IR interface, and the like.

[0200] 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 typically includes other peripheral output devices (not shown), such as speakers, a printer, and so on.

[0201] The computer (2002) may operate in a networked environment using logical connections to one or more remote computers, such as remote computer(s) (2048), via wired and / or wireless communications. The remote computer(s) (2048) may be a workstation, a server computer, a router, a personal computer, a portable computer, a microprocessor-based entertainment device, a peer device, or other conventional network node, and generally include many or all of the components described for the computer (2002), although for simplicity, only the memory storage device (2050) is shown. The logical connections shown include wired / wireless connections to a local area network (LAN) (2052) and / or a larger network, such as 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 may be connected to a worldwide computer network, such as the Internet.

[0202] 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 communications to the LAN (2052), which may also include a wireless access point installed therein for communicating with the wireless adapter (2056). When used in a WAN networking environment, the computer (2002) may include a modem (2058), be connected to a communications server on the WAN (2054), or have other means for establishing communications over the WAN (2054), such as via the Internet. The modem (2058), which may be internal or external and wired or wireless, is connected to the system bus (2008) via a serial port interface (2042). In a networked environment, program modules described for the computer (2002) or portions thereof may be stored in a remote memory / storage device (2050). It will be appreciated that the network connections depicted are exemplary and that other means of establishing a communications link between the computers may be used.

[0203] The computer (2002) communicates with any wireless device or object that is configured and operates via wireless communication, such as a printer, a scanner, a desktop and / or portable computer, a portable data assistant (PDA), a communication satellite, any equipment or location associated with a radio-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 may simply be an ad hoc communication between at least two devices.

[0204] Meanwhile, the method according to the various embodiments described above can be implemented in the form of a computer program stored in a computer-readable recording medium programmed to perform each step of the method, and can also be implemented in the form of a computer-readable recording medium storing a computer program programmed to perform each step of the method.

[0205] The above description is merely an illustrative illustration of the technical idea of ​​the present invention, and those skilled in the art will appreciate that various modifications and variations can be made without departing from the essential quality of the present invention. Therefore, the embodiments disclosed in the present invention are intended to illustrate, rather than limit, the technical idea of ​​the present invention, and the scope of the technical idea of ​​the present invention is not limited by these embodiments. The scope of protection of the present invention should be interpreted by the following claims, and all technical ideas within a scope equivalent thereto should be interpreted as being included within the scope of the rights of the present invention.

Claims

1. A molecular diagnostic test result reporting method comprising the following steps performed in a molecular diagnostic test result reporting device: A step of receiving a multiplex molecular diagnostic (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 judgment result and a Ct value; A step of retrieving a reference test result obtained through multiplex MDx that includes the same target as at least one target determined positive among the multiplex MDx test results of the subject, among the multiplex MDx test results previously stored in a database (DB) connected to the reporting device, wherein the reference test result includes a positive / negative determination result and a Ct value; A step of processing and analyzing the above-mentioned retrieved reference test results; and A step of reporting the multiplex MDx test results of the above-mentioned patient; the reporting includes the results of processing / analysis of the multiplex MDx test results of the above-mentioned patient and the results of the reference test results.

2. In paragraph 1, The multiplex MDx test results stored in the database of the above reporting device are: Characterized in that at least one meta information selected from the group consisting of a subject identifier, subject information including age and gender, test date, product name, product version information, and catalog number is labeled. Method for reporting molecular diagnostic test results.

3. In paragraph 1, The processing / analysis result of the above reference test result is characterized in that it includes statistical results of the reference test result. Method for reporting molecular diagnostic test results.

4. In paragraph 1, The statistical results of the above reference test results are: Characterized in that it includes at least one selected from the group consisting of prevalence statistics, Ct value statistics, infection statistics by age / gender, infection pattern statistics for single infection and multiple infection, and follow-up observation statistics of Ct values ​​for a given target of the subject. Method for reporting molecular diagnostic test results.

5. In paragraph 4, Follow-up statistics of Ct values ​​for the test subject's target are as follows: It is characterized by processing and analyzing the Ct value of the HPV test of the subject using follow-up observation. Method for reporting molecular diagnostic test results.

6. In paragraph 4, The processing / analysis results of the reference inspection results in the above reporting step are as follows: Characterized in that the above reference test results include Ct value statistical results in single infection corresponding to each of the one or more targets and Ct value statistical results in multiple infections. Method for reporting molecular diagnostic test results.

7. In paragraph 4, The processing / analysis results of the reference inspection results in the above reporting step are as follows: Characterized in that the above reference test results include statistical results of the number of patients in single infection corresponding to each of the one or more targets and statistical results of the number of patients in multiple infections. Method for reporting molecular diagnostic test results.

8. In paragraph 4, The above reporting steps are: Characterized in that the statistical distribution of the reference test results included in the processing / analysis results is displayed as a UI and the statistical location of the multiplex MDx test results of the patient is displayed on the statistical distribution of the UI. Method for reporting molecular diagnostic test results.

9. In paragraph 8, The above reporting steps are: Characterized in that it displays a controller UI that can change the processing analysis conditions for the above reference inspection results. Method for reporting molecular diagnostic test results.

10. In paragraph 1, The steps of processing and analyzing the above reference test results are: It is characterized by selecting a similarity case similar to the multiplex MDx test result of the patient among the above reference test results. Method for reporting molecular diagnostic test results.

11. In paragraph 10, The above similarity case is, It is characterized by being selected by considering the positive / negative judgment result and Ct value of the multiplex MDx test result. Method for reporting molecular diagnostic test results.

12. In paragraph 11, The above similarity case is, It is characterized by being selected by further considering the modification of the data set of the amplification reaction of the multiplex MDx test results. Method for reporting molecular diagnostic test results.

13. In paragraph 11, The above similarity case is, In the multiplex MDx test results, it is characterized by selection taking into further consideration age and / or gender. Method for reporting molecular diagnostic test results.

14. In paragraph 10, The steps of processing and analyzing the above reference test results are: After selecting the above similarity case, at least one EMR (Electronic Health Record) data selected from the group consisting of the type of symptom of the above similarity case, the degree of symptom, the patient's age, sex, underlying disease, medication record, treatment record, treatment progress record, vaccination history, and lifestyle habits is acquired, The processing / analysis results of the reference inspection results in the above reporting step are as follows: characterized in that it further includes the above similarity case and at least one EMR data thereof. Method for reporting molecular diagnostic test results.

15. In paragraph 14, The above reporting steps are: Characterized in that the statistical distribution of the EMR data of the similarity case included in the at least one EMR data is displayed as a UI, and the statistical location of the EMR data corresponding to the patient is further displayed on the statistical distribution of the UI. Method for reporting molecular diagnostic test results.

16. In paragraph 14, Selecting the above similarity case is as follows: It is characterized by comparing the multiplex MDx test result of the above-mentioned patient with the reference test result and searching for a reference test result having a similarity higher than a preset threshold value. Method for reporting molecular diagnostic test results.

17. In paragraph 1, The step of retrieving the above reference test results is: Obtain the filtering-in conditions of the above reference inspection results, Retrieving reference test results that satisfy the above-mentioned filtering-in conditions. Method for reporting molecular diagnostic test results.

18. In paragraph 1, The above multiplex MDx test results are: characterized by including at least one of an infection test or a genetic test; Method for reporting molecular diagnostic test results.

19. In paragraph 1, The processing / analysis results of the reference inspection results in the above reporting step are as follows: It is characterized by including the comparison result of the processing / analysis result of the multiplex MDx test result of the above patient and the reference test result. Method for reporting molecular diagnostic test results.

20. In paragraph 1, The above patient's multiplex MDx test results and the above reference test results Characterized by the MDx test results using at least one of the same series of MDx test reagent products using the same MDx technology. Method for reporting molecular diagnostic test results.

21. In paragraph 1, The same MDx technology as above, A method for determining a target gene sequence and amplicon, 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 one label in one channel, a signal processing technology, a positive / negative determination technology, and a nucleic acid extraction technology, characterized in that at least one technology is the same. Method for reporting molecular diagnostic test results.

22. In paragraph 1, The terminal of the clinician who uses one or more of the MDx test reagent products of the same series is characterized by using the same analysis software. Method for reporting molecular diagnostic test results.

23. In paragraph 1, The above analysis software, Characterized in that it 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. Method for reporting molecular diagnostic test results.

24. A molecular diagnostic test result reporting device that reports the results of a multiplex molecular diagnostic (multiplex MDx) test of a patient, Memory that stores at least one instruction; network; and A processor configured to execute at least one instruction stored in the memory, The at least one instruction, when executed by the processor, causes the processor to perform a method, the method comprising: A step of receiving a multiplex molecular diagnostic (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 judgment result and a Ct value; A step of retrieving a reference test result obtained through multiplex MDx that includes the same target as at least one target determined positive among the multiplex MDx test results of the subject, among the multiplex MDx test results previously stored in a database (DB) connected to the reporting device, wherein the reference test result includes a positive / negative determination result and a Ct value; A step of processing and analyzing the above-mentioned retrieved reference test results; and A method comprising: reporting the multiplex MDx test results of the subject; characterized in that the reporting includes the processing / analysis results of the multiplex MDx test results of the subject and the reference test results. Molecular diagnostic test result reporting device.

25. A computer-readable, non-transitory recording medium that stores a computer program, The computer program comprises instructions that, when executed by one or more processors, cause the one or more processors to perform the following method, the method comprising: A step of receiving a multiplex molecular diagnostic (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 judgment result and a Ct value; A step of retrieving a reference test result obtained through multiplex MDx that includes the same target as at least one target determined positive among the multiplex MDx test results of the subject, among the multiplex MDx test results previously stored in a database (DB) connected to the reporting device, wherein the reference test result includes a positive / negative determination result and a Ct value; A step of processing and analyzing the above-mentioned retrieved reference test results; and A step of reporting the multiplex MDx test results of the above-mentioned patient; wherein the reporting includes the processing / analysis results of the multiplex MDx test results of the above-mentioned patient and the reference test results. A computer-readable, non-transitory recording medium that stores computer programs.

26. A computer program stored on a computer-readable, non-transitory recording medium, The computer program comprises instructions that, when executed by one or more processors, cause the one or more processors to perform the following method, the method comprising: A step of receiving a multiplex molecular diagnostic (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 judgment result and a Ct value; A step of retrieving a reference test result obtained through multiplex MDx that includes the same target as at least one target determined positive among the multiplex MDx test results of the subject, among the multiplex MDx test results previously stored in a database (DB) connected to the reporting device, wherein the reference test result includes a positive / negative determination result and a Ct value; A step of processing and analyzing the above-mentioned retrieved reference test results; and A step of reporting the multiplex MDx test results of the above-mentioned patient; wherein the reporting includes the processing / analysis results of the multiplex MDx test results of the above-mentioned patient and the reference test results. A computer program stored on a computer-readable, non-transitory storage medium.

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