A system for interpreting results of a genetic methylation detection

Abstract

The application belongs to the technical field of gene methylation detection and analysis, and specifically provides a gene methylation detection result interpretation system, which comprises a sample management module, a data interpretation module, a report generation module and a background management module; the sample management module is used for encoding the imported gene methylation detection sample information and automatically generating a corresponding detection serial number; the data interpretation module is used for interpreting the gene methylation detection result and obtaining an interpretation conclusion; and the report generation module is used for automatically generating a corresponding report according to the gene methylation detection result. Compared with the prior art, the application has the advantages of simple operation, wide compatibility, editability and clear information, etc.

Description

Technical Field

[0001] This invention belongs to the field of gene methylation detection and analysis technology, and relates to a gene methylation detection result interpretation system. Background Technology

[0002] Currently, common methods for cervical cancer detection include hrHPV testing and cytology. A negative hrHPV test result is highly significant, indicating a very low likelihood of developing cancer in the short term, but a positive result is not entirely meaningful. Cytology examines exfoliated cervical epithelial cells for morphological inflammatory proliferative lesions, nuclear atypia, or malignant changes, effectively diagnosing cervical inflammation or cancer. However, the diagnostic accuracy of cytology screening is closely related to the quality of the sample taken by the clinician and the interpreting skills of the cytopathologist; the clinical sensitivity is approximately 53%–81%.

[0003] The PAX1 gene is a key tumor suppressor gene that regulates cell differentiation and maturation. Abnormal methylation of the gene is closely related to the occurrence, development, and carcinogenesis of tumors. In cervical cells, methylation of the PAX1 promoter can silence or inactivate the gene, thus losing its function of suppressing tumor growth. Abnormal cells then become uncontrolled, leading to cervical cancer. This mechanism has been widely studied and recognized internationally.

[0004] Currently, testing products using the PAX1 gene are available in several hospitals. However, the standard analysis process involves a series of complex steps, including data export, data processing, calculation, and result interpretation. When analyzing large datasets, the analysis time is long, and calculation errors are prone to occur, leading to inaccurate results and hindering product development and promotion. Summary of the Invention

[0005] The purpose of this invention is to provide a gene methylation detection and analysis system that can automatically analyze PAX1 gene methylation detection data based on the data analysis process and result interpretation standards, so as to realize one-click operation from sample entry to automatic reporting.

[0006] This invention provides a gene methylation detection result interpretation system for interpreting gene methylation detection results and obtaining the interpretation results; it includes a sample management module, a data interpretation module, a report generation module, and a background management module; The sample management module is used to encode the imported gene methylation detection sample information and automatically generate the corresponding detection serial number; The data interpretation module is used to interpret the gene methylation detection results and obtain the interpretation conclusions. The report generation module is used to automatically generate corresponding reports based on the gene methylation detection results.

[0007] Furthermore, the gene methylation detection sample information includes gene methylation information of several subjects being tested; The gene methylation information of a single subject being tested includes identity information, at least one sample barcode, and the detection result corresponding to the single sample barcode; the detection result includes target_Ct, internal standard_Ct, target fluorescence value, and internal standard fluorescence value.

[0008] Furthermore, the sample management module includes an information import unit, a detection serial number generation unit, and an information management unit; The information import unit is used to import gene methylation detection sample information and generate a unique code for each gene methylation detection sample. The detection serial number generation unit is used to automatically generate the corresponding detection serial number based on the unique code of the single gene methylation detection sample information. The information management unit queries the information of the tested samples based on the generated test serial number, encrypts and associates the unique test serial number corresponding to any tested subject with the sample barcode and test result, generates a report, and exports the information.

[0009] Furthermore, the gene methylation detection result interpretation system also includes a background management module; The background management module is used to customize and edit key values ​​in the sample management module and to manage the model of PCR amplification instruments that can export data in the data interpretation module.

[0010] Furthermore, the key values ​​in the sample management module can be customized as follows: Assign the value A1 to the corresponding position in the target_Ct and / or internal standard_Ct in the detection serial number where there is no actual detection data; The standard value used to determine whether the internal standard _Ct is normal is assigned to B1; The standard value used to determine whether the △Ct value is positive is assigned the value B2; The standard value of the amplified negative control was assigned the value of C1; The standard value of the amplified positive quality control sample is assigned the value C2; The standard value of the negative control sample was assigned to C3. The standard value of the positive control sample was assigned the value of C4. The standard value used to determine whether the target fluorescence value and / or internal standard fluorescence value are normal is assigned the value D1.

[0011] Furthermore, the data interpretation module includes a first interpretation unit and a second interpretation unit, and the analysis logic of the first interpretation unit and the second interpretation unit are different from each other.

[0012] Furthermore, the specific process of using the first interpretation unit to interpret the gene methylation detection sample information is as follows: Step 1: Extract the target_Ct and internal standard_Ct from the detection result corresponding to the unique detection serial number of any detected subject in the sample management module, and organize the extracted target_Ct and internal standard_Ct into a table including the detection serial number column and the target_Ct and internal standard_Ct columns corresponding to the current detection serial number column; Step 2: Check the detection serial number column and the corresponding target_Ct and internal standard_Ct columns. If there are corresponding detection values ​​in both the target_Ct and internal standard_Ct columns corresponding to the detection serial number column, proceed to Step 3; if there is no corresponding detection value in any of the detection serial number columns, assign it the value A1 so that the values ​​in the target_Ct and internal standard_Ct columns can be analyzed separately later. Step 3: Determine whether the value of the internal standard _Ct is normal; the specific steps are as follows: When the index_Ct≤B1, the index_Ct is judged to be normal, that is, the index_Ct proceeds to step 4 for further analysis; When the internal standard _Ct > B1, the internal standard _Ct data is determined to be invalid, meaning that the internal standard _Ct will not be further analyzed. Step 4: Calculate the ΔCt value for the data where the internal standard _Ct is normal using the following formula: △Ct = target_Ct - internal_index_Ct; Step 5: Interpret the results based on the calculated △Ct value, as follows: When △Ct≤B2, the result is interpreted as positive; When △Ct>B2, the result is interpreted as negative.

[0013] Furthermore, the specific process of using the second interpretation unit to interpret the gene methylation detection sample information is as follows: Step 1: Extract the target_Ct, internal standard_Ct, target fluorescence value, and internal standard fluorescence value from the test results corresponding to the unique test serial number of any tested subject in the sample management module. Then, organize the extracted target_Ct, internal standard_Ct, target fluorescence value, and internal standard fluorescence value into a table that includes a test serial number column and target_Ct, internal standard_Ct, target fluorescence value, and internal standard fluorescence value columns corresponding to the current test serial number column. Step ②: Check the detection serial number column and the corresponding target_Ct column and internal standard_Ct column. If the target fluorescence value and / or internal standard fluorescence value are ≥D1, proceed to step ③ for further analysis; if the target fluorescence value and / or internal standard fluorescence value are <D1, assign the corresponding target_Ct and / or internal standard_Ct value to A1. When the index_Ct≤B1, the index is considered normal, meaning that the index_Ct proceeds to step ③ for further analysis; when the index_Ct>B1, the index_Ct is considered invalid, meaning that the index_Ct will not be further analyzed. Step ③: For the normal data of internal standard Ct, calculate the ΔCt value and fluorescence value ratio using the following formula; △Ct = target_Ct - internal_index_Ct; Fluorescence value ratio = target fluorescence value / internal standard fluorescence value.

[0014] Step 4: Interpret the results based on the ratio of ΔCt value to fluorescence value, as detailed below: When ΔCt≤B2 and the target fluorescence value / internal standard fluorescence value≥B3, the result is interpreted as positive; When ΔCt≤B2 and the target fluorescence value / internal standard fluorescence value<B3, the result is interpreted as a retest; when ΔCt>B2, the result is interpreted as negative.

[0015] Furthermore, the data interpretation module also includes an experimental conclusion interpretation unit, which is used to perform quality control on the interpretation conclusions obtained by the first interpretation unit and the second interpretation unit.

[0016] Furthermore, the data interpretation module also includes a difference data prompting unit, which establishes anomaly matching early warning rules to highlight abnormal data.

[0017] Compared with the prior art, the present invention has the following beneficial effects: (1) Easy to operate; Paishian ® PAX1 gene methylation detection data analysis previously relied on manual operation and interpretation by laboratory personnel. This requires a certain level of computer skills and a solid foundation in biomolecular detection theory. With large sample sizes, the process is cumbersome, time-consuming, and prone to errors, leading to inaccurate results. This invention enables one-click data export and analysis, solving the problems of cumbersome data analysis and error-prone processes during manual operation, thus improving work efficiency.

[0018] (2) Wide compatibility. The ABI7500 and LC480II are from Pastian. ®This invention relates to a matching detection instrument for the PAX1 gene methylation detection reagent. Besides ensuring accurate matching and convenient analysis of exported data from the matching instrument, it is also compatible with other mainstream qPCR instruments on the market, enabling unified analysis of exported data in various formats.

[0019] (3) Editability. The present invention allows for customized editing of key values ​​in data interpretation, thus enabling it to match not only PAX1 methylation detection items but also other single-gene methylation detection items.

[0020] (4) Clear information. In addition to analyzing the sample test data, the test data of the corresponding negative / positive quality control samples can also be interpreted to determine whether the experiment was successful and to briefly indicate the reasons for the experiment failure. This makes it easier for the experimenter to find the problem after the experiment fails and saves experimental time.

[0021] (5) According to the molecular experimental detection procedure, it can accurately match Paishian. ® The PAX1 gene methylation detection project, in addition to the official supporting instruments, is compatible with most qPCR instruments on the market. No manual analysis is required; data analysis and report generation are completed with a single click, saving 50%-70% of the time and improving work efficiency. Furthermore, it is suitable for most single-gene methylation detection projects, requiring no secondary software development.

[0022] In addition to the objectives, features, and advantages described above, the present invention has other objectives, features, and advantages. The invention will now be described in further detail with reference to the figures. Attached Figure Description

[0023] The accompanying drawings, which form part of this application, are used to provide a further understanding of the invention. The illustrative embodiments of the invention and their descriptions are used to explain the invention and do not constitute an undue limitation of the invention. In the drawings: Figure 1 This is a schematic diagram of a gene methylation detection result interpretation system in an embodiment of the present invention. Detailed Implementation

[0024] To make the above-mentioned objectives, features and advantages of the present invention clearer and easier to understand, the specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings.

[0025] Example: See Figure 1 As shown, the gene methylation detection result interpretation system provided by the present invention is used to interpret gene methylation detection results and obtain the interpretation results; specifically, it includes a sample management module, a data interpretation module, a report generation module, and a background management module; The sample management module is used to encode the imported gene methylation detection sample information and automatically generate the corresponding detection serial number; The data interpretation module is specifically developed based on the result interpretation logic of the PAX1 gene methylation detection reagent and is used to interpret the gene methylation detection results to obtain the interpretation conclusion. The report generation module is used to automatically generate corresponding reports based on the gene methylation detection results; The background management module is used to customize and edit key values ​​in the sample management module and to manage the model of PCR amplification instruments that can export data in the data interpretation module.

[0026] Preferably, the gene methylation detection sample information includes gene methylation information of several subjects being tested, and the gene methylation information of a single subject being tested includes identity information, at least one sample barcode, and the detection result corresponding to the single sample barcode; the detection result includes target_Ct, internal standard_Ct, target fluorescence value, and internal standard fluorescence value.

[0027] Preferably, the sample management module includes an information import unit, a detection serial number generation unit, and an information management unit; the information import unit is used to import gene methylation detection sample information and generate a unique code for each gene methylation detection sample information; the detection serial number generation unit is used to automatically generate a corresponding detection serial number based on the unique code of each gene methylation detection sample information; the information management unit queries the information of the tested samples based on the generated detection serial number, encrypts and associates the unique detection serial number corresponding to any tested subject with the sample barcode and the detection result, generates a report, and exports information.

[0028] Preferably, in this embodiment, to facilitate the data interpretation module's analysis and interpretation of the detection serial numbers and corresponding detection results in the sample management module, the key values ​​in the sample management module involved in this embodiment are customized and edited as follows: Assign the value A1 to the corresponding position in the target_Ct and / or internal standard_Ct in the detection serial number where there is no actual detection data; The standard value used to determine whether the internal standard _Ct is normal is assigned to B1; The standard value used to determine whether the △Ct value is positive is assigned the value B2; The standard value of the amplified negative control was assigned the value of C1; The standard value of the amplified positive quality control sample is assigned the value C2; The standard value of the negative control sample was assigned to C3. The standard value of the positive control sample was assigned the value of C4. The standard value used to determine whether the target fluorescence value and / or internal standard fluorescence value are normal is assigned the value D1.

[0029] Specifically: In actual data analysis, when the target gene has a high methylation level, an amplification curve is detected, showing a specific Ct value, and ΔCt can be directly calculated. However, when there is no methylation or the methylation level is below the reagent's detection limit, no amplification curve is detected, and the system displays "undetermined" without a specific value. Therefore, for subsequent ΔCt calculation, the Ct value of the target gene needs to be manually assigned in this case. Generally, it is the number of cycles in the amplification program; in this embodiment, A1 is set to 50.

[0030] In methylation detection amplification, a very small number of negative samples may exhibit erroneous increases in the amplification curve due to primer mismatch, instrument fluctuations, or other factors, resulting in false Ct values ​​displayed by the system. These "false" amplification curves are generally chaotic, lacking a typical S-shaped amplification pattern and exhibiting low fluorescence signal values. To avoid false positives in subsequent analyses, a value D1 is assigned based on the amplified fluorescence signal value to determine the authenticity of the Ct value. If the signal value is less than D1, it is considered a "false" amplification, the Ct value is invalid, and it is assigned a value according to the logic of A1 undetermined.

[0031] In methylation data analysis, a higher internal standard Ct value indicates a lower nucleic acid concentration in the template, and vice versa. When the internal standard Ct value exceeds a certain threshold, it indicates that the nucleic acid concentration is too low, rendering subsequent results meaningless and the sample invalid. Therefore, the internal standard Ct value of the sample must be used to determine whether further analysis is necessary. Thus, B1 is the value used to determine whether the internal standard Ct value is acceptable; in this embodiment, B1 is set to 35.

[0032] △Ct is the difference between the Ct value of the target gene and the Ct value of the internal control gene. A larger △Ct value indicates a lower degree of methylation, and vice versa. The △Ct value is used to determine the positivity or positivity of the sample. B2 is the standard value for determining the positivity or positivity of △Ct; in this embodiment, B2 is set to 11.

[0033] For the LC480 II platform only, in addition to determining the positive or negative result of a sample using the ΔCt value, it is also necessary to determine whether it is a false positive by judging the ratio of the amplification signal value of the target gene to the amplification signal value of the internal control gene. The reason is similar to D1: when ΔCt ≤ B2 and the signal ratio < B3, the system judges it as a false positive, and retesting is required. In this embodiment, B3 is set to 0.3.

[0034] C1 is the standard value for amplifying the negative control. Theoretically, neither the target gene nor the internal control gene should have an amplification curve. Therefore, when the target or internal control Ct ≤ C1, contamination can be determined during the amplification process. In this embodiment, C1 is set to 38.

[0035] C2 is the standard value for amplified positive control samples. Theoretically, both the target and internal control genes of the amplified positive control sample should have typical S-shaped amplification curves, and the Ct value should fluctuate within a small range. When the Ct value of the target or internal control exceeds this range (≥C2), it indicates that there is a problem with the amplification and the amplification has failed. In this embodiment, C2 is set to 30.

[0036] C3 is the standard value for transforming negative control samples. Theoretically, only the internal control gene can be normally amplified when transforming negative control samples, while the target gene is not amplified. Therefore, only the internal control gene has a Ct value, while the target gene is unterminated and has no Ct value. Thus, when the target gene Ct value is ≤ C3, it indicates contamination during the transformation process, and this contamination affects the detection results. In this embodiment, C3 is set to 38.

[0037] C4 is the standard value for a positive transformation control. Theoretically, both the target gene and the internal control gene should exhibit typical S-shaped amplification curves, and the Ct value should fluctuate within a certain range. When the Ct value of the target or internal control exceeds this range (≥C4), it indicates a problem with the transformation and extraction, and the experiment fails. In this embodiment, C4 is set to 35.

[0038] Preferably, the data interpretation module includes a first interpretation unit and a second interpretation unit, depending on the data export format of different PCR amplification instruments. The analysis logic of the first and second interpretation units is different to correspond to the data export formats of different amplification instruments, so that the data interpretation module can be compatible with the data export formats of mainstream brands such as ABI / Roche and Aquarius. Specifically, the first interpretation unit is mainly adapted to the data export formats of most qPCR instruments except LC480II, such as ABI 7500, Tianlong Gentier 96E / 96R, etc.; the second interpretation unit is mainly adapted to the data export formats of LC480II and similar models.

[0039] A further preferred embodiment of the process for interpreting gene methylation detection sample information using the first interpretation unit is as follows: Step 1: Extract the target_Ct and internal standard_Ct from the detection result corresponding to the unique detection serial number of any detected subject in the sample management module, and organize the extracted target_Ct and internal standard_Ct into the table shown in Table 1; Table 1: Correspondence between Detection Serial Number, Target_Ct, and Internal Standard_Ct

[0040] Step 2: Check the detection serial number column and the corresponding target_Ct and internal standard_Ct columns. If both the target_Ct and internal standard_Ct columns corresponding to the detection serial number column have corresponding detection values, proceed to Step 3; if any one of the corresponding columns in the detection serial number column does not have a corresponding detection value (i.e., it is undetermined), assign it the value A1 so that the values ​​in the target_Ct and internal standard_Ct columns can be analyzed separately later. Step 3: Determine whether the value of the internal standard _Ct is normal; the specific steps are as follows: When the index_Ct≤B1, the index_Ct is judged to be normal, that is, the index_Ct proceeds to step 4 for further analysis; When the internal standard _Ct > B1, the internal standard _Ct data is determined to be invalid, meaning that the internal standard _Ct will not be further analyzed. Step 4: Calculate the ΔCt value for the data where the internal standard _Ct is normal using the following formula: △Ct = target_Ct - internal_index_Ct; Step 5: Interpret the results based on the calculated △Ct value, as follows: When △Ct≤B2, the result is interpreted as positive; When △Ct>B2, the result is interpreted as negative.

[0041] A further preferred embodiment of the process for interpreting gene methylation detection sample information using the second interpretation unit is as follows: Step 1: Extract the target_Ct, internal standard_Ct, target fluorescence value, and internal standard fluorescence value from the test results corresponding to the unique test serial number of any subject being tested in the sample management module, and organize the extracted target_Ct, internal standard_Ct, target fluorescence value, and internal standard fluorescence value as shown in Table 2. Table 2: Correspondence between Detection Serial Number, Target_Ct, Internal Standard_Ct, Target Fluorescence Value, and Internal Standard Fluorescence Value

[0042] Step ②: Check the detection serial number column and the corresponding target_Ct column and internal standard_Ct column. If the target fluorescence value and / or internal standard fluorescence value are ≥D1, proceed to step ③ for further analysis; if the target fluorescence value and / or internal standard fluorescence value are <D1, assign the corresponding target_Ct and / or internal standard_Ct value to A1. When the index_Ct≤B1, the index is considered normal, meaning that the index_Ct proceeds to step ③ for further analysis; when the index_Ct>B1, the index_Ct is considered invalid, meaning that the index_Ct will not be further analyzed. Step ③: For the normal data of internal standard Ct, calculate the ΔCt value and fluorescence value ratio using the following formula; △Ct = target_Ct - internal_index_Ct; Fluorescence value ratio = target fluorescence value / internal standard fluorescence value.

[0043] Step 4: Interpret the results based on the ratio of ΔCt value to fluorescence value, as detailed below: When ΔCt≤B2 and the target fluorescence value / internal standard fluorescence value≥B3, the result is interpreted as positive; When ΔCt≤B2 and the target fluorescence value / internal standard fluorescence value<B3, the result is interpreted as a retest; when ΔCt>B2, the result is interpreted as negative.

[0044] As a further embodiment of the present invention, the data interpretation module further includes an experimental conclusion interpretation unit, which is used to perform quality control on the interpretation conclusions (converted into negative or positive conclusions for quality control) obtained by the first interpretation unit and the second interpretation unit, amplify the detection values ​​of the negative or positive quality control samples, and determine whether the experiment was successful and whether there was any contamination. The specific judgment logic is shown in Table 3.

[0045] Table 3: Judgment Logic for Quality Control Products Based on the Judgment Conclusions Obtained from the First and Second Judgment Units

[0046] As a further embodiment of the present invention, the data interpretation module also includes a difference data prompting unit. By establishing anomaly matching early warning rules, abnormal data is highlighted. When the results of automatic data analysis are transferred to the manual review interface, the reviewer is reminded to manually correct the abnormal data. A review traceability database is constructed to fully record modification traces and operator identities. A multi-threaded data association engine is established, and finally, the detection data and the examinee information are automatically associated.

[0047] Preferably, the report generation module includes a dynamic template engine unit, allowing operators to select information such as report header, organization logo, sample information, amplification graph, tested subject, reviewer's signature, organization's signature, and clinical interpretation according to their own needs.

[0048] More preferably, the report generation module also includes a digital signature unit, so that relevant personnel can digitally sign the report to meet the CFDA electronic report certification requirements.

[0049] Compared with manual operation, the gene methylation detection result interpretation system provided by this invention improves the report generation efficiency by 12 times (traditional 2 hours / batch → 10 minutes / batch) and reduces the data association error rate to below 0.2% (traditional manual operation error rate is about 5%-7%), taking 92 samples as an example.

[0050] The above description is merely a preferred embodiment of the present invention and is not intended to limit the invention. Various modifications and variations can be made to the present invention by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A gene methylation detection result interpretation system, used to interpret gene methylation detection results and obtain the interpretation result; characterized in that, It includes a sample management module, a data interpretation module, a report generation module, and a back-end management module; The sample management module is used to encode the imported gene methylation detection sample information and automatically generate the corresponding detection serial number; The data interpretation module is used to interpret the gene methylation detection results and obtain the interpretation conclusions. The report generation module is used to automatically generate corresponding reports based on the gene methylation detection results; The data interpretation module includes a first interpretation unit and a second interpretation unit, and the analysis logic of the first interpretation unit and the second interpretation unit are different from each other; The specific process of interpreting gene methylation detection sample information using the first interpretation unit is as follows: Step 1: Extract the target_Ct and internal standard_Ct from the detection result corresponding to the unique detection serial number of any detected subject in the sample management module, and organize the extracted target_Ct and internal standard_Ct into a table including the detection serial number column and the target_Ct and internal standard_Ct columns corresponding to the current detection serial number column; Step 2: Check the detection serial number column and the corresponding target_Ct and internal standard_Ct columns. If there are corresponding detection values ​​in both the target_Ct and internal standard_Ct columns corresponding to the detection serial number column, proceed to Step 3; if there is no corresponding detection value in any of the detection serial number columns, assign it the value A1 so that the values ​​in the target_Ct and internal standard_Ct columns can be analyzed separately later. Step 3: Determine whether the value of the internal standard _Ct is normal; the specific steps are as follows: When the index_Ct≤B1, the index_Ct is judged to be normal, that is, the index_Ct proceeds to step 4 for further analysis; When the internal standard _Ct > B1, the internal standard _Ct data is determined to be invalid, meaning that the internal standard _Ct will not be further analyzed. Step 4: Calculate the ΔCt value for the data where the internal standard _Ct is normal using the following formula: △Ct = target_Ct - internal_index_Ct; Step 5: Interpret the results based on the calculated △Ct value, as follows: When △Ct≤B2, the result is interpreted as positive; When △Ct>B2, the result is interpreted as negative; The specific process of interpreting gene methylation detection sample information using the second interpretation unit is as follows: Step 1: Extract the target_Ct, internal standard_Ct, target fluorescence value, and internal standard fluorescence value from the test results corresponding to the unique test serial number of any tested subject in the sample management module. Then, organize the extracted target_Ct, internal standard_Ct, target fluorescence value, and internal standard fluorescence value into a table that includes a test serial number column and target_Ct, internal standard_Ct, target fluorescence value, and internal standard fluorescence value columns corresponding to the current test serial number column. Step ②: Check the detection serial number column and the corresponding target_Ct column and internal standard_Ct column. If the target fluorescence value and / or internal standard fluorescence value are ≥D1, proceed to step ③ for further analysis; if the target fluorescence value and / or internal standard fluorescence value are <D1, assign the corresponding target_Ct and / or internal standard_Ct value to A1. When the index_Ct≤B1, the index is considered normal, meaning that the index_Ct proceeds to step ③ for further analysis; when the index_Ct>B1, the index_Ct is considered invalid, meaning that the index_Ct will not be further analyzed. Step ③: For the normal data of internal standard Ct, calculate the ΔCt value and fluorescence value ratio using the following formula; △Ct = target_Ct - internal_index_Ct; Fluorescence value ratio = target fluorescence value / internal standard fluorescence value; Step 4: Interpret the results based on the ratio of ΔCt value to fluorescence value, as detailed below: When ΔCt≤B2 and the target fluorescence value / internal standard fluorescence value≥B3, the result is interpreted as positive; When ΔCt≤B2 and the target fluorescence value / internal standard fluorescence value<B3, the result is interpreted as a retest; when ΔCt>B2, the result is interpreted as negative. The data interpretation module also includes an experimental conclusion interpretation unit, which is used to perform quality control on the interpretation conclusions obtained by the first interpretation unit and the second interpretation unit.

2. The gene methylation detection result interpretation system according to claim 1, characterized in that, The gene methylation detection sample information includes gene methylation information of several subjects being tested; The gene methylation information of a single subject being tested includes identity information, at least one sample barcode, and the detection result corresponding to the single sample barcode; the detection result includes target_Ct, internal standard_Ct, target fluorescence value, and internal standard fluorescence value.

3. The gene methylation detection result interpretation system according to claim 1, characterized in that, The sample management module includes an information import unit, a detection serial number generation unit, and an information management unit; The information import unit is used to import gene methylation detection sample information and generate a unique code for each gene methylation detection sample. The detection serial number generation unit is used to automatically generate the corresponding detection serial number based on the unique code of the single gene methylation detection sample information. The information management unit queries the information of the tested samples based on the generated test serial number, encrypts and associates the unique test serial number corresponding to any tested subject with the sample barcode and test result, generates a report, and exports the information.

4. The gene methylation detection result interpretation system according to any one of claims 1-3, characterized in that, It also includes a backend management module; The background management module is used to customize and edit key values ​​in the sample management module and to manage the model of PCR amplification instruments that can export data in the data interpretation module.

5. The gene methylation detection result interpretation system according to claim 4, characterized in that, The key values ​​in the sample management module can be customized as follows: Assign the value A1 to the corresponding position in the target_Ct and / or internal standard_Ct in the detection serial number where there is no actual detection data; The standard value used to determine whether the internal standard _Ct is normal is assigned to B1; The standard value used to determine whether the △Ct value is positive is assigned the value B2; The standard value of the amplified negative control was assigned the value of C1; The standard value of the amplified positive quality control sample is assigned the value C2; The standard value of the negative control sample was assigned to C3. The standard value of the positive control sample was assigned the value of C4. The standard value used to determine whether the target fluorescence value and / or internal standard fluorescence value are normal is assigned the value D1.

6. The gene methylation detection result interpretation system according to claim 1, characterized in that, The data interpretation module also includes a difference data prompting unit, which establishes anomaly matching early warning rules to highlight abnormal data.

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