Gene methylation detection result interpretation system

Abstract

The invention belongs to the technical field of gene methylation detection analysis, and particularly 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 coding the imported gene methylation detection sample information and automatically generating a corresponding detection serial number; the data interpretation module is used for interpreting a gene methylation detection result to obtain an interpretation conclusion; and the report generation module is used for automatically generating a corresponding report according to a gene methylation detection result. Compared with the prior art, the method has the advantages of simplicity and convenience in operation, wide compatibility, editability, clear information and the like.

Description

Technical Field

[0001] The present invention belongs to the technical field of gene methylation detection and analysis, and relates to a gene methylation detection result interpretation system. Background Art

[0002] Currently, common methods for cervical cancer detection include hrHPV testing and cytology. A negative hrHPV test result is very meaningful, indicating a low likelihood of developing cancer in the short term, but the significance of a positive result is unclear. Cytology effectively diagnoses cervical inflammation or cancer by examining cervical epithelial cells for morphological signs of inflammatory proliferative changes, nuclear heterogeneity, or malignant changes. However, the diagnostic quality of cytology screening is closely related to the clinician's satisfaction with the sample and the cytopathologist's ability to interpret the images, with a clinical sensitivity of approximately 53%-81%.

[0003] The PAX1 gene is a key tumor suppressor gene that regulates cell differentiation and maturation. Abnormal gene methylation is closely linked to the development, progression, and carcinogenesis of tumors. In cervical cells, methylation of the PAX1 promoter causes the gene to be silenced or inactivated, thereby losing its ability to suppress tumor growth. This leads to uncontrolled growth of abnormal cells, ultimately leading to cervical cancer. This mechanism has been widely studied and recognized internationally.

[0004] Currently, PAX1 gene testing products are being used in numerous hospitals. However, the standard analysis process requires a complex series of operations, including data export, effective data organization, data calculation, and result interpretation. When analyzing large numbers of samples, analysis time is long and data calculation errors are prone to occur, resulting in inaccurate results and hindering product development and promotion. Summary of the Invention

[0005] The purpose of the present 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 criteria, so as to achieve one-click operation from sample entry to automatic reporting.

[0006] The present invention provides a gene methylation detection result interpretation system, which is used to interpret the gene methylation detection results and obtain 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 conclusion; The report generation module is used to automatically generate a corresponding report based on the gene methylation detection results.

[0007] Furthermore, the gene methylation detection sample information includes gene methylation information of several detected subjects; The gene methylation information of a single tested subject includes identity information, at least one sample barcode, and a test result corresponding to the single sample barcode; the test 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 test serial number generation unit and an information management unit; The information importing unit is used to import gene methylation detection sample information and generate a unique code for a single gene methylation detection sample information; The detection serial number generating unit is used to automatically generate a corresponding detection serial number according to the unique code of the single gene methylation detection sample information; The information management unit queries the information of the tested samples according to 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, and 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 the key values in the sample management module and manage the models of PCR amplifiers that can export data in the data interpretation module.

[0010] Furthermore, the key values in the sample management module are customized and edited as follows: Assign the corresponding position of the target_Ct and / or internal standard_Ct in the test serial number without actual test data to A1; Assign the standard value used to judge whether the internal standard _Ct is normal to B1; The standard value used to judge whether the △Ct value is positive is assigned to B2; Assign the standard value of the amplified negative quality control product to C1; Assign the standard value of the amplified positive quality control product to C2; Assign the standard value of the negative quality control product to C3; Assign the standard value of the transformed positive quality control product to C4; The standard value used to judge whether the target fluorescence value and / or the internal standard fluorescence value is normal is assigned as D1.

[0011] Furthermore, the data interpretation module includes a first interpretation unit and a second interpretation unit, and the analysis logics 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 in the test result corresponding to the unique test serial number corresponding to any tested subject in the sample management module, and organize the extracted target_Ct and internal standard_Ct into a table including a test serial number column and a target_Ct column and internal standard_Ct column corresponding to the current test serial number column; Step 2: Check the test serial number column and the target_Ct column and internal standard_Ct column corresponding to the test serial number column. If both the target_Ct column and the internal standard_Ct column corresponding to the test serial number column have corresponding test values, proceed to step 3. If any of the columns corresponding to the test serial number column does not have a corresponding test value, assign it the A1 value so that the values of the target_Ct column and the internal standard_Ct column can be analyzed separately in the future. Step 3: Determine whether the value of the internal standard _Ct is normal; the details are as follows: When internal standard_Ct≤B1, the internal standard_Ct is judged to be normal, that is, the internal standard_Ct enters step 4 for further analysis; When internal standard_Ct>B1, the internal standard_Ct data is judged to be an invalid value, that is, the internal standard_Ct will not be used for subsequent analysis; Step 4: Calculate the ΔCt value using the following formula for normal data of the internal standard _Ct: ΔCt = target_Ct - internal standard_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 judged 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, extracting the target_Ct, internal standard_Ct, target fluorescence value and internal standard fluorescence value in the test result corresponding to the unique test serial number corresponding to any tested subject in the sample management module, and arranging the extracted target_Ct, internal standard_Ct, target fluorescence value and internal standard fluorescence value into a table including a test serial number column and a target_Ct column, internal standard_Ct column, target fluorescence value column and internal standard fluorescence value column corresponding to the current test serial number column; Step ②, check the test serial number column and the target_Ct column and internal standard_Ct column corresponding to the test serial number column. When the target fluorescence value and / or internal standard fluorescence value ≥ D1, proceed to step ③ for further analysis; when the target fluorescence value and / or internal standard fluorescence value < D1, assign the corresponding target_Ct and / or internal standard_Ct value A1; When the internal standard_Ct≤B1, the internal standard is judged to be normal, that is, the internal standard_Ct enters step ③ for further analysis; when the internal standard_Ct>B1, the internal standard_Ct is judged to be invalid, that is, the internal standard_Ct will not be subjected to subsequent analysis; Step 3: Calculate the ΔCt value and fluorescence value ratio using the following formula for the data with normal internal standard _Ct; ΔCt = target_Ct - internal standard_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 follows: When △Ct≤B2 and target fluorescence value / internal standard fluorescence value≥B3, the result is interpreted as positive; When △Ct≤B2 and target fluorescence value / internal standard fluorescence value<B3, the result is interpreted as retest; when △Ct>B2, the result is interpreted as negative.

[0015] Furthermore, the data interpretation module further includes an experimental conclusion interpretation unit for performing 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 is used to emphasize marking abnormal data by establishing abnormal matching warning rules.

[0017] Compared with the prior art, the present invention has the following beneficial effects: (1) Easy to operate; Paxon ® PAX1 gene methylation detection data analysis requires manual operation and interpretation by the experimenter. This requires a certain level of computer proficiency and theoretical knowledge of biomolecular detection. For large sample sizes, the operation is cumbersome, time-consuming, and error-prone, leading to inaccurate interpretation of the final results. This invention enables one-click analysis of exported data, resolving the issues of tedious and error-prone data analysis during manual operation and improving work efficiency.

[0018] (2) Wide compatibility. ABI7500 and LC480II are Paxon ®The PAX1 gene methylation detection reagent is a companion instrument. In addition to accurately matching the derived data from the companion instrument and enabling convenient analysis, the present invention is also compatible with other mainstream QPCR instruments on the market, enabling unified analysis of derived data in various formats.

[0019] (3) Editability. The present invention allows for custom editing of key values in data interpretation, so in addition to accurately matching PAX1 methylation detection projects, it can also match other single gene methylation detection projects.

[0020] (4) Clear information. In addition to analyzing the sample test data, the corresponding negative / positive quality control test data can also be interpreted to determine whether the experiment is successful and briefly indicate the reason for the failure of the experiment. 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 process, it can accurately match Paishan ® The PAX1 gene methylation assay is compatible with most commercially available QPCR instruments, in addition to the official supporting instruments. This eliminates the need for manual analysis, enabling one-click data analysis and report generation, saving 50%-70% of time and improving productivity. Furthermore, it is suitable for most single-gene methylation assays, eliminating the need for additional software development.

[0022] In addition to the above-described objects, features and advantages, the present invention has other objects, features and advantages. The present invention will be further described in detail below with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] The accompanying drawings, which constitute part of this application, are intended to provide a further understanding of the present invention. The exemplary embodiments of the present invention and their descriptions are intended to explain the present invention and do not constitute an undue limitation of the present invention. In the accompanying drawings: Figure 1 Schematic diagram of a gene methylation detection result interpretation system in an embodiment of the present invention. DETAILED DESCRIPTION

[0024] In order to make the above-mentioned objects, features and advantages of the present invention more clear and easy to understand, the specific embodiments of the present invention are described in detail below with reference to the accompanying drawings.

[0025] Example: See also Figure 1 As shown, the present invention provides a gene methylation detection result interpretation system, which is used to interpret the 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 Paxan® PAX1 gene methylation detection reagent, and is used to interpret the gene methylation detection results and obtain its interpretation conclusion; The report generation module is used to automatically generate a corresponding report based on the gene methylation detection results; The background management module is used to customize the key values in the sample management module and manage the models of PCR amplifiers that can export data in the data interpretation module.

[0026] Preferably, the gene methylation detection sample information includes gene methylation information of several detected subjects, and the gene methylation information of a single detected subject includes identity information, at least one sample barcode and a 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 the gene methylation detection sample information and generate a unique code for the single 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 the single gene methylation detection sample information; the information management unit queries the information of the tested sample 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, and generates a report and exports the information.

[0028] Preferably, in this embodiment, in order to facilitate the data interpretation module to analyze and interpret the test serial number in the sample management module and the test results corresponding to the test serial number, the key values in the sample management module involved in this embodiment are customized and edited as follows: Assign the corresponding position of the target_Ct and / or internal standard_Ct in the test serial number without actual test data to A1; Assign the standard value used to judge whether the internal standard _Ct is normal to B1; The standard value used to judge whether the △Ct value is positive is assigned to B2; Assign the standard value of the amplified negative quality control product to C1; Assign the standard value of the amplified positive quality control product to C2; Assign the standard value of the negative quality control product to C3; Assign the standard value of the transformed positive quality control product to C4; The standard value used to judge whether the target fluorescence value and / or the internal standard fluorescence value is normal is assigned as D1.

[0029] Specifically: In actual data analysis, when the target gene has a high methylation level, the test will produce an amplification curve, displaying a specific Ct value, and allowing direct calculation of ΔCt. However, when there is no methylation or the methylation level is below the reagent's detection limit, no amplification curve is produced, and the system assigns an undetermined value, without a specific numerical value. Therefore, in these cases, the Ct value of the target gene must be manually assigned for subsequent ΔCt calculations. This is typically the number of cycles in the amplification program; in this example, A1 is set to 50.

[0030] In methylation detection amplification, a very small number of negative samples may experience an erroneous rise in the amplification curve due to primer mismatches, instrument fluctuations, and other factors, resulting in the system displaying a false Ct value. This "false" amplification curve is typically chaotic, lacking the typical S-shaped amplification pattern and exhibiting a low fluorescence signal. To avoid false positives in subsequent analysis, a value D1 is set based on the amplified fluorescence signal to determine if the Ct value of the amplification curve is legitimate. If the signal value is less than D1, it is considered "false" amplification, the Ct value is invalid, and the value is assigned according to the logic of A1 undetermined.

[0031] In methylation data analysis, the larger the internal standard Ct value, the lower the template nucleic acid concentration, and vice versa. When the internal standard Ct value is higher than a certain value, it indicates that the nucleic acid concentration is too low, and subsequent results are no longer meaningful, and the sample is invalid. Therefore, the internal standard Ct value of the sample must first be used to determine whether to proceed with subsequent analysis. Therefore, B1 is the value used to determine whether the internal standard Ct value is qualified. In this example, B1 is set to 35.

[0032] ΔCt is the difference between the Ct value of the target gene and the Ct value of the internal reference gene. A larger ΔCt value indicates a lower degree of methylation, and vice versa. The ΔCt value is used to determine whether a sample is positive or negative. B2 is the standard value for determining ΔCt positive or negative. In this example, B2 is set to 11.

[0033] For the LC480 II platform only, in addition to determining sample positive / negative based on the ΔCt value, the ratio of the target gene's amplification signal to the internal standard gene's amplification signal is also used to determine false positives. The reasoning is similar to D1: when ΔCt ≤ B2 and the signal ratio is less than B3, the system determines it as a false positive and requires retesting. In this example, B3 is set to 0.3.

[0034] C1 is the standard value for amplifying a negative control. Theoretically, amplifying a negative control will show no amplification curve for either the target or internal standard gene. Therefore, when the target or internal standard Ct ≤ C1, contamination is detected during the experimental amplification process. In this example, C1 was set to 38.

[0035] C2 is the standard value for amplifying positive quality control samples. Theoretically, amplification of both the target and internal standard genes should exhibit a typical S-shaped amplification curve, with Ct values fluctuating within a narrow range. If the target or internal standard Ct value exceeds this range (i.e., ≥ C2), it indicates a problem with amplification and amplification failure. In this example, C2 was set to 30.

[0036] C3 is the standard value for negative conversion controls. Theoretically, only the internal standard gene is amplified correctly for negative conversion controls, while the target gene is not. Therefore, only the internal standard gene's Ct value is present, while the target gene remains unterminated. Therefore, a Ct value of ≤ C3 for the target gene indicates contamination during the conversion process, which can affect the test results. In this example, C3 was set to 38.

[0037] C4 is the standard value for conversion-positive quality control samples. Ideally, both the target and internal standard genes should exhibit a typical S-shaped amplification curve, with Ct values fluctuating within a certain range. If the target or internal standard Ct value exceeds this range (i.e., ≥ C4), there is a problem with the conversion extraction, and the experiment has failed. In this example, C4 was set to 35.

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

[0039] Further preferably, 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 test results corresponding to the unique test serial number corresponding to any tested subject in the sample management module, and organize the extracted target_Ct and internal standard_Ct into a table as shown in Table 1; Table 1: Correspondence table of test serial number, target_Ct and internal standard_Ct

[0040] Step 2: Check the test serial number column and the target_Ct column and internal standard_Ct column corresponding to the test serial number column. If both the target_Ct column and the internal standard_Ct column corresponding to the test serial number column have corresponding test values, proceed to step 3. If any of the columns corresponding to the test serial number column does not have a corresponding test value (i.e., it is undetermined), assign it the value A1 so that the values of the target_Ct column and the internal standard_Ct column can be analyzed separately later. Step 3: Determine whether the value of the internal standard _Ct is normal; the details are as follows: When internal standard_Ct≤B1, the internal standard_Ct is judged to be normal, that is, the internal standard_Ct enters step 4 for further analysis; When internal standard_Ct>B1, the internal standard_Ct data is judged to be an invalid value, that is, the internal standard_Ct will not be used for subsequent analysis; Step 4: Calculate the ΔCt value using the following formula for normal data of the internal standard _Ct: ΔCt = target_Ct - internal standard_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 judged as negative.

[0041] Further preferably, 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 in the test results corresponding to the unique test serial number corresponding to any detected subject in the sample management module, and organize the extracted target_Ct, internal standard_Ct, target fluorescence value and internal standard fluorescence value into a table as shown in Table 2; Table 2: Correspondence table of test serial number, target_Ct, internal standard_Ct, target fluorescence value and internal standard fluorescence value

[0042] Step ②, check the test serial number column and the target_Ct column and internal standard_Ct column corresponding to the test serial number column. When the target fluorescence value and / or internal standard fluorescence value ≥ D1, proceed to step ③ for further analysis; when the target fluorescence value and / or internal standard fluorescence value < D1, assign the corresponding target_Ct and / or internal standard_Ct value A1; When the internal standard_Ct≤B1, the internal standard is judged to be normal, that is, the internal standard_Ct enters step ③ for further analysis; when the internal standard_Ct>B1, the internal standard_Ct is judged to be invalid, that is, the internal standard_Ct will not be subjected to subsequent analysis; Step 3: Calculate the ΔCt value and fluorescence value ratio using the following formula for the data with normal internal standard _Ct; ΔCt = target_Ct - internal standard_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 follows: When △Ct≤B2 and target fluorescence value / internal standard fluorescence value≥B3, the result is interpreted as positive; When △Ct≤B2 and target fluorescence value / internal standard fluorescence value<B3, the result is interpreted as retest; when △Ct>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 configured to process the interpretation conclusions obtained by the first and second interpretation units (converted to negative or positive conclusions for quality control samples), amplify the detection values of the negative or positive quality control samples, and determine whether the experiment is successful and whether there is contamination. The specific judgment logic is shown in Table 3.

[0045] Table 3: Judgment logic for quality control products based on the interpretation conclusions obtained by the first interpretation unit and the second interpretation unit

[0046] As a further embodiment of the present invention, the data interpretation module also includes a discrepancy data prompting unit. This unit establishes anomaly matching warning rules to highlight abnormal data. When the results of the automatic data analysis are transferred to the manual review interface, the reviewer is prompted to manually correct the abnormal data. An audit traceability database is then constructed to fully record modification traces and operator identities. Finally, a multi-threaded data association engine is established to automatically associate the test data with the subject's information.

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

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

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

[0050] The foregoing description is merely a preferred embodiment of the present invention and is not intended to limit the present invention. Those skilled in the art will readily appreciate that various modifications and variations of the present invention are possible. Any modifications, equivalent substitutions, or improvements made within the spirit and principles of the present invention are intended to be 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 results; characterized in that: Including sample management module, data interpretation module, report generation module and 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 conclusion; The report generation module is used to automatically generate a corresponding report based on the gene methylation detection results.

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 detected subjects; The gene methylation information of a single tested subject includes identity information, at least one sample barcode, and a test result corresponding to the single sample barcode; the test 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 test serial number generation unit and an information management unit; The information importing unit is used to import gene methylation detection sample information and generate a unique code for a single gene methylation detection sample information; The detection serial number generating unit is used to automatically generate a corresponding detection serial number according to the unique code of the single gene methylation detection sample information; The information management unit queries the information of the tested samples according to 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, and generates a report and exports the information.

4. The gene methylation detection result interpretation system according to any one of claims 1 to 3, characterized in that: Also includes background management module; The background management module is used to customize the key values in the sample management module and manage the models of PCR amplifiers that can export data in the data interpretation module.

5. The gene methylation detection result interpretation system according to claim 4, characterized in that: Customize and edit the key values in the sample management module as follows: Assign the corresponding position of the target_Ct and / or internal standard_Ct in the test serial number without actual test data to A1; Assign the standard value used to judge whether the internal standard _Ct is normal to B1; The standard value used to judge whether the △Ct value is positive is assigned to B2; Assign the standard value of the amplified negative quality control product to C1; Assign the standard value of the amplified positive quality control product to C2; Assign the standard value of the negative quality control product to C3; Assign the standard value of the transformed positive quality control product to C4; The standard value used to judge whether the target fluorescence value and / or the internal standard fluorescence value is normal is assigned as D1.

6. The gene methylation detection result interpretation system according to claim 5, characterized in that: The data interpretation module includes a first interpretation unit and a second interpretation unit, and the analysis logics of the first interpretation unit and the second interpretation unit are different from each other.

7. The gene methylation detection result interpretation system according to claim 6, characterized in that: 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 in the test result corresponding to the unique test serial number corresponding to any tested subject in the sample management module, and organize the extracted target_Ct and internal standard_Ct into a table including a test serial number column and a target_Ct column and internal standard_Ct column corresponding to the current test serial number column; Step 2: Check the test serial number column and the target_Ct column and internal standard_Ct column corresponding to the test serial number column. If both the target_Ct column and the internal standard_Ct column corresponding to the test serial number column have corresponding test values, proceed to step 3. If any of the columns corresponding to the test serial number column does not have a corresponding test value, assign it the A1 value so that the values of the target_Ct column and the internal standard_Ct column can be analyzed separately in the future. Step 3: Determine whether the value of the internal standard _Ct is normal; the details are as follows: When internal standard_Ct≤B1, the internal standard_Ct is judged to be normal, that is, the internal standard_Ct enters step 4 for further analysis; When internal standard_Ct>B1, the internal standard_Ct data is judged to be an invalid value, that is, the internal standard_Ct will not be used for subsequent analysis; Step 4: Calculate the ΔCt value using the following formula for normal data of the internal standard _Ct: ΔCt = target_Ct - internal standard_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 judged as negative.

8. The gene methylation detection result interpretation system according to claim 6, characterized in that: The specific process of using the second interpretation unit to interpret the gene methylation detection sample information is as follows: Step ①, extracting the target_Ct, internal standard_Ct, target fluorescence value and internal standard fluorescence value in the test result corresponding to the unique test serial number corresponding to any tested subject in the sample management module, and arranging the extracted target_Ct, internal standard_Ct, target fluorescence value and internal standard fluorescence value into a table including a test serial number column and a target_Ct column, internal standard_Ct column, target fluorescence value column and internal standard fluorescence value column corresponding to the current test serial number column; Step ②, check the test serial number column and the target_Ct column and internal standard_Ct column corresponding to the test serial number column. When the target fluorescence value and / or internal standard fluorescence value ≥ D1, proceed to step ③ for further analysis; when the target fluorescence value and / or internal standard fluorescence value < D1, assign the corresponding target_Ct and / or internal standard_Ct value A1; When the internal standard_Ct≤B1, the internal standard is judged to be normal, that is, the internal standard_Ct enters step ③ for further analysis; when the internal standard_Ct>B1, the internal standard_Ct is judged to be invalid, that is, the internal standard_Ct will not be subjected to subsequent analysis; Step 3: Calculate the ΔCt value and fluorescence value ratio using the following formula for the data with normal internal standard _Ct; ΔCt = target_Ct - internal standard_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 follows: When △Ct≤B2 and target fluorescence value / internal standard fluorescence value≥B3, the result is interpreted as positive; When △Ct≤B2 and target fluorescence value / internal standard fluorescence value<B3, the result is interpreted as retest; when △Ct>B2, the result is interpreted as negative.

9. The gene methylation detection result interpretation system according to claim 7 or 8, characterized in that: The data interpretation module further 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.

10. The gene methylation detection result interpretation system according to claim 9, characterized in that: The data interpretation module also includes a difference data prompting unit, which is used to highlight abnormal data by establishing abnormal matching warning rules.

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