Data processing method and device, equipment and medium

Abstract

The invention discloses a data processing method, device and equipment and a storage medium, and the method comprises the steps: obtaining a concentration test value of a quality control sample, and determining a target quality control result according to the concentration test value of the quality control sample, the concentration test value of the quality control sample being determined based on a preset original standard curve; when the target quality control result represents that the quality control is unqualified, determining a concentration test value of a calibration product based on the original standard curve, and adjusting the original standard curve according to the concentration test value of the calibration product and the concentration standard value of the calibration product to obtain a calibration standard curve; and updating the preset original standard curve into the corrected standard curve, carrying out data processing based on the corrected standard curve, correcting the preset standard curve through a calibrator when the quality control result of the quality control sample represents that the quality control sample is unqualified, and determining the quality control result of the quality control sample according to the corrected standard curve under the condition that the standard curve is arranged in the flow cytometer. The sample concentration test accuracy and the test efficiency are improved.

Description

Technical Field

[0001] The present invention relates to the field of data processing technology, and in particular to a data processing method, device, equipment and medium. Background Art

[0002] Flow cytometry can perform fast, accurate, multi-parameter, high-throughput detection and analysis of cells or particles of similar size to cells. It is widely used in many fields such as cell biology, molecular biology, immunology, hematology, oncology, genetics, pharmacy, botany, marine biology, clinical medicine, etc. Its working principle is to use laser to excite fluorescently labeled particles, detect the scattered light and fluorescence signals generated by them, and thus reflect the various parameters of the particles. The particles enter the flow chamber filled with sheath fluid under gas pressure, and the signal is excited by the laser, amplified by the photomultiplier tube, and analyzed by the computer system. Flow fluorescence technology uses coded microspheres to capture the molecules to be tested in the solution, and uses flow cytometers for detection and analysis. At present, this technology has been widely used in immunoassay, nucleic acid research, enzymatic analysis, receptor and ligand recognition, etc., and has been highly recognized by various institutions and the medical community.

[0003] The outstanding features of flow cytometers are that they can perform high-speed and efficient multi-index joint testing, can analyze both proteins and nucleic acids, are suitable for both clinical testing and scientific research, and can perform qualitative or quantitative analysis with high-sensitivity fluorescence. In addition, the sample volume required for testing is extremely small, making them particularly suitable for multi-index analysis of some precious samples. Unlike platforms such as chemiluminescence that have built-in calibration curves and automatically report the concentration values ​​of the tested samples, when using flow cytometers to test each batch of samples, calibration products need to be tested at the same time to obtain a standard curve, and the mean fluorescence intensity (MFI) value reported by the instrument needs to be entered into the data analysis software. The MFI value must be back-calculated with the standard curve to obtain the final sample concentration test value, and the data processing and calculation methods are complex. Summary of the invention

[0004] The present invention provides a data processing method, device, equipment and medium to solve the technical problems of complex measurement method and low accuracy when the existing flow cytometer analyzes the fluorescent signal on the coded microsphere.

[0005] According to one aspect of the present invention, there is provided a data processing method, comprising:

[0006] Obtaining a quality control sample concentration test value of the quality control sample, and determining a target quality control result according to the quality control sample concentration test value, wherein the quality control sample concentration test value is determined based on a preset original standard curve;

[0007] When the target quality control result indicates that the quality control is unqualified, determining a calibrator concentration test value of the calibrator based on the original standard curve, adjusting the original standard curve according to the calibrator concentration test value and the calibrator concentration standard value to obtain a correction standard curve;

[0008] The preset original standard curve is updated to the calibration standard curve, so as to perform data processing based on the calibration standard curve.

[0009] Optionally, based on the above solution, determining the target quality control result according to the quality control sample concentration test value includes:

[0010] Evaluate the concentration test value of the quality control sample based on the set quality control rules;

[0011] When the test value of the quality control sample concentration exceeds the set quality control threshold, the initial quality control result is evaluated, and the target quality control result is determined according to the evaluation result.

[0012] Optionally, based on the above solution, the initial quality control result is evaluated, and the target quality control result is determined according to the evaluation result, including:

[0013] Acquire the core test parameters of the quality control sample as the first test parameters, and the test parameters of the original standard curve as the second test parameters;

[0014] Determining whether the first test parameter is consistent with the second test parameter;

[0015] If the first test parameter is consistent with the second test parameter, it is determined that the target quality control result indicates that the quality control is unqualified.

[0016] Optionally, based on the above solution, it also includes:

[0017] If the first test parameter is inconsistent with the second test parameter, the first test parameter is adjusted to the second test parameter, the quality control sample is retested, and the target quality control result is re-determined based on the retest result of the quality control sample.

[0018] Optionally, based on the above scheme, the core test parameters include test kit parameters, test environment parameters and test equipment parameters.

[0019] Optionally, based on the above scheme, the calibrator concentration test value of the calibrator is determined based on the original standard curve, and the original standard curve is adjusted according to the calibrator concentration test value and the calibrator concentration standard value to obtain a correction standard curve, including:

[0020] Determining a concentration value deviation between the calibrator concentration test value and the calibrator concentration standard value;

[0021] When the concentration value deviation is within the set deviation threshold, the original standard curve is corrected to obtain the corrected standard curve;

[0022] When the concentration value deviation is not within the set deviation threshold, recalibration is performed to obtain the calibration standard curve.

[0023] Optionally, based on the above scheme, the calibration of the original standard curve includes:

[0024] A compensation curve is generated according to the calibrator concentration test value and the calibrator concentration standard value, and the original standard curve is corrected based on the compensation curve.

[0025] According to another aspect of the present invention, there is provided a data processing device, comprising:

[0026] A quality control result determination module, used for obtaining a quality control sample concentration test value of a quality control sample, and determining a target quality control result according to the quality control sample concentration test value, wherein the quality control sample concentration test value is determined based on a preset original standard curve;

[0027] A calibration curve determination module, for determining a calibration substance concentration test value of the calibrator based on the original standard curve when the target quality control result indicates that the quality control is unqualified, and adjusting the original standard curve according to the calibrator concentration test value and the calibrator concentration standard value to obtain a calibration standard curve;

[0028] The standard curve updating module is used to update the preset original standard curve to the calibration standard curve, so as to perform data processing based on the calibration standard curve.

[0029] According to another aspect of the present invention, an electronic device is provided, the electronic device comprising:

[0030] at least one processor; and

[0031] a memory communicatively connected to the at least one processor; wherein,

[0032] The memory stores a computer program that can be executed by the at least one processor, and the computer program is executed by the at least one processor so that the at least one processor can perform the data processing method described in any embodiment of the present invention.

[0033] According to another aspect of the present invention, a computer-readable storage medium is provided, wherein the computer-readable storage medium stores computer instructions, and the computer instructions are used to enable a processor to implement the data processing method described in any embodiment of the present invention when executed.

[0034] The technical solution of the embodiment of the present invention is to obtain a quality control sample concentration test value of a quality control sample, and determine a target quality control result according to the quality control sample concentration test value, wherein the quality control sample concentration test value is determined based on a pre-set original standard curve; when the target quality control result indicates that the quality control is unqualified, determine a calibrator concentration test value of the calibrator based on the original standard curve, adjust the original standard curve according to the calibrator concentration test value and the calibrator concentration standard value, and obtain a correction standard curve; update the pre-set original standard curve to the correction standard curve, and perform data processing based on the correction standard curve, and by correcting the pre-set standard curve through the calibrator when the quality control result of the quality control sample indicates that it is unqualified, when the standard curve is built into the flow cytometer, the sample concentration test accuracy and test efficiency are improved.

[0035] It should be understood that the contents described in this section are not intended to identify the key or important features of the embodiments of the present invention, nor are they intended to limit the scope of the present invention. Other features of the present invention will become easily understood through the following description. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the following briefly introduces the drawings required for use in the description of the embodiments. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work.

[0037] Figure 1 is a flow chart of a data processing method provided according to Embodiment 1 of the present invention;

[0038] Figure 2a is a flow chart of a data processing method provided according to Embodiment 2 of the present invention;

[0039] Figure 2b It is a schematic diagram of a standard curve of item-1 provided in Example 2 of the present invention;

[0040] Figure 2c It is a schematic diagram of a standard curve of item-2 provided in Example 2 of the present invention;

[0041] Figure 3 is a structural schematic diagram of a data processing device provided according to Embodiment 3 of the present invention;

[0042] Figure 4 It is a schematic diagram of the structure of an electronic device provided according to Embodiment 4 of the present invention. DETAILED DESCRIPTION

[0043] In order to enable those skilled in the art to better understand the scheme of the present invention, the technical scheme in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work should fall within the scope of protection of the present invention.

[0044] It should be noted that the terms "first", "second", etc. in the specification and claims of the present invention and the above-mentioned drawings are used to distinguish similar objects, and are not necessarily used to describe a specific order or sequence. It should be understood that the data used in this way can be interchanged where appropriate, so that the embodiments of the present invention described herein can be implemented in an order other than those illustrated or described herein. In addition, the terms "including" and "having" and any variations thereof are intended to cover non-exclusive inclusions, for example, a process, method, system, product or device that includes a series of steps or units is not necessarily limited to those steps or units that are clearly listed, but may include other steps or units that are not clearly listed or inherent to these processes, methods, products or devices.

[0045] Embodiment 1

[0046] Figure 1 This is a flow chart of a data processing method provided according to the first embodiment of the present invention. This embodiment is applicable to the case where a flow cytometer is used for testing. The method can be executed by a data processing device. The data processing device can be implemented in the form of hardware and / or software. The data processing device can be configured in an electronic device, such as a flow cytometer. That is, the data processing method provided by the embodiment of the present invention can be applied to a flow cytometer. Figure 1 As shown, the method includes:

[0047] S110, obtaining a quality control sample concentration test value of the quality control sample, and determining a target quality control result according to the quality control sample concentration test value, wherein the quality control sample concentration test value is determined based on a preset original standard curve.

[0048] In this embodiment, a standard curve is pre-built into the flow cytometer, so that after the fluorescence intensity of the test sample is measured, the concentration value of the test sample can be directly calculated based on the built-in standard curve and the fluorescence intensity obtained by the test. However, considering that the built-in standard curve may be inaccurate due to instrument reasons, sample reasons, equipment reasons, etc., affecting the accuracy of the concentration value of the test sample, the accuracy of the standard curve is judged by quality control of the test sample. Optionally, the accuracy of the standard curve can be judged by obtaining part of the test samples as quality control samples and by daily monitoring and analyzing the test results of the quality control samples (quality control sample concentration test values). Among them, the quality control samples can be test samples randomly selected or set within the test cycle, such as protein samples, nucleic acid samples, antigen samples, cytokine samples, etc.

[0049] Exemplarily, a test sample having a solution concentration of a set concentration can be selected from the test samples within a set time period as a quality control sample. The specific set concentration can be set based on actual needs. For example, the solution concentration of the test sample can be randomly selected as the set concentration, and a sample can be randomly selected from the test sample as a quality control sample; the set concentration can also be set to the lowest and highest values ​​of the solution concentration of the test sample, and the samples with the lowest and highest solution concentrations of the test sample can be selected as quality control samples; the set concentration can also be set to the middle value of the solution concentration of the test sample, and the sample with the test sample solution concentration at the middle value can be selected as the quality control sample, etc., and there is no limitation here. Exemplarily, the set concentration can be set to 8pg / mL and 200pg / mL, and test samples with solution concentrations of 8pg / mL and 200pg / mL can be obtained as quality control samples.

[0050] After determining the quality control samples and obtaining the quality control sample concentration test values ​​of the quality control samples, determine the quality control results according to the set quality control rules, and adjust the standard curve when the quality control results indicate that the quality control is unqualified, so that the concentration values ​​of the test samples determined based on the adjusted standard curve are more accurate.

[0051] In one embodiment of the present invention, determining a target quality control result according to the quality control sample concentration test value includes:

[0052] Evaluate the concentration test value of the quality control sample based on the set quality control rules;

[0053] When the test value of the quality control sample concentration exceeds the set quality control threshold, the quality control result is evaluated and the quality control result is determined according to the evaluation result.

[0054] Optionally, the quality control sample concentration test value of the quality control sample can be quality controlled by an existing quality control method, such as the Jennings (Levi-Jennings) control method, the Westgard (Westgard) multi-rule quality control method, etc., to obtain the quality control results of the quality control sample. Preferably, the quality control sample concentration test value of the quality control sample can be quality controlled by the Westgard multi-rule quality control method. Westgard has developed error detection characteristic curves for various control rules based on probability theory. The curve reflects the sensitivity of the rule to the detection of unstable errors, and the possibility of misreporting a stable state error as a false out-of-control report, that is, the specificity of error detection, which can accurately evaluate the quality control sample concentration test value of the quality control sample from multiple dimensions.

[0055] After obtaining the initial quality control result of the quality control sample, the quality control result can be compared with the set quality control threshold, and the target quality control result can be determined according to the comparison result. In one embodiment, the initial quality control result can be directly used as the target quality control result. When the quality control result exceeds the set quality control threshold, it is determined that the error of the quality control sample concentration test value of the quality control sample is large, and the initial quality control result indicates that the quality control is unqualified, that is, the target quality control result indicates that the quality control is unqualified. When the quality control is unqualified, it is necessary to calibrate the pre-set standard curve, and the test sample concentration is measured by the calibrated standard curve; when the quality control result is within the set quality control threshold, it is determined that the error of the quality control sample concentration test value of the quality control sample is not large, and the initial quality control result indicates that the quality control is qualified, that is, the target quality control result indicates that the quality control is qualified. When the target quality control result indicates that the quality control is qualified, the pre-set standard curve can continue to be used to measure the test sample concentration. Optionally, the initial quality control results may include parameters such as relative deviation and coefficient of variation. A corresponding quality control threshold may be set for each parameter, and each parameter may be compared with its corresponding quality control threshold to determine the quality control result of the quality control sample.

[0056] By performing quality control on quality control samples, we can monitor whether the built-in standard curve is invalid and whether there are systematic errors or random errors. When abnormal results are observed, we can take corresponding corrective measures to avoid uncertain analysis that affects the timeliness of the report and to avoid reporting results when the quality control exceeds the predetermined range, which affects the accuracy of the sample results.

[0057] On the basis of the above scheme, considering that the quality control of the quality control sample may fail due to the change of the test parameters, after obtaining the quality control results, the quality control results are evaluated, and the rationality of the initial quality control results is determined based on the evaluation results. On the basis of the above scheme, the evaluation of the initial quality control results and the determination of the target quality control results based on the evaluation results include:

[0058] Acquire the core test parameters of the quality control sample as the first test parameters, and the test parameters of the original standard curve as the second test parameters;

[0059] Determining whether the first test parameter is consistent with the second test parameter;

[0060] If the first test parameter is consistent with the second test parameter, it is determined that the target quality control result indicates that the quality control is unqualified.

[0061] Among them, the core test parameters include test kit parameters, test environment parameters and test equipment parameters. The test kit, environment and test equipment can all have a significant impact on the test results of the test sample. Based on this, the test kit parameters, test environment parameters and test equipment parameters are used as core test parameters. Specifically, the test kit parameters may include the test kit manufacturer and the test kit batch number, the test environment parameters may include ambient humidity and ambient temperature, and the test equipment parameters may include laser power, photomultiplier tube (PMT) voltage, and pipeline pressure. Accordingly, judging whether the first test parameter is consistent with the second test parameter may include: judging whether the laser power is lower than the calibration value, judging whether the PMT voltage changes, judging whether the pipeline is unobstructed, judging whether the sample flow rate is uniform, etc.

[0062] Optionally, the quality control results can be evaluated from the dimension of core test parameters. If the core test parameters used in the quality control sample test are consistent with the core test parameters used in the original standard curve construction, it means that the test environment, test equipment and other parameters used in the quality control sample test are the same as those used in the original standard solution test, and the error in the test result is not caused by the difference in core test parameters. The core test parameters will not affect the test result, indicating that the original standard curve affects the accuracy of the test result, that is, the target quality control result indicates that the quality control is unqualified, and the original standard curve needs to be adjusted.

[0063] In addition to the above solutions, it also includes:

[0064] If the first test parameter is inconsistent with the second test parameter, the first test parameter is adjusted to the second test parameter, the quality control sample is retested, and the target quality control result is re-determined based on the retest result of the quality control sample.

[0065] If the core test parameters used in the quality control sample test are inconsistent with the core test parameters used in the original standard curve construction, it means that the test environment, test equipment and other parameters when the quality control sample is tested are different from those when the original standard solution is tested. The inaccurate test results may be due to the different core test parameters. At this time, it is necessary to adjust the current test parameters to the original test parameters when the standard solution is tested, retest the quality control sample, and evaluate the quality control results based on the retest results.

[0066] By performing quality control on the quality control samples, when the quality control fails, it is necessary to calibrate the pre-set standard curve and calculate the concentration of the test samples using the calibrated standard curve. When the target quality control results indicate that the quality control is qualified, the pre-set standard curve can continue to be used to calculate the concentration of the test samples to avoid uncertain analysis when the standard curve fails, which affects the timeliness of the report and the accuracy of the sample results.

[0067] In the above scheme, when testing the test sample, the test sample is tested using a flow cytometer, and the test data is obtained as the test fluorescence intensity of the test sample, and the sample concentration test value of the test sample is determined according to the test sample fluorescence intensity and the standard curve. Optionally, the test sample can be directly tested once, and the data of the single test can be used as the test fluorescence intensity, or the test sample can be repeatedly tested multiple times, and the characteristic values ​​of the results of the multiple tests can be taken as the test fluorescence intensity of the test sample, such as taking the mean, median, etc. of the results of the multiple tests as the test fluorescence intensity of the test sample. Exemplarily, the test sample can be tested once to obtain the test result A, and the test result A can be used as the test fluorescence intensity of the test sample; the test sample can also be repeatedly tested n times, where n is a positive integer greater than 1, and the average of the n test results can be taken as the test fluorescence intensity of the test sample.

[0068] In order to avoid the need to calibrate first and then import the standard curve into the data analysis software before calculating the concentration when determining the concentration parameters of the test sample, in the present embodiment, the standard curve is determined in advance based on standard solutions of different concentrations, and the standard curve is built into the flow cytometer, so that the flow cytometer can directly determine the concentration parameters of the test sample based on the test fluorescence intensity and the pre-built-in standard curve after measuring the test fluorescence intensity of the test sample.

[0069] Optionally, the concentration parameter of the test sample is determined according to the test fluorescence intensity and a preset standard curve, which can be determined based on an existing concentration determination method, such as substituting the test fluorescence intensity into the curve equation of the standard curve to obtain the concentration test value of the test sample.

[0070] In an embodiment of the present invention, a standard solution can be tested in advance, and a standard curve can be generated based on the solution concentration of the standard solution and the test result of the standard solution. Optionally, the determination of the standard curve includes: testing multiple standard solutions to obtain the fluorescence intensity of each of the standard solutions, wherein the concentrations of the multiple standard solutions are different; drawing a relationship curve with the fluorescence intensity of the standard solution as the ordinate and the concentration of the standard solution as the abscissa; when the correlation coefficient corresponding to the relationship curve is higher than a set correlation threshold, the relationship curve is used as the standard curve.

[0071] Optionally, multiple standard solutions with different concentrations may be provided, and the standard solutions may be sampled and tested using a flow cytometer to obtain the fluorescence intensity of the standard solutions, and a standard curve may be drawn according to the concentration of the standard solutions and the fluorescence intensity of the standard solutions.

[0072] The difference multiples between adjacent concentrations of multiple standard solutions are set according to actual needs, such as a standard solution with a concentration difference of 2-5 times between adjacent standard curve samples. The number and concentration of standard solutions can be set based on actual needs and solution characteristics. For example, standard solutions with concentrations of 0, 2, 8, etc. can be obtained as multiple standard solutions, and the fluorescence intensity of each standard solution can be tested separately.

[0073] In this embodiment, for each standard solution, a single test can be performed on the standard solution, and the fluorescence intensity measured once is used as the fluorescence intensity of the standard solution; on this basis, in order to make the determination of the fluorescence intensity more accurate, the standard solution can be repeatedly tested multiple times, and the fluorescence intensity of the standard solution can be determined based on the fluorescence intensity obtained from the multiple tests. For example, the fluorescence intensity obtained from the multiple tests of the standard solution can be taken as a characteristic value as the fluorescence intensity of the standard solution. For example, the characteristic values ​​such as the mean and median of the fluorescence intensity obtained from the multiple tests of the standard solution can be used as the fluorescence intensity of the standard solution.

[0074] When drawing a standard curve, for each standard solution, the solution concentration of the standard solution can be used as the horizontal coordinate, and the fluorescence intensity of the standard solution can be used as the vertical coordinate to construct the coordinate points corresponding to the standard solution. The coordinate points corresponding to each standard solution can also be determined in the above manner. According to the coordinate points corresponding to each standard solution, the relationship curve between the solution concentration and the fluorescence intensity can be obtained. In order to ensure that the relationship curve can accurately characterize the relationship between the solution concentration and the fluorescence intensity, the correlation coefficient between the solution concentration and the fluorescence intensity can be further calculated. When the correlation coefficient is higher than the set correlation threshold, the relationship curve drawn is used as the standard curve; when the correlation coefficient is not higher than the set correlation threshold, the standard solution can be retested to draw the relationship curve until the correlation coefficient corresponding to the drawn relationship curve is higher than the set correlation threshold, and the standard curve is obtained. Among them, the setting of the correlation threshold can be set according to actual needs, such as the setting of the correlation threshold of the correlation coefficient can be set to 0.99, that is, when the correlation coefficient is set to> 0.99, the relationship curve drawn is used as the standard curve.

[0075] The relationship curve can be drawn by referring to the existing curve drawing methods, such as fitting the relationship curve based on the coordinate points, automatically drawing the gate to analyze the relationship curve, etc. The specific fitting method can be Logistic curve fitting, least squares fitting, spline interpolation, etc., which are not limited here. The calculation method of the correlation coefficient can also refer to the existing correlation coefficient calculation method, which is not limited here.

[0076] For example, assuming that the plurality of standard solutions include a standard solution A with a concentration of A, a standard solution B with a concentration of B, a standard solution C with a concentration of C, a standard solution D with a concentration of D, a standard solution E with a concentration of E, and a standard solution F with a concentration of F, and the fluorescence intensity of the standard solution A is measured to be A', the fluorescence intensity of the standard solution B is B', the fluorescence intensity of the standard solution C is C', the fluorescence intensity of the standard solution D is D', the fluorescence intensity of the standard solution E is E', and the fluorescence intensity of the standard solution F is F', then the coordinate point corresponding to the standard solution A is constructed as (A, A'), and the coordinate point corresponding to the standard solution B is constructed as ( The coordinate point corresponding to the standard solution C is (C, C'), the coordinate point corresponding to the standard solution D is (D, D'), the coordinate point corresponding to the standard solution E is (E, E'), and the coordinate point corresponding to the standard solution A is (F, F'). When drawing the relationship curve, the curve fitting can be performed based on the coordinate points (A, A'), (B, B'), (C, C'), (D, D'), (E, E') and (F, F') to obtain the relationship curve, and the correlation coefficient corresponding to the relationship curve is calculated. When the correlation coefficient is higher than the set correlation threshold, the fitted relationship curve is used as the standard curve. When the correlation coefficient is not higher than the set correlation threshold, the fluorescence intensity of the standard solution is retested to draw the relationship curve.

[0077] It should be noted that the standard solutions of multiple items can be tested in advance by the above method, and standard curves of multiple items can be drawn. When the concentration of the test sample is measured, the corresponding standard curve is determined based on the test items of the test sample.

[0078] S120. When the quality control result indicates that the quality control is unqualified, determine the calibrator concentration test value of the calibrator based on the original standard curve, adjust the original standard curve according to the calibrator concentration test value and the calibrator concentration standard value, and obtain a correction standard curve.

[0079] When the quality control result indicates that the quality control is unqualified, it means that the sample concentration test value calculated based on the original standard curve is inaccurate, and the original standard curve needs to be adjusted to calculate the concentration based on the corrected standard curve.

[0080] The adjustment of the original standard curve can be adjusted based on the test of the calibrator of a given concentration provided by the detection kit. It is understood that the calibrator concentration test value of the calibrator can be obtained according to the original standard curve, and the calibrator concentration standard value of the calibrator is given, and the original standard curve can be adjusted based on the deviation between the calibrator concentration test value and the calibrator concentration standard value.

[0081] In this embodiment, adjusting the original standard curve may include two methods: correction based on the preset original standard curve and recalibration. Recalibration may be retesting the standard solution and drawing the standard curve based on the test results, or resetting multiple standard solutions, testing the re-set standard solutions, and drawing the standard curve based on the test results.

[0082] Optionally, the deviation between the calibrator concentration test value and the calibrator concentration standard value can be used to determine which of the above methods is used to adjust the standard curve. Accordingly, the calibrator concentration test value of the calibrator is determined based on the original standard curve, and the original standard curve is adjusted according to the calibrator concentration test value and the calibrator concentration standard value to obtain a corrected standard curve, including:

[0083] Determining a concentration value deviation between the calibrator concentration test value and the calibrator concentration standard value;

[0084] When the concentration value deviation is within the set deviation threshold, the original standard curve is corrected to obtain the corrected standard curve;

[0085] When the concentration value deviation is not within the set deviation threshold, recalibration is performed to obtain the calibration standard curve.

[0086] The deviation threshold can be set in advance. When the concentration value deviation is less than the set deviation threshold, it means that the accuracy of the original standard curve has a certain reference value, and the standard curve can be calibrated directly. When the concentration value deviation exceeds the set deviation threshold, it means that the accuracy of the original standard curve is poor, and you can choose to recalibrate to get a new standard curve. Among them, the set deviation threshold can be set based on actual needs and is not limited here.

[0087] Based on the above scheme, the calibration of the original standard curve includes:

[0088] A compensation curve is generated according to the calibrator concentration test value and the calibrator concentration standard value, and the original standard curve is corrected based on the compensation curve.

[0089] Optionally, the coordinate points corresponding to each calibrator can be constructed based on the concentration test value and the concentration standard value of each calibrator, a relationship curve can be drawn based on the coordinate points corresponding to all calibrators as a compensation curve, and the original standard curve can be corrected based on the compensation curve. The method of drawing the compensation curve can refer to the method of drawing the standard curve in the above embodiment, which will not be repeated here.

[0090] The original standard curve can be corrected based on the compensation curve by: keeping the X coordinate on the original main curve unchanged, inversely calculating the corresponding compensated Y coordinate according to the compensation curve equation and the original standard curve equation, and fitting a new curve according to the X coordinate and the compensated Y coordinate as the corrected standard curve.

[0091] Adjusting the original standard curve using calibrators of known concentrations can further ensure the accuracy of the calibration standard curve.

[0092] S130: Update the preset original standard curve to the calibration standard curve, so as to perform data processing based on the calibration standard curve.

[0093] After obtaining the calibration standard curve, the built-in original standard curve is updated to the calibration standard curve. After the test sample is tested, the concentration value of the test sample is calculated according to the test fluorescence intensity of the test sample and the calibration standard curve.

[0094] The technical solution of the embodiment of the present invention obtains the quality control sample concentration test value of the quality control sample, and determines the target quality control result according to the quality control sample concentration test value, wherein the quality control sample concentration test value is determined based on a preset original standard curve; when the target quality control result indicates that the quality control is unqualified, the calibrator concentration test value of the calibrator is determined based on the original standard curve, and the original standard curve is adjusted according to the calibrator concentration test value and the calibrator concentration standard value to obtain a correction standard curve; the preset original standard curve is updated to the correction standard curve, and data processing is performed based on the correction standard curve, and when the quality control result of the quality control sample indicates that it is unqualified, the calibrator is used to correct the preset standard curve, and when the standard curve is built into the flow cytometer, the sample concentration test accuracy and test efficiency are improved.

[0095] Embodiment 2

[0096] Figure 2a 1 is a flow chart of a data processing method for a flow cytometer according to the second embodiment of the present invention. This embodiment provides a preferred embodiment based on the above embodiment. Figure 2a As shown, the method mainly includes:

[0097] First, generate a standard curve. Specifically, prepare at least 7 standard solutions with adjacent concentrations differing by 2-5 times. Use a flow cytometer to perform a sample test on the standard solution to be tested. Repeat the measurement for 3 times for each point. Draw a curve of the relationship between MFI and concentration, with the MFI value of the standard solution as the ordinate and the standard solution concentration value corresponding to the MFI value as the abscissa. The standard curve has a correlation coefficient of not less than 0.99.

[0098] Optionally, standard curves can be generated and built-in for multiple projects.

[0099] Exemplarily, Table 1 schematically shows the test results of the fluorescence intensity MFI of standard solutions of different concentrations of Item-1, Item-2, Item-3, Item-4 and Item-5.

[0100] Table 1

[0101]

[0102]

[0103] As shown in Table 1, each cell in Table 1 is the test result of its corresponding horizontal header (item) and its corresponding vertical name, such as a1 is the test result of the fluorescence intensity of D1 test of item-1. In Table 1, for the standard solution of the same concentration, three repeated sample addition tests were carried out. For example, for the standard solution of the same concentration, three repeated sample addition tests of D1, E1 and F1 were carried out. The mean of the test results (a1, a2 and a3) of the three sample addition tests was used as the fluorescence intensity MFI of the standard solution of this concentration under this item. Similarly, the mean of a4, a5 and a6 corresponds to the fluorescence intensity of the standard solution of this concentration under item-1, ..., and the mean of a25, a26 and a27 is used as the fluorescence intensity of the standard solution of its corresponding concentration under item-1. Through the above calculation method, the fluorescence intensity of the standard solution at different concentrations under different items can be obtained. Based on the concentration and fluorescence intensity of the standard solution, the coordinate points are constructed to obtain the coordinate points corresponding to each standard solution under each item, and the standard curve corresponding to each item is drawn.

[0104] Figure 2b is a schematic diagram of a standard curve of item-1 provided in Example 2 of the present invention, Figure 2c is a schematic diagram of a standard curve of item-2 provided in Example 2 of the present invention, Figure 2b The coordinate points are constructed using the data column corresponding to item-1 in Table 1, and the standard curve of item-1 is drawn. Figure 2c Use the data column corresponding to Item-2 in Table 1 to construct coordinate points and draw the standard curve of Item-2. Figure 2b and Figure 2cIn the figure, the horizontal axis is the concentration of the standard solution, and the vertical axis is the fluorescence intensity MFI of the standard solution. Similarly, the standard curves of Project-3, Project-4, and Project-5 can be drawn by constructing coordinate points based on the data columns corresponding to Project-3, Project-4, and Project-5, respectively.

[0105] After determining the standard curve, preset the original standard curve into the flow cytometer. When testing the sample, the instrument will substitute the sample's test value into the standard curve and automatically analyze and report the sample's concentration value. When the standard curve is built in, the key test parameters corresponding to the standard curve need to be built in at the same time, such as the name of the test kit, manufacturer, batch number, expiration date, and the corresponding position of the coded microspheres for multiple inspection items, and the PMT voltage used, the expiration date of the mobile phase and other information are ready for selection. When the instrument parameters (installation location) are the same (or close) to those of the laboratory, the laboratory's cumulative standard curve can be directly built into the instrument as the original standard curve. At this time, enter the reagent manufacturer, collection item, and reagent batch number to correspond to the unique batch number of the test kit.

[0106] When conducting daily quality control monitoring, you can select test samples with high and low concentrations as quality control samples for daily quality control monitoring. You can make statistics on the degree of compliance with the quality control according to the standards, and make warning signs when the quality control exceeds the preset quality control threshold. Make statistics on the quality control data and quality of daily testing, and make corresponding warning signs for data out of the range according to quality control rules.

[0107] Exemplarily, two levels of quality control, 8 pg / mL and 200 pg / mL, can be selected. The relative deviation RD of the test result mean and the labeled value can be set to not exceed ±10%. When the coefficient of variation CV is ≤15%, the quality control is judged to be under control; otherwise, the quality control is judged to be out of control.

[0108] Table 2

[0109]

[0110] Table 2 schematically shows the quality control data of Project-1. Specifically, the relative deviations RD of the quality control data of 8pg / mL and 200pg / mL levels of Project-1 were 6.5% and -9.2%, respectively, both less than ±10%, and the CV values ​​were 7.9% and 2.2%, respectively, both less than 15%. Therefore, the quality control level of Project-1 was under control.

[0111] When the quality control is not under control, the warning data and the corresponding reagent and instrument related information are retrieved as the key test parameters to determine whether the key test parameters are consistent with the key parameters during the built-in calibration. If not, the test parameters are adjusted to be consistent with the key parameters during the built-in calibration and retested; if consistent, the master curve can be corrected using the three given concentrations of low, medium and high provided in the detection kit. Specifically, the low value is the concentration near the cut-off, and the high value is the linear upper limit concentration point. The test values ​​of the above three calibrators are tested, and the test value deviation between the concentration test value of the calibrator and the concentration standard value. If the test value deviation is within the set deviation threshold (such as 30%), the standard curve is corrected. If the test value deviation exceeds the set deviation threshold, the instrument parameters are adjusted, such as maintaining the instrument, or recalibrating. Among them, the standard curve can be corrected as follows: a compensation curve is drawn based on the standard parameters of the calibrator, the X coordinate on the master curve is kept unchanged, and the corresponding compensated Y coordinate is calculated inversely according to the compensation curve equation and the standard curve equation, and a new working curve is obtained by fitting, that is, the three-point corrected standard curve is used as the corrected standard curve. If the reagent kit batch number is changed, recalibration is required. The built-in standard curve information is not limited to self-produced reagent kits and is compatible with the standard curves in all reagent kits on the market.

[0112] The embodiment of the present invention improves the concentration measurement efficiency of the test sample by presetting the standard curve in the flow cytometer, and monitors and analyzes the test results of the quality control products at two concentration levels on a daily basis, such as according to the Westgard multi-rule quality control method, to monitor whether the built-in standard curve is invalid and whether there is a systematic error or a random error. When abnormal results are observed, corresponding corrective measures can be taken to avoid uncertain analysis that affects the timeliness of the report and to avoid reporting the results even though the quality control exceeds the predetermined range, which affects the accuracy of the sample results.

[0113] Embodiment 3

[0114] Figure 3 1 is a schematic diagram of the structure of a data processing device provided according to Embodiment 3 of the present invention, and the data processing device can be applied to a flow cytometer. Figure 3 As shown, the device comprises:

[0115] The quality control result determination module 310 is used to obtain a quality control sample concentration test value of the quality control sample, and determine a target quality control result according to the quality control sample concentration test value, wherein the quality control sample concentration test value is determined based on a preset original standard curve;

[0116] A calibration curve determination module 320 is used to determine a calibration substance concentration test value of the calibrator based on the original standard curve when the target quality control result indicates that the quality control is unqualified, and to adjust the original standard curve according to the calibrator concentration test value and the calibrator concentration standard value to obtain a calibration standard curve;

[0117] The standard curve updating module 330 is used to update the preset original standard curve to the calibration standard curve, so as to perform data processing based on the calibration standard curve.

[0118] The technical solution of the embodiment of the present invention obtains the quality control sample concentration test value of the quality control sample, and determines the target quality control result according to the quality control sample concentration test value, wherein the quality control sample concentration test value is determined based on a preset original standard curve; when the target quality control result indicates that the quality control is unqualified, the calibrator concentration test value of the calibrator is determined based on the original standard curve, and the original standard curve is adjusted according to the calibrator concentration test value and the calibrator concentration standard value to obtain a correction standard curve; the preset original standard curve is updated to the correction standard curve, and data processing is performed based on the correction standard curve, and when the quality control result of the quality control sample indicates that it is unqualified, the calibrator is used to correct the preset standard curve, and when the standard curve is built into the flow cytometer, the sample concentration test accuracy and test efficiency are improved.

[0119] Optionally, based on the above solution, the quality control result determination module 310 is specifically used for:

[0120] Evaluate the concentration test value of the quality control sample based on the set quality control rules;

[0121] When the test value of the quality control sample concentration exceeds the set quality control threshold, the initial quality control result is evaluated, and the target quality control result is determined according to the evaluation result.

[0122] Optionally, based on the above solution, the quality control result determination module 310 is specifically used for:

[0123] Acquire the core test parameters of the quality control sample as the first test parameters, and the test parameters of the original standard curve as the second test parameters;

[0124] Determining whether the first test parameter is consistent with the second test parameter;

[0125] If the first test parameter is consistent with the second test parameter, it is determined that the target quality control result indicates that the quality control is unqualified.

[0126] Optionally, based on the above solution, the quality control result determination module 310 is further used to:

[0127] If the first test parameter is inconsistent with the second test parameter, the first test parameter is adjusted to the second test parameter, the quality control sample is retested, and the target quality control result is re-determined based on the retest result of the quality control sample.

[0128] Optionally, based on the above scheme, the core test parameters include test kit parameters, test environment parameters and test equipment parameters.

[0129] Optionally, based on the above solution, the calibration curve determination module 320 is specifically used for:

[0130] Determining a concentration value deviation between the calibrator concentration test value and the calibrator concentration standard value;

[0131] When the concentration value deviation is within the set deviation threshold, the original standard curve is corrected to obtain the corrected standard curve;

[0132] When the concentration value deviation is not within the set deviation threshold, recalibration is performed to obtain the calibration standard curve.

[0133] Optionally, based on the above solution, the calibration curve determination module 320 is specifically used for:

[0134] A compensation curve is generated according to the calibrator concentration test value and the calibrator concentration standard value, and the original standard curve is corrected based on the compensation curve.

[0135] The data processing device provided in the embodiment of the present invention can execute the data processing method provided in any embodiment of the present invention, and has the corresponding functional modules and beneficial effects of the execution method.

[0136] Embodiment 4

[0137] Figure 4 It is a schematic diagram of the structure of an electronic device provided according to Embodiment 4 of the present invention. Figure 4 A schematic diagram of the structure of an electronic device 10 that can be used to implement an embodiment of the present invention is shown. The electronic device is intended to represent various forms of digital computers, such as laptop computers, desktop computers, workstations, personal digital assistants, servers, blade servers, mainframe computers, and other suitable computers. The electronic device can also represent various forms of mobile devices, such as personal digital processing, cellular phones, smart phones, wearable devices (such as helmets, glasses, watches, etc.) and other similar computing devices. The components shown herein, their connections and relationships, and their functions are merely examples and are not intended to limit the implementation of the present invention described and / or required herein.

[0138] like Figure 4 As shown, the electronic device 10 includes at least one processor 11, and a memory connected to the at least one processor 11, such as a read-only memory (ROM) 12, a random access memory (RAM) 13, etc., wherein the memory stores a computer program that can be executed by at least one processor, and the processor 11 can perform various appropriate actions and processes according to the computer program stored in the read-only memory (ROM) 12 or the computer program loaded from the storage unit 18 to the random access memory (RAM) 13. In the RAM 13, various programs and data required for the operation of the electronic device 10 can also be stored. The processor 11, ROM 12 and RAM 13 are connected to each other through a bus 14. The input / output (I / O) interface 15 is also connected to the bus 14. Optionally, the electronic device can be a flow cytometer, which has components of a flow cytometer.

[0139] A number of components in the electronic device 10 are connected to the I / O interface 15, including: an input unit 16, such as a keyboard, a mouse, etc.; an output unit 17, such as various types of displays, speakers, etc.; a storage unit 18, such as a disk, an optical disk, etc.; and a communication unit 19, such as a network card, a modem, a wireless communication transceiver, etc. The communication unit 19 allows the electronic device 10 to exchange information / data with other devices through a computer network such as the Internet and / or various telecommunication networks.

[0140] The processor 11 may be a variety of general and / or special processing components with processing and computing capabilities. Some examples of the processor 11 include, but are not limited to, a central processing unit (CPU), a graphics processing unit (GPU), various dedicated artificial intelligence (AI) computing chips, various processors running machine learning model algorithms, a digital signal processor (DSP), and any appropriate processor, controller, microcontroller, etc. The processor 11 performs the various methods and processes described above, such as a data processing method.

[0141] In some embodiments, the data processing method may be implemented as a computer program, which is tangibly contained in a computer-readable storage medium, such as a storage unit 18. In some embodiments, part or all of the computer program may be loaded and / or installed on the electronic device 10 via the ROM 12 and / or the communication unit 19. When the computer program is loaded into the RAM 13 and executed by the processor 11, one or more steps of the data processing method described above may be performed. Alternatively, in other embodiments, the processor 11 may be configured to perform the data processing method in any other appropriate manner (e.g., by means of firmware).

[0142] Various implementations of the systems and techniques described above herein can be implemented in digital electronic circuit systems, integrated circuit systems, field programmable gate arrays (FPGAs), application specific integrated circuits (ASICs), application specific standard products (ASSPs), systems on chips (SOCs), load programmable logic devices (CPLDs), computer hardware, firmware, software, and / or combinations thereof. These various implementations can include: being implemented in one or more computer programs that can be executed and / or interpreted on a programmable system including at least one programmable processor, which can be a special purpose or general purpose programmable processor that can receive data and instructions from a storage system, at least one input device, and at least one output device, and transmit data and instructions to the storage system, the at least one input device, and the at least one output device.

[0143] Computer programs for implementing the methods of the present invention may be written in any combination of one or more programming languages. These computer programs may be provided to a processor of a general-purpose computer, a special-purpose computer, or other programmable data processing device, so that when the computer program is executed by the processor, the functions / operations specified in the flow chart and / or block diagram are implemented. The computer program may be executed entirely on the machine, partially on the machine, partially on the machine and partially on a remote machine as a stand-alone software package, or entirely on a remote machine or server.

[0144] In the context of the present invention, a computer-readable storage medium may be a tangible medium that may contain or store a computer program for use by or in combination with an instruction execution system, device or equipment. A computer-readable storage medium may include, but is not limited to, electronic, magnetic, optical, electromagnetic, infrared, or semiconductor systems, devices or equipment, or any suitable combination of the foregoing. Alternatively, a computer-readable storage medium may be a machine-readable signal medium. A more specific example of a machine-readable storage medium may include an electrical connection based on one or more lines, a portable computer disk, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or flash memory), an optical fiber, a portable compact disk read-only memory (CD-ROM), an optical storage device, a magnetic storage device, or any suitable combination of the foregoing.

[0145] To provide interaction with a user, the systems and techniques described herein may be implemented on an electronic device having: a display device (e.g., a CRT (cathode ray tube) or LCD (liquid crystal display) monitor) for displaying information to the user; and a keyboard and a pointing device (e.g., a mouse or trackball) through which the user can provide input to the electronic device. Other types of devices may also be used to provide interaction with the user; for example, the feedback provided to the user may be any form of sensory feedback (e.g., visual feedback, auditory feedback, or tactile feedback); and input from the user may be received in any form (including acoustic input, voice input, or tactile input).

[0146] The systems and techniques described herein may be implemented in a computing system that includes backend components (e.g., as a data server), or a computing system that includes middleware components (e.g., an application server), or a computing system that includes frontend components (e.g., a user computer with a graphical user interface or a web browser through which a user can interact with implementations of the systems and techniques described herein), or a computing system that includes any combination of such backend components, middleware components, or frontend components. The components of the system may be interconnected by any form or medium of digital data communication (e.g., a communication network). Examples of communication networks include: a local area network (LAN), a wide area network (WAN), a blockchain network, and the Internet.

[0147] A computing system may include a client and a server. The client and the server are generally remote from each other and usually interact through a communication network. The client and server relationship is generated by computer programs running on the corresponding computers and having a client-server relationship with each other. The server may be a cloud server, also known as a cloud computing server or cloud host, which is a host product in the cloud computing service system to solve the defects of difficult management and weak business scalability in traditional physical hosts and VPS services.

[0148] It should be understood that the various forms of processes shown above can be used to reorder, add or delete steps. For example, the steps described in the present invention can be executed in parallel, sequentially or in different orders, as long as the desired results of the technical solution of the present invention can be achieved, and this document does not limit this.

[0149] The above specific implementations do not constitute a limitation on the protection scope of the present invention. It should be understood by those skilled in the art that various modifications, combinations, sub-combinations and substitutions can be made according to design requirements and other factors. Any modification, equivalent substitution and improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A data processing method, characterized in that: include: Obtaining a quality control sample concentration test value of the quality control sample, and determining a target quality control result according to the quality control sample concentration test value, wherein the quality control sample concentration test value is determined based on a preset original standard curve; When the target quality control result indicates that the quality control is unqualified, determining the concentration test value of the calibrator based on the original standard curve, adjusting the original standard curve according to the calibrator concentration test value and the calibrator concentration standard value to obtain a correction standard curve; The preset original standard curve is updated to the calibration standard curve, so as to perform data processing based on the calibration standard curve.

2. The method according to claim 1, characterized in that Determining the target quality control result according to the quality control sample concentration test value includes: Evaluate the concentration test value of the quality control sample based on the set quality control rules; When the test value of the quality control sample concentration exceeds the set quality control threshold, the initial quality control result is evaluated, and the target quality control result is determined according to the evaluation result.

3. The method according to claim 2, characterized in that The step of evaluating the initial quality control result and determining the target quality control result according to the evaluation result includes: Acquiring the core test parameters of the quality control sample as the first test parameters, and the test parameters of the original standard curve as the second test parameters; Determining whether the first test parameter is consistent with the second test parameter; If the first test parameter is consistent with the second test parameter, it is determined that the target quality control result indicates that the quality control is unqualified.

4. The method according to claim 3, characterized in that Also includes: If the first test parameter is inconsistent with the second test parameter, the first test parameter is adjusted to the second test parameter, the quality control sample is retested, and the target quality control result is re-determined based on the retest result of the quality control sample.

5. The method according to claim 3, characterized in that: The core test parameters include test kit parameters, test environment parameters and test equipment parameters.

6. The method according to claim 1, characterized in that The method of determining the concentration test value of the calibrator based on the original standard curve, and adjusting the original standard curve according to the concentration test value of the calibrator and the standard value of the calibrator concentration to obtain a calibration standard curve includes: Determining a concentration value deviation between the calibrator concentration test value and the calibrator concentration standard value; When the concentration value deviation is within the set deviation threshold, the original standard curve is corrected to obtain the corrected standard curve; When the concentration value deviation is not within the set deviation threshold, recalibration is performed to obtain the calibration standard curve.

7. The method according to claim 6, characterized in that The correcting the original standard curve comprises: A compensation curve is generated according to the calibrator concentration test value and the calibrator concentration standard value, and the original standard curve is corrected based on the compensation curve.

8. A data processing device, characterized in that: include: A quality control result determination module, used for obtaining a quality control sample concentration test value of a quality control sample, and determining a target quality control result according to the quality control sample concentration test value, wherein the quality control sample concentration test value is determined based on a preset original standard curve; A calibration curve determination module, for determining a calibration substance concentration test value of the calibrator based on the original standard curve when the target quality control result indicates that the quality control is unqualified, and adjusting the original standard curve according to the calibrator concentration test value and the calibrator concentration standard value to obtain a calibration standard curve; The standard curve updating module is used to update the preset original standard curve to the calibration standard curve, so as to perform data processing based on the calibration standard curve.

9. An electronic device, characterized in that: The electronic device comprises: at least one processor; and a memory communicatively connected to the at least one processor; wherein, The memory stores a computer program executable by the at least one processor, and the computer program is executed by the at least one processor so that the at least one processor can perform the data processing method according to any one of claims 1 to 7.

10. A computer-readable storage medium, characterized in that: The computer-readable storage medium stores computer instructions, and the computer instructions are used to enable a processor to implement the data processing method according to any one of claims 1 to 7 when executed.

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