Sample analysis instrument quality control methods, devices, systems, and storage media

Abstract

The sample analysis instrument quality control method, device, system and storage medium disclosed by the embodiments of the present application comprise the following steps: under the condition that a preset quality control trigger condition is met, a target sample meeting a preset standard condition is screened from detected samples that have been detected according to a sample detection result measured by a sample analysis instrument; the target sample is transmitted to at least one other sample analysis instrument, the at least one other sample analysis instrument respectively sucks part of the sample from the target sample for analysis to obtain at least one group of detection data of the same type; consistency analysis is performed on the at least one other sample analysis instrument according to the at least one group of detection data to obtain a consistency analysis result of the at least one other sample analysis instrument; and when it is determined that one sample analysis instrument of the at least one other sample analysis instrument is out of control according to the consistency analysis result, an alarm prompt of the one sample analysis instrument is output.

Description

Technical Field

[0001] This invention relates to the field of in vitro diagnostics, and more particularly to a method, apparatus, system, and storage medium for quality control of sample analysis instruments. Background Technology

[0002] Currently, internal quality control requires specific control materials. The process of using these materials for quality control generally involves operations such as rewarming, mixing, and storage according to specific procedures after use, which makes the quality control process complex. In addition, in order to extend the shelf life of the control materials, a fixative is also needed to fix them. During the process of using these materials for quality control, the materials may become insensitive to abnormal conditions. For example, low-temperature dilution can cause inaccurate measurement of mean corpuscular volume (MCV) by a hematology analyzer, resulting in low accuracy of the quality control results.

[0003] Application content

[0004] To address the aforementioned technical problems, embodiments of the present invention aim to provide a method, apparatus, system, and storage medium for quality control of sample analysis instruments.

[0005] The technical solution of this invention is implemented as follows:

[0006] In a first aspect, embodiments of the present invention provide a quality control method for a sample analysis instrument, the method comprising:

[0007] Under the preset quality control trigger conditions, target samples that meet the preset standard conditions are selected from the already tested samples based on the sample test results measured by the sample analysis instrument.

[0008] The target sample is transmitted to at least one other sample analysis instrument, which then extracts a portion of the target sample for analysis to obtain at least one set of detection data of the same type. Each of the at least one other sample analysis instrument corresponds to one set of detection data. The at least one other sample analysis instrument is configured to perform at least one detection item of the same type on a portion of the target sample.

[0009] Based on the at least one set of detection data, a consistency analysis is performed on the other at least one sample analysis instrument to obtain the consistency analysis result of the other at least one sample analysis instrument;

[0010] When it is determined from the consistency analysis results that one of the other at least one sample analysis instrument is out of control, an alarm message for that sample analysis instrument is output.

[0011] Secondly, embodiments of the present invention provide a quality control device for a sample analysis instrument, the sample analysis instrument quality control device comprising:

[0012] The screening unit is used to screen target samples that meet preset standard conditions from the already tested samples based on the sample test results measured by the sample analysis instrument, under preset quality control trigger conditions.

[0013] A data detection unit is used to transmit the target sample to at least one other sample analysis instrument, so that each of the other at least one sample analysis instrument can extract a portion of the target sample for analysis to obtain at least one set of detection data of the same type; each of the other at least one sample analysis instrument corresponds to a set of detection data; the other at least one sample analysis instrument is configured to perform at least one detection item of the same type on a portion of the target sample;

[0014] A consistency analysis unit is used to perform consistency analysis on the other at least one sample analysis instrument based on the at least one set of detection data, and obtain the consistency analysis result of the other at least one sample analysis instrument;

[0015] The prompting unit is used to output an alarm prompt for one of the sample analyzers when it is determined from the consistency analysis results that one of the other at least one sample analyzer is out of control.

[0016] Thirdly, embodiments of the present invention provide a sample detection system, the sample detection system comprising: a sample analysis instrument, a control system, and a data management system;

[0017] The control system is used to, under preset quality control triggering conditions, control the selection of target samples that meet preset standard conditions from the already tested samples based on the sample test results measured by the sample analysis instrument; and control the scheduling device to transmit the target samples to at least one other sample analysis instrument, wherein the other at least one sample analysis instrument is configured to perform at least one of the same type of test items on a portion of the target samples.

[0018] The other at least one sample analysis instrument is used to extract a portion of the sample from the target sample for analysis, and obtain at least one set of detection data of the same type; each of the other at least one sample analysis instrument corresponds to one set of detection data;

[0019] The data management system is used to acquire the at least one set of detection information, perform consistency analysis on the other at least one sample analysis instrument based on the at least one set of detection data, and obtain the consistency analysis result of the other at least one sample analysis instrument.

[0020] The control system is further configured to output an alarm message for the sample analyzer when it is determined, based on the consistency analysis results, that one of the other at least one sample analyzer is out of control.

[0021] Fourthly, embodiments of the present invention provide a storage medium storing a computer program applied to a sample detection system, wherein the computer program, when executed by a processor, implements the method described in any of the preceding claims.

[0022] This invention provides a method, apparatus, system, and storage medium for quality control of sample analysis instruments. The method includes: under preset quality control triggering conditions, selecting target samples that meet preset standard conditions from the already tested samples based on the sample detection results measured by the sample analysis instrument; transmitting the target samples to at least one other sample analysis instrument, whereby each of the other sample analysis instruments extracts a portion of the target samples for analysis, obtaining at least one set of detection data of the same type; each of the other sample analysis instruments corresponds to one set of detection data; the other sample analysis instruments are configured to perform at least one detection item of the same type on a portion of the target samples; performing consistency analysis on the other sample analysis instruments based on the at least one set of detection data to obtain consistency analysis results for the other sample analysis instruments; and outputting an alarm prompt for one of the other sample analysis instruments when the consistency analysis results determine that one of the other sample analysis instruments is out of control. Using the above method, consistency analysis of the target sample with at least one other sample analysis instrument is performed without the need for long-term sample storage. The sample analysis instrument can automatically screen the target sample, transfer it to at least one other sample analysis instrument, and perform consistency analysis based on at least one set of test data, simplifying the quality control process. At the same time, the sample can sense abnormal conditions, and using the target sample to perform consistency analysis with at least one other sample analysis instrument can improve the accuracy of the quality control results. Attached Figure Description

[0023] Figure 1 A flowchart of a sample analysis instrument quality control method provided in this embodiment of the invention. Figure 1 ;

[0024] Figure 2 This is a schematic diagram illustrating the process of a sample detection system performing consistency analysis on a sample analysis instrument, as provided in an embodiment of the present invention.

[0025] Figure 3A schematic diagram of the variation curves of an exemplary sample analysis instrument in different ranges of MCV parameters, provided for an embodiment of the present invention;

[0026] Figure 4 A schematic diagram illustrating the comparison display results between an exemplary C1 RBC machine and a standard sample analysis instrument, provided as an embodiment of the present invention;

[0027] Figure 5 This is a schematic diagram of the structure of a quality control device for a sample analysis instrument provided in an embodiment of the present invention;

[0028] Figure 6 This is a schematic diagram of the structure of a sample detection system provided in an embodiment of the present invention. Detailed Implementation

[0029] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the specific technical solutions of the invention will be further described in detail below with reference to the accompanying drawings of the embodiments of the present invention. The following embodiments are used to illustrate this application, but are not intended to limit the scope of this application.

[0030] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein is for the purpose of describing embodiments of the invention only and is not intended to be limiting of the application.

[0031] In the following description, references are made to “some embodiments,” which describe a subset of all possible embodiments. However, it is understood that “some embodiments” may be the same subset or different subsets of all possible embodiments and may be combined with each other without conflict.

[0032] It should be noted that the terms "first, second, and third" used in the embodiments of the present invention are merely used to distinguish similar objects and do not represent a specific ordering of objects. It is understood that "first, second, and third" can be interchanged in a specific order or sequence where permitted, so that the embodiments of the present invention described herein can be implemented in an order other than that illustrated or described herein.

[0033] To address the aforementioned problems, embodiments of the present invention provide a quality control method for sample analysis instruments, such as... Figure 1 As shown, the method may include:

[0034] S101. Under the preset quality control triggering conditions, based on the sample detection results measured by the sample analysis instrument, select target samples that meet the preset standard conditions from the already tested samples.

[0035] Sample analysis instruments can include blood cell analyzers, C-reactive protein (CRP) analyzers, and glycation end products (GEP) analyzers in a sample testing system. The system also includes transmission devices and a data management system. The transmission device connects the various sample analysis instruments in the system, and the data management system controls the transmission device to transfer samples to each instrument for analysis.

[0036] It should be noted that the test samples and target samples proposed in the embodiments of this application can be ethylenediaminetetraacetic acid (EDTA) samples from blood routine tests, serum samples from biochemical and immunological tests, sodium citrate anticoagulation samples from coagulation tests, etc.

[0037] In one optional embodiment, a sample analysis instrument is pre-selected from the sample detection system. This instrument is used to screen target samples from the tested samples that meet preset standard conditions. Specifically, the user pre-sets quality control trigger conditions, including preset load conditions and / or preset time intervals. The sample detection system acquires the load of the sample detection system and / or the quality control time interval of the sample analysis instrument in real time, and compares the load of the sample detection system with the preset load conditions, and / or compares the quality control time interval with the preset quality control time interval. If it is determined that the load of the sample detection system meets the preset load conditions, and / or the quality control time interval is greater than or equal to the preset quality control time interval, the sample detection system determines that the preset quality control trigger conditions are met.

[0038] The preset load conditions in the preset quality control trigger conditions may include: the preset number of sample analysis instruments, the number of sample detection systems, and the maximum number of samples that the sample detection system can detect. The sample detection system obtains the number of sample analysis instruments currently without samples to be analyzed. When this number is greater than the preset number of sample analysis instruments, the sample detection system determines that the preset quality control trigger conditions are met. Alternatively, the sample detection system obtains the number of samples currently to be analyzed. When this number is less than the number of sample detection systems, the sample detection system determines that the preset quality control trigger conditions are met. Finally, the sample detection system obtains the number of samples analyzed within a preset historical time period. When this number is less than the maximum number of samples that the sample detection system can detect, the sample detection system determines that the preset quality control trigger conditions are met.

[0039] It should be noted that the preset load conditions can be obtained by increasing or decreasing the number of sample analysis instruments, the number of sample detection systems, and the maximum number of samples that the sample detection system can detect by a certain factor.

[0040] For example, the preset load conditions include the following three:

[0041] 1. In the sample detection system, at least one sample analysis instrument has no sample to be analyzed, and this one sample analysis instrument is the preset number of sample analysis instruments;

[0042] 2. The number of samples to be analyzed in the sample detection system is less than or equal to X * the number of sample detection systems, where X is a positive integer;

[0043] 3. The number of samples analyzed within the past N minutes is less than the maximum number of samples that the sample detection system can detect, %M, where N and M are both positive integers.

[0044] Optionally, the quality control time interval in the preset quality control trigger conditions can be a fixed time, such as 8:00 AM, 12:00 PM, or 4:00 PM every day, or set to Monday or Friday of the week; the quality control time interval in the preset quality control trigger conditions can also be the time interval since the previous round of sample analysis instrument quality control, such as performing sample analysis instrument quality control once every other day; the quality control time interval in the preset quality control trigger conditions can also be determined according to the detection frequency of sample analysis instrument, such as performing sample analysis instrument quality control when the detection frequency of sample analysis instrument is less than the detection frequency of 5 tubes of blood samples per hour. The specific selection can be made according to the actual situation, and the embodiments of the present invention do not impose specific limitations.

[0045] It should be noted that the sample analysis instrument quality control start indicator can also be displayed on the visual interface. When a touch operation is received on the sample analysis instrument quality control indicator, the sample analysis instrument quality control process is triggered. At this time, the sample analysis instrument performs sample testing on the test sample and selects target samples that meet the preset standard conditions from the test samples that have been tested based on the measured sample test results.

[0046] Once the preset quality control trigger conditions are met, the control transmission device inputs the test sample into the sample analysis instrument. The sample analysis instrument performs sample testing on the test sample and, based on the measured sample test results, selects target samples that meet the preset standard conditions from the test samples that have already been tested.

[0047] It should be noted that the user pre-sets the preset standard conditions for the target samples used for consistency analysis, including: preset sample size threshold, monitoring parameters and their corresponding parameter ranges, anomaly information, re-inspection rules, etc. The sample analysis instrument performs sample testing on the test samples and obtains sample test results corresponding to the preset standard conditions. Specifically, the sample analysis instrument first determines the sample size for testing; when the sample size for testing is greater than or equal to the preset sample size threshold, the sample analysis instrument selects samples from the sample test results that meet the parameter range of the monitoring parameters as target samples; and / or selects samples from the sample test results that include anomaly information as quality control samples; and / or selects samples from the sample test results that meet the re-inspection rules as quality control samples.

[0048] Specifically, the sample analyzer detects the monitoring parameter values ​​of the sample, the alarm information of the sample, and / or the re-inspection status of the sample detection system. When the monitoring parameter values ​​of the sample meet the parameter range of the monitoring parameters, and / or when the alarm information of the sample includes abnormal information, and / or when the re-inspection status meets the re-inspection rules, the sample is identified as the target sample.

[0049] Optionally, the monitoring parameters can be white blood cells (WBC), red blood cells (RBC), hemoglobin (HGB), red blood cell specific volume (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), and blood platelets (PLT), etc. The corresponding parameter ranges can be 9.5 > WBC > 3.5, 5.8 > RBC > 3.8, 175 > HGB > 115, 0.35 > HCT > 0.50, 100 > MCV > 82, 34 > MCH > 27, 354 > MCHC > 316, and 350 > PLT > 125.

[0050] Optionally, alarm information includes immature granulocytes, primitive cells, anemia, iron deficiency anemia, reduction of three lineages, thrombocytopenia, thrombocytosis, etc. The target sample with low platelet count can be screened according to the alarm information of "thrombocytopenia" for consistency evaluation.

[0051] Optionally, the sample testing system can screen normal samples that do not require retesting and are automatically reviewed, or it can screen target samples by setting retesting rules (such as PLT < 80).

[0052] It should be noted that target samples with different parameter ranges can be selected from the test samples, such as high-value samples, medium-value samples, and low-value samples. Among them, the WBC parameter range corresponding to high-value samples can be 15.0 × 10. 9 / L~20.0×10 9 The parameter range for the WBC parameter corresponding to / L and the median sample can be 10.0 × 10. 9 / L~12.0×10 9 / L, the parameter range of the WBC parameter corresponding to low-value samples can be 3.0×10. 9 / L~8.0×10 9 / L; and the number of target samples in different parameter ranges can be one or more, without specific limitations here.

[0053] In another alternative embodiment, the user can also select target samples from the test samples. Specifically, the sample analysis instrument tests the test samples to obtain the sample test results, and the user selects target samples from the test samples based on the sample test results.

[0054] S102. The target sample is transferred to at least one other sample analysis instrument, and each of the other at least one sample analysis instruments extracts a portion of the target sample for analysis to obtain at least one set of detection data of the same type; each of the other at least one sample analysis instrument corresponds to a set of detection data; the other at least one sample analysis instrument is configured to perform at least one detection item of the same type on a portion of the target sample.

[0055] The sample detection system uses a Laboratory Information Management System (LIS) or middleware to obtain the rack number or sample identifier of the target sample; it then associates the rack number or sample identifier with the instrument number of at least one other sample analyzer. When the target sample on the rack needs to be transported to at least one other sample analyzer for testing, the system can use a transfer device to transport the rack containing the target sample to the other analyzer. Each analyzer uses its own sampling needle to aspirate a portion of the sample from the rack and transfers it to a reaction vessel, where it reacts with reagents. It should be noted that the reagents in the reaction vessel can be added before, after, or simultaneously with the sample transfer; no specific limitation is made here. Afterward, the partially reacted sample is analyzed to obtain at least one set of detection data of the same type.

[0056] It should be noted that at least one other sample analysis instrument is configured to perform at least one of the same type of test on a portion of the target sample. This means that at least one other sample analysis instrument is of the same brand or different brands, such as at least one hematology analyzer, at least one glycated blood glucose analyzer, at least one blood cell morphology analyzer (also known as a "slice reader"), etc.; or at least one other sample analysis instrument is a sample analyzer that performs the same test, such as white blood cell count in a complete blood count, liver function test in a biochemistry instrument, fibrinogen test in a coagulation instrument, hepatitis B test in an immunology instrument, etc.

[0057] In this embodiment of the invention, at least one other sample analysis instrument analyzes a set of monitoring parameters for a portion of the samples to obtain at least one set of detection data corresponding to the monitoring parameters, wherein each set of monitoring parameters corresponds one-to-one with each set of detection data.

[0058] S103. Based on at least one set of test data, perform consistency analysis on at least one other sample analysis instrument to obtain the consistency analysis results of at least one other sample analysis instrument.

[0059] In this embodiment of the invention, the sample detection system acquires at least one set of detection data from at least one other sample analysis instrument. Then, it performs quality control analysis on the corresponding sample analysis instrument based on each set of detection data to obtain the quality control analysis result corresponding to the sample analysis instrument. At least one quality control analysis result corresponding to the other at least one sample analysis instrument is determined as the consistency analysis result of the other at least one sample analysis instrument.

[0060] In this embodiment of the invention, different parameter ranges are selected for different monitoring parameters, and the criteria for judging loss of control are also different. Therefore, the sample detection system sets a preset loss of control threshold for each monitoring parameter and the parameter range corresponding to each monitoring parameter.

[0061] For example, as shown in Table 1, different preset runaway threshold values ​​are set for different monitoring parameters and parameter ranges.

[0062] Table 1. Industry Standard 5.8.2 Comparison Indicator Requirements for WS / T 406-2012

[0063]

[0064] Specifically, taking a sample analysis instrument as an example, the process of the sample detection system performing quality control analysis on a corresponding sample analysis instrument based on a set of test data to obtain the quality control analysis results for a sample analysis instrument includes: the sample detection system determining a set of deviation data between a set of test data and the corresponding standard test data; the sample detection system finding a set of preset out-of-control thresholds corresponding to a set of test data, and comparing the set of deviation data corresponding to a set of test data with the corresponding set of preset out-of-control thresholds respectively.

[0065] Optionally, the sample testing system can determine the standard test data in two ways: First, by calculating at least one mean from at least one set of test data; and then determining that at least one mean as the standard test data. Second, by identifying a standard sample analyzer from the sample analyzer and / or at least one other sample analyzer; and then determining the set of test data corresponding to the standard sample analyzer as the standard test data.

[0066] In this embodiment of the invention, a set of deviation data can also be normalized, and the normalization results can be compared with 1. When the normalization result is greater than 1, it is determined that the sample analysis instrument is out of control. When the normalization result is less than or equal to 1, it is determined that the sample analysis instrument is under control.

[0067] In one optional embodiment, the normalization result is a relative deviation. The process of normalizing the deviation data to obtain the relative deviation is shown in Formula 1.

[0068] Relative deviation = (Detection data - Standard detection data corresponding to the detection data) / Standard detection data corresponding to the detection data / Out-of-control threshold value corresponding to the detection data (1)

[0069] In another optional embodiment, the normalization result is the absolute deviation. The process of normalizing a set of deviation data to obtain the absolute deviation is shown in Formula 2.

[0070] Absolute deviation = (test data - standard test data corresponding to the test data) / runaway threshold value corresponding to the test data (2)

[0071] If the first deviation data in a set of deviation data exceeds the first preset out-of-control threshold, the sample detection system determines that a sample analysis instrument is out of control. The first deviation data corresponds to the first detection data in a set of detection data, and the first preset out-of-control threshold is the out-of-control threshold value of the monitoring parameter corresponding to the first detection data.

[0072] In this embodiment of the invention, when it is determined that the first deviation data exceeds the first preset out-of-control threshold, the sample detection system determines whether there is a measurement abnormality; when it is determined that there is a measurement abnormality, the sample detection system prompts the measurement abnormality.

[0073] Specifically, when the first deviation data exceeds the first preset out-of-control threshold, the sample analysis instrument re-screens the target sample and transmits the re-screened target sample to at least one other sample analysis instrument for analysis, obtaining a set of updated detection data corresponding to the monitoring parameters; then, an updated set of deviation data between the updated set of detection data and the corresponding standard detection data is determined; only when the first updated deviation data in the updated set of deviation data exceeds the first preset out-of-control threshold does the sample detection system determine that the corresponding sample analysis instrument is out of control.

[0074] If the first deviation data is determined not to exceed the first preset out-of-control threshold, the sample detection system acquires the first historical deviation data corresponding to the first deviation data, and determines whether a sample analysis instrument is trending out of control based on the first historical deviation data and the first deviation data. At this time, the sample detection system determines a set of deviation data and out-of-control judgment results as the consistency analysis results of a sample analysis instrument, wherein the out-of-control judgment results include whether at least one other sample analysis instrument is out of control, and / or whether at least one other sample analysis instrument is trending out of control.

[0075] like Figure 2 As shown, the process by which the sample testing system judges the consistency analysis results of a sample analysis instrument includes:

[0076] 1. Calculate the deviation between the test data of a sample analyzer and the standard test data;

[0077] 2. Compare the deviation data with the corresponding preset runaway threshold value;

[0078] 3. If the deviation data exceeds the corresponding preset out-of-control threshold, check for any measurement anomaly alarms;

[0079] 4. If a measurement anomaly alarm is detected, indicate the measurement problem and execute step 6;

[0080] 5. If no measurement anomaly alarm is detected, proceed to step 6;

[0081] 6. Re-screen the target samples and transfer them to the sample analysis instrument for measurement to obtain updated test data;

[0082] 7. Determine the updated deviation data between the updated test data and the standard test data, and compare the updated deviation data with the preset runaway threshold value;

[0083] 8. If the updated deviation data exceeds the preset out-of-control threshold, identify a sample analysis instrument out of control and prompt manual investigation.

[0084] 9. If the updated deviation data does not exceed the preset out-of-control threshold, identify one sample analysis instrument as being under control;

[0085] 10. If the deviation data does not exceed the corresponding preset runaway threshold, determine whether there is a trend problem based on the deviation data and the corresponding historical deviation data;

[0086] 11. If a trend problem is identified, indicate that a sample analysis instrument is experiencing a trend of loss of control.

[0087] 12. If it is determined that there is no trend problem, identify one sample analysis instrument under control.

[0088] S104. When it is determined from the consistency analysis results that one of the other at least one sample analyzer is out of control, an alarm message for one sample analyzer shall be output.

[0089] In this embodiment of the invention, if a sample analysis instrument is determined to be trending out of control based on the first historical deviation data and the first deviation data, the sample detection system will indicate that a sample analysis instrument is trending out of control.

[0090] In this embodiment of the invention, the sample detection system displays the consistency analysis results and consistency change trends of at least one other sample analysis instrument, wherein the consistency change trend is determined based on the deviation data and the historical deviation data corresponding to the deviation data.

[0091] Specifically, the sample detection system sequentially acquires the historical detection data, target sample analysis instrument, target monitoring parameters, and parameter range corresponding to each detection data in at least one set of detection data; and sequentially obtains the change curve corresponding to the target monitoring parameters of the target sample analysis instrument based on each detection data and the historical detection data corresponding to each detection data; until at least one set of change curves corresponding to at least one other sample analysis instrument is obtained; the sample detection system displays at least one set of change curves on the analysis results interface.

[0092] After the sample detection system displays at least one set of change curves on the analysis results interface, the user can also adjust the display of at least one set of change curves according to different filtering conditions. Specifically, upon receiving a filtering instruction, the sample detection system determines the filtering conditions according to the filtering instruction; then, based on the filtering conditions, it filters out the target change curve from at least one set of change curves and displays the target change curve on the analysis results interface.

[0093] It should be noted that the points corresponding to deviation data exceeding the runaway threshold can be highlighted on the change curve. The highlighting can be done by using red or other colors to distinguish the point, and / or by making the point bold.

[0094] In this embodiment of the invention, the screening conditions may include at least one of the following: monitoring parameters, parameter range, detection period, and sample analysis instrument.

[0095] Optionally, you can select to display the variation curves of any one of at least one other sample analyzer across multiple parameter ranges for a given monitored parameter. For example... Figure 3 As shown, curve 1 shows the variation of the sample analysis instrument within the range of 87-97 for the MCV parameter, and curve 2 shows the variation of the sample analysis instrument within the range of 96-106 for the MCV parameter.

[0096] Optionally, you can select to display the target change curve of any one or several other sample analyzers from at least one other sample analyzer.

[0097] Optionally, you can select to display the target change curve of at least one other sample analysis instrument within a certain detection period.

[0098] Optionally, a certain monitoring parameter can be used for filtering, such as displaying the change curve of the WBC parameter of any one or several other sample analyzers.

[0099] Optionally, filtering can be performed using the parameter range of a certain monitoring parameter, such as displaying the WBC parameter of any one or several other sample analyzers among at least one sample analyzer that is within 10.0 × 10. 9 / L~12.0×109 The curve showing the variation within the / L interval.

[0100] It should be noted that the embodiments of the present invention are not limited to selecting one of the above-mentioned screening conditions, but can also combine any of the above-mentioned screening conditions, and use the combined screening conditions to filter at least one set of change curves.

[0101] It should be noted that the analysis results display interface can also show the runaway line corresponding to the runaway threshold of the target monitoring parameter, and / or the change curve of the target detection parameter corresponding to the standard detection data.

[0102] In this embodiment of the invention, the runaway line of the runaway threshold and the change curve corresponding to the target detection parameter of the standard detection data can be displayed differently on the analysis result display interface using different colors or line thicknesses. For example, a red line can be used to display the runaway line of the runaway threshold, and a green line can be used to display the change curve corresponding to the target detection parameter of the standard detection data.

[0103] Optionally, a comparison of one or more other sample analysis instruments and a standard sample analysis instrument can be displayed on a single graph. For example, such as... Figure 4 The image shows the comparison results between the RBC of machine C1 and the standard sample analyzer (target machine). The curve represents the change curve of the RBC of machine C1. The value points on the curve correspond to the relative deviation data between machine C1 and the standard sample analyzer. Lines 1 and 7 are out-of-control lines, lines 2 and 6 are warning lines, lines 3 and 5 are normal lines, and line 4 is the standard line of the standard sample analyzer.

[0104] Optionally, filtering can be performed using the parameter range of a certain monitoring parameter of the standard sample analyzer. For example, only displaying the WBC parameter value of the standard sample analyzer within 10.0 × 10⁻⁶. 9 / L~12.0×10 9 Consistency analysis results and consistency change trends within the / L interval.

[0105] Understandably, users can set different filtering conditions according to different needs, and the displayed change curves will be the quality control analysis results that the user is most concerned about. Moreover, different filtering conditions can perform multi-angle analysis on at least one other sample analysis instrument.

[0106] Furthermore, upon completion of the sample analysis instrument quality control process, the sample testing system can also store at least one set of test data, consistency analysis results, and consistency change trends in the data management software; and / or export at least one set of test data, consistency analysis results, and consistency change trends from the data management software, and generate corresponding analysis reports to send to other devices for further analysis based on the analysis reports.

[0107] Understandably, using the target sample to perform consistency analysis on at least one other sample analysis instrument eliminates the need for long-term sample storage. Furthermore, the sample analysis instrument can automatically screen the target sample, transfer it to at least one other sample analysis instrument, and perform consistency analysis based on at least one set of test data, simplifying the quality control process. At the same time, the sample can detect abnormal conditions, and using the target sample to perform consistency analysis on at least one other sample analysis instrument can improve the accuracy of the quality control results.

[0108] Based on the foregoing embodiments, this invention also provides a sample analysis instrument quality control device 1, such as... Figure 5 As shown, the quality control device 1 of the sample analysis instrument includes:

[0109] The screening unit 10 is used to screen target samples that meet preset standard conditions from the already tested samples based on the sample test results measured by the sample analysis instrument, under preset quality control trigger conditions.

[0110] The data detection unit 11 is used to transmit the target sample to at least one other sample analysis instrument, so that each of the other at least one sample analysis instrument can extract a portion of the target sample for analysis to obtain at least one set of detection data of the same type; each of the other at least one sample analysis instrument corresponds to a set of detection data; the other at least one sample analysis instrument is configured to perform at least one detection item of the same type on a portion of the target sample;

[0111] The consistency analysis unit 12 is used to perform consistency analysis on the other at least one sample analysis instrument based on the at least one set of detection data, and obtain the consistency analysis result of the other at least one sample analysis instrument;

[0112] The prompting unit 13 is used to output an alarm prompt for one of the sample analyzers when it is determined from the consistency analysis results that one of the other at least one sample analyzer is out of control.

[0113] Optionally, the sample analysis instrument quality control device 1 further includes: an acquisition unit;

[0114] The acquisition unit is used to acquire the load and / or quality control time interval of the sample detection system; the sample detection system includes the sample analysis instrument and at least one other sample analysis instrument, which are connected by a transmission device;

[0115] The screening unit 10 is further configured to determine a preset quality control trigger condition when the load of the sample detection system meets a preset load condition and / or the quality control time interval is greater than or equal to a preset time interval.

[0116] Optionally, the sample analysis instrument quality control device further includes: a determination unit;

[0117] The determining unit is used to determine the sample size of the detected sample;

[0118] The screening unit 10 is further configured to select, when the sample size of the detected sample is greater than or equal to a preset sample size threshold, samples that meet the parameter range of the monitoring parameters in the sample detection results as target samples; and / or select samples that include abnormal information in the sample detection results as quality control samples; and / or select samples that meet the re-inspection rules in the sample detection results as quality control samples.

[0119] Optionally, the sample analysis instrument quality control device further includes: a judgment unit;

[0120] The determining unit is further configured to determine a set of deviation data between the set of test data and the corresponding standard test data; if it is determined that the first deviation data in the set of deviation data exceeds a first preset out-of-control threshold, it is determined that the sample analysis instrument is out of control, wherein the first deviation data corresponds to the first test data in the set of test data, and the first preset out-of-control threshold is the out-of-control threshold of the monitoring parameter corresponding to the first test data; and the set of deviation data and the out-of-control judgment result are determined as the consistency analysis result of the sample analysis instrument.

[0121] The judgment unit is used to obtain the first historical deviation data corresponding to the first deviation data when it is determined that the first deviation data does not exceed the first preset out-of-control threshold, and to determine whether the sample analysis instrument is in a trend of out-of-control based on the first historical deviation data and the first deviation data.

[0122] The consistency analysis unit 12 is also used to determine the multiple quality control analysis results corresponding to the other at least one sample analysis instrument as the consistency analysis results of the other at least one sample analysis instrument.

[0123] Optionally, the sample analysis instrument quality control device further includes: a display unit;

[0124] The display unit is used to display the consistency analysis results and consistency change trends of the other at least one sample analysis instrument, wherein the consistency change trend is determined based on the deviation data and the historical deviation data corresponding to the deviation data.

[0125] Based on the foregoing embodiments, this invention also provides a sample detection system 2, such as... Figure 6 As shown, the sample detection system 2 includes: a sample analysis instrument 20, a control system 21, and a data management system 22;

[0126] The control system 21 is used to control the sample analysis instrument 20 to screen target samples that meet preset standard conditions from the already tested samples based on the measured sample test results, under preset quality control trigger conditions; and to control the scheduling device to transfer the target samples to at least one other sample analysis instrument, which is configured to perform at least one of the same type of test items on some of the target samples; for example, the scheduling device can be a transport track, especially a transport track on a production line containing multiple sample testing devices.

[0127] The other at least one sample analysis instrument 20 is used to extract a portion of the sample from the target sample for analysis, and obtain at least one set of detection data of the same type; each of the other at least one sample analysis instrument corresponds to one set of detection data;

[0128] The data management system 22 is used to acquire the at least one set of detection information, perform consistency analysis on the other at least one sample analysis instrument based on the at least one set of detection data, and obtain the consistency analysis result of the other at least one sample analysis instrument.

[0129] The control system 21 is also configured to output an alarm message for the sample analyzer when it is determined, based on the consistency analysis results, that one of the other at least one sample analyzer is out of control.

[0130] It should be noted that the data management system 22 includes a processor 220, a memory 221, and a display 222. The display 222 is used to display the alarm prompts of the sample analysis instrument. The memory 221 is used to store various types of data, such as computer programs and the test results of at least one other sample analysis instrument, including at least one set of test data, consistency analysis results, etc. The processor 220 can be used to execute programs to perform accuracy management on the data detection system. Accuracy management can include judging the accuracy of the test results of the sample analysis instrument, quality judgment, etc., which can also be referred to as quality control.

[0131] It should be noted that the control system can exist independently of the data management system, such as a standalone computer or cloud platform, or it can be integrated into a certain instrument or the data management system. The specific form of the control system can be selected according to the actual situation, and the embodiments of the present invention do not impose specific limitations.

[0132] In this embodiment of the invention, if the above method is implemented as a software functional module and sold or used as an independent product, it can also be stored in a computer-readable storage medium. Based on this understanding, the technical solution of this embodiment of the invention, or the part that contributes to the prior art, can be embodied in the form of a software product. This computer software product is stored in a storage medium and includes several instructions to cause a computer device (which may be a personal computer, server, or network device, etc.) to execute all or part of the methods described in the various embodiments of this application. The aforementioned storage medium includes various media capable of storing program code, such as a USB flash drive, portable hard drive, read-only memory (ROM), magnetic disk, or optical disk. Thus, this embodiment of the invention is not limited to any specific hardware and software combination.

[0133] Accordingly, this embodiment of the invention further provides a computer storage medium storing a measurement program, which, when executed, implements the steps of the sample analysis instrument quality control method provided in the above embodiments.

[0134] It should be understood that the phrase "one embodiment" or "an embodiment" throughout the specification means that a specific feature, structure, or characteristic related to the embodiment is included in at least one embodiment of this application. Therefore, "in one embodiment" or "in an embodiment" appearing throughout the specification does not necessarily refer to the same embodiment. Furthermore, these specific features, structures, or characteristics can be combined in any suitable manner in one or more embodiments. It should be understood that in the various embodiments of this application, the sequence numbers of the above-described processes do not imply a sequential order of execution; the execution order of each process should be determined by its function and internal logic, and should not constitute any limitation on the implementation process of the embodiments of the present invention. The sequence numbers of the above-described embodiments of the present invention are merely descriptive and do not represent the superiority or inferiority of the embodiments.

[0135] It should be noted that, in this document, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Unless otherwise specified, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes that element.

[0136] In the several embodiments provided in this application, it should be understood that the disclosed devices and methods can be implemented in other ways. The device embodiments described above are merely illustrative. For example, the division of units is only a logical functional division, and in actual implementation, there may be other division methods, such as: multiple units or components can be combined, or integrated into another system, or some features can be ignored or not executed. In addition, the coupling, direct coupling, or communication connection between the various components shown or discussed can be through some interfaces, and the indirect coupling or communication connection between devices or units can be electrical, mechanical, or other forms.

[0137] The units described above as separate components may or may not be physically separate. The components shown as units may or may not be physical units. They may be located in one place or distributed across multiple network units. Some or all of the units may be selected to achieve the purpose of this embodiment according to actual needs.

[0138] In addition, each functional unit in the various embodiments of this application can be integrated into one processing unit, or each unit can be a separate unit, or two or more units can be integrated into one unit; the integrated unit can be implemented in hardware or in the form of hardware plus software functional units.

[0139] Those skilled in the art will understand that all or part of the steps of the above method embodiments can be implemented by hardware related to program instructions. The aforementioned program can be stored in a computer-readable storage medium. When the program is executed, it performs the steps of the above method embodiments. The aforementioned storage medium includes various media that can store program code, such as mobile storage devices, read-only memory (ROM), magnetic disks, or optical disks.

[0140] Alternatively, if the integrated units described above are implemented as software functional modules and sold or used as independent products, they can also be stored in a computer-readable storage medium. Based on this understanding, the technical solutions of the embodiments of the present invention, or the parts that contribute to the prior art, can be embodied in the form of a software product. This computer software product is stored in a storage medium and includes several instructions to cause a computer device (which may be a personal computer, server, or network device, etc.) to execute all or part of the methods described in the various embodiments of this application. The aforementioned storage medium includes various media capable of storing program code, such as mobile storage devices, ROMs, magnetic disks, or optical disks.

[0141] The above description is merely a specific embodiment of this application, but the scope of protection of this application is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in this application should be included within the scope of protection of this application. Therefore, the scope of protection of this application should be determined by the scope of the claims.

Claims

1. A quality control method for sample analysis instruments, characterized in that, The method includes: Under the preset quality control trigger conditions, target samples that meet the preset standard conditions are selected from the already tested samples based on the sample test results measured by the sample analysis instrument. The target sample is transmitted to at least one other sample analysis instrument, which then extracts a portion of the target sample for analysis to obtain at least one set of detection data of the same type. Each of the at least one other sample analysis instrument corresponds to one set of detection data. The at least one other sample analysis instrument is configured to perform at least one detection item of the same type on a portion of the target sample. Based on the at least one set of detection data, a consistency analysis is performed on the other at least one sample analysis instrument to obtain the consistency analysis results of the other at least one sample analysis instrument, including: Determine a set of deviation data between the set of test data and the corresponding standard test data; If it is determined that the first deviation data in the set of deviation data exceeds the first preset out-of-control threshold, it is determined that the sample analysis instrument is out of control. The first deviation data corresponds to the first detection data in the set of detection data. The first preset out-of-control threshold is the out-of-control threshold value of the monitoring parameter corresponding to the first detection data. If it is determined that the first deviation data does not exceed the first preset runaway threshold, the first historical deviation data corresponding to the first deviation data is obtained, and based on the first historical deviation data and the first deviation data, it is determined whether the sample analysis instrument is experiencing a trend of runaway. The set of deviation data and the out-of-control judgment results are determined as the consistency analysis results of the sample analysis instrument. When it is determined from the consistency analysis results that one of the other at least one sample analysis instrument is out of control, an alarm message for that sample analysis instrument is output.

2. The method according to claim 1, characterized in that, The method further includes: The load and / or quality control time interval of the sample detection system are obtained; the sample detection system includes the sample analysis instrument and at least one other sample analysis instrument, which are connected by a transmission device; When the load of the sample detection system meets the preset load condition, and / or the quality control time interval is greater than or equal to the preset quality control time interval, the preset quality control trigger condition is determined.

3. The method according to claim 1 or 2, characterized in that, The method further includes: Determine the sample size of the test sample; When the sample size of the detected sample is greater than or equal to a preset sample size threshold, samples that meet the parameter range of the monitoring parameters in the sample detection results are selected as target samples; and / or samples that include abnormal information in the sample detection results are selected as target samples; and / or samples that meet the re-inspection rules in the sample detection results are selected as target samples.

4. The method according to claim 3, characterized in that, The method further includes: Set corresponding preset out-of-control threshold values ​​for the monitoring parameters and the parameter range.

5. The method according to claim 3, characterized in that, The other at least one sample analysis instrument respectively extracts a portion of the target sample for analysis, obtaining at least one set of detection data of the same type, including: The other at least one sample analysis instrument respectively extracts a portion of the sample from the target sample and analyzes a set of monitoring parameters of the portion of the sample to obtain at least one set of detection data corresponding to the monitoring parameters. The set of monitoring parameters corresponds one-to-one with each set of detection data.

6. The method according to claim 4, characterized in that, The method further includes: Calculate at least one mean of the at least one set of detection data; The at least one mean is determined as the standard test data.

7. The method according to claim 4, characterized in that, The method further includes: A standard sample analysis instrument is determined from the sample analysis instrument and / or at least one other sample analysis instrument; The set of test data corresponding to the standard sample analysis instrument is determined as the standard test data.

8. The method according to claim 4, characterized in that, The method further includes: If it is determined that the first deviation data exceeds the first preset out-of-control threshold, the sample analysis instrument re-screens the target sample and transmits the re-screened target sample to at least one other sample analysis instrument for analysis to obtain a set of updated detection data corresponding to the monitoring parameter. Determine an updated set of deviation data between the updated set of test data and the corresponding standard test data; If the first updated deviation data in the set of updated deviation data exceeds the first preset runaway threshold, the corresponding sample analysis instrument is determined to be out of control.

9. The method according to claim 4, characterized in that, After determining whether a sample analysis instrument is experiencing a trend of out-of-control based on the first historical deviation data and the first deviation data, the method further includes: If, based on the first historical deviation data and the first deviation data, it is determined that the sample analysis instrument is trending out of control, a notification is sent indicating that the sample analysis instrument is trending out of control.

10. The method according to claim 8, characterized in that, The method further includes: If the first deviation data is determined to exceed the first preset runaway threshold, it is determined whether there is a measurement anomaly; When a measurement anomaly is detected, a measurement anomaly message will be displayed.

11. The method according to claim 1, characterized in that, The method further includes: The consistency analysis results and consistency trend of at least one other sample analysis instrument are displayed, and the consistency trend is determined based on the deviation data and the historical deviation data corresponding to the deviation data.

12. The method according to claim 11, characterized in that, The display of the consistency analysis results and consistency change trends of the other at least one sample analysis instrument includes: Sequentially acquire the historical detection data, target sample analysis instrument, target monitoring parameters, and parameter range corresponding to each of the at least one set of detection data; Based on each detection data and the corresponding historical detection data, the change curve of the target monitoring parameter of the target sample analysis instrument is obtained sequentially. Until at least one set of change curves corresponding to at least one other sample analysis instrument is obtained; the at least one set of change curves is displayed on the analysis results interface.

13. The method according to claim 12, characterized in that, The method further includes: Upon receiving a filtering instruction, the filtering conditions are determined according to the filtering instruction; The target change curve is selected from the at least one set of change curves according to the filtering criteria, and the target change curve is displayed on the analysis results interface.

14. The method according to claim 13, characterized in that, The screening criteria include at least one of the following: monitoring parameters, parameter range, detection period, and sample analysis instrument.

15. The method according to claim 12, characterized in that, The method further includes: The analysis results display interface shows the runaway line corresponding to the runaway threshold of the target monitoring parameter, and / or the change curve corresponding to the target detection parameter of the standard detection data.

16. The method according to claim 1, characterized in that, The method further includes: The test tube rack number or sample identifier of the target sample is obtained using a Laboratory Information Management System (LIS) or middleware. Associate the test tube rack number or sample identifier with the instrument number of the other at least one sample analysis instrument.

17. The method according to claim 1 or 11, characterized in that, The method further includes: The at least one set of detection data, the consistency analysis results, and the consistency change trend are stored in the data management software; And / or export the at least one set of detection data, the consistency analysis results, and the consistency change trend from the data management software, and generate a corresponding analysis report to send to other devices.

18. A quality control device for a sample analysis instrument, characterized in that, The quality control device for the sample analysis instrument includes: The screening unit is used to screen target samples that meet preset standard conditions from the already tested samples based on the sample test results measured by the sample analysis instrument, under preset quality control trigger conditions. A data detection unit is used to transmit the target sample to at least one other sample analysis instrument, so that each of the other at least one sample analysis instrument can extract a portion of the target sample for analysis to obtain at least one set of detection data of the same type; each of the other at least one sample analysis instrument corresponds to a set of detection data; the other at least one sample analysis instrument is configured to perform at least one detection item of the same type on a portion of the target sample; A consistency analysis unit is used to perform consistency analysis on the other at least one sample analysis instrument based on the at least one set of detection data, and obtain the consistency analysis result of the other at least one sample analysis instrument; A determining unit is configured to determine a set of deviation data between the set of test data and the corresponding standard test data; if it is determined that the first deviation data in the set of deviation data exceeds a first preset out-of-control threshold, the sample analyzer is determined to be out of control, wherein the first deviation data corresponds to the first test data in the set of test data, and the first preset out-of-control threshold is the out-of-control threshold of the monitoring parameter corresponding to the first test data; the set of deviation data and the out-of-control judgment result are determined as the consistency analysis result of the sample analyzer. The judgment unit is used to obtain the first historical deviation data corresponding to the first deviation data when it is determined that the first deviation data does not exceed the first preset out-of-control threshold, and to determine whether the sample analysis instrument is in a trend of out-of-control based on the first historical deviation data and the first deviation data. The consistency analysis unit is also used to determine multiple quality control analysis results corresponding to the other at least one sample analysis instrument as the consistency analysis results of the other at least one sample analysis instrument; The prompting unit is used to output an alarm prompt for one of the sample analyzers when it is determined from the consistency analysis results that one of the other at least one sample analyzer is out of control.

19. The sample analysis instrument quality control device according to claim 18, characterized in that, The sample analysis instrument quality control device further includes: an acquisition unit; The acquisition unit is used to acquire the load and / or quality control time interval of the sample detection system; the sample detection system includes the sample analysis instrument and at least one other sample analysis instrument, which are connected by a transmission device; The screening unit is further configured to determine a preset quality control trigger condition when the load of the sample detection system meets a preset load condition and / or the quality control time interval is greater than or equal to a preset time interval.

20. The sample analysis instrument quality control device according to claim 18 or 19, characterized in that, The determining unit is also used to determine the sample size of the detected sample; The filtering unit is also used to select samples from the sample detection results that meet the parameter range of the monitoring parameters as target samples when the sample size of the detected sample is greater than or equal to a preset sample size threshold. And / or select samples containing abnormal information in the sample detection results as target samples; and / or select samples in the sample detection results that meet the re-inspection rules as target samples.

21. The sample analysis instrument quality control device according to claim 18, characterized in that, The sample analysis instrument quality control device also includes: a display unit; The display unit is used to display the consistency analysis results and consistency change trends of the other at least one sample analysis instrument, wherein the consistency change trend is determined based on the deviation data and the historical deviation data corresponding to the deviation data.

22. A sample detection system, characterized in that, The sample detection system includes: a sample analysis instrument, a control system, and a data management system; The control system is used to select target samples that meet preset standard conditions from the already tested samples based on the sample test results measured by the sample analysis instrument, under preset quality control trigger conditions; the control scheduling device transmits the target samples to at least one other sample analysis instrument, which is configured to perform at least one of the same type of test items on some of the target samples. The other at least one sample analysis instrument is used to extract a portion of the sample from the target sample for analysis, and obtain at least one set of detection data of the same type; each of the other at least one sample analysis instrument corresponds to one set of detection data; The data management system is used to acquire the at least one set of detection information, and to perform consistency analysis on the other at least one sample analysis instrument based on the at least one set of detection data to obtain the consistency analysis result of the other at least one sample analysis instrument; specifically, it is used to: determine a set of deviation data between the set of detection data and the corresponding standard detection data; if it is determined that the first deviation data in the set of deviation data exceeds a first preset out-of-control threshold, determine that the sample analysis instrument is out of control, wherein the first deviation data corresponds to the first detection data in the set of detection data, and the first preset out-of-control threshold is the out-of-control threshold of the monitoring parameter corresponding to the first detection data; if it is determined that the first deviation data does not exceed the first preset out-of-control threshold, acquire the first historical deviation data corresponding to the first deviation data, and determine whether the sample analysis instrument is trending out of control based on the first historical deviation data and the first deviation data; and determine the set of deviation data and the out-of-control determination result as the consistency analysis result of the sample analysis instrument. The control system is further configured to output an alarm message for the sample analyzer when it is determined, based on the consistency analysis results, that one of the other at least one sample analyzer is out of control.

23. A storage medium having a computer program stored thereon, used in a sample detection system, characterized in that, When the computer program is executed by a processor, it implements the method as described in any one of claims 1-17.

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