CN112034190A

CN112034190A - Sample analyzer quality control method, device, system and storage medium

Info

Publication number: CN112034190A
Application number: CN202010833095.0A
Authority: CN
Inventors: 张国军; 徐保重; 赵晖; 史从宁; 李虓; 田江峰
Original assignee: Shenzhen Mindray Bio Medical Electronics Co Ltd; Beijing Tiantan Hospital
Current assignee: Shenzhen Mindray Bio Medical Electronics Co Ltd; Beijing Tiantan Hospital
Priority date: 2020-08-18
Filing date: 2020-08-18
Publication date: 2020-12-04

Abstract

The embodiment of the invention discloses a quality control method, a device, a system and a storage medium for a sample analysis instrument, wherein the method comprises the following steps: under the condition of meeting a preset quality control triggering condition, screening a target sample meeting a preset standard condition from detected samples which are detected according to a sample detection result measured by a sample analyzer; the target sample is transmitted to at least one other sample analysis instrument, and the other at least one sample analysis instrument respectively absorbs part of samples from the target sample to analyze so as to obtain at least one group of detection data with the same type; performing consistency analysis on 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 determining that one of the at least one other sample analysis instrument is out of control according to the consistency analysis result, outputting an alarm prompt of the sample analysis instrument.

Description

Sample analyzer quality control method, device, system and storage medium

Technical Field

The invention relates to the field of in-vitro diagnosis, in particular to a sample analysis instrument quality control method, device, system and storage medium.

Background

At present, indoor quality control needs specific quality control materials, and in the process of using the quality control materials to carry out quality control, the operations of rewarming, uniformly mixing, storing according to a specific flow after use and the like are generally included, so that the quality control process is complicated; and in order to prolong the effective period of the quality control material, the quality control material is required to be shaped by using a shaping agent, and the quality control material is not sensitive to abnormal conditions in the process of utilizing the quality control material, such as: the low-temperature diluent can lead to inaccurate measurement of Mean Corpuscular Volume (MCV) of a blood corpuscle instrument, and the problem of low accuracy of quality control results.

Content of application

To solve the foregoing technical problems, embodiments of the present invention are directed to a method, an apparatus, a system, and a storage medium for quality control of a sample analyzer.

The technical scheme of the embodiment of the invention is realized as follows:

in a first aspect, an embodiment of the present invention provides a quality control method for a sample analyzer, where the method includes:

under the condition of meeting a preset quality control triggering condition, screening a target sample meeting a preset standard condition from detected samples which are detected according to a sample detection result measured by a sample analyzer;

transmitting the target sample to at least one other sample analysis instrument, wherein the at least one other sample analysis instrument respectively absorbs a part of samples from the target sample to analyze, so as to obtain at least one group of detection data with the same type; each sample analysis instrument of the at least one other sample analysis instrument corresponds to a set of detection data; the at least one other sample analysis instrument is configured to perform at least one detection item of a same type on a portion of the target sample;

performing consistency analysis 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 determining that one of the at least one other sample analysis instrument is out of control according to the consistency analysis result, outputting an alarm prompt of the sample analysis instrument.

In a second aspect, an embodiment of the present invention provides a quality control device for a sample analyzer, including:

the screening unit is used for screening target samples meeting preset standard conditions from detected detection samples which are detected according to sample detection results measured by a sample analyzer under the condition that the preset quality control triggering conditions are met;

the data detection unit is used for transmitting the target sample to at least one other sample analysis instrument, so that the at least one other sample analysis instrument respectively absorbs partial samples from the target sample for analysis to obtain at least one group of detection data with the same type; each sample analysis instrument of the at least one other sample analysis instrument corresponds to a set of detection data; the at least one other sample analysis instrument is configured to perform at least one detection item of a same type on a portion of the target sample;

the consistency analysis unit is used for carrying out consistency analysis 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 the prompting unit is used for outputting an alarm prompt of one sample analysis instrument when the fact that one sample analysis instrument out of the at least one other sample analysis instrument is out of control is determined according to the consistency analysis result.

In a third aspect, an embodiment of the present invention provides a sample detection system, where the sample detection system includes: a sample analyzer, a control system, and a data management system;

the control system is used for controlling to screen target samples meeting preset standard conditions from detected samples which are detected according to sample detection results measured by a sample analyzer under the condition that preset quality control triggering conditions are met; controlling a scheduling device to transmit the target sample to at least one other sample analysis instrument, wherein the at least one other sample analysis instrument is configured to perform at least one detection item of the same type on a part of samples in the target sample;

the other at least one sample analysis instrument is used for sucking a part of samples from the target samples for analysis to obtain at least one group of detection data with the same type; each sample analysis instrument of the at least one other sample analysis instrument corresponds to a set of detection data;

the data management system is used for acquiring the at least one group of detection information, and performing consistency analysis on the at least one other sample analysis instrument according to the at least one group of detection information to obtain a consistency analysis result of the at least one other sample analysis instrument;

and the control system is further used for controlling and outputting an alarm prompt of one sample analysis instrument when the fact that one sample analysis instrument out of the at least one other sample analysis instrument is out of control is determined according to the consistency analysis result.

In a fourth aspect, an embodiment of the present invention provides a storage medium, on which a computer program is stored, for use in a sample detection system, the computer program, when executed by a processor, implementing the method according to any one of the above.

The embodiment of the invention provides a quality control method, a device, a system and a storage medium for a sample analysis instrument, wherein the method comprises the following steps: under the condition of meeting a preset quality control triggering condition, screening a target sample meeting a preset standard condition from detected samples which are detected according to a sample detection result measured by a sample analyzer; the target sample is transmitted to at least one other sample analysis instrument, and the other at least one sample analysis instrument respectively absorbs part of samples from the target sample to analyze so as to obtain at least one group of detection data with the same type; each sample analysis instrument of the at least one other 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 samples in the target sample; performing consistency analysis on 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 determining that one sample analysis instrument of the at least one other sample analysis instrument is out of control according to the consistency analysis result, outputting an alarm prompt of the sample analysis instrument. By adopting the method, the target sample is used for carrying out consistency analysis on at least one other sample analysis instrument, the sample does not need to be stored for a long time, the sample analysis instrument can automatically realize the processes of screening and transmitting the target sample to at least one other sample analysis instrument and carrying out consistency analysis according to at least one group of detection data, the quality control process is simplified, meanwhile, the sample can sense abnormal conditions, and the consistency analysis on at least one other sample analysis instrument by using the target sample can improve the accuracy of the quality control result.

Drawings

Fig. 1 is a first flowchart of a method for controlling a sample analyzer according to an embodiment of the present invention;

fig. 2 is a schematic flow chart illustrating a consistency analysis result determination performed by an exemplary sample testing system on a sample analyzer according to an embodiment of the present invention;

FIG. 3 is a schematic diagram of a variation curve of an exemplary sample analyzer within different ranges of MCV parameters according to an embodiment of the present invention;

fig. 4 is a schematic diagram showing the comparison between an exemplary RBC machine No. C1 and a standard sample analyzer according to an embodiment of the present invention;

fig. 5 is a schematic structural diagram of a quality control apparatus of a sample analyzer according to an embodiment of the present invention;

fig. 6 is a schematic structural diagram of a sample detection system according to an embodiment of the present invention.

Detailed Description

In order to make the objects, technical solutions and advantages of the embodiments of the present invention clearer, the following describes specific technical solutions of the present invention in further detail with reference to the accompanying drawings in the embodiments of the present invention. The following examples are intended to illustrate the present application but are not intended to limit the scope of the present application.

Unless defined otherwise, 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.

In the following description, reference is made to "some embodiments" which describe a subset of all possible embodiments, but 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.

It should be noted that the terms "first \ second \ third" related to the embodiments of the present invention merely distinguish similar objects and do not represent specific ordering for the objects, and it should be understood that "first \ second \ third" may exchange specific orders or sequences where allowed, so that the embodiments of the present invention described herein can be implemented in an order other than that shown or described herein.

In view of the above problems, an embodiment of the present invention provides a method for controlling quality of a sample analyzer, as shown in fig. 1, the method may include:

s101, under the condition that a preset quality control trigger condition is met, according to a sample detection result measured by a sample analyzer, screening a target sample meeting a preset standard condition from detected samples.

The sample analyzer may be a blood cell analyzer, a C-reactive protein (CRP) analyzer, a glycation analyzer, etc. in a sample testing system, and the sample testing system further includes a transmission device, a data management system, etc. The transmission device connects the sample analyzers in the sample detection system, and the data management system can control the transmission device to transmit the samples to the sample analyzers so that the sample analyzers can detect the samples.

The detection sample and the target sample provided in the embodiments of the present application may be a blood-based conventional ethylenediaminetetraacetic Acid (EDTA) sample, a biochemical immune serum sample, a coagulated sodium citrate anticoagulation sample, or the like.

In an alternative embodiment, a sample analyzer is selected from a sample testing system in advance, and the sample analyzer is used to screen out a target sample satisfying a predetermined standard condition from a testing sample, specifically, the user sets a quality control trigger condition in advance, including: presetting load conditions and/or preset time intervals and the like, acquiring the load of a sample detection system and/or the quality control time interval of the quality control of a sample analysis instrument in real time by a sample detection system, comparing the load of the sample detection system with the preset load conditions, and/or comparing the quality control time interval with the preset quality control time interval; and under the condition that the load of the sample detection system is judged to meet the preset load condition 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 condition is met.

The preset load condition in the preset quality control trigger condition may include: the number of sample analyzers, the number of sample detection systems, the number of samples of the maximum detectable samples of the sample detection systems, etc. are preset. The method comprises the steps that a sample detection system obtains the number of sample analyzers without samples to be analyzed currently, when the number of the sample analyzers without the samples to be analyzed currently is larger than the number of the preset sample analyzers, the sample detection system judges that a preset quality control trigger condition is met, and/or the sample detection system obtains the number of the samples to be analyzed currently, when the number of the samples to be analyzed currently is smaller than the number of the sample detection systems, the sample detection system judges that the preset quality control trigger condition is met, and/or the sample detection system obtains the number of the samples of the analyzed samples in a preset historical time period, and when the number of the samples of the analyzed samples in the historical time period is smaller than the number of the samples of the maximum detectable samples of the sample detection system, the sample detection system judges that the preset quality control trigger condition is met.

It should be noted that the preset number of sample analyzers, the number of sample detection systems, the number of samples of the maximum detectable samples of the sample detection systems, and the like may be expanded or reduced by a certain factor to obtain the preset load condition.

Illustratively, the preset load conditions include the following three:

1. at least one sample analyzer in the sample detection system has no sample to be analyzed, wherein one sample analyzer is the number of preset sample analyzers;

2. the number of samples of the samples to be analyzed in the sample detection system is less than or equal to X times the number of the sample detection systems, wherein X is a positive integer;

3. the number of samples analyzed in the historical N minutes is less than the% M sample number of the largest detectable sample of the sample detection system, where N, M is a positive integer.

Optionally, the quality control time interval in the preset quality control trigger condition may be a fixed time, such as 8 am, 12 am, and 4 pm every day, or may be set as monday and friday in one week; the preset quality control time interval in the quality control triggering condition can also be a time interval from the quality control of the sample analyzer in the previous round, for example, the quality control of the sample analyzer is performed once every other day; the preset quality control time interval in the quality control trigger condition may also be determined according to the detection frequency of the sample analyzer for performing sample detection, for example, when the detection frequency of the sample analyzer for performing sample detection is less than the detection frequency of 5 tubes of blood samples per hour, the quality control of the sample analyzer is performed, which may be specifically selected according to actual conditions, and the embodiment of the present invention is not specifically limited.

It should be noted that the quality control starting identifier of the sample analyzer may also be displayed on the visual interface, and when a touch operation on the quality control identifier of the sample analyzer is received, the quality control process of the sample analyzer is triggered, at this time, the sample analyzer performs sample detection on a detection sample, and according to a detected sample detection result, a target sample meeting a preset standard condition is screened from the detected detection sample.

And under the condition that the preset quality control triggering condition is met, controlling the transmission device to input the detection sample into the sample analysis instrument, carrying out sample detection on the detection sample by the sample analysis instrument, and screening out a target sample meeting the preset standard condition from the detection sample which is detected according to the detected sample detection result.

It should be noted that, the user preset the preset standard conditions of the target sample for consistency analysis, including: the method comprises the steps of presetting a sample size threshold value, monitoring parameters, parameter ranges corresponding to the monitoring parameters, abnormal information, rechecking rules and the like, and carrying out sample detection on a detection sample by a sample analyzer to obtain a sample detection result corresponding to a preset standard condition. Specifically, a sample analyzer first determines the sample size of a test sample; when the sample amount of the detection sample is larger than or equal to a preset sample amount threshold value, the sample analysis instrument selects a sample which meets the parameter range of the monitoring parameters in the sample detection result as a target sample; and/or selecting a sample including abnormal information in the sample detection result as a quality control sample; and/or selecting samples meeting the reinspection rule in the sample detection results as quality control samples.

Specifically, the sample analyzer detects a monitoring parameter value of the detection sample, alarm information of the detection sample and/or a retest condition of the sample detection system, and determines the detection sample as the target sample when the monitoring parameter value of the detection sample meets a parameter range of the monitoring parameter, and/or when the alarm information of the detection sample includes abnormal information, and/or when the retest condition meets a retest rule.

Alternatively, the monitored parameter may be White Blood Cells (WBC), Red Blood Cells (RBC), Hemoglobin (Determination of Hemoglobin in Blood, HGB), hematocrit (Red Blood Cell specific Volume, HCT), Mean Corpuscular Volume (MCV), Mean Corpuscular Hemoglobin content (MCH), Mean Hemoglobin Concentration (MCHC), platelets (Blood plasma Concentration, MCHC), etc., and the corresponding monitored parameter may range from 9.5 > 3.5, 5.8 > RBC > 3.8, 175 > HGB > 115, 0.35 > HCT > 0.50, 100 > MCH V > 82, 34 > 27, 354 > 350 > MCHC > 125.

Optionally, the alarm information includes alarm information such as immature granulocytes, primitive cells, anemia, iron-deficiency anemia, three-line reduction, thrombocytopenia, thrombocytosis, and the like, and the target sample of low-value platelets can be screened out for consistency evaluation according to the alarm information of thrombopenia.

Optionally, the sample detection system may screen a normal sample without review and automatic review, or may screen a target sample according to a set review rule (e.g., PLT < 80).

It should be noted that, target samples with different parameter intervals, such as high value sample, median sample, and low value sample, may be screened from the detection sample, where the parameter interval of the WBC parameter corresponding to the high value sample may be 15.0 × 10⁹/L～20.0×10⁹The parameter interval of WBC parameters corresponding to the/L and median samples can be 10.0 multiplied by 10⁹/L～12.0×10⁹The parameter interval of the WBC parameter corresponding to the/L and low-value sample can be 3.0 multiplied by 10⁹/L～8.0×10⁹L; the number of the target samples in different parameter intervals may be one or multiple, and is not specifically limited herein.

In another optional embodiment, the user may also select the target sample from the detection samples by himself, specifically, the sample analyzer detects the detection samples to obtain a sample detection result of the detection samples, and the user selects the target sample from the detection samples by himself according to the sample detection result.

S102, transmitting the target sample to at least one other sample analysis instrument, and respectively absorbing partial samples from the target sample by the at least one other sample analysis instrument for analysis to obtain at least one group of detection data with the same type; each sample analysis instrument of the at least one other 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 of the same type of test items on a portion of the target sample.

The sample detection system adopts a laboratory information management system LIS or middleware to obtain a test tube frame number or a sample identification of a target sample; the test tube rack number or sample identification is associated with an instrument number of the at least one other sample analysis instrument. When the target sample on the test tube rack needs to be transported to at least one other sample analyzer for detection, the sample detection system may transport the test tube rack loaded with the target sample to at least one other sample analyzer by using the transport device, and at least one other sample analyzer may use its own sampling needle to suck a portion of the sample from the test tube, transport the sucked portion of the sample to the reaction container, and react with the reagent in the reaction container. And then, analyzing the part of the sample after the reaction is finished to obtain at least one group of detection data with the same type.

It should be noted that the other at least one sample analyzer is configured to perform at least one test item of the same type on a part of the samples in the target sample, wherein the other at least one sample analyzer is at least one sample analyzer of the same brand or a different brand, such as at least one blood corpuscular analyzer, at least one saccharification analyzer, at least one blood cell morphology analyzer (also called "slide reader"), and the like; or the other sample analyzer with at least one sample analyzer is a sample analyzer with the same detection item, such as blood conventional leucocyte detection, liver function detection of biochemical instruments, fibrinogen detection of coagulation instruments, hepatitis B detection of immunity instruments and the like.

In the embodiment of the present invention, the other at least one sample analyzer respectively analyzes a group of monitoring parameters of the partial sample to obtain at least one group of detection data corresponding to the monitoring parameters, wherein the group of monitoring parameters corresponds to each group of detection data one to one.

S103, performing consistency analysis on the other at least one sample analysis instrument according to the at least one group of detection data to obtain a consistency analysis result of the other at least one sample analysis instrument.

In the embodiment of the invention, the sample detection system acquires at least one group of detection data from at least one other sample analyzer, and then performs quality control analysis on the corresponding sample analyzer according to the group of detection data to obtain a quality control analysis result corresponding to the sample analyzer; and determining at least one quality control analysis result corresponding to at least one other sample analysis instrument as a consistency analysis result of the at least one other sample analysis instrument.

In the embodiment of the invention, the selected parameter ranges are different and the criterion for determining the out-of-control is also different aiming at different monitoring parameters, so that the sample detection system sets the preset out-of-control threshold value for each monitoring parameter and the parameter range corresponding to each monitoring parameter.

For example, as shown in table 1, different preset runaway threshold values are set for different monitoring parameters and parameter ranges.

TABLE 1 WS/T406-

Specifically, taking a sample analyzer as an example, the process of the sample detection system performing quality control analysis on a corresponding sample analyzer according to a set of detection data to obtain a quality control analysis result corresponding to the sample analyzer includes: the sample detection system determines a set of deviation data between a set of detection data and corresponding standard detection data; the sample detection system searches a group of preset runaway thresholds corresponding to a group of detection data, and compares a group of deviation data corresponding to the group of detection data with a group of corresponding preset runaway thresholds respectively.

Optionally, the sample detection system may determine the standard detection data in two ways: the first is to calculate at least one mean value of at least one set of detection data; at least one mean is determined as standard test data. The second is to determine a standard sample analysis instrument from the sample analysis instrument and/or at least one other sample analysis instrument; and determining a set of detection data corresponding to the standard sample analysis instrument as standard detection data.

In the embodiment of the present invention, a group of deviation data may be normalized, and a group of normalized results is compared with 1, and when the normalized result is greater than 1, it is determined that the sample analyzer is out of control, and when the normalized result is less than or equal to 1, it is determined that the sample analyzer is in control.

In an alternative embodiment, the normalization result is a relative deviation, and the deviation data is normalized to obtain the relative deviation as shown in equation 1,

relative deviation (detection data-standard detection data corresponding to detection data)/standard detection data corresponding to detection data/runaway threshold value corresponding to detection data (1)

In another alternative embodiment, the normalization result is an absolute deviation, and the normalization process is performed on a set of deviation data to obtain the absolute deviation as shown in formula 2,

absolute deviation (detection data-standard detection data corresponding to detection data)/runaway threshold value corresponding to detection data (2)

Under the condition that it is determined that first deviation data in a group of deviation data exceeds a first preset runaway threshold, the sample detection system determines that one sample analysis instrument is out of control, wherein the first deviation data corresponds to first detection data in a group of detection data, and the first preset runaway threshold is a runaway threshold of a monitoring parameter corresponding to the first detection data.

In the embodiment of the invention, under the condition that the first deviation data is determined to exceed the first preset runaway threshold value, the sample detection system judges whether the measurement is abnormal or not; and when the abnormal measurement is judged, the sample detection system prompts the abnormal measurement.

Specifically, when it is determined that the first deviation data exceeds a first preset runaway threshold, the sample analyzer re-screens the target sample, and transmits the re-screened target sample to at least one other sample analyzer for analysis, so as to obtain a set of updated detection data corresponding to the monitoring parameters; thereafter, determining an updated set of deviation data between the updated set of test data and the corresponding standard test data; the sample detection system determines that a corresponding sample analyzer is out of control when a first updated deviation data in the set of updated deviation data exceeds a first preset out-of-control threshold value.

Under the condition that the first deviation data is determined not to exceed a first preset out-of-control threshold value, the sample detection system acquires first historical deviation data corresponding to the first deviation data, and judges whether one sample analysis instrument is out of control of trend or not according to the first historical deviation data and the first deviation data; at this time, the sample detection system determines a set of deviation data and an out-of-control judgment result as a consistency analysis result of one sample analysis instrument, wherein the out-of-control judgment result includes whether at least one other sample analysis instrument is out of control and/or whether at least one other sample analysis instrument is trended out of control.

As shown in fig. 2, the process of the sample detection system for determining the consistency analysis result of one sample analyzer includes:

1. calculating deviation data between the detection data and standard detection data of one sample analyzer;

2. comparing the deviation data with a corresponding preset out-of-control threshold value;

3. detecting whether a measurement abnormity alarm exists or not under the condition that the deviation data exceeds a corresponding preset runaway threshold value;

4. when the abnormal measurement alarm is detected, prompting the measurement problem and executing 6;

5. executing step 6 under the condition that no measurement abnormity alarm is detected;

6. re-screening the target sample, and transmitting the target sample to a sample analyzer for measurement to obtain updated detection data;

7. determining updated deviation data between the updated detection data and the standard detection data, and comparing the updated deviation data with a preset runaway threshold value;

8. determining that one sample analysis instrument is out of control under the condition that the updated deviation data exceeds a preset out-of-control threshold value, and prompting manual further investigation;

9. determining that a sample analyzer is under control when the updated deviation data does not exceed a preset out-of-control threshold value;

10. under the condition that the deviation data does not exceed the corresponding preset runaway threshold value, judging whether a trend problem exists according to the deviation data and the corresponding historical deviation data;

11. under the condition that the trend problem is judged to exist, prompting that one sample analysis instrument is out of control in trend;

12. and determining that one sample analysis instrument is in control under the condition that the trend problem does not exist.

And S104, when determining that one sample analysis instrument of the at least one other sample analysis instrument is out of control according to the consistency analysis result, outputting an alarm prompt of the sample analysis instrument.

In the embodiment of the invention, under the condition that one sample analysis instrument is judged to be out of control in trend according to the first historical deviation data and the first deviation data, the sample detection system prompts that one sample analysis instrument is out of control in trend.

In the embodiment of the invention, the sample detection system displays the consistency analysis result and the consistency change trend of at least one other sample analysis instrument, wherein the consistency change trend is determined according to the deviation data and historical deviation data corresponding to the deviation data.

Specifically, the sample detection system sequentially obtains historical detection data, a target sample analyzer, target monitoring parameters and parameter ranges corresponding to each detection data in at least one group of detection data; sequentially obtaining a change curve corresponding to a target monitoring parameter of the target sample analyzer according to each detection data and the historical detection data corresponding to each detection data; until at least one group of variation curves corresponding to at least one other sample analysis instrument is obtained; the sample detection system displays at least one set of variation curves on the analysis result interface.

After the sample detection system displays at least one group of variation curves on the analysis result interface, a user can also adjust the display of at least one group of variation curves according to different filtering conditions, and specifically, under the condition that a screening instruction is received, the sample detection system determines the screening condition according to the screening instruction; and then screening a target change curve from at least one group of change curves according to the screening condition, and displaying the target change curve on an analysis result interface.

It should be noted that the point corresponding to the deviation data exceeding the runaway threshold may be highlighted on the variation curve, and the highlighted form may be a form in which the point is distinguished by using other colors such as red, and/or the point is displayed in a bold manner.

In the embodiment of the present invention, the screening condition may include: monitoring at least one of a parameter, a parameter range, a detection time period, and a sample analysis instrument.

Optionally, a change curve of any one of the at least one other sample analysis instrument in a plurality of parameter intervals of a monitored parameter may be selectively displayed. As shown in FIG. 3, the sample analyzer has a variation curve 1 in the range of 87-97 of MCV parameters and a variation curve 2 in the range of 96-106 of MCV parameters.

Optionally, the target variation curve of any one or several of the at least one other sample analysis instrument may be selectively displayed.

Optionally, the target variation curve of at least one other sample analyzer within a certain detection period may be selectively displayed.

Optionally, filtering may be performed using a monitored parameter, such as displaying a variation curve corresponding to a WBC parameter of any one or more of the at least one other sample analysis devices.

Optionally, the parameter range of a monitored parameter may be used for filtering, such as displaying the WBC parameter of any one or more of the at least one other sample analysis instruments at 10.0 × 10⁹/L～12.0×10⁹The change curve in the/L interval.

It should be noted that the embodiment of the present invention is not limited to the selection of the selection condition, and any one of the selection conditions may be combined, and at least one set of variation curves may be filtered by using the combined selection condition.

It should be noted that, on the analysis result display interface, an out-of-control line of an out-of-control threshold corresponding to the target monitoring parameter and/or a change curve corresponding to the target detection parameter of the standard detection data may also be displayed.

In the embodiment of the invention, the runaway line of the runaway threshold value and/or the change curve corresponding to the target detection parameter of the standard detection data can be displayed differently in different display modes such as different colors or line thicknesses on the analysis result display interface. If the red line is used for displaying the out-of-control line of the out-of-control threshold value, the green line is used for displaying the change curve corresponding to the target detection parameter of the standard detection data.

Optionally, the comparison of one or more other at least one sample analysis instrument with the standard sample analysis instrument may be displayed on a graph. Illustratively, as shown in fig. 4, the results are displayed for the comparison between the RBC machine No. C1 and the standard sample analyzer (target), wherein the curve is a variation curve of the RBC machine No. C1, the values on the variation curve correspond to the relative deviation data between the RBC machine No. C1 and the standard sample analyzer, lines 1 and 7 are loss 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.

Optionally, can be usedFiltering by parameter ranges of certain monitored parameters of the standard sample analyzer, e.g., only showing standard sample analyzer WBC parameter values at 10.0 × 10⁹/L～12.0×10⁹Consistency analysis results and consistency change trends in the/L interval.

It can be understood that the user can set different filtering conditions according to different needs, and then at least one group of displayed variation curves are the quality control analysis result most concerned by the user, and different filtering conditions can perform multi-angle analysis on at least one other sample analysis instrument.

Further, when the quality control process of the sample analyzer in the current round is completed, the sample detection system can also store at least one group of detection data, the consistency analysis result and the consistency change trend into data management software; and/or deriving at least one group of detection data, consistency analysis results and consistency change trends from the data management software, and generating corresponding analysis reports to be sent to other equipment for further analysis by other equipment based on the analysis reports.

It can be understood that, the consistency analysis is carried out on at least one other sample analysis instrument by utilizing the target sample, the sample does not need to be stored for a long time, and the sample analysis instrument can automatically realize the processes of screening the target sample, transmitting the target sample to at least one other sample analysis instrument and carrying out the consistency analysis according to at least one group of detection data, so that the quality control process is simplified, meanwhile, the sample can sense abnormal conditions, and then the accuracy of the quality control result can be improved by utilizing the target sample to carry out the consistency analysis on at least one other sample analysis instrument.

Based on the foregoing embodiments, an embodiment of the present invention further provides a sample analyzer quality control device 1, as shown in fig. 5, where the sample analyzer quality control device 1 includes:

the screening unit 10 is used for screening target samples meeting preset standard conditions from detected detection samples which are detected according to sample detection results measured by a sample analyzer under the condition that the preset quality control triggering conditions are met;

the data detection unit 11 is configured to transmit the target sample to at least one other sample analyzer, so that the at least one other sample analyzer respectively sucks a part of the sample from the target sample for analysis, so as to obtain at least one set of detection data with the same type; each sample analysis instrument of the at least one other sample analysis instrument corresponds to a set of detection data; the at least one other sample analysis instrument is configured to perform at least one detection item of a same type on a portion of the target sample;

the consistency analysis unit 12 is configured to perform consistency analysis 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 the prompting unit 13 is configured to output an alarm prompt of one sample analyzer when it is determined that one sample analyzer of the at least one other sample analyzer is out of control according to the consistency analysis result.

Optionally, the sample analyzer quality control device 1 further includes: an acquisition unit;

the acquisition unit is used for acquiring the load and/or the quality control time interval of the sample detection system; the sample detection system comprises the sample analysis instrument and the at least one other sample analysis instrument connected by a transport device;

the screening unit 10 is further configured to determine that a preset quality control trigger condition is met 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.

Optionally, the sample analyzer quality control device further includes: a determination unit;

the determining unit is used for determining the sample amount of the detection sample;

the screening unit 10 is further configured to select, as a target sample, a sample that satisfies a parameter range of a monitoring parameter in the sample detection result when the sample size of the detection sample is greater than or equal to a preset sample size threshold; and/or selecting a sample including abnormal information in the sample detection result as a quality control sample; and/or selecting samples meeting the reinspection rule in the sample detection results as quality control samples.

Optionally, the sample analyzer quality control device further includes: a judgment unit;

a determining unit, further configured to determine a set of deviation data between the set of detection data and the corresponding standard detection data; determining that the sample analysis instrument is out of control under the condition that it is determined that first deviation data in the group of deviation data exceeds a first preset out-of-control threshold value, wherein the first deviation data corresponds to first detection data in the group of detection data, and the first preset out-of-control threshold value is an out-of-control threshold value of a monitoring parameter corresponding to the first detection data; determining the group of deviation data and the out-of-control judgment result as a consistency analysis result of the sample analysis instrument;

the judging unit is used for acquiring first historical deviation data corresponding to the first deviation data under the condition that the first deviation data is determined not to exceed the first preset runaway threshold value, and judging whether the sample analysis instrument is in trend runaway or not according to the first historical deviation data and the first deviation data;

the consistency analysis unit 12 is further configured to determine a plurality of quality control analysis results corresponding to the at least one other sample analysis instrument as consistency analysis results of the at least one other sample analysis instrument.

Optionally, the sample analyzer quality control device further includes: a display unit;

and the display unit is used for displaying the consistency analysis result and the consistency change trend of the at least one other sample analysis instrument, and the consistency change trend is determined according to the deviation data and historical deviation data corresponding to the deviation data.

Based on the foregoing embodiments, an embodiment of the present invention further provides a sample detection system 2, as shown in fig. 6, where the sample detection system 2 includes: sample analysis instrument 20, control system 21, and data management system 22;

the control system 21 is configured to control the sample analyzer 20 to screen a target sample meeting a preset standard condition from the detected sample according to the detected sample detection result, when a preset quality control trigger condition is met; controlling a scheduling device to transmit the target sample to at least one other sample analysis instrument, wherein the at least one other sample analysis instrument is configured to perform at least one detection item of the same type on a part of samples in the target sample; for example, the scheduling device may be a transportation track, particularly a transportation track on a production line including a plurality of sample testing apparatuses.

The other at least one sample analyzer 20 is configured to suck a part of the sample from the target sample for analysis, so as to obtain at least one set of detection data with the same type; each sample analysis instrument of the at least one other sample analysis instrument corresponds to a set of detection data;

the data management system 22 is configured to obtain the at least one set of detection information, perform consistency analysis on the at least one other sample analyzer according to the at least one set of detection information, and obtain a consistency analysis result of the at least one other sample analyzer;

the control system 21 is further configured to control to output an alarm prompt of one of the at least one other sample analyzer when it is determined that one of the at least one other sample analyzer is out of control according to the consistency analysis result.

It should be noted that the data management system 22 includes a processor 220, a memory 221, and a display 222, where the display 222 is used for displaying an alarm prompt of the sample analyzer; the memory 221 is used for storing various data, such as a computer program, a detection result of at least one other sample analyzer, including at least one set of detection data, a consistency analysis result, and the like; the processor 220 may be configured to execute a program to perform quality control on the data detection system, where the quality control may include accuracy determination, quality determination, and the like of the detection result of the sample analyzer.

It should be noted that the control system may exist independently from the data management system, such as an independent computer, a cloud platform, or the like, may also be integrated in a certain instrument, or may also be integrated in the data management system, and the existence form of the specific control system may be selected according to the actual situation, which is not specifically limited in the embodiment of the present invention.

In the embodiment of the present invention, if the method is implemented in the form of a software functional module and sold or used as a standalone product, the method may also be stored in a computer-readable storage medium. Based on such understanding, the technical solutions of the embodiments of the present invention may be essentially implemented or a part contributing to the prior art may be embodied in the form of a software product, which is stored in a storage medium and includes several instructions for enabling a computer device (which may be a personal computer, a server, or a network device) to execute all or part of the methods described in the embodiments of the present application. And the aforementioned storage medium includes: various media capable of storing program codes, such as a usb disk, a removable hard disk, a Read Only Memory (ROM), a magnetic disk, or an optical disk. Thus, embodiments of the invention are not limited to any specific combination of hardware and software.

Accordingly, an embodiment of the present invention further provides a computer storage medium, where the computer storage medium stores a measurement program, and the measurement program, when executed, implements the steps of the quality control method for the sample analyzer provided in the above embodiment.

It should be appreciated that reference throughout this specification to "one embodiment" or "an embodiment" means that a particular feature, structure or characteristic described in connection with the embodiment is included in at least one embodiment of the present application. Thus, the appearances of the phrases "in one embodiment" or "in an embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments. It should be understood that, in the various embodiments of the present application, the sequence numbers of the above-mentioned processes do not mean the execution sequence, and the execution sequence of the processes should be determined by their functions and inherent logic, and should not constitute any limitation to the implementation process of the embodiments of the present invention. The above-mentioned serial numbers of the embodiments of the present invention are merely for description and do not represent the merits of the embodiments.

It should be noted that, in this document, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising an … …" does not exclude the presence of other like elements in a process, method, article, or apparatus that comprises the element.

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

The units described as separate parts may or may not be physically separate, and parts displayed as units may or may not be physical units; can be located in one place or distributed on a plurality of network units; some or all of the units can be selected according to actual needs to achieve the purpose of the solution of the embodiment.

In addition, all functional units in the embodiments of the present application may be integrated into one processing unit, or each unit may be separately regarded as one unit, or two or more units may be integrated into one unit; the integrated unit can be realized in a form of hardware, or in a form of hardware plus a software functional unit.

Those of ordinary skill in the art will understand that: all or part of the steps for realizing the method embodiments can be completed by hardware related to program instructions, the program can be stored in a computer readable storage medium, and the program executes the steps comprising the method embodiments when executed; and the aforementioned storage medium includes: various media that can store program codes, such as a removable Memory device, a Read Only Memory (ROM), a magnetic disk, or an optical disk.

Alternatively, the integrated units described above in the present application may be stored in a computer-readable storage medium if they are implemented in the form of software functional modules and sold or used as independent products. Based on such understanding, the technical solutions of the embodiments of the present invention may be essentially implemented or a part contributing to the prior art may be embodied in the form of a software product, which is stored in a storage medium and includes several instructions for enabling a computer device (which may be a personal computer, a server, or a network device) to execute all or part of the methods described in the embodiments of the present application. And the aforementioned storage medium includes: a removable storage device, a ROM, a magnetic or optical disk, or other various media that can store program code.

The above description is only for the specific embodiments of the present application, but the scope of the present application is not limited thereto, and any person skilled in the art can easily conceive of the changes or substitutions within the technical scope of the present application, and shall be covered by the scope of the present application. Therefore, the protection scope of the present application shall be subject to the protection scope of the claims.

Claims

1. A method for quality control of a sample analyzer, the method comprising:

2. The method of claim 1, further comprising:

acquiring a load and/or a quality control time interval of a sample detection system; the sample detection system comprises the sample analysis instrument and the at least one other sample analysis instrument connected by a transport device;

and determining that a preset quality control triggering condition is met under the condition that 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 quality control time interval.

3. The method according to claim 1 or 2, characterized in that the method further comprises:

determining a sample size of the test sample;

when the sample amount of the detection sample is larger than or equal to a preset sample amount threshold value, selecting a sample which meets the parameter range of the monitoring parameter in the sample detection result as a target sample; and/or selecting a sample including abnormal information in the sample detection result as a quality control sample; and/or selecting samples meeting the reinspection rule in the sample detection results as quality control samples.

4. The method of claim 3, further comprising:

and setting corresponding preset runaway threshold values for the monitoring parameters and the parameter ranges.

5. The method of claim 3, wherein the at least one other sample analysis instrument respectively extracts a portion of the sample from the target sample for analysis, and obtains at least one set of detection data with the same type, including:

and the other at least one sample analysis instrument respectively absorbs partial samples from the target samples and analyzes a group of monitoring parameters of the partial samples to obtain at least one group of detection data corresponding to the monitoring parameters, wherein the group of monitoring parameters correspond to each group of detection data one to one.

6. The method of claim 4, wherein the performing the consistency analysis on the at least one other sample analysis instrument according to the at least one set of test data to obtain the consistency analysis result of the at least one other sample analysis instrument comprises:

respectively performing quality control analysis on a corresponding sample analysis instrument according to a group of detection data to obtain a quality control analysis result corresponding to the sample analysis instrument;

and determining at least one quality control analysis result corresponding to the at least one other sample analysis instrument as a consistency analysis result of the at least one other sample analysis instrument.

7. The method of claim 6, wherein the performing the quality control analysis on a corresponding sample analyzer according to a set of detection data to obtain a quality control analysis result corresponding to the sample analyzer comprises:

determining a set of deviation data between the set of test data and corresponding standard test data;

determining that the sample analysis instrument is out of control under the condition that it is determined that first deviation data in the group of deviation data exceeds a first preset out-of-control threshold value, wherein the first deviation data corresponds to first detection data in the group of detection data, and the first preset out-of-control threshold value is an out-of-control threshold value of a monitoring parameter corresponding to the first detection data;

under the condition that the first deviation data is determined not to exceed the first preset runaway threshold value, acquiring first historical deviation data corresponding to the first deviation data, and judging whether the sample analysis instrument is in trend runaway or not according to the first historical deviation data and the first deviation data;

and determining the set of deviation data and the out-of-control judgment result as a consistency analysis result of the sample analysis instrument.

8. The method of claim 7, further comprising:

calculating at least one mean value of the at least one set of detection data;

determining the at least one mean as the standard detection data.

9. The method of claim 7, further comprising:

determining a standard sample analysis instrument from the sample analysis instrument and/or the at least one other sample analysis instrument;

and determining a set of detection data corresponding to the standard sample analysis instrument as the standard detection data.

10. The method of claim 7, further comprising:

when the first deviation data is determined to exceed a first preset runaway threshold value, the sample analyzer re-screens the target sample, and transmits the re-screened target sample to the at least one other sample analyzer for analysis, so as to obtain a group of updated detection data corresponding to the monitoring parameters;

determining an updated set of deviation data between the updated set of test data and the corresponding standard test data;

and determining that the corresponding sample analysis instrument is out of control when a first updated deviation data in the set of updated deviation data exceeds a first preset out-of-control threshold value.

11. The method of claim 7, wherein after determining whether the sample analysis instrument is trending away based on the first historical deviation data and the first deviation data, the method further comprises:

and prompting that the trend of the sample analysis instrument is out of control when the trend of the sample analysis instrument is judged to be out of control according to the first historical deviation data and the first deviation data.

12. The method of claim 10, further comprising:

under the condition that the first deviation data is determined to exceed a first preset runaway threshold value, judging whether measurement abnormity exists or not;

and when the measurement abnormity is judged to exist, prompting the measurement abnormity.

13. The method of claim 1 or 6, further comprising:

and displaying the consistency analysis result and the consistency change trend of the other at least one sample analysis instrument, wherein the consistency change trend is determined according to the deviation data and historical deviation data corresponding to the deviation data.

14. The method of claim 13, wherein displaying the consistency analysis results and the consistency change trend of the at least one other sample analysis instrument comprises:

sequentially acquiring historical detection data, a target sample analyzer, target monitoring parameters and parameter ranges corresponding to each detection data in the at least one group of detection data;

obtaining a change curve corresponding to a target monitoring parameter of the target sample analyzer according to each detection data and historical detection data corresponding to each detection data in sequence;

until at least one group of variation curves corresponding to the other at least one sample analysis instrument is obtained; and displaying the at least one group of variation curves on an analysis result interface.

15. The method of claim 14, further comprising:

determining a screening condition according to a screening instruction under the condition that the screening instruction is received;

and screening a target change curve from the at least one group of change curves according to the screening condition, and displaying the target change curve on the analysis result interface.

16. The method of claim 15, wherein the screening condition comprises at least one of a monitoring parameter, a parameter range, a detection period, and a sample analysis instrument.

17. The method of claim 14, further comprising:

and displaying an out-of-control line of the out-of-control threshold value corresponding to the target monitoring parameter and/or a change curve corresponding to the target detection parameter of the standard detection data on the analysis result display interface.

18. The method of claim 1, further comprising:

acquiring a test tube rack number or a sample identifier of the target sample by using a laboratory information management system LIS or middleware;

associating the test tube rack number or sample identification with an instrument number of the at least one other sample analysis instrument.

19. The method according to claim 1 or 13, further comprising:

storing the at least one set of detection data, the consistency analysis result and the consistency change trend into data management software;

and/or deriving the at least one group of detection data, the consistency analysis result and the consistency change trend from the data management software, and generating a corresponding analysis report to be sent to other equipment.

20. A sample analysis instrument quality control device, comprising:

21. The sample analysis instrument quality control device of claim 20, further comprising: an acquisition unit;

the screening unit is further configured to determine that a preset quality control trigger condition is met under the condition that 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.

22. The sample analysis instrument quality control device of claim 20 or 21, further comprising: a determination unit;

the screening unit is further used for selecting a sample which meets the parameter range of the monitoring parameters in the sample detection result as a target sample when the sample amount of the detection sample is larger than or equal to a preset sample amount threshold value; and/or selecting a sample including abnormal information in the sample detection result as a quality control sample; and/or selecting samples meeting the reinspection rule in the sample detection results as quality control samples.

23. The sample analysis instrument quality control device of claim 20, further comprising: a judgment unit;

the consistency analysis unit is further configured to determine a plurality of quality control analysis results corresponding to the at least one other sample analysis instrument as consistency analysis results of the at least one other sample analysis instrument.

24. The sample analysis instrument quality control device of claim 20, further comprising: a display unit;

25. A sample detection system, comprising: a sample analyzer, a control system, and a data management system;

the control system is used for screening target samples meeting preset standard conditions from detected samples which are detected according to sample detection results measured by a sample analyzer under the condition that preset quality control triggering conditions are met; controlling a scheduling device to transmit the target sample to at least one other sample analysis instrument, wherein the at least one other sample analysis instrument is configured to perform at least one detection item of the same type on a part of samples in the target sample;

26. A storage medium having stored thereon a computer program for use in a sample detection system, wherein the computer program, when executed by a processor, implements the method of any one of claims 1-19.