CN111696655A - Internet-based real-time sharing blood screening indoor quality control system and method - Google Patents
Internet-based real-time sharing blood screening indoor quality control system and method Download PDFInfo
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Abstract
The invention relates to an internet-based real-time shared blood screening indoor quality control system and method. The method comprises the following steps: collecting the effective indoor quality control data of a certain commercial brand reagent in a plurality of laboratories and the reagent batch number and the quality control product batch number corresponding to the data; grouping the data according to the reagent batch number and the quality control product batch number; respectively calculating the mean and the variance of the detection values of the quality control products in the group; calculating the total SD; calculating the composition ratio of each group of data quantity in the total data; according to the composition ratio of each group of data quantity, weighting the respective average of the sum, and calculating the total average; setting the quality control limit of the reagent as the total SD of +/-2 times of the total mean number; the quality control quality detection result is under control within the quality control limit, otherwise, the quality control quality detection result is out of control. The invention can be used for the serological detection of infectious disease markers and the indoor quality control of nucleic acid detection in blood screening and clinical detection, can provide more accurate judgment results, and can realize real-time online analysis and shared analysis of reagent grouping indoor quality control results.
Description
Technical Field
The invention relates to the field of indoor quality control of blood screening, in particular to an indoor quality control system and method for blood screening based on real-time sharing of the Internet.
Background
Indoor Quality Control (IQC) is a work that laboratory staff takes certain methods and steps to continuously evaluate the reliability of the laboratory work to monitor the precision of the laboratory routine work, determine whether the experimental result is reliable, and can send a report. The blood infectious disease screening is performed on healthy blood donors, and is more dependent on laboratory detection in the absence of medical history and physical signs, and suspected infected persons are selected from the healthy blood donors according to the detection result, so that the blood screening needs higher stability and reliability of the detection result of the laboratory. Quality control of blood screening is an effective means to ensure reliable test results. The detection of clinical infectious disease indexes is similar, and indoor quality control can ensure the stability and reliability of detection results. However, virus marker detection is different from general chemical detection, the traditional quality control method based on normal distribution principle may not be suitable for virus marker detection of non-normal distribution, and the indoor quality control method thereof is always a hot spot discussed in the industry.
The indoor quality control techniques commonly used in the detection laboratories at present include: firstly, a sample with 2-5 times of detection Limit (LOD) concentration is selected for qualitative monitoring, and is mostly used for blood screening virus nucleic acid detection; secondly, using the detection value of the quality control product as an index to serve as a quality control diagram, and judging whether the detection is in control by a Westgard multiple-rule quality control method, wherein the detection is mostly seen in serological detection and is also seen in nucleic acid detection; and thirdly, on the basis of qualitative monitoring, setting a series of judgment indexes and comprehensively analyzing the indoor quality control of the detection result.
A sample with 2-5 times of LOD concentration is used for qualitative indoor quality control monitoring, and certain defects exist. First, the LOD concentration is possible only for antigen and nucleic acid detection, while antibody detection is not quantitative and the concentration of antibody detection quality control is not easily determined. Secondly, because the detection of the quality control material is independent of the sample to be detected, for the detection of nucleic acid, the detection condition of the single indoor quality control material cannot completely represent the real reaction condition of other samples to be detected, and the simple qualitative monitoring cannot necessarily find the systematic deviation and most random deviations of the laboratory.
For the Westgard multi-rule quality control method for judging whether the detection is in control, the method can provide more stability and repeatability information than simple qualitative monitoring, but as the detection values among samples of the infectious disease detection indexes such as S/Co values detected by serology or Ct values detected by nucleic acid are not always in linear relation, particularly the Ct values detected by nucleic acid are in exponential relation, the detection values cannot be statistically analyzed by using the normal distribution methods such as t test or variance analysis, and the like, so that the Westgard multi-rule quality control method for judging whether the detection result of the infectious disease marker is in control can cause a lot of false runaway.
On the basis of qualitative monitoring, a series of judgment indexes are set, and indoor quality control of infectious disease marker detection is comprehensively analyzed, so that the purpose of indoor quality control can be achieved.
With the application of the internet 5G technology, a brand new indoor quality control mode combining the indoor quality control of infectious disease marker detection and the internet technology becomes possible. The laboratory using the same reagent uses indoor quality control products of the same batch number, detects the quality control products according to the same rule, submits the detection results of the quality control products of each day to the Internet, and can longitudinally compare the quality control results of the day through cloud computing of the Internet, and observe whether the detection results are within the quality control limit computed according to a certain rule; meanwhile, the detection results in the near term can be transversely compared with the reagent groups, and the detection conditions of other laboratories in the same reagent group are observed, so that the laboratory deviation is known to be caused by the reagent or the laboratory self. Compared with the conventional method, the method can provide more quality control information in time, effectively help a laboratory to find problems in detection in time and ensure the detection quality.
However, to realize real-time on-line analysis based on the internet and shared analysis between laboratories using the same reagent, the problem of the quality control analysis method must be solved first. The continuous use of the qualitative monitoring method obviously loses more useful information; the Westgard multiple-rule quality control method is not suitable for detection of most infectious disease markers; the comprehensive analysis method combined with the performance index is not suitable for internet comparison. Therefore, it is important to establish a new quality control method for effectively distinguishing normal variation from abnormal variation. Secondly, an internet data acquisition and analysis method must be established, so that the quality control technology can conveniently and timely provide friendly services for laboratories.
The applicant's article published in "journal of chinese blood transfusion" 2019, 32 nd 9 th volume, "application discussion of internet-based real-time shared indoor quality control technology in blood screening nucleic acid detection", learns the feasibility of internet-based real-time shared indoor quality control technology in domestic blood screening nucleic acid detection. The method comprises the following steps: in the daily nucleic acid detection of 5 domestic blood centers by using a Roche PCR method and a Piperu TMA method, QConnect quality control product detection of an Australian national serological reference laboratory (NRL) is added, whether the detection is in control is judged according to the daily quality control rule of each laboratory, QConnect detection results and daily quality control detection results of all control detection batches in 2019 in 1-5 months are collected, and the omission factor and the out-of-control rate of the quality control products are compared and analyzed by using 3 methods such as qualitative monitoring, Westgard multiple rules, NRL quality control limits and the like. As a result: the qualitative monitoring shows that 2.48-4.48% of QConnect quality control products Roche mixed sample HCV detection results have missed detection, which is probably related to the low concentration of QConnect HCV quality control products. The 10.61% of missed tests that occurred in the 1 lab may be associated with the laboratory's own testing problems. In a controlled detection batch, the Westgard multiple rule still judges that 1.54% -7.69% of the control is out of control, and the method is not suitable for indoor quality control of nucleic acid detection; the NRL quality control limit judgment can better reflect the control situation of a laboratory and find out possible detection problems in the laboratory. And (4) conclusion: under the condition of further optimizing QConnect quality control products, the real-time shared quality control method based on the Internet can be used for indoor quality control of blood screening nucleic acid detection in China.
However, the QConnect quality control product is an imported product which cannot be purchased at home, and according to the article, the matched EDCnet software analysis system still has defects and is not completely suitable for home. It is still necessary to develop new quality control analysis methods to better apply to the internet-based real-time shared blood screening indoor quality control.
Disclosure of Invention
The invention aims to provide an internet-based real-time shared indoor blood screening quality control method aiming at the defects in the prior art.
It is still another object of the present invention to provide an internet-based real-time shared indoor quality control system for blood screening.
In order to achieve the first purpose, the invention adopts the technical scheme that:
an internet-based real-time shared blood screening indoor quality control method comprises the following steps:
s1, collecting the effective quality control data in the controlled room of a plurality of laboratory certain commercial brands and the reagent batch number and quality control product batch number corresponding to the data;
s2, grouping the data according to the reagent batch number and the quality control product batch number, and respectively calculating the mean and the variance of the quality control product detection values in the group;
s3, calculate total SD: the total variance is the sum of the differences of all the components, and the total SD is the square root of the total variance;
s4, calculating the composition ratio of each group of data quantity in the total data;
s5, according to the data quantity composition ratio of each group, weighting the respective average of the sum, and calculating the total average;
s6, setting the quality control limit of the brand reagent to be total SD of +/-2 times of the total average number, and if the detection result of the laboratory quality control product is in the range, indicating that the batch of detection is in control; if the detection result of the laboratory quality control product exceeds the range, the detection result indicates that the batch of detection has the risk of being out of control.
As a preferred example of the present invention, when a new lot number reagent is used, all laboratories in the quality control system need only submit total more than or equal to 50 in-control detection data of the same quality control product, and the quality control limit of the quality control product is recalculated in a manner weighted by the steps S2 to S5.
More preferably, according to the quality control limit calculated by the new batch number reagent, the computer system automatically rejects the out-of-control number, and immediately adjusts the quality control limit according to the control result, and the more the accumulated data, the more stable and reliable the quality control limit.
As another preferred example of the present invention, in step S2, the grouping principle is that the results of detecting the quality control products of the same lot number by the reagents of the same lot number are grouped.
As another preferred example of the present invention, the data amount per group must be > 50.
As another preferred example of the present invention, the data size of each commercial brand reagent must be 200 or more, and the number of laboratories participating in data collection must be 3 or more.
In order to achieve the second object, the invention adopts the technical scheme that:
an internet-based real-time shared blood screening indoor quality control system, comprising:
a laboratory: the laboratory is an organization for implementing blood screening or infectious disease detection, and the laboratory purchases commercialized reagents to complete blood screening or infectious disease detection and purchases commercialized quality control products to carry out quality control of the laboratory;
indoor quality control data: the indoor quality control data is the effective indoor quality control data of each commercial brand reagent from the laboratory and the reagent batch number and the quality control product batch number corresponding to the data;
quality control platform: the quality control platform is used for collecting the indoor quality control data; grouping the indoor quality control data according to the reagent batch number and the quality control product batch number, and respectively calculating the mean and the variance of the quality control product detection values in the group; calculating the total SD: the total variance is the sum of the differences of all the components, and the total SD is the square root of the total variance; calculating the composition ratio of each group of data quantity in the total data; according to the composition ratio of each group of data quantity, weighting the respective average of the sum, and calculating the total average; setting the quality control limit of the brand reagent as the total SD of +/-2 times of the total mean; comparing the indoor quality control detection result of each laboratory with the quality control limit obtained by calculation, obtaining a conclusion and outputting a result: if the detection value of the quality control product is within the quality control limit range, the batch of detection is in control and effective, and if the detection value of the quality control product exceeds the quality control limit range, the batch of detection has the risk of losing control, and the reason of losing control is irrelevant to normal variation of laboratories, difference among different laboratories, difference among reagent batches and difference among quality control product batches.
As a preferred example of the present invention, the principle that the quality control platform groups the indoor quality control data is that the results of detecting quality control products of the same lot number by the reagents of the same lot number are grouped into one group.
As another preferred example of the present invention, the data amount per group must be > 50.
As another preferred example of the present invention, the data size of each commercial brand reagent must be 200 or more, and the number of laboratories participating in data collection must be 3 or more.
The invention has the advantages that:
1. the invention establishes a new method and a system for controlling the indoor quality of laboratory blood screening, calculates the upper and lower quality control limits through a unique weighting algorithm on the basis of big data according to the principle that the detection result of an infectious disease marker is in abnormal distribution, judges whether the detection is controlled or not according to the quality control limits, can more effectively distinguish normal variation and abnormal deviation, can carry out transverse comparison among different laboratories using the same reagent when the deviation occurs, and quickly distinguish the problem of the reagent from the problem of the laboratory per se, effectively solves the problem of the indoor quality control of the infectious marker detection, and avoids the defect that the traditional method is easy to cause false runaway;
2. the quality control system in the laboratory blood screening room established by the invention can conveniently acquire quality control data, carry out comparative analysis at the cloud end of the Internet and feed back the result to a user in various chart forms in real time and on line; the quality control standard can be unified, comparison can be easily carried out in different laboratories, and differences among different laboratories can be found in time; the method is beneficial to comparing the detection history of the laboratory with the detection history of the laboratory, and discovering the system deviation of the laboratory in time; the computer internet system performs data collection, calculation and result feedback, and has the advantages of quick response, working time saving, convenience and easy use;
3. the method can automatically remove the out-of-control number by the computer system in the using process and immediately adjust the quality control limit according to the in-control result, thereby ensuring that the calculation of the quality control limit is the most accurate so as to obtain the result which is more in line with the actual condition whether the laboratory is in control or not.
In general, the invention can be used for the indoor quality control of serological detection and nucleic acid detection of infectious disease markers in blood screening and clinical detection, can provide more accurate judgment results, and can realize real-time online analysis and shared analysis of the indoor quality control results in reagent groups.
Drawings
FIG. 1 is a flow chart of a real-time shared blood screening indoor quality control method based on the Internet in example 1.
FIG. 2 is a flow chart of a real-time shared blood screening indoor quality control method based on the Internet in example 2.
FIG. 3 is a block diagram of the Internet-based real-time shared blood screening indoor quality control system according to the present invention.
FIG. 4 is a data processing schematic diagram of the Internet-based real-time shared blood screening indoor quality control system of the invention.
Detailed Description
The following detailed description of the present invention will be made with reference to the accompanying drawings.
The reference numerals and components referred to in the drawings are as follows:
1. laboratory 2. indoor quality control data
3. Quality control platform
Embodiment 1 the invention relates to an internet-based real-time shared blood screening indoor quality control method (I)
Referring to fig. 1, the internet-based real-time shared blood screening indoor quality control method of the embodiment includes the following steps:
s1, collecting the control data and the reagent batch number and quality control product batch number corresponding to the data in the control room where certain commercial brand reagent is effective in the blood station laboratory, wherein the data volume of each commercial brand reagent is required to be more than or equal to 200, and the number of laboratories participating in data collection is required to be more than or equal to 3.
And S2, grouping the data according to the reagent batch number and the quality control product batch number, and respectively calculating the mean and the variance of the quality control product detection values in the group. The data size of each group must be greater than or equal to 50.
And S3, the total variance is the sum of the differences of all the components, and the total SD is the square root of the total variance.
And S4, calculating the composition ratio of each group of data quantity in the total data.
S5, according to the data quantity composition ratio of each group, the respective average numbers are weighted and summed up, and the total average number is calculated.
S6, setting the quality control limit of the brand reagent as the total SD of the total average number +/-2 times. The quality control limit is 95% of the range of the quality control detection value calculated according to the brand reagent historical data, and the range includes normal laboratory variation, difference between different laboratories, difference between reagent batches and difference of quality control products, if the quality control detection value is within the range, the batch of detection is in control and effective, and if the quality control detection value is beyond the range, the batch of detection has the risk of out-of-control.
S7, when a new reagent batch is on the market, all laboratories in the quality control system only need to submit the detection data of the same quality control product with the total number more than or equal to 50, and the quality control limit of the quality control product is recalculated in the weighting mode. And the quality control limit of the new batch number reagent can be automatically removed by the computer system in the using process, and the quality control limit is adjusted in real time according to the control result. The more data accumulated, the more stable and reliable the quality control limit.
The above method is explained in more detail below by way of example and code numbers:
s1, collecting indoor quality control data of 5 laboratories for a marker of the same infectious disease, as follows:
it is assumed that the reagent lot numbers and the quality control lot numbers used by the laboratories are different, but the reagent lot numbers and the quality control lot numbers are not changed in the laboratories during the data acquisition period, so that the laboratories form a group. As can be seen from the table, for the commercial brand "agent X", the data volume is: 80+70+150 is equal to or more than 200; for the commercial brand "reagent Y", the data volume is: 200 is more than or equal to 200 when 120+80 is equal to the total weight of the product; the data provided by each laboratory (each group) is more than 50, and the conditions for calculating the quality control limit are met. However, the number of laboratories using reagent Y and quality control b is only 2, and the number of laboratories participating in data collection is not more than 3, so that the quality control limit of reagent Y and quality control b cannot be calculated without adding a new data collection laboratory. The laboratory using the reagent X and the quality control product a is 3, which meets the requirement and can be used to calculate the quality control limit. The detection data of the quality control product provided by each laboratory is valid and in-control data judged according to the existing indoor control standard of the laboratory.
S2, grouped as follows:
the following analysis and calculation were carried out only on the results of the detection of quality control a using reagent X.
S3, calculate total SD:
calculating the variance S (one) of the detection values of 80 quality control articles a in the laboratory 1 (group 1);
calculating the variance S (II) of the detection values of 70 quality control articles a in the laboratory 3 (group 2);
the variance S (three) of the detected values of 150 quality control substances a in the laboratory 5 (group 3) was calculated.
The total variance S (total) is S (one) + S (two) + S (three);
total SD is the square root of S (Total).
S4, calculating the composition ratio of each group of data quantity in the total data:
the composition ratio R (one) of the data amounts of laboratory 1 (group 1) in the total data was 80/(80+70+150) ═ 0.27;
the composition ratio R (two) of the data amounts of laboratory 3 (group 2) in the total data was 70/(80+70+150) ═ 0.23;
the composition ratio R (three) of the data amounts of laboratory 5 (group 3) in the total data was 150/(80+70+150) ═ 0.5.
S5, according to the data quantity composition ratio of each group, weighting the respective average of the sum, and calculating the total average:
the average of the detection values of the quality control substance a by the laboratory 1 (group 1) is represented by mean (one), the average of the detection values of the quality control substance a by the laboratory 3 (group 2) is represented by mean (two), and the average of the detection values of the quality control substance a by the laboratory 5 (group 3) is represented by mean (three), and then the total average mean (total) is mean (one) × 0.27+ mean (two) × 0.23+ mean (three) × 0.5.
S6, setting the quality control limit of the reagent X for detecting the quality control substance a as the total SD of +/-2 times of the total mean number, and then all detection batches of which the detection values A of the quality control substance a are within the range of mean (total) -2 xSD (total) < A < mean (total) +2 xSD (total) are in-control batches, and the laboratory can send reports on the detection results. And when the detection result A of the quality control material a is less than or equal to mean (total) -2 xSD (total) or A is more than or equal to mean (total) +2 xSD (total), the method can judge that the reason of the out-of-control is necessary to analyze in the experiment when the out-of-control is detected in the batch, and detect the samples of the batch again after the problems are corrected. For a routine blood screening laboratory, along with the increase of detection batches of the laboratory, the detection limit of each time is updated and calculated according to continuously accumulated data, and the more the accumulated data is, the more stable and reliable the quality control limit is.
S7, like laboratory 1 later use new reagent Z, if there have other laboratories in the quality control system using the same lot number of reagent Z, and laboratory 1 used with other laboratories the same brand and lot number of quality control c, laboratory 1 can directly use according to other laboratories to calculate the quality control limit of quality control c to control, and the quality control limit will be along with laboratory 1 data join and automatic adjustment, make the quality control limit more accurate and reliable.
If the laboratory 1 uses the reagent Z with a new batch number or uses the quality control product c with different batch numbers, and other laboratories already use the reagent Z with the original batch number or the quality control product c in the quality control system, the laboratory needs to submit more than or equal to 50 detection data under control of the quality control product c using the reagent Z with the new batch number, calculate the mean and the variance of the detection values, calculate the new mean and the total SD by weighting again according to the proportion of the data, and judge whether the detection is under control according to the new quality control limit.
If a new reagent Z used in the laboratory 1 or a new quality control material c is used for the first time in the entire quality control system, as in the case of the reagent Y and the quality control material b used in example 1, it is possible to recalculate the quality control limit in the above-described manner when the reagent or the quality control material is used in at least 3 different laboratories.
It should be noted that the "reagent lot number" refers to a lot number of a certain reagent produced by a manufacturer, and the same reagent lot number indicates that the reagents belong to the same manufacturer and have the same lot number; similarly, the "lot number of the quality control product" refers to a lot number of a certain quality control product produced by a manufacturer, and the same lot number of the quality control product indicates that the quality control products belong to the same manufacturer and have the same lot number. In step S2, the grouping principle is that the result of detecting the quality control items of the same lot number by the reagent of the same lot number is grouped together, and if the reagent lot number is replaced, the grouping should be newly established, and if the quality control item lot number is replaced, the grouping should be newly established. In the using process, the computer system can automatically remove the out-of-control number and immediately adjust the quality control limit according to the in-control result, so that the calculation of the quality control limit is ensured to be the most accurate, and the result which is more in line with the actual condition whether the laboratory is in control or not is obtained.
Embodiment 2 Internet-based real-time sharing blood screening indoor quality control method (II) of the present invention
Referring to fig. 2, the internet-based real-time shared blood screening indoor quality control method of the embodiment includes the following steps:
s1, collecting the effective quality control data in the controlled room of a certain commercial brand reagent in the blood station laboratory and the reagent batch number and the quality control product batch number corresponding to the data, wherein the data volume of each commercial brand reagent must be more than or equal to 200, and the number of laboratories participating in data collection of each commercial brand reagent must be more than or equal to 3.
And S2, grouping the data according to the reagent batch number and the quality control product batch number, and respectively calculating the mean number and the variance of the detection values of the quality control products in the group. The data size of each group must be greater than or equal to 50.
And S3, the total variance is the sum of the differences of all the components, and the total SD is the square root of the total variance.
And S4, calculating the composition ratio of each group of data quantity in the total data.
S5, according to the data quantity composition ratio of each group, the respective average numbers are weighted and summed up, and the total average number is calculated.
S6, setting the quality control limit of the brand reagent as the total SD of the total average number +/-2 times. The quality control limit is 95% range of quality control detection value calculated according to the brand reagent historical data, the range comprises normal variation of laboratories, difference between different laboratories, difference between reagent batches and difference of quality control products, if the detection value of the quality control products is in the range, the batch detection result is in control and effective, and the quality control product detection result exceeding the range indicates that the batch detection has the risk of out-of-control.
It should be noted that the "reagent lot number" refers to a lot number of a certain reagent produced by a manufacturer, and the same reagent lot number indicates that the reagents belong to the same manufacturer and the same lot number; similarly, the "quality control product batch number" refers to a batch number of a certain quality control product produced by a manufacturer, and the same quality control product batch number indicates that the quality control products belong to the same manufacturer and have the same batch number. In step S2, the grouping principle is that the result of detecting the quality control items of the same lot number by the reagent of the same lot number is grouped together, and if the reagent lot number is replaced, the grouping should be newly established, and if the quality control item lot number is replaced, the grouping should be newly established.
Example 3 application example
Compared with the difference of Australian quality control analysis software, the invention discloses a method for detecting HCV detection data of NRLQConnect quality control products by using Roche COBASs 201 MPX v2.0 reagents and a mixed sample detection method in 4 blood stations of the Shanghai city blood center, Shenzhen city blood center, Shandong province blood center and Dalian city blood center from 2019, wherein the method is used for detecting the HCV detection data of the NRLQConnect quality control products. The materials and the method are basically the same as the application discussion of the internet-based real-time shared indoor quality control technology in the blood screening nucleic acid detection in the article published in China blood transfusion journal, 32 nd volume, 9 th volume, 2019 by the applicant, but the research time is prolonged, and partial laboratory data is enriched compared with the original text.
S1, collecting HCV detection data of NRLQConnect quality control products detected by the 4 blood station laboratories Roche COBASS 201 MPX v2.0 reagent mixed sample, eliminating invalid and out-of-control data, and reserving valid and in-control data, wherein the basic data condition is shown in the table. 685 effective data of HCV detection of the NRL QConnect quality control product obtained by the Roche COBASS 201 MPX v2.0 reagent mixed sample detection are met, the requirement of the calculated quality control limit is met, the number of laboratories participating in data collection is 4, is not less than 3, and the requirement of the calculated quality control limit is met.
TABLE 1
And S2, grouping the data according to the reagent batch numbers and the quality control product batch numbers, wherein 4 laboratories use reagents with different batch numbers, but the quality control product batch numbers are the same, each laboratory forms a group, and the mean number and the variance in the group of the detection values of the quality control products in the group are respectively calculated (see Table 1). The data volume of each group is more than or equal to 50, and the requirement of calculating quality control limit is met.
S3, calculating the total variance of 7.23 (see table 1) and the total SD of 2.69, based on the intra-group variance, which is the square root of 7.23.
S4, calculating the composition ratio of each group of data quantity in the total data (see table 1).
S5, a ratio is formed from the respective sets of data amounts, and the respective averages are summed up by weighting, and the total average is calculated to be 38.72.
And S6, setting the quality control limit to be the total SD of +/-2 times of the total mean number. The lower quality control limit is 33.34 and the upper quality control limit is 44.10. If the HCV detection value of NRL QConnect quality control product is between 33.34 and 44.10 by Roche COBASS 201 MPX v2.0 reagent mixed detection, when batch detection is in control, if the detection value is out of the range (including on the quality control limit), the batch detection is out of control.
However, the same set of data, calculated in the quality control analysis software for NRL, gave a lower quality control limit for NRL of 18.00 and an upper quality control limit for NRL of 57.20. The quality control limit range is too wide, the upper limit of the quality control is 57.20, which means that as long as a laboratory can make positive results on the quality control product, no matter how late the Ct value is detected, the batch of detection can never be out of control, and the method is obviously unreasonable.
At present, a calculation method of NRL quality control limit is not clear, but the quality control limit calculated by the method better accords with the detection rule, and is suitable for the practice of nucleic acid detection of blood screening in China.
Example 4 application example
Taking the nucleic acid detection blood screening quality control data of the blood center clinical laboratory in the Shanghai city as an example, the applicability of different indoor quality control methods is further compared.
Materials and methods
1NAT blood screening method: the laboratory of Shanghai blood center mainly adopts Roche COBASS TaqScreens201 MPX v2.0 method (Roche for short) and Grifoles procleixTMThe TIGRIS Ultro plus TMA method (abbreviated as coverslip recovery) was used to screen blood for nucleic acids, and the data herein mainly comes from these 2 detection methods.
2, quality control: the laboratory used QConnect quality control, HBV DNA 50IU/mL, supplied by the Australian national serology reference laboratory (NRL); HCV RNA50 IU/mL; HIV RNA 250 IU/mL. The quality control product suitable for Roche is a multi-label sample with three labels mixed together, and the quality control product suitable for covering and compounding is a single-label sample.
3, detection of quality control products and data acquisition: and (3) detecting the quality control product and the conventional blood sample together, collecting the detection result of the quality control product from 14 days in 1 month to 30 days in 6 months in 2019, and recording the detection result into an Excel table for analysis and calculation. The detection results of all quality control products come from the detection batches judged to be in control according to the quality control rules for daily detection.
43 comparison indoor quality control methods:
4.1Westgard multiple-rule quality control method the detection result of QConnect quality control product is used as Levey-Jennings diagram, and the previous 20 points are calculated
And SD, and is drawn on the figure
X. + -. 2SD and
and (4) quality control limit, judging whether the batch detection is in control or not according to a Westgard multiple rule.
4.2 the quality control limit method of QConnect inputs the test result of the quality control product of QConnect into the quality control analysis software provided by NRL, the system directly calculates the quality control limit of NRL, and judges whether each batch of test is in control according to the quality control limit.
4.3 the quality control limit method of the invention calculates the quality control limit according to the method introduced in the embodiment 3 according to the detection results of the same reagents and quality control products provided by the Shenzhen city blood center, the Chongqing city blood center, the Shandong province blood center and the Dalian city blood center, and judges whether each batch of detection is in control according to the quality control limit.
Second, result in
1. The out-of-control condition is judged according to the Westgard multi-rule quality control method shown in Table 2, and the out-of-control rate is 0.60-10.54% and can reach 10.54% at most according to different detection items, and all detection batches are in-control and effective, so that the large difference appears, which indicates that the Westgard multi-rule quality control method is not suitable for indoor quality control of daily detection of blood screening.
TABLE 2
2. The case of out-of-control was judged by NRL quality control limit calculation as shown in Table 3, except that the HCV quality control limit range was not in accordance with the normal theory (same as example 3), the HBV and HIV quality control limit ranges were substantially reasonable, and 2 results were out-of-control in the detection using Roche reagent.
TABLE 3
3. The quality control limit is calculated according to the method of the invention, the out-of-control condition is judged according to the quality control limit, which is shown in table 4, only 2 out-of-control conditions occur in the HCV detection, and the quality control limit calculated according to the method of the invention is reasonable and available.
TABLE 4
Example 5 the internet-based real-time shared blood screening system of the present invention
Referring to fig. 3, fig. 3 is a block diagram illustrating a blood screening system based on internet real-time sharing according to the present invention. The internet-based real-time shared blood screening system comprises:
laboratory 1: the laboratory 1 is a blood screening facility, and generally, such a laboratory purchases a commercialized reagent to perform blood screening or infectious disease detection, and purchases a commercialized quality control product to perform quality control of the laboratory. The laboratory 1 may be a blood station laboratory set up for the national government, a clinical laboratory entrusted with the development of blood screening, or a laboratory or detection center set up by a commercial institution. In the system of the present invention, the larger the number of the laboratories 1, the more accurate and reliable the quality control limit, and generally, the number of the laboratories 1 should be preferably greater than or equal to 3 for each detection reagent.
Indoor quality control data 2: the indoor quality control data 2 is effective for each commercial brand reagent from the laboratory 1, and the in-control indoor quality control data and the reagent batch number and quality control product batch number corresponding to the data. In the system of the present invention, the data volume for each commercial brand of agent is preferably ≧ 200.
Quality control platform 3: the quality control platform 3 is used for collecting indoor quality control data 2; grouping the indoor quality control data 2 according to the reagent batch number and the quality control product batch number, and respectively calculating the mean number and the variance of detection values of the quality control products in the group; calculating the total SD: the total variance is the sum of the differences of all the components, and the total SD is the square root of the total variance; calculating the composition ratio of each group of data quantity in the total data; according to the composition ratio of each group of data quantity, weighting the respective average of the sum, and calculating the total average; setting the quality control limit of the brand reagent as the total SD of +/-2 times of the total mean; comparing the indoor quality control data 2 of each laboratory 1 with the quality control limit obtained by calculation, obtaining a conclusion and outputting a result: if the detection result of the quality control product is within the quality control limit range, the batch detection is in control and effective; if the detection result of the quality control product exceeds the quality control limit range, when the batch detection is out of control, the reason of the out of control is probably irrelevant to the normal variation of laboratories, the difference among different laboratories, the difference among reagent batches and the difference of the quality control product.
It should be noted that, due to the safety and ethical requirements of the data in the blood screening laboratory and the clinical testing laboratory, many laboratories do not allow direct design of programs to capture indoor quality control data from the laboratory information system, and some laboratory information systems cannot communicate with the internet. Therefore, the system of the invention can be independent of a laboratory information system, for example, a carrier such as a mobile phone or a computer connected to the Internet is used for obtaining indoor quality control data every day in a manual input or two-dimensional code scanning mode. The quality control platform 3 preferably performs real-time calculations on the collected data to adjust the quality control limit in real time. The quality control platform 3 preferably outputs calculation results in a chart form in real time, gives an on-control conclusion or an out-of-control warning, and also provides a plurality of results such as comparison of laboratory historical results, comparison of detection results of different laboratories in reagent groups and the like. Referring to fig. 4, fig. 4 is a data processing schematic diagram of the internet-based real-time shared blood screening indoor quality control system of the present invention, and the quality control platform 3 collects data, calculates the data, determines whether the control is in progress, and compares the results.
The above description is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, several modifications and additions can be made without departing from the method of the present invention, and these modifications and additions should also be regarded as the protection scope of the present invention.
Claims (10)
1. An internet-based real-time shared blood screening indoor quality control method is characterized by comprising the following steps:
s1, collecting the effective quality control data in the controlled room of a plurality of laboratory certain commercial brands and the reagent batch number and quality control product batch number corresponding to the data;
s2, grouping the data according to the reagent batch number and the quality control product batch number, and respectively calculating the mean and the variance of the quality control product detection values in the group;
s3, calculate total SD: the total variance is the sum of the differences of all the components, and the total SD is the square root of the total variance;
s4, calculating the composition ratio of each group of data quantity in the total data;
s5, according to the data quantity composition ratio of each group, weighting the respective average of the sum, and calculating the total average;
s6, setting the quality control limit of the brand reagent to be total SD of +/-2 times of the total average number, and if the detection result of the laboratory quality control product is in the range, indicating that the batch of detection is in control; if the detection result of the quality control product exceeds the range, the detection result indicates that the batch of detection has the risk of being out of control.
2. The method for quality control in a blood screening room of claim 1, wherein when a new lot number reagent is used, the laboratory only needs to submit the detection data of more than or equal to 50 identical quality control products in total, and the quality control limit of the quality control product is recalculated in a manner weighted by the steps S2 to S5.
3. The indoor quality control method for blood screening according to claim 2, wherein the computer system automatically rejects out-of-control number according to the quality control limit calculated by the new lot number reagent, and adjusts the quality control limit in real time according to the control result, and the more the accumulated data, the more stable and reliable the quality control limit.
4. The method for quality control in a blood screening room of claim 1, wherein in step S2, the grouping principle is that the reagents of the same lot number test the quality control products of the same lot number into one group.
5. The method for quality control in a blood screening room according to claim 1, wherein the data volume of each group must be greater than or equal to 50.
6. The method for quality control in blood screening rooms according to claim 1, wherein the data volume of each commercial brand reagent must be 200 or more, and the number of laboratories participating in data collection must be 3 or more.
7. An internet-based real-time shared blood screening indoor quality control system, comprising:
a laboratory: the laboratory is an organization for implementing blood screening or infectious disease detection, and the laboratory purchases commercialized reagents to complete blood screening or infectious disease detection and purchases commercialized quality control products to carry out quality control of the laboratory;
indoor quality control data: the indoor quality control data is the effective indoor quality control data of each commercial brand reagent from the laboratory and the reagent batch number and the quality control product batch number corresponding to the data;
quality control platform: the quality control platform is used for collecting the indoor quality control data; grouping the indoor quality control data according to the reagent batch number and the quality control product batch number, and respectively calculating the mean and the variance of the quality control product detection values in the group; calculating the total SD: the total variance is the sum of the differences of all the components, and the total SD is the square root of the total variance; calculating the composition ratio of each group of data quantity in the total data; according to the composition ratio of each group of data quantity, weighting the respective average of the sum, and calculating the total average; setting the quality control limit of the brand reagent as the total SD of +/-2 times of the total mean; comparing the indoor quality control detection result of each laboratory with the quality control limit obtained by calculation, obtaining a conclusion and outputting a result: when the detection result of the quality control product is within the quality control limit range, the batch of detection is in control and effective, and when the detection result of the quality control product exceeds the quality control limit range, the batch of detection has the risk of out of control, and the out of control reason is irrelevant to normal variation of laboratories, difference among different laboratories, difference among reagent batches and difference among quality control product batches.
8. The indoor quality control system for blood screening of claim 7, wherein the principle that the quality control platform groups the indoor quality control data is that the reagents of the same batch number detect the quality control products of the same batch number, and the results are grouped.
9. The quality control system in the blood screening room as claimed in claim 7, wherein the data volume of each group must be greater than or equal to 50.
10. The indoor quality control system for blood screening according to claim 7, wherein the data volume of each reagent of commercial brand must be greater than or equal to 200, and the number of laboratories participating in data collection must be greater than or equal to 3.
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