CN111696655B - Internet-based real-time shared blood screening indoor quality control system and method - Google Patents
Internet-based real-time shared 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 effective and in-control indoor quality control data of a plurality of laboratory certain commercial brands of reagents and reagent batch numbers and quality control product batch numbers corresponding to the data; grouping the data according to the reagent lot number and the quality control lot number; respectively calculating the average number and the intra-group variance of the detection values of the intra-group quality control products; calculating the total SD; calculating the composition ratio of each group of data volume in the total data; according to the composition ratio of the data quantity of each group, the weighted sum is respectively averaged, and the total average is calculated; setting the quality control limit of the reagent to be total SD which is +/-2 times of the total average value; and the quality control product detection result is in control within the quality control limit, otherwise, the quality control product detection result is out of control. The invention can be used for serological detection of infectious disease markers and 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 indoor quality control results in reagent groups.
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 of real-time shared blood screening based on the Internet.
Background
The indoor quality control (internal quality control, IQC) is a task in which laboratory workers take certain methods and steps to continuously evaluate the reliability of the laboratory work to monitor the precision of the laboratory routine work and determine whether the experimental result is reliable or not and whether a report can be sent. The subjects for blood infectious disease screening are healthy blood donors, and under the condition of lacking medical history and signs, laboratory detection is more dependent, suspected infectious agents are selected from the healthy blood donors according to detection results, so that the blood screening needs to have higher stability and reliability of the detection results of the laboratory. Quality control of blood screening is an effective means of ensuring reliable test results. The detection of clinical infectious disease indexes is similar, and the indoor quality control can ensure the stability and reliability of the detection result. However, unlike general chemical detection, traditional quality control methods based on the principle of normal distribution may not be suitable for detection of viral markers that are not normally distributed, and indoor quality control methods have been a hotspot in the industry.
The indoor quality control technology commonly used in each detection laboratory at present comprises the following steps: (1) selecting a sample with the detection Limit (LOD) concentration of 2-5 times of the detection method for qualitative monitoring, which is most commonly found in blood screening virus nucleic acid detection; (2) taking the detection value of the quality control product as an index as a quality control chart, and judging whether detection is under control or not by using a Westgard multi-rule quality control method, which is mostly found in serological detection and also can be found in nucleic acid detection; (3) on the basis of qualitative monitoring, a series of judging indexes are set, and the indoor quality control of the detection result is comprehensively analyzed.
The qualitative indoor quality control monitoring by using a sample with the LOD concentration of 2-5 times has certain defects. First, only antigen and nucleic acid detection may have LOD concentration, but antibody detection cannot be quantified, and the concentration of antibody detection quality control product cannot be easily determined. Secondly, because the detection of the quality control product is independent of the sample to be detected, for nucleic acid detection, the detection condition of the indoor quality control product alone cannot completely represent the actual reaction condition of other samples to be detected, and simple qualitative monitoring cannot necessarily find systematic deviation and most random deviation of a laboratory.
For judging whether the detection is under control or not by using the Westgard multi-rule quality control method, the method can provide more stability and repeatability information than the simple qualitative monitoring, but because the detection indexes of infectious diseases, such as S/Co values of serological detection or Ct values of nucleic acid detection, detection values among samples are not always linear, particularly Ct values of nucleic acid detection are exponential, statistical analysis can not be performed on the detection values by using normal distribution methods such as t-test or variance analysis, and therefore, the Westgard multi-rule quality control method can judge whether the detection result of the infectious disease marker is under control or not, and a plurality of false runaway can be caused.
On the basis of qualitative monitoring, a series of judging indexes are set, and the aim of indoor quality control can be achieved by comprehensively analyzing the indoor quality control of infectious disease marker detection, but a plurality of indexes in the method are determined by performing performance verification on a detection method in a laboratory, so that the method is complex in operation, more abundant experience and long-term verification are required, the laboratory characteristics of all indexes are obvious, and the comparison of indoor quality control results among different laboratories cannot be realized.
With the application of the internet 5G technology, a new indoor quality control mode combining the indoor quality control of the infectious disease marker detection and the internet technology becomes possible. Each laboratory using the same reagent uses indoor quality control products with the same batch number, the quality control products are detected according to the same rule, the detection results of the quality control products are submitted to the Internet, the laboratory can carry out longitudinal comparison of the quality control results of the same day through cloud computing of the Internet, and whether the detection results are within the quality control limit computed according to a certain rule is observed; meanwhile, the recent detection result can be transversely compared with the reagent group, and detection conditions of other laboratories between the reagent group and the laboratory can be observed, so that whether the laboratory deviation is caused by the reagent or the laboratory is caused by the laboratory. Compared with the current common method, the method can provide more quality control information in time, can effectively help a laboratory to discover problems in detection in time, and ensures the detection quality.
However, to achieve real-time online analysis based on the internet and shared analysis between laboratories using the same reagents, the problem of the quality control analysis method must be solved first. Continuing to use the qualitative monitoring method obviously loses more useful information; the Westgard multi-rule quality control method is not applicable to detection of most infectious disease markers; the comprehensive analysis method combining the performance indexes is not suitable for internet comparison. Therefore, it is important to establish a new quality control method to effectively distinguish 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 service for laboratories.
The applicant published in the article "application discussion of real-time shared indoor quality control technology based on Internet in blood screening nucleic acid detection" of volume 32 and 9 of Chinese journal of blood transfusion in 2019, and has known the feasibility of application of real-time shared indoor quality control technology based on Internet in domestic blood screening nucleic acid detection. The method comprises the following steps: in the daily nucleic acid detection of domestic 5 blood centers by using a Roche PCR method and a Gaolifu TMA method, QConnect quality control product detection of an Australian national serology reference laboratory (NRL) is added, whether detection is under control is judged according to daily quality control rules of each laboratory, all detection results of QConnect detection batches under control and detection results of daily quality control in 2019 month 1-5 are collected, and the omission ratio and the runaway ratio of the quality control products are compared and analyzed by using 3 methods such as qualitative monitoring, westgard multiple rules, NRL quality control limit and the like. Results: qualitative monitoring shows that 2.48% -4.48% of detection results of the QConnect quality control product Roche mixed sample HCV show missing detection, and the detection results may be related to the fact that the concentration of the QConnect HCV quality control product is too low. The 10.61% of the missed tests occurring in 1 laboratory may be related to the detection problems of the laboratory itself. In the controlled detection batch, the Westgard multi-rule still judges that 1.54-7.69% of the detection batch is out of control, which indicates that the method is not suitable for indoor quality control of nucleic acid detection; the NRL quality control limit judgment can better reflect the control condition of a laboratory and find possible detection problems of the laboratory. Conclusion: under the condition of further optimizing QConnect quality control, the real-time sharing quality control method based on the Internet can be used for the indoor quality control of blood screening nucleic acid detection in China.
However, qfonnect quality control is an imported product which cannot be purchased in China, and according to the qfonnect quality control, the matched EDCNet software analysis system still has defects, and is not completely suitable for China. It remains necessary to study new quality control analysis methods for better indoor quality control for internet-based, real-time shared blood screening.
Disclosure of Invention
The invention aims at overcoming the defects in the prior art and provides an Internet-based real-time shared indoor quality control method for blood screening.
It is yet another object of the present invention to provide an internet-based real-time shared blood screening indoor quality control system.
In order to achieve the first object, the invention adopts the following technical scheme:
an internet-based real-time shared blood screening indoor quality control method comprises the following steps:
s1, collecting effective and controlled indoor quality control data of a plurality of laboratory commercial brands of reagents and reagent batch numbers and quality control product batch numbers corresponding to the data;
s2, grouping data according to the reagent batch number and the quality control batch number, and respectively calculating the average number and the intra-group variance of the detection values of the quality control products in the group;
s3, calculating total SD: the total variance is the sum of the variances of each group, and the total SD is the square root of the total variance;
s4, calculating the composition ratio of each group of data volume in the total data;
s5, calculating the total average value according to the data volume composition ratio of each group and the respective average value of the weighted sum;
s6, setting the quality control limit of the brand reagent to be total SD which is +/-2 times of the total average value, and if the detection result of the laboratory quality control product is within the range, indicating that the batch detection is in control; if the detection result of the laboratory quality control product exceeds the range, the batch detection is indicated to have a risk of out of control.
As a preferred example of the invention, when a new batch of reagents is used, all laboratories in the quality control system only need to submit the on-control detection data of more than or equal to 50 identical quality control products in total, and the quality control limit of the quality control products is recalculated in a weighted manner according to the steps S2 to S5.
More preferably, the computer system automatically eliminates the out-of-control number according to the quality control limit calculated by the new batch number reagent, and instantly 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 together.
As another preferred embodiment of the present invention, the data volume of each group must be equal to or greater than 50.
As another preferred example of the invention, the data size of each commercial brand reagent 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.
In order to achieve the second purpose, the invention adopts the following technical scheme:
an internet-based real-time shared blood screening indoor quality control system, comprising:
laboratory: the laboratory is a mechanism for implementing blood screening or infectious disease detection, and buys commercial reagents to complete blood screening or infectious disease detection and buys commercial quality control products to control the quality of the laboratory;
indoor quality control data: the indoor quality control data are effective indoor quality control data of each commercial brand reagent from the laboratory and reagent batch numbers and quality control product batch numbers corresponding to the data;
and a 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 average number and the intra-group variance of the detection values of the intra-group quality control products; total SD was calculated: the total variance is the sum of the variances of each group, and the total SD is the square root of the total variance; calculating the composition ratio of each group of data volume in the total data; according to the composition ratio of the data quantity of each group, the weighted sum is respectively averaged, and the total average is calculated; setting the quality control limit of the brand reagent to be total SD which is +/-2 times of the total average number; comparing the indoor quality control detection results of all laboratories with the quality control limit calculated by the above steps to obtain a conclusion and output the result: if the detection value of the quality control product is within the quality control limit range, the batch detection is controlled and effective, and if the detection value of the quality control product is beyond the quality control limit range, the batch detection may have a risk of out-of-control, and the reason for out-of-control may be irrelevant to normal variation of laboratories, differences among different laboratories, differences among reagent lot numbers, and differences among quality control product lot numbers.
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 the quality control products of the same lot number by the reagent of the same lot number are grouped into one group.
As another preferred embodiment of the present invention, the data volume of each group must be equal to or greater than 50.
As another preferred example of the invention, the data size of each commercial brand reagent 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.
The invention has the advantages that:
1. the invention establishes a new laboratory blood screening indoor quality control method and system, calculates upper and lower quality control limits through a unique weighting algorithm based on big data according to the principle that the detection result of infectious disease markers is in non-normal distribution, judges whether detection is in control or not according to the quality control limits, can more effectively distinguish normal variation and abnormal deviation, and can carry out transverse comparison among different laboratories using the same reagent when the deviation occurs, so as to rapidly distinguish the problem of the reagent from the problem of the laboratory itself, effectively solve the indoor quality control problem of infectious disease marker detection, and avoid the defect that the traditional method is easy to cause false runaway;
2. the laboratory blood screening indoor quality control system established by the invention can conveniently collect quality control data, carry out comparison analysis on the Internet cloud, and feed back the results to the user in various chart forms in real time on line; the method is favorable for unifying quality control standards, is easy to compare in different laboratories, and can find the differences among different laboratories in time; the comparison of the laboratory and the self detection history is facilitated, and the systematic deviation of the laboratory is found in time; the computer internet system is used for data collection, calculation and result feedback, and has the advantages of rapid response, working time saving, convenience and easy use;
3. the method of the invention can automatically remove the out-of-control number by the computer system in the use process, and instantly adjust the quality control limit according to the in-control result, thus ensuring the calculation of the quality control limit to be the most accurate so as to obtain the result which accords with whether the actual laboratory is in control or not.
In general, the invention can be used for serological detection of infectious disease markers and 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 indoor quality control results in reagent groups.
Drawings
FIG. 1 is a flow chart of an in-house quality control method for Internet-based real-time sharing of blood screening according to example 1.
Fig. 2 is a flow chart of a real-time internet-based shared blood screening indoor quality control method of example 2.
Fig. 3 is a block diagram of the real-time shared blood screening indoor quality control system based on the internet.
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.
Detailed Description
The following detailed description of the invention provides specific embodiments with reference to the accompanying drawings.
Reference numerals and components referred to in the drawings are as follows:
1. laboratory 2. Indoor quality control data
3. Quality control platform
Example 1 Internet-based real-time shared blood screening indoor quality control method (I)
Referring to fig. 1, the method for controlling the indoor quality of the internet-based real-time shared blood screening according to the present embodiment includes the following steps:
s1, collecting effective and controlled indoor quality control data of certain commercial brand reagents in a blood station laboratory, and reagent batch numbers and quality control product batch numbers corresponding to the data, wherein the data volume of each commercial brand reagent is more than or equal to 200, and the number of laboratories participating in data collection is more than or equal to 3.
S2, grouping the data according to the reagent lot number and the quality control lot number, and respectively calculating the average number and the intra-group variance of the detection values of the quality control matters in the group. Each group of data must be greater than or equal to 50.
S3, the total variance is the sum of the variances of all groups, and the total SD is the square root of the total variance.
S4, calculating the composition ratio of each group of data amount in the total data.
S5, according to the data volume composition ratio of each group, the weighted sum averages, and the total averages are calculated.
S6, setting the quality control limit of the brand reagent to be total SD which is +/-2 times of the total average number. The quality control limit is a 95% range of quality control product detection values calculated according to the brand reagent historical data, the range comprises laboratory normal variation, differences among different laboratories, differences among reagent lot numbers and differences of quality control products, if the quality control product detection values are in the range, the batch detection is controlled and effective, and if the quality control product detection values are out of the range, the batch detection may be at risk of out of control.
And S7, after the new reagent lot number is marketed, all laboratories in the quality control system only need to submit the in-control 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 of reagents can be automatically removed by the computer system in the use process, and the quality control limit is adjusted in real time according to the control result. The more data are accumulated, the more stable and reliable the quality control limit is.
A more detailed explanation of the above method is given below by way of example and code:
s1, collecting indoor quality control data of 5 laboratories for a certain same infectious disease marker, as follows:
the reagent lot number and the quality control lot number used by each laboratory are assumed to be different, but the reagent lot number and the quality control lot number are not replaced by each laboratory during data acquisition, so that each laboratory is self-organized. As can be seen from the table, for commercial brand "reagent X", the data amounts are: 80+70+150=300 is greater than or equal to 200; for commercial brand "reagent Y", the data amounts are: 120+80=200 is greater than or equal to 200; the data provided by each laboratory (each group) are > 50, and all the conditions for calculating the quality control limit are met. However, the number of laboratories using the reagent Y and the quality control b is not equal to or greater than 3, but only 2 laboratories using the reagent Y and the quality control b cannot be calculated without adding a new data collection laboratory. Laboratory = 3 using reagent X and quality control a, as required, can be used to calculate the quality control limit. The detection data of the quality control product provided by each laboratory are data which are judged to be valid and controlled according to the existing indoor control standard of the laboratory.
S2, grouping as follows:
only the results of detecting the quality control product a using the reagent X are analyzed and calculated below.
S3, calculating total SD:
calculating the variance S (I) of the detection values of the total 80 quality control products a of the laboratory 1 (group 1);
calculating the variance S (II) of 70 quality control product a detection values in the laboratory 3 (group 2);
the variance S (three) of the detected values of 150 quality controls a in total in laboratory 5 (group 3) was calculated.
Total variance S (total) =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 volume in the total data:
the composition ratio R (one) of the laboratory 1 (group 1) data amount in the total data is 80/(80+70+150) =0.27;
the composition ratio R (two) of the laboratory 3 (group 2) data amount in the total data was 70/(80+70+150) =0.23;
the composition ratio R (three) of the data amount of laboratory 5 (group 3) in the total data was 150/(80+70+150) =0.5.
S5, according to the data volume composition ratio of each group, calculating the total average value by weighting the average value of each sum:
the average number of detection values of the quality control a by the laboratory 1 (group 1) is represented by mean (one), the average number of detection values of the quality control a by the laboratory 3 (group 2) is represented by mean (two), and the average number of detection values of the quality control a by the laboratory 5 (group 3) is represented by mean (three), then the total average number mean (total) =mean (one) ×0.27+mean (two) ×0.23+mean (three) ×0.5.
S6, setting the quality control limit of the reagent X detection quality control product a as the total SD which is +/-2 times of the total average, wherein detection batches with detection values A of all quality control products a within the range of mean (total) -2 XSD (total) < A < mean (total) +2 XSD (total) are all under control batches in the future, and a laboratory can report the detection results. And when the detection result A of the quality control product 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), judging that the experiment has to analyze the cause of the runaway when the runaway is detected, and detecting the samples of the lot again after correcting the problem. For a conventional blood screening laboratory, with the increase of laboratory detection batches, 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, when a new reagent Z is used in the later stage of the laboratory 1, and other laboratories in the quality control system are already using reagents Z with the same lot number and the laboratory 1 is using quality control products c with the same brand and lot number as other laboratories, the laboratory 1 can directly utilize the quality control limit of the quality control products c calculated according to other laboratories to perform quality control, and the quality control limit can be automatically adjusted along with the addition of data of the laboratory 1, so that the quality control limit is more accurate and reliable.
If the laboratory 1 uses a new lot of reagent Z or uses a quality control product c with a different lot, and other laboratories already use the original lot of reagent Z or quality control product c in the quality control system, the laboratory needs to submit more than or equal to 50 pieces of under-control detection data of the quality control product c using the new lot of reagent Z, calculate the mean and variance of the detection values, re-weight and calculate the new mean and total SD according to the ratio of the parts of data, and judge whether the detection is under control according to the new quality control limit.
If a new reagent Z, or a new quality control c, is used for the first time in the overall quality control system, as in the case of reagent Y and quality control b in example 1, it is only possible to recalculate the quality control limit according to the method described above if at least 3 different laboratories use the reagent or quality control.
The "reagent lot" refers to lot numbers of a certain reagent produced by a manufacturer, and the same reagent lot indicates that the reagent belongs to the same manufacturer and the same lot numbers; similarly, the "quality control lot number" refers to the lot number of a certain quality control produced by a manufacturer, and the same quality control lot number indicates that the quality control belongs to the same manufacturer and the same lot number. 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 together, and if the reagent lot number is replaced, the group should be newly established, and if the quality control product lot number is replaced, the group should be newly established. In the using process, the computer system automatically eliminates the out-of-control number, and the quality control limit is adjusted in time according to the in-control result, so that the most accurate calculation of the quality control limit can be ensured, and the result which is more in line with the actual laboratory in-control or not can be obtained.
Example 2 Internet-based real-time shared blood screening indoor quality control method (II)
Referring to fig. 2, the method for controlling the indoor quality of the internet-based real-time shared blood screening according to the present embodiment includes the following steps:
s1, collecting effective and controlled indoor quality control data of certain commercial brand reagents in a blood station laboratory, and reagent batch numbers and quality control product batch numbers corresponding to the data, wherein the data volume of each commercial brand reagent is more than or equal to 200, and the laboratory number of each commercial brand reagent participating in data collection is more than or equal to 3.
S2, grouping the data according to the reagent lot number and the quality control lot number, and respectively calculating the average value and the intra-group variance of the detection values of the quality control in the group. Each group of data must be greater than or equal to 50.
S3, the total variance is the sum of the variances of all groups, and the total SD is the square root of the total variance.
S4, calculating the composition ratio of each group of data amount in the total data.
S5, according to the data volume composition ratio of each group, the weighted sum averages, and the total averages are calculated.
S6, setting the quality control limit of the brand reagent to be total SD which is +/-2 times of the total average number. The quality control limit is a 95% range of quality control product detection values calculated according to the brand reagent historical data, the range comprises laboratory normal variation, differences among different laboratories, differences among reagent lot numbers and differences of quality control products, and if the detection values of the quality control products are in the range, the quality control product detection results beyond the range indicate that the risk of out-of-control exists in batch detection when the batch detection results are in control and effective.
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 reagent belongs to the same manufacturer and the same lot number; similarly, the "quality control lot number" refers to the lot number of a certain quality control produced by a manufacturer, and the same quality control lot number indicates that the quality control belongs to the same manufacturer and the same lot number. 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 together, and if the reagent lot number is replaced, the group should be newly established, and if the quality control product lot number is replaced, the group should be newly established.
Example 3 application example
Taking 1 month to 8 months in 2019, the HCV detection data of NRL QConnect quality control products are detected by using Roche COBAS s201 MPX v2.0 reagent by using a mixed sample detection method in Shanghai blood center, shenzhen blood center, shandong province blood center and Dalian blood center 4 blood stations as examples, and comparing the difference between the invention patent and Australian quality control analysis software. The materials and the methods are basically the same as the application discussion of the Internet-based real-time shared indoor quality control technology in blood screening nucleic acid detection, which is published in the article of Chinese journal of blood transfusion, volume 32, 9 of 2019 by the applicant, except that the research time is prolonged and part of laboratory data is more abundant than the original text.
S1, collecting HCV detection data of the 4 blood station laboratory Roche COBAS S201 MPX v2.0 reagent mixed sample detection NRL QConnect quality control product, removing invalid and uncontrolled data, and retaining valid and in-control data, wherein the basic conditions of the data are shown in the table below. The 685 effective data of HCV detection of the NRL QConnect quality control product is detected by mixing the Roche COBAS 201 MPX v2.0 reagent, the requirement of calculating the quality control limit is met, the number of laboratories participating in data collection is 4, the number of laboratories participating in data collection is more than or equal to 3, and the requirement of calculating the quality control limit is met.
TABLE 1
S2, grouping data according to reagent lot numbers and quality control lot numbers, wherein 4 laboratories use reagents with different lot numbers, but the quality control lot numbers are the same, each laboratory self-forms a group, and the average value and the intra-group variance of detection values of quality control in the group are calculated respectively (see table 1). Each group of data quantity is more than or equal to 50, and meets the requirement of calculating the quality control limit.
S3, calculating the total variance=7.23 (see table 1) from the intra-group variances, the total SD being the square root of 7.23, and the total sd=2.69.
S4, calculating the composition ratio of each group of data amount in the total data (see table 1).
And S5, calculating total average number=38.72 according to the data volume composition ratio of each group and the respective average numbers of the weighted sums.
S6, setting a quality control limit to be the total SD which is +/-2 times of the total average value. The lower quality control limit is 33.34 and the upper quality control limit is 44.10. If the HCV detection value of the NRL QConnect quality control is between 33.34 and 44.10 in the Roche COBAS 201 MPX v2.0 reagent mix detection, the batch detection is in control, and 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 of NRL, gave a lower quality control limit of 18.00 for NRL and an upper quality control limit of 57.20 for NRL. The quality control limit range is too wide, and the quality control is limited to 57.20, which means that whenever a laboratory can give a positive result on a quality control product, no matter how late the Ct value is detected, the batch detection is never out of control, which is obviously not reasonable.
The calculation method of the NRL quality control limit is not clear at present, but the quality control limit calculated by the method accords with the detection rule, and is suitable for the detection practice of blood screening nucleic acid in China.
Example 4 application example
Taking the quality control data of nucleic acid detection blood screening of Shanghai blood center clinical laboratory as an example, the applicability of different indoor quality control methods is further compared.
1. Materials and methods
1NAT blood screening method: shanghai blood center laboratories use mainly Roche COBAS TaqScreen s201 MPX v2.0 methods (abbreviated as "Roche") and Grifoles procleix TM The TIGRIS Ultrio plus TMA method (abbreviated as "top-up") performs nucleic acid screening of blood, and the data herein comes primarily from these 2 detection methods.
2 quality control: the laboratory used qfonnect quality control, 50IU/mL HBV DNA, supplied by the national serological reference laboratory in australia (NRL); HCV RNA50IU/mL; HIV RNA 250IU/mL. The quality control product suitable for Rogowski is a multi-label sample in which three labels are mixed together, and the quality control product suitable for Galith is a single-label sample.
3, detecting quality control products and collecting data: and detecting the quality control product and a conventional blood sample, collecting detection results of the quality control product from 14 days of 1 month to 30 days of 6 months in 2019, and inputting the detection results into an Excel table for analysis and calculation. The detection results of all quality control products are from the detection batch which is judged to be in control according to the quality control rule for daily detection.
4 3 comparison indoor quality control method:
4.1Westgard Multi-rule quality control method the detection result of QConnect quality control product is used as level-Jennings graph, and the previous 20 points are calculated
And SD, and ++are plotted on the graph>
X.+ -. 2SD and ±>
And judging whether the batch detection is in control or not according to the quality control limit and the Westgard multi-rule.
And 4.2, inputting the detection result of the QConnect quality control product into quality control analysis software provided by NRL by using an NRL quality control limit method, directly calculating the NRL quality control limit by using a system, and judging whether each batch of detection is under 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 detection results of the same reagent and quality control product provided by Shenzhen, chongqing, shandong provincial and Dalian blood centers, and judges whether each batch of detection is in control according to the quality control limit according to the method described in the embodiment 3.
2. Results
1. The out-of-control condition is judged according to the Westgard multi-rule quality control method in Table 2, and the out-of-control rate is 0.60% -10.54% and up to 10.54% according to different detection items, and all the detection batches are in control and effective, so great difference appears, which proves that the Westgard multi-rule quality control method is not suitable for indoor quality control for daily detection of blood screening.
TABLE 2
2. The conditions of the runaway judgment according to the NRL quality control limit calculation method are shown in Table 3, except that the quality control limit range of HCV does not meet the normal conditions (same as in example 3), the quality control limit ranges of HBV and HIV are basically reasonable, and 2 results are out of control in the detection using the Roche reagent respectively.
TABLE 3 Table 3
3. The quality control limit is calculated according to the method of the invention, the out-of-control condition is shown in table 4 according to the quality control limit, only 2 out-of-control conditions occur in the detection of HCV, and the quality control limit calculated according to the method of the invention is reasonable and available.
TABLE 4 Table 4
Example 5 Internet-based real-time shared blood screening System of the present invention
Referring to fig. 3, fig. 3 is a block diagram of a real-time internet-based shared blood screening system according to the present invention. The internet-based real-time shared blood screening system includes:
laboratory 1: the laboratory 1 is a blood screening facility, typically such a laboratory purchases commercial reagents to perform blood screening or infectious disease detection and commercial quality control to perform quality control of the laboratory. The laboratory 1 may be a laboratory or a test center set up for a blood station laboratory established by the national government, a clinical laboratory or a commercial establishment entrusted with conducting blood screening. In the system of the invention, the more the number of the laboratories 1 is, the more accurate and reliable the quality control limit is, and generally, the number of the laboratories 1 should be preferably equal to or more than 3 for each detection reagent.
Indoor quality control data 2: the indoor quality control data 2 are effective and in-control indoor quality control data of each commercial brand reagent from the laboratory 1 and reagent batch numbers and quality control lot numbers corresponding to the data. In the system of the present invention, the data amount of each commercial branding 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 average value and the intra-group variance of the detection values of the quality control products in the group; total SD was calculated: the total variance is the sum of the variances of each group, and the total SD is the square root of the total variance; calculating the composition ratio of each group of data volume in the total data; according to the composition ratio of the data quantity of each group, the weighted sum is respectively averaged, and the total average is calculated; setting the quality control limit of the brand reagent to be total SD which is +/-2 times of the total average number; comparing the indoor quality control data 2 of each laboratory 1 with the quality control limit calculated by the above, 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 controlled and effective; if the detection result of the quality control product exceeds the quality control limit range, the batch detection may be out of control, and the reasons for the out of control may be irrelevant to normal variation of the laboratory, the difference between different laboratories, the difference between reagent batch numbers and the difference of the quality control product.
It should be noted that, due to the requirements of data security and ethics in the blood screening laboratory and the clinical testing laboratory, many laboratories are not allowed to directly design programs to capture the data of the quality control in the laboratory from the laboratory information system, and part of the laboratory information systems cannot be communicated with the internet. Therefore, the system of the invention can obtain indoor quality control data every day in a manner of manual input or two-dimension code scanning and the like independently of a laboratory information system, for example, by using a carrier such as a mobile phone or a computer connected with the Internet. The quality control platform 3 preferably calculates the collected data in real time to adjust the quality control limits in real time. The quality control platform 3 preferably outputs the calculation result in a chart form in real time, gives a control conclusion or a runaway warning, and simultaneously provides various results such as laboratory historical result comparison, different laboratory detection result comparison in the reagent group and the like. Referring to fig. 4, fig. 4 is a schematic diagram of data processing of the internet-based real-time shared blood screening indoor quality control system, the quality control platform 3 collects data, and after calculation, determines whether to control, and compares results.
The foregoing is merely a preferred embodiment of the present invention, and it should be noted that modifications and additions may be made to those skilled in the art without departing from the method of the present invention, which modifications and additions are also to be considered as within the scope of the present invention.
Claims (10)
1. The real-time shared blood screening indoor quality control method based on the Internet is characterized by comprising the following steps of:
s1, collecting effective and in-control indoor quality control data of each commercial brand reagent in a plurality of laboratories and reagent batch numbers and quality control product batch numbers corresponding to the data;
s2, grouping data according to the reagent batch number and the quality control batch number, and respectively calculating the average number and the intra-group variance of the detection values of the quality control products in the group;
s3, calculating total SD: the total variance is the sum of the variances of each group, and the total SD is the square root of the total variance;
s4, calculating the composition ratio of each group of data volume in the total data;
s5, calculating the total average value according to the data volume composition ratio of each group and the respective average value of the weighted sum;
s6, setting the quality control limit of the brand reagent to be total SD which is +/-2 times of the total average value, and if the detection result of the laboratory quality control product is within the range, indicating that the batch detection is in control; if the detection result of the quality control product exceeds the range, the detection of the batch is indicated to have the risk of out-of-control.
2. The method according to claim 1, wherein when a new lot number is used, the laboratory only needs to submit more than or equal to 50 in total on-control detection data of the same quality control product, and recalculate the quality control limit of the quality control product in a weighted manner according to steps S2 to S5.
3. The method for controlling the quality in a blood screening room according to claim 2, wherein the computer system automatically eliminates the runaway 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 according to claim 1, wherein in step S2, the grouping principle is that the results of detecting the same lot of quality control products by the same lot of reagents are grouped together.
5. The method for controlling the quality of a blood screening room according to claim 1, wherein the data amount of each group is not less than 50.
6. The method of claim 1, wherein the data for each commercial brand of reagent 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.
7. An internet-based real-time shared blood screening indoor quality control system, comprising:
laboratory: the laboratory is a mechanism for implementing blood screening or infectious disease detection, and buys commercial reagents to complete blood screening or infectious disease detection and buys commercial quality control products to control the quality of the laboratory;
indoor quality control data: the indoor quality control data are effective indoor quality control data of each commercial brand reagent from the laboratory and reagent batch numbers and quality control product batch numbers corresponding to the data;
and a 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 average number and the intra-group variance of the detection values of the intra-group quality control products; total SD was calculated: the total variance is the sum of the variances of each group, and the total SD is the square root of the total variance; calculating the composition ratio of each group of data volume in the total data; according to the composition ratio of the data quantity of each group, the weighted sum is respectively averaged, and the total average is calculated; setting the quality control limit of the brand reagent to be total SD which is +/-2 times of the total average number; comparing the indoor quality control detection results of all laboratories with the quality control limit calculated by the above steps to obtain a conclusion and output the result: when the detection result of the quality control product is within the quality control limit range, the batch detection is in control and effective, and when the detection result of the quality control product exceeds the quality control limit range, the batch detection may have a risk of out-of-control, and the reason of out-of-control may be irrelevant to normal variation of a laboratory, differences among different laboratories, differences among reagent lot numbers and differences among quality control product lot numbers.
8. The system of claim 7, wherein the quality control platform groups the indoor quality control data based on the principle that the same lot of reagents detect the same lot of quality control products.
9. The in-blood screening room quality control system of claim 7, wherein the amount of data per set must be greater than or equal to 50.
10. The in-house quality control system for blood screening according to claim 7, wherein the data amount of each commercial brand reagent must be equal to or more than 200 and the number of laboratories participating in data collection must be equal to or more than 3.
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