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CN108108863B - Laboratory system error allowable range evaluation method based on quality control data - Google Patents

Laboratory system error allowable range evaluation method based on quality control data Download PDF

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CN108108863B
CN108108863B CN201611049948.1A CN201611049948A CN108108863B CN 108108863 B CN108108863 B CN 108108863B CN 201611049948 A CN201611049948 A CN 201611049948A CN 108108863 B CN108108863 B CN 108108863B
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周之炜
程伟志
张国立
范勇辉
李玉君
张强
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Shanghai Qualab Biotechnology Co ltd
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Abstract

The invention discloses a laboratory system error allowable range evaluation method based on quality control data, which comprises the following steps: carrying out mean value statistics on the quality control data; establishing an allowable error standard TEa of a corresponding project according to relevant regulations; generating a horn diagram according to the statistical mean and the acceptable error standard TEa; generating a corresponding graph according to the currently acquired quality control data and intersecting the corresponding graph with the horn graph to obtain an intersection point; obtaining a new allowable range of the error of the laboratory system according to the obtained intersection points; re-determining a new linear range of acceptable error by being above a standard of acceptable error established as specified; in the case of systematic errors, the existing data are analyzed to obtain a narrower temporary range of acceptable total errors, and the detection result in the range can meet the requirement of total errors (national or industrial standard) and is accepted.

Description

Laboratory system error allowable range evaluation method based on quality control data
Technical Field
The invention relates to the technical field of quality control, in particular to a laboratory system error allowable range evaluation method based on quality control data.
Background
Quality control, hereinafter referred to as quality control; in routine quantitative detection in a clinical laboratory, detection data presents first-order linearity in a certain range. This range has also been achieved in everyday work. The essence of the obtaining method is as follows: the difference between the detected data and the real data within a certain detection range (whether random error or detection limit of the detection method results in the difference) is within an acceptable total error range without systematic error. However, in practice, systematic errors are ever present. At each different concentration point in the whole linear range, there must be an error, and the error magnitude is different. This error, caused by systematic errors that cannot be eliminated, exhibits first order linearity. This means that in a certain smaller concentration range within the known linear range, the error is still acceptable (corresponding to a shortening of the linear range). In a clinical laboratory, since the linear range with system errors cannot be estimated, all experimental results in the whole range are generally rejected, and all samples need to be re-detected after the system errors are corrected. And still a significant portion of the sample with acceptable errors. This results in a huge waste of time and resources.
Disclosure of Invention
In view of the above-mentioned shortcomings, the present invention provides a laboratory system error tolerance range evaluation method based on quality control data, which can obtain a narrower temporary range acceptable for total error.
In order to achieve the above purpose, the embodiment of the invention adopts the following technical scheme:
a laboratory system error allowable range evaluation method based on quality control data comprises the following steps:
carrying out mean value statistics on the quality control data;
establishing an allowable error standard TEa of a corresponding project according to relevant regulations;
generating a horn diagram according to the statistical mean and the acceptable error standard TEa;
generating a corresponding graph according to the currently acquired quality control data and intersecting the corresponding graph with the horn graph to obtain an intersection point;
and obtaining a new allowable range of the laboratory system error according to the obtained intersection points.
According to one aspect of the invention, the averaging of the quality control data comprises: indoor quality control statistics and indoor quality control room intervaring statistics, statistics is the mean value.
According to one aspect of the invention, indoor quality control is performed according to state-related standards and measurement data is collected, at least once a day, and at least two data samples at a time.
According to one aspect of the invention, the generating a horn plot from the statistical mean and the acceptable error criterion, TEa, comprises: and forming a coordinate system by taking the statistical mean as a horizontal axis and the actual measured value as a vertical axis, and drawing the acceptable error standard TEa in the coordinate system to form a horn diagram.
According to one aspect of the invention, the horizontal axis is: the average value of indoor quality control results in a certain time period or the average value of indoor quality control room internationalized results in a certain time period.
According to one aspect of the invention, the longitudinal axis is: indoor quality control detection value at a certain moment or indoor quality control detection mean value in a certain time period.
According to one aspect of the invention, the new allowable range of laboratory system error is obtained from the obtained intersection points as follows: the vertical axis range between the intersections is the new linear range for which the total error magnitude is still allowed under the existing systematic error.
The implementation of the invention has the advantages that: the laboratory system error allowable range evaluation method based on the quality control data comprises the following steps: carrying out mean value statistics on the quality control data; establishing an allowable error standard TEa of a corresponding project according to relevant regulations; generating a horn diagram according to the statistical mean and the acceptable error standard TEa; generating a corresponding graph according to the currently acquired quality control data and intersecting the corresponding graph with the horn graph to obtain an intersection point; obtaining a new allowable range of the error of the laboratory system according to the obtained intersection points; re-determining a new linear range of acceptable error by being above a standard of acceptable error established as specified; in the case of systematic errors, the existing data are analyzed to obtain a narrower temporal range acceptable for the total error. Detection results within this range are acceptable and meet the total error requirements (national or industry standards).
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In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings needed to be used in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and it is obvious for those skilled in the art that other drawings can be obtained according to these drawings without creative efforts.
FIG. 1 is a schematic diagram of the method for evaluating the error tolerance of a laboratory system based on quality control data according to the present invention;
fig. 2 is a schematic structural diagram of a horn according to an embodiment of the present invention.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
As shown in fig. 1 and fig. 2, a method for evaluating an error tolerance of a laboratory system based on quality control data includes the following steps:
step S1: carrying out mean value statistics on the quality control data;
the specific implementation manner of the step S1 of performing mean value statistics on the quality control data may be: the indoor quality control statistical method comprises indoor quality control statistics and indoor quality control indoor compartmentalization statistics, wherein the statistics are mean values.
In practical application, indoor quality control is carried out according to national relevant standards, and measured data is collected at least once a day, and at least two data are collected each time; the more data is accumulated, the more accurate the error interval estimation is. For example, an indoor quality control scheme for a certain project developed in a laboratory refers to GB/T20468-. That is, independent third-party quality control substances with 2 concentration levels are used every day and are detected once, and the quality control raw data are as follows:
Figure BDA0001161827730000031
Figure BDA0001161827730000041
step S2: establishing an allowable error standard TEa of a corresponding project according to relevant regulations;
the specific implementation of the step S2 of establishing the acceptable error criterion TEa of the corresponding project according to the project-related rule may be: the acceptable error criterion, TEa, is established for each project according to national regulations, i.e. an acceptable error level between the two. The range is determined by the total error, which is derived from national or industry standards.
Step S3: generating a horn diagram according to the statistical mean and the acceptable error standard TEa;
the specific implementation of the step S3 of generating the horn diagram according to the statistical mean and the acceptable error criterion TEa may be: and forming a coordinate system by taking the statistical mean as a horizontal axis and the actual measured value as a vertical axis, and drawing the acceptable error standard TEa in the coordinate system to form a horn diagram.
The horizontal axis is as follows: the average value of indoor quality control results in a certain time period or the average value of indoor quality control room internationalized results in a certain time period. The longitudinal axis is: indoor quality control detection value at a certain moment or indoor quality control detection mean value in a certain time period.
In practical applications, assuming that the horizontal axis is X axis and the vertical axis is Y axis, a straight line may be defined as Y ═ X, which represents an ideal state that the current detection value Y is equal to the statistical mean value X, and because of the permanent existence of the systematic error, the acceptable error criterion TEa formed according to the systematic error forms two trumpet-shaped rays in the coordinate system.
Step S4: generating a corresponding graph according to the currently acquired quality control data and intersecting the corresponding graph with the horn graph to obtain an intersection point;
the specific implementation manner of the step S4 of generating the corresponding graph according to the currently acquired measurement data and intersecting the horn graph to obtain the intersection point may be: generating a quality control detection value at a certain moment or a mean value of the quality control detection values in a certain time period on a coordinate system where the horn image is located, wherein at least 2 quality control data points with concentration exist according to national standards; and then obtaining a first-order fitting curve according to the quality control data points, and intersecting the horn diagram according to the first-order fitting curve and obtaining an intersection point.
In practical applications, when there are only two data points, the two points are connected and elongated, intersecting the horn pattern, to obtain an intersection point.
In practical application, when more than 2 data points exist, a first-order linear regression equation of the data points is obtained, and after a graph of the equation is drawn, the equation is intersected with a horn graph to obtain an intersection point.
Step S5: and obtaining a new allowable range of the laboratory system error according to the obtained intersection points.
The specific implementation of the step S5 for deriving the acceptable new range of laboratory system error according to the obtained intersection point may be: and calculating the coordinates of the intersection points, wherein the acceptable error range is a closed interval formed by longitudinal coordinate values of the coordinates of the two intersection points.
The implementation of the invention has the advantages that: the laboratory system error allowable range evaluation method based on the quality control data comprises the following steps: carrying out mean value statistics on the quality control data; establishing an allowable error standard TEa of a corresponding project according to relevant regulations; generating a horn diagram according to the statistical mean and the acceptable error standard TEa; generating a corresponding graph according to the currently acquired quality control data and intersecting the corresponding graph with the horn graph to obtain an intersection point; obtaining a new allowable range of the error of the laboratory system according to the obtained intersection points; re-determining a new linear range of acceptable error by being above a standard of acceptable error established as specified; in the case of systematic errors, the existing data are analyzed to obtain a narrower temporal range acceptable for the total error. Detection results within this range are acceptable and meet the total error requirements (national or industry standards).
The above description is only an embodiment of the present invention, but the scope of the present invention is not limited thereto, and any changes or substitutions that can be easily conceived by those skilled in the art within the technical scope of the present invention disclosed herein are intended to be covered by the scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the appended claims.

Claims (7)

1. The method for evaluating the error allowable range of the laboratory system based on the quality control data is characterized by comprising the following steps of:
carrying out mean value statistics on the quality control data;
establishing an allowable error standard TEa of a corresponding project according to relevant regulations;
generating a horn diagram according to the statistical mean and the acceptable error standard TEa;
generating a corresponding graph according to the currently acquired quality control data and intersecting the corresponding graph with the horn graph to obtain an intersection point; the method specifically comprises the following steps: generating a quality control detection value at a certain moment or a mean value of the quality control detection values in a certain time period on a coordinate system where the horn image is located, wherein at least 2 quality control data points of concentration exist; then according to a first-order fitting curve obtained by the quality control data points, intersecting the curve with the horn diagram to obtain an intersection point;
and obtaining a new allowable range of the laboratory system error according to the obtained intersection points.
2. The method of claim 1, wherein performing mean value statistics on the quality control data comprises: indoor quality control statistics and indoor quality control room intervaring statistics, statistics is the mean value.
3. The method of claim 1, wherein the indoor quality control is performed according to a national standard, and the measured data is collected at least once a day and at least two data are collected at a time.
4. The quality control data-based laboratory system error tolerance assessment method according to claim 1, wherein said generating a horn plot according to a statistical mean and an acceptable error criterion, TEA, comprises: and forming a coordinate system by taking the statistical mean as a horizontal axis and the actual measured value as a vertical axis, and drawing the acceptable error standard TEa in the coordinate system to form a horn diagram.
5. The method of claim 4, wherein the horizontal axis is: the average value of indoor quality control results in a certain time period or the average value of indoor quality control room internationalized results in a certain time period.
6. The method of claim 4, wherein the vertical axis is: indoor quality control detection value at a certain moment or indoor quality control detection mean value in a certain time period.
7. The method for evaluating the error tolerance of the laboratory system based on the quality control data according to one of claims 1 to 6, wherein the step of deriving the new error tolerance of the laboratory system according to the obtained intersection points comprises: the vertical axis range between the intersections is the new linear range for which the total error magnitude is still allowed under the existing systematic error.
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CN104122308A (en) * 2014-07-15 2014-10-29 浙江工商大学 Difference degree calculation method and tea quality identification method based on electronic tongue detection
CN105045220A (en) * 2015-05-08 2015-11-11 上海质晟生物科技有限公司 Quality control method based on Z-score quality control chart for multiple variables
CN105843870A (en) * 2016-03-17 2016-08-10 南京地质矿产研究所 Repeatability and reproducibility analysis methods and their applications

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CN104122308A (en) * 2014-07-15 2014-10-29 浙江工商大学 Difference degree calculation method and tea quality identification method based on electronic tongue detection
CN105045220A (en) * 2015-05-08 2015-11-11 上海质晟生物科技有限公司 Quality control method based on Z-score quality control chart for multiple variables
CN105843870A (en) * 2016-03-17 2016-08-10 南京地质矿产研究所 Repeatability and reproducibility analysis methods and their applications

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