Method for performing reliability evaluation on result of quantitative detection item of detection system, and use

Abstract

The invention provides a method for performing reliability evaluation on a result of a quantitative detection item of a detection system, and a use, and relates to the technical field of quality control of a medical laboratory. According to the method, actual experimental samples in the laboratory are used as evaluation samples, and there is no matrix effect compared with quality control. Representative samples are selected, that is, the experimental samples comprise an experimental sample in which a detection value of the quantitative detection item is less than a normal reference range, an experimental sample greater than the normal reference range, and an experimental sample within the normal reference range. In addition, the judging criteria of the method not only consider the requirements of quality objectives in the unique analysis of the detection item of the medical laboratory, but also consider the requirements of statistical linear regression. Therefore, the reliability of the result of the quantitative detection item of the detection system can be evaluated by the method in a simple and convenient, operable and efficient manner, and the method has an important practicalvalue on the quality control of the medical laboratory and the guarantee of the diagnosis and treatment of patients.

Description

technical field

[0001] The invention relates to the technical field of medical laboratory quality control, in particular to a method and application for reliability evaluation of the results of quantitative detection items of a detection system. Background technique

[0002] Medical laboratories must carry out internal quality control (referred to as: internal quality control) to monitor the analytical performance of the test method. Therefore, laboratories generally test quality control products and use statistical methods based on quality control results to infer whether the test method needs to be corrected and whether the results of patient samples can be clinically accepted.

[0003] However, there are matrix differences between quality control products and real patient samples, and the resulting matrix effect will cause the quality control results to fail to truly reflect the reliability of patient test results. And because in the actual work process, medical laborato...

Examples

Embodiment 1

[0068] This embodiment provides a method for evaluating the reliability of the results of the quantitative detection items of the detection system. The schematic diagram of the changes in the results of different levels of quality control products before and after the batch number of the reagent or standard is changed is as follows: figure 1 As shown, the process of the method of this embodiment refers to figure 2 shown.

[0069] A. Selection of evaluation samples: select 10 real patient serum samples that have been tested before the batch number of the reagent / calibrator is changed as evaluation samples, and among these 10 samples, the detection values ​​of 4 samples are within the normal reference range. The detection values ​​of 3 samples were lower than the normal reference range, and the detection values ​​of 3 samples were higher than the normal reference range. image 3 shown.

[0070] B. Detection of evaluation samples: test the above 10 evaluation samples with a ne...

Embodiment 2

[0076] A laboratory uses a brand A chemiluminescence instrument (supporting reagents) to detect thyroid-stimulating hormone (TSH), and the normal reference range of TSH is 0.3-3.0mIU / L. The laboratory also uses Kunlai Composite immunoassay non-fixed value quality control product (double level), when the reagent batch number is changed on the 15th, the quality control parameters and quality control graphics are as follows Figure 5 with Image 6 Shown, where the abscissa is the date, and the ordinate is the detection of thyroid-stimulating hormone (TSH), the unit is μIU / mL. The raw values ​​of quality control results are shown in Table 1-Table 3.

[0077] Table 1 Raw values ​​of quality control results

[0078]

[0079] Table 2 Raw values ​​of quality control results

[0080]

[0081] Table 3 Raw values ​​of quality control results

[0082]

[0083] Depend on Figure 5 with Image 6From the data in Table 1-Table 3, it can be clearly found that after changing th...

technical field

[0001] The invention relates to the technical field of medical laboratory quality control, in particular to a method and application for reliability evaluation of the results of quantitative detection items of a detection system. Background technique

[0002] Medical laboratories must carry out internal quality control (referred to as: internal quality control) to monitor the analytical performance of the test method. Therefore, laboratories generally test quality control products and use statistical methods based on quality control results to infer whether the test method needs to be corrected and whether the results of patient samples can be clinically accepted.

[0003] However, there are matrix differences between quality control products and real patient samples, and the resulting matrix effect will cause the quality control results to fail to truly reflect the reliability of patient test results. And because in the actual work process, medical laborato...

Examples

Embodiment 1

[0068] This embodiment provides a method for evaluating the reliability of the results of the quantitative detection items of the detection system. The schematic diagram of the changes in the results of different levels of quality control products before and after the batch number of the reagent or standard is changed is as follows: figure 1 As shown, the process of the method of this embodiment refers to figure 2 shown.

[0069] A. Selection of evaluation samples: select 10 real patient serum samples that have been tested before the batch number of the reagent / calibrator is changed as evaluation samples, and among these 10 samples, the detection values ​​of 4 samples are within the normal reference range. The detection values ​​of 3 samples were lower than the normal reference range, and the detection values ​​of 3 samples were higher than the normal reference range. image 3 shown.

[0070] B. Detection of evaluation samples: test the above 10 evaluation samples with a ne...

Embodiment 2

[0076] A laboratory uses a brand A chemiluminescence instrument (supporting reagents) to detect thyroid-stimulating hormone (TSH), and the normal reference range of TSH is 0.3-3.0mIU / L. The laboratory also uses Kunlai Composite immunoassay non-fixed value quality control product (double level), when the reagent batch number is changed on the 15th, the quality control parameters and quality control graphics are as follows Figure 5 with Image 6 Shown, where the abscissa is the date, and the ordinate is the detection of thyroid-stimulating hormone (TSH), the unit is μIU / mL. The raw values ​​of quality control results are shown in Table 1-Table 3.

[0077] Table 1 Raw values ​​of quality control results

[0078]

[0079] Table 2 Raw values ​​of quality control results

[0080]

[0081] Table 3 Raw values ​​of quality control results

[0082]

[0083] Depend on Figure 5 with Image 6From the data in Table 1-Table 3, it can be clearly found that after changing th...

Images