Method and device for generating methodology verification report of clinical chromatography-mass spectrometry technology

Abstract

A method for generating a methodology verification report of a clinical chromatography-mass spectrometry technology comprises the steps that a detection target object selected by a user and corresponding verification parameters are received, a file uploaded by the user is received, and the file is a detection data file including the methodology verification parameters of the detection target object; searching a target data table corresponding to the verification parameter from a file, extracting a header column name of the target data table, and extracting corresponding verification data according to the header column name; performing corresponding calculation according to the verification data to obtain a calculation result; performing corresponding judgment according to a calculation result and a judgment standard of the verification parameter to obtain a verification conclusion of the verification parameter; and when the verification conclusion passes, generating a methodology verification report containing the verification parameters. According to the method and the device, the data files in different formats and the data corresponding to the verification parameters can be extracted and sorted into the verification report in a unified format, so that a tedious data sorting process is avoided, and the efficiency of issuing the verification report is greatly improved.

Description

technical field [0001] The invention relates to the field of medical testing, in particular to a method and device for generating a methodological verification report of clinical chromatographic mass spectrometry technology. Background technique [0002] At present, the application of domestic clinical chromatography-mass spectrometry technology is not standardized enough. Due to the complexity of its technology, there are great differences in the parameters, verification methods or interpretation rules that need to be verified in various laboratories. Since this technology is a new technology in the field of medical testing, it mainly serves the clinic in the form of LDT in China at present. According to the relevant quality system requirements of medical laboratories, any testing project using clinical chromatography-mass spectrometry technology requires a complete methodological performance evaluation. Or regularly conduct methodological checks. Therefore, for applicatio...

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Problems solved by technology

[0003] For different testing items, the manufacturers of the testing instruments used in each testing item are not the same, and the data file types and layouts exported by the testing instruments of different manufacturers are often not the same, which will lead to the generation of multiple verification parameters. A large amount of data collation and calculation work is involved in the method validation report

At present, the collation and writing of methodological verification reports are mainly completed by the corresponding testing personnel of each project. The process of manual collation of reports is not only time-consuming and labor-intensive, but also error-prone

In addition, each test item currently has its own way of sorting out the report, and the format of the final verification report is not the same, which brings great inconvenience to the final review of the report when verifying multiple items

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