The application of certified reference materials for clinical mass spectrometry

BACKGROUND: In the application process of clinical mass spectrometry, there are difficulties such as standardization, low degree of automation, complex instruments, and high requirements for operations, which will affect the accuracy and comparability of results. Reference materials are one of the major approaches to achieve measurement accuracy and metrological comparability. METHODS: Based on the problems of reference materials in clinical mass spectrometry, the precautions for the use of reference materials are summarized in the aspects of measurement method validation, calibrator usage, and quality control in this article. Additionally, combined with the previous experience of the author's laboratory, the operation mode and acceptance criteria of the new calibration solution lot replacement were formulated to ensure the continuous comparability of the measurement system. CONCLUSION: Carefully understand and correctly regulate the use and management of reference materials to ensure the accuracy of test results, thereby improving the comparability and consistency of results between laboratories.