T/CAGR 007-2022 Laboratory Guide for Liquid Chromatography-Tandem Mass Spectrometry Detection of 25-Hydroxy Vitamin D

Scope

Scope: This document describes a standardized method for detecting serum 25-hydroxyvitamin D [25(OH)D] by liquid chromatography-tandem mass spectrometry (LC-MS/MS), including the selection of calibration substances and internal standards, optimization of chromatographic and mass spectrometric parameters, preparation of instruments and reagents for detection, method validation and verification, quality control management, and personnel requirements. This document is applicable to clinical medical laboratories using LC-MS/MS to detect 25(OH)D, including 25-hydroxyvitamin D2 [25(OH)D2] and 25-hydroxyvitamin D3 [25(OH)D3]. Other laboratories using LC-MS/MS to detect 25(OH)D can refer to this document. Main technical content: The main physiological function of vitamin D is to maintain normal blood calcium and phosphorus levels, thereby ensuring bone health and normal neuromuscular function. With more and more research reports on the extraskeletal effects of vitamin D (including its effects on muscles, cardiovascular system, metabolism, immunity, tumor occurrence, pregnancy, etc.), vitamin D has received widespread attention. Epidemiological data show that vitamin D deficiency is prevalent in China, and the demand for vitamin D testing is increasing. Serum 25-hydroxyvitamin D [25(OH)D] is recognized as the best indicator of vitamin D levels, and liquid chromatography-tandem mass spectrometry (LC-MS/MS) is the gold standard for medical laboratories to detect 25(OH)D. In recent years, the number of laboratories in China using LC-MS/MS to detect 25(OH)D has increased rapidly, but most of them are self-developed methods. Due to factors such as differences in the selection of calibration substances, internal standards, sample pretreatment methods, chromatographic conditions, and mass spectrometric parameters, the results of LC-MS/MS detection of 25(OH)D within the same laboratory and between different laboratories may have significant deviations. To guide medical laboratories

Development Information

Related Standards