Liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for measuring serum (plasma) steroid hormones has shown advanced characteristics including high specificity, wide analytical measurement range and simultaneous analysis for multiple markers, compared with traditional immunoassays, which has become the preferred method applied in lab diagnosis of endocrinological diseases. Currently, measurement of serum/plasma steroid hormones by LC-MS/MS in our national lab mainly refer to the general operation and testing procedures guided by academic publications or general operation manuals of the instruments. However, there are great difficulties in measurement of serum/plasma steroid hormones by LC-MS/MS method, and most lab staffs lack of professional training and practical experience in mass spectrometry, and the general procedures lack specificity and practical operation, especially there is no specific systemic documents covering testing procedures and quality assurance, consequently, testing results vary considerably between laboratories, hindering its clinical application. In order to normalize our national serum/plasma steroid hormones by LC-MS/MS, this consensus aims to provide detailed information and specific suggestions for pre-analytical, analytical, post-analytical and quality assuarance, and to provide reference for the application of LC-MS/MS in medical laboratories for serum/plasma steroid hormone measurements, in order to improve consistency of serum/plasma steroid hormone measurements with LC-MS/MS and promote its clinical application in China.

Liquid chromatography mass spectrometry; Steroid hormone; Standardization; Quality assurance