1B-O1-1445 PDF
Clinical and societal implementation of mass spectrometry in Japan ―Challenges and Promises―
Short Abstract: Mass spectrometry (MS) has undergone rapid technical development and its clinical applications are growing. Tandem mass spectrometry for newborn screening is now available nationwide in Japan. Also, LC-MS/MS is an effective tool in therapeutic drug monitoring and toxicology. More recently, bacterial identification using MALDI-TOF MS has been introduced into the real world medicine, making a revolutionary shift in clinical diagnostic microbiology. Although LC-MS/MS has a number of advantages over traditional immunoassays including enhanced specificity, ability to simultaneously measure multiple analytes at a time, MS applications in clinical chemistry laboratories, however, has remained very limited because of substantial challenges. These challenges include the high capital cost of equipment, requirements for a skilled labor force, lack of standardization and automation, and regulatory
uncertainty ( PMDA clearance of MS as an established detector and reimbursement issues)