Mass Spec Receiving Broader Application

Mass spectrometry (MS) is rapidly transitioning from specialized clinical testing—drugs of abuse confirmations, newborn screening, and steroid analysis—to being broadly applied throughout clinical laboratory medicine. Interest in MS is driven by its analytical specificity and sensitivity. In clinical laboratories, MS is being used for detection of small molecules (biogenic amines, amino acids, and organic acids) and larger compounds (proteins and ribosomal RNA). Its use has penetrated most areas of laboratory medicine including microbiology, anatomic pathology, genetic disorders and pharmacogenetics, immunology, endocrinology, and toxicology. A special January 2016 issue of Clinical Chemistry was dedicated to exploring current uses of MS in clinical laboratories, challenges to employing the technology, and emerging areas of potential advancement.

Despite the widening adoption of clinical MS, real challenges remain to expanded application. Among the areas experts say that improvements can be made are: increasing ease of use, including, cutting sample prep and better connectivity to automation and laboratory information systems/laboratory information management systems; bringing down the high capital cost of equipment ($200,000 to $500,000); addressing lack of automation which necessitates a skilled labor force (especially for design and validation of laboratory-developed tests); and resolving regulatory uncertainty. In addition to the general regulatory uncertainty around laboratory-developed tests, MS experts say that there is a lack of U.S. Food and Drug Administration- (FDA-) approved methods leading to differences in MS methods between laboratories affecting reproducibility, as well as existing variance in data libraries.

“Until MS becomes ‘just another detector’ on an automated FDA-approved platform, the full benefit of the technology will not be realized,” write Paul J. Jannetto, Ph.D., from the Mayo Clinic, Rochester, Minn. and Robert L. Fitzgerald, Ph.D., from University of California, San Diego, in a review in the Clinical Chemistry special issue. While some of these issues are being addressed, manufacturers and researchers are exploring new areas of opportunity for MS to expand, including direct tissue analysis, point-of-care feasibility, and application to proteomics and genomics.