Mass spectrometry in the clinical laboratory: Determining the need and avoiding pitfalls

While mass spectrometry (MS) has been available as an analytical tool for more than 100 years and analytical methods based on MS have been used by both scientific researchers and industrial application scientists for quantitative and qualitative analyses routinely, the use of this technology in clinical laboratories is a relatively new development. Based on emerging needs for patient care, the importance of MS in the clinical laboratory is increasing, and doesn't appear to be slowing down any time soon. Emerging unmet needs for testing often occur because vendors of in vitro diagnostic devices wait until the clinical utility of a particular assay is established and widely accepted prior to the development of a commercial assay. As a result, improvements in patient care from these new clinical tests can be delayed until a commercial assay is available. For laboratories with the capability to develop and implement laboratory-developed tests, MS provides an attractive alternative solution based on the ability to rapidly develop an analytically robust assay with excellent analytical sensitivity and specificity. In some cases, it offers an attractive alternative to commercially available assays that have already been developed, but do not offer acceptable performance relative to the clinical decision point. Liquid chromatography (LC)-MS technology shows significant potential as a tool to rapidly develop clinical assays for emerging biomarkers, and advances in instrumentation are likely to enable application of LC-MS technology in routine clinical diagnostic testing.