Whenshould a new instrumental technique or analytical method be adopted for use in clinical chemical analyses? Many clinical methods are approved by the FDA based on the 510 k process, which requires demonstration that a new test is at least as good as those already in the marketplace. This is justified from both a scientific and free-market regulatory perspective when replacement of a sound method or technique is being considered. It is particularly true when considering adopting new instrumentation. Bowers and Borts in this issue (1) provide a powerful example of the need for circumspection when considering replacement of an existing instrumental technique with a new and supposedly better one. Their paper also presents a strong case for the perennial need for good sample preparation techniques. Clearly, advances in instrumentation, combined with reduced costs, have established mass spectrometry (MS) as an essential tool in bioanalytical research. The increased availability of modern instrumentation has had and will continue to have a positive influence on clinical chemistry—particularly for analytes that are not amenable to quantification by more conventional methods. At the same time, there is often a continuing temptation to attribute aspects of the panacea—the universal curative—to a new or improved type of instrument. Users of MS often seem to be particularly susceptible to this lure of an instrumental cure-all that makes all measurements simpler, faster, and more sensitive than earlier instruments.
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Fitzgerald et al. (1997) studied this question.
Synapse has enriched 2 closely related papers on similar clinical questions. Consider them for comparative context: