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Editorials |
Laboratory Service, VAMCSan Diego and Department of Pathology, UCSD, San Diego, CA 92161, National Institute of Child Health and Human Development, 10 Center Dr., Rm. 6C208, Bethesda, MD 20892, Fax 301/402-0263, E-mail aly@helix.nih.gov
a Author for correspondence.
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.
References
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