Advances in diagnostics for microbial agents: can clinical validation keep pace with the technical promises?

New technologies are revolutionizing diagnostic microbiology, but implementation of methodological advances in test evaluation has been extraordinarily slow. Published reports frequently fail to clearly distinguish between studies of analytical accuracy and those of clinical diagnostic performance. We argue that the evaluation of sensitivity and specificity, while necessary and occasionally problematic, is often inadequate to define the appropriate role of a new diagnostic test.