摘要：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. To determine whether a test adds additional (incremental) value to the diagnostic information
already available to the clinician, evaluation studies with a multivariable approach may also be
needed. The impact of a test on patient outcome is best measured by a randomized controlled trial,
but this may be unnecessary in certain well-defined situations. To improve the quality of published
test evaluations close collaboration between clinicians, clinical microbiologists, and epidemiologists,
as well as insistence by journal editors on the use of established reporting standards are essential.
关键词：laboratory techniques and procedures, diagnostic tests, sensitivity and specificity, microbiology,
translational medicine.
