Evaluation of new technology in the clinical microbiology laboratory.

Technology capable of significantly influencing the practice of clinical microbiology is evolving at an ever-accelerating rate. During their early developmental years, it is difficult to predict which evolving technologies will prove amenable for use in hospital laboratory settings. With the considerable and increasing cost constraints placed on our medical institutions and the resulting budgetary pressures exerted on clinical laboratories, evaluation of developing technology is essential. The Clinical Laboratory Improvement Act of 1988 mandates correlation studies by clinical laboratories as part of the evaluation of all new assays to compare their sensitivities and specificities with those obtained using established methodologies. With shrinking numbers of technologists available for such evaluations, however, the mechanism with which this will be accomplished promises to pose a significant challenge. Factors that demand consideration in any such evaluation include (but are not restricted to) utility, accuracy, prospective time savings, cost of related instrumentation and reagents, and potential for diverse applications. Specific current examples that exemplify the need for such evaluations include the emergence of gene-based techniques such as the polymerase chain reaction as clinical tools, availability of new blood culture systems based on divergent sensor systems, and varying techniques for the the detection of antibodies and antigens for the serodiagnosis of infectious diseases. We as clinical microbiologists have the opportunity to approach the challenges confronting us regarding evaluation of developing technologies with responsible innovation and insight. Only by embracing these responsibilities can we hope to influence the impact of health care reform in the hospital laboratory setting.