Second, due to the fact that they emerged and were adopted quickly as a superior method to culture, adoption has outpaced evidence of clinical utility for some tests and populations. First, they are superior in analytical sensitivity and speed compared to the syndromic approaches they replaced, that is viral and bacterial cultures. There are common themes among all of these panels. This includes panels for gastrointestinal, central nervous system and respiratory tract infection-associated potential pathogens. “Syndromic panel” is a term commonly used in clinical microbiology when referring to rapid, multiplexed amplification and detection platforms that received US FDA approval or clearance for a set list of targets in a specific sample type. This review will highlight recent studies developing and applying emerging molecular infectious disease technologies and touch on limited published data on clinical utility and stewardship approaches. Although this is not a direct-specimen application, we can begin to draw parallels with direct-specimen molecular testing. Only through this approach can the technology lead to faster time to optimal therapy, shorter hospital stays, and associated hospital cost savings for very specific scenarios. What we have learned from these studies is that in order to see some benefit from this specific technology, an antimicrobial stewardship program (ASP) must be engaged to direct changes in treatment. However, numerous studies, some almost a decade old, have shown that without any intervention, simply implementing this relatively expensive technology has no clinical or economic impact. These platforms provide significantly decreased turnaround times for limited organism and resistance marker identification. Several rapid, multiplexed molecular panels received US FDA clearance in the last 5 to 10 years. One of the early applications in this wave of technology is species and antimicrobial resistance marker identification from positive blood culture broth. As a result, there is also room for novel stewardship strategies around these types of testing. However, each comes with its own set of significant limitations including cost considerations and potentially negative consequences, such as over-utilization. Given the continued emergence and spread of novel antimicrobial resistance mechanisms paired with increasingly complex patient populations, these technologic advances may become important factors in patient care. These advanced techniques offer an opportunity to provide laboratory diagnoses at a speed, sensitivity, and breadth never before possible with conventional microbiology. While the first direct-specimen molecular testing for infectious diseases was approved by the US FDA 26 years ago, there has been a very recent explosion of molecular technology in two major directions: (1) direct-specimen rapid amplification and detection platforms and (2) next-generation sequencing. More studies are needed to assess their prospective impacts on patient management and antimicrobial stewardship efforts as the future state of infectious disease diagnostics will see continued expansion of these technologic advances. The appropriate utilization of rapid molecular testing and clinical metagenomics has not been well established. This review also highlights the future directions for both of these technologies. This review will summarize the most recent literature on these two categories of technologic advances and discuss the few studies that have looked at utilization and stewardship approaches. While these tests allow for a breadth of interrogation not possible with conventional microbiology, they pose new challenges for diagnostic and antimicrobial stewardship programs. Rapid molecular testing and, to a lesser degree, clinical metagenomics are now being routinely used in clinical practice. Physicians must understand the limitations to and appropriate utilization of these technologies in order to provide cost-effective and well-informed care for their patients. Major technologic advances in two main areas of molecular infectious disease diagnostics have resulted in accelerated adoption or ordering, outpacing implementation, and clinical utility studies.
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