World Health Organization (WHO) and the international community as healthcare systems around the world have dedicated themselves to combating public health risks for nearly two centuries. These risks are seen as major threats to health security and require ongoing efforts to address.
Outbreaks of infectious diseases are of great concern to national governments and the international community due to their substantial impacts on social, economic, and even political systems. Whether providing care for an individual patient with an infectious disease or responding to a global pandemic, the prompt and precise identification of the microbial cause is essential for providing quality care.
Clinicians need access to rapid, simple tests that can rule in or out infection, diagnose a syndrome (sepsis, pneumonia), or identify a specific pathogen or resistance determinant. Despite significant advancements in diagnostic technologies, many patients with suspected infections are still treated with empiric antimicrobial therapy instead of receiving appropriate therapy based on the rapid identification of the infectious agent.
This has led to the overuse of our limited inventory of effective antimicrobials, whose numbers are decreasing due to rising levels of antimicrobial resistance. New technologies have emerged that enable the detection and measurement of pathogen burden with unprecedented speed, sensitivity, and ease of use. However, there are significant obstacles to developing, obtaining regulatory approval for, and integrating diagnostic tests that utilize these new technologies into clinical practice.
Despite these challenges, there is a pressing need for diagnostics that can advance clinical care and public health, and a crucial opportunity exists to leverage new technologies to address the most significant unmet needs. While there have been noteworthy advancements in clinical microbiology and an increase in the availability of molecular and other diagnostic tests, these tests are not yet fully integrated into clinical care to provide optimal benefits to patients.
Clinical microbiology laboratories are currently undergoing a transformation in diagnostic testing. Microbiologists are now expected to support classical culture and other methods with suboptimal performance characteristics while also embracing and validating new technologies that are often more complex and expensive.
Certain tests on existing molecular platforms can take a full day to complete and demand technologists with specialized training in molecular techniques. Depending on the specific assay, laboratory space may need to be reorganized to accommodate the platform and prevent contamination within the laboratory. If the volume of testing is low, then practical issues such as cost and employee proficiency must be considered for the larger platforms.
Historically, single test instruments have been costly both in terms of initial capital and cost per reportable result, and many smaller laboratories therefore did not embrace them. However, the target is now moving, and the value of these instruments is being increasingly recognized. FDA-approved or cleared molecular tests are available for a remarkably limited number of pathogens and generally diagnostics are notably underutilized.
Some of the major issues that prevent broad adoption of diagnostic tests include slow turnaround time, poor test performance characteristics, high complexity testing that cannot be easily adopted in many clinical settings, lack of understanding of the value of diagnostics, limited access to testing, and high cost. When such a test is available, it can dramatically improve patient care and reduce healthcare costs.
Caliendo AM, Gilbert DN, Ginocchio CC, Hanson KE, May L. Better Tests , Better Care : Improved Diagnostics for Infectious Diseases. Improved Infectious Diseases Diagnostics. 2013;57:139–70.
Owusu M, Nkrumah B, Acheampong G, Mensah EK, Komei AA, Sroda FK, et al. Improved detection of microbiological pathogens : role of partner and non- governmental organizations. BMC Infectious Diseases. BMC Infectious Diseases; 2021;21(303).
