![]() Adopting such a strategy would represent a significant paradigm shift in FDA regulatory policy for IVDs, but this shift does need to happen to improve our defenses. New R&D quality tests can be loaded into open-access POC systems within 1-2 weeks of initial pathogen identification, rather than ~8 weeks which is more typical for manufacturers of today’s “closed-access” POC systems. The abundance of manufacturers means new tests can be synthesized at scale very quickly and shipped at room temperature to any location needing new tests. The most useful open-access systems utilize real-time PCR chemistry, which is considered a gold standard chemistry and is manufactured by many vendors worldwide. Open-access POC systems are microfluidic and draw reagents from bulk reservoirs that hold enough material to perform many tests. The most important requirement to modernize our POC testing solutions for pandemic prevention is to promote POC systems that are “open access”. Many clinicians, patients, epidemiologists, and public health officials want technology that provides a positive identification of the cause of symptoms, but the unwillingness of insurance companies to cover more of the higher cost of multiplex tests has presented a barrier to more widespread adoption. There are about 20 pathogens that can cause respiratory illness 2 so getting a negative result on a person who is symptomatic is not uncommon when using a single-plex test during the middle of cold and flu season. ![]() When a COVID-only test returns a negative result on an individual who is symptomatic, the healthcare provider and patient wonders if the result was a false negative for COVID or if the symptoms are being caused by a different pathogen. It is critical that the cause of the symptoms be determined as early as possible without the need for re-testing. Multiplexing is also a key factor, particularly for those who are symptomatic. Speed (in proximity to the patient) is not the only important factor. To make a significant impact, these systems need to be omnipresent, so that they are in use on every floor of every hospital and inside all urgent care clinics, pharmacies, large places of employment, doctors’ offices, and even schools. These technologies can return results in 45 min to 3 hours, which is a stark improvement over tests sent to a distant reference laboratory. Fortunately, advancements in microfluidics have resulted in the development of PCR-based technologies that can process samples at the POC. Unfortunately, due to the complexity of molecular testing, the vast majority of molecular tests are performed in reference laboratories. Instead, we need to focus our efforts on molecular testing, which has superior sensitivity. There is a wide range of technologies for point-of-care testing, however, the vast majority used today are antigen-based, and these have poor sensitivity. Meaningful time-to-result improvements can only be achieved by supporting technologies that are operated at the point-of-care (POC) so that shipping samples to distant reference laboratories can be avoided. Shortening time-to-result can have a significant impact on preventing additional infections. Three Ways to Modernize Diagnostics to Curb Infectious Disease Promote Molecular Point-of-Care Testing If investments are made now in the right type of diagnostics and surveillance infrastructure, as described below, I believe the future world will be better prepared to prevent the loss of many lives caused by the next inevitable threat. We need to modernize our defenses against sudden and unexpected microbial attacks, which could come from the next novel pathogen, referred to in pandemic prevention planning as Disease X. The response of the United States to this pandemic was and continues to be ineffective in the area of containment due to lack of preparation, planning, education, and the absence of pandemic-fighting technologies.Īs of this writing, the United States has lost >527K citizens 1 and sustained significant economic losses in a little over one year. The responsibility falls on current and past leaderships who have not adequately addressed the weaknesses in our defenses, despite arguably decades of warnings from virologists, microbiologists, epidemiologists, and members of our public health community. The intent of this article is not to cast stones, but to offer a strategy on how diagnostics can be revamped to better meet the unpredictability of the microbial world. Improved point-of-care molecular diagnostics will save lives when the next pandemic emerges. Pandemic containment in the United States has proved ineffective due to a lack of preparation and deployment of modern pathogen-detection technologies. ![]()
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