Dr. Brian DuChateau, VP US Clinical and Scientific Affairs, LumiraDx09.16.22
We live in an increasingly impatient world where our need for immediate results has trickled into all aspects of our lives, including our health care expectations.
At least one fortunate by-product of the pandemic has been the rapid implementation and adoption of innovative technologies which fulfil those expectations for us today. These instant health care delivery tools, including point of care antigen tests have transformed the way we deliver health care at the point of need, especially in community-based settings. These paramount tools allow speed and accuracy at the nexus of action or the point of need where critical split-second medical decisions are made.
While rapid diagnostics provide an effective care delivery model at the point of need, they are also crucial for controlling infectious outbreaks. Bill Gates, in his recent book, “How to Prevent the Next Pandemic” presents a detailed strategy on what can be done at a global scale to avoid the catastrophic impact of another pandemic. His recommended framework for pandemic prevention and response coordination specifically calls out point of care diagnostics as having untapped potential, which we can apply to disease outbreaks.
If we are to future proof our health system today, we must ensure diagnostic equity—integrating point of care diagnostics into every part of our health system—not just hospitals, but also pharmacies, schools, and other community settings.
Laboratory-run PCR tests are expensive, require skilled labor to perform and do not guarantee this level of efficiency, especially for care centers in remote communities. Laboratory tests may take days to run, and the facilities are often miles away from community hospitals, not an enabling ecosystem for treatment follow through for people that travel long distances.
Additionally, rapid antigen tests also circumvent the “persistent positive” results common to PCR tests, which indicate an infection for an extended period even when the person is likely no longer contagious. Antigen tests offer an advantageous alternative, since a growing body of evidence demonstrate that antigen tests correlate more closely to culture suggesting they only detect active infections. This level of certainty empowers our ability to go back to “normal.”
The power of next generation point of care diagnostics was discussed at the recent American Association for Clinical Chemistry (AACC) Annual Conference in Chicago this summer. The discussion presented data-backed insights on the impact of LumiraDx advanced microfluidic technology over lateral flow point-of-care antigen tests, and the role of these rapid immunoassays in response to the COVID-19 pandemic.
LumiraDx, established in 2014, is transforming community-based healthcare by providing fast, accurate, and comprehensive diagnostic information to healthcare providers at the point of need, thereby enabling better medical decisions and improved patient outcomes at a much lower cost.
As the Scientific & Clinical Affairs Vice President at LumiraDx, I spoke alongside Dr. Paul Drain, associate professor at the University of Washington in the Departments of Global Health, Medicine (Infectious Diseases), and Epidemiology at the session. Dr. Drain presented his prospective validation study of the LumiraDx severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) rapid antigen test, which uses a high-sensitivity, microfluidic immunoassay to detect the nucleocapsid protein of SARS-CoV-2 for diagnosing acute coronavirus disease 2019 (COVID-19) in adults and children across point of care settings.
The study showed that, among 512 participants, the LumiraDx SARS-CoV-2 Ag has a 97.6% positive agreement to RT PCR in patients up to 12 days following symptom onset, and 100% PPA up to Ct 33. These findings testify to the effectiveness of rapid, high-sensitivity assay using nasopharyngeal or anterior nasal sampling, offering significant improvements for diagnosing acute SARS-CoV-2 infection in clinic- and community-based settings. Dr. Drain also shared more recent data showing that differences between Delta and Omicron variants did not affect the performance of the LumiraDx SARS-CoV-2 Antigen Test.
As we look ahead, immediacy is central to meeting patient care needs and optimizing provider decision making. Given the looming challenges of future pandemics, we should support policies that invest in integrated, scalable diagnostic solutions, which we can deploy rapidly at the point of care, especially in communities where little healthcare infrastructure is present. This will enable effective decision-making at the point of need, save health care costs, and improve patient outcomes.
Brian K. DuChateau, Ph.D., D (ABMLI) is a board-certified clinical laboratory immunologist. He received his Ph.D. in immunology and medical microbiology from the University of Wisconsin and completed a post-doctoral residency at the Chicago Medical School. DuChateau has over 20 years of experience as a clinical laboratory director and 12 years of in vitro diagnostics experience. He has served as a Clinical Laboratory Director at PathLab, LabCorp, BloodCenter of WI, and ConVerge diagnostic services. He has held leadership positions at Dako and The Binding Site. He currently serves as the Vice President of Scientific and Clinical Affairs at LumiraDx.
At least one fortunate by-product of the pandemic has been the rapid implementation and adoption of innovative technologies which fulfil those expectations for us today. These instant health care delivery tools, including point of care antigen tests have transformed the way we deliver health care at the point of need, especially in community-based settings. These paramount tools allow speed and accuracy at the nexus of action or the point of need where critical split-second medical decisions are made.
While rapid diagnostics provide an effective care delivery model at the point of need, they are also crucial for controlling infectious outbreaks. Bill Gates, in his recent book, “How to Prevent the Next Pandemic” presents a detailed strategy on what can be done at a global scale to avoid the catastrophic impact of another pandemic. His recommended framework for pandemic prevention and response coordination specifically calls out point of care diagnostics as having untapped potential, which we can apply to disease outbreaks.
If we are to future proof our health system today, we must ensure diagnostic equity—integrating point of care diagnostics into every part of our health system—not just hospitals, but also pharmacies, schools, and other community settings.
Laboratory-run PCR tests are expensive, require skilled labor to perform and do not guarantee this level of efficiency, especially for care centers in remote communities. Laboratory tests may take days to run, and the facilities are often miles away from community hospitals, not an enabling ecosystem for treatment follow through for people that travel long distances.
Additionally, rapid antigen tests also circumvent the “persistent positive” results common to PCR tests, which indicate an infection for an extended period even when the person is likely no longer contagious. Antigen tests offer an advantageous alternative, since a growing body of evidence demonstrate that antigen tests correlate more closely to culture suggesting they only detect active infections. This level of certainty empowers our ability to go back to “normal.”
The power of next generation point of care diagnostics was discussed at the recent American Association for Clinical Chemistry (AACC) Annual Conference in Chicago this summer. The discussion presented data-backed insights on the impact of LumiraDx advanced microfluidic technology over lateral flow point-of-care antigen tests, and the role of these rapid immunoassays in response to the COVID-19 pandemic.
LumiraDx, established in 2014, is transforming community-based healthcare by providing fast, accurate, and comprehensive diagnostic information to healthcare providers at the point of need, thereby enabling better medical decisions and improved patient outcomes at a much lower cost.
As the Scientific & Clinical Affairs Vice President at LumiraDx, I spoke alongside Dr. Paul Drain, associate professor at the University of Washington in the Departments of Global Health, Medicine (Infectious Diseases), and Epidemiology at the session. Dr. Drain presented his prospective validation study of the LumiraDx severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) rapid antigen test, which uses a high-sensitivity, microfluidic immunoassay to detect the nucleocapsid protein of SARS-CoV-2 for diagnosing acute coronavirus disease 2019 (COVID-19) in adults and children across point of care settings.
The study showed that, among 512 participants, the LumiraDx SARS-CoV-2 Ag has a 97.6% positive agreement to RT PCR in patients up to 12 days following symptom onset, and 100% PPA up to Ct 33. These findings testify to the effectiveness of rapid, high-sensitivity assay using nasopharyngeal or anterior nasal sampling, offering significant improvements for diagnosing acute SARS-CoV-2 infection in clinic- and community-based settings. Dr. Drain also shared more recent data showing that differences between Delta and Omicron variants did not affect the performance of the LumiraDx SARS-CoV-2 Antigen Test.
As we look ahead, immediacy is central to meeting patient care needs and optimizing provider decision making. Given the looming challenges of future pandemics, we should support policies that invest in integrated, scalable diagnostic solutions, which we can deploy rapidly at the point of care, especially in communities where little healthcare infrastructure is present. This will enable effective decision-making at the point of need, save health care costs, and improve patient outcomes.
Brian K. DuChateau, Ph.D., D (ABMLI) is a board-certified clinical laboratory immunologist. He received his Ph.D. in immunology and medical microbiology from the University of Wisconsin and completed a post-doctoral residency at the Chicago Medical School. DuChateau has over 20 years of experience as a clinical laboratory director and 12 years of in vitro diagnostics experience. He has served as a Clinical Laboratory Director at PathLab, LabCorp, BloodCenter of WI, and ConVerge diagnostic services. He has held leadership positions at Dako and The Binding Site. He currently serves as the Vice President of Scientific and Clinical Affairs at LumiraDx.
