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Understanding Antibody Immunity

A Critical Step Towards Understanding Antibodies Immunity Is Underway

Covid-19 management so far relies on testing. Learn about the new tailoring testing strategy as a critical step taken towards understanding antibodies and immunity.

Covid-19 has been with us for some time now. Since its emergence, things have not been the same in all areas of life, and different agencies are trying to unfold ways they can manage the pandemic. So far, testing has been the basis of Covid-19 control. Efforts such as using viral tests to find the number of active infections and establish the prevalence of Covid-19 in a given community and antibody testing to see how many patients develop antibodies for Covid-19 after infection. The tests are playing a vital role in understanding the virus and making decisions concerning the management of the virus.

Tailoring testing strategies to specific patient populations and develop an in-depth understanding of the virus

As time goes by, there has been a need to evaluate Covid-19 testing and restructuring the strategies for a better understanding of the impact of the virus on populations and its management. Different bodies and agencies at the forefront in fighting Covid-19 are looking for ways to come up with tailor-made testing strategies for individual patient populations to understand the virus better and develop better fighting strategies. In effect, the U.S. Food and Drug Administration (FDA) expressed that they were intending to use real data to assess the development and progress of Covid-19 antibody tests through what they term as a multi-stakeholder public-private partnership. ‘ This happened on June 19, 2020. The FDA initiated project is called Diagnostics Evidence Accelerator and is being organized by the Reagan-Udall Foundation. It is a non-profit put together by Congress to accelerate innovation and modernize product development. Friends of Cancer Research, a nonprofit advocacy organization, will also be participating actively in the projects implementation.

The role of the Diagnostics Evidence Accelerator

The project, Diagnostics Evidence Accelerator, will be tasked with many roles. The project will be exploring ways to come with tailor testing strategies, specific to given populations. This way, they will be able to develop a deeper understanding of immunity and antibodies in relation to Covid-19. According to Dr. Jeff Shuren, who is the director of the FDA’s Center for Devices and Radiology Health, it will take a different approach to effectively assess the accuracy of diagnostics. Data integration and analysis will play a crucial role in this. In his statement, he added that the Diagnostics Evidence Accelerator project’s strategy involves proposing questions, refining the questions, and evaluating the feasibility of various approaches. He also stated that the project would bring together groups that have data, as they are in the best place to answer questions and create lasting solutions. The Diagnostics Evidence Accelerator project expects that with real-world data availability, it will be possible to provide results that can be more generalized and can be read out more rapidly compared to the existing traditional clinical trials. The project will need the contribution of different stakeholders for it to be successful. Device manufacturers, payers, professional societies, and other relevant stakeholders will be expected to give their input. These developments will go a long way in making the data generated from testing more useful in understanding Covid-19.

​Paul Singh, MHA, BA
Chairman
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​Covid Antibody Diagnostics​™
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255 Primera Blvd 
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References
https://www.evidenceaccelerator.org/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4552348/
https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-
gottlieb-md-and-jeff-shuren-md-director-center-devices-and