Developers of SARS-CoV-2 diagnostic tests trust Element to serve as their nimble and responsive viral diagnostic test development partner.
Diagnostic developers accelerate response times to viral mutations and evolving public-health needs with the comprehensive support of Element’s industry-leading scientists. With Element by their side, viral diagnostic test developers can ensure complete solutions are submitted to the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA), bringing critical diagnostic tests to market as quickly as possible. Leverage Element’s deep bench of viral and immunological diagnostic expertise, purpose-built laboratories, and consultative experts to ensure the next generation of COVID-19 diagnostics comply with ever-changing regulatory landscapes and agency guidelines.
Extensive SARS-CoV-2 diagnostic development expertise
- Molecular diagnostic tests
- Antigen diagnostic tests
- Serology and antibody tests
- Neutralizing antibody (NAbs) assays
- Virus neutralization assays
Industry-leading support for US FDA COVID-19 Emergency Use Authorization (EUA)
Confidently understand and navigate the EUA standard with Element’s consultative team of regulatory and scientific experts by your side. Leverage Element’s expertise and understanding of regulatory approval processes, including the generation of scientific data and regulatory support needed to apply for and obtain Emergency Use Authorization (EUA) from FDA for viral and immunological diagnostics.
The EUA pathway is unique in that it requires less evidence than the FDA’s full approval, clearance, or licensing standard processes. When a well-composed submission is submitted to the FDA that establishes the effectiveness of a product and demonstrates the known and potential benefits outweigh the known and potential risks, the agency can then authorize the emergency use of medical products within days or weeks, rather than months or years. The FDA is currently prioritizing the review of EUA requests for tests where authorization would increase testing accessibility and for tests that would significantly increase testing capacity.
The Element advantage
Element is committed to providing comprehensive, industry-leading scientific and regulatory support to the world's leading healthcare brands in the ever-evolving fight against COVID-19 and its variants. As a true partner, Element has several options for potential co-development arrangements as the next generation of COVID-19 testing platforms are developed and brought to market, fulfilling critical public health needs.
For more information about Element’s COVID-19 diagnostic test development services or to request a quote, contact us today.
Molecular Diagnostic Tests
Pandemic control strategies often incorporate highly sensitive molecular diagnostic tests (e.g. Nucleic Acid Amplification Tests (NAATs), such as RT-PCR or droplet digital PCR), as they can detect both early and asymptomatic infections. With the use of molecular diagnostic tests, active infections can be identified, viral load can be quantified, and a determination can be made as to when individuals have fully cleared the virus post-recovery.
Antigen Diagnostic Tests
One or more specific proteins (i.e. antigens) from viral particles are identified with the use of highly specific antigen diagnostic tests. A majority of currently authorized COVID-19 antigen tests can be used in point-of-care (POC) formats to rapidly deliver answers in as little as 15 minutes. Although antigen tests tend to be less sensitive than molecular tests, advantages include rapid turnaround time, relatively low production costs and ease of use.
Serology and Antibody Tests
Serology tests use blood samples to detect and identify different types of antibodies (e.g. IgG, IgM, etc.) produced by a patient’s immune response to the SARS-CoV-2 virus, with immunoglobulin G (IgG) and immunoglobulin M (IgM) being the two most commonly tested types of antibodies. Rapid result lateral flow assays (LFA) and laboratory-performed enzyme-linked immunosorbent assays (ELISA) are the two most common platforms for serology tests and antibody identification.
Neutralizing Antibody Assays
Many public health experts believe the most prevalent need to protect communities against COVID-19 is to understand the level of protective, neutralizing antibodies (NAbs) in both patients who have recovered from COVID-19 infections and those participating in longitudinal studies of vaccine response. By measuring neutralizing antibodies in vaccinated and recovered individuals, a determination can be made regarding the span of immunity against the SARS-CoV-2 virus and its variants.
Virus Neutralization Assays
Viral neutralization is regarded as the “gold standard” to ascertain antibody efficacy. Viral neutralization assays are relied upon to quantify the levels of antibodies that block host cell infection, establishing whether a patient’s antibody response will truly protect against future infection. Several successful COVID-19 NAb tests determine whether antibodies successfully block a receptor binding domain (RBD) from binding to angiotensin converting enzyme 2 (ACE2), as SARS-CoV-2 invades host cells by binding to ACE2 using a RBD on spike protein. Element’s team of industry-leading scientists are highly skilled in navigating the complex development of virus neutralization assays.
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