CE marked assay based on well-established ELISA technology expands EUROIMMUN’s offerings for labs that seek to understand immune response to COVID-19

EUROIMMUN, a PerkinElmer, Inc. Company, has announced the launch of the SARS-CoV-2 NeutraLISA™ assay, a surrogate neutralization test intended for the detection of neutralizing antibodies against SARS-CoV-2, the pathogen causing COVID-19. The CE marked assay adds to the Company’s broad portfolio of COVID-19 diagnostics and is currently available in more than 30 countries that accept the CE mark.

In COVID-19, antibodies that target the viral receptor binding domain (RBD) in the S1 domain of the SARS-CoV-2 spike protein have been shown to exhibit a virus-neutralizing capacity, which predominately are IgG antibodies.

SARS-CoV-2 enters a human host cell through interaction of its RBD with the host cell ACE2 receptor. However, if the RBD is blocked by specific antibodies formed during immune response, the virus cannot continue to infect and proliferate within the human body. This is why many leading COVID-19 vaccine developments are also based on this protein domain.  

The EUROIMMUN SARS-CoV-2 NeutraLISA imitates this natural process by determining the inhibitory effect of antibodies capable of hampering the interaction between biochemically produced RBD and ACE2. Unlike standard neutralization tests, which can be labor-intensive and require handling of the live virus in a specialized high-safety laboratory setting, the SARS-CoV-2-NeutraLISA assay is based on well-established ELISA technology and uses non-pathogenic viral proteins. As such, the assay can be processed in common lab settings either manually or automatically.

“In addition to disturbing or altogether inhibiting the pathogen from binding to a host cell, neutralizing antibodies may last for years in the human body and can potentially prevent SARS-CoV-2 infection and reinfection,” said Dr. Wolfgang Schlumberger, CEO of EUROIMMUN. “The SARS-CoV-2 NeutraLISA assay supplements EUROIMMUN’s existing CE-marked QuantiVac™ ELISA and SARS-CoV-2 Interferon-gamma Release Assay which is expected to be available with CE mark soon. In combination, the assays make a powerful trio to help evaluate the immune response to SARS-CoV-2 induced through natural infection or vaccination with S1/RBD-based vaccines from multiple angles.”

EUROIMMUN offers a comprehensive COVID-19 product portfolio, including real-time PCR tests, an antigen detection assay for acute diagnostics, multiple antibody tests and a dried blood spot solution to support assessment of the immune response. In addition, EUROIMMUN offers the Interferon-gamma Release Assay to evaluate specific T-cell response, currently available for research use only, and provides automation systems for small, medium and high sample throughput workflows.

View COVID-19 product portfolio

About PerkinElmer

PerkinElmer enables scientists, researchers and clinicians to address their most critical challenges across science and healthcare. With a mission focused on innovating for a healthier world, we deliver unique solutions to serve the diagnostics, life sciences, food and applied markets. We strategically partner with customers to enable earlier and more accurate insights supported by deep market knowledge and technical expertise. Our dedicated team of about 14,000 employees worldwide is passionate about helping customers work to create healthier families, improve the quality of life, and sustain the wellbeing and longevity of people globally. The Company reported revenue of approximately $3.8 billion in 2020, serves customers in 190 countries, and is a component of the S&P 500 index.

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