Eurofins launches a new CE marked serological assay for the identification and quantification of antibodies to SARS-CoV-2. This ELISA kit can support vaccination campaigns by confirming the success of a vaccination and monitoring the antibody levels over time.
Vaccination against COVID-19 is a critical element in the fight against the pandemic. The spike protein covers the surface of the SARS-CoV-2 virus and is responsible for attachment and invasion of human cells. All currently approved vaccines use the spike protein to train the immune system to detect and neutralise this virus.
The GSD NovaLisa® SARS-CoV-2 (COVID-19) quantitative IgG is an ELISA assay designed to mimic this target by using the native, trimeric form of the spike protein and detect all long-lasting IgG antibodies raised by a vaccination or natural infection. A standard curve allows for quantification to monitor if antibody levels increase or decrease over time. Currently, it is not known how long a vaccination will protect from COVID-19 and if a booster vaccination might be required if the antibody levels drop below a certain threshold that is currently not scientifically established. Supporting the establishment of an international reference value, the new assay is calibrated against the first WHO International Standard (NIBSC code: 20/136). This provides customers with the option to report results in international standard units.
Supplementary to vaccination monitoring, the kit shows excellent clinical performance in detecting antibodies raised naturally by a true SARS-CoV-2 infection. 15 days after symptom onset, the assay identifies antibodies to the spike protein in 97% of patients with a PCR confirmed infection. A diagnostic specificity of 99.94% was validated with over 500 samples from healthy controls.
Validation of the test with capillary blood samples enables the use with self-sampling devices for less invasive and more comfortable sample collection that could simplify large scale screening programmes.
The combination of this new assay with our established ELISA range based on the Nucleocapsid antigen introduces the opportunity to discriminate between vaccinated individuals and those that went through an asymptomatic infection before or after the vaccination. This is possible by monitoring if antibodies are present against the vaccination target only or against other viral proteins that the immune system gets in contact with in the course of a natural infection only.
The kit can be purchased here: Eurofins Technologies website
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About Eurofins – the global leader in bio-analysis
Eurofins is Testing for Life. Eurofins is a global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.
With over 50,000 staff across a decentralised and entrepreneurial network of more than 800 laboratories in over 50 countries, Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of a wide range of products, as well as providing innovative clinical diagnostic testing services and in-vitro diagnostic products.
The Group’s objective is to provide its customers with high-quality services, innovative solutions and accurate results on time. Eurofins is ideally positioned to support its clients’ increasingly stringent quality and safety standards and the increasing demands of regulatory authorities as well as the requirements of healthcare practitioners around the world.
In 2020, Eurofins reacted quickly to meet the global challenge of COVID-19, by creating the capacity to help over 10 million patients monthly who may have been impacted by the pandemic with our testing products and our services and directly supporting healthcare professionals working on the front line to fight the virus. The Group has established widespread PCR testing capabilities and has carried out over 10 million tests in its own laboratories, is supporting the development of a number of vaccines and has established its SAFER@WORK™ testing, monitoring and consulting programmes to help ensure safer environments during COVID-19.
Eurofins has grown very strongly since its inception and its strategy is to continue expanding its technology portfolio and its geographic reach. Through R&D and acquisitions, the Group draws on the latest developments in the field of biotechnology and analytical chemistry to offer its clients unique analytical solutions.
Shares in Eurofins Scientific are listed on the Euronext Paris Stock Exchange (ISIN FR0014000MR3, Reuters EUFI.PA, Bloomberg ERF FP).
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This press release contains forward-looking statements and estimates that involve risks and uncertainties. The forward-looking statements and estimates contained herein represent the judgment of Eurofins Scientific’s management as of the date of this release. These forward-looking statements are not guarantees for future performance, and the forward-looking events discussed in this release may not occur. Eurofins Scientific disclaims any intent or obligation to update any of these forward-looking statements and estimates. All statements and estimates are made based on the information available to the Company’s management as of the date of publication, but no guarantees can be made as to their completeness or validity.