The current world-wide increase in SARS-CoV-2 infections pushes qRT-PCR testing capacities to their limits. The GSD NovaPrime® SARS-CoV-2 Mplex FLA (Sanger) kit launched today by Eurofins Technologies utilizes the well-established Fragment Length Analysis principle on Sanger sequencing instruments (e.g. ABI 3730xl). There are a very large number of such instruments installed worldwide and this launch can significantly boost high throughput capacities of highly sensitive tests beyond what is available for qRT-PCR systems. This assay enables each ABI 3730xl sequencer to process more than 2,000 samples per day. This new kit also provides sensitivity and time to results similar to qRT-PCR testing.
The GSD NovaPrime® SARS-CoV-2 Mplex FLA (Sanger) assay detects two highly specific N gene fragments of the SARS-CoV-2 viral genome with high sensitivity. Its limit of detection (5 copies/reaction) matches the performance of the best available qRT-PCR assays. The kit´s multiplex reactions also cover an intrinsic human housekeeping gene which serves as internal control to confirm the successful entire sampling, extraction, amplification and detection process.
To support the fast adoption of the kit for ramp-up of testing capacities, the Research Use Only (RUO) version of the GSD NovaPrime® SARS-CoV-2 Mplex FLA (Sanger) kit is launched today in Europe to enable laboratories to initiate their internal validation and implementation activities. The CE-IVD marked kit is close to completion and will be available within the next few weeks. In addition, Eurofins GSD will apply for emergency use authorization (EUA) of this kit with the US FDA.
Eurofins Genomics led the development of this kit which will be deployed together with Eurofins Clinical testing laboratories in Europe to expand capacity of high sensitivity tests offered to healthcare authorities in Europe. The kit can be purchased here : https://www.eurofins-technologies.com/products/covid-19-testing.html
For more information, please visit www.eurofins.com.
Notes to editors:
About Eurofins – the global leader in bio-analysis
Eurofins Scientific, through its subsidiaries (hereinafter “Eurofins” or “the Group”), believes it is the global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies. In addition, Eurofins is one of the leading global emerging players in esoteric and molecular clinical diagnostic testing. With over 50,000 staff across a network of more than 900 independent companies in over 50 countries generally specialised by end client markets and operating more than 800 laboratories, 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. The Group’s objective is to provide its customers with high-quality and innovative services, accurate results on time and, when requested, expert advice by its highly-qualified staff.
Eurofins is committed to pursuing its dynamic growth strategy by expanding both 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 and a very large range of testing methods.
As one of the most innovative and quality-oriented international groups in its industry, Eurofins is ideally positioned to support its clients’ increasingly stringent quality and safety standards and the increasing demands of regulatory authorities and healthcare practitioners around the world.
Shares in Eurofins Scientific are listed on the Euronext Paris Stock Exchange (ISIN FR0000038259, Reuters EUFI.PA, Bloomberg ERF FP).
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