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.

Eurofins is the global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global market leaders in testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in esoteric and molecular clinical diagnostic testing.

Source: Company Press Release