Eurofins Technologies has launched a fast and cost-effective high throughput kit, GSD NovaPrime SARS-CoV-2 Mplex FLA (Sanger), for Covid-19 testing.
The device works on the fragment length analysis principle on Sanger sequencing instruments such as ABI 3730xl.
The assay enables each ABI 3730xl sequencer to manage over 2,000 samples a day.
With the pandemic pushing qRT-PCR testing capacities to its limits, the kit can substantially improve high throughput capacities of highly sensitive tests.
Designed to detect two highly specific N1 and N2 gene fragments of the SARS-CoV-2 viral genome with high sensitivity, GSD NovaPrime SARS-CoV-2 Mplex FLA (Sanger) assay’s limit of detection equals best available qRT-PCR assays.
The kit’s limit of detection is five copies per reaction.
Furthermore, sensitivity and time to results of the new kit are similar to qRT-PCR testing.
Its multiplex reactions include a human housekeeping gene that acts as an intrinsic control in RNA extracted from nasopharyngeal swabs to enable successful sampling, extraction, amplification, and detection process.
Currently, research-use-only (RUO) version of the GSD NovaPrime SARS-CoV-2 Mplex FLA (Sanger) kit has been launched in Europe to help laboratories to start their internal validation and implementation activities.
The CE-IVD marked kit will be completed and made available soon.
Eurofins also plans to submit an application with the Food and Drug Administration (FDA) for emergency use authorisation (EUA) of the kit.
Development of the kit was led by Eurofins Genomics. The kit will be deployed with Eurofins Clinical testing laboratories in Europe to provide high sensitivity tests to healthcare authorities in the continent.