Luxembourg-based Eurofins’ test kit uses the fragment length analysis principle on Sanger sequencing instruments, such as the ABI 373xl, with the assay enabling each sequencer to process more than 2,000 samples per day while the kit provides sensitivity and time to results similar to qRT-PCR testing, according to a news release.
The GSD NovaPrime assay detects two highly specific N gene fragments of the SARS-CoV-2 viral genome with high sensitivity, Eurofins said. Its limit of detection (5 copies/reaction) matches the performance of other available qRT-PCR assays and its multiplex reactions cover an intrinsic human housekeeping gene with severs to confirm the successful sampling, extraction, amplification and detection process.
Eurofins said that, in an effort to support the fast adoption of the kit for ramping up testing capacities, the research-use-only version of the GSD NovaPrime SARS-CoV-2 Mplex FLA (Sanger) kit is now available in Europe to enable laboratories to initiate their internal validation and implementation activities.
The kit will be available within the next few weeks and Eurofins will apply for FDA emergency use authorization to bring the test kit to the U.S.