The NeuMoDx SARS-CoV-2 assay from NeuMoDx Molecular, Ann Arbor, Mich, has received FDA emergency use authorization (EUA). The assay is a rapid, automated in vitro real-time RT-PCR diagnostic for the direct detection of SARS-CoV-2 coronavirus RNA from nasopharyngeal, oropharyngeal, and nasal swab specimens in transport medium from individuals with signs and symptoms of infection of covid-19.
The multiplexed assay detects highly conserved regions of two SARS-CoV-2 genes, the Nsp2 gene and N gene, and uses different fluorophores for reporting each target. The assay is available to CLIA-certified hospital and reference laboratories with experience performing high-complexity tests.
Sundu Brahmasandra, PhD, NeuMoDx Molecular.
The high-throughput, fully automated NeuMoDx 288 and NeuMoDx 96 molecular systems can provide the first test results in as little as 80 minutes from primary collection or daughter tubes.
“Our proprietary NeuDry technology enables efficient automation of the NeuMoDx SARS-CoV-2 assay, as all reagents and consumables do not require refrigeration and are provided in a ‘ready to use’ format for immediate processing,” says Sundu Brahmasandra, PhD, president and chief operating officer of NeuMoDx.
For more information, visit NeuMoDx Molecular.
