CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
April 2, 2020—NeuMoDx Molecular announced that the FDA has issued an emergency use authorization for the NeuMoDx SARS-CoV-2 Assay implemented on NeuMoDx molecular systems.
The NeuMoDx SARS-CoV-2 Assay is a rapid, automated in vitro real-time RT-PCR diagnostic test for the direct detection of SARS-CoV-2 coronavirus RNA from nasopharyngeal, oropharyngeal, and nasal swab specimens in transport medium from patients 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 hospitals and reference laboratories with experience performing high-complexity tests.