Promega applied to the U.S. Food and Drug Administration for an emergency use authorization (EUA) for its new serological antibody test for COVID-19, Lumit Dx. The SARS-CoV-2 immunoassay is an IVD test that detects the presence of antibodies against SARS-CoV-2.
Among patients whose COVID-19 was confirmed by polymerase chain reaction (PCR) 20-plus days after symptom onset, Lumit Dx has a sensitivity of 93.5% when used in patients with varying disease levels. It has a 100% sensitivity when used in hospitalized patients. It has a specificity of 99.4% in samples presumed negative for SARS-CoV-2 and 97.7% in samples exhibiting other illnesses, according to Promega.
Lumit Dx requires no wash steps, offers reliable results in less than an hour, and is easily adaptable to most liquid handlers, according to the firm.
