The Lyra SARS-CoV-2 Assay is a real-time RT-PCR assay intended for the in vitro qualitative detection of human coronavirus SARS-CoV-2 from viral RNA extracted from nasal, nasopharyngeal or oropharyngeal swab specimens from patients with signs and symptoms of COVID-19. The authorized testing consists of nucleic acid extraction on the bioMerieux NucliSENS easyMAG system or EMAG system, followed by RT-PCR on six thermocyclers.
The Sofia SARS Antigen Fluorescent Immunoassay (FIA) uses advanced immunofluorescence-based lateral flow technology in a sandwich design for qualitative detection of nucleocapsid protein from SARS-CoV-2. The Sofia SARS Antigen FIA, with the Sofia 2 and Sofia analyzers, provides automated and objective results in 15 minutes, allowing for testing of patients suspected of COVID-19/2019-nCoV in near-patient testing environments.
The Lyra Direct SARS-CoV-2 Assay is a real-time RT-PCR assay intended for the in vitro qualitative detection of human coronavirus SARS-CoV-2 from viral RNA extracted from nasal, nasopharyngeal or oropharyngeal swab specimens from patients with signs and symptoms of COVID-19. The assay targets the non-structural Polyprotein (pp1ab) of the SARS-CoV-2 virus and has a one-step reagent set-up and three-step sample prep with test results available in less than 70 minutes.
Quidel Corporation, a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, has entered into definitive agreements to acquire the Triage MeterPro cardiovascular (CV) and toxicology assets (“Triage business”) and the B-type Naturietic Peptide (BNP) assay business run on Beckman Coulter analyzers (“BNP business”) from Alere Inc. These products are being divested in order to obtain antitrust approvals required for Abbott’s pending acquisition of Alere.
The Sofia Strep A+ FIA uses advanced immunofluorescence-based lateral-flow technology to detect Group A Streptococcal antigens from throat swabs of symptomatic patients. It offers fast time to results of five minutes for truly rapid strep testing and uses self-contained test cassette that is clean, easy to use and dispose.