COVID-19 Updates: First Antigen Test for rapid detection, First Diagnostic Test using at-home saliva collection, Documents for Reopening, Updated COVID-19 resources
Sofia 2 SARS Antigen FIA
First Antigen Test to Help in Rapid Detection of COVID-19 virus
Quidel Corporation
INDICATION: Qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens directly
ADDRESSING AN UNMET NEED:
- New category of tests for use in ongoing pandemic
- Quick detection of protein fragments found on or within the virus
DESCRIPTION:
- Lateral flow immunofluorescent sandwich assay for the qualitative detection of nucleocapsid protein antigen from SARSCoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens
- SARS-CoV-2 nucleocapsid protein antigen is generally detectable in respiratory specimens during the acute phase of infection
- Positive results are indicative of presence of SARS-CoV-2 nucleocapsid protein antigen, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status
- Negative results should be treated as presumptive and confirmed with a molecular assay
REGULATORY PATHWAY: Emergency Use Authorization
First Diagnostic Test Using At-Home Collection of Saliva Specimens
TaqPath SARS-CoV-2 Assay
Rutgers Clinical Genomics Laboratory
Spectrum Solutions LLC SDNA-1000 Saliva Collection Device
INDICATION: Qualitative detection of nucleic acid from SARS-CoV-2 in oropharyngeal (throat) swab, nasopharyngeal swab, anterior nasal swab, mid-turbinate nasal swab, and bronchoalveolar lavage (BAL) fluid from individuals. This test is for use with saliva specimens that are self-collected at home with the LLC SDNA -1000 collection device
ADDRESSING UNMET NEED: First diagnostic test where nasal specimens can be collected at home
DESCRIPTION:
- Qualitative test for detection of nucleic acid from SARS-CoV-2
- Self-collection saliva specimens at home or in a healthcare setting
- SARS-CoV-2 nucleic acid generally detectable in respiratory specimens during the acute phase of infection
- Positive results are indicative of the presence of SARS-CoV-2 nucleic acid; clinical correlation with patient history and other diagnostic information is necessary to
determine patient infection status - Positive results do not rule out bacterial infection or coinfection with other viruses
REGULATORY PATHWAY: Emergency Use Authorization
Documents to support Reopening
FDA issued documents designed to assist retail food establishments in preparing to reopen
- Help businesses that prepare food to serve or sell to the public directly, such as restaurants, bakeries, bars and carry-outs, protect employee and public health as they reopen for business
Updated COVID-19 Resources
FAQs on Testing for SARS-CoV-2
FDA COVID-19 Response: At-A-Glance Summary
Image credit: FDA