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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

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

AUTHORIZATION


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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

Food Safety Checklist

Infographic 


Updated COVID-19 Resources

FAQs on Testing for SARS-CoV-2

FDA COVID-19 Response: At-A-Glance Summary


Image credit: FDA