The Briefing provides an at-a-glance view of some important developments in the information universe surrounding COVID-19. The views presented here are solely those of ECRI Horizon Scanning and have not been vetted by other stakeholders.

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The World Health Organization (WHO) recently reported a record rise in new cases globally, and concerns exist across the United States regarding possible coronavirus risks created with the reopening of schools, complications due to the approaching flu season, and the possibility of coronavirus reinfection.

Some scientists propose that natural herd immunity to the novel 2019 coronavirus could take up to 3 epidemic cycles and cost from a half-million to 2 million US lives. However, researchers have been gathering insights into a possible “path to immunity” and how vaccines might help us follow that path.

Continued developments in COVID-19 diagnostics might help control the spread of the virus and help infected patients get timely care. The newest tests collect samples in a more patient-friendly way than previous tests (see Saliva-based Nucleic Acid Assays in Topics to Watch) and return results more rapidly (see BinaxNOW COVID-19 Ag Card in Topics to Watch). They can be given regardless of the patient's location (eg, hospital, doctor’s office, or even at home). The next wave of tests aimed at the Food and Drug Administration (FDA) Emergency Use Authorization (EUA) includes a variety of breathalyzer tests that purport to be highly specific to the electrical signature of either the virus itself or markers of the virus.

BinaxNOW COVID-19 Ag Card Point-of-Care Test to Diagnose COVID-19

At a Glance

  • BinaxNOW COVID-19 Ag Card (BinaxNOW) is a simple point-of care test that uses nasal swabs and works like a home pregnancy test. It can be read in about 15 minutes to help health care practitioners rapidly start treating and isolating infected people.
  • BinaxNOW had a sensitivity of 97.1% and a specificity of 98.5% compared with an EUA RT-PCR assay.
  • In August 2020, the FDA granted an EUA to BinaxNOW.
  • The manufacturer claims that each test costs $5 and results can be sent to a mobile device app (NAVICA), which might be used as a temporary digital health pass.

Saliva-based Nucleic Acid Assays to Diagnose COVID-19

At a Glance

  • Saliva-based nucleic acid assay sampling can be performed at home or health centers to detect coronavirus nucleic acids in a patient-collected saliva sample, a less invasive and less costly method than standard nasopharyngeal swab sample collection.
  • A rapid systematic review of published reports found that saliva-based nucleic acid tests were comparable to nasopharyngeal swab-based testing.
  • The FDA granted an EUA to 3 tests, CRL Rapid Response, SalivaDirect, and TaqPath SARS-CoV-2, for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The EUAs for CRL Rapid Response and TaqPath SARS-CoV-2 allow patients to collect samples at home.

Commentary in this COVID-19 Scan reflects preliminary views of ECRI Horizon Scanning and internal ECRI stakeholders.
The information contained in this document has not been vetted by other stakeholders.

We welcome your comments on this Scan. Send them by email to [email protected].

Posted: September 23, 2020

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