Written by: Apoorva Kakkilaya Edited by: Esther Melamed On November 17, 2020, the FDA issued its first emergency use authorization (EUA) for a self-test kit that can be administered entirely at home. The Lucira COVID-19 All-In-One Test Kit utilizes RT-LAMP technology to detect SARS-CoV-2 RNA from self-collected nasal swab samples. Swabs are placed in an included test unit and a positive or negative result is displayed within 30 minutes. Data from the manufacturer indicates sensitivity of 94.1% and specificity of 98.0%. Access to this test requires a prescription from a health care provider …
Developments in Antibody Tests for Convalescent Plasma
Convalescent plasma therapy recently received EUA from the FDA for the treatment of hospitalized COVID-19 patients. Although the efficacy of this treatment is still not well understood and clinical trials are ongoing (read more about the current standing of this therapy on our blog’s clinical trials page), identifying possible plasma donors who may have sufficient antibody levels is an important aspect of this therapy. The FDA threshold value of virus-neutralizing (VN) antibody titer for plasma donations is 1:160, meaning that a 1:160 dilution of a given unit of plasma has activity against …
Wastewater Testing for SARS-CoV-2 Surveillance
Wastewater-Based Epidemiology is an approach for infectious disease surveillance and can serve as an early warning system for disease outbreaks (Sims and Kasprzyk-Hordern 2020). Wide application of wastewater surveillance began in the 1990s with efforts to eradicate poliovirus. Although SARS-CoV-2 is not primarily spread through fecal-oral transmission like polio, the presence of SARS-CoV-2 RNA has been detected in feces of patients. The presence of viral RNA in feces stems from the ability of the virus to infect ACE2-expressing cells in the small intestine (Zang et. al, 2020). Currently, …