Diagnostic information company Virality Diagnostics LLC reported on Thursday the receipt of the Food and Drug Administration's (FDA) Emergency Use Authorization (EUA) for a rapid COVID-19 antibody test manufactured by Biohit (Hefei) and distributed by Virality Diagnostics.
This test is a rapid SARS-CoV-2 lateral flow immunoassay (LFA) which detects both IgG and IgM antibodies with 98.5% accuracy.
It requires a simple finger-prick and only one drop of blood and delivers easily interpreted results within 15 minutes.
Recent trials involving over 1,500 patients at multiple sites, including Yale University and the National Cancer Institute (NCI), validated that Virality's tests exhibit near perfect (98.8%) specificity for the novel coronavirus and extremely high sensitivity (94.9%) for patients tested at least two weeks from symptom onset.
US FDA Distributes First Round of SARS-CoV-2 Reference Panel Materials
US FDA says country on target to reach a COVID-19 vaccine by 2020 or early 2021
Bavarian Nordic receives European marketing authorisation for Ebola vaccine
Microbrush reports launch of new nasopharyngeal test swabs for COVID-19 testing
Anivive begins two pre-clinical studies of GC376 for the treatment of COVID-19
PolyPid begins first phase three clinical trial of D-PLEX100
US FDA grants Orphan Drug Designation to ISA Pharmaceuticals' ISA101b
Affinity discovers potent antibodies that can completely neutralize SARS-CoV-2 infection
Gravity Diagnostics announces Kroger Health's home collection kit to expand COVID-19 testing
Meissa Vaccines Provides a Pipeline Update on Vaccine Candidates for COVID-19 and RSV
Mezzion Pharma submits New Drug Application to US FDA for Udenafil
US FDA, FTC Warn Companies to Stop Selling Unapproved COVID-19 Products