FDA Authorizes 15-Minute Antibody Testing Kit
The finger-prick test showed 98.8% specificity for novel coronavirus in assessments including 1500 patients.
The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to Virtality Diagnostics for a rapid coronavirus 2019 (COVID-19) antibody test which detects both IgG and IgM antibodies with 98.5% accuracy.
The diagnostic test, which requires a drop of blood from a finger prick, delivers results in 15 minutes, according to the company.
As an antibody test, it is capable of measuring the body’s immune response and determining whether a person’s body produced an antibody response to SARS-CoV-2 infection—indicating both past exposure to and infection by novel coronavirus.
The Virality test’s efficacy was evidenced in a recent series of trials involving 1500-plus patients from multiple sites in the US. The test exhibited 98.8% specificity for novel coronavirus, and a high sensitivity (94.9%) for patients tested at least 2 weeks from symptom onset.
These results indicate the test is performatively better than a majority of current rapid LFA tests authorized by the FDA, as well as some ELISA tests being primarily used for SARS-CoV-2 antibody detection.
The company anticipates it could provide a million-plus antibody test kits daily. David A. Spiegel, MD, PhD, chief scientific advisor and co-founder of Virality, emphasized the company’s aim in contributing to the gamut of available, reliable antibody tests during the pandemic.
“Nearly everyone who recovers from COVID develops IgG and IgM antibodies, and it is likely that these antibodies reflect some degree of immunity to the disease,” he said in a statement.