Rapid Antigen Detection Test
A simple and rapid COVID-19 test that can detect the presence of the SARS-CoV-2 antigen within 15 minutes.
- COVISTIX™ is approved under Emergency Use Authorization (EUA) in Mexico by COFEPRIS1 and in Brazil by ANVISA2 and cleared for commercialization.
- Sorrento has received CE Mark and marketing authorization from FAMHP3 to place COVISTIX on the market in the European Economic Area.
- Not yet available in the United States
1. Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) is the regulatory authority responsible for medical device registration and marketing authorization in Mexico.
2. Agência Nacional de Vigilância Sanitária (ANVISA) is the regulatory authority responsible for medical device registration and marketing authorization in Brazil.
3. Federal Agency for Medicines and Health Products (FAMHP) – REF: CE-COV-ST01S & CE-COV-ST01; Registration Number BE/CA01/1-17633-00001-IVD; Authorized Representative Qarad EC-REP BV, Belgium; 13 July 2021.
COVISTIX™ is one of the most sensitive and specific tests on the market. Performed in the hands of your most trusted healthcare professionals, convenient testing is provided with safe and accurate results. This lateral flow immunoassay test is designed to be used by symptomatic and asymptomatic patients to help guide them in testing to inform decisions in the prevention of COVID-19 infection and community spread.