ANNOUNCEMENT ON CE APPROVAL FOR COVID-19 ANTIGEN RAPID TEST KIT (Saliva) SELF-TESTING
The COVID-19 Antigen Rapid Test (Saliva) is a single-use test kit intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19.
This test is intended for home use with self-collected saliva samples in individuals aged 18 and older. Sampling from anyone under the age of 18 should be performed under the guidance of an adult. People who are unable to carry out the test on their own should seek support.
This test utilizes the lateral flow immunoassay technology for the detection of nucleocapsid protein antigen in individuals with known or suspected COVID-19.
Positive results are indicative of the presence of SARS-CoV-2. Individuals who test positive should self-isolate and seek additional care from their healthcare provider. Positive results do not rule out bacterial infection or co-infection with other viruses.
Negative results do not preclude SARS-CoV-2 infection. Individuals who test negative and continue to experience COVID-like symptoms should seek follow up care from their healthcare provider.