Additional Information

Description

The OSOM® COVID-19 Antigen Rapid Test is an in vitro diagnostic tool designed for the qualitative detection of SARS-CoV-2 antigens in nasal swab specimens. This test is intended for use in individuals who are suspected of having COVID-19, especially within the first 7 days of symptom onset. It is authorized for use under an FDA Emergency Use Authorization (EUA).

This rapid test detects the nucleocapsid protein antigen of the SARS-CoV-2 virus using a lateral flow chromatographic immunoassay. The test requires a direct mid-turbinate nasal swab specimen collected by a healthcare provider. The test is authorized for use at the Point of Care (POC) in various settings, including those with a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

The OSOM® COVID-19 Antigen Rapid Test provides results within a short time frame, and positive results indicate the presence of viral antigens. Positive results should be confirmed with additional diagnostic information, as they do not rule out bacterial infections or co-infection with other viruses.