Intended use – The Atomo Covid19 Antigen test is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in anterior nasal swab specimens directly collected from individuals at the point of care (POC).
Results are for the identification of the SARS-CoV-2 nucleocapsid protein antigen, generally detected during the acute phase of the infection.
Positive results indicate the presence of viral antigens, but the clinical correlation with patient history and other diagnostic information is necessary to determine infection status.
Negative results should be treated as presumptive, and do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions.
The Atomo COVID-19 Antigen Test is intended for use by medical and healthcare professionals who are proficient in performing tests in point of care settings or trained clinical laboratory personnel.