AffiDX® SARS-CoV-2 Antigen Lateral Flow Test

Description

Intended Use:

The Avacta AffiDX® SARS-CoV-2 Antigen Lateral Flow Test is a
qualitative in vitro diagnostic (IVD) test to detect SARS-CoV-2 antigen in
human anterior nasal swabs. The test is intended for professional use only.
Assay validation and clinical evaluations of the test were conducted in the UK
and EU using routine prospective samples in general population and healthcare
settings*.

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