The FaStep COVID-19 Antigen Pen Home Test is a rapid lateral flow immunoassay device intended for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus. This 2-pack kit allows for convenient at-home testing with no lab required and no special equipment needed.

Each kit includes 2 antigen test cards, 2 sterilized swabs, 2 extraction buffer tubes, and a quick reference instruction guide. Results are delivered in 15 to 20 minutes. Do not read results before 15 minutes or after 30 minutes, as results outside this window may be inaccurate. This product is HSA and FSA eligible.

The test is authorized under FDA Emergency Use Authorization (EUA #220191) for non-prescription home use. Self-collected anterior nasal swab samples can be used by individuals aged 14 years and older. Adult-collected anterior nasal swab samples can be used for individuals aged 2 years and older. The test is authorized for use with or without symptoms of COVID-19. In a prospective clinical study, the FaStep correctly identified 82.7% of positive samples and 99.1% of negative samples compared to EUA molecular reference tests. UPC: 810022630426.