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Self Test for COVID-19 Infection with CareStart™ Antigen Home Test

• FAST - Result in 10 minutes
• CONVENIENT - No prescription required
• EASY - Self-test with shallow nasal swab
• Detects known variants
• PPA: 87%, NPA: 98%
• For Use Under FDA Emergency Use Authorization (EUA) only
• Made in U.S.A.

The CareStart™ COVID-19 Antigen Home Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigens from SARS-CoV-2. Under FDA’s EUA, CareStart™ COVID-19 Antigen Home Test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older with symptoms of COVID-19 within the first 7 days of symptom onset. This test is also authorized for non-prescription home use with adult-collected nasal (nares) swab samples from individuals aged 2 years or older with symptoms of COVID-19 within the first 7 days of symptom onset.

This test is also authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older, or adult-collected anterior nasal (nares) swab samples from individuals aged 2 years or older, with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests.

FACT SHEET FOR HEALTHCARE PROVIDERS

USER INSTRUCTIONS (QRI) AND FACT SHEET FOR INDIVIDUALS

INSTRUCTIONS FOR USE (IFU) FOR HEALTHCARE PROVIDERS

FDA EMERGENCY USE AUTHORIZATION LETTER

DISCLAIMER