The Advin COVID-19 Antigen Test @ Home is a qualitative immunoassay test for the detection of nucleocapsid protein antigens from SARS-CoV-2 in anterior nasal swab specimens.
This test is authorized for both CLIA Waived Point-of-Care use and non-prescription home use with self-collected anterior nasal swab samples from individuals aged 14 years or older or with adult-collected anterior nasal samples from individuals aged 2 years or older. This test is authorized for individuals with symptoms of COVID-19 within the first 7 days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when test at least three times over five days with at least 48 hours between tests.
Product Information
- Product Code: COV-19C25AD
- Quantity: 25
- Sample: Anterior nasal swab
- Format: Cassette
- Time-to-Result: 10 minutes
- Storage Condition: 35.6-86°F/2-30°C
- Test Principle: Lateral Flow Assay
Contents
- 25 Test cassettes
- 25 Extraction buffer tubes
- 25 Sterile nasal swabs
- 25 Disposable bags
- Quick reference guide
- Instructions for Use
Disclaimers
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The Advin COVID-19 Antigen Test @ Home is intended for non-prescription self-use and/or, as applicable for an adult lay user testing another person aged 2 years or older in a non-laboratory setting. The Advin COVID-19 Antigen Test @ Home is only for use under the Food and Drug Administration’s Emergency Use Authorization. This product has not been FDA cleared or approved.
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The Advin COVID-19 Antigen Test @Home does not differentiate between SARS-CoV and SARS-CoV-2.
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In the USA, this product has not been FDA cleared or approved but has been authorized by FDA under an Emergency Use Authorization.
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This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.
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The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated, or authorization is revoked sooner.
