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 tested at least three times over five days with at least 48 hours between tests.
- 25 Test cassettes
- 25 Extraction buffer tubes
- 25 Sterile nasal swabs
- 25 Disposable bags
- Quick reference guide
- Instructions for Use
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 tested at least three times over five days with at least 48 hours between tests.
- 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.
- The Advin COVID-19 Antigen Test @Home does not differentiate between SARS-CoV and SARS-CoV-2.
- In the USA, this product has not been FDA cleared or approved, but has been authorized by FDA under an Emergency Use Authorization.
- This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.
- 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.
- Please note that certain products may only be available in specific regions; kindly consult with a sales representative for further information regarding product availability.
- The information provided on this website is for educational purposes only and should not be construed as medical advice. Always consult with a qualified healthcare professional regarding any medical concerns or conditions.
- Our products are intended for use as specified in the product documentation. It is important to carefully read and follow all instructions provided with the product
Canada