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Advin COVID-19 Antigen Test @ Home (1pk)

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The Advin COVID-19 Antigen Test @ Home is a lateral flow immunoassay device intended for the qualitative detection of nucleocapsid protein antigens from SARS-CoV-2. 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.
  • 1 test per box
  • NDC#: 60010003312
  • Collects anterior nasal swab specimens without deep nasal penetration, ensuring a comfortable testing experience.
  • Boasts a Positive Percent Agreement (PPA) of 82.5% and a Negative Percent Agreement (NPA) of 100%, providing reliable and accurate results.
  • Application: Respiratory Test Kit
  • Each Kit Contains: (1) Test Cassette, (1) Extraction Buffer Tube, (1) Disposal Bag, (1) Disposable Nasal Swab, Quick Ref Guide
  • Sample Type: Anterior Nasal Swab Sample
  • Specialty: Immunoassay
  • Test Kit Type: Rapid
  • Test Method: Lateral Flow
  • Time to Results: 10 Minute Results

Product Documentation

Fact Sheet for Healthcare Professional

Healthcare Provider Instructions for Use

Quick Reference Guide

Letter of Authorization

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.

Determining a negative result requires multiple tests. You may need to purchase additional tests to perform serial (repeat) testing. This test is more likely to give you a false negative result when you have COVID-19 than a lab-based molecular test.

About Advin
Innovative Manufacturer of Premium Quality, FDA Cleared Drug Tests
Founded by lateral-flow scientists in 2009, Advin Biotech, Inc. is an FDA registered purveyor of lateral-flow rapid diagnostics, specializing in the innovative design, structured development, and efficient manufacture of premium quality, competitively priced drugs of abuse test kits for distribution in the U.S. and internationally.
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