March 6, 2023

Advin

COVID-19 Testing

Advin COVID-19 Antigen Test @ Home

FDA-EUA Authorized 1-3 COVID-19 Antigen Test for OTC and Point of Care

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.

  • Simple, Quick, Accurate
  • Rapid Result in 10 minutes

For FDA Emergency Use Authorization (EUA) only. For In Vitro Diagnostic use.

Kit Information

Contents of Each Test Kit:

  • Sterile Nasal Swab
  • Extraction Buffer Tube
  • Test Cassette
  • Disposable Bag
  • Quick Reference Guide

Packaging

Test kit is available in:

  • 2 Tests

Specifications

  • Sample type: Nasal swab
  • Accuracy: 98%
  • Time to result: 10 minutes

How It Works

This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older or with adult-collected anterior nasal (nares) 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.

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Test Procedure

For more information of all the test prodecures, please download the Quick Reference Guide (QRG) at the bottom of this page.

Prepare

Remove nasal swab from its packaging. DO NOT touch the swab tip

Swab

Gently insert swab ½ - ¾ inch into first nostril, or until you feel resistance. Slowly make at least 5 rotations with the swab firmly against the walls of the nostril for approximately 15 seconds. Repeat step in your second nostril using the same swab.

Stir & Squeeze

Take the tube out of the tube holder. Place the swab into the tube, ensure the swab tip is in the liquid inside the tube. Stir the swab tip against the bottom and side of the tube for at least 15 times. While squeezing the sides of the vial firmly, pull the swab out to remove excess liquid.

Drip

Add 3 drops of solution into the circular sample well, labeled as "S" on the test cassette.

Wait 10 minutes

Set timer for 10 minutes. Do not move or lift the test cassette. Read the test result at 10 minutes.

Advin FAQs

Most tests are U.S. FDA cleared to be 99.9% accurate, as well as CLIA waived and approved for home use, certifying that they are sufficiently simple to operate and interpret. Any test we make that may be considered a niche test, for which the FDA has not yet established guidelines, is held to this same standard and will be cleared after protocols are established by the FDA.
Negative results may be seen in as little as one minute. Positive results may be read after 5 minutes. Results should not be read after 60 minutes.
Some tests do not distinguish between therapeutic use of a drug and abuse of the same drug. A test may yield preliminary positive results when prescription tricyclic antidepressants, barbiturates, benzodiazepines, methadone, buprenorphine or opiates are ingested, even at therapeutic doses. There are no uniformly recognized drug levels for these prescription drugs in urine.
Room temperature storage, or 2-30 degrees Celsius / 35.6-86 degrees Fahrenheit is recommended. Do not freeze the test. The expiration date is written on the pouch that contains the device, most tests have a shelf life of 2 years from the date of manufacture.
A red or pink line next to the “T1” or “T2” (drug test line) under the drug name indicates a negative result for that drug, even if the line is very faint. In the case of a positive result, there will be NO line at all. ANY line, no matter how faint, indicates a negative result.
Go to contact us page and fill out a form to inquire. A sales representative will be in contact within 24 hours.
Ordering Information
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Resources

Learn More

For more information about our products or to make a purchase, please contact us using the form and we will get back to you shortly.


Disclaimers

  1. This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA;
  2. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and,
  3. 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.
  4. 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.

References

  1. COVID-19 Fact Sheet for Healthcare Professionals
  2. Advin COVID-19 Antigen Test @home Quick Reference Guide
  3. Healthcare Provider Instructions for Use (IFU)