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Genbody COVID-19 Antigen Test

A front-line choice for quick SARS-CoV-2 POC antigen testing.

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How it works

Offers results in 15 minutes and allows for near patient testing without the need for instrument or special equipment at the point of care.

  1. Prepare extraction solution.
  2. Collect patient sample and begin testing.
  3. Read and report result.

Identify Active Infection of SARS-CoV-2 in 15 Minutes

To keep life moving forward, even as new variants may continue to emerge, COVID-19 testing remains important as an aid to ensure appropriate patient management and to support the government’s Test to Treat initiative.

SARS-CoV-2 antigen testing can be an alternative first line of defense when compared to PCR testing, particularly for symptomatic patients within a specific window from symptom onset and where tests are repeated frequently (i.e., weekly testing.¹)

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Keep Life Moving

Antigen tests can be run on similar patient populations as PCR tests, such as, those who are suspected of COVID-19 infection by their healthcare providers for various reasons, including known exposure or working in high-risk environments.2

There may be value in providing results with antigen tests even though they may have lower sensitivity than PCR tests, particularly in settings where a combination of accuracy, high-throughput and rapid turnaround time is required.2

Antigen tests can round out the test offering for your community depending on the testing strategy in place.2

Product Specifications3

Turnaround Time

15 minutes

Performance

92.31% PPA (Sensitivity)
99.04% NPA (Specificity)

Sample Type

Nasal mid-turbinate swab

Kit Storage

2-30° C

Test Kit Size

25 tests per kit

Shelf-life

12 months from date of manufacture

CPT Code

87811

GenBody COVID-19 AG Test Technical Resources

Visit our Help & Support page for product labeling, instructions for use, and other helpful documentation.

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TALIS BIOMEDICAL

The GenBody COVID-19 Ag Test is for use under Emergency Use Authorization (EUA) only. For In Vitro Diagnostic (IVD) use. For prescription use only. Talis is an authorized distributor of the GenBody COVID-19 Ag test.

†The Talis One Test System is not authorized, cleared, or approved by the FDA and is not available for sale.

© Talis and Talis One are trademarks of Talis Biomedical Corporation. All Rights Reserved.

* Testing solutions are currently in development and not available for sale.

This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories; 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.

REFERENCES:

  1. https://www.cdc.gov/coronavirus/2019-ncov/hcp/testing-overview.html#ConsiderationsWhenTesting, Accessed December 10, 2021
  2. https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antigen-tests-guidelines.html, Accessed December 10, 2021
  3. Instructions for Use (IFU for GenBody COVID-19 Ag Test 2021.11.12 (Rev. 2)