Genbody COVID-19
Antigen Test

A front-line choice for quick, high volume
SARS-CoV-2 antigen testing

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

Testing for COVID-19 is in high demand. 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)

  • Antigen tests can be run on similar patient populations as PCR tests, e.g., those who are suspected of COVID-19 infection by their healthcare providers for various reasons, including known exposure or working in high-risk environments2
  • 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 required2
  • Antigen tests can round out the test offering for your community depending on the testing strategy in place2

GenBody COVID-19 Ag Procedure Steps3

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

Product Specifications3

Turnaround Time

15 minutes

Performance

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

Sample Type

Anterior nasal 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

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How to use the GenBody COVID-19 Ag Test

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)

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