GenBody Rapid COVID-19 Ag Test is an affordable and sensitive test that does not require an additional reader, with a processing time of 15-20 minutes.
The GenBody COVID-19 Ag test is a quick, qualitative immunochromatographic assay for determining the presence of SARS-CoV-2 antigens in human nasopharyngeal or anterior nasal swab specimens and is supported by the NIH. Mouse monoclonal antibodies to the nucleocapsid protein (NP) of SARS-CoV-2 are present on the test strip in each instrument.
Features consist of:
- Full Detection of SARS-CoV-2 nucleocapsid protein antigen.
- Quick results in 15-20 minutes
- Detects acute infection with a sensitivity of 92.31% and specificity of 99.04 %
- For use in facilities providing patient care that is covered by CLIA Certificates of Waiver, Compliance, or Accreditation
- Medical practitioners or operators skilled in running tests in point-of-care situations should utilize the GenBody COVID-19 Ag. The Food and Drug Administration's Emergency Use Authorization is the sole circumstance under which the GenBody COVID-19 Ag may be used.
Current Stamped Expiration Date: November 2025
FDA EUA
92.31% sensitivity and 99.04 % specificity
- FDA EUA Authorized rapid antigen test
- Anterior nasal swab specimen collection for comfort (SHALLOW NASAL SWAB)
- Identifies acute infection with a 92.31% sensitivity and 99.04 % specificity
- Selected by NIH for the Rapid Acceleration of Diagnostics, for US production of the GenBody COVID-19 Ag test
- For use in the Point-of-Care setting
- Made in the USA (Q4 2021) and South Korea
- For more information click here: Features/Procedure
KIT COMPONENT:
25 Single Use Test Devices Individually Foil-Pouched
2 Bottles of Extraction Solution
25 Single Use Extraction Tubes
25 Single-Use Dropper Tips
25 Sterilized anterior nasal swabs
DISCLAIMER:
The GenBody COVID-19 Ag test has not been FDA-cleared or approved but has been authorized by FDA under a EUA for use by authorized laboratories. The product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and, 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.
IMPORTANT INFORMATION
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