GenBody COVID-19 Rapid Antigen Test Kit Instruction Manual
- June 4, 2024
- GenBody
Table of Contents
GenBody COVID-19 Rapid Antigen Test Kit Instruction Manual
Rapid detection of SARS-CoV-2 will play a key role in the global spread of the virus.
Affordable and sensitive test that does not require an additional reader, with a processing time of 15-20 minutes.
For use under an Emergency Use Authorization (El-JA) Only
For in vitro diagnostic use only
For professional use only
RX Only
Features
Detects SARS-CoV-2 nucleocapsid protein antigen
Rapid results in 15-20 minutes
Anterior nasal swab specimen collection
Identifies acute infection with a 92.31% sensitivity and 99.04% specificity
For use in patient care settings operating under a CLIA Certificate of Waiver,
Certificate of Compliance or Certificate of Accreditation.
The confirmed LOD for the GenBody COVID-19 Ag is 1.11 x 10 TCID50/mL.
Our Competitive Advantage
Large manufacturing capacity and immediately available for distribution
Global sales and regulatory approval throughout Europe, Asia and South America
Selected by NIH for the Rapid Acceleration of
Diagnostics program, for the US production of the GenBody COVID-19 Ag test.
Made in the USA (Q4 2021) and South Korea
The GenBody COVID-19 Ag test detects the Sars- COV-2 variants.
The GenBody COVID-19 Ag is an immunochromatographic rapid diagnostic test (RDT) intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasopharyngeal swab (NP) or anterior nasal (AN) specimens from individuals who are suspected of COVID-19 by their healthcare provider within the first six days of symptom onset. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 5263a, that meet the requirements to perform moderate, high or waived complexiFy’ tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance or Certificate of Accreditation.
GenBody COVID-19 Ag Packaging Information
Refer to the GenBody COVID-19 Ag IFU or download detailed instructions at
www.kwelllabs.com
GenBody COVID-19 Performance Comparison
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; 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. 5 360bbb-3(b)(1 ), unless the declaration is terminated or authorization is revoked sooner.
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