Genbody COVID-19 EUA Authorized Rapid Antigen Test (POC)

Product 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%
• For use in For use in the Point-of-Care setting

https://www.fda.gov/media/150786/download

Please refer to "Patient Fact Sheet" Below:

https://www.fda.gov/media/150787/download

Below is a link to Instruction for Use "IFU"  and Quick Reference Guide.

https://www.fda.gov/media/150788/download

Please refer to "FDA Emergency Use Authorization(EUA)" Below:

https://www.fda.gov/media/150785/download

Please refer to FDA Shelf Life Extension Below:

https://www.fda.gov/media/159259/download

Warnings and Precautions:

• For in vitro diagnostic use only.
• For prescription use only.
• This product has not been FDA cleared or approved; but has been authorized by FDA under an EUA for use by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C.§263a, to perform moderate, high or waived complexity tests. This product 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.
• Federal Law restricts this device to sale by or on the order of a licensed practitioner (US only).
• 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.
• Laboratories within the United States and its territories are required to report all results to the appropriate public health laboratories.
• Do not use kit past its expiration date.
• Do not store or test specimens in viral transport media, as it may result in false positive or false negative results.
• It is recommended that personal protection equipment and gloves (not provided) be worn when running each test and handling patient specimens.
• The Extraction Solution in this kit contains a detergent and a preservative that will inactivate cells and virus particles. Samples eluted in this solution are not suitable for culture.
• Test Devices are single use only and should be discarded after use. Do not re-use the Test Device.
• Proper sample collection, storage and transport are essential for correct results. Specimens should be prepared in accordance with the instructions provided in the "Specimen Collection and Storage" section.
• Excess blood or mucus on the swab specimen may interfere with test performance, potentially yielding an inaccurate result. Avoid touching any bleeding areas of the nasopharynx when collecting specimens.
• Users should test specimens as quickly as possible after specimen collection.