GenBody -COVID-19 Antigen Rapid Test Kit
An immunochromatographic rapid diagnostic test (RDT) intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasopharyngeal (NP) or anteriornasal (AN) swab specimens. Authorized for use under an Emergency Use Authorization (EUA) and 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.
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- 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 collection swabs
- 1 External positive control
- Rapid results:
Visual read-out in 15-20 minutes - Sensitivity:
Identifies acute infection with a 92.3% sensitivity and 99% specificity - Storage:
Between 2°C to 30°C