GenBody COVID-19 Antigen Rapid Test Kit
Features & Benefits:
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.
Kit Includes:
• 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 (AN) collection swabs
• 1 External positive control
No additional equipment needed!
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
Easy, 4-Step Procedure
Step 1
Step 2
Step 3
Step 4
Interpretation of Results
Start the timer
Read the results between 15-20 minutes.
Do not read after 20 minutes.
Positive
SARS-CoV-2 antigen present does not rule out co-infection with other pathogens. The color intensity in the test region will vary depending on the amount of SARS-CoV-2 antigen present in the sample. Any faint colored line(s) in the test region(s) should be considered as positive.
Negative
Negative test results do not preclude infection and should not be used as the sole basis for treatment or other patient management decisions, including infection control decisions. It is recommended that these results be confirmed by a molecular testing method, if necessary for patient management.
Invalid
Re-run the test one time using the remaining specimen in the extraction vial if an invalid result is obtained during initial testing.
Thank you so much for all of your help! It was such a pleasure dealing with you, Nina, and your company. Thanks for making us feel important even for such a small job. How refreshing in this day and age. Thanks.
