How to Order
If you would like to place an order or contact us, please fill out the information below or call us at 949-561-0664
GenBody America
GenBody COVID-19 Rapid Ag Test
Product Model: COVAG025-NU
Point-of-care Use
ts@genbodyamerica.com | 949-561-0664
Catalog Number
Price (USD)
Unit Size
COVAG025-NU
Request Quote
25 Tests / Kit
Product Overview
Documents
Intended Use
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 (NP) or anterior nasal (AN)
swab specimens from individuals who are suspected of COVID-19 by their healthcare provider within the first six
days of symptom onset, or from individuals without symptoms or other epidemiological reasons to suspect COVID-19
when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests. Testing
is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42
U.S.C. §263a, that meet the requirements 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.
Results are for the identification of SARS-CoV-2 nucleocapsid antigen. Antigen is generally detectable in
nasopharyngeal (NP) or anterior nasal (AN) swab specimens during the acute phase of infection. Positive results
indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic
information is necessary to determine infection status. Positive results do not rule out bacterial infection or
co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within
the United States and its territories are required to report all results to the appropriate public health
authorities.
Specifications | |
---|---|
Certificate/ Compliance |
FDA Emergency Use Authorized (EUA) |
Control Sets | Positive, Negative |
CLIA Complexity | Waiver |
Detectable Analysis | SARS-CoV-2 |
Format | Test Cassette Kit |
Sample Type | Nasal Swab |
Type | In Vitro Diagnostic |
Sensitivity | 92.31% |
Specificity | 99.04% |
Organism Group | Virus |
Quantity | 25 Tests |
Shelf Life | 21 Months |
Test Time | 15-20 Minutes |
Content and Storage
- 25 single-use test devices with individual foil pouches.
- 25 single-use individually sleeved sterilized anterior nasal swabs
- 1 positive and negative external control swabs
- 25 single-use extraction tubes and dropper tips
- 2 bottles of extraction solution
- GenBody COVID-19 Ag kit should be stored between 2 to 30°C (35.6 to 86°F)
Documents & Downloads
- Safety Data Sheet
- GenBody COVID-19 Antigen Rapid Test Kit Anterior Nasal Swab
- EUA Authorization Letter
- Shelf-Life Extension Approval Letter
- Expiration Date Extension Letter
- Omicron Detection Bulletin
- Instructions for Use
- Quick Reference Instructions
- Fact sheet for Healthcare Providers
- Fact Sheet for Patients
Material Safety Data Sheets
Sales Flyers
FDA Authorization Letters
Product Bulletin
Package Inserts
Data Sheets
Contact Us
If you would like to place an order, please fill out the information below or call us at 949-561-0664