Features:
- Contains: (25) Single Use Test Devices, (2) Bottles of 9 mL Extraction Solution, (25) Single Use Tubes, (25) Single Use Dropper Tips, (25) Single Use Anterior Nasal Specimen Sampling Swabs, Single Use External Positive Control, Single Use External Negative Control, IFU, Quick Reference Instructions
- Visual Read Type
- Anterior Nasal Swab Sample
- Cassette Format
- 15 Minute Results
- The GenBody COVID-19 Ag Test if for use under an FDA Emergency Use Authorization: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2
- 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 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 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
- 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
- Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities
- Negative results should be treated as presumptive and may be confirmed with a molecular assay, if necessary, for patient management
- Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions
- Negative results should be considered in the context of a patient’s recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19
- The GenBody COVID-19 Ag is intended for use by medical professionals or operators trained in performing tests in point of care settings
- GenBody COVID-19 Ag test allows for near patient testing without the need for instrumentation or special equipment
- Made in South Korea