Learn About The GenBody COVID-19 Ag Test
The GenBody COVID-19 Ag test is an immunochromatographic rapid diagnostic test that is intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasopharyngeal (NP) or anterior nasal (AN) swab specimens derived from individuals who are suspected of being infected with 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 having COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests.
Results are for the identification of SARS-CoV-2 nucleocapsid antigen. The antigen is generally detectable in nasopharyngeal (NP) or anterior nasal (AN) swab specimens during the acute phase of infection. Positive test 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 the disease.
Laboratories within the United States and its territories are required to report all COVID-19 test results to the appropriate public health authorities. Negative test results should be treated as presumptive and may be confirmed with a molecular assay, if necessary, for patient management. Negative test 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 COVID-19 Ag test 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.
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.
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
The GenBody COVID-19 Ag Test Overview:
- Provides direct detection of SARS-CoV-2 antigens from nasal swabs
- A qualitative immunoassay that offers reliable results in 15 minutes for better patient management
- GenBody COVID-19 Ag test allows for near-patient testing without the need for instrumentation or special equipment
- Used for detection of SARS-CoV-2 antigen from nasal swab without the need for instrumentation
- For diagnosis of patients suspected of having a COVID-19 infection or asymptomatic patients or serial screening
- Detection of SARS-CoV-2 antigens indicates an active infection
- 900 COVID-19 rapid antigen tests are included in each case.
GenBody COVID-19 Ag Rapid Antigen Test Specs:
- Detects an active COVID-19 infection
- Get your COVID-19 test results in just 15 minutes
- Easy to follow, illustrated step-by-step instructions
- Requires a minimally invasive nasal swab sample
- Know your COVID-19 test result now, without the need to wait for results from your healthcare provider
- Performance: 92.31% PPA / 99.04% NPA