Description

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

FAQs about GenBody COVID-19 Ag Test

What is the GenBody COVID-19 Ag Test?

The GenBody COVID-19 Ag Test is a type of COVID-19 test called an antigen test. Antigen tests are specifically designed to detect proteins from the SARS-CoV-2 virus in direct nasopharyngeal or from anterior nasal swabs. The presence of these viral proteins indicates that you may have been infected with the SARS-CoV-2 virus and are likely to be contagious.

What does serial testing mean?

Serial testing is when a single person is tested for COVID-19 more than once using the same COVID-19 test. Because the amount of antigen in your sample may change over time and false results may occur, repeated testing may identify more individuals with COVID-19 than a single antigen test. By repeating the testing, it may be possible to more quickly identify cases of COVID-19 and to reduce the spread of infection. Additional testing with a molecular COVID-19 test may be necessary, which will depend on your individual risk factors and test results.

What’s the difference between the GenBody COVID-19 antigen test and other tests?

There are different kinds of COVID-19 tests.

1) Molecular tests (also known as PCR tests) detect genetic material from the virus.

2) Antigen tests detect proteins from the virus. Antigen tests are very specific for the virus but are not as sensitive as molecular tests. This means that a positive COVID-19 test result is highly accurate, but a negative result does not necessarily rule out SARS-CoV-2 infection.

Is GenBody COVID-19 rapid antigen test FDA-approved or cleared?

No. The GenBody COVID-19 Ag test is not yet approved or cleared by the United States FDA. When there are no FDA approved or cleared COVID-19 tests available, and other criteria are met, the FDA can make COVID-19 tests available under an emergency access mechanism called an Emergency Use Authorization (EUA) by authorized laboratories certified under the CLIA, 42 U.S.C. §263a, that meets requirements to perform moderate, high or waived complexity tests.

The EUA for the GenBody COVID-19 Ag test is supported by the Secretary of Health and Human Services (HHS) declaration that circumstances exist to justify the emergency use of in vitro diagnostics for the detection and/or diagnosis of the virus that causes the COVID-19 infection.

As of now, this EUA will remain in effect (meaning this test can be used) for the duration of the COVID-19 declaration, which justifies the emergency use of in vitro diagnostics - unless it is terminated or revoked by FDA (after which the test may no longer be used).

Are there approved alternatives to the GenBody COVID-19 Ag Test?

There are no approved alternative COVID-19 antigen tests, like GenBody’s. Any rapid antigen tests that have received full marketing status (e.g., cleared & approved), as opposed to a EUA, by the FDA can be found by searching the medical device databases of the FDA.gov website.

Downloads:

• Product Brochure
• Quick Reference Guide
• Package Insert
• Healthcare Providers Fact Sheet
• Patient Fact Sheet
• Safety Data Sheet