Frequently Asked
Questions

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.

The only certificate the administering healthcare provider must have is the CLIA Certificate of Waiver. Anyone associated with the CLIA Waiver holder can administer the test. There is no mandatory operator certificate involved with our test kits.

No, our test is FDA authorized under EUA only for Point of Care sites for professional use. There must be an operator to administer the test on a patient.

It is recommended that external control testing be performed with each new operator before using a new lot or shipment of GenBody COVID-19 Ag kits to confirm the expected Quality Control (QC) results. The frequency of additional QC tests should be conducted according to your laboratory’s standard QC procedures and local, state, and federal regulations or accreditation requirements.

The GenBody COVID-19 Ag test can be stored in 2°-30°C (35.6°-86°F). Before test administration and quality control testing, let the test materials equilibrate to room temperature at 15°-30°C (59°-86°F). Do not expose the test devices and extraction solutions to temperatures outside of room temperature during testing.

COVID-19 is caused by the SARS-CoV-2 virus, which is a new virus in humans causing a contagious respiratory illness. COVID-19 can present with a mild to severe illness, although some people infected with COVID-19 may have no symptoms at all. Older adults and people of any age who have underlying medical conditions have a higher risk of severe illness from COVID-19. Serious outcomes of COVID-19 include hospitalization and death. The SARS-CoV-2 virus can be spread to others not just while one is sick but even before a person shows signs or symptoms of being ill (e.g., fever, coughing, difficulty breathing, etc.).

The most up-to-date information on COVID-19 is available at the CDC General webpage: https://www.cdc.gov/COVID19.

Yes, the tests have two indirect pieces of evidence that indicate the GenBody COVID-19 Rapid Antigen Test performs well against the Delta variant. First, during laboratory testing, there were no changes in our calculated limit of detection. Second, we performed our anterior nasal trials in July, during which time the Delta variant was noted to be rampant. Our data showed improvement in sensitivity related to our nasopharyngeal trials, which is a strong indication that the Delta variant does not impact the performance of the tests. The Omicron variant was just recently discovered, and no trials have yet to be conducted.

Some known potential risks include possible discomfort or other complications during sample collection and possible incorrect test results.

Serial testing is when one person is tested for COVID-19 more than once, as antigen tests may be less sensitive than other COVID-19 tests, and false results may occur. Repeated testing may identify results more accurately than a single test. After a single test, an additional molecular COVID-19 test may be necessary, depending on an individual’s risk factors and test results.

There are different kinds of tests for diagnosing COVID-19. PCR tests or molecular tests detect genetic material from the virus. Antigen tests detect protein from the virus. Antigen tests are more specific for the virus being tested for but are less sensitive than the molecular test. This means that a positive result is highly accurate, but a negative result does not rule out infections. Suppose the patient has received two negative tests within a 24 to 36 hours period but is still experiencing COVID-19 symptoms such as coughing, shortness of breath, or fever, you should discuss the need for additional testing with the patient.

No, this test is not yet approved or cleared by the United States FDA. The FDA may issue an Emergency Use Authorization (EUA) when certain criteria are met, which includes that there are no adequate, approved, available alternatives. The EUA for this test is supported by the Secretary of Health and Human Services (HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics for the detection and/or diagnosis of the virus that causes COVID-19.

There are no approved available alternative antigen tests.

If the patient’s first test is negative, you should test again in 24 to 46 hours to ensure the best accuracy.

No. Each test is intended for single-use and is to be disposed of after the test is complete.

The GenBody COVID-19 Rapid Ag Test is manufactured in California, USA.

GenBody Antigen Rapid Tests were compared to molecular tests (PCR) that the FDA authorized for SARS-CoV-2 assay to determine test performance. We have correctly identified 92% sensitivity and 99% specificity (false positive against false negative)

If you have a positive test result, it is very likely that you have COVID-19 because protein from the virus was founding your sample. Therefore, it is also likely that you may be placed in isolation to avoid spreading the virus to others. There is a very small chance that this test can give a positive result that is wrong or false positive. Should you test positive with the GenBody Antigen Rapid Test, you should self-isolate and seek follow-up care with your healthcare provider as additional testing may be necessary.

A negative test result means that protein from the virus that causes the COVID-19 was not found in your sample. It is possible for this test to give an incorrect negative result. The amount of antigen in a sample may decrease the longer you have symptoms of infection. In symptomatic people, specimens collected after you have had symptoms for more than seven days may be more likely to be negative compared to a molecular assay. Suppose you test negative and continue to experience COVID-19 symptoms like fever, cough, and shortness of breath. In that case, you should seek follow-up care with your healthcare provider, and they may suggest you need another test to determine if you have contracted the virus causing COVID-19.

You can download our English Instructions here: https://www.fda.gov/media/150788/download

No, the gentle nasal swab is not sharp, and it should not hurt. Only the lower part of the nostril should be swabbed. If the patient feels pain, please stop the test immediately.

A positive result means that it is very likely your patient has COVID-19, and it is important to instruct the patient to isolate themselves at home to avoid spreading the virus to others. There is a very small chance that this test can give positive results that are wrong. Please instruct the patient to follow CDC quarantine guidelines which can be found here: https://www.cdc.gov/coronavirus/2019-ncov/your-health/quarantine-isolation.html

If your patient received a second negative result 24 to 36 hours after the first negative test, then your patient is likely not infected with COVID-19. If your patient has symptoms, they may have a different virus or type of infection. Your patient might have COVID-19 and still get a negative result if the test was not performed correctly, such as not swabbing correctly or not waiting 15 minutes for test results. The level of antigen from the COVID-19 virus was below the test limits. Suppose your patient has had signs and symptoms of COVID-19 for more than seven days. This means your patient can still have COVID-19 even though the test was negative. Please advise your patient to see their healthcare provider. Their healthcare provider will consider the test result along with all other aspects of their medical history, including symptoms specific to COVID-19, and decide how to care for them.

If you don’t have a control line on the result of your test within 15-20 minutes, your test is invalid. Re-test with a new GenBody COVID-19 Ag and call the GenBody customer service at 888-552-5204 or email customer support at ts@genbodyamerica.com.

No, the solution in the tube contains potentially harmful chemicals; however, studies have shown them to be non-toxic at the level contained in the solution. The extraction solution should only be used as directed. Do not ingest, keep out of reach of children, and avoid contact with skin and eyes.

There are no age restrictions on administering our test—however, consent from parents or guardians for children too young to give support.

Yes, even vaccinated individuals may carry the virus that could infect others. Testing along with vaccinations are essential tools to prevent the spreading of COVID-19. Frequent testing is another way to reduce the further spreading of the virus.

An authorized CLIA number and address with documentation are necessary before purchases can be shipped. Purchased tests can only be sent to the designated address associated with the CLIA number.

For questions regarding GenBody Products, please get in touch with us at our website or email us at ts@genbodyamerica.com