A diagnostic test can show if you have an active coronavirus infection and should take steps to quarantine or isolate yourself from others. Currently there are two types of diagnostic tests – molecular (RT-PCR) tests that detect the virus’s genetic material, and antigen tests that detect specific proteins on the surface of the virus. Samples are typically collected with a nasal or throat swab, or saliva collected by spitting into a tube. An antibody test looks for antibodies that are made by the immune system in response to a threat, such as a specific virus. Antibodies can help fight infections. Antibodies can take several days or weeks to develop after you have an infection and may stay in your blood for several weeks after recovery. Because of this, antibody tests should not be used to diagnose an active coronavirus infection. At this time, researchers do not know if the presence of antibodies means that you are immune to the coronavirus in the future. While there is a lot of uncertainty with this new virus, it is also possible that, over time, broad use of antibody tests and clinical follow-up will provide the medical community with more information on whether or not, and how long, a person who has recovered from the virus is at lower risk of infection if they are exposed to the virus again. Samples are typically blood from a finger prick or blood draw. Learn more about antibody tests.
The CovClear™ Rapid Antigen test is a rapid live virus test that can detect the presence of COVID-19 antigens in as few as two days after exposure, and before viral loads become infectious. The CovClear™ Rapid antigen test is simple to use and delivers results in 3-10 minutes.
A: The ImmunoPass™ Neutralizing Antibody (NAb) test demonstrates the ability of antibodies to block the binding of the RBD on spike protein to ACE2, the cellular receptor. RBD is the principle neutralizing determinant for SARS-CoV-2. The ImmunoPass™ Neutralizing Antibody (NAb) test provides semi-quantitative determination of COVID-19 neutralizing antibodies in serum and plasma. The ImmunoPass™ Neutralizing Antibody Test can provide valuable insight into an in individuals immunity to COVID-19.
A: The ImmunoPass™ Neutralizing Antibody (NAb) test results are for the semi-quantitative measurement of antibodies that neutralize the infectivity of SARS CoV-2. Antibodies, including Neutralizing antibodies to SARS-CoV-2, are generally detectable in blood several days after initial infection. The ImmunoPass™ Neutralizing Antibody (NAb) test analyzes the ability of antibodies to prevent RBD from binding to ACE2, thus neutralizing the COVID-19 virus. The test results show the level of antibody neutralization. Results are reported as High, Moderate or Low/No levels of neutralizing antibodies.
A: Currently, the use of the ImmunoPass™ SARS-Cov-2 Neutralizing Antibody Rapid Test is limited to laboratory personnel who have been trained. It is not for home use.
A: Coronavirus disease 2019 (COVID-19) is a respiratory illness that can spread from person to person. CDC has information on COVID-19 symptoms and caring for yourself and others. COVID-19 is a new disease, caused by a novel (or new) coronavirus that has not previously been seen in humans.
A: People with COVID-19 have reported a wide range of symptoms – from mild symptoms to severe illness. Symptoms may appear 2-14 days after exposure to the virus. If you have fever, cough, or other symptoms, you might have COVID-19.
A: On February 11, 2020, the World Health Organization announced an official name for the disease that is causing the 2019 novel coronavirus outbreak, first identified in Wuhan China. The new name of this disease is coronavirus disease 2019, abbreviated as COVID-19. In COVID-19, ‘CO’ stands for ‘corona,’ ‘VI’ for ‘virus,’ and ‘D’ for disease. Formerly, this disease was referred to as “2019 novel coronavirus” or “2019-nCoV”. There are many types of human coronaviruses including some that commonly cause mild upper-respiratory tract illnesses. COVID-19 is a new disease, caused by a novel (or new) coronavirus that has not previously been seen in humans.
A: COVID-19 is thought to spread mainly through close contact from person-to-person. Some people without symptoms may be able to spread the virus. We are still learning about how the virus spreads and the severity of illness it causes. The CDC has additional information on how COVID-19 spreads.
A: Yes, the FDA has authorized two different types of tests (diagnostic and antibody tests) for use during the COVID-19 emergency. Though there are currently no FDA-approved or cleared tests for COVID-19, the FDA has issued over 200 Emergency Use Authorizations (EUAs) for such tests. These EUAs allow the emergency use of tests during the COVID-19 emergency when the FDA determines certain criteria are met. These criteria include that the test may be effective at diagnosing or detecting antibodies to COVID-19 and that the known and potential benefits outweigh the known and potential risks. The CDC provides additional information about COVID-19 tests.
A: A First Generation antibody test indicates the presence of antibodies, but does not indicate the antibodies effectiveness against COVID-19. A Second Generation Neutralizing Antibody (NAb) test, like the ImmunoPass™, shows levels (high, moderate, or low) of neutralizing antibodies. Neutralizing antibodies block and neutralize the COVID-19 virus. A Neutralizing Antibody test can provide insight into one’s COVID-19 immunity.
A: Convalescent refers to anyone recovering from a disease. Plasma is the yellow, liquid part of blood that contains antibodies. Antibodies are proteins made by the body in response to infections. Convalescent plasma from patients who have already recovered from coronavirus disease 2019 (COVID-19) may contain antibodies against COVID-19. The FDA has issued an emergency use authorization for the use of convalescent plasma in hospitalized patients. It is being investigated for the treatment of COVID-19 because there is no approved treatment for this disease. Based on scientific evidence available, the FDA concluded this product may be effective in treating COVID-19 and that the known and potential benefits of the product outweigh the known and potential risks of the product for patients hospitalized with COVID-19. Learn more about donating from this video.
A: COVID-19 convalescent plasma must only be collected from recovered individuals if they are eligible to donate blood. Individuals must have had a prior diagnosis of COVID-19 documented by a laboratory test and meet other laboratory criteria. Individuals must have fully recovered from COVID-19, with complete resolution of symptoms for at least 14 days before donation of convalescent plasma. You can ask your local blood center if there are options to donate convalescent plasma in your area. Learn more about how to donate.