Both PCR and antigen testing are intended to diagnose active COVID-19 infections, using saliva or a nasal swab. While an individual has an active infection, both PCR and antigen test will be positive. Once an individual has recovered, both the PCR and antigen test will be negative. Antibody tests do not detect active infection. Instead, they are designed to detect an immune response to a past exposure to COVID-19. Antibody tests conducted too early following an infection (<7 days) will read negative. Once an individual develops an immune response, the antibody test will read positive.
The United States (U.S.) FDA has made this test available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics (IVDs) for the detection and/or diagnosis of the virus that causesCOVID-19.An IVD made available under an EUA has not undergone the same type of review as an FDA-approved or cleared IVD. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, available alternatives, and based on the totality of scientific evidence available, it is reasonable to believe that this IVD may be effective.The EUA for the test you received is in effect for the duration of the COVID-19 declaration justifying emergency use of IVDs, unless terminated or revoked (after which the test may no longer be used).
The COVID-19 Rapid Antibody Test is designed to detect antibodies that are produced by the body in response to the virus that causes COVID-19. COVID-19 antibodies are proteins which the body produces days or weeks after fighting the infection, and typically indicate an individual has developed an immune response after recovering from the virus, even if a person didn’t exhibit any symptoms of the COVID-19 disease.
A fingerstick is used to collect a small amount of blood from your finger to be tested. The healthcare professional will then apply your blood on the Test, which will show results within 15 minutes.
Your result may indicate that you have contracted COVID-19 and that you may need to quarantine to avoid spreading the virus to other individuals. A positive result may also indicate previous infection that is no longer active. There is also the small chance that this Test provided a false positive result, which could be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E, or such false positive could arise from other factors. The healthcare professional conducting the Test will explain the results to you once the Test is done.
A negative Test result means the antibodies to the virus that causes COVID-19 were not detected in your sample. That could be due to the fact that you were either not infected with COVID-19, or if you are tested too early in your illness, that your body hasn’t had the opportunity to produce antibodies to the infection. A false negative could also arise from other facts involving the Test, the blood sample or the testing procedures. This false negative result means that you could possibly still have contracted COVID-19 even though the Test result is negative.
These tests dectect the presence of immunoglobin G (IgG) and M (IgM) antibodies.
This test can quickly show if a person developed antibodies following a Corona virus infection with COVID-19.
The test for Covid-19 (Sars-CoV-2) is based on the principle of antigen-antibody reaction and immunoassay technique.
Antibodies are produced after the invasion of the virus. Immunoglobulin M (IgM) comes first, acting on the first signs of infection. Immunoglobulin G (IgG) comes later, with a stronger and specific reaction to the virus.
Please read the product insert included with the test kit carefully for details on how to collect the sample and administer the test correctly.
Click Here for more information on the CDC’s guidlines for collecting, handling, and testing clinical specimens.
These tests will detect if there has been an adaptive immune response to COVID-19 indicating recent or prior infection.
These tests are designed for use by Medical Healthcare professionals only. Give us a call.