Serology (blood) tests detect antibodies to certain foreign substances in a person’s body. This test looks for the specific antibodies for the SARS CoV2 virus that is known to cause COVID-19 disease by using SARS-COV2 antigen coated particles. Antibody tests are an effective way to evaluate immunity. In this case, it can detect immunity to COVID-19 disease.
Because our knowledge of COVID-9 immunity is still evolving, the following recommendations are conservative estimates for patient behavior after testing and are modeled after SARS-CoV comparison research and H1N1 Antibody distributions. These diseases were used for modeling due to similar pathogenesis and persistent antibodies/immunity status for several years after exposure or vaccination. They are not a guarantee of immunity and these behavioral concepts are only examples, for informational purposes only. These results do not replace an evaluation from a qualified Physician.
* Please note that all antibody tests should be performed on completely asymptomatic individuals – conservatively at least seven days since last symptom or if never symptomatic. If test is performed earlier than that, the clinical reliability may be compromised. It is best to be at least 7 days since the last symptom or never symptomatic.
The test is being run by or under the supervision of California licensed Clinical Lab Scientists under Cytogen Laboratory’s high complexity CLIA certification and accreditation under COLA. The test has been fast tracked under the Emergency Authorization Use (EAU) and is believed to be a valid way to detect potential immunity. CMS direction states all serology tests with or without an EUA be run by a moderate or high complexity medical laboratory.
The test methodology is for detection of antibodies that reflect immunity only. It is not to be used as the sole criteria for the diagnosis of SARS-CoV2. Negative results do not rule out SARS-CoV2 infection, especially those who have been exposed to the virus. Follow-up testing with a molecular method should be considered to rule out infection in those individuals.
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The COVID-19 antibody test is an effective way to evaluate immunity to COVID-19. It does NOT diagnose COVID-19. While the COVID-19 RNA Viral Test will determine the presence of the virus, the COVID-19 Antibody Test only detects the presence of viral exposure and shows immunity. As such, it can be an identifier test, as well as, a return to duty test to clear sick workers. If a person has immunity, he/she is safe from getting or spreading the virus. They have protection.
The COVID-19 Antibody Test should be performed on individuals with no symptoms at all-conservatively, at least seven days since last symptom or never symptomatic. If the test is performed earlier than that, the clinical reliability may be compromised.
This test is considered a point of care test (POCT) and is administered through a simple finger prick. Results for the COVID-19 Antibody Test only takes about 15 minutes.
Positive or Negative IgG/IgM results can indicate recent or past infection and potential immunity, giving you or your employer information about how safe it is for you to return to work. It also aides the Centers for Disease Control in determining societal immunity
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