The antibody test (also known as the Covid-19 Serology Total tests) will help find out if you have antibodies to the virus that causes COVID-19.
COVID-19 Total Antibody Serology Test or SARS-CoV-2 total antibody assay using the Roche COBAS Electrochemiluminescence Immunoassay (ECLIA) method. The immunoassay is designed to detect IgG, IgA, and IgM antibodies to the recombinant nucleocapsid protein of SARS-CoV-2 in serum intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.
COVID-19 symptoms include fever, cough, and shortness of breath, but other symptoms may be present as well. Trouble breathing is a more serious symptom that means you should get medical attention.
If you have any symptoms mentioned above, please do not go to a CPL Patient Service Center for COVID-19 testing and follow the CDC guidelines.
Call 911 if you have a medical emergency: Notify the operator that you have, or think you might have, COVID-19. If possible, put on a cloth face covering before medical help arrives.
For additional information, please visit the CDC website or use the like below.
The antibody tests and the molecular tests (together “All tests”) have not been FDA cleared or approved
All tests have been authorized by FDA under EUAs for use by authorized laboratories
The antibody tests have been authorized only for the detection of IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens
The molecular tests have been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens and All tests are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for the detection and/or diagnosis of COVID-19 under Section
APPROVED BY FDA AND PART OF CDC SURVEILLANCE STRATEGY, CDC has a strategy for using antibody testing as part of surveillance efforts to better understand how much of the U.S. population has been infected with SARS-CoV-2 and how the virus is spreading through the population over time.
To detect antibodies to SARS-CoV-2 that indicate whether you have been infected with the virus; to help track the pandemic.
These antibody tests are designed to provide results to individuals or healthcare providers and determine whether you were previously infected with SARS-CoV-2. On the other hand, these tests have limitations. Specificity (doesn’t detect non-target viruses) and sensitivity (true positive rate) of antibody tests vary.
Antibody test results are not to be used as the only source to diagnose someone with an active SARS-CoV-2 infection. It usually takes one to three weeks after someone becomes infected with SARS-CoV-2 for their body to develop antibodies; some people may take longer to develop antibodies. Depending on when someone was infected and the timing of the test, the test may not find antibodies in someone with an active infection.
Antibody test: When you previously had or suspected you had COVID-19.
CDC’s serologic test is intended to detect antibodies produced in response to SARS-CoV-2 and to avoid the detection of antibodies against other common coronaviruses that cause less severe illnesses, such as colds.
