Serology antibody tests determine whether a person has recently had a COVID-19 infection. These tests should not be used to determine immunity status. Results availalbe 48 to 72 hours after sample arrival at the laboratory.
Assays: DiaSorin IgM and IgG, Beckman Coulter IgG, Siemens and DIaSorin IgM, IgG and Total*
*These tests are only for use under the Food and Drug Administration's Emergency Use Authorization. This laboratory-developed test has been validated in accordance with CLIA and FDA's Guidance Document (Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff Document). This test service has not been FDA cleared or approved.
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Antibody testing is done with blood samples because we look for evidence of the body's immune response to the virus. After your body is exposed to a foreign pathogen, your white blood cells make antibodies to neutralize it. When an antibody test comes back positive for COVID-19 it means that you were exposed to SARS-CoV-2 at some point in the past, and your immune system was robust enough to launch an antibody-forming immune response.
You will have the opportunity to speak with a licensed physician to discuss your test results.
The antibody test will tell us if a person currently has or had a COVID-19 (SARS-CoV-2) infection, unlike a throat or nasal swab-based test that looks for virus indicating only an active infection.
Typically, Immunoglobulin G (IgG) is the most abundant antibody to be produced our immune system’s in response to an infection and is maintained in the body after initial exposure for long-term immune response. Immunoglobulin M (IgM) is the first antibody to be produced by our immune system in response to an infection and is primarily detected during the early stages of infection. While, these are the typical responses to most viruses, the body may not respond to COVID-19 this way.
Together, the presence of these two antibodies in a person's blood is indicative of a COVID-19 infection within the past ~3-40 days. Note this test is only for qualitative detection and should not be the sole basis for clinical diagnosis and treatment or used in place of FDA-authorized molecular viral tests.
These assay are intended for use as an aid in identifying individuals with an adaptive immune response to SARS‑CoV‑2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. These assays should not be used to diagnose acute SARS‑CoV‑2 infection. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 U.S.C 263a, that meet requirements to perform moderate or high complexity tests.
Results are for the detection IgM, IgG, and total antibodies. Antibodies to SARS‑CoV‑2 are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post‑infection is not well characterized. Individuals may have detectable virus present for several weeks following seroconversion. Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities. The sensitivity of these assays early after infection is unknown. Negative results do not preclude acute SARS‑CoV‑2 infection. If acute infection is suspected, direct testing for SARS‑CoV‑2 is necessary. False positive results may occur due to cross-reactivity from pre-existing antibodies or other possible causes. These assays are only for use under the Food and Drug Administration’s Emergency Use Authorization.