COVID-19 Antibody TestDetect COVID-19 antibodies from a previous infection or vaccination. Read more
Antibodies are proteins that the body produces in response to an infection or vaccine. There are 2 types of COVID-19 antibody tests: a spike protein test and a nucleocapsid test.
This COVID-19 Antibody Test is a spike protein test which can detect antibodies from a prior or recent infection, regardless of whether symptoms were present. Positive results may also occur after a COVID-19 vaccination, but the clinical significance is not yet known. A nucleocapsid test can only detect antibodies from a prior or recent infection.
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- The Quest Diagnostics molecular test and other authorized molecular tests (together the “molecular tests”) have not been FDA cleared or approved
- The molecular tests have been authorized by FDA under an EUA for use by authorized laboratories
- The molecular tests have been authorized only for the detection of nucleic acid from SARSCoV-2, not for any other viruses or pathogens an,
- The molecular tests are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner
The IgG and IgM antibody tests are intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Results are for the detection of SARS CoV-2 antibodies. IgG and IgM 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. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. Individuals may have detectable virus present for several weeks following seroconversion. Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, molecular testing for SARSCoV-2 is necessary. The tests should not be used to diagnose acute SARS-CoV-2 infection. False positive results for the test may occur due to cross-reactivity from pre-existing antibodies or other possible causes. The sensitivity of the IgM test early after infection is unknown. Due to the risk of false positive results, confirmation of positive results should be considered using a second, different IgM assay or an IgG assay. Samples should only be tested for IgM from individuals with 15 days to 30 days post symptom onset. SARS-CoV-2 antibody negative samples collected 15 days or more post symptom onset should be reflexed to a test that detects and reports SARS-CoV-2 IgG.