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- COVID-19 Spike Antibody Test
COVID-19 Spike Antibody Test
This test requires a blood draw. You DO NOT need to be fasting. LabCorp is contracted to draw the sample at no extra cost to you. Please present your printed Lab Order at your LabCorp visit.
Once you order this test, you will receive the lab order via email within 24 hours. You will receive the results in an encrypted email within 72 hours of the blood draw.
SARS-COV-2 Semi-Quantitative Total Antibody to Spike Protein
- Spike Protein Antibody Testing measures the presence and amount of antibodies made against either virus exposure or mRNA vaccination. The antibodies are generally present within 10-18 days of symptom onset and 14-21 days of viral infection and can remain positive for many months. Antibody levels generally become positive 2-3 weeks after vaccination except in immuno-compromised patients.
On May 19, 2021, the FDA issued a safety communication reiterating that "antibody testing should not be used to evaluate a person's level of immunity or protection from COVID-19 at any time, and especially after the person received a COVID-19 vaccination." Visit http://www.fda.gov/medical-devices/safety-communications/antibody-testing-not-currently-recommended-assess-immunity-after-covid-19-vaccination-fda-safety for more information.
This test should not be used to diagnose or exclude acute SARS-CoV-2 infection. The results should always be assessed in conjunction with patient's medical history, clinical presentation, and other findings. A negative test result does not rule out the possibility of an infection with SARS-CoV-2. Serum or plasma samples from the very early (pre-seroconversion) phase can yield negative findings. Therefore, this test cannot be used to diagnose an acute infection. It has also been reported that certain patients with confirmed infection do not develop SARS-CoV-2 antibodies. Furthermore, waning of antibody titers has been reported in some individuals within a range of months after infection, a feature which has also been reported for other coronaviruses.
This test has not been FDA cleared or approved. This test has been authorized by FDA under an Emergency Use Authorization (EUA). This test is 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. This test has been authorized only for detecting the presence of antibodies against SARS-CoV-2, not for any other viruses or pathogens.