SARS-CoV-2 Semi-Quantitative Total Antibody, Spike

Casandra

Casandra Test Code LC07031Version 1 (DRAFT)

Performing Lab

Lab LabcorpLab Test ID 164090CPT Code 86769

SARS-CoV-2 Semi-Quantitative Total Antibody, Spike

Also known as: SARS-CoV-2 Antibody Titer

Clinical Use

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Use

Qualitative and semi-quantitative detection of antibodies to SARS-CoV-2 spike protein receptor binding domain (RBD). Aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time it is unknown how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The performance of this test has not been established in individuals that have received a COVID-19 vaccine. The clinical significance of a positive or negative antibody result following COVID-19 vaccination has not been established and the result from this test should not be interpreted as an indication or degree of protection from infection after vaccination.

Special Instructions

Not provided.

Limitations

This test is not designed to diagnose or exclude acute SARS-CoV-2 infection. Results should be evaluated alongside the patient's medical history and clinical presentation. A negative result does not rule out SARS-CoV-2 infection, especially during the early phase of infection when seroconversion may not have occurred. Additionally, some patients with confirmed infections may not develop detectable antibodies. Antibody titers may decline over time, as observed with other coronaviruses. This test has only been authorized by the FDA under an Emergency Use Authorization (EUA) for detecting antibodies against SARS-CoV-2.

Test Details