SARS-CoV-2 Antibody Profile, Nucleocapsid and Spike

Casandra

Casandra Test Code LC87420Version 1 (DRAFT)

Performing Lab

Lab LabcorpLab Test ID 160236CPT Code 86769

SARS-CoV-2 Antibody Profile, Nucleocapsid and Spike

Also known as: SARS-CoV-2

Clinical Use

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Use

To evaluate for evidence of previous SARS-CoV-2 infection in individuals with a history of COVID-19 vaccination to aide in the diagnosis of Multisystem Inflammatory Syndrome in children (MIS-C) or adults (MIS-A). The presence of antibodies specific to the SARS-CoV-2 viral nucleocapsid protein is consistent with natural infection as currently available COVID-19 vaccines induce antibodies against the viral spike protein receptor binding domain (RBD) only.

Special Instructions

This is an Electrochemiluminescence Immunoassay (ECLIA). Turnaround time is 1 to 3 days from specimen pickup to result release to the ordering provider. Additional time may be required for confirmatory or reflex tests.

Limitations

These tests should not be used to diagnose or exclude acute SARS-CoV-2 infection. Results should be assessed alongside patient's medical history and other clinical findings. Negative results do not rule out the possibility of SARS-CoV-2 infection, especially in pre-seroconversion phases. Some patients may not develop antibodies even after confirmed infection. Antibody titers may wane within months post-infection. The test is authorized under FDA EUA but not cleared or fully approved. It is authorized for detecting antibodies against SARS-CoV-2 only, not for other pathogens.

Test Details