Providing qualitative detection of SARS-CoV-2 antibodies against the nucleocapsid protein. Results are positive 10-14 days post-infection in most patients, and negative in uninfected individuals who have received a Health Canada vaccine.
May provide clinical utility in the following contexts:
1. Hospitalized patients with a high index of suspicion and are at least 3 weeks from symptom onset with two negative PCR tests.
2. Suspected Guillain–Barré syndrome or severe neurological illness compatible with COVID-19 with a negative PCR test.
3. Patients suspected to have multisystem inflammatory syndrome in children (MIS-C) or adults (MIS-A) with a negative, indeterminate, or inconclusive PCR test result or who were not tested.
SARS-CoV-2 serology (nucleocapsid) should NOT be used for:
1. The diagnosis of acute infection, reinfection, or determining the infectivity of the patient.
2. Determining immune status of the patient (i.e. protection against future infection).
3. Determining COVID-19 vaccination status of the patient or serological response to vaccination.
4. Treatment decisions for patients who are eligible for monoclonal antibody therapy (note: this requires an anti-spike assay).