Additional Information

SARS-CoV-2 Total Spike Antibody – This test will detect antibodies developed due to prior or current infection and will also likely detect antibodies against spike glycoprotein of SARS-CoV-2 generated following vaccination. This test will not differentiate between the 2 events. The absence of antibodies in this assay does not rule out recent infection.
SARS-CoV-2 Total Nucleocapsid Antibody – This test provides qualitative detection of serum antibodies against the nucleocapsid protein of SARS-CoV-2 indicating recent or prior infection. This test will not yield a positive result following vaccination against SARS-CoV-2.
https://www.fda.gov/media/144036/download https://www.fda.gov/media/148561/download

Serology Test Results:

Negative or Non-Reactive Test results:
• A Negative or Non-Reactive result indicates there are no detectable antibodies to SARS-CoV-2.
• Negative Antibody results do not rule out current or recent SARS-CoV-2 infection. If SARS-CoV-2 infection is suspected follow up with Molecular PCR testing for Covid-19.
• False-negative Antibody results may occur in serum collected too soon after symptom onset or exposure. Typically, the majority of patients seroconvert within 1 to 3 weeks.
• Over time, antibody titers may decline and eventually become negative.
• A negative result may be found in patients with a depressed immune response including the elderly, immunocompromised or immunosuppressed patient.

Equivocal Results:
• Equivocal results should only be interpreted as initial evidence for detection of antibodies to SARS-CoV-2. Additional testing is recommended for equivocal test results. Serological evidence is best obtained by testing of paired acute and convalescent phase samples obtained several weeks apart.

Positive or Reactive Test Results:
• A Positive or Reactive result indicates that antibodies were detected to SARS-CoV-2.
• A Positive or Reactive results indicates likely past exposure or past infection by SARS-CoV-2.
• Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
• Protective immunity cannot be inferred based on these results alone.
• The duration and relative amount of antibodies remaining in the blood following COVID-19 is unknown.
• Positive Serological results should not be used to diagnose recent SARS-CoV-2 Infection; If SARS-CoV-2 infection or recent exposure is suspected follow up with Molecular PCR testing for Covid-19.