SARS CoV-2 Nucleocapsid, Total Antibody, Serum

Label Mnemonic: COVIDT
Epic code: LAB9602
Commercial Mailout Laboratory
6240-8 RCP
356-8593
Specimen(s):
Plasma
Collection Medium:
BD Gold SST 5 mL Vacutainer
Minimum:

1.5 mL serum

Testing Schedule:

Monday, Wednesday, Friday

Turn Around Time:

1–4 days upon receipt at performing laboratory

Reference Range:

Negative

Interpretive Data:

Negative:


No antibodies to SARS-CoV-2 detected. Negative results may occur in serum collected too soon following infection, in patients who are immunosuppressed, or in patients with mild or asymptomatic infection. This test does not rule out active or recent COVID-19 infection and will not detect SARS-CoV-2 vaccine-induced antibodies. Follow-up testing with a molecular test is recommended in symptomatic patients.


Positive:


Severe acute respiratory syndrome coronavirus 2 antibodies to the nucleocapsid protein detected. Results suggest recent or prior infection with SARS-CoV-2. Serologic results should not be used to diagnose recent SARS-CoV-2 infection.

Test Limitations:

Negative results do not preclude SARS-CoV-2 infections. If an acute infection is suspected, direct testing for SARS-CoV-2 virus is necessary. See Ordering Guidance.


This test detects total antibodies against the SARS-CoV-2 nucleocapsid protein. All current SARS-CoV-2 vaccines induce antibodies to the spike glycoprotein only. Therefore, this assay will not detect SARS-CoV-2 vaccine induced anti-spike glycoprotein antibodies and cannot be used to measure vaccine response.


False-positive results for Roche Anti-SARS-CoV-2 IgG test may occur due to cross-reactivity from pre-existing antibodies or other possible causes.


Serum biotin concentrations up to 1200 ng/mL do not interfere with this assay. Extremely high concentrations of biotin in patient serum due to heavy administration or supplementation of biotin may falsely depress anti-SARS-CoV-2 antibody detection.


Performance characteristics have not been established for the following specimen characteristics:

  • Potential endogenous interferences, eg, hemolysis, bilirubin, rheumatoid factors, and pharmaceutical compounds other than biotin, have not been tested, and therefore, interference cannot be excluded
  • Containing particulate matter
  • Cadaveric specimens
Methodology:

Electrochemiluminescence immunoassay

CPT Code:
86769