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HelpEpic Test Code LAB2020 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Nucleocapsid, Total Antibody, Serum
Additional Codes
MML:COVTA
LAB Use Only: LAB1861
Ordering Guidance
Molecular testing is recommended for diagnosis of COVID-19 in symptomatic patients. For more information, see HPCOV / Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Molecular Detection, Varies
For the most up to date COVID-19 epidemiology and testing recommendations, visit www.cdc.gov/coronavirus/2019-ncov/index.html
Necessary Information
Specimen Required
Supplies: Sarstedt Aliquot Tube, 5 mL (T914)
Collection Container/Tube:
Preferred: Serum gel
Acceptable: Red top
Submission Container/Tube: Plastic vial
Specimen Volume: 0.6 mL
Collection Instructions: Within 2 hours of collection, centrifuge and aliquot serum into a plastic vial.
Useful For
Aiding in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection
Method Name
Chemiluminescence Immunoassay (CIA)
Reporting Name
SARS-CoV-2 Nucleocapsid Total Ab, SSpecimen Type
SerumSpecimen Minimum Volume
0.5 mL
Specimen Stability Information
| Specimen Type | Temperature | Time |
|---|---|---|
| Serum | Refrigerated (preferred) | 14 days |
| Frozen | 28 days | |
| Ambient | 7 days |
Reject Due To
| Gross hemolysis | Reject |
| Gross lipemia | Reject |
| Gross icterus | Reject |
Clinical Information
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is an enveloped, single-stranded RNA virus of the family Coronaviridae, genus Betacoronavirus. All coronaviruses share similarities in the organization and expression of their genome, which encodes 16 nonstructural proteins and the 4 structural proteins: spike (S), envelope (E), membrane (M), and nucleocapsid (N).
Detection of antibodies against the SARS-CoV-2 nucleocapsid indicates recent or prior infection with the virus. This assay will not detect an immune response to SARS-CoV-2 vaccination as the N antigen is not in current vaccine preparations.
Reference Values
Negative
Interpretation
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.
Cautions
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
Specimen Retention Time
14 daysPerforming Laboratory
Mayo Clinic Laboratories in Rochester
CPT Code Information
86769
NY State Approved
YesDay(s) Performed
Monday, Wednesday, Friday