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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:
-COVOO / Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) RNA Detection, Varies
-CVOOA / Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) RNA 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
1. Patient's race and ethnicity, as well as collection date, are required.
2. If ordering electronically, answers must be provided for the order entry questions.
3. If not ordering electronically, patient race and ethnicity must be provided on the request form.
Specimen Required
Collection Container/Tube:
Preferred: Serum gel
Acceptable: Red top
Submission Container/Tube: Plastic vial
Specimen Volume: 0.6 mL
Collection Instructions: Centrifuge and aliquot serum within 2 hours of collection.
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 | Special Container |
|---|---|---|---|
| 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).
Results are for the detection of SARS-CoV-2 antibodies. Antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection; although the duration of time antibodies are present postinfection is not well characterized. Patients may have detectable virus present for several weeks following seroconversion.
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 and will not detect SARS-CoV-2 vaccine-induced antibodies. Follow-up testing with a molecular test is recommended in symptomatic patients.
Positive:
SARS-CoV-2 antibodies to the nucleocapsid protein detected. Results suggest recent or prior infection with SARS-CoV-2. Correlation with epidemiologic risk factors and other clinical and laboratory findings is recommended. Serologic results should not be used to diagnose recent SARS-CoV-2 infection. Protective immunity cannot be inferred based on these results alone. False-positive results may occur due to cross-reactivity from pre-existing antibodies or other possible causes.
Cautions
The sensitivity of Roche Elecsys Anti-SARS-CoV-2 test in early infection is unknown. 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
7 daysPerforming Laboratory
Mayo Clinic Laboratories in Rochester
CPT Code Information
86769
NY State Approved
YesDay(s) Performed
Monday through Sunday