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HelpTest Code COVTA Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Nucleocapsid, Total Antibody, Serum
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.
Secondary ID
609709Useful For
Aiding in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection
Highlights
This test provides qualitative detection of serum antibodies against the nucleocapsid protein of SARS-CoV-2, the causative agent of COVID-19.
This test will not yield a positive result following vaccination against SARS-CoV-2.
This test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.
Fact sheets for this emergency use authorization assay can be found at the following links:
For healthcare providers: www.fda.gov/media/137603/download
For patients: www.fda.gov/media/137604/download
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.
Method Description
The Roche Elecsys anti-SARS-CoV-2 assay uses a recombinant protein representing the nucleocapsid (N) antigen for the determination of antibodies against SARS-CoV-2. In the first incubation the sample, biotinylated SARS-CoV-2-specific recombinant antigen and SARS-CoV-2-specific recombinant antigen labeled with a ruthenium complex form a sandwich complex. During the second incubation, after addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin. The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed. Application of a voltage to the electrode induces chemiluminescent emission, which is measured by a photomultiplier. Results are determined automatically by the software by comparing the electrochemiluminescence signal obtained from the reaction product of the sample with the signal of the cutoff value previously obtained by calibration.(Package insert: Elecsys Anti-SARS-CoV-2. Roche Diagnostics; v 4.0. 08/2020)
Performing Laboratory
Mayo Clinic Laboratories in Rochester
Test Classification
This test has received Emergency Use Authorization (EUA) by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.CPT Code Information
86769
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| COVTA | SARS-CoV-2 Nucleocapsid Total Ab, S | 94762-2 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| COVTI | SARS-CoV-2 Nucleocapsid Total Ab, S | 94762-2 |
| SRACE | Patient's Race | 72826-1 |
| SETHN | Patient's Ethnicity | 69490-1 |
Day(s) Performed
Monday through Sunday