Test Id : COVTA
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Nucleocapsid, Total Antibody, Serum
Useful For
Suggests clinical disorders or settings where the test may be helpful
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
A short description of the method used to perform the test
Chemiluminescence Immunoassay (CIA)
NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.
Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test
Aliases
Lists additional common names for a test, as an aid in searching
Coronavirus
Coronavirus Ab
Coronavirus antibody
COVID-19
COVID-19 Ab
COVID-19 antibody
SARS CoV-2
SARS CoV-2 Ab
SARS CoV-2 antibody
COVTA
Specimen Type
Describes the specimen type validated for testing
Serum
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
Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing
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.
Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.
0.5 mL
Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected
| Gross hemolysis | Reject |
| Gross lipemia | Reject |
| Gross icterus | Reject |
Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum | Refrigerated (preferred) | 14 days | |
| Ambient | 7 days | ||
| Frozen | 28 days |
Useful For
Suggests clinical disorders or settings where the test may be helpful
Aiding in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection
Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
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
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
Negative
Interpretation
Provides information to assist in interpretation of the test results
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
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
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
Clinical Reference
Recommendations for in-depth reading of a clinical nature
1. Zhang W, Du RH, Li B, et al. Molecular and serological investigation of 2019-nCoV infected patients: implication of multiple shedding routes. Emerg Microbes Infect. 2020;9(1):386-389. doi:10.1080/22221751.2020.1729071
2. Okba NMA, Müller MA, Li W, et al. Severe acute respiratory syndrome coronavirus 2-specific antibody responses in coronavirus disease patients. Emerg Infect Dis. 2020;26(7):1478-1488. doi:10.3201/eid2607.200841
3. Guo L, Ren L, Yang S, et al. Profiling early humoral response to diagnose novel coronavirus disease (COVID-19). Clin Infect Dis. 2020;71(15):778-785. doi:10.1093/cid/ciaa310
4. Wolfel R, Corman VM, Guggemos W, et al. Virological assessment of hospitalized patients with COVID-2019. Nature. 2020;581(7809):465-469. doi:10.1038/s41586-020-2196-x
5. Su S, Wong G, Shi W, et al. Epidemiology, genetic recombination, and pathogenesis of coronaviruses. Trends Microbiol. 2016;24(6):490-502. doi:10.1016/j.tim.2016.03.003
6. Zhu N, Zhang D, Wang W, et al. A novel coronavirus from patients with pneumonia in China, 2019. N Engl J Med. 2020;382(8):727-733. doi:10.1056/NEJMoa2001017
7. Liu L, Liu W, Zheng Y, et al. A preliminary study on serological assay for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in 238 admitted hospital patients. Microbes Infect. 2020;22(4-5):206-211. doi:10.1016/j.micinf.2020.05.008
8. Zhang W, Du RH, Li B, et al. Molecular and serological investigation of 2019-nCoV infected patients: implication of multiple shedding routes. Emerg Microbes Infect. 2020;9(1):386-389. doi:10.1080/22221751.2020.1729071
Method Description
Describes how the test is performed and provides a method-specific reference
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)
PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information
Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.
Monday through Friday, Sunday
Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.
Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location
Indicates the location of the laboratory that performs the test
Fees :
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.
- Authorized users can sign in to Test Prices for detailed fee information.
- Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
- Prospective clients should contact their account representative. For assistance, contact Customer Service.
Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.
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
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
CPT codes are provided by the performing laboratory.
CPT codes are provided by the performing laboratory.
86769
LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.
| 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
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
|
|---|---|---|
| COVTI | SARS-CoV-2 Nucleocapsid Total Ab, S | 94762-2 |