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Test ID COVTA Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Nucleocapsid, Total Antibody, Serum


Advisory Information


Molecular testing is recommended for diagnosis of coronavirus disease 2019 (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

-RSARS / Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2), Molecular Detection, Rapid, Varies

-SCOV2 / 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


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


Patient Preparation: For 12 hours before specimen collection do not take multivitamins or dietary supplements containing biotin (vitamin B7), which is commonly found in hair, skin, and nail supplements and multivitamins.

Container/Tube:

Preferred: Serum gel

Acceptable: Red top

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 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), indicating recent or prior infection

Method Name

Chemiluminescence Immunoassay (CIA)

Reporting Name

SARS-CoV-2 Nucleocapsid Total Ab, S

Specimen Type

Serum

Specimen Minimum Volume

0.5 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 7 days
  Frozen  28 days
  Ambient  7 days

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 severe acute respiratory syndrome coronavirus 2 (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 coronavirus disease 2019 (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.

Clinical Reference

1. Zhang W, Du RH, Li B, et al: Molecular and serologic investigation of 2019-nCoV infected patients: implication of multiple shedding routes. Emerg Microbes Infect. 2020 Feb 17;9(1):386-389. doi: 10.1080/22221751.2020.1729071

2. Okba N, Muller MA, Li W, et al: Severe acute respiratory syndrome coronavirus 2-specific antibody responses in coronavirus disease 2019 patients. Emerg Infect Dis. 2020 Apr 8;26(7). 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;ciaa310. doi: 10.1093/cid/ciaa310

4. Wolfel R, Corman VM, Guggemos W, et al. Virological assessment of hospitalized patients with COVID-2019. Nature. 2020 May;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;S1286-4579(20)30086-1. doi: 10.1016/j.micinf.2020.05.008

8. Zhang W, Du RH, Li B, et al: Molecular and serologic investigation of 2019-nCoV infected patients: implication of multiple shedding routes. Emerg Microbes Infect. 2020 Feb 17;9(1):386-389. doi: 10.1080/22221751.2020.1729071

Test Classification

This test has received Emergency Use Authorization (EUA) by the U.S. 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