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Test ID COVSQ Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Spike Antibody, Semi-Quantitative, Serum


Advisory Information


This test will detect antibodies developed due to prior or current infection and will also likely detect antibodies against spike glycoprotein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) generated following vaccination. This test will not differentiate between the 2 events. The absence of antibodies in this assay does not rule out recent infection.

 

For confirmation of prior infection in the presence of vaccination, order COVTA / Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-Cov-2), Nucleocapsid, Total Antibody, Serum.

 

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

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

For the most up-to-date coronavirus disease 2019 (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


Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Specimen Volume: 1 mL


Useful For

Aiding in the identification of individuals with an adaptive immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), indicating prior infection or vaccination

 

Manufacture of coronavirus disease 2019 (COVID-19) convalescent plasma

Method Name

Electrochemiluminescence Immunoassay (ECLIA) 

Reporting Name

SARS-CoV-2 Spike Ab, Semi-Quant, S

Specimen Type

Serum

Specimen Minimum Volume

0.75 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 7 days
  Frozen  28 days
  Ambient  72 hours

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 semi-quantitative detection of total antibodies (without differentiation between immunoglobulin classes) against the SARS-CoV-2 spike protein, specifically against the receptor binding domain (RBD). Antibodies to SARS-CoV-2 are detectable in over 90% of patients by two weeks after symptom onset or vaccination. While antiviral antibodies remain for at least 3-4 months post-infection, the long-term duration for antibodies continues to be defined. Patients may have detectable virus present for several weeks following seroconversion.

Reference Values

Negative

Interpretation

This assay provides qualitative and semi-quantitative results for the presence of antibodies to the receptor binding domain on the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike glycoprotein. Both vaccine and active infection can stimulate antibodies against this domain.

 

Negative:

No antibodies to SARS-CoV-2 spike glycoprotein detected. Negative results may occur in serum collected too soon following infection or vaccination, in immunosuppressed patients or in patients with mild or asymptomatic infection. This test does not rule out active or recent coronavirus disease 2019 (COVID-19) infection or vaccination. Follow up testing with a molecular test for SARS-CoV-2 is recommended in symptomatic patients.

 

Positive:

Antibodies to the SARS-CoV-2 spike glycoprotein detected. These results suggest recent or prior SARS-CoV-2 infection or vaccination. No minimum antibody level or threshold has been established to indicate long-term protective immunity against re-infection. 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. False-positive results for IgG antibodies may occur due to cross-reactivity from pre-existing antibodies or other possible causes.

 

For the manufacture of COVID-19 convalescent plasma using the Roche Diagnostics anti-SARS-CoV-2 spike electro-chemiluminescence immunoassays (ECLIA), per current FDA Emergency Use Authorization (EUA) guidelines, high-titer cyclic citrullinated peptide (CCP) is defined as plasma units with a semi-quantitative value of 132 U/mL and above (see appendix A: www.fda.gov/media/141477/download).

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
COVSQ SARS-CoV-2 Spike Ab, Semi-Quant, S 94769-7

 

Result ID Test Result Name Result LOINC Value
COVIN SARS-CoV-2 Spike Ab, Interp, S 94762-2
COVQN SARS-CoV-2 Spike Ab, Quant, S 94769-7
SRACE Patient's Race 72826-1
SETHN Patient's Ethnicity 69490-1