TEST CATALOG ORDERING & RESULTS SPECIMEN HANDLING CUSTOMER SERVICE EDUCATION & INSIGHTS
Test Catalog

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

Useful For Suggests clinical disorders or settings where the test may be helpful

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

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).

 

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 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

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).

Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

The sensitivity of Roche Elecsys Anti-SARS-CoV-2 test in early infection is unknown. Negative results do not preclude severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections. If an acute infection is suspected, direct testing for SARS-CoV-2 virus is necessary.

 

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.

 

It is not known at this time if the presence of antibodies to SARS-CoV-2 confers immunity to re-infection.

 

In rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.

 

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.

Clinical Reference Recommendations for in-depth reading of a clinical nature

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