Sign in →

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


Ordering Guidance


This test will detect antibodies developed due to prior or current infection and will detect antibodies against the spike glycoprotein of SARS-CoV-2 generated following vaccination. This test will not differentiate between the two 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 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 coronavirus disease 2019 (COVID-19) epidemiology and testing recommendations, visit www.cdc.gov/coronavirus/2019-ncov/index.html.



Necessary Information


 



Specimen Required


Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions: Centrifuge and aliquot serum into a plastic vial


Useful For

Aiding in the identification of individuals with an adaptive immune response to SARS-CoV-2, indicating prior infection or vaccination

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
Serum Refrigerated (preferred) 14 days
  Frozen  28 days
  Ambient  72 hours

Interpretation

This assay provides qualitative and semi-quantitative results for the presence of antibodies to the receptor binding domain on the SARS-CoV-2 spike glycoprotein. Both vaccine and recent 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 COVID-19 infection. 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. Results suggest recent or prior SARS-CoV-2 infection or vaccination. Serologic results should not be used to diagnose recent SARS-CoV-2 infection as antibodies remain detectable for months to years after infection/vaccination.

 

For the manufacture of COVID-19 convalescent plasma using the Roche Diagnostics anti-SARS-CoV-2 spike electro-chemiluminescence immunoassays, per current US Food and Drug Administration Emergency Use Authorization guidelines, high-titer convalescent plasma 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;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;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;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 serologic 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

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
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 94661-6
COVQN SARS-CoV-2 Spike Ab, Quant, S 94769-7

Day(s) Performed

Monday, Wednesday, Friday

Report Available

1 to 3 days