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HelpTest Code COVSQ Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Spike Antibody, Semi-Quantitative, Serum
Ordering Guidance
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 COVOO / Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) RNA 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
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
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
Manufacture of COVID-19 convalescent plasma
Method Name
Electrochemiluminescence Immunoassay (ECLIA)
Reporting Name
SARS-CoV-2 Spike Ab, Semi-Quant, SSpecimen Type
SerumSpecimen Minimum Volume
0.75 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| 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 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 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. Antibody levels greater than or equal to 0.80 U/mL are considered positive by this assay. No minimum antibody level or threshold has been established to indicate long-term protective immunity against re-infection. 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, 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 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 Jun;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 Feb 20;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 May-Jun;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 Feb 17;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 |
| SRACE | Patient's Race | 72826-1 |
| SETHN | Patient's Ethnicity | 69490-1 |
Day(s) Performed
Monday through Saturday