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HelpTest Code COVSQ; SQ: COVAB Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Spike Antibody, Semi-Quantitative, Serum
Additional Codes
Sunquest test code is COVAB
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
Secondary ID
614035Useful 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
Highlights
This test provides semi-quantitative detection of serum antibodies against the spike glycoprotein of the SARS-CoV-2, the causative agent of COVID-19.
This test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating prior infection and/or vaccination.
Fact sheets for this emergency use authorization assay can be found at the following links:
For healthcare providers: www.fda.gov/media/144035/download
For patients: www.fda.gov/media/144036/download
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 |
Reject Due To
| Gross hemolysis | Reject |
| Gross lipemia | OK |
| Gross icterus | OK |
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 semiquantitative detection of total antibodies (without differentiation between immunoglobulin classes) against the SARS-CoV-2 spike protein, specifically against the receptor binding domain). Antibodies to SARS-CoV-2 are detectable in over 90% of patients by 2 weeks after symptom onset or vaccination. While antiviral antibodies remain for at least 3 to 4 months postinfection, the long-term duration for antibodies continues to be defined. Patients may have detectable virus present for several weeks following seroconversion.
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).
Method Description
Testing is performed on a Roche cobas e801. The Roche Elecsys Anti-SARS-CoV-2 S assay uses a double-antigen sandwich principle. This assay predominantly detects anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) IgG but anti-SARS-CoV-2 IgA and IgM as well. Patient specimen is added to biotinylated SARS-CoV-2 S-receptor binding domain (RBD)-specific recombinant antigen and SARS-CoV-2 S-RBD-specific recombinant antigen labeled with a ruthenium complex to form a sandwich complex. After addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin. This reaction mixture is aspirated into the measuring cell where the bound microparticles are magnetically captured onto the surface of the electrode, and unbound substances are removed. Voltage is applied to the electrode inducing a chemiluminescent emission, which is then measured against a calibration curve to determine the amount of SARS-CoV-2 S antibody in the patient specimen.(Package insert: cobas Elecsys Anti-SARS-CoV-2 S Antibody. Roche Diagnostics; V 1.0 English, 12/2020)
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