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HelpEpic Test Code LAB2020 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Spike Antibody, Semi-Quantitative, Serum
Additional Codes
MML:COVSQ
LAB USE Only: LAB1860
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, SSpecimen Type
SerumSpecimen Minimum Volume
0.75 mL
Specimen Stability Information
| Specimen Type | Temperature | Time |
|---|---|---|
| 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, and 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 and can remain detectable for months to years following resolution of infection and after repeat vaccination.
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).
Cautions
Negative results do not preclude 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.
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.
In rare cases, some individuals can develop antibodies to mouse or other animal antibodies (often referred to as human antimouse antibodies [HAMA] or heterophile antibodies), which may cause interference in some immunoassays. The presence of antibodies to streptavidin or ruthenium rarely occur and may also interfere with this assay. Caution should be used in interpretation of results, and the laboratory should be alerted if the result does not correlate with the clinical presentation.
Specimen Retention Time
14 daysPerforming Laboratory
Mayo Clinic Laboratories in Rochester
CPT Code Information
86769
NY State Approved
YesDay(s) Performed
Monday, Wednesday, Friday