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HelpTest Code Billings Clinic: 0313 Mayo: COVSQ Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Spike Antibody, Semi-Quantitative, Serum
Reporting Name
SARS-CoV-2 Spike Ab, Semi-Quant, SPerforming Laboratory
Mayo Clinic Laboratories in Rochester
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)
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
Specimen 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 |
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).
Day(s) Performed
Monday, Wednesday, Friday
Report Available
1 to 3 daysTest 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 |