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Test 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


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


Secondary ID

622462

Useful For

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

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, 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

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).

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

Day(s) Performed

Monday, Wednesday, Friday