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Test ID COVSQ Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Spike Antibody, Semi-Quantitative, Serum


Ordering Guidance


This test will detect antibodies developed due to prior or current infection and will likely detect antibodies against spike glycoprotein of SARS-CoV-2 generated following vaccination. This test will not differentiate between the 2 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 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

614035

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, 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

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.

Cautions

The sensitivity of Roche Elecsys Anti-SARS-CoV-2 test in early infection is unknown. 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.

 

It is not known at this time if the presence of antibodies to SARS-CoV-2 confers immunity to re-infection.

 

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.

Day(s) Performed

Monday through Saturday

Report Available

1 to 3 days

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

NY State Approved

Yes