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HelpTest ID COVSQ Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Spike Antibody, Semi-Quantitative, Serum
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
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
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).
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.
Clinical Reference
1. Zhang W, Du RH, Li B, et al: Molecular and serologic investigation of 2019-nCoV infected patients: implication of multiple shedding routes. Emerg Microbes Infect. 2020 Feb 17;9(1):386-389. doi: 10.1080/22221751.2020.1729071
2. Okba N, Muller MA, Li W, et al: Severe acute respiratory syndrome coronavirus 2-specific antibody responses in coronavirus disease 2019 patients. Emerg Infect Dis. 2020 Apr 8;26(7). doi: 10.3201/eid2607.200841
3. Guo L, Ren L, Yang S, et al: Profiling early humoral response to diagnose novel coronavirus disease (COVID-19). Clin Infect Dis. 2020;ciaa310. doi: 10.1093/cid/ciaa310
4. Wolfel R, Corman VM, Guggemos W, et al. Virological assessment of hospitalized patients with COVID-2019. Nature. 2020 May;581(7809):465-469. doi: 10.1038/s41586-020-2196-x
5. Su S, Wong G, Shi W, et al: Epidemiology, genetic recombination, and pathogenesis of coronaviruses. Trends Microbiol. 2016 Jun;24(6):490-502. doi: 10.1016/j.tim.2016.03.003
6. Zhu N, Zhang D, Wang W, et al: A novel coronavirus from patients with pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017
7. Liu L, Liu W, Zheng Y, et al: A preliminary study on serological assay for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in 238 admitted hospital patients. Microbes Infect. 2020 May-Jun;22(4-5):206-211;. doi: 10.1016/j.micinf.2020.05.008
8. Zhang W, Du RH, Li B, et al: Molecular and serologic investigation of 2019-nCoV infected patients: implication of multiple shedding routes. Emerg Microbes Infect. 2020 Feb 17;9(1):386-389. doi: 10.1080/22221751.2020.1729071
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)
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
YesDay(s) Performed
Monday through Saturday