Test Catalog

Test Id : COVSQ

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

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

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
A short description of the method used to perform the test

Electrochemiluminescence Immunoassay (ECLIA)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

SARS-CoV-2 Spike Ab, Semi-Quant, S

Aliases
Lists additional common names for a test, as an aid in searching

Coronavirus

Coronavirus Ab

Coronavirus antibody

COVID-19 Ab

COVID-19

COVID-19 antibody

SARS CoV-2 Ab

SARS CoV-2

SARS CoV-2 antibody

COVID

Specimen Type
Describes the specimen type validated for testing

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.

ORDER QUESTIONS AND ANSWERS

Question ID Description Answers
SRACE Patient's Race American Indian or Alaska Native
Asian
Black or African American
Native Hawaiian/Other Pacific Islander
White
Other Race
Refused to Answer
Unknown
SETHN Patient's Ethnicity Hispanic or Latino
Not Hispanic or Latino
Not Obtainable
Refused
Asked but Unknown
Unknown

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

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 Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.75 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis Reject
Gross lipemia OK
Gross icterus OK

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 14 days
Frozen 28 days
Ambient 72 hours

Useful For
Suggests clinical disorders or settings where the test may be helpful

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

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

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.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

An interpretative report will be provided.

Interpretation
Provides information to assist in interpretation of the test results

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
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

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
Recommendations for in-depth reading of a clinical nature

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
Describes how the test is performed and provides a method-specific reference

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)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Saturday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

1 to 3 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

3 Months

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their account representative. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

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
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

86769

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

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
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
SRACE Patient's Race 72826-1
SETHN Patient's Ethnicity 69490-1
COVIN SARS-CoV-2 Spike Ab, Interp, S 94661-6
COVQN SARS-CoV-2 Spike Ab, Quant, S 94769-7

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

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Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports