COVID-19 spike antibody test: Roche Elecsys Anti-SARS-CoV-2-S

Introducing a new test for the quantitative determination of antibodies against the SARS-CoV-2 spike protein – Roche Elecsys® Anti-SARS-CoV-2 S.

This blood test enables the determination of both the presence and level of antibodies to the SARS-CoV-2 spike protein, which is the target of many COVID-19 vaccines,.  It can can signal whether a person has already been infected and has potentially developed immunity to the virus., and plays an important part in characterising a vaccine-induced immune response.

If an individual has been infected with SARS-CoV-2 they may have detectable antibodies to both the Nucleocapsid (N) and the Receptor Binding Domain (RBD) Spike antigens. Baseline antibody tests for both N and RBD antigens are therefore helpful to identify patients who have been previously infected with SARS-CoV-2.

If an individual has been vaccinated against SARS-CoV-2, with no history of natural infection, the antibodies they develop are to the RBD Spike antigen. As  this test targets antibodies against the spike protein, the levels of these antibodies could play a role in establishing vaccine efficacy and vaccine-induced immune response.

Structure of the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2).
Source:  https://diagnostics.roche.com/global/en/products/params/elecsys-anti-sars-cov-2.html

 Roche Elecsys
Anti-SARS-CoV-2 S
(SPIKE) NEWRoche Elecsys
Anti-SARS-CoV-2
(Total Antibody)Abbott
Anti-SARS-CoV-2
(IgG)PlatformRoche e801Roche e801Abbott ArchitectAssay typeElectrochemiluminescence immunoassay (ECLIA)Electrochemiluminescence immunoassay (ECLIA)Electrochemiluminescence immunoassay (ECLIA)Reporting formatQUANTITATIVEQualitativeQualitativeReporting rangesPositive with value reported in U/ml / NegativePositive / NegativePositive / NegativeAntigen usedReceptor binding domain (RBD) of Spike antigenNucleocapsidNucleocapsidAnalyte targetSARS-CoV-2 AntibodiesSARS-CoV-2 Antibodies (IgG/IgM) Total AntibodySARS-CoV-2 Antibodies (IgG)Sample type verifiedSerum – Venous or Capillary self-collectionSerum – Venous or Capillary self-collectionSerum – VenousSensitivity99.98%97.4%99.1%Specificity98.8% in samples taken 14 days or later after positive PCR100%100%Seasonal Corona
Virus panel24/24 Negative26/26 Negative26/26 Negative

Example reports

Sample typeRoche Elecys Anti-SARS-CoV-2 SSerum: Venous/Capillary self-collection
(Release date for self-collection
to be confirmed)Roche Elecys Anti-SARS-CoV-2 IgG/IgM Total AntibodySerum: Venous/Capillary self-collectionAbbott Anti-SARS-CoV-2 IgGSerum: Venous

Reporting formatRoche Elecys Anti-SARS-CoV-2 SQUANTITATIVERoche Elecys Anti-SARS-CoV-2 IgG/IgM Total AntibodyQualitativeAbbott Anti-SARS-CoV-2 IgGQualitative

Antigen usedRoche Elecys Anti-SARS-CoV-2 SRBC of SPIKE AntigenRoche Elecys Anti-SARS-CoV-2 IgG/IgM Total AntibodyNucleocapsidAbbott Anti-SARS-CoV-2 IgGNucleocapsid

Sample stabilityRoche Elecys Anti-SARS-CoV-2 S7 daysRoche Elecys Anti-SARS-CoV-2 IgG/IgM Total Antibody7 daysAbbott Anti-SARS-CoV-2 IgG7 days

Please note:

• Antibody tests cannot diagnose acute infection.
• Not everyone will develop an antibody response to COVID infection or vaccine.
• Timing of seroconversion following vaccine ≥ 14 days.
• Results from different manufacturers of commercial assays should not be compared