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

Wednesday, 27 January 2021

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 SARS-CoV-2 © Roche

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) NEW

Roche Elecsys
Anti-SARS-CoV-2
(Total Antibody)

Abbott
Anti-SARS-CoV-2
(IgG)

Platform

Roche e801

Roche e801

Abbott Architect

Assay type

Electrochemiluminescence immunoassay (ECLIA)

Electrochemiluminescence immunoassay (ECLIA)

Electrochemiluminescence immunoassay (ECLIA)

Reporting format

QUANTITATIVE

Qualitative

Qualitative

Reporting ranges

Positive with value reported in U/ml / Negative

Positive / Negative

Positive / Negative

Antigen used

Receptor binding domain (RBD) of Spike antigen

Nucleocapsid

Nucleocapsid

Analyte target

SARS-CoV-2 Antibodies

SARS-CoV-2 Antibodies (IgG/IgM) Total Antibody

SARS-CoV-2 Antibodies (IgG)

Sample type verified

Serum – Venous or Capillary self-collection

Serum – Venous or Capillary self-collection

Serum – Venous

Sensitivity

99.98%

97.4%

99.1%

Specificity

98.8% in samples taken 14 days or later after positive PCR

100%

100%

Seasonal Corona
Virus panel

24/24 Negative

26/26 Negative

26/26 Negative

 

Example reports

 

Example report 1

 

Example report 2

 

 

Estimated course of Markers in SARS-CoV-2 Infection diagram

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

 

 

Sample type

Roche Elecys Anti-SARS-CoV-2 S

Serum: Venous/Capillary self-collection
(Release date for self-collection
to be confirmed)

Roche Elecys Anti-SARS-CoV-2 IgG/IgM Total Antibody

Serum: Venous/Capillary self-collection

Abbott Anti-SARS-CoV-2 IgG

Serum: Venous

 

Reporting format

Roche Elecys Anti-SARS-CoV-2 S

QUANTITATIVE

Roche Elecys Anti-SARS-CoV-2 IgG/IgM Total Antibody

Qualitative

Abbott Anti-SARS-CoV-2 IgG

Qualitative

 

Antigen used

Roche Elecys Anti-SARS-CoV-2 S

RBC of SPIKE Antigen

Roche Elecys Anti-SARS-CoV-2 IgG/IgM Total Antibody

Nucleocapsid

Abbott Anti-SARS-CoV-2 IgG

Nucleocapsid

 

Sample stability

Roche Elecys Anti-SARS-CoV-2 S

7 days

Roche Elecys Anti-SARS-CoV-2 IgG/IgM Total Antibody

7 days

Abbott Anti-SARS-CoV-2 IgG

7 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