The Fight to Standardize COVID-19 Antibody Tests

A new collaboration will help define the threshold for standardizing COVID-19 antibody tests. Siemens Healthineers is teaming up with the Centers for Disease Control and Prevention and the Joint Research Centre (JRC) of the European Commission on the research project.

Antibody tests differ among test manufacturers and currently cannot be analytically compared because they target different SARS-CoV-2 proteins.

Here’s where Siemens comes in. The Erlangen, Germany-based company will develop a process for standardizing SARS-CoV-2 assays by anchoring each protein to a neutralization antibody titer—a level of antibody present to block the virus from entering cells in laboratory experiments. The thresholds displayed in the standardized unit of measure for IgG—arising either from natural infection or vaccination—may likely contribute to a standardized interpretation of immunity through test results.

"One barrier to antibody test adoption is we don't currently have an established process to determine immunity," Deepak Nath, PhD, President of Laboratory Diagnostics, Siemens Healthineers, said in a release. "Different SARS-CoV-2 antibody targets produce different levels of neutralization. Our R&D team recognized that if you could define a level at which neutralization is conferred for different targets, you could create a common ground to standardize assays—not just on antibody production, but their ability to provide immunity. Our collaboration with the CDC and JRC will develop the framework that all antibody test manufacturers would be expected to adopt moving forward for greater benefit to patient care as the pandemic evolves."

Recently, Siemens won EUA for the ADIVA Centaur COV2G and Atellica IM COV2G semi-quantitative Sars-CoV-2 IgG antibody tests.  These semi-quantitative don’t display the precise measurement but estimate the quantity of a patient’s antibodies produced against infection with the virus that causes COVID-19.

With these tests, the company began to change the conversation surrounding antibody tests.

Antibody Tests

COVID-19 Antibody testing has been controversial during the pandemic – mostly because of issues with accuracy.

Chembio Diagnostics, one of the first companies to receive an emergency use authorization (EUA) for an antibody test during the pandemic, had the designation revoked. The Medford, NY-based company recently announced it would pursue EUA for a new test the DPP SARS-CoV-2 IgM/IgG.

Chembio said the test provides results in 15 minutes from finger stick, venous whole blood, plasma, or serum samples.

The firm also revoked EUA of Autobio Diagnostics Co.’s Anti-SARS-CoV-2 rapid tests for the qualitative detection of IgM and IgG antibodies to SARS-CoV-2 in human plasma from anticoagulated blood (Heparin / EDTA / sodium citrate) or serum 2 due to performance concerns with the accuracy of the test.

The plan to standardize antibody tests come at the time when there are about 29.6 million cases of COVID-19 across the globe with 936,079 deaths, according to data from worldometers.info. The web site shows that about 21.4 million people have recovered from COVID-19.