The new reference materials can be used to check the correct functioning of SARS-CoV-2 antibody tests. They can also support research on immunity against COVID-19 and help monitor the efficiency of experimental vaccines.
The JRC is releasing two new reference materials, developed to function as quality assurance tools for the SARS-CoV-2 antibody tests used to verify if an individual has been infected by the COVID-19 virus.
Mariya Gabriel, Commissioner for Innovation, Research, Culture, Education and Youth, said: "The correct functioning of antibody tests is particularly important in epidemiological investigations to describe the prevalence of the infection and in research on immunity against COVID-19. The reference material developed by the JRC is another piece of the puzzle that can support these efforts."
The reference materials enable laboratories to verify whether their antibody tests are functioning properly.
In practice, if the laboratories are able to measure the antibodies against SARS-CoV-2 present in the reference material, they are also able to measure the antibodies formed against the virus in human blood.
The reference material is also a first step in ensuring that the results obtained with various SARS-CoV-2 tests are comparable.
Accurate antibody tests are essential for epidemiological studies and vaccine development
SARS-CoV-2 antibody tests (or serological tests) detect the presence of antibodies against the SARS-CoV-2 virus in the human body.
Testing for these antibodies can tell whether a person was previously infected with SARS-CoV-2 and provide information about possible protection against new infection.
In addition, this knowledge helps to determine the extent of the pandemic and understand the development of immunity among the population.
Antibody tests can also be used to verify whether experimental vaccines work: A good candidate vaccine will stimulate the production of neutralising antibodies that will bind to the virus and eliminate it before infection takes place.
New reference materials will facilitate quality control and validation of tests
Numerous SARS-CoV-2 antibody tests have been developed around the world, with varying levels of clinical performance.
To ensure that safe and effective tests are being used in the EU, the Commission has issued guidance on COVID-19 in vitro diagnostic tests and their performance.
This guidance recommends additional validation of the clinical performance of tests, but it also identifies the scarcity of reference materials as an obstacle for such validation studies.
The newly certified reference materials expand the toolbox of validation methods, now enabling also the validation of SARS-CoV-2 antibody tests.
The JRC has also created a database of COVID-19 in vitro diagnostic devices and test methods.
The database gathers information on available tests in one place, thus helping healthcare operators make informed choices when selecting testing methods.
What is a reference material?
Reference materials are reliable quality assurance tools used to validate test results obtained by laboratories.
They play a key role in the calibration of laboratory instruments by providing precise reference values and data.
The JRC is one of the major developers and producers of reference materials in the world.
It currently provides over 760 reference materials, and distributes around 20,000 units per year to testing laboratories worldwide.
- 7 december 2020