Choose the product options

Shopping cart
Clear cart
Clear cart

Two new reference materials for the quality control of SARS-CoV-2 antibody tests released

7 December 2020

The JRC released two new reference materials EURM-017 and EURM-018, which contain natural antibodies against SARS-CoV-2 in a human serum background. They can be used as quality control materials for various SARS-CoV-2 antibody tests.

The results of SARS-CoV-2 antibody tests (or serological tests) can tell whether a person was previously infected with SARS-CoV-2and provide information about potential protection against new infection. This knowledge helps to determine the extent of the epidemic and understand the development of immunity among the population. In addition, SARS-CoV-2 antibody tests could also be used to monitor the immune response after vaccination.

Numerous commercial immunoassays detecting SARS-CoV-2 antibodies have been developed around the world, with varying levels of clinical performance. These immunoassays measure different types of antibodies depending on the SARS-CoV-2 protein that is included as target (or antigen). Moreover, some assays only give qualitative results (positive / negative) while others quantitatively measure the antibodies. Consequently, comparing the results from the various immunoassays is difficult and establishing a correlation between test results and potential immunity is even more challenging.

Only a subsection of SARS-CoV-2 antibodies can really block the interaction of the virus with its host cells and prevent an infection. These so-called neutralising antibodies play an important role in the immunity against SARS-CoV-2. Virus neutralisation tests (VNTs) are the gold standard assays for the detection and quantification of the neutralising antibodies. VNTs require handling of the infectious SARS-CoV-2 virus and are therefore only performed in specialised virology laboratories.

The JRC has developed the reference materials EURM-017 and EURM-018 from serum samples of donors who previously had an SARS-CoV-2 infection. Six expert virology laboratories within Europe confirmed the presence of the neutralising antibodies. In addition, several manufactures also verified that the antibodies measured in their commercial immunoassays are present. EURM-017 is mainly intended as quality control material for immunoassays while EURM-018 is recommended for virus neutralisation assays. These reference materials are also a first step in the harmonisation of the SARS-CoV-2 antibody tests. This final goal of this process is to ensure that the results obtained with various tests are comparable.

« Back to overview

More shops