The new CE-marked SARS-CoV-2 NeutraLISA from EUROIMMUN provides fast and economical determination of the inhibiting effect of anti- SARS-CoV-2 antibodies in patient samples, serving as a surrogate virus neutralisation test.

The assay is based on competitive binding between neutralising antibodies in the samples and labelled angiotensinconverting enzyme 2 (ACE2) receptors to recombinant S1 coated onto the microplate wells. Results from the test are evaluated qualitatively using a cut-off of 25% inhibition.

The SARS-CoV-2 NeutraLISA demonstrates a high agreement (98.6%) with the plaque reduction neutralisation test (PRNT) and a strong correlation with the WHO reference standard (NIBSC code: 20/136) up to an inhibition of 67%. The ELISA-based test is much quicker to perform than the gold standard PRNT, with results being available within hours rather than days. Moreover, in contrast to the PRNT, it does not require biosafety level 3 laboratory conditions and is therefore suitable for routine laboratory diagnostics. The assay can be fully automated, making it ideal for use in a high-throughput capacity.

The SARS-CoV-2 NeutraLISA complements EUROIMMUN’s extensive portfolio of COVID-19 diagnostic tests, which encompasses RT-PCR assays, ELISAs for quantitative (S1) or semiquantitative (S1, NCP) antibody detection, an immunoblot for multiplex detection of SARS-CoV-2 and HCoV antibodies, and a CE-marked set for convenient collection of capillary blood for IgG analysis using ELISA.