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. 2020 Sep;38(9):1073-1078.
doi: 10.1038/s41587-020-0631-z. Epub 2020 Jul 23.

A SARS-CoV-2 surrogate virus neutralization test based on antibody-mediated blockage of ACE2-spike protein-protein interaction

Chee Wah Tan #  1 , Wan Ni Chia #  1 , Xijian Qin  2 , Pei Liu  2 , Mark I-C Chen  3   4 , Charles Tiu  1 , Zhiliang Hu  5   6 , Vivian Chih-Wei Chen  1 , Barnaby E Young  3   7   8 , Wan Rong Sia  1 , Yee-Joo Tan  9   10 , Randy Foo  1 , Yongxiang Yi  5 , David C Lye  3   7   8   11 , Danielle E Anderson  12   13 , Lin-Fa Wang  14   15
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A SARS-CoV-2 surrogate virus neutralization test based on antibody-mediated blockage of ACE2-spike protein-protein interaction

Chee Wah Tan et al. Nat Biotechnol. 2020 Sep.

Abstract

A robust serological test to detect neutralizing antibodies to SARS-CoV-2 is urgently needed to determine not only the infection rate, herd immunity and predicted humoral protection, but also vaccine efficacy during clinical trials and after large-scale vaccination. The current gold standard is the conventional virus neutralization test requiring live pathogen and a biosafety level 3 laboratory. Here, we report a SARS-CoV-2 surrogate virus neutralization test that detects total immunodominant neutralizing antibodies targeting the viral spike (S) protein receptor-binding domain in an isotype- and species-independent manner. Our simple and rapid test is based on antibody-mediated blockage of the interaction between the angiotensin-converting enzyme 2 (ACE2) receptor protein and the receptor-binding domain. The test, which has been validated with two cohorts of patients with COVID-19 in two different countries, achieves 99.93% specificity and 95-100% sensitivity, and differentiates antibody responses to several human coronaviruses. The surrogate virus neutralization test does not require biosafety level 3 containment, making it broadly accessible to the wider community for both research and clinical applications.

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