Intended use

Coronavirus disease 2019 (COVID-19), caused by the novel human coronavirus SARS-CoV-2, is currently a major threat to public health worldwide. The genome of coronavirus encodes four structural proteins, namely Nucleoprotein, small membrane protein, membrane protein and Spike protein (S protein). The virus receptor-binding domain (RBD) is an important domain in Spike protein and is the main structural domains for inducing neutralizing antibodies and T-cell immune responses. The viral spike protein binds the host receptor angiotensin-converting enzyme 2 (ACE2) via the receptor-binding domain (RBD) , and thus is believed to be a major target to block viral entry, neutralizing antibodies that had receptor binding motif of RBD compete strongly with human ACE2.

Plaque reduction neutralization (PRN) assay is gold standard method to detect neutralizing antibodies to SARS-CoV-2, but it need a biosafety level 3 laboratory and more than 3 day to finish the test. Enzyme-linked immunosorbent assay (ELISA) and lateral flow assay (LFA) rapid tests are also effective test methods.

SARS-CoV-2 Neutralizing Antibody Detection Kit is a rapid, scrological test to detect neutralizing antibodies to SARS-CoV-2 and is urgently needed to determine not only predicted humoral protection, but also vaccine efficacy during clinical trials and after large-scale vaccination. The test based on fluorescence immunochromatographic assay analysis technics, which can give a result within 15 minutes. Our kits is a preliminary screening reagent. Any result needs to be confirmed by clinical symptoms, epidemiology, and gold standard reagents.

For Medical Professional Use Only.