Abstract
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-neutralizing antibody (NAb) production is a crucial humoral response that can reduce re-infection or breakthrough infection. The conventional test used to measure NAb production capacity levels is the live virus-neutralizing assay. However, this test must be conducted under biosafety level-3 containment. Pseudovirus or surrogate NAb tests, such as angiotensin-converting enzyme 2 inhibition tests, can be performed under level-2 containment. The aim of this study was to evaluate the performance of a surrogate SARS-CoV-2 NAb assay (sNAb) using samples from naturally infected individuals and vaccine recipients in comparison with the live virus microneutralization assay (vMN). Three hundred and eighty serum samples which were collected from 197 patients with COVID-19, 96 vaccine recipients and 84 normal individuals were analyzed. Overall, the sensitivity, specificity, positive predictive value, and negative predictive value of the sNAb (iFlash-2019-NAb assay, Shenzhen, China) were 97.9%, 94.9%, 98.2%, and 93.8%, respectively. Agreement for the assay relative to vMN for naturally infected individuals and vaccine recipients were 98.5% and 93.9%, respectively. A correlation analysis between sNAb and the vMN for both of these groups yielded an R2 value of 0.83. The iFlash RBD NAb assay is found to be sensitive and reliable for neutralizing antibody measurement in patients with the 2019 coronavirus disease and those who have been vaccinated against it.
Highlights
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been causing a global pandemic for more than 1 year, which as of the end of July 2021 has affected about 200 million people and killed more than 4 million people [1]
380 serum samples were collected from 197 patients with COVID-19 infection, 96 vaccine recipients and 84 normal individuals
Ninety-nine serum samples were collected from the 96 vaccine recipients (81 BNT162b2 and 15 Sinovac) who did not have SARSCoV-2 infection before vaccination; three samples were collected before vaccination with BNT162b2 (Comirnaty; Fosun–BioNTech, Pfizer, German) or Sinovac (Coronavac, Sinovac Life Sciences, Beijing, China)
Summary
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been causing a global pandemic for more than 1 year, which as of the end of July 2021 has affected about 200 million people and killed more than 4 million people [1]. Antibody binding to the RBD can prevent SARS-CoV-2 from entering the nasal epithelium, and alveolar macrophages recognize neutralized viruses and apoptotic cells and clear them by phagocytosis [3]. Such neutralization is crucial to reduce reinfection or breakthrough infection. The Moderna (mRNA-1273) and BNT162b2 (Comirnaty, BNT162b2-Pfizer) vaccines were developed using a platform based on mRNA encoding of the viral protein which is encapsulated in lipid nanoparticles [7]. The transfusion of COVID-19 convalescent plasma to patients with severe COVID-19 has been shown to reduce mortality [9] This treatment strategy is based on high neutralizing antibody (NAb) titers in donor plasma from previously infected individuals
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