Abstract
The unusual cases of pneumonia outbreak were reported from Wuhan city in late December 2019. Serological testing provides a powerful tool for the identification of prior infection and for epidemiological studies. Pseudotype virus neutralization assays are widely used for many viruses and applications in the fields of serology. The accuracy of pseudotype neutralizing assay allows for its use in low biosafety lab and provides a safe and effective alternative to the use of wild-type viruses. In this study, we evaluated the performance of this assay compared to the standard microneutralization assay as a reference. The lentiviral pseudotype particles were generated harboring the Spike gene of SARS-CoV-2. The generated pseudotype particles assay was used to evaluate the activity of neutralizing antibodies in 300 human serum samples from a COVID-19 sero-epidemiological study. Testing of these samples resulted in 55 positive samples and 245 negative samples by pseudotype viral particles assay while microneutralization assay resulted in 64 positive and 236 negative by MN assay. Compared to the MN, the pseudotyped viral particles assay showed a sensitivity of 85.94% and a specificity of 100%. Based on the data generated from this study, the pseudotype-based neutralization assay showed a reliable performance for the detection of neutralizing antibodies against SARS-CoV-2 and can be used safely and efficiently as a diagnostic tool in a biosafety level 2 laboratory.
Highlights
The first case of unusual pneumonia was reported from Wuhan, China in late December 2019 and designated as COVID-19
The immunogenic responses to the viral diseases against S glycoprotein can be distinguished by using multiple tools including virus microneutralization (MN) assays or enzyme-linked immunosorbent assay (ELISA), and ELISA variants, such as lateral flow assay (LFA) and chemiluminescence immunoassay (CLIA) [13,14,15]
We have evaluated the performance of pseudotype lentiviral particles using the Spike gene of SARS-CoV-2 and to validate the efficacy of pseudotype particles assay in detecting neutralizing antibodies against SARS-CoV-2 in serum samples collected in a sero-epidemiological study from Jeddah, Saudi Arabia
Summary
The first case of unusual pneumonia was reported from Wuhan, China in late December 2019 and designated as COVID-19. The causative agent was identified similar to SARS-CoV reported in 2003 falling under the betacoronavirus group [1,2,3]. The immunogenic responses to the viral diseases against S glycoprotein can be distinguished by using multiple tools including virus microneutralization (MN) assays or enzyme-linked immunosorbent assay (ELISA), and ELISA variants, such as lateral flow assay (LFA) and chemiluminescence immunoassay (CLIA) [13,14,15]. The major drawback of these assays is that they are not capable of detecting the neutralization ability of the positive samples [16,17,18,19]. Despite the usefulness of SARS-CoV-2 MN assays and their ability to detect neutralizing antibodies and continue to be the gold standard method, the MN assay needs a biosafety-level-3 facility and well-trained personnel with specialized skills [20]
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