Abstract
The plaque reduction neutralization test (PRNT) is a preferred method for the detection of functional, SARS-CoV-2 specific neutralizing antibodies from serum samples. Alternatively, surrogate enzyme-linked immunosorbent assays (ELISAs) using ACE2 as the target structure for the detection of neutralization-competent antibodies have been developed. They are capable of high throughput, have a short turnaround time, and can be performed under standard laboratory safety conditions. However, there are very limited data on their clinical performance and how they compare to the PRNT. We evaluated three surrogate immunoassays (GenScript SARS-CoV-2 Surrogate Virus Neutralization Test Kit (GenScript Biotech, Piscataway Township, NJ, USA), the TECO® SARS-CoV-2 Neutralization Antibody Assay (TECOmedical AG, Sissach, Switzerland), and the Leinco COVID-19 ImmunoRank™ Neutralization MICRO-ELISA (Leinco Technologies, Fenton, MO, USA)) and one automated quantitative SARS-CoV-2 Spike protein-based IgG antibody assay (Abbott GmbH, Wiesbaden, Germany) by testing 78 clinical samples, including several follow-up samples of six BNT162b2 (BioNTech/Pfizer, Mainz, Germany/New York, NY, USA) vaccinated individuals. Using the PRNT as a reference method, the overall sensitivity of the examined assays ranged from 93.8 to 100% and specificity ranged from 73.9 to 91.3%. Weighted kappa demonstrated a substantial to almost perfect agreement. The findings of our study allow these assays to be considered when a PRNT is not available. However, the latter still should be the preferred choice. For optimal clinical performance, the cut-off value of the TECO assay should be individually adapted.
Highlights
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the causative agent of the ongoing coronavirus disease 2019 (COVID-19), which was first reported inWuhan, China in late 2019 [1,2]
The aim of our study was to evaluate the clinical performance of three manual surrogate enzyme-linked immunosorbent assays (ELISAs) and one automated quantitative SARS-CoV-2 S protein-based IgG antibody assay by comparing test results to the plaque reduction neutralization test (PRNT) conducted in parallel
We investigated the value of different SARS-CoV-2 surrogate enzymelinked immunosorbent assays for the detection of neutralization-competent antibodies compared to a cell culture-based method (PRNT) and a quantitative anti-receptor-binding domain (RBD)
Summary
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the causative agent of the ongoing coronavirus disease 2019 (COVID-19), which was first reported inWuhan, China in late 2019 [1,2]. Despite the early detection of new infections and rigorous infection control measures, the presence or absence of protective immunity will affect future spread, illness severity, and public health response [4]. Vaccine (BioNTech/Pfizer) reduced the risk of symptomatic COVID-19 disease by 94% and the risk of asymptomatic SARS-CoV-2 infection by 90% [5]. This suggests that vaccinated individuals are less likely to transmit the pathogen. To measure the humoral mediated immune response caused by SARSCoV-2, several commercially available and laboratory-developed antibody tests have been established [6,7,8]. The sensitivity and specificity of these assays vary widely, depending on the used technology, detected antibody class, disease severity, and moment of testing in the infection phase
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