Publications
Analytical and bioanalytical chemistryMar 2021 DOI:
10.1007/s00216-021-03298-4

Spike vs nucleocapsid SARS-CoV-2 antigen detection: application in nasopharyngeal swab specimens

Barlev-Gross, Moria; Weiss, Shay; Ben-Shmuel, Amir; Sittner, Assa; Eden, Keren; Mazuz, Noam; Glinert, Itai; Bar-David, Elad; Puni, Reut; Amit, Sharon; Kriger, Or; Schuster, Ofir; Alcalay, Ron; Makdasi, Efi; Epstein, Eyal; Noy-Porat, Tal; Rosenfeld, Ronit; Achdout, Hagit; Mazor, Ohad; Israely, Tomer; Levy, Haim; Mechaly, Adva
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Abstract
Public health experts emphasize the need for quick, point-of-care SARS-CoV-2 detection as an effective strategy for controlling virus spread. To this end, many "antigen" detection devices were developed and commercialized. These devices are mostly based on detecting SARS-CoV-2's nucleocapsid protein. Recently, alerts issued by both the FDA and the CDC raised concerns regarding the devices' tendency to exhibit false positive results. In this work, we developed a novel alternative spike-based antigen assay, comprising four high-affinity, specific monoclonal antibodies, directed against different epitopes on the spike's S1 subunit. The assay's performance was evaluated for COVID-19 detection from nasopharyngeal swabs, compared to an in-house nucleocapsid-based assay, composed of novel antibodies directed against the nucleocapsid. Detection of COVID-19 was carried out in a cohort of 284 qRT-PCR positive and negative nasopharyngeal swab samples. The time resolved fluorescence (TRF) ELISA spike assay displayed very high specificity (99%) accompanied with a somewhat lower sensitivity (66% for Ct 
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