A Serological Snapshot of COVID-19 Initial Stages in Israel by a 6-Plex Antigen Array

Fisher, Morly; Levy, Haim; Fatelevich, Ella; Afrimov, Yafa; Ben-Shmuel, Amir; Rosenfeld, Ronit; Noy-Porat, Tal; Glinert, Itai; Sittner, Assa; Biber, Asaf; Belkin, Ana; Bar-David, Elad; Puni, Reut; Levy, Itzchak; Mazor, Ohad; Weiss, Shay; Mechaly, Adva

doi:10.1128/spectrum.00870-21

Cited by 2 publications

(13 citation statements)

References 27 publications

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“…Similar data sheets are generated for each of the antigen–antibody combinations of the array (a total of nine discreet data sheets). The left panel of Figure 1 (Loading) illustrates the slide plan, including three controls: a blank sample (reagents control, comprised of the three fluorescently labeled secondary antibodies diluted in array buffer), a negative control (naïve pre-pandemic commercial sera), and a positive control (serum from a qRT-PCR positive, severely ill, recuperating individual, which was collected and characterized previously 5 ). As a proof of concept, several dilutions of the positive control serum (P) are analyzed on the slide.…”

Section: Resultsmentioning

confidence: 99%

“…We further evaluated the specificity by applying random qRT-PCR positive and negative samples from a previous study. 5 These samples consisted of four qRT-PCR positive patients/recuperating individuals ( Figure 4 B, red dots, n = 4) and four qRT-PCR negative volunteers ( Figure 4 B, blue dots, n = 4), whose sera were collected at the very early stages of the COVID-19 pandemic in Israel (April 2020) and are thus considered naïve. Figure 4 B shows highly correlated anti-RBD versus anti-S2P MFI values for IgG, IgA, and IgM antibodies.…”

Section: Resultsmentioning

confidence: 99%

“…qRT-PCR positive sera samples ( n = 18) were previously obtained from Sheba Hospital (Tel HaShomer Israel) from patients with severe symptoms (approval number 7036-20-SMC). 5 Sera from qRT-PCR-negative volunteers ( n = 24) were collected on April 24, 2020. 5 A pre-pandemic commercial normal human serum preparation (Human pooled serum, Cat.…”

Section: Experimental Sectionmentioning

confidence: 99%

“… 5 Sera from qRT-PCR-negative volunteers ( n = 24) were collected on April 24, 2020. 5 A pre-pandemic commercial normal human serum preparation (Human pooled serum, Cat. 2931149, Lot.…”

Section: Experimental Sectionmentioning

confidence: 99%

“…We recently reported the development of a 6-plex antigen microarray that was applied for the characterization of seroprevalence and seroconversion in the Israeli adult population in the early stages of the COVID-19 pandemic in Israel. 5 Based on the results and technical knowledge acquired during this effort, we developed a 3-plex array containing a stabilized version of the SARS-CoV-2 spike ectodomain (S2P), SARS-CoV-2 receptor binding domain (RBD), and the virus’s nucleocapsid (NC), which is currently used for the characterization of the humoral immune response developed during clinical trials (phase I/II) of BriLife, the VSV-spike-based Israeli vaccine. 6 Antibodies against the spike proteins (S2P and RBD) were found to correlate with neutralization 7 and as such are considered essential for determining the vaccines’ efficacy.…”

Section: Introductionmentioning

confidence: 99%

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A Novel Quantitative Multi-Component Serological Assay for SARS-CoV-2 Vaccine Evaluation

et al. 2022

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A multi-component microarray, applying a novel analysis algorithm, was developed for quantitative evaluation of the SARS-CoV-2 vaccines’ immunogenicity. The array enables simultaneous quantitation of IgG, IgM, and IgA, specific to the SARS-CoV-2 spike, receptor binding domain, and nucleocapsid proteins. The developed methodology is based on calculating an apparent immunoglobulin signal from the linear range of the fluorescent read-outs generated by scanning the microarray slides at different exposure times. A dedicated algorithm, employing a rigorous set of embedded conditions, then generates a normalized signal for each of the unique assays. Qualification of the multi-component array performance (evaluating linearity, extended dynamic-range, specificity, precision, and accuracy) was carried out with an in-house COVID-19, qRT-PCR positive serum, as well as pre-pandemic commercial negative sera. Results were compared to the WHO international standard for anti-SARS-CoV-2 immunoglobulins. Specific IgG, IgM, and IgA signals obtained by this array enabled successful discrimination between SARS-CoV-2 q-RT-PCR positive (seroconverted SARS-CoV-2 patients) and negative (naïve) samples. This array is currently used for evaluation of the humoral response to BriLife, the VSV-based Israeli vaccine during phase I/II clinical trials.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Experimental Sectionmentioning

confidence: 99%

“… 5 Sera from qRT-PCR-negative volunteers ( n = 24) were collected on April 24, 2020. 5 A pre-pandemic commercial normal human serum preparation (Human pooled serum, Cat. 2931149, Lot.…”

Section: Experimental Sectionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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A Novel Quantitative Multi-Component Serological Assay for SARS-CoV-2 Vaccine Evaluation

et al. 2022

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rVSV-ΔG-SARS-CoV-2-S vaccine: repeated intramuscular (IM) toxicity, local tolerance, immunogenicity and biodistribution study in NZW rabbits

et al. 2022

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BriLife ® , a vector-based vaccine that utilizes the recombinant vesicular stomatitis virus (VSV) platform to express and present the spike antigen of SARS-CoV-2, is undergoing testing in a phase 2 clinical trial in Israel. A nonclinical repeated-dose (GLP) toxicity study in New Zealand white rabbits was performed to evaluate the potential toxicity, local tolerance, immunogenicity and biodistribution of the vaccine. rVSV-ΔG-SARS-CoV-2-S (or vehicle) was administered intramuscularly to two groups of animals (10 6 , 10 7 PFU/animal, n = 10/sex/group) on three occasions, at 2-week intervals, followed by a 3-week recovery period. Systemic clinical signs, local reactions, body weight, body temperature, food consumption, ophthalmology, urinalysis, clinical pathology, C-reactive protein, viremia and antibody levels were monitored. Gross pathology was performed, followed by organs/tissues collection for biodistribution and histopathological evaluation. Treatment-related changes were restricted to multifocal minimal myofiber necrosis at the injection sites, and increased lymphocytic cellularity in the iliac and mesenteric lymph nodes and in the spleen. These changes were considered related to the inflammatory reaction elicited, and correlated with a trend for recovery. Detection of rVSV-ΔG-SARS-CoV-2-S vaccine RNA was noted in the regional iliac lymph node in animals assigned to the high-dose group, at both termination time points. A significant increase in binding and neutralizing antibody titers was observed following vaccination at both vaccine doses. In view of the findings, it was concluded that the rVSV-ΔG-SARS-CoV-2-S vaccine is safe. These results supported the initiation of clinical trials. Supplementary Information The online version contains supplementary material available at 10.1007/s00204-022-03302-5.

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A Serological Snapshot of COVID-19 Initial Stages in Israel by a 6-Plex Antigen Array

Cited by 2 publications

References 27 publications

A Novel Quantitative Multi-Component Serological Assay for SARS-CoV-2 Vaccine Evaluation

A Novel Quantitative Multi-Component Serological Assay for SARS-CoV-2 Vaccine Evaluation

rVSV-ΔG-SARS-CoV-2-S vaccine: repeated intramuscular (IM) toxicity, local tolerance, immunogenicity and biodistribution study in NZW rabbits

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