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Related Experiment Video

Updated: Nov 22, 2025

Detection of SARS-CoV-2 Neutralizing Antibodies using High-Throughput Fluorescent Imaging of Pseudovirus Infection

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Published on: June 5, 2021

Temporal Analysis of Serial Donations Reveals Decrease in Neutralizing Capacity and Justifies Revised Qualifying

Roxie C Girardin¹, Alan P Dupuis¹, Anne F Payne¹

¹Wadsworth Center, New York State Department of Health, Albany, New York, USA.

The Journal of Infectious Diseases

|January 8, 2021

Summary

COVID-19 convalescent plasma (CCP) high-titer labeling needs better correlation with neutralizing capacity. The Ortho VITROS SARS-CoV-2 IgG test ratio can help identify potent CCP for COVID-19 treatment.

Keywords:

COVID-19 convalescent plasma neutralizing antibody

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Area of Science:

Immunology and Virology
Therapeutic Plasma Development

Background:

Coronavirus disease 2019 (COVID-19) convalescent plasma (CCP) received Emergency Use Authorization (EUA) from the FDA.
High-titer CCP is defined by a signal-to-cutoff ratio (≥12) using the Ortho VITROS SARS-CoV-2 IgG test (OVSARS2IgG).
The relationship between OVSARS2IgG ratio and the neutralizing capacity of CCP against SARS-CoV-2 is not well understood.

Purpose of the Study:

To investigate the correlation between the OVSARS2IgG ratio and the neutralizing capacity of CCP.
To determine if the OVSARS2IgG test can accurately identify CCP with high neutralizing titers for COVID-19 treatment.

Main Methods:

Analyzed 981 samples from 196 repeat CCP donors within 0-119 days post-initial donation (DPID).
Assessed neutralizing capacity using 50% (PRNT50) and 90% (PRNT90) plaque reduction neutralization tests (PRNT).
Evaluated a subset of 91 donations using OVSARS2IgG and compared results to PRNT titers for diagnostic accuracy.

Main Results:

Neutralizing titers decreased over time; only 14.0% (PRNT90) and 48.8% (PRNT50) met initial cutoffs ≥85 DPID.
CCP with OVSARS2IgG ratios linked to therapeutic benefit showed neutralizing titers of ≥1:640 (PRNT50) and/or ≥1:80 (PRNT90).
Optimal specificity and positive predictive value for identifying highly neutralizing CCP were achieved with OVSARS2IgG ratios significantly above the FDA cutoff.

Conclusions:

The OVSARS2IgG test ratio correlates with neutralizing capacity, enabling better characterization of CCP.
Refining the OVSARS2IgG cutoff can improve the selection of effective CCP for COVID-19 treatment.