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Updated: Oct 19, 2025

Detection of Antibodies That Neutralize the Cellular Uptake of Enzyme Replacement Therapies with a Cell-based Assay
Published on: September 10, 2018
Analytical and clinical performance of cPass neutralizing antibodies assay
Joanna Jung1, Deepthi Rajapakshe2, Christopher Julien3
1Department of Pathology & Immunology, Baylor College of Medicine, Houston, TX 77030, United States; Section of Clinical Chemistry, Division of Laboratory Medicine, Department of Pathology, Texas Children's Hospital, Houston, TX 77030, United States.
Abstract:
Serological tests for SARS-CoV-2 are a critical component of disease control strategies. SARS-CoV-2 serology tests used in clinical diagnostic should not accurately evaluate total levels the antibodies but also closely correlate with neutralizing antibodies titers. However, only limited data is available reporting correlation of neutralization antibody assays with commercial high-throughput serological assays widely used in clinical laboratories. We performed evaluation of the GenScript cPass neutralizing antibody detection assay, to assess its value for routine clinical use to measure neutralizing titers in patients who recovered from coronavirus disease 2019 (COVID-19) or have been vaccinated. We tested its clinical performance against the commonly used Ortho Vitros IgG assay. Our combined data shows that GenScript cPass neutralizing antibody assay has satisfactory analytical and clinical performance and good correlation with Ortho Vitros IgG, supporting its use as a tool for accurate SARS-COV-2 immune surveillance of recovered or vaccinated individuals.

