Evaluation and Real-world Experience of a Neutralization Susceptibility Screening Assay for Broadly Neutralizing Anti-HIV-1 Antibodies.

ABSTRACT:

Background

Development of a screening assay for the clinical use of broadly neutralizing antibodies (bnAbs) is a priority for HIV therapy and cure initiatives.

Methods

We assessed the PhenoSense Monoclonal Antibody Assay (Labcorp-Monogram Biosciences), which is Clinical Laboratory Improvement Amendments (CLIA) validated and has been used prospectively and retrospectively in multiple recent bnAb clinical trials.

Results

When performed on plasma and longitudinal peripheral blood mononuclear cell samples (before and during antiretroviral therapy, respectively), as sourced from a recent clinical trial, the PhenoSense assay produced robust reproducibility, concordance across sample types, and expected ranges in the susceptibility measures of bnAbs in clinical development.

SUBMITTER: Pahus MH 

PROVIDER: S-EPMC11841631 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature