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Microbiology Spectrum|March 4, 2025
The development and validation of a microneutralization assay for the detection and quantification of anti-yellow fever virus antibodies in human serumKatherine Fries, Ping Luo, Rebekah Baldwin, et al.
Diagnostic Microbiology and Infectious Disease|December 17, 2019
Evaluation of dengue serological tests available in Puerto Rico for identification of prior dengue infection for prevaccination screeningMatthew Bonaparte, James Huleatt, Shekema Hodge, et al.
Infectious Diseases and Therapy|September 3, 2021
A New Electrochemiluminescence-Based Multiplex Assay for the Assessment of Human Antibody Responses to Bordetella pertussis VaccinesKucku Varghese, William Bartlett, Lingyi Zheng, et al.
The Lancet. Infectious Diseases|September 26, 2025
Human monoclonal antibody MAM01 for protection against malaria in adults in the USA: a first-in-human, phase 1, dose-escalation, double-blind, placebo-controlled, adaptive trialKirsten E Lyke, Andrea A Berry, Matthew B Laurens, et al.
NPJ Vaccines|April 20, 2021
Immunogenicity and efficacy of mRNA COVID-19 vaccine MRT5500 in preclinical animal modelsKirill V Kalnin, Timothy Plitnik, Michael Kishko, et al.
Bioanalysis|June 22, 2026
Vaccine Ligand Binding Assay Life Cycle Management, Assay Maintenance, Monitoring and TransferJeroen Stoop, James Huleatt, Luc Gagnon, et al.
Bioanalysis|November 14, 2024
Harmonization of Vaccine Ligand Binding Assays ValidationFrancis Dessy, Ivo Sonderegger, Leslie Wagner, et al.
Bioanalysis|January 25, 2025
2024 White Paper on Recent Issues in Bioanalysis: Evolution of Immunogenicity Assessment beyond ADA/NAb; Regulated Genomic/NGS Assays; Hypersensitivity Reactions; Minimum Noise Reduction; False Positive Range; Modernized Vaccine Approaches; NAb/TAb Correlation <u>(PART 3A</u> - Recommendations on Advanced Strategies for Molecular Assays and Immunogenicity of Gene Therapy, Cell Therapy, Vaccine; Biotherapeutics Immunogenicity Assessment & Clinical Relevance <u>PART 3B</u> - Regulatory Agencies' Input on Immunogenicity/Technologies of Biotherapeutics, Gene, Cell & Vaccine Therapies)Omar Tounekti, Sandra Prior, Sarah Wassmer, et al.
Bioanalysis|January 29, 2026
2025 White Paper on Recent Issues in Bioanalysis: Biomarkers Calibrators & Stability; Evaluation of NULISA; Neurofilament & Autoantibody Biomarker Assays; Removing IgM Interference; ELISpot & FluoroSpot Best Practices; Modular HD Cytometry; Single-cell Analysis Imaging Cytometry (PART 2A - Recommendations on Biomarkers Discovery, Development, Validation & Regulatory Approval, Ligand-Binding Assays (LBA) and Cell-Based Assays (CBA) PART 2B - Regulatory Agencies' Input on Biomarkers, IVD/CDx and Biomarker Assay Validation (BAV))Sarah Hersey, Kristina McGuire, Olga Kholmanskikh, et al.
Bioanalysis|August 16, 2023
2022 White Paper on Recent Issues in Bioanalysis: Enzyme Assay Validation, BAV for Primary End Points, Vaccine Functional Assays, Cytometry in Tissue, LBA in Rare Matrices, Complex NAb Assays, Spectral Cytometry, Endogenous Analytes, Extracellular Vesicles <u>Part 2</u> - Recommendations on Biomarkers/CDx, Flow Cytometry, Ligand-Binding Assays Development & Validation; Emerging Technologies; Critical Reagents Deep CharacterizationGiane Sumner, Steve Keller, James Huleatt, et al.
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