Development and validation of a chemiluminescent immunoassay platform for rapid detection of lymphocytic choriomeningitis virus antibodies
Year: 2026
Type: article
Abstract: A practical example of the diagnostic inadequacy surrounding lymphocytic choriomeningitis virus (LCMV) detection is illustrated by the 2005 organ transplant cluster in which four recipients developed fatal LCMV infection from a single donor whose infection went undetected by conventional screening methodologies. The present research describes the development, analytical validation, and clinical evaluation of a novel chemiluminescent immunoassay (CLIA) platform for the rapid detection of LCMV-specific IgG and IgM antibodies. The CLIA platform employed recombinant LCMV nucleoprotein expressed in a baculovirus system as the capture antigen, conjugated to acridinium ester chemiluminescent labels. Analytical validation using 240 characterized serum panels demonstrated sensitivity of 96.8% and specificity of 98.4% for IgG detection, with a turnaround time of 45 minutes compared to 180 minutes for conventional ELISA. The assay maintained reliable performance across serum dilutions up to 1:256, significantly exceeding the analytical range of standard ELISA (1:128) and IFA (1:64). Clinical evaluation using 180 prospective samples from patients with suspected LCMV infection yielded concordance rates of 94.2% with RT-PCR-confirmed diagnoses. The developed CLIA platform represents a significant advancement in LCMV diagnostic capability, offering enhanced sensitivity, reduced turnaround time, and potential for automated high-throughput implementation in clinical laboratories.
Author: Antoine Dubois-Laurent
Language: English
Subfield: Biomedical Engineering
Field: Engineering
Domain: Physical Sciences
Open Access status: bronze
OpenAlex ID: W7170041977