Comprehensive performance evaluation of a high-throughput automated system for pathogen nucleic acid detection in clinical settings.

ABSTRACT:

Objective

This study evaluates the clinical performance of a high-throughput automated molecular detection system and proposes a comprehensive and standardized performance validation framework to address gaps in existing methodologies and provide a robust reference for future evaluations.

Methods

Performance was validated for EBV DNA, HCMV DNA, and RSV RNA using clinical samples at various concentrations, along with WHO and national reference standards. The validation included concordance rate, accuracy, linearity, precision, limit of detection, interference testing, cross-reactivity, and carryover contamination.

Results

The positive, negative, and overall concordance rates for EBV DNA, HCMV DNA, and RSV RNA were all 100%. Both intra-assay and inter-assay precision sh

SUBMITTER: Lu R 

PROVIDER: S-EPMC12206697 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature