ArticleFrontiers in microbiology2025
Comprehensive performance evaluation of a high-throughput automated system for pathogen nucleic acid detection in clinical settings.
Article in Frontiers in microbiology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
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 showed coefficients of variation (CV) below 5%. The linear correlation coefficient (| r|) for EBV DNA and HCMV DNA was ≥ 0.98, demonstrating excellent linearity. The limits of detection (LoD) were 10 IU/mL for EBV DNA and HCMV DNA, and 200 copies/mL for RSV RNA. Both interference and cross-reactivity assessments met the CLSI EP07 standards, and no carryover contamination was observed. Conclusion: The system demonstrated excellent performance in terms of concordance, accuracy, precision, linearity, interference testing, and cross-reactivity. It is highly suited for large-scale pathogen screening and routine nucleic acid testing in clinical laboratories, both for qualitative and quantitative analyses. Additionally, this study introduces a comprehensive and standardized performance validation framework that addresses critical gaps in existing methodologies, offering a robust foundation for the rigorous evaluation of diagnostic systems and serving as a valuable reference for future research.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.