Development and clinical evaluation of a novel fully automated qualitative PCR assay for the diagnosis of anogenital herpes simplex virus infection.

摘要: Abstract Molecular detection of viral infections has the potential to improve microbial diagnostics, particularly with emergence rapid automated systems. We describe design IDbox fully cassette-based system for nucleic acid extraction and real-time PCR amplification perform a clinical evaluation diagnosis genital herpes simplex infections. At optimal cutoff values determined by receiver-operator curves, showed sensitivities 94.9% (95% confidence interval [CI] 84.9–98.7%) 97.0% CI 88.5–99.5%) specificities 96.7% 91.2–98.9%) 97.3% 91.9–99.3%) relative virus culture PCR, respectively. discuss relevant characteristics approaches used each step analytical process enhance assay sensitivity provide accurate results in presence cross-reactive organisms interfering substances.