Clinical performance of the multiplex solid-phase "Direct Strip PCR" for infectious uveitis: a multicenter diagnostic accuracy study - PubMed
5 hours ago
- #Multiplex PCR
- #Diagnostic Accuracy
- #Infectious Uveitis
- Multiplex solid-phase 'Direct Strip PCR' kit evaluated for diagnosing infectious uveitis using 475 ocular-fluid samples (aqueous and vitreous humor) from 29 sites in Japan.
- Direct Strip PCR targets 9 pathogens (HSV-1, HSV-2, VZV, EBV, CMV, HHV-6, HTLV-1, Toxoplasma gondii, Treponema pallidum) with no DNA extraction required and includes internal controls.
- Showed high concordance with qPCR: positive agreement of 98.0% (aqueous humor) and 95.7% (vitreous fluid); overall agreement of 98.5% and 96.4%, respectively, exceeding 90% thresholds.
- Discordant results were rare (10 out of 4275 targets), mostly in low-copy samples near detection limits, and DNA copy numbers strongly correlated between methods (r = 0.948-0.996).
- No adverse events reported; the kit's solid-phase, extraction-free format supports practical use for regulatory submissions and global dissemination in diagnosing and monitoring infectious uveitis.