Diagnostic Performance of a Silver-Amplified vs. a Non-Amplified Lateral Flow Kit for Adenoviral Conjunctivitis: A Multicenter Prospective Study.

Accurate diagnosis of adenoviral conjunctivitis is critical for timely treatment and infection control. However, conventional lateral flow kits often lack sufficient sensitivity, especially in mild cases. This multicenter prospective study evaluated the diagnostic performance of silver-amplified lateral flow kits (SA-LFKs) compared with non-silver-amplified kits (NSA-LFKs), using real-time polymerase chain reaction (qPCR) as the reference standard. Tear samples from 200 patients with suspected adenoviral conjunctivitis were collected across four clinics and analyzed for sensitivity, specificity, and genotype coverage. The SA-LFK demonstrated significantly higher sensitivity (86.0%) than the NSA-LFK (72.0%) (p < 0.001), with both kits showing high specificity (100% and 98.1%, respectively). Pooled analysis revealed that sensitivity was significantly lower in mild-to-moderate cases than in severe cases for both kits, suggesting that clinical severity influences detection performance. Across all severity levels, the SA-LFK consistently demonstrated higher sensitivity than the NSA-LFK, including in mild-to-moderate cases (77.8% vs. 59.3%, p = 0.004), supporting its superior diagnostic performance. The SA-LFK showed robust performance across eight identified adenovirus genotypes and maintained higher positivity rates even at lower viral loads. These findings support the clinical utility of SA-LFKs for early diagnosis and outbreak containment in diverse settings.