Diagnostic Performance and Regulatory Readiness of Dengue Rapid Diagnostic Tests Commercially Available in the United States

Dengue is an emerging public health threat in the United States, and currently, no FDA-approved rapid diagnostic test (RDT) is available. A reliable RDT could support timely clinical management and outbreak response. We evaluated nine commercially available dengue RDTs using 197 stored serum samples: 99 from acute laboratory-confirmed dengue cases, 88 negative by RT-PCR, IgM ELISA, and NS1 ELISA, and 10 from acute confirmed Zika cases. Test performance varied, with sensitivity ranging from 36%–82% and specificity from 78%–100%. The CTK Biotech and Artron tests showed the highest sensitivity (80% and 82%, respectively), but only CTK Biotech maintained high specificity (98%). Cross-reactivity with Zika virus was low (0%–20%). These findings suggest that RDTs could enhance dengue detection in clinical settings, though further validation under field conditions is warranted, and some of these tests may be suitable for regulatory approval, which could lead to broader availability and use.