Performance of Two Commercial Dengue NS1 Rapid Tests for the Diagnosis of Adult Patients with Dengue Infection

Abstract

Objective: To determine the diagnostic performance of two commercially available dengue NS1 antigen rapid detection tests (RDTs), namely, SD BIOLINE Dengue NS1Ag and ImmuneMed Dengue NS1 Rapid, for the diagnosis of adult patients with dengue infection Methods: The study was performed by using archived samples from 237 patients with laboratory-confirmed dengue infection. Archived, well-characterized samples from an additional 208 febrile individuals from Thailand were used as the control group. Reference testing to confirm the diagnosis in the dengue patients included RT-PCR and in-house NS1 ELISA, in-house IgM, and IgG capture ELISAs. Results: The sensitivity of the SD BIOLINE Dengue NS1 Ag was 100%, and its specificity was 99% (95% CI; 96.6–99.7%). False positive results were found in 2 samples, specifically from patients with scrub typhus. The sensitivity and specificity of the ImmuneMed Dengue NS1 Ag Rapid were 97.4% (95% CI, 95.5–99.5%) and 96.6% (95% CI; 93.5–98.4%), respectively. False positive results were found in 7 patients, specifically from patients with murine typhus, scrub typhus, and influenza. Conclusion: Both RDTs showed comparable sensitivity and specificity in this study population. Data from this study could be used to facilitate data-driven laboratory test choices for managing patient care during dengue outbreaks.

Keywords

• Dengue infection, nonstructural protein -1,
• Rapid detection test