Clinical Performance of the ImmuneMed Dengue NS1 Ag Rapid I Test for the Diagnosis of Dengue Fever: a Diagnostic Accuracy Study

Background: Dengue virus (DENV) is transmitted by mosquitoes and is becoming a global threat owing to an increase in the number of cases and mortality, especially in low- and middle-income tropical countries. Rapid and easy-to-use diagnostic tests are required to differentiate dengue fever from other febrile illnesses. Methods: We evaluated the clinical performance of the ImmuneMed Dengue NS1 Ag Rapid I test (ImmuneMed, Inc.) using positive and negative sera collected from patients with confirmed DENV infection and healthy individuals, respectively. The AccuPower® ZIKV (DENV, CHIKV) multiplex real-time reverse transcription polymerase chain reaction (RT-PCR) assay (Bioneer) was used as the reference standard to confirm DENV infection. Results: One hundred DENV-positive and 161 DENV-negative samples were evaluated. Overall, the sensitivity and specificity were 100% (95% confidence interval [CI], 96%–100%) and 100% (95% CI, 98%–100%), respectively. The sensitivity and specificity were 100% for both DENV-1 and DENV- 2. The sensitivity was the same (100%) for sera collected < 3 days and ≥ 3 days from symptom onset. The performance of the ImmuneMed Dengue NS1 Ag Rapid I and realtime RT-PCR tests showed strong overall agreement. Conclusion: The ImmuneMed Dengue NS1 Ag Rapid I test was highly specific for DENV and as sensitive as RT-PCR. These findings suggest that the ImmuneMed Dengue NS1 Ag Rapid I test may be a useful point-of-care test for dengue fever.