Clinical performance of the ImmuneMed Dengue NS1 Ag Rapid I test for the diagnosis of dengue fever: a diagnostic accuracy study

Abstract

Background: Dengue virus (DENV) is transmitted by mosquitoes and is becoming a globalthreat owing to an increase in the number of cases and mortality, especially in low- andmiddle-income tropical countries. Rapid and easy-to-use diagnostic tests are required todifferentiate dengue fever from other febrile illnesses. Methods: We evaluated the clinical performance of the ImmuneMed Dengue NS1 Ag RapidI test (ImmuneMed, Inc.) using positive and negative sera collected from patients withconfirmed 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-1and DENV- 2. The sensitivity was the same (100%) for sera collected ＜ 3 days and ≥ 3 daysfrom 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 andas sensitive as RT-PCR. These findings suggest that the ImmuneMed Dengue NS1 Ag Rapid Itest may be a useful point-of-care test for dengue fever.