Evaluation of OneStep Dengue NS1 RapiDip™ InstaTest and OneStep Dengue Fever IgG/IgM RapiCard™ InstaTest during the course of a dengue type 1 epidemic

Abstract

We determined the diagnostic performance of the OneStep NS1 and the OneStep IgG/IgM RDT kits against a panel of samples which comprised of 174 dengue positive and 165 dengue negative sera characterized by three reference enzyme-linked immunosorbent assays (ELISAs). The diagnostic sensitivities of the OneStep kits for the detection of individual biomarkers of NS1, IgM and IgG were 90% (95% CI: 82.1–94.7), 32.4% (95% CI: 24.8–40.8) and 44.4% (95% CI: 38.2–50.7), respectively. The combination of the OneStep IgG/IgM kit with the OneStep NS1 kit demonstrated significantly higher sensitivities for the combined NS1/IgM (96.8%; 95% CI: 90.9–99.3) and NS1/IgM/IgG (99.5%; 95% CI: 97.1–99.9)(P<0.001). In conclusion, the OneStep NS1 kit has high sensitivity and specificity and is highly recommended for use. The low sensitivities for IgG (44.4%) and for IgM (32.4%) of the OneStep IgG/IgM kit when used alone suggest it is best used in combination with the OneStep NS1 kit to enhance its overall diagnostic performance.