Clinical and analytical performance of the AP Biotech Discovery® Dengue Virus RT-PCR Detection Kit.

Abstract

Dengue is a mosquito-transmitted viral disease caused by the positive-sense RNA dengue virus (DENV), which comprises four antigenically distinct serotypes (1–4). Although DENV circulates predominantly in tropical and subtropical regions, its global incidence continues to increase. As most patients present viremia at the onset of clinical manifestations, realtime RT-PCR has become a widely adopted method for early dengue detection. The AP Biotech Discovery® Dengue Virus RT-PCR Detection Kit enables qualitative detection of DENV RNA (serotypes 1–4) by real-time RT-PCR in serum or plasma samples. The assay was recently cleared by ANMAT (National Administration of Drugs, Food and Medical Technology) as an in vitro diagnostic (IVD) assay. The Limit of Detection (LoD) was calculated for all 4 serotypes. Clinical validation was conducted among 296 serum and 221 plasma samples previously characterized as DENV-positive and -negative specimens. Among the positive samples, 56 had serotype characterization, including 25 DENV-1 and 31 DENV-2 samples. The resulting clinical sensitivity and specificity were 97.8%, 100.0% and 100.0%, 99.1% respectively. Additional validation studies demonstrated high reproducibility across three independent laboratories, absence of cross-reactivity with other febrile pathogens, and no interference from endogenous and exogenous substances at clinical levels. Collectively, these findings support the AP Biotech Discovery® Dengue Virus RT-PCR Detection Kit (AP Biotech, Lomas de Zamora, Argentina) as a sensitive, specific, and highly reproducible device for early dengue diagnosis and surveillance.