Clinical evaluation of a developed paper-based Dengue NS1 rapid diagnostic test for febrile illness patients

Abstract

Objectives: This study aimed to evaluate a microfluidic paper-based analytical device (DEN-NS1-PAD) based on a rapid NS1 antigen test for diagnosing dengue at the point of care. Methods: 219 serum samples from suspected dengue cases were tested with the developed DEN-NS1-PAD and commercial RDT by SD BIOLINE. The results were compared with the nested-PCR results. Results: The limit of detection of DEN-NS1-PAD was 0.78 ng mL−1. It showed 88.89% sensitivity, 86.67% specificity, and a substantial agreement correlation (κ = 0.7522) compared with nested-PCR. In contrast, SD BIOLINE for NS1 (SD-NS1) detection showed 87.88% sensitivity, 90.00% specificity, and had a substantial agreement correlation with nested-PCR (κ = 0.7788). Conclusions: DEN-NS1-PAD is a valuable tool for diagnosing DENV infections, especially for diagnosed patients with early acute phase samples with high viral load. DEN-NS1-PAD has better sensitivity than SD-NS1 but less specificity.