Design and Development of a Syringe-Based POCT Prototype Using Track-Etched PET Membranes for Simple and Rapid Detection of Group A Rotavirus in Human Samples.

Abstract

Point-of-care tests (POCTs) can be applied widely across various epidemiological contexts and clinical situations. However, many of these tests are manufactured in high-income countries (HICs), making them less accessible and affordable for low- and middle-income countries (LMICs). In this study, we present a proof of concept for a simple syringe-based assay (SBA) biosensor that uses PET track-etched membranes (PET-TMs) for the rapid and cost-effective visual detection of group A Rotavirus (RVA) in human samples. Several optimization experiments were conducted focusing on the type of membrane, the concentration of anti-RVA antibodies, and the adsorption time for these antibodies on the TMs. Preliminary tests showed that the membranes with the immobilized antibodies had good storage stability under the evaluated conditions. The limit of detection (LoD) for our SBA method was established at approximately 2.0 × 10⁸ viral particles. Notably, this POCT prototype demonstrated promising results in a side-by-side comparison with the lateral flow assay (LFA) and ELISA tests for RVA detection, where our SBA prototype exhibited a sensitivity of 96.55% and a specificity of 90.91%. Designed for ease of use, our SBA does not require trained personnel, and results are visually detectable. Furthermore, aside from the membrane, the other components can be made from reusable materials, significantly lowering costs, reducing environmental pollution, and improving accessibility in economically disadvantaged areas.