The ability to rapidly diagnose new infections is crucial to limiting the spread of COVID-19, particularly in low-resource areas where vaccination rollout or medical infrastructure is inadequate. To rapidly expand testing without straining medical facilities, employing point-of-care (POC) testing such as lateral flow assays (LFA) is a promising solution. In particular, LFA for detecting salivary antigens are rapid, inexpensive, simple-to-use, and instrument-free. However, because of saliva dilution during sample preparation, current COVID-19 LFA sensitivities are significantly below the ≥ 80% sensitivity set by the WHO target product profile (TPP) for SARS-CoV-2 POC testing.
To address this challenge, the DiagnosDisk is a novel flow-through device that employs temperature-responsive polymers for sample enrichment. The test is inexpensive and rapid (≤ 30 minutes), and has been demonstrated to improve biomarker detection by concentrating analytes from greater specimen volumes. Specifically, the DiagnosDisk detects salivary SARS-CoV-2 antigens by capturing enriched target analytes on a membrane as the sample solution flows through the device via capillary forces. Ultimately, the DiagnosDisk enables rapid, sensitive, simple, and inexpensive POC testing that will help to limit the spread of viral infections, especially in low-resource settings.